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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

A simple, flexible, and versatile way to ensure The AGA Research Foundation can continue our work for years to come is a gift in your will or living trust, known as a charitable bequest. To make a charitable bequest, you need a current will or living trust.

Your gift can be made as a percentage of your estate. Or you can make a specific bequest by contributing a certain amount of cash, securities, or property. After your lifetime, the AGA Research Foundation receives your gift.

We hope you’ll consider including a gift to the AGA Research Foundation in your will or living trust. It’s simple – just a few sentences in your will or trust are all that is needed. The official bequest language for the AGA Research Foundation is: “I, [name], of [city, state, ZIP], give, devise, and bequeath to the AGA Research Foundation [written amount or percentage of the estate or description of property] for its unrestricted use and purpose.”

When planning a future gift, it’s sometimes difficult to determine what size donation will make sense. Emergencies happen, and you need to make sure your family is financially taken care of first. Including a bequest of a percentage of your estate ensures that your gift will remain proportionate, no matter how your estate’s value fluctuates over the years.

Whether you would like to put your donation to work today or benefit us after your lifetime, you can find a charitable plan that lets you provide for your family and support the AGA Research Foundation.

Please contact us for more information at [email protected] or visit http://gastro.planmylegacy.org.

A simple, flexible, and versatile way to ensure The AGA Research Foundation can continue our work for years to come is a gift in your will or living trust, known as a charitable bequest. To make a charitable bequest, you need a current will or living trust.

Your gift can be made as a percentage of your estate. Or you can make a specific bequest by contributing a certain amount of cash, securities, or property. After your lifetime, the AGA Research Foundation receives your gift.

We hope you’ll consider including a gift to the AGA Research Foundation in your will or living trust. It’s simple – just a few sentences in your will or trust are all that is needed. The official bequest language for the AGA Research Foundation is: “I, [name], of [city, state, ZIP], give, devise, and bequeath to the AGA Research Foundation [written amount or percentage of the estate or description of property] for its unrestricted use and purpose.”

When planning a future gift, it’s sometimes difficult to determine what size donation will make sense. Emergencies happen, and you need to make sure your family is financially taken care of first. Including a bequest of a percentage of your estate ensures that your gift will remain proportionate, no matter how your estate’s value fluctuates over the years.

Whether you would like to put your donation to work today or benefit us after your lifetime, you can find a charitable plan that lets you provide for your family and support the AGA Research Foundation.

Please contact us for more information at [email protected] or visit http://gastro.planmylegacy.org.

A simple, flexible, and versatile way to ensure The AGA Research Foundation can continue our work for years to come is a gift in your will or living trust, known as a charitable bequest. To make a charitable bequest, you need a current will or living trust.

Your gift can be made as a percentage of your estate. Or you can make a specific bequest by contributing a certain amount of cash, securities, or property. After your lifetime, the AGA Research Foundation receives your gift.

We hope you’ll consider including a gift to the AGA Research Foundation in your will or living trust. It’s simple – just a few sentences in your will or trust are all that is needed. The official bequest language for the AGA Research Foundation is: “I, [name], of [city, state, ZIP], give, devise, and bequeath to the AGA Research Foundation [written amount or percentage of the estate or description of property] for its unrestricted use and purpose.”

When planning a future gift, it’s sometimes difficult to determine what size donation will make sense. Emergencies happen, and you need to make sure your family is financially taken care of first. Including a bequest of a percentage of your estate ensures that your gift will remain proportionate, no matter how your estate’s value fluctuates over the years.

Whether you would like to put your donation to work today or benefit us after your lifetime, you can find a charitable plan that lets you provide for your family and support the AGA Research Foundation.

Please contact us for more information at [email protected] or visit http://gastro.planmylegacy.org.

It was almost a year ago that the American College of Obstetricians and Gynecologists came out unequivocally in favor of universal screening for perinatal depression.

In the revised policy statement from ACOG’s Committee on Obstetric Practice, the college recommended that physicians screen women for depression and anxiety symptoms at least once during the perinatal period using a standard, validated tool. ACOG also noted that screening must be coupled with appropriate follow-up and that clinical staff must be prepared to start therapy or refer patients to treatment (Obstet. Gynecol. 2015;125:1268-71).

This move toward routine screening was intuitive given the prevalence of perinatal mood and anxiety disorders.

Fast forward to January 2016 and the U.S. Preventive Services Task Force final recommendation calling for screening all adults for depression, including the at-risk populations of pregnant and postpartum women. Much like the ACOG guidelines, the USPSTF recommendations call for adequate systems to ensure treatment and follow-up (JAMA. 2016 Jan. 26;315[4]:380-7).

