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E. coli resistant to colistin and carbapenems found in U.S. patient
The first strain of Escherichia coli harboring the antibiotic-resistant genes mcr-1 and blaNDM-5 was isolated in the urine of a U.S. patient, according to a report in mBio.
A 76-year-old man was admitted to a tertiary-care hospital in New Jersey with a fever and flank pain in August 2014. The patient emigrated from India and resided in the United States for 1 year prior to this presentation. He had a history of prostate cancer treated with radiation therapy and subsequently developed recurrent urinary tract infections. He had also experienced bladder perforation requiring bilateral placement of nephrostomy tubes, which were clamped 5 days prior to presentation.
Using molecular analysis, the E. coli isolate from the study case (named MCR1_NJ) was shown to carry both mcr-1 and blaNDM-5 genes. In addition to mcr-1 and blaNDM-5, strain MCR1_NJ was found to harbor resistance genes for aminoglycosides, beta-lactams, chloramphenicol, fluoroquinolones, rifampin, sulfonamides, and tetracycline.
“This strain was isolated in August 2014, highlighting an earlier presence of mcr-1 within the region than previously known and raising the likelihood of ongoing undetected transmission,” wrote José R. Mediavilla, MBS, MPH of the New Jersey Medical School, Rutgers University, Newark, N.J., and his coauthors. “Active surveillance efforts involving all polymyxin- and carbapenem-resistant organisms are imperative in order to determine mcr-1 prevalence and prevent further dissemination.”
Find the full study in mBio (doi: 10.1128/mBio.01191-16).
The first strain of Escherichia coli harboring the antibiotic-resistant genes mcr-1 and blaNDM-5 was isolated in the urine of a U.S. patient, according to a report in mBio.
A 76-year-old man was admitted to a tertiary-care hospital in New Jersey with a fever and flank pain in August 2014. The patient emigrated from India and resided in the United States for 1 year prior to this presentation. He had a history of prostate cancer treated with radiation therapy and subsequently developed recurrent urinary tract infections. He had also experienced bladder perforation requiring bilateral placement of nephrostomy tubes, which were clamped 5 days prior to presentation.
Using molecular analysis, the E. coli isolate from the study case (named MCR1_NJ) was shown to carry both mcr-1 and blaNDM-5 genes. In addition to mcr-1 and blaNDM-5, strain MCR1_NJ was found to harbor resistance genes for aminoglycosides, beta-lactams, chloramphenicol, fluoroquinolones, rifampin, sulfonamides, and tetracycline.
“This strain was isolated in August 2014, highlighting an earlier presence of mcr-1 within the region than previously known and raising the likelihood of ongoing undetected transmission,” wrote José R. Mediavilla, MBS, MPH of the New Jersey Medical School, Rutgers University, Newark, N.J., and his coauthors. “Active surveillance efforts involving all polymyxin- and carbapenem-resistant organisms are imperative in order to determine mcr-1 prevalence and prevent further dissemination.”
Find the full study in mBio (doi: 10.1128/mBio.01191-16).
The first strain of Escherichia coli harboring the antibiotic-resistant genes mcr-1 and blaNDM-5 was isolated in the urine of a U.S. patient, according to a report in mBio.
A 76-year-old man was admitted to a tertiary-care hospital in New Jersey with a fever and flank pain in August 2014. The patient emigrated from India and resided in the United States for 1 year prior to this presentation. He had a history of prostate cancer treated with radiation therapy and subsequently developed recurrent urinary tract infections. He had also experienced bladder perforation requiring bilateral placement of nephrostomy tubes, which were clamped 5 days prior to presentation.
Using molecular analysis, the E. coli isolate from the study case (named MCR1_NJ) was shown to carry both mcr-1 and blaNDM-5 genes. In addition to mcr-1 and blaNDM-5, strain MCR1_NJ was found to harbor resistance genes for aminoglycosides, beta-lactams, chloramphenicol, fluoroquinolones, rifampin, sulfonamides, and tetracycline.
“This strain was isolated in August 2014, highlighting an earlier presence of mcr-1 within the region than previously known and raising the likelihood of ongoing undetected transmission,” wrote José R. Mediavilla, MBS, MPH of the New Jersey Medical School, Rutgers University, Newark, N.J., and his coauthors. “Active surveillance efforts involving all polymyxin- and carbapenem-resistant organisms are imperative in order to determine mcr-1 prevalence and prevent further dissemination.”
Find the full study in mBio (doi: 10.1128/mBio.01191-16).
Unexplained subfertility in RA linked to periconceptional NSAID use
Women with rheumatoid arthritis are more often diagnosed with unexplained subfertility, compared with women in the general population, according to a new study published in Arthritis Care & Research.
This finding may imply that fertility in female RA patients is influenced by disease-related factors, specifically the use of periconceptional NSAIDs, according to the investigators.
In addition, when women with RA try to conceive, their antirheumatic treatment regimens need to be adjusted, which increases risk for permanent joint damage, the investigators wrote, adding that “understanding the underlying mechanisms of subfertility in RA, and treatment of these mechanisms whenever possible, would be an important step forward in the care for these patients.”
To study the outcome of fertility assessments in women with RA and subfertility, Dr. Brouwer and her associates performed a cross-sectional study of 260 female RA patients who were recruited from the Pregnancy-induced Amelioration of RA study, a Dutch nationwide prospective observational trial of women diagnosed with RA who were in their first trimester of pregnancy or who were trying to conceive.
Each eligible participant received a questionnaire that included questions regarding reproductive history, time to pregnancy, mode of conception for prior pregnancies, fertility assessments, and fertility treatments. For the 178 (68%) women who returned completed questionnaires, additional gynecologic histories and diagnoses were collected from medical histories and/or patient files.
Analysis of these data revealed that 82 women (46%; 95% confidence interval, 39%-53%) with RA were considered subfertile. Subfertility was most often unexplained (48% of known diagnoses) or caused by anovulation (28%) or semen abnormalities (16%).
“In comparison to the general population, female RA patients appear to be more often diagnosed with unexplained subfertility, whereas the percentage of subfertile women with anovulation was equal or slightly increased compared to percentages found in the general population,” the investigators wrote.
The majority of subfertile RA patients received fertility treatments, and “a considerable number of all pregnancies were conceived after women had been treated for subfertility,” according to the researchers.
The significant association between periconceptional NSAIDs use and unexplained subfertility “is in concordance with a previous study within the PARA cohort where we have shown that a longer [time to pregnancy] was associated with the periconceptional use of NSAIDs,” Dr. Brouwer and her associates wrote.
“In daily practice, when an RA patient wishes to conceive, NSAIDs should be avoided, and early consultation with an expert rheumatologist and a fertility specialist should be considered to optimize the patient’s chance of a complete family,” the investigators recommended.
This study was funded by the Dutch Arthritis Foundation. One investigator reported received financial compensation from UCB Pharma; the other investigators reported having no relevant disclosures.
[email protected]
On Twitter @jessnicolecraig
Women with rheumatoid arthritis are more often diagnosed with unexplained subfertility, compared with women in the general population, according to a new study published in Arthritis Care & Research.
This finding may imply that fertility in female RA patients is influenced by disease-related factors, specifically the use of periconceptional NSAIDs, according to the investigators.
In addition, when women with RA try to conceive, their antirheumatic treatment regimens need to be adjusted, which increases risk for permanent joint damage, the investigators wrote, adding that “understanding the underlying mechanisms of subfertility in RA, and treatment of these mechanisms whenever possible, would be an important step forward in the care for these patients.”
To study the outcome of fertility assessments in women with RA and subfertility, Dr. Brouwer and her associates performed a cross-sectional study of 260 female RA patients who were recruited from the Pregnancy-induced Amelioration of RA study, a Dutch nationwide prospective observational trial of women diagnosed with RA who were in their first trimester of pregnancy or who were trying to conceive.
Each eligible participant received a questionnaire that included questions regarding reproductive history, time to pregnancy, mode of conception for prior pregnancies, fertility assessments, and fertility treatments. For the 178 (68%) women who returned completed questionnaires, additional gynecologic histories and diagnoses were collected from medical histories and/or patient files.
Analysis of these data revealed that 82 women (46%; 95% confidence interval, 39%-53%) with RA were considered subfertile. Subfertility was most often unexplained (48% of known diagnoses) or caused by anovulation (28%) or semen abnormalities (16%).
“In comparison to the general population, female RA patients appear to be more often diagnosed with unexplained subfertility, whereas the percentage of subfertile women with anovulation was equal or slightly increased compared to percentages found in the general population,” the investigators wrote.
The majority of subfertile RA patients received fertility treatments, and “a considerable number of all pregnancies were conceived after women had been treated for subfertility,” according to the researchers.
The significant association between periconceptional NSAIDs use and unexplained subfertility “is in concordance with a previous study within the PARA cohort where we have shown that a longer [time to pregnancy] was associated with the periconceptional use of NSAIDs,” Dr. Brouwer and her associates wrote.
“In daily practice, when an RA patient wishes to conceive, NSAIDs should be avoided, and early consultation with an expert rheumatologist and a fertility specialist should be considered to optimize the patient’s chance of a complete family,” the investigators recommended.
This study was funded by the Dutch Arthritis Foundation. One investigator reported received financial compensation from UCB Pharma; the other investigators reported having no relevant disclosures.
[email protected]
On Twitter @jessnicolecraig
Women with rheumatoid arthritis are more often diagnosed with unexplained subfertility, compared with women in the general population, according to a new study published in Arthritis Care & Research.
This finding may imply that fertility in female RA patients is influenced by disease-related factors, specifically the use of periconceptional NSAIDs, according to the investigators.
In addition, when women with RA try to conceive, their antirheumatic treatment regimens need to be adjusted, which increases risk for permanent joint damage, the investigators wrote, adding that “understanding the underlying mechanisms of subfertility in RA, and treatment of these mechanisms whenever possible, would be an important step forward in the care for these patients.”
To study the outcome of fertility assessments in women with RA and subfertility, Dr. Brouwer and her associates performed a cross-sectional study of 260 female RA patients who were recruited from the Pregnancy-induced Amelioration of RA study, a Dutch nationwide prospective observational trial of women diagnosed with RA who were in their first trimester of pregnancy or who were trying to conceive.
Each eligible participant received a questionnaire that included questions regarding reproductive history, time to pregnancy, mode of conception for prior pregnancies, fertility assessments, and fertility treatments. For the 178 (68%) women who returned completed questionnaires, additional gynecologic histories and diagnoses were collected from medical histories and/or patient files.
Analysis of these data revealed that 82 women (46%; 95% confidence interval, 39%-53%) with RA were considered subfertile. Subfertility was most often unexplained (48% of known diagnoses) or caused by anovulation (28%) or semen abnormalities (16%).
“In comparison to the general population, female RA patients appear to be more often diagnosed with unexplained subfertility, whereas the percentage of subfertile women with anovulation was equal or slightly increased compared to percentages found in the general population,” the investigators wrote.
The majority of subfertile RA patients received fertility treatments, and “a considerable number of all pregnancies were conceived after women had been treated for subfertility,” according to the researchers.
The significant association between periconceptional NSAIDs use and unexplained subfertility “is in concordance with a previous study within the PARA cohort where we have shown that a longer [time to pregnancy] was associated with the periconceptional use of NSAIDs,” Dr. Brouwer and her associates wrote.
“In daily practice, when an RA patient wishes to conceive, NSAIDs should be avoided, and early consultation with an expert rheumatologist and a fertility specialist should be considered to optimize the patient’s chance of a complete family,” the investigators recommended.
This study was funded by the Dutch Arthritis Foundation. One investigator reported received financial compensation from UCB Pharma; the other investigators reported having no relevant disclosures.
[email protected]
On Twitter @jessnicolecraig
FROM ARTHRITIS CARE & RESEARCH
Key clinical point:
Major finding: Of 178 women with RA, 46% were considered subfertile. Subfertility was most often unexplained (48% of known diagnoses) or caused by anovulation (28%).
Data source: Cross-sectional study of 260 female RA patients.
Disclosures: This study was funded by the Dutch Arthritis Foundation. One investigator reported received financial compensation from UCB Pharma; the other investigators reported having no relevant disclosures.
Number of Zika-infected pregnant women continues to climb
The number of pregnant women with laboratory evidence of Zika infection increased by 209 for the week ending Oct. 6, the second-largest weekly increase so far in the United States in 2016, according to the Centers for Disease Control and Prevention.
Another liveborn infant with Zika-related birth defects also was reported for the week, bringing the total for the year to 23 for the 50 states and the District of Columbia. There were no new cases of Zika-related pregnancy losses reported, so the 50-state/DC total remains at five.
Of the 209 new cases reported for the week ending Oct. 6, 41 were in the states/D.C. and 168 were in the territories. The total number of U.S. Zika cases in pregnant women for the year is 2,684: 878 in the states/D.C. and 1,806 in the territories, the CDC said.
Among all Americans, there were 29,891 cases reported as of Oct. 12: 3,936 in the states/D.C. and 25,955 in the territories. Of the territorial cases, 98% have been in Puerto Rico, the CDC reported.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
The pregnancy-related figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.
The number of pregnant women with laboratory evidence of Zika infection increased by 209 for the week ending Oct. 6, the second-largest weekly increase so far in the United States in 2016, according to the Centers for Disease Control and Prevention.
Another liveborn infant with Zika-related birth defects also was reported for the week, bringing the total for the year to 23 for the 50 states and the District of Columbia. There were no new cases of Zika-related pregnancy losses reported, so the 50-state/DC total remains at five.
Of the 209 new cases reported for the week ending Oct. 6, 41 were in the states/D.C. and 168 were in the territories. The total number of U.S. Zika cases in pregnant women for the year is 2,684: 878 in the states/D.C. and 1,806 in the territories, the CDC said.
Among all Americans, there were 29,891 cases reported as of Oct. 12: 3,936 in the states/D.C. and 25,955 in the territories. Of the territorial cases, 98% have been in Puerto Rico, the CDC reported.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
The pregnancy-related figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.
The number of pregnant women with laboratory evidence of Zika infection increased by 209 for the week ending Oct. 6, the second-largest weekly increase so far in the United States in 2016, according to the Centers for Disease Control and Prevention.
Another liveborn infant with Zika-related birth defects also was reported for the week, bringing the total for the year to 23 for the 50 states and the District of Columbia. There were no new cases of Zika-related pregnancy losses reported, so the 50-state/DC total remains at five.
Of the 209 new cases reported for the week ending Oct. 6, 41 were in the states/D.C. and 168 were in the territories. The total number of U.S. Zika cases in pregnant women for the year is 2,684: 878 in the states/D.C. and 1,806 in the territories, the CDC said.
Among all Americans, there were 29,891 cases reported as of Oct. 12: 3,936 in the states/D.C. and 25,955 in the territories. Of the territorial cases, 98% have been in Puerto Rico, the CDC reported.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
The pregnancy-related figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.
Pancreaticobiliary potpourri
The session at the annual Digestive Disease Week entitled Pancreaticobiliary Potpourri encompassed three lectures. Suresh Chari, MD, from Mayo Clinic, Rochester, Minn., presented a lecture titled, “The cystic pancreas.” Gregory Gores, MD, AGAF, also of Mayo Clinic presented a lecture on “Managing the possibly malignant biliary stricture.” Finally, I, Todd H. Baron, MD, from the University of North Carolina at Chapel Hill delivered a lecture titled, “Preventing and managing complications of acute pancreatitis.”
Dr. Gores relayed that there are a variety of etiologies of biliary strictures. Discerning benign from malignant causes involves the use of cross-sectional imaging, PET-CT, serum tests, and endoscopy to include endoscopic retrograde cholangiopancreatography (ERCP) and EUS. IgG4, or autoimmune disease, is an important treatable cause of biliary obstruction. The diagnosis requires a high index of suspicion. Notably, an elevated serum IgG4 level can be seen in patients with cholangiocarcinoma. Fluorescence in situ hybridization (FISH) applied to biliary brush samples at the time of cytologic evaluation has been shown to markedly improve the sensitivity, compared with standard brush cytology. Cholangioscopy with targeted biopsies has been shown to have a sensitivity of 66% and specificity of 97%.
I emphasized the importance of preventing pancreatitis by careful selection of patients for ERCP, by limiting contrast injection during ERCP, and by the use of rectally administered nonsteroidal anti-inflammatory agents at the time of ERCP. Prevention of complications after onset of ERCP is the focus in patients with clinically severe acute pancreatitis, which is usually the result of pancreatic and/or peripancreatic necrosis. Early management consists of prompt and appropriate volume resuscitation, with recent evidence showing Lactated Ringer’s solution being superior to saline. Routine administration of antibiotics is not recommended, but early enteral feeding is recommended. Finally, interventions should be delayed as long as possible with minimally invasive techniques, including endoscopic drainage for walled-off pancreatic necrosis favored over traditional open procedures.
This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016. Dr. Baron is professor of medicine and director of advanced therapeutic endoscopy in the division of gastroenterology and hepatology in the school of medicine at the University of North Carolina at Chapel Hill. He has consulted and been a speaker for BSCI, Cook Endoscopy, and Olympus; and consulted for W.L. Gore.
The session at the annual Digestive Disease Week entitled Pancreaticobiliary Potpourri encompassed three lectures. Suresh Chari, MD, from Mayo Clinic, Rochester, Minn., presented a lecture titled, “The cystic pancreas.” Gregory Gores, MD, AGAF, also of Mayo Clinic presented a lecture on “Managing the possibly malignant biliary stricture.” Finally, I, Todd H. Baron, MD, from the University of North Carolina at Chapel Hill delivered a lecture titled, “Preventing and managing complications of acute pancreatitis.”
Dr. Gores relayed that there are a variety of etiologies of biliary strictures. Discerning benign from malignant causes involves the use of cross-sectional imaging, PET-CT, serum tests, and endoscopy to include endoscopic retrograde cholangiopancreatography (ERCP) and EUS. IgG4, or autoimmune disease, is an important treatable cause of biliary obstruction. The diagnosis requires a high index of suspicion. Notably, an elevated serum IgG4 level can be seen in patients with cholangiocarcinoma. Fluorescence in situ hybridization (FISH) applied to biliary brush samples at the time of cytologic evaluation has been shown to markedly improve the sensitivity, compared with standard brush cytology. Cholangioscopy with targeted biopsies has been shown to have a sensitivity of 66% and specificity of 97%.
I emphasized the importance of preventing pancreatitis by careful selection of patients for ERCP, by limiting contrast injection during ERCP, and by the use of rectally administered nonsteroidal anti-inflammatory agents at the time of ERCP. Prevention of complications after onset of ERCP is the focus in patients with clinically severe acute pancreatitis, which is usually the result of pancreatic and/or peripancreatic necrosis. Early management consists of prompt and appropriate volume resuscitation, with recent evidence showing Lactated Ringer’s solution being superior to saline. Routine administration of antibiotics is not recommended, but early enteral feeding is recommended. Finally, interventions should be delayed as long as possible with minimally invasive techniques, including endoscopic drainage for walled-off pancreatic necrosis favored over traditional open procedures.
This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016. Dr. Baron is professor of medicine and director of advanced therapeutic endoscopy in the division of gastroenterology and hepatology in the school of medicine at the University of North Carolina at Chapel Hill. He has consulted and been a speaker for BSCI, Cook Endoscopy, and Olympus; and consulted for W.L. Gore.
The session at the annual Digestive Disease Week entitled Pancreaticobiliary Potpourri encompassed three lectures. Suresh Chari, MD, from Mayo Clinic, Rochester, Minn., presented a lecture titled, “The cystic pancreas.” Gregory Gores, MD, AGAF, also of Mayo Clinic presented a lecture on “Managing the possibly malignant biliary stricture.” Finally, I, Todd H. Baron, MD, from the University of North Carolina at Chapel Hill delivered a lecture titled, “Preventing and managing complications of acute pancreatitis.”
