COPENHAGEN – A wave of novel investigational antipsychotic agents advancing through the regulatory approval process was spotlighted at the annual congress of the European College of Neuropsychopharmacology.

Two of the highlighted agents – pimavanserin and SEP-363856 – were designed to eschew the traditional antipsychotic target, the dopamine D2 receptor, in favor of other mechanisms of action aimed at the negative symptoms of schizophrenia, for which there is a long-recognized major unmet need for better therapies.

A third agent, known for now as ALKS 3831, is composed of a combination of olanzapine and samidorphan, an opioid receptor antagonist. This once-daily oral combination of olanzapine/samidorphan (OLA/SAM) is designed to retain the clinical efficacy of olanzapine while mitigating the drug’s limiting side effect of substantial weight gain.
 

OLA/SAM New Drug Application expected soon

Christine Graham, PhD, presented highlights of the pivotal phase 3 ENLIGHTEN-2 study, a double-blind clinical trial in which 661 U.S. outpatients with schizophrenia were randomized to OLA/SAM or olanzapine alone at 10 or 20 mg/day for 24 weeks, at which point everyone was switched to open-label OLA/SAM at 10 or 20 mg/10 mg for an additional 52-week extension safety study.

Bruce Jancin/MDedge News

At 24 weeks, the OLA/SAM group had a mean 4.21% weight gain from baseline, significantly less than the 6.59% gain with olanzapine alone. A clinically meaningful and unwelcome weight gain of 7% or greater occurred in 27.5% of OLA/SAM patients, compared with 42.7% of controls, for an adjusted 50% reduction in risk in the group on the investigational medication. Similarly, a 10% or greater weight gain occurred in 17.8% of OLA/SAM patients and 29.8% of controls; once again, that represented a 50% relative risk reduction. The two therapies were equally effective, achieving roughly 10-point reductions in the Positive and Negative Syndrome Scale (PANSS) for schizophrenia total score.

Both treatments showed similar weight gain trajectories for the first 4 weeks. However, by week 6 the trajectories diverged, with body weight plateauing in the OLA/SAM group and remaining stable throughout the remainder of the 76-week, two-part study. Meanwhile, body weight continued to climb in the olanzapine-only group throughout the 24 weeks, reported Dr. Graham, senior clinical research scientist at Alkermes, in Waltham, Mass.

“The waist circumference results were surprising: We saw that waist circumference separated between the two groups as early as week 1, considerably earlier than the week 6 separation in weight. This suggests to us that even when weight gain is similar between the two treatments, OLA/SAM is showing an early effect at limiting central fat accumulation – and this has important health implications, as central fat has been shown to be potentially pathogenic for developing diabetes, cardiovascular disease, and even some forms of cancer,” she said.

The safety profile of OLA/SAM was essentially the same as for olanzapine-only, with the exception of the weight gain.

Alkermes is planning to submit its New Drug Application for OLA/SAM to the Food and Drug Administration before the year’s end. FDA officials have urged the company to broaden the application to include not only the treatment of schizophrenia, but bipolar I disorder as well, since olanzapine is an approved, well-established treatment for that disorder. Dr. Graham and coinvestigators have demonstrated that OLA/SAM has no clinically significant effect on the pharmacokinetics of lithium or valproate (Clin Drug Investig. 2019 Oct 4. doi: 10.1007/s40261-019-00860-y).

 

Phase 3 trial on pimavanserin underway

Pimavanserin is an oral selective serotonin inverse agonist, or SSIA, with a high affinity for 5-HT2A receptors, very low affinity for 5-HT2C receptors, and “absolutely no affinity” for dopaminergic, histaminergic, adrenergic, or muscarinic receptors, explained Dragana Bugarski-Kirola, MD, a psychiatrist and vice president of clinical development at Acadia Pharmaceuticals in San Diego.

Bruce Jancin/MDedge News

“Those sites are thought to contribute to sedation, cognitive impairment, and orthostatic hypotension,” she noted.

Pimavanserin is at present FDA approved for a narrow indication: Treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. But the drug’s unique mechanism of action suggests broad efficacy across a range of psychiatric disorders.

Indeed, after a successful phase 2 clinical trial of pimavanserin for treatment of Alzheimer’s-related psychosis, a phase 3 randomized, double-blind, placebo-controlled clinical trial of the drug for relapse prevention in dementia-related psychosis is now enrolling a planned 360 outpatients at 95 centers in 13 countries. This 26-week study, known as HARMONY, is preceded by open-label psychotherapy to ensure that study participants truly need pharmacotherapy. Patients are eligible regardless of their type of dementia, because psychosis in patients with various forms of dementia is clinically pretty much the same, whether the underlying disorder is Alzheimer’s disease, vascular dementia, Parkinson’s disease, or Lewy body dementia, according to Dr. Bugarski-Kirola.

In addition, pimavanserin also is the subject of an ongoing phase 3 randomized trial in patients with major depressive disorder inadequately responsive to an selective serotonin reuptake inhibitor or a selective norepinephrine reuptake inhibitor. A 380-patient phase 2 study of the drug as adjunctive treatment for negative symptoms of schizophrenia also is underway based upon earlier promising results.

Across the board for these potential indications, the drug has been well tolerated, with a side effect profile similar to that of placebo. Importantly, pimavanserin has not been associated with cognitive impairment when used for dementia-related psychosis, unlike the antipsychotics now being used off label in clinical practice, the psychiatrist said.
 

SEP-363856 part of ‘novel class’

SEP-363856 is a nondopaminergic D2, trace amine-associated receptor agonist (TAAR1) under development for treatment of schizophrenia. Phase 3 trials in adults and adolescents with schizophrenia will begin before the end of the year on the strength of positive phase 2 results, according to Kenneth S. Koblan, PhD, head of global translational medicine and early development, as well as head of discovery sciences, at Sunovion Pharmaceuticals, Marlborough, Mass.

Bruce Jancin/MDedge News

“We believe that SEP-363856 actually represents the first candidate in a novel class of antipsychotics. It’s a monoamine receptor activator, unlike the atypical antipsychotics, which work through blockade of the monoamine receptor via dopamine and serotonin. We believe that it’s the monoamine receptor activation that leads to the safety and efficacy of the class,” he explained.

In the four-country, double-blind, 4-week phase 2 trial conducted in 245 hospitalized acutely psychotic patients, oral SEP-363856 flexibly dosed at 50 or 75 mg/day had a side effect profile like that of placebo. Negative symptoms as assessed via the Brief Negative Symptom Scale improved by an average of 7.1 points at 4 weeks with SEP-363856, significantly more than the 2.7-point improvement with placebo. The PANSS total score improved by 17.2 points in the SEP-363856 group and 9.7 points in controls at 4 weeks, with a further 10-point drop in PANSS during a 6-month open-label extension phase of the study. Moreover, the SEP-363856 cohort showed significant functional improvement at 4 weeks in the UCSD Performance-Based Skills Assessment, with continued improvement during the open-label extension study.

Dr. Koblan said the pharmaceutical industry has overemphasized the development of dopaminergic D2-based drugs for schizophrenia. In the past 2 decades, roughly 30,000 patients have been enrolled in industry-sponsored, placebo-controlled, phase 2 or 3 randomized trials of drugs with that mechanism. Many of the those drugs have reached the marketplace. In contrast, there have been far fewer RCTs – and no product launches – of antipsychotics with non-D2 mechanisms of action.

“When you consider that the cost is about $50,000 per research subject and 50,000 subjects have been studied since 2000, the pharmaceutical industry has invested on the order of billions of dollars to try to come up with the next breakthrough medication,” he said.

[email protected]

COPENHAGEN – A wave of novel investigational antipsychotic agents advancing through the regulatory approval process was spotlighted at the annual congress of the European College of Neuropsychopharmacology.

Two of the highlighted agents – pimavanserin and SEP-363856 – were designed to eschew the traditional antipsychotic target, the dopamine D2 receptor, in favor of other mechanisms of action aimed at the negative symptoms of schizophrenia, for which there is a long-recognized major unmet need for better therapies.

A third agent, known for now as ALKS 3831, is composed of a combination of olanzapine and samidorphan, an opioid receptor antagonist. This once-daily oral combination of olanzapine/samidorphan (OLA/SAM) is designed to retain the clinical efficacy of olanzapine while mitigating the drug’s limiting side effect of substantial weight gain.
 

OLA/SAM New Drug Application expected soon

Christine Graham, PhD, presented highlights of the pivotal phase 3 ENLIGHTEN-2 study, a double-blind clinical trial in which 661 U.S. outpatients with schizophrenia were randomized to OLA/SAM or olanzapine alone at 10 or 20 mg/day for 24 weeks, at which point everyone was switched to open-label OLA/SAM at 10 or 20 mg/10 mg for an additional 52-week extension safety study.

Bruce Jancin/MDedge News

At 24 weeks, the OLA/SAM group had a mean 4.21% weight gain from baseline, significantly less than the 6.59% gain with olanzapine alone. A clinically meaningful and unwelcome weight gain of 7% or greater occurred in 27.5% of OLA/SAM patients, compared with 42.7% of controls, for an adjusted 50% reduction in risk in the group on the investigational medication. Similarly, a 10% or greater weight gain occurred in 17.8% of OLA/SAM patients and 29.8% of controls; once again, that represented a 50% relative risk reduction. The two therapies were equally effective, achieving roughly 10-point reductions in the Positive and Negative Syndrome Scale (PANSS) for schizophrenia total score.

Both treatments showed similar weight gain trajectories for the first 4 weeks. However, by week 6 the trajectories diverged, with body weight plateauing in the OLA/SAM group and remaining stable throughout the remainder of the 76-week, two-part study. Meanwhile, body weight continued to climb in the olanzapine-only group throughout the 24 weeks, reported Dr. Graham, senior clinical research scientist at Alkermes, in Waltham, Mass.

“The waist circumference results were surprising: We saw that waist circumference separated between the two groups as early as week 1, considerably earlier than the week 6 separation in weight. This suggests to us that even when weight gain is similar between the two treatments, OLA/SAM is showing an early effect at limiting central fat accumulation – and this has important health implications, as central fat has been shown to be potentially pathogenic for developing diabetes, cardiovascular disease, and even some forms of cancer,” she said.

The safety profile of OLA/SAM was essentially the same as for olanzapine-only, with the exception of the weight gain.

Alkermes is planning to submit its New Drug Application for OLA/SAM to the Food and Drug Administration before the year’s end. FDA officials have urged the company to broaden the application to include not only the treatment of schizophrenia, but bipolar I disorder as well, since olanzapine is an approved, well-established treatment for that disorder. Dr. Graham and coinvestigators have demonstrated that OLA/SAM has no clinically significant effect on the pharmacokinetics of lithium or valproate (Clin Drug Investig. 2019 Oct 4. doi: 10.1007/s40261-019-00860-y).

 

Phase 3 trial on pimavanserin underway

Pimavanserin is an oral selective serotonin inverse agonist, or SSIA, with a high affinity for 5-HT2A receptors, very low affinity for 5-HT2C receptors, and “absolutely no affinity” for dopaminergic, histaminergic, adrenergic, or muscarinic receptors, explained Dragana Bugarski-Kirola, MD, a psychiatrist and vice president of clinical development at Acadia Pharmaceuticals in San Diego.

Bruce Jancin/MDedge News

“Those sites are thought to contribute to sedation, cognitive impairment, and orthostatic hypotension,” she noted.

Pimavanserin is at present FDA approved for a narrow indication: Treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. But the drug’s unique mechanism of action suggests broad efficacy across a range of psychiatric disorders.

Indeed, after a successful phase 2 clinical trial of pimavanserin for treatment of Alzheimer’s-related psychosis, a phase 3 randomized, double-blind, placebo-controlled clinical trial of the drug for relapse prevention in dementia-related psychosis is now enrolling a planned 360 outpatients at 95 centers in 13 countries. This 26-week study, known as HARMONY, is preceded by open-label psychotherapy to ensure that study participants truly need pharmacotherapy. Patients are eligible regardless of their type of dementia, because psychosis in patients with various forms of dementia is clinically pretty much the same, whether the underlying disorder is Alzheimer’s disease, vascular dementia, Parkinson’s disease, or Lewy body dementia, according to Dr. Bugarski-Kirola.

In addition, pimavanserin also is the subject of an ongoing phase 3 randomized trial in patients with major depressive disorder inadequately responsive to an selective serotonin reuptake inhibitor or a selective norepinephrine reuptake inhibitor. A 380-patient phase 2 study of the drug as adjunctive treatment for negative symptoms of schizophrenia also is underway based upon earlier promising results.

Across the board for these potential indications, the drug has been well tolerated, with a side effect profile similar to that of placebo. Importantly, pimavanserin has not been associated with cognitive impairment when used for dementia-related psychosis, unlike the antipsychotics now being used off label in clinical practice, the psychiatrist said.
 

SEP-363856 part of ‘novel class’

SEP-363856 is a nondopaminergic D2, trace amine-associated receptor agonist (TAAR1) under development for treatment of schizophrenia. Phase 3 trials in adults and adolescents with schizophrenia will begin before the end of the year on the strength of positive phase 2 results, according to Kenneth S. Koblan, PhD, head of global translational medicine and early development, as well as head of discovery sciences, at Sunovion Pharmaceuticals, Marlborough, Mass.

Bruce Jancin/MDedge News

“We believe that SEP-363856 actually represents the first candidate in a novel class of antipsychotics. It’s a monoamine receptor activator, unlike the atypical antipsychotics, which work through blockade of the monoamine receptor via dopamine and serotonin. We believe that it’s the monoamine receptor activation that leads to the safety and efficacy of the class,” he explained.

In the four-country, double-blind, 4-week phase 2 trial conducted in 245 hospitalized acutely psychotic patients, oral SEP-363856 flexibly dosed at 50 or 75 mg/day had a side effect profile like that of placebo. Negative symptoms as assessed via the Brief Negative Symptom Scale improved by an average of 7.1 points at 4 weeks with SEP-363856, significantly more than the 2.7-point improvement with placebo. The PANSS total score improved by 17.2 points in the SEP-363856 group and 9.7 points in controls at 4 weeks, with a further 10-point drop in PANSS during a 6-month open-label extension phase of the study. Moreover, the SEP-363856 cohort showed significant functional improvement at 4 weeks in the UCSD Performance-Based Skills Assessment, with continued improvement during the open-label extension study.

Dr. Koblan said the pharmaceutical industry has overemphasized the development of dopaminergic D2-based drugs for schizophrenia. In the past 2 decades, roughly 30,000 patients have been enrolled in industry-sponsored, placebo-controlled, phase 2 or 3 randomized trials of drugs with that mechanism. Many of the those drugs have reached the marketplace. In contrast, there have been far fewer RCTs – and no product launches – of antipsychotics with non-D2 mechanisms of action.

