Introduction

Autism spectrum disorder is a neurodevelopmental condition characterized by a heterogeneous grouping of social-communication impairments and behavioral phenomena that are observed in early development and often accompanied by an array of co-occurring issues. The prevalence of autism spectrum disorder (ASD) has risen markedly in the last several years (1 in 68 per a 2014 CDC estimate), and the evidence base for early intervention and other treatment strategies supports the idea that a timely and appropriate diagnosis is critical for promoting positive outcomes for children and their families.

With ASD, there can be wide variety in a young child’s presenting symptoms. Although some youth clearly manifest the hallmark features of ASD, ever-changing development, complicated cognitive profiles, family difficulties, co-occurring mental health problems, and evolving nosology (such as DSM changes) can contribute to the difficulty providers encounter in fully interpreting and identifying ASD symptoms in the course of a typical primary care visit. This case example outlines assessment and diagnostic strategies that may help pediatricians to better understand the complexities of diagnosis, assessment, and treatment for children suspected of having ASD. Ideally, a diagnostic evaluation would quickly follow a standardized screening tool that is positive for concern for ASD (such as the Modified Checklist for Autism in Toddlers – Revised) between the ages of 18 and 24 months.

Case summary

Everett is a 4-year-old boy who presents to an autism diagnostic clinic after his parents expressed concerns about his behavior. Everett is described to be a rigid, stubborn, strong-willed, and easily frustrated boy who began to exhibit aggressive behaviors at 18 months of age. He continues to have almost daily temper tantrums. Notably, Everett did not begin to use single words with communicative intent until he was 24 months old. He will often repeat words nonfunctionally and utter nonsensical verbalizations while spinning in circles and rocking back and forth. Everett enjoys being around peers but has difficulties engaging appropriately with other children, exhibiting poor physical boundaries. Everett’s hearing and vision were previously tested to be without deficit, and there is no history of seizure activity or indication of an underlying metabolic disorder.

Discussion

Everett presents with some signs and symptoms to suggest ASD (namely his communication and language impairments accompanied by some atypical social relatedness and repetitive behaviors). His presentation, however, has many characteristics that while common to ASD are not entirely specific to the diagnosis in a preschooler, and could occur with other disorders. For example, Everett’s social difficulties could be the result of an emerging behavioral disorder (an oppositional defiant disorder) or a primary expressive language disorder, which may manifest with frustration intolerance due to communication difficulties.

With children like Everett, a comprehensive autism diagnostic assessment should be obtained and preferably be comprised of a minimum of two components – a caregiver interview and an observational assessment ideally conducted by an experienced clinical interdisciplinary team. Additionally, evaluations of adaptive skills, cognitive profile, family functioning, social-emotional/behavioral functioning, and sensory issues can be useful to inform treatment planning and diagnosis. Ultimately, the diagnosis of ASD is made after clinicians integrate available information and fully consider the range of differential diagnoses. Clinicians who may participate in the diagnostic process include developmental pediatricians, child psychiatrists, clinical psychologists, speech-language pathologists, and other allied health professionals.

Clinical guidelines suggest that gathering a thorough developmental history, assessing for the characteristic impairments that support an ASD diagnosis, and establishing current levels of functioning can be performed using the semistructured Autism Diagnostic Interview – Revised (ADI-R) with primary caregivers. Information about a child’s social interactions also can be obtained with the use of the Social Responsiveness Scale (SRS), which can yield multi-informant data that helps to capture a youth’s functioning and peer interactions in different settings, including home and school.

The observational assessment ideally utilizes the Autism Diagnostic Observation Schedule (ADOS), a standardized instrument that can evaluate domains of reciprocal social interaction, communication, restricted interests, and repetitive behaviors in a developmentally informed manner. Clinicians should be mindful that certain behaviors may not be displayed during the diagnostic evaluation, and as such, scoring on the ADOS should be integrated with other sources of information and interpreted within a developmental framework; no single result on one instrument is sufficient to make or break an autism diagnosis.

The above-mentioned tools were used in Everett’s assessment. Appraising the collected data, his scoring on the ADOS suggested an autism diagnosis, but information from the ADI-R and SRS were not conclusive. To further evaluate Everett, we incorporated a broad developmental evaluation tool, the Mullen Scales of Early Learning, which provided us with a lens through which to interpret his profile of impairments and strengths. Everett scored with average to above-average skills across all domains, which helped us conceptualize that his social, language, and behavioral struggles were not the result of a global developmental delay or intellectual disability.

Additionally, Everett’s family completed the Vineland Adaptive Behavior Scales (his adaptive socialization skills were a relative weakness, and motor skills were a strength) and Child Behavior Checklists, which revealed the endorsement of emotionally reactive and aggressive behavior symptoms from both parents. Everett’s parents’ mental wellness was assessed with Adult Behavior Checklists in order to provide informed family-based treatment recommendations.

In Everett’s evaluation, enduring challenges in the core symptom domains characterizing ASD were noted. His atypical social affect, limited social awareness, and repetitive patterns of behavior provided evidence that Everett met diagnostic criteria for ASD. Also noted were protective factors that promoted his well-being (he’s verbal, has the capacity to play imaginatively, presents with a supportive family, and demonstrates no significant cognitive deficiencies), which were incorporated into our treatment recommendations. Recommendations included enrollment in structured educational and behavioral interventions, and corresponding parent training treatments to help his caregivers manage his disruptive behaviors while reducing the risk for the development of further emotional/behavioral problems in the future.

Everett’s ASD diagnosis also warranted a referral for genetic testing and/or counseling to help the family to obtain information about the etiology of the disorder, screen for other conditions, and help guide appropriate medical management. There were no other indications to pursue additional medical, imaging, or neurological consultations.

Clinical pearl

For some children, the diagnosis of ASD is unclear. Problems arise in making an accurate diagnosis for a variety of reasons, and fully appreciating a child’s (or adolescent’s) developmental challenges can be difficult, especially given the considerable symptom overlap ASD has with other learning, medical, cognitive, or mental health diagnoses. These children require a diagnostic evaluation using a family-focused and culturally sensitive multidisciplinary approach that incorporates standardized tools. As a primary care provider, it can often be difficult to tease out symptoms and have the time to do a thorough assessment; primary providers should be aware of their local assessment expert resources and referral options.

Jeremiah Dickerson, M.D., a child and adolescent psychiatrist, is an assistant professor of psychiatry at the University of Vermont. Dr. Dickerson is the director of the university’s autism diagnostic clinic. Contact Dr. Dickerson at [email protected].

Introduction

Autism spectrum disorder is a neurodevelopmental condition characterized by a heterogeneous grouping of social-communication impairments and behavioral phenomena that are observed in early development and often accompanied by an array of co-occurring issues. The prevalence of autism spectrum disorder (ASD) has risen markedly in the last several years (1 in 68 per a 2014 CDC estimate), and the evidence base for early intervention and other treatment strategies supports the idea that a timely and appropriate diagnosis is critical for promoting positive outcomes for children and their families.

With ASD, there can be wide variety in a young child’s presenting symptoms. Although some youth clearly manifest the hallmark features of ASD, ever-changing development, complicated cognitive profiles, family difficulties, co-occurring mental health problems, and evolving nosology (such as DSM changes) can contribute to the difficulty providers encounter in fully interpreting and identifying ASD symptoms in the course of a typical primary care visit. This case example outlines assessment and diagnostic strategies that may help pediatricians to better understand the complexities of diagnosis, assessment, and treatment for children suspected of having ASD. Ideally, a diagnostic evaluation would quickly follow a standardized screening tool that is positive for concern for ASD (such as the Modified Checklist for Autism in Toddlers – Revised) between the ages of 18 and 24 months.

Case summary

Everett is a 4-year-old boy who presents to an autism diagnostic clinic after his parents expressed concerns about his behavior. Everett is described to be a rigid, stubborn, strong-willed, and easily frustrated boy who began to exhibit aggressive behaviors at 18 months of age. He continues to have almost daily temper tantrums. Notably, Everett did not begin to use single words with communicative intent until he was 24 months old. He will often repeat words nonfunctionally and utter nonsensical verbalizations while spinning in circles and rocking back and forth. Everett enjoys being around peers but has difficulties engaging appropriately with other children, exhibiting poor physical boundaries. Everett’s hearing and vision were previously tested to be without deficit, and there is no history of seizure activity or indication of an underlying metabolic disorder.

Discussion

Everett presents with some signs and symptoms to suggest ASD (namely his communication and language impairments accompanied by some atypical social relatedness and repetitive behaviors). His presentation, however, has many characteristics that while common to ASD are not entirely specific to the diagnosis in a preschooler, and could occur with other disorders. For example, Everett’s social difficulties could be the result of an emerging behavioral disorder (an oppositional defiant disorder) or a primary expressive language disorder, which may manifest with frustration intolerance due to communication difficulties.

With children like Everett, a comprehensive autism diagnostic assessment should be obtained and preferably be comprised of a minimum of two components – a caregiver interview and an observational assessment ideally conducted by an experienced clinical interdisciplinary team. Additionally, evaluations of adaptive skills, cognitive profile, family functioning, social-emotional/behavioral functioning, and sensory issues can be useful to inform treatment planning and diagnosis. Ultimately, the diagnosis of ASD is made after clinicians integrate available information and fully consider the range of differential diagnoses. Clinicians who may participate in the diagnostic process include developmental pediatricians, child psychiatrists, clinical psychologists, speech-language pathologists, and other allied health professionals.

Clinical guidelines suggest that gathering a thorough developmental history, assessing for the characteristic impairments that support an ASD diagnosis, and establishing current levels of functioning can be performed using the semistructured Autism Diagnostic Interview – Revised (ADI-R) with primary caregivers. Information about a child’s social interactions also can be obtained with the use of the Social Responsiveness Scale (SRS), which can yield multi-informant data that helps to capture a youth’s functioning and peer interactions in different settings, including home and school.

The observational assessment ideally utilizes the Autism Diagnostic Observation Schedule (ADOS), a standardized instrument that can evaluate domains of reciprocal social interaction, communication, restricted interests, and repetitive behaviors in a developmentally informed manner. Clinicians should be mindful that certain behaviors may not be displayed during the diagnostic evaluation, and as such, scoring on the ADOS should be integrated with other sources of information and interpreted within a developmental framework; no single result on one instrument is sufficient to make or break an autism diagnosis.

The above-mentioned tools were used in Everett’s assessment. Appraising the collected data, his scoring on the ADOS suggested an autism diagnosis, but information from the ADI-R and SRS were not conclusive. To further evaluate Everett, we incorporated a broad developmental evaluation tool, the Mullen Scales of Early Learning, which provided us with a lens through which to interpret his profile of impairments and strengths. Everett scored with average to above-average skills across all domains, which helped us conceptualize that his social, language, and behavioral struggles were not the result of a global developmental delay or intellectual disability.

Additionally, Everett’s family completed the Vineland Adaptive Behavior Scales (his adaptive socialization skills were a relative weakness, and motor skills were a strength) and Child Behavior Checklists, which revealed the endorsement of emotionally reactive and aggressive behavior symptoms from both parents. Everett’s parents’ mental wellness was assessed with Adult Behavior Checklists in order to provide informed family-based treatment recommendations.