Dr. Gores relayed that there are a variety of etiologies of biliary strictures. Discerning benign from malignant causes involves the use of cross-sectional imaging, PET-CT, serum tests, and endoscopy to include endoscopic retrograde cholangiopancreatography (ERCP) and EUS. IgG4, or autoimmune disease, is an important treatable cause of biliary obstruction. The diagnosis requires a high index of suspicion. Notably, an elevated serum IgG4 level can be seen in patients with cholangiocarcinoma. Fluorescence in situ hybridization (FISH) applied to biliary brush samples at the time of cytologic evaluation has been shown to markedly improve the sensitivity, compared with standard brush cytology. Cholangioscopy with targeted biopsies has been shown to have a sensitivity of 66% and specificity of 97%.
I emphasized the importance of preventing pancreatitis by careful selection of patients for ERCP, by limiting contrast injection during ERCP, and by the use of rectally administered nonsteroidal anti-inflammatory agents at the time of ERCP. Prevention of complications after onset of ERCP is the focus in patients with clinically severe acute pancreatitis, which is usually the result of pancreatic and/or peripancreatic necrosis. Early management consists of prompt and appropriate volume resuscitation, with recent evidence showing Lactated Ringer’s solution being superior to saline. Routine administration of antibiotics is not recommended, but early enteral feeding is recommended. Finally, interventions should be delayed as long as possible with minimally invasive techniques, including endoscopic drainage for walled-off pancreatic necrosis favored over traditional open procedures.
This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016. Dr. Baron is professor of medicine and director of advanced therapeutic endoscopy in the division of gastroenterology and hepatology in the school of medicine at the University of North Carolina at Chapel Hill. He has consulted and been a speaker for BSCI, Cook Endoscopy, and Olympus; and consulted for W.L. Gore.
Early menopause a risk factor for type 2 diabetes
“What we see in our data is that indeed, early onset of menopause is associated with increased risk of type 2 diabetes, and this association is independent of potential intermediate risk factors: obesity, insulin, glucose, inflammation, but also of estradiol and other endogenous sex hormone levels,” said Taulant Muka, MD, PhD, in an interview.
Dr. Muka, a postdoctoral fellow at Erasmus Medical College, Rotterdam, the Netherlands, presented the analysis from a large, prospective cohort of menopausal women at the annual meeting of the North American Menopause Society.
In an interview, Dr. Muka noted that the study investigated whether the association between early age at natural menopause (ANM) and type 2 diabetes is independent of intermediate risk factors for type 2 diabetes, such as obesity. Finally, the study also assessed whether endogenous sex hormone levels play a role in the link between early ANM and type 2 diabetes.
Enrollment in the Rotterdam study has been continuing in waves since the 1990s, with enrollment for participants in this particular study cohort occurring in 1997 and with additional cohorts enrolled in 2000-2001 and 2006-2008.
“I think this is the first prospective study with such long follow-up data and with a broad adjustment for confounding factors. Previous studies have been mainly cross-sectional, providing conflicting results,” said Dr. Muka.
Using self-reported age at menopause, the investigators excluded from the study women whose menopausal status was not known, who were actually not menopausal, or whose menopause had not occurred naturally. The study population also excluded women with prevalent type 2 diabetes or for whom no information about diabetes follow-up could be found.
The remaining 3,210 women who were included in the study had a median age of 67 years and had reached menopause at a median of 49.9 years. Most women (82.6%) had an ANM of 45-55 years; ANM for 8.8% was 40-44 years, while just 2.3% had an ANM of under 40 years. Mean body mass index was 27.1 kg/m2.
Participants were considered to have incident diabetes based on several sources: a general practitioner’s records, hospital discharge paperwork, or glucose measurements from visits during the Rotterdam study. Participants also were classified as having diabetes if they used a hypoglycemic medication or had a fasting blood glucose level of at least 7 mmol/L (126 mg/dL) or, in the absence of a fasting blood glucose measurement, a nonfasting blood glucose of at least 11.1 mmol/L (200 mg/dL).
Dr. Muka said he and his coinvestigators identified and adjusted for a large number of variables, using a series of three Cox proportion hazard models.
The first model adjusted for age, which wave of enrollment (cohort) participants were in, hormone therapy status, age at menarche, and the number of pregnancies that reached at least 6 months’ gestation.
The second model used all of the factors in model 1, and added BMI and glucose and insulin levels. The third model used all of the factors in model 2, and also added total cholesterol level, systolic blood pressure, the use of lipid-lowering or antihypertensive medications, alcohol and tobacco use, educational level, prevalent cardiovascular disease, and C-reactive protein levels.
The association of early ANM with the risk of type 2 diabetes was statistically significant in all three models (P less than .001), with very similar hazard ratios (HRs) in all models. For the third, the most comprehensive model, the HR was 1.42 (95% confidence interval, 0.83-2.45).
Extensive sensitivity analyses were carried out, and the association held independent of physical activity level, smoking status, use of hormone therapy, and age. The investigators also used multivariable analyses to ensure that the effect was not mediated by serum levels of thyroid-stimulating hormone, dihydroepiandosterone (DHEA) and DHEA sulfate, estradiol, testosterone, sex hormone–binding globulin (SHBG), or androstenedione.
This study was the first in this population to obtain and adjust for serum sex hormone and SHBG levels, said Dr. Muka.
The prospective design of the study and the long follow-up period were study strengths, said Dr. Muka. Additionally, blood glucose readings taken at study visits, together with electronically linked pharmacy dispensing records, were used for incident diabetes diagnoses.
Study limitations, Dr. Muka said, included the possibility of survival bias, since enrollees “may represent survivors of early menopause who did not develop [type 2 diabetes] or die prior to enrollment.” However, he said, this would mean that “we have underestimated the association, so the risk would be even higher.” Also, all study participants were white, so the results cannot be extrapolated to nonwhite populations.
Dr. Muka said that the largely American audience for his presentation was interested in the fact that the association existed independent of BMI, an obesity marker, based on questions and comments following the talk. “Indeed, we stratified the analysis, and we didn’t find any difference between participants who were obese and nonobese.” Also, he said that there were queries about whether the analyses had corrected for DEXA measurements, in order to assess lean versus fat body composition more accurately. This analysis has not been done, but Dr. Muka plans to complete it on his return to Rotterdam, he said.
Up to 10% of women will reach menopause before the age of 45, said Dr. Muka, so this analysis has the potential to impact primary care for millions of women. “Women who undergo early menopause may be a target for type 2 diabetes prevention measures and might need to be screened for other cardiovascular risk factors like high blood pressure and dyslipidemia, since they are also at risk for cardiovascular disease.”
Dr. Muka reported no outside funding sources and had no relevant financial disclosures.
[email protected]
On Twitter @karioakes
“What we see in our data is that indeed, early onset of menopause is associated with increased risk of type 2 diabetes, and this association is independent of potential intermediate risk factors: obesity, insulin, glucose, inflammation, but also of estradiol and other endogenous sex hormone levels,” said Taulant Muka, MD, PhD, in an interview.
Dr. Muka, a postdoctoral fellow at Erasmus Medical College, Rotterdam, the Netherlands, presented the analysis from a large, prospective cohort of menopausal women at the annual meeting of the North American Menopause Society.
In an interview, Dr. Muka noted that the study investigated whether the association between early age at natural menopause (ANM) and type 2 diabetes is independent of intermediate risk factors for type 2 diabetes, such as obesity. Finally, the study also assessed whether endogenous sex hormone levels play a role in the link between early ANM and type 2 diabetes.
Enrollment in the Rotterdam study has been continuing in waves since the 1990s, with enrollment for participants in this particular study cohort occurring in 1997 and with additional cohorts enrolled in 2000-2001 and 2006-2008.
“I think this is the first prospective study with such long follow-up data and with a broad adjustment for confounding factors. Previous studies have been mainly cross-sectional, providing conflicting results,” said Dr. Muka.
Using self-reported age at menopause, the investigators excluded from the study women whose menopausal status was not known, who were actually not menopausal, or whose menopause had not occurred naturally. The study population also excluded women with prevalent type 2 diabetes or for whom no information about diabetes follow-up could be found.
The remaining 3,210 women who were included in the study had a median age of 67 years and had reached menopause at a median of 49.9 years. Most women (82.6%) had an ANM of 45-55 years; ANM for 8.8% was 40-44 years, while just 2.3% had an ANM of under 40 years. Mean body mass index was 27.1 kg/m2.
Participants were considered to have incident diabetes based on several sources: a general practitioner’s records, hospital discharge paperwork, or glucose measurements from visits during the Rotterdam study. Participants also were classified as having diabetes if they used a hypoglycemic medication or had a fasting blood glucose level of at least 7 mmol/L (126 mg/dL) or, in the absence of a fasting blood glucose measurement, a nonfasting blood glucose of at least 11.1 mmol/L (200 mg/dL).
Dr. Muka said he and his coinvestigators identified and adjusted for a large number of variables, using a series of three Cox proportion hazard models.
The first model adjusted for age, which wave of enrollment (cohort) participants were in, hormone therapy status, age at menarche, and the number of pregnancies that reached at least 6 months’ gestation.
The second model used all of the factors in model 1, and added BMI and glucose and insulin levels. The third model used all of the factors in model 2, and also added total cholesterol level, systolic blood pressure, the use of lipid-lowering or antihypertensive medications, alcohol and tobacco use, educational level, prevalent cardiovascular disease, and C-reactive protein levels.
The association of early ANM with the risk of type 2 diabetes was statistically significant in all three models (P less than .001), with very similar hazard ratios (HRs) in all models. For the third, the most comprehensive model, the HR was 1.42 (95% confidence interval, 0.83-2.45).
