Introduction

Often, it can be difficult for providers to fully understand why children may be presenting with behavioral problems that appear to be occurring principally in specific environments. Parents may bring their children for an evaluation based upon reports they are receiving from teachers and other school personnel who may be observing more prominent oppositionality, social struggles, troubles following instructions, and frustration intolerance than the parents are experiencing in the home. Additionally, youth may begin to display school refusal and voice strong negative feelings about school. Although at face value, these problems may indicate potential diagnoses like oppositional defiant disorder and attention-deficit/hyperactivity disorder, one also should consider other underlying “non–mental health” issues that could greatly influence school success and present with a range of emotional and behavioral struggles.

Case Summary

Brynn is an animated, social, and strong-willed 4 year-old girl who experienced delays in her receptive and expressive language that prompted her engagement in early intervention around 18 months of age. She and her family continued to receive developmental services over the next few years and, at the age of 3 years, because of ongoing speech and language challenges, she was enrolled in a preschool individualized education program. In her program, Brynn participates in an array of specialized instruction, but her educators comment that she is not making expected academic progress and has troubles “holding onto information,” focusing, and participating meaningfully with peers in a consistent manner.

At times, Brynn can be impulsive, aggressive, and volatile – behavioral traits that mom denies are occurring in the home. A diagnosis of an autism spectrum disorder has been ruled out, and Brynn’s hearing and vision are tested to be normal. Brynn’s mother feels confused by the reports she’s getting from school; “I want Brynn to be happy,” she shares. “I needed special help to read in high school, and I worry about her future.”

Discussion

Learning disorders (or learning disabilities, using educational terminology) are defined as neurologically rooted problems that affect academic achievement via the receiving, processing, or communication of information. They occur in 1 in 10 children (Pediatrics. 2007 Feb;119 Suppl 1:S77-83) and can present with specific problems in reading, writing, and mathematics while having considerable influence on related aptitudes in language, social ability, self-help, and motor functioning. Dyslexia – a developmental reading disorder – is the most common type of learning disorder (LD). Although it’s not clear what causes learning disorders, there are several factors that are thought to play a role in their development, including hereditary factors and problems with pregnancy and birth. Having developmental delays also can place children at risk for having later learning problems that may not be identifiable until a child enters a more structured learning environment. At clinical visits during the preschool years, particularly with a child who may have had earlier developmental concerns, the pediatrician should inquire about a range of “warning signs” that may indicate a need for additional screening and evaluation for specific learning issues.

The National Center for Learning Disabilities offers a range of practical tips for pediatricians who may want to further explore parental and teacher concerns by asking questions related to literacy, writing, language, and social-emotional skills, attention, and gross and fine motor movements in a developmentally informed manner. Further exploring Brynn’s mother’s comments in the context of her daughter not progressing in school revealed a history of difficulty retaining new words, troubles learning colors and shapes, challenges remembering rules, and particular difficulties engaging in group play with other 4-year-olds – all potential signals for a learning disorder. This alerted educators that she may indeed be struggling with issues beyond that of an enduring speech-language delay.

With the suspicion that Brynn was presenting with signs and symptoms suggestive of a learning disorder, her family was educated about the Individuals with Disabilities Education Act, and it was recommended she receive a comprehensive psychoeducational evaluation to further assess her intellectual profile, academic achievement, social functioning, and performance in the classroom using standardized tools. These tools, among other objectives, can help the child’s team offer a more definitive LD diagnosis while informing the potential development of special education supports and assessing for an intellectual disability. The DSM 5 indicates that LD diagnostic criteria are to be met based upon a clinical synthesis of history, school reports, and psychoeducational assessment.

©Bigandt_Photography/Thinkstock

It’s been long established that children with learning problems frequently have co-occurring emotional and behavioral troubles (Arch Dis Child. 1974 Apr; 49[4]:249-56), many of which also should be considered as differential diagnoses in a child with school problems – as such, a complicated interplay of learning disorders and internalizing and externalizing conditions is often appreciated in school-age children with academic difficulties. At times, learning disorders can lead to emotional distress and could also be misdiagnosed as primary emotional and behavioral challenges. Specifically, children with learning problems are at risk for struggling with low self-esteem, loneliness, and anxiety, which also can be associated with mood disorders, school dropout, victimization, and engaging in substance use.

In Brynn’s case, the results of the Teacher Report Forms and Child Behavior Checklists were reviewed, revealing some evidence that she was experiencing clinical-level problems with her attention, but a discrepancy was noted between the teacher and parent report (the teachers endorsing more clinically significant symptoms). Although co-occurring attention-deficit/hyperactivity disorder (ADHD) is not uncommon in children with a learning disorder (Pediatrics. 2011 Mar;127[3]:462-70), we did not feel Brynn met criteria for this. We elected not to provide an ADHD diagnosis but are mindful that her attentional concerns should be closely monitored over time; a diagnosis may be more relevant in the future, perhaps influencing Brynn’s eligibility for services and treatment planning. Furthermore, comorbidity with ADHD is predictive of worse mental health outcomes, compared with learning disabilities presenting without ADHD.

Clinical Pearl

Pediatricians should consider the possibility of a child having a learning disorder in youth who display risk factors (family history of learning concerns, atypical development, prematurity, etc.) and have problems at school. Such problems may be presenting with emotional and behavioral symptoms that could mask a child’s primary learning impairments. Learning disorders also frequently co-occur with psychiatric conditions, but engaging children in effective interventions (school-based supports) could potentially attenuate the risk for the development of mental health problems. Also, promoting emotional wellness and fostering self-worth may improve the academic performance of children with learning disorders.

Dr. Dickerson, a child and adolescent psychiatrist, is an assistant professor of psychiatry at the University of Vermont, Burlington. He is the director of the university’s autism diagnostic clinic. Dr. Dickerson said he had no relevant financial disclosures. Contact Dr. Dickerson at pdnews@frontlinemedcom.com.

Introduction

Often, it can be difficult for providers to fully understand why children may be presenting with behavioral problems that appear to be occurring principally in specific environments. Parents may bring their children for an evaluation based upon reports they are receiving from teachers and other school personnel who may be observing more prominent oppositionality, social struggles, troubles following instructions, and frustration intolerance than the parents are experiencing in the home. Additionally, youth may begin to display school refusal and voice strong negative feelings about school. Although at face value, these problems may indicate potential diagnoses like oppositional defiant disorder and attention-deficit/hyperactivity disorder, one also should consider other underlying “non–mental health” issues that could greatly influence school success and present with a range of emotional and behavioral struggles.

Case Summary

Brynn is an animated, social, and strong-willed 4 year-old girl who experienced delays in her receptive and expressive language that prompted her engagement in early intervention around 18 months of age. She and her family continued to receive developmental services over the next few years and, at the age of 3 years, because of ongoing speech and language challenges, she was enrolled in a preschool individualized education program. In her program, Brynn participates in an array of specialized instruction, but her educators comment that she is not making expected academic progress and has troubles “holding onto information,” focusing, and participating meaningfully with peers in a consistent manner.

At times, Brynn can be impulsive, aggressive, and volatile – behavioral traits that mom denies are occurring in the home. A diagnosis of an autism spectrum disorder has been ruled out, and Brynn’s hearing and vision are tested to be normal. Brynn’s mother feels confused by the reports she’s getting from school; “I want Brynn to be happy,” she shares. “I needed special help to read in high school, and I worry about her future.”

Discussion

Learning disorders (or learning disabilities, using educational terminology) are defined as neurologically rooted problems that affect academic achievement via the receiving, processing, or communication of information. They occur in 1 in 10 children (Pediatrics. 2007 Feb;119 Suppl 1:S77-83) and can present with specific problems in reading, writing, and mathematics while having considerable influence on related aptitudes in language, social ability, self-help, and motor functioning. Dyslexia – a developmental reading disorder – is the most common type of learning disorder (LD). Although it’s not clear what causes learning disorders, there are several factors that are thought to play a role in their development, including hereditary factors and problems with pregnancy and birth. Having developmental delays also can place children at risk for having later learning problems that may not be identifiable until a child enters a more structured learning environment. At clinical visits during the preschool years, particularly with a child who may have had earlier developmental concerns, the pediatrician should inquire about a range of “warning signs” that may indicate a need for additional screening and evaluation for specific learning issues.

The National Center for Learning Disabilities offers a range of practical tips for pediatricians who may want to further explore parental and teacher concerns by asking questions related to literacy, writing, language, and social-emotional skills, attention, and gross and fine motor movements in a developmentally informed manner. Further exploring Brynn’s mother’s comments in the context of her daughter not progressing in school revealed a history of difficulty retaining new words, troubles learning colors and shapes, challenges remembering rules, and particular difficulties engaging in group play with other 4-year-olds – all potential signals for a learning disorder. This alerted educators that she may indeed be struggling with issues beyond that of an enduring speech-language delay.

With the suspicion that Brynn was presenting with signs and symptoms suggestive of a learning disorder, her family was educated about the Individuals with Disabilities Education Act, and it was recommended she receive a comprehensive psychoeducational evaluation to further assess her intellectual profile, academic achievement, social functioning, and performance in the classroom using standardized tools. These tools, among other objectives, can help the child’s team offer a more definitive LD diagnosis while informing the potential development of special education supports and assessing for an intellectual disability. The DSM 5 indicates that LD diagnostic criteria are to be met based upon a clinical synthesis of history, school reports, and psychoeducational assessment.

