NEW ORLEANS – The benefits of an 18-month behavioral intervention to reduce inappropriate antibiotic prescribing in the primary care setting were maintained 18 months after the intervention ended, according to follow-up data from a cluster randomized clinical trial.

During the 18-month intervention period, physicians at 47 adult and pediatric practices that participated in the trial, which compared three behavioral interventions and intervention combinations, significantly reduced their inappropriate prescribing.

After 18 months, the results were durable – and particularly so in the groups that received interventions that used “social motivation,” Jeffrey Linder, MD, of Brigham & Women’s Hospital and Harvard Medical School, Boston, reported at an annual scientific meeting on infectious diseases.

A total of 16,959 antibiotic-inappropriate visits (visits for nonspecific upper respiratory tract infections, acute bronchitis, and influenza) were made to 248 clinicians during the 18-month intervention period, and 3,192 such visits were made to 224 clinicians during the postintervention period (JAMA. 2016 Feb 9;315[6]:562-70).

The interventions included “suggested alternatives,” which was an electronic health record-based approach that prompted the prescriber to answer whether a prescription was for an acute respiratory infection. A “yes” answer resulted in the prescriber receiving information about appropriate prescribing, along with a list of “easy nonantibiotic alternatives,” Dr. Linder explained, noting that the interventions involved “trying to make it easy to do the right thing.”

An “accountable justification” intervention used a similar process, but rather than suggesting alternative options, the program asked the prescriber to input a “tweet-length justification” of the prescription. The justification was then entered into the patient’s chart.

The third intervention involved “peer comparison.” Prescribers received monthly e-mail feedback regarding how their prescribing stacked up to that of their peers – specifically noting whether they were or were not “top performers.”

Some of the groups in the trial received combinations of these interventions, but the follow-up analysis showed that the latter two approaches, which involved “social motivation,” had the most durable effects.

For example, the inappropriate antibiotic prescribing rate for those in the “accountable justification” group decreased from 23.2% to 5.2% at the end of the 18-month intervention period (absolute difference, -18.1%) and increased to 9% at the end of follow-up.

The inappropriate prescribing rate decreased from about 20% to about 4% in the “peer comparison” group at the end of the intervention period (absolute difference of -16.3%), then increased to 5% at the end of follow-up, Dr. Linder said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

“The statistically best player here – the peer comparison group – went from 20% to 4% to 5%, so it only went back up 1% even after we turned the intervention off for 18 months,” he said.

Antibiotics often are inappropriately prescribed for acute respiratory infections in primary care. Such infections – including colds, sinusitis, strep throat, nonstrep pharyngitis, acute bronchitis, and influenza – make up only 10% of all ambulatory visits in the United States, but they account for 44% of all antibiotic prescribing, Dr. Linder said.

An estimated 50% of antibiotic prescriptions for acute respiratory infections are inappropriate, he added, noting that little success has been achieved with prior antibiotic stewardship efforts that focused largely on clinician education.

“So, we tried to tackle it a bit differently,” he said. “We saw a persistent significant change in antibiotic prescribing in the peer comparison intervention group. ... I would say that interventions that take advantage of social motivation appear to be effective or persistent.”

Dr. Linder reported having no relevant disclosures.

[email protected]

NEW ORLEANS – The benefits of an 18-month behavioral intervention to reduce inappropriate antibiotic prescribing in the primary care setting were maintained 18 months after the intervention ended, according to follow-up data from a cluster randomized clinical trial.

During the 18-month intervention period, physicians at 47 adult and pediatric practices that participated in the trial, which compared three behavioral interventions and intervention combinations, significantly reduced their inappropriate prescribing.

After 18 months, the results were durable – and particularly so in the groups that received interventions that used “social motivation,” Jeffrey Linder, MD, of Brigham & Women’s Hospital and Harvard Medical School, Boston, reported at an annual scientific meeting on infectious diseases.

A total of 16,959 antibiotic-inappropriate visits (visits for nonspecific upper respiratory tract infections, acute bronchitis, and influenza) were made to 248 clinicians during the 18-month intervention period, and 3,192 such visits were made to 224 clinicians during the postintervention period (JAMA. 2016 Feb 9;315[6]:562-70).

The interventions included “suggested alternatives,” which was an electronic health record-based approach that prompted the prescriber to answer whether a prescription was for an acute respiratory infection. A “yes” answer resulted in the prescriber receiving information about appropriate prescribing, along with a list of “easy nonantibiotic alternatives,” Dr. Linder explained, noting that the interventions involved “trying to make it easy to do the right thing.”

An “accountable justification” intervention used a similar process, but rather than suggesting alternative options, the program asked the prescriber to input a “tweet-length justification” of the prescription. The justification was then entered into the patient’s chart.

The third intervention involved “peer comparison.” Prescribers received monthly e-mail feedback regarding how their prescribing stacked up to that of their peers – specifically noting whether they were or were not “top performers.”

Some of the groups in the trial received combinations of these interventions, but the follow-up analysis showed that the latter two approaches, which involved “social motivation,” had the most durable effects.

For example, the inappropriate antibiotic prescribing rate for those in the “accountable justification” group decreased from 23.2% to 5.2% at the end of the 18-month intervention period (absolute difference, -18.1%) and increased to 9% at the end of follow-up.

The inappropriate prescribing rate decreased from about 20% to about 4% in the “peer comparison” group at the end of the intervention period (absolute difference of -16.3%), then increased to 5% at the end of follow-up, Dr. Linder said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

“The statistically best player here – the peer comparison group – went from 20% to 4% to 5%, so it only went back up 1% even after we turned the intervention off for 18 months,” he said.

Antibiotics often are inappropriately prescribed for acute respiratory infections in primary care. Such infections – including colds, sinusitis, strep throat, nonstrep pharyngitis, acute bronchitis, and influenza – make up only 10% of all ambulatory visits in the United States, but they account for 44% of all antibiotic prescribing, Dr. Linder said.

An estimated 50% of antibiotic prescriptions for acute respiratory infections are inappropriate, he added, noting that little success has been achieved with prior antibiotic stewardship efforts that focused largely on clinician education.

“So, we tried to tackle it a bit differently,” he said. “We saw a persistent significant change in antibiotic prescribing in the peer comparison intervention group. ... I would say that interventions that take advantage of social motivation appear to be effective or persistent.”

Dr. Linder reported having no relevant disclosures.

[email protected]

NEW ORLEANS – The benefits of an 18-month behavioral intervention to reduce inappropriate antibiotic prescribing in the primary care setting were maintained 18 months after the intervention ended, according to follow-up data from a cluster randomized clinical trial.

During the 18-month intervention period, physicians at 47 adult and pediatric practices that participated in the trial, which compared three behavioral interventions and intervention combinations, significantly reduced their inappropriate prescribing.

After 18 months, the results were durable – and particularly so in the groups that received interventions that used “social motivation,” Jeffrey Linder, MD, of Brigham & Women’s Hospital and Harvard Medical School, Boston, reported at an annual scientific meeting on infectious diseases.

A total of 16,959 antibiotic-inappropriate visits (visits for nonspecific upper respiratory tract infections, acute bronchitis, and influenza) were made to 248 clinicians during the 18-month intervention period, and 3,192 such visits were made to 224 clinicians during the postintervention period (JAMA. 2016 Feb 9;315[6]:562-70).

The interventions included “suggested alternatives,” which was an electronic health record-based approach that prompted the prescriber to answer whether a prescription was for an acute respiratory infection. A “yes” answer resulted in the prescriber receiving information about appropriate prescribing, along with a list of “easy nonantibiotic alternatives,” Dr. Linder explained, noting that the interventions involved “trying to make it easy to do the right thing.”

An “accountable justification” intervention used a similar process, but rather than suggesting alternative options, the program asked the prescriber to input a “tweet-length justification” of the prescription. The justification was then entered into the patient’s chart.

The third intervention involved “peer comparison.” Prescribers received monthly e-mail feedback regarding how their prescribing stacked up to that of their peers – specifically noting whether they were or were not “top performers.”