Extensive sensitivity analyses were carried out, and the association held independent of physical activity level, smoking status, use of hormone therapy, and age. The investigators also used multivariable analyses to ensure that the effect was not mediated by serum levels of thyroid-stimulating hormone, dihydroepiandosterone (DHEA) and DHEA sulfate, estradiol, testosterone, sex hormone–binding globulin (SHBG), or androstenedione.
This study was the first in this population to obtain and adjust for serum sex hormone and SHBG levels, said Dr. Muka.
The prospective design of the study and the long follow-up period were study strengths, said Dr. Muka. Additionally, blood glucose readings taken at study visits, together with electronically linked pharmacy dispensing records, were used for incident diabetes diagnoses.
Study limitations, Dr. Muka said, included the possibility of survival bias, since enrollees “may represent survivors of early menopause who did not develop [type 2 diabetes] or die prior to enrollment.” However, he said, this would mean that “we have underestimated the association, so the risk would be even higher.” Also, all study participants were white, so the results cannot be extrapolated to nonwhite populations.
Dr. Muka said that the largely American audience for his presentation was interested in the fact that the association existed independent of BMI, an obesity marker, based on questions and comments following the talk. “Indeed, we stratified the analysis, and we didn’t find any difference between participants who were obese and nonobese.” Also, he said that there were queries about whether the analyses had corrected for DEXA measurements, in order to assess lean versus fat body composition more accurately. This analysis has not been done, but Dr. Muka plans to complete it on his return to Rotterdam, he said.
Up to 10% of women will reach menopause before the age of 45, said Dr. Muka, so this analysis has the potential to impact primary care for millions of women. “Women who undergo early menopause may be a target for type 2 diabetes prevention measures and might need to be screened for other cardiovascular risk factors like high blood pressure and dyslipidemia, since they are also at risk for cardiovascular disease.”
Dr. Muka reported no outside funding sources and had no relevant financial disclosures.
[email protected]
On Twitter @karioakes
“What we see in our data is that indeed, early onset of menopause is associated with increased risk of type 2 diabetes, and this association is independent of potential intermediate risk factors: obesity, insulin, glucose, inflammation, but also of estradiol and other endogenous sex hormone levels,” said Taulant Muka, MD, PhD, in an interview.
Dr. Muka, a postdoctoral fellow at Erasmus Medical College, Rotterdam, the Netherlands, presented the analysis from a large, prospective cohort of menopausal women at the annual meeting of the North American Menopause Society.
In an interview, Dr. Muka noted that the study investigated whether the association between early age at natural menopause (ANM) and type 2 diabetes is independent of intermediate risk factors for type 2 diabetes, such as obesity. Finally, the study also assessed whether endogenous sex hormone levels play a role in the link between early ANM and type 2 diabetes.
Enrollment in the Rotterdam study has been continuing in waves since the 1990s, with enrollment for participants in this particular study cohort occurring in 1997 and with additional cohorts enrolled in 2000-2001 and 2006-2008.
“I think this is the first prospective study with such long follow-up data and with a broad adjustment for confounding factors. Previous studies have been mainly cross-sectional, providing conflicting results,” said Dr. Muka.
Using self-reported age at menopause, the investigators excluded from the study women whose menopausal status was not known, who were actually not menopausal, or whose menopause had not occurred naturally. The study population also excluded women with prevalent type 2 diabetes or for whom no information about diabetes follow-up could be found.
The remaining 3,210 women who were included in the study had a median age of 67 years and had reached menopause at a median of 49.9 years. Most women (82.6%) had an ANM of 45-55 years; ANM for 8.8% was 40-44 years, while just 2.3% had an ANM of under 40 years. Mean body mass index was 27.1 kg/m2.
Participants were considered to have incident diabetes based on several sources: a general practitioner’s records, hospital discharge paperwork, or glucose measurements from visits during the Rotterdam study. Participants also were classified as having diabetes if they used a hypoglycemic medication or had a fasting blood glucose level of at least 7 mmol/L (126 mg/dL) or, in the absence of a fasting blood glucose measurement, a nonfasting blood glucose of at least 11.1 mmol/L (200 mg/dL).
Dr. Muka said he and his coinvestigators identified and adjusted for a large number of variables, using a series of three Cox proportion hazard models.
The first model adjusted for age, which wave of enrollment (cohort) participants were in, hormone therapy status, age at menarche, and the number of pregnancies that reached at least 6 months’ gestation.
The second model used all of the factors in model 1, and added BMI and glucose and insulin levels. The third model used all of the factors in model 2, and also added total cholesterol level, systolic blood pressure, the use of lipid-lowering or antihypertensive medications, alcohol and tobacco use, educational level, prevalent cardiovascular disease, and C-reactive protein levels.
The association of early ANM with the risk of type 2 diabetes was statistically significant in all three models (P less than .001), with very similar hazard ratios (HRs) in all models. For the third, the most comprehensive model, the HR was 1.42 (95% confidence interval, 0.83-2.45).
Extensive sensitivity analyses were carried out, and the association held independent of physical activity level, smoking status, use of hormone therapy, and age. The investigators also used multivariable analyses to ensure that the effect was not mediated by serum levels of thyroid-stimulating hormone, dihydroepiandosterone (DHEA) and DHEA sulfate, estradiol, testosterone, sex hormone–binding globulin (SHBG), or androstenedione.
This study was the first in this population to obtain and adjust for serum sex hormone and SHBG levels, said Dr. Muka.
The prospective design of the study and the long follow-up period were study strengths, said Dr. Muka. Additionally, blood glucose readings taken at study visits, together with electronically linked pharmacy dispensing records, were used for incident diabetes diagnoses.
Study limitations, Dr. Muka said, included the possibility of survival bias, since enrollees “may represent survivors of early menopause who did not develop [type 2 diabetes] or die prior to enrollment.” However, he said, this would mean that “we have underestimated the association, so the risk would be even higher.” Also, all study participants were white, so the results cannot be extrapolated to nonwhite populations.
Dr. Muka said that the largely American audience for his presentation was interested in the fact that the association existed independent of BMI, an obesity marker, based on questions and comments following the talk. “Indeed, we stratified the analysis, and we didn’t find any difference between participants who were obese and nonobese.” Also, he said that there were queries about whether the analyses had corrected for DEXA measurements, in order to assess lean versus fat body composition more accurately. This analysis has not been done, but Dr. Muka plans to complete it on his return to Rotterdam, he said.
Up to 10% of women will reach menopause before the age of 45, said Dr. Muka, so this analysis has the potential to impact primary care for millions of women. “Women who undergo early menopause may be a target for type 2 diabetes prevention measures and might need to be screened for other cardiovascular risk factors like high blood pressure and dyslipidemia, since they are also at risk for cardiovascular disease.”
Dr. Muka reported no outside funding sources and had no relevant financial disclosures.
[email protected]
On Twitter @karioakes
Key clinical point: Early menopause is associated with an increased risk for type 2 diabetes.
Major finding: Age at menopause between 40 and 45 was associated with a relative risk of 1.49 for type 2 diabetes.
Data source: A prospective cohort study of an initial cohort of 3,210 menopausal women.
Disclosures: No outside funding source was reported. Dr. Muka reported having no relevant financial conflicts.
Patients want surgery for ventral hernia despite risks and comorbidity obstacles
An in-depth qualitative survey of patients’ expectations and satisfaction regarding ventral hernia management showed that while most were satisfied with surgical outcomes, many were uninformed about postoperative adverse outcomes and many were dissatisfied with nonoperative management.
Zeinab M. Alawadi, MD, and a team of researchers at the University of Texas Health Sciences Center, Houston, initially interviewed 30 patients seeking care for ventral hernia at a safety-net hospital prior to their surgical consultation about factors guiding their decision-making framework. A second interview was conducted 6 months later, asking about their level of satisfaction with their care and outcomes. The study appeared online Oct. 11 in the Journal of the American College of Surgeons.
The initial interview revealed that most patients had limited knowledge about risks and potential adverse outcomes of surgery, but nearly three-quarters of them wanted to undergo surgery for their ventral hernias. Only 7 of the 30 patients were treated surgically and of those, 2 reported an unexpected level of postoperative pain and dissatisfaction with the surgery outcome. The remaining five patients who had surgery were extremely satisfied with their decision.
Most of those interviewed had nonoperative management of their hernias, due to factors such as obesity, diabetes, and smoking. These patients expressed dissatisfaction with the obstacles of meeting surgical criteria, in particular the difficulties of losing weight and coping with diabetes. “From patients’ perspectives, the additional challenges of managing their diabetes and difficulties with exercising due to painful hernias represent overwhelming barriers to treating their obesity. Patients’ accounts do not reflect a simple failure to adhere to medical recommendations but substantial obstacles to losing weight,” the researchers noted. But these patients also expressed willingness to try to meet surgical criteria and to take responsibility for recurrence prevention by self-management.
This study provides insight into patient perceptions and expectation of ventral hernia surgery. “Several findings in this study suggest a need for better education and counseling of patients regarding the natural history of hernias and the risks and benefits of different management strategies. Self-contradicting patient responses regarding knowledge of surgical risks and benefits may represent poor communication by the physicians or poor understanding by the patients. As a result, patients appeared to have unrealistic expectations of surgery. In addition, contrary to the literature, patients appeared to disregard the physicians’ risk assessment and persisted in their preferences for surgical management, even after counseling.”
This work was supported by the Center for Clinical and Translational Sciences, which is funded by National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences. The authors had no disclosures.
Read the complete study at goo.gl/pq4fjz.
An in-depth qualitative survey of patients’ expectations and satisfaction regarding ventral hernia management showed that while most were satisfied with surgical outcomes, many were uninformed about postoperative adverse outcomes and many were dissatisfied with nonoperative management.
Zeinab M. Alawadi, MD, and a team of researchers at the University of Texas Health Sciences Center, Houston, initially interviewed 30 patients seeking care for ventral hernia at a safety-net hospital prior to their surgical consultation about factors guiding their decision-making framework. A second interview was conducted 6 months later, asking about their level of satisfaction with their care and outcomes. The study appeared online Oct. 11 in the Journal of the American College of Surgeons.