©Bigandt_Photography/Thinkstock

It’s been long established that children with learning problems frequently have co-occurring emotional and behavioral troubles (Arch Dis Child. 1974 Apr; 49[4]:249-56), many of which also should be considered as differential diagnoses in a child with school problems – as such, a complicated interplay of learning disorders and internalizing and externalizing conditions is often appreciated in school-age children with academic difficulties. At times, learning disorders can lead to emotional distress and could also be misdiagnosed as primary emotional and behavioral challenges. Specifically, children with learning problems are at risk for struggling with low self-esteem, loneliness, and anxiety, which also can be associated with mood disorders, school dropout, victimization, and engaging in substance use.

In Brynn’s case, the results of the Teacher Report Forms and Child Behavior Checklists were reviewed, revealing some evidence that she was experiencing clinical-level problems with her attention, but a discrepancy was noted between the teacher and parent report (the teachers endorsing more clinically significant symptoms). Although co-occurring attention-deficit/hyperactivity disorder (ADHD) is not uncommon in children with a learning disorder (Pediatrics. 2011 Mar;127[3]:462-70), we did not feel Brynn met criteria for this. We elected not to provide an ADHD diagnosis but are mindful that her attentional concerns should be closely monitored over time; a diagnosis may be more relevant in the future, perhaps influencing Brynn’s eligibility for services and treatment planning. Furthermore, comorbidity with ADHD is predictive of worse mental health outcomes, compared with learning disabilities presenting without ADHD.

Clinical Pearl

Pediatricians should consider the possibility of a child having a learning disorder in youth who display risk factors (family history of learning concerns, atypical development, prematurity, etc.) and have problems at school. Such problems may be presenting with emotional and behavioral symptoms that could mask a child’s primary learning impairments. Learning disorders also frequently co-occur with psychiatric conditions, but engaging children in effective interventions (school-based supports) could potentially attenuate the risk for the development of mental health problems. Also, promoting emotional wellness and fostering self-worth may improve the academic performance of children with learning disorders.

Dr. Dickerson, a child and adolescent psychiatrist, is an assistant professor of psychiatry at the University of Vermont, Burlington. He is the director of the university’s autism diagnostic clinic. Dr. Dickerson said he had no relevant financial disclosures. Contact Dr. Dickerson at pdnews@frontlinemedcom.com.

Introduction

Often, it can be difficult for providers to fully understand why children may be presenting with behavioral problems that appear to be occurring principally in specific environments. Parents may bring their children for an evaluation based upon reports they are receiving from teachers and other school personnel who may be observing more prominent oppositionality, social struggles, troubles following instructions, and frustration intolerance than the parents are experiencing in the home. Additionally, youth may begin to display school refusal and voice strong negative feelings about school. Although at face value, these problems may indicate potential diagnoses like oppositional defiant disorder and attention-deficit/hyperactivity disorder, one also should consider other underlying “non–mental health” issues that could greatly influence school success and present with a range of emotional and behavioral struggles.

Case Summary

Brynn is an animated, social, and strong-willed 4 year-old girl who experienced delays in her receptive and expressive language that prompted her engagement in early intervention around 18 months of age. She and her family continued to receive developmental services over the next few years and, at the age of 3 years, because of ongoing speech and language challenges, she was enrolled in a preschool individualized education program. In her program, Brynn participates in an array of specialized instruction, but her educators comment that she is not making expected academic progress and has troubles “holding onto information,” focusing, and participating meaningfully with peers in a consistent manner.

At times, Brynn can be impulsive, aggressive, and volatile – behavioral traits that mom denies are occurring in the home. A diagnosis of an autism spectrum disorder has been ruled out, and Brynn’s hearing and vision are tested to be normal. Brynn’s mother feels confused by the reports she’s getting from school; “I want Brynn to be happy,” she shares. “I needed special help to read in high school, and I worry about her future.”

Discussion

Learning disorders (or learning disabilities, using educational terminology) are defined as neurologically rooted problems that affect academic achievement via the receiving, processing, or communication of information. They occur in 1 in 10 children (Pediatrics. 2007 Feb;119 Suppl 1:S77-83) and can present with specific problems in reading, writing, and mathematics while having considerable influence on related aptitudes in language, social ability, self-help, and motor functioning. Dyslexia – a developmental reading disorder – is the most common type of learning disorder (LD). Although it’s not clear what causes learning disorders, there are several factors that are thought to play a role in their development, including hereditary factors and problems with pregnancy and birth. Having developmental delays also can place children at risk for having later learning problems that may not be identifiable until a child enters a more structured learning environment. At clinical visits during the preschool years, particularly with a child who may have had earlier developmental concerns, the pediatrician should inquire about a range of “warning signs” that may indicate a need for additional screening and evaluation for specific learning issues.

The National Center for Learning Disabilities offers a range of practical tips for pediatricians who may want to further explore parental and teacher concerns by asking questions related to literacy, writing, language, and social-emotional skills, attention, and gross and fine motor movements in a developmentally informed manner. Further exploring Brynn’s mother’s comments in the context of her daughter not progressing in school revealed a history of difficulty retaining new words, troubles learning colors and shapes, challenges remembering rules, and particular difficulties engaging in group play with other 4-year-olds – all potential signals for a learning disorder. This alerted educators that she may indeed be struggling with issues beyond that of an enduring speech-language delay.

With the suspicion that Brynn was presenting with signs and symptoms suggestive of a learning disorder, her family was educated about the Individuals with Disabilities Education Act, and it was recommended she receive a comprehensive psychoeducational evaluation to further assess her intellectual profile, academic achievement, social functioning, and performance in the classroom using standardized tools. These tools, among other objectives, can help the child’s team offer a more definitive LD diagnosis while informing the potential development of special education supports and assessing for an intellectual disability. The DSM 5 indicates that LD diagnostic criteria are to be met based upon a clinical synthesis of history, school reports, and psychoeducational assessment.

©Bigandt_Photography/Thinkstock

It’s been long established that children with learning problems frequently have co-occurring emotional and behavioral troubles (Arch Dis Child. 1974 Apr; 49[4]:249-56), many of which also should be considered as differential diagnoses in a child with school problems – as such, a complicated interplay of learning disorders and internalizing and externalizing conditions is often appreciated in school-age children with academic difficulties. At times, learning disorders can lead to emotional distress and could also be misdiagnosed as primary emotional and behavioral challenges. Specifically, children with learning problems are at risk for struggling with low self-esteem, loneliness, and anxiety, which also can be associated with mood disorders, school dropout, victimization, and engaging in substance use.

In Brynn’s case, the results of the Teacher Report Forms and Child Behavior Checklists were reviewed, revealing some evidence that she was experiencing clinical-level problems with her attention, but a discrepancy was noted between the teacher and parent report (the teachers endorsing more clinically significant symptoms). Although co-occurring attention-deficit/hyperactivity disorder (ADHD) is not uncommon in children with a learning disorder (Pediatrics. 2011 Mar;127[3]:462-70), we did not feel Brynn met criteria for this. We elected not to provide an ADHD diagnosis but are mindful that her attentional concerns should be closely monitored over time; a diagnosis may be more relevant in the future, perhaps influencing Brynn’s eligibility for services and treatment planning. Furthermore, comorbidity with ADHD is predictive of worse mental health outcomes, compared with learning disabilities presenting without ADHD.

Clinical Pearl

Pediatricians should consider the possibility of a child having a learning disorder in youth who display risk factors (family history of learning concerns, atypical development, prematurity, etc.) and have problems at school. Such problems may be presenting with emotional and behavioral symptoms that could mask a child’s primary learning impairments. Learning disorders also frequently co-occur with psychiatric conditions, but engaging children in effective interventions (school-based supports) could potentially attenuate the risk for the development of mental health problems. Also, promoting emotional wellness and fostering self-worth may improve the academic performance of children with learning disorders.

Dr. Dickerson, a child and adolescent psychiatrist, is an assistant professor of psychiatry at the University of Vermont, Burlington. He is the director of the university’s autism diagnostic clinic. Dr. Dickerson said he had no relevant financial disclosures. Contact Dr. Dickerson at pdnews@frontlinemedcom.com.

BOSTON – In sarcoma as in other cancers, experience counts.

That’s the conclusion of investigators who found that patients with extra-abdominal sarcomas who were treated in high-volume hospitals had half the 30-day mortality rate, higher likelihood of negative surgical margins, and better overall survival, compared with patients treated in low-volume hospitals.

“It appears there is a direct association between hospital volume and short-term as well as long-term outcomes for soft-tissue sarcomas outside the abdomen,” said Dr. Sanjay P. Bagaria of the Mayo Clinic in Jacksonville, Fla.

The findings support centralization of services at the national level in centers specializing in the management of sarcomas, he said at the annual Society of Surgical Oncology Cancer Symposium.

Previous studies have shown that patients treated in high-volume centers for cancers of the esophagus, pancreas, and lung have better outcomes than patients treated in low-volume centers, he noted.

Given the rarity of sarcomas, with an incidence of approximately 12,000 in the U.S. annually, their complexity, with more than 60 histologic subtypes, and the multimodality approach required for them, it seemed likely that a positive association between volume and outcomes could be found, Dr. Bagaria said.

He and colleagues queried the U.S. National Cancer Database, a hospital registry of data from more than 1,500 facilities accredited by the Commission on Cancer.

