Sharon Worcester

Myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS, should be renamed systemic exertion intolerance disease to better convey the complexity, severity, and key symptomatology of this very real illness, according to a new report from the Institute of Medicine.

The IOM committee that wrote the report also developed new evidence-based diagnostic criteria for the disorder based on an extensive literature review and input from patients, caregivers, and clinicians, and recommended that it be assigned a new code in the International Classification of Disease, Tenth Edition (ICD-10).

According to the new criteria proposed by the IOM Committee on the Diagnostic Criteria for ME/CFS, a diagnosis requires evidence of three core symptoms, which can typically be identified by a thorough patient history, physical examination, and medical work-up. The core symptoms include:

• A substantial reduction or impairment in the ability to engage in pre-illness levels of activities. This impairment should be accompanied by fatigue, which is often profound, and which is of new or definite onset rather than the result of ongoing excessive exertion, and is not substantially alleviated by rest.

• Postexertional malaise following physical, cognitive, or emotional stress.

• Unrefreshing sleep.

Additionally, patients should have cognitive impairment and/or experience orthostatic intolerance. The symptoms should persist for at least 6 months at a moderate, substantial, or severe intensity at least half of the time.

“This disorder should be diagnosed when individuals meet the criteria,” Dr. Ellen Wright Clayton, the committee chair, said during a press briefing on the report.

The diagnosis should be made regardless of whether patients have comorbid conditions unless another condition explains all of the patient’s symptoms.

“That is extremely unlikely. The point that we’re trying to make is that it is incumbent on the clinician to make the diagnosis, to think about comorbidities – because they are common – and if there are comorbidities to diagnose them and treat them, but that their existence does not preclude a diagnosis of this disorder,” said Dr. Clayton, a professor of pediatrics and law, and cofounder of the Center for Biomedical Ethics and Society at Vanderbilt University, Nashville.

Also, the 6-month duration criteria is important for distinguishing the disorder from other fatiguing disorders that resolve in less than 6 months, but it is important to understand that even if symptoms haven’t persisted for 6 months, they need to be identified and treated, she said.

“These patients have real symptoms, and they deserve real care and real therapy whether they meet the criteria for this disorder or not,” she added.

The same is true for pediatric patients, according to Dr. Peter Rowe, director of the Chronic Fatigue Clinic at Johns Hopkins Children’s Center in Baltimore.

Dr. Rowe noted that the condition is relatively common in the pediatric population, and can have profound effects on the social and educational development of children and adolescents.

“It is one of the most common causes of prolonged school absence, and it is time to put to rest the notion that this represents either school phobia or school refusal. The point is that it isn’t that these children don’t want to go to school, it’s that they can’t,” he said during the briefing.

The pediatric evidence base is much smaller than the adult evidence base, and many more data are needed to understand the disease in children, but the available evidence is sufficient to show that “orthostatic intolerance and autonomic dysfunction are common in pediatric ME/CFS, that the neurocognitive abnormalities – while not present at baseline when patients are tested in the supine position – will emerge when patients are tested under conditions of orthostatic stress or if another condition like distraction is introduced,” he said.

There clearly is a high prevalence of profound fatigue, unrefreshing sleep, and postexertional exacerbation of symptoms in children, just as there is in adults, and the evidence is strong that the condition can follow acute infectious mononucleosis or Epstein-Barr virus in some patients, he added.

The duration of illness is similar to that in adults, and the condition does not require a specific pediatric definition, he said.

To assist clinicians with making an appropriate diagnosis, and to promote the use of the new criteria, the committee recommended that the U.S. Department of Health & Human Services develop a toolkit for use in a variety of clinical settings. The kit will replace currently available tools, which are too complex and too difficult to use in a busy clinical practice, Dr. Clayton said.

The aim is to enable all clinicians, including primary care physicians, emergency medicine doctors, and subspecialists to make this diagnosis, she added.

ME/CFS, or what will now be termed systemic exertion intolerance disease (SEID) under the new recommendations, affects between 836,000 and 2.5 million Americans, but it is likely that only about 10% receive a diagnosis, she said, noting that those patients who do receive a diagnosis often struggle for years beforehand.

“They often face a really frustrating process,” she said, explaining that clinicians frequently dismiss their concerns.

The commonly used term “chronic fatigue syndrome” perpetuates misunderstanding of the illness, as well as the dismissive attitudes from health care providers and the public.

“It’s clear [the term] chronic fatigue syndrome does tremendous disservice to patients. If I don’t hear another person say to me, ‘I’m chronically fatigued, too.’ or ‘Is this a real disease?’ it won’t be too soon. We’ve got to get over this one,” Dr. Clayton said.

The term myalgic encephalomyelitis also fails to describe the essence of the disorder, she said.

SEID, conversely, describes the central element of the disorder, she explained.

As for the need for a new ICD-10 code, the recommendation was made to ensure that “we’re not stuck with benign ME or CFS,” Dr. Clayton said.

“This needs its own diagnostic criteria, which will be helpful not only for patients, but frankly for the research enterprise going forward,” she said.

She and her colleagues believe the new name, along with the new criteria, will “provide a clear path for clinicians to make the diagnosis.”

“It’s a fresh start. … the diagnostic criteria are evidence-based, which means they will be very convincing to physicians, and I think that people will be able to start to see this illness. We wanted to be sure that symptoms that may have been previously overlooked by clinicians are put front and center in this diagnosis. I think it will make a very big difference not only for primary care, but also for specialists,” said Dr. Lucinda Bateman, committee member and director of the Fatigue Consultation Clinic in Salt Lake City.

The committee called for additional research on the etiology and pathophysiology of the disease, as well as on potential treatments, and for reassessment of the diagnostic criteria within 5 years or sooner if emerging evidence warrants earlier modifications.

The IOM report was sponsored by the Office on Women’s Health within the U.S. Department of Health & Human Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Agency for Healthcare Research and Quality, and the U.S. Social Security Administration.

Is SEID a legitimate diagnosis? Take our poll by clicking here.

Myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS, should be renamed systemic exertion intolerance disease to better convey the complexity, severity, and key symptomatology of this very real illness, according to a new report from the Institute of Medicine.

The IOM committee that wrote the report also developed new evidence-based diagnostic criteria for the disorder based on an extensive literature review and input from patients, caregivers, and clinicians, and recommended that it be assigned a new code in the International Classification of Disease, Tenth Edition (ICD-10).

According to the new criteria proposed by the IOM Committee on the Diagnostic Criteria for ME/CFS, a diagnosis requires evidence of three core symptoms, which can typically be identified by a thorough patient history, physical examination, and medical work-up. The core symptoms include:

• A substantial reduction or impairment in the ability to engage in pre-illness levels of activities. This impairment should be accompanied by fatigue, which is often profound, and which is of new or definite onset rather than the result of ongoing excessive exertion, and is not substantially alleviated by rest.

• Postexertional malaise following physical, cognitive, or emotional stress.

• Unrefreshing sleep.

Additionally, patients should have cognitive impairment and/or experience orthostatic intolerance. The symptoms should persist for at least 6 months at a moderate, substantial, or severe intensity at least half of the time.

“This disorder should be diagnosed when individuals meet the criteria,” Dr. Ellen Wright Clayton, the committee chair, said during a press briefing on the report.

The diagnosis should be made regardless of whether patients have comorbid conditions unless another condition explains all of the patient’s symptoms.

“That is extremely unlikely. The point that we’re trying to make is that it is incumbent on the clinician to make the diagnosis, to think about comorbidities – because they are common – and if there are comorbidities to diagnose them and treat them, but that their existence does not preclude a diagnosis of this disorder,” said Dr. Clayton, a professor of pediatrics and law, and cofounder of the Center for Biomedical Ethics and Society at Vanderbilt University, Nashville.

Also, the 6-month duration criteria is important for distinguishing the disorder from other fatiguing disorders that resolve in less than 6 months, but it is important to understand that even if symptoms haven’t persisted for 6 months, they need to be identified and treated, she said.

“These patients have real symptoms, and they deserve real care and real therapy whether they meet the criteria for this disorder or not,” she added.

The same is true for pediatric patients, according to Dr. Peter Rowe, director of the Chronic Fatigue Clinic at Johns Hopkins Children’s Center in Baltimore.

Dr. Rowe noted that the condition is relatively common in the pediatric population, and can have profound effects on the social and educational development of children and adolescents.

“It is one of the most common causes of prolonged school absence, and it is time to put to rest the notion that this represents either school phobia or school refusal. The point is that it isn’t that these children don’t want to go to school, it’s that they can’t,” he said during the briefing.

The pediatric evidence base is much smaller than the adult evidence base, and many more data are needed to understand the disease in children, but the available evidence is sufficient to show that “orthostatic intolerance and autonomic dysfunction are common in pediatric ME/CFS, that the neurocognitive abnormalities – while not present at baseline when patients are tested in the supine position – will emerge when patients are tested under conditions of orthostatic stress or if another condition like distraction is introduced,” he said.

There clearly is a high prevalence of profound fatigue, unrefreshing sleep, and postexertional exacerbation of symptoms in children, just as there is in adults, and the evidence is strong that the condition can follow acute infectious mononucleosis or Epstein-Barr virus in some patients, he added.

The duration of illness is similar to that in adults, and the condition does not require a specific pediatric definition, he said.

To assist clinicians with making an appropriate diagnosis, and to promote the use of the new criteria, the committee recommended that the U.S. Department of Health & Human Services develop a toolkit for use in a variety of clinical settings. The kit will replace currently available tools, which are too complex and too difficult to use in a busy clinical practice, Dr. Clayton said.

The aim is to enable all clinicians, including primary care physicians, emergency medicine doctors, and subspecialists to make this diagnosis, she added.

ME/CFS, or what will now be termed systemic exertion intolerance disease (SEID) under the new recommendations, affects between 836,000 and 2.5 million Americans, but it is likely that only about 10% receive a diagnosis, she said, noting that those patients who do receive a diagnosis often struggle for years beforehand.

“They often face a really frustrating process,” she said, explaining that clinicians frequently dismiss their concerns.

The commonly used term “chronic fatigue syndrome” perpetuates misunderstanding of the illness, as well as the dismissive attitudes from health care providers and the public.

“It’s clear [the term] chronic fatigue syndrome does tremendous disservice to patients. If I don’t hear another person say to me, ‘I’m chronically fatigued, too.’ or ‘Is this a real disease?’ it won’t be too soon. We’ve got to get over this one,” Dr. Clayton said.

The term myalgic encephalomyelitis also fails to describe the essence of the disorder, she said.

SEID, conversely, describes the central element of the disorder, she explained.

As for the need for a new ICD-10 code, the recommendation was made to ensure that “we’re not stuck with benign ME or CFS,” Dr. Clayton said.

“This needs its own diagnostic criteria, which will be helpful not only for patients, but frankly for the research enterprise going forward,” she said.

She and her colleagues believe the new name, along with the new criteria, will “provide a clear path for clinicians to make the diagnosis.”

“It’s a fresh start. … the diagnostic criteria are evidence-based, which means they will be very convincing to physicians, and I think that people will be able to start to see this illness. We wanted to be sure that symptoms that may have been previously overlooked by clinicians are put front and center in this diagnosis. I think it will make a very big difference not only for primary care, but also for specialists,” said Dr. Lucinda Bateman, committee member and director of the Fatigue Consultation Clinic in Salt Lake City.

The committee called for additional research on the etiology and pathophysiology of the disease, as well as on potential treatments, and for reassessment of the diagnostic criteria within 5 years or sooner if emerging evidence warrants earlier modifications.

The IOM report was sponsored by the Office on Women’s Health within the U.S. Department of Health & Human Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Agency for Healthcare Research and Quality, and the U.S. Social Security Administration.

Is SEID a legitimate diagnosis? Take our poll by clicking here.

Myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS, should be renamed systemic exertion intolerance disease to better convey the complexity, severity, and key symptomatology of this very real illness, according to a new report from the Institute of Medicine.

The IOM committee that wrote the report also developed new evidence-based diagnostic criteria for the disorder based on an extensive literature review and input from patients, caregivers, and clinicians, and recommended that it be assigned a new code in the International Classification of Disease, Tenth Edition (ICD-10).

According to the new criteria proposed by the IOM Committee on the Diagnostic Criteria for ME/CFS, a diagnosis requires evidence of three core symptoms, which can typically be identified by a thorough patient history, physical examination, and medical work-up. The core symptoms include:

• A substantial reduction or impairment in the ability to engage in pre-illness levels of activities. This impairment should be accompanied by fatigue, which is often profound, and which is of new or definite onset rather than the result of ongoing excessive exertion, and is not substantially alleviated by rest.

• Postexertional malaise following physical, cognitive, or emotional stress.

• Unrefreshing sleep.

Additionally, patients should have cognitive impairment and/or experience orthostatic intolerance. The symptoms should persist for at least 6 months at a moderate, substantial, or severe intensity at least half of the time.

“This disorder should be diagnosed when individuals meet the criteria,” Dr. Ellen Wright Clayton, the committee chair, said during a press briefing on the report.

The diagnosis should be made regardless of whether patients have comorbid conditions unless another condition explains all of the patient’s symptoms.

“That is extremely unlikely. The point that we’re trying to make is that it is incumbent on the clinician to make the diagnosis, to think about comorbidities – because they are common – and if there are comorbidities to diagnose them and treat them, but that their existence does not preclude a diagnosis of this disorder,” said Dr. Clayton, a professor of pediatrics and law, and cofounder of the Center for Biomedical Ethics and Society at Vanderbilt University, Nashville.

Also, the 6-month duration criteria is important for distinguishing the disorder from other fatiguing disorders that resolve in less than 6 months, but it is important to understand that even if symptoms haven’t persisted for 6 months, they need to be identified and treated, she said.

“These patients have real symptoms, and they deserve real care and real therapy whether they meet the criteria for this disorder or not,” she added.

The same is true for pediatric patients, according to Dr. Peter Rowe, director of the Chronic Fatigue Clinic at Johns Hopkins Children’s Center in Baltimore.

Dr. Rowe noted that the condition is relatively common in the pediatric population, and can have profound effects on the social and educational development of children and adolescents.

“It is one of the most common causes of prolonged school absence, and it is time to put to rest the notion that this represents either school phobia or school refusal. The point is that it isn’t that these children don’t want to go to school, it’s that they can’t,” he said during the briefing.

The pediatric evidence base is much smaller than the adult evidence base, and many more data are needed to understand the disease in children, but the available evidence is sufficient to show that “orthostatic intolerance and autonomic dysfunction are common in pediatric ME/CFS, that the neurocognitive abnormalities – while not present at baseline when patients are tested in the supine position – will emerge when patients are tested under conditions of orthostatic stress or if another condition like distraction is introduced,” he said.

There clearly is a high prevalence of profound fatigue, unrefreshing sleep, and postexertional exacerbation of symptoms in children, just as there is in adults, and the evidence is strong that the condition can follow acute infectious mononucleosis or Epstein-Barr virus in some patients, he added.