“When you consider that the cost is about $50,000 per research subject and 50,000 subjects have been studied since 2000, the pharmaceutical industry has invested on the order of billions of dollars to try to come up with the next breakthrough medication,” he said.

[email protected]

COPENHAGEN – A wave of novel investigational antipsychotic agents advancing through the regulatory approval process was spotlighted at the annual congress of the European College of Neuropsychopharmacology.

Two of the highlighted agents – pimavanserin and SEP-363856 – were designed to eschew the traditional antipsychotic target, the dopamine D2 receptor, in favor of other mechanisms of action aimed at the negative symptoms of schizophrenia, for which there is a long-recognized major unmet need for better therapies.

A third agent, known for now as ALKS 3831, is composed of a combination of olanzapine and samidorphan, an opioid receptor antagonist. This once-daily oral combination of olanzapine/samidorphan (OLA/SAM) is designed to retain the clinical efficacy of olanzapine while mitigating the drug’s limiting side effect of substantial weight gain.
 

OLA/SAM New Drug Application expected soon

Christine Graham, PhD, presented highlights of the pivotal phase 3 ENLIGHTEN-2 study, a double-blind clinical trial in which 661 U.S. outpatients with schizophrenia were randomized to OLA/SAM or olanzapine alone at 10 or 20 mg/day for 24 weeks, at which point everyone was switched to open-label OLA/SAM at 10 or 20 mg/10 mg for an additional 52-week extension safety study.

Bruce Jancin/MDedge News

At 24 weeks, the OLA/SAM group had a mean 4.21% weight gain from baseline, significantly less than the 6.59% gain with olanzapine alone. A clinically meaningful and unwelcome weight gain of 7% or greater occurred in 27.5% of OLA/SAM patients, compared with 42.7% of controls, for an adjusted 50% reduction in risk in the group on the investigational medication. Similarly, a 10% or greater weight gain occurred in 17.8% of OLA/SAM patients and 29.8% of controls; once again, that represented a 50% relative risk reduction. The two therapies were equally effective, achieving roughly 10-point reductions in the Positive and Negative Syndrome Scale (PANSS) for schizophrenia total score.

Both treatments showed similar weight gain trajectories for the first 4 weeks. However, by week 6 the trajectories diverged, with body weight plateauing in the OLA/SAM group and remaining stable throughout the remainder of the 76-week, two-part study. Meanwhile, body weight continued to climb in the olanzapine-only group throughout the 24 weeks, reported Dr. Graham, senior clinical research scientist at Alkermes, in Waltham, Mass.

“The waist circumference results were surprising: We saw that waist circumference separated between the two groups as early as week 1, considerably earlier than the week 6 separation in weight. This suggests to us that even when weight gain is similar between the two treatments, OLA/SAM is showing an early effect at limiting central fat accumulation – and this has important health implications, as central fat has been shown to be potentially pathogenic for developing diabetes, cardiovascular disease, and even some forms of cancer,” she said.

The safety profile of OLA/SAM was essentially the same as for olanzapine-only, with the exception of the weight gain.

Alkermes is planning to submit its New Drug Application for OLA/SAM to the Food and Drug Administration before the year’s end. FDA officials have urged the company to broaden the application to include not only the treatment of schizophrenia, but bipolar I disorder as well, since olanzapine is an approved, well-established treatment for that disorder. Dr. Graham and coinvestigators have demonstrated that OLA/SAM has no clinically significant effect on the pharmacokinetics of lithium or valproate (Clin Drug Investig. 2019 Oct 4. doi: 10.1007/s40261-019-00860-y).

 

Phase 3 trial on pimavanserin underway

Pimavanserin is an oral selective serotonin inverse agonist, or SSIA, with a high affinity for 5-HT2A receptors, very low affinity for 5-HT2C receptors, and “absolutely no affinity” for dopaminergic, histaminergic, adrenergic, or muscarinic receptors, explained Dragana Bugarski-Kirola, MD, a psychiatrist and vice president of clinical development at Acadia Pharmaceuticals in San Diego.

Bruce Jancin/MDedge News

“Those sites are thought to contribute to sedation, cognitive impairment, and orthostatic hypotension,” she noted.

Pimavanserin is at present FDA approved for a narrow indication: Treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. But the drug’s unique mechanism of action suggests broad efficacy across a range of psychiatric disorders.

Indeed, after a successful phase 2 clinical trial of pimavanserin for treatment of Alzheimer’s-related psychosis, a phase 3 randomized, double-blind, placebo-controlled clinical trial of the drug for relapse prevention in dementia-related psychosis is now enrolling a planned 360 outpatients at 95 centers in 13 countries. This 26-week study, known as HARMONY, is preceded by open-label psychotherapy to ensure that study participants truly need pharmacotherapy. Patients are eligible regardless of their type of dementia, because psychosis in patients with various forms of dementia is clinically pretty much the same, whether the underlying disorder is Alzheimer’s disease, vascular dementia, Parkinson’s disease, or Lewy body dementia, according to Dr. Bugarski-Kirola.

In addition, pimavanserin also is the subject of an ongoing phase 3 randomized trial in patients with major depressive disorder inadequately responsive to an selective serotonin reuptake inhibitor or a selective norepinephrine reuptake inhibitor. A 380-patient phase 2 study of the drug as adjunctive treatment for negative symptoms of schizophrenia also is underway based upon earlier promising results.

Across the board for these potential indications, the drug has been well tolerated, with a side effect profile similar to that of placebo. Importantly, pimavanserin has not been associated with cognitive impairment when used for dementia-related psychosis, unlike the antipsychotics now being used off label in clinical practice, the psychiatrist said.
 

SEP-363856 part of ‘novel class’

SEP-363856 is a nondopaminergic D2, trace amine-associated receptor agonist (TAAR1) under development for treatment of schizophrenia. Phase 3 trials in adults and adolescents with schizophrenia will begin before the end of the year on the strength of positive phase 2 results, according to Kenneth S. Koblan, PhD, head of global translational medicine and early development, as well as head of discovery sciences, at Sunovion Pharmaceuticals, Marlborough, Mass.

Bruce Jancin/MDedge News

“We believe that SEP-363856 actually represents the first candidate in a novel class of antipsychotics. It’s a monoamine receptor activator, unlike the atypical antipsychotics, which work through blockade of the monoamine receptor via dopamine and serotonin. We believe that it’s the monoamine receptor activation that leads to the safety and efficacy of the class,” he explained.

In the four-country, double-blind, 4-week phase 2 trial conducted in 245 hospitalized acutely psychotic patients, oral SEP-363856 flexibly dosed at 50 or 75 mg/day had a side effect profile like that of placebo. Negative symptoms as assessed via the Brief Negative Symptom Scale improved by an average of 7.1 points at 4 weeks with SEP-363856, significantly more than the 2.7-point improvement with placebo. The PANSS total score improved by 17.2 points in the SEP-363856 group and 9.7 points in controls at 4 weeks, with a further 10-point drop in PANSS during a 6-month open-label extension phase of the study. Moreover, the SEP-363856 cohort showed significant functional improvement at 4 weeks in the UCSD Performance-Based Skills Assessment, with continued improvement during the open-label extension study.

Dr. Koblan said the pharmaceutical industry has overemphasized the development of dopaminergic D2-based drugs for schizophrenia. In the past 2 decades, roughly 30,000 patients have been enrolled in industry-sponsored, placebo-controlled, phase 2 or 3 randomized trials of drugs with that mechanism. Many of the those drugs have reached the marketplace. In contrast, there have been far fewer RCTs – and no product launches – of antipsychotics with non-D2 mechanisms of action.

“When you consider that the cost is about $50,000 per research subject and 50,000 subjects have been studied since 2000, the pharmaceutical industry has invested on the order of billions of dollars to try to come up with the next breakthrough medication,” he said.

[email protected]

Early-career researchers who are interested in studying mantle cell lymphoma can now apply for a $50,000 grant from the American Society of Clinical Oncology’s Conquer Cancer foundation.

The young investigator grant is for a 1-year period and the award is used to fund a project focused on clinical or translational research on the clinical biology, natural history, prevention, screening, diagnosis, therapy, or epidemiology of MCL.

The purpose of this annual award, according to ASCO, is to fund physicians during the transition from a fellowship program to a faculty appointment.

Eligible applicants must be physicians currently in the last 2 years of final subspecialty training and within 10 years of having obtained his or her medical degree. Additionally, applicants must be planning a research career in clinical oncology, with a focus on MCL.

The grant selection committee’s primary criteria include the significance and originality of the proposed study and hypothesis, the feasibility of the experiment and methodology, whether it has an appropriate and detailed statistical analysis plan, and if the research is patient oriented.

The application deadline is Jan. 7, 2020, and the award term is July 1, 2020–June 30, 2021.

Application instructions are available on the ASCO website.

[email protected]

Early-career researchers who are interested in studying mantle cell lymphoma can now apply for a $50,000 grant from the American Society of Clinical Oncology’s Conquer Cancer foundation.

The young investigator grant is for a 1-year period and the award is used to fund a project focused on clinical or translational research on the clinical biology, natural history, prevention, screening, diagnosis, therapy, or epidemiology of MCL.

The purpose of this annual award, according to ASCO, is to fund physicians during the transition from a fellowship program to a faculty appointment.

Eligible applicants must be physicians currently in the last 2 years of final subspecialty training and within 10 years of having obtained his or her medical degree. Additionally, applicants must be planning a research career in clinical oncology, with a focus on MCL.

The grant selection committee’s primary criteria include the significance and originality of the proposed study and hypothesis, the feasibility of the experiment and methodology, whether it has an appropriate and detailed statistical analysis plan, and if the research is patient oriented.

The application deadline is Jan. 7, 2020, and the award term is July 1, 2020–June 30, 2021.

Application instructions are available on the ASCO website.

[email protected]

Early-career researchers who are interested in studying mantle cell lymphoma can now apply for a $50,000 grant from the American Society of Clinical Oncology’s Conquer Cancer foundation.

The young investigator grant is for a 1-year period and the award is used to fund a project focused on clinical or translational research on the clinical biology, natural history, prevention, screening, diagnosis, therapy, or epidemiology of MCL.

The purpose of this annual award, according to ASCO, is to fund physicians during the transition from a fellowship program to a faculty appointment.

Eligible applicants must be physicians currently in the last 2 years of final subspecialty training and within 10 years of having obtained his or her medical degree. Additionally, applicants must be planning a research career in clinical oncology, with a focus on MCL.

The grant selection committee’s primary criteria include the significance and originality of the proposed study and hypothesis, the feasibility of the experiment and methodology, whether it has an appropriate and detailed statistical analysis plan, and if the research is patient oriented.

The application deadline is Jan. 7, 2020, and the award term is July 1, 2020–June 30, 2021.

Application instructions are available on the ASCO website.

[email protected]

A cardiologist friend of mine told me a story about one of his patients. The man had recently been in to see him for an office visit. He had quite a scare needing two stents after an episode of prolonged chest pain and, during the office visit, apparently had said that he had “found religion” and was going to change his ways. He showed off the Fitbit that he had gotten and shared his excitement about using a new app to track his diet on his smart phone. His blood pressure was a little elevated, so my friend added a third antihypertensive in an effort to get his blood pressure under control. He referred the patient back to his primary care physician to address his elevated hemoglobin A_1c.

My friend saw the patient again a couple of weeks later – this time at the mall. As he was driving through the parking lot, he noticed his patient sitting on a bench outside the entrance. He also noticed a cigarette in his patient’s right hand and saw the Fitbit still on his wrist. Now, it’s not that there is anything wrong with wearing a Fitbit, but …

My friend is an incredibly respectful person, and very nice. He decided not to say hello and risk embarrassing his patient, so he walked to a different door far from the bench and went inside. Nonetheless, the image bothered him. It bothered him enough to repeat the story to me 2 weeks later. It bothers me too.

The other day I was talking to a healthy young nurse with whom I work. She has been trying to get into shape, and her goal is to get to the gym 5 days a week after work. She read on a popular website that she should use a heart rate monitor to keep track of her training and that, if her heart rate is too slow, she should run faster and, if her heart rate is too fast, she should slow down. She was discouraged the other day, however, because her watch indicated that her pulse was going up to 170 while she was running hard, and she had heard that could be dangerous for her heart.

When she doesn’t push hard, though, she told me that her heart rate often plateaus at about 110, sometimes 115. She has been finding it difficult to achieve her calculated target heart rate of 120-160 beats per minute. She is frustrated and was going to skip her workout that evening. I explained to her that she should stop checking her pulse and just run – if she felt she was running too slow she could run faster.

Technology holds great promise to help us improve our health, but an over-reliance on technology can get in our way. With everything that we have learned about science and technology, the reality is that we are still people, with all our weaknesses and strengths. We often set goals with ambivalence, then rush forward hoping that a technological solution will move us in the direction we think we want to move. Unfortunately, owning a Fitbit will not make us more fit, and checking our pulse every five minutes while working out will not lead to a better exercise session. With the availability of so much technology for tracking our daily exercise, vital signs, and various other measures of health, we need to be more careful than ever to determine specifically what it is that we are trying to accomplish with the use of our technology.

When it comes to good health, it is the fundamentals that matter, and achieving the fundamentals requires being mindful and making repeated efforts to master them. For almost all adults, the most important habits to develop are still related to diet and exercise. Consuming the right diet and exercising adequately requires that the correct choices be made each and every day, all day long. Technology can help but will not do it for us. We need to be thoughtful about how we use technology and explicit about how we expect it to help. After a reasonable amount of time, we should evaluate to see if it is working for us. If it is, then we should continue to use it. If it is not, then we should stop using it or make a different change, like performing a new type of exercise.

Our goal should be to have intelligent empathic integration of technological and behavioral techniques to achieve an optimal health outcome. Putting running shoes by the bed at night is a great thing to do to encourage us to run in the morning. Choosing motivational music can help us get the energy and enthusiasm to go for that run (our favorites include the Rocky theme song and “I Didn’t Come this Far to Only Come this Far”). A visual reminder over the refrigerator can “nudge” us to make good choices as we open the door.

For those who want to learn more about how to integrate behavioral management into their advice for patients we highly recommend reading “Switch: How to Change Things When Change Is Hard” by Chip Heath and “Nudge: Improving Decisions About Health, Wealth, and Happiness” by Richard Thaler. We have always been, and remain, excited about the promise of technology to help us accomplish our goals. That said, we told the nurse to stop checking her pulse, to put on some music, and to appreciate the leaves on the trees this autumn while she was running. As for the gentleman outside the mall, well …

We are interested in your thoughts. Please email us at [email protected].