They drew records on all patients diagnosed with extra-abdominal sarcomas from 2003 through 2007 who underwent surgery at the reporting hospitals, and divided the cases into terciles as either low volume (3 or fewer surgical cases per year), medium volume (3.2-11.6 per year), or high volume (12 or more cases per year).

One third (33%) of all cases were concentrated in just 44 high-volume hospitals, which comprised just 4% of the total hospital sample of 1,163. An additional third (34%) of cases were managed among 196 medium-volume hospitals (17% of the hospital sample), and the remaining third (33%) were spread among 923 low-volume hospitals (79%).

The 30-day mortality rates for low-, medium-, and high-volume hospitals, respectively, were 1.7%, 1.1%, and 0.6% (P less than .0001).

Similarly, the rates of negative margins (R0 resections) were 73.%, 78.2%, and 84.2% (P less than .0001).

Five-year overall survival was identical for low- and medium-volume centers (65% each), but was significantly better for patients treated at high-volume centers (69%, P less than .001)

Compared with low-volume centers, patients treated at high-volume centers had an adjusted odds ratio (OR) for 30-day mortality of 0.46 (P = .01), an adjusted OR for R0 margins of 1.87 (P less than .001), and OR for overall mortality of 0.92 (P = .04).

Dr. Bagaria noted that the study was limited by missing data about disease-specific survival and by possible selection bias associated with the choice of Commission on Cancer-accredited institutions, which account for 70% of cancer cases nationwide but comprise one-third of all hospitals.

BOSTON – In sarcoma as in other cancers, experience counts.

That’s the conclusion of investigators who found that patients with extra-abdominal sarcomas who were treated in high-volume hospitals had half the 30-day mortality rate, higher likelihood of negative surgical margins, and better overall survival, compared with patients treated in low-volume hospitals.

“It appears there is a direct association between hospital volume and short-term as well as long-term outcomes for soft-tissue sarcomas outside the abdomen,” said Dr. Sanjay P. Bagaria of the Mayo Clinic in Jacksonville, Fla.

The findings support centralization of services at the national level in centers specializing in the management of sarcomas, he said at the annual Society of Surgical Oncology Cancer Symposium.

Previous studies have shown that patients treated in high-volume centers for cancers of the esophagus, pancreas, and lung have better outcomes than patients treated in low-volume centers, he noted.

Given the rarity of sarcomas, with an incidence of approximately 12,000 in the U.S. annually, their complexity, with more than 60 histologic subtypes, and the multimodality approach required for them, it seemed likely that a positive association between volume and outcomes could be found, Dr. Bagaria said.

He and colleagues queried the U.S. National Cancer Database, a hospital registry of data from more than 1,500 facilities accredited by the Commission on Cancer.

They drew records on all patients diagnosed with extra-abdominal sarcomas from 2003 through 2007 who underwent surgery at the reporting hospitals, and divided the cases into terciles as either low volume (3 or fewer surgical cases per year), medium volume (3.2-11.6 per year), or high volume (12 or more cases per year).

One third (33%) of all cases were concentrated in just 44 high-volume hospitals, which comprised just 4% of the total hospital sample of 1,163. An additional third (34%) of cases were managed among 196 medium-volume hospitals (17% of the hospital sample), and the remaining third (33%) were spread among 923 low-volume hospitals (79%).

The 30-day mortality rates for low-, medium-, and high-volume hospitals, respectively, were 1.7%, 1.1%, and 0.6% (P less than .0001).

Similarly, the rates of negative margins (R0 resections) were 73.%, 78.2%, and 84.2% (P less than .0001).

Five-year overall survival was identical for low- and medium-volume centers (65% each), but was significantly better for patients treated at high-volume centers (69%, P less than .001)

Compared with low-volume centers, patients treated at high-volume centers had an adjusted odds ratio (OR) for 30-day mortality of 0.46 (P = .01), an adjusted OR for R0 margins of 1.87 (P less than .001), and OR for overall mortality of 0.92 (P = .04).

Dr. Bagaria noted that the study was limited by missing data about disease-specific survival and by possible selection bias associated with the choice of Commission on Cancer-accredited institutions, which account for 70% of cancer cases nationwide but comprise one-third of all hospitals.

BOSTON – In sarcoma as in other cancers, experience counts.

That’s the conclusion of investigators who found that patients with extra-abdominal sarcomas who were treated in high-volume hospitals had half the 30-day mortality rate, higher likelihood of negative surgical margins, and better overall survival, compared with patients treated in low-volume hospitals.

“It appears there is a direct association between hospital volume and short-term as well as long-term outcomes for soft-tissue sarcomas outside the abdomen,” said Dr. Sanjay P. Bagaria of the Mayo Clinic in Jacksonville, Fla.

The findings support centralization of services at the national level in centers specializing in the management of sarcomas, he said at the annual Society of Surgical Oncology Cancer Symposium.

Previous studies have shown that patients treated in high-volume centers for cancers of the esophagus, pancreas, and lung have better outcomes than patients treated in low-volume centers, he noted.

Given the rarity of sarcomas, with an incidence of approximately 12,000 in the U.S. annually, their complexity, with more than 60 histologic subtypes, and the multimodality approach required for them, it seemed likely that a positive association between volume and outcomes could be found, Dr. Bagaria said.

He and colleagues queried the U.S. National Cancer Database, a hospital registry of data from more than 1,500 facilities accredited by the Commission on Cancer.

They drew records on all patients diagnosed with extra-abdominal sarcomas from 2003 through 2007 who underwent surgery at the reporting hospitals, and divided the cases into terciles as either low volume (3 or fewer surgical cases per year), medium volume (3.2-11.6 per year), or high volume (12 or more cases per year).

One third (33%) of all cases were concentrated in just 44 high-volume hospitals, which comprised just 4% of the total hospital sample of 1,163. An additional third (34%) of cases were managed among 196 medium-volume hospitals (17% of the hospital sample), and the remaining third (33%) were spread among 923 low-volume hospitals (79%).

The 30-day mortality rates for low-, medium-, and high-volume hospitals, respectively, were 1.7%, 1.1%, and 0.6% (P less than .0001).

Similarly, the rates of negative margins (R0 resections) were 73.%, 78.2%, and 84.2% (P less than .0001).

Five-year overall survival was identical for low- and medium-volume centers (65% each), but was significantly better for patients treated at high-volume centers (69%, P less than .001)

Compared with low-volume centers, patients treated at high-volume centers had an adjusted odds ratio (OR) for 30-day mortality of 0.46 (P = .01), an adjusted OR for R0 margins of 1.87 (P less than .001), and OR for overall mortality of 0.92 (P = .04).

Dr. Bagaria noted that the study was limited by missing data about disease-specific survival and by possible selection bias associated with the choice of Commission on Cancer-accredited institutions, which account for 70% of cancer cases nationwide but comprise one-third of all hospitals.

BOSTON – CT scans appear to be effective for detecting local recurrences and pulmonary metastases in patients treated for soft-tissue sarcomas of the extremities, for about a third less than the cost of follow-up with MRI.

In a retrospective study by Dr. Allison Maciver and her colleagues, among 91 patients with soft-tissue sarcomas of the extremity followed with CT, 11 patients had a total of 14 local recurrences detected on CT, and 11 of the recurrences were in patients who were clinically asymptomatic.

Surveillance CT also identified 15 cases of pulmonary metastases, and 4 incidental second primary malignancies, Dr. Maciver of the Roswell Park Cancer Institute in Buffalo, N.Y., and her coinvestigators found, and there was only one false-positive recurrence.

The benefits of CT over extremity MRI in this population include decreased imaging time, lower cost, and a larger field of view, allowing for detection of second primary malignancies, she noted in a poster session at the annual Society of Surgical Oncology Cancer Symposium.

Many sarcomas of the extremities are highly aggressive, and timely detection of local recurrences could improve chances for limb-sparing salvage therapies. Although MRI has typically been used to follow patients with sarcomas, it is expensive and has a limited field of view, Dr. Maciver said.

In addition, the risk of pulmonary metastases with some soft-tissue sarcomas is high, necessitating the use of chest CT as a surveillance tool.

To see whether CT scans of the chest and extremities could be a cost-effective surveillance strategy for both local recurrences and pulmonary metastases, the investigators did a retrospective study of a prospective database of patients who underwent surgical resection for soft-tissue sarcomas of the extremities from 2001 through 2014 and who had CT as the primary follow-up imaging modality.

They identified a total of 91 high-risk patients followed for a median of 50.5 months. The patients had an estimated 5-year freedom from local recurrence of 82%, and from distant recurrence of 80%. Five-year overall survival was 76%.

Of the 15 patients found on CT to have pulmonary metastases, there were 4 incidentally discovered second primary cancers, including 1 each of non–small cell lung cancer, pancreatic adenocarcinoma, Merkel cell carcinomatosis, and myxofibrosarcoma. There were no false-positive pulmonary metastases.

The estimated cost of 10 years of surveillance, based on 2014 gross technical costs, was $64,969 per patient for chest CT and extremity MRI, compared with $41,595 per patient for chest and extremity CT surveillance, a potential cost savings with the CT-only strategy of $23,374 per patient.

The investigators said that the overall benefits of CT, including the cost savings in an accountable care organization model, “appear to outweigh the slightly increased radiation exposure.”

The study was internally funded. The authors reported having no relevant financial disclosures.

BOSTON – CT scans appear to be effective for detecting local recurrences and pulmonary metastases in patients treated for soft-tissue sarcomas of the extremities, for about a third less than the cost of follow-up with MRI.