The initial interview revealed that most patients had limited knowledge about risks and potential adverse outcomes of surgery, but nearly three-quarters of them wanted to undergo surgery for their ventral hernias. Only 7 of the 30 patients were treated surgically and of those, 2 reported an unexpected level of postoperative pain and dissatisfaction with the surgery outcome. The remaining five patients who had surgery were extremely satisfied with their decision.
Most of those interviewed had nonoperative management of their hernias, due to factors such as obesity, diabetes, and smoking. These patients expressed dissatisfaction with the obstacles of meeting surgical criteria, in particular the difficulties of losing weight and coping with diabetes. “From patients’ perspectives, the additional challenges of managing their diabetes and difficulties with exercising due to painful hernias represent overwhelming barriers to treating their obesity. Patients’ accounts do not reflect a simple failure to adhere to medical recommendations but substantial obstacles to losing weight,” the researchers noted. But these patients also expressed willingness to try to meet surgical criteria and to take responsibility for recurrence prevention by self-management.
This study provides insight into patient perceptions and expectation of ventral hernia surgery. “Several findings in this study suggest a need for better education and counseling of patients regarding the natural history of hernias and the risks and benefits of different management strategies. Self-contradicting patient responses regarding knowledge of surgical risks and benefits may represent poor communication by the physicians or poor understanding by the patients. As a result, patients appeared to have unrealistic expectations of surgery. In addition, contrary to the literature, patients appeared to disregard the physicians’ risk assessment and persisted in their preferences for surgical management, even after counseling.”
This work was supported by the Center for Clinical and Translational Sciences, which is funded by National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences. The authors had no disclosures.
Read the complete study at goo.gl/pq4fjz.
An in-depth qualitative survey of patients’ expectations and satisfaction regarding ventral hernia management showed that while most were satisfied with surgical outcomes, many were uninformed about postoperative adverse outcomes and many were dissatisfied with nonoperative management.
Zeinab M. Alawadi, MD, and a team of researchers at the University of Texas Health Sciences Center, Houston, initially interviewed 30 patients seeking care for ventral hernia at a safety-net hospital prior to their surgical consultation about factors guiding their decision-making framework. A second interview was conducted 6 months later, asking about their level of satisfaction with their care and outcomes. The study appeared online Oct. 11 in the Journal of the American College of Surgeons.
The initial interview revealed that most patients had limited knowledge about risks and potential adverse outcomes of surgery, but nearly three-quarters of them wanted to undergo surgery for their ventral hernias. Only 7 of the 30 patients were treated surgically and of those, 2 reported an unexpected level of postoperative pain and dissatisfaction with the surgery outcome. The remaining five patients who had surgery were extremely satisfied with their decision.
Most of those interviewed had nonoperative management of their hernias, due to factors such as obesity, diabetes, and smoking. These patients expressed dissatisfaction with the obstacles of meeting surgical criteria, in particular the difficulties of losing weight and coping with diabetes. “From patients’ perspectives, the additional challenges of managing their diabetes and difficulties with exercising due to painful hernias represent overwhelming barriers to treating their obesity. Patients’ accounts do not reflect a simple failure to adhere to medical recommendations but substantial obstacles to losing weight,” the researchers noted. But these patients also expressed willingness to try to meet surgical criteria and to take responsibility for recurrence prevention by self-management.
This study provides insight into patient perceptions and expectation of ventral hernia surgery. “Several findings in this study suggest a need for better education and counseling of patients regarding the natural history of hernias and the risks and benefits of different management strategies. Self-contradicting patient responses regarding knowledge of surgical risks and benefits may represent poor communication by the physicians or poor understanding by the patients. As a result, patients appeared to have unrealistic expectations of surgery. In addition, contrary to the literature, patients appeared to disregard the physicians’ risk assessment and persisted in their preferences for surgical management, even after counseling.”
This work was supported by the Center for Clinical and Translational Sciences, which is funded by National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences. The authors had no disclosures.
Read the complete study at goo.gl/pq4fjz.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Novel fractional laser eased genitourinary syndrome of menopause
DENVER – Novel fractional laser therapy achieved significant 12-month reductions in vaginal dryness, burning, pain, and itching associated with menopause, Eric Sokol, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
Most patients – 92% – said they were satisfied or very satisfied with the treatment, said Dr. Sokol of Stanford (Calif.) University. “Treatments take 45 seconds and are painless,” he added. “We are part of a group that is planning a larger multicenter randomized trial of this laser, as well as some histologic studies.”
The two-center pilot study included 30 women with vulvovaginal atrophy treated with a novel fractional carbon dioxide laser system called SmartXide2 V2LR (MonaLisa Touch). The system has a maximum power of 60 W and emits laser energy at a 10,600-nm wavelength, Dr. Sokol noted. Patients underwent three treatments spaced by 6 weeks, and used 10-point visual analogue scales to score baseline and subsequent levels of vaginal pain, burning, itching, dryness, dyspareunia, and dysuria.
Average scores on the Female Sexual Function Index rose from 11.3 at baseline to 21.25 at 12 months, a statistically significant improvement.
Laser therapy caused no major adverse events, but about 10% of patients developed slight vaginal discharge or minor spotting after treatment, Dr. Sokol reported. Patients were not allowed to use lubricants or estrogens during the study.
The study was supported by DEKA M.E.L.A. Srl, using an investigator-initiated protocol. Patients did not pay for treatment. Dr. Sokol reported that he has no financial disclosures related to this study. His coinvestigator is a paid consultant for Cynosure.
DENVER – Novel fractional laser therapy achieved significant 12-month reductions in vaginal dryness, burning, pain, and itching associated with menopause, Eric Sokol, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
Most patients – 92% – said they were satisfied or very satisfied with the treatment, said Dr. Sokol of Stanford (Calif.) University. “Treatments take 45 seconds and are painless,” he added. “We are part of a group that is planning a larger multicenter randomized trial of this laser, as well as some histologic studies.”
The two-center pilot study included 30 women with vulvovaginal atrophy treated with a novel fractional carbon dioxide laser system called SmartXide2 V2LR (MonaLisa Touch). The system has a maximum power of 60 W and emits laser energy at a 10,600-nm wavelength, Dr. Sokol noted. Patients underwent three treatments spaced by 6 weeks, and used 10-point visual analogue scales to score baseline and subsequent levels of vaginal pain, burning, itching, dryness, dyspareunia, and dysuria.
Average scores on the Female Sexual Function Index rose from 11.3 at baseline to 21.25 at 12 months, a statistically significant improvement.
Laser therapy caused no major adverse events, but about 10% of patients developed slight vaginal discharge or minor spotting after treatment, Dr. Sokol reported. Patients were not allowed to use lubricants or estrogens during the study.
The study was supported by DEKA M.E.L.A. Srl, using an investigator-initiated protocol. Patients did not pay for treatment. Dr. Sokol reported that he has no financial disclosures related to this study. His coinvestigator is a paid consultant for Cynosure.
DENVER – Novel fractional laser therapy achieved significant 12-month reductions in vaginal dryness, burning, pain, and itching associated with menopause, Eric Sokol, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
Most patients – 92% – said they were satisfied or very satisfied with the treatment, said Dr. Sokol of Stanford (Calif.) University. “Treatments take 45 seconds and are painless,” he added. “We are part of a group that is planning a larger multicenter randomized trial of this laser, as well as some histologic studies.”
The two-center pilot study included 30 women with vulvovaginal atrophy treated with a novel fractional carbon dioxide laser system called SmartXide2 V2LR (MonaLisa Touch). The system has a maximum power of 60 W and emits laser energy at a 10,600-nm wavelength, Dr. Sokol noted. Patients underwent three treatments spaced by 6 weeks, and used 10-point visual analogue scales to score baseline and subsequent levels of vaginal pain, burning, itching, dryness, dyspareunia, and dysuria.
Average scores on the Female Sexual Function Index rose from 11.3 at baseline to 21.25 at 12 months, a statistically significant improvement.
Laser therapy caused no major adverse events, but about 10% of patients developed slight vaginal discharge or minor spotting after treatment, Dr. Sokol reported. Patients were not allowed to use lubricants or estrogens during the study.
The study was supported by DEKA M.E.L.A. Srl, using an investigator-initiated protocol. Patients did not pay for treatment. Dr. Sokol reported that he has no financial disclosures related to this study. His coinvestigator is a paid consultant for Cynosure.
Key clinical point:
Major finding: Reductions in dryness and dyspareunia were especially marked, dropping by an average of about 75% and 66%, respectively.
Data source: A two-center pilot study of 30 women with genitourinary syndrome of atrophy (previously known as vaginal atrophy).
Disclosures: The study was supported by DEKA M.E.L.A. Srl, using an investigator-initiated protocol. Patients did not pay for treatment. Dr. Sokol reported that he has no financial disclosures related to this study. His coinvestigator is a paid consultant for Cynosure.
Topical anticholinergic for axillary hyperhidrosis hits marks in phase III
VIENNA – An investigational topical cholinergic receptor antagonist known as DRM04 achieved its efficacy and safety endpoints for the treatment of primary axillary hyperhidrosis in the pivotal phase III ATMOS-1 and ATMOS-2 trials.
“We haven’t had any good new treatment options for patients with hyperhidrosis for a long time,” Dr. David M. Pariser said, in presenting the pivotal trial outcomes data at the annual congress of the European Academy of Dermatology and Venereology.
ATMOS-1 and ATMOS-2 were identically designed 4-week, double-blind studies involving 697 patients with excessive underarm sweating who were randomized 2:1 to once daily use of DRM04 3.75% wipes or a vehicle control. The patients averaged 33 years of age, although as Dr. Pariser noted, primary axillary hyperhidrosis often begins in adolescence and patients as young as age 9 were enrolled. The majority of participants were female. Roughly two-thirds of subjects were grade 3 on the 4-point Hyperhidrosis Disease Severity Scale. The rest were grade 4.