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

A cardiologist friend of mine told me a story about one of his patients. The man had recently been in to see him for an office visit. He had quite a scare needing two stents after an episode of prolonged chest pain and, during the office visit, apparently had said that he had “found religion” and was going to change his ways. He showed off the Fitbit that he had gotten and shared his excitement about using a new app to track his diet on his smart phone. His blood pressure was a little elevated, so my friend added a third antihypertensive in an effort to get his blood pressure under control. He referred the patient back to his primary care physician to address his elevated hemoglobin A_1c.

My friend saw the patient again a couple of weeks later – this time at the mall. As he was driving through the parking lot, he noticed his patient sitting on a bench outside the entrance. He also noticed a cigarette in his patient’s right hand and saw the Fitbit still on his wrist. Now, it’s not that there is anything wrong with wearing a Fitbit, but …

My friend is an incredibly respectful person, and very nice. He decided not to say hello and risk embarrassing his patient, so he walked to a different door far from the bench and went inside. Nonetheless, the image bothered him. It bothered him enough to repeat the story to me 2 weeks later. It bothers me too.

The other day I was talking to a healthy young nurse with whom I work. She has been trying to get into shape, and her goal is to get to the gym 5 days a week after work. She read on a popular website that she should use a heart rate monitor to keep track of her training and that, if her heart rate is too slow, she should run faster and, if her heart rate is too fast, she should slow down. She was discouraged the other day, however, because her watch indicated that her pulse was going up to 170 while she was running hard, and she had heard that could be dangerous for her heart.

When she doesn’t push hard, though, she told me that her heart rate often plateaus at about 110, sometimes 115. She has been finding it difficult to achieve her calculated target heart rate of 120-160 beats per minute. She is frustrated and was going to skip her workout that evening. I explained to her that she should stop checking her pulse and just run – if she felt she was running too slow she could run faster.

Technology holds great promise to help us improve our health, but an over-reliance on technology can get in our way. With everything that we have learned about science and technology, the reality is that we are still people, with all our weaknesses and strengths. We often set goals with ambivalence, then rush forward hoping that a technological solution will move us in the direction we think we want to move. Unfortunately, owning a Fitbit will not make us more fit, and checking our pulse every five minutes while working out will not lead to a better exercise session. With the availability of so much technology for tracking our daily exercise, vital signs, and various other measures of health, we need to be more careful than ever to determine specifically what it is that we are trying to accomplish with the use of our technology.

When it comes to good health, it is the fundamentals that matter, and achieving the fundamentals requires being mindful and making repeated efforts to master them. For almost all adults, the most important habits to develop are still related to diet and exercise. Consuming the right diet and exercising adequately requires that the correct choices be made each and every day, all day long. Technology can help but will not do it for us. We need to be thoughtful about how we use technology and explicit about how we expect it to help. After a reasonable amount of time, we should evaluate to see if it is working for us. If it is, then we should continue to use it. If it is not, then we should stop using it or make a different change, like performing a new type of exercise.

Our goal should be to have intelligent empathic integration of technological and behavioral techniques to achieve an optimal health outcome. Putting running shoes by the bed at night is a great thing to do to encourage us to run in the morning. Choosing motivational music can help us get the energy and enthusiasm to go for that run (our favorites include the Rocky theme song and “I Didn’t Come this Far to Only Come this Far”). A visual reminder over the refrigerator can “nudge” us to make good choices as we open the door.

For those who want to learn more about how to integrate behavioral management into their advice for patients we highly recommend reading “Switch: How to Change Things When Change Is Hard” by Chip Heath and “Nudge: Improving Decisions About Health, Wealth, and Happiness” by Richard Thaler. We have always been, and remain, excited about the promise of technology to help us accomplish our goals. That said, we told the nurse to stop checking her pulse, to put on some music, and to appreciate the leaves on the trees this autumn while she was running. As for the gentleman outside the mall, well …

We are interested in your thoughts. Please email us at [email protected].

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

A cardiologist friend of mine told me a story about one of his patients. The man had recently been in to see him for an office visit. He had quite a scare needing two stents after an episode of prolonged chest pain and, during the office visit, apparently had said that he had “found religion” and was going to change his ways. He showed off the Fitbit that he had gotten and shared his excitement about using a new app to track his diet on his smart phone. His blood pressure was a little elevated, so my friend added a third antihypertensive in an effort to get his blood pressure under control. He referred the patient back to his primary care physician to address his elevated hemoglobin A_1c.

My friend saw the patient again a couple of weeks later – this time at the mall. As he was driving through the parking lot, he noticed his patient sitting on a bench outside the entrance. He also noticed a cigarette in his patient’s right hand and saw the Fitbit still on his wrist. Now, it’s not that there is anything wrong with wearing a Fitbit, but …

My friend is an incredibly respectful person, and very nice. He decided not to say hello and risk embarrassing his patient, so he walked to a different door far from the bench and went inside. Nonetheless, the image bothered him. It bothered him enough to repeat the story to me 2 weeks later. It bothers me too.

The other day I was talking to a healthy young nurse with whom I work. She has been trying to get into shape, and her goal is to get to the gym 5 days a week after work. She read on a popular website that she should use a heart rate monitor to keep track of her training and that, if her heart rate is too slow, she should run faster and, if her heart rate is too fast, she should slow down. She was discouraged the other day, however, because her watch indicated that her pulse was going up to 170 while she was running hard, and she had heard that could be dangerous for her heart.

When she doesn’t push hard, though, she told me that her heart rate often plateaus at about 110, sometimes 115. She has been finding it difficult to achieve her calculated target heart rate of 120-160 beats per minute. She is frustrated and was going to skip her workout that evening. I explained to her that she should stop checking her pulse and just run – if she felt she was running too slow she could run faster.

Technology holds great promise to help us improve our health, but an over-reliance on technology can get in our way. With everything that we have learned about science and technology, the reality is that we are still people, with all our weaknesses and strengths. We often set goals with ambivalence, then rush forward hoping that a technological solution will move us in the direction we think we want to move. Unfortunately, owning a Fitbit will not make us more fit, and checking our pulse every five minutes while working out will not lead to a better exercise session. With the availability of so much technology for tracking our daily exercise, vital signs, and various other measures of health, we need to be more careful than ever to determine specifically what it is that we are trying to accomplish with the use of our technology.

When it comes to good health, it is the fundamentals that matter, and achieving the fundamentals requires being mindful and making repeated efforts to master them. For almost all adults, the most important habits to develop are still related to diet and exercise. Consuming the right diet and exercising adequately requires that the correct choices be made each and every day, all day long. Technology can help but will not do it for us. We need to be thoughtful about how we use technology and explicit about how we expect it to help. After a reasonable amount of time, we should evaluate to see if it is working for us. If it is, then we should continue to use it. If it is not, then we should stop using it or make a different change, like performing a new type of exercise.

Our goal should be to have intelligent empathic integration of technological and behavioral techniques to achieve an optimal health outcome. Putting running shoes by the bed at night is a great thing to do to encourage us to run in the morning. Choosing motivational music can help us get the energy and enthusiasm to go for that run (our favorites include the Rocky theme song and “I Didn’t Come this Far to Only Come this Far”). A visual reminder over the refrigerator can “nudge” us to make good choices as we open the door.

For those who want to learn more about how to integrate behavioral management into their advice for patients we highly recommend reading “Switch: How to Change Things When Change Is Hard” by Chip Heath and “Nudge: Improving Decisions About Health, Wealth, and Happiness” by Richard Thaler. We have always been, and remain, excited about the promise of technology to help us accomplish our goals. That said, we told the nurse to stop checking her pulse, to put on some music, and to appreciate the leaves on the trees this autumn while she was running. As for the gentleman outside the mall, well …

We are interested in your thoughts. Please email us at [email protected].

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

ORLANDO – Transwomen are more likely to have a lower bone mineral density (BMD) before beginning hormone therapy, compared with male reference populations, but there are no short- or long-term risks to bone health over the life of a transperson who receives hormone therapy, according to a presentation at the annual meeting of the American Society for Bone and Mineral Research.

“Hormonal treatment of transgender people is safe with respect to bone,” said Martin den Heijer, MD, PhD, of the VU University Medical Center in Amsterdam.

At baseline, transwomen have lower bone mass than do male reference populations, said Dr. den Heijer, citing a study that found 25 transwomen had less muscle mass (P less than or equal to .001), strength (P less than or equal to .05), and lower BMD at the hip, femoral neck, and spine (P less than .001), compared with 25 cisgender men in a control group and 941 men in a male reference population (Bone. 2013;54[1]:92-7). In a 2019 study from his own group, Dr. den Heijer said the z score in the lumbar spine for 711 transwomen was -0.9 and the incidence of osteoporosis was 14.2%, compared with a z score of 0.0 and 2.4% incidence of osteoporosis in 543 transmen (J Bone Min Res. 2019;34[3]:447-54).

In the prospective European Network for the Investigation of Gender Incongruence (ENIGI) study, researchers examined short-term effects of hormone therapy on BMD in 144 transwomen and 162 transmen who had a normal body mass index and were mostly white. The percentage of patients who reported they were current smokers was between 25% and 30%, and fewer than 10% said they consumed more than seven units of alcohol per week. Transwomen received estradiol (an oral estradiol valerate at a dose of 4 mg/day or an estradiol patch) together with 100 mg/day of cyproterone acetate, and transmen received testosterone in the form of a gel (50 mg/day), intramuscular esters (250 mg every 2-3 weeks), or intramuscular undecanoate at a dose of 1,000 mg every 12 weeks (J Sex Med. 2016;13[6]:994-9).

After 1 year of treatment, there were significant increases in BMD in transwomen in the lumbar spine (3.67%; 95% confidence interval, 3.20%-4.13%), femoral neck (1.86%; 95% CI, 1.41%-2.31%), and total hip (0.97%; 95% CI, 0.62%-1.31%). Transmen also had increased BMD in the lumbar spine (0.86%; 95% CI, 0.38%-1.35%) and total hip (1.04%; 95% CI, 0.64%-1.44%), with a slight decrease in femoral neck BMD (–0.46%; 95% CI, –1.07% to 0.16%).

Dr. den Heijer also discussed the long-term effects of hormone therapy on BMD in the Amsterdam Cohort of Dysphoria (ACOG) study, which consisted of 711 transwomen and 543 transmen and followed some patients out to 2 years, 5 years, and 10 years after beginning hormone therapy (J Sex Med. 2018;15[4]:582-90). Among transwomen, the median age was 33 years, 68.9% had begun hormone therapy, and 75.3% received a gonadectomy; among transmen, the median age was 25 years, 72.9% had begun hormone therapy, and 83.8% received a gonadectomy. Of these patients, dual-energy x-ray absorptiometry data were available for the lumbar spine BMD for 234 transwomen and 236 transmen at 2 years, 174 transwomen and 95 transmen at 5 years, and 102 transwomen and 70 transmen at 10 years.

Although there was no significant mean change in absolute BMD over the 10-year period, the concentration of estradiol in transwomen and transmen affected change in BMD the longer the transperson was receiving hormone therapy: Transwomen who received an estradiol concentration of 118 pmol/L had a decrease of –0.026% at 2 years, –0.044% at 5 years, and –0.009% at 10 years, compared with a dose of 443 pmol/L (+0.044% at 2 years, +0.025% at 5 years, +0.063% at 10 years), whereas transmen also had decreased BMD at the lowest estradiol concentrations of 95 pmol/L (–0.007% at 2 years, –0.024% at 5 years, +0.010% at 10 years), compared with transmen receiving the highest doses of 323 pmol/L (+0.028% at 2 years, +0.002% at 5 years, +0.053% at 10 years). There was no significant change in BMD in either group at any time point with regard to testosterone concentration.

When the investigators linked these patients to a national statistics database in the Netherlands to evaluate fracture incidence (J Bone Miner Res. 2019 Sep 5. doi: 10.1002/jbmr.3862), pairing five cisgender female controls and five cisgender male controls to every transgender patient, the researchers found transwomen had a higher incidence of osteoporotic fracture of the hip, spine, forearm, and humerus (41.8%), compared with cisgender men (26.6%; P = .014) and cisgender women (36.0%; P = .381). There was not enough information in the study to examine fracture information for transmen, Dr. den Heijer said. Transwomen and transmen who experienced a fracture were more likely to be a current smoker and have lower estradiol concentrations than were transwomen and transmen, respectively, who did not have a fracture.

“Attention for lifestyle factors remains important, especially smoking cessation, vitamin D intake, and regular exercise,” Dr. den Heijer said. “It remains important for everybody, but especially for transgender women.”

Dr. den Heijer reported no relevant conflicts of interest.
 

ORLANDO – Transwomen are more likely to have a lower bone mineral density (BMD) before beginning hormone therapy, compared with male reference populations, but there are no short- or long-term risks to bone health over the life of a transperson who receives hormone therapy, according to a presentation at the annual meeting of the American Society for Bone and Mineral Research.

“Hormonal treatment of transgender people is safe with respect to bone,” said Martin den Heijer, MD, PhD, of the VU University Medical Center in Amsterdam.

At baseline, transwomen have lower bone mass than do male reference populations, said Dr. den Heijer, citing a study that found 25 transwomen had less muscle mass (P less than or equal to .001), strength (P less than or equal to .05), and lower BMD at the hip, femoral neck, and spine (P less than .001), compared with 25 cisgender men in a control group and 941 men in a male reference population (Bone. 2013;54[1]:92-7). In a 2019 study from his own group, Dr. den Heijer said the z score in the lumbar spine for 711 transwomen was -0.9 and the incidence of osteoporosis was 14.2%, compared with a z score of 0.0 and 2.4% incidence of osteoporosis in 543 transmen (J Bone Min Res. 2019;34[3]:447-54).

In the prospective European Network for the Investigation of Gender Incongruence (ENIGI) study, researchers examined short-term effects of hormone therapy on BMD in 144 transwomen and 162 transmen who had a normal body mass index and were mostly white. The percentage of patients who reported they were current smokers was between 25% and 30%, and fewer than 10% said they consumed more than seven units of alcohol per week. Transwomen received estradiol (an oral estradiol valerate at a dose of 4 mg/day or an estradiol patch) together with 100 mg/day of cyproterone acetate, and transmen received testosterone in the form of a gel (50 mg/day), intramuscular esters (250 mg every 2-3 weeks), or intramuscular undecanoate at a dose of 1,000 mg every 12 weeks (J Sex Med. 2016;13[6]:994-9).

After 1 year of treatment, there were significant increases in BMD in transwomen in the lumbar spine (3.67%; 95% confidence interval, 3.20%-4.13%), femoral neck (1.86%; 95% CI, 1.41%-2.31%), and total hip (0.97%; 95% CI, 0.62%-1.31%). Transmen also had increased BMD in the lumbar spine (0.86%; 95% CI, 0.38%-1.35%) and total hip (1.04%; 95% CI, 0.64%-1.44%), with a slight decrease in femoral neck BMD (–0.46%; 95% CI, –1.07% to 0.16%).