These recommendations, although timely, derive from relatively sparse data on the actual effectiveness of perinatal screening. Although the move toward screening is welcome and simply commonsense, it is concerning that there has been very little systematic study of the effectiveness of screening for such a prevalent and impactful illness. At the end of the day, the question remains: Will screening for perinatal depression in obstetric and possibly pediatric settings lead to improved outcomes for patients and families?

We’re screening, but will it make a difference?

As more U.S. states, along with other countries around the world, have begun routine screening of women in the perinatal period, it’s become clear that screening itself is easy to do. What has yet to be adequately demonstrated is how screening moves us toward getting women into treatment and ultimately toward getting women well.

New Jersey and Illinois are good examples of states that should be applauded for recognizing early on how important it is to identify women with perinatal depression. But even in these early-adopter states, the actual implementation of referral systems has been lacking.

©monkeybusinessimages/thinkstockphotos.com

Here in Massachusetts, we have a state-funded program designed to teach local women’s health providers – including ob.gyns. – about diagnosing perinatal depression. The MCPAP (Massachusetts Child Psychiatry Access Project) for Moms program also offers resources for consultation and referral. The program is fairly new, so it’s still unclear whether ob.gyns. and primary care physicians will accept the role of de facto mental health treaters, as well as whether the women who are identified through screening will go on to recover acutely and, more importantly, over the long term.

These experiences among the states highlight how great a challenge it is to go from screening to positive health outcomes for women.

Downstream difficulties

A lack of evidence isn’t the only problem. A recent editorial in the Lancet raised the concern that the currently available screening tests are not suitable for clinical practice. The suggestion read to some like heresy.

The Edinburgh Postnatal Depression Scale, which is the most commonly used screening instrument, has a positive predictive value of detecting major depressive disorder of 47%-64%, according to the editorial, making it prone to delivering false positives (doi: 10.1016/S0140-6736[16]00265-8).

“This situation is potentially dangerous,” the Lancet editorial noted, since results of qualitative studies “suggest that women are extremely concerned about depression screening, about the stigma associated with a diagnosis of depression, and that a positive result might lead to an automatic social service referral, and potentially removal of their baby.”

A recent article, published in the New York Times, raises an additional concern about what a depression diagnosis could mean for insurability. The article highlights the experience of a woman whose diagnosis of postpartum depression is creating difficulties for her in getting life insurance. The point is underscored that it is perfectly legal for life and disability insurers to charge more to patients with a diagnosis of mental illness or to deny coverage outright.

No going back

The whole issue of perinatal depression screening has opened a Pandora’s box, and that is a good thing. The conversation is long overdue in America. It is time for greater national awareness and focus on a disease that is as prevalent as perinatal depression and as disabling for women and their families.

The focus up to this point has been on perinatal depression screening, but we’re about to see a shift toward building the community infrastructure that will be critical for managing patients, including those women who have previously been marginalized and have had very poor access to care.

Widespread screening and treatment will also require a level of cooperation between advocacy groups and providers who are multidisciplinary in their approach, taking advantage of both pharmacologic and nonpharmacologic approaches. A model of crossdisciplinary collaboration will include, for example, providers from psychiatrists to therapists to doulas to social workers to clinicians who focus on mother-infant interaction. It is a long list and models for such collaboration are somewhat lacking.

One good example of a pilot effort for such a collaboration is the Massachusetts Postpartum Depression Commission, which includes a full spectrum of participants from doulas, social workers, and perinatal psychiatrists to lay people. The partnerships and the networking that’s going on across disciplines is absolutely new and is going to be essential if we’re going to manage an issue as large as the treatment of perinatal depression.

The enhanced awareness of the need to screen for, identify, and treat postpartum depression will also lead to better tools with greater specificity, perhaps using new technologies for better identification and treatment, everything from telemedicine to smartphone applications.

There will certainly be growing pains as we gather evidence, refine our screening instruments, and build referral systems, but I don’t see this as a reason not to identify illness in this vulnerable population. Rather, it is a charge to the field that there is work to be done.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications.

It was almost a year ago that the American College of Obstetricians and Gynecologists came out unequivocally in favor of universal screening for perinatal depression.

In the revised policy statement from ACOG’s Committee on Obstetric Practice, the college recommended that physicians screen women for depression and anxiety symptoms at least once during the perinatal period using a standard, validated tool. ACOG also noted that screening must be coupled with appropriate follow-up and that clinical staff must be prepared to start therapy or refer patients to treatment (Obstet. Gynecol. 2015;125:1268-71).

This move toward routine screening was intuitive given the prevalence of perinatal mood and anxiety disorders.