In a retrospective study by Dr. Allison Maciver and her colleagues, among 91 patients with soft-tissue sarcomas of the extremity followed with CT, 11 patients had a total of 14 local recurrences detected on CT, and 11 of the recurrences were in patients who were clinically asymptomatic.

Surveillance CT also identified 15 cases of pulmonary metastases, and 4 incidental second primary malignancies, Dr. Maciver of the Roswell Park Cancer Institute in Buffalo, N.Y., and her coinvestigators found, and there was only one false-positive recurrence.

The benefits of CT over extremity MRI in this population include decreased imaging time, lower cost, and a larger field of view, allowing for detection of second primary malignancies, she noted in a poster session at the annual Society of Surgical Oncology Cancer Symposium.

Many sarcomas of the extremities are highly aggressive, and timely detection of local recurrences could improve chances for limb-sparing salvage therapies. Although MRI has typically been used to follow patients with sarcomas, it is expensive and has a limited field of view, Dr. Maciver said.

In addition, the risk of pulmonary metastases with some soft-tissue sarcomas is high, necessitating the use of chest CT as a surveillance tool.

To see whether CT scans of the chest and extremities could be a cost-effective surveillance strategy for both local recurrences and pulmonary metastases, the investigators did a retrospective study of a prospective database of patients who underwent surgical resection for soft-tissue sarcomas of the extremities from 2001 through 2014 and who had CT as the primary follow-up imaging modality.

They identified a total of 91 high-risk patients followed for a median of 50.5 months. The patients had an estimated 5-year freedom from local recurrence of 82%, and from distant recurrence of 80%. Five-year overall survival was 76%.

Of the 15 patients found on CT to have pulmonary metastases, there were 4 incidentally discovered second primary cancers, including 1 each of non–small cell lung cancer, pancreatic adenocarcinoma, Merkel cell carcinomatosis, and myxofibrosarcoma. There were no false-positive pulmonary metastases.

The estimated cost of 10 years of surveillance, based on 2014 gross technical costs, was $64,969 per patient for chest CT and extremity MRI, compared with $41,595 per patient for chest and extremity CT surveillance, a potential cost savings with the CT-only strategy of $23,374 per patient.

The investigators said that the overall benefits of CT, including the cost savings in an accountable care organization model, “appear to outweigh the slightly increased radiation exposure.”

The study was internally funded. The authors reported having no relevant financial disclosures.

BOSTON – CT scans appear to be effective for detecting local recurrences and pulmonary metastases in patients treated for soft-tissue sarcomas of the extremities, for about a third less than the cost of follow-up with MRI.

In a retrospective study by Dr. Allison Maciver and her colleagues, among 91 patients with soft-tissue sarcomas of the extremity followed with CT, 11 patients had a total of 14 local recurrences detected on CT, and 11 of the recurrences were in patients who were clinically asymptomatic.

Surveillance CT also identified 15 cases of pulmonary metastases, and 4 incidental second primary malignancies, Dr. Maciver of the Roswell Park Cancer Institute in Buffalo, N.Y., and her coinvestigators found, and there was only one false-positive recurrence.

The benefits of CT over extremity MRI in this population include decreased imaging time, lower cost, and a larger field of view, allowing for detection of second primary malignancies, she noted in a poster session at the annual Society of Surgical Oncology Cancer Symposium.

Many sarcomas of the extremities are highly aggressive, and timely detection of local recurrences could improve chances for limb-sparing salvage therapies. Although MRI has typically been used to follow patients with sarcomas, it is expensive and has a limited field of view, Dr. Maciver said.

In addition, the risk of pulmonary metastases with some soft-tissue sarcomas is high, necessitating the use of chest CT as a surveillance tool.

To see whether CT scans of the chest and extremities could be a cost-effective surveillance strategy for both local recurrences and pulmonary metastases, the investigators did a retrospective study of a prospective database of patients who underwent surgical resection for soft-tissue sarcomas of the extremities from 2001 through 2014 and who had CT as the primary follow-up imaging modality.

They identified a total of 91 high-risk patients followed for a median of 50.5 months. The patients had an estimated 5-year freedom from local recurrence of 82%, and from distant recurrence of 80%. Five-year overall survival was 76%.

Of the 15 patients found on CT to have pulmonary metastases, there were 4 incidentally discovered second primary cancers, including 1 each of non–small cell lung cancer, pancreatic adenocarcinoma, Merkel cell carcinomatosis, and myxofibrosarcoma. There were no false-positive pulmonary metastases.

The estimated cost of 10 years of surveillance, based on 2014 gross technical costs, was $64,969 per patient for chest CT and extremity MRI, compared with $41,595 per patient for chest and extremity CT surveillance, a potential cost savings with the CT-only strategy of $23,374 per patient.

The investigators said that the overall benefits of CT, including the cost savings in an accountable care organization model, “appear to outweigh the slightly increased radiation exposure.”

The study was internally funded. The authors reported having no relevant financial disclosures.

NEW ORLEANS—“Ocrelizumab is the first investigational treatment to reach primary and key secondary efficacy end points in a phase III primary progressive MS [PPMS] study,” reported Jerry S. Wolinsky, MD, Bartels Family Professor and Opal C. Rankin Professor in Neurology at the University of Texas Health Science Center at Houston. On behalf of his study collaborators, Dr. Wolinsky presented the results from a subgroup analysis of the ORATORIO study at the ACTRIMS 2016 Forum.

Consistent with other PPMS study populations, ORATORIO study patients included several individuals with T1 gadolinium-enhancing lesions at baseline. “The efficacy of ocrelizumab versus placebo in patients with and without gadolinium–positive lesions at baseline was consistent with what was seen in the overall study population,” Dr. Wolinsky concluded.

Ocrelizumab is a humanized monoclonal antibody that selectively targets and depletes CD20+ B cells. In ORATORIO, a randomized, double-blind, placebo-controlled phase III trial, ocrelizumab significantly reduced disease activity in patients with PPMS. Further, ORATORIO was the first major clinical trial in PPMS to achieve positive results. The main study results were reported in 2015 at the ECTRIMS meeting in Barcelona.

For the study reported at ACTRIMS, Dr. Wolinsky and his reseach colleagues sought to evaluate the efficacy of ocrelizumab in the ORATORIO patient subgroups with and without T1 gadolinium-enhancing lesions at baseline.

A total of 732 patients were randomized 2 to 1 to receive ocrelizumab (600 mg) or placebo as two 300-mg IV infusions 14 days apart every 24 weeks for at least 120 weeks and until a prespecified number of 12-week confirmed disability progression events occurred. Key eligibility criteria included age between 18 and 55, diagnosis of PPMS according to the 2005 revised McDonald criteria, Expanded Disability Status Scale (EDSS) score of 3 to 6.5, and documented history of elevated immunoglobulin index and/or presence of two or more oligoclonal bands in the CSF.

Although not powered for comparisons, prespecified subgroups included age (45 or younger vs older than 45), sex, BMI (less than 25 versus 25 or greater), weight (less than 75 kg vs 75 kg or more), region (US vs the rest of the world), treatment history, symptom duration, and disease activity (EDSS score of 5.5 or less vs more than 5 and presence or absence of T1 gadolinium-enhancing lesions) at baseline.

Efficacy of ocrelizumab on confirmed disability progression at 12 weeks or more and at 24 weeks or more, change in total T2 lesion volume at 120 weeks, and other secondary outcomes were evaluated in the subgroups with presence or absence of T1 gadolinium-enhancing lesions at baseline.

Compared with placebo, ocrelizumab significantly reduced the relative risk of 12-week confirmed disability progression by 24% (hazard ratio, 0.76) and 24-week confirmed disability progression by 25% (hazard ratio, 0.75). T1 gadolinium-enhancing lesions were present at baseline in 27.5% of ocrelizumab-treated patients versus 24.7% of placebo-treated patients. In patients with and without T1 gadolinium-enhancing lesions at baseline, respectively, ocrelizumab reduced the risk of 12-week confirmed disability progression by 35% (hazard ratio, 0.65) and 16% (hazard ratio, 0.84), the risk of 24-week confirmed disability progression by 33% (hazard ratio, 0.67) and 19% (hazard ratio, 0.81), and total T2 lesion volume by –3.8% versus +12.0% with placebo and by –3.1% versus +6.1% with placebo. Because of confidence intervals, not all of these end points analyses reached statistical significance.

“The study was in no way powered to approach this type of subgroup analysis. Rather, the analysis was an attempt to understand the data better,” said Dr. Wolinsky.

—Glenn S. Williams

NEW ORLEANS—“Ocrelizumab is the first investigational treatment to reach primary and key secondary efficacy end points in a phase III primary progressive MS [PPMS] study,” reported Jerry S. Wolinsky, MD, Bartels Family Professor and Opal C. Rankin Professor in Neurology at the University of Texas Health Science Center at Houston. On behalf of his study collaborators, Dr. Wolinsky presented the results from a subgroup analysis of the ORATORIO study at the ACTRIMS 2016 Forum.

Consistent with other PPMS study populations, ORATORIO study patients included several individuals with T1 gadolinium-enhancing lesions at baseline. “The efficacy of ocrelizumab versus placebo in patients with and without gadolinium–positive lesions at baseline was consistent with what was seen in the overall study population,” Dr. Wolinsky concluded.

