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Device approved to treat PDA in premature infants
weighing as little as 2 pounds.
PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.
FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.
“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.
Find the full press release on the Abbott website.
weighing as little as 2 pounds.
PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.
FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.
“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.
Find the full press release on the Abbott website.
weighing as little as 2 pounds.
PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.
FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.
“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.
Find the full press release on the Abbott website.
Early lead exposure tied to greater psychopathology in adulthood
Lead exposure during childhood appears tied to a significant increase in the risk of psychopathology in adulthood, results of a multidecade, prospective cohort study show.
“These results suggest that early life lead exposure in the era of leaded gasoline experienced by individuals who are currently adults may have contributed to subtle, lifelong differences in emotion and behavior that are detectable at least up to 38 years of age,” Aaron Reuben and his coauthors wrote in JAMA Psychiatry.
The ongoing Dunedin longitudinal cohort study in New Zealand has followed 1,037 individuals born during 1972-1973. Of these individuals, 579 were tested for lead exposure at 11 years of age. The study assessed their mental health at 18, 21, 26, 32, and 38 years of age.
“Although follow-up studies of lead-tested children have reported the persistence of lead-related cognitive deficits well into adulthood, apart from antisocial outcomes, the long-term mental and behavioral health consequences of early life lead exposure have not been fully characterized,” wrote Mr. Reuben, a PhD student in the department of psychology and neuroscience at Duke University in Durham, N.C., and his coauthors.
Researchers saw that, for each 5-mcg/dL increase in childhood blood lead level, there was a significant 1.34-point increase in general psychopathology (P = 0.03), which was largely driven by a 1.41-point increase in internalizing (P = 0.02) and 1.30-point increase in thought-disorder symptoms (P = 0.04). Those associations were seen after adjustment for covariates, such as family socioeconomic status, maternal IQ, and family history of mental illness.
Adults who had higher lead exposure during childhood also were described by their informants – close friends or family members – as being significantly more neurotic, less agreeable, and less conscientious. However, they showed no significant differences in extroversion or in openness to experience, compared with those with less lead exposure.
“These results suggest that early-life lead exposure in the era of leaded gasoline experienced by individuals who are currently adults may have contributed to subtle, lifelong differences in emotion and behavior that are detectable at least up to 38 years of age,” the authors wrote.
They noted that the size of the effect was around one-third the size of the associations seen between psychopathology and other risk factors, such as family history of mental illness and childhood maltreatment. However, the effects of lead exposure on adult psychopathology were similar to its effects on IQ and stronger than the associations seen between lead exposure and criminal offending.
The researchers also examined how early these psychopathology symptoms could be detected with use of parent- and teacher-reported measures of antisocial behavior, hyperactivity, and internalizing from 11 years of age. This showed that individuals with higher lead exposure scored higher on these measures even at 11 years of age, “suggesting that
Mr. Reuben and his associates cited several limitations. One is that the study used a cohort that was predominantly white and born in the 1970s. Also, as an observational study, it does not establish causality between lead exposure and psychopathology.
Nevertheless, they wrote, the study results suggest that adult patients who were exposed to high levels of lead as children might benefit from increased screening and access to mental health services.
The Dunedin study is supported by the New Zealand Health Research Council and the New Zealand Ministry of Business, Innovation, and Employment. This study was supported by several entities, including the National Institute on Aging, the U.K. Medical Research Council, the National Institute of Child Health and Human Development, and the National Institute of Environmental Health Sciences. The authors reported no conflicts of interest.
SOURCE: Reuben A et al. JAMA Psychiatry. 2019 Jan 23. doi: 10.1001/jamapsychiatry.2018.4192.
Lead exposure during childhood appears tied to a significant increase in the risk of psychopathology in adulthood, results of a multidecade, prospective cohort study show.
“These results suggest that early life lead exposure in the era of leaded gasoline experienced by individuals who are currently adults may have contributed to subtle, lifelong differences in emotion and behavior that are detectable at least up to 38 years of age,” Aaron Reuben and his coauthors wrote in JAMA Psychiatry.
The ongoing Dunedin longitudinal cohort study in New Zealand has followed 1,037 individuals born during 1972-1973. Of these individuals, 579 were tested for lead exposure at 11 years of age. The study assessed their mental health at 18, 21, 26, 32, and 38 years of age.
“Although follow-up studies of lead-tested children have reported the persistence of lead-related cognitive deficits well into adulthood, apart from antisocial outcomes, the long-term mental and behavioral health consequences of early life lead exposure have not been fully characterized,” wrote Mr. Reuben, a PhD student in the department of psychology and neuroscience at Duke University in Durham, N.C., and his coauthors.
Researchers saw that, for each 5-mcg/dL increase in childhood blood lead level, there was a significant 1.34-point increase in general psychopathology (P = 0.03), which was largely driven by a 1.41-point increase in internalizing (P = 0.02) and 1.30-point increase in thought-disorder symptoms (P = 0.04). Those associations were seen after adjustment for covariates, such as family socioeconomic status, maternal IQ, and family history of mental illness.
Adults who had higher lead exposure during childhood also were described by their informants – close friends or family members – as being significantly more neurotic, less agreeable, and less conscientious. However, they showed no significant differences in extroversion or in openness to experience, compared with those with less lead exposure.
“These results suggest that early-life lead exposure in the era of leaded gasoline experienced by individuals who are currently adults may have contributed to subtle, lifelong differences in emotion and behavior that are detectable at least up to 38 years of age,” the authors wrote.
They noted that the size of the effect was around one-third the size of the associations seen between psychopathology and other risk factors, such as family history of mental illness and childhood maltreatment. However, the effects of lead exposure on adult psychopathology were similar to its effects on IQ and stronger than the associations seen between lead exposure and criminal offending.
The researchers also examined how early these psychopathology symptoms could be detected with use of parent- and teacher-reported measures of antisocial behavior, hyperactivity, and internalizing from 11 years of age. This showed that individuals with higher lead exposure scored higher on these measures even at 11 years of age, “suggesting that
Mr. Reuben and his associates cited several limitations. One is that the study used a cohort that was predominantly white and born in the 1970s. Also, as an observational study, it does not establish causality between lead exposure and psychopathology.
Nevertheless, they wrote, the study results suggest that adult patients who were exposed to high levels of lead as children might benefit from increased screening and access to mental health services.
The Dunedin study is supported by the New Zealand Health Research Council and the New Zealand Ministry of Business, Innovation, and Employment. This study was supported by several entities, including the National Institute on Aging, the U.K. Medical Research Council, the National Institute of Child Health and Human Development, and the National Institute of Environmental Health Sciences. The authors reported no conflicts of interest.
SOURCE: Reuben A et al. JAMA Psychiatry. 2019 Jan 23. doi: 10.1001/jamapsychiatry.2018.4192.
Lead exposure during childhood appears tied to a significant increase in the risk of psychopathology in adulthood, results of a multidecade, prospective cohort study show.
“These results suggest that early life lead exposure in the era of leaded gasoline experienced by individuals who are currently adults may have contributed to subtle, lifelong differences in emotion and behavior that are detectable at least up to 38 years of age,” Aaron Reuben and his coauthors wrote in JAMA Psychiatry.
The ongoing Dunedin longitudinal cohort study in New Zealand has followed 1,037 individuals born during 1972-1973. Of these individuals, 579 were tested for lead exposure at 11 years of age. The study assessed their mental health at 18, 21, 26, 32, and 38 years of age.
“Although follow-up studies of lead-tested children have reported the persistence of lead-related cognitive deficits well into adulthood, apart from antisocial outcomes, the long-term mental and behavioral health consequences of early life lead exposure have not been fully characterized,” wrote Mr. Reuben, a PhD student in the department of psychology and neuroscience at Duke University in Durham, N.C., and his coauthors.
Researchers saw that, for each 5-mcg/dL increase in childhood blood lead level, there was a significant 1.34-point increase in general psychopathology (P = 0.03), which was largely driven by a 1.41-point increase in internalizing (P = 0.02) and 1.30-point increase in thought-disorder symptoms (P = 0.04). Those associations were seen after adjustment for covariates, such as family socioeconomic status, maternal IQ, and family history of mental illness.
Adults who had higher lead exposure during childhood also were described by their informants – close friends or family members – as being significantly more neurotic, less agreeable, and less conscientious. However, they showed no significant differences in extroversion or in openness to experience, compared with those with less lead exposure.
“These results suggest that early-life lead exposure in the era of leaded gasoline experienced by individuals who are currently adults may have contributed to subtle, lifelong differences in emotion and behavior that are detectable at least up to 38 years of age,” the authors wrote.
They noted that the size of the effect was around one-third the size of the associations seen between psychopathology and other risk factors, such as family history of mental illness and childhood maltreatment. However, the effects of lead exposure on adult psychopathology were similar to its effects on IQ and stronger than the associations seen between lead exposure and criminal offending.
The researchers also examined how early these psychopathology symptoms could be detected with use of parent- and teacher-reported measures of antisocial behavior, hyperactivity, and internalizing from 11 years of age. This showed that individuals with higher lead exposure scored higher on these measures even at 11 years of age, “suggesting that
Mr. Reuben and his associates cited several limitations. One is that the study used a cohort that was predominantly white and born in the 1970s. Also, as an observational study, it does not establish causality between lead exposure and psychopathology.
Nevertheless, they wrote, the study results suggest that adult patients who were exposed to high levels of lead as children might benefit from increased screening and access to mental health services.