The coprimary endpoints in ATMOS-1 and ATMOS-2 were a 4-point or greater improvement on the Axillary Sweating Daily Diary (ASDD) between baseline and week 4, and the absolute change from baseline in axillary sweat production measured gravimetrically.
The ASDD is a new patient-reported outcome measure developed specifically for the ATMOS trials. At baseline, participants scored a mean of 7.2 points on the 0-10 scale. A 4-point or greater improvement was seen at week 4 in 52.8% of ATMOS-1 participants on DRM04, compared with 28.3% of controls. In ATMOS-2, the spread was 66.1% vs. 26.9%.
Mean baseline sweat production was roughly 175 mg/5 min per armpit, a prodigious rate given that 50 mg/5 min is considered excessive. In ATMOS-1, the rate dropped by an adjusted average of 96.2 mg/5 min per armpit with active therapy, compared with 90.6 mg/5 min in the control group. In ATMOS-2, the DRM04 users had a mean drop in sweat production of 110.3 mg/5 min, compared with a reduction of 92.2 mg/5 min in the control group. Both of these differences were statistically significant and clinically meaningful, Dr. Pariser said.
The secondary endpoint in the studies was change in the Dermatology Life Quality Index from baseline to week 4. The improvement in DRM04 users averaged 8.1 points in ATMOS-1 and 8.6 points in ATMOS-2, both significantly greater than the 4.3- and 5.0-point improvements in the control arms.
In ATMOS-1, 9.2% of patients in the DRM04 arm dropped out of the study, in many cases because of anticholinergic side effects, the most common of which included dry mouth, dry eyes, urinary hesitation or less frequently retention, and constipation. These were mostly mild to moderate in nature and were generally responsive to temporary treatment discontinuation, which the study protocol allowed. The dropout rate in the DRM04 arm of ATMOS-2 was 6.8%.
Seven percent of subjects in the DRM04 study arms experienced mydriasis, most often unilaterally. Dr. Pariser said this might be due to patients touching an eye while they still had DRM04 on their hands, a problem that can be readily addressed in the medication use instructions.
The dropout rates in the control groups were 2.6% and 5%.
More than 80% of ATMOS-1 and ATMOS-2 participants enrolled in ARIDO, the 48-week, open label, phase III extension study of DRM04. Dermira, which is developing DRM04, has announced it plans to file for marketing approval by the Food and Drug Administration in the second half of 2017.
Dr. Pariser reported serving as an investigator for and consultant to Dermira, Brickell Biotech, and TheraVida.
VIENNA – An investigational topical cholinergic receptor antagonist known as DRM04 achieved its efficacy and safety endpoints for the treatment of primary axillary hyperhidrosis in the pivotal phase III ATMOS-1 and ATMOS-2 trials.
“We haven’t had any good new treatment options for patients with hyperhidrosis for a long time,” Dr. David M. Pariser said, in presenting the pivotal trial outcomes data at the annual congress of the European Academy of Dermatology and Venereology.
ATMOS-1 and ATMOS-2 were identically designed 4-week, double-blind studies involving 697 patients with excessive underarm sweating who were randomized 2:1 to once daily use of DRM04 3.75% wipes or a vehicle control. The patients averaged 33 years of age, although as Dr. Pariser noted, primary axillary hyperhidrosis often begins in adolescence and patients as young as age 9 were enrolled. The majority of participants were female. Roughly two-thirds of subjects were grade 3 on the 4-point Hyperhidrosis Disease Severity Scale. The rest were grade 4.
The coprimary endpoints in ATMOS-1 and ATMOS-2 were a 4-point or greater improvement on the Axillary Sweating Daily Diary (ASDD) between baseline and week 4, and the absolute change from baseline in axillary sweat production measured gravimetrically.
The ASDD is a new patient-reported outcome measure developed specifically for the ATMOS trials. At baseline, participants scored a mean of 7.2 points on the 0-10 scale. A 4-point or greater improvement was seen at week 4 in 52.8% of ATMOS-1 participants on DRM04, compared with 28.3% of controls. In ATMOS-2, the spread was 66.1% vs. 26.9%.
Mean baseline sweat production was roughly 175 mg/5 min per armpit, a prodigious rate given that 50 mg/5 min is considered excessive. In ATMOS-1, the rate dropped by an adjusted average of 96.2 mg/5 min per armpit with active therapy, compared with 90.6 mg/5 min in the control group. In ATMOS-2, the DRM04 users had a mean drop in sweat production of 110.3 mg/5 min, compared with a reduction of 92.2 mg/5 min in the control group. Both of these differences were statistically significant and clinically meaningful, Dr. Pariser said.
The secondary endpoint in the studies was change in the Dermatology Life Quality Index from baseline to week 4. The improvement in DRM04 users averaged 8.1 points in ATMOS-1 and 8.6 points in ATMOS-2, both significantly greater than the 4.3- and 5.0-point improvements in the control arms.
In ATMOS-1, 9.2% of patients in the DRM04 arm dropped out of the study, in many cases because of anticholinergic side effects, the most common of which included dry mouth, dry eyes, urinary hesitation or less frequently retention, and constipation. These were mostly mild to moderate in nature and were generally responsive to temporary treatment discontinuation, which the study protocol allowed. The dropout rate in the DRM04 arm of ATMOS-2 was 6.8%.
Seven percent of subjects in the DRM04 study arms experienced mydriasis, most often unilaterally. Dr. Pariser said this might be due to patients touching an eye while they still had DRM04 on their hands, a problem that can be readily addressed in the medication use instructions.
The dropout rates in the control groups were 2.6% and 5%.
More than 80% of ATMOS-1 and ATMOS-2 participants enrolled in ARIDO, the 48-week, open label, phase III extension study of DRM04. Dermira, which is developing DRM04, has announced it plans to file for marketing approval by the Food and Drug Administration in the second half of 2017.
Dr. Pariser reported serving as an investigator for and consultant to Dermira, Brickell Biotech, and TheraVida.
VIENNA – An investigational topical cholinergic receptor antagonist known as DRM04 achieved its efficacy and safety endpoints for the treatment of primary axillary hyperhidrosis in the pivotal phase III ATMOS-1 and ATMOS-2 trials.
“We haven’t had any good new treatment options for patients with hyperhidrosis for a long time,” Dr. David M. Pariser said, in presenting the pivotal trial outcomes data at the annual congress of the European Academy of Dermatology and Venereology.
ATMOS-1 and ATMOS-2 were identically designed 4-week, double-blind studies involving 697 patients with excessive underarm sweating who were randomized 2:1 to once daily use of DRM04 3.75% wipes or a vehicle control. The patients averaged 33 years of age, although as Dr. Pariser noted, primary axillary hyperhidrosis often begins in adolescence and patients as young as age 9 were enrolled. The majority of participants were female. Roughly two-thirds of subjects were grade 3 on the 4-point Hyperhidrosis Disease Severity Scale. The rest were grade 4.
The coprimary endpoints in ATMOS-1 and ATMOS-2 were a 4-point or greater improvement on the Axillary Sweating Daily Diary (ASDD) between baseline and week 4, and the absolute change from baseline in axillary sweat production measured gravimetrically.
The ASDD is a new patient-reported outcome measure developed specifically for the ATMOS trials. At baseline, participants scored a mean of 7.2 points on the 0-10 scale. A 4-point or greater improvement was seen at week 4 in 52.8% of ATMOS-1 participants on DRM04, compared with 28.3% of controls. In ATMOS-2, the spread was 66.1% vs. 26.9%.
Mean baseline sweat production was roughly 175 mg/5 min per armpit, a prodigious rate given that 50 mg/5 min is considered excessive. In ATMOS-1, the rate dropped by an adjusted average of 96.2 mg/5 min per armpit with active therapy, compared with 90.6 mg/5 min in the control group. In ATMOS-2, the DRM04 users had a mean drop in sweat production of 110.3 mg/5 min, compared with a reduction of 92.2 mg/5 min in the control group. Both of these differences were statistically significant and clinically meaningful, Dr. Pariser said.
The secondary endpoint in the studies was change in the Dermatology Life Quality Index from baseline to week 4. The improvement in DRM04 users averaged 8.1 points in ATMOS-1 and 8.6 points in ATMOS-2, both significantly greater than the 4.3- and 5.0-point improvements in the control arms.
In ATMOS-1, 9.2% of patients in the DRM04 arm dropped out of the study, in many cases because of anticholinergic side effects, the most common of which included dry mouth, dry eyes, urinary hesitation or less frequently retention, and constipation. These were mostly mild to moderate in nature and were generally responsive to temporary treatment discontinuation, which the study protocol allowed. The dropout rate in the DRM04 arm of ATMOS-2 was 6.8%.
Seven percent of subjects in the DRM04 study arms experienced mydriasis, most often unilaterally. Dr. Pariser said this might be due to patients touching an eye while they still had DRM04 on their hands, a problem that can be readily addressed in the medication use instructions.
The dropout rates in the control groups were 2.6% and 5%.
More than 80% of ATMOS-1 and ATMOS-2 participants enrolled in ARIDO, the 48-week, open label, phase III extension study of DRM04. Dermira, which is developing DRM04, has announced it plans to file for marketing approval by the Food and Drug Administration in the second half of 2017.
Dr. Pariser reported serving as an investigator for and consultant to Dermira, Brickell Biotech, and TheraVida.
AT THE EADV CONGRESS
Key clinical point: A once-daily topical anticholinergic agent called DRM04 achieved positive outcomes for the treatment of primary axillary hyperhidrosis in two pivotal phase III trials.
Major finding: 53% and 66% of subjects on DRM04 in two large studies achieved clinically meaningful improvement in axillary sweating, compared with 28% and 27%, respectively, of controls.