Dr. den Heijer also discussed the long-term effects of hormone therapy on BMD in the Amsterdam Cohort of Dysphoria (ACOG) study, which consisted of 711 transwomen and 543 transmen and followed some patients out to 2 years, 5 years, and 10 years after beginning hormone therapy (J Sex Med. 2018;15[4]:582-90). Among transwomen, the median age was 33 years, 68.9% had begun hormone therapy, and 75.3% received a gonadectomy; among transmen, the median age was 25 years, 72.9% had begun hormone therapy, and 83.8% received a gonadectomy. Of these patients, dual-energy x-ray absorptiometry data were available for the lumbar spine BMD for 234 transwomen and 236 transmen at 2 years, 174 transwomen and 95 transmen at 5 years, and 102 transwomen and 70 transmen at 10 years.

Although there was no significant mean change in absolute BMD over the 10-year period, the concentration of estradiol in transwomen and transmen affected change in BMD the longer the transperson was receiving hormone therapy: Transwomen who received an estradiol concentration of 118 pmol/L had a decrease of –0.026% at 2 years, –0.044% at 5 years, and –0.009% at 10 years, compared with a dose of 443 pmol/L (+0.044% at 2 years, +0.025% at 5 years, +0.063% at 10 years), whereas transmen also had decreased BMD at the lowest estradiol concentrations of 95 pmol/L (–0.007% at 2 years, –0.024% at 5 years, +0.010% at 10 years), compared with transmen receiving the highest doses of 323 pmol/L (+0.028% at 2 years, +0.002% at 5 years, +0.053% at 10 years). There was no significant change in BMD in either group at any time point with regard to testosterone concentration.

When the investigators linked these patients to a national statistics database in the Netherlands to evaluate fracture incidence (J Bone Miner Res. 2019 Sep 5. doi: 10.1002/jbmr.3862), pairing five cisgender female controls and five cisgender male controls to every transgender patient, the researchers found transwomen had a higher incidence of osteoporotic fracture of the hip, spine, forearm, and humerus (41.8%), compared with cisgender men (26.6%; P = .014) and cisgender women (36.0%; P = .381). There was not enough information in the study to examine fracture information for transmen, Dr. den Heijer said. Transwomen and transmen who experienced a fracture were more likely to be a current smoker and have lower estradiol concentrations than were transwomen and transmen, respectively, who did not have a fracture.

“Attention for lifestyle factors remains important, especially smoking cessation, vitamin D intake, and regular exercise,” Dr. den Heijer said. “It remains important for everybody, but especially for transgender women.”

Dr. den Heijer reported no relevant conflicts of interest.
 

ORLANDO – Transwomen are more likely to have a lower bone mineral density (BMD) before beginning hormone therapy, compared with male reference populations, but there are no short- or long-term risks to bone health over the life of a transperson who receives hormone therapy, according to a presentation at the annual meeting of the American Society for Bone and Mineral Research.

“Hormonal treatment of transgender people is safe with respect to bone,” said Martin den Heijer, MD, PhD, of the VU University Medical Center in Amsterdam.

At baseline, transwomen have lower bone mass than do male reference populations, said Dr. den Heijer, citing a study that found 25 transwomen had less muscle mass (P less than or equal to .001), strength (P less than or equal to .05), and lower BMD at the hip, femoral neck, and spine (P less than .001), compared with 25 cisgender men in a control group and 941 men in a male reference population (Bone. 2013;54[1]:92-7). In a 2019 study from his own group, Dr. den Heijer said the z score in the lumbar spine for 711 transwomen was -0.9 and the incidence of osteoporosis was 14.2%, compared with a z score of 0.0 and 2.4% incidence of osteoporosis in 543 transmen (J Bone Min Res. 2019;34[3]:447-54).

In the prospective European Network for the Investigation of Gender Incongruence (ENIGI) study, researchers examined short-term effects of hormone therapy on BMD in 144 transwomen and 162 transmen who had a normal body mass index and were mostly white. The percentage of patients who reported they were current smokers was between 25% and 30%, and fewer than 10% said they consumed more than seven units of alcohol per week. Transwomen received estradiol (an oral estradiol valerate at a dose of 4 mg/day or an estradiol patch) together with 100 mg/day of cyproterone acetate, and transmen received testosterone in the form of a gel (50 mg/day), intramuscular esters (250 mg every 2-3 weeks), or intramuscular undecanoate at a dose of 1,000 mg every 12 weeks (J Sex Med. 2016;13[6]:994-9).

After 1 year of treatment, there were significant increases in BMD in transwomen in the lumbar spine (3.67%; 95% confidence interval, 3.20%-4.13%), femoral neck (1.86%; 95% CI, 1.41%-2.31%), and total hip (0.97%; 95% CI, 0.62%-1.31%). Transmen also had increased BMD in the lumbar spine (0.86%; 95% CI, 0.38%-1.35%) and total hip (1.04%; 95% CI, 0.64%-1.44%), with a slight decrease in femoral neck BMD (–0.46%; 95% CI, –1.07% to 0.16%).

Dr. den Heijer also discussed the long-term effects of hormone therapy on BMD in the Amsterdam Cohort of Dysphoria (ACOG) study, which consisted of 711 transwomen and 543 transmen and followed some patients out to 2 years, 5 years, and 10 years after beginning hormone therapy (J Sex Med. 2018;15[4]:582-90). Among transwomen, the median age was 33 years, 68.9% had begun hormone therapy, and 75.3% received a gonadectomy; among transmen, the median age was 25 years, 72.9% had begun hormone therapy, and 83.8% received a gonadectomy. Of these patients, dual-energy x-ray absorptiometry data were available for the lumbar spine BMD for 234 transwomen and 236 transmen at 2 years, 174 transwomen and 95 transmen at 5 years, and 102 transwomen and 70 transmen at 10 years.

Although there was no significant mean change in absolute BMD over the 10-year period, the concentration of estradiol in transwomen and transmen affected change in BMD the longer the transperson was receiving hormone therapy: Transwomen who received an estradiol concentration of 118 pmol/L had a decrease of –0.026% at 2 years, –0.044% at 5 years, and –0.009% at 10 years, compared with a dose of 443 pmol/L (+0.044% at 2 years, +0.025% at 5 years, +0.063% at 10 years), whereas transmen also had decreased BMD at the lowest estradiol concentrations of 95 pmol/L (–0.007% at 2 years, –0.024% at 5 years, +0.010% at 10 years), compared with transmen receiving the highest doses of 323 pmol/L (+0.028% at 2 years, +0.002% at 5 years, +0.053% at 10 years). There was no significant change in BMD in either group at any time point with regard to testosterone concentration.

When the investigators linked these patients to a national statistics database in the Netherlands to evaluate fracture incidence (J Bone Miner Res. 2019 Sep 5. doi: 10.1002/jbmr.3862), pairing five cisgender female controls and five cisgender male controls to every transgender patient, the researchers found transwomen had a higher incidence of osteoporotic fracture of the hip, spine, forearm, and humerus (41.8%), compared with cisgender men (26.6%; P = .014) and cisgender women (36.0%; P = .381). There was not enough information in the study to examine fracture information for transmen, Dr. den Heijer said. Transwomen and transmen who experienced a fracture were more likely to be a current smoker and have lower estradiol concentrations than were transwomen and transmen, respectively, who did not have a fracture.

“Attention for lifestyle factors remains important, especially smoking cessation, vitamin D intake, and regular exercise,” Dr. den Heijer said. “It remains important for everybody, but especially for transgender women.”

Dr. den Heijer reported no relevant conflicts of interest.
 

The Centers for Medicare & Medicaid Services needs to be doing a better job overseeing the administrative costs associated with the implementation of work requirements in Medicaid, the Government Accountability Office said in a new report.

thinkstockphotos.com

The government watchdog found two key weaknesses in CMS’s oversight of the administrative costs of the Medicaid demonstration projects related to work requirements for Medicaid.

First, the GAO report notes that no consideration of the administrative costs of the work requirements is given during the administration of the approval process.

The GAO reports that, of five states’ approvals, the estimated administrative costs range from the low end of $6.1 million for New Hampshire (with 50,000 beneficiaries subject to the work requirement) to $271.6 million for Kentucky (with 620,000 beneficiaries subject to the work requirement). Indiana, with 420,000 beneficiaries subject to work requirements, has an estimated cost of $35.1 million.

A significant portion of Kentucky’s funding was for a the development of a new information technology system to help track work requirements.

“GAO found that CMS does not require states to provide projections of administrative costs when requesting demonstration approvals,” the report states. “Thus, the cost of administering demonstrations, including those with work requirements, is not transparent to the public or included in CMS’s assessment of whether a demonstration is budget neutral – that is, that federal spending will be no higher under the demonstration than it would have been without it.”

The GAO also reported that, by not requiring cost estimates, it also fails to meet the demonstration objective of transparency, something that goes hand in hand with budget neutrality.

The second weakness identified by GAO is that current procedures “may be insufficient to ensure that costs are allowable and matched at the correct rate.” Three of the five states examined in the report had received CMS approval for federal funds for administrative costs that were either not allowable for matching or were matched at higher rates than appropriate, based on CMS guidance.

The government watchdog noted that CMS did implement “procedures that may provide additional information on demonstrations’ administrative costs. ... However, it is unclear whether these efforts will result in data that improves CMS’s oversight.”

The GAO made three recommendations in the report. First, the CMS should require states to submit public projections of administrative costs when seeking approval for demonstration projects. Second, the administrative costs should be a part of the calculation for assessing the budget neutrality of demonstration project applications. Finally, CMS should do a better job assessing the risk that federal funds are being used to cover administrative costs that are not allowable and should improve oversight procedures as needed.

The GAO report included the Department of Health & Human Services’s response to the recommendations. To the first, the agency said that “its experience suggests that demonstration administrative costs will be a relatively small portion of total costs and therefore HHS believes making information about these costs available would provide stakeholders little to no value.”

Similarly, to the second recommendation, HHS countered that the information would provide little to no value given that administrative costs represent a relatively small portion of the total demonstration costs.

To the final recommendation on the need for better risk assessment, HHS said its existing approach “is appropriate for the low level of risk that administrative expenditures represent. ... CMS officials told us that they had not assessed wither current procedures sufficiently address risks posed by administrative costs for work requirements and had no plans to do so.”

[email protected]

The Centers for Medicare & Medicaid Services needs to be doing a better job overseeing the administrative costs associated with the implementation of work requirements in Medicaid, the Government Accountability Office said in a new report.

thinkstockphotos.com

The government watchdog found two key weaknesses in CMS’s oversight of the administrative costs of the Medicaid demonstration projects related to work requirements for Medicaid.

First, the GAO report notes that no consideration of the administrative costs of the work requirements is given during the administration of the approval process.

The GAO reports that, of five states’ approvals, the estimated administrative costs range from the low end of $6.1 million for New Hampshire (with 50,000 beneficiaries subject to the work requirement) to $271.6 million for Kentucky (with 620,000 beneficiaries subject to the work requirement). Indiana, with 420,000 beneficiaries subject to work requirements, has an estimated cost of $35.1 million.

A significant portion of Kentucky’s funding was for a the development of a new information technology system to help track work requirements.

“GAO found that CMS does not require states to provide projections of administrative costs when requesting demonstration approvals,” the report states. “Thus, the cost of administering demonstrations, including those with work requirements, is not transparent to the public or included in CMS’s assessment of whether a demonstration is budget neutral – that is, that federal spending will be no higher under the demonstration than it would have been without it.”

The GAO also reported that, by not requiring cost estimates, it also fails to meet the demonstration objective of transparency, something that goes hand in hand with budget neutrality.

The second weakness identified by GAO is that current procedures “may be insufficient to ensure that costs are allowable and matched at the correct rate.” Three of the five states examined in the report had received CMS approval for federal funds for administrative costs that were either not allowable for matching or were matched at higher rates than appropriate, based on CMS guidance.

The government watchdog noted that CMS did implement “procedures that may provide additional information on demonstrations’ administrative costs. ... However, it is unclear whether these efforts will result in data that improves CMS’s oversight.”

The GAO made three recommendations in the report. First, the CMS should require states to submit public projections of administrative costs when seeking approval for demonstration projects. Second, the administrative costs should be a part of the calculation for assessing the budget neutrality of demonstration project applications. Finally, CMS should do a better job assessing the risk that federal funds are being used to cover administrative costs that are not allowable and should improve oversight procedures as needed.

The GAO report included the Department of Health & Human Services’s response to the recommendations. To the first, the agency said that “its experience suggests that demonstration administrative costs will be a relatively small portion of total costs and therefore HHS believes making information about these costs available would provide stakeholders little to no value.”

Similarly, to the second recommendation, HHS countered that the information would provide little to no value given that administrative costs represent a relatively small portion of the total demonstration costs.

To the final recommendation on the need for better risk assessment, HHS said its existing approach “is appropriate for the low level of risk that administrative expenditures represent. ... CMS officials told us that they had not assessed wither current procedures sufficiently address risks posed by administrative costs for work requirements and had no plans to do so.”

[email protected]

The Centers for Medicare & Medicaid Services needs to be doing a better job overseeing the administrative costs associated with the implementation of work requirements in Medicaid, the Government Accountability Office said in a new report.

thinkstockphotos.com

The government watchdog found two key weaknesses in CMS’s oversight of the administrative costs of the Medicaid demonstration projects related to work requirements for Medicaid.

First, the GAO report notes that no consideration of the administrative costs of the work requirements is given during the administration of the approval process.

The GAO reports that, of five states’ approvals, the estimated administrative costs range from the low end of $6.1 million for New Hampshire (with 50,000 beneficiaries subject to the work requirement) to $271.6 million for Kentucky (with 620,000 beneficiaries subject to the work requirement). Indiana, with 420,000 beneficiaries subject to work requirements, has an estimated cost of $35.1 million.

A significant portion of Kentucky’s funding was for a the development of a new information technology system to help track work requirements.

“GAO found that CMS does not require states to provide projections of administrative costs when requesting demonstration approvals,” the report states. “Thus, the cost of administering demonstrations, including those with work requirements, is not transparent to the public or included in CMS’s assessment of whether a demonstration is budget neutral – that is, that federal spending will be no higher under the demonstration than it would have been without it.”

The GAO also reported that, by not requiring cost estimates, it also fails to meet the demonstration objective of transparency, something that goes hand in hand with budget neutrality.

The second weakness identified by GAO is that current procedures “may be insufficient to ensure that costs are allowable and matched at the correct rate.” Three of the five states examined in the report had received CMS approval for federal funds for administrative costs that were either not allowable for matching or were matched at higher rates than appropriate, based on CMS guidance.