The Dunedin study is supported by the New Zealand Health Research Council and the New Zealand Ministry of Business, Innovation, and Employment. This study was supported by several entities, including the National Institute on Aging, the U.K. Medical Research Council, the National Institute of Child Health and Human Development, and the National Institute of Environmental Health Sciences. The authors reported no conflicts of interest.
SOURCE: Reuben A et al. JAMA Psychiatry. 2019 Jan 23. doi: 10.1001/jamapsychiatry.2018.4192.
FROM JAMA PSYCHIATRY
Key clinical point: Higher lead exposure in childhood is linked to psychopathology in adulthood.
Major finding: Children who experienced more lead exposure in childhood show more internalizing and thought-disorder symptoms in adulthood.
Study details: Longitudinal cohort study of 579 individuals.
Disclosures: The Dunedin study is supported by the New Zealand Health Research Council and the New Zealand Ministry of Business, Innovation, and Employment. This study was supported by several entities, including the National Institute on Aging, the U.K. Medical Research Council, the National Institute of Child Health and Human Development, and the National Institute of Environmental Health Sciences. The authors reported no conflicts of interest.
Source: Reuben A et al. JAMA Psychiatry. 2019 Jan 23. doi: 10.1001/jamapsychiatry.2018.4192.
Cost-of-care counseling can be done, but does it help?
Here’s a novel idea: Help patients figure out how large a bite health care will take from their life savings.
A pilot study of a randomized intervention showed that practice-based counseling of patients about the actual out-of-pocket costs of chemotherapy is both “feasible and acceptable.”
But the larger question about whether any of it does any good remains unanswered, reported Sheetal M. Kircher, MD, from Northwestern University in Chicago and her colleagues.
“The majority of participants found the FC [financial counseling] consultation helpful, but they felt the same about their finances after the intervention. Although it is reassuring that no participants felt worse about their cancer costs after the intervention, the variability in perceived value of the FC consultation highlights that the content of a financial intervention needs to be tailored to the patient’s individual needs,” they wrote in the Journal of Oncology Practice.
The investigators conducted a randomized trial with 95 patients at the Robert H. Lurie Comprehensive Cancer Center at Northwestern to study whether financial counseling about the estimated total costs to them of one cycle of chemotherapy could help patients weather financial distress.
The participants first completed a baseline assessment of their financial distress, health-related quality of life, and degree of health insurance literacy. They were then randomized to either standard of care or to a financial-counseling intervention consisting of education, financial-assistance screening, and a tool for estimating total billed charges and out-of-pocket costs. Participants in the experimental arm received a phone call and in-person visit from a financial counselor.
Financial distress was measured using the Comprehensive Score for Financial Toxicity (COST), InCharge Financial Distress/Financial Well-Being Scale, and a single European Organisation for Research and Treatment of Cancer (EORTC) question.
Patients in the standard-of-care arm had access to financial counselors on request, but they were not automatically assigned counseling.
Of the 95 patients randomized, 65 completed both the baseline and follow-up assessments. The investigators noted that participants tended to have more advanced disease; six patients in the standard-of-care arm and five in financial-counseling arm died before they could complete the follow-up assessment.
Of the 43 participants randomized to counseling, 42 (98%) completed the phone call, 20 (47%) completed the in-person visit, and 13 (30%) completed the entire intervention.
At the second, follow-up assessment, 83% of participants in the counseling arm said they were comfortable with answering questions about how the costs of treatment affected their pocketbooks, and 76% reported that they did not have difficulty understanding the estimation tool, and 88% said that the financial counselor helped them to understand their out-of-pocket costs “somewhat” or “a lot.”
However, when they were asked how they felt about paying for their care after completing the intervention, 76% said they felt about the same, 18% said they felt “a little better,” and only 6% said they felt “much better.”
In addition there were no statistically significant differences in any of the financial distress measures between the intervention and standard-of-care groups.
The investigators speculated that the study was underpowered to detect differences in COST (financial toxicity) scores.
High financial distress was significantly associated with worse emotional functioning (P = .0189), whereas being married or in a cohabiting relationship was associated with less financial distress (P = .0092).
“Future studies should aim to better understand patient perspectives and preferences around discussing transparent cost data and design system-level interventions to identify and assist patients efficiently with their specific financial concerns,” Dr. Kircher and her colleagues concluded.
The study was supported by the Robert H. Lurie Comprehensive Cancer Center and the Cancer Survivorship Institute of Northwestern University. Dr. Kircher disclosed stock or ownership interest in Penrose TherapeuTx. Five coauthors reported research funding, travel expenses, and/or honoraria from multiple other companies, as well as consulting/roles.
SOURCE: Kircher SM et al. J Oncol Pract. 2019 Jan 9. doi: 10.1200/JOP.18.00270.
Here’s a novel idea: Help patients figure out how large a bite health care will take from their life savings.
A pilot study of a randomized intervention showed that practice-based counseling of patients about the actual out-of-pocket costs of chemotherapy is both “feasible and acceptable.”
But the larger question about whether any of it does any good remains unanswered, reported Sheetal M. Kircher, MD, from Northwestern University in Chicago and her colleagues.
“The majority of participants found the FC [financial counseling] consultation helpful, but they felt the same about their finances after the intervention. Although it is reassuring that no participants felt worse about their cancer costs after the intervention, the variability in perceived value of the FC consultation highlights that the content of a financial intervention needs to be tailored to the patient’s individual needs,” they wrote in the Journal of Oncology Practice.
The investigators conducted a randomized trial with 95 patients at the Robert H. Lurie Comprehensive Cancer Center at Northwestern to study whether financial counseling about the estimated total costs to them of one cycle of chemotherapy could help patients weather financial distress.
The participants first completed a baseline assessment of their financial distress, health-related quality of life, and degree of health insurance literacy. They were then randomized to either standard of care or to a financial-counseling intervention consisting of education, financial-assistance screening, and a tool for estimating total billed charges and out-of-pocket costs. Participants in the experimental arm received a phone call and in-person visit from a financial counselor.
Financial distress was measured using the Comprehensive Score for Financial Toxicity (COST), InCharge Financial Distress/Financial Well-Being Scale, and a single European Organisation for Research and Treatment of Cancer (EORTC) question.
Patients in the standard-of-care arm had access to financial counselors on request, but they were not automatically assigned counseling.
Of the 95 patients randomized, 65 completed both the baseline and follow-up assessments. The investigators noted that participants tended to have more advanced disease; six patients in the standard-of-care arm and five in financial-counseling arm died before they could complete the follow-up assessment.
Of the 43 participants randomized to counseling, 42 (98%) completed the phone call, 20 (47%) completed the in-person visit, and 13 (30%) completed the entire intervention.
At the second, follow-up assessment, 83% of participants in the counseling arm said they were comfortable with answering questions about how the costs of treatment affected their pocketbooks, and 76% reported that they did not have difficulty understanding the estimation tool, and 88% said that the financial counselor helped them to understand their out-of-pocket costs “somewhat” or “a lot.”
However, when they were asked how they felt about paying for their care after completing the intervention, 76% said they felt about the same, 18% said they felt “a little better,” and only 6% said they felt “much better.”
In addition there were no statistically significant differences in any of the financial distress measures between the intervention and standard-of-care groups.
The investigators speculated that the study was underpowered to detect differences in COST (financial toxicity) scores.
High financial distress was significantly associated with worse emotional functioning (P = .0189), whereas being married or in a cohabiting relationship was associated with less financial distress (P = .0092).
“Future studies should aim to better understand patient perspectives and preferences around discussing transparent cost data and design system-level interventions to identify and assist patients efficiently with their specific financial concerns,” Dr. Kircher and her colleagues concluded.
The study was supported by the Robert H. Lurie Comprehensive Cancer Center and the Cancer Survivorship Institute of Northwestern University. Dr. Kircher disclosed stock or ownership interest in Penrose TherapeuTx. Five coauthors reported research funding, travel expenses, and/or honoraria from multiple other companies, as well as consulting/roles.
SOURCE: Kircher SM et al. J Oncol Pract. 2019 Jan 9. doi: 10.1200/JOP.18.00270.
Here’s a novel idea: Help patients figure out how large a bite health care will take from their life savings.
A pilot study of a randomized intervention showed that practice-based counseling of patients about the actual out-of-pocket costs of chemotherapy is both “feasible and acceptable.”
But the larger question about whether any of it does any good remains unanswered, reported Sheetal M. Kircher, MD, from Northwestern University in Chicago and her colleagues.
“The majority of participants found the FC [financial counseling] consultation helpful, but they felt the same about their finances after the intervention. Although it is reassuring that no participants felt worse about their cancer costs after the intervention, the variability in perceived value of the FC consultation highlights that the content of a financial intervention needs to be tailored to the patient’s individual needs,” they wrote in the Journal of Oncology Practice.
The investigators conducted a randomized trial with 95 patients at the Robert H. Lurie Comprehensive Cancer Center at Northwestern to study whether financial counseling about the estimated total costs to them of one cycle of chemotherapy could help patients weather financial distress.
The participants first completed a baseline assessment of their financial distress, health-related quality of life, and degree of health insurance literacy. They were then randomized to either standard of care or to a financial-counseling intervention consisting of education, financial-assistance screening, and a tool for estimating total billed charges and out-of-pocket costs. Participants in the experimental arm received a phone call and in-person visit from a financial counselor.
Financial distress was measured using the Comprehensive Score for Financial Toxicity (COST), InCharge Financial Distress/Financial Well-Being Scale, and a single European Organisation for Research and Treatment of Cancer (EORTC) question.
Patients in the standard-of-care arm had access to financial counselors on request, but they were not automatically assigned counseling.
Of the 95 patients randomized, 65 completed both the baseline and follow-up assessments. The investigators noted that participants tended to have more advanced disease; six patients in the standard-of-care arm and five in financial-counseling arm died before they could complete the follow-up assessment.
Of the 43 participants randomized to counseling, 42 (98%) completed the phone call, 20 (47%) completed the in-person visit, and 13 (30%) completed the entire intervention.
At the second, follow-up assessment, 83% of participants in the counseling arm said they were comfortable with answering questions about how the costs of treatment affected their pocketbooks, and 76% reported that they did not have difficulty understanding the estimation tool, and 88% said that the financial counselor helped them to understand their out-of-pocket costs “somewhat” or “a lot.”
However, when they were asked how they felt about paying for their care after completing the intervention, 76% said they felt about the same, 18% said they felt “a little better,” and only 6% said they felt “much better.”
In addition there were no statistically significant differences in any of the financial distress measures between the intervention and standard-of-care groups.
The investigators speculated that the study was underpowered to detect differences in COST (financial toxicity) scores.
High financial distress was significantly associated with worse emotional functioning (P = .0189), whereas being married or in a cohabiting relationship was associated with less financial distress (P = .0092).
“Future studies should aim to better understand patient perspectives and preferences around discussing transparent cost data and design system-level interventions to identify and assist patients efficiently with their specific financial concerns,” Dr. Kircher and her colleagues concluded.
The study was supported by the Robert H. Lurie Comprehensive Cancer Center and the Cancer Survivorship Institute of Northwestern University. Dr. Kircher disclosed stock or ownership interest in Penrose TherapeuTx. Five coauthors reported research funding, travel expenses, and/or honoraria from multiple other companies, as well as consulting/roles.
SOURCE: Kircher SM et al. J Oncol Pract. 2019 Jan 9. doi: 10.1200/JOP.18.00270.
FROM JOURNAL OF ONCOLOGY PRACTICE
Key clinical point: A practice-based, financial-counseling intervention did not significantly change how patients felt about the costs of cancer care, compared with the standard of care.
Major finding: Participants found the intervention acceptable, but there were no significant differences in measures of financial distress between the intervention and control arms.
Study details: Randomized study in 95 patients assigned to financial counseling or standard of care.
Disclosures: The study was supported by the Robert H. Lurie Comprehensive Cancer Center and the Cancer Survivorship Institute of Northwestern University. Dr. Kircher disclosed stock or ownership interest in Penrose TherapeuTx. Five coauthors reported research funding, travel expenses, and/or honoraria from multiple other companies, as well as consulting/roles.
Source: Kircher SM et al. J Oncol Pract. 2019 Jan 9. doi: 10.1200/JOP.18.00270.
Pembrolizumab bests chemo in PD-L1-positive esophageal cancer
SAN FRANCISCO – The immune checkpoint inhibitor pembrolizumab (Keytruda) may soon unseat chemotherapy as standard second-line therapy for certain advanced cancers of the esophagus or gastroesophageal junction, according to data from the global phase 3 KEYNOTE-181 trial.
“Patients with advanced esophageal cancer after first-line therapy have a poor prognosis and limited treatment options,” said lead investigator Takashi Kojima, MD, of the National Cancer Center Hospital East, Kashiwa, Japan. “Taxanes and irinotecan are commonly used after first-line chemotherapy; however, no overall survival benefit has been demonstrated for chemotherapy in a phase 3 study.”
The 628 patients in KEYNOTE-181 were randomly assigned to chemotherapy (paclitaxel, docetaxel, or irinotecan, left to investigator’s choice) or pembrolizumab, an antibody to programmed death 1 (PD-1). Currently, pembrolizumab is approved in the United States for use as third- or later-line therapy for gastric or gastroesophageal junction cancer that is positive for programmed death ligand 1 (PD-L1) as defined by a combined positive score (CPS) of 1 or greater, among many other indications.
Main trial results reported at the 2019 GI Cancers Symposium showed that among patients with high PD-L1 expression, defined by a CPS of 10 or higher, pembrolizumab reduced risk of death by about one-third, prolonging survival by 2.6 months. The difference met the predefined threshold for statistical significance.
There was a more modest, nonsignificant benefit among patients with tumors having squamous cell carcinoma histology and among the entire intention-to-treat population.
The rate of treatment-related adverse events of grade 3-5 was roughly half as high with pembrolizumab versus chemotherapy (18.2% vs. 40.9%).
“These data suggest that pembrolizumab should be considered a new standard of care for patients with PD-L1 CPS of 10 or greater metastatic esophageal cancer in the second-line setting,” Dr. Kojima concluded.
Implications for practice
“In the intention-to-treat population, the KEYNOTE-181 study failed to meet its primary endpoint of overall survival, so pembrolizumab is not indicated in unselected esophageal cancer patients,” said invited discussant Harry H. Yoon, MD, cochair of the Esophageal/Gastric Cancer Disease Group at the Mayo Clinic Cancer Center, Rochester, Minn.
For the patients with squamous histology, the negative findings are unlikely to be due to underpowering and may instead be related to the trial’s use of multiple primary endpoints, in his opinion. “Some may advocate using pembrolizumab off protocol [in this population], particularly for patients who cannot tolerate chemotherapy, because it is after all better tolerated than chemo. This can be a discussion point for guideline committees,” he said.
The results for the group with PD-L1 CPS scores of 10 or higher are statistically significant and clinically meaningful, as well as internally valid – with the caveat that patients were not stratified by PD-L1 status and some favorable risk factors were more common in the pembrolizumab group, according to Dr. Yoon. The 43% survival rate at 12 months translates to a number needed to treat of just four patients for one patient to be alive at that time point.
“A multivariate analysis could help clarify whether the positive results in the PD-L1 CPS 10-or-higher subgroup are explained by a higher frequency of favorable patient characteristics in the pembrolizumab arm,” he noted. “The strength of those results could influence guideline recommendations and implementation in clinical practice.”
Subgroup analyses suggested benefit was mainly seen in Asian patients, who tend to have higher prevalence of squamous tumors, Dr. Yoon said. Potential molecular differences at play here may be elucidated by ongoing research.
Ultimately, the findings in the PD-L1 CPS 10-or-higher group have potential implications for biomarker testing. “For the patient in front of me, I currently order PD-L1 and HER2 at first metastatic diagnosis in gastroesophageal adenocarcinomas,” he elaborated. “It’s reasonable to consider a practice change. This means ordering PD-L1 at first metastatic diagnosis in patients with squamous carcinoma of the esophagus. This would also mean some pathology labs may need to report a more detailed PD-L1 CPS score, if they don’t already.”
These findings also have potential implications for treatment. “For the second-line setting, for squamous carcinoma of the esophagus, esophageal adenocarcinomas, and Siewert 1 adenocarcinomas with a PD-L1 CPS of 10 or more, it’s reasonable to consider pembrolizumab,” Dr. Yoon noted. “This should be discussed within guideline committees, and the results will be submitted to regulatory authorities, who will have access to more detailed data. It’s possible that these recommendations could be modified in the near future.”
Study details
As KEYNOTE-181 had three primary endpoints (overall survival in each of three populations), P values required for statistical significance were defined accordingly. “The study was positive if one of the primary endpoints was met,” Dr. Kojima explained at the symposium, which was sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Some 35% of trial patients had a PD-L1 CPS of 10 or greater. In this population, median overall survival was 9.3 months with pembrolizumab and 6.7 months with chemotherapy. The hazard ratio was 0.69, with the P value (.0074) meeting that predefined for statistical significance in this population (less than or equal to .0085). The 12-month rate of overall survival was 43% and 20%, respectively.
About 64% of trial patients had squamous cell carcinoma histology. In this population, median overall survival was 8.2 months with pembrolizumab and 7.1 months with chemotherapy. The hazard ratio was 0.78, but the P value (.0095) did not meet that predefined for statistical significance in this group (less than or equal to .0077).
Finally, in the entire intention-to-treat population, median overall survival was identical, at 7.1 months, with pembrolizumab and with chemotherapy. The hazard ratio was 0.89 in favor of the antibody, but the P value (.0560) did not meet that predefined for statistical significance in this population (less than or equal to .0077).
A similar pattern was seen for other outcomes, with patients having PD-L1 CPS greater than or equal to 10 deriving greatest benefit from pembrolizumab over chemotherapy in terms of progression-free survival (hazard ratio, 0.73), response rate (21.5% vs. 6.1%), and median duration of response (9.3 vs. 7.7 months).
“Toxicity profiles were in line with previous reports of each treatment. No new safety signals were observed,” Dr. Kojima reported. Pembrolizumab was associated with a higher rate of immune-mediated and infusion reactions (23.2% vs. 7.4%), but lower rates of most gastrointestinal and hematologic adverse events.
Dr. Kojima disclosed ties to Oncolys BioPharma, Astellas, Amgen, MSD, Ono Pharmaceutical, and Shionogi. Merck Sharp & Dohme sponsored the trial.
SOURCE: Kojima T et al. GI Cancers Symposium Abstract 2, https://meetinglibrary.asco.org/record/169377/abstract.