In Everett’s evaluation, enduring challenges in the core symptom domains characterizing ASD were noted. His atypical social affect, limited social awareness, and repetitive patterns of behavior provided evidence that Everett met diagnostic criteria for ASD. Also noted were protective factors that promoted his well-being (he’s verbal, has the capacity to play imaginatively, presents with a supportive family, and demonstrates no significant cognitive deficiencies), which were incorporated into our treatment recommendations. Recommendations included enrollment in structured educational and behavioral interventions, and corresponding parent training treatments to help his caregivers manage his disruptive behaviors while reducing the risk for the development of further emotional/behavioral problems in the future.

Everett’s ASD diagnosis also warranted a referral for genetic testing and/or counseling to help the family to obtain information about the etiology of the disorder, screen for other conditions, and help guide appropriate medical management. There were no other indications to pursue additional medical, imaging, or neurological consultations.

Clinical pearl

For some children, the diagnosis of ASD is unclear. Problems arise in making an accurate diagnosis for a variety of reasons, and fully appreciating a child’s (or adolescent’s) developmental challenges can be difficult, especially given the considerable symptom overlap ASD has with other learning, medical, cognitive, or mental health diagnoses. These children require a diagnostic evaluation using a family-focused and culturally sensitive multidisciplinary approach that incorporates standardized tools. As a primary care provider, it can often be difficult to tease out symptoms and have the time to do a thorough assessment; primary providers should be aware of their local assessment expert resources and referral options.

Jeremiah Dickerson, M.D., a child and adolescent psychiatrist, is an assistant professor of psychiatry at the University of Vermont. Dr. Dickerson is the director of the university’s autism diagnostic clinic. Contact Dr. Dickerson at [email protected].

Introduction

Autism spectrum disorder is a neurodevelopmental condition characterized by a heterogeneous grouping of social-communication impairments and behavioral phenomena that are observed in early development and often accompanied by an array of co-occurring issues. The prevalence of autism spectrum disorder (ASD) has risen markedly in the last several years (1 in 68 per a 2014 CDC estimate), and the evidence base for early intervention and other treatment strategies supports the idea that a timely and appropriate diagnosis is critical for promoting positive outcomes for children and their families.

With ASD, there can be wide variety in a young child’s presenting symptoms. Although some youth clearly manifest the hallmark features of ASD, ever-changing development, complicated cognitive profiles, family difficulties, co-occurring mental health problems, and evolving nosology (such as DSM changes) can contribute to the difficulty providers encounter in fully interpreting and identifying ASD symptoms in the course of a typical primary care visit. This case example outlines assessment and diagnostic strategies that may help pediatricians to better understand the complexities of diagnosis, assessment, and treatment for children suspected of having ASD. Ideally, a diagnostic evaluation would quickly follow a standardized screening tool that is positive for concern for ASD (such as the Modified Checklist for Autism in Toddlers – Revised) between the ages of 18 and 24 months.

Case summary

Everett is a 4-year-old boy who presents to an autism diagnostic clinic after his parents expressed concerns about his behavior. Everett is described to be a rigid, stubborn, strong-willed, and easily frustrated boy who began to exhibit aggressive behaviors at 18 months of age. He continues to have almost daily temper tantrums. Notably, Everett did not begin to use single words with communicative intent until he was 24 months old. He will often repeat words nonfunctionally and utter nonsensical verbalizations while spinning in circles and rocking back and forth. Everett enjoys being around peers but has difficulties engaging appropriately with other children, exhibiting poor physical boundaries. Everett’s hearing and vision were previously tested to be without deficit, and there is no history of seizure activity or indication of an underlying metabolic disorder.

Discussion

Everett presents with some signs and symptoms to suggest ASD (namely his communication and language impairments accompanied by some atypical social relatedness and repetitive behaviors). His presentation, however, has many characteristics that while common to ASD are not entirely specific to the diagnosis in a preschooler, and could occur with other disorders. For example, Everett’s social difficulties could be the result of an emerging behavioral disorder (an oppositional defiant disorder) or a primary expressive language disorder, which may manifest with frustration intolerance due to communication difficulties.

With children like Everett, a comprehensive autism diagnostic assessment should be obtained and preferably be comprised of a minimum of two components – a caregiver interview and an observational assessment ideally conducted by an experienced clinical interdisciplinary team. Additionally, evaluations of adaptive skills, cognitive profile, family functioning, social-emotional/behavioral functioning, and sensory issues can be useful to inform treatment planning and diagnosis. Ultimately, the diagnosis of ASD is made after clinicians integrate available information and fully consider the range of differential diagnoses. Clinicians who may participate in the diagnostic process include developmental pediatricians, child psychiatrists, clinical psychologists, speech-language pathologists, and other allied health professionals.

Clinical guidelines suggest that gathering a thorough developmental history, assessing for the characteristic impairments that support an ASD diagnosis, and establishing current levels of functioning can be performed using the semistructured Autism Diagnostic Interview – Revised (ADI-R) with primary caregivers. Information about a child’s social interactions also can be obtained with the use of the Social Responsiveness Scale (SRS), which can yield multi-informant data that helps to capture a youth’s functioning and peer interactions in different settings, including home and school.

The observational assessment ideally utilizes the Autism Diagnostic Observation Schedule (ADOS), a standardized instrument that can evaluate domains of reciprocal social interaction, communication, restricted interests, and repetitive behaviors in a developmentally informed manner. Clinicians should be mindful that certain behaviors may not be displayed during the diagnostic evaluation, and as such, scoring on the ADOS should be integrated with other sources of information and interpreted within a developmental framework; no single result on one instrument is sufficient to make or break an autism diagnosis.

The above-mentioned tools were used in Everett’s assessment. Appraising the collected data, his scoring on the ADOS suggested an autism diagnosis, but information from the ADI-R and SRS were not conclusive. To further evaluate Everett, we incorporated a broad developmental evaluation tool, the Mullen Scales of Early Learning, which provided us with a lens through which to interpret his profile of impairments and strengths. Everett scored with average to above-average skills across all domains, which helped us conceptualize that his social, language, and behavioral struggles were not the result of a global developmental delay or intellectual disability.

Additionally, Everett’s family completed the Vineland Adaptive Behavior Scales (his adaptive socialization skills were a relative weakness, and motor skills were a strength) and Child Behavior Checklists, which revealed the endorsement of emotionally reactive and aggressive behavior symptoms from both parents. Everett’s parents’ mental wellness was assessed with Adult Behavior Checklists in order to provide informed family-based treatment recommendations.

In Everett’s evaluation, enduring challenges in the core symptom domains characterizing ASD were noted. His atypical social affect, limited social awareness, and repetitive patterns of behavior provided evidence that Everett met diagnostic criteria for ASD. Also noted were protective factors that promoted his well-being (he’s verbal, has the capacity to play imaginatively, presents with a supportive family, and demonstrates no significant cognitive deficiencies), which were incorporated into our treatment recommendations. Recommendations included enrollment in structured educational and behavioral interventions, and corresponding parent training treatments to help his caregivers manage his disruptive behaviors while reducing the risk for the development of further emotional/behavioral problems in the future.

Everett’s ASD diagnosis also warranted a referral for genetic testing and/or counseling to help the family to obtain information about the etiology of the disorder, screen for other conditions, and help guide appropriate medical management. There were no other indications to pursue additional medical, imaging, or neurological consultations.

Clinical pearl

For some children, the diagnosis of ASD is unclear. Problems arise in making an accurate diagnosis for a variety of reasons, and fully appreciating a child’s (or adolescent’s) developmental challenges can be difficult, especially given the considerable symptom overlap ASD has with other learning, medical, cognitive, or mental health diagnoses. These children require a diagnostic evaluation using a family-focused and culturally sensitive multidisciplinary approach that incorporates standardized tools. As a primary care provider, it can often be difficult to tease out symptoms and have the time to do a thorough assessment; primary providers should be aware of their local assessment expert resources and referral options.

Jeremiah Dickerson, M.D., a child and adolescent psychiatrist, is an assistant professor of psychiatry at the University of Vermont. Dr. Dickerson is the director of the university’s autism diagnostic clinic. Contact Dr. Dickerson at [email protected].

BALTIMORE –Aggressive decompression dramatically improved survival in patients who had trapped ventricle syndrome as a result of tumor or intracerebral hemorrhage in a retrospective study.

Overall mortality in the cohort was 70% among those who had no decompression, Dr. Gabriel L. Pagani-Estevez said at the annual meeting of the American Neurological Association. But it dropped to 19% among those who underwent some form of decompression therapy. Even after controlling for confounding factors like age, etiology, and hemorrhage volume, decompression remained a significant independent predictor of survival, said Dr. Pagani-Estevez, a neurology resident at the Mayo Clinic, Rochester, Minn.

Despite all the methodological issues inherent in a retrospective study, the findings “provide at least a suggestion that neurosurgical intervention can markedly reduce mortality in trapped ventricle syndrome,” he said. “Now, research needs to clarify the ideal intervention, the effect of decompression on functional outcome, and which patients might derive the most benefit from treatment.”

The cohort comprised 392 patients who developed ventricular trapping and were treated during 2002-2010. They were a mean of 58 years old. Most (223) were not on anticoagulation therapy. A total of 80 patients were taking aspirin, and the remainder were taking other anticoagulants. The median midline shift was about 10 mm.

Trapping was caused by a tumor in 177 patients. Other etiologies included intracerebral hemorrhage (80), subdural hematoma (55), trauma (26), and stroke (18). Unspecified causes made up the remainder.

The left lateral ventricle was most often involved (176). The right lateral ventricle was trapped in 159 patients and both were involved in 32. Thirteen patients had a trapped fourth ventricle, and 12 had unspecified trapping.

Some kind of decompression procedure was performed on 221 patients. These included craniotomy (126), craniectomy (26), external ventricular drain (30), ventricular-peritoneal shunt (23), and endoscopic septum pellucidum fenestration (16).

Comparisons showed significantly decreased mortality for intervention vs. nonintervention in groups with various causes of ventricular trapping: intracerebral hemorrhage (48% vs. 95%), tumor (12% vs. 47%), and subdural hematoma (20% vs. 90%).

There were nonsignificant declines in mortality among patients who underwent intervention for ventricular trapping caused by trauma or ischemic stroke, but the number of patients in those subgroups were small, which probably confounded the results, Dr. Pagani-Estevez said.

He then conducted a multivariate analysis to determine patient characteristics that might have contributed to survival. Patients who had a decompression procedure were 87% less likely to die than were those who had not – a highly significant finding (P = .0001). A midline shift conferred a slight increase in the risk of death, while having intracerebral hemorrhage as the trapping etiology increased the risk fourfold.

Trapped ventricle carries a notoriously poor prognosis, said Dr. Alejandro A. Rabinstein, a coauthor on the study. “By the time you develop it, it’s a very bad situation, so whatever way you can achieve decompression may improve the situation,” said Dr. Rabinstein, a critical care neurologist who is also at the Mayo Clinic in Rochester. “If you don’t think the patient has enough left to merit the intervention, then you just don’t do it. But despite that limitation, if you think the patient can recover some function, it’s appropriate. An intervention will make patients survive way more often than no intervention. Without something, though, the prospect of survival is bleak.”