The government watchdog noted that CMS did implement “procedures that may provide additional information on demonstrations’ administrative costs. ... However, it is unclear whether these efforts will result in data that improves CMS’s oversight.”

The GAO made three recommendations in the report. First, the CMS should require states to submit public projections of administrative costs when seeking approval for demonstration projects. Second, the administrative costs should be a part of the calculation for assessing the budget neutrality of demonstration project applications. Finally, CMS should do a better job assessing the risk that federal funds are being used to cover administrative costs that are not allowable and should improve oversight procedures as needed.

The GAO report included the Department of Health & Human Services’s response to the recommendations. To the first, the agency said that “its experience suggests that demonstration administrative costs will be a relatively small portion of total costs and therefore HHS believes making information about these costs available would provide stakeholders little to no value.”

Similarly, to the second recommendation, HHS countered that the information would provide little to no value given that administrative costs represent a relatively small portion of the total demonstration costs.

To the final recommendation on the need for better risk assessment, HHS said its existing approach “is appropriate for the low level of risk that administrative expenditures represent. ... CMS officials told us that they had not assessed wither current procedures sufficiently address risks posed by administrative costs for work requirements and had no plans to do so.”

[email protected]

Practice Puzzlers are an entertaining way to challenge your clinical expertise. To make the experience more enjoyable, here's how to use the tools located in the bar above the crossword.

• Away from your computer? Click “Print” to download and print a blank puzzle or the answer key to the puzzle.
• With the "group tool" invite colleagues to play with you and share final scores.
• To keep it fun, you can “Reveal” or “Check” a letter, word, or the entire grid; change the “Settings” to suit your preferences; or use the “Pencil” toggle to enter the answer in gray and later make it a normal entry when you’re sure about it.

Scoring

You get 10 points for each correct word completed. Revealing letters or words will cost you points. For each square you reveal, you lose 1 point, but you can still get the 10 points if you get the word right. You get 0 points if you reveal an entire word. The target time to complete this puzzle is 15 minutes. When you complete the puzzle, you will get a bonus of 15 points for every full minute under the target. There is no penalty for going over the time limit.

Practice Puzzlers are an entertaining way to challenge your clinical expertise. To make the experience more enjoyable, here's how to use the tools located in the bar above the crossword.

• Away from your computer? Click “Print” to download and print a blank puzzle or the answer key to the puzzle.
• With the "group tool" invite colleagues to play with you and share final scores.
• To keep it fun, you can “Reveal” or “Check” a letter, word, or the entire grid; change the “Settings” to suit your preferences; or use the “Pencil” toggle to enter the answer in gray and later make it a normal entry when you’re sure about it.

Scoring

You get 10 points for each correct word completed. Revealing letters or words will cost you points. For each square you reveal, you lose 1 point, but you can still get the 10 points if you get the word right. You get 0 points if you reveal an entire word. The target time to complete this puzzle is 15 minutes. When you complete the puzzle, you will get a bonus of 15 points for every full minute under the target. There is no penalty for going over the time limit.

Practice Puzzlers are an entertaining way to challenge your clinical expertise. To make the experience more enjoyable, here's how to use the tools located in the bar above the crossword.

• Away from your computer? Click “Print” to download and print a blank puzzle or the answer key to the puzzle.
• With the "group tool" invite colleagues to play with you and share final scores.
• To keep it fun, you can “Reveal” or “Check” a letter, word, or the entire grid; change the “Settings” to suit your preferences; or use the “Pencil” toggle to enter the answer in gray and later make it a normal entry when you’re sure about it.

Scoring

You get 10 points for each correct word completed. Revealing letters or words will cost you points. For each square you reveal, you lose 1 point, but you can still get the 10 points if you get the word right. You get 0 points if you reveal an entire word. The target time to complete this puzzle is 15 minutes. When you complete the puzzle, you will get a bonus of 15 points for every full minute under the target. There is no penalty for going over the time limit.

Allogeneic hematopoietic cell transplantation is a better option than consolidation chemotherapy in patients with secondary acute myeloid leukemia, yielding significantly better survival outcomes, according to findings from an observational study.

National Institutes of Health/Wikimedia Commons/Public Domain

Although secondary AML has been identified as an independent predictor of poor prognosis, it is not included in current risk classifications that provide the basis of deciding when to perform HCT.

Christer Nilsson, MD, of Karolinska Institute, Stockholm, and colleagues, used two nationwide Swedish registries – the Swedish AML Registry and the Swedish Cancer Registry – to characterize how often HCT is performed in these patients and to evaluate its impact in a real-world setting. The registries include all patients with AML diagnosed between 1997 and 2013.

Their findings are in Biology of Blood and Marrow Transplantation.

The analysis included 3,337 adult patients with AML who were intensively treated and did not have acute promyelocytic leukemia. More than three-quarters of the patients had de novo AML and the remainder had secondary AML that was either therapy related or developed after an antecedent myeloid disease. In total, 100 patients with secondary AML underwent HCT while in first complete remission.

In terms of crude survival at 5 years after diagnosis, patients with secondary AML who did not undergo HCT did very poorly. The survival rate was 0% in those with AML preceded by myeloproliferative neoplasm (MPN-AML), 2% in patients with AML preceded by myelodysplastic syndrome (MDS-AML), and 4% in patients with therapy-related AML (t-AML). In contrast, the 5-year overall survival in patients who underwent HCT at any time point or disease stage was 32% for patients with MPN-AML, 18% for patients with MDS-AML, and 25% for patients t-AML.

These crude survival figures suggest that “HCT is the sole realistic curable treatment option for [secondary] AML,” the researchers wrote.

The researchers also performed a propensity score matching analysis of HCT versus chemotherapy consolidation in patients with secondary AML who had been in first complete remission for more than 90 days. The model matched 45 patients who underwent HCT with 66 patients treated with chemotherapy consolidation. The projected 5-year overall survival was 48% in the HCT group, compared with 20% in the consolidation group (P = .01). Similarly, 5-year relapse-free survival was also higher in the HCT group, compared with the consolidation group (43% vs. 21%, P = .02).

“Ideally, the role of transplantation in [secondary] AML should be evaluated in a prospective randomized trial, minimizing the risk of any bias,” the researchers wrote. “However, such a trial is lacking and most likely will never be performed.”

The researchers concluded that HCT should be considered for all patients with secondary AML who are eligible and fit for transplantation.

The study was supported by the Swedish Cancer Foundation, Swedish Research Council, Stockholm County Council, Gothenberg Medical Society, and Assar Gabrielsson Foundation. The researchers reported having no conflicts of interest.

[email protected]

SOURCE: Nilson C et al. Biol Blood Marrow Tranplant. 2019;25:1770-8.

Allogeneic hematopoietic cell transplantation is a better option than consolidation chemotherapy in patients with secondary acute myeloid leukemia, yielding significantly better survival outcomes, according to findings from an observational study.

National Institutes of Health/Wikimedia Commons/Public Domain

Although secondary AML has been identified as an independent predictor of poor prognosis, it is not included in current risk classifications that provide the basis of deciding when to perform HCT.

Christer Nilsson, MD, of Karolinska Institute, Stockholm, and colleagues, used two nationwide Swedish registries – the Swedish AML Registry and the Swedish Cancer Registry – to characterize how often HCT is performed in these patients and to evaluate its impact in a real-world setting. The registries include all patients with AML diagnosed between 1997 and 2013.

Their findings are in Biology of Blood and Marrow Transplantation.

The analysis included 3,337 adult patients with AML who were intensively treated and did not have acute promyelocytic leukemia. More than three-quarters of the patients had de novo AML and the remainder had secondary AML that was either therapy related or developed after an antecedent myeloid disease. In total, 100 patients with secondary AML underwent HCT while in first complete remission.

In terms of crude survival at 5 years after diagnosis, patients with secondary AML who did not undergo HCT did very poorly. The survival rate was 0% in those with AML preceded by myeloproliferative neoplasm (MPN-AML), 2% in patients with AML preceded by myelodysplastic syndrome (MDS-AML), and 4% in patients with therapy-related AML (t-AML). In contrast, the 5-year overall survival in patients who underwent HCT at any time point or disease stage was 32% for patients with MPN-AML, 18% for patients with MDS-AML, and 25% for patients t-AML.

These crude survival figures suggest that “HCT is the sole realistic curable treatment option for [secondary] AML,” the researchers wrote.

The researchers also performed a propensity score matching analysis of HCT versus chemotherapy consolidation in patients with secondary AML who had been in first complete remission for more than 90 days. The model matched 45 patients who underwent HCT with 66 patients treated with chemotherapy consolidation. The projected 5-year overall survival was 48% in the HCT group, compared with 20% in the consolidation group (P = .01). Similarly, 5-year relapse-free survival was also higher in the HCT group, compared with the consolidation group (43% vs. 21%, P = .02).

“Ideally, the role of transplantation in [secondary] AML should be evaluated in a prospective randomized trial, minimizing the risk of any bias,” the researchers wrote. “However, such a trial is lacking and most likely will never be performed.”

The researchers concluded that HCT should be considered for all patients with secondary AML who are eligible and fit for transplantation.

The study was supported by the Swedish Cancer Foundation, Swedish Research Council, Stockholm County Council, Gothenberg Medical Society, and Assar Gabrielsson Foundation. The researchers reported having no conflicts of interest.

[email protected]

SOURCE: Nilson C et al. Biol Blood Marrow Tranplant. 2019;25:1770-8.

Allogeneic hematopoietic cell transplantation is a better option than consolidation chemotherapy in patients with secondary acute myeloid leukemia, yielding significantly better survival outcomes, according to findings from an observational study.

National Institutes of Health/Wikimedia Commons/Public Domain

Although secondary AML has been identified as an independent predictor of poor prognosis, it is not included in current risk classifications that provide the basis of deciding when to perform HCT.

Christer Nilsson, MD, of Karolinska Institute, Stockholm, and colleagues, used two nationwide Swedish registries – the Swedish AML Registry and the Swedish Cancer Registry – to characterize how often HCT is performed in these patients and to evaluate its impact in a real-world setting. The registries include all patients with AML diagnosed between 1997 and 2013.

Their findings are in Biology of Blood and Marrow Transplantation.

The analysis included 3,337 adult patients with AML who were intensively treated and did not have acute promyelocytic leukemia. More than three-quarters of the patients had de novo AML and the remainder had secondary AML that was either therapy related or developed after an antecedent myeloid disease. In total, 100 patients with secondary AML underwent HCT while in first complete remission.

In terms of crude survival at 5 years after diagnosis, patients with secondary AML who did not undergo HCT did very poorly. The survival rate was 0% in those with AML preceded by myeloproliferative neoplasm (MPN-AML), 2% in patients with AML preceded by myelodysplastic syndrome (MDS-AML), and 4% in patients with therapy-related AML (t-AML). In contrast, the 5-year overall survival in patients who underwent HCT at any time point or disease stage was 32% for patients with MPN-AML, 18% for patients with MDS-AML, and 25% for patients t-AML.

These crude survival figures suggest that “HCT is the sole realistic curable treatment option for [secondary] AML,” the researchers wrote.

The researchers also performed a propensity score matching analysis of HCT versus chemotherapy consolidation in patients with secondary AML who had been in first complete remission for more than 90 days. The model matched 45 patients who underwent HCT with 66 patients treated with chemotherapy consolidation. The projected 5-year overall survival was 48% in the HCT group, compared with 20% in the consolidation group (P = .01). Similarly, 5-year relapse-free survival was also higher in the HCT group, compared with the consolidation group (43% vs. 21%, P = .02).

“Ideally, the role of transplantation in [secondary] AML should be evaluated in a prospective randomized trial, minimizing the risk of any bias,” the researchers wrote. “However, such a trial is lacking and most likely will never be performed.”

The researchers concluded that HCT should be considered for all patients with secondary AML who are eligible and fit for transplantation.

The study was supported by the Swedish Cancer Foundation, Swedish Research Council, Stockholm County Council, Gothenberg Medical Society, and Assar Gabrielsson Foundation. The researchers reported having no conflicts of interest.

[email protected]

SOURCE: Nilson C et al. Biol Blood Marrow Tranplant. 2019;25:1770-8.

Hospital medicine has grown dramatically over the past 20 years.^1,2 A recent survey regarding hospitalists’ clinical roles showed an expansion to triaging emergency department (ED) medical admissions and transfers from outside hospitals.³ From the hospitalist perspective, triaging involves the evaluation of patients for potential admission.⁴ With scrutiny on ED metrics, such as wait times (https://www.medicare.gov/hospitalcompare/search.html), health system administrators have heightened expectations for efficient patient flow, which increasingly falls to hospitalists.^5-7

Despite the growth in hospitalists’ triagist activities, there has been little formal assessment of their role. We hypothesized that this role differs from inpatient care in significant ways.^6-8 We sought to describe the triagist role in adult academic inpatient medicine settings to understand the responsibilities and skill set required.

Ten academic medical center (AMC) sites were recruited from Research Committee session attendees at the 2014 Society of Hospital Medicine national meeting and the 2014 Society of General Internal Medicine southern regional meeting. The AMCs were geographically diverse: three Western, two Midwestern, two Southern, one Northeastern, and two Southeastern. Site representatives were identified and completed a web-based questionnaire about their AMC (see Appendix 1 for the information collected). Clarifications regarding survey responses were performed via conference calls between the authors (STV, ESW) and site representatives.

Hospitalist Survey

In January 2018, surveys were sent to 583 physicians who worked as triagists. Participants received an anonymous 28-item RedCap survey by e-mail and were sent up to five reminder e-mails over six weeks (see Appendix 2 for the questions analyzed in this paper). Respondents were given the option to be entered in a gift card drawing.

Demographic information and individual workflow/practices were obtained. A 5-point Likert scale (strongly disagree – strongly agree) was used to assess hospitalists’ concurrence with current providers (eg, ED, clinic providers) regarding the management and whether patients must meet the utilization management (UM) criteria for admission. Time estimates used 5% increments and were categorized into four frequency categories based on the local modes provided in responses: Seldom (0%-10%), Occasional (15%-35%), Half-the-Time (40%-60%), and Frequently (65%-100%). Free text responses on effective/ineffective triagist qualities were elicited. Responses were included for analysis if at least 70% of questions were completed.

Data Analysis

Quantitative

Descriptive statistics were calculated for each variable. The Kruskal-Wallis test was used to evaluate differences across AMCs in the time spent on in-person evaluation and communication. Weighting, based on the ratio of hospitalists to survey respondents at each AMC, was used to calculate the average institutional percentages across the study sample.

Qualitative

Responses to open-ended questions were analyzed using thematic analysis.⁹ Three independent reviewers (STV, JC, ESW) read, analyzed, and grouped the responses by codes. Codes were then assessed for overlap and grouped into themes by one reviewer (STV). A table of themes with supporting quotes and the number of mentions was subsequently developed by all three reviewers. Similar themes were combined to create domains. The domains were reviewed by the steering committee members to create a consensus description (Appendix 3).

The University of Texas Health San Antonio’s Institutional Review Board and participating institutions approved the study as exempt.

Site Characteristics

Representatives from 10 AMCs reported data on a range of one to four hospitals for a total of 22 hospitals. The median reported that the number of medical patients admitted in a 24-hour period was 31-40 (range, 11-20 to >50). The median group size of hospitalists was 41-50 (range, 0-10 to >70).

The survey response rate was 40% (n = 235), ranging from 9%-70% between institutions. Self-identified female hospitalists accounted for 52% of respondents. Four percent were 25-29 years old, 66% were 30-39 years old, 24% were 40-49 years old, and 6% were ≥50 years old. The average clinical time spent as a triagist was 16%.

Description of Triagist Activities

The activities identified by the majority of respondents across all sites included transferring patients within the hospital (73%), and assessing/approving patient transfers from outside hospitals and clinics (82%). Internal transfer activities reported by >50% of respondents included allocating patients within the hospital or bed capacity coordination, assessing intensive care unit transfers, assigning ED admissions, and consulting other services. The ED accounted for an average of 55% of calls received. Respondents also reported being involved with the documentation related to these activities.

Similarities and Differences across AMCs

Two AMCs did not have a dedicated triagist; instead, physicians supervised residents and advanced practice providers. Among the eight sites with triagists, triaging was predominantly done by faculty physicians contacted via pagers. At seven of these sites, 100% of hospitalists worked as triagists. The triage service was covered by faculty physicians from 8-24 hours per day.

Bed boards and transfer centers staffed by registered nurses, nurse coordinators, house supervisors, or physicians were common support systems, though this infrastructure was organized differently across institutions. A UM review before admission was performed at three institutions 24 hours/day. The remaining institutions reviewed patients retrospectively.

Twenty-eight percent of hospitalists across all sites “Disagreed” or “Strongly disagreed” that a patient must meet UM criteria for admission. Forty-two percent had “Frequent” different opinions regarding patient management than the consulting provider.

Triagist and current provider communication practices varied widely across AMCs (Figure). There was significant variability in verbal communication (P = .02), with >70% of respondents at two AMCs reporting verbal communication at least half the time, but <30% reporting this frequency at two other AMCs. Respondents reported variable use of electronic communication (ie, notes/orders in the electronic health record) across AMCs (P < .0001). Half of the hospitalists use it “Seldom”, 20% use it “Occasionally”, and 23% use it “Frequently”.

Differences within AMCs

Variability within AMCs was greatest for the rate of verbal communication practices, with a typical interquartile range (IQR) of 20% to 90% among the hospitalists within a given AMC and for the rate of electronic communication with a typical IQR of 0% to 50%. For other survey questions, the IQR was typically 15 to 20 percentage points.

Thematic Analysis

We received 207 and 203 responses (88% and 86%, respectively) to the open-ended questions “What qualities does an effective triagist have?’ and ‘What qualities make a triagist ineffective?” We identified 22 themes for effective and ineffective qualities, which were grouped into seven domains (Table). All themes had at least three mentions by respondents. The three most frequently mentioned themes, communication skills, efficiency, and systems knowledge, had greater than 60 mentions.

Our study of the triagist role at 10 AMCs describes critical triagist functions and identifies key findings across and within AMCs. Twenty-eight percent of hospitalists reported admitting patients even when the patient did not meet the admission criteria, consistent with previous research demonstrating the influence of factors other than clinical disease severity on triage decisions.¹⁰ However, preventable admissions remain a hospital-level quality metric.^11,12 Triagists must often balance each patient’s circumstances with the complexities of the system. Juggling the competing demands of the system while providing patient-centered care can be challenging and may explain why attending physicians are more frequently filling this role.¹³

Local context/culture is likely to play a role in the variation across sites; however, compensation for the time spent may also be a factor. If triage activities are not reimbursable, this could lead to less documentation and a lower likelihood that patients are evaluated in person.¹⁴ This reason may also explain why all hospitalists were required to serve as a triagist at most sites.

Currently, no consensus definition of the triagist role has been developed. Our results demonstrate that this role is heterogeneous and grounded in the local healthcare system practices. We propose the following working definition of the triagist: a physician who assesses patients for admission, actively supporting the transition of the patient from the outpatient to the inpatient setting. A triagist should be equipped with a skill set that includes not only clinical knowledge but also emphasizes systems knowledge, awareness of others’ goals, efficiency, an ability to communicate effectively, and the knowledge of UM. We recommend that medical directors of hospitalist programs focus their attention on locally specific, systems-based skills development when orienting new hospitalists. The financial aspects of cost should be considered and delineated as well.

Our analysis is limited in several respects. Participant AMCs were not randomly chosen, but do represent a broad array of facility types, group size, and geographic regions. The low response rates at some AMCs may result in an inaccurate representation of those sites. Data was not obtained on hospitalists that did not respond to the survey; therefore, nonresponse bias may affect outcomes. This research used self-report rather than direct observation, which could be subject to recall and social desirability bias. Finally, our results may not be generalizable to nonacademic institutions.

The hospitalist role as triagist at AMCs emphasizes communication, organizational skills, efficiency, systems-based practice, and UM knowledge. Although we found significant variation across and within AMCs, internal transfer activities were common across programs. Hospitalist programs should focus on systems-based skills development to prepare hospitalists for the role. The skill set necessary for triagist responsibilities also has implications for internal medicine resident education.⁴ With increasing emphasis on value and system effectiveness in care delivery, further studies of the triagist role should be undertaken.

Acknowledgments

The TRIAGIST Collaborative Group consists of: Maralyssa Bann, MD, Andrew White, MD (University of Washington); Jagriti Chadha, MD (University of Kentucky); Joel Boggan, MD (Duke University); Sherwin Hsu, MD (UCLA); Jeff Liao, MD (Harvard Medical School); Tabatha Matthias, DO (University of Nebraska Medical Center); Tresa McNeal, MD (Scott and White Texas A&M); Roxana Naderi, MD, Khooshbu Shah, MD (University of Colorado); David Schmit, MD (University of Texas Health San Antonio); Manivannan Veerasamy, MD (Michigan State University).

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.

Hospital medicine has grown dramatically over the past 20 years.^1,2 A recent survey regarding hospitalists’ clinical roles showed an expansion to triaging emergency department (ED) medical admissions and transfers from outside hospitals.³ From the hospitalist perspective, triaging involves the evaluation of patients for potential admission.⁴ With scrutiny on ED metrics, such as wait times (https://www.medicare.gov/hospitalcompare/search.html), health system administrators have heightened expectations for efficient patient flow, which increasingly falls to hospitalists.^5-7

Despite the growth in hospitalists’ triagist activities, there has been little formal assessment of their role. We hypothesized that this role differs from inpatient care in significant ways.^6-8 We sought to describe the triagist role in adult academic inpatient medicine settings to understand the responsibilities and skill set required.

Ten academic medical center (AMC) sites were recruited from Research Committee session attendees at the 2014 Society of Hospital Medicine national meeting and the 2014 Society of General Internal Medicine southern regional meeting. The AMCs were geographically diverse: three Western, two Midwestern, two Southern, one Northeastern, and two Southeastern. Site representatives were identified and completed a web-based questionnaire about their AMC (see Appendix 1 for the information collected). Clarifications regarding survey responses were performed via conference calls between the authors (STV, ESW) and site representatives.

Hospitalist Survey

In January 2018, surveys were sent to 583 physicians who worked as triagists. Participants received an anonymous 28-item RedCap survey by e-mail and were sent up to five reminder e-mails over six weeks (see Appendix 2 for the questions analyzed in this paper). Respondents were given the option to be entered in a gift card drawing.

Demographic information and individual workflow/practices were obtained. A 5-point Likert scale (strongly disagree – strongly agree) was used to assess hospitalists’ concurrence with current providers (eg, ED, clinic providers) regarding the management and whether patients must meet the utilization management (UM) criteria for admission. Time estimates used 5% increments and were categorized into four frequency categories based on the local modes provided in responses: Seldom (0%-10%), Occasional (15%-35%), Half-the-Time (40%-60%), and Frequently (65%-100%). Free text responses on effective/ineffective triagist qualities were elicited. Responses were included for analysis if at least 70% of questions were completed.

Data Analysis

Quantitative

Descriptive statistics were calculated for each variable. The Kruskal-Wallis test was used to evaluate differences across AMCs in the time spent on in-person evaluation and communication. Weighting, based on the ratio of hospitalists to survey respondents at each AMC, was used to calculate the average institutional percentages across the study sample.

Qualitative

Responses to open-ended questions were analyzed using thematic analysis.⁹ Three independent reviewers (STV, JC, ESW) read, analyzed, and grouped the responses by codes. Codes were then assessed for overlap and grouped into themes by one reviewer (STV). A table of themes with supporting quotes and the number of mentions was subsequently developed by all three reviewers. Similar themes were combined to create domains. The domains were reviewed by the steering committee members to create a consensus description (Appendix 3).

The University of Texas Health San Antonio’s Institutional Review Board and participating institutions approved the study as exempt.

Site Characteristics

Representatives from 10 AMCs reported data on a range of one to four hospitals for a total of 22 hospitals. The median reported that the number of medical patients admitted in a 24-hour period was 31-40 (range, 11-20 to >50). The median group size of hospitalists was 41-50 (range, 0-10 to >70).

The survey response rate was 40% (n = 235), ranging from 9%-70% between institutions. Self-identified female hospitalists accounted for 52% of respondents. Four percent were 25-29 years old, 66% were 30-39 years old, 24% were 40-49 years old, and 6% were ≥50 years old. The average clinical time spent as a triagist was 16%.

Description of Triagist Activities

The activities identified by the majority of respondents across all sites included transferring patients within the hospital (73%), and assessing/approving patient transfers from outside hospitals and clinics (82%). Internal transfer activities reported by >50% of respondents included allocating patients within the hospital or bed capacity coordination, assessing intensive care unit transfers, assigning ED admissions, and consulting other services. The ED accounted for an average of 55% of calls received. Respondents also reported being involved with the documentation related to these activities.

Similarities and Differences across AMCs

Two AMCs did not have a dedicated triagist; instead, physicians supervised residents and advanced practice providers. Among the eight sites with triagists, triaging was predominantly done by faculty physicians contacted via pagers. At seven of these sites, 100% of hospitalists worked as triagists. The triage service was covered by faculty physicians from 8-24 hours per day.

Bed boards and transfer centers staffed by registered nurses, nurse coordinators, house supervisors, or physicians were common support systems, though this infrastructure was organized differently across institutions. A UM review before admission was performed at three institutions 24 hours/day. The remaining institutions reviewed patients retrospectively.

Twenty-eight percent of hospitalists across all sites “Disagreed” or “Strongly disagreed” that a patient must meet UM criteria for admission. Forty-two percent had “Frequent” different opinions regarding patient management than the consulting provider.

Triagist and current provider communication practices varied widely across AMCs (Figure). There was significant variability in verbal communication (P = .02), with >70% of respondents at two AMCs reporting verbal communication at least half the time, but <30% reporting this frequency at two other AMCs. Respondents reported variable use of electronic communication (ie, notes/orders in the electronic health record) across AMCs (P < .0001). Half of the hospitalists use it “Seldom”, 20% use it “Occasionally”, and 23% use it “Frequently”.

Differences within AMCs

Variability within AMCs was greatest for the rate of verbal communication practices, with a typical interquartile range (IQR) of 20% to 90% among the hospitalists within a given AMC and for the rate of electronic communication with a typical IQR of 0% to 50%. For other survey questions, the IQR was typically 15 to 20 percentage points.

Thematic Analysis

We received 207 and 203 responses (88% and 86%, respectively) to the open-ended questions “What qualities does an effective triagist have?’ and ‘What qualities make a triagist ineffective?” We identified 22 themes for effective and ineffective qualities, which were grouped into seven domains (Table). All themes had at least three mentions by respondents. The three most frequently mentioned themes, communication skills, efficiency, and systems knowledge, had greater than 60 mentions.

Our study of the triagist role at 10 AMCs describes critical triagist functions and identifies key findings across and within AMCs. Twenty-eight percent of hospitalists reported admitting patients even when the patient did not meet the admission criteria, consistent with previous research demonstrating the influence of factors other than clinical disease severity on triage decisions.¹⁰ However, preventable admissions remain a hospital-level quality metric.^11,12 Triagists must often balance each patient’s circumstances with the complexities of the system. Juggling the competing demands of the system while providing patient-centered care can be challenging and may explain why attending physicians are more frequently filling this role.¹³

Local context/culture is likely to play a role in the variation across sites; however, compensation for the time spent may also be a factor. If triage activities are not reimbursable, this could lead to less documentation and a lower likelihood that patients are evaluated in person.¹⁴ This reason may also explain why all hospitalists were required to serve as a triagist at most sites.

Currently, no consensus definition of the triagist role has been developed. Our results demonstrate that this role is heterogeneous and grounded in the local healthcare system practices. We propose the following working definition of the triagist: a physician who assesses patients for admission, actively supporting the transition of the patient from the outpatient to the inpatient setting. A triagist should be equipped with a skill set that includes not only clinical knowledge but also emphasizes systems knowledge, awareness of others’ goals, efficiency, an ability to communicate effectively, and the knowledge of UM. We recommend that medical directors of hospitalist programs focus their attention on locally specific, systems-based skills development when orienting new hospitalists. The financial aspects of cost should be considered and delineated as well.

Our analysis is limited in several respects. Participant AMCs were not randomly chosen, but do represent a broad array of facility types, group size, and geographic regions. The low response rates at some AMCs may result in an inaccurate representation of those sites. Data was not obtained on hospitalists that did not respond to the survey; therefore, nonresponse bias may affect outcomes. This research used self-report rather than direct observation, which could be subject to recall and social desirability bias. Finally, our results may not be generalizable to nonacademic institutions.

The hospitalist role as triagist at AMCs emphasizes communication, organizational skills, efficiency, systems-based practice, and UM knowledge. Although we found significant variation across and within AMCs, internal transfer activities were common across programs. Hospitalist programs should focus on systems-based skills development to prepare hospitalists for the role. The skill set necessary for triagist responsibilities also has implications for internal medicine resident education.⁴ With increasing emphasis on value and system effectiveness in care delivery, further studies of the triagist role should be undertaken.