Ocrelizumab is a humanized monoclonal antibody that selectively targets and depletes CD20+ B cells. In ORATORIO, a randomized, double-blind, placebo-controlled phase III trial, ocrelizumab significantly reduced disease activity in patients with PPMS. Further, ORATORIO was the first major clinical trial in PPMS to achieve positive results. The main study results were reported in 2015 at the ECTRIMS meeting in Barcelona.

For the study reported at ACTRIMS, Dr. Wolinsky and his reseach colleagues sought to evaluate the efficacy of ocrelizumab in the ORATORIO patient subgroups with and without T1 gadolinium-enhancing lesions at baseline.

A total of 732 patients were randomized 2 to 1 to receive ocrelizumab (600 mg) or placebo as two 300-mg IV infusions 14 days apart every 24 weeks for at least 120 weeks and until a prespecified number of 12-week confirmed disability progression events occurred. Key eligibility criteria included age between 18 and 55, diagnosis of PPMS according to the 2005 revised McDonald criteria, Expanded Disability Status Scale (EDSS) score of 3 to 6.5, and documented history of elevated immunoglobulin index and/or presence of two or more oligoclonal bands in the CSF.

Although not powered for comparisons, prespecified subgroups included age (45 or younger vs older than 45), sex, BMI (less than 25 versus 25 or greater), weight (less than 75 kg vs 75 kg or more), region (US vs the rest of the world), treatment history, symptom duration, and disease activity (EDSS score of 5.5 or less vs more than 5 and presence or absence of T1 gadolinium-enhancing lesions) at baseline.

Efficacy of ocrelizumab on confirmed disability progression at 12 weeks or more and at 24 weeks or more, change in total T2 lesion volume at 120 weeks, and other secondary outcomes were evaluated in the subgroups with presence or absence of T1 gadolinium-enhancing lesions at baseline.

Compared with placebo, ocrelizumab significantly reduced the relative risk of 12-week confirmed disability progression by 24% (hazard ratio, 0.76) and 24-week confirmed disability progression by 25% (hazard ratio, 0.75). T1 gadolinium-enhancing lesions were present at baseline in 27.5% of ocrelizumab-treated patients versus 24.7% of placebo-treated patients. In patients with and without T1 gadolinium-enhancing lesions at baseline, respectively, ocrelizumab reduced the risk of 12-week confirmed disability progression by 35% (hazard ratio, 0.65) and 16% (hazard ratio, 0.84), the risk of 24-week confirmed disability progression by 33% (hazard ratio, 0.67) and 19% (hazard ratio, 0.81), and total T2 lesion volume by –3.8% versus +12.0% with placebo and by –3.1% versus +6.1% with placebo. Because of confidence intervals, not all of these end points analyses reached statistical significance.

“The study was in no way powered to approach this type of subgroup analysis. Rather, the analysis was an attempt to understand the data better,” said Dr. Wolinsky.

—Glenn S. Williams

NEW ORLEANS—“Ocrelizumab is the first investigational treatment to reach primary and key secondary efficacy end points in a phase III primary progressive MS [PPMS] study,” reported Jerry S. Wolinsky, MD, Bartels Family Professor and Opal C. Rankin Professor in Neurology at the University of Texas Health Science Center at Houston. On behalf of his study collaborators, Dr. Wolinsky presented the results from a subgroup analysis of the ORATORIO study at the ACTRIMS 2016 Forum.

Consistent with other PPMS study populations, ORATORIO study patients included several individuals with T1 gadolinium-enhancing lesions at baseline. “The efficacy of ocrelizumab versus placebo in patients with and without gadolinium–positive lesions at baseline was consistent with what was seen in the overall study population,” Dr. Wolinsky concluded.

Ocrelizumab is a humanized monoclonal antibody that selectively targets and depletes CD20+ B cells. In ORATORIO, a randomized, double-blind, placebo-controlled phase III trial, ocrelizumab significantly reduced disease activity in patients with PPMS. Further, ORATORIO was the first major clinical trial in PPMS to achieve positive results. The main study results were reported in 2015 at the ECTRIMS meeting in Barcelona.

For the study reported at ACTRIMS, Dr. Wolinsky and his reseach colleagues sought to evaluate the efficacy of ocrelizumab in the ORATORIO patient subgroups with and without T1 gadolinium-enhancing lesions at baseline.

A total of 732 patients were randomized 2 to 1 to receive ocrelizumab (600 mg) or placebo as two 300-mg IV infusions 14 days apart every 24 weeks for at least 120 weeks and until a prespecified number of 12-week confirmed disability progression events occurred. Key eligibility criteria included age between 18 and 55, diagnosis of PPMS according to the 2005 revised McDonald criteria, Expanded Disability Status Scale (EDSS) score of 3 to 6.5, and documented history of elevated immunoglobulin index and/or presence of two or more oligoclonal bands in the CSF.

Although not powered for comparisons, prespecified subgroups included age (45 or younger vs older than 45), sex, BMI (less than 25 versus 25 or greater), weight (less than 75 kg vs 75 kg or more), region (US vs the rest of the world), treatment history, symptom duration, and disease activity (EDSS score of 5.5 or less vs more than 5 and presence or absence of T1 gadolinium-enhancing lesions) at baseline.

Efficacy of ocrelizumab on confirmed disability progression at 12 weeks or more and at 24 weeks or more, change in total T2 lesion volume at 120 weeks, and other secondary outcomes were evaluated in the subgroups with presence or absence of T1 gadolinium-enhancing lesions at baseline.

Compared with placebo, ocrelizumab significantly reduced the relative risk of 12-week confirmed disability progression by 24% (hazard ratio, 0.76) and 24-week confirmed disability progression by 25% (hazard ratio, 0.75). T1 gadolinium-enhancing lesions were present at baseline in 27.5% of ocrelizumab-treated patients versus 24.7% of placebo-treated patients. In patients with and without T1 gadolinium-enhancing lesions at baseline, respectively, ocrelizumab reduced the risk of 12-week confirmed disability progression by 35% (hazard ratio, 0.65) and 16% (hazard ratio, 0.84), the risk of 24-week confirmed disability progression by 33% (hazard ratio, 0.67) and 19% (hazard ratio, 0.81), and total T2 lesion volume by –3.8% versus +12.0% with placebo and by –3.1% versus +6.1% with placebo. Because of confidence intervals, not all of these end points analyses reached statistical significance.

“The study was in no way powered to approach this type of subgroup analysis. Rather, the analysis was an attempt to understand the data better,” said Dr. Wolinsky.

—Glenn S. Williams

In the era of individualized (or precision) medicine, we are presented with a unique opportunity to peer into the genetic “maps” of our patients. Through this window, we can envision the self-evident present or predict a possible future.

For the front-line provider, knowing that we could someday have a large amount of these data to deal with can be overwhelming. We may be loath to think that, amongst all the other daily battles we wage with current disease states, we may now need to understand and explain risk for future disease states.

But would we be more likely to use these data if we thought that they would change patient behavior? Maybe.

So does it?

Gareth Hollands, Ph.D., of the University of Cambridge, England, and his colleagues conducted a brilliantly timed and welcome systematic review of the literature assessing the impact of communicating DNA-based disease risk estimates on risk-reducing health behaviors and motivation to engage in such behaviors (BMJ. 2016 Mar 15;352:i1102).

Eighteen studies were found reporting on seven behavioral outcomes, including smoking cessation (six studies, n = 2,663), diet (seven studies, n = 1,784), and physical activity (six studies, n = 1,704). The smoking studies related genetic risk for lung or esophageal cancer; the diet studies related risk for diabetes, obesity, cardiovascular disease, hypertension, hyperlipidemia, and Alzheimer’s disease; and the physical activity studies related risks similar to the diet studies.

No evidence was found that communicating DNA-based risk increased smoking cessation or led to positive changes in diet or physical activity. Nor did the investigators find any effects on motivation to change behavior. Although this information is not motivating to patients, no evidence was found suggesting that it is demotivating, either.

If neither behavior nor motivation is modified by DNA-based risk assessment, what is it good for? As the authors pointed out, this information can be used for clinical risk stratification and for refining screening and treatment procedures.

It’s important to note that this puts the responsibility for the required action in response to DNA data in the hands of medical providers – sadly reminding us that the list of ways to motivate patients to change behavior remains frustratingly short.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

In the era of individualized (or precision) medicine, we are presented with a unique opportunity to peer into the genetic “maps” of our patients. Through this window, we can envision the self-evident present or predict a possible future.

For the front-line provider, knowing that we could someday have a large amount of these data to deal with can be overwhelming. We may be loath to think that, amongst all the other daily battles we wage with current disease states, we may now need to understand and explain risk for future disease states.

But would we be more likely to use these data if we thought that they would change patient behavior? Maybe.

So does it?

Gareth Hollands, Ph.D., of the University of Cambridge, England, and his colleagues conducted a brilliantly timed and welcome systematic review of the literature assessing the impact of communicating DNA-based disease risk estimates on risk-reducing health behaviors and motivation to engage in such behaviors (BMJ. 2016 Mar 15;352:i1102).

Eighteen studies were found reporting on seven behavioral outcomes, including smoking cessation (six studies, n = 2,663), diet (seven studies, n = 1,784), and physical activity (six studies, n = 1,704). The smoking studies related genetic risk for lung or esophageal cancer; the diet studies related risk for diabetes, obesity, cardiovascular disease, hypertension, hyperlipidemia, and Alzheimer’s disease; and the physical activity studies related risks similar to the diet studies.