SAN FRANCISCO – The immune checkpoint inhibitor pembrolizumab (Keytruda) may soon unseat chemotherapy as standard second-line therapy for certain advanced cancers of the esophagus or gastroesophageal junction, according to data from the global phase 3 KEYNOTE-181 trial.
“Patients with advanced esophageal cancer after first-line therapy have a poor prognosis and limited treatment options,” said lead investigator Takashi Kojima, MD, of the National Cancer Center Hospital East, Kashiwa, Japan. “Taxanes and irinotecan are commonly used after first-line chemotherapy; however, no overall survival benefit has been demonstrated for chemotherapy in a phase 3 study.”
The 628 patients in KEYNOTE-181 were randomly assigned to chemotherapy (paclitaxel, docetaxel, or irinotecan, left to investigator’s choice) or pembrolizumab, an antibody to programmed death 1 (PD-1). Currently, pembrolizumab is approved in the United States for use as third- or later-line therapy for gastric or gastroesophageal junction cancer that is positive for programmed death ligand 1 (PD-L1) as defined by a combined positive score (CPS) of 1 or greater, among many other indications.
Main trial results reported at the 2019 GI Cancers Symposium showed that among patients with high PD-L1 expression, defined by a CPS of 10 or higher, pembrolizumab reduced risk of death by about one-third, prolonging survival by 2.6 months. The difference met the predefined threshold for statistical significance.
There was a more modest, nonsignificant benefit among patients with tumors having squamous cell carcinoma histology and among the entire intention-to-treat population.
The rate of treatment-related adverse events of grade 3-5 was roughly half as high with pembrolizumab versus chemotherapy (18.2% vs. 40.9%).
“These data suggest that pembrolizumab should be considered a new standard of care for patients with PD-L1 CPS of 10 or greater metastatic esophageal cancer in the second-line setting,” Dr. Kojima concluded.
Implications for practice
“In the intention-to-treat population, the KEYNOTE-181 study failed to meet its primary endpoint of overall survival, so pembrolizumab is not indicated in unselected esophageal cancer patients,” said invited discussant Harry H. Yoon, MD, cochair of the Esophageal/Gastric Cancer Disease Group at the Mayo Clinic Cancer Center, Rochester, Minn.
For the patients with squamous histology, the negative findings are unlikely to be due to underpowering and may instead be related to the trial’s use of multiple primary endpoints, in his opinion. “Some may advocate using pembrolizumab off protocol [in this population], particularly for patients who cannot tolerate chemotherapy, because it is after all better tolerated than chemo. This can be a discussion point for guideline committees,” he said.
The results for the group with PD-L1 CPS scores of 10 or higher are statistically significant and clinically meaningful, as well as internally valid – with the caveat that patients were not stratified by PD-L1 status and some favorable risk factors were more common in the pembrolizumab group, according to Dr. Yoon. The 43% survival rate at 12 months translates to a number needed to treat of just four patients for one patient to be alive at that time point.
“A multivariate analysis could help clarify whether the positive results in the PD-L1 CPS 10-or-higher subgroup are explained by a higher frequency of favorable patient characteristics in the pembrolizumab arm,” he noted. “The strength of those results could influence guideline recommendations and implementation in clinical practice.”
Subgroup analyses suggested benefit was mainly seen in Asian patients, who tend to have higher prevalence of squamous tumors, Dr. Yoon said. Potential molecular differences at play here may be elucidated by ongoing research.
Ultimately, the findings in the PD-L1 CPS 10-or-higher group have potential implications for biomarker testing. “For the patient in front of me, I currently order PD-L1 and HER2 at first metastatic diagnosis in gastroesophageal adenocarcinomas,” he elaborated. “It’s reasonable to consider a practice change. This means ordering PD-L1 at first metastatic diagnosis in patients with squamous carcinoma of the esophagus. This would also mean some pathology labs may need to report a more detailed PD-L1 CPS score, if they don’t already.”
These findings also have potential implications for treatment. “For the second-line setting, for squamous carcinoma of the esophagus, esophageal adenocarcinomas, and Siewert 1 adenocarcinomas with a PD-L1 CPS of 10 or more, it’s reasonable to consider pembrolizumab,” Dr. Yoon noted. “This should be discussed within guideline committees, and the results will be submitted to regulatory authorities, who will have access to more detailed data. It’s possible that these recommendations could be modified in the near future.”
Study details
As KEYNOTE-181 had three primary endpoints (overall survival in each of three populations), P values required for statistical significance were defined accordingly. “The study was positive if one of the primary endpoints was met,” Dr. Kojima explained at the symposium, which was sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Some 35% of trial patients had a PD-L1 CPS of 10 or greater. In this population, median overall survival was 9.3 months with pembrolizumab and 6.7 months with chemotherapy. The hazard ratio was 0.69, with the P value (.0074) meeting that predefined for statistical significance in this population (less than or equal to .0085). The 12-month rate of overall survival was 43% and 20%, respectively.
About 64% of trial patients had squamous cell carcinoma histology. In this population, median overall survival was 8.2 months with pembrolizumab and 7.1 months with chemotherapy. The hazard ratio was 0.78, but the P value (.0095) did not meet that predefined for statistical significance in this group (less than or equal to .0077).
Finally, in the entire intention-to-treat population, median overall survival was identical, at 7.1 months, with pembrolizumab and with chemotherapy. The hazard ratio was 0.89 in favor of the antibody, but the P value (.0560) did not meet that predefined for statistical significance in this population (less than or equal to .0077).
A similar pattern was seen for other outcomes, with patients having PD-L1 CPS greater than or equal to 10 deriving greatest benefit from pembrolizumab over chemotherapy in terms of progression-free survival (hazard ratio, 0.73), response rate (21.5% vs. 6.1%), and median duration of response (9.3 vs. 7.7 months).
“Toxicity profiles were in line with previous reports of each treatment. No new safety signals were observed,” Dr. Kojima reported. Pembrolizumab was associated with a higher rate of immune-mediated and infusion reactions (23.2% vs. 7.4%), but lower rates of most gastrointestinal and hematologic adverse events.
Dr. Kojima disclosed ties to Oncolys BioPharma, Astellas, Amgen, MSD, Ono Pharmaceutical, and Shionogi. Merck Sharp & Dohme sponsored the trial.
SOURCE: Kojima T et al. GI Cancers Symposium Abstract 2, https://meetinglibrary.asco.org/record/169377/abstract.
SAN FRANCISCO – The immune checkpoint inhibitor pembrolizumab (Keytruda) may soon unseat chemotherapy as standard second-line therapy for certain advanced cancers of the esophagus or gastroesophageal junction, according to data from the global phase 3 KEYNOTE-181 trial.
“Patients with advanced esophageal cancer after first-line therapy have a poor prognosis and limited treatment options,” said lead investigator Takashi Kojima, MD, of the National Cancer Center Hospital East, Kashiwa, Japan. “Taxanes and irinotecan are commonly used after first-line chemotherapy; however, no overall survival benefit has been demonstrated for chemotherapy in a phase 3 study.”
The 628 patients in KEYNOTE-181 were randomly assigned to chemotherapy (paclitaxel, docetaxel, or irinotecan, left to investigator’s choice) or pembrolizumab, an antibody to programmed death 1 (PD-1). Currently, pembrolizumab is approved in the United States for use as third- or later-line therapy for gastric or gastroesophageal junction cancer that is positive for programmed death ligand 1 (PD-L1) as defined by a combined positive score (CPS) of 1 or greater, among many other indications.
Main trial results reported at the 2019 GI Cancers Symposium showed that among patients with high PD-L1 expression, defined by a CPS of 10 or higher, pembrolizumab reduced risk of death by about one-third, prolonging survival by 2.6 months. The difference met the predefined threshold for statistical significance.
There was a more modest, nonsignificant benefit among patients with tumors having squamous cell carcinoma histology and among the entire intention-to-treat population.
The rate of treatment-related adverse events of grade 3-5 was roughly half as high with pembrolizumab versus chemotherapy (18.2% vs. 40.9%).
“These data suggest that pembrolizumab should be considered a new standard of care for patients with PD-L1 CPS of 10 or greater metastatic esophageal cancer in the second-line setting,” Dr. Kojima concluded.
Implications for practice
“In the intention-to-treat population, the KEYNOTE-181 study failed to meet its primary endpoint of overall survival, so pembrolizumab is not indicated in unselected esophageal cancer patients,” said invited discussant Harry H. Yoon, MD, cochair of the Esophageal/Gastric Cancer Disease Group at the Mayo Clinic Cancer Center, Rochester, Minn.
For the patients with squamous histology, the negative findings are unlikely to be due to underpowering and may instead be related to the trial’s use of multiple primary endpoints, in his opinion. “Some may advocate using pembrolizumab off protocol [in this population], particularly for patients who cannot tolerate chemotherapy, because it is after all better tolerated than chemo. This can be a discussion point for guideline committees,” he said.
The results for the group with PD-L1 CPS scores of 10 or higher are statistically significant and clinically meaningful, as well as internally valid – with the caveat that patients were not stratified by PD-L1 status and some favorable risk factors were more common in the pembrolizumab group, according to Dr. Yoon. The 43% survival rate at 12 months translates to a number needed to treat of just four patients for one patient to be alive at that time point.
