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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.
When is it time to stop hormone therapy?
Extended use of systemic hormone therapy represents one area that clinicians commonly encounter. However, because randomized trial data are not available, helping women make decisions regarding long-term use of hormone therapy is controversial. When it is finalized, the 2016 hormone therapy position statement from the North American Menopause Society will address this topic.
Here I’m referring to the patient who likely started systemic hormone therapy when she was a younger, or more recently menopausal, woman (perhaps in her early 50s), but now she’s in her 60s. In my practice, a patient in this age range would likely be on a lower-than-standard dose of hormone therapy than what she began with originally.
And now the question is, Should she continue, or should she stop, hormone therapy? The median duration of bothersome symptoms is about 10 or 11 years, from the best available data – far longer than what many physicians assume.
And risk stratification also becomes relevant. Let’s say the patient is a slender white or Asian woman with a low body mass index , or she has a parent who had a hip fracture. Continuing low-dose systemic hormone therapy in this case, particularly for osteoporosis prevention when vasomotor symptoms are no longer present, might make sense. However, if the patient is obese, and, therefore has a lower risk for osteoporosis, it may be that ongoing use of systemic hormone therapy would not be indicated, and that patient should be encouraged to discontinue at that point.
Also, if a uterus is not present – and we’re talking only about estrogen therapy, given its greater safety profile with long-term use with respect to breast cancer – clinicians and women can be more comfortable with continued use of low-dose systemic hormone therapy for osteoporosis prevention. If a uterus is present, then women making decisions about long-term use of hormone therapy need to be aware of the small, but I believe real, elevated risk of breast cancer. With each office visit and when decisions about refilling prescriptions or continuing hormone therapy are made, this is an important issue to discuss, particularly if there’s an intact uterus. These discussions also need to be documented in the record.
What about the route of estrogen? Age, BMI, and oral estrogen therapy each represent independent risk factors for venous thromboembolism. For older, as well as obese menopausal women, who are candidates for systemic hormone therapy, I prefer transdermal over oral estrogen therapy.
Finally, I counsel women that although vasomotor symptoms/hot flashes improve as women age, the same is not true for genitourinary syndrome of menopause (GSM, also known as genital atrophy). If vaginal dryness, pain with sex, or other manifestations of GSM occur in women tapering their dose of systemic hormone therapy or in women who have discontinued systemic hormone therapy, initiation and long-term use of low-dose vaginal estrogen should be considered.
References
1. Menopause. 2014 Jun;21(6):679-81.
Dr. Kaunitz is a professor and associate chair of the department of obstetrics and gynecology, University of Florida in Jacksonville. He is on the board of trustees of the North American Menopause Society. He reports being a consultant or on the advisory board or review panel of several pharmaceutical companies, and receiving grant support from several pharmaceutical companies. He receives royalties from UpToDate.
Extended use of systemic hormone therapy represents one area that clinicians commonly encounter. However, because randomized trial data are not available, helping women make decisions regarding long-term use of hormone therapy is controversial. When it is finalized, the 2016 hormone therapy position statement from the North American Menopause Society will address this topic.
Here I’m referring to the patient who likely started systemic hormone therapy when she was a younger, or more recently menopausal, woman (perhaps in her early 50s), but now she’s in her 60s. In my practice, a patient in this age range would likely be on a lower-than-standard dose of hormone therapy than what she began with originally.
And now the question is, Should she continue, or should she stop, hormone therapy? The median duration of bothersome symptoms is about 10 or 11 years, from the best available data – far longer than what many physicians assume.
And risk stratification also becomes relevant. Let’s say the patient is a slender white or Asian woman with a low body mass index , or she has a parent who had a hip fracture. Continuing low-dose systemic hormone therapy in this case, particularly for osteoporosis prevention when vasomotor symptoms are no longer present, might make sense. However, if the patient is obese, and, therefore has a lower risk for osteoporosis, it may be that ongoing use of systemic hormone therapy would not be indicated, and that patient should be encouraged to discontinue at that point.