The duration of illness is similar to that in adults, and the condition does not require a specific pediatric definition, he said.

To assist clinicians with making an appropriate diagnosis, and to promote the use of the new criteria, the committee recommended that the U.S. Department of Health & Human Services develop a toolkit for use in a variety of clinical settings. The kit will replace currently available tools, which are too complex and too difficult to use in a busy clinical practice, Dr. Clayton said.

The aim is to enable all clinicians, including primary care physicians, emergency medicine doctors, and subspecialists to make this diagnosis, she added.

ME/CFS, or what will now be termed systemic exertion intolerance disease (SEID) under the new recommendations, affects between 836,000 and 2.5 million Americans, but it is likely that only about 10% receive a diagnosis, she said, noting that those patients who do receive a diagnosis often struggle for years beforehand.

“They often face a really frustrating process,” she said, explaining that clinicians frequently dismiss their concerns.

The commonly used term “chronic fatigue syndrome” perpetuates misunderstanding of the illness, as well as the dismissive attitudes from health care providers and the public.

“It’s clear [the term] chronic fatigue syndrome does tremendous disservice to patients. If I don’t hear another person say to me, ‘I’m chronically fatigued, too.’ or ‘Is this a real disease?’ it won’t be too soon. We’ve got to get over this one,” Dr. Clayton said.

The term myalgic encephalomyelitis also fails to describe the essence of the disorder, she said.

SEID, conversely, describes the central element of the disorder, she explained.

As for the need for a new ICD-10 code, the recommendation was made to ensure that “we’re not stuck with benign ME or CFS,” Dr. Clayton said.

“This needs its own diagnostic criteria, which will be helpful not only for patients, but frankly for the research enterprise going forward,” she said.

She and her colleagues believe the new name, along with the new criteria, will “provide a clear path for clinicians to make the diagnosis.”

“It’s a fresh start. … the diagnostic criteria are evidence-based, which means they will be very convincing to physicians, and I think that people will be able to start to see this illness. We wanted to be sure that symptoms that may have been previously overlooked by clinicians are put front and center in this diagnosis. I think it will make a very big difference not only for primary care, but also for specialists,” said Dr. Lucinda Bateman, committee member and director of the Fatigue Consultation Clinic in Salt Lake City.

The committee called for additional research on the etiology and pathophysiology of the disease, as well as on potential treatments, and for reassessment of the diagnostic criteria within 5 years or sooner if emerging evidence warrants earlier modifications.

The IOM report was sponsored by the Office on Women’s Health within the U.S. Department of Health & Human Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Agency for Healthcare Research and Quality, and the U.S. Social Security Administration.

Is SEID a legitimate diagnosis? Take our poll by clicking here.

Modern postoperative radiotherapy, or PORT, appears to provide an additional overall survival advantage in patients with N2 non–small cell lung cancer treated with complete resection and adjuvant chemotherapy, according to a review of the National Cancer Database.

The median survival was 45.2 months in 1,850 patients treated with PORT at a dose of at least 45 Gy (median 54 Gy over 43 days), compared with 40.7 months in 2,633 who were not treated with PORT. The 3- and 5-year survival rates were 59.3% vs. 55.2% and 39.3% vs. 34.8% in the groups, respectively, and on multivariable analysis, PORT was an independent predictor of improved overall survival (hazard ratio, 0.886), as was younger age, female sex, urban population, lower Charlson score, smaller tumor size, multiagent chemotherapy, and resection with at least a lobectomy, Dr. Clifford G. Robinson and his colleagues at Washington University, St. Louis, reported online Feb. 9 in the Journal of Clinical Oncology.

Patients included in the review had pathologic stage IIIA (N2) NSCLC, underwent complete resection and adjuvant chemotherapy between 2006 and 2010, and were followed for median of 22 months. Those who received neoadjuvant chemotherapy or radiotherapy, were missing data on adjuvant therapy timing, had evidence of metastatic disease, were treated with palliative intent, or had incomplete resection were excluded (J. Clin. Oncol. 2015 Feb. 9 [doi:10.1200/JCO.2014.58.5380]).

Although studies of PORT in the 1960s and 1970s showed a lack of benefit in patients with NSCLC, this was felt to be due in large part to competing cardiac and pulmonary toxicity from outdated equipment, techniques, and dosing; patients in the current study were likely treated with modern techniques, including computed tomography, simulation, and at least linear accelerator–based, three-dimensional, conformal radiotherapy, the investigators said, noting that the finding of a possible survival advantage with PORT underscores the importance of enrolling patients in randomized trials such as LungART.

Dr. Robinson is on the speakers’ bureau for ViewRay, which has paid for travel, accommodations, and other expenses. Several of his coauthors also reported receiving research funding, honoraria, and expenses, or serving as a consultant or advisor for a number of companies, including ViewRay, Varian, Traxxsson, Agennix, Lilly, Pfizer, Daiichi Sankyo, Spectrum Pharmaceuticals, Astex Therapeutics, Novartis, Genentech, Transgene, Eisai, New Link Genetics Corp., Merck, Puma, Roche, Incyte, Boehringer Ingelheim, Celgene, Wyeth, ImClone Systems, Merrimack, Bristol-Meyers Squibb, Onocyte, Astex Therapeutics, Onyx, GlaxoSmithKline, Bayer, Covidien, and Ethicon.

Modern postoperative radiotherapy, or PORT, appears to provide an additional overall survival advantage in patients with N2 non–small cell lung cancer treated with complete resection and adjuvant chemotherapy, according to a review of the National Cancer Database.

The median survival was 45.2 months in 1,850 patients treated with PORT at a dose of at least 45 Gy (median 54 Gy over 43 days), compared with 40.7 months in 2,633 who were not treated with PORT. The 3- and 5-year survival rates were 59.3% vs. 55.2% and 39.3% vs. 34.8% in the groups, respectively, and on multivariable analysis, PORT was an independent predictor of improved overall survival (hazard ratio, 0.886), as was younger age, female sex, urban population, lower Charlson score, smaller tumor size, multiagent chemotherapy, and resection with at least a lobectomy, Dr. Clifford G. Robinson and his colleagues at Washington University, St. Louis, reported online Feb. 9 in the Journal of Clinical Oncology.

Patients included in the review had pathologic stage IIIA (N2) NSCLC, underwent complete resection and adjuvant chemotherapy between 2006 and 2010, and were followed for median of 22 months. Those who received neoadjuvant chemotherapy or radiotherapy, were missing data on adjuvant therapy timing, had evidence of metastatic disease, were treated with palliative intent, or had incomplete resection were excluded (J. Clin. Oncol. 2015 Feb. 9 [doi:10.1200/JCO.2014.58.5380]).

Although studies of PORT in the 1960s and 1970s showed a lack of benefit in patients with NSCLC, this was felt to be due in large part to competing cardiac and pulmonary toxicity from outdated equipment, techniques, and dosing; patients in the current study were likely treated with modern techniques, including computed tomography, simulation, and at least linear accelerator–based, three-dimensional, conformal radiotherapy, the investigators said, noting that the finding of a possible survival advantage with PORT underscores the importance of enrolling patients in randomized trials such as LungART.

Dr. Robinson is on the speakers’ bureau for ViewRay, which has paid for travel, accommodations, and other expenses. Several of his coauthors also reported receiving research funding, honoraria, and expenses, or serving as a consultant or advisor for a number of companies, including ViewRay, Varian, Traxxsson, Agennix, Lilly, Pfizer, Daiichi Sankyo, Spectrum Pharmaceuticals, Astex Therapeutics, Novartis, Genentech, Transgene, Eisai, New Link Genetics Corp., Merck, Puma, Roche, Incyte, Boehringer Ingelheim, Celgene, Wyeth, ImClone Systems, Merrimack, Bristol-Meyers Squibb, Onocyte, Astex Therapeutics, Onyx, GlaxoSmithKline, Bayer, Covidien, and Ethicon.

Modern postoperative radiotherapy, or PORT, appears to provide an additional overall survival advantage in patients with N2 non–small cell lung cancer treated with complete resection and adjuvant chemotherapy, according to a review of the National Cancer Database.

The median survival was 45.2 months in 1,850 patients treated with PORT at a dose of at least 45 Gy (median 54 Gy over 43 days), compared with 40.7 months in 2,633 who were not treated with PORT. The 3- and 5-year survival rates were 59.3% vs. 55.2% and 39.3% vs. 34.8% in the groups, respectively, and on multivariable analysis, PORT was an independent predictor of improved overall survival (hazard ratio, 0.886), as was younger age, female sex, urban population, lower Charlson score, smaller tumor size, multiagent chemotherapy, and resection with at least a lobectomy, Dr. Clifford G. Robinson and his colleagues at Washington University, St. Louis, reported online Feb. 9 in the Journal of Clinical Oncology.

Patients included in the review had pathologic stage IIIA (N2) NSCLC, underwent complete resection and adjuvant chemotherapy between 2006 and 2010, and were followed for median of 22 months. Those who received neoadjuvant chemotherapy or radiotherapy, were missing data on adjuvant therapy timing, had evidence of metastatic disease, were treated with palliative intent, or had incomplete resection were excluded (J. Clin. Oncol. 2015 Feb. 9 [doi:10.1200/JCO.2014.58.5380]).

Although studies of PORT in the 1960s and 1970s showed a lack of benefit in patients with NSCLC, this was felt to be due in large part to competing cardiac and pulmonary toxicity from outdated equipment, techniques, and dosing; patients in the current study were likely treated with modern techniques, including computed tomography, simulation, and at least linear accelerator–based, three-dimensional, conformal radiotherapy, the investigators said, noting that the finding of a possible survival advantage with PORT underscores the importance of enrolling patients in randomized trials such as LungART.

Dr. Robinson is on the speakers’ bureau for ViewRay, which has paid for travel, accommodations, and other expenses. Several of his coauthors also reported receiving research funding, honoraria, and expenses, or serving as a consultant or advisor for a number of companies, including ViewRay, Varian, Traxxsson, Agennix, Lilly, Pfizer, Daiichi Sankyo, Spectrum Pharmaceuticals, Astex Therapeutics, Novartis, Genentech, Transgene, Eisai, New Link Genetics Corp., Merck, Puma, Roche, Incyte, Boehringer Ingelheim, Celgene, Wyeth, ImClone Systems, Merrimack, Bristol-Meyers Squibb, Onocyte, Astex Therapeutics, Onyx, GlaxoSmithKline, Bayer, Covidien, and Ethicon.

Overall response rates and progression-free survival in patients with advanced non–small-cell lung cancer are strongly associated at the trial level, and responders have better progression-free survival and overall survival than do nonresponders, according to findings from Food and Drug Administration trial– and patient-level analyses.

Based on data from 14 trials of treatments for advanced NSCLC, which involved 12,567 patients and which were submitted to the FDA between 2003 and 2013, the association between overall response rates (ORR) and progression-free survival (PFS) was strong using scatterplots of the treatment effects on the log-scale (R² = 0.89), but no association was seen between ORR and overall survival (R² = 0.09) or between PFS and overall survival (R² = 0.08) – possibly because of factors confounding overall survival analysis, such as cross-over, subsequent therapies, and long post-progression survival, reported Dr. Gideon M. Blumenthal and his colleagues at the FDA, White Oak, Md.

Patient-level analyses showed that those who achieved a response had improved PFS and overall survival compared with nonresponders (hazard ratio, 0.40 for both), the investigators noted (J. Clin. Oncol. 2015 Feb. 9 [doi:10.1200/JCO.2014.59.0489]).

The findings, which suggest that a therapy for advanced NSCLC that has a large magnitude of effect on ORR may also have a large effect on PFS, have implications for drug approvals, as “accelerated approval can be granted based on improvement in a surrogate endpoint reasonably likely to predict clinical benefit, such as ORR of large magnitude and long duration,” the researchers wrote, noting that “ORR may not be the optimal endpoint for hypothesis generation or expedited approval pathways for cytostatic therapies and immunotherapies, in which alternate endpoints may be needed to estimate activity and PFS or OS may be required to confirm clinical benefit,” and that novel methods for assessing drug activity warrant further investigation.

The authors reported having no disclosures.

Overall response rates and progression-free survival in patients with advanced non–small-cell lung cancer are strongly associated at the trial level, and responders have better progression-free survival and overall survival than do nonresponders, according to findings from Food and Drug Administration trial– and patient-level analyses.

Based on data from 14 trials of treatments for advanced NSCLC, which involved 12,567 patients and which were submitted to the FDA between 2003 and 2013, the association between overall response rates (ORR) and progression-free survival (PFS) was strong using scatterplots of the treatment effects on the log-scale (R² = 0.89), but no association was seen between ORR and overall survival (R² = 0.09) or between PFS and overall survival (R² = 0.08) – possibly because of factors confounding overall survival analysis, such as cross-over, subsequent therapies, and long post-progression survival, reported Dr. Gideon M. Blumenthal and his colleagues at the FDA, White Oak, Md.

Patient-level analyses showed that those who achieved a response had improved PFS and overall survival compared with nonresponders (hazard ratio, 0.40 for both), the investigators noted (J. Clin. Oncol. 2015 Feb. 9 [doi:10.1200/JCO.2014.59.0489]).

The findings, which suggest that a therapy for advanced NSCLC that has a large magnitude of effect on ORR may also have a large effect on PFS, have implications for drug approvals, as “accelerated approval can be granted based on improvement in a surrogate endpoint reasonably likely to predict clinical benefit, such as ORR of large magnitude and long duration,” the researchers wrote, noting that “ORR may not be the optimal endpoint for hypothesis generation or expedited approval pathways for cytostatic therapies and immunotherapies, in which alternate endpoints may be needed to estimate activity and PFS or OS may be required to confirm clinical benefit,” and that novel methods for assessing drug activity warrant further investigation.

The authors reported having no disclosures.

Overall response rates and progression-free survival in patients with advanced non–small-cell lung cancer are strongly associated at the trial level, and responders have better progression-free survival and overall survival than do nonresponders, according to findings from Food and Drug Administration trial– and patient-level analyses.

Based on data from 14 trials of treatments for advanced NSCLC, which involved 12,567 patients and which were submitted to the FDA between 2003 and 2013, the association between overall response rates (ORR) and progression-free survival (PFS) was strong using scatterplots of the treatment effects on the log-scale (R² = 0.89), but no association was seen between ORR and overall survival (R² = 0.09) or between PFS and overall survival (R² = 0.08) – possibly because of factors confounding overall survival analysis, such as cross-over, subsequent therapies, and long post-progression survival, reported Dr. Gideon M. Blumenthal and his colleagues at the FDA, White Oak, Md.

Patient-level analyses showed that those who achieved a response had improved PFS and overall survival compared with nonresponders (hazard ratio, 0.40 for both), the investigators noted (J. Clin. Oncol. 2015 Feb. 9 [doi:10.1200/JCO.2014.59.0489]).