“A multivariate analysis could help clarify whether the positive results in the PD-L1 CPS 10-or-higher subgroup are explained by a higher frequency of favorable patient characteristics in the pembrolizumab arm,” he noted. “The strength of those results could influence guideline recommendations and implementation in clinical practice.”
Subgroup analyses suggested benefit was mainly seen in Asian patients, who tend to have higher prevalence of squamous tumors, Dr. Yoon said. Potential molecular differences at play here may be elucidated by ongoing research.
Ultimately, the findings in the PD-L1 CPS 10-or-higher group have potential implications for biomarker testing. “For the patient in front of me, I currently order PD-L1 and HER2 at first metastatic diagnosis in gastroesophageal adenocarcinomas,” he elaborated. “It’s reasonable to consider a practice change. This means ordering PD-L1 at first metastatic diagnosis in patients with squamous carcinoma of the esophagus. This would also mean some pathology labs may need to report a more detailed PD-L1 CPS score, if they don’t already.”
These findings also have potential implications for treatment. “For the second-line setting, for squamous carcinoma of the esophagus, esophageal adenocarcinomas, and Siewert 1 adenocarcinomas with a PD-L1 CPS of 10 or more, it’s reasonable to consider pembrolizumab,” Dr. Yoon noted. “This should be discussed within guideline committees, and the results will be submitted to regulatory authorities, who will have access to more detailed data. It’s possible that these recommendations could be modified in the near future.”
Study details
As KEYNOTE-181 had three primary endpoints (overall survival in each of three populations), P values required for statistical significance were defined accordingly. “The study was positive if one of the primary endpoints was met,” Dr. Kojima explained at the symposium, which was sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Some 35% of trial patients had a PD-L1 CPS of 10 or greater. In this population, median overall survival was 9.3 months with pembrolizumab and 6.7 months with chemotherapy. The hazard ratio was 0.69, with the P value (.0074) meeting that predefined for statistical significance in this population (less than or equal to .0085). The 12-month rate of overall survival was 43% and 20%, respectively.
About 64% of trial patients had squamous cell carcinoma histology. In this population, median overall survival was 8.2 months with pembrolizumab and 7.1 months with chemotherapy. The hazard ratio was 0.78, but the P value (.0095) did not meet that predefined for statistical significance in this group (less than or equal to .0077).
Finally, in the entire intention-to-treat population, median overall survival was identical, at 7.1 months, with pembrolizumab and with chemotherapy. The hazard ratio was 0.89 in favor of the antibody, but the P value (.0560) did not meet that predefined for statistical significance in this population (less than or equal to .0077).
A similar pattern was seen for other outcomes, with patients having PD-L1 CPS greater than or equal to 10 deriving greatest benefit from pembrolizumab over chemotherapy in terms of progression-free survival (hazard ratio, 0.73), response rate (21.5% vs. 6.1%), and median duration of response (9.3 vs. 7.7 months).
“Toxicity profiles were in line with previous reports of each treatment. No new safety signals were observed,” Dr. Kojima reported. Pembrolizumab was associated with a higher rate of immune-mediated and infusion reactions (23.2% vs. 7.4%), but lower rates of most gastrointestinal and hematologic adverse events.
Dr. Kojima disclosed ties to Oncolys BioPharma, Astellas, Amgen, MSD, Ono Pharmaceutical, and Shionogi. Merck Sharp & Dohme sponsored the trial.
SOURCE: Kojima T et al. GI Cancers Symposium Abstract 2, https://meetinglibrary.asco.org/record/169377/abstract.
REPORTING FROM THE 2019 GI CANCERS SYMPOSIUM
Key clinical point: .
Major finding: Among patients with a PD-L1 combined positive score of 10 or higher, median overall survival was 9.3 months with pembrolizumab and 6.7 months with chemotherapy (hazard ratio, 0.69; P = .0074).
Study details: A phase 3 randomized controlled trial among 628 patients having progression after first-line therapy for advanced cancer of the esophagus or GEJ (KEYNOTE-181).
Disclosures: Dr. Kojima disclosed ties to Oncolys BioPharma, Astellas, Amgen, MSD, Ono Pharmaceutical, and Shionogi. Merck Sharp & Dohme sponsored the trial.
Source: Kojima T et al. GI Cancers Symposium, Abstract 2.
Bedbugs in the Workplace
Product Update: Spectrum, Viera, YO, and SmartCurve
PREIMPLANTATION GENETIC TESTING
In a retrospective study published in Fertility and Sterility, Spectrum, a single-nucleotide polymorphism (SNP)-based PGT-A technology, was successful in screening all 24 chromosomes to provide comprehensive embryo aneuploidy results. Natera says that the study results showed that use of Spectrum PGT-A during IVF led to excellent implantation (70%), clinical pregnancy (71%), and live birth (65%) rates during single embryo transfer.
Spectrum evaluates the number of chromosomes in embryos to detect extra or missing chromosomes and screens for inherited genetic disorders to help provide the best chance of transferring a healthy embryo with the correct number of chromosomes.
FOR MORE INFORMATION, VISIT: https://www.natera.com/spectrum
PORTABLE BREAST ULTRASOUND
Viera is a wireless, handheld breast ultrasound scanner that Hologic says produces exceptional image quality. The scanner uses a 14-4 MHz linear transducer, contains 192 elements, and has 4 parallel software beamformers. It utilizes spatial compounding to reduce image noise and speckle. Presets are available for breast, dense breast, and interventional procedures with B, M, power Doppler, color Doppler, and needle enhancement modes. On-demand high-resolution images are transmitted wirelessly to smart devices and patient archive systems (PACS) in the office, exam room, or surgical suite, or to the Cloud for efficient documentation. Smart device platforms include iOS and Android devices using WiFi and Bluetooth connectivity. The system includes a 1.2-lb scanner, 2 rechargeable batteries, and a charger with global AC adapter.
FOR MORE INFORMATION, VISIT: https://www.vieraportableultrasound.com
HOME SPERM TEST
The customer downloads the smart-phone app and acquires the YO Kit. After collecting a semen sample, he uses a pipette from the kit to place semen on a slide, which is slipped into the Yo Clip. The clip slides onto the smartphone, which uses its camera to take a high-resolution video. Test results and the sperm video appear in about 2 minutes.
At $59.95, the YO Kit includes 2 tests, in case a second sample is desired.
FOR MORE INFORMATION, VISIT:
https://www.yospermtest.com
Continue to Improving the Mammography Experience…
IMPROVING THE MAMMOGRAPHY EXPERIENCE
SmartCurve is standard on Hologic’s new 3Dimensions™ mammography system and as an enhancement option to existing Hologic Selenia®Dimensions® systems.
FOR MORE INFORMATION, VISIT:https://www.smartcurvesystem.com
Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.
PREIMPLANTATION GENETIC TESTING
In a retrospective study published in Fertility and Sterility, Spectrum, a single-nucleotide polymorphism (SNP)-based PGT-A technology, was successful in screening all 24 chromosomes to provide comprehensive embryo aneuploidy results. Natera says that the study results showed that use of Spectrum PGT-A during IVF led to excellent implantation (70%), clinical pregnancy (71%), and live birth (65%) rates during single embryo transfer.
Spectrum evaluates the number of chromosomes in embryos to detect extra or missing chromosomes and screens for inherited genetic disorders to help provide the best chance of transferring a healthy embryo with the correct number of chromosomes.
FOR MORE INFORMATION, VISIT: https://www.natera.com/spectrum
PORTABLE BREAST ULTRASOUND
Viera is a wireless, handheld breast ultrasound scanner that Hologic says produces exceptional image quality. The scanner uses a 14-4 MHz linear transducer, contains 192 elements, and has 4 parallel software beamformers. It utilizes spatial compounding to reduce image noise and speckle. Presets are available for breast, dense breast, and interventional procedures with B, M, power Doppler, color Doppler, and needle enhancement modes. On-demand high-resolution images are transmitted wirelessly to smart devices and patient archive systems (PACS) in the office, exam room, or surgical suite, or to the Cloud for efficient documentation. Smart device platforms include iOS and Android devices using WiFi and Bluetooth connectivity. The system includes a 1.2-lb scanner, 2 rechargeable batteries, and a charger with global AC adapter.
FOR MORE INFORMATION, VISIT: https://www.vieraportableultrasound.com
HOME SPERM TEST
The customer downloads the smart-phone app and acquires the YO Kit. After collecting a semen sample, he uses a pipette from the kit to place semen on a slide, which is slipped into the Yo Clip. The clip slides onto the smartphone, which uses its camera to take a high-resolution video. Test results and the sperm video appear in about 2 minutes.
At $59.95, the YO Kit includes 2 tests, in case a second sample is desired.
FOR MORE INFORMATION, VISIT:
https://www.yospermtest.com
Continue to Improving the Mammography Experience…
IMPROVING THE MAMMOGRAPHY EXPERIENCE
SmartCurve is standard on Hologic’s new 3Dimensions™ mammography system and as an enhancement option to existing Hologic Selenia®Dimensions® systems.
FOR MORE INFORMATION, VISIT:https://www.smartcurvesystem.com
Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.
PREIMPLANTATION GENETIC TESTING
In a retrospective study published in Fertility and Sterility, Spectrum, a single-nucleotide polymorphism (SNP)-based PGT-A technology, was successful in screening all 24 chromosomes to provide comprehensive embryo aneuploidy results. Natera says that the study results showed that use of Spectrum PGT-A during IVF led to excellent implantation (70%), clinical pregnancy (71%), and live birth (65%) rates during single embryo transfer.