Acknowledgments

The TRIAGIST Collaborative Group consists of: Maralyssa Bann, MD, Andrew White, MD (University of Washington); Jagriti Chadha, MD (University of Kentucky); Joel Boggan, MD (Duke University); Sherwin Hsu, MD (UCLA); Jeff Liao, MD (Harvard Medical School); Tabatha Matthias, DO (University of Nebraska Medical Center); Tresa McNeal, MD (Scott and White Texas A&M); Roxana Naderi, MD, Khooshbu Shah, MD (University of Colorado); David Schmit, MD (University of Texas Health San Antonio); Manivannan Veerasamy, MD (Michigan State University).

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.

Hospital medicine has grown dramatically over the past 20 years.^1,2 A recent survey regarding hospitalists’ clinical roles showed an expansion to triaging emergency department (ED) medical admissions and transfers from outside hospitals.³ From the hospitalist perspective, triaging involves the evaluation of patients for potential admission.⁴ With scrutiny on ED metrics, such as wait times (https://www.medicare.gov/hospitalcompare/search.html), health system administrators have heightened expectations for efficient patient flow, which increasingly falls to hospitalists.^5-7

Despite the growth in hospitalists’ triagist activities, there has been little formal assessment of their role. We hypothesized that this role differs from inpatient care in significant ways.^6-8 We sought to describe the triagist role in adult academic inpatient medicine settings to understand the responsibilities and skill set required.

Ten academic medical center (AMC) sites were recruited from Research Committee session attendees at the 2014 Society of Hospital Medicine national meeting and the 2014 Society of General Internal Medicine southern regional meeting. The AMCs were geographically diverse: three Western, two Midwestern, two Southern, one Northeastern, and two Southeastern. Site representatives were identified and completed a web-based questionnaire about their AMC (see Appendix 1 for the information collected). Clarifications regarding survey responses were performed via conference calls between the authors (STV, ESW) and site representatives.

Hospitalist Survey

In January 2018, surveys were sent to 583 physicians who worked as triagists. Participants received an anonymous 28-item RedCap survey by e-mail and were sent up to five reminder e-mails over six weeks (see Appendix 2 for the questions analyzed in this paper). Respondents were given the option to be entered in a gift card drawing.

Demographic information and individual workflow/practices were obtained. A 5-point Likert scale (strongly disagree – strongly agree) was used to assess hospitalists’ concurrence with current providers (eg, ED, clinic providers) regarding the management and whether patients must meet the utilization management (UM) criteria for admission. Time estimates used 5% increments and were categorized into four frequency categories based on the local modes provided in responses: Seldom (0%-10%), Occasional (15%-35%), Half-the-Time (40%-60%), and Frequently (65%-100%). Free text responses on effective/ineffective triagist qualities were elicited. Responses were included for analysis if at least 70% of questions were completed.

Data Analysis

Quantitative

Descriptive statistics were calculated for each variable. The Kruskal-Wallis test was used to evaluate differences across AMCs in the time spent on in-person evaluation and communication. Weighting, based on the ratio of hospitalists to survey respondents at each AMC, was used to calculate the average institutional percentages across the study sample.

Qualitative

Responses to open-ended questions were analyzed using thematic analysis.⁹ Three independent reviewers (STV, JC, ESW) read, analyzed, and grouped the responses by codes. Codes were then assessed for overlap and grouped into themes by one reviewer (STV). A table of themes with supporting quotes and the number of mentions was subsequently developed by all three reviewers. Similar themes were combined to create domains. The domains were reviewed by the steering committee members to create a consensus description (Appendix 3).

The University of Texas Health San Antonio’s Institutional Review Board and participating institutions approved the study as exempt.

Site Characteristics

Representatives from 10 AMCs reported data on a range of one to four hospitals for a total of 22 hospitals. The median reported that the number of medical patients admitted in a 24-hour period was 31-40 (range, 11-20 to >50). The median group size of hospitalists was 41-50 (range, 0-10 to >70).

The survey response rate was 40% (n = 235), ranging from 9%-70% between institutions. Self-identified female hospitalists accounted for 52% of respondents. Four percent were 25-29 years old, 66% were 30-39 years old, 24% were 40-49 years old, and 6% were ≥50 years old. The average clinical time spent as a triagist was 16%.

Description of Triagist Activities

The activities identified by the majority of respondents across all sites included transferring patients within the hospital (73%), and assessing/approving patient transfers from outside hospitals and clinics (82%). Internal transfer activities reported by >50% of respondents included allocating patients within the hospital or bed capacity coordination, assessing intensive care unit transfers, assigning ED admissions, and consulting other services. The ED accounted for an average of 55% of calls received. Respondents also reported being involved with the documentation related to these activities.

Similarities and Differences across AMCs

Two AMCs did not have a dedicated triagist; instead, physicians supervised residents and advanced practice providers. Among the eight sites with triagists, triaging was predominantly done by faculty physicians contacted via pagers. At seven of these sites, 100% of hospitalists worked as triagists. The triage service was covered by faculty physicians from 8-24 hours per day.

Bed boards and transfer centers staffed by registered nurses, nurse coordinators, house supervisors, or physicians were common support systems, though this infrastructure was organized differently across institutions. A UM review before admission was performed at three institutions 24 hours/day. The remaining institutions reviewed patients retrospectively.

Twenty-eight percent of hospitalists across all sites “Disagreed” or “Strongly disagreed” that a patient must meet UM criteria for admission. Forty-two percent had “Frequent” different opinions regarding patient management than the consulting provider.

Triagist and current provider communication practices varied widely across AMCs (Figure). There was significant variability in verbal communication (P = .02), with >70% of respondents at two AMCs reporting verbal communication at least half the time, but <30% reporting this frequency at two other AMCs. Respondents reported variable use of electronic communication (ie, notes/orders in the electronic health record) across AMCs (P < .0001). Half of the hospitalists use it “Seldom”, 20% use it “Occasionally”, and 23% use it “Frequently”.

Differences within AMCs

Variability within AMCs was greatest for the rate of verbal communication practices, with a typical interquartile range (IQR) of 20% to 90% among the hospitalists within a given AMC and for the rate of electronic communication with a typical IQR of 0% to 50%. For other survey questions, the IQR was typically 15 to 20 percentage points.

Thematic Analysis

We received 207 and 203 responses (88% and 86%, respectively) to the open-ended questions “What qualities does an effective triagist have?’ and ‘What qualities make a triagist ineffective?” We identified 22 themes for effective and ineffective qualities, which were grouped into seven domains (Table). All themes had at least three mentions by respondents. The three most frequently mentioned themes, communication skills, efficiency, and systems knowledge, had greater than 60 mentions.

Our study of the triagist role at 10 AMCs describes critical triagist functions and identifies key findings across and within AMCs. Twenty-eight percent of hospitalists reported admitting patients even when the patient did not meet the admission criteria, consistent with previous research demonstrating the influence of factors other than clinical disease severity on triage decisions.¹⁰ However, preventable admissions remain a hospital-level quality metric.^11,12 Triagists must often balance each patient’s circumstances with the complexities of the system. Juggling the competing demands of the system while providing patient-centered care can be challenging and may explain why attending physicians are more frequently filling this role.¹³

Local context/culture is likely to play a role in the variation across sites; however, compensation for the time spent may also be a factor. If triage activities are not reimbursable, this could lead to less documentation and a lower likelihood that patients are evaluated in person.¹⁴ This reason may also explain why all hospitalists were required to serve as a triagist at most sites.

Currently, no consensus definition of the triagist role has been developed. Our results demonstrate that this role is heterogeneous and grounded in the local healthcare system practices. We propose the following working definition of the triagist: a physician who assesses patients for admission, actively supporting the transition of the patient from the outpatient to the inpatient setting. A triagist should be equipped with a skill set that includes not only clinical knowledge but also emphasizes systems knowledge, awareness of others’ goals, efficiency, an ability to communicate effectively, and the knowledge of UM. We recommend that medical directors of hospitalist programs focus their attention on locally specific, systems-based skills development when orienting new hospitalists. The financial aspects of cost should be considered and delineated as well.

Our analysis is limited in several respects. Participant AMCs were not randomly chosen, but do represent a broad array of facility types, group size, and geographic regions. The low response rates at some AMCs may result in an inaccurate representation of those sites. Data was not obtained on hospitalists that did not respond to the survey; therefore, nonresponse bias may affect outcomes. This research used self-report rather than direct observation, which could be subject to recall and social desirability bias. Finally, our results may not be generalizable to nonacademic institutions.

The hospitalist role as triagist at AMCs emphasizes communication, organizational skills, efficiency, systems-based practice, and UM knowledge. Although we found significant variation across and within AMCs, internal transfer activities were common across programs. Hospitalist programs should focus on systems-based skills development to prepare hospitalists for the role. The skill set necessary for triagist responsibilities also has implications for internal medicine resident education.⁴ With increasing emphasis on value and system effectiveness in care delivery, further studies of the triagist role should be undertaken.

Acknowledgments

The TRIAGIST Collaborative Group consists of: Maralyssa Bann, MD, Andrew White, MD (University of Washington); Jagriti Chadha, MD (University of Kentucky); Joel Boggan, MD (Duke University); Sherwin Hsu, MD (UCLA); Jeff Liao, MD (Harvard Medical School); Tabatha Matthias, DO (University of Nebraska Medical Center); Tresa McNeal, MD (Scott and White Texas A&M); Roxana Naderi, MD, Khooshbu Shah, MD (University of Colorado); David Schmit, MD (University of Texas Health San Antonio); Manivannan Veerasamy, MD (Michigan State University).

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.

Acute pancreatitis (AP) is the most common gastrointestinal discharge diagnosis in the United States, with a mortality rate of 1%-5%.¹ Recent data demonstrate increasing AP-related admissions, making AP management of utmost importance to hospitalists.¹ The American Gastroenterological Association (AGA) guideline specifically addresses AP management in the initial 48-72 hours of admission, during which management decisions can alter disease course and length of stay. AP requires two of the following three criteria for diagnosis: characteristic abdominal pain, elevation of lipase or amylase ≥3 times the upper limit of normal, and/or radiographic evidence of pancreatitis on cross-sectional imaging. The guideline provides eight recommendations, which we consolidated to highlight practice changing recommendations: fluids, nutrition, management of the most common causes, and prophylactic antibiotics.^2,3

KEY RECOMMENDATIONS FOR THE HOSPITALIST

Fluids

Recommendation 1. In patients with AP, use goal-directed isotonic crystalloids for fluid management (conditional recommendation, very low-quality evidence).

The guideline emphasizes goal-directed fluid management despite low-quality, heterogeneous evidence and does not recommend Ringer’s lactate over normal saline. “Goal-directed” fluid management involves the use of crystalloid infusions titrated to improve physiologic and biochemical markers, but no target volume is specified by the guideline. Frequent reassessments should look for signs of volume overload, the primary risk of harm with fluid therapy. Despite failure to reduce mortality or morbidities such as pancreatic necrosis or persistent multi-organ failure, the AGA cites the mortality benefit of goal-directed therapy in sepsis as justification for this approach in AP, given the similar physiologic abnormalities.

Nutrition

Recommendation 2. Begin feeding early in patients with AP regardless of predicted severity. If oral nutrition is not tolerated, enteral feeding with either a nasogastric or nasojejunal tube is preferred to parenteral nutrition (strong recommendation, moderate-quality evidence).

Early feeding (ie, within 24 hours) is recommended regardless of AP severity. This represents a change from prior practices of bowel rest, theorized to prevent continued stimulation of an inflamed pancreas. Although early feeding has not been linked to improved mortality, it has demonstrated lower rates of multi-organ failure and infected pancreatic necrosis, possibly due to maintenance of the gut mucosal barrier and reduced bacterial translocation. When oral feeding is not tolerated, enteral nutrition is preferred over parenteral nutrition due to less risks. The preferred dietary composition guidance for patients with persistent pain or ileus is not addressed.

Management of the Most Common Causes of AP in Adults

Recommendation 3. Patients with mild acute biliary pancreatitis should have cholecystectomy during the initial admission (strong recommendation, moderate-quality evidence).

All patients with suspected biliary pancreatitis should receive a surgical consultation for cholecystectomy during the index admission. At the time of the guideline release, only one trial was available to support the recommendation of early cholecystectomy; however, newer studies similarly support cholecystectomy during index admission by demonstrating reductions in composite outcomes of mortality and gallstone-related complications, readmission for pancreatitis, and other pancreatobiliary complications.⁴ A Cochrane review included in the guideline found no differences in complication rates even in patients with severe biliary pancreatitis. In the absence of cholangitis, urgent endoscopic retrograde cholangiography (ERCP) is not indicated as most stones causing biliary pancreatitis pass spontaneously.

Recommendation 4. In patients with acute alcoholic pancreatitis, brief alcohol intervention should occur during admission (strong recommendation, moderate-quality evidence).

Ongoing alcohol consumption is a risk factor for recurrent acute and chronic pancreatitis. Only one trial assessed the impact of inpatient alcohol cessation counseling on recurrent AP, noting a trend toward reduced readmissions.⁵ However, indirect evidence from similar interventions in ambulatory settings demonstrates reductions in alcohol intake, leading to the AGA recommendation for inpatients with alcohol-induced AP.³

Antibiotics

Recommendation 5. Avoid empiric antibiotics in patients with AP who otherwise lack an indication, regardless of predicted severity (conditional recommendation, low-quality evidence).

Since 2002, well performed trials have consistently failed to demonstrate improvement in outcomes such as multi-organ failure or length of stay with use of prophylactic antibiotics for AP, even severe AP and pancreatic necrosis. Therefore, the AGA recommends against prophylactic antibiotics in initial management of AP regardless of disease severity. Lack of blinding in the majority of trial designs conducted before 2002 contributed to the overall assessment of low-quality evidence. The guideline does not address acute biliary pancreatitis with cholangitis, for which antibiotics and ERCP for decompression are critical.

CRITIQUE

The AGA Institute supported this guideline development and employed the rigorous and standardized GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. This approach allowed the guideline panel members to account not only for evidence quality, but also the benefits and harms of an intervention and resource utilization. None of the authors had any stated conflicts of interest.

The guideline heavily weighted results from randomized control trials, most of which excluded key populations cared for by hospitalists (eg, patients older than 75 years, with end-stage renal disease). Particular areas where this creates challenges for clinicians and patients alike include goal-directed fluid therapy and when to consider more invasive interventions such as ERCP and early cholecystectomy. For example, patients considered to be poor surgical candidates may benefit from ERCP with biliary sphincterotomy to reduce the risk of recurrent biliary pancreatitis.