Also, if a uterus is not present – and we’re talking only about estrogen therapy, given its greater safety profile with long-term use with respect to breast cancer – clinicians and women can be more comfortable with continued use of low-dose systemic hormone therapy for osteoporosis prevention. If a uterus is present, then women making decisions about long-term use of hormone therapy need to be aware of the small, but I believe real, elevated risk of breast cancer. With each office visit and when decisions about refilling prescriptions or continuing hormone therapy are made, this is an important issue to discuss, particularly if there’s an intact uterus. These discussions also need to be documented in the record.
What about the route of estrogen? Age, BMI, and oral estrogen therapy each represent independent risk factors for venous thromboembolism. For older, as well as obese menopausal women, who are candidates for systemic hormone therapy, I prefer transdermal over oral estrogen therapy.
Finally, I counsel women that although vasomotor symptoms/hot flashes improve as women age, the same is not true for genitourinary syndrome of menopause (GSM, also known as genital atrophy). If vaginal dryness, pain with sex, or other manifestations of GSM occur in women tapering their dose of systemic hormone therapy or in women who have discontinued systemic hormone therapy, initiation and long-term use of low-dose vaginal estrogen should be considered.
References
1. Menopause. 2014 Jun;21(6):679-81.
Dr. Kaunitz is a professor and associate chair of the department of obstetrics and gynecology, University of Florida in Jacksonville. He is on the board of trustees of the North American Menopause Society. He reports being a consultant or on the advisory board or review panel of several pharmaceutical companies, and receiving grant support from several pharmaceutical companies. He receives royalties from UpToDate.
Extended use of systemic hormone therapy represents one area that clinicians commonly encounter. However, because randomized trial data are not available, helping women make decisions regarding long-term use of hormone therapy is controversial. When it is finalized, the 2016 hormone therapy position statement from the North American Menopause Society will address this topic.
Here I’m referring to the patient who likely started systemic hormone therapy when she was a younger, or more recently menopausal, woman (perhaps in her early 50s), but now she’s in her 60s. In my practice, a patient in this age range would likely be on a lower-than-standard dose of hormone therapy than what she began with originally.
And now the question is, Should she continue, or should she stop, hormone therapy? The median duration of bothersome symptoms is about 10 or 11 years, from the best available data – far longer than what many physicians assume.
And risk stratification also becomes relevant. Let’s say the patient is a slender white or Asian woman with a low body mass index , or she has a parent who had a hip fracture. Continuing low-dose systemic hormone therapy in this case, particularly for osteoporosis prevention when vasomotor symptoms are no longer present, might make sense. However, if the patient is obese, and, therefore has a lower risk for osteoporosis, it may be that ongoing use of systemic hormone therapy would not be indicated, and that patient should be encouraged to discontinue at that point.
Also, if a uterus is not present – and we’re talking only about estrogen therapy, given its greater safety profile with long-term use with respect to breast cancer – clinicians and women can be more comfortable with continued use of low-dose systemic hormone therapy for osteoporosis prevention. If a uterus is present, then women making decisions about long-term use of hormone therapy need to be aware of the small, but I believe real, elevated risk of breast cancer. With each office visit and when decisions about refilling prescriptions or continuing hormone therapy are made, this is an important issue to discuss, particularly if there’s an intact uterus. These discussions also need to be documented in the record.
What about the route of estrogen? Age, BMI, and oral estrogen therapy each represent independent risk factors for venous thromboembolism. For older, as well as obese menopausal women, who are candidates for systemic hormone therapy, I prefer transdermal over oral estrogen therapy.
Finally, I counsel women that although vasomotor symptoms/hot flashes improve as women age, the same is not true for genitourinary syndrome of menopause (GSM, also known as genital atrophy). If vaginal dryness, pain with sex, or other manifestations of GSM occur in women tapering their dose of systemic hormone therapy or in women who have discontinued systemic hormone therapy, initiation and long-term use of low-dose vaginal estrogen should be considered.
References
1. Menopause. 2014 Jun;21(6):679-81.
Dr. Kaunitz is a professor and associate chair of the department of obstetrics and gynecology, University of Florida in Jacksonville. He is on the board of trustees of the North American Menopause Society. He reports being a consultant or on the advisory board or review panel of several pharmaceutical companies, and receiving grant support from several pharmaceutical companies. He receives royalties from UpToDate.