Spectrum evaluates the number of chromosomes in embryos to detect extra or missing chromosomes and screens for inherited genetic disorders to help provide the best chance of transferring a healthy embryo with the correct number of chromosomes.
FOR MORE INFORMATION, VISIT: https://www.natera.com/spectrum
PORTABLE BREAST ULTRASOUND
Viera is a wireless, handheld breast ultrasound scanner that Hologic says produces exceptional image quality. The scanner uses a 14-4 MHz linear transducer, contains 192 elements, and has 4 parallel software beamformers. It utilizes spatial compounding to reduce image noise and speckle. Presets are available for breast, dense breast, and interventional procedures with B, M, power Doppler, color Doppler, and needle enhancement modes. On-demand high-resolution images are transmitted wirelessly to smart devices and patient archive systems (PACS) in the office, exam room, or surgical suite, or to the Cloud for efficient documentation. Smart device platforms include iOS and Android devices using WiFi and Bluetooth connectivity. The system includes a 1.2-lb scanner, 2 rechargeable batteries, and a charger with global AC adapter.
FOR MORE INFORMATION, VISIT: https://www.vieraportableultrasound.com
HOME SPERM TEST
The customer downloads the smart-phone app and acquires the YO Kit. After collecting a semen sample, he uses a pipette from the kit to place semen on a slide, which is slipped into the Yo Clip. The clip slides onto the smartphone, which uses its camera to take a high-resolution video. Test results and the sperm video appear in about 2 minutes.
At $59.95, the YO Kit includes 2 tests, in case a second sample is desired.
FOR MORE INFORMATION, VISIT:
https://www.yospermtest.com
Continue to Improving the Mammography Experience…
IMPROVING THE MAMMOGRAPHY EXPERIENCE
SmartCurve is standard on Hologic’s new 3Dimensions™ mammography system and as an enhancement option to existing Hologic Selenia®Dimensions® systems.
FOR MORE INFORMATION, VISIT:https://www.smartcurvesystem.com
Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.
Increasing inpatient attending supervision does not decrease medical errors
Clinical question: What is the effect of increasing attending physician supervision on a resident inpatient team for both patient safety and education?
Background: Residents need autonomy to help develop their clinical skills and to gain competence to practice independently; however, there is rising concern that increased supervision is needed for patient safety.
Study Design: Randomized, crossover clinical trial.
Setting: 1,100-bed academic medical center at Massachusetts General Hospital, Boston.
Synopsis: Twenty-two attending physicians participated in the study over 44 2-week teaching blocks with a total of 1,259 patient hospitalizations on the general medicine teaching service. In the intervention arm, attendings were present during work rounds; in the control arm, attendings discussed established patients with the resident via card flip. New patients were discussed at the bedside in both arms. There was no statistically significant difference in the number of medical errors or patient safety events between the two groups. Residents in the intervention group, however, felt less efficient and autonomous and were less able to make independent decisions. Limitations include this being a single-center study at a program emphasizing resident autonomy and therefore may limit generalizability. Current literature on supervision and patient safety has variable results. This study suggests that increasing attending supervision may not increase patient safety, but may negatively affect resident education and autonomy.
Bottom line: Attending physician presence on work rounds does not improve patient safety and may have deleterious effects on resident education.
Citation: Finn KM et al. Effect of increased inpatient attending physician supervision on medical errors, patient safety, and resident education. JAMA Intern Med. 2018;178(7):925-59
Dr. Ciarkowski is clinical instructor of medicine and an academic hospitalist, University of Utah, Salt Lake City.
Clinical question: What is the effect of increasing attending physician supervision on a resident inpatient team for both patient safety and education?
Background: Residents need autonomy to help develop their clinical skills and to gain competence to practice independently; however, there is rising concern that increased supervision is needed for patient safety.
Study Design: Randomized, crossover clinical trial.
Setting: 1,100-bed academic medical center at Massachusetts General Hospital, Boston.
Synopsis: Twenty-two attending physicians participated in the study over 44 2-week teaching blocks with a total of 1,259 patient hospitalizations on the general medicine teaching service. In the intervention arm, attendings were present during work rounds; in the control arm, attendings discussed established patients with the resident via card flip. New patients were discussed at the bedside in both arms. There was no statistically significant difference in the number of medical errors or patient safety events between the two groups. Residents in the intervention group, however, felt less efficient and autonomous and were less able to make independent decisions. Limitations include this being a single-center study at a program emphasizing resident autonomy and therefore may limit generalizability. Current literature on supervision and patient safety has variable results. This study suggests that increasing attending supervision may not increase patient safety, but may negatively affect resident education and autonomy.
Bottom line: Attending physician presence on work rounds does not improve patient safety and may have deleterious effects on resident education.
Citation: Finn KM et al. Effect of increased inpatient attending physician supervision on medical errors, patient safety, and resident education. JAMA Intern Med. 2018;178(7):925-59
Dr. Ciarkowski is clinical instructor of medicine and an academic hospitalist, University of Utah, Salt Lake City.
Clinical question: What is the effect of increasing attending physician supervision on a resident inpatient team for both patient safety and education?
Background: Residents need autonomy to help develop their clinical skills and to gain competence to practice independently; however, there is rising concern that increased supervision is needed for patient safety.
Study Design: Randomized, crossover clinical trial.
Setting: 1,100-bed academic medical center at Massachusetts General Hospital, Boston.
Synopsis: Twenty-two attending physicians participated in the study over 44 2-week teaching blocks with a total of 1,259 patient hospitalizations on the general medicine teaching service. In the intervention arm, attendings were present during work rounds; in the control arm, attendings discussed established patients with the resident via card flip. New patients were discussed at the bedside in both arms. There was no statistically significant difference in the number of medical errors or patient safety events between the two groups. Residents in the intervention group, however, felt less efficient and autonomous and were less able to make independent decisions. Limitations include this being a single-center study at a program emphasizing resident autonomy and therefore may limit generalizability. Current literature on supervision and patient safety has variable results. This study suggests that increasing attending supervision may not increase patient safety, but may negatively affect resident education and autonomy.
Bottom line: Attending physician presence on work rounds does not improve patient safety and may have deleterious effects on resident education.
Citation: Finn KM et al. Effect of increased inpatient attending physician supervision on medical errors, patient safety, and resident education. JAMA Intern Med. 2018;178(7):925-59
Dr. Ciarkowski is clinical instructor of medicine and an academic hospitalist, University of Utah, Salt Lake City.
Prescribed opioids increase pneumonia risk in patients with, without HIV
Prescribed opioids were associated with an increase in community-acquired pneumonia in patients with and without HIV infection, according to results of a large database study.
People living with HIV (PLWH) appeared to have a greater community-acquired pneumonia (CAP) risk at lower opioid doses and particularly with immunosuppressive opioids compared with uninfected patients, although the difference was not significant, E. Jennifer Edelman, MD, of Yale University, New Haven, Conn., and her colleagues wrote in JAMA Internal Medicine.
The researchers performed a nested case-control study comprising 25,392 participants (98.9% men; mean age, 55 years) in the Veterans Aging Cohort Study from Jan. 1, 2000, through Dec. 31, 2012.
Dr. Edelman and her colleagues compared the characteristics of 4,246 CAP cases with those of 21,146 uninfected controls in the sample. They also compared cases and controls by HIV status. They ran bivariate and multivariate analysis to estimate odds ratios for CAP risk associated with opioid exposure. In addition, the researchers ran models stratified by HIV status and formally checked for an interaction between prescribed opioid characteristics and HIV status.
In unadjusted logistic regression, prescribed opioids were associated with increased odds of CAP, with the greatest risk observed with currently prescribed opioids, compared with past prescribed opioids or no opioids.
Prescribed opioids remained associated with CAP in the adjusted models for past unknown or nonimmunosuppressive (adjusted OR, 1.24; 95% confidence interval, 1.09-1.40) and past immunosuppressive opioid use (aOR, 1.42; 95% CI, 1.21-1.67).
For currently prescribed opioids, nonimmunosuppressive or unknown, the aOR was 1.23 (95% CI, 1.03-1.48). For currently prescribed immunosuppressive opioids, the aOR was 3.18 (95% CI, 2.44-4.14).
The researchers also found evidence of a dose-response effect such that currently prescribed high-dose opioids were associated with the greatest CAP risk, followed by medium- and then by low-dose opioids, whether immunosuppressive or not.
With regard to the effect of HIV status in stratified, adjusted analyses, CAP risk tended to be greater among PLWH with current prescribed opioids, especially immunosuppressive opioids, compared with uninfected patients. However, the overall interaction term for opioid × HIV status was not significant (P = .36).
Although the researchers stated that a limitation of their study was an inability to prove causality or rule out respiratory depression (vs. immunosuppression) as the cause of the increased CAP risk, “the observed effects of opioid immunosuppressive properties and CAP risk lend support to our hypothesis that opioids have clinically relevant immunosuppressive properties.”
Dr. Edelman and her colleagues cited several limitations. For example, they were not able to determine whether patients took their prescribed medications appropriately and assess whether the patients took nonmedically prescribed opioids. Also, because men made up such a large portion of the study population, it is unclear whether the results are generalizable to women.
Nevertheless, the study “adds to growing evidence of potential medical harms associated with prescribed opioids,” they wrote.