Some of the groups in the trial received combinations of these interventions, but the follow-up analysis showed that the latter two approaches, which involved “social motivation,” had the most durable effects.

For example, the inappropriate antibiotic prescribing rate for those in the “accountable justification” group decreased from 23.2% to 5.2% at the end of the 18-month intervention period (absolute difference, -18.1%) and increased to 9% at the end of follow-up.

The inappropriate prescribing rate decreased from about 20% to about 4% in the “peer comparison” group at the end of the intervention period (absolute difference of -16.3%), then increased to 5% at the end of follow-up, Dr. Linder said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

“The statistically best player here – the peer comparison group – went from 20% to 4% to 5%, so it only went back up 1% even after we turned the intervention off for 18 months,” he said.

Antibiotics often are inappropriately prescribed for acute respiratory infections in primary care. Such infections – including colds, sinusitis, strep throat, nonstrep pharyngitis, acute bronchitis, and influenza – make up only 10% of all ambulatory visits in the United States, but they account for 44% of all antibiotic prescribing, Dr. Linder said.

An estimated 50% of antibiotic prescriptions for acute respiratory infections are inappropriate, he added, noting that little success has been achieved with prior antibiotic stewardship efforts that focused largely on clinician education.

“So, we tried to tackle it a bit differently,” he said. “We saw a persistent significant change in antibiotic prescribing in the peer comparison intervention group. ... I would say that interventions that take advantage of social motivation appear to be effective or persistent.”

Dr. Linder reported having no relevant disclosures.

[email protected]

VIENNA – An adjunctive aerobic exercise program improved cognitive impairment in patients hospitalized for depression in a Swiss randomized controlled trial, Christian Imboden, MD, reported at the annual congress of the European College of Neuropsychopharmacology.

This study addresses a major unmet need in the treatment of depression: namely, options to improve the cognitive dysfunction that accompanies the mood disorder.

Bruce Jancin/Frontline Medical News

At the end of 6 weeks, the 16 patients in the exercise group demonstrated significantly greater improvement in working memory reaction time than controls.

“It’s a medium effect size for working memory,” Dr. Imboden said.

The exercisers also showed a trend, albeit not statistically significant, for greater improvement on a measure of alertness, compared with the controls.

The exercise group and controls showed similar improvements in core depressive symptoms over time. After 6 weeks, their mean Hamilton score had improved from 21.7 to 8.6. This result differs from numerous prior studies by other investigators, which have found – typically in outpatients – that exercise significantly reduced depressive symptom severity relative to controls in patients with mild to moderate depression.

Dr. Imboden believes he knows the explanation for the divergent findings. “We have a very effective inpatient treatment program with evidence-based pharmacology, CBT [cognitive-behavioral therapy], and CBT-I for sleep problems. All of our patients were below 10 on the Hamilton score. I think the added value of exercise is very difficult to show under these circumstances, especially with a small sample size,” he said in an interview.

Also, the control arms in exercise research studies often tend to show a large placebo effect. When sedentary patients in the depth of depression are able to overcome their lassitude and sign up for an exercise trial, even simple stretching represents a significant increase in bodily movement, the psychiatrist added.

The biggest need now is to come up with ways to facilitate the transfer of exercise programs from the treatment setting into posttreatment daily life, according to Dr. Imboden.

“Everybody who’s exercising knows it’s helpful, but it can be difficult to create a routine,” he said.

The study was funded by a health research foundation grant, a Swiss health insurance company, and the Canton of Solothurn. Dr. Imboden reported having no financial disclosures.

[email protected]

VIENNA – An adjunctive aerobic exercise program improved cognitive impairment in patients hospitalized for depression in a Swiss randomized controlled trial, Christian Imboden, MD, reported at the annual congress of the European College of Neuropsychopharmacology.

This study addresses a major unmet need in the treatment of depression: namely, options to improve the cognitive dysfunction that accompanies the mood disorder.

Bruce Jancin/Frontline Medical News

At the end of 6 weeks, the 16 patients in the exercise group demonstrated significantly greater improvement in working memory reaction time than controls.

“It’s a medium effect size for working memory,” Dr. Imboden said.

The exercisers also showed a trend, albeit not statistically significant, for greater improvement on a measure of alertness, compared with the controls.

The exercise group and controls showed similar improvements in core depressive symptoms over time. After 6 weeks, their mean Hamilton score had improved from 21.7 to 8.6. This result differs from numerous prior studies by other investigators, which have found – typically in outpatients – that exercise significantly reduced depressive symptom severity relative to controls in patients with mild to moderate depression.

Dr. Imboden believes he knows the explanation for the divergent findings. “We have a very effective inpatient treatment program with evidence-based pharmacology, CBT [cognitive-behavioral therapy], and CBT-I for sleep problems. All of our patients were below 10 on the Hamilton score. I think the added value of exercise is very difficult to show under these circumstances, especially with a small sample size,” he said in an interview.

Also, the control arms in exercise research studies often tend to show a large placebo effect. When sedentary patients in the depth of depression are able to overcome their lassitude and sign up for an exercise trial, even simple stretching represents a significant increase in bodily movement, the psychiatrist added.

The biggest need now is to come up with ways to facilitate the transfer of exercise programs from the treatment setting into posttreatment daily life, according to Dr. Imboden.

“Everybody who’s exercising knows it’s helpful, but it can be difficult to create a routine,” he said.

The study was funded by a health research foundation grant, a Swiss health insurance company, and the Canton of Solothurn. Dr. Imboden reported having no financial disclosures.

[email protected]

VIENNA – An adjunctive aerobic exercise program improved cognitive impairment in patients hospitalized for depression in a Swiss randomized controlled trial, Christian Imboden, MD, reported at the annual congress of the European College of Neuropsychopharmacology.

This study addresses a major unmet need in the treatment of depression: namely, options to improve the cognitive dysfunction that accompanies the mood disorder.

Bruce Jancin/Frontline Medical News

At the end of 6 weeks, the 16 patients in the exercise group demonstrated significantly greater improvement in working memory reaction time than controls.

“It’s a medium effect size for working memory,” Dr. Imboden said.

The exercisers also showed a trend, albeit not statistically significant, for greater improvement on a measure of alertness, compared with the controls.

The exercise group and controls showed similar improvements in core depressive symptoms over time. After 6 weeks, their mean Hamilton score had improved from 21.7 to 8.6. This result differs from numerous prior studies by other investigators, which have found – typically in outpatients – that exercise significantly reduced depressive symptom severity relative to controls in patients with mild to moderate depression.

Dr. Imboden believes he knows the explanation for the divergent findings. “We have a very effective inpatient treatment program with evidence-based pharmacology, CBT [cognitive-behavioral therapy], and CBT-I for sleep problems. All of our patients were below 10 on the Hamilton score. I think the added value of exercise is very difficult to show under these circumstances, especially with a small sample size,” he said in an interview.

Also, the control arms in exercise research studies often tend to show a large placebo effect. When sedentary patients in the depth of depression are able to overcome their lassitude and sign up for an exercise trial, even simple stretching represents a significant increase in bodily movement, the psychiatrist added.

The biggest need now is to come up with ways to facilitate the transfer of exercise programs from the treatment setting into posttreatment daily life, according to Dr. Imboden.

“Everybody who’s exercising knows it’s helpful, but it can be difficult to create a routine,” he said.

The study was funded by a health research foundation grant, a Swiss health insurance company, and the Canton of Solothurn. Dr. Imboden reported having no financial disclosures.

[email protected]

NEW ORLEANS – Daily supplementation with high-dose omega-3 fatty acids significantly slashed levels of triglycerides and C-reactive protein (CRP) among people with HIV infection at 2 years, according to a randomized study.

“This is the longest randomized, controlled trial to date of high-dose omega-3 in the HIV infected to evaluate long-term effects on lipids, inflammation, and vascular function,” Gretchen Volpe, MD, said at an annual scientific meeting on infectious diseases. Prior studies were limited to 24 weeks or fewer of omega-3 supplementation, she added.

The trial is part of a bigger trend, one where investigators strive to improve duration and quality of life for people living with HIV/AIDS because of the field’s success in managing HIV infection itself.

“Cardiovascular disease is prevalent in persons with HIV,” said Dr. Volpe of Tufts Medical Center in Boston. “HIV increases cardiovascular disease through several pathways – including dyslipidemia, chronic inflammation, and vascular dysfunction.” Both HIV infection itself as well as antiretroviral therapy can have atherogenic effects on vasculature, she added.

Omega-3 fatty acids have been shown to reduce triglycerides in HIV-infected and non–HIV infected people, and they may reduce inflammation by decreasing the inflammatory mediator arachidonic acid, Dr. Volpe said.

She and her colleagues enrolled HIV-infected adults on stable antiretroviral therapy with fasting triglycerides between 150 mg/dL and 2,500 mg/dL at baseline. They randomized 43 people to 4 g omega-3 (Lovaza) daily, and another 40 people to placebo in an intent-to-treat analysis.

The mean age was 51 years, 21% were women, and there were no significant differences between groups at baseline on lipid parameters or statin use. Most patients (95%) were virologically suppressed, with a mean CD4+ count of 648 cells/mcL. The mean duration of HIV infection was 16 years.

The median decrease in triglycerides at 24 months was 68 mg/dL in the omega-3 group, compared with 22 mg/dL in the placebo group, a significant difference (P = .041). Another primary outcome, change in C-reactive protein as an indication of systemic inflammation, decreased 0.3 mg/L in treated participants, versus an increase of 0.6 mg/L in the placebo group. That difference also was statistically significant (P = .008).

In contrast, there were no significant differences in HDL-C changes, arterial stiffness, or brachial artery reactivity between groups at 2 years. Serious adverse event rates did not differ, either, Dr. Volpe reported at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society

“Adherence even over a 2-year trial is feasible, and efficacy may increase over time – we noted our 24-month data were more statistically significant than our 12-month data,” Dr. Volpe observed. Omega-3 fatty acid supplementation is well tolerated with limited side effects, she added. “Omega-3 fatty acid supplementation [also] may reduce inflammation as measured by CRP, even for those whose CRP was in the normal range at baseline.”

Total cholesterol did not significantly differ between groups at any time point, Dr. Volpe noted. “But we noticed a trend toward greater reduction in total cholesterol in the treatment group at 12 months and 24 months. There we no differences at any time point between groups in LDL cholesterol, which allays some concerns that fatty acids might increase LDL.”

The use of the prescription formulation of omega-3 fatty acids could be a limitation of the study, Dr. Volpe said, because not all people at risk may be able to access or afford it.

During a question session after the presentation, a meeting attendee asked about over-the-counter formulations that she could recommend to her patients. “We used the high dose, because some previous studies showed a dose-dependent response,” Dr. Volpe responded. “This was a purified formulation, so we could know what we were giving. ... I don’t know how to solve that problem in real life, but maybe use the best preparation that you are most familiar with.”

Another attendee asked about any differences between groups in statin use, alcohol consumption, or smoking. “We had about 30% statin users in either arm,” Dr. Volpe replied. “Some studies have shown that statins reduce or eliminate the effects of omega-3s, whereas other studies have shown that high-dose, high-efficacy statins improve the effects of omega-3s. Whatever the effect was, it was well distributed between groups.” Smoking and drinking rates did not significantly different between groups, she noted.

In a video interview at the meeting, Dr. Volpe discussed the study and its findings.

Dr. Volpe had no relevant disclosures.

[email protected]

NEW ORLEANS – Daily supplementation with high-dose omega-3 fatty acids significantly slashed levels of triglycerides and C-reactive protein (CRP) among people with HIV infection at 2 years, according to a randomized study.

“This is the longest randomized, controlled trial to date of high-dose omega-3 in the HIV infected to evaluate long-term effects on lipids, inflammation, and vascular function,” Gretchen Volpe, MD, said at an annual scientific meeting on infectious diseases. Prior studies were limited to 24 weeks or fewer of omega-3 supplementation, she added.

The trial is part of a bigger trend, one where investigators strive to improve duration and quality of life for people living with HIV/AIDS because of the field’s success in managing HIV infection itself.

“Cardiovascular disease is prevalent in persons with HIV,” said Dr. Volpe of Tufts Medical Center in Boston. “HIV increases cardiovascular disease through several pathways – including dyslipidemia, chronic inflammation, and vascular dysfunction.” Both HIV infection itself as well as antiretroviral therapy can have atherogenic effects on vasculature, she added.

Omega-3 fatty acids have been shown to reduce triglycerides in HIV-infected and non–HIV infected people, and they may reduce inflammation by decreasing the inflammatory mediator arachidonic acid, Dr. Volpe said.

She and her colleagues enrolled HIV-infected adults on stable antiretroviral therapy with fasting triglycerides between 150 mg/dL and 2,500 mg/dL at baseline. They randomized 43 people to 4 g omega-3 (Lovaza) daily, and another 40 people to placebo in an intent-to-treat analysis.

The mean age was 51 years, 21% were women, and there were no significant differences between groups at baseline on lipid parameters or statin use. Most patients (95%) were virologically suppressed, with a mean CD4+ count of 648 cells/mcL. The mean duration of HIV infection was 16 years.

The median decrease in triglycerides at 24 months was 68 mg/dL in the omega-3 group, compared with 22 mg/dL in the placebo group, a significant difference (P = .041). Another primary outcome, change in C-reactive protein as an indication of systemic inflammation, decreased 0.3 mg/L in treated participants, versus an increase of 0.6 mg/L in the placebo group. That difference also was statistically significant (P = .008).

In contrast, there were no significant differences in HDL-C changes, arterial stiffness, or brachial artery reactivity between groups at 2 years. Serious adverse event rates did not differ, either, Dr. Volpe reported at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society

“Adherence even over a 2-year trial is feasible, and efficacy may increase over time – we noted our 24-month data were more statistically significant than our 12-month data,” Dr. Volpe observed. Omega-3 fatty acid supplementation is well tolerated with limited side effects, she added. “Omega-3 fatty acid supplementation [also] may reduce inflammation as measured by CRP, even for those whose CRP was in the normal range at baseline.”

Total cholesterol did not significantly differ between groups at any time point, Dr. Volpe noted. “But we noticed a trend toward greater reduction in total cholesterol in the treatment group at 12 months and 24 months. There we no differences at any time point between groups in LDL cholesterol, which allays some concerns that fatty acids might increase LDL.”

The use of the prescription formulation of omega-3 fatty acids could be a limitation of the study, Dr. Volpe said, because not all people at risk may be able to access or afford it.

During a question session after the presentation, a meeting attendee asked about over-the-counter formulations that she could recommend to her patients. “We used the high dose, because some previous studies showed a dose-dependent response,” Dr. Volpe responded. “This was a purified formulation, so we could know what we were giving. ... I don’t know how to solve that problem in real life, but maybe use the best preparation that you are most familiar with.”

Another attendee asked about any differences between groups in statin use, alcohol consumption, or smoking. “We had about 30% statin users in either arm,” Dr. Volpe replied. “Some studies have shown that statins reduce or eliminate the effects of omega-3s, whereas other studies have shown that high-dose, high-efficacy statins improve the effects of omega-3s. Whatever the effect was, it was well distributed between groups.” Smoking and drinking rates did not significantly different between groups, she noted.

In a video interview at the meeting, Dr. Volpe discussed the study and its findings.

Dr. Volpe had no relevant disclosures.

[email protected]

NEW ORLEANS – Daily supplementation with high-dose omega-3 fatty acids significantly slashed levels of triglycerides and C-reactive protein (CRP) among people with HIV infection at 2 years, according to a randomized study.

“This is the longest randomized, controlled trial to date of high-dose omega-3 in the HIV infected to evaluate long-term effects on lipids, inflammation, and vascular function,” Gretchen Volpe, MD, said at an annual scientific meeting on infectious diseases. Prior studies were limited to 24 weeks or fewer of omega-3 supplementation, she added.

The trial is part of a bigger trend, one where investigators strive to improve duration and quality of life for people living with HIV/AIDS because of the field’s success in managing HIV infection itself.