Fast forward to January 2016 and the U.S. Preventive Services Task Force final recommendation calling for screening all adults for depression, including the at-risk populations of pregnant and postpartum women. Much like the ACOG guidelines, the USPSTF recommendations call for adequate systems to ensure treatment and follow-up (JAMA. 2016 Jan. 26;315[4]:380-7).

These recommendations, although timely, derive from relatively sparse data on the actual effectiveness of perinatal screening. Although the move toward screening is welcome and simply commonsense, it is concerning that there has been very little systematic study of the effectiveness of screening for such a prevalent and impactful illness. At the end of the day, the question remains: Will screening for perinatal depression in obstetric and possibly pediatric settings lead to improved outcomes for patients and families?

We’re screening, but will it make a difference?

As more U.S. states, along with other countries around the world, have begun routine screening of women in the perinatal period, it’s become clear that screening itself is easy to do. What has yet to be adequately demonstrated is how screening moves us toward getting women into treatment and ultimately toward getting women well.

New Jersey and Illinois are good examples of states that should be applauded for recognizing early on how important it is to identify women with perinatal depression. But even in these early-adopter states, the actual implementation of referral systems has been lacking.

©monkeybusinessimages/thinkstockphotos.com

Here in Massachusetts, we have a state-funded program designed to teach local women’s health providers – including ob.gyns. – about diagnosing perinatal depression. The MCPAP (Massachusetts Child Psychiatry Access Project) for Moms program also offers resources for consultation and referral. The program is fairly new, so it’s still unclear whether ob.gyns. and primary care physicians will accept the role of de facto mental health treaters, as well as whether the women who are identified through screening will go on to recover acutely and, more importantly, over the long term.

These experiences among the states highlight how great a challenge it is to go from screening to positive health outcomes for women.

Downstream difficulties

A lack of evidence isn’t the only problem. A recent editorial in the Lancet raised the concern that the currently available screening tests are not suitable for clinical practice. The suggestion read to some like heresy.

The Edinburgh Postnatal Depression Scale, which is the most commonly used screening instrument, has a positive predictive value of detecting major depressive disorder of 47%-64%, according to the editorial, making it prone to delivering false positives (doi: 10.1016/S0140-6736[16]00265-8).

“This situation is potentially dangerous,” the Lancet editorial noted, since results of qualitative studies “suggest that women are extremely concerned about depression screening, about the stigma associated with a diagnosis of depression, and that a positive result might lead to an automatic social service referral, and potentially removal of their baby.”

A recent article, published in the New York Times, raises an additional concern about what a depression diagnosis could mean for insurability. The article highlights the experience of a woman whose diagnosis of postpartum depression is creating difficulties for her in getting life insurance. The point is underscored that it is perfectly legal for life and disability insurers to charge more to patients with a diagnosis of mental illness or to deny coverage outright.

No going back

The whole issue of perinatal depression screening has opened a Pandora’s box, and that is a good thing. The conversation is long overdue in America. It is time for greater national awareness and focus on a disease that is as prevalent as perinatal depression and as disabling for women and their families.

The focus up to this point has been on perinatal depression screening, but we’re about to see a shift toward building the community infrastructure that will be critical for managing patients, including those women who have previously been marginalized and have had very poor access to care.

Widespread screening and treatment will also require a level of cooperation between advocacy groups and providers who are multidisciplinary in their approach, taking advantage of both pharmacologic and nonpharmacologic approaches. A model of crossdisciplinary collaboration will include, for example, providers from psychiatrists to therapists to doulas to social workers to clinicians who focus on mother-infant interaction. It is a long list and models for such collaboration are somewhat lacking.

One good example of a pilot effort for such a collaboration is the Massachusetts Postpartum Depression Commission, which includes a full spectrum of participants from doulas, social workers, and perinatal psychiatrists to lay people. The partnerships and the networking that’s going on across disciplines is absolutely new and is going to be essential if we’re going to manage an issue as large as the treatment of perinatal depression.

The enhanced awareness of the need to screen for, identify, and treat postpartum depression will also lead to better tools with greater specificity, perhaps using new technologies for better identification and treatment, everything from telemedicine to smartphone applications.

There will certainly be growing pains as we gather evidence, refine our screening instruments, and build referral systems, but I don’t see this as a reason not to identify illness in this vulnerable population. Rather, it is a charge to the field that there is work to be done.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications.

It was almost a year ago that the American College of Obstetricians and Gynecologists came out unequivocally in favor of universal screening for perinatal depression.