The findings, which suggest that a therapy for advanced NSCLC that has a large magnitude of effect on ORR may also have a large effect on PFS, have implications for drug approvals, as “accelerated approval can be granted based on improvement in a surrogate endpoint reasonably likely to predict clinical benefit, such as ORR of large magnitude and long duration,” the researchers wrote, noting that “ORR may not be the optimal endpoint for hypothesis generation or expedited approval pathways for cytostatic therapies and immunotherapies, in which alternate endpoints may be needed to estimate activity and PFS or OS may be required to confirm clinical benefit,” and that novel methods for assessing drug activity warrant further investigation.

The authors reported having no disclosures.

SAN DIEGO – Fetal growth rates vary significantly among racial and ethnic groups, according to findings from a prospective cohort study.

The findings, which suggest that a single standard is not appropriate for all population subgroups, have implications for the development of fetal growth standards in the United States, Dr. Katherine Laughon Grantz reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is potential for significant misclassification if standards are used that are based on either one race or that use a pooled racial ethnic group, and a single standard is not appropriate for fetal growth in contemporary U.S. obstetrical calculations,” she said.

Of 2,334 healthy women with low-risk singleton pregnancies who participated in the trial – a National Institute of Child Health and Human Development (NICHD) growth study – 26% were Caucasian, 26% were African American, 28% were Hispanic, and 20% were Asian. After exclusion of those who developed pregnancy complications or were lost to follow-up, 1,737 remained.

The growth curves began to differ between the groups beginning at 16 weeks gestation, and extended to delivery, said Dr. Grantz of the NICHD in Rockville, Md.

After 20 weeks’ gestation, highly significant differences were seen between the groups in estimated fetal weight. At 35 weeks’ gestation, the 10th, 50th, and 90th estimated fetal weight percentiles were 2,305 g, 2,727 g, and 3,227 g for Caucasians; 2,179 g, 2,607 g, and 3,121 g for Hispanics; 2,140 g, 2,530 g, and 2,987 g for Asians; and 2,140 g, 2,528 g, and 2,987 g for African Americans.

Differences in abdominal circumference paralleled the differences in estimated fetal weight, Dr. Grantz said.

After 25 weeks’ gestation, statistically significant differences in head circumference emerged, and at 35 weeks, median head circumference was 320 cm in Caucasians, 317 cm in Hispanics, 316 cm in Asians, and 314 cm in African Americans, she said.

Other differences included humerus and femur length, which were longer throughout gestation in African Americans than in the other racial/ethnic groups – similar to adult proportions.

The women were recruited between 2010 and 2013 from 12 clinical sites. They were screened between 8 weeks and 13 weeks plus 6 days for low-risk status associated with optimal fetal growth. The women were then randomized to one of four serial 2D/3D ultrasonology schedules with quality assurance for longitudinal fetal measurements. This approach was taken to allow for adequate representation of each gestational week without subjecting the women to too many ultrasounds, Dr. Grantz said.

The differences remained statistically significant after adjustment for various demographic differences between the groups.

“Optimal fetal growth is the foundation of long-term health,” Dr. Grantz said, noting that despite this understanding, identifying normal fetal growth remains a pressing challenge.

The current findings suggest that fetuses growing in optimal conditions, with normal maternal size and normal pregnancy outcomes, differ in proportion and size by race/ethnicity, she said.

Dr. Grantz is an employee of the NICHD, which supported the study.

SAN DIEGO – Fetal growth rates vary significantly among racial and ethnic groups, according to findings from a prospective cohort study.

The findings, which suggest that a single standard is not appropriate for all population subgroups, have implications for the development of fetal growth standards in the United States, Dr. Katherine Laughon Grantz reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is potential for significant misclassification if standards are used that are based on either one race or that use a pooled racial ethnic group, and a single standard is not appropriate for fetal growth in contemporary U.S. obstetrical calculations,” she said.

Of 2,334 healthy women with low-risk singleton pregnancies who participated in the trial – a National Institute of Child Health and Human Development (NICHD) growth study – 26% were Caucasian, 26% were African American, 28% were Hispanic, and 20% were Asian. After exclusion of those who developed pregnancy complications or were lost to follow-up, 1,737 remained.

The growth curves began to differ between the groups beginning at 16 weeks gestation, and extended to delivery, said Dr. Grantz of the NICHD in Rockville, Md.

After 20 weeks’ gestation, highly significant differences were seen between the groups in estimated fetal weight. At 35 weeks’ gestation, the 10th, 50th, and 90th estimated fetal weight percentiles were 2,305 g, 2,727 g, and 3,227 g for Caucasians; 2,179 g, 2,607 g, and 3,121 g for Hispanics; 2,140 g, 2,530 g, and 2,987 g for Asians; and 2,140 g, 2,528 g, and 2,987 g for African Americans.

Differences in abdominal circumference paralleled the differences in estimated fetal weight, Dr. Grantz said.

After 25 weeks’ gestation, statistically significant differences in head circumference emerged, and at 35 weeks, median head circumference was 320 cm in Caucasians, 317 cm in Hispanics, 316 cm in Asians, and 314 cm in African Americans, she said.

Other differences included humerus and femur length, which were longer throughout gestation in African Americans than in the other racial/ethnic groups – similar to adult proportions.

The women were recruited between 2010 and 2013 from 12 clinical sites. They were screened between 8 weeks and 13 weeks plus 6 days for low-risk status associated with optimal fetal growth. The women were then randomized to one of four serial 2D/3D ultrasonology schedules with quality assurance for longitudinal fetal measurements. This approach was taken to allow for adequate representation of each gestational week without subjecting the women to too many ultrasounds, Dr. Grantz said.

The differences remained statistically significant after adjustment for various demographic differences between the groups.

“Optimal fetal growth is the foundation of long-term health,” Dr. Grantz said, noting that despite this understanding, identifying normal fetal growth remains a pressing challenge.

The current findings suggest that fetuses growing in optimal conditions, with normal maternal size and normal pregnancy outcomes, differ in proportion and size by race/ethnicity, she said.

Dr. Grantz is an employee of the NICHD, which supported the study.

SAN DIEGO – Fetal growth rates vary significantly among racial and ethnic groups, according to findings from a prospective cohort study.

The findings, which suggest that a single standard is not appropriate for all population subgroups, have implications for the development of fetal growth standards in the United States, Dr. Katherine Laughon Grantz reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is potential for significant misclassification if standards are used that are based on either one race or that use a pooled racial ethnic group, and a single standard is not appropriate for fetal growth in contemporary U.S. obstetrical calculations,” she said.

Of 2,334 healthy women with low-risk singleton pregnancies who participated in the trial – a National Institute of Child Health and Human Development (NICHD) growth study – 26% were Caucasian, 26% were African American, 28% were Hispanic, and 20% were Asian. After exclusion of those who developed pregnancy complications or were lost to follow-up, 1,737 remained.

The growth curves began to differ between the groups beginning at 16 weeks gestation, and extended to delivery, said Dr. Grantz of the NICHD in Rockville, Md.

After 20 weeks’ gestation, highly significant differences were seen between the groups in estimated fetal weight. At 35 weeks’ gestation, the 10th, 50th, and 90th estimated fetal weight percentiles were 2,305 g, 2,727 g, and 3,227 g for Caucasians; 2,179 g, 2,607 g, and 3,121 g for Hispanics; 2,140 g, 2,530 g, and 2,987 g for Asians; and 2,140 g, 2,528 g, and 2,987 g for African Americans.

Differences in abdominal circumference paralleled the differences in estimated fetal weight, Dr. Grantz said.

After 25 weeks’ gestation, statistically significant differences in head circumference emerged, and at 35 weeks, median head circumference was 320 cm in Caucasians, 317 cm in Hispanics, 316 cm in Asians, and 314 cm in African Americans, she said.

Other differences included humerus and femur length, which were longer throughout gestation in African Americans than in the other racial/ethnic groups – similar to adult proportions.

The women were recruited between 2010 and 2013 from 12 clinical sites. They were screened between 8 weeks and 13 weeks plus 6 days for low-risk status associated with optimal fetal growth. The women were then randomized to one of four serial 2D/3D ultrasonology schedules with quality assurance for longitudinal fetal measurements. This approach was taken to allow for adequate representation of each gestational week without subjecting the women to too many ultrasounds, Dr. Grantz said.

The differences remained statistically significant after adjustment for various demographic differences between the groups.

“Optimal fetal growth is the foundation of long-term health,” Dr. Grantz said, noting that despite this understanding, identifying normal fetal growth remains a pressing challenge.

The current findings suggest that fetuses growing in optimal conditions, with normal maternal size and normal pregnancy outcomes, differ in proportion and size by race/ethnicity, she said.

Dr. Grantz is an employee of the NICHD, which supported the study.

SAN DIEGO– Early treatment of pregnant women with prediabetes led to lower hemoglobin A_1C (HbA_1C) levels during the second trimester and at delivery in a randomized, controlled trial.

Study subjects were 83 women with a first trimester HbA_1C of 5.7%-6.4% (median of 5.8%) indicative of prediabetes. HbA_1C levels during the second trimester were 5.2% and 5.3% in the 42 women who were randomized to receive early treatment and in the 41 who received routine care, respectively, and the levels at delivery were 5.5% and 5.8%, respectively, Dr. Sarah Osmundson reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The overall rate of positive glucose tolerance tests (GTT) or insulin use prior to the GTT – the primary study outcome – did not differ significantly between the groups but did trend toward lower in the early treatment group (45.2% vs. 55%; relative risk, 0.82), said Dr. Osmundson of Stanford (Calif.) University.

Further, although no difference was seen in the rate of gestational diabetes mellitus (GDM) among women with prepregnancy obesity in the early treatment and routine care groups, early treatment was associated with a 50% lower rate of GDM in nonobese women (29.6% vs. 59.1%, relative risk, 0.50), she said.

The participants had a singleton pregnancy, no chronic steroid use, and no preexisting diabetes. They were enrolled between May 2012 and June 2014, and all met with a certified diabetes educator at study entry to discuss healthy weight gain strategies in pregnancy and to set personalized weight gain goals.

Those in the early treatment group also were counseled to keep a diary to track food intake, were advised to monitor portion size, and limit carbohydrate intake to no more than 45% of total diet, and were seen by a dietitian or obstetrician every 2 weeks. They self-monitored blood glucose levels four times daily, and insulin was initiated if more than 20% of values were elevated.

The routine care group received usual prenatal care, including a visit with a provider every 4 weeks.

Patients in both groups underwent an oral GTT between 26 and 28 weeks of gestation.

Patients in the early treatment group with a positive GTT continued treatment, and those with a negative GTT continued treatment, but reduced monitoring to twice daily – returning to four times daily testing if levels increased. Those in the routine care group initiated treatment if the GTT was positive, and continued usual care if it was negative.

The groups gained a similar amount of weight during the study and did not differ in terms of insulin use, but the early treatment group started insulin at an earlier gestational age, and nonsignificant trends were seen toward a decrease in the primary outcome and toward lower GTT values in that group. The early treatment group patients also had a lower cesarean delivery rate (29.4% vs. 47,2%; RR, 0.63), but the difference did not reach statistical significance, Dr. Osmundson said.

Similarly, nonsignificant trends were seen toward lower infant birth weight, less macrosomia, and lower umbilical cord C-peptide levels in the early treatment group.

Glycosylated HbA_1C is widely used for monitoring glycemic control, but was only recently adopted as an additional method of screening for diabetes. The measure has several advantages over the oral GTT, as it can be performed in a nonfasting state, requires only one blood draw, and provides information about average glucose exposure over time, she said.

The American Diabetes Association accepted HbA_1C as an additional method for diagnosing type 2 diabetes in 2009, and classified those with levels between 5.7% and 6.4% as having prediabetes. That same year, an International Association of Diabetes in Pregnancy study group recommended that HbA_1C of 6.5% or greater in pregnancy be considered overt diabetes, but made no recommendations regarding the management of those with prediabetic HbA_1C, Dr. Osmundson said.

Prediabetes predicts a 50% cumulative incidence of type 2 diabetes within 5 years in nonpregnant patients, but much less is known about the condition in pregnant women, she added, noting that recent studies suggest a threefold increased risk for gestational diabetes in the second trimester – and perhaps even greater risk in obese women – among those with prediabetes.

The addition of HbA_1C to the prenatal panel in California, along with a recommendation that those with prediabetes be diagnosed with and treated for gestational diabetes, provided the opportunity to evaluate whether such treatment affected the incidence of gestational diabetes as compared with usual care, she noted.

“We hypothesized that treatment would lower the risk of GDM, especially among obese women,” she said.

Though limited by the sample size and the fact that providers were not blinded to patients’ treatment group, the randomized, controlled study design is a strength, and the findings add to the limited data on HbA_1C in pregnancy and the management of prediabetes in pregnant patients, she said.

The study was underpowered to determine whether early treatment reduces the risk of GDM in women with prediabetes, but the findings suggest that such treatment may reduce the risk among nonobese women.

“While this finding is unexpected, we think the findings are consistent with literature suggesting that women with prepregnancy obesity remain at higher risk of adverse perinatal outcomes even in absence of GDM or excessive weight gain. We hypothesize that any small effect may be attenuated by the morbidity associated with prepregnancy adiposity. Larger studies powered to examine the primary outcomes and perinatal outcomes are required,” she concluded.

This study was funded by the American College of Obstetricians and Gynecologists Abbott Nutrition Research Fellowship, the Stanford Child Health Institute, and the Valley Foundation for the California Institute of Medical Research. Dr. Osmundson reported having no disclosures.

SAN DIEGO– Early treatment of pregnant women with prediabetes led to lower hemoglobin A_1C (HbA_1C) levels during the second trimester and at delivery in a randomized, controlled trial.

Study subjects were 83 women with a first trimester HbA_1C of 5.7%-6.4% (median of 5.8%) indicative of prediabetes. HbA_1C levels during the second trimester were 5.2% and 5.3% in the 42 women who were randomized to receive early treatment and in the 41 who received routine care, respectively, and the levels at delivery were 5.5% and 5.8%, respectively, Dr. Sarah Osmundson reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The overall rate of positive glucose tolerance tests (GTT) or insulin use prior to the GTT – the primary study outcome – did not differ significantly between the groups but did trend toward lower in the early treatment group (45.2% vs. 55%; relative risk, 0.82), said Dr. Osmundson of Stanford (Calif.) University.

Further, although no difference was seen in the rate of gestational diabetes mellitus (GDM) among women with prepregnancy obesity in the early treatment and routine care groups, early treatment was associated with a 50% lower rate of GDM in nonobese women (29.6% vs. 59.1%, relative risk, 0.50), she said.

The participants had a singleton pregnancy, no chronic steroid use, and no preexisting diabetes. They were enrolled between May 2012 and June 2014, and all met with a certified diabetes educator at study entry to discuss healthy weight gain strategies in pregnancy and to set personalized weight gain goals.