Data source: Based on findings from ATMOS-1 and ATMOS-2, identically designed, 4-week, double-blind, vehicle-controlled clinical trials including a total of 687 patients with primary axillary hyperhidrosis.
Disclosures: The studies were funded by Dermira. The presenter reported serving as an investigator for and consultant to the company.
R-CHOP and intensive R-HDS comparable in DLBCL
Two front-line treatment regimens for patients with high-risk diffuse large B-cell lymphomas (DLBCL) produced comparable outcomes, according to new data.
Patients who received rituximab combined with high-dose sequential chemotherapy (R-HDS) plus autologous stem-cell transplantation (ASCT) had similar results in terms of overall response rate and long-term outcomes, compared to patients treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
It was presumed that event-free survival would be improved with chemotherapy and ASCT, but that result was not observed at 3-year follow up, wrote Sergio Cortelazzo, MD, of Humanitas Gavazzeni, Bergamo, Italy, and coauthors.
“Our results indicate that CHOP chemotherapy, optimally supplemented by eight doses of rituximab, remains the standard of care also for this group of patients at higher risk for disease resistance or recurrence,” they wrote in a study published online ahead of print in the Journal of Clinical Oncology (J Clin Oncol. 2016 Oct 3. doi: 10.1200/JCO.2016.67.2980).
The benefit of R-HDS chemotherapy with ASCT as front-line therapy for this patient population is still a matter of debate. To address that issue, Dr. Cortelazzo and his colleagues conducted a phase III randomized trial in which 246 high-risk patients with a high-intermediate (56%) or high (44%) International Prognostic Index (IPI) score were assigned to receive either R-CHOP or R-HDS.
The primary efficacy endpoint was 3-year, event-free survival, and the results were analyzed on an intent-to-treat basis.
At a median follow-up of 5 years (range, 0.05-9.49), with an intent-to-treat analysis, the 3-year, event-free survival was 62% (95% CI, 54%-71%) for the R-CHOP arm, compared with 65% (95% CI, 56% to 74%) for those treated with R-HDS (P = .83; hazard ratio, 0.99; 95% CI, 0.66-1.48).
There was no difference in event-free survival even when analyzed within the IPI subgroups.
The 3-year progression free survival also did not significantly differ between groups; 65% in the R-CHOP arm (95% CI, 57% to 74%) versus 75% (95% CI, 67%-83%; P = .119) for the R-HDS arm in the whole population, as well as within IPI subgroups.
Of note, the 3-year disease-free survival was better in the R-HDS group (79% vs. 91%, respectively; P = .034), but this difference subsequently disappeared with longer follow-up.
Grade 3-4 hematologic toxicity was lower in the R-CHOP arm compared with the R-HDS arm, with at least one episode of neutropenia in 34% versus 84% of patients (P less than .001), anemia in 15% versus 71% of patients (P less than .001), and thrombocytopenia in 5% versus 86% (P less than .001).
The study was supported in part by the Associazione Italiana Lotta alla Leucemia sezione di Bergamo, the Associazione Italiana per la Ricerca sul Cancro, Ministero Istruzione, Universita e Ricerca and unrestricted grants from Roche SpA and Amgen, Italy. Dr Cortelazzo had no relevant disclosures. Several coauthors indicated relationships with industry.
Two front-line treatment regimens for patients with high-risk diffuse large B-cell lymphomas (DLBCL) produced comparable outcomes, according to new data.
Patients who received rituximab combined with high-dose sequential chemotherapy (R-HDS) plus autologous stem-cell transplantation (ASCT) had similar results in terms of overall response rate and long-term outcomes, compared to patients treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
It was presumed that event-free survival would be improved with chemotherapy and ASCT, but that result was not observed at 3-year follow up, wrote Sergio Cortelazzo, MD, of Humanitas Gavazzeni, Bergamo, Italy, and coauthors.
“Our results indicate that CHOP chemotherapy, optimally supplemented by eight doses of rituximab, remains the standard of care also for this group of patients at higher risk for disease resistance or recurrence,” they wrote in a study published online ahead of print in the Journal of Clinical Oncology (J Clin Oncol. 2016 Oct 3. doi: 10.1200/JCO.2016.67.2980).
The benefit of R-HDS chemotherapy with ASCT as front-line therapy for this patient population is still a matter of debate. To address that issue, Dr. Cortelazzo and his colleagues conducted a phase III randomized trial in which 246 high-risk patients with a high-intermediate (56%) or high (44%) International Prognostic Index (IPI) score were assigned to receive either R-CHOP or R-HDS.
The primary efficacy endpoint was 3-year, event-free survival, and the results were analyzed on an intent-to-treat basis.
At a median follow-up of 5 years (range, 0.05-9.49), with an intent-to-treat analysis, the 3-year, event-free survival was 62% (95% CI, 54%-71%) for the R-CHOP arm, compared with 65% (95% CI, 56% to 74%) for those treated with R-HDS (P = .83; hazard ratio, 0.99; 95% CI, 0.66-1.48).
There was no difference in event-free survival even when analyzed within the IPI subgroups.
The 3-year progression free survival also did not significantly differ between groups; 65% in the R-CHOP arm (95% CI, 57% to 74%) versus 75% (95% CI, 67%-83%; P = .119) for the R-HDS arm in the whole population, as well as within IPI subgroups.
Of note, the 3-year disease-free survival was better in the R-HDS group (79% vs. 91%, respectively; P = .034), but this difference subsequently disappeared with longer follow-up.
Grade 3-4 hematologic toxicity was lower in the R-CHOP arm compared with the R-HDS arm, with at least one episode of neutropenia in 34% versus 84% of patients (P less than .001), anemia in 15% versus 71% of patients (P less than .001), and thrombocytopenia in 5% versus 86% (P less than .001).
The study was supported in part by the Associazione Italiana Lotta alla Leucemia sezione di Bergamo, the Associazione Italiana per la Ricerca sul Cancro, Ministero Istruzione, Universita e Ricerca and unrestricted grants from Roche SpA and Amgen, Italy. Dr Cortelazzo had no relevant disclosures. Several coauthors indicated relationships with industry.
Two front-line treatment regimens for patients with high-risk diffuse large B-cell lymphomas (DLBCL) produced comparable outcomes, according to new data.
Patients who received rituximab combined with high-dose sequential chemotherapy (R-HDS) plus autologous stem-cell transplantation (ASCT) had similar results in terms of overall response rate and long-term outcomes, compared to patients treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
It was presumed that event-free survival would be improved with chemotherapy and ASCT, but that result was not observed at 3-year follow up, wrote Sergio Cortelazzo, MD, of Humanitas Gavazzeni, Bergamo, Italy, and coauthors.
“Our results indicate that CHOP chemotherapy, optimally supplemented by eight doses of rituximab, remains the standard of care also for this group of patients at higher risk for disease resistance or recurrence,” they wrote in a study published online ahead of print in the Journal of Clinical Oncology (J Clin Oncol. 2016 Oct 3. doi: 10.1200/JCO.2016.67.2980).
The benefit of R-HDS chemotherapy with ASCT as front-line therapy for this patient population is still a matter of debate. To address that issue, Dr. Cortelazzo and his colleagues conducted a phase III randomized trial in which 246 high-risk patients with a high-intermediate (56%) or high (44%) International Prognostic Index (IPI) score were assigned to receive either R-CHOP or R-HDS.
The primary efficacy endpoint was 3-year, event-free survival, and the results were analyzed on an intent-to-treat basis.
At a median follow-up of 5 years (range, 0.05-9.49), with an intent-to-treat analysis, the 3-year, event-free survival was 62% (95% CI, 54%-71%) for the R-CHOP arm, compared with 65% (95% CI, 56% to 74%) for those treated with R-HDS (P = .83; hazard ratio, 0.99; 95% CI, 0.66-1.48).
There was no difference in event-free survival even when analyzed within the IPI subgroups.
The 3-year progression free survival also did not significantly differ between groups; 65% in the R-CHOP arm (95% CI, 57% to 74%) versus 75% (95% CI, 67%-83%; P = .119) for the R-HDS arm in the whole population, as well as within IPI subgroups.
Of note, the 3-year disease-free survival was better in the R-HDS group (79% vs. 91%, respectively; P = .034), but this difference subsequently disappeared with longer follow-up.
Grade 3-4 hematologic toxicity was lower in the R-CHOP arm compared with the R-HDS arm, with at least one episode of neutropenia in 34% versus 84% of patients (P less than .001), anemia in 15% versus 71% of patients (P less than .001), and thrombocytopenia in 5% versus 86% (P less than .001).
The study was supported in part by the Associazione Italiana Lotta alla Leucemia sezione di Bergamo, the Associazione Italiana per la Ricerca sul Cancro, Ministero Istruzione, Universita e Ricerca and unrestricted grants from Roche SpA and Amgen, Italy. Dr Cortelazzo had no relevant disclosures. Several coauthors indicated relationships with industry.
Key clinical point:
Major finding: At a median follow-up of 5 years, the 3-year event-free survival was similar for both groups: 62% versus 65% (P = .83).
Data source: A randomized phase III trial that included 246 patients with diffuse large B-cell lymphomas.
Disclosures: The study was supported in part by the Associazione Italiana Lotta alla Leucemia sezione di Bergamo, the Associazione Italiana per la Ricerca sul Cancro, Ministero Istruzione, Universita e Ricerca and unrestricted grants from Roche SpA and Amgen, Italy. Dr Cortelazzo has no disclosures. Several coauthors indicate relationships with industry.
MACRA options offer flexibility for smaller practices
Federal flexibility in compliance with the first year of MACRA reforms is a win for most physicians.
The American Gastroenterological Association “is pleased that CMS [the Centers for Medicare and Medicaid Services] is providing physicians woth more flexible options for reporting and that, most importantly, no physician will be penalized in 2019 for their reporting in 2017,” the association said in a statement. “Since the release of the MACRA [Medicare Access and CHIP Reauthorization Act of 2015] proposd rule, AGA has been advocating to Congress and CMS that the agency provide physicians with mor eflexibility to coply with the law and have opportunities to succeed in the new payment system.”