“Cardiovascular disease is prevalent in persons with HIV,” said Dr. Volpe of Tufts Medical Center in Boston. “HIV increases cardiovascular disease through several pathways – including dyslipidemia, chronic inflammation, and vascular dysfunction.” Both HIV infection itself as well as antiretroviral therapy can have atherogenic effects on vasculature, she added.

Omega-3 fatty acids have been shown to reduce triglycerides in HIV-infected and non–HIV infected people, and they may reduce inflammation by decreasing the inflammatory mediator arachidonic acid, Dr. Volpe said.

She and her colleagues enrolled HIV-infected adults on stable antiretroviral therapy with fasting triglycerides between 150 mg/dL and 2,500 mg/dL at baseline. They randomized 43 people to 4 g omega-3 (Lovaza) daily, and another 40 people to placebo in an intent-to-treat analysis.

The mean age was 51 years, 21% were women, and there were no significant differences between groups at baseline on lipid parameters or statin use. Most patients (95%) were virologically suppressed, with a mean CD4+ count of 648 cells/mcL. The mean duration of HIV infection was 16 years.

The median decrease in triglycerides at 24 months was 68 mg/dL in the omega-3 group, compared with 22 mg/dL in the placebo group, a significant difference (P = .041). Another primary outcome, change in C-reactive protein as an indication of systemic inflammation, decreased 0.3 mg/L in treated participants, versus an increase of 0.6 mg/L in the placebo group. That difference also was statistically significant (P = .008).

In contrast, there were no significant differences in HDL-C changes, arterial stiffness, or brachial artery reactivity between groups at 2 years. Serious adverse event rates did not differ, either, Dr. Volpe reported at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society

“Adherence even over a 2-year trial is feasible, and efficacy may increase over time – we noted our 24-month data were more statistically significant than our 12-month data,” Dr. Volpe observed. Omega-3 fatty acid supplementation is well tolerated with limited side effects, she added. “Omega-3 fatty acid supplementation [also] may reduce inflammation as measured by CRP, even for those whose CRP was in the normal range at baseline.”

Total cholesterol did not significantly differ between groups at any time point, Dr. Volpe noted. “But we noticed a trend toward greater reduction in total cholesterol in the treatment group at 12 months and 24 months. There we no differences at any time point between groups in LDL cholesterol, which allays some concerns that fatty acids might increase LDL.”

The use of the prescription formulation of omega-3 fatty acids could be a limitation of the study, Dr. Volpe said, because not all people at risk may be able to access or afford it.

During a question session after the presentation, a meeting attendee asked about over-the-counter formulations that she could recommend to her patients. “We used the high dose, because some previous studies showed a dose-dependent response,” Dr. Volpe responded. “This was a purified formulation, so we could know what we were giving. ... I don’t know how to solve that problem in real life, but maybe use the best preparation that you are most familiar with.”

Another attendee asked about any differences between groups in statin use, alcohol consumption, or smoking. “We had about 30% statin users in either arm,” Dr. Volpe replied. “Some studies have shown that statins reduce or eliminate the effects of omega-3s, whereas other studies have shown that high-dose, high-efficacy statins improve the effects of omega-3s. Whatever the effect was, it was well distributed between groups.” Smoking and drinking rates did not significantly different between groups, she noted.

In a video interview at the meeting, Dr. Volpe discussed the study and its findings.

Dr. Volpe had no relevant disclosures.

[email protected]

WASHINGTON – The relatively low number of women and minority-group patients enrolled into cardiovascular disease clinical trials may skew the results, based on a comparison of outcomes following coronary stenting in an analysis of more than 4,000 patients.

During 12 months following coronary-disease treatment with percutaneous coronary intervention (PCI), women of diverse racial and ethnic backgrounds had a statistically significant 60% relative increase in death and myocardial infarctions, compared with white men, after adjustment for known baseline variables, Wayne B. Batchelor, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Minority patients, a mix of women and men, had a 90% relative rise in death and MIs, and a 60% higher rate of MIs after adjustment, both statistically significant differences.

Dr. Batchelor and his associates have not yet analyzed what factors are behind these worse outcomes in women and minority patients. But he suspects social and economic factors may provide at least some explanation, including income, education, language fluency, exercise habits, and access to health care.

“I think the trends we saw are real; the question is what accounts for the differences,” said Dr. Batchelor, an interventional cardiologist in Tallahassee, Fla. Regardless of the causes, he believes that the outcome differences have important immediate messages.

“We need to ensure better representation of women and minorities in clinical trials,” he said in an interview. “We don’t collect enough data from women and minorities. Historically, they have been underrepresented in trials.”

Another lesson is the importance of putting women and minority patients with cardiovascular disease on guideline-directed treatment, including dual antiplatelet therapy, lipid-lowering drugs, and antihypertensive drugs. The results show potential opportunity to further improve outcomes in women and minority patients, Dr. Batchelor said at the meeting, sponsored by the Cardiovascular Research Foundation.

The PLATINUM Diversity trial enrolled 1,501 women and men from minority groups with coronary disease who required PCI at one of 52 U.S. sites. For his analysis, Dr. Batchelor combined the 12-month outcomes of these patients with 12-month data from 2,687 unselected patients enrolled in the PROMUS Element Plus post-marketing approval study, a group of mostly white men.

The PLATINUM Diversity trial was sponsored by Boston Scientific. Dr. Batchelor has received research support from and has been a speaker for and consultant to Boston Scientific. He also has been a speaker for and consultant to Abbott Vascular and Medtronic.

[email protected] On Twitter @mitchelzoler

WASHINGTON – The relatively low number of women and minority-group patients enrolled into cardiovascular disease clinical trials may skew the results, based on a comparison of outcomes following coronary stenting in an analysis of more than 4,000 patients.

During 12 months following coronary-disease treatment with percutaneous coronary intervention (PCI), women of diverse racial and ethnic backgrounds had a statistically significant 60% relative increase in death and myocardial infarctions, compared with white men, after adjustment for known baseline variables, Wayne B. Batchelor, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Minority patients, a mix of women and men, had a 90% relative rise in death and MIs, and a 60% higher rate of MIs after adjustment, both statistically significant differences.

Dr. Batchelor and his associates have not yet analyzed what factors are behind these worse outcomes in women and minority patients. But he suspects social and economic factors may provide at least some explanation, including income, education, language fluency, exercise habits, and access to health care.

“I think the trends we saw are real; the question is what accounts for the differences,” said Dr. Batchelor, an interventional cardiologist in Tallahassee, Fla. Regardless of the causes, he believes that the outcome differences have important immediate messages.

“We need to ensure better representation of women and minorities in clinical trials,” he said in an interview. “We don’t collect enough data from women and minorities. Historically, they have been underrepresented in trials.”

Another lesson is the importance of putting women and minority patients with cardiovascular disease on guideline-directed treatment, including dual antiplatelet therapy, lipid-lowering drugs, and antihypertensive drugs. The results show potential opportunity to further improve outcomes in women and minority patients, Dr. Batchelor said at the meeting, sponsored by the Cardiovascular Research Foundation.

The PLATINUM Diversity trial enrolled 1,501 women and men from minority groups with coronary disease who required PCI at one of 52 U.S. sites. For his analysis, Dr. Batchelor combined the 12-month outcomes of these patients with 12-month data from 2,687 unselected patients enrolled in the PROMUS Element Plus post-marketing approval study, a group of mostly white men.

The PLATINUM Diversity trial was sponsored by Boston Scientific. Dr. Batchelor has received research support from and has been a speaker for and consultant to Boston Scientific. He also has been a speaker for and consultant to Abbott Vascular and Medtronic.

[email protected] On Twitter @mitchelzoler

WASHINGTON – The relatively low number of women and minority-group patients enrolled into cardiovascular disease clinical trials may skew the results, based on a comparison of outcomes following coronary stenting in an analysis of more than 4,000 patients.

During 12 months following coronary-disease treatment with percutaneous coronary intervention (PCI), women of diverse racial and ethnic backgrounds had a statistically significant 60% relative increase in death and myocardial infarctions, compared with white men, after adjustment for known baseline variables, Wayne B. Batchelor, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Minority patients, a mix of women and men, had a 90% relative rise in death and MIs, and a 60% higher rate of MIs after adjustment, both statistically significant differences.

Dr. Batchelor and his associates have not yet analyzed what factors are behind these worse outcomes in women and minority patients. But he suspects social and economic factors may provide at least some explanation, including income, education, language fluency, exercise habits, and access to health care.

“I think the trends we saw are real; the question is what accounts for the differences,” said Dr. Batchelor, an interventional cardiologist in Tallahassee, Fla. Regardless of the causes, he believes that the outcome differences have important immediate messages.

“We need to ensure better representation of women and minorities in clinical trials,” he said in an interview. “We don’t collect enough data from women and minorities. Historically, they have been underrepresented in trials.”

Another lesson is the importance of putting women and minority patients with cardiovascular disease on guideline-directed treatment, including dual antiplatelet therapy, lipid-lowering drugs, and antihypertensive drugs. The results show potential opportunity to further improve outcomes in women and minority patients, Dr. Batchelor said at the meeting, sponsored by the Cardiovascular Research Foundation.

The PLATINUM Diversity trial enrolled 1,501 women and men from minority groups with coronary disease who required PCI at one of 52 U.S. sites. For his analysis, Dr. Batchelor combined the 12-month outcomes of these patients with 12-month data from 2,687 unselected patients enrolled in the PROMUS Element Plus post-marketing approval study, a group of mostly white men.

The PLATINUM Diversity trial was sponsored by Boston Scientific. Dr. Batchelor has received research support from and has been a speaker for and consultant to Boston Scientific. He also has been a speaker for and consultant to Abbott Vascular and Medtronic.

[email protected] On Twitter @mitchelzoler

ATLANTA – While there is no question about the need to address pockets of increasing vaccine refusals, determining how to address it requires a better understanding of the forces underlying vaccine hesitancy.

This area of research is still young, but Glen Nowak, PhD, a visiting communication scientist at the National Vaccine Program Office and director of the Grady College Center for Health & Risk Communication at the University of Georgia in Athens, drew on multiple recent studies and an in-progress review of vaccine hesitancy and confidence literature to distill five key findings from recent research into vaccine hesitancy. He presented that summary at a conference sponsored by the Centers for Disease Control and Prevention.
 

The first insight: There is a lot of interest in understanding vaccine hesitancy and confidence. But the rub is that many inconsistencies and uncertainties exist, because efforts remain in the early stages of research.

Dr. Nowak referenced the November 2014 report of the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on Immunization to define vaccine hesitancy as the “delay in acceptance or refusal of vaccines despite availability of vaccine services.” But that hesitancy is complex and context specific, varying across time, place, and type of vaccine, the report found.

Those who are hesitant about vaccines are not a homogeneous group, Dr. Nowak said. Their degree of indecision ranges from refusing all vaccines, refusing some and accepting others, or delaying some but not others, to full acceptance of all vaccines despite hesitancy. Their attitudes also vary about vaccination overall and about specific vaccines.

“Vaccines hesitancy is influenced by several factors: complacency, convenience, and confidence,” Dr. Nowak said.

“Generally speaking, the end goal of all of our efforts is vaccine coverage, and before that is vaccine acceptance,” he said. “Before acceptance is hesitancy, and confidence is considered the precursor to hesitancy.” But no clear definition or measure of “vaccine confidence” exists yet.

Dr. Nowak next highlighted the second key finding: that research has identified an association between vaccine hesitancy or vaccine-related hesitancy and vaccine acceptance.

A 2016 study found that scores from the Attitudes about Childhood Vaccines Survey predicted under-immunization in children at 19 months of age, and three studies from 2008 through 2012 found a greater likelihood to delay or refuse vaccines among parents who had vaccine-related doubts.

Focus groups have found that parents who express hesitation or a lack of trust in vaccines also tend to mention using “alternative schedules,” including delaying vaccines or only vaccinating their children with select vaccines instead of all the recommended immunizations.

The third key finding Dr. Nowak discussed returned to the idea of “vaccine confidence,” which has aroused more interest in research but which requires refinement before it can become a truly helpful concept. Studies have already found links between confidence and parents vaccinating their children, but the field lacks standard measures.

“There are all different definitions that are out there, but they have not been measured,” Dr. Nowak said.

For example, the 2015 National Vaccine Advisory Committee report defined vaccine confidence as parents’ or health care providers’ trust in three areas: the immunizations recommended by the CDC’s Advisory Committee on Immunization Practices, the providers who administer the vaccines, and the processes that lead to vaccine licensure and vaccine recommendations.

But other definitions might include having faith that a person will benefit from a vaccine or that they won’t experience harm, or lacking any concerns about potential adverse outcomes.

The fourth key finding of recent research delivered positive news, Dr. Nowak noted: “Vaccines do relatively well compared to other health-related products that parents of young children have to make decisions about, such as antibiotics, over-the-counter medicines and vitamins.”

For example, in one study, the mean score (scale 1-10) of parents’ confidence that their child will not have a bad or serious adverse reaction to a recommended vaccine was 6.6, the same as the confidence level for antibiotics and only slightly below the scores of 6.8 for OTC medications and 7.3 for vitamins. Vaccines and antibiotics tied for the highest score for parents’ confidence in their effectiveness: 7.1, compared with 6.3 for OTC medications and 5.8 for vitamins. And of all four products, parents had the highest faith in vaccines as benefiting their children’s health.

But it was the final finding Dr. Nowak discussed that can present some of the greatest challenges to addressing vaccine hesitancy: Parents’ direct and indirect experiences play a significant role in their confidence about vaccines.

One study found that nearly a quarter of parents reported knowing someone who had a “bad reaction” to a vaccine (aside from soreness, fever, redness, or swelling), compared with 16.7% reporting that someone they knew had a bad reaction to an OTC medication. About one-third of parents reported the same for antibiotics.

Similarly, the measles outbreak at Disneyland in 2015 increased parents’ confidence in the safety and effectiveness of the CDC-recommended childhood vaccination schedule, and in the belief that their child’s health would benefit from receiving all the recommended vaccines.

Dr. Nowak reported no disclosures.

[email protected]

ATLANTA – While there is no question about the need to address pockets of increasing vaccine refusals, determining how to address it requires a better understanding of the forces underlying vaccine hesitancy.

This area of research is still young, but Glen Nowak, PhD, a visiting communication scientist at the National Vaccine Program Office and director of the Grady College Center for Health & Risk Communication at the University of Georgia in Athens, drew on multiple recent studies and an in-progress review of vaccine hesitancy and confidence literature to distill five key findings from recent research into vaccine hesitancy. He presented that summary at a conference sponsored by the Centers for Disease Control and Prevention.
 

The first insight: There is a lot of interest in understanding vaccine hesitancy and confidence. But the rub is that many inconsistencies and uncertainties exist, because efforts remain in the early stages of research.

Dr. Nowak referenced the November 2014 report of the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on Immunization to define vaccine hesitancy as the “delay in acceptance or refusal of vaccines despite availability of vaccine services.” But that hesitancy is complex and context specific, varying across time, place, and type of vaccine, the report found.

Those who are hesitant about vaccines are not a homogeneous group, Dr. Nowak said. Their degree of indecision ranges from refusing all vaccines, refusing some and accepting others, or delaying some but not others, to full acceptance of all vaccines despite hesitancy. Their attitudes also vary about vaccination overall and about specific vaccines.

“Vaccines hesitancy is influenced by several factors: complacency, convenience, and confidence,” Dr. Nowak said.

“Generally speaking, the end goal of all of our efforts is vaccine coverage, and before that is vaccine acceptance,” he said. “Before acceptance is hesitancy, and confidence is considered the precursor to hesitancy.” But no clear definition or measure of “vaccine confidence” exists yet.

Dr. Nowak next highlighted the second key finding: that research has identified an association between vaccine hesitancy or vaccine-related hesitancy and vaccine acceptance.

A 2016 study found that scores from the Attitudes about Childhood Vaccines Survey predicted under-immunization in children at 19 months of age, and three studies from 2008 through 2012 found a greater likelihood to delay or refuse vaccines among parents who had vaccine-related doubts.

Focus groups have found that parents who express hesitation or a lack of trust in vaccines also tend to mention using “alternative schedules,” including delaying vaccines or only vaccinating their children with select vaccines instead of all the recommended immunizations.

The third key finding Dr. Nowak discussed returned to the idea of “vaccine confidence,” which has aroused more interest in research but which requires refinement before it can become a truly helpful concept. Studies have already found links between confidence and parents vaccinating their children, but the field lacks standard measures.

“There are all different definitions that are out there, but they have not been measured,” Dr. Nowak said.

For example, the 2015 National Vaccine Advisory Committee report defined vaccine confidence as parents’ or health care providers’ trust in three areas: the immunizations recommended by the CDC’s Advisory Committee on Immunization Practices, the providers who administer the vaccines, and the processes that lead to vaccine licensure and vaccine recommendations.

But other definitions might include having faith that a person will benefit from a vaccine or that they won’t experience harm, or lacking any concerns about potential adverse outcomes.

The fourth key finding of recent research delivered positive news, Dr. Nowak noted: “Vaccines do relatively well compared to other health-related products that parents of young children have to make decisions about, such as antibiotics, over-the-counter medicines and vitamins.”

For example, in one study, the mean score (scale 1-10) of parents’ confidence that their child will not have a bad or serious adverse reaction to a recommended vaccine was 6.6, the same as the confidence level for antibiotics and only slightly below the scores of 6.8 for OTC medications and 7.3 for vitamins. Vaccines and antibiotics tied for the highest score for parents’ confidence in their effectiveness: 7.1, compared with 6.3 for OTC medications and 5.8 for vitamins. And of all four products, parents had the highest faith in vaccines as benefiting their children’s health.

But it was the final finding Dr. Nowak discussed that can present some of the greatest challenges to addressing vaccine hesitancy: Parents’ direct and indirect experiences play a significant role in their confidence about vaccines.

One study found that nearly a quarter of parents reported knowing someone who had a “bad reaction” to a vaccine (aside from soreness, fever, redness, or swelling), compared with 16.7% reporting that someone they knew had a bad reaction to an OTC medication. About one-third of parents reported the same for antibiotics.

Similarly, the measles outbreak at Disneyland in 2015 increased parents’ confidence in the safety and effectiveness of the CDC-recommended childhood vaccination schedule, and in the belief that their child’s health would benefit from receiving all the recommended vaccines.

Dr. Nowak reported no disclosures.

[email protected]

ATLANTA – While there is no question about the need to address pockets of increasing vaccine refusals, determining how to address it requires a better understanding of the forces underlying vaccine hesitancy.

This area of research is still young, but Glen Nowak, PhD, a visiting communication scientist at the National Vaccine Program Office and director of the Grady College Center for Health & Risk Communication at the University of Georgia in Athens, drew on multiple recent studies and an in-progress review of vaccine hesitancy and confidence literature to distill five key findings from recent research into vaccine hesitancy. He presented that summary at a conference sponsored by the Centers for Disease Control and Prevention.
 

The first insight: There is a lot of interest in understanding vaccine hesitancy and confidence. But the rub is that many inconsistencies and uncertainties exist, because efforts remain in the early stages of research.

Dr. Nowak referenced the November 2014 report of the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on Immunization to define vaccine hesitancy as the “delay in acceptance or refusal of vaccines despite availability of vaccine services.” But that hesitancy is complex and context specific, varying across time, place, and type of vaccine, the report found.

Those who are hesitant about vaccines are not a homogeneous group, Dr. Nowak said. Their degree of indecision ranges from refusing all vaccines, refusing some and accepting others, or delaying some but not others, to full acceptance of all vaccines despite hesitancy. Their attitudes also vary about vaccination overall and about specific vaccines.

“Vaccines hesitancy is influenced by several factors: complacency, convenience, and confidence,” Dr. Nowak said.

“Generally speaking, the end goal of all of our efforts is vaccine coverage, and before that is vaccine acceptance,” he said. “Before acceptance is hesitancy, and confidence is considered the precursor to hesitancy.” But no clear definition or measure of “vaccine confidence” exists yet.

Dr. Nowak next highlighted the second key finding: that research has identified an association between vaccine hesitancy or vaccine-related hesitancy and vaccine acceptance.

A 2016 study found that scores from the Attitudes about Childhood Vaccines Survey predicted under-immunization in children at 19 months of age, and three studies from 2008 through 2012 found a greater likelihood to delay or refuse vaccines among parents who had vaccine-related doubts.

Focus groups have found that parents who express hesitation or a lack of trust in vaccines also tend to mention using “alternative schedules,” including delaying vaccines or only vaccinating their children with select vaccines instead of all the recommended immunizations.

The third key finding Dr. Nowak discussed returned to the idea of “vaccine confidence,” which has aroused more interest in research but which requires refinement before it can become a truly helpful concept. Studies have already found links between confidence and parents vaccinating their children, but the field lacks standard measures.

“There are all different definitions that are out there, but they have not been measured,” Dr. Nowak said.

For example, the 2015 National Vaccine Advisory Committee report defined vaccine confidence as parents’ or health care providers’ trust in three areas: the immunizations recommended by the CDC’s Advisory Committee on Immunization Practices, the providers who administer the vaccines, and the processes that lead to vaccine licensure and vaccine recommendations.

But other definitions might include having faith that a person will benefit from a vaccine or that they won’t experience harm, or lacking any concerns about potential adverse outcomes.

The fourth key finding of recent research delivered positive news, Dr. Nowak noted: “Vaccines do relatively well compared to other health-related products that parents of young children have to make decisions about, such as antibiotics, over-the-counter medicines and vitamins.”

For example, in one study, the mean score (scale 1-10) of parents’ confidence that their child will not have a bad or serious adverse reaction to a recommended vaccine was 6.6, the same as the confidence level for antibiotics and only slightly below the scores of 6.8 for OTC medications and 7.3 for vitamins. Vaccines and antibiotics tied for the highest score for parents’ confidence in their effectiveness: 7.1, compared with 6.3 for OTC medications and 5.8 for vitamins. And of all four products, parents had the highest faith in vaccines as benefiting their children’s health.

But it was the final finding Dr. Nowak discussed that can present some of the greatest challenges to addressing vaccine hesitancy: Parents’ direct and indirect experiences play a significant role in their confidence about vaccines.

One study found that nearly a quarter of parents reported knowing someone who had a “bad reaction” to a vaccine (aside from soreness, fever, redness, or swelling), compared with 16.7% reporting that someone they knew had a bad reaction to an OTC medication. About one-third of parents reported the same for antibiotics.

Similarly, the measles outbreak at Disneyland in 2015 increased parents’ confidence in the safety and effectiveness of the CDC-recommended childhood vaccination schedule, and in the belief that their child’s health would benefit from receiving all the recommended vaccines.

Dr. Nowak reported no disclosures.

[email protected]

SHM recently partnered with the Human Diagnosis Project, also referred to as Human Dx, for Global Morning Report. Human Dx is the world’s first open diagnostic system, which aims to understand the fundamental data structure of diagnosis and considerably impact the future cost of, access to, and effectiveness of healthcare globally.

The Hospitalist spoke with Shantanu Nundy, MD, MBA, a primary-care physician for the Human Diagnosis Project, to learn more about its inception and SHM’s partnership.

Question: How did the Global Morning Report project start?

Answer: We were at the University of California, San Francisco (UCSF), working on a morning report with master diagnostician Gurpreet Dhaliwal, MD, when we had an “aha moment” of sorts. Instead of the typical morning report, which uses a whiteboard or slide deck, residents and Dr. Dhaliwal worked through the case using the Human Dx open case collaboration software. At the end of the morning report, the case was tweeted out on social media for anyone in the world to solve, and within minutes, a medical student in Bangladesh not only was able to access the case but also access insights from the UCSF residents and Dr. Dhaliwal. That’s when we realized we were onto something big.

Q: What are the goals of Human Dx and Global Morning Report?

A: Repeated, rapid cycles of practice, feedback, and reinforcement are key components of learning. Sports training is a useful analogy—the best athletes practice drills daily, often for hours a day, and monitor their performance rigorously—but the same can be said for many other professions, including musicians, chefs, and public speakers.

In medicine, we call seeing patients every day “practice.” But we aren’t practicing if we aren’t getting feedback and improving—we are just performing. None of us can hope to be the Michael Phelps, Yo-Yo Ma, or Grant Achatz of medicine that our patients deserve us to be without real practice.

Human Dx builds on the science of learning by enabling physicians and students to quickly test and get feedback on their clinical reasoning skills. This is done both by receiving input on their own cases as well as giving input on other contributors’ cases to compare their thinking with physicians and students from around the world. Our goal is for Global Morning Report to become the daily personalized workout schedule for doctors everywhere. What I’d like to see is that rigorous practice and pursuit of excellence in clinical reasoning, diagnosis, and management becoming a core part of the physician experience.

Q: What kind of feedback are you hearing from participants?

A: Doctors love it! Many tell us this is their daily Sudoku or crossword that they do every morning to wake their minds up on the way to work. And our numbers show it: The average active participant contributes five cases per week. And today, that’s without any CME credit or other clear reward other than learning and enjoyment.

That said, we have much to improve, and we aren’t resting on our laurels. The whole ethos of the Human Diagnosis Project is created and led by the global medical community. We are lucky to have an incredible community of physicians and trainees globally who keep us moving forward each day.

Q: Why was a partnership with SHM appealing for this project?

A: At Human Dx, we look at ourselves simply as enablers. We are making it possible for the global medical community to come together and build something important for current and future generations. As such, we want to work with the best institutions in medicine to take their expertise, content, and community and make them more available to the world. As one of the largest, fastest growing, and innovative communities in medicine, SHM is an ideal partner, and we count ourselves very fortunate to have your support.

Q: How can hospitalists participate?

A: Start contributing cases! Not every doctor is interested in medical education, technology, or policy, but every physician I know has great cases and insights to share with the world. My hope is that for physicians and medical students, contributing to Human Dx is their 10 minutes a day to be a part of something greater than themselves, allowing them to share their insights with humankind, build a resource for current and future generations, and, in doing so, renew the reasons that brought them to medicine in the first place and find joy in clinical practice. TH

Join the movement today and solve a case now at www.humandx.org/shm.

SHM recently partnered with the Human Diagnosis Project, also referred to as Human Dx, for Global Morning Report. Human Dx is the world’s first open diagnostic system, which aims to understand the fundamental data structure of diagnosis and considerably impact the future cost of, access to, and effectiveness of healthcare globally.

The Hospitalist spoke with Shantanu Nundy, MD, MBA, a primary-care physician for the Human Diagnosis Project, to learn more about its inception and SHM’s partnership.

Question: How did the Global Morning Report project start?

Answer: We were at the University of California, San Francisco (UCSF), working on a morning report with master diagnostician Gurpreet Dhaliwal, MD, when we had an “aha moment” of sorts. Instead of the typical morning report, which uses a whiteboard or slide deck, residents and Dr. Dhaliwal worked through the case using the Human Dx open case collaboration software. At the end of the morning report, the case was tweeted out on social media for anyone in the world to solve, and within minutes, a medical student in Bangladesh not only was able to access the case but also access insights from the UCSF residents and Dr. Dhaliwal. That’s when we realized we were onto something big.

Q: What are the goals of Human Dx and Global Morning Report?

A: Repeated, rapid cycles of practice, feedback, and reinforcement are key components of learning. Sports training is a useful analogy—the best athletes practice drills daily, often for hours a day, and monitor their performance rigorously—but the same can be said for many other professions, including musicians, chefs, and public speakers.

In medicine, we call seeing patients every day “practice.” But we aren’t practicing if we aren’t getting feedback and improving—we are just performing. None of us can hope to be the Michael Phelps, Yo-Yo Ma, or Grant Achatz of medicine that our patients deserve us to be without real practice.

Human Dx builds on the science of learning by enabling physicians and students to quickly test and get feedback on their clinical reasoning skills. This is done both by receiving input on their own cases as well as giving input on other contributors’ cases to compare their thinking with physicians and students from around the world. Our goal is for Global Morning Report to become the daily personalized workout schedule for doctors everywhere. What I’d like to see is that rigorous practice and pursuit of excellence in clinical reasoning, diagnosis, and management becoming a core part of the physician experience.

Q: What kind of feedback are you hearing from participants?

A: Doctors love it! Many tell us this is their daily Sudoku or crossword that they do every morning to wake their minds up on the way to work. And our numbers show it: The average active participant contributes five cases per week. And today, that’s without any CME credit or other clear reward other than learning and enjoyment.

That said, we have much to improve, and we aren’t resting on our laurels. The whole ethos of the Human Diagnosis Project is created and led by the global medical community. We are lucky to have an incredible community of physicians and trainees globally who keep us moving forward each day.

Q: Why was a partnership with SHM appealing for this project?

A: At Human Dx, we look at ourselves simply as enablers. We are making it possible for the global medical community to come together and build something important for current and future generations. As such, we want to work with the best institutions in medicine to take their expertise, content, and community and make them more available to the world. As one of the largest, fastest growing, and innovative communities in medicine, SHM is an ideal partner, and we count ourselves very fortunate to have your support.

Q: How can hospitalists participate?

A: Start contributing cases! Not every doctor is interested in medical education, technology, or policy, but every physician I know has great cases and insights to share with the world. My hope is that for physicians and medical students, contributing to Human Dx is their 10 minutes a day to be a part of something greater than themselves, allowing them to share their insights with humankind, build a resource for current and future generations, and, in doing so, renew the reasons that brought them to medicine in the first place and find joy in clinical practice. TH

Join the movement today and solve a case now at www.humandx.org/shm.

SHM recently partnered with the Human Diagnosis Project, also referred to as Human Dx, for Global Morning Report. Human Dx is the world’s first open diagnostic system, which aims to understand the fundamental data structure of diagnosis and considerably impact the future cost of, access to, and effectiveness of healthcare globally.

The Hospitalist spoke with Shantanu Nundy, MD, MBA, a primary-care physician for the Human Diagnosis Project, to learn more about its inception and SHM’s partnership.

Question: How did the Global Morning Report project start?

Answer: We were at the University of California, San Francisco (UCSF), working on a morning report with master diagnostician Gurpreet Dhaliwal, MD, when we had an “aha moment” of sorts. Instead of the typical morning report, which uses a whiteboard or slide deck, residents and Dr. Dhaliwal worked through the case using the Human Dx open case collaboration software. At the end of the morning report, the case was tweeted out on social media for anyone in the world to solve, and within minutes, a medical student in Bangladesh not only was able to access the case but also access insights from the UCSF residents and Dr. Dhaliwal. That’s when we realized we were onto something big.

Q: What are the goals of Human Dx and Global Morning Report?

A: Repeated, rapid cycles of practice, feedback, and reinforcement are key components of learning. Sports training is a useful analogy—the best athletes practice drills daily, often for hours a day, and monitor their performance rigorously—but the same can be said for many other professions, including musicians, chefs, and public speakers.

In medicine, we call seeing patients every day “practice.” But we aren’t practicing if we aren’t getting feedback and improving—we are just performing. None of us can hope to be the Michael Phelps, Yo-Yo Ma, or Grant Achatz of medicine that our patients deserve us to be without real practice.

Human Dx builds on the science of learning by enabling physicians and students to quickly test and get feedback on their clinical reasoning skills. This is done both by receiving input on their own cases as well as giving input on other contributors’ cases to compare their thinking with physicians and students from around the world. Our goal is for Global Morning Report to become the daily personalized workout schedule for doctors everywhere. What I’d like to see is that rigorous practice and pursuit of excellence in clinical reasoning, diagnosis, and management becoming a core part of the physician experience.