Neither Dr. Pagani-Estevez nor Dr. Rabinstein had any financial disclosures.

[email protected]

On Twitter @alz_gal

BALTIMORE –Aggressive decompression dramatically improved survival in patients who had trapped ventricle syndrome as a result of tumor or intracerebral hemorrhage in a retrospective study.

Overall mortality in the cohort was 70% among those who had no decompression, Dr. Gabriel L. Pagani-Estevez said at the annual meeting of the American Neurological Association. But it dropped to 19% among those who underwent some form of decompression therapy. Even after controlling for confounding factors like age, etiology, and hemorrhage volume, decompression remained a significant independent predictor of survival, said Dr. Pagani-Estevez, a neurology resident at the Mayo Clinic, Rochester, Minn.

Despite all the methodological issues inherent in a retrospective study, the findings “provide at least a suggestion that neurosurgical intervention can markedly reduce mortality in trapped ventricle syndrome,” he said. “Now, research needs to clarify the ideal intervention, the effect of decompression on functional outcome, and which patients might derive the most benefit from treatment.”

The cohort comprised 392 patients who developed ventricular trapping and were treated during 2002-2010. They were a mean of 58 years old. Most (223) were not on anticoagulation therapy. A total of 80 patients were taking aspirin, and the remainder were taking other anticoagulants. The median midline shift was about 10 mm.

Trapping was caused by a tumor in 177 patients. Other etiologies included intracerebral hemorrhage (80), subdural hematoma (55), trauma (26), and stroke (18). Unspecified causes made up the remainder.

The left lateral ventricle was most often involved (176). The right lateral ventricle was trapped in 159 patients and both were involved in 32. Thirteen patients had a trapped fourth ventricle, and 12 had unspecified trapping.

Some kind of decompression procedure was performed on 221 patients. These included craniotomy (126), craniectomy (26), external ventricular drain (30), ventricular-peritoneal shunt (23), and endoscopic septum pellucidum fenestration (16).

Comparisons showed significantly decreased mortality for intervention vs. nonintervention in groups with various causes of ventricular trapping: intracerebral hemorrhage (48% vs. 95%), tumor (12% vs. 47%), and subdural hematoma (20% vs. 90%).

There were nonsignificant declines in mortality among patients who underwent intervention for ventricular trapping caused by trauma or ischemic stroke, but the number of patients in those subgroups were small, which probably confounded the results, Dr. Pagani-Estevez said.

He then conducted a multivariate analysis to determine patient characteristics that might have contributed to survival. Patients who had a decompression procedure were 87% less likely to die than were those who had not – a highly significant finding (P = .0001). A midline shift conferred a slight increase in the risk of death, while having intracerebral hemorrhage as the trapping etiology increased the risk fourfold.

Trapped ventricle carries a notoriously poor prognosis, said Dr. Alejandro A. Rabinstein, a coauthor on the study. “By the time you develop it, it’s a very bad situation, so whatever way you can achieve decompression may improve the situation,” said Dr. Rabinstein, a critical care neurologist who is also at the Mayo Clinic in Rochester. “If you don’t think the patient has enough left to merit the intervention, then you just don’t do it. But despite that limitation, if you think the patient can recover some function, it’s appropriate. An intervention will make patients survive way more often than no intervention. Without something, though, the prospect of survival is bleak.”

Neither Dr. Pagani-Estevez nor Dr. Rabinstein had any financial disclosures.

[email protected]

On Twitter @alz_gal

BALTIMORE –Aggressive decompression dramatically improved survival in patients who had trapped ventricle syndrome as a result of tumor or intracerebral hemorrhage in a retrospective study.

Overall mortality in the cohort was 70% among those who had no decompression, Dr. Gabriel L. Pagani-Estevez said at the annual meeting of the American Neurological Association. But it dropped to 19% among those who underwent some form of decompression therapy. Even after controlling for confounding factors like age, etiology, and hemorrhage volume, decompression remained a significant independent predictor of survival, said Dr. Pagani-Estevez, a neurology resident at the Mayo Clinic, Rochester, Minn.

Despite all the methodological issues inherent in a retrospective study, the findings “provide at least a suggestion that neurosurgical intervention can markedly reduce mortality in trapped ventricle syndrome,” he said. “Now, research needs to clarify the ideal intervention, the effect of decompression on functional outcome, and which patients might derive the most benefit from treatment.”

The cohort comprised 392 patients who developed ventricular trapping and were treated during 2002-2010. They were a mean of 58 years old. Most (223) were not on anticoagulation therapy. A total of 80 patients were taking aspirin, and the remainder were taking other anticoagulants. The median midline shift was about 10 mm.

Trapping was caused by a tumor in 177 patients. Other etiologies included intracerebral hemorrhage (80), subdural hematoma (55), trauma (26), and stroke (18). Unspecified causes made up the remainder.

The left lateral ventricle was most often involved (176). The right lateral ventricle was trapped in 159 patients and both were involved in 32. Thirteen patients had a trapped fourth ventricle, and 12 had unspecified trapping.

Some kind of decompression procedure was performed on 221 patients. These included craniotomy (126), craniectomy (26), external ventricular drain (30), ventricular-peritoneal shunt (23), and endoscopic septum pellucidum fenestration (16).

Comparisons showed significantly decreased mortality for intervention vs. nonintervention in groups with various causes of ventricular trapping: intracerebral hemorrhage (48% vs. 95%), tumor (12% vs. 47%), and subdural hematoma (20% vs. 90%).

There were nonsignificant declines in mortality among patients who underwent intervention for ventricular trapping caused by trauma or ischemic stroke, but the number of patients in those subgroups were small, which probably confounded the results, Dr. Pagani-Estevez said.

He then conducted a multivariate analysis to determine patient characteristics that might have contributed to survival. Patients who had a decompression procedure were 87% less likely to die than were those who had not – a highly significant finding (P = .0001). A midline shift conferred a slight increase in the risk of death, while having intracerebral hemorrhage as the trapping etiology increased the risk fourfold.

Trapped ventricle carries a notoriously poor prognosis, said Dr. Alejandro A. Rabinstein, a coauthor on the study. “By the time you develop it, it’s a very bad situation, so whatever way you can achieve decompression may improve the situation,” said Dr. Rabinstein, a critical care neurologist who is also at the Mayo Clinic in Rochester. “If you don’t think the patient has enough left to merit the intervention, then you just don’t do it. But despite that limitation, if you think the patient can recover some function, it’s appropriate. An intervention will make patients survive way more often than no intervention. Without something, though, the prospect of survival is bleak.”

Neither Dr. Pagani-Estevez nor Dr. Rabinstein had any financial disclosures.

[email protected]

On Twitter @alz_gal

PHILADELPHIA—Internal medicine residents are obtaining transfusion consent from patients despite having poor knowledge of transfusion medicine, according to a study of nearly 500 residents in 9 countries.

On an exam assessing transfusion knowledge, the residents’ mean score was 45.7%.

And in a survey, an overwhelming majority of residents said they had “beginner” or “intermediate” transfusion knowledge.

Still, 89% said they had obtained patient consent for a transfusion.

Richard Haspel, MD, PhD, of Beth Israel Deacon Medical Center and Harvard Medical School in Boston, presented these data at the AABB Annual Meeting 2014 (abstract S45-030G).

“We all know there’s a problem with clinicians not knowing how to transfuse blood,” Dr Haspel began. “I would argue, though, that there are a lot of questions we don’t know the answer to. How prevalent is this problem? Are there some places that do it better than others? What areas need improvement?”

With these questions in mind, Dr Haspel and his colleagues used a 23-question survey and a 20-question exam (validated by the BEST Collaborative) to assess 474 internal medicine residents from 23 sites in 9 countries: Australia, Canada, England, Ireland, Italy, Germany, The Netherlands, Spain, and the US.

The mean score of correct responses in the exam was 45.7%. The mean score was significantly lower for first-year residents (43.9%) than for third- (47.1%; P=0.02) and fourth-year residents (50.6%, P=0.002).

However, as 50.6% was the highest mean score, exam scores were poor regardless of a resident’s time served, Dr Haspel noted. Scores were poor across the different study sites as well, ranging from about 32% to 55%.

The exam included questions on red cells, platelets, plasma, allergic reactions, transfusion-related acute lung injury (TRALI), and transfusion-associated circulatory overload (TACO), among other topics.

As an example, Dr Haspel pointed out that, for the 3 questions on TRALI, the percentage of correct responses did not exceed 15%. This was the topic about which residents seemed the least informed.

Dr Haspel noted that, in general, residents with more medical school hours spent learning about transfusion medicine and those with better perceived quality of their training tended to score higher on the exam. Still, there wasn’t much of a difference in exam scores between residents who said they had beginner, intermediate, or advanced knowledge of transfusion medicine.

Twelve percent of residents said they did not receive any transfusion medicine training in medical school, and 28% said they didn’t receive any training during their residency. About 35% said they received more than 2 hours of training in medical school, and 18% said they received more than 2 hours of training during their residency.

“In terms of the quality of the training, most rated it ‘slightly’ or ‘moderately’ effective,” Dr Haspel said. “In terms of attitudes and perceptions, most of them considered themselves a beginner [48%] or intermediate [48%] in regard to transfusion medicine knowledge.”

Ninety-seven percent of residents said they know how to contact the blood bank, and 72% said they know how to contact a transfusion medicine doctor. But 14% percent of residents did not know if their hospital had transfusion guidelines, and 1% wrongly said their hospital did not have guidelines.

Yet 89% of residents said they had obtained consent for a transfusion from a patient.

On the other hand, most residents (77%) said knowledge of transfusion medicine is “very” or “extremely” important in providing appropriate patient care. And 65% said they would find additional training “very” or “extremely” helpful.

PHILADELPHIA—Internal medicine residents are obtaining transfusion consent from patients despite having poor knowledge of transfusion medicine, according to a study of nearly 500 residents in 9 countries.

On an exam assessing transfusion knowledge, the residents’ mean score was 45.7%.

And in a survey, an overwhelming majority of residents said they had “beginner” or “intermediate” transfusion knowledge.

Still, 89% said they had obtained patient consent for a transfusion.

Richard Haspel, MD, PhD, of Beth Israel Deacon Medical Center and Harvard Medical School in Boston, presented these data at the AABB Annual Meeting 2014 (abstract S45-030G).

“We all know there’s a problem with clinicians not knowing how to transfuse blood,” Dr Haspel began. “I would argue, though, that there are a lot of questions we don’t know the answer to. How prevalent is this problem? Are there some places that do it better than others? What areas need improvement?”

With these questions in mind, Dr Haspel and his colleagues used a 23-question survey and a 20-question exam (validated by the BEST Collaborative) to assess 474 internal medicine residents from 23 sites in 9 countries: Australia, Canada, England, Ireland, Italy, Germany, The Netherlands, Spain, and the US.

The mean score of correct responses in the exam was 45.7%. The mean score was significantly lower for first-year residents (43.9%) than for third- (47.1%; P=0.02) and fourth-year residents (50.6%, P=0.002).

However, as 50.6% was the highest mean score, exam scores were poor regardless of a resident’s time served, Dr Haspel noted. Scores were poor across the different study sites as well, ranging from about 32% to 55%.