“Health care professionals should be aware of this additional CAP risk when they prescribe opioids, and future studies should investigate the effects of opioids prescribed for longer durations and on other immune-related outcomes,” wrote Dr. Edelman and her colleagues. “Understanding whether mitigating the risk of prescribed opioids for CAP is possible by using a lower dose and nonimmunosuppressive opioids awaits further study.”
However, without such data, when prescribed opioids are warranted, physicians should attempt to modify other factors known to affect CAP risk, including smoking and lack of vaccination, Dr. Edelman and her colleagues concluded.
Several U.S. government agencies and Yale University provided funding for the study. The authors reported that they had no conflicts.
SOURCE: Edelman EJ et al. JAMA Intern Med. 2019 Jan 7. doi: 10.1001/jamainternmed.2018.6101.
Prescribed opioids were associated with an increase in community-acquired pneumonia in patients with and without HIV infection, according to results of a large database study.
People living with HIV (PLWH) appeared to have a greater community-acquired pneumonia (CAP) risk at lower opioid doses and particularly with immunosuppressive opioids compared with uninfected patients, although the difference was not significant, E. Jennifer Edelman, MD, of Yale University, New Haven, Conn., and her colleagues wrote in JAMA Internal Medicine.
The researchers performed a nested case-control study comprising 25,392 participants (98.9% men; mean age, 55 years) in the Veterans Aging Cohort Study from Jan. 1, 2000, through Dec. 31, 2012.
Dr. Edelman and her colleagues compared the characteristics of 4,246 CAP cases with those of 21,146 uninfected controls in the sample. They also compared cases and controls by HIV status. They ran bivariate and multivariate analysis to estimate odds ratios for CAP risk associated with opioid exposure. In addition, the researchers ran models stratified by HIV status and formally checked for an interaction between prescribed opioid characteristics and HIV status.
In unadjusted logistic regression, prescribed opioids were associated with increased odds of CAP, with the greatest risk observed with currently prescribed opioids, compared with past prescribed opioids or no opioids.
Prescribed opioids remained associated with CAP in the adjusted models for past unknown or nonimmunosuppressive (adjusted OR, 1.24; 95% confidence interval, 1.09-1.40) and past immunosuppressive opioid use (aOR, 1.42; 95% CI, 1.21-1.67).
For currently prescribed opioids, nonimmunosuppressive or unknown, the aOR was 1.23 (95% CI, 1.03-1.48). For currently prescribed immunosuppressive opioids, the aOR was 3.18 (95% CI, 2.44-4.14).
The researchers also found evidence of a dose-response effect such that currently prescribed high-dose opioids were associated with the greatest CAP risk, followed by medium- and then by low-dose opioids, whether immunosuppressive or not.
With regard to the effect of HIV status in stratified, adjusted analyses, CAP risk tended to be greater among PLWH with current prescribed opioids, especially immunosuppressive opioids, compared with uninfected patients. However, the overall interaction term for opioid × HIV status was not significant (P = .36).
Although the researchers stated that a limitation of their study was an inability to prove causality or rule out respiratory depression (vs. immunosuppression) as the cause of the increased CAP risk, “the observed effects of opioid immunosuppressive properties and CAP risk lend support to our hypothesis that opioids have clinically relevant immunosuppressive properties.”
Dr. Edelman and her colleagues cited several limitations. For example, they were not able to determine whether patients took their prescribed medications appropriately and assess whether the patients took nonmedically prescribed opioids. Also, because men made up such a large portion of the study population, it is unclear whether the results are generalizable to women.
Nevertheless, the study “adds to growing evidence of potential medical harms associated with prescribed opioids,” they wrote.
“Health care professionals should be aware of this additional CAP risk when they prescribe opioids, and future studies should investigate the effects of opioids prescribed for longer durations and on other immune-related outcomes,” wrote Dr. Edelman and her colleagues. “Understanding whether mitigating the risk of prescribed opioids for CAP is possible by using a lower dose and nonimmunosuppressive opioids awaits further study.”
However, without such data, when prescribed opioids are warranted, physicians should attempt to modify other factors known to affect CAP risk, including smoking and lack of vaccination, Dr. Edelman and her colleagues concluded.
Several U.S. government agencies and Yale University provided funding for the study. The authors reported that they had no conflicts.
SOURCE: Edelman EJ et al. JAMA Intern Med. 2019 Jan 7. doi: 10.1001/jamainternmed.2018.6101.
Prescribed opioids were associated with an increase in community-acquired pneumonia in patients with and without HIV infection, according to results of a large database study.
People living with HIV (PLWH) appeared to have a greater community-acquired pneumonia (CAP) risk at lower opioid doses and particularly with immunosuppressive opioids compared with uninfected patients, although the difference was not significant, E. Jennifer Edelman, MD, of Yale University, New Haven, Conn., and her colleagues wrote in JAMA Internal Medicine.
The researchers performed a nested case-control study comprising 25,392 participants (98.9% men; mean age, 55 years) in the Veterans Aging Cohort Study from Jan. 1, 2000, through Dec. 31, 2012.
Dr. Edelman and her colleagues compared the characteristics of 4,246 CAP cases with those of 21,146 uninfected controls in the sample. They also compared cases and controls by HIV status. They ran bivariate and multivariate analysis to estimate odds ratios for CAP risk associated with opioid exposure. In addition, the researchers ran models stratified by HIV status and formally checked for an interaction between prescribed opioid characteristics and HIV status.
In unadjusted logistic regression, prescribed opioids were associated with increased odds of CAP, with the greatest risk observed with currently prescribed opioids, compared with past prescribed opioids or no opioids.
Prescribed opioids remained associated with CAP in the adjusted models for past unknown or nonimmunosuppressive (adjusted OR, 1.24; 95% confidence interval, 1.09-1.40) and past immunosuppressive opioid use (aOR, 1.42; 95% CI, 1.21-1.67).
For currently prescribed opioids, nonimmunosuppressive or unknown, the aOR was 1.23 (95% CI, 1.03-1.48). For currently prescribed immunosuppressive opioids, the aOR was 3.18 (95% CI, 2.44-4.14).
The researchers also found evidence of a dose-response effect such that currently prescribed high-dose opioids were associated with the greatest CAP risk, followed by medium- and then by low-dose opioids, whether immunosuppressive or not.
With regard to the effect of HIV status in stratified, adjusted analyses, CAP risk tended to be greater among PLWH with current prescribed opioids, especially immunosuppressive opioids, compared with uninfected patients. However, the overall interaction term for opioid × HIV status was not significant (P = .36).
Although the researchers stated that a limitation of their study was an inability to prove causality or rule out respiratory depression (vs. immunosuppression) as the cause of the increased CAP risk, “the observed effects of opioid immunosuppressive properties and CAP risk lend support to our hypothesis that opioids have clinically relevant immunosuppressive properties.”
Dr. Edelman and her colleagues cited several limitations. For example, they were not able to determine whether patients took their prescribed medications appropriately and assess whether the patients took nonmedically prescribed opioids. Also, because men made up such a large portion of the study population, it is unclear whether the results are generalizable to women.
Nevertheless, the study “adds to growing evidence of potential medical harms associated with prescribed opioids,” they wrote.
“Health care professionals should be aware of this additional CAP risk when they prescribe opioids, and future studies should investigate the effects of opioids prescribed for longer durations and on other immune-related outcomes,” wrote Dr. Edelman and her colleagues. “Understanding whether mitigating the risk of prescribed opioids for CAP is possible by using a lower dose and nonimmunosuppressive opioids awaits further study.”
However, without such data, when prescribed opioids are warranted, physicians should attempt to modify other factors known to affect CAP risk, including smoking and lack of vaccination, Dr. Edelman and her colleagues concluded.
Several U.S. government agencies and Yale University provided funding for the study. The authors reported that they had no conflicts.
SOURCE: Edelman EJ et al. JAMA Intern Med. 2019 Jan 7. doi: 10.1001/jamainternmed.2018.6101.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Prescribed opioids, especially those with immunosuppressive properties, are associated with increased community-acquired pneumonia risk.
Major finding: For currently prescribed immunosuppressive opioids, the adjusted odds ratio for community-acquired pneumonia was 3.18 (95% confidence interval, 2.44-4.14).
Study details: A nested case-control study of 25,392 patients in the Veterans Aging Cohort Study from Jan. 1, 2000, through Dec. 31, 2012.
Disclosures: Funding was provided by a variety of government organizations and Yale University, New Haven, Conn. The authors reported that they had no conflicts.
Source: Edelman EJ et al. JAMA Intern Med. 2019 Jan 7. doi: 10.1001/jamainternmed.2018.6101.
Four distinct IgG4-related disease groups described in study
IgG4-related disease can be grouped into four distinct clusters based on the distribution of organs involved, according to researchers who analyzed a large, multicenter cohort of patients with this heterogeneous, autoimmune-mediated condition.
The four groups also varied by age, race, sex, time to diagnosis, and concentration of serum IgG4, according to the investigators, led by Zachary S. Wallace, MD, of the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, both in Boston.
“These phenotypes may be used by clinicians to improve recognition of IgG4-related disease,” Dr. Wallace and his coauthors wrote in a report on the study that appears in the Annals of the Rheumatic Diseases.
First described in a Japanese population, IgG4-related disease has been subsequently seen in all racial and ethnic groups, according to the researchers. It is associated with organ failure and can affect nearly any organ or anatomic site, most notably the lungs, kidneys, lymph nodes, salivary glands, pancreatobiliary structures, and retroperitoneum.
In the present study, Dr. Wallace and his coinvestigators used a novel cluster analysis method, called latent class analysis, to categorize 765 cases of IgG4-related disease submitted by 52 investigators from 17 countries. The investigators included 493 of those cases in a primary study population, and the remaining 272 in a smaller cohort used to replicate the results.
In the larger, primary study cohort, about 65% of cases were male, 58% were non-Asian and 40% were white, and the mean age at diagnosis was 59.5 years. The replication cohort had similar characteristics, according to the investigators.
The clustering analysis revealed four distinct subgroups, characterized by pancreato-hepatobiliary, accounting for 31% of cases; retroperitoneal fibrosis and/or aortitis in 24%; disease generally limited to head and neck structures in 24%, and head and neck disease consistent with Mikulicz syndrome plus systemic involvement in 22%.
The highest IgG4 concentrations were seen in the group of patients with Mikulicz syndrome and systemic involvement, according to Dr. Wallace and his coauthors. The serum concentration was 1,170 mg/dL in that group, compared with 445 mg/dL in the group of patients with head and neck-limited disease, 316 mg/dL in the pancreato-hepatobiliary group, and just 178 mg/dL in the retroperitoneal fibrosis/aorta group.
Female and Asian patients were overrepresented in the group characterized by head and neck involvement, investigators also found. Moreover, that group had a significantly lower mean age at diagnosis than did the other groups.
Those variations suggested differences in genetic or environmental risk factors between clusters, according to the investigators.
“Given the similar distribution of subspecialists among investigators in this study practicing in Asian and non-Asian countries, the observed differences are unlikely to be the result of detection or selection biases,” they said in their report.
The findings of this study help to inform subsequent investigations intended to evaluate those factors in more detail, they said.
Dr. Wallace and his coauthors reported no conflicts of interest related to their work, which was previously presented at the American College of Rheumatology annual meeting.
SOURCE: Wallace ZS et al. Ann Rheum Dis. 2019 Jan 5. doi: 10.1136/annrheumdis-2018-214603
IgG4-related disease can be grouped into four distinct clusters based on the distribution of organs involved, according to researchers who analyzed a large, multicenter cohort of patients with this heterogeneous, autoimmune-mediated condition.
The four groups also varied by age, race, sex, time to diagnosis, and concentration of serum IgG4, according to the investigators, led by Zachary S. Wallace, MD, of the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, both in Boston.
“These phenotypes may be used by clinicians to improve recognition of IgG4-related disease,” Dr. Wallace and his coauthors wrote in a report on the study that appears in the Annals of the Rheumatic Diseases.
First described in a Japanese population, IgG4-related disease has been subsequently seen in all racial and ethnic groups, according to the researchers. It is associated with organ failure and can affect nearly any organ or anatomic site, most notably the lungs, kidneys, lymph nodes, salivary glands, pancreatobiliary structures, and retroperitoneum.
In the present study, Dr. Wallace and his coinvestigators used a novel cluster analysis method, called latent class analysis, to categorize 765 cases of IgG4-related disease submitted by 52 investigators from 17 countries. The investigators included 493 of those cases in a primary study population, and the remaining 272 in a smaller cohort used to replicate the results.
In the larger, primary study cohort, about 65% of cases were male, 58% were non-Asian and 40% were white, and the mean age at diagnosis was 59.5 years. The replication cohort had similar characteristics, according to the investigators.
The clustering analysis revealed four distinct subgroups, characterized by pancreato-hepatobiliary, accounting for 31% of cases; retroperitoneal fibrosis and/or aortitis in 24%; disease generally limited to head and neck structures in 24%, and head and neck disease consistent with Mikulicz syndrome plus systemic involvement in 22%.
The highest IgG4 concentrations were seen in the group of patients with Mikulicz syndrome and systemic involvement, according to Dr. Wallace and his coauthors. The serum concentration was 1,170 mg/dL in that group, compared with 445 mg/dL in the group of patients with head and neck-limited disease, 316 mg/dL in the pancreato-hepatobiliary group, and just 178 mg/dL in the retroperitoneal fibrosis/aorta group.
Female and Asian patients were overrepresented in the group characterized by head and neck involvement, investigators also found. Moreover, that group had a significantly lower mean age at diagnosis than did the other groups.
Those variations suggested differences in genetic or environmental risk factors between clusters, according to the investigators.
“Given the similar distribution of subspecialists among investigators in this study practicing in Asian and non-Asian countries, the observed differences are unlikely to be the result of detection or selection biases,” they said in their report.
The findings of this study help to inform subsequent investigations intended to evaluate those factors in more detail, they said.
Dr. Wallace and his coauthors reported no conflicts of interest related to their work, which was previously presented at the American College of Rheumatology annual meeting.
SOURCE: Wallace ZS et al. Ann Rheum Dis. 2019 Jan 5. doi: 10.1136/annrheumdis-2018-214603
IgG4-related disease can be grouped into four distinct clusters based on the distribution of organs involved, according to researchers who analyzed a large, multicenter cohort of patients with this heterogeneous, autoimmune-mediated condition.
The four groups also varied by age, race, sex, time to diagnosis, and concentration of serum IgG4, according to the investigators, led by Zachary S. Wallace, MD, of the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, both in Boston.
“These phenotypes may be used by clinicians to improve recognition of IgG4-related disease,” Dr. Wallace and his coauthors wrote in a report on the study that appears in the Annals of the Rheumatic Diseases.
First described in a Japanese population, IgG4-related disease has been subsequently seen in all racial and ethnic groups, according to the researchers. It is associated with organ failure and can affect nearly any organ or anatomic site, most notably the lungs, kidneys, lymph nodes, salivary glands, pancreatobiliary structures, and retroperitoneum.
In the present study, Dr. Wallace and his coinvestigators used a novel cluster analysis method, called latent class analysis, to categorize 765 cases of IgG4-related disease submitted by 52 investigators from 17 countries. The investigators included 493 of those cases in a primary study population, and the remaining 272 in a smaller cohort used to replicate the results.
In the larger, primary study cohort, about 65% of cases were male, 58% were non-Asian and 40% were white, and the mean age at diagnosis was 59.5 years. The replication cohort had similar characteristics, according to the investigators.
The clustering analysis revealed four distinct subgroups, characterized by pancreato-hepatobiliary, accounting for 31% of cases; retroperitoneal fibrosis and/or aortitis in 24%; disease generally limited to head and neck structures in 24%, and head and neck disease consistent with Mikulicz syndrome plus systemic involvement in 22%.
The highest IgG4 concentrations were seen in the group of patients with Mikulicz syndrome and systemic involvement, according to Dr. Wallace and his coauthors. The serum concentration was 1,170 mg/dL in that group, compared with 445 mg/dL in the group of patients with head and neck-limited disease, 316 mg/dL in the pancreato-hepatobiliary group, and just 178 mg/dL in the retroperitoneal fibrosis/aorta group.
Female and Asian patients were overrepresented in the group characterized by head and neck involvement, investigators also found. Moreover, that group had a significantly lower mean age at diagnosis than did the other groups.
Those variations suggested differences in genetic or environmental risk factors between clusters, according to the investigators.
“Given the similar distribution of subspecialists among investigators in this study practicing in Asian and non-Asian countries, the observed differences are unlikely to be the result of detection or selection biases,” they said in their report.
The findings of this study help to inform subsequent investigations intended to evaluate those factors in more detail, they said.
Dr. Wallace and his coauthors reported no conflicts of interest related to their work, which was previously presented at the American College of Rheumatology annual meeting.
SOURCE: Wallace ZS et al. Ann Rheum Dis. 2019 Jan 5. doi: 10.1136/annrheumdis-2018-214603
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point:
Major finding: The highest IgG4 concentrations (1,170 mg/dL) were seen in a group of patients with Mikulicz syndrome and systemic involvement. Females and Asian patients were overrepresented in a group characterized by head and neck involvement.
Study details: Two cross-sectional studies including a total of 765 cases of IgG4-related disease submitted by 52 investigators in 17 countries.
Disclosures: Authors reported no conflicts of interest.
Source: Wallace ZS et al. Ann Rheum Dis. 2019 Jan 5. doi: 10.1136/annrheumdis-2018-214603.
Violence against women: Gail Robinson
Dr. Robinson is professor of psychiatry and obstetrics/gynecology and professor of equality, gender, and population at the University of Toronto. She’s also chair of GAP’s Committee on Gender & Mental Health. In this episode, Dr. Robinson delves into strategies for interacting with survivors of violence, the roots of the “Me Too” movement, as well as rising rates of maternal mortality in the United States.
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Dr. Robinson is professor of psychiatry and obstetrics/gynecology and professor of equality, gender, and population at the University of Toronto. She’s also chair of GAP’s Committee on Gender & Mental Health. In this episode, Dr. Robinson delves into strategies for interacting with survivors of violence, the roots of the “Me Too” movement, as well as rising rates of maternal mortality in the United States.
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Apple Podcasts
Google Podcasts
Spotify
Dr. Robinson is professor of psychiatry and obstetrics/gynecology and professor of equality, gender, and population at the University of Toronto. She’s also chair of GAP’s Committee on Gender & Mental Health. In this episode, Dr. Robinson delves into strategies for interacting with survivors of violence, the roots of the “Me Too” movement, as well as rising rates of maternal mortality in the United States.
Amazon
Apple Podcasts
Google Podcasts
Spotify