Coding: Things often forgotten
First, I want to correct a misstatement I made in a recent column regarding incident to billing by an extender (Dermatology News, July 2016, p. 1) When an extender sees a patient for an established problem, they can bill at 100% if there is a supervising physician in the house, AND it should be under that supervising physician’s number – NOT necessarily by the physician who saw the original problem. This change was promulgated by the Centers for Medicare & Medicaid Services in the proposed rule, and everyone thought it was a done deal, but the billing remained unchanged in the final rule. Apologies for any confusion.
Coding
As all of you know, in 2010, the Centers for Medicare & Medicaid Services stopped recognizing the Current Procedural Terminology (CPT) consultation codes for Medicare Part B payment CMS decided (after an Office of Inspector General study) that consultations were really just new patient visits and stopped paying for consultations. Visits are now coded with new or follow-up patient evaluation and management codes. This is unfortunate, because a consultation pays more, and importantly, does not establish the patient as a patient in your practice for the next three years. If originally billed as a consultation, the patient can be seen back for another problem in the next three years, and be billed for a consultation, or a new patient as appropriate. Therefore, it is a big advantage to be able to bill for a consultation, assuming another doctor has asked your opinion and you call with or send them a report of your findings.
Just because Medicare says you cannot bill for consultations does not mean that all insurers are the same. The consultation codes are still in the CPT code book and your contracts with private insurers probably stipulate that the insurers must comply with CPT convention. In this case, you can bill your private insurers (including Medicare Advantage Plans, which are private insurers) for consultations when your documentation supports it. Be aware, that some of the more popular electronic health records that perform billing automatically default to a new patient visit, when a new patient consultation might be more appropriate.
While discussing evaluation and management coding, you should be aware that 97% of visits billed by dermatologists are level 3 or lower. This means that, even if your EHR can propel you to heights unimagined before, that it could become a problem. You cannot bill a higher level beyond what is medically appropriate. For example, you don’t usually need to do a full-body skin exam during an acne follow-up.
I’ll never forget the poor soul who explained to me that she was being audited “because all my visits were level 4 or 5, and the software agreed with it.” The software company (or the consultant) will not be sharing the joys of an audit with you. You can do a quick and easy check of your evaluation and management patterns, compared with others by checking either of the online Medicare databases, the Wall Street Journal’s “Medicare Unmasked” site or the “Treatment Tracker” for Doctors and Services in Medicare Part B, on the ProPublica website.
While you are there, check your procedure numbers against others. Are you a freeze-y king? Are you the shave master? There are often valid and justifiable reasons for unusual billing patterns. If you are an outlier, make sure you have a good reason to be there. For example, I am in the top 10% paid per patient visit in the state of Ohio. The reason is that I treat only skin cancer, and it usually involves surgery. The world is looking at these data. So should you.
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].
First, I want to correct a misstatement I made in a recent column regarding incident to billing by an extender (Dermatology News, July 2016, p. 1) When an extender sees a patient for an established problem, they can bill at 100% if there is a supervising physician in the house, AND it should be under that supervising physician’s number – NOT necessarily by the physician who saw the original problem. This change was promulgated by the Centers for Medicare & Medicaid Services in the proposed rule, and everyone thought it was a done deal, but the billing remained unchanged in the final rule. Apologies for any confusion.
Coding
As all of you know, in 2010, the Centers for Medicare & Medicaid Services stopped recognizing the Current Procedural Terminology (CPT) consultation codes for Medicare Part B payment CMS decided (after an Office of Inspector General study) that consultations were really just new patient visits and stopped paying for consultations. Visits are now coded with new or follow-up patient evaluation and management codes. This is unfortunate, because a consultation pays more, and importantly, does not establish the patient as a patient in your practice for the next three years. If originally billed as a consultation, the patient can be seen back for another problem in the next three years, and be billed for a consultation, or a new patient as appropriate. Therefore, it is a big advantage to be able to bill for a consultation, assuming another doctor has asked your opinion and you call with or send them a report of your findings.