The exam included questions on red cells, platelets, plasma, allergic reactions, transfusion-related acute lung injury (TRALI), and transfusion-associated circulatory overload (TACO), among other topics.

As an example, Dr Haspel pointed out that, for the 3 questions on TRALI, the percentage of correct responses did not exceed 15%. This was the topic about which residents seemed the least informed.

Dr Haspel noted that, in general, residents with more medical school hours spent learning about transfusion medicine and those with better perceived quality of their training tended to score higher on the exam. Still, there wasn’t much of a difference in exam scores between residents who said they had beginner, intermediate, or advanced knowledge of transfusion medicine.

Twelve percent of residents said they did not receive any transfusion medicine training in medical school, and 28% said they didn’t receive any training during their residency. About 35% said they received more than 2 hours of training in medical school, and 18% said they received more than 2 hours of training during their residency.

“In terms of the quality of the training, most rated it ‘slightly’ or ‘moderately’ effective,” Dr Haspel said. “In terms of attitudes and perceptions, most of them considered themselves a beginner [48%] or intermediate [48%] in regard to transfusion medicine knowledge.”

Ninety-seven percent of residents said they know how to contact the blood bank, and 72% said they know how to contact a transfusion medicine doctor. But 14% percent of residents did not know if their hospital had transfusion guidelines, and 1% wrongly said their hospital did not have guidelines.

Yet 89% of residents said they had obtained consent for a transfusion from a patient.

On the other hand, most residents (77%) said knowledge of transfusion medicine is “very” or “extremely” important in providing appropriate patient care. And 65% said they would find additional training “very” or “extremely” helpful.

PHILADELPHIA—Internal medicine residents are obtaining transfusion consent from patients despite having poor knowledge of transfusion medicine, according to a study of nearly 500 residents in 9 countries.

On an exam assessing transfusion knowledge, the residents’ mean score was 45.7%.

And in a survey, an overwhelming majority of residents said they had “beginner” or “intermediate” transfusion knowledge.

Still, 89% said they had obtained patient consent for a transfusion.

Richard Haspel, MD, PhD, of Beth Israel Deacon Medical Center and Harvard Medical School in Boston, presented these data at the AABB Annual Meeting 2014 (abstract S45-030G).

“We all know there’s a problem with clinicians not knowing how to transfuse blood,” Dr Haspel began. “I would argue, though, that there are a lot of questions we don’t know the answer to. How prevalent is this problem? Are there some places that do it better than others? What areas need improvement?”

With these questions in mind, Dr Haspel and his colleagues used a 23-question survey and a 20-question exam (validated by the BEST Collaborative) to assess 474 internal medicine residents from 23 sites in 9 countries: Australia, Canada, England, Ireland, Italy, Germany, The Netherlands, Spain, and the US.

The mean score of correct responses in the exam was 45.7%. The mean score was significantly lower for first-year residents (43.9%) than for third- (47.1%; P=0.02) and fourth-year residents (50.6%, P=0.002).

However, as 50.6% was the highest mean score, exam scores were poor regardless of a resident’s time served, Dr Haspel noted. Scores were poor across the different study sites as well, ranging from about 32% to 55%.

The exam included questions on red cells, platelets, plasma, allergic reactions, transfusion-related acute lung injury (TRALI), and transfusion-associated circulatory overload (TACO), among other topics.

As an example, Dr Haspel pointed out that, for the 3 questions on TRALI, the percentage of correct responses did not exceed 15%. This was the topic about which residents seemed the least informed.

Dr Haspel noted that, in general, residents with more medical school hours spent learning about transfusion medicine and those with better perceived quality of their training tended to score higher on the exam. Still, there wasn’t much of a difference in exam scores between residents who said they had beginner, intermediate, or advanced knowledge of transfusion medicine.

Twelve percent of residents said they did not receive any transfusion medicine training in medical school, and 28% said they didn’t receive any training during their residency. About 35% said they received more than 2 hours of training in medical school, and 18% said they received more than 2 hours of training during their residency.

“In terms of the quality of the training, most rated it ‘slightly’ or ‘moderately’ effective,” Dr Haspel said. “In terms of attitudes and perceptions, most of them considered themselves a beginner [48%] or intermediate [48%] in regard to transfusion medicine knowledge.”

Ninety-seven percent of residents said they know how to contact the blood bank, and 72% said they know how to contact a transfusion medicine doctor. But 14% percent of residents did not know if their hospital had transfusion guidelines, and 1% wrongly said their hospital did not have guidelines.

Yet 89% of residents said they had obtained consent for a transfusion from a patient.

On the other hand, most residents (77%) said knowledge of transfusion medicine is “very” or “extremely” important in providing appropriate patient care. And 65% said they would find additional training “very” or “extremely” helpful.

Lab mice

Credit: Aaron Logan

A new method of genome editing can cure hemophilia B in mice, researchers have reported in Nature.

This new technique doesn’t require the co-delivery of an endonuclease to clip the recipient’s DNA at specific locations, and it doesn’t rely on the co-insertion of genetic promoters to activate the new gene’s expression.

These differences may make the new approach both safer and longer-lasting than other genome editing methods, according to researchers.

“It appears that we may be able to achieve lifelong expression of the inserted gene, which is particularly important when treating genetic diseases like hemophilia and severe combined immunodeficiency,” said study author Mark Kay, MD, PhD, of the Stanford University School of Medicine in California.

“We’re able to do this without using promoters or nucleases, which significantly reduces the chances of cancers that can result if the new gene inserts itself at random places in the genome.”

Using their new technique, Dr Kay and his colleagues were able to insert a working copy of the human coagulation factor IX gene into the DNA of mice with hemophilia B. Although the insertion was accomplished in only about 1% of liver cells, those cells made enough factor IX to ameliorate the disorder.

Instead of using nucleases to cut the DNA or a promoter to drive expression of the factor IX gene, the researchers hitched the expression of the new gene to that of albumin.

They used a modified version of adeno-associated virus and relied on homologous recombination to insert the factor IX gene near the albumin gene.

Using a special DNA linker between the genes, the researchers were able to ensure that the clotting factor protein was made hand-in-hand with the highly expressed albumin protein.

During homologous recombination, the cell takes advantage of the fact that it has two copies of every chromosome. By lining up the damaged and undamaged chromosomes, the cell can “crib” off the intact copy to repair the damage without losing vital genetic information.

The researchers used this natural process to copy sequences from the viral vector into the genome at places they chose—in this case, after the albumin gene.

When they tested their approach in newborn lab mice with hemophilia, the team found the animals began to express levels of factor IX that were between 7% and 20% of normal. That amount of clotting factor has been shown in previous studies to be therapeutic in mice.

The researchers further showed that the technique worked as well in adult animals, even though the gene was successfully inserted in fewer than 1 in every 100 liver cells.

“We expected this approach to work best in newborn animals because the liver is still growing,” Dr Kay said. “However, because homologous recombination has been thought to occur mostly in proliferating cells, we didn’t expect it to work as well as it did in adult animals.”

The researchers are now planning to test the technique in mice with livers composed of human and mouse cells, a model that may be a good surrogate to further predict what will happen in humans.

Lab mice

Credit: Aaron Logan

A new method of genome editing can cure hemophilia B in mice, researchers have reported in Nature.

This new technique doesn’t require the co-delivery of an endonuclease to clip the recipient’s DNA at specific locations, and it doesn’t rely on the co-insertion of genetic promoters to activate the new gene’s expression.

These differences may make the new approach both safer and longer-lasting than other genome editing methods, according to researchers.

“It appears that we may be able to achieve lifelong expression of the inserted gene, which is particularly important when treating genetic diseases like hemophilia and severe combined immunodeficiency,” said study author Mark Kay, MD, PhD, of the Stanford University School of Medicine in California.

“We’re able to do this without using promoters or nucleases, which significantly reduces the chances of cancers that can result if the new gene inserts itself at random places in the genome.”

Using their new technique, Dr Kay and his colleagues were able to insert a working copy of the human coagulation factor IX gene into the DNA of mice with hemophilia B. Although the insertion was accomplished in only about 1% of liver cells, those cells made enough factor IX to ameliorate the disorder.

Instead of using nucleases to cut the DNA or a promoter to drive expression of the factor IX gene, the researchers hitched the expression of the new gene to that of albumin.

They used a modified version of adeno-associated virus and relied on homologous recombination to insert the factor IX gene near the albumin gene.

Using a special DNA linker between the genes, the researchers were able to ensure that the clotting factor protein was made hand-in-hand with the highly expressed albumin protein.

During homologous recombination, the cell takes advantage of the fact that it has two copies of every chromosome. By lining up the damaged and undamaged chromosomes, the cell can “crib” off the intact copy to repair the damage without losing vital genetic information.

The researchers used this natural process to copy sequences from the viral vector into the genome at places they chose—in this case, after the albumin gene.

When they tested their approach in newborn lab mice with hemophilia, the team found the animals began to express levels of factor IX that were between 7% and 20% of normal. That amount of clotting factor has been shown in previous studies to be therapeutic in mice.

The researchers further showed that the technique worked as well in adult animals, even though the gene was successfully inserted in fewer than 1 in every 100 liver cells.

“We expected this approach to work best in newborn animals because the liver is still growing,” Dr Kay said. “However, because homologous recombination has been thought to occur mostly in proliferating cells, we didn’t expect it to work as well as it did in adult animals.”

The researchers are now planning to test the technique in mice with livers composed of human and mouse cells, a model that may be a good surrogate to further predict what will happen in humans.

Lab mice

Credit: Aaron Logan

A new method of genome editing can cure hemophilia B in mice, researchers have reported in Nature.

This new technique doesn’t require the co-delivery of an endonuclease to clip the recipient’s DNA at specific locations, and it doesn’t rely on the co-insertion of genetic promoters to activate the new gene’s expression.

These differences may make the new approach both safer and longer-lasting than other genome editing methods, according to researchers.

“It appears that we may be able to achieve lifelong expression of the inserted gene, which is particularly important when treating genetic diseases like hemophilia and severe combined immunodeficiency,” said study author Mark Kay, MD, PhD, of the Stanford University School of Medicine in California.

“We’re able to do this without using promoters or nucleases, which significantly reduces the chances of cancers that can result if the new gene inserts itself at random places in the genome.”

Using their new technique, Dr Kay and his colleagues were able to insert a working copy of the human coagulation factor IX gene into the DNA of mice with hemophilia B. Although the insertion was accomplished in only about 1% of liver cells, those cells made enough factor IX to ameliorate the disorder.

Instead of using nucleases to cut the DNA or a promoter to drive expression of the factor IX gene, the researchers hitched the expression of the new gene to that of albumin.

They used a modified version of adeno-associated virus and relied on homologous recombination to insert the factor IX gene near the albumin gene.

Using a special DNA linker between the genes, the researchers were able to ensure that the clotting factor protein was made hand-in-hand with the highly expressed albumin protein.

During homologous recombination, the cell takes advantage of the fact that it has two copies of every chromosome. By lining up the damaged and undamaged chromosomes, the cell can “crib” off the intact copy to repair the damage without losing vital genetic information.

The researchers used this natural process to copy sequences from the viral vector into the genome at places they chose—in this case, after the albumin gene.