Those in the early treatment group also were counseled to keep a diary to track food intake, were advised to monitor portion size, and limit carbohydrate intake to no more than 45% of total diet, and were seen by a dietitian or obstetrician every 2 weeks. They self-monitored blood glucose levels four times daily, and insulin was initiated if more than 20% of values were elevated.

The routine care group received usual prenatal care, including a visit with a provider every 4 weeks.

Patients in both groups underwent an oral GTT between 26 and 28 weeks of gestation.

Patients in the early treatment group with a positive GTT continued treatment, and those with a negative GTT continued treatment, but reduced monitoring to twice daily – returning to four times daily testing if levels increased. Those in the routine care group initiated treatment if the GTT was positive, and continued usual care if it was negative.

The groups gained a similar amount of weight during the study and did not differ in terms of insulin use, but the early treatment group started insulin at an earlier gestational age, and nonsignificant trends were seen toward a decrease in the primary outcome and toward lower GTT values in that group. The early treatment group patients also had a lower cesarean delivery rate (29.4% vs. 47,2%; RR, 0.63), but the difference did not reach statistical significance, Dr. Osmundson said.

Similarly, nonsignificant trends were seen toward lower infant birth weight, less macrosomia, and lower umbilical cord C-peptide levels in the early treatment group.

Glycosylated HbA_1C is widely used for monitoring glycemic control, but was only recently adopted as an additional method of screening for diabetes. The measure has several advantages over the oral GTT, as it can be performed in a nonfasting state, requires only one blood draw, and provides information about average glucose exposure over time, she said.

The American Diabetes Association accepted HbA_1C as an additional method for diagnosing type 2 diabetes in 2009, and classified those with levels between 5.7% and 6.4% as having prediabetes. That same year, an International Association of Diabetes in Pregnancy study group recommended that HbA_1C of 6.5% or greater in pregnancy be considered overt diabetes, but made no recommendations regarding the management of those with prediabetic HbA_1C, Dr. Osmundson said.

Prediabetes predicts a 50% cumulative incidence of type 2 diabetes within 5 years in nonpregnant patients, but much less is known about the condition in pregnant women, she added, noting that recent studies suggest a threefold increased risk for gestational diabetes in the second trimester – and perhaps even greater risk in obese women – among those with prediabetes.

The addition of HbA_1C to the prenatal panel in California, along with a recommendation that those with prediabetes be diagnosed with and treated for gestational diabetes, provided the opportunity to evaluate whether such treatment affected the incidence of gestational diabetes as compared with usual care, she noted.

“We hypothesized that treatment would lower the risk of GDM, especially among obese women,” she said.

Though limited by the sample size and the fact that providers were not blinded to patients’ treatment group, the randomized, controlled study design is a strength, and the findings add to the limited data on HbA_1C in pregnancy and the management of prediabetes in pregnant patients, she said.

The study was underpowered to determine whether early treatment reduces the risk of GDM in women with prediabetes, but the findings suggest that such treatment may reduce the risk among nonobese women.

“While this finding is unexpected, we think the findings are consistent with literature suggesting that women with prepregnancy obesity remain at higher risk of adverse perinatal outcomes even in absence of GDM or excessive weight gain. We hypothesize that any small effect may be attenuated by the morbidity associated with prepregnancy adiposity. Larger studies powered to examine the primary outcomes and perinatal outcomes are required,” she concluded.

This study was funded by the American College of Obstetricians and Gynecologists Abbott Nutrition Research Fellowship, the Stanford Child Health Institute, and the Valley Foundation for the California Institute of Medical Research. Dr. Osmundson reported having no disclosures.

SAN DIEGO– Early treatment of pregnant women with prediabetes led to lower hemoglobin A_1C (HbA_1C) levels during the second trimester and at delivery in a randomized, controlled trial.

Study subjects were 83 women with a first trimester HbA_1C of 5.7%-6.4% (median of 5.8%) indicative of prediabetes. HbA_1C levels during the second trimester were 5.2% and 5.3% in the 42 women who were randomized to receive early treatment and in the 41 who received routine care, respectively, and the levels at delivery were 5.5% and 5.8%, respectively, Dr. Sarah Osmundson reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The overall rate of positive glucose tolerance tests (GTT) or insulin use prior to the GTT – the primary study outcome – did not differ significantly between the groups but did trend toward lower in the early treatment group (45.2% vs. 55%; relative risk, 0.82), said Dr. Osmundson of Stanford (Calif.) University.

Further, although no difference was seen in the rate of gestational diabetes mellitus (GDM) among women with prepregnancy obesity in the early treatment and routine care groups, early treatment was associated with a 50% lower rate of GDM in nonobese women (29.6% vs. 59.1%, relative risk, 0.50), she said.

The participants had a singleton pregnancy, no chronic steroid use, and no preexisting diabetes. They were enrolled between May 2012 and June 2014, and all met with a certified diabetes educator at study entry to discuss healthy weight gain strategies in pregnancy and to set personalized weight gain goals.

Those in the early treatment group also were counseled to keep a diary to track food intake, were advised to monitor portion size, and limit carbohydrate intake to no more than 45% of total diet, and were seen by a dietitian or obstetrician every 2 weeks. They self-monitored blood glucose levels four times daily, and insulin was initiated if more than 20% of values were elevated.

The routine care group received usual prenatal care, including a visit with a provider every 4 weeks.

Patients in both groups underwent an oral GTT between 26 and 28 weeks of gestation.

Patients in the early treatment group with a positive GTT continued treatment, and those with a negative GTT continued treatment, but reduced monitoring to twice daily – returning to four times daily testing if levels increased. Those in the routine care group initiated treatment if the GTT was positive, and continued usual care if it was negative.

The groups gained a similar amount of weight during the study and did not differ in terms of insulin use, but the early treatment group started insulin at an earlier gestational age, and nonsignificant trends were seen toward a decrease in the primary outcome and toward lower GTT values in that group. The early treatment group patients also had a lower cesarean delivery rate (29.4% vs. 47,2%; RR, 0.63), but the difference did not reach statistical significance, Dr. Osmundson said.

Similarly, nonsignificant trends were seen toward lower infant birth weight, less macrosomia, and lower umbilical cord C-peptide levels in the early treatment group.

Glycosylated HbA_1C is widely used for monitoring glycemic control, but was only recently adopted as an additional method of screening for diabetes. The measure has several advantages over the oral GTT, as it can be performed in a nonfasting state, requires only one blood draw, and provides information about average glucose exposure over time, she said.

The American Diabetes Association accepted HbA_1C as an additional method for diagnosing type 2 diabetes in 2009, and classified those with levels between 5.7% and 6.4% as having prediabetes. That same year, an International Association of Diabetes in Pregnancy study group recommended that HbA_1C of 6.5% or greater in pregnancy be considered overt diabetes, but made no recommendations regarding the management of those with prediabetic HbA_1C, Dr. Osmundson said.

Prediabetes predicts a 50% cumulative incidence of type 2 diabetes within 5 years in nonpregnant patients, but much less is known about the condition in pregnant women, she added, noting that recent studies suggest a threefold increased risk for gestational diabetes in the second trimester – and perhaps even greater risk in obese women – among those with prediabetes.

The addition of HbA_1C to the prenatal panel in California, along with a recommendation that those with prediabetes be diagnosed with and treated for gestational diabetes, provided the opportunity to evaluate whether such treatment affected the incidence of gestational diabetes as compared with usual care, she noted.

“We hypothesized that treatment would lower the risk of GDM, especially among obese women,” she said.

Though limited by the sample size and the fact that providers were not blinded to patients’ treatment group, the randomized, controlled study design is a strength, and the findings add to the limited data on HbA_1C in pregnancy and the management of prediabetes in pregnant patients, she said.

The study was underpowered to determine whether early treatment reduces the risk of GDM in women with prediabetes, but the findings suggest that such treatment may reduce the risk among nonobese women.

“While this finding is unexpected, we think the findings are consistent with literature suggesting that women with prepregnancy obesity remain at higher risk of adverse perinatal outcomes even in absence of GDM or excessive weight gain. We hypothesize that any small effect may be attenuated by the morbidity associated with prepregnancy adiposity. Larger studies powered to examine the primary outcomes and perinatal outcomes are required,” she concluded.

This study was funded by the American College of Obstetricians and Gynecologists Abbott Nutrition Research Fellowship, the Stanford Child Health Institute, and the Valley Foundation for the California Institute of Medical Research. Dr. Osmundson reported having no disclosures.

ORLANDO – Generational dermatology can be conceptualized by looking at patients now in their 50s, 60s, and 70s and thinking about what aspects of aging could have been targeted 20 years ago had currently available tools been available then, according to Dr. Wendy E. Roberts.

“What interventions would we select for our patients, and what tools do we have that we did not have then?” said Dr. Roberts of Rancho Mirage, Calif.

One area for intervention that stands out is integumentary system collapse, with such features as stress tears, purpura, and photodamage, she said, noting that these aren’t things that happen overnight. Preventive measures, beginning with a focus on the skin barrier, can go a long way toward preventing this type of organ damage.

“Skin barrier has been upgraded to a major feature of a variety of common disease states, so I encourage everyone to start your therapeutic plan by assessing this skin care component – assessing the integrity of the skin,” she said, explaining that entities including xerosis, pruritus, purpura, and rosacea share a common factor: skin barrier abnormalities.

Understanding what is normal, what indicates injury, and what is considered progressive pathology with respect to skin barrier is important.

Consider xerosis, for example.

For a long time, the condition was relegated to “just dry skin.” But xerosis is the No. 1 aging skin issue for both men and women, she noted.

Further, it contributes to other important skin pathology, including pruritus, lichen simplex chronicus, and foot fissures.

“This happens because over the course of our lifetime, we have decreasing epidermal keratinocyte transit time,” she explained.

Of note, foot ulcers are a billion dollar burden on the American health care system, and a major contributing factor – accounting for about 70% of foot ulcers – is hyperkeratosis, she said, adding that “there’s something to be said about foot care and moisturization.”

“I always recommend this in my evolving aging patients. It’s something we really need to think about, and we can’t wait to think about it in the 7th decade,” she said referring to moisturization and good skin care habits.

Moisturization is the key, and it involves the use of protectants that produce an additional barrier to water loss, hydration with moisturizers that decrease transepidermal water loss and restore water to the epidermis, and emollients that intercalate and form a nice skin barrier. Using all three is advisable, as each has a specific function, she said.

Other pearls for xerosis management include a review of all possible contributors: photodamage, menopausal status, hormonal status, comorbidities, thyroid status, and emerging medication issues. Statins and systemic retinoids, in particular, can contribute.

Climate and living environment also should be considered, as cold (and use of heating units), high altitude, and desert areas can increase the risk of xerosis.

Advise patients with xerosis to avoid prolonged contact with hot water and with detergent cleansers (in lieu of moisturizing cleansers), and recommend twice daily application of cream- or oil-based vehicles rather than lotions. Supplements, including omega-3s, vitamin A, vitamin B, and primrose may also provide some benefit, she said.

Among the other tools that Dr. Roberts recommended for use earlier in life to help improve outcomes across the lifespan are imaging technologies and full-body skin exams.

Visual interactive systems that can bring patients awareness regarding the aging process, and imaging of pigmented lesions via dermoscopy that can help track changes over time are examples of imaging modalities that can be used. Programs exist that allow patients to log in to a program from home and view the images of their skin online.

Examples include Touch MD by Alphaeon, MelaFind by MELA Sciences, and Visia by Canfield Scientific which can be useful not only for cosmetic dermatology, but also for medical dermatology, she said.

“These tools aren’t just research tools; these tools really help communicate the attributes of all aspects of aging skin and can be very beneficial,” she said.

Such images can be useful in children as well, as they can show the early effects of photodamage and encourage parents to begin sun protection efforts early.

Full-body skin exams are a must, because the most deadly skin cancers occur most often on typically covered sites. Such exams also can be used as a tool to discuss medical, cosmetic, and oncologic issues that are important throughout the aging process, she said.

Dr. Roberts reported that she is a speaker or consultant for, and/or has received honoraria from Allergan, Colorescience, L’Oreal, La Roche-Posay, NeoStrata, SkinMedica, Theraplex, and Top MD Skincare.

ORLANDO – Generational dermatology can be conceptualized by looking at patients now in their 50s, 60s, and 70s and thinking about what aspects of aging could have been targeted 20 years ago had currently available tools been available then, according to Dr. Wendy E. Roberts.

“What interventions would we select for our patients, and what tools do we have that we did not have then?” said Dr. Roberts of Rancho Mirage, Calif.

One area for intervention that stands out is integumentary system collapse, with such features as stress tears, purpura, and photodamage, she said, noting that these aren’t things that happen overnight. Preventive measures, beginning with a focus on the skin barrier, can go a long way toward preventing this type of organ damage.

“Skin barrier has been upgraded to a major feature of a variety of common disease states, so I encourage everyone to start your therapeutic plan by assessing this skin care component – assessing the integrity of the skin,” she said, explaining that entities including xerosis, pruritus, purpura, and rosacea share a common factor: skin barrier abnormalities.

Understanding what is normal, what indicates injury, and what is considered progressive pathology with respect to skin barrier is important.

Consider xerosis, for example.

For a long time, the condition was relegated to “just dry skin.” But xerosis is the No. 1 aging skin issue for both men and women, she noted.

Further, it contributes to other important skin pathology, including pruritus, lichen simplex chronicus, and foot fissures.

“This happens because over the course of our lifetime, we have decreasing epidermal keratinocyte transit time,” she explained.

Of note, foot ulcers are a billion dollar burden on the American health care system, and a major contributing factor – accounting for about 70% of foot ulcers – is hyperkeratosis, she said, adding that “there’s something to be said about foot care and moisturization.”

“I always recommend this in my evolving aging patients. It’s something we really need to think about, and we can’t wait to think about it in the 7th decade,” she said referring to moisturization and good skin care habits.

Moisturization is the key, and it involves the use of protectants that produce an additional barrier to water loss, hydration with moisturizers that decrease transepidermal water loss and restore water to the epidermis, and emollients that intercalate and form a nice skin barrier. Using all three is advisable, as each has a specific function, she said.

Other pearls for xerosis management include a review of all possible contributors: photodamage, menopausal status, hormonal status, comorbidities, thyroid status, and emerging medication issues. Statins and systemic retinoids, in particular, can contribute.

Climate and living environment also should be considered, as cold (and use of heating units), high altitude, and desert areas can increase the risk of xerosis.

Advise patients with xerosis to avoid prolonged contact with hot water and with detergent cleansers (in lieu of moisturizing cleansers), and recommend twice daily application of cream- or oil-based vehicles rather than lotions. Supplements, including omega-3s, vitamin A, vitamin B, and primrose may also provide some benefit, she said.

Among the other tools that Dr. Roberts recommended for use earlier in life to help improve outcomes across the lifespan are imaging technologies and full-body skin exams.

Visual interactive systems that can bring patients awareness regarding the aging process, and imaging of pigmented lesions via dermoscopy that can help track changes over time are examples of imaging modalities that can be used. Programs exist that allow patients to log in to a program from home and view the images of their skin online.