No evidence was found that communicating DNA-based risk increased smoking cessation or led to positive changes in diet or physical activity. Nor did the investigators find any effects on motivation to change behavior. Although this information is not motivating to patients, no evidence was found suggesting that it is demotivating, either.

If neither behavior nor motivation is modified by DNA-based risk assessment, what is it good for? As the authors pointed out, this information can be used for clinical risk stratification and for refining screening and treatment procedures.

It’s important to note that this puts the responsibility for the required action in response to DNA data in the hands of medical providers – sadly reminding us that the list of ways to motivate patients to change behavior remains frustratingly short.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

In the era of individualized (or precision) medicine, we are presented with a unique opportunity to peer into the genetic “maps” of our patients. Through this window, we can envision the self-evident present or predict a possible future.

For the front-line provider, knowing that we could someday have a large amount of these data to deal with can be overwhelming. We may be loath to think that, amongst all the other daily battles we wage with current disease states, we may now need to understand and explain risk for future disease states.

But would we be more likely to use these data if we thought that they would change patient behavior? Maybe.

So does it?

Gareth Hollands, Ph.D., of the University of Cambridge, England, and his colleagues conducted a brilliantly timed and welcome systematic review of the literature assessing the impact of communicating DNA-based disease risk estimates on risk-reducing health behaviors and motivation to engage in such behaviors (BMJ. 2016 Mar 15;352:i1102).

Eighteen studies were found reporting on seven behavioral outcomes, including smoking cessation (six studies, n = 2,663), diet (seven studies, n = 1,784), and physical activity (six studies, n = 1,704). The smoking studies related genetic risk for lung or esophageal cancer; the diet studies related risk for diabetes, obesity, cardiovascular disease, hypertension, hyperlipidemia, and Alzheimer’s disease; and the physical activity studies related risks similar to the diet studies.

No evidence was found that communicating DNA-based risk increased smoking cessation or led to positive changes in diet or physical activity. Nor did the investigators find any effects on motivation to change behavior. Although this information is not motivating to patients, no evidence was found suggesting that it is demotivating, either.

If neither behavior nor motivation is modified by DNA-based risk assessment, what is it good for? As the authors pointed out, this information can be used for clinical risk stratification and for refining screening and treatment procedures.

It’s important to note that this puts the responsibility for the required action in response to DNA data in the hands of medical providers – sadly reminding us that the list of ways to motivate patients to change behavior remains frustratingly short.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

In early March, AGA attended the usually closed-door American Board of Internal Medicine (ABIM) GI Specialty Board meeting. Dr. Suzanne Rose, AGA Institute education and training councillor, along with Lori Marks, Ph.D., AGA vice president for education and training, were there to advocate that ABIM reform maintenance of certification (MOC). Although we are viewing the invitation to attend this meeting as a positive step, we wish we had better news to report. It seems that ABIM has no definitive approach to change the high-stakes examination and that their current efforts are focused on maintaining business as usual.

ABIM acknowledged AGA’s call for ending the every-10-year, closed-book exam. ABIM’s own Assessment 2020 report even suggested consideration of alternative assessment strategies. Despite these appeals, and more from the medical community to end the exam, ABIM pointed to their research proving its validity. AGA leadership is both disappointed and frustrated by ABIM’s intransigence on this point. They are clinging to an exam that flies in the face of adult-learning theory and that is not relevant to practice. Closed-book assessments do not represent the current realities of medicine in the digital age.

Please see AGA’s alternate pathway to recertification, The Gastroenterologist: Accountable Professionalism in Practice or G-APP,which fosters active learning. We support the principles of lifelong learning as evidenced by ongoing CME activities, rather than lifelong testing.

We commit to you that we will keep up the pressure and push on multiple fronts for ABIM to reform MOC, and specifically, to end the MOC exam. We will keep you informed as we move forward.

In early March, AGA attended the usually closed-door American Board of Internal Medicine (ABIM) GI Specialty Board meeting. Dr. Suzanne Rose, AGA Institute education and training councillor, along with Lori Marks, Ph.D., AGA vice president for education and training, were there to advocate that ABIM reform maintenance of certification (MOC). Although we are viewing the invitation to attend this meeting as a positive step, we wish we had better news to report. It seems that ABIM has no definitive approach to change the high-stakes examination and that their current efforts are focused on maintaining business as usual.

ABIM acknowledged AGA’s call for ending the every-10-year, closed-book exam. ABIM’s own Assessment 2020 report even suggested consideration of alternative assessment strategies. Despite these appeals, and more from the medical community to end the exam, ABIM pointed to their research proving its validity. AGA leadership is both disappointed and frustrated by ABIM’s intransigence on this point. They are clinging to an exam that flies in the face of adult-learning theory and that is not relevant to practice. Closed-book assessments do not represent the current realities of medicine in the digital age.

Please see AGA’s alternate pathway to recertification, The Gastroenterologist: Accountable Professionalism in Practice or G-APP,which fosters active learning. We support the principles of lifelong learning as evidenced by ongoing CME activities, rather than lifelong testing.

We commit to you that we will keep up the pressure and push on multiple fronts for ABIM to reform MOC, and specifically, to end the MOC exam. We will keep you informed as we move forward.

In early March, AGA attended the usually closed-door American Board of Internal Medicine (ABIM) GI Specialty Board meeting. Dr. Suzanne Rose, AGA Institute education and training councillor, along with Lori Marks, Ph.D., AGA vice president for education and training, were there to advocate that ABIM reform maintenance of certification (MOC). Although we are viewing the invitation to attend this meeting as a positive step, we wish we had better news to report. It seems that ABIM has no definitive approach to change the high-stakes examination and that their current efforts are focused on maintaining business as usual.

ABIM acknowledged AGA’s call for ending the every-10-year, closed-book exam. ABIM’s own Assessment 2020 report even suggested consideration of alternative assessment strategies. Despite these appeals, and more from the medical community to end the exam, ABIM pointed to their research proving its validity. AGA leadership is both disappointed and frustrated by ABIM’s intransigence on this point. They are clinging to an exam that flies in the face of adult-learning theory and that is not relevant to practice. Closed-book assessments do not represent the current realities of medicine in the digital age.

Please see AGA’s alternate pathway to recertification, The Gastroenterologist: Accountable Professionalism in Practice or G-APP,which fosters active learning. We support the principles of lifelong learning as evidenced by ongoing CME activities, rather than lifelong testing.

We commit to you that we will keep up the pressure and push on multiple fronts for ABIM to reform MOC, and specifically, to end the MOC exam. We will keep you informed as we move forward.

The 2016 AGA Postgraduate Course: Cognitive and Technical Skills for the Gastroenterologist is set to teach the newest advances in cancer, colonoscopy, and care on May 22, 2016, during Digestive Disease Week^® (DDW). John Inadomi, M.D., AGAF, session moderator and AGA clinical research councilor, will address a series of innovations alongside other world-renowned faculty. As gastroenterologists and scientists, you lead the charge in advancing colon care.

Session topics include:

• Advances in Understanding Pathogenesis of Common GI Cancers for the Practicing Gastroenterologist – Implications for Therapy: Richard Boland, M.D., AGAF.

• Colon Cancer Screening: John Inadomi, M.D., AGAF.

• Hereditary and Familial Colorectal Cancer: Lynch, Familial Polyposis and Beyond: Uri Ladabaum, M.D.

• Mastering the Difficult Colonoscopy and Polypectomy – Tricks of the Trade: Douglas Rex, M.D., AGAF, FASGE.

• Quality Using Bundled Care: Rajeev Jain, M.D., AGAF.

Visit pgcourse.gastro.org/pgcourse/home to learn more and register.

The 2016 AGA Postgraduate Course: Cognitive and Technical Skills for the Gastroenterologist is set to teach the newest advances in cancer, colonoscopy, and care on May 22, 2016, during Digestive Disease Week^® (DDW). John Inadomi, M.D., AGAF, session moderator and AGA clinical research councilor, will address a series of innovations alongside other world-renowned faculty. As gastroenterologists and scientists, you lead the charge in advancing colon care.

Session topics include:

• Advances in Understanding Pathogenesis of Common GI Cancers for the Practicing Gastroenterologist – Implications for Therapy: Richard Boland, M.D., AGAF.

• Colon Cancer Screening: John Inadomi, M.D., AGAF.

• Hereditary and Familial Colorectal Cancer: Lynch, Familial Polyposis and Beyond: Uri Ladabaum, M.D.

• Mastering the Difficult Colonoscopy and Polypectomy – Tricks of the Trade: Douglas Rex, M.D., AGAF, FASGE.

• Quality Using Bundled Care: Rajeev Jain, M.D., AGAF.

Visit pgcourse.gastro.org/pgcourse/home to learn more and register.

The 2016 AGA Postgraduate Course: Cognitive and Technical Skills for the Gastroenterologist is set to teach the newest advances in cancer, colonoscopy, and care on May 22, 2016, during Digestive Disease Week^® (DDW). John Inadomi, M.D., AGAF, session moderator and AGA clinical research councilor, will address a series of innovations alongside other world-renowned faculty. As gastroenterologists and scientists, you lead the charge in advancing colon care.

Session topics include:

• Advances in Understanding Pathogenesis of Common GI Cancers for the Practicing Gastroenterologist – Implications for Therapy: Richard Boland, M.D., AGAF.

• Colon Cancer Screening: John Inadomi, M.D., AGAF.