When they tested their approach in newborn lab mice with hemophilia, the team found the animals began to express levels of factor IX that were between 7% and 20% of normal. That amount of clotting factor has been shown in previous studies to be therapeutic in mice.

The researchers further showed that the technique worked as well in adult animals, even though the gene was successfully inserted in fewer than 1 in every 100 liver cells.

“We expected this approach to work best in newborn animals because the liver is still growing,” Dr Kay said. “However, because homologous recombination has been thought to occur mostly in proliferating cells, we didn’t expect it to work as well as it did in adult animals.”

The researchers are now planning to test the technique in mice with livers composed of human and mouse cells, a model that may be a good surrogate to further predict what will happen in humans.

Myron S. Czuczman, MD

NEW YORK—With both the pro and con positions drawing on data from the phase 3 CLL11 trial, two speakers at the Lymphoma & Myeloma2014 congress faced off on whether it’s necessary to use chlorambucil with obinutuzumab in untreated chronic lymphocytic leukemia (CLL).

Myron S. Czuczman, MD, of Roswell Park Cancer Institute in Buffalo, New York, argued in favor of using chlorambucil. And Richard R. Furman, MD, of Weill Cornell Medical College in New York, argued against it.

Obinutuzumab is a glycoengineered, humanized, monoclonal antibody that selectively binds to the extracellular domain of the CD20 antigen on B cells.

It was approved by the US Food and Drug Administration based on initial results from the phase 3 CLL11 study, in which 781 patients were randomized to receive chlorambucil alone or chlorambucil with either obinutuzumab or rituximab.

Pro

Dr Czuczman pointed out that while the obinutuzumab-chlorambucil combination had more toxicity than the rituximab-chlorambucil combination, the overall response rate and complete response rate with obinutuzumab were significantly higher than with rituximab (P<0.0001).

Progression-free survival (PFS), which was the primary endpoint, was significantly higher with either obinutuzumab at 26.7 months, or rituximab, at 16.3 months, than with chlorambucil alone, at 11.1 months.

And in the head-to-head portion of CLL11, PFS with obinutuzumab-chlorambucil was significantly better at 26.7 months than with rituximab-chlorambucil, at 15.2 months (P<0.001).

Dr Czuczman also reviewed data on obinutuzumab combined with drugs other than chlorambucil.

The GALTON trial, a small, phase 1b trial in untreated CLL, compared obinutuzumab plus fludarabine and cyclophosphamide to obinutuzumab plus bendamustine.

Dr Czuczman showed that while there is more toxicity when obinutuzumab is combined with cyclophosphamide or bendamustine than with chlorambucil, “there is not much more activity.”

He said it’s not clear whether obinutuzumab with cyclophosphamide is better than rituximab with cyclophosphamide or if obinutuzumab with bendamustine is better than rituximab with bendamustine in upfront CLL.

“For now,” he said, “chloramubucil should be the only chemo agent combined with obinutuzumab to treat upfront CLL—outside of clinical trial participation.”

Con

Dr Furman also reviewed the CLL11 trial, noting that rituximab did not add very much to chlorambucil, but obinutuzumab did, in terms of overall survival and PFS. He cautioned, however, that additive or synergistic effects cannot be ruled out in the combination studies.

He then reviewed the GAGE trial, which compared 2 doses of single-agent obinutuzumab in untreated CLL. The 2000 mg dose produced a greater overall response rate than the 1000 mg dose, but the difference between the 2 arms was not significant (P=0.08).

PFS was 21 months in the 1000 mg arm and 20 months in the 2000 mg arm (P=0.07). PFS for obinutuzumab plus chlorambucil in the CLL11 trial was 26.7 months.

However, second cancers may be more of an issue with chlorambucil. In CALGB 9011, investigators reported 27 epithelial cancers, 9 with fludarabine, 11 with chlorambucil, and 7 with fludarabine plus chlorambucil.

Dr Furman concluded that while chlorambucil may aid obinutuzumab by reducing bulk, it may be unnecessary if higher doses of the antibody are used. Single-agent obinutuzumab produces a similar PFS as the combination with chlorambucil, and there are greater toxicities with chlorambucil.

Myron S. Czuczman, MD

NEW YORK—With both the pro and con positions drawing on data from the phase 3 CLL11 trial, two speakers at the Lymphoma & Myeloma2014 congress faced off on whether it’s necessary to use chlorambucil with obinutuzumab in untreated chronic lymphocytic leukemia (CLL).

Myron S. Czuczman, MD, of Roswell Park Cancer Institute in Buffalo, New York, argued in favor of using chlorambucil. And Richard R. Furman, MD, of Weill Cornell Medical College in New York, argued against it.

Obinutuzumab is a glycoengineered, humanized, monoclonal antibody that selectively binds to the extracellular domain of the CD20 antigen on B cells.

It was approved by the US Food and Drug Administration based on initial results from the phase 3 CLL11 study, in which 781 patients were randomized to receive chlorambucil alone or chlorambucil with either obinutuzumab or rituximab.

Pro

Dr Czuczman pointed out that while the obinutuzumab-chlorambucil combination had more toxicity than the rituximab-chlorambucil combination, the overall response rate and complete response rate with obinutuzumab were significantly higher than with rituximab (P<0.0001).

Progression-free survival (PFS), which was the primary endpoint, was significantly higher with either obinutuzumab at 26.7 months, or rituximab, at 16.3 months, than with chlorambucil alone, at 11.1 months.

And in the head-to-head portion of CLL11, PFS with obinutuzumab-chlorambucil was significantly better at 26.7 months than with rituximab-chlorambucil, at 15.2 months (P<0.001).

Dr Czuczman also reviewed data on obinutuzumab combined with drugs other than chlorambucil.

The GALTON trial, a small, phase 1b trial in untreated CLL, compared obinutuzumab plus fludarabine and cyclophosphamide to obinutuzumab plus bendamustine.

Dr Czuczman showed that while there is more toxicity when obinutuzumab is combined with cyclophosphamide or bendamustine than with chlorambucil, “there is not much more activity.”

He said it’s not clear whether obinutuzumab with cyclophosphamide is better than rituximab with cyclophosphamide or if obinutuzumab with bendamustine is better than rituximab with bendamustine in upfront CLL.

“For now,” he said, “chloramubucil should be the only chemo agent combined with obinutuzumab to treat upfront CLL—outside of clinical trial participation.”

Con

Dr Furman also reviewed the CLL11 trial, noting that rituximab did not add very much to chlorambucil, but obinutuzumab did, in terms of overall survival and PFS. He cautioned, however, that additive or synergistic effects cannot be ruled out in the combination studies.

He then reviewed the GAGE trial, which compared 2 doses of single-agent obinutuzumab in untreated CLL. The 2000 mg dose produced a greater overall response rate than the 1000 mg dose, but the difference between the 2 arms was not significant (P=0.08).

PFS was 21 months in the 1000 mg arm and 20 months in the 2000 mg arm (P=0.07). PFS for obinutuzumab plus chlorambucil in the CLL11 trial was 26.7 months.

However, second cancers may be more of an issue with chlorambucil. In CALGB 9011, investigators reported 27 epithelial cancers, 9 with fludarabine, 11 with chlorambucil, and 7 with fludarabine plus chlorambucil.

Dr Furman concluded that while chlorambucil may aid obinutuzumab by reducing bulk, it may be unnecessary if higher doses of the antibody are used. Single-agent obinutuzumab produces a similar PFS as the combination with chlorambucil, and there are greater toxicities with chlorambucil.

Myron S. Czuczman, MD

NEW YORK—With both the pro and con positions drawing on data from the phase 3 CLL11 trial, two speakers at the Lymphoma & Myeloma2014 congress faced off on whether it’s necessary to use chlorambucil with obinutuzumab in untreated chronic lymphocytic leukemia (CLL).

Myron S. Czuczman, MD, of Roswell Park Cancer Institute in Buffalo, New York, argued in favor of using chlorambucil. And Richard R. Furman, MD, of Weill Cornell Medical College in New York, argued against it.

Obinutuzumab is a glycoengineered, humanized, monoclonal antibody that selectively binds to the extracellular domain of the CD20 antigen on B cells.

It was approved by the US Food and Drug Administration based on initial results from the phase 3 CLL11 study, in which 781 patients were randomized to receive chlorambucil alone or chlorambucil with either obinutuzumab or rituximab.

Pro

Dr Czuczman pointed out that while the obinutuzumab-chlorambucil combination had more toxicity than the rituximab-chlorambucil combination, the overall response rate and complete response rate with obinutuzumab were significantly higher than with rituximab (P<0.0001).

Progression-free survival (PFS), which was the primary endpoint, was significantly higher with either obinutuzumab at 26.7 months, or rituximab, at 16.3 months, than with chlorambucil alone, at 11.1 months.

And in the head-to-head portion of CLL11, PFS with obinutuzumab-chlorambucil was significantly better at 26.7 months than with rituximab-chlorambucil, at 15.2 months (P<0.001).

Dr Czuczman also reviewed data on obinutuzumab combined with drugs other than chlorambucil.

The GALTON trial, a small, phase 1b trial in untreated CLL, compared obinutuzumab plus fludarabine and cyclophosphamide to obinutuzumab plus bendamustine.

Dr Czuczman showed that while there is more toxicity when obinutuzumab is combined with cyclophosphamide or bendamustine than with chlorambucil, “there is not much more activity.”

He said it’s not clear whether obinutuzumab with cyclophosphamide is better than rituximab with cyclophosphamide or if obinutuzumab with bendamustine is better than rituximab with bendamustine in upfront CLL.

“For now,” he said, “chloramubucil should be the only chemo agent combined with obinutuzumab to treat upfront CLL—outside of clinical trial participation.”

Con

Dr Furman also reviewed the CLL11 trial, noting that rituximab did not add very much to chlorambucil, but obinutuzumab did, in terms of overall survival and PFS. He cautioned, however, that additive or synergistic effects cannot be ruled out in the combination studies.

He then reviewed the GAGE trial, which compared 2 doses of single-agent obinutuzumab in untreated CLL. The 2000 mg dose produced a greater overall response rate than the 1000 mg dose, but the difference between the 2 arms was not significant (P=0.08).

PFS was 21 months in the 1000 mg arm and 20 months in the 2000 mg arm (P=0.07). PFS for obinutuzumab plus chlorambucil in the CLL11 trial was 26.7 months.

However, second cancers may be more of an issue with chlorambucil. In CALGB 9011, investigators reported 27 epithelial cancers, 9 with fludarabine, 11 with chlorambucil, and 7 with fludarabine plus chlorambucil.

Dr Furman concluded that while chlorambucil may aid obinutuzumab by reducing bulk, it may be unnecessary if higher doses of the antibody are used. Single-agent obinutuzumab produces a similar PFS as the combination with chlorambucil, and there are greater toxicities with chlorambucil.

Doctor with clipboard

A survey of nearly 5000 US physicians showed that the average doctor spent 16.6% of his or her working hours on non-patient-related paperwork.

This includes tasks such as billing, obtaining insurance approvals, financial and personnel management, and negotiating contracts.

The more time doctors spent on such tasks, the less satisfied they were with medicine as a career.

Researchers detailed these findings in the International Journal of Health Services.