Just because Medicare says you cannot bill for consultations does not mean that all insurers are the same. The consultation codes are still in the CPT code book and your contracts with private insurers probably stipulate that the insurers must comply with CPT convention. In this case, you can bill your private insurers (including Medicare Advantage Plans, which are private insurers) for consultations when your documentation supports it. Be aware, that some of the more popular electronic health records that perform billing automatically default to a new patient visit, when a new patient consultation might be more appropriate.
While discussing evaluation and management coding, you should be aware that 97% of visits billed by dermatologists are level 3 or lower. This means that, even if your EHR can propel you to heights unimagined before, that it could become a problem. You cannot bill a higher level beyond what is medically appropriate. For example, you don’t usually need to do a full-body skin exam during an acne follow-up.
I’ll never forget the poor soul who explained to me that she was being audited “because all my visits were level 4 or 5, and the software agreed with it.” The software company (or the consultant) will not be sharing the joys of an audit with you. You can do a quick and easy check of your evaluation and management patterns, compared with others by checking either of the online Medicare databases, the Wall Street Journal’s “Medicare Unmasked” site or the “Treatment Tracker” for Doctors and Services in Medicare Part B, on the ProPublica website.
While you are there, check your procedure numbers against others. Are you a freeze-y king? Are you the shave master? There are often valid and justifiable reasons for unusual billing patterns. If you are an outlier, make sure you have a good reason to be there. For example, I am in the top 10% paid per patient visit in the state of Ohio. The reason is that I treat only skin cancer, and it usually involves surgery. The world is looking at these data. So should you.
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].
First, I want to correct a misstatement I made in a recent column regarding incident to billing by an extender (Dermatology News, July 2016, p. 1) When an extender sees a patient for an established problem, they can bill at 100% if there is a supervising physician in the house, AND it should be under that supervising physician’s number – NOT necessarily by the physician who saw the original problem. This change was promulgated by the Centers for Medicare & Medicaid Services in the proposed rule, and everyone thought it was a done deal, but the billing remained unchanged in the final rule. Apologies for any confusion.
Coding
As all of you know, in 2010, the Centers for Medicare & Medicaid Services stopped recognizing the Current Procedural Terminology (CPT) consultation codes for Medicare Part B payment CMS decided (after an Office of Inspector General study) that consultations were really just new patient visits and stopped paying for consultations. Visits are now coded with new or follow-up patient evaluation and management codes. This is unfortunate, because a consultation pays more, and importantly, does not establish the patient as a patient in your practice for the next three years. If originally billed as a consultation, the patient can be seen back for another problem in the next three years, and be billed for a consultation, or a new patient as appropriate. Therefore, it is a big advantage to be able to bill for a consultation, assuming another doctor has asked your opinion and you call with or send them a report of your findings.
Just because Medicare says you cannot bill for consultations does not mean that all insurers are the same. The consultation codes are still in the CPT code book and your contracts with private insurers probably stipulate that the insurers must comply with CPT convention. In this case, you can bill your private insurers (including Medicare Advantage Plans, which are private insurers) for consultations when your documentation supports it. Be aware, that some of the more popular electronic health records that perform billing automatically default to a new patient visit, when a new patient consultation might be more appropriate.
While discussing evaluation and management coding, you should be aware that 97% of visits billed by dermatologists are level 3 or lower. This means that, even if your EHR can propel you to heights unimagined before, that it could become a problem. You cannot bill a higher level beyond what is medically appropriate. For example, you don’t usually need to do a full-body skin exam during an acne follow-up.
I’ll never forget the poor soul who explained to me that she was being audited “because all my visits were level 4 or 5, and the software agreed with it.” The software company (or the consultant) will not be sharing the joys of an audit with you. You can do a quick and easy check of your evaluation and management patterns, compared with others by checking either of the online Medicare databases, the Wall Street Journal’s “Medicare Unmasked” site or the “Treatment Tracker” for Doctors and Services in Medicare Part B, on the ProPublica website.
While you are there, check your procedure numbers against others. Are you a freeze-y king? Are you the shave master? There are often valid and justifiable reasons for unusual billing patterns. If you are an outlier, make sure you have a good reason to be there. For example, I am in the top 10% paid per patient visit in the state of Ohio. The reason is that I treat only skin cancer, and it usually involves surgery. The world is looking at these data. So should you.
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].