Examples include Touch MD by Alphaeon, MelaFind by MELA Sciences, and Visia by Canfield Scientific which can be useful not only for cosmetic dermatology, but also for medical dermatology, she said.

“These tools aren’t just research tools; these tools really help communicate the attributes of all aspects of aging skin and can be very beneficial,” she said.

Such images can be useful in children as well, as they can show the early effects of photodamage and encourage parents to begin sun protection efforts early.

Full-body skin exams are a must, because the most deadly skin cancers occur most often on typically covered sites. Such exams also can be used as a tool to discuss medical, cosmetic, and oncologic issues that are important throughout the aging process, she said.

Dr. Roberts reported that she is a speaker or consultant for, and/or has received honoraria from Allergan, Colorescience, L’Oreal, La Roche-Posay, NeoStrata, SkinMedica, Theraplex, and Top MD Skincare.

ORLANDO – Generational dermatology can be conceptualized by looking at patients now in their 50s, 60s, and 70s and thinking about what aspects of aging could have been targeted 20 years ago had currently available tools been available then, according to Dr. Wendy E. Roberts.

“What interventions would we select for our patients, and what tools do we have that we did not have then?” said Dr. Roberts of Rancho Mirage, Calif.

One area for intervention that stands out is integumentary system collapse, with such features as stress tears, purpura, and photodamage, she said, noting that these aren’t things that happen overnight. Preventive measures, beginning with a focus on the skin barrier, can go a long way toward preventing this type of organ damage.

“Skin barrier has been upgraded to a major feature of a variety of common disease states, so I encourage everyone to start your therapeutic plan by assessing this skin care component – assessing the integrity of the skin,” she said, explaining that entities including xerosis, pruritus, purpura, and rosacea share a common factor: skin barrier abnormalities.

Understanding what is normal, what indicates injury, and what is considered progressive pathology with respect to skin barrier is important.

Consider xerosis, for example.

For a long time, the condition was relegated to “just dry skin.” But xerosis is the No. 1 aging skin issue for both men and women, she noted.

Further, it contributes to other important skin pathology, including pruritus, lichen simplex chronicus, and foot fissures.

“This happens because over the course of our lifetime, we have decreasing epidermal keratinocyte transit time,” she explained.

Of note, foot ulcers are a billion dollar burden on the American health care system, and a major contributing factor – accounting for about 70% of foot ulcers – is hyperkeratosis, she said, adding that “there’s something to be said about foot care and moisturization.”

“I always recommend this in my evolving aging patients. It’s something we really need to think about, and we can’t wait to think about it in the 7th decade,” she said referring to moisturization and good skin care habits.

Moisturization is the key, and it involves the use of protectants that produce an additional barrier to water loss, hydration with moisturizers that decrease transepidermal water loss and restore water to the epidermis, and emollients that intercalate and form a nice skin barrier. Using all three is advisable, as each has a specific function, she said.

Other pearls for xerosis management include a review of all possible contributors: photodamage, menopausal status, hormonal status, comorbidities, thyroid status, and emerging medication issues. Statins and systemic retinoids, in particular, can contribute.

Climate and living environment also should be considered, as cold (and use of heating units), high altitude, and desert areas can increase the risk of xerosis.

Advise patients with xerosis to avoid prolonged contact with hot water and with detergent cleansers (in lieu of moisturizing cleansers), and recommend twice daily application of cream- or oil-based vehicles rather than lotions. Supplements, including omega-3s, vitamin A, vitamin B, and primrose may also provide some benefit, she said.

Among the other tools that Dr. Roberts recommended for use earlier in life to help improve outcomes across the lifespan are imaging technologies and full-body skin exams.

Visual interactive systems that can bring patients awareness regarding the aging process, and imaging of pigmented lesions via dermoscopy that can help track changes over time are examples of imaging modalities that can be used. Programs exist that allow patients to log in to a program from home and view the images of their skin online.

Examples include Touch MD by Alphaeon, MelaFind by MELA Sciences, and Visia by Canfield Scientific which can be useful not only for cosmetic dermatology, but also for medical dermatology, she said.

“These tools aren’t just research tools; these tools really help communicate the attributes of all aspects of aging skin and can be very beneficial,” she said.

Such images can be useful in children as well, as they can show the early effects of photodamage and encourage parents to begin sun protection efforts early.

Full-body skin exams are a must, because the most deadly skin cancers occur most often on typically covered sites. Such exams also can be used as a tool to discuss medical, cosmetic, and oncologic issues that are important throughout the aging process, she said.

Dr. Roberts reported that she is a speaker or consultant for, and/or has received honoraria from Allergan, Colorescience, L’Oreal, La Roche-Posay, NeoStrata, SkinMedica, Theraplex, and Top MD Skincare.

SAN DIEGO – A shift from a conventional private practice model to a 24-hour obstetrician and midwifery model was associated with a dramatic decrease in the nulliparous term single vertex cesarean delivery rate, and an increase in the vaginal birth after cesarean delivery (VBAC) rate among privately insured women who delivered at a single community hospital.

The nulliparous term single vertex cesarean delivery (NTSV CD) rate among privately insured women prior to the model change was 32.2%, compared with 25% after the change, with a 5% decrease at the time of the change, and a nearly 2% decrease per year thereafter. Prior to the change, the rate had been increasing by 0.6% annually, which was similar to national trends. The odds ratio for NTSV CD was 0.56 after adjustment for maternal age, race/ethnicity, induction , epidural use, birth weight, gestational age, maternal medical problems, and birth year, Dr. Melissa Rosenstein reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, the VBAC rate, which was decreasing slightly each year before the change, increased from 13% to 22% after the change (adjusted odds ratio, 1.94), and increased by about 8% per year thereafter, said Dr. Rosenstein of the University of California, San Francisco.

Prior to the change, privately insured women were managed by their individual obstetricians; only publicly insured women utilized the hospitalist model. The rates of NTSV CD and VBAC in the publicly insured women did not change significantly during the study period – the NTSV CD rates were 15.7% and 15.8% before and after the change, and VBAC rates were 33.9% and 27.9% before and after the change (aOR, 0.84 and 0.76, respectively), she said.

Interrupted time series analyses showed that the change in VBAC rates among the publicly insured women represented a persistent trend rather than any change from the intervention and also showed no significant adverse effect of the intervention on short-term neonatal outcomes, she noted.

The prospective cohort study included all singleton term deliveries at the community hospital between January 2005 and April 2014. The model shift occurred in April 2011. Overall, 3,684 NTSV deliveries and 1,375 deliveries in women with a prior cesarean delivery were included in the analysis.

The pre- and post-model change cohorts were similar with respect to delivery volume, gestational age, maternal age, and ethnic makeup.

The findings are notable, because the practice of obstetrics in the United States faces multiple challenges, Dr. Rosenstein said, noting that nearly a third of all births are by cesarean section, while VBAC rates continue to decline.

“These trends are accompanied by increasing maternal complications and rising costs,” she said.

Additionally, work force concerns are leading to decreased provider satisfaction and burnout among those who perform deliveries – due in part to the inherent conflict between labor and delivery responsibilities and office practice – and the difficulty of balancing these demands.

“At the same time, there have been increasing calls for expanding the availability of 24-hour in-house obstetric coverage to improve patient safety and decrease liability,” she said.

A potential solution to the problem of a shrinking workforce and rising cesarean delivery rates is increased use of midwives, whose involvement in deliveries is associated with excellent maternal and neonatal outcomes, Dr. Rosenstein noted.

Additionally, the employment of laborists, who provide in-house labor and delivery coverage without competing clinical duties, is increasing, and has been endorsed by the American College of Obstetricians and Gynecologists as a potential solution to improve provider satisfaction and patient safety. Data on outcomes associated with such a model are sparse, but encouraging, she said.

The shift from the private practice model to the laborist and midwifery model at a community hospital that provides services for an equal number of privately and publicly insured women posed an opportunity for University of California, San Francisco, researchers to prospectively study the effects of the model.

“We observed that the expansion of midwifery and laborist services in a collaborative practice model, was associated with decreased rate of primary cesarean delivery and an increased rate of VBAC, with cesarean rates continuing to decline during the 3 years after the practice change,” Dr Rosenstein said, noting that “the changes were seen to a statistically significant degree only in the group of women exposed to the practice change, suggesting causation rather than secular trends for other hospital-wide interventions.”

“We believe that this model could be instituted at other U.S. hospitals that are seeking to decrease their cesarean delivery rates,” she concluded.

This study was funded by the National Institutes of Health and the Prima Medical Foundation. Dr. Rosenstein reported having no disclosures.

SAN DIEGO – A shift from a conventional private practice model to a 24-hour obstetrician and midwifery model was associated with a dramatic decrease in the nulliparous term single vertex cesarean delivery rate, and an increase in the vaginal birth after cesarean delivery (VBAC) rate among privately insured women who delivered at a single community hospital.

The nulliparous term single vertex cesarean delivery (NTSV CD) rate among privately insured women prior to the model change was 32.2%, compared with 25% after the change, with a 5% decrease at the time of the change, and a nearly 2% decrease per year thereafter. Prior to the change, the rate had been increasing by 0.6% annually, which was similar to national trends. The odds ratio for NTSV CD was 0.56 after adjustment for maternal age, race/ethnicity, induction , epidural use, birth weight, gestational age, maternal medical problems, and birth year, Dr. Melissa Rosenstein reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, the VBAC rate, which was decreasing slightly each year before the change, increased from 13% to 22% after the change (adjusted odds ratio, 1.94), and increased by about 8% per year thereafter, said Dr. Rosenstein of the University of California, San Francisco.

Prior to the change, privately insured women were managed by their individual obstetricians; only publicly insured women utilized the hospitalist model. The rates of NTSV CD and VBAC in the publicly insured women did not change significantly during the study period – the NTSV CD rates were 15.7% and 15.8% before and after the change, and VBAC rates were 33.9% and 27.9% before and after the change (aOR, 0.84 and 0.76, respectively), she said.

Interrupted time series analyses showed that the change in VBAC rates among the publicly insured women represented a persistent trend rather than any change from the intervention and also showed no significant adverse effect of the intervention on short-term neonatal outcomes, she noted.

The prospective cohort study included all singleton term deliveries at the community hospital between January 2005 and April 2014. The model shift occurred in April 2011. Overall, 3,684 NTSV deliveries and 1,375 deliveries in women with a prior cesarean delivery were included in the analysis.

The pre- and post-model change cohorts were similar with respect to delivery volume, gestational age, maternal age, and ethnic makeup.

The findings are notable, because the practice of obstetrics in the United States faces multiple challenges, Dr. Rosenstein said, noting that nearly a third of all births are by cesarean section, while VBAC rates continue to decline.

“These trends are accompanied by increasing maternal complications and rising costs,” she said.

Additionally, work force concerns are leading to decreased provider satisfaction and burnout among those who perform deliveries – due in part to the inherent conflict between labor and delivery responsibilities and office practice – and the difficulty of balancing these demands.

“At the same time, there have been increasing calls for expanding the availability of 24-hour in-house obstetric coverage to improve patient safety and decrease liability,” she said.

A potential solution to the problem of a shrinking workforce and rising cesarean delivery rates is increased use of midwives, whose involvement in deliveries is associated with excellent maternal and neonatal outcomes, Dr. Rosenstein noted.

Additionally, the employment of laborists, who provide in-house labor and delivery coverage without competing clinical duties, is increasing, and has been endorsed by the American College of Obstetricians and Gynecologists as a potential solution to improve provider satisfaction and patient safety. Data on outcomes associated with such a model are sparse, but encouraging, she said.

The shift from the private practice model to the laborist and midwifery model at a community hospital that provides services for an equal number of privately and publicly insured women posed an opportunity for University of California, San Francisco, researchers to prospectively study the effects of the model.

“We observed that the expansion of midwifery and laborist services in a collaborative practice model, was associated with decreased rate of primary cesarean delivery and an increased rate of VBAC, with cesarean rates continuing to decline during the 3 years after the practice change,” Dr Rosenstein said, noting that “the changes were seen to a statistically significant degree only in the group of women exposed to the practice change, suggesting causation rather than secular trends for other hospital-wide interventions.”

“We believe that this model could be instituted at other U.S. hospitals that are seeking to decrease their cesarean delivery rates,” she concluded.

This study was funded by the National Institutes of Health and the Prima Medical Foundation. Dr. Rosenstein reported having no disclosures.

SAN DIEGO – A shift from a conventional private practice model to a 24-hour obstetrician and midwifery model was associated with a dramatic decrease in the nulliparous term single vertex cesarean delivery rate, and an increase in the vaginal birth after cesarean delivery (VBAC) rate among privately insured women who delivered at a single community hospital.

The nulliparous term single vertex cesarean delivery (NTSV CD) rate among privately insured women prior to the model change was 32.2%, compared with 25% after the change, with a 5% decrease at the time of the change, and a nearly 2% decrease per year thereafter. Prior to the change, the rate had been increasing by 0.6% annually, which was similar to national trends. The odds ratio for NTSV CD was 0.56 after adjustment for maternal age, race/ethnicity, induction , epidural use, birth weight, gestational age, maternal medical problems, and birth year, Dr. Melissa Rosenstein reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Further, the VBAC rate, which was decreasing slightly each year before the change, increased from 13% to 22% after the change (adjusted odds ratio, 1.94), and increased by about 8% per year thereafter, said Dr. Rosenstein of the University of California, San Francisco.

Prior to the change, privately insured women were managed by their individual obstetricians; only publicly insured women utilized the hospitalist model. The rates of NTSV CD and VBAC in the publicly insured women did not change significantly during the study period – the NTSV CD rates were 15.7% and 15.8% before and after the change, and VBAC rates were 33.9% and 27.9% before and after the change (aOR, 0.84 and 0.76, respectively), she said.

Interrupted time series analyses showed that the change in VBAC rates among the publicly insured women represented a persistent trend rather than any change from the intervention and also showed no significant adverse effect of the intervention on short-term neonatal outcomes, she noted.

The prospective cohort study included all singleton term deliveries at the community hospital between January 2005 and April 2014. The model shift occurred in April 2011. Overall, 3,684 NTSV deliveries and 1,375 deliveries in women with a prior cesarean delivery were included in the analysis.

The pre- and post-model change cohorts were similar with respect to delivery volume, gestational age, maternal age, and ethnic makeup.

The findings are notable, because the practice of obstetrics in the United States faces multiple challenges, Dr. Rosenstein said, noting that nearly a third of all births are by cesarean section, while VBAC rates continue to decline.

“These trends are accompanied by increasing maternal complications and rising costs,” she said.

Additionally, work force concerns are leading to decreased provider satisfaction and burnout among those who perform deliveries – due in part to the inherent conflict between labor and delivery responsibilities and office practice – and the difficulty of balancing these demands.