Q: What kind of feedback are you hearing from participants?

A: Doctors love it! Many tell us this is their daily Sudoku or crossword that they do every morning to wake their minds up on the way to work. And our numbers show it: The average active participant contributes five cases per week. And today, that’s without any CME credit or other clear reward other than learning and enjoyment.

That said, we have much to improve, and we aren’t resting on our laurels. The whole ethos of the Human Diagnosis Project is created and led by the global medical community. We are lucky to have an incredible community of physicians and trainees globally who keep us moving forward each day.

Q: Why was a partnership with SHM appealing for this project?

A: At Human Dx, we look at ourselves simply as enablers. We are making it possible for the global medical community to come together and build something important for current and future generations. As such, we want to work with the best institutions in medicine to take their expertise, content, and community and make them more available to the world. As one of the largest, fastest growing, and innovative communities in medicine, SHM is an ideal partner, and we count ourselves very fortunate to have your support.

Q: How can hospitalists participate?

A: Start contributing cases! Not every doctor is interested in medical education, technology, or policy, but every physician I know has great cases and insights to share with the world. My hope is that for physicians and medical students, contributing to Human Dx is their 10 minutes a day to be a part of something greater than themselves, allowing them to share their insights with humankind, build a resource for current and future generations, and, in doing so, renew the reasons that brought them to medicine in the first place and find joy in clinical practice. TH

Join the movement today and solve a case now at www.humandx.org/shm.

Brentuximab vedotin (Adcetris)

Photo from Business Wire

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to brentuximab vedotin (Adcetris) as a treatment for 2 subtypes of cutaneous T-cell lymphoma (CTCL).

The drug now has this designation for the treatment of patients with CD30-expressing mycosis fungoides (MF) and patients with primary cutaneous anaplastic large-cell lymphoma (pcALCL) who require systemic therapy and have received 1 prior systemic therapy.

The FDA’s breakthrough therapy designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

Breakthrough designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Brentuximab vedotin in CTCL

Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50% of patients with CTCL. The drug is being developed by Seattle Genetics and Takeda Pharmaceutical Company Limited.

Brentuximab vedotin has orphan drug designation from the FDA for the treatment of MF. The drug also received orphan drug designation from the European Commission for CTCL, including subtypes pcALCL and MF.

Brentuximab vedotin has been evaluated in CD30-expressing CTCL in investigator- and corporate-sponsored clinical trials, including the phase 3 ALCANZA trial.

This trial was designed to compare single-agent brentuximab vedotin to investigator’s choice of standard therapies—methotrexate or bexarotene—in patients with CD30-expressing CTCL, including those with pcALCL or MF.

The trial has enrolled 131 patients at 50 sites globally. Patients with pcALCL must have received at least 1 prior systemic or radiation therapy, and patients with MF must have received at least 1 prior systemic therapy.

The study’s primary endpoint is objective response lasting at least 4 months (ORR4), as assessed by Global Response Score, in the brentuximab vedotin arm compared to the control arm. Key secondary endpoints are complete response rate, progression-free survival, and reduction in the burden of symptoms during treatment.

Topline results of the trial were announced in August. The data showed a significant improvement in the ORR4 for the brentuximab vedotin arm compared to the control arm. The ORR4 was 56.3% and 12.5%, respectively (P<0.0001).

The key secondary endpoints were all statistically significant in favor of the brentuximab vedotin arm. And investigators said the safety profile of brentuximab vedotin was generally consistent with the existing prescribing information.

An abstract detailing results of the ALCANZA trial was accepted for oral presentation at the upcoming ASH Annual Meeting (abstract 182).

Brentuximab vedotin (Adcetris)

Photo from Business Wire

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to brentuximab vedotin (Adcetris) as a treatment for 2 subtypes of cutaneous T-cell lymphoma (CTCL).

The drug now has this designation for the treatment of patients with CD30-expressing mycosis fungoides (MF) and patients with primary cutaneous anaplastic large-cell lymphoma (pcALCL) who require systemic therapy and have received 1 prior systemic therapy.

The FDA’s breakthrough therapy designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

Breakthrough designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Brentuximab vedotin in CTCL

Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50% of patients with CTCL. The drug is being developed by Seattle Genetics and Takeda Pharmaceutical Company Limited.

Brentuximab vedotin has orphan drug designation from the FDA for the treatment of MF. The drug also received orphan drug designation from the European Commission for CTCL, including subtypes pcALCL and MF.

Brentuximab vedotin has been evaluated in CD30-expressing CTCL in investigator- and corporate-sponsored clinical trials, including the phase 3 ALCANZA trial.

This trial was designed to compare single-agent brentuximab vedotin to investigator’s choice of standard therapies—methotrexate or bexarotene—in patients with CD30-expressing CTCL, including those with pcALCL or MF.

The trial has enrolled 131 patients at 50 sites globally. Patients with pcALCL must have received at least 1 prior systemic or radiation therapy, and patients with MF must have received at least 1 prior systemic therapy.

The study’s primary endpoint is objective response lasting at least 4 months (ORR4), as assessed by Global Response Score, in the brentuximab vedotin arm compared to the control arm. Key secondary endpoints are complete response rate, progression-free survival, and reduction in the burden of symptoms during treatment.

Topline results of the trial were announced in August. The data showed a significant improvement in the ORR4 for the brentuximab vedotin arm compared to the control arm. The ORR4 was 56.3% and 12.5%, respectively (P<0.0001).

The key secondary endpoints were all statistically significant in favor of the brentuximab vedotin arm. And investigators said the safety profile of brentuximab vedotin was generally consistent with the existing prescribing information.

An abstract detailing results of the ALCANZA trial was accepted for oral presentation at the upcoming ASH Annual Meeting (abstract 182).

Brentuximab vedotin (Adcetris)

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The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to brentuximab vedotin (Adcetris) as a treatment for 2 subtypes of cutaneous T-cell lymphoma (CTCL).

The drug now has this designation for the treatment of patients with CD30-expressing mycosis fungoides (MF) and patients with primary cutaneous anaplastic large-cell lymphoma (pcALCL) who require systemic therapy and have received 1 prior systemic therapy.

The FDA’s breakthrough therapy designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

Breakthrough designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Brentuximab vedotin in CTCL

Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50% of patients with CTCL. The drug is being developed by Seattle Genetics and Takeda Pharmaceutical Company Limited.

Brentuximab vedotin has orphan drug designation from the FDA for the treatment of MF. The drug also received orphan drug designation from the European Commission for CTCL, including subtypes pcALCL and MF.

Brentuximab vedotin has been evaluated in CD30-expressing CTCL in investigator- and corporate-sponsored clinical trials, including the phase 3 ALCANZA trial.

This trial was designed to compare single-agent brentuximab vedotin to investigator’s choice of standard therapies—methotrexate or bexarotene—in patients with CD30-expressing CTCL, including those with pcALCL or MF.

The trial has enrolled 131 patients at 50 sites globally. Patients with pcALCL must have received at least 1 prior systemic or radiation therapy, and patients with MF must have received at least 1 prior systemic therapy.

The study’s primary endpoint is objective response lasting at least 4 months (ORR4), as assessed by Global Response Score, in the brentuximab vedotin arm compared to the control arm. Key secondary endpoints are complete response rate, progression-free survival, and reduction in the burden of symptoms during treatment.

Topline results of the trial were announced in August. The data showed a significant improvement in the ORR4 for the brentuximab vedotin arm compared to the control arm. The ORR4 was 56.3% and 12.5%, respectively (P<0.0001).

The key secondary endpoints were all statistically significant in favor of the brentuximab vedotin arm. And investigators said the safety profile of brentuximab vedotin was generally consistent with the existing prescribing information.

An abstract detailing results of the ALCANZA trial was accepted for oral presentation at the upcoming ASH Annual Meeting (abstract 182).

LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.

In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.

Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.

In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.

Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.

In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.

Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.

“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.

The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.

However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.

“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.

The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.

However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.

“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.

The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.

However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

SDEF and this news organization are owned by the same parent company.

While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.

Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

University of Miami

While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.

Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

University of Miami

While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.

Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

University of Miami