“Our crazy health financing system is demoralizing doctors and wasting vast resources,” said study author David Himmelstein, MD, a professor at Hunter College of the City University of New York.

“Turning healthcare into a business means we spend more and more time on billing, insurance paperwork, and the bottom line. We need to move to a simple, nonprofit national health insurance system that lets doctors and hospitals focus on patients, not finances.”

Dr Himmelstein and colleague Steffie Woolhandler, MD, analyzed confidential data from the 2008 Health Tracking Physician Survey (the most recent data available). The survey included information from a nationally representative sample of 4720 physicians who practiced at least 20 hours per week.

The data showed that the average doctor spent 8.7 hours per week, or 16.6% of his or her working time, on non-patient-related administration. This excludes tasks such as writing chart notes, communicating with other doctors, and ordering lab tests.

In total, patient-care physicians spent 168.4 million hours on non-patient-related administrative tasks in 2008. Drs Himmelstein and Woolhandler estimate that the total cost of physician time spent on administration in 2014 will amount to $102 billion.

Career satisfaction was lower for physicians who spent more time on administration. “Very satisfied” doctors spent, on average, 16.1% of their time on administration. “Very dissatisfied” doctors spent 20.6% of their time on such tasks.

Among various specialties, psychiatrists spent the most time on administration (20.3%), followed by internists (17.3%) and family/general practitioners (17.3%). Pediatricians spent the least amount of time (14.1%) on non-patient-related administrative tasks and were the most satisfied group of doctors.

Solo practice was associated with more administrative work, but small group practice was not. Doctors practicing in groups of 100 or more actually spent more time (19.7%) on such tasks than those in small groups (16.3%).

The researchers were surprised to find that physicians who used electronic health records spent more time (17.2% for those using entirely electronic records, 18% for those using a mix of paper and electronic) on administration than those who used only paper records (15.5%).

The pair noted that physicians in Canada spend far less time on administration than US doctors, and they attributed the difference to Canada’s single-payer system, which has greatly simplified billing and reduced bureaucracy.

The researchers pointed out that the only previous nationally representative survey of this kind was carried out in 1995, and that study showed that administration and insurance-related matters accounted for 13.5% of physicians’ total work time. Other, less representative studies also suggest the bureaucratic burden on physicians has grown in the past two decades.

“American doctors are drowning in paperwork,” Dr Woolhandler said. “Our study almost certainly understates physicians’ current administrative burden.”

“Since 2008, when the survey we analyzed was collected, tens of thousands of doctors have moved from small private practices with minimal bureaucracy into giant group practices where bureaucracy is rampant. And under the accountable care organizations favored by insurers, more doctors are facing HMO-type incentives to deny care to their patients, a move that our data shows drives up administrative work.”

Doctor with clipboard

A survey of nearly 5000 US physicians showed that the average doctor spent 16.6% of his or her working hours on non-patient-related paperwork.

This includes tasks such as billing, obtaining insurance approvals, financial and personnel management, and negotiating contracts.

The more time doctors spent on such tasks, the less satisfied they were with medicine as a career.

Researchers detailed these findings in the International Journal of Health Services.

“Our crazy health financing system is demoralizing doctors and wasting vast resources,” said study author David Himmelstein, MD, a professor at Hunter College of the City University of New York.

“Turning healthcare into a business means we spend more and more time on billing, insurance paperwork, and the bottom line. We need to move to a simple, nonprofit national health insurance system that lets doctors and hospitals focus on patients, not finances.”

Dr Himmelstein and colleague Steffie Woolhandler, MD, analyzed confidential data from the 2008 Health Tracking Physician Survey (the most recent data available). The survey included information from a nationally representative sample of 4720 physicians who practiced at least 20 hours per week.

The data showed that the average doctor spent 8.7 hours per week, or 16.6% of his or her working time, on non-patient-related administration. This excludes tasks such as writing chart notes, communicating with other doctors, and ordering lab tests.

In total, patient-care physicians spent 168.4 million hours on non-patient-related administrative tasks in 2008. Drs Himmelstein and Woolhandler estimate that the total cost of physician time spent on administration in 2014 will amount to $102 billion.

Career satisfaction was lower for physicians who spent more time on administration. “Very satisfied” doctors spent, on average, 16.1% of their time on administration. “Very dissatisfied” doctors spent 20.6% of their time on such tasks.

Among various specialties, psychiatrists spent the most time on administration (20.3%), followed by internists (17.3%) and family/general practitioners (17.3%). Pediatricians spent the least amount of time (14.1%) on non-patient-related administrative tasks and were the most satisfied group of doctors.

Solo practice was associated with more administrative work, but small group practice was not. Doctors practicing in groups of 100 or more actually spent more time (19.7%) on such tasks than those in small groups (16.3%).

The researchers were surprised to find that physicians who used electronic health records spent more time (17.2% for those using entirely electronic records, 18% for those using a mix of paper and electronic) on administration than those who used only paper records (15.5%).

The pair noted that physicians in Canada spend far less time on administration than US doctors, and they attributed the difference to Canada’s single-payer system, which has greatly simplified billing and reduced bureaucracy.

The researchers pointed out that the only previous nationally representative survey of this kind was carried out in 1995, and that study showed that administration and insurance-related matters accounted for 13.5% of physicians’ total work time. Other, less representative studies also suggest the bureaucratic burden on physicians has grown in the past two decades.

“American doctors are drowning in paperwork,” Dr Woolhandler said. “Our study almost certainly understates physicians’ current administrative burden.”

“Since 2008, when the survey we analyzed was collected, tens of thousands of doctors have moved from small private practices with minimal bureaucracy into giant group practices where bureaucracy is rampant. And under the accountable care organizations favored by insurers, more doctors are facing HMO-type incentives to deny care to their patients, a move that our data shows drives up administrative work.”

Doctor with clipboard

A survey of nearly 5000 US physicians showed that the average doctor spent 16.6% of his or her working hours on non-patient-related paperwork.

This includes tasks such as billing, obtaining insurance approvals, financial and personnel management, and negotiating contracts.

The more time doctors spent on such tasks, the less satisfied they were with medicine as a career.

Researchers detailed these findings in the International Journal of Health Services.

“Our crazy health financing system is demoralizing doctors and wasting vast resources,” said study author David Himmelstein, MD, a professor at Hunter College of the City University of New York.

“Turning healthcare into a business means we spend more and more time on billing, insurance paperwork, and the bottom line. We need to move to a simple, nonprofit national health insurance system that lets doctors and hospitals focus on patients, not finances.”

Dr Himmelstein and colleague Steffie Woolhandler, MD, analyzed confidential data from the 2008 Health Tracking Physician Survey (the most recent data available). The survey included information from a nationally representative sample of 4720 physicians who practiced at least 20 hours per week.

The data showed that the average doctor spent 8.7 hours per week, or 16.6% of his or her working time, on non-patient-related administration. This excludes tasks such as writing chart notes, communicating with other doctors, and ordering lab tests.

In total, patient-care physicians spent 168.4 million hours on non-patient-related administrative tasks in 2008. Drs Himmelstein and Woolhandler estimate that the total cost of physician time spent on administration in 2014 will amount to $102 billion.

Career satisfaction was lower for physicians who spent more time on administration. “Very satisfied” doctors spent, on average, 16.1% of their time on administration. “Very dissatisfied” doctors spent 20.6% of their time on such tasks.

Among various specialties, psychiatrists spent the most time on administration (20.3%), followed by internists (17.3%) and family/general practitioners (17.3%). Pediatricians spent the least amount of time (14.1%) on non-patient-related administrative tasks and were the most satisfied group of doctors.

Solo practice was associated with more administrative work, but small group practice was not. Doctors practicing in groups of 100 or more actually spent more time (19.7%) on such tasks than those in small groups (16.3%).

The researchers were surprised to find that physicians who used electronic health records spent more time (17.2% for those using entirely electronic records, 18% for those using a mix of paper and electronic) on administration than those who used only paper records (15.5%).

The pair noted that physicians in Canada spend far less time on administration than US doctors, and they attributed the difference to Canada’s single-payer system, which has greatly simplified billing and reduced bureaucracy.

The researchers pointed out that the only previous nationally representative survey of this kind was carried out in 1995, and that study showed that administration and insurance-related matters accounted for 13.5% of physicians’ total work time. Other, less representative studies also suggest the bureaucratic burden on physicians has grown in the past two decades.

“American doctors are drowning in paperwork,” Dr Woolhandler said. “Our study almost certainly understates physicians’ current administrative burden.”

“Since 2008, when the survey we analyzed was collected, tens of thousands of doctors have moved from small private practices with minimal bureaucracy into giant group practices where bureaucracy is rampant. And under the accountable care organizations favored by insurers, more doctors are facing HMO-type incentives to deny care to their patients, a move that our data shows drives up administrative work.”

The Food and Drug Administration has released an online resource to help consumers find FDA-certified mammography facilities by location, the agency announced Oct. 29.

The FDA hopes that women will continue to keep screening and prevention in mind well beyond Breast Cancer Awareness Month, they said. Mammograms are the best way to screen for cancer early, because they can help detect lumps that may be too small for a patient or physician to find during a self-breast exam.

National Institutes of Health/Department of Health and Human Services

The FDA conducts annual inspections of mammography facilities to ensure they meet standards for equipment and staff training under the Mammography Quality Standards Act. Facilities must be FDA-certified to legally perform mammogram services in the United States.

The agency has also recently approved new 3-D imaging technology that creates cross-sectional images to help doctors evaluate dense tissue and that may even find hidden tumors, they said. The FDA warns that other tools such as thermograms and nipple aspirate tests are not substitutes for mammograms.

The FDA has more information about breast cancer screening at its website, as well as a list of certified mammography facility near you.

The Food and Drug Administration has released an online resource to help consumers find FDA-certified mammography facilities by location, the agency announced Oct. 29.

The FDA hopes that women will continue to keep screening and prevention in mind well beyond Breast Cancer Awareness Month, they said. Mammograms are the best way to screen for cancer early, because they can help detect lumps that may be too small for a patient or physician to find during a self-breast exam.

National Institutes of Health/Department of Health and Human Services

The FDA conducts annual inspections of mammography facilities to ensure they meet standards for equipment and staff training under the Mammography Quality Standards Act. Facilities must be FDA-certified to legally perform mammogram services in the United States.

The agency has also recently approved new 3-D imaging technology that creates cross-sectional images to help doctors evaluate dense tissue and that may even find hidden tumors, they said. The FDA warns that other tools such as thermograms and nipple aspirate tests are not substitutes for mammograms.

The FDA has more information about breast cancer screening at its website, as well as a list of certified mammography facility near you.

The Food and Drug Administration has released an online resource to help consumers find FDA-certified mammography facilities by location, the agency announced Oct. 29.

The FDA hopes that women will continue to keep screening and prevention in mind well beyond Breast Cancer Awareness Month, they said. Mammograms are the best way to screen for cancer early, because they can help detect lumps that may be too small for a patient or physician to find during a self-breast exam.

National Institutes of Health/Department of Health and Human Services

The FDA conducts annual inspections of mammography facilities to ensure they meet standards for equipment and staff training under the Mammography Quality Standards Act. Facilities must be FDA-certified to legally perform mammogram services in the United States.