“At the same time, there have been increasing calls for expanding the availability of 24-hour in-house obstetric coverage to improve patient safety and decrease liability,” she said.

A potential solution to the problem of a shrinking workforce and rising cesarean delivery rates is increased use of midwives, whose involvement in deliveries is associated with excellent maternal and neonatal outcomes, Dr. Rosenstein noted.

Additionally, the employment of laborists, who provide in-house labor and delivery coverage without competing clinical duties, is increasing, and has been endorsed by the American College of Obstetricians and Gynecologists as a potential solution to improve provider satisfaction and patient safety. Data on outcomes associated with such a model are sparse, but encouraging, she said.

The shift from the private practice model to the laborist and midwifery model at a community hospital that provides services for an equal number of privately and publicly insured women posed an opportunity for University of California, San Francisco, researchers to prospectively study the effects of the model.

“We observed that the expansion of midwifery and laborist services in a collaborative practice model, was associated with decreased rate of primary cesarean delivery and an increased rate of VBAC, with cesarean rates continuing to decline during the 3 years after the practice change,” Dr Rosenstein said, noting that “the changes were seen to a statistically significant degree only in the group of women exposed to the practice change, suggesting causation rather than secular trends for other hospital-wide interventions.”

“We believe that this model could be instituted at other U.S. hospitals that are seeking to decrease their cesarean delivery rates,” she concluded.

This study was funded by the National Institutes of Health and the Prima Medical Foundation. Dr. Rosenstein reported having no disclosures.

SAN DIEGO – Fetal electrocardiogram ST segment analysis, or STAN, is commonly used in Europe as an adjunct to conventional intrapartum fetal heart rate monitoring, but adding STAN did not improve perinatal outcomes or decrease operative deliveries in a large, multicenter U.S. study.

Of 11,108 patients included in the 26-center study, 149 women experienced the composite primary outcome of at least one of the following: intrapartum fetal death, neonatal death, Apgar score of 3 or less at 5 minutes, neonatal seizure, cord artery pH of 7.05 or less plus base deficit of at least 12 mmol/L, intubation for ventilation at delivery, and neonatal encephalopathy, Dr. George R. Saade reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The number of patients experiencing the composite outcome did not differ between those randomized to open or masked STAN fetal heart rate monitoring, with 79 of 5,532 in the open monitoring group (1.43%) and 70 of 5,576 in the masked monitoring group (1.26%) experiencing one or more events (relative risk, 1.14), said Dr. Saade, a professor at the University of Texas, Galveston, who presented the findings on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network in Bethesda, Md.

The open group monitors displayed relevant information used for decision making in the event of uncertain fetal heart rate patterns; the masked monitors functioned as normal monitors, he explained.

Study participants were women attempting vaginal singleton delivery at gestation of 36 weeks and 1 day or greater with cervical dilation of 2-7 cm between November 2010 and March 2014. The open and masked STAN monitoring groups did not differ with respect to baseline characteristics or with respect to parity, type of labor, cervical dilation at study entry, and study period.

The groups also did not differ in secondary study outcomes, including the type of delivery and measures of morbidity.

For example, operative vaginal delivery occurred in 5.9% of patients in both groups (relative risk, 1.02), and cesarean delivery occurred in 16.9% and 16.2% of the open and masked group patients, respectively (RR, 1.05). Additionally, intermediate/NICU stay was required in 9.0% and 8.4% of patients in the groups, respectively (RR, 1.07), meconium aspiration occurred in 0.4% of patients of both groups (RR, 1.01), and shoulder dystocia occurred in 2.5% and 2.8% (RR, 0.90).

All participating providers were trained and certified per approved management guidelines for STAN, and a training pilot study involving 1,527 women from 31 centers was conducted at each site prior to the randomized controlled trial.

“This is the largest fetal ECG randomized trial conducted to date, with the highest rate of available cord gasses. We feel that our study is more applicable to U.S. practice than [are] all other prior studies,” Dr. Saade said, concluding that the validity of the results is strengthened by the “intensive training and rigorous certification,” of providers, as well as by the inclusion of real-time review feedback after training, central review of outcomes, and the use of an independent data coordinating center.

Many community and university hospitals were represented in the study, as were a variety of providers – including residents and midwives – and types of practices.

Even in subgroup analyses, and after controlling for site of service, there were no differences in outcomes observed between the study groups. This suggests that the findings are generalizable across the United States, Dr. Saade said.

When asked why European studies have shown a benefit with STAN monitoring, Dr. Saade said that the main difference seen in systematic reviews was a lower rate of fetal scalp sampling with STAN monitoring. “In the United States, we don’t do fetal scalp sampling, so that won’t help us here,” he said.

Dr. Saade reported having no financial disclosures.

SAN DIEGO – Fetal electrocardiogram ST segment analysis, or STAN, is commonly used in Europe as an adjunct to conventional intrapartum fetal heart rate monitoring, but adding STAN did not improve perinatal outcomes or decrease operative deliveries in a large, multicenter U.S. study.

Of 11,108 patients included in the 26-center study, 149 women experienced the composite primary outcome of at least one of the following: intrapartum fetal death, neonatal death, Apgar score of 3 or less at 5 minutes, neonatal seizure, cord artery pH of 7.05 or less plus base deficit of at least 12 mmol/L, intubation for ventilation at delivery, and neonatal encephalopathy, Dr. George R. Saade reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The number of patients experiencing the composite outcome did not differ between those randomized to open or masked STAN fetal heart rate monitoring, with 79 of 5,532 in the open monitoring group (1.43%) and 70 of 5,576 in the masked monitoring group (1.26%) experiencing one or more events (relative risk, 1.14), said Dr. Saade, a professor at the University of Texas, Galveston, who presented the findings on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network in Bethesda, Md.

The open group monitors displayed relevant information used for decision making in the event of uncertain fetal heart rate patterns; the masked monitors functioned as normal monitors, he explained.

Study participants were women attempting vaginal singleton delivery at gestation of 36 weeks and 1 day or greater with cervical dilation of 2-7 cm between November 2010 and March 2014. The open and masked STAN monitoring groups did not differ with respect to baseline characteristics or with respect to parity, type of labor, cervical dilation at study entry, and study period.

The groups also did not differ in secondary study outcomes, including the type of delivery and measures of morbidity.

For example, operative vaginal delivery occurred in 5.9% of patients in both groups (relative risk, 1.02), and cesarean delivery occurred in 16.9% and 16.2% of the open and masked group patients, respectively (RR, 1.05). Additionally, intermediate/NICU stay was required in 9.0% and 8.4% of patients in the groups, respectively (RR, 1.07), meconium aspiration occurred in 0.4% of patients of both groups (RR, 1.01), and shoulder dystocia occurred in 2.5% and 2.8% (RR, 0.90).

All participating providers were trained and certified per approved management guidelines for STAN, and a training pilot study involving 1,527 women from 31 centers was conducted at each site prior to the randomized controlled trial.

“This is the largest fetal ECG randomized trial conducted to date, with the highest rate of available cord gasses. We feel that our study is more applicable to U.S. practice than [are] all other prior studies,” Dr. Saade said, concluding that the validity of the results is strengthened by the “intensive training and rigorous certification,” of providers, as well as by the inclusion of real-time review feedback after training, central review of outcomes, and the use of an independent data coordinating center.

Many community and university hospitals were represented in the study, as were a variety of providers – including residents and midwives – and types of practices.

Even in subgroup analyses, and after controlling for site of service, there were no differences in outcomes observed between the study groups. This suggests that the findings are generalizable across the United States, Dr. Saade said.

When asked why European studies have shown a benefit with STAN monitoring, Dr. Saade said that the main difference seen in systematic reviews was a lower rate of fetal scalp sampling with STAN monitoring. “In the United States, we don’t do fetal scalp sampling, so that won’t help us here,” he said.

Dr. Saade reported having no financial disclosures.

SAN DIEGO – Fetal electrocardiogram ST segment analysis, or STAN, is commonly used in Europe as an adjunct to conventional intrapartum fetal heart rate monitoring, but adding STAN did not improve perinatal outcomes or decrease operative deliveries in a large, multicenter U.S. study.

Of 11,108 patients included in the 26-center study, 149 women experienced the composite primary outcome of at least one of the following: intrapartum fetal death, neonatal death, Apgar score of 3 or less at 5 minutes, neonatal seizure, cord artery pH of 7.05 or less plus base deficit of at least 12 mmol/L, intubation for ventilation at delivery, and neonatal encephalopathy, Dr. George R. Saade reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The number of patients experiencing the composite outcome did not differ between those randomized to open or masked STAN fetal heart rate monitoring, with 79 of 5,532 in the open monitoring group (1.43%) and 70 of 5,576 in the masked monitoring group (1.26%) experiencing one or more events (relative risk, 1.14), said Dr. Saade, a professor at the University of Texas, Galveston, who presented the findings on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network in Bethesda, Md.

The open group monitors displayed relevant information used for decision making in the event of uncertain fetal heart rate patterns; the masked monitors functioned as normal monitors, he explained.

Study participants were women attempting vaginal singleton delivery at gestation of 36 weeks and 1 day or greater with cervical dilation of 2-7 cm between November 2010 and March 2014. The open and masked STAN monitoring groups did not differ with respect to baseline characteristics or with respect to parity, type of labor, cervical dilation at study entry, and study period.

The groups also did not differ in secondary study outcomes, including the type of delivery and measures of morbidity.

For example, operative vaginal delivery occurred in 5.9% of patients in both groups (relative risk, 1.02), and cesarean delivery occurred in 16.9% and 16.2% of the open and masked group patients, respectively (RR, 1.05). Additionally, intermediate/NICU stay was required in 9.0% and 8.4% of patients in the groups, respectively (RR, 1.07), meconium aspiration occurred in 0.4% of patients of both groups (RR, 1.01), and shoulder dystocia occurred in 2.5% and 2.8% (RR, 0.90).

All participating providers were trained and certified per approved management guidelines for STAN, and a training pilot study involving 1,527 women from 31 centers was conducted at each site prior to the randomized controlled trial.

“This is the largest fetal ECG randomized trial conducted to date, with the highest rate of available cord gasses. We feel that our study is more applicable to U.S. practice than [are] all other prior studies,” Dr. Saade said, concluding that the validity of the results is strengthened by the “intensive training and rigorous certification,” of providers, as well as by the inclusion of real-time review feedback after training, central review of outcomes, and the use of an independent data coordinating center.

Many community and university hospitals were represented in the study, as were a variety of providers – including residents and midwives – and types of practices.

Even in subgroup analyses, and after controlling for site of service, there were no differences in outcomes observed between the study groups. This suggests that the findings are generalizable across the United States, Dr. Saade said.

When asked why European studies have shown a benefit with STAN monitoring, Dr. Saade said that the main difference seen in systematic reviews was a lower rate of fetal scalp sampling with STAN monitoring. “In the United States, we don’t do fetal scalp sampling, so that won’t help us here,” he said.

Dr. Saade reported having no financial disclosures.

ORLANDO – About 8 million people in the United States are diagnosed with hyperhidrosis, including about 1.6% of adolescents and 0.6% of prepubertal children.

Strikingly, about 70% of patients with symptoms of hyperhidrosis do not consult a physician about their symptoms, but it is likely they are well aware that something isn’t right; patients with hyperhidrosis sweat at a rate that is about four to five times greater than that in healthy controls, according to Dr. Adam Friedman.

Hyperhidrosis peaks between the ages of 18 and 54 years – the prime college and working years – so the impact on day-to-day activities can be substantial, if not disabling. In fact, patients rate the effects of hyperhidrosis on quality of life as greater than those associated with psoriasis and eczema. Similarly, school-age children can be dramatically affected by the condition, as handwriting, keeping papers and keyboards dry, sports activities, and use of handheld electronics pose specific challenges, Dr. Friedman said at the Orlando Dermatology Aesthetic and Clinical conference.

Patients may have general or focal hyperhidrosis. General hyperhidrosis can be secondary to any number of substances or conditions, including drugs, toxins, substance use, cardiovascular disorders, respiratory failure, infections, malignancies, or endocrine/metabolic disorders. Focal hyperhidrosis may be primary idiopathic, associated with neuropathies, or secondary to spinal disease or injury.

There is no known etiology, but genetics may play a role; 65% of patients in one study reported a family history of the condition.

When evaluating patients, begin with a review of systems, especially if there is concern that the hyperhidrosis is secondary to another condition. Ask about age of onset, location (about half of all patients have axillary hyperhidrosis), triggers, and symptoms. Perform a physical exam, looking for any anatomical abnormalities, as postsurgical anatomic abnormalities are a major cause of focal hyperhidrosis, and be sure to ask patients about the extent of their symptoms and the effects of the disease on their daily activities, advised Dr. Friedman, director of dermatologic research at the Albert Einstein College of Medicine, New York.

In terms of laboratory evaluation, gravimetric testing is “the golden tool” for research, but a starch iodine test to define the extent and areas of disease is the best clinical tool, he said.

A primary hyperhidrosis diagnosis requires that the patients have focal, visible, excessive sweating of 6 months duration with no apparent cause, and two of the following: bilateral and symmetric sweating, impairment of daily activities, at least one episode per week, onset of less than 25 years, positive family history, and cessation during sleep.

Noninvasive treatment options include topical antiperspirants and other topical agents, systemic medications, and iontophoresis, and minimally invasive options include botulinum toxin injections and energy-based treatments.

The standard, first-line, go-to topical treatment is aluminum salts, which come in a variety of formulations. The concentration used depends on the area affected. For example, 10%-25% can be used for the axillae, and 30%-40% can be used for the palms and soles.

Over-the-counter clinical strength products also are available and are formulated to cause less skin irritation.

Optimal use of topical treatments requires that the product remain on the skin for 6-8 hours. Overnight application is ideal, because patients typically don’t sweat at night, Dr. Friedman said, adding that the medication should be washed off before daytime sweating begins.

Nonmedicated deodorant can be used in the morning after bathing.

Dr. Friedman also recommended waiting 24-48 hours after shaving to apply topical medications, and he noted that patients should be advised to wear white or light-colored clothing, as aluminum salts will stain.

Additionally, prewashing the area to be treated is not advisable, as this introduces moisture, which can form hydrochloric acid when combined with the aluminum chloride. If irritation does occur, treat with low-potency topical steroids.

Pediatric use of topical treatments has not been specifically studied, but treatment is generally the same as in older patients. However, compliance can be a problem.

“I usually recommend application every night for the first month under occlusion with a tight-fitting white T-shirt, and then three times per week thereafter,” he said.

Noninvasive treatments are pretty simple, but require educating the patients to ensure correct use, he noted.

Keep in mind that many insurance companies consider other treatments, including iontophoresis and onabotulinumtoxinA to be medically necessary only when topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash, he added.

As for systemic agents, none have been specifically tested for hyperhidrosis in clinical trials, so use is off-label and based on case reports or small case series. Anticholinergics, including glycopyrrolate and oxybutynin, have been used with some success.