• Hereditary and Familial Colorectal Cancer: Lynch, Familial Polyposis and Beyond: Uri Ladabaum, M.D.

• Mastering the Difficult Colonoscopy and Polypectomy – Tricks of the Trade: Douglas Rex, M.D., AGAF, FASGE.

• Quality Using Bundled Care: Rajeev Jain, M.D., AGAF.

Visit pgcourse.gastro.org/pgcourse/home to learn more and register.

SAN DIEGO – Prescription medications are a major contributor to unnecessary health care spending.

According to data from the Centers for Medicare & Medicaid Services, retail spending on prescription drugs grew 12.2% to $297.7 billion in 2014, compared with the 2.4% growth in 2013. That’s one key reason why medication reconciliation should be performed at every inpatient and outpatient visit and prior to every hospital discharge, Dr. Aparna Kamath said in a video interview at the annual meeting of the Society of Hospital Medicine. “The focus should be on clear indications for each medication prescribed, substitution of generics when possible, and consideration of an individual patient’s insurance formulary and ability to meet out-of-pocket costs.”

A recent article in JAMA Internal Medicine discussed the practice of “deprescribing” in an effort to reduce the number of prescribed drugs (2015;175[5]:827-34). According to Dr. Kamath of the department of medicine at Duke University Health System, Durham, N.C., who was not involved with the article, deprescribing “means safely narrowing, discontinuing, or withdrawing medications for our patients. It has been shown that deprescribing might actually improve outpatient outcomes by making the medication list safer for our patients and hopefully also improve medication adherence by making them more affordable for our patients.”

The study authors proposed a five-step protocol for deprescribing:

• Ascertain all drugs the patient is currently taking and the reasons for each one.

• Consider overall risk of drug-induced harm in individual patients in determining the required intensity of deprescribing intervention.

• Assess each drug in regard to its current or future benefit potential, compared with current or future harm or burden potential.

• Prioritize drugs for discontinuation that have the lowest benefit-harm ratio and lowest likelihood of adverse withdrawal reactions or disease rebound syndromes.

• Implement a discontinuation regimen and monitor patients closely for improvement in outcomes or onset of adverse effects.

According to Dr. Kamath, other medication reconciliation strategies include referring patients to a social worker to inquire about drug assistance programs; following up with the patient’s primary care or prescribing physician; partnering with pharmacists; and educating patients about variance in prescription drug prices. “I think it’s important to inform the patients that these drugs are priced differently in different pharmacies,” she said. “According to Consumer Reports, we should ask the patient to shop around, maybe call the medication pharmacies in their local area to find out where they can find the drugs at a most affordable price. We can also advise our patients to ask for discounts or coupons, and check for monthly price changes,” Dr. Kamath said. She recommended the following websites, which allow patients to compare costs and/or inquire about discounts:

• www.goodrx.com.

• https://www.rxpricequotes.com.

• www.needymeds.org.

• www.pparx.org.

• www.rxoutreach.org.

• https://www.blinkhealth.com.

Dr. Kamath reported having no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Prescription medications are a major contributor to unnecessary health care spending.

According to data from the Centers for Medicare & Medicaid Services, retail spending on prescription drugs grew 12.2% to $297.7 billion in 2014, compared with the 2.4% growth in 2013. That’s one key reason why medication reconciliation should be performed at every inpatient and outpatient visit and prior to every hospital discharge, Dr. Aparna Kamath said in a video interview at the annual meeting of the Society of Hospital Medicine. “The focus should be on clear indications for each medication prescribed, substitution of generics when possible, and consideration of an individual patient’s insurance formulary and ability to meet out-of-pocket costs.”

A recent article in JAMA Internal Medicine discussed the practice of “deprescribing” in an effort to reduce the number of prescribed drugs (2015;175[5]:827-34). According to Dr. Kamath of the department of medicine at Duke University Health System, Durham, N.C., who was not involved with the article, deprescribing “means safely narrowing, discontinuing, or withdrawing medications for our patients. It has been shown that deprescribing might actually improve outpatient outcomes by making the medication list safer for our patients and hopefully also improve medication adherence by making them more affordable for our patients.”

The study authors proposed a five-step protocol for deprescribing:

• Ascertain all drugs the patient is currently taking and the reasons for each one.

• Consider overall risk of drug-induced harm in individual patients in determining the required intensity of deprescribing intervention.

• Assess each drug in regard to its current or future benefit potential, compared with current or future harm or burden potential.

• Prioritize drugs for discontinuation that have the lowest benefit-harm ratio and lowest likelihood of adverse withdrawal reactions or disease rebound syndromes.

• Implement a discontinuation regimen and monitor patients closely for improvement in outcomes or onset of adverse effects.

According to Dr. Kamath, other medication reconciliation strategies include referring patients to a social worker to inquire about drug assistance programs; following up with the patient’s primary care or prescribing physician; partnering with pharmacists; and educating patients about variance in prescription drug prices. “I think it’s important to inform the patients that these drugs are priced differently in different pharmacies,” she said. “According to Consumer Reports, we should ask the patient to shop around, maybe call the medication pharmacies in their local area to find out where they can find the drugs at a most affordable price. We can also advise our patients to ask for discounts or coupons, and check for monthly price changes,” Dr. Kamath said. She recommended the following websites, which allow patients to compare costs and/or inquire about discounts:

• www.goodrx.com.

• https://www.rxpricequotes.com.

• www.needymeds.org.

• www.pparx.org.

• www.rxoutreach.org.

• https://www.blinkhealth.com.

Dr. Kamath reported having no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Prescription medications are a major contributor to unnecessary health care spending.

According to data from the Centers for Medicare & Medicaid Services, retail spending on prescription drugs grew 12.2% to $297.7 billion in 2014, compared with the 2.4% growth in 2013. That’s one key reason why medication reconciliation should be performed at every inpatient and outpatient visit and prior to every hospital discharge, Dr. Aparna Kamath said in a video interview at the annual meeting of the Society of Hospital Medicine. “The focus should be on clear indications for each medication prescribed, substitution of generics when possible, and consideration of an individual patient’s insurance formulary and ability to meet out-of-pocket costs.”

A recent article in JAMA Internal Medicine discussed the practice of “deprescribing” in an effort to reduce the number of prescribed drugs (2015;175[5]:827-34). According to Dr. Kamath of the department of medicine at Duke University Health System, Durham, N.C., who was not involved with the article, deprescribing “means safely narrowing, discontinuing, or withdrawing medications for our patients. It has been shown that deprescribing might actually improve outpatient outcomes by making the medication list safer for our patients and hopefully also improve medication adherence by making them more affordable for our patients.”

The study authors proposed a five-step protocol for deprescribing:

• Ascertain all drugs the patient is currently taking and the reasons for each one.

• Consider overall risk of drug-induced harm in individual patients in determining the required intensity of deprescribing intervention.

• Assess each drug in regard to its current or future benefit potential, compared with current or future harm or burden potential.

• Prioritize drugs for discontinuation that have the lowest benefit-harm ratio and lowest likelihood of adverse withdrawal reactions or disease rebound syndromes.

• Implement a discontinuation regimen and monitor patients closely for improvement in outcomes or onset of adverse effects.

According to Dr. Kamath, other medication reconciliation strategies include referring patients to a social worker to inquire about drug assistance programs; following up with the patient’s primary care or prescribing physician; partnering with pharmacists; and educating patients about variance in prescription drug prices. “I think it’s important to inform the patients that these drugs are priced differently in different pharmacies,” she said. “According to Consumer Reports, we should ask the patient to shop around, maybe call the medication pharmacies in their local area to find out where they can find the drugs at a most affordable price. We can also advise our patients to ask for discounts or coupons, and check for monthly price changes,” Dr. Kamath said. She recommended the following websites, which allow patients to compare costs and/or inquire about discounts:

• www.goodrx.com.

• https://www.rxpricequotes.com.

• www.needymeds.org.

• www.pparx.org.

• www.rxoutreach.org.

• https://www.blinkhealth.com.

Dr. Kamath reported having no financial disclosures.

dbrunk@frontlinemedcom.com

Connect and engage with your fellow researchers and clinicians at the 2016 James W. Freston Conference: Intestinal Metaplasia in the Esophagus and Stomach – Origins, Differences, Similarities and Significance. The conference will take place Aug. 19-21 in Chicago, Ill.

By attending, you’ll be able to explore novel ideas that may lead to enhanced therapies and management strategies for the prevention of intestinal metaplasia. Faculty will guide you through an interactive program that provides greater insight on the clinical and histological issues of intestinal metaplasia, and the role of inflammation in the development of intestinal metaplasia.

A consensus will take place at the end of the conference, which will attempt to develop standard terminology, identify potential preventive strategies, and suggest future directions for research.

Don’t miss this unique and intimate forum, bringing together more than 100 attendees from around the world. For program and registration details, visit the conference Web page.

Connect and engage with your fellow researchers and clinicians at the 2016 James W. Freston Conference: Intestinal Metaplasia in the Esophagus and Stomach – Origins, Differences, Similarities and Significance. The conference will take place Aug. 19-21 in Chicago, Ill.

By attending, you’ll be able to explore novel ideas that may lead to enhanced therapies and management strategies for the prevention of intestinal metaplasia. Faculty will guide you through an interactive program that provides greater insight on the clinical and histological issues of intestinal metaplasia, and the role of inflammation in the development of intestinal metaplasia.

A consensus will take place at the end of the conference, which will attempt to develop standard terminology, identify potential preventive strategies, and suggest future directions for research.

Don’t miss this unique and intimate forum, bringing together more than 100 attendees from around the world. For program and registration details, visit the conference Web page.

Connect and engage with your fellow researchers and clinicians at the 2016 James W. Freston Conference: Intestinal Metaplasia in the Esophagus and Stomach – Origins, Differences, Similarities and Significance. The conference will take place Aug. 19-21 in Chicago, Ill.

By attending, you’ll be able to explore novel ideas that may lead to enhanced therapies and management strategies for the prevention of intestinal metaplasia. Faculty will guide you through an interactive program that provides greater insight on the clinical and histological issues of intestinal metaplasia, and the role of inflammation in the development of intestinal metaplasia.

A consensus will take place at the end of the conference, which will attempt to develop standard terminology, identify potential preventive strategies, and suggest future directions for research.

Don’t miss this unique and intimate forum, bringing together more than 100 attendees from around the world. For program and registration details, visit the conference Web page.

LOS ANGELES – It only took a few minutes for idarucizumab to normalize blood-clotting parameters in 18 patients with dabigatran-associated intracranial hemorrhages, according to interim results from an ongoing phase III trial presented at the International Stroke Conference.

“When I put patients on [dabigatran], they always ask me what happens if they bleed or need surgery. … Until now, I haven’t been able to tell them with any confidence that I have a way of reversing it. Now I think I can. ... It makes a big difference” in their comfort, said lead investigator Dr. Richard Bernstein, a Northwestern University neurology professor and director of the stroke program at Northwestern Memorial Hospital, in Chicago.

“We would love to know if hematoma expansion was limited [and outcomes improved] by giving this reversal agent,” but the study so far is too small. “We hope to have a larger cohort of brain hemorrhage patients to answer these questions,” he said.

Approved in October 2015, idarucizumab (Praxbind) was fast tracked by the Food and Drug Administration to reverse the blockbuster atrial fibrillation anticoagulant dabigatran (Pradaxa); the labeling for idarucizumab doesn’t mention intracranial hemorrhage patients specifically. Boehringer Ingelheim makes both drugs, and funded Dr. Bernstein’s work.

Eleven of the 18 patients were men, and the average age in the study was about 80 years. The patients had either subdural hematomas or bleeding into the brain itself. They were culled from the 90 subjects analyzed so far in the idarucizumab trial, dubbed RE-VERSE AD (Reversal Effects of Idarucizumab in Patients on Active Dabigatran).

The team followed label dosing: 5 g total given as two separate 2.5-g infusions. Blood samples were taken in between to check how well idarucizumab worked. The whole process took no more than 15 minutes.

The first 2.5 g completely reversed dabigatran in all 18 patients, based on their dilute thrombin or ecarin clotting times. Patients “remained reversed out to 12 hours, and all but one out to 24 hours,” Dr. Bernstein said at the conference, sponsored by the American Heart Association.

Idarucizumab is a monoclonal antibody fragment that binds dabigatran more powerfully than dabigatran binds thrombin. In vitro studies have found no prothrombotic effects. “It has no endogenous target, so the drug has no effect on any other clotting factors that we can tell. We did have, I think, five thrombotic events in our cohort, most of them many days after the dabigatran was reversed. It may have just been a reversion to [patient] clotting risks,” he said.

When – or if – to restart dabigatran “is a clinical question.” If bleeding is controlled or patients are stable after surgery, you can go back on the next day,” he said.

Idarucizumab’s labeling notes that 5% or more of patients developed hypokalemia, delirium, constipation, pyrexia, and pneumonia. It wasn’t clear these events were drug related. Patients had dabigatran reversed either for serious bleeding or emergency surgery.

Dr. Bernstein is a speaker and adviser for Boehringer Ingelheim, and reported honoraria from the company.

aotto@frontlinemedcom.com

LOS ANGELES – It only took a few minutes for idarucizumab to normalize blood-clotting parameters in 18 patients with dabigatran-associated intracranial hemorrhages, according to interim results from an ongoing phase III trial presented at the International Stroke Conference.

“When I put patients on [dabigatran], they always ask me what happens if they bleed or need surgery. … Until now, I haven’t been able to tell them with any confidence that I have a way of reversing it. Now I think I can. ... It makes a big difference” in their comfort, said lead investigator Dr. Richard Bernstein, a Northwestern University neurology professor and director of the stroke program at Northwestern Memorial Hospital, in Chicago.

“We would love to know if hematoma expansion was limited [and outcomes improved] by giving this reversal agent,” but the study so far is too small. “We hope to have a larger cohort of brain hemorrhage patients to answer these questions,” he said.

Approved in October 2015, idarucizumab (Praxbind) was fast tracked by the Food and Drug Administration to reverse the blockbuster atrial fibrillation anticoagulant dabigatran (Pradaxa); the labeling for idarucizumab doesn’t mention intracranial hemorrhage patients specifically. Boehringer Ingelheim makes both drugs, and funded Dr. Bernstein’s work.

Eleven of the 18 patients were men, and the average age in the study was about 80 years. The patients had either subdural hematomas or bleeding into the brain itself. They were culled from the 90 subjects analyzed so far in the idarucizumab trial, dubbed RE-VERSE AD (Reversal Effects of Idarucizumab in Patients on Active Dabigatran).

The team followed label dosing: 5 g total given as two separate 2.5-g infusions. Blood samples were taken in between to check how well idarucizumab worked. The whole process took no more than 15 minutes.

The first 2.5 g completely reversed dabigatran in all 18 patients, based on their dilute thrombin or ecarin clotting times. Patients “remained reversed out to 12 hours, and all but one out to 24 hours,” Dr. Bernstein said at the conference, sponsored by the American Heart Association.

Idarucizumab is a monoclonal antibody fragment that binds dabigatran more powerfully than dabigatran binds thrombin. In vitro studies have found no prothrombotic effects. “It has no endogenous target, so the drug has no effect on any other clotting factors that we can tell. We did have, I think, five thrombotic events in our cohort, most of them many days after the dabigatran was reversed. It may have just been a reversion to [patient] clotting risks,” he said.

When – or if – to restart dabigatran “is a clinical question.” If bleeding is controlled or patients are stable after surgery, you can go back on the next day,” he said.

Idarucizumab’s labeling notes that 5% or more of patients developed hypokalemia, delirium, constipation, pyrexia, and pneumonia. It wasn’t clear these events were drug related. Patients had dabigatran reversed either for serious bleeding or emergency surgery.

Dr. Bernstein is a speaker and adviser for Boehringer Ingelheim, and reported honoraria from the company.

aotto@frontlinemedcom.com

LOS ANGELES – It only took a few minutes for idarucizumab to normalize blood-clotting parameters in 18 patients with dabigatran-associated intracranial hemorrhages, according to interim results from an ongoing phase III trial presented at the International Stroke Conference.

“When I put patients on [dabigatran], they always ask me what happens if they bleed or need surgery. … Until now, I haven’t been able to tell them with any confidence that I have a way of reversing it. Now I think I can. ... It makes a big difference” in their comfort, said lead investigator Dr. Richard Bernstein, a Northwestern University neurology professor and director of the stroke program at Northwestern Memorial Hospital, in Chicago.

“We would love to know if hematoma expansion was limited [and outcomes improved] by giving this reversal agent,” but the study so far is too small. “We hope to have a larger cohort of brain hemorrhage patients to answer these questions,” he said.

Approved in October 2015, idarucizumab (Praxbind) was fast tracked by the Food and Drug Administration to reverse the blockbuster atrial fibrillation anticoagulant dabigatran (Pradaxa); the labeling for idarucizumab doesn’t mention intracranial hemorrhage patients specifically. Boehringer Ingelheim makes both drugs, and funded Dr. Bernstein’s work.

Eleven of the 18 patients were men, and the average age in the study was about 80 years. The patients had either subdural hematomas or bleeding into the brain itself. They were culled from the 90 subjects analyzed so far in the idarucizumab trial, dubbed RE-VERSE AD (Reversal Effects of Idarucizumab in Patients on Active Dabigatran).

The team followed label dosing: 5 g total given as two separate 2.5-g infusions. Blood samples were taken in between to check how well idarucizumab worked. The whole process took no more than 15 minutes.

The first 2.5 g completely reversed dabigatran in all 18 patients, based on their dilute thrombin or ecarin clotting times. Patients “remained reversed out to 12 hours, and all but one out to 24 hours,” Dr. Bernstein said at the conference, sponsored by the American Heart Association.

Idarucizumab is a monoclonal antibody fragment that binds dabigatran more powerfully than dabigatran binds thrombin. In vitro studies have found no prothrombotic effects. “It has no endogenous target, so the drug has no effect on any other clotting factors that we can tell. We did have, I think, five thrombotic events in our cohort, most of them many days after the dabigatran was reversed. It may have just been a reversion to [patient] clotting risks,” he said.

When – or if – to restart dabigatran “is a clinical question.” If bleeding is controlled or patients are stable after surgery, you can go back on the next day,” he said.

Idarucizumab’s labeling notes that 5% or more of patients developed hypokalemia, delirium, constipation, pyrexia, and pneumonia. It wasn’t clear these events were drug related. Patients had dabigatran reversed either for serious bleeding or emergency surgery.

Dr. Bernstein is a speaker and adviser for Boehringer Ingelheim, and reported honoraria from the company.

aotto@frontlinemedcom.com