The agency has also recently approved new 3-D imaging technology that creates cross-sectional images to help doctors evaluate dense tissue and that may even find hidden tumors, they said. The FDA warns that other tools such as thermograms and nipple aspirate tests are not substitutes for mammograms.

The FDA has more information about breast cancer screening at its website, as well as a list of certified mammography facility near you.

Lifestyle modifications, including eating a Mediterranean or DASH-style diet, should be encouraged to lower an individual’s risk of first-time stroke, according to new guidelines for the primary prevention of stroke from the American Heart Association and American Stroke Association.

Mediterranean and DASH (Dietary Approaches to Stop Hypertension) dietary plans are characterized by their emphasis on fruits, vegetables, whole grains, legumes, nuts, seeds, poultry, and fish, while limiting red meats, sweets, and any foods with saturated fats. This new guidelines – which have been endorsed by the American Academy of Neurology, American Association of Neurological Surgeons, Congress of Neurological Surgeons, and Preventive Cardiovascular Nurses Association – suggest that adopting either of these diets in addition to a few other healthy living habits can dramatically reduce an individual’s odds of suffering a stroke (Stroke 2014;45 [doi: 10.1161/STR.0000000000000046]).

©snyferok/thinkstockphoto.com

“We have a huge opportunity to improve how we prevent new strokes, because risk factors that can be changed or controlled – especially high blood pressure – account for 90% of strokes,” said Dr. James Meschia, chair of the writing committee and chairman of neurology at the Mayo Clinic in Jacksonville, Fla., in a statement. The last such guidelines were released 3 years ago (Stroke 2011;42:517-84)

The writing committee gathered data pertaining to the age, birth weight, race/ethnicity, and genetic factors, among several others. Studies examined included a U.S. Nationwide Inpatient Sample, which showed that stroke hospitalizations increased between 1998 and 2007 for individuals aged 25-34 years and 35-44 years; the Framingham Heart Study, which estimated that the odds of a middle-aged adult suffering a stroke are 1 in 6; an analysis of South Carolina Medicaid beneficiaries under age 50, which revealed that individuals born weighing less than 2,500 g were twice as likely to have a stroke as those born heavier; and an Atherosclerosis Risk in Communities (ARIC) study that showed Latino and African American populations being at higher risk for stroke due to hypertension, obesity, and diabetes.

Because blood pressure, hypertension, diabetes, and obesity are so commonly linked to stroke risk, the new American Heart Association/American Stroke Association (AHA/ASA) guidelines highly recommend a Mediterranean or DASH-style diet supplemented with nuts. Additionally, the guidelines advise health care professionals to advise patients to cut down on sodium intake, regularly monitor their blood pressure, talk to their physicians immediately if any medication does not do what it is intended to or creates negative side effects, and quit smoking, and, for women, consider an alternative to oral birth control pills.

Hypertension, “the most important, well-documented, modifiable stroke risk factor,” should be treated with antihypertensive medication to a target blood pressure of less than 140/90 mm Hg, the guidelines state.

Furthermore, the ASA/AHA guidelines continue to recommend regular physical exercise and acute monitoring of individuals’ cholesterol levels, such as LDL, HDL, and triglycerides, as failure to keep these numbers in check can easily lead to a serious stroke. The guidelines also state that although heavy alcohol consumption can increase the chance of stroke, “light to moderate” alcohol consumption can actually decrease the odds of suffering a stroke.

The AHA/ASA guidelines also examine factors such as migraines, which are associated with stroke in women under age 55, and hyperhomocysteinemia, which is also associated with an increased risk of stroke. Other factors like hypercoagulability and sleep apnea were not shown to have any identifiable relationship with an increased risk of stroke.

“As health professionals, we must ensure that progress in preventing stroke does not lead to complacency,” say the guidelines. “We must acknowledge that several recommendations remain vague because of suboptimal clinical trial evidence or, even more concerning, may be out of date and therefore irrelevant.”

Dr. Meschia and his associates warn that although medications are helpful, the best way to safeguard against a stroke is to change a person’s lifestyle into one of healthy eating and exercise habits. Unfortunately, say the authors, “it is easier to convince a patient to take a pill than to radically change his or her lifestyle, [but] we must expect the same standards of evidence for lifestyle interventions.”

Dr. Meschia disclosed that his research grant comes from the National Institute of Neurological Disorders and Stroke. He had no other relevant financial disclosures of interest. Several of the guidelines’ coauthors had disclosures of their own, which are listed in the statement.

[email protected]

Lifestyle modifications, including eating a Mediterranean or DASH-style diet, should be encouraged to lower an individual’s risk of first-time stroke, according to new guidelines for the primary prevention of stroke from the American Heart Association and American Stroke Association.

Mediterranean and DASH (Dietary Approaches to Stop Hypertension) dietary plans are characterized by their emphasis on fruits, vegetables, whole grains, legumes, nuts, seeds, poultry, and fish, while limiting red meats, sweets, and any foods with saturated fats. This new guidelines – which have been endorsed by the American Academy of Neurology, American Association of Neurological Surgeons, Congress of Neurological Surgeons, and Preventive Cardiovascular Nurses Association – suggest that adopting either of these diets in addition to a few other healthy living habits can dramatically reduce an individual’s odds of suffering a stroke (Stroke 2014;45 [doi: 10.1161/STR.0000000000000046]).

©snyferok/thinkstockphoto.com

“We have a huge opportunity to improve how we prevent new strokes, because risk factors that can be changed or controlled – especially high blood pressure – account for 90% of strokes,” said Dr. James Meschia, chair of the writing committee and chairman of neurology at the Mayo Clinic in Jacksonville, Fla., in a statement. The last such guidelines were released 3 years ago (Stroke 2011;42:517-84)

The writing committee gathered data pertaining to the age, birth weight, race/ethnicity, and genetic factors, among several others. Studies examined included a U.S. Nationwide Inpatient Sample, which showed that stroke hospitalizations increased between 1998 and 2007 for individuals aged 25-34 years and 35-44 years; the Framingham Heart Study, which estimated that the odds of a middle-aged adult suffering a stroke are 1 in 6; an analysis of South Carolina Medicaid beneficiaries under age 50, which revealed that individuals born weighing less than 2,500 g were twice as likely to have a stroke as those born heavier; and an Atherosclerosis Risk in Communities (ARIC) study that showed Latino and African American populations being at higher risk for stroke due to hypertension, obesity, and diabetes.

Because blood pressure, hypertension, diabetes, and obesity are so commonly linked to stroke risk, the new American Heart Association/American Stroke Association (AHA/ASA) guidelines highly recommend a Mediterranean or DASH-style diet supplemented with nuts. Additionally, the guidelines advise health care professionals to advise patients to cut down on sodium intake, regularly monitor their blood pressure, talk to their physicians immediately if any medication does not do what it is intended to or creates negative side effects, and quit smoking, and, for women, consider an alternative to oral birth control pills.

Hypertension, “the most important, well-documented, modifiable stroke risk factor,” should be treated with antihypertensive medication to a target blood pressure of less than 140/90 mm Hg, the guidelines state.

Furthermore, the ASA/AHA guidelines continue to recommend regular physical exercise and acute monitoring of individuals’ cholesterol levels, such as LDL, HDL, and triglycerides, as failure to keep these numbers in check can easily lead to a serious stroke. The guidelines also state that although heavy alcohol consumption can increase the chance of stroke, “light to moderate” alcohol consumption can actually decrease the odds of suffering a stroke.

The AHA/ASA guidelines also examine factors such as migraines, which are associated with stroke in women under age 55, and hyperhomocysteinemia, which is also associated with an increased risk of stroke. Other factors like hypercoagulability and sleep apnea were not shown to have any identifiable relationship with an increased risk of stroke.

“As health professionals, we must ensure that progress in preventing stroke does not lead to complacency,” say the guidelines. “We must acknowledge that several recommendations remain vague because of suboptimal clinical trial evidence or, even more concerning, may be out of date and therefore irrelevant.”

Dr. Meschia and his associates warn that although medications are helpful, the best way to safeguard against a stroke is to change a person’s lifestyle into one of healthy eating and exercise habits. Unfortunately, say the authors, “it is easier to convince a patient to take a pill than to radically change his or her lifestyle, [but] we must expect the same standards of evidence for lifestyle interventions.”

Dr. Meschia disclosed that his research grant comes from the National Institute of Neurological Disorders and Stroke. He had no other relevant financial disclosures of interest. Several of the guidelines’ coauthors had disclosures of their own, which are listed in the statement.

[email protected]

Lifestyle modifications, including eating a Mediterranean or DASH-style diet, should be encouraged to lower an individual’s risk of first-time stroke, according to new guidelines for the primary prevention of stroke from the American Heart Association and American Stroke Association.

Mediterranean and DASH (Dietary Approaches to Stop Hypertension) dietary plans are characterized by their emphasis on fruits, vegetables, whole grains, legumes, nuts, seeds, poultry, and fish, while limiting red meats, sweets, and any foods with saturated fats. This new guidelines – which have been endorsed by the American Academy of Neurology, American Association of Neurological Surgeons, Congress of Neurological Surgeons, and Preventive Cardiovascular Nurses Association – suggest that adopting either of these diets in addition to a few other healthy living habits can dramatically reduce an individual’s odds of suffering a stroke (Stroke 2014;45 [doi: 10.1161/STR.0000000000000046]).

©snyferok/thinkstockphoto.com

“We have a huge opportunity to improve how we prevent new strokes, because risk factors that can be changed or controlled – especially high blood pressure – account for 90% of strokes,” said Dr. James Meschia, chair of the writing committee and chairman of neurology at the Mayo Clinic in Jacksonville, Fla., in a statement. The last such guidelines were released 3 years ago (Stroke 2011;42:517-84)

The writing committee gathered data pertaining to the age, birth weight, race/ethnicity, and genetic factors, among several others. Studies examined included a U.S. Nationwide Inpatient Sample, which showed that stroke hospitalizations increased between 1998 and 2007 for individuals aged 25-34 years and 35-44 years; the Framingham Heart Study, which estimated that the odds of a middle-aged adult suffering a stroke are 1 in 6; an analysis of South Carolina Medicaid beneficiaries under age 50, which revealed that individuals born weighing less than 2,500 g were twice as likely to have a stroke as those born heavier; and an Atherosclerosis Risk in Communities (ARIC) study that showed Latino and African American populations being at higher risk for stroke due to hypertension, obesity, and diabetes.

Because blood pressure, hypertension, diabetes, and obesity are so commonly linked to stroke risk, the new American Heart Association/American Stroke Association (AHA/ASA) guidelines highly recommend a Mediterranean or DASH-style diet supplemented with nuts. Additionally, the guidelines advise health care professionals to advise patients to cut down on sodium intake, regularly monitor their blood pressure, talk to their physicians immediately if any medication does not do what it is intended to or creates negative side effects, and quit smoking, and, for women, consider an alternative to oral birth control pills.

Hypertension, “the most important, well-documented, modifiable stroke risk factor,” should be treated with antihypertensive medication to a target blood pressure of less than 140/90 mm Hg, the guidelines state.