“I actually prefer glycopyrrolate, because it does not cross the blood-brain barrier, so it is associated with fewer overall systemic and neurologic side effects,” Dr. Friedman said, noting that he starts with 1 mg twice daily, titrated slowly up to a maximum of 6 mg daily.

An oral solution is available, which is useful for treating children, he said, noting that data suggest anticholinergics can be very effective in children. In one recent study, 90% of 31 children treated with an average dose of 2 mg per day of glycopyrrolate experienced improvement (J. Am. Acad. Dermatol. 2012;67:918-23). In a review of 59 children treated with oxybutynin for palmar-plantar hyperhidrosis titrated up to 5 mg twice daily, 90% experienced improvement (Pediatr. Dermatol. 2014 Dec. 10 [doi:10.1111/pde.12385]). Central nervous system side effects were more common in the latter study, however.

The downside of using anticholinergics is the need for long-term therapy and the long list of possible side effects, including dry mouth, dry eyes, constipation, blurred vision, and urinary retention – among many others, he said.

For patients with hyperhidrosis due to social phobia and performance anxiety, consider using beta-blockers. Give 10-20 mg about an hour before performance, or 5 mg in those with low blood pressure, slow baseline heart rate, or very small body mass index. A trial run at home before a performance is advisable. A number of contraindications to beta-blocker use exist, including bradycardia, atrioventricular block, and asthma, just to name a few, Dr. Friedman said.

Minimally invasive treatment options include botulinum toxin injections and energy based treatments.

Botulinum toxin injections last 3-7 months and are quite effective, with 90% of patients reporting improvement, but they can be painful and are expensive at $1,400-$1,600 per treatment.

Among new and emerging treatments that show promise are MiraDry, a microwave energy technology approved in 2011 for axillary hyperhidrosis, and topical botulinum toxin, delivered without needles thanks to nanotechnology.

The latter is currently under development by at least two companies, and trials are underway. Early data suggest treatment reduces sweating by 40%, Dr. Friedman said.

Dr. Friedman reported having no relevant financial disclosures.

ORLANDO – About 8 million people in the United States are diagnosed with hyperhidrosis, including about 1.6% of adolescents and 0.6% of prepubertal children.

Strikingly, about 70% of patients with symptoms of hyperhidrosis do not consult a physician about their symptoms, but it is likely they are well aware that something isn’t right; patients with hyperhidrosis sweat at a rate that is about four to five times greater than that in healthy controls, according to Dr. Adam Friedman.

Hyperhidrosis peaks between the ages of 18 and 54 years – the prime college and working years – so the impact on day-to-day activities can be substantial, if not disabling. In fact, patients rate the effects of hyperhidrosis on quality of life as greater than those associated with psoriasis and eczema. Similarly, school-age children can be dramatically affected by the condition, as handwriting, keeping papers and keyboards dry, sports activities, and use of handheld electronics pose specific challenges, Dr. Friedman said at the Orlando Dermatology Aesthetic and Clinical conference.

Patients may have general or focal hyperhidrosis. General hyperhidrosis can be secondary to any number of substances or conditions, including drugs, toxins, substance use, cardiovascular disorders, respiratory failure, infections, malignancies, or endocrine/metabolic disorders. Focal hyperhidrosis may be primary idiopathic, associated with neuropathies, or secondary to spinal disease or injury.

There is no known etiology, but genetics may play a role; 65% of patients in one study reported a family history of the condition.

When evaluating patients, begin with a review of systems, especially if there is concern that the hyperhidrosis is secondary to another condition. Ask about age of onset, location (about half of all patients have axillary hyperhidrosis), triggers, and symptoms. Perform a physical exam, looking for any anatomical abnormalities, as postsurgical anatomic abnormalities are a major cause of focal hyperhidrosis, and be sure to ask patients about the extent of their symptoms and the effects of the disease on their daily activities, advised Dr. Friedman, director of dermatologic research at the Albert Einstein College of Medicine, New York.

In terms of laboratory evaluation, gravimetric testing is “the golden tool” for research, but a starch iodine test to define the extent and areas of disease is the best clinical tool, he said.

A primary hyperhidrosis diagnosis requires that the patients have focal, visible, excessive sweating of 6 months duration with no apparent cause, and two of the following: bilateral and symmetric sweating, impairment of daily activities, at least one episode per week, onset of less than 25 years, positive family history, and cessation during sleep.

Noninvasive treatment options include topical antiperspirants and other topical agents, systemic medications, and iontophoresis, and minimally invasive options include botulinum toxin injections and energy-based treatments.

The standard, first-line, go-to topical treatment is aluminum salts, which come in a variety of formulations. The concentration used depends on the area affected. For example, 10%-25% can be used for the axillae, and 30%-40% can be used for the palms and soles.

Over-the-counter clinical strength products also are available and are formulated to cause less skin irritation.

Optimal use of topical treatments requires that the product remain on the skin for 6-8 hours. Overnight application is ideal, because patients typically don’t sweat at night, Dr. Friedman said, adding that the medication should be washed off before daytime sweating begins.

Nonmedicated deodorant can be used in the morning after bathing.

Dr. Friedman also recommended waiting 24-48 hours after shaving to apply topical medications, and he noted that patients should be advised to wear white or light-colored clothing, as aluminum salts will stain.

Additionally, prewashing the area to be treated is not advisable, as this introduces moisture, which can form hydrochloric acid when combined with the aluminum chloride. If irritation does occur, treat with low-potency topical steroids.

Pediatric use of topical treatments has not been specifically studied, but treatment is generally the same as in older patients. However, compliance can be a problem.

“I usually recommend application every night for the first month under occlusion with a tight-fitting white T-shirt, and then three times per week thereafter,” he said.

Noninvasive treatments are pretty simple, but require educating the patients to ensure correct use, he noted.

Keep in mind that many insurance companies consider other treatments, including iontophoresis and onabotulinumtoxinA to be medically necessary only when topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash, he added.

As for systemic agents, none have been specifically tested for hyperhidrosis in clinical trials, so use is off-label and based on case reports or small case series. Anticholinergics, including glycopyrrolate and oxybutynin, have been used with some success.

“I actually prefer glycopyrrolate, because it does not cross the blood-brain barrier, so it is associated with fewer overall systemic and neurologic side effects,” Dr. Friedman said, noting that he starts with 1 mg twice daily, titrated slowly up to a maximum of 6 mg daily.

An oral solution is available, which is useful for treating children, he said, noting that data suggest anticholinergics can be very effective in children. In one recent study, 90% of 31 children treated with an average dose of 2 mg per day of glycopyrrolate experienced improvement (J. Am. Acad. Dermatol. 2012;67:918-23). In a review of 59 children treated with oxybutynin for palmar-plantar hyperhidrosis titrated up to 5 mg twice daily, 90% experienced improvement (Pediatr. Dermatol. 2014 Dec. 10 [doi:10.1111/pde.12385]). Central nervous system side effects were more common in the latter study, however.

The downside of using anticholinergics is the need for long-term therapy and the long list of possible side effects, including dry mouth, dry eyes, constipation, blurred vision, and urinary retention – among many others, he said.

For patients with hyperhidrosis due to social phobia and performance anxiety, consider using beta-blockers. Give 10-20 mg about an hour before performance, or 5 mg in those with low blood pressure, slow baseline heart rate, or very small body mass index. A trial run at home before a performance is advisable. A number of contraindications to beta-blocker use exist, including bradycardia, atrioventricular block, and asthma, just to name a few, Dr. Friedman said.

Minimally invasive treatment options include botulinum toxin injections and energy based treatments.

Botulinum toxin injections last 3-7 months and are quite effective, with 90% of patients reporting improvement, but they can be painful and are expensive at $1,400-$1,600 per treatment.

Among new and emerging treatments that show promise are MiraDry, a microwave energy technology approved in 2011 for axillary hyperhidrosis, and topical botulinum toxin, delivered without needles thanks to nanotechnology.

The latter is currently under development by at least two companies, and trials are underway. Early data suggest treatment reduces sweating by 40%, Dr. Friedman said.

Dr. Friedman reported having no relevant financial disclosures.

ORLANDO – About 8 million people in the United States are diagnosed with hyperhidrosis, including about 1.6% of adolescents and 0.6% of prepubertal children.

Strikingly, about 70% of patients with symptoms of hyperhidrosis do not consult a physician about their symptoms, but it is likely they are well aware that something isn’t right; patients with hyperhidrosis sweat at a rate that is about four to five times greater than that in healthy controls, according to Dr. Adam Friedman.

Hyperhidrosis peaks between the ages of 18 and 54 years – the prime college and working years – so the impact on day-to-day activities can be substantial, if not disabling. In fact, patients rate the effects of hyperhidrosis on quality of life as greater than those associated with psoriasis and eczema. Similarly, school-age children can be dramatically affected by the condition, as handwriting, keeping papers and keyboards dry, sports activities, and use of handheld electronics pose specific challenges, Dr. Friedman said at the Orlando Dermatology Aesthetic and Clinical conference.

Patients may have general or focal hyperhidrosis. General hyperhidrosis can be secondary to any number of substances or conditions, including drugs, toxins, substance use, cardiovascular disorders, respiratory failure, infections, malignancies, or endocrine/metabolic disorders. Focal hyperhidrosis may be primary idiopathic, associated with neuropathies, or secondary to spinal disease or injury.

There is no known etiology, but genetics may play a role; 65% of patients in one study reported a family history of the condition.

When evaluating patients, begin with a review of systems, especially if there is concern that the hyperhidrosis is secondary to another condition. Ask about age of onset, location (about half of all patients have axillary hyperhidrosis), triggers, and symptoms. Perform a physical exam, looking for any anatomical abnormalities, as postsurgical anatomic abnormalities are a major cause of focal hyperhidrosis, and be sure to ask patients about the extent of their symptoms and the effects of the disease on their daily activities, advised Dr. Friedman, director of dermatologic research at the Albert Einstein College of Medicine, New York.

In terms of laboratory evaluation, gravimetric testing is “the golden tool” for research, but a starch iodine test to define the extent and areas of disease is the best clinical tool, he said.

A primary hyperhidrosis diagnosis requires that the patients have focal, visible, excessive sweating of 6 months duration with no apparent cause, and two of the following: bilateral and symmetric sweating, impairment of daily activities, at least one episode per week, onset of less than 25 years, positive family history, and cessation during sleep.

Noninvasive treatment options include topical antiperspirants and other topical agents, systemic medications, and iontophoresis, and minimally invasive options include botulinum toxin injections and energy-based treatments.

The standard, first-line, go-to topical treatment is aluminum salts, which come in a variety of formulations. The concentration used depends on the area affected. For example, 10%-25% can be used for the axillae, and 30%-40% can be used for the palms and soles.

Over-the-counter clinical strength products also are available and are formulated to cause less skin irritation.

Optimal use of topical treatments requires that the product remain on the skin for 6-8 hours. Overnight application is ideal, because patients typically don’t sweat at night, Dr. Friedman said, adding that the medication should be washed off before daytime sweating begins.

Nonmedicated deodorant can be used in the morning after bathing.

Dr. Friedman also recommended waiting 24-48 hours after shaving to apply topical medications, and he noted that patients should be advised to wear white or light-colored clothing, as aluminum salts will stain.

Additionally, prewashing the area to be treated is not advisable, as this introduces moisture, which can form hydrochloric acid when combined with the aluminum chloride. If irritation does occur, treat with low-potency topical steroids.

Pediatric use of topical treatments has not been specifically studied, but treatment is generally the same as in older patients. However, compliance can be a problem.

“I usually recommend application every night for the first month under occlusion with a tight-fitting white T-shirt, and then three times per week thereafter,” he said.

Noninvasive treatments are pretty simple, but require educating the patients to ensure correct use, he noted.

Keep in mind that many insurance companies consider other treatments, including iontophoresis and onabotulinumtoxinA to be medically necessary only when topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash, he added.

As for systemic agents, none have been specifically tested for hyperhidrosis in clinical trials, so use is off-label and based on case reports or small case series. Anticholinergics, including glycopyrrolate and oxybutynin, have been used with some success.

“I actually prefer glycopyrrolate, because it does not cross the blood-brain barrier, so it is associated with fewer overall systemic and neurologic side effects,” Dr. Friedman said, noting that he starts with 1 mg twice daily, titrated slowly up to a maximum of 6 mg daily.

An oral solution is available, which is useful for treating children, he said, noting that data suggest anticholinergics can be very effective in children. In one recent study, 90% of 31 children treated with an average dose of 2 mg per day of glycopyrrolate experienced improvement (J. Am. Acad. Dermatol. 2012;67:918-23). In a review of 59 children treated with oxybutynin for palmar-plantar hyperhidrosis titrated up to 5 mg twice daily, 90% experienced improvement (Pediatr. Dermatol. 2014 Dec. 10 [doi:10.1111/pde.12385]). Central nervous system side effects were more common in the latter study, however.

The downside of using anticholinergics is the need for long-term therapy and the long list of possible side effects, including dry mouth, dry eyes, constipation, blurred vision, and urinary retention – among many others, he said.

For patients with hyperhidrosis due to social phobia and performance anxiety, consider using beta-blockers. Give 10-20 mg about an hour before performance, or 5 mg in those with low blood pressure, slow baseline heart rate, or very small body mass index. A trial run at home before a performance is advisable. A number of contraindications to beta-blocker use exist, including bradycardia, atrioventricular block, and asthma, just to name a few, Dr. Friedman said.

Minimally invasive treatment options include botulinum toxin injections and energy based treatments.

Botulinum toxin injections last 3-7 months and are quite effective, with 90% of patients reporting improvement, but they can be painful and are expensive at $1,400-$1,600 per treatment.

Among new and emerging treatments that show promise are MiraDry, a microwave energy technology approved in 2011 for axillary hyperhidrosis, and topical botulinum toxin, delivered without needles thanks to nanotechnology.

The latter is currently under development by at least two companies, and trials are underway. Early data suggest treatment reduces sweating by 40%, Dr. Friedman said.

Dr. Friedman reported having no relevant financial disclosures.

High-risk human papillomavirus testing is acceptable as a primary approach to cervical cancer screening in women aged 25 years and older, according to interim clinical guidance from an expert panel convened by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology.

Based on several large studies published since 2011 when screening guidelines were last updated, the panel concluded that a negative high-risk HPV (hrHPV) test provides greater reassurance of low cervical intraepithelial neoplasia grade 3–positive (CIN3+) risk than does a negative cytology result, and that “because of equivalent or superior effectiveness, primary hrHPV screening can be considered as an alternative to current U.S. cytology-based cervical cancer screening methods.”

The guidance was simultaneously published on Jan. 8 in Gynecologic Oncology (2015 [doi:10.1016/j.ygyno.2014.12.022]), the Journal of Lower Genital Tract Disease, and Obstetrics & Gynecology (2015;125:330-7 [doi:10.1097/AOG.0000000000000669]).

xrender/ Thinkstock.com

The 13-member panel was convened when an application was submitted to the U.S. Food and Drug Administration for a currently marketed HPV test to be labeled for the indication of primary cervical cancer screening; that application was approved in April 2013.