Those who choose the Merit-Based Incentive Payment System (MIPS) track now have three options for when they must start reporting data next year. Data reported in 2017 will serve as the benchmark for bonus payments paid in 2019.
Option 1
Report “some data” in 2017. Doctors who report some data to the Quality Payments Program (QPP) – the official name for MACRA-required reforms – will not face a Medicare pay cut. CMS considers even this low level of reporting a test for whether physicians will be ready for more intense MACRA involvement in 2018 and 2019. Exactly how much “some data” is currently is not defined.
Option 2
Participate for part of 2017. Those who choose to report data to QPP for some of the year also will be testing their systems for future MACRA compliance and may end up with a small Medicare pay increase. Again, the duration of reporting was not defined by the CMS at press time.
Option 3
Participate for the full year. Doctors who begin to report data from all parts of QPP on Jan. 1 will be eligible for a “modest” Medicare pay increase in 2019. Data on quality measures, use of technology, and practice improvement must be reported.
For those who are eligible for participation in Advanced Alternative Payment Models (APMs), that track will begin Jan. 1, 2017.
The American Medical Association commended federal officials “for listening to physicians’ concerns about the timeline that was originally proposed for MACRA,” AMA President Andrew Gurman, MD, said in a statement. “The AMA believes the actions that the administration announced today will help give physicians a fair shot in the first year of MACRA implementation. This is the flexibility that physicians were seeking all along.”
Not all see the new flexibility as a good thing, particularly for larger group practices that are ready to fully participate in MACRA as of Jan. 1.
“This flexibility is especially important for small provider groups that may have legitimate logistical issues around MACRA’s reporting requirements,” Donald Fisher, PhD, president and CEO of AMGA, said in a statement. (AMGA was formerly known as the American Medical Group Association.)
“However, our membership is deeply concerned that the creation of these new reporting options will have the unintended result of penalizing the very provider groups that have made the largest investments to meet MACRA’s goals of better quality, improved clinical practice activities, better use of electronic medical records, and lower resource use. These groups have already begun the transition from volume to value, and it is disappointing the rewards for their effort will be compromised rather than rewarded, as was MACRA’s stated purpose by Congress and the administration.”
By offering options for compliance, the CMS could potentially limit the amount of bonus payments in order to meet MACRA’s budget-neutral requirements, according to Chet Speed, vice president of public policy at AMGA. There will be no potential penalties that would offset bonuses for organizations that are performing at a high rate, which could result in having to lower the maximum bonuses an organization would be eligible to receive.
“You’ve compressed rewards to a level where it just penalizes those who have made the investments” in upgrading their systems to prepare for the Jan. 1 start date, Mr. Speed said.
He emphasized that the CMS could still address this and make the full bonus payments available to those who are prepared to participate on Jan. 1, but that will not be known until the final rule is published. He applauded the agency’s efforts in continually reaching out to the physician community throughout the MACRA development process and said he is hopeful there will be resolution to these concerns in the final rule.
Federal flexibility in compliance with the first year of MACRA reforms is a win for most physicians.
The American Gastroenterological Association “is pleased that CMS [the Centers for Medicare and Medicaid Services] is providing physicians woth more flexible options for reporting and that, most importantly, no physician will be penalized in 2019 for their reporting in 2017,” the association said in a statement. “Since the release of the MACRA [Medicare Access and CHIP Reauthorization Act of 2015] proposd rule, AGA has been advocating to Congress and CMS that the agency provide physicians with mor eflexibility to coply with the law and have opportunities to succeed in the new payment system.”
Those who choose the Merit-Based Incentive Payment System (MIPS) track now have three options for when they must start reporting data next year. Data reported in 2017 will serve as the benchmark for bonus payments paid in 2019.
Option 1
Report “some data” in 2017. Doctors who report some data to the Quality Payments Program (QPP) – the official name for MACRA-required reforms – will not face a Medicare pay cut. CMS considers even this low level of reporting a test for whether physicians will be ready for more intense MACRA involvement in 2018 and 2019. Exactly how much “some data” is currently is not defined.
Option 2
Participate for part of 2017. Those who choose to report data to QPP for some of the year also will be testing their systems for future MACRA compliance and may end up with a small Medicare pay increase. Again, the duration of reporting was not defined by the CMS at press time.
Option 3
Participate for the full year. Doctors who begin to report data from all parts of QPP on Jan. 1 will be eligible for a “modest” Medicare pay increase in 2019. Data on quality measures, use of technology, and practice improvement must be reported.
For those who are eligible for participation in Advanced Alternative Payment Models (APMs), that track will begin Jan. 1, 2017.
The American Medical Association commended federal officials “for listening to physicians’ concerns about the timeline that was originally proposed for MACRA,” AMA President Andrew Gurman, MD, said in a statement. “The AMA believes the actions that the administration announced today will help give physicians a fair shot in the first year of MACRA implementation. This is the flexibility that physicians were seeking all along.”
Not all see the new flexibility as a good thing, particularly for larger group practices that are ready to fully participate in MACRA as of Jan. 1.
“This flexibility is especially important for small provider groups that may have legitimate logistical issues around MACRA’s reporting requirements,” Donald Fisher, PhD, president and CEO of AMGA, said in a statement. (AMGA was formerly known as the American Medical Group Association.)
“However, our membership is deeply concerned that the creation of these new reporting options will have the unintended result of penalizing the very provider groups that have made the largest investments to meet MACRA’s goals of better quality, improved clinical practice activities, better use of electronic medical records, and lower resource use. These groups have already begun the transition from volume to value, and it is disappointing the rewards for their effort will be compromised rather than rewarded, as was MACRA’s stated purpose by Congress and the administration.”
By offering options for compliance, the CMS could potentially limit the amount of bonus payments in order to meet MACRA’s budget-neutral requirements, according to Chet Speed, vice president of public policy at AMGA. There will be no potential penalties that would offset bonuses for organizations that are performing at a high rate, which could result in having to lower the maximum bonuses an organization would be eligible to receive.
“You’ve compressed rewards to a level where it just penalizes those who have made the investments” in upgrading their systems to prepare for the Jan. 1 start date, Mr. Speed said.
He emphasized that the CMS could still address this and make the full bonus payments available to those who are prepared to participate on Jan. 1, but that will not be known until the final rule is published. He applauded the agency’s efforts in continually reaching out to the physician community throughout the MACRA development process and said he is hopeful there will be resolution to these concerns in the final rule.
Federal flexibility in compliance with the first year of MACRA reforms is a win for most physicians.
The American Gastroenterological Association “is pleased that CMS [the Centers for Medicare and Medicaid Services] is providing physicians woth more flexible options for reporting and that, most importantly, no physician will be penalized in 2019 for their reporting in 2017,” the association said in a statement. “Since the release of the MACRA [Medicare Access and CHIP Reauthorization Act of 2015] proposd rule, AGA has been advocating to Congress and CMS that the agency provide physicians with mor eflexibility to coply with the law and have opportunities to succeed in the new payment system.”
Those who choose the Merit-Based Incentive Payment System (MIPS) track now have three options for when they must start reporting data next year. Data reported in 2017 will serve as the benchmark for bonus payments paid in 2019.
Option 1
Report “some data” in 2017. Doctors who report some data to the Quality Payments Program (QPP) – the official name for MACRA-required reforms – will not face a Medicare pay cut. CMS considers even this low level of reporting a test for whether physicians will be ready for more intense MACRA involvement in 2018 and 2019. Exactly how much “some data” is currently is not defined.
Option 2
Participate for part of 2017. Those who choose to report data to QPP for some of the year also will be testing their systems for future MACRA compliance and may end up with a small Medicare pay increase. Again, the duration of reporting was not defined by the CMS at press time.
Option 3
Participate for the full year. Doctors who begin to report data from all parts of QPP on Jan. 1 will be eligible for a “modest” Medicare pay increase in 2019. Data on quality measures, use of technology, and practice improvement must be reported.
For those who are eligible for participation in Advanced Alternative Payment Models (APMs), that track will begin Jan. 1, 2017.
The American Medical Association commended federal officials “for listening to physicians’ concerns about the timeline that was originally proposed for MACRA,” AMA President Andrew Gurman, MD, said in a statement. “The AMA believes the actions that the administration announced today will help give physicians a fair shot in the first year of MACRA implementation. This is the flexibility that physicians were seeking all along.”
Not all see the new flexibility as a good thing, particularly for larger group practices that are ready to fully participate in MACRA as of Jan. 1.
“This flexibility is especially important for small provider groups that may have legitimate logistical issues around MACRA’s reporting requirements,” Donald Fisher, PhD, president and CEO of AMGA, said in a statement. (AMGA was formerly known as the American Medical Group Association.)
“However, our membership is deeply concerned that the creation of these new reporting options will have the unintended result of penalizing the very provider groups that have made the largest investments to meet MACRA’s goals of better quality, improved clinical practice activities, better use of electronic medical records, and lower resource use. These groups have already begun the transition from volume to value, and it is disappointing the rewards for their effort will be compromised rather than rewarded, as was MACRA’s stated purpose by Congress and the administration.”
By offering options for compliance, the CMS could potentially limit the amount of bonus payments in order to meet MACRA’s budget-neutral requirements, according to Chet Speed, vice president of public policy at AMGA. There will be no potential penalties that would offset bonuses for organizations that are performing at a high rate, which could result in having to lower the maximum bonuses an organization would be eligible to receive.
“You’ve compressed rewards to a level where it just penalizes those who have made the investments” in upgrading their systems to prepare for the Jan. 1 start date, Mr. Speed said.
He emphasized that the CMS could still address this and make the full bonus payments available to those who are prepared to participate on Jan. 1, but that will not be known until the final rule is published. He applauded the agency’s efforts in continually reaching out to the physician community throughout the MACRA development process and said he is hopeful there will be resolution to these concerns in the final rule.