Lack of specificity in the guidelines for goal-directed fluid management and enteral feeding regimens makes it challenging to standardize hospitalists’ approach to the early care of patients with AP. Interestingly, the 2013 American College of Gastroenterology (ACG) Guideline for the Management of AP included strong recommendations for the use of Ringer’s lactate and volume targets in the initial management of AP.⁶ Evidence supporting the use of Ringer’s lactate versus normal saline is based largely upon improved inflammatory markers, theoretical potentiation of pancreatic enzyme activation with hypercholemic metabolic acidosis, and small studies demonstrating trends toward improved mortality.⁷ The ACG guideline was released prior to mounting evidence suggesting that goal-directed fluid therapy in sepsis does not improve mortality versus usual care.⁸ The growing uncertainty regarding the efficacy of goal-directed fluids for septic shock, as well limitations of studies on AP, may contribute to the differences between the AGA and ACG recommendations.

Finally, as the guideline covers the initial therapeutic management of AP, no recommendations are made for diagnostic studies such as right upper quadrant ultrasound. This noninvasive and readily available test plays a critical role in evaluating for presence of gallstones and other potential etiologies of abdominal pain.

AREAS IN NEED OF FUTURE STUDY

Additional research is needed to better understand goal-directed fluid therapy with respect to the fluid type, amount, and target outcomes. Similarly, determining the optimal enteral feeding regimens for patients failing oral intake would help clinicians meet the recommendation for early nutrition. Finally, clarification on the roles and timing of endoscopic and surgical procedures for patients with severe biliary pancreatitis, as well as geriatric and medically complex populations, would help hospitalists advocate for a multidisciplinary approach to this common and often serious disease.

Disclosures

The authors have nothing to disclose.

Acute pancreatitis (AP) is the most common gastrointestinal discharge diagnosis in the United States, with a mortality rate of 1%-5%.¹ Recent data demonstrate increasing AP-related admissions, making AP management of utmost importance to hospitalists.¹ The American Gastroenterological Association (AGA) guideline specifically addresses AP management in the initial 48-72 hours of admission, during which management decisions can alter disease course and length of stay. AP requires two of the following three criteria for diagnosis: characteristic abdominal pain, elevation of lipase or amylase ≥3 times the upper limit of normal, and/or radiographic evidence of pancreatitis on cross-sectional imaging. The guideline provides eight recommendations, which we consolidated to highlight practice changing recommendations: fluids, nutrition, management of the most common causes, and prophylactic antibiotics.^2,3

KEY RECOMMENDATIONS FOR THE HOSPITALIST

Fluids

Recommendation 1. In patients with AP, use goal-directed isotonic crystalloids for fluid management (conditional recommendation, very low-quality evidence).

The guideline emphasizes goal-directed fluid management despite low-quality, heterogeneous evidence and does not recommend Ringer’s lactate over normal saline. “Goal-directed” fluid management involves the use of crystalloid infusions titrated to improve physiologic and biochemical markers, but no target volume is specified by the guideline. Frequent reassessments should look for signs of volume overload, the primary risk of harm with fluid therapy. Despite failure to reduce mortality or morbidities such as pancreatic necrosis or persistent multi-organ failure, the AGA cites the mortality benefit of goal-directed therapy in sepsis as justification for this approach in AP, given the similar physiologic abnormalities.

Nutrition

Recommendation 2. Begin feeding early in patients with AP regardless of predicted severity. If oral nutrition is not tolerated, enteral feeding with either a nasogastric or nasojejunal tube is preferred to parenteral nutrition (strong recommendation, moderate-quality evidence).

Early feeding (ie, within 24 hours) is recommended regardless of AP severity. This represents a change from prior practices of bowel rest, theorized to prevent continued stimulation of an inflamed pancreas. Although early feeding has not been linked to improved mortality, it has demonstrated lower rates of multi-organ failure and infected pancreatic necrosis, possibly due to maintenance of the gut mucosal barrier and reduced bacterial translocation. When oral feeding is not tolerated, enteral nutrition is preferred over parenteral nutrition due to less risks. The preferred dietary composition guidance for patients with persistent pain or ileus is not addressed.

Management of the Most Common Causes of AP in Adults

Recommendation 3. Patients with mild acute biliary pancreatitis should have cholecystectomy during the initial admission (strong recommendation, moderate-quality evidence).

All patients with suspected biliary pancreatitis should receive a surgical consultation for cholecystectomy during the index admission. At the time of the guideline release, only one trial was available to support the recommendation of early cholecystectomy; however, newer studies similarly support cholecystectomy during index admission by demonstrating reductions in composite outcomes of mortality and gallstone-related complications, readmission for pancreatitis, and other pancreatobiliary complications.⁴ A Cochrane review included in the guideline found no differences in complication rates even in patients with severe biliary pancreatitis. In the absence of cholangitis, urgent endoscopic retrograde cholangiography (ERCP) is not indicated as most stones causing biliary pancreatitis pass spontaneously.

Recommendation 4. In patients with acute alcoholic pancreatitis, brief alcohol intervention should occur during admission (strong recommendation, moderate-quality evidence).

Ongoing alcohol consumption is a risk factor for recurrent acute and chronic pancreatitis. Only one trial assessed the impact of inpatient alcohol cessation counseling on recurrent AP, noting a trend toward reduced readmissions.⁵ However, indirect evidence from similar interventions in ambulatory settings demonstrates reductions in alcohol intake, leading to the AGA recommendation for inpatients with alcohol-induced AP.³

Antibiotics

Recommendation 5. Avoid empiric antibiotics in patients with AP who otherwise lack an indication, regardless of predicted severity (conditional recommendation, low-quality evidence).

Since 2002, well performed trials have consistently failed to demonstrate improvement in outcomes such as multi-organ failure or length of stay with use of prophylactic antibiotics for AP, even severe AP and pancreatic necrosis. Therefore, the AGA recommends against prophylactic antibiotics in initial management of AP regardless of disease severity. Lack of blinding in the majority of trial designs conducted before 2002 contributed to the overall assessment of low-quality evidence. The guideline does not address acute biliary pancreatitis with cholangitis, for which antibiotics and ERCP for decompression are critical.

CRITIQUE

The AGA Institute supported this guideline development and employed the rigorous and standardized GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. This approach allowed the guideline panel members to account not only for evidence quality, but also the benefits and harms of an intervention and resource utilization. None of the authors had any stated conflicts of interest.

The guideline heavily weighted results from randomized control trials, most of which excluded key populations cared for by hospitalists (eg, patients older than 75 years, with end-stage renal disease). Particular areas where this creates challenges for clinicians and patients alike include goal-directed fluid therapy and when to consider more invasive interventions such as ERCP and early cholecystectomy. For example, patients considered to be poor surgical candidates may benefit from ERCP with biliary sphincterotomy to reduce the risk of recurrent biliary pancreatitis.

Lack of specificity in the guidelines for goal-directed fluid management and enteral feeding regimens makes it challenging to standardize hospitalists’ approach to the early care of patients with AP. Interestingly, the 2013 American College of Gastroenterology (ACG) Guideline for the Management of AP included strong recommendations for the use of Ringer’s lactate and volume targets in the initial management of AP.⁶ Evidence supporting the use of Ringer’s lactate versus normal saline is based largely upon improved inflammatory markers, theoretical potentiation of pancreatic enzyme activation with hypercholemic metabolic acidosis, and small studies demonstrating trends toward improved mortality.⁷ The ACG guideline was released prior to mounting evidence suggesting that goal-directed fluid therapy in sepsis does not improve mortality versus usual care.⁸ The growing uncertainty regarding the efficacy of goal-directed fluids for septic shock, as well limitations of studies on AP, may contribute to the differences between the AGA and ACG recommendations.

Finally, as the guideline covers the initial therapeutic management of AP, no recommendations are made for diagnostic studies such as right upper quadrant ultrasound. This noninvasive and readily available test plays a critical role in evaluating for presence of gallstones and other potential etiologies of abdominal pain.

AREAS IN NEED OF FUTURE STUDY

Additional research is needed to better understand goal-directed fluid therapy with respect to the fluid type, amount, and target outcomes. Similarly, determining the optimal enteral feeding regimens for patients failing oral intake would help clinicians meet the recommendation for early nutrition. Finally, clarification on the roles and timing of endoscopic and surgical procedures for patients with severe biliary pancreatitis, as well as geriatric and medically complex populations, would help hospitalists advocate for a multidisciplinary approach to this common and often serious disease.

Disclosures

The authors have nothing to disclose.

Acute pancreatitis (AP) is the most common gastrointestinal discharge diagnosis in the United States, with a mortality rate of 1%-5%.¹ Recent data demonstrate increasing AP-related admissions, making AP management of utmost importance to hospitalists.¹ The American Gastroenterological Association (AGA) guideline specifically addresses AP management in the initial 48-72 hours of admission, during which management decisions can alter disease course and length of stay. AP requires two of the following three criteria for diagnosis: characteristic abdominal pain, elevation of lipase or amylase ≥3 times the upper limit of normal, and/or radiographic evidence of pancreatitis on cross-sectional imaging. The guideline provides eight recommendations, which we consolidated to highlight practice changing recommendations: fluids, nutrition, management of the most common causes, and prophylactic antibiotics.^2,3

KEY RECOMMENDATIONS FOR THE HOSPITALIST

Fluids

Recommendation 1. In patients with AP, use goal-directed isotonic crystalloids for fluid management (conditional recommendation, very low-quality evidence).

The guideline emphasizes goal-directed fluid management despite low-quality, heterogeneous evidence and does not recommend Ringer’s lactate over normal saline. “Goal-directed” fluid management involves the use of crystalloid infusions titrated to improve physiologic and biochemical markers, but no target volume is specified by the guideline. Frequent reassessments should look for signs of volume overload, the primary risk of harm with fluid therapy. Despite failure to reduce mortality or morbidities such as pancreatic necrosis or persistent multi-organ failure, the AGA cites the mortality benefit of goal-directed therapy in sepsis as justification for this approach in AP, given the similar physiologic abnormalities.

Nutrition

Recommendation 2. Begin feeding early in patients with AP regardless of predicted severity. If oral nutrition is not tolerated, enteral feeding with either a nasogastric or nasojejunal tube is preferred to parenteral nutrition (strong recommendation, moderate-quality evidence).

Early feeding (ie, within 24 hours) is recommended regardless of AP severity. This represents a change from prior practices of bowel rest, theorized to prevent continued stimulation of an inflamed pancreas. Although early feeding has not been linked to improved mortality, it has demonstrated lower rates of multi-organ failure and infected pancreatic necrosis, possibly due to maintenance of the gut mucosal barrier and reduced bacterial translocation. When oral feeding is not tolerated, enteral nutrition is preferred over parenteral nutrition due to less risks. The preferred dietary composition guidance for patients with persistent pain or ileus is not addressed.

Management of the Most Common Causes of AP in Adults

Recommendation 3. Patients with mild acute biliary pancreatitis should have cholecystectomy during the initial admission (strong recommendation, moderate-quality evidence).

All patients with suspected biliary pancreatitis should receive a surgical consultation for cholecystectomy during the index admission. At the time of the guideline release, only one trial was available to support the recommendation of early cholecystectomy; however, newer studies similarly support cholecystectomy during index admission by demonstrating reductions in composite outcomes of mortality and gallstone-related complications, readmission for pancreatitis, and other pancreatobiliary complications.⁴ A Cochrane review included in the guideline found no differences in complication rates even in patients with severe biliary pancreatitis. In the absence of cholangitis, urgent endoscopic retrograde cholangiography (ERCP) is not indicated as most stones causing biliary pancreatitis pass spontaneously.

Recommendation 4. In patients with acute alcoholic pancreatitis, brief alcohol intervention should occur during admission (strong recommendation, moderate-quality evidence).

Ongoing alcohol consumption is a risk factor for recurrent acute and chronic pancreatitis. Only one trial assessed the impact of inpatient alcohol cessation counseling on recurrent AP, noting a trend toward reduced readmissions.⁵ However, indirect evidence from similar interventions in ambulatory settings demonstrates reductions in alcohol intake, leading to the AGA recommendation for inpatients with alcohol-induced AP.³

Antibiotics

Recommendation 5. Avoid empiric antibiotics in patients with AP who otherwise lack an indication, regardless of predicted severity (conditional recommendation, low-quality evidence).

Since 2002, well performed trials have consistently failed to demonstrate improvement in outcomes such as multi-organ failure or length of stay with use of prophylactic antibiotics for AP, even severe AP and pancreatic necrosis. Therefore, the AGA recommends against prophylactic antibiotics in initial management of AP regardless of disease severity. Lack of blinding in the majority of trial designs conducted before 2002 contributed to the overall assessment of low-quality evidence. The guideline does not address acute biliary pancreatitis with cholangitis, for which antibiotics and ERCP for decompression are critical.

CRITIQUE

The AGA Institute supported this guideline development and employed the rigorous and standardized GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. This approach allowed the guideline panel members to account not only for evidence quality, but also the benefits and harms of an intervention and resource utilization. None of the authors had any stated conflicts of interest.

The guideline heavily weighted results from randomized control trials, most of which excluded key populations cared for by hospitalists (eg, patients older than 75 years, with end-stage renal disease). Particular areas where this creates challenges for clinicians and patients alike include goal-directed fluid therapy and when to consider more invasive interventions such as ERCP and early cholecystectomy. For example, patients considered to be poor surgical candidates may benefit from ERCP with biliary sphincterotomy to reduce the risk of recurrent biliary pancreatitis.

Lack of specificity in the guidelines for goal-directed fluid management and enteral feeding regimens makes it challenging to standardize hospitalists’ approach to the early care of patients with AP. Interestingly, the 2013 American College of Gastroenterology (ACG) Guideline for the Management of AP included strong recommendations for the use of Ringer’s lactate and volume targets in the initial management of AP.⁶ Evidence supporting the use of Ringer’s lactate versus normal saline is based largely upon improved inflammatory markers, theoretical potentiation of pancreatic enzyme activation with hypercholemic metabolic acidosis, and small studies demonstrating trends toward improved mortality.⁷ The ACG guideline was released prior to mounting evidence suggesting that goal-directed fluid therapy in sepsis does not improve mortality versus usual care.⁸ The growing uncertainty regarding the efficacy of goal-directed fluids for septic shock, as well limitations of studies on AP, may contribute to the differences between the AGA and ACG recommendations.

Finally, as the guideline covers the initial therapeutic management of AP, no recommendations are made for diagnostic studies such as right upper quadrant ultrasound. This noninvasive and readily available test plays a critical role in evaluating for presence of gallstones and other potential etiologies of abdominal pain.

AREAS IN NEED OF FUTURE STUDY

Additional research is needed to better understand goal-directed fluid therapy with respect to the fluid type, amount, and target outcomes. Similarly, determining the optimal enteral feeding regimens for patients failing oral intake would help clinicians meet the recommendation for early nutrition. Finally, clarification on the roles and timing of endoscopic and surgical procedures for patients with severe biliary pancreatitis, as well as geriatric and medically complex populations, would help hospitalists advocate for a multidisciplinary approach to this common and often serious disease.

Disclosures

The authors have nothing to disclose.