The panel included representatives from the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology.

Cytology alone and cotesting remain the screening options specifically recommended in existing major guidelines. The interim guidance does not supplant those guidelines, but provides clinicians with an additional screening tool, Dr. Warner K. Huh of the University of Alabama at Birmingham, and his colleagues reported.

“The scientific evidence clearly demonstrates that primary HPV testing outperforms cytology or Pap as a screening test. This has been confirmed from numerous European and Canadian studies as well as the ATHENA trial. There are going to be fewer false negatives with HPV, and arguably, we have been using a less sensitive test for screening for a while now,” Dr. Huh said in a statement, adding that “pap smears miss a fair number of adenocarcinomas.”

The ATHENA HPV trial is a longitudinal study of the HPV test sponsored by Roche Diagnostics, and the end-of-study results, which were used along with other study data and expert opinion in the guidance panel’s deliberations, were published in Gynecologic Oncology 2014 [doi:10.1016/j.ygyno.2014.11.076].

Previously approved labeling for HPV tests included triage of equivocal cytology and as an adjunct to cytology in women aged 30 years and older – two uses that are “widely recommended by numerous stakeholder societies and organizations, as well as the U.S. Preventive Services Task Force,” the authors noted, adding that hrHPV testing was also approved for identifying specific high-risk types of HPV for triage in select settings.

Primary hrHPV testing was not indicated “in most clinical settings,” mainly due to substantial concerns about the specificity of primary hrHPV screening and the potential harms, the lack of a well-defined and evaluated strategy to manage hrHPV-positive women, and inadequate information to define appropriate screening intervals for those who test negative, the panel wrote.

But since that time, several large studies have been published strengthening the evidence in support of primary hrHPV screening. The new studies “consistently demonstrate an improved sensitivity of primary hrHPV screening for detecting cervical cancer precursor lesions, compared with cytology alone,” the panel wrote.

Based on this evidence, the expert panel also concluded that:

• Triage of hrHPV-positive women using a combination of genotyping for HPV-16 and -18, and reflex cytology for women positive for the 12 other hrHPV genotypes appears to be a reasonable approach to managing hrHPV-positive women.

• Rescreening after a negative primary hrHPV screen should occur no sooner than every 3 years.

• Primary hrHPV screening should not be initiated before age 25.

The panel called primary hrHPV screening “an important scientific and clinical advance in cervical cancer screening because it offers better reassurance of low cancer risk, compared with cytology-only screening conducted at the same interval.”

More data on triage options should be available soon and could lead to updated triage recommendations, the panel noted.

“Primary hrHPV screening at 25-29 years of age may lead to increased CIN 3 detection, but the impact of increased number of colposcopies, integration with screening before age 25, and actual impact on cancer prevention needs further investigation,” the panel wrote. “While there continue to be numerous practical and research questions, primary hrHPV testing has the potential to further reduce morbidity and mortality of cervical cancer in the United States. However, to achieve the maximum benefit of screening, we need to continue to identify women who are either unscreened or under-screened.”

In fact, most women who have cervical cancer have not been screened or have not been adequately screened, according to Dr. Andrew Menzin, associate chief of gynecologic oncology at North Shore LIJ Health System, and professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y.

“That’s still the challenge, and I expect that having the opportunity to use a primary HPV test will facilitate enhanced screening,” he said in an interview.

Dr. Menzin said that use and acceptance of cotesting has been widespread, and predicts that the 3-year minimum testing interval for primary hrHPV testing recommended by the guidance panel could serve to ease some of the discomfort that many clinicians felt as guidelines expanded screening intervals from 1 year to 3 years, and then to 5 years with cotesting, thereby promoting acceptance of primary hrHPV testing.

“The information provided in the interim guidance speaks to a trend in the advancement of cervical cancer screening of allowing technological advances to be coupled with ongoing evolution in our knowledge of the natural history of disease and to focus on tests that have high accuracy and important predictive value,” he said. “The inclusion of the hrHPV test as an additional primary screening tool in the cervical cancer screening armamentarium will also help to evolve the triage of testing to focus on patients at greatest risk while minimizing the burden of testing and evaluation on those who are low risk, thereby optimizing care delivery.”

The panel’s work was funded by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. Dr. Huh is on the scientific advisory board of Merck. Dr. Menzin said he had no financial disclosures.

High-risk human papillomavirus testing is acceptable as a primary approach to cervical cancer screening in women aged 25 years and older, according to interim clinical guidance from an expert panel convened by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology.

Based on several large studies published since 2011 when screening guidelines were last updated, the panel concluded that a negative high-risk HPV (hrHPV) test provides greater reassurance of low cervical intraepithelial neoplasia grade 3–positive (CIN3+) risk than does a negative cytology result, and that “because of equivalent or superior effectiveness, primary hrHPV screening can be considered as an alternative to current U.S. cytology-based cervical cancer screening methods.”

The guidance was simultaneously published on Jan. 8 in Gynecologic Oncology (2015 [doi:10.1016/j.ygyno.2014.12.022]), the Journal of Lower Genital Tract Disease, and Obstetrics & Gynecology (2015;125:330-7 [doi:10.1097/AOG.0000000000000669]).

xrender/ Thinkstock.com

The 13-member panel was convened when an application was submitted to the U.S. Food and Drug Administration for a currently marketed HPV test to be labeled for the indication of primary cervical cancer screening; that application was approved in April 2013.

The panel included representatives from the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology.

Cytology alone and cotesting remain the screening options specifically recommended in existing major guidelines. The interim guidance does not supplant those guidelines, but provides clinicians with an additional screening tool, Dr. Warner K. Huh of the University of Alabama at Birmingham, and his colleagues reported.

“The scientific evidence clearly demonstrates that primary HPV testing outperforms cytology or Pap as a screening test. This has been confirmed from numerous European and Canadian studies as well as the ATHENA trial. There are going to be fewer false negatives with HPV, and arguably, we have been using a less sensitive test for screening for a while now,” Dr. Huh said in a statement, adding that “pap smears miss a fair number of adenocarcinomas.”

The ATHENA HPV trial is a longitudinal study of the HPV test sponsored by Roche Diagnostics, and the end-of-study results, which were used along with other study data and expert opinion in the guidance panel’s deliberations, were published in Gynecologic Oncology 2014 [doi:10.1016/j.ygyno.2014.11.076].

Previously approved labeling for HPV tests included triage of equivocal cytology and as an adjunct to cytology in women aged 30 years and older – two uses that are “widely recommended by numerous stakeholder societies and organizations, as well as the U.S. Preventive Services Task Force,” the authors noted, adding that hrHPV testing was also approved for identifying specific high-risk types of HPV for triage in select settings.

Primary hrHPV testing was not indicated “in most clinical settings,” mainly due to substantial concerns about the specificity of primary hrHPV screening and the potential harms, the lack of a well-defined and evaluated strategy to manage hrHPV-positive women, and inadequate information to define appropriate screening intervals for those who test negative, the panel wrote.

But since that time, several large studies have been published strengthening the evidence in support of primary hrHPV screening. The new studies “consistently demonstrate an improved sensitivity of primary hrHPV screening for detecting cervical cancer precursor lesions, compared with cytology alone,” the panel wrote.

Based on this evidence, the expert panel also concluded that:

• Triage of hrHPV-positive women using a combination of genotyping for HPV-16 and -18, and reflex cytology for women positive for the 12 other hrHPV genotypes appears to be a reasonable approach to managing hrHPV-positive women.

• Rescreening after a negative primary hrHPV screen should occur no sooner than every 3 years.

• Primary hrHPV screening should not be initiated before age 25.

The panel called primary hrHPV screening “an important scientific and clinical advance in cervical cancer screening because it offers better reassurance of low cancer risk, compared with cytology-only screening conducted at the same interval.”

More data on triage options should be available soon and could lead to updated triage recommendations, the panel noted.

“Primary hrHPV screening at 25-29 years of age may lead to increased CIN 3 detection, but the impact of increased number of colposcopies, integration with screening before age 25, and actual impact on cancer prevention needs further investigation,” the panel wrote. “While there continue to be numerous practical and research questions, primary hrHPV testing has the potential to further reduce morbidity and mortality of cervical cancer in the United States. However, to achieve the maximum benefit of screening, we need to continue to identify women who are either unscreened or under-screened.”

In fact, most women who have cervical cancer have not been screened or have not been adequately screened, according to Dr. Andrew Menzin, associate chief of gynecologic oncology at North Shore LIJ Health System, and professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y.

“That’s still the challenge, and I expect that having the opportunity to use a primary HPV test will facilitate enhanced screening,” he said in an interview.

Dr. Menzin said that use and acceptance of cotesting has been widespread, and predicts that the 3-year minimum testing interval for primary hrHPV testing recommended by the guidance panel could serve to ease some of the discomfort that many clinicians felt as guidelines expanded screening intervals from 1 year to 3 years, and then to 5 years with cotesting, thereby promoting acceptance of primary hrHPV testing.

“The information provided in the interim guidance speaks to a trend in the advancement of cervical cancer screening of allowing technological advances to be coupled with ongoing evolution in our knowledge of the natural history of disease and to focus on tests that have high accuracy and important predictive value,” he said. “The inclusion of the hrHPV test as an additional primary screening tool in the cervical cancer screening armamentarium will also help to evolve the triage of testing to focus on patients at greatest risk while minimizing the burden of testing and evaluation on those who are low risk, thereby optimizing care delivery.”

The panel’s work was funded by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. Dr. Huh is on the scientific advisory board of Merck. Dr. Menzin said he had no financial disclosures.

High-risk human papillomavirus testing is acceptable as a primary approach to cervical cancer screening in women aged 25 years and older, according to interim clinical guidance from an expert panel convened by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology.

Based on several large studies published since 2011 when screening guidelines were last updated, the panel concluded that a negative high-risk HPV (hrHPV) test provides greater reassurance of low cervical intraepithelial neoplasia grade 3–positive (CIN3+) risk than does a negative cytology result, and that “because of equivalent or superior effectiveness, primary hrHPV screening can be considered as an alternative to current U.S. cytology-based cervical cancer screening methods.”

The guidance was simultaneously published on Jan. 8 in Gynecologic Oncology (2015 [doi:10.1016/j.ygyno.2014.12.022]), the Journal of Lower Genital Tract Disease, and Obstetrics & Gynecology (2015;125:330-7 [doi:10.1097/AOG.0000000000000669]).

xrender/ Thinkstock.com

The 13-member panel was convened when an application was submitted to the U.S. Food and Drug Administration for a currently marketed HPV test to be labeled for the indication of primary cervical cancer screening; that application was approved in April 2013.

The panel included representatives from the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology.

Cytology alone and cotesting remain the screening options specifically recommended in existing major guidelines. The interim guidance does not supplant those guidelines, but provides clinicians with an additional screening tool, Dr. Warner K. Huh of the University of Alabama at Birmingham, and his colleagues reported.

“The scientific evidence clearly demonstrates that primary HPV testing outperforms cytology or Pap as a screening test. This has been confirmed from numerous European and Canadian studies as well as the ATHENA trial. There are going to be fewer false negatives with HPV, and arguably, we have been using a less sensitive test for screening for a while now,” Dr. Huh said in a statement, adding that “pap smears miss a fair number of adenocarcinomas.”

The ATHENA HPV trial is a longitudinal study of the HPV test sponsored by Roche Diagnostics, and the end-of-study results, which were used along with other study data and expert opinion in the guidance panel’s deliberations, were published in Gynecologic Oncology 2014 [doi:10.1016/j.ygyno.2014.11.076].

Previously approved labeling for HPV tests included triage of equivocal cytology and as an adjunct to cytology in women aged 30 years and older – two uses that are “widely recommended by numerous stakeholder societies and organizations, as well as the U.S. Preventive Services Task Force,” the authors noted, adding that hrHPV testing was also approved for identifying specific high-risk types of HPV for triage in select settings.

Primary hrHPV testing was not indicated “in most clinical settings,” mainly due to substantial concerns about the specificity of primary hrHPV screening and the potential harms, the lack of a well-defined and evaluated strategy to manage hrHPV-positive women, and inadequate information to define appropriate screening intervals for those who test negative, the panel wrote.

But since that time, several large studies have been published strengthening the evidence in support of primary hrHPV screening. The new studies “consistently demonstrate an improved sensitivity of primary hrHPV screening for detecting cervical cancer precursor lesions, compared with cytology alone,” the panel wrote.

Based on this evidence, the expert panel also concluded that:

• Triage of hrHPV-positive women using a combination of genotyping for HPV-16 and -18, and reflex cytology for women positive for the 12 other hrHPV genotypes appears to be a reasonable approach to managing hrHPV-positive women.

• Rescreening after a negative primary hrHPV screen should occur no sooner than every 3 years.

• Primary hrHPV screening should not be initiated before age 25.

The panel called primary hrHPV screening “an important scientific and clinical advance in cervical cancer screening because it offers better reassurance of low cancer risk, compared with cytology-only screening conducted at the same interval.”

More data on triage options should be available soon and could lead to updated triage recommendations, the panel noted.

“Primary hrHPV screening at 25-29 years of age may lead to increased CIN 3 detection, but the impact of increased number of colposcopies, integration with screening before age 25, and actual impact on cancer prevention needs further investigation,” the panel wrote. “While there continue to be numerous practical and research questions, primary hrHPV testing has the potential to further reduce morbidity and mortality of cervical cancer in the United States. However, to achieve the maximum benefit of screening, we need to continue to identify women who are either unscreened or under-screened.”

In fact, most women who have cervical cancer have not been screened or have not been adequately screened, according to Dr. Andrew Menzin, associate chief of gynecologic oncology at North Shore LIJ Health System, and professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y.

“That’s still the challenge, and I expect that having the opportunity to use a primary HPV test will facilitate enhanced screening,” he said in an interview.

Dr. Menzin said that use and acceptance of cotesting has been widespread, and predicts that the 3-year minimum testing interval for primary hrHPV testing recommended by the guidance panel could serve to ease some of the discomfort that many clinicians felt as guidelines expanded screening intervals from 1 year to 3 years, and then to 5 years with cotesting, thereby promoting acceptance of primary hrHPV testing.

“The information provided in the interim guidance speaks to a trend in the advancement of cervical cancer screening of allowing technological advances to be coupled with ongoing evolution in our knowledge of the natural history of disease and to focus on tests that have high accuracy and important predictive value,” he said. “The inclusion of the hrHPV test as an additional primary screening tool in the cervical cancer screening armamentarium will also help to evolve the triage of testing to focus on patients at greatest risk while minimizing the burden of testing and evaluation on those who are low risk, thereby optimizing care delivery.”

The panel’s work was funded by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. Dr. Huh is on the scientific advisory board of Merck. Dr. Menzin said he had no financial disclosures.