Furthermore, the ASA/AHA guidelines continue to recommend regular physical exercise and acute monitoring of individuals’ cholesterol levels, such as LDL, HDL, and triglycerides, as failure to keep these numbers in check can easily lead to a serious stroke. The guidelines also state that although heavy alcohol consumption can increase the chance of stroke, “light to moderate” alcohol consumption can actually decrease the odds of suffering a stroke.

The AHA/ASA guidelines also examine factors such as migraines, which are associated with stroke in women under age 55, and hyperhomocysteinemia, which is also associated with an increased risk of stroke. Other factors like hypercoagulability and sleep apnea were not shown to have any identifiable relationship with an increased risk of stroke.

“As health professionals, we must ensure that progress in preventing stroke does not lead to complacency,” say the guidelines. “We must acknowledge that several recommendations remain vague because of suboptimal clinical trial evidence or, even more concerning, may be out of date and therefore irrelevant.”

Dr. Meschia and his associates warn that although medications are helpful, the best way to safeguard against a stroke is to change a person’s lifestyle into one of healthy eating and exercise habits. Unfortunately, say the authors, “it is easier to convince a patient to take a pill than to radically change his or her lifestyle, [but] we must expect the same standards of evidence for lifestyle interventions.”

Dr. Meschia disclosed that his research grant comes from the National Institute of Neurological Disorders and Stroke. He had no other relevant financial disclosures of interest. Several of the guidelines’ coauthors had disclosures of their own, which are listed in the statement.

[email protected]

A program that’s designed to help hospitals reduce readmissions after inpatient treatment for a heart attack or heart failure is being launched in 35 selected hospitals.

The Patient Navigator Program is sponsored by the American College of Cardiology and AstraZeneca, which provided $10 million in funding for the 2-year pilot program, but was not involved in selection of facilities or any other aspect.

It’s “a unique collaboration between the cardiovascular care team, patients, and families to manage the stress of hospitalization for complex conditions in a way that allows patients to return home, remain healthy, and avoid the need for readmission whenever possible,” said ACC President Patrick T. O’Gara, in a statement.

Hospitals have been under pressure to reduce readmissions since the fall of 2012. That’s when Medicare began penalizing facilities up to 1% of their inpatient admissions for excess readmissions within 30 days of patients with acute myocardial infarctions, heart failure, and pneumonia. The penalty increased to 2% in fiscal year 2014, and went up to 3% in the fiscal year that started Oct. 1. For this year, chronic obstructive pulmonary disease and hip/knee arthroplasty were added to the list of conditions being monitored for readmissions.

The penalties have already been assessed for fiscal year 2015.

Medicare’s Readmissions Reduction Program bases penalties on a prior 3-year period. Fiscal 2015 penalties were based on readmissions from 2010 to 2013.

The Medicare penalties were the driving force behind the creation of the program a few years ago, said Dr. Mary Norine Walsh, chair of the ACC’s Care Transition Oversight Program. But it also represented a chance “to pursue excellence,” said Dr. Walsh in an interview.

The 35 hospitals that are participating were selected by ACC senior staff and cardiologists like Dr. Walsh who are involved in the ACC’s quality improvement efforts. To be eligible, they had to be participants in the ACC’s National Cardiovascular Data Registry ACTION Registry–GWTG, which, according to the ACC, “is a risk-adjusted, outcomes-based quality improvement program that focuses exclusively on high-risk STEMI/NSTEMI myocardial infarction patients.” The registry helps hospitals apply ACC and American Heart Association clinical guideline recommendations and provides quality improvement tools.

They also had to be part of the ACC’s Hospital to Home Initiative, which helps hospitals and cardiovascular care providers improve transitions from hospital to homes.

All 35 hospitals are eligible to receive $80,000 a year for 2 years. Most likely, the facilities will use that money to hire an individual or individuals who can act as a navigator for heart failure and MI patients, said Dr. Walsh, who is the medical director of the heart failure and cardiac transplant program at St. Vincent Heart Center, Indianapolis, Ind.

While there are few randomized, controlled trials that examine what works to reduce readmission rates, there are several interventions that have been shown to help, she said. Patient eduction and getting patients in for follow-up care within 7 days are two key components that can make a difference, said Dr. Walsh. Multidisciplinary heart failure programs also have an impact.

The participating hospitals will share their processes and models, and at the end of the 2 years, the hope is that the facilities will continue to fund the program, said Dr. Walsh.

The ACC will also “be interested to find out what success looks like,” she said.

The Patient Navigator Program probably won’t help hospitals avoid penalties until fiscal year 2017 at the earliest, Dr. Walsh noted. However, the model will still be important, she said.

“We know that value-based purchasing is moving on, and the penalties will almost certainly extend to other diagnoses each sequential year, so hospitals are interested in preparing for the future,” said Dr. Walsh.

[email protected]

On Twitter @aliciaault

A program that’s designed to help hospitals reduce readmissions after inpatient treatment for a heart attack or heart failure is being launched in 35 selected hospitals.

The Patient Navigator Program is sponsored by the American College of Cardiology and AstraZeneca, which provided $10 million in funding for the 2-year pilot program, but was not involved in selection of facilities or any other aspect.

It’s “a unique collaboration between the cardiovascular care team, patients, and families to manage the stress of hospitalization for complex conditions in a way that allows patients to return home, remain healthy, and avoid the need for readmission whenever possible,” said ACC President Patrick T. O’Gara, in a statement.

Hospitals have been under pressure to reduce readmissions since the fall of 2012. That’s when Medicare began penalizing facilities up to 1% of their inpatient admissions for excess readmissions within 30 days of patients with acute myocardial infarctions, heart failure, and pneumonia. The penalty increased to 2% in fiscal year 2014, and went up to 3% in the fiscal year that started Oct. 1. For this year, chronic obstructive pulmonary disease and hip/knee arthroplasty were added to the list of conditions being monitored for readmissions.

The penalties have already been assessed for fiscal year 2015.

Medicare’s Readmissions Reduction Program bases penalties on a prior 3-year period. Fiscal 2015 penalties were based on readmissions from 2010 to 2013.

The Medicare penalties were the driving force behind the creation of the program a few years ago, said Dr. Mary Norine Walsh, chair of the ACC’s Care Transition Oversight Program. But it also represented a chance “to pursue excellence,” said Dr. Walsh in an interview.

The 35 hospitals that are participating were selected by ACC senior staff and cardiologists like Dr. Walsh who are involved in the ACC’s quality improvement efforts. To be eligible, they had to be participants in the ACC’s National Cardiovascular Data Registry ACTION Registry–GWTG, which, according to the ACC, “is a risk-adjusted, outcomes-based quality improvement program that focuses exclusively on high-risk STEMI/NSTEMI myocardial infarction patients.” The registry helps hospitals apply ACC and American Heart Association clinical guideline recommendations and provides quality improvement tools.

They also had to be part of the ACC’s Hospital to Home Initiative, which helps hospitals and cardiovascular care providers improve transitions from hospital to homes.

All 35 hospitals are eligible to receive $80,000 a year for 2 years. Most likely, the facilities will use that money to hire an individual or individuals who can act as a navigator for heart failure and MI patients, said Dr. Walsh, who is the medical director of the heart failure and cardiac transplant program at St. Vincent Heart Center, Indianapolis, Ind.

While there are few randomized, controlled trials that examine what works to reduce readmission rates, there are several interventions that have been shown to help, she said. Patient eduction and getting patients in for follow-up care within 7 days are two key components that can make a difference, said Dr. Walsh. Multidisciplinary heart failure programs also have an impact.

The participating hospitals will share their processes and models, and at the end of the 2 years, the hope is that the facilities will continue to fund the program, said Dr. Walsh.

The ACC will also “be interested to find out what success looks like,” she said.

The Patient Navigator Program probably won’t help hospitals avoid penalties until fiscal year 2017 at the earliest, Dr. Walsh noted. However, the model will still be important, she said.

“We know that value-based purchasing is moving on, and the penalties will almost certainly extend to other diagnoses each sequential year, so hospitals are interested in preparing for the future,” said Dr. Walsh.

[email protected]

On Twitter @aliciaault

A program that’s designed to help hospitals reduce readmissions after inpatient treatment for a heart attack or heart failure is being launched in 35 selected hospitals.

The Patient Navigator Program is sponsored by the American College of Cardiology and AstraZeneca, which provided $10 million in funding for the 2-year pilot program, but was not involved in selection of facilities or any other aspect.

It’s “a unique collaboration between the cardiovascular care team, patients, and families to manage the stress of hospitalization for complex conditions in a way that allows patients to return home, remain healthy, and avoid the need for readmission whenever possible,” said ACC President Patrick T. O’Gara, in a statement.

Hospitals have been under pressure to reduce readmissions since the fall of 2012. That’s when Medicare began penalizing facilities up to 1% of their inpatient admissions for excess readmissions within 30 days of patients with acute myocardial infarctions, heart failure, and pneumonia. The penalty increased to 2% in fiscal year 2014, and went up to 3% in the fiscal year that started Oct. 1. For this year, chronic obstructive pulmonary disease and hip/knee arthroplasty were added to the list of conditions being monitored for readmissions.

The penalties have already been assessed for fiscal year 2015.

Medicare’s Readmissions Reduction Program bases penalties on a prior 3-year period. Fiscal 2015 penalties were based on readmissions from 2010 to 2013.

The Medicare penalties were the driving force behind the creation of the program a few years ago, said Dr. Mary Norine Walsh, chair of the ACC’s Care Transition Oversight Program. But it also represented a chance “to pursue excellence,” said Dr. Walsh in an interview.

The 35 hospitals that are participating were selected by ACC senior staff and cardiologists like Dr. Walsh who are involved in the ACC’s quality improvement efforts. To be eligible, they had to be participants in the ACC’s National Cardiovascular Data Registry ACTION Registry–GWTG, which, according to the ACC, “is a risk-adjusted, outcomes-based quality improvement program that focuses exclusively on high-risk STEMI/NSTEMI myocardial infarction patients.” The registry helps hospitals apply ACC and American Heart Association clinical guideline recommendations and provides quality improvement tools.

They also had to be part of the ACC’s Hospital to Home Initiative, which helps hospitals and cardiovascular care providers improve transitions from hospital to homes.

All 35 hospitals are eligible to receive $80,000 a year for 2 years. Most likely, the facilities will use that money to hire an individual or individuals who can act as a navigator for heart failure and MI patients, said Dr. Walsh, who is the medical director of the heart failure and cardiac transplant program at St. Vincent Heart Center, Indianapolis, Ind.

While there are few randomized, controlled trials that examine what works to reduce readmission rates, there are several interventions that have been shown to help, she said. Patient eduction and getting patients in for follow-up care within 7 days are two key components that can make a difference, said Dr. Walsh. Multidisciplinary heart failure programs also have an impact.

The participating hospitals will share their processes and models, and at the end of the 2 years, the hope is that the facilities will continue to fund the program, said Dr. Walsh.

The ACC will also “be interested to find out what success looks like,” she said.

The Patient Navigator Program probably won’t help hospitals avoid penalties until fiscal year 2017 at the earliest, Dr. Walsh noted. However, the model will still be important, she said.

“We know that value-based purchasing is moving on, and the penalties will almost certainly extend to other diagnoses each sequential year, so hospitals are interested in preparing for the future,” said Dr. Walsh.

[email protected]

On Twitter @aliciaault