In the revised policy statement from ACOG’s Committee on Obstetric Practice, the college recommended that physicians screen women for depression and anxiety symptoms at least once during the perinatal period using a standard, validated tool. ACOG also noted that screening must be coupled with appropriate follow-up and that clinical staff must be prepared to start therapy or refer patients to treatment (Obstet. Gynecol. 2015;125:1268-71).

This move toward routine screening was intuitive given the prevalence of perinatal mood and anxiety disorders.

Fast forward to January 2016 and the U.S. Preventive Services Task Force final recommendation calling for screening all adults for depression, including the at-risk populations of pregnant and postpartum women. Much like the ACOG guidelines, the USPSTF recommendations call for adequate systems to ensure treatment and follow-up (JAMA. 2016 Jan. 26;315[4]:380-7).

These recommendations, although timely, derive from relatively sparse data on the actual effectiveness of perinatal screening. Although the move toward screening is welcome and simply commonsense, it is concerning that there has been very little systematic study of the effectiveness of screening for such a prevalent and impactful illness. At the end of the day, the question remains: Will screening for perinatal depression in obstetric and possibly pediatric settings lead to improved outcomes for patients and families?

We’re screening, but will it make a difference?

As more U.S. states, along with other countries around the world, have begun routine screening of women in the perinatal period, it’s become clear that screening itself is easy to do. What has yet to be adequately demonstrated is how screening moves us toward getting women into treatment and ultimately toward getting women well.

New Jersey and Illinois are good examples of states that should be applauded for recognizing early on how important it is to identify women with perinatal depression. But even in these early-adopter states, the actual implementation of referral systems has been lacking.

©monkeybusinessimages/thinkstockphotos.com

Here in Massachusetts, we have a state-funded program designed to teach local women’s health providers – including ob.gyns. – about diagnosing perinatal depression. The MCPAP (Massachusetts Child Psychiatry Access Project) for Moms program also offers resources for consultation and referral. The program is fairly new, so it’s still unclear whether ob.gyns. and primary care physicians will accept the role of de facto mental health treaters, as well as whether the women who are identified through screening will go on to recover acutely and, more importantly, over the long term.

These experiences among the states highlight how great a challenge it is to go from screening to positive health outcomes for women.

Downstream difficulties

A lack of evidence isn’t the only problem. A recent editorial in the Lancet raised the concern that the currently available screening tests are not suitable for clinical practice. The suggestion read to some like heresy.

The Edinburgh Postnatal Depression Scale, which is the most commonly used screening instrument, has a positive predictive value of detecting major depressive disorder of 47%-64%, according to the editorial, making it prone to delivering false positives (doi: 10.1016/S0140-6736[16]00265-8).

“This situation is potentially dangerous,” the Lancet editorial noted, since results of qualitative studies “suggest that women are extremely concerned about depression screening, about the stigma associated with a diagnosis of depression, and that a positive result might lead to an automatic social service referral, and potentially removal of their baby.”

A recent article, published in the New York Times, raises an additional concern about what a depression diagnosis could mean for insurability. The article highlights the experience of a woman whose diagnosis of postpartum depression is creating difficulties for her in getting life insurance. The point is underscored that it is perfectly legal for life and disability insurers to charge more to patients with a diagnosis of mental illness or to deny coverage outright.

No going back

The whole issue of perinatal depression screening has opened a Pandora’s box, and that is a good thing. The conversation is long overdue in America. It is time for greater national awareness and focus on a disease that is as prevalent as perinatal depression and as disabling for women and their families.

The focus up to this point has been on perinatal depression screening, but we’re about to see a shift toward building the community infrastructure that will be critical for managing patients, including those women who have previously been marginalized and have had very poor access to care.

Widespread screening and treatment will also require a level of cooperation between advocacy groups and providers who are multidisciplinary in their approach, taking advantage of both pharmacologic and nonpharmacologic approaches. A model of crossdisciplinary collaboration will include, for example, providers from psychiatrists to therapists to doulas to social workers to clinicians who focus on mother-infant interaction. It is a long list and models for such collaboration are somewhat lacking.

One good example of a pilot effort for such a collaboration is the Massachusetts Postpartum Depression Commission, which includes a full spectrum of participants from doulas, social workers, and perinatal psychiatrists to lay people. The partnerships and the networking that’s going on across disciplines is absolutely new and is going to be essential if we’re going to manage an issue as large as the treatment of perinatal depression.

The enhanced awareness of the need to screen for, identify, and treat postpartum depression will also lead to better tools with greater specificity, perhaps using new technologies for better identification and treatment, everything from telemedicine to smartphone applications.

There will certainly be growing pains as we gather evidence, refine our screening instruments, and build referral systems, but I don’t see this as a reason not to identify illness in this vulnerable population. Rather, it is a charge to the field that there is work to be done.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications.