Clinical question: In patients with peptic ulcer bleeding, are oral PPIs of equal benefit to intravenous PPIs?

Background: PPI therapy has been shown in several studies to reduce re-bleeding risk in patients when used adjunctively for peptic ulcer bleeding. In spite of this data, there is still uncertainty about the optimal dose and route of administration.

Study design: Meta-analysis of prospective, randomized control trials.

Setting: OVID database search in June 2012.

Synopsis: A literature search identified six prospective randomized control trials. Overall, 615 patients were included across the six trials. No significant difference in risk of re-bleeding was discovered between the two groups (8.6% oral vs. 9.3% IV, RR: 0.92, 95% CI: 0.56–1.5). Length of hospital stay was statistically significantly lower for oral PPIs (-0.74 day, 95% CI: -1.10 to -0.39 day).

Because these findings are based on a meta-analysis of studies with notable flaws—including lack of blinding—it is difficult to draw any definitive conclusions from this data. Hospitalists should use care before changing their practice patterns, given the risk of bias and need for further study.

Bottom line: Oral PPIs may reduce hospital length of stay without an increased risk of re-bleeding; however, further study with a well-powered, double-blind, randomized control trial is necessary.

Citation: Tsoi KK, Hirai HW, Sung JJ. Meta-analysis: Comparison of oral vs. intravenous proton pump inhibitors in patients with peptic ulcer bleeding. Aliment Pharmacol Ther. 2013;38(7):721-728.

Visit our website for more information on the use of proton pump inhibitors.

Clinical question: In patients with peptic ulcer bleeding, are oral PPIs of equal benefit to intravenous PPIs?

Background: PPI therapy has been shown in several studies to reduce re-bleeding risk in patients when used adjunctively for peptic ulcer bleeding. In spite of this data, there is still uncertainty about the optimal dose and route of administration.

Study design: Meta-analysis of prospective, randomized control trials.

Setting: OVID database search in June 2012.

Synopsis: A literature search identified six prospective randomized control trials. Overall, 615 patients were included across the six trials. No significant difference in risk of re-bleeding was discovered between the two groups (8.6% oral vs. 9.3% IV, RR: 0.92, 95% CI: 0.56–1.5). Length of hospital stay was statistically significantly lower for oral PPIs (-0.74 day, 95% CI: -1.10 to -0.39 day).

Because these findings are based on a meta-analysis of studies with notable flaws—including lack of blinding—it is difficult to draw any definitive conclusions from this data. Hospitalists should use care before changing their practice patterns, given the risk of bias and need for further study.

Bottom line: Oral PPIs may reduce hospital length of stay without an increased risk of re-bleeding; however, further study with a well-powered, double-blind, randomized control trial is necessary.

Citation: Tsoi KK, Hirai HW, Sung JJ. Meta-analysis: Comparison of oral vs. intravenous proton pump inhibitors in patients with peptic ulcer bleeding. Aliment Pharmacol Ther. 2013;38(7):721-728.

Visit our website for more information on the use of proton pump inhibitors.

Clinical question: In patients with peptic ulcer bleeding, are oral PPIs of equal benefit to intravenous PPIs?

Background: PPI therapy has been shown in several studies to reduce re-bleeding risk in patients when used adjunctively for peptic ulcer bleeding. In spite of this data, there is still uncertainty about the optimal dose and route of administration.

Study design: Meta-analysis of prospective, randomized control trials.

Setting: OVID database search in June 2012.

Synopsis: A literature search identified six prospective randomized control trials. Overall, 615 patients were included across the six trials. No significant difference in risk of re-bleeding was discovered between the two groups (8.6% oral vs. 9.3% IV, RR: 0.92, 95% CI: 0.56–1.5). Length of hospital stay was statistically significantly lower for oral PPIs (-0.74 day, 95% CI: -1.10 to -0.39 day).

Because these findings are based on a meta-analysis of studies with notable flaws—including lack of blinding—it is difficult to draw any definitive conclusions from this data. Hospitalists should use care before changing their practice patterns, given the risk of bias and need for further study.

Bottom line: Oral PPIs may reduce hospital length of stay without an increased risk of re-bleeding; however, further study with a well-powered, double-blind, randomized control trial is necessary.

Citation: Tsoi KK, Hirai HW, Sung JJ. Meta-analysis: Comparison of oral vs. intravenous proton pump inhibitors in patients with peptic ulcer bleeding. Aliment Pharmacol Ther. 2013;38(7):721-728.

Visit our website for more information on the use of proton pump inhibitors.

Tell me a story. Is there anyone who hasn’t uttered those four words? As humans we are hard wired to both tell and listen to stories. Indeed, professional storyteller Bill Harley, in a 2012 TEDx talk entitled, "Stories Out Loud," said that storytelling is "at the very center of what it means to be human."

This is why storytelling is a powerful marketing tool for you and your practice. In a noisy social media world, stories allow your voice to be heard.

Here are some reasons why you should be using storytelling to market your practice:

• A story is experiential – it shares an experience or observation.

• Stories help us make sense of our lives.

• They help you connect with your patients, build trust, and market your brand.

• They can capture your patients’ attention.

• They can inspire and appeal to emotions.

• Stories are easier to remember than facts and statistics.

• They feel authentic and help show the real you and real patients.

• Stories can be educational by putting difficult concepts into meaningful context.

• They can be an effective call to action for patients.

How powerful is storytelling? Do an Internet search of "patient stories," and the results will feature some of the country’s top hospitals such as the Mayo Clinic, Memorial Sloan-Kettering Cancer Center, and St. Jude's Children's Research Hospital. Take some time visiting these sites. Watch a few videos and ask yourself what makes them effective.

When it comes to marketing your practice, you can tell stories in person to patients, on video, in blog posts, or even in images on sites like Pinterest. Although videos can be done by a professional videographer using ambient lighting and music, they don’t have to be. You might decide to videotape a procedure with your video camera or upload patient stories using your iPhone.

Before using a story, remember to respect patients’ privacy and to get their consent appropriately if they are identifiable in a story. Make sure your story is short, relevant, and compelling and leaves the consumer with a better understanding of the issue.

Do you use stories in your practice? Do you have tips for physicians on how to use stories effectively in their practice? Please share them.

Dr. Benabio is a practicing dermatologist and physician director of health care transformation at Kaiser Permanente in San Diego. Connect with him on Twitter @Dermdoc or drop him a line at benabio@gmail.com.

Tell me a story. Is there anyone who hasn’t uttered those four words? As humans we are hard wired to both tell and listen to stories. Indeed, professional storyteller Bill Harley, in a 2012 TEDx talk entitled, "Stories Out Loud," said that storytelling is "at the very center of what it means to be human."

This is why storytelling is a powerful marketing tool for you and your practice. In a noisy social media world, stories allow your voice to be heard.

Here are some reasons why you should be using storytelling to market your practice:

• A story is experiential – it shares an experience or observation.

• Stories help us make sense of our lives.

• They help you connect with your patients, build trust, and market your brand.

• They can capture your patients’ attention.

• They can inspire and appeal to emotions.

• Stories are easier to remember than facts and statistics.

• They feel authentic and help show the real you and real patients.

• Stories can be educational by putting difficult concepts into meaningful context.

• They can be an effective call to action for patients.

How powerful is storytelling? Do an Internet search of "patient stories," and the results will feature some of the country’s top hospitals such as the Mayo Clinic, Memorial Sloan-Kettering Cancer Center, and St. Jude's Children's Research Hospital. Take some time visiting these sites. Watch a few videos and ask yourself what makes them effective.

When it comes to marketing your practice, you can tell stories in person to patients, on video, in blog posts, or even in images on sites like Pinterest. Although videos can be done by a professional videographer using ambient lighting and music, they don’t have to be. You might decide to videotape a procedure with your video camera or upload patient stories using your iPhone.

Before using a story, remember to respect patients’ privacy and to get their consent appropriately if they are identifiable in a story. Make sure your story is short, relevant, and compelling and leaves the consumer with a better understanding of the issue.

Do you use stories in your practice? Do you have tips for physicians on how to use stories effectively in their practice? Please share them.

Dr. Benabio is a practicing dermatologist and physician director of health care transformation at Kaiser Permanente in San Diego. Connect with him on Twitter @Dermdoc or drop him a line at benabio@gmail.com.

Tell me a story. Is there anyone who hasn’t uttered those four words? As humans we are hard wired to both tell and listen to stories. Indeed, professional storyteller Bill Harley, in a 2012 TEDx talk entitled, "Stories Out Loud," said that storytelling is "at the very center of what it means to be human."

This is why storytelling is a powerful marketing tool for you and your practice. In a noisy social media world, stories allow your voice to be heard.

Here are some reasons why you should be using storytelling to market your practice:

• A story is experiential – it shares an experience or observation.

• Stories help us make sense of our lives.

• They help you connect with your patients, build trust, and market your brand.

• They can capture your patients’ attention.

• They can inspire and appeal to emotions.

• Stories are easier to remember than facts and statistics.

• They feel authentic and help show the real you and real patients.

• Stories can be educational by putting difficult concepts into meaningful context.

• They can be an effective call to action for patients.

How powerful is storytelling? Do an Internet search of "patient stories," and the results will feature some of the country’s top hospitals such as the Mayo Clinic, Memorial Sloan-Kettering Cancer Center, and St. Jude's Children's Research Hospital. Take some time visiting these sites. Watch a few videos and ask yourself what makes them effective.

When it comes to marketing your practice, you can tell stories in person to patients, on video, in blog posts, or even in images on sites like Pinterest. Although videos can be done by a professional videographer using ambient lighting and music, they don’t have to be. You might decide to videotape a procedure with your video camera or upload patient stories using your iPhone.

Before using a story, remember to respect patients’ privacy and to get their consent appropriately if they are identifiable in a story. Make sure your story is short, relevant, and compelling and leaves the consumer with a better understanding of the issue.

Do you use stories in your practice? Do you have tips for physicians on how to use stories effectively in their practice? Please share them.

Dr. Benabio is a practicing dermatologist and physician director of health care transformation at Kaiser Permanente in San Diego. Connect with him on Twitter @Dermdoc or drop him a line at benabio@gmail.com.

CHAMPIONSGATE, FLA. – Injections of botulinum neurotoxin type A on the nose, cheeks, and chin can significantly improve the appearance of some rosacea patients, in part by reducing overactivity of the sebaceous gland, according to Dr. Erin Gilbert of SUNY Downstate Medical Center, New York.

"I have had remarkably consistent results" using neuromodulators to treat patients with papulopustular and erythematotelangiectatic rosacea, Dr. Gilbert said in a presentation at the Orlando Dermatology Aesthetic and Clinical Conference.

Current therapies for rosacea include topical antibiotics, azelaic acid, metronidazole, sodium sulfacetamide, and the recently approved brimonidine, Dr. Gilbert said. Subantimicrobially dosed doxycycline remains the first and only oral therapy currently approved by the Food and Drug Administration, she noted.

Botulinum toxin represents a cutting-edge treatment option for rosacea that capitalizes on the skin’s biochemistry: Specific neuropeptide genes are up- or downregulated in rosacea patients, explained Dr. Gilbert, who also holds a Ph.D. in neural and behavioral sciences.

In addition, the expression of non-neuronal transient receptor potential (TRPV2, 3, and 4) ion channels is differentially upregulated in phymatous, erythematotelangiectatic, and papulopustular rosacea subtypes, she said.

When botulinum toxin type A is injected in the nose, cheeks, and chin of rosacea patients, the sebaceous gland activity and vasodilatory responses decrease. This translates to clinical findings, including reduced flushing and oil production, decreased inflammatory lesion counts, and reduced pore size, said Dr. Gilbert.

"The question is, what’s the mechanism?" she said. The answer: "Rosacea is likely improving when nerves stop talking to blood vessels and to the immune system."

For what it is worth, histology on patients with papulopustular and erythematotelangiectatic rosacea shows significant fibrosis, she noted.

Additional research is needed, but Dr. Steven H. Dayan of the University of Illinois, Chicago, and his colleagues published data on a short series of 13 patients in the Journal of Drugs in Dermatology. Their data showed substantial reduction of flushing, redness, and inflammation within a week of treatment, with effects lasting up to 3 months. No adverse events were reported (J. Drugs Dermatol. 2012;11:e76-e79).

To treat rosacea patients with botulinum toxin type A, "you have to map out the treatment area," Dr. Gilbert said. She uses 0.5-2 units in intradermal blebs spaced 1 cm apart.

She has observed improvements at 7-14 days after a single treatment, with a maximum effect evident in 2-8 weeks, but with effects persisting for an average of 4-6 months and sometimes as long as 7 months.

Her additional treatment pearls include reconstituting each of the three FDA-approved neurotoxins with 1 cc of saline, and using small syringes. She generally injects 7-10 units per cheek. "Don’t forget to treat the nose," she said.

Botulinum toxin type A (onabotulinumtoxinA) is not approved by the FDA to treat rosacea, but a randomized, double-blind, placebo-controlled pilot study comparing incobotulinumtoxinA to placebo for the treatment of rosacea is underway, conducted by Dr. Dayan and sponsored by Merz Pharmaceuticals.

Dr. Gilbert has served as a consultant for Merz Aesthetics, Allergan, and Medicis Aesthetics, and as a consultant and speaker for Johnson & Johnston and Glytone.

hsplete@frontlinemedcom.com

On Twitter @hsplete

CHAMPIONSGATE, FLA. – Injections of botulinum neurotoxin type A on the nose, cheeks, and chin can significantly improve the appearance of some rosacea patients, in part by reducing overactivity of the sebaceous gland, according to Dr. Erin Gilbert of SUNY Downstate Medical Center, New York.

"I have had remarkably consistent results" using neuromodulators to treat patients with papulopustular and erythematotelangiectatic rosacea, Dr. Gilbert said in a presentation at the Orlando Dermatology Aesthetic and Clinical Conference.

Current therapies for rosacea include topical antibiotics, azelaic acid, metronidazole, sodium sulfacetamide, and the recently approved brimonidine, Dr. Gilbert said. Subantimicrobially dosed doxycycline remains the first and only oral therapy currently approved by the Food and Drug Administration, she noted.

Botulinum toxin represents a cutting-edge treatment option for rosacea that capitalizes on the skin’s biochemistry: Specific neuropeptide genes are up- or downregulated in rosacea patients, explained Dr. Gilbert, who also holds a Ph.D. in neural and behavioral sciences.

In addition, the expression of non-neuronal transient receptor potential (TRPV2, 3, and 4) ion channels is differentially upregulated in phymatous, erythematotelangiectatic, and papulopustular rosacea subtypes, she said.

When botulinum toxin type A is injected in the nose, cheeks, and chin of rosacea patients, the sebaceous gland activity and vasodilatory responses decrease. This translates to clinical findings, including reduced flushing and oil production, decreased inflammatory lesion counts, and reduced pore size, said Dr. Gilbert.

"The question is, what’s the mechanism?" she said. The answer: "Rosacea is likely improving when nerves stop talking to blood vessels and to the immune system."

For what it is worth, histology on patients with papulopustular and erythematotelangiectatic rosacea shows significant fibrosis, she noted.

Additional research is needed, but Dr. Steven H. Dayan of the University of Illinois, Chicago, and his colleagues published data on a short series of 13 patients in the Journal of Drugs in Dermatology. Their data showed substantial reduction of flushing, redness, and inflammation within a week of treatment, with effects lasting up to 3 months. No adverse events were reported (J. Drugs Dermatol. 2012;11:e76-e79).

To treat rosacea patients with botulinum toxin type A, "you have to map out the treatment area," Dr. Gilbert said. She uses 0.5-2 units in intradermal blebs spaced 1 cm apart.

She has observed improvements at 7-14 days after a single treatment, with a maximum effect evident in 2-8 weeks, but with effects persisting for an average of 4-6 months and sometimes as long as 7 months.

Her additional treatment pearls include reconstituting each of the three FDA-approved neurotoxins with 1 cc of saline, and using small syringes. She generally injects 7-10 units per cheek. "Don’t forget to treat the nose," she said.

Botulinum toxin type A (onabotulinumtoxinA) is not approved by the FDA to treat rosacea, but a randomized, double-blind, placebo-controlled pilot study comparing incobotulinumtoxinA to placebo for the treatment of rosacea is underway, conducted by Dr. Dayan and sponsored by Merz Pharmaceuticals.

Dr. Gilbert has served as a consultant for Merz Aesthetics, Allergan, and Medicis Aesthetics, and as a consultant and speaker for Johnson & Johnston and Glytone.

hsplete@frontlinemedcom.com

On Twitter @hsplete

CHAMPIONSGATE, FLA. – Injections of botulinum neurotoxin type A on the nose, cheeks, and chin can significantly improve the appearance of some rosacea patients, in part by reducing overactivity of the sebaceous gland, according to Dr. Erin Gilbert of SUNY Downstate Medical Center, New York.

"I have had remarkably consistent results" using neuromodulators to treat patients with papulopustular and erythematotelangiectatic rosacea, Dr. Gilbert said in a presentation at the Orlando Dermatology Aesthetic and Clinical Conference.

Current therapies for rosacea include topical antibiotics, azelaic acid, metronidazole, sodium sulfacetamide, and the recently approved brimonidine, Dr. Gilbert said. Subantimicrobially dosed doxycycline remains the first and only oral therapy currently approved by the Food and Drug Administration, she noted.

Botulinum toxin represents a cutting-edge treatment option for rosacea that capitalizes on the skin’s biochemistry: Specific neuropeptide genes are up- or downregulated in rosacea patients, explained Dr. Gilbert, who also holds a Ph.D. in neural and behavioral sciences.

In addition, the expression of non-neuronal transient receptor potential (TRPV2, 3, and 4) ion channels is differentially upregulated in phymatous, erythematotelangiectatic, and papulopustular rosacea subtypes, she said.

When botulinum toxin type A is injected in the nose, cheeks, and chin of rosacea patients, the sebaceous gland activity and vasodilatory responses decrease. This translates to clinical findings, including reduced flushing and oil production, decreased inflammatory lesion counts, and reduced pore size, said Dr. Gilbert.

"The question is, what’s the mechanism?" she said. The answer: "Rosacea is likely improving when nerves stop talking to blood vessels and to the immune system."

For what it is worth, histology on patients with papulopustular and erythematotelangiectatic rosacea shows significant fibrosis, she noted.

Additional research is needed, but Dr. Steven H. Dayan of the University of Illinois, Chicago, and his colleagues published data on a short series of 13 patients in the Journal of Drugs in Dermatology. Their data showed substantial reduction of flushing, redness, and inflammation within a week of treatment, with effects lasting up to 3 months. No adverse events were reported (J. Drugs Dermatol. 2012;11:e76-e79).

To treat rosacea patients with botulinum toxin type A, "you have to map out the treatment area," Dr. Gilbert said. She uses 0.5-2 units in intradermal blebs spaced 1 cm apart.

She has observed improvements at 7-14 days after a single treatment, with a maximum effect evident in 2-8 weeks, but with effects persisting for an average of 4-6 months and sometimes as long as 7 months.

Her additional treatment pearls include reconstituting each of the three FDA-approved neurotoxins with 1 cc of saline, and using small syringes. She generally injects 7-10 units per cheek. "Don’t forget to treat the nose," she said.

Botulinum toxin type A (onabotulinumtoxinA) is not approved by the FDA to treat rosacea, but a randomized, double-blind, placebo-controlled pilot study comparing incobotulinumtoxinA to placebo for the treatment of rosacea is underway, conducted by Dr. Dayan and sponsored by Merz Pharmaceuticals.

Dr. Gilbert has served as a consultant for Merz Aesthetics, Allergan, and Medicis Aesthetics, and as a consultant and speaker for Johnson & Johnston and Glytone.

hsplete@frontlinemedcom.com

On Twitter @hsplete

Bag of saline solution

The US Food and Drug Administration (FDA) has acknowledged the current shortage of intravenous (IV) solutions, particularly 0.9% sodium chloride injection (ie, saline), which is used as a priming solution and to provide patients with the necessary fluids for hydration.

The agency said the shortage has been triggered by a range of factors. A few manufacturers have cited increased demand as the cause, and the FDA said this could be a result of flu season.

The agency is now working with 3 manufacturers of IV solutions, Baxter Healthcare Corp., B. Braun Medical Inc., and Hospira Inc., to help preserve the supply of these products.

However, the FDA noted that addressing the shortage will depend on the demand of these products and supplier production. Millions of these IV solutions are used each week by healthcare professionals.

Visit the FDA’s drug shortage webpage for updates.

Bag of saline solution

The US Food and Drug Administration (FDA) has acknowledged the current shortage of intravenous (IV) solutions, particularly 0.9% sodium chloride injection (ie, saline), which is used as a priming solution and to provide patients with the necessary fluids for hydration.

The agency said the shortage has been triggered by a range of factors. A few manufacturers have cited increased demand as the cause, and the FDA said this could be a result of flu season.

The agency is now working with 3 manufacturers of IV solutions, Baxter Healthcare Corp., B. Braun Medical Inc., and Hospira Inc., to help preserve the supply of these products.

However, the FDA noted that addressing the shortage will depend on the demand of these products and supplier production. Millions of these IV solutions are used each week by healthcare professionals.

Visit the FDA’s drug shortage webpage for updates.

Bag of saline solution

The US Food and Drug Administration (FDA) has acknowledged the current shortage of intravenous (IV) solutions, particularly 0.9% sodium chloride injection (ie, saline), which is used as a priming solution and to provide patients with the necessary fluids for hydration.

The agency said the shortage has been triggered by a range of factors. A few manufacturers have cited increased demand as the cause, and the FDA said this could be a result of flu season.

The agency is now working with 3 manufacturers of IV solutions, Baxter Healthcare Corp., B. Braun Medical Inc., and Hospira Inc., to help preserve the supply of these products.

However, the FDA noted that addressing the shortage will depend on the demand of these products and supplier production. Millions of these IV solutions are used each week by healthcare professionals.

Visit the FDA’s drug shortage webpage for updates.

Monoclonal antibodies

Credit: Linda Bartlett

The Japanese Ministry of Health, Labour and Welfare has approved brentuximab vedotin (Adcetris) for the treatment of patients with relapsed or refractory, CD30+ Hodgkin lymphoma (HL) or anaplastic large-cell lymphoma (ALCL).

The approval was based on a phase 1/2 trial in Japanese patients with relapsed or refractory, CD30+ HL or systemic ALCL, as well as data from two phase 2 trials—one of 102 HL patients and one of 58 patients with ALCL.

Brentuximab vedotin is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E.

The conjugate employs a linker system designed to be stable in the bloodstream but release monomethyl auristatin E upon internalization into CD30-expressing tumor cells.

Brentuximab vedotin was approved by the US Food and Drug Administration (FDA) in August 2011 and gained conditional approval from Health Canada in February 2013 for the following indications:

• To treat HL patients who had failed autologous stem cell transplant (auto-SCT) or were not eligible for auto-SCT and had failed at least 2 prior multi-agent chemotherapy regimens
• To treat patients with systemic ALCL after they failed at least 1 multi-agent chemotherapy regimen.

The drug received conditional marketing authorization by the European Commission in October 2012 to treat:

• Adult patients with relapsed or refractory, systemic ALCL
• Adults with relapsed or refractory, CD30-positive HL who had undergone auto-SCT or received 2 prior therapies when auto-SCT or multi-agent chemotherapy were not appropriate.

The FDA has granted brentuximab vedotin orphan designation to treat mycosis fungoides. And trials have suggested the drug is active in diffuse large B-cell lymphoma, as well as leukemias and multiple myeloma.

However, brentuximab vedotin also made the FDA watch list due to adverse events associated with the drug’s use. The FDA added a boxed warning to the drug’s label in January 2012, after 3 cases of progressive multifocal leukoencephalopathy were reported in patients receiving brentuximab vedotin.

Monoclonal antibodies

Credit: Linda Bartlett

The Japanese Ministry of Health, Labour and Welfare has approved brentuximab vedotin (Adcetris) for the treatment of patients with relapsed or refractory, CD30+ Hodgkin lymphoma (HL) or anaplastic large-cell lymphoma (ALCL).

The approval was based on a phase 1/2 trial in Japanese patients with relapsed or refractory, CD30+ HL or systemic ALCL, as well as data from two phase 2 trials—one of 102 HL patients and one of 58 patients with ALCL.

Brentuximab vedotin is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E.

The conjugate employs a linker system designed to be stable in the bloodstream but release monomethyl auristatin E upon internalization into CD30-expressing tumor cells.

Brentuximab vedotin was approved by the US Food and Drug Administration (FDA) in August 2011 and gained conditional approval from Health Canada in February 2013 for the following indications:

• To treat HL patients who had failed autologous stem cell transplant (auto-SCT) or were not eligible for auto-SCT and had failed at least 2 prior multi-agent chemotherapy regimens
• To treat patients with systemic ALCL after they failed at least 1 multi-agent chemotherapy regimen.

The drug received conditional marketing authorization by the European Commission in October 2012 to treat:

• Adult patients with relapsed or refractory, systemic ALCL
• Adults with relapsed or refractory, CD30-positive HL who had undergone auto-SCT or received 2 prior therapies when auto-SCT or multi-agent chemotherapy were not appropriate.

The FDA has granted brentuximab vedotin orphan designation to treat mycosis fungoides. And trials have suggested the drug is active in diffuse large B-cell lymphoma, as well as leukemias and multiple myeloma.

However, brentuximab vedotin also made the FDA watch list due to adverse events associated with the drug’s use. The FDA added a boxed warning to the drug’s label in January 2012, after 3 cases of progressive multifocal leukoencephalopathy were reported in patients receiving brentuximab vedotin.

Monoclonal antibodies

Credit: Linda Bartlett

The Japanese Ministry of Health, Labour and Welfare has approved brentuximab vedotin (Adcetris) for the treatment of patients with relapsed or refractory, CD30+ Hodgkin lymphoma (HL) or anaplastic large-cell lymphoma (ALCL).

The approval was based on a phase 1/2 trial in Japanese patients with relapsed or refractory, CD30+ HL or systemic ALCL, as well as data from two phase 2 trials—one of 102 HL patients and one of 58 patients with ALCL.

Brentuximab vedotin is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E.

The conjugate employs a linker system designed to be stable in the bloodstream but release monomethyl auristatin E upon internalization into CD30-expressing tumor cells.

Brentuximab vedotin was approved by the US Food and Drug Administration (FDA) in August 2011 and gained conditional approval from Health Canada in February 2013 for the following indications:

• To treat HL patients who had failed autologous stem cell transplant (auto-SCT) or were not eligible for auto-SCT and had failed at least 2 prior multi-agent chemotherapy regimens
• To treat patients with systemic ALCL after they failed at least 1 multi-agent chemotherapy regimen.

The drug received conditional marketing authorization by the European Commission in October 2012 to treat:

• Adult patients with relapsed or refractory, systemic ALCL
• Adults with relapsed or refractory, CD30-positive HL who had undergone auto-SCT or received 2 prior therapies when auto-SCT or multi-agent chemotherapy were not appropriate.

The FDA has granted brentuximab vedotin orphan designation to treat mycosis fungoides. And trials have suggested the drug is active in diffuse large B-cell lymphoma, as well as leukemias and multiple myeloma.

However, brentuximab vedotin also made the FDA watch list due to adverse events associated with the drug’s use. The FDA added a boxed warning to the drug’s label in January 2012, after 3 cases of progressive multifocal leukoencephalopathy were reported in patients receiving brentuximab vedotin.

Drug production

Credit: FDA

A new study suggests the US Food and Drug Administration (FDA) does not hold drug trials to the same set of standards.

The research revealed substantial differences in trials used to support drugs approved between 2005 and 2012.

Some drugs were approved based on results from multiple studies, while other approvals were based on data from a single trial.

Furthermore, trials varied greatly with regard to size, length of study period, type of comparator, and metrics of efficacy.

These results appear in the current issue of JAMA.

“Based on our analysis, some drugs are approved on the basis of large, high-quality clinical trials, while others are approved based on results of smaller trials,” said senior study author Joseph Ross, MD, of the Yale School of Medicine in New Haven, Connecticut.

“There was a lack of uniformity in the level of evidence the FDA used. We also found that only 40% of drug approvals involved a clinical trial that compared a new drug to existing treatment offerings. This is an important step for determining whether the new drug is a better option than existing, older drugs.”

Dr Ross and his colleagues evaluated the strength of clinical trial evidence supporting FDA approval decisions by characterizing key features of efficacy trials, such as size, duration, and endpoints.

The researchers used publicly available FDA documents to identify 188 drugs approved between 2005 and 2012 for 206 indications on the basis of 448 pivotal efficacy trials.

The team identified trials for 201 of the indications. Four drugs (including 1 used for 2 different indications) were approved without a pivotal efficacy trial.

So among the 201 indications, the median number of trials reviewed per indication was 2 (interquartile range [IQR], 1-2.5). Seventy-four indications (36.8%) were approved on the basis of a single trial, 77 (38.3%) on data from 2 trials, and 50 (24.9%) on data from 3 or more trials.

Most trials were randomized (89.3%) and double-blinded (79.5%). The median duration of a trial was 14.0 weeks (IQR, 6.0-26.0 weeks), and 113 trials (25.2%) lasted 6 months or longer.

The median number of total subjects enrolled in a trial was 446 (IQR, 205-678), and the median number of patients in the intervention arm of a study was 271 (IQR, 133-426).

More than half of trials (55.1%) used a placebo for comparison, 31.9% used an active comparator (such as another drug), and 12.9% had no comparator.

The primary endpoint was a surrogate outcome in 48.9% of trials, a clinical outcome for 29%, and a clinical scale for 22.1%.

These results suggest the quality of clinical trial evidence the FDA uses to make approval decisions varies widely across indications, the researchers said.

Study author Nicholas S. Downing, a student at the Yale School of Medicine, noted that survey data suggest patients expect drugs approved by the FDA to be both safe and effective.

“Based on our study of the data, we can’t be certain that this expectation is necessarily justified,” he said, “given the quantity and quality of the variability we saw in the drug approval process.”

Drug production

Credit: FDA

A new study suggests the US Food and Drug Administration (FDA) does not hold drug trials to the same set of standards.

The research revealed substantial differences in trials used to support drugs approved between 2005 and 2012.

Some drugs were approved based on results from multiple studies, while other approvals were based on data from a single trial.

Furthermore, trials varied greatly with regard to size, length of study period, type of comparator, and metrics of efficacy.

These results appear in the current issue of JAMA.

“Based on our analysis, some drugs are approved on the basis of large, high-quality clinical trials, while others are approved based on results of smaller trials,” said senior study author Joseph Ross, MD, of the Yale School of Medicine in New Haven, Connecticut.

“There was a lack of uniformity in the level of evidence the FDA used. We also found that only 40% of drug approvals involved a clinical trial that compared a new drug to existing treatment offerings. This is an important step for determining whether the new drug is a better option than existing, older drugs.”

Dr Ross and his colleagues evaluated the strength of clinical trial evidence supporting FDA approval decisions by characterizing key features of efficacy trials, such as size, duration, and endpoints.

The researchers used publicly available FDA documents to identify 188 drugs approved between 2005 and 2012 for 206 indications on the basis of 448 pivotal efficacy trials.

The team identified trials for 201 of the indications. Four drugs (including 1 used for 2 different indications) were approved without a pivotal efficacy trial.

So among the 201 indications, the median number of trials reviewed per indication was 2 (interquartile range [IQR], 1-2.5). Seventy-four indications (36.8%) were approved on the basis of a single trial, 77 (38.3%) on data from 2 trials, and 50 (24.9%) on data from 3 or more trials.

Most trials were randomized (89.3%) and double-blinded (79.5%). The median duration of a trial was 14.0 weeks (IQR, 6.0-26.0 weeks), and 113 trials (25.2%) lasted 6 months or longer.

The median number of total subjects enrolled in a trial was 446 (IQR, 205-678), and the median number of patients in the intervention arm of a study was 271 (IQR, 133-426).

More than half of trials (55.1%) used a placebo for comparison, 31.9% used an active comparator (such as another drug), and 12.9% had no comparator.

The primary endpoint was a surrogate outcome in 48.9% of trials, a clinical outcome for 29%, and a clinical scale for 22.1%.

These results suggest the quality of clinical trial evidence the FDA uses to make approval decisions varies widely across indications, the researchers said.

Study author Nicholas S. Downing, a student at the Yale School of Medicine, noted that survey data suggest patients expect drugs approved by the FDA to be both safe and effective.

“Based on our study of the data, we can’t be certain that this expectation is necessarily justified,” he said, “given the quantity and quality of the variability we saw in the drug approval process.”

Drug production

Credit: FDA

A new study suggests the US Food and Drug Administration (FDA) does not hold drug trials to the same set of standards.

The research revealed substantial differences in trials used to support drugs approved between 2005 and 2012.

Some drugs were approved based on results from multiple studies, while other approvals were based on data from a single trial.

Furthermore, trials varied greatly with regard to size, length of study period, type of comparator, and metrics of efficacy.

These results appear in the current issue of JAMA.

“Based on our analysis, some drugs are approved on the basis of large, high-quality clinical trials, while others are approved based on results of smaller trials,” said senior study author Joseph Ross, MD, of the Yale School of Medicine in New Haven, Connecticut.

“There was a lack of uniformity in the level of evidence the FDA used. We also found that only 40% of drug approvals involved a clinical trial that compared a new drug to existing treatment offerings. This is an important step for determining whether the new drug is a better option than existing, older drugs.”

Dr Ross and his colleagues evaluated the strength of clinical trial evidence supporting FDA approval decisions by characterizing key features of efficacy trials, such as size, duration, and endpoints.

The researchers used publicly available FDA documents to identify 188 drugs approved between 2005 and 2012 for 206 indications on the basis of 448 pivotal efficacy trials.

The team identified trials for 201 of the indications. Four drugs (including 1 used for 2 different indications) were approved without a pivotal efficacy trial.

So among the 201 indications, the median number of trials reviewed per indication was 2 (interquartile range [IQR], 1-2.5). Seventy-four indications (36.8%) were approved on the basis of a single trial, 77 (38.3%) on data from 2 trials, and 50 (24.9%) on data from 3 or more trials.

Most trials were randomized (89.3%) and double-blinded (79.5%). The median duration of a trial was 14.0 weeks (IQR, 6.0-26.0 weeks), and 113 trials (25.2%) lasted 6 months or longer.

The median number of total subjects enrolled in a trial was 446 (IQR, 205-678), and the median number of patients in the intervention arm of a study was 271 (IQR, 133-426).

More than half of trials (55.1%) used a placebo for comparison, 31.9% used an active comparator (such as another drug), and 12.9% had no comparator.

The primary endpoint was a surrogate outcome in 48.9% of trials, a clinical outcome for 29%, and a clinical scale for 22.1%.

These results suggest the quality of clinical trial evidence the FDA uses to make approval decisions varies widely across indications, the researchers said.

Study author Nicholas S. Downing, a student at the Yale School of Medicine, noted that survey data suggest patients expect drugs approved by the FDA to be both safe and effective.

“Based on our study of the data, we can’t be certain that this expectation is necessarily justified,” he said, “given the quantity and quality of the variability we saw in the drug approval process.”

By their very nature, antidotes and detoxification agents are needed in situations where the health and well-being of the mother are in jeopardy. In nearly all such cases, the mother’s condition will take priority over the safety of the embryo-fetus. Only two of the drugs (ethanol and penicillamine) are known to cause embryo or fetal harm but, for most of these drugs, the reported human pregnancy experience is very limited or absent. Nevertheless, pregnant women should be treated the same way as nonpregnant women.

Activated charcoal prevents absorption of substances from the gut and is no risk to the mother or her pregnancy. Similarly, ipecac syrup, which is used to induce vomiting, is safe in pregnancy.

Several agents are available for the reversal of opioid (natural or synthetic) overdose that is causing respiratory depression and/or marked sedation: naloxone, naltrexone, and nalmefene, a long-acting derivative of naltrexone (plasma half-life about 10 hours). Of the three agents, naloxone is the one for which there is the most human pregnancy experience. It has no intrinsic respiratory depressive activity or other narcotic effects of its own. All of these agents can be used in pregnancy for acute narcotic overdose.

Acetylcysteine is used to prevent or lessen hepatic injury following the ingestion of potentially hepatic toxic doses of acetaminophen. The antidote is not teratogenic or embryo toxic, and limited human pregnancy data have not shown fetal toxicity. After IV administration, acetylcysteine crosses the placenta in sufficient amounts to achieve protective serum levels in the fetus.

Potentially life-threatening digoxin overdose can be treated with IV digoxin immune Fab (ovine). The use of the agent has been reported in 44 pregnancies, but none of the cases involved digitalis overdose (all women had severe preeclampsia). No fetal harm secondary to the drug was observed.

Flumazenil is indicated for the reversal of benzodiazepine overdose. The drug is not teratogenic or embryo-fetal toxic in animals at systemic exposures near those obtained in humans. Based on very limited data, it appears to cross the human placenta and to reverse the depressive effects of benzodiazepines on the fetus.

Fomepizole is used for the treatment of ethylene glycol or methanol ingestion. It inhibits alcohol dehydrogenase, an enzyme that catalyzes the oxidation of the two chemicals to their toxic metabolites. The drug was not teratogenic in mice, but only one case of human pregnancy exposure has been reported, and the pregnancy outcome was unknown. Ethanol also has been used for poisonings with these two chemicals. Although the fetal effects of this short-term (24-48 hours) use have not been studied, neurotoxicity is a potential complication.

Glucarpidase is indicated for the treatment of toxic plasma methotrexate levels. It converts methotrexate to inactive metabolites. There are no reports of its use in human or animal pregnancies. Human reports are unlikely because methotrexate is contraindicated in pregnancy.

There are six agents available to treat heavy metal (arsenic, gold, iron, lead, and mercury) intoxication: deferasirox (iron), deferoxamine (iron), dimercaprol (arsenic, gold, lead, and mercury), edetate calcium disodium (lead), penicillamine (copper and mercury), and succimer (lead).

Deferasirox is indicated for chronic iron overload due to blood transfusions. Three reports have described its use in the first half of pregnancy without embryo or fetal harm. Deferoxamine is used for the treatment of both acute and chronic iron overload. Although the drug causes toxicity in two animal species, the human pregnancy experience is substantial, and no embryo or fetal adverse effects attributable to the agent have been reported. Dimercaprol (British anti-Lewisite; BAL) is used for the treatment of arsenic, gold, and acute mercury poisoning (not effective for chronic mercury poisoning). It is also combined with edetate calcium disodium for lead poisoning. High doses are embryotoxic and teratogenic in mice. The published human pregnancy experience is limited and all involved exposures after the first trimester. High levels of arsenic or lead were found in the newborns in two cases.

Edetate calcium disodium forms stable chelates with a number of metals, but it is primarily used for lead overdose, either alone or in combination with dimercaprol. There are only a few reports of its use in human pregnancy, all occurring late in gestation. A potential complication of therapy is maternal hypotension that could jeopardize placental perfusion. The agent also chelates zinc, resulting in zinc deficiency. This mechanism was thought to be involved in the teratogenic effects seen in animals.

Penicillamine has been used in mercury poisoning (one report), in addition to its indication as a chelating agent for copper in the treatment of Wilson’s disease. Exposure in the first trimester is related to a risk of connective tissue anomalies, primarily cutis laxa. Succimer (dimercaptosuccinic acid; DMSA) has been used for lead, arsenic, mercury, and cadmium poisoning. It also chelates zinc quite effectively. The agent is toxic and/or teratogenic in mice and rats, but some of the effects may have been secondary to zinc deficiency. Because of the complete absence of human pregnancy experience, antidotes other than succimer probably are preferable.

Lanthanum carbonate and sevelamer are indicated to reduce serum phosphate levels in patients with end-stage renal disease. The drugs bind dietary phosphate from food during digestion in the gut. There are no reports of their use in human pregnancy. The systemic bioavailability is minimal, and the drugs should have no effect on the embryo or fetus. However, they may prevent intestinal vitamin absorption, especially of fat-soluble vitamins.

The cholinergic agent physostigmine is capable of reversing the central nervous system effects of anticholinergics, such as scopolamine and tricyclic antidepressants. The reported human pregnancy experience is limited to the third trimester.

Methylene blue has been used for cyanide poisoning. In humans, it is teratogenic and fetal toxic when given by intra-amniotic injection, but its oral use as an antidote in pregnancy has not been reported. The cyanide antidote package contains amyl nitrite, sodium nitrite, and sodium thiosulfate. The effects of these agents on human pregnancy also are unknown, as are the effects of high-dose hydroxocobalamin, an analogue of vitamin B₁₂ also used in cyanide poisoning.

Pralidoxime (2-PAM) reactivates cholinesterase that has been inactivated by organophosphate pesticides and chemicals with anticholinesterase activity, thereby relieving the paralysis of the muscles of respiration. The drug is available in an autoinjector that can be used rapidly in cases of exposure to nerve agents possessing anticholinesterase activity (organophosphate poisoning). Animal reproduction tests have not been conducted with pralidoxime, and the human pregnancy experience is limited to a few cases of insecticide poisoning (second and third trimesters). Healthy infants were later delivered in these cases.

Four antivenins are commercially available for acute envenomation: black widow spider antivenin, Centruroides (scorpion) immune F(ab\')₂ (equine), crotalidae polyvalent immune Fab (ovine) (North American rattlesnake), and North American coral snake antivenin (equine). In addition, botulism antitoxin heptavalent (equine) is used for food poisoning caused by the neurotoxic bacterium Clostridium botulinum. Animal reproduction studies have not been conducted with these products, and human reports are limited or absent.

Sapropterin, a cofactor for the enzyme phenylalanine hydroxylase, reduces blood phenylalanine levels in patients with phenylketonuria. The drug is given daily if diet alone does not control maternal phenylalanine levels. Use of the drug in human pregnancy has not been reported.

A number of other agents can be classified as antidotes, in addition to their primary indications, because they can reverse the toxic effects of other agents. These antidotes include atropine (severe bradycardia, poisonings with organophosphates and carbamates), calcium chloride or gluconate (severe hypocalcemia, calcium-channel-blocker overdose, exposure to hydrofluoric acid), glucagon (hypoglycemia), folinic acid (methotrexate overdose), protamine (heparin overdose), pyridoxine (isoniazid-induced seizures; adjunct in ethylene glycol poisoning), and vitamin K (phytonadione) (warfarin overdose). The pregnancy data are extensive for many of these agents and are not suggestive of significant embryo or fetal risk.

Mr. Briggs is a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of "Drugs in Pregnancy and Lactation," and coeditor of "Diseases, Complications, and Drug Therapy in Obstetrics." He had no relevant financial disclosures. Contact him at obnews@frontlinemedcom.com.

By their very nature, antidotes and detoxification agents are needed in situations where the health and well-being of the mother are in jeopardy. In nearly all such cases, the mother’s condition will take priority over the safety of the embryo-fetus. Only two of the drugs (ethanol and penicillamine) are known to cause embryo or fetal harm but, for most of these drugs, the reported human pregnancy experience is very limited or absent. Nevertheless, pregnant women should be treated the same way as nonpregnant women.

Activated charcoal prevents absorption of substances from the gut and is no risk to the mother or her pregnancy. Similarly, ipecac syrup, which is used to induce vomiting, is safe in pregnancy.

Several agents are available for the reversal of opioid (natural or synthetic) overdose that is causing respiratory depression and/or marked sedation: naloxone, naltrexone, and nalmefene, a long-acting derivative of naltrexone (plasma half-life about 10 hours). Of the three agents, naloxone is the one for which there is the most human pregnancy experience. It has no intrinsic respiratory depressive activity or other narcotic effects of its own. All of these agents can be used in pregnancy for acute narcotic overdose.

Acetylcysteine is used to prevent or lessen hepatic injury following the ingestion of potentially hepatic toxic doses of acetaminophen. The antidote is not teratogenic or embryo toxic, and limited human pregnancy data have not shown fetal toxicity. After IV administration, acetylcysteine crosses the placenta in sufficient amounts to achieve protective serum levels in the fetus.

Potentially life-threatening digoxin overdose can be treated with IV digoxin immune Fab (ovine). The use of the agent has been reported in 44 pregnancies, but none of the cases involved digitalis overdose (all women had severe preeclampsia). No fetal harm secondary to the drug was observed.

Flumazenil is indicated for the reversal of benzodiazepine overdose. The drug is not teratogenic or embryo-fetal toxic in animals at systemic exposures near those obtained in humans. Based on very limited data, it appears to cross the human placenta and to reverse the depressive effects of benzodiazepines on the fetus.

Fomepizole is used for the treatment of ethylene glycol or methanol ingestion. It inhibits alcohol dehydrogenase, an enzyme that catalyzes the oxidation of the two chemicals to their toxic metabolites. The drug was not teratogenic in mice, but only one case of human pregnancy exposure has been reported, and the pregnancy outcome was unknown. Ethanol also has been used for poisonings with these two chemicals. Although the fetal effects of this short-term (24-48 hours) use have not been studied, neurotoxicity is a potential complication.

Glucarpidase is indicated for the treatment of toxic plasma methotrexate levels. It converts methotrexate to inactive metabolites. There are no reports of its use in human or animal pregnancies. Human reports are unlikely because methotrexate is contraindicated in pregnancy.

There are six agents available to treat heavy metal (arsenic, gold, iron, lead, and mercury) intoxication: deferasirox (iron), deferoxamine (iron), dimercaprol (arsenic, gold, lead, and mercury), edetate calcium disodium (lead), penicillamine (copper and mercury), and succimer (lead).

Deferasirox is indicated for chronic iron overload due to blood transfusions. Three reports have described its use in the first half of pregnancy without embryo or fetal harm. Deferoxamine is used for the treatment of both acute and chronic iron overload. Although the drug causes toxicity in two animal species, the human pregnancy experience is substantial, and no embryo or fetal adverse effects attributable to the agent have been reported. Dimercaprol (British anti-Lewisite; BAL) is used for the treatment of arsenic, gold, and acute mercury poisoning (not effective for chronic mercury poisoning). It is also combined with edetate calcium disodium for lead poisoning. High doses are embryotoxic and teratogenic in mice. The published human pregnancy experience is limited and all involved exposures after the first trimester. High levels of arsenic or lead were found in the newborns in two cases.

Edetate calcium disodium forms stable chelates with a number of metals, but it is primarily used for lead overdose, either alone or in combination with dimercaprol. There are only a few reports of its use in human pregnancy, all occurring late in gestation. A potential complication of therapy is maternal hypotension that could jeopardize placental perfusion. The agent also chelates zinc, resulting in zinc deficiency. This mechanism was thought to be involved in the teratogenic effects seen in animals.

Penicillamine has been used in mercury poisoning (one report), in addition to its indication as a chelating agent for copper in the treatment of Wilson’s disease. Exposure in the first trimester is related to a risk of connective tissue anomalies, primarily cutis laxa. Succimer (dimercaptosuccinic acid; DMSA) has been used for lead, arsenic, mercury, and cadmium poisoning. It also chelates zinc quite effectively. The agent is toxic and/or teratogenic in mice and rats, but some of the effects may have been secondary to zinc deficiency. Because of the complete absence of human pregnancy experience, antidotes other than succimer probably are preferable.

Lanthanum carbonate and sevelamer are indicated to reduce serum phosphate levels in patients with end-stage renal disease. The drugs bind dietary phosphate from food during digestion in the gut. There are no reports of their use in human pregnancy. The systemic bioavailability is minimal, and the drugs should have no effect on the embryo or fetus. However, they may prevent intestinal vitamin absorption, especially of fat-soluble vitamins.

The cholinergic agent physostigmine is capable of reversing the central nervous system effects of anticholinergics, such as scopolamine and tricyclic antidepressants. The reported human pregnancy experience is limited to the third trimester.

Methylene blue has been used for cyanide poisoning. In humans, it is teratogenic and fetal toxic when given by intra-amniotic injection, but its oral use as an antidote in pregnancy has not been reported. The cyanide antidote package contains amyl nitrite, sodium nitrite, and sodium thiosulfate. The effects of these agents on human pregnancy also are unknown, as are the effects of high-dose hydroxocobalamin, an analogue of vitamin B₁₂ also used in cyanide poisoning.

Pralidoxime (2-PAM) reactivates cholinesterase that has been inactivated by organophosphate pesticides and chemicals with anticholinesterase activity, thereby relieving the paralysis of the muscles of respiration. The drug is available in an autoinjector that can be used rapidly in cases of exposure to nerve agents possessing anticholinesterase activity (organophosphate poisoning). Animal reproduction tests have not been conducted with pralidoxime, and the human pregnancy experience is limited to a few cases of insecticide poisoning (second and third trimesters). Healthy infants were later delivered in these cases.

Four antivenins are commercially available for acute envenomation: black widow spider antivenin, Centruroides (scorpion) immune F(ab\')₂ (equine), crotalidae polyvalent immune Fab (ovine) (North American rattlesnake), and North American coral snake antivenin (equine). In addition, botulism antitoxin heptavalent (equine) is used for food poisoning caused by the neurotoxic bacterium Clostridium botulinum. Animal reproduction studies have not been conducted with these products, and human reports are limited or absent.

Sapropterin, a cofactor for the enzyme phenylalanine hydroxylase, reduces blood phenylalanine levels in patients with phenylketonuria. The drug is given daily if diet alone does not control maternal phenylalanine levels. Use of the drug in human pregnancy has not been reported.

A number of other agents can be classified as antidotes, in addition to their primary indications, because they can reverse the toxic effects of other agents. These antidotes include atropine (severe bradycardia, poisonings with organophosphates and carbamates), calcium chloride or gluconate (severe hypocalcemia, calcium-channel-blocker overdose, exposure to hydrofluoric acid), glucagon (hypoglycemia), folinic acid (methotrexate overdose), protamine (heparin overdose), pyridoxine (isoniazid-induced seizures; adjunct in ethylene glycol poisoning), and vitamin K (phytonadione) (warfarin overdose). The pregnancy data are extensive for many of these agents and are not suggestive of significant embryo or fetal risk.

Mr. Briggs is a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of "Drugs in Pregnancy and Lactation," and coeditor of "Diseases, Complications, and Drug Therapy in Obstetrics." He had no relevant financial disclosures. Contact him at obnews@frontlinemedcom.com.

By their very nature, antidotes and detoxification agents are needed in situations where the health and well-being of the mother are in jeopardy. In nearly all such cases, the mother’s condition will take priority over the safety of the embryo-fetus. Only two of the drugs (ethanol and penicillamine) are known to cause embryo or fetal harm but, for most of these drugs, the reported human pregnancy experience is very limited or absent. Nevertheless, pregnant women should be treated the same way as nonpregnant women.

Activated charcoal prevents absorption of substances from the gut and is no risk to the mother or her pregnancy. Similarly, ipecac syrup, which is used to induce vomiting, is safe in pregnancy.

Several agents are available for the reversal of opioid (natural or synthetic) overdose that is causing respiratory depression and/or marked sedation: naloxone, naltrexone, and nalmefene, a long-acting derivative of naltrexone (plasma half-life about 10 hours). Of the three agents, naloxone is the one for which there is the most human pregnancy experience. It has no intrinsic respiratory depressive activity or other narcotic effects of its own. All of these agents can be used in pregnancy for acute narcotic overdose.

Acetylcysteine is used to prevent or lessen hepatic injury following the ingestion of potentially hepatic toxic doses of acetaminophen. The antidote is not teratogenic or embryo toxic, and limited human pregnancy data have not shown fetal toxicity. After IV administration, acetylcysteine crosses the placenta in sufficient amounts to achieve protective serum levels in the fetus.

Potentially life-threatening digoxin overdose can be treated with IV digoxin immune Fab (ovine). The use of the agent has been reported in 44 pregnancies, but none of the cases involved digitalis overdose (all women had severe preeclampsia). No fetal harm secondary to the drug was observed.

Flumazenil is indicated for the reversal of benzodiazepine overdose. The drug is not teratogenic or embryo-fetal toxic in animals at systemic exposures near those obtained in humans. Based on very limited data, it appears to cross the human placenta and to reverse the depressive effects of benzodiazepines on the fetus.

Fomepizole is used for the treatment of ethylene glycol or methanol ingestion. It inhibits alcohol dehydrogenase, an enzyme that catalyzes the oxidation of the two chemicals to their toxic metabolites. The drug was not teratogenic in mice, but only one case of human pregnancy exposure has been reported, and the pregnancy outcome was unknown. Ethanol also has been used for poisonings with these two chemicals. Although the fetal effects of this short-term (24-48 hours) use have not been studied, neurotoxicity is a potential complication.

Glucarpidase is indicated for the treatment of toxic plasma methotrexate levels. It converts methotrexate to inactive metabolites. There are no reports of its use in human or animal pregnancies. Human reports are unlikely because methotrexate is contraindicated in pregnancy.

There are six agents available to treat heavy metal (arsenic, gold, iron, lead, and mercury) intoxication: deferasirox (iron), deferoxamine (iron), dimercaprol (arsenic, gold, lead, and mercury), edetate calcium disodium (lead), penicillamine (copper and mercury), and succimer (lead).

Deferasirox is indicated for chronic iron overload due to blood transfusions. Three reports have described its use in the first half of pregnancy without embryo or fetal harm. Deferoxamine is used for the treatment of both acute and chronic iron overload. Although the drug causes toxicity in two animal species, the human pregnancy experience is substantial, and no embryo or fetal adverse effects attributable to the agent have been reported. Dimercaprol (British anti-Lewisite; BAL) is used for the treatment of arsenic, gold, and acute mercury poisoning (not effective for chronic mercury poisoning). It is also combined with edetate calcium disodium for lead poisoning. High doses are embryotoxic and teratogenic in mice. The published human pregnancy experience is limited and all involved exposures after the first trimester. High levels of arsenic or lead were found in the newborns in two cases.

Edetate calcium disodium forms stable chelates with a number of metals, but it is primarily used for lead overdose, either alone or in combination with dimercaprol. There are only a few reports of its use in human pregnancy, all occurring late in gestation. A potential complication of therapy is maternal hypotension that could jeopardize placental perfusion. The agent also chelates zinc, resulting in zinc deficiency. This mechanism was thought to be involved in the teratogenic effects seen in animals.

Penicillamine has been used in mercury poisoning (one report), in addition to its indication as a chelating agent for copper in the treatment of Wilson’s disease. Exposure in the first trimester is related to a risk of connective tissue anomalies, primarily cutis laxa. Succimer (dimercaptosuccinic acid; DMSA) has been used for lead, arsenic, mercury, and cadmium poisoning. It also chelates zinc quite effectively. The agent is toxic and/or teratogenic in mice and rats, but some of the effects may have been secondary to zinc deficiency. Because of the complete absence of human pregnancy experience, antidotes other than succimer probably are preferable.

Lanthanum carbonate and sevelamer are indicated to reduce serum phosphate levels in patients with end-stage renal disease. The drugs bind dietary phosphate from food during digestion in the gut. There are no reports of their use in human pregnancy. The systemic bioavailability is minimal, and the drugs should have no effect on the embryo or fetus. However, they may prevent intestinal vitamin absorption, especially of fat-soluble vitamins.

The cholinergic agent physostigmine is capable of reversing the central nervous system effects of anticholinergics, such as scopolamine and tricyclic antidepressants. The reported human pregnancy experience is limited to the third trimester.

Methylene blue has been used for cyanide poisoning. In humans, it is teratogenic and fetal toxic when given by intra-amniotic injection, but its oral use as an antidote in pregnancy has not been reported. The cyanide antidote package contains amyl nitrite, sodium nitrite, and sodium thiosulfate. The effects of these agents on human pregnancy also are unknown, as are the effects of high-dose hydroxocobalamin, an analogue of vitamin B₁₂ also used in cyanide poisoning.

Pralidoxime (2-PAM) reactivates cholinesterase that has been inactivated by organophosphate pesticides and chemicals with anticholinesterase activity, thereby relieving the paralysis of the muscles of respiration. The drug is available in an autoinjector that can be used rapidly in cases of exposure to nerve agents possessing anticholinesterase activity (organophosphate poisoning). Animal reproduction tests have not been conducted with pralidoxime, and the human pregnancy experience is limited to a few cases of insecticide poisoning (second and third trimesters). Healthy infants were later delivered in these cases.

Four antivenins are commercially available for acute envenomation: black widow spider antivenin, Centruroides (scorpion) immune F(ab\')₂ (equine), crotalidae polyvalent immune Fab (ovine) (North American rattlesnake), and North American coral snake antivenin (equine). In addition, botulism antitoxin heptavalent (equine) is used for food poisoning caused by the neurotoxic bacterium Clostridium botulinum. Animal reproduction studies have not been conducted with these products, and human reports are limited or absent.

Sapropterin, a cofactor for the enzyme phenylalanine hydroxylase, reduces blood phenylalanine levels in patients with phenylketonuria. The drug is given daily if diet alone does not control maternal phenylalanine levels. Use of the drug in human pregnancy has not been reported.

A number of other agents can be classified as antidotes, in addition to their primary indications, because they can reverse the toxic effects of other agents. These antidotes include atropine (severe bradycardia, poisonings with organophosphates and carbamates), calcium chloride or gluconate (severe hypocalcemia, calcium-channel-blocker overdose, exposure to hydrofluoric acid), glucagon (hypoglycemia), folinic acid (methotrexate overdose), protamine (heparin overdose), pyridoxine (isoniazid-induced seizures; adjunct in ethylene glycol poisoning), and vitamin K (phytonadione) (warfarin overdose). The pregnancy data are extensive for many of these agents and are not suggestive of significant embryo or fetal risk.

Mr. Briggs is a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of "Drugs in Pregnancy and Lactation," and coeditor of "Diseases, Complications, and Drug Therapy in Obstetrics." He had no relevant financial disclosures. Contact him at obnews@frontlinemedcom.com.

The U.S. Preventive Services Task Force has released updated recommendations regarding screening for intimate partner violence and abuse of elderly and vulnerable adults. While their previous recommendations in 2004 gave intimate partner violence screening an "I" recommendation, meaning that the evidence was inconclusive regarding the balance of benefits and intimate partner violence harms, the current recommendation has been upgraded to a "B" recommendation, meaning there is moderate certainty that there is a net benefit from screening. This puts the USPSTF recommendation in alignment with those of most other groups, including the American Medical Association and the *American College of Obstetricians and Gynecologists.

Forms of abuse

The recommendations regarding intimate partner violence in these guidelines refer to physical, sexual, or psychological abuse of women of reproductive age by a current or former partner or spouse. The issue of intimate partner violence is important because research shows that approximately 31% of women and 26% of men have experienced intimate partner violence within their lifetime, and that intimate partner violence is usually undetected. It is also estimated that these numbers are likely to be low because of underreporting. In one large study, the 1-year incidence of abuse was 8% within the last year and 15% within the last 5 years. Approximately 1.5%-5% of pregnant women report being abused. Among older and vulnerable adults, the rate of physical, psychological, or sexual abuse; neglect; or financial exploitation is estimated to be between 2% and 10%.

Intimate partner violence has important and long-lasting effects on victims. Harmful effects include immediate injuries resulting from direct trauma as well as long-term physical and mental health consequences. Long-term physical consequences include sexually transmitted diseases, unintended pregnancy, and worse pregnancy outcomes, as well as higher rates of chronic pain, gastrointestinal disorders, migraine headaches, and disability. Long-term mental health consequences include depression, post-traumatic stress disorder, anxiety disorders, substance abuse, and a higher rate of suicide.

Screening of women

Intimate partner violence in women can be detected with a high level of certainty. There are specific factors that can influence the chances that an individual is at risk for intimate partner violence and can alert clinicians to have increased vigilance for abuse. These risk factors have four categories. The first category is individual, focusing on an individual’s self-esteem. The second is relationship, which focuses on marriage conflict and stability within relationships. Third is community, which is looking at socioeconomic background. Fourth are the societal factors of traditional gender roles.

Many screening instruments exist that have been carefully studied. For instance, the HITS instrument, available in English and Spanish, is a four-item questionnaire that asks about being hurt, insulted, screamed at, or threatened. In one study, it had a sensitivity of 86% and a specificity of 99% for detecting intimate partner violence. The interval for screening is not clear.

Treatment

Once intimate partner violence among women is detected, many approaches are available to help these women. For example, one trial was set up to test the effectiveness of a mentoring support group vs. usual care. All women who entered this trial had discussed intimate partner violence with their primary care physician. After the intervention program, the women who were in the intervention group had significantly reduced scores of abuse as opposed to the comparison group. Another example is a study of pregnant women who reported abuse, who were then randomized to a counseling intervention vs. usual care. Women in the counseling group had decreased pregnancy coercion and were more likely to discontinue an unhealthy or unsafe relationship.

Approaches vary from counseling to social work interventions brought to peoples’ homes, information cards, referral to community services, and mentoring support services. It appears that varied interventions decrease recurrent abuse. There is no reported harm in screening for intimate partner violence. It is necessary for the primary care doctor to be aware of the laws specific to intimate partner violence reporting and privacy within the doctor’s specific region.

Elderly and vulnerable adults

In contrast to screening for intimate partner violence in women, there is a lack of evidence for abuse screening in elderly and vulnerable adult populations. There is a lack of evidence on the benefits of detection and, surprisingly, a lack of evidence on the benefits of early intervention. It is also possible that the harms of detecting abuse in this group may be different, although the risk appears to be small. Some potential harm includes shame, guilt, fear of retaliation, and abandonment by caretakers who have been accused of abuse.

While the evidence to support screening elderly and vulnerable adults is limited, state and local laws vary about the obligation and logistics of reporting elderly abuse. A main conclusion of the USPSTF is that more evidence-based research needs to be done for the population of elderly and vulnerable adults.

Bottom line

Intimate partner violence is common, affecting a quarter of all adults at some point in their life. The mental and physical effects of intimate partner violence can be severe and long-lasting. Screening for intimate partner violence is effective, and effective interventions can be carried out to help women who are victims of intimate partner violence. The USPSTF recommends routine screening of women of reproductive age for intimate partner violence. The data on screening for abuse in the elderly and vulnerable adults is insufficient for the USPSTF to make a recommendation for or against screening.

Reference

• Screening for Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: U.S. Preventive Services Task Force Recommendation Statement. (Ann. Intern. Med. 2013:158;478-86).

Ms. Skolnik attends Drexel University, Philadelphia, and is a research assistant at the Children’s Hospital of Pennsylvania. Dr. Clouse is an associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital.

*Correction 1/23/14: A previous version of this article misstated the name of the American College of Obstetricians and Gynecologists. This version has been updated. 

The U.S. Preventive Services Task Force has released updated recommendations regarding screening for intimate partner violence and abuse of elderly and vulnerable adults. While their previous recommendations in 2004 gave intimate partner violence screening an "I" recommendation, meaning that the evidence was inconclusive regarding the balance of benefits and intimate partner violence harms, the current recommendation has been upgraded to a "B" recommendation, meaning there is moderate certainty that there is a net benefit from screening. This puts the USPSTF recommendation in alignment with those of most other groups, including the American Medical Association and the *American College of Obstetricians and Gynecologists.

Forms of abuse

The recommendations regarding intimate partner violence in these guidelines refer to physical, sexual, or psychological abuse of women of reproductive age by a current or former partner or spouse. The issue of intimate partner violence is important because research shows that approximately 31% of women and 26% of men have experienced intimate partner violence within their lifetime, and that intimate partner violence is usually undetected. It is also estimated that these numbers are likely to be low because of underreporting. In one large study, the 1-year incidence of abuse was 8% within the last year and 15% within the last 5 years. Approximately 1.5%-5% of pregnant women report being abused. Among older and vulnerable adults, the rate of physical, psychological, or sexual abuse; neglect; or financial exploitation is estimated to be between 2% and 10%.

Intimate partner violence has important and long-lasting effects on victims. Harmful effects include immediate injuries resulting from direct trauma as well as long-term physical and mental health consequences. Long-term physical consequences include sexually transmitted diseases, unintended pregnancy, and worse pregnancy outcomes, as well as higher rates of chronic pain, gastrointestinal disorders, migraine headaches, and disability. Long-term mental health consequences include depression, post-traumatic stress disorder, anxiety disorders, substance abuse, and a higher rate of suicide.

Screening of women

Intimate partner violence in women can be detected with a high level of certainty. There are specific factors that can influence the chances that an individual is at risk for intimate partner violence and can alert clinicians to have increased vigilance for abuse. These risk factors have four categories. The first category is individual, focusing on an individual’s self-esteem. The second is relationship, which focuses on marriage conflict and stability within relationships. Third is community, which is looking at socioeconomic background. Fourth are the societal factors of traditional gender roles.

Many screening instruments exist that have been carefully studied. For instance, the HITS instrument, available in English and Spanish, is a four-item questionnaire that asks about being hurt, insulted, screamed at, or threatened. In one study, it had a sensitivity of 86% and a specificity of 99% for detecting intimate partner violence. The interval for screening is not clear.

Treatment

Once intimate partner violence among women is detected, many approaches are available to help these women. For example, one trial was set up to test the effectiveness of a mentoring support group vs. usual care. All women who entered this trial had discussed intimate partner violence with their primary care physician. After the intervention program, the women who were in the intervention group had significantly reduced scores of abuse as opposed to the comparison group. Another example is a study of pregnant women who reported abuse, who were then randomized to a counseling intervention vs. usual care. Women in the counseling group had decreased pregnancy coercion and were more likely to discontinue an unhealthy or unsafe relationship.

Approaches vary from counseling to social work interventions brought to peoples’ homes, information cards, referral to community services, and mentoring support services. It appears that varied interventions decrease recurrent abuse. There is no reported harm in screening for intimate partner violence. It is necessary for the primary care doctor to be aware of the laws specific to intimate partner violence reporting and privacy within the doctor’s specific region.

Elderly and vulnerable adults

In contrast to screening for intimate partner violence in women, there is a lack of evidence for abuse screening in elderly and vulnerable adult populations. There is a lack of evidence on the benefits of detection and, surprisingly, a lack of evidence on the benefits of early intervention. It is also possible that the harms of detecting abuse in this group may be different, although the risk appears to be small. Some potential harm includes shame, guilt, fear of retaliation, and abandonment by caretakers who have been accused of abuse.

While the evidence to support screening elderly and vulnerable adults is limited, state and local laws vary about the obligation and logistics of reporting elderly abuse. A main conclusion of the USPSTF is that more evidence-based research needs to be done for the population of elderly and vulnerable adults.

Bottom line

Intimate partner violence is common, affecting a quarter of all adults at some point in their life. The mental and physical effects of intimate partner violence can be severe and long-lasting. Screening for intimate partner violence is effective, and effective interventions can be carried out to help women who are victims of intimate partner violence. The USPSTF recommends routine screening of women of reproductive age for intimate partner violence. The data on screening for abuse in the elderly and vulnerable adults is insufficient for the USPSTF to make a recommendation for or against screening.

Reference

• Screening for Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: U.S. Preventive Services Task Force Recommendation Statement. (Ann. Intern. Med. 2013:158;478-86).

Ms. Skolnik attends Drexel University, Philadelphia, and is a research assistant at the Children’s Hospital of Pennsylvania. Dr. Clouse is an associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital.

*Correction 1/23/14: A previous version of this article misstated the name of the American College of Obstetricians and Gynecologists. This version has been updated. 

The U.S. Preventive Services Task Force has released updated recommendations regarding screening for intimate partner violence and abuse of elderly and vulnerable adults. While their previous recommendations in 2004 gave intimate partner violence screening an "I" recommendation, meaning that the evidence was inconclusive regarding the balance of benefits and intimate partner violence harms, the current recommendation has been upgraded to a "B" recommendation, meaning there is moderate certainty that there is a net benefit from screening. This puts the USPSTF recommendation in alignment with those of most other groups, including the American Medical Association and the *American College of Obstetricians and Gynecologists.

Forms of abuse

The recommendations regarding intimate partner violence in these guidelines refer to physical, sexual, or psychological abuse of women of reproductive age by a current or former partner or spouse. The issue of intimate partner violence is important because research shows that approximately 31% of women and 26% of men have experienced intimate partner violence within their lifetime, and that intimate partner violence is usually undetected. It is also estimated that these numbers are likely to be low because of underreporting. In one large study, the 1-year incidence of abuse was 8% within the last year and 15% within the last 5 years. Approximately 1.5%-5% of pregnant women report being abused. Among older and vulnerable adults, the rate of physical, psychological, or sexual abuse; neglect; or financial exploitation is estimated to be between 2% and 10%.

Intimate partner violence has important and long-lasting effects on victims. Harmful effects include immediate injuries resulting from direct trauma as well as long-term physical and mental health consequences. Long-term physical consequences include sexually transmitted diseases, unintended pregnancy, and worse pregnancy outcomes, as well as higher rates of chronic pain, gastrointestinal disorders, migraine headaches, and disability. Long-term mental health consequences include depression, post-traumatic stress disorder, anxiety disorders, substance abuse, and a higher rate of suicide.

Screening of women

Intimate partner violence in women can be detected with a high level of certainty. There are specific factors that can influence the chances that an individual is at risk for intimate partner violence and can alert clinicians to have increased vigilance for abuse. These risk factors have four categories. The first category is individual, focusing on an individual’s self-esteem. The second is relationship, which focuses on marriage conflict and stability within relationships. Third is community, which is looking at socioeconomic background. Fourth are the societal factors of traditional gender roles.

Many screening instruments exist that have been carefully studied. For instance, the HITS instrument, available in English and Spanish, is a four-item questionnaire that asks about being hurt, insulted, screamed at, or threatened. In one study, it had a sensitivity of 86% and a specificity of 99% for detecting intimate partner violence. The interval for screening is not clear.

Treatment

Once intimate partner violence among women is detected, many approaches are available to help these women. For example, one trial was set up to test the effectiveness of a mentoring support group vs. usual care. All women who entered this trial had discussed intimate partner violence with their primary care physician. After the intervention program, the women who were in the intervention group had significantly reduced scores of abuse as opposed to the comparison group. Another example is a study of pregnant women who reported abuse, who were then randomized to a counseling intervention vs. usual care. Women in the counseling group had decreased pregnancy coercion and were more likely to discontinue an unhealthy or unsafe relationship.

Approaches vary from counseling to social work interventions brought to peoples’ homes, information cards, referral to community services, and mentoring support services. It appears that varied interventions decrease recurrent abuse. There is no reported harm in screening for intimate partner violence. It is necessary for the primary care doctor to be aware of the laws specific to intimate partner violence reporting and privacy within the doctor’s specific region.

Elderly and vulnerable adults

In contrast to screening for intimate partner violence in women, there is a lack of evidence for abuse screening in elderly and vulnerable adult populations. There is a lack of evidence on the benefits of detection and, surprisingly, a lack of evidence on the benefits of early intervention. It is also possible that the harms of detecting abuse in this group may be different, although the risk appears to be small. Some potential harm includes shame, guilt, fear of retaliation, and abandonment by caretakers who have been accused of abuse.

While the evidence to support screening elderly and vulnerable adults is limited, state and local laws vary about the obligation and logistics of reporting elderly abuse. A main conclusion of the USPSTF is that more evidence-based research needs to be done for the population of elderly and vulnerable adults.

Bottom line

Intimate partner violence is common, affecting a quarter of all adults at some point in their life. The mental and physical effects of intimate partner violence can be severe and long-lasting. Screening for intimate partner violence is effective, and effective interventions can be carried out to help women who are victims of intimate partner violence. The USPSTF recommends routine screening of women of reproductive age for intimate partner violence. The data on screening for abuse in the elderly and vulnerable adults is insufficient for the USPSTF to make a recommendation for or against screening.

Reference

• Screening for Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: U.S. Preventive Services Task Force Recommendation Statement. (Ann. Intern. Med. 2013:158;478-86).

Ms. Skolnik attends Drexel University, Philadelphia, and is a research assistant at the Children’s Hospital of Pennsylvania. Dr. Clouse is an associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital.

*Correction 1/23/14: A previous version of this article misstated the name of the American College of Obstetricians and Gynecologists. This version has been updated. 

With ever more data demonstrating that patient-centered medical homes are the core of successful ACOs, it’s becoming clear that primary care physicians can have a meaningful role in the accountable care movement. In fact, primary care physicians have the opportunity to lead ACO development.

Some primary care physicians have stepped up to leadership and have been very successful. Others want to but don’t know where to start, because there is no precedent for this.

So, what’s required to make a primary care physician a successful ACO leader? It begins with these five fundamental steps:

1. Be the most prepared person in the room. Before you lead, you must understand. And understanding ACOs isn’t a lengthy process. You truly can become one of the most knowledgeable people about ACOs in a matter of hours, not weeks. As you start developing an ACO or collaborative care initiative, your knowledge and positive informed contributions will earn you the respect and confidence of others – foundations upon which leadership rests.

2. Get out of your silo. Accountable care is a team game. Be part of that team by networking intentionally with other primary care physicians, specialists, and hospital administrators. Seek out ways to interact. There is a window of opportunity for the physician willing to bridge gaps.

3. Exercise quiet leadership. There is no need to seize the podium and tell others what to do. That will backfire, of course. Facilitate discussions, and ask others leading questions to find out what they think. Convene breakfasts with members of the medical staff in your community. Engage hospital leadership. An informed primary care physician ACO champion soon will be a much-desired commodity. Lead from behind, as it were. Your goal is to increase awareness and buy-in to a vision, and ideally, it should be the group consensus. You do not need or want to be getting the credit.

4. Do the due diligence. Find out what is going on. What’s out there in your market? Are there medical home networks forming ACOs in your state? What is Medicaid considering? What are the private payers considering?

5. Be wise about who will welcome your leadership. Start with public and private payers. They want higher quality at lower cost, and they’re coming to understand the advantages of the medical home–centric ACO in achieving these goals. Thus, they’re more open to primary care medical home leadership. Enlightened specialists and hospitals are embracing primary care leadership for the same reason. They want to ride the winning horse, and the medical home–centric ACO is often that choice. Others who aren’t as enlightened won’t welcome the loss of control and will resist.

Will leadership be worth it? In our experience, primary care physician leadership has clearly been worth it to those physicians who pursue it, for four reasons. First, their ACO or collaborative care organization is more likely to be successful. Second, their ACO’s savings pool is bigger, and its outcomes are better. Third, they’ve enjoyed restoring the multispecialty collegiality from their days of medical training. And finally, their contributions have been more valuable – and the ACO payments to them based on contributions have been correspondingly more substantial.

Mr. Bobbitt is a senior partner and head of the health law group at the Smith Anderson law firm in Raleigh, N.C. He has many years of experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at bbobbitt@smithlaw.com or 919-821-6612.

With ever more data demonstrating that patient-centered medical homes are the core of successful ACOs, it’s becoming clear that primary care physicians can have a meaningful role in the accountable care movement. In fact, primary care physicians have the opportunity to lead ACO development.

Some primary care physicians have stepped up to leadership and have been very successful. Others want to but don’t know where to start, because there is no precedent for this.

So, what’s required to make a primary care physician a successful ACO leader? It begins with these five fundamental steps:

1. Be the most prepared person in the room. Before you lead, you must understand. And understanding ACOs isn’t a lengthy process. You truly can become one of the most knowledgeable people about ACOs in a matter of hours, not weeks. As you start developing an ACO or collaborative care initiative, your knowledge and positive informed contributions will earn you the respect and confidence of others – foundations upon which leadership rests.

2. Get out of your silo. Accountable care is a team game. Be part of that team by networking intentionally with other primary care physicians, specialists, and hospital administrators. Seek out ways to interact. There is a window of opportunity for the physician willing to bridge gaps.

3. Exercise quiet leadership. There is no need to seize the podium and tell others what to do. That will backfire, of course. Facilitate discussions, and ask others leading questions to find out what they think. Convene breakfasts with members of the medical staff in your community. Engage hospital leadership. An informed primary care physician ACO champion soon will be a much-desired commodity. Lead from behind, as it were. Your goal is to increase awareness and buy-in to a vision, and ideally, it should be the group consensus. You do not need or want to be getting the credit.

4. Do the due diligence. Find out what is going on. What’s out there in your market? Are there medical home networks forming ACOs in your state? What is Medicaid considering? What are the private payers considering?

5. Be wise about who will welcome your leadership. Start with public and private payers. They want higher quality at lower cost, and they’re coming to understand the advantages of the medical home–centric ACO in achieving these goals. Thus, they’re more open to primary care medical home leadership. Enlightened specialists and hospitals are embracing primary care leadership for the same reason. They want to ride the winning horse, and the medical home–centric ACO is often that choice. Others who aren’t as enlightened won’t welcome the loss of control and will resist.

Will leadership be worth it? In our experience, primary care physician leadership has clearly been worth it to those physicians who pursue it, for four reasons. First, their ACO or collaborative care organization is more likely to be successful. Second, their ACO’s savings pool is bigger, and its outcomes are better. Third, they’ve enjoyed restoring the multispecialty collegiality from their days of medical training. And finally, their contributions have been more valuable – and the ACO payments to them based on contributions have been correspondingly more substantial.

Mr. Bobbitt is a senior partner and head of the health law group at the Smith Anderson law firm in Raleigh, N.C. He has many years of experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at bbobbitt@smithlaw.com or 919-821-6612.

With ever more data demonstrating that patient-centered medical homes are the core of successful ACOs, it’s becoming clear that primary care physicians can have a meaningful role in the accountable care movement. In fact, primary care physicians have the opportunity to lead ACO development.

Some primary care physicians have stepped up to leadership and have been very successful. Others want to but don’t know where to start, because there is no precedent for this.

So, what’s required to make a primary care physician a successful ACO leader? It begins with these five fundamental steps:

1. Be the most prepared person in the room. Before you lead, you must understand. And understanding ACOs isn’t a lengthy process. You truly can become one of the most knowledgeable people about ACOs in a matter of hours, not weeks. As you start developing an ACO or collaborative care initiative, your knowledge and positive informed contributions will earn you the respect and confidence of others – foundations upon which leadership rests.

2. Get out of your silo. Accountable care is a team game. Be part of that team by networking intentionally with other primary care physicians, specialists, and hospital administrators. Seek out ways to interact. There is a window of opportunity for the physician willing to bridge gaps.

3. Exercise quiet leadership. There is no need to seize the podium and tell others what to do. That will backfire, of course. Facilitate discussions, and ask others leading questions to find out what they think. Convene breakfasts with members of the medical staff in your community. Engage hospital leadership. An informed primary care physician ACO champion soon will be a much-desired commodity. Lead from behind, as it were. Your goal is to increase awareness and buy-in to a vision, and ideally, it should be the group consensus. You do not need or want to be getting the credit.

4. Do the due diligence. Find out what is going on. What’s out there in your market? Are there medical home networks forming ACOs in your state? What is Medicaid considering? What are the private payers considering?

5. Be wise about who will welcome your leadership. Start with public and private payers. They want higher quality at lower cost, and they’re coming to understand the advantages of the medical home–centric ACO in achieving these goals. Thus, they’re more open to primary care medical home leadership. Enlightened specialists and hospitals are embracing primary care leadership for the same reason. They want to ride the winning horse, and the medical home–centric ACO is often that choice. Others who aren’t as enlightened won’t welcome the loss of control and will resist.

Will leadership be worth it? In our experience, primary care physician leadership has clearly been worth it to those physicians who pursue it, for four reasons. First, their ACO or collaborative care organization is more likely to be successful. Second, their ACO’s savings pool is bigger, and its outcomes are better. Third, they’ve enjoyed restoring the multispecialty collegiality from their days of medical training. And finally, their contributions have been more valuable – and the ACO payments to them based on contributions have been correspondingly more substantial.

Mr. Bobbitt is a senior partner and head of the health law group at the Smith Anderson law firm in Raleigh, N.C. He has many years of experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at bbobbitt@smithlaw.com or 919-821-6612.

The Training Program Experience

By Mara B. Antonoff, M.D., Resident Medical Editor

The new thoracic surgery curriculum has arrived. Debuting this past summer, the curriculum resulted as a joint endeavor of several key organizations heavily vested in thoracic surgical education, with the aim of providing a web-based, multimedia repository of educational materials, accompanied by a formal structure and schedule of weekly topic coverage. Conceptually, the new curriculum has much to offer, with immense theoretical benefits to both the teacher and the student. But what about in practice? Now several months after its launch, the materials provided via the Moodle site and WebBrain have been accessed by the majority of training programs in this country.

How are these tools being utilized by the various programs, and what feedback do they have based on their experiences? The goal of this article will be to explore the various usage patterns of several institutions and their strategies for implementing the materials and integrating them with on-the-ground educational activities. Both the strengths and drawbacks from a programmatic standpoint will be addressed. As you read this article, perhaps you will be motivated to take another look at the curriculum, with new ideas as to how it might best suit your program’s needs.

At Oregon Health and Science University (OHSU), the new curriculum was officially introduced to the trainees and faculty members in a very formal and organized manner, heavily employing the provided instructional videos to become quickly oriented to the new system ("How-To: Utilizing the Thoracic Surgery Brain WebBrain," by Dr. Craig Baker; "How-To: Navigating Moodle," by Dr. Ara Vaporciyan; and "Overview of Teaching Cardiothoracic Surgery" – all available from the Moodle site, http:// jctse.mrooms.net, under Resources on the right hand column). OHSU Program Coordinator Jill Rose reports that she also received helpful information about accessing the curriculum when she attended the "Educate the Educators" course in June, sponsored by the Joint Council on Thoracic Surgery Education (JCTSE). Ms. Rose states, "Faculty and learners enthusiastically adopted this new curriculum and immediately put it to use at least twice a week." When the weekly emails come out, the relevant articles and videos are sent to the trainees and faculty members in the form of a reminder email, including links to the online videos and all related PDF’s as attachments. The residents and fellows then engage in formal curriculum review sessions with faculty, students, and mid-level practitioners – covering the cardiac topics on Monday mornings and thoracic topics on Friday mornings.

At Loma Linda University Health, the residents meet with a faculty moderator on a weekly basis to cover the materials related to the weekly Thoracic Surgery Curriculum topics. The style of presentation is left to the discretion of the attending surgeon, with the majority of the didactic sessions following an oral-board, case-based scenario format. Rather than directly accessing the Moodle pages and WebBrain site, the majority of the faculty and trainees have found that they prefer to have the materials provided to them as hard copies. Consequently, these materials are downloaded and distributed by the program coordinator on a weekly basis.

As with any new educational program, there may be a need for adjustments in initial plans and utilization based on early experiences. For the first few months following release of the curriculum, the Loma Linda group aimed to cover two topics per week – cardiac on Monday mornings and thoracic on Thursday mornings. However, with a tremendous amount of material available for each topic, they ultimately decided to transition to a single weekly session.

While the Loma Linda program has attempted to adhere to the schedule according to the weekly curriculum emails, other programs have chosen to utilize the available materials within the framework of alternative curricular schedules. Rose Haselden, the program coordinator at the Medical University of South Carolina (MUSC), explains that they created their own timeline for covering the materials, based on their specific needs and objectives.

Dr. John Ikonomidis, program director at MUSC, recalls being quick to adopt the new thoracic surgery curriculum. He states, "We were very impressed with its scope and current referencing. When it became available, we went through its entire corpus and divided it into sections which could be covered in 30 minutes. Then we developed a schedule where two topics (one adult or pediatric cardiac and one thoracic) would be covered in our weekly one-hour didactic sessions." Dr. Ikonomidis continues, "The residents are expected to read the material beforehand and faculty are assigned to quiz the residents during the session." In this way, the MUSC program has found a way to use the full breadth of materials, but tailoring the exact learning objectives for their trainees.

While some programs have taken to re-organizing the materials and producing hard copies of the resources for the residents, others have chosen to use the curriculum in its native structure, as a freestanding means of educational supplementation. At Washington University in St. Louis, the trainees are taught how to access the materials and encouraged to both follow the weekly thoracic surgery curriculum emails for independent reading and to utilize the immense resources available for investigating topics relevant to specific cases, conferences, and research interests. Dr. Marc Moon, program director at Washington University, explains that "we have not utilized the materials in any formal, assigned manner; rather, we choose to use the curriculum as a resource for independent study, encouraging our residents to access the multimedia materials both for at-home study and point-of-care reference." Dr. Moon expresses gratitude for the new curriculum, reporting that the faculty members "are grateful that our trainees are able to access these curricular materials through the WebBrain and Moodle, as they serve as an outstanding educational supplement to a high volume operative experience." Dr. Moon further emphasizes, "We find that the new curriculum functions as an excellent adjunct to our clinical teaching."

There are a number of proposed strengths to the new curriculum – its breadth, its ease of access, its correlation with the educational objectives of the American Board of Thoracic Surgery. But what are the benefits being identified from the level of the training program? Dr. Paul Schipper, program director at OHSU, expresses appreciation for the greater volume of material accessible by the trainees, as compared with the older curriculum previously sponsored by the Thoracic Surgery Directors Association (TSDA). States Dr. Schipper, "We’ve been using the TSDA emailed curriculum for several years. With the release of WebBrain, we’ve switched over and been very pleased. Residents are accessing the material and digging deeper into it than previously. In our teaching sessions, we are spending more time on applying the material and less time on explaining it, and I think this is good." Appreciation for the breadth and depth of the material was also noted by Dr. Moon, who identifies the program’s strengths as its ease of access, its large volume, and its applicability to a wide range of educational needs.

Despite the generally laudatory praise, there have been a few issues identified by the training programs that could benefit from some improvement.

Certainly, this is not surprising, as with any educational program, practice and feedback are necessary to optimize the execution for the users. Further, with a resource collection of such enormity, minor tweaks will likely continue in the background at all times in order to ensure ongoing quality-control.

In considering further revision, Dr. Wallen raises some concerns regarding format. He states that "all the moving around on the links makes people crazy," and, for this reason, at Loma Linda, all of the materials are distributed from the WebBrain to the faculty and trainees by the program coordinator. "Otherwise, we would have a revolt," Dr. Jason Wallen explains, This distaste for accessing the materials via the WebBrain is not shared by all users, but it provides feedback, suggesting that changes could be made to optimize formatting to increase ease of use.

Certainly, the leaders in the TSDA, JCTSE, and Thoracic Surgery Residents Association (TSRA) who contributed to the development of the new curriculum are eager for this kind of feedback, welcoming all users to provide constructive criticism. Dr. Ara Vaporciyan, program director at the University of Texas MD Anderson Cancer Center, co-chair of the TSDA/JCTSE Curriculum Committee, and one of the 4 section editors for the curriculum itself, has been a key player in the development of the new curriculum.

States Dr. Vaporciyan, "I never expected this to be perfect on the first try and this is exactly the feedback we need. If we can start an honest conversation about the flaws in the system we can better allocate resources to fixing the most pervasive issues."

Despite the challenges that have been identified, Dr. Wallen remains positive about the curriculum, stating, "We are excited to have an electronic curriculum that our residents can access from anywhere that includes readings and multimedia content. We anticipate that following the curriculum will enhance our residents’ performance on future inservice exams and pave the path to certification."

Dr. Ikonomidis shares Dr. Wallen’s enthusiasm, summarizing that his "residents are constantly engaged and we believe that their learning efficiency has increased." Notes Dr. Schipper, "I am hopeful that this system will stay current and realize and appreciate the effort this has and will take to do so."

Certainly, the new curriculum has already been heavily utilized and appreciated by a number of training programs. While there will always be minor adjustments to be made, the innovators behind the Thoracic Surgery WebBrain and Moodle site are receptive to feedback and clearly dedicated to its ongoing growth.

Perhaps this article has encouraged those of you that aren’t using the curriculum regularly to incorporate it into your institution’s educational structure. For those of you already heavily engaged, perhaps you’ve been inspired to try some new strategies of implementation. Moreover, for all users of the system – trainees, educators, and coordinators – regardless of your program’s current level of use, the take-home message from the creators of the curriculum is that you are encouraged to provide feedback to allow evolution and improvement of the program.

The Trainee Experience

By Sanford M. Zeigler, M.D., Resident Medical Editor

Dr. Antonoff has detailed how different programs have chosen to implement the new curriculum. Of course, in order for the curriculum to work in any setting, people have to actually sit down, access the material, and learn from it. The modules need to be easily accessible, logically organized, and appropriate for the audience for which they are intended. To that end, the folks behind the new curriculum worked diligently to organize all the material into the WebBrain format, which attempts to organize the content by the logic of the human brain, using mind maps, and Moodle, which compartmentalizes the readings into individual curricular assignments that are served up on each resident’s personal Moodle page.

The overall architecture of the WebBrain is very organic; the "Brain" is split into four main branches, comprised of Foundations of Surgery, Cardiovascular, Thoracic, and Congenital headings. From these, the subject matter continues to divide and subdivide again until you reach a terminal branch, where the reader can open a number of different sources, both primary and secondary, on a given subject. The brains’ power lies in the connections that can be made across these fluid boundaries. An example can be seen with one reference that discusses MRI imaging of pericardial disease and cardiac masses. When this is selected, the thought leads the reader back to both the pericardial disease heading and the cardiac tumors heading. The subject selection feature allows the reader to wander throughout the entire WebBrain in a free-flowing but logical manner. Connections across different subjects are, at this point, still rarely utilized. The cross-referencing feature could be a boon for more junior integrated residents and general surgery residents if more of the basic concepts section were connected to cardiac and thoracic subjects, and could allow more self-directed reading to residents that find the time to do so. The WebBrain has some basic search functionality embedded in it that could be used to help understand specific clinical scenarios as they are encountered. Layered upon all of the subject matter are tags, which correspond to the weekly curricular readings. If trainees search for the tag "CV08," for example, they will be directed to each source with that tag, bringing the weekly source matter right to the front. Thus, the WebBrain can be used as a guide for casual reading, as a reference for a particular question or clinical scenario encountered in practice, and also as the source for material covered in didactic session.

The Moodle interface is the gateway to the WebBrain. While it may sound easier to deliver the contents of the WebBrain to each resident rather than go through Moodle, this interface serves two functions. In order to license the content for the curriculum, publishers of many of the textbooks require tight security to prevent unauthorized duplication of the materials. Moodle, by requiring a unique login to access the single WebBrain, provides that security and also allows the WebBrain to be modified in the Cloud, rather than at the level of the end-user. Moodle also provides other testing and tracking tools that have not been completely rolled out. Over the coming months, its full architecture will be used to incorporate quizzes, collaborative message boards, and personal tracking to help residents and their program directors ensure that the material is being covered adequately.

Nearly every resident and faculty member I asked about the new curriculum agreed that the update in content and delivery was badly needed. As an intern in an integrated cardiothoracic surgery program, I remember feeling very jealous of my general surgery colleagues’ access to the SCORE portal, which gave them an easily navigable curriculum accessible from anywhere, with instruction in everything from basic science and physiology to advanced surgical diagnosis and technique. The rollout of the Moodle interface and Web Brain content is the first step to a similar, comprehensive compendium of the necessary knowledge to master cardiac and thoracic surgery.

Response to the rollout has been generally positive from the residents. Most residents agree that the content provides a great sample of landmark papers, lecture videos, book chapters, and consensus statements. A fellow Stanford resident, George Dimeling, wrote: "I like the weekly focus and the topic organization. The content is good, but tough to access." The articles and chapters are often more up to date than printed textbooks, and, once the reader accesses the Brain, are instantly viewable with no further log ins or downloads.

Of course, for a busy resident, it may not always be possible to cover a long book chapter quickly, and the primary literature sometimes fails to cover an entire topic. Justin Schaffer, another Stanford resident, offered this thought: "There’s either a short paper or a 40-page book chapter – there is no solid review of the subject matter. They need something like the Doty lecture series and the TSRA publications to get you warmed up if you don’t have all that time." In fact, the WebBrain incorporates many chapters of the TSRA Cardiothoracic Review book, and the TSRA Clinical Scenarios were added to Moodle on Dec. 12.

One of the more common complaints had little to do with the content but more to do with delivery. At my own institution, most of our hospital computers run an outdated copy of Internet Explorer and have restricted access to update or install a new browser. The out-of-date or restricted software packages that are pervasive in institutional machines nullify many of the advantages of the WebBrain/Moodle format, as the majority of computers at Stanford Hospital cannot access the WebBrain. Furthermore, the WebBrain interface can be laggy and slow even with compatible software.

Others have complained that it is not always easy to find the readings, especially if a program does not follow one of the standardized curricula included with the rollout. First, one must find which content they are responsible for via departmental website or reference to the curricula. Next, the resident logs into the Moodle room, and the proper WebBrain course is launched, then each article for the week is selected and downloaded. Only after that can the content be read, saved, or printed. Using the tag function is helpful, but each time a tagged article is selected, the resident is taken away from the search and to the specific content area, away from the other material assigned for the week. Though it isn’t very difficult to navigate back to the search, all of the steps above make it a bit more of a process to access the material than is convenient for a resident trying to fit in readings between cases or while waiting to round. The new software is a definite improvement, yet still has not reached its full potential.

As Dr. Antonoff pointed out, one residency program has easily overcome this obstacle by consolidating and emailing the appropriate material every week. While the Moodle portion of the curriculum still sees limited functionality, this is probably the best solution to all of the problems. If the articles are in your mailbox, they are accessible anywhere, without the bother of logging in and navigating the Brain.

I discussed this with Dr. Jim Fann, who has been very involved in developing the curriculum, and he explained that direct delivery of the content to each resident had been part of the original goal. As mentioned before, however, publishers require that the delivery of the material is secure from unauthorized duplication. Within the context of an individual institution, those issues are less confining. While individual programs work to integrate the material into their own traditions, it may be worthwhile to designate a resident or office staff member to be in charge of distributing the week’s reading. One little-recognized feature of Moodle is the ability to upload calendars. Perhaps this area could be used by each program to keep the curricular and departmental calendars adjacent to the WebBrain link for easier access.

The recent changes in cardiothoracic surgical education have been myriad, and the rollout of the new curriculum is one of the most pervasive and visible signs of that change. The new curriculum has been designed and updated to reflect not only updates in medical knowledge and consensus, but also changes in the demographic of the cardiothoracic surgery resident and new paradigms in surgical education. The content and delivery systems, while not perfect, remain an ever improving work in progress, which aims to bring cardiothoracic surgical education into the collaborative, cloud based learning era while broadening its reach to both green cardiothoracic surgery interns and traditional fellows with a full general surgery residency behind them. All things considered, the rollout has been very successful, and as more functionality is added and bugs are worked out, things can only improve.

The Training Program Experience

By Mara B. Antonoff, M.D., Resident Medical Editor

The new thoracic surgery curriculum has arrived. Debuting this past summer, the curriculum resulted as a joint endeavor of several key organizations heavily vested in thoracic surgical education, with the aim of providing a web-based, multimedia repository of educational materials, accompanied by a formal structure and schedule of weekly topic coverage. Conceptually, the new curriculum has much to offer, with immense theoretical benefits to both the teacher and the student. But what about in practice? Now several months after its launch, the materials provided via the Moodle site and WebBrain have been accessed by the majority of training programs in this country.

How are these tools being utilized by the various programs, and what feedback do they have based on their experiences? The goal of this article will be to explore the various usage patterns of several institutions and their strategies for implementing the materials and integrating them with on-the-ground educational activities. Both the strengths and drawbacks from a programmatic standpoint will be addressed. As you read this article, perhaps you will be motivated to take another look at the curriculum, with new ideas as to how it might best suit your program’s needs.

At Oregon Health and Science University (OHSU), the new curriculum was officially introduced to the trainees and faculty members in a very formal and organized manner, heavily employing the provided instructional videos to become quickly oriented to the new system ("How-To: Utilizing the Thoracic Surgery Brain WebBrain," by Dr. Craig Baker; "How-To: Navigating Moodle," by Dr. Ara Vaporciyan; and "Overview of Teaching Cardiothoracic Surgery" – all available from the Moodle site, http:// jctse.mrooms.net, under Resources on the right hand column). OHSU Program Coordinator Jill Rose reports that she also received helpful information about accessing the curriculum when she attended the "Educate the Educators" course in June, sponsored by the Joint Council on Thoracic Surgery Education (JCTSE). Ms. Rose states, "Faculty and learners enthusiastically adopted this new curriculum and immediately put it to use at least twice a week." When the weekly emails come out, the relevant articles and videos are sent to the trainees and faculty members in the form of a reminder email, including links to the online videos and all related PDF’s as attachments. The residents and fellows then engage in formal curriculum review sessions with faculty, students, and mid-level practitioners – covering the cardiac topics on Monday mornings and thoracic topics on Friday mornings.

At Loma Linda University Health, the residents meet with a faculty moderator on a weekly basis to cover the materials related to the weekly Thoracic Surgery Curriculum topics. The style of presentation is left to the discretion of the attending surgeon, with the majority of the didactic sessions following an oral-board, case-based scenario format. Rather than directly accessing the Moodle pages and WebBrain site, the majority of the faculty and trainees have found that they prefer to have the materials provided to them as hard copies. Consequently, these materials are downloaded and distributed by the program coordinator on a weekly basis.

As with any new educational program, there may be a need for adjustments in initial plans and utilization based on early experiences. For the first few months following release of the curriculum, the Loma Linda group aimed to cover two topics per week – cardiac on Monday mornings and thoracic on Thursday mornings. However, with a tremendous amount of material available for each topic, they ultimately decided to transition to a single weekly session.

While the Loma Linda program has attempted to adhere to the schedule according to the weekly curriculum emails, other programs have chosen to utilize the available materials within the framework of alternative curricular schedules. Rose Haselden, the program coordinator at the Medical University of South Carolina (MUSC), explains that they created their own timeline for covering the materials, based on their specific needs and objectives.

Dr. John Ikonomidis, program director at MUSC, recalls being quick to adopt the new thoracic surgery curriculum. He states, "We were very impressed with its scope and current referencing. When it became available, we went through its entire corpus and divided it into sections which could be covered in 30 minutes. Then we developed a schedule where two topics (one adult or pediatric cardiac and one thoracic) would be covered in our weekly one-hour didactic sessions." Dr. Ikonomidis continues, "The residents are expected to read the material beforehand and faculty are assigned to quiz the residents during the session." In this way, the MUSC program has found a way to use the full breadth of materials, but tailoring the exact learning objectives for their trainees.

While some programs have taken to re-organizing the materials and producing hard copies of the resources for the residents, others have chosen to use the curriculum in its native structure, as a freestanding means of educational supplementation. At Washington University in St. Louis, the trainees are taught how to access the materials and encouraged to both follow the weekly thoracic surgery curriculum emails for independent reading and to utilize the immense resources available for investigating topics relevant to specific cases, conferences, and research interests. Dr. Marc Moon, program director at Washington University, explains that "we have not utilized the materials in any formal, assigned manner; rather, we choose to use the curriculum as a resource for independent study, encouraging our residents to access the multimedia materials both for at-home study and point-of-care reference." Dr. Moon expresses gratitude for the new curriculum, reporting that the faculty members "are grateful that our trainees are able to access these curricular materials through the WebBrain and Moodle, as they serve as an outstanding educational supplement to a high volume operative experience." Dr. Moon further emphasizes, "We find that the new curriculum functions as an excellent adjunct to our clinical teaching."

There are a number of proposed strengths to the new curriculum – its breadth, its ease of access, its correlation with the educational objectives of the American Board of Thoracic Surgery. But what are the benefits being identified from the level of the training program? Dr. Paul Schipper, program director at OHSU, expresses appreciation for the greater volume of material accessible by the trainees, as compared with the older curriculum previously sponsored by the Thoracic Surgery Directors Association (TSDA). States Dr. Schipper, "We’ve been using the TSDA emailed curriculum for several years. With the release of WebBrain, we’ve switched over and been very pleased. Residents are accessing the material and digging deeper into it than previously. In our teaching sessions, we are spending more time on applying the material and less time on explaining it, and I think this is good." Appreciation for the breadth and depth of the material was also noted by Dr. Moon, who identifies the program’s strengths as its ease of access, its large volume, and its applicability to a wide range of educational needs.

Despite the generally laudatory praise, there have been a few issues identified by the training programs that could benefit from some improvement.

Certainly, this is not surprising, as with any educational program, practice and feedback are necessary to optimize the execution for the users. Further, with a resource collection of such enormity, minor tweaks will likely continue in the background at all times in order to ensure ongoing quality-control.

In considering further revision, Dr. Wallen raises some concerns regarding format. He states that "all the moving around on the links makes people crazy," and, for this reason, at Loma Linda, all of the materials are distributed from the WebBrain to the faculty and trainees by the program coordinator. "Otherwise, we would have a revolt," Dr. Jason Wallen explains, This distaste for accessing the materials via the WebBrain is not shared by all users, but it provides feedback, suggesting that changes could be made to optimize formatting to increase ease of use.

Certainly, the leaders in the TSDA, JCTSE, and Thoracic Surgery Residents Association (TSRA) who contributed to the development of the new curriculum are eager for this kind of feedback, welcoming all users to provide constructive criticism. Dr. Ara Vaporciyan, program director at the University of Texas MD Anderson Cancer Center, co-chair of the TSDA/JCTSE Curriculum Committee, and one of the 4 section editors for the curriculum itself, has been a key player in the development of the new curriculum.

States Dr. Vaporciyan, "I never expected this to be perfect on the first try and this is exactly the feedback we need. If we can start an honest conversation about the flaws in the system we can better allocate resources to fixing the most pervasive issues."

Despite the challenges that have been identified, Dr. Wallen remains positive about the curriculum, stating, "We are excited to have an electronic curriculum that our residents can access from anywhere that includes readings and multimedia content. We anticipate that following the curriculum will enhance our residents’ performance on future inservice exams and pave the path to certification."

Dr. Ikonomidis shares Dr. Wallen’s enthusiasm, summarizing that his "residents are constantly engaged and we believe that their learning efficiency has increased." Notes Dr. Schipper, "I am hopeful that this system will stay current and realize and appreciate the effort this has and will take to do so."

Certainly, the new curriculum has already been heavily utilized and appreciated by a number of training programs. While there will always be minor adjustments to be made, the innovators behind the Thoracic Surgery WebBrain and Moodle site are receptive to feedback and clearly dedicated to its ongoing growth.

Perhaps this article has encouraged those of you that aren’t using the curriculum regularly to incorporate it into your institution’s educational structure. For those of you already heavily engaged, perhaps you’ve been inspired to try some new strategies of implementation. Moreover, for all users of the system – trainees, educators, and coordinators – regardless of your program’s current level of use, the take-home message from the creators of the curriculum is that you are encouraged to provide feedback to allow evolution and improvement of the program.

The Trainee Experience

By Sanford M. Zeigler, M.D., Resident Medical Editor

Dr. Antonoff has detailed how different programs have chosen to implement the new curriculum. Of course, in order for the curriculum to work in any setting, people have to actually sit down, access the material, and learn from it. The modules need to be easily accessible, logically organized, and appropriate for the audience for which they are intended. To that end, the folks behind the new curriculum worked diligently to organize all the material into the WebBrain format, which attempts to organize the content by the logic of the human brain, using mind maps, and Moodle, which compartmentalizes the readings into individual curricular assignments that are served up on each resident’s personal Moodle page.

The overall architecture of the WebBrain is very organic; the "Brain" is split into four main branches, comprised of Foundations of Surgery, Cardiovascular, Thoracic, and Congenital headings. From these, the subject matter continues to divide and subdivide again until you reach a terminal branch, where the reader can open a number of different sources, both primary and secondary, on a given subject. The brains’ power lies in the connections that can be made across these fluid boundaries. An example can be seen with one reference that discusses MRI imaging of pericardial disease and cardiac masses. When this is selected, the thought leads the reader back to both the pericardial disease heading and the cardiac tumors heading. The subject selection feature allows the reader to wander throughout the entire WebBrain in a free-flowing but logical manner. Connections across different subjects are, at this point, still rarely utilized. The cross-referencing feature could be a boon for more junior integrated residents and general surgery residents if more of the basic concepts section were connected to cardiac and thoracic subjects, and could allow more self-directed reading to residents that find the time to do so. The WebBrain has some basic search functionality embedded in it that could be used to help understand specific clinical scenarios as they are encountered. Layered upon all of the subject matter are tags, which correspond to the weekly curricular readings. If trainees search for the tag "CV08," for example, they will be directed to each source with that tag, bringing the weekly source matter right to the front. Thus, the WebBrain can be used as a guide for casual reading, as a reference for a particular question or clinical scenario encountered in practice, and also as the source for material covered in didactic session.

The Moodle interface is the gateway to the WebBrain. While it may sound easier to deliver the contents of the WebBrain to each resident rather than go through Moodle, this interface serves two functions. In order to license the content for the curriculum, publishers of many of the textbooks require tight security to prevent unauthorized duplication of the materials. Moodle, by requiring a unique login to access the single WebBrain, provides that security and also allows the WebBrain to be modified in the Cloud, rather than at the level of the end-user. Moodle also provides other testing and tracking tools that have not been completely rolled out. Over the coming months, its full architecture will be used to incorporate quizzes, collaborative message boards, and personal tracking to help residents and their program directors ensure that the material is being covered adequately.

Nearly every resident and faculty member I asked about the new curriculum agreed that the update in content and delivery was badly needed. As an intern in an integrated cardiothoracic surgery program, I remember feeling very jealous of my general surgery colleagues’ access to the SCORE portal, which gave them an easily navigable curriculum accessible from anywhere, with instruction in everything from basic science and physiology to advanced surgical diagnosis and technique. The rollout of the Moodle interface and Web Brain content is the first step to a similar, comprehensive compendium of the necessary knowledge to master cardiac and thoracic surgery.

Response to the rollout has been generally positive from the residents. Most residents agree that the content provides a great sample of landmark papers, lecture videos, book chapters, and consensus statements. A fellow Stanford resident, George Dimeling, wrote: "I like the weekly focus and the topic organization. The content is good, but tough to access." The articles and chapters are often more up to date than printed textbooks, and, once the reader accesses the Brain, are instantly viewable with no further log ins or downloads.

Of course, for a busy resident, it may not always be possible to cover a long book chapter quickly, and the primary literature sometimes fails to cover an entire topic. Justin Schaffer, another Stanford resident, offered this thought: "There’s either a short paper or a 40-page book chapter – there is no solid review of the subject matter. They need something like the Doty lecture series and the TSRA publications to get you warmed up if you don’t have all that time." In fact, the WebBrain incorporates many chapters of the TSRA Cardiothoracic Review book, and the TSRA Clinical Scenarios were added to Moodle on Dec. 12.

One of the more common complaints had little to do with the content but more to do with delivery. At my own institution, most of our hospital computers run an outdated copy of Internet Explorer and have restricted access to update or install a new browser. The out-of-date or restricted software packages that are pervasive in institutional machines nullify many of the advantages of the WebBrain/Moodle format, as the majority of computers at Stanford Hospital cannot access the WebBrain. Furthermore, the WebBrain interface can be laggy and slow even with compatible software.

Others have complained that it is not always easy to find the readings, especially if a program does not follow one of the standardized curricula included with the rollout. First, one must find which content they are responsible for via departmental website or reference to the curricula. Next, the resident logs into the Moodle room, and the proper WebBrain course is launched, then each article for the week is selected and downloaded. Only after that can the content be read, saved, or printed. Using the tag function is helpful, but each time a tagged article is selected, the resident is taken away from the search and to the specific content area, away from the other material assigned for the week. Though it isn’t very difficult to navigate back to the search, all of the steps above make it a bit more of a process to access the material than is convenient for a resident trying to fit in readings between cases or while waiting to round. The new software is a definite improvement, yet still has not reached its full potential.

As Dr. Antonoff pointed out, one residency program has easily overcome this obstacle by consolidating and emailing the appropriate material every week. While the Moodle portion of the curriculum still sees limited functionality, this is probably the best solution to all of the problems. If the articles are in your mailbox, they are accessible anywhere, without the bother of logging in and navigating the Brain.

I discussed this with Dr. Jim Fann, who has been very involved in developing the curriculum, and he explained that direct delivery of the content to each resident had been part of the original goal. As mentioned before, however, publishers require that the delivery of the material is secure from unauthorized duplication. Within the context of an individual institution, those issues are less confining. While individual programs work to integrate the material into their own traditions, it may be worthwhile to designate a resident or office staff member to be in charge of distributing the week’s reading. One little-recognized feature of Moodle is the ability to upload calendars. Perhaps this area could be used by each program to keep the curricular and departmental calendars adjacent to the WebBrain link for easier access.

The recent changes in cardiothoracic surgical education have been myriad, and the rollout of the new curriculum is one of the most pervasive and visible signs of that change. The new curriculum has been designed and updated to reflect not only updates in medical knowledge and consensus, but also changes in the demographic of the cardiothoracic surgery resident and new paradigms in surgical education. The content and delivery systems, while not perfect, remain an ever improving work in progress, which aims to bring cardiothoracic surgical education into the collaborative, cloud based learning era while broadening its reach to both green cardiothoracic surgery interns and traditional fellows with a full general surgery residency behind them. All things considered, the rollout has been very successful, and as more functionality is added and bugs are worked out, things can only improve.

The Training Program Experience

By Mara B. Antonoff, M.D., Resident Medical Editor

The new thoracic surgery curriculum has arrived. Debuting this past summer, the curriculum resulted as a joint endeavor of several key organizations heavily vested in thoracic surgical education, with the aim of providing a web-based, multimedia repository of educational materials, accompanied by a formal structure and schedule of weekly topic coverage. Conceptually, the new curriculum has much to offer, with immense theoretical benefits to both the teacher and the student. But what about in practice? Now several months after its launch, the materials provided via the Moodle site and WebBrain have been accessed by the majority of training programs in this country.

How are these tools being utilized by the various programs, and what feedback do they have based on their experiences? The goal of this article will be to explore the various usage patterns of several institutions and their strategies for implementing the materials and integrating them with on-the-ground educational activities. Both the strengths and drawbacks from a programmatic standpoint will be addressed. As you read this article, perhaps you will be motivated to take another look at the curriculum, with new ideas as to how it might best suit your program’s needs.

At Oregon Health and Science University (OHSU), the new curriculum was officially introduced to the trainees and faculty members in a very formal and organized manner, heavily employing the provided instructional videos to become quickly oriented to the new system ("How-To: Utilizing the Thoracic Surgery Brain WebBrain," by Dr. Craig Baker; "How-To: Navigating Moodle," by Dr. Ara Vaporciyan; and "Overview of Teaching Cardiothoracic Surgery" – all available from the Moodle site, http:// jctse.mrooms.net, under Resources on the right hand column). OHSU Program Coordinator Jill Rose reports that she also received helpful information about accessing the curriculum when she attended the "Educate the Educators" course in June, sponsored by the Joint Council on Thoracic Surgery Education (JCTSE). Ms. Rose states, "Faculty and learners enthusiastically adopted this new curriculum and immediately put it to use at least twice a week." When the weekly emails come out, the relevant articles and videos are sent to the trainees and faculty members in the form of a reminder email, including links to the online videos and all related PDF’s as attachments. The residents and fellows then engage in formal curriculum review sessions with faculty, students, and mid-level practitioners – covering the cardiac topics on Monday mornings and thoracic topics on Friday mornings.

At Loma Linda University Health, the residents meet with a faculty moderator on a weekly basis to cover the materials related to the weekly Thoracic Surgery Curriculum topics. The style of presentation is left to the discretion of the attending surgeon, with the majority of the didactic sessions following an oral-board, case-based scenario format. Rather than directly accessing the Moodle pages and WebBrain site, the majority of the faculty and trainees have found that they prefer to have the materials provided to them as hard copies. Consequently, these materials are downloaded and distributed by the program coordinator on a weekly basis.

As with any new educational program, there may be a need for adjustments in initial plans and utilization based on early experiences. For the first few months following release of the curriculum, the Loma Linda group aimed to cover two topics per week – cardiac on Monday mornings and thoracic on Thursday mornings. However, with a tremendous amount of material available for each topic, they ultimately decided to transition to a single weekly session.

While the Loma Linda program has attempted to adhere to the schedule according to the weekly curriculum emails, other programs have chosen to utilize the available materials within the framework of alternative curricular schedules. Rose Haselden, the program coordinator at the Medical University of South Carolina (MUSC), explains that they created their own timeline for covering the materials, based on their specific needs and objectives.

Dr. John Ikonomidis, program director at MUSC, recalls being quick to adopt the new thoracic surgery curriculum. He states, "We were very impressed with its scope and current referencing. When it became available, we went through its entire corpus and divided it into sections which could be covered in 30 minutes. Then we developed a schedule where two topics (one adult or pediatric cardiac and one thoracic) would be covered in our weekly one-hour didactic sessions." Dr. Ikonomidis continues, "The residents are expected to read the material beforehand and faculty are assigned to quiz the residents during the session." In this way, the MUSC program has found a way to use the full breadth of materials, but tailoring the exact learning objectives for their trainees.

While some programs have taken to re-organizing the materials and producing hard copies of the resources for the residents, others have chosen to use the curriculum in its native structure, as a freestanding means of educational supplementation. At Washington University in St. Louis, the trainees are taught how to access the materials and encouraged to both follow the weekly thoracic surgery curriculum emails for independent reading and to utilize the immense resources available for investigating topics relevant to specific cases, conferences, and research interests. Dr. Marc Moon, program director at Washington University, explains that "we have not utilized the materials in any formal, assigned manner; rather, we choose to use the curriculum as a resource for independent study, encouraging our residents to access the multimedia materials both for at-home study and point-of-care reference." Dr. Moon expresses gratitude for the new curriculum, reporting that the faculty members "are grateful that our trainees are able to access these curricular materials through the WebBrain and Moodle, as they serve as an outstanding educational supplement to a high volume operative experience." Dr. Moon further emphasizes, "We find that the new curriculum functions as an excellent adjunct to our clinical teaching."

There are a number of proposed strengths to the new curriculum – its breadth, its ease of access, its correlation with the educational objectives of the American Board of Thoracic Surgery. But what are the benefits being identified from the level of the training program? Dr. Paul Schipper, program director at OHSU, expresses appreciation for the greater volume of material accessible by the trainees, as compared with the older curriculum previously sponsored by the Thoracic Surgery Directors Association (TSDA). States Dr. Schipper, "We’ve been using the TSDA emailed curriculum for several years. With the release of WebBrain, we’ve switched over and been very pleased. Residents are accessing the material and digging deeper into it than previously. In our teaching sessions, we are spending more time on applying the material and less time on explaining it, and I think this is good." Appreciation for the breadth and depth of the material was also noted by Dr. Moon, who identifies the program’s strengths as its ease of access, its large volume, and its applicability to a wide range of educational needs.

Despite the generally laudatory praise, there have been a few issues identified by the training programs that could benefit from some improvement.

Certainly, this is not surprising, as with any educational program, practice and feedback are necessary to optimize the execution for the users. Further, with a resource collection of such enormity, minor tweaks will likely continue in the background at all times in order to ensure ongoing quality-control.

In considering further revision, Dr. Wallen raises some concerns regarding format. He states that "all the moving around on the links makes people crazy," and, for this reason, at Loma Linda, all of the materials are distributed from the WebBrain to the faculty and trainees by the program coordinator. "Otherwise, we would have a revolt," Dr. Jason Wallen explains, This distaste for accessing the materials via the WebBrain is not shared by all users, but it provides feedback, suggesting that changes could be made to optimize formatting to increase ease of use.

Certainly, the leaders in the TSDA, JCTSE, and Thoracic Surgery Residents Association (TSRA) who contributed to the development of the new curriculum are eager for this kind of feedback, welcoming all users to provide constructive criticism. Dr. Ara Vaporciyan, program director at the University of Texas MD Anderson Cancer Center, co-chair of the TSDA/JCTSE Curriculum Committee, and one of the 4 section editors for the curriculum itself, has been a key player in the development of the new curriculum.

States Dr. Vaporciyan, "I never expected this to be perfect on the first try and this is exactly the feedback we need. If we can start an honest conversation about the flaws in the system we can better allocate resources to fixing the most pervasive issues."

Despite the challenges that have been identified, Dr. Wallen remains positive about the curriculum, stating, "We are excited to have an electronic curriculum that our residents can access from anywhere that includes readings and multimedia content. We anticipate that following the curriculum will enhance our residents’ performance on future inservice exams and pave the path to certification."

Dr. Ikonomidis shares Dr. Wallen’s enthusiasm, summarizing that his "residents are constantly engaged and we believe that their learning efficiency has increased." Notes Dr. Schipper, "I am hopeful that this system will stay current and realize and appreciate the effort this has and will take to do so."

Certainly, the new curriculum has already been heavily utilized and appreciated by a number of training programs. While there will always be minor adjustments to be made, the innovators behind the Thoracic Surgery WebBrain and Moodle site are receptive to feedback and clearly dedicated to its ongoing growth.

Perhaps this article has encouraged those of you that aren’t using the curriculum regularly to incorporate it into your institution’s educational structure. For those of you already heavily engaged, perhaps you’ve been inspired to try some new strategies of implementation. Moreover, for all users of the system – trainees, educators, and coordinators – regardless of your program’s current level of use, the take-home message from the creators of the curriculum is that you are encouraged to provide feedback to allow evolution and improvement of the program.

The Trainee Experience

By Sanford M. Zeigler, M.D., Resident Medical Editor

Dr. Antonoff has detailed how different programs have chosen to implement the new curriculum. Of course, in order for the curriculum to work in any setting, people have to actually sit down, access the material, and learn from it. The modules need to be easily accessible, logically organized, and appropriate for the audience for which they are intended. To that end, the folks behind the new curriculum worked diligently to organize all the material into the WebBrain format, which attempts to organize the content by the logic of the human brain, using mind maps, and Moodle, which compartmentalizes the readings into individual curricular assignments that are served up on each resident’s personal Moodle page.

The overall architecture of the WebBrain is very organic; the "Brain" is split into four main branches, comprised of Foundations of Surgery, Cardiovascular, Thoracic, and Congenital headings. From these, the subject matter continues to divide and subdivide again until you reach a terminal branch, where the reader can open a number of different sources, both primary and secondary, on a given subject. The brains’ power lies in the connections that can be made across these fluid boundaries. An example can be seen with one reference that discusses MRI imaging of pericardial disease and cardiac masses. When this is selected, the thought leads the reader back to both the pericardial disease heading and the cardiac tumors heading. The subject selection feature allows the reader to wander throughout the entire WebBrain in a free-flowing but logical manner. Connections across different subjects are, at this point, still rarely utilized. The cross-referencing feature could be a boon for more junior integrated residents and general surgery residents if more of the basic concepts section were connected to cardiac and thoracic subjects, and could allow more self-directed reading to residents that find the time to do so. The WebBrain has some basic search functionality embedded in it that could be used to help understand specific clinical scenarios as they are encountered. Layered upon all of the subject matter are tags, which correspond to the weekly curricular readings. If trainees search for the tag "CV08," for example, they will be directed to each source with that tag, bringing the weekly source matter right to the front. Thus, the WebBrain can be used as a guide for casual reading, as a reference for a particular question or clinical scenario encountered in practice, and also as the source for material covered in didactic session.

The Moodle interface is the gateway to the WebBrain. While it may sound easier to deliver the contents of the WebBrain to each resident rather than go through Moodle, this interface serves two functions. In order to license the content for the curriculum, publishers of many of the textbooks require tight security to prevent unauthorized duplication of the materials. Moodle, by requiring a unique login to access the single WebBrain, provides that security and also allows the WebBrain to be modified in the Cloud, rather than at the level of the end-user. Moodle also provides other testing and tracking tools that have not been completely rolled out. Over the coming months, its full architecture will be used to incorporate quizzes, collaborative message boards, and personal tracking to help residents and their program directors ensure that the material is being covered adequately.

Nearly every resident and faculty member I asked about the new curriculum agreed that the update in content and delivery was badly needed. As an intern in an integrated cardiothoracic surgery program, I remember feeling very jealous of my general surgery colleagues’ access to the SCORE portal, which gave them an easily navigable curriculum accessible from anywhere, with instruction in everything from basic science and physiology to advanced surgical diagnosis and technique. The rollout of the Moodle interface and Web Brain content is the first step to a similar, comprehensive compendium of the necessary knowledge to master cardiac and thoracic surgery.

Response to the rollout has been generally positive from the residents. Most residents agree that the content provides a great sample of landmark papers, lecture videos, book chapters, and consensus statements. A fellow Stanford resident, George Dimeling, wrote: "I like the weekly focus and the topic organization. The content is good, but tough to access." The articles and chapters are often more up to date than printed textbooks, and, once the reader accesses the Brain, are instantly viewable with no further log ins or downloads.

Of course, for a busy resident, it may not always be possible to cover a long book chapter quickly, and the primary literature sometimes fails to cover an entire topic. Justin Schaffer, another Stanford resident, offered this thought: "There’s either a short paper or a 40-page book chapter – there is no solid review of the subject matter. They need something like the Doty lecture series and the TSRA publications to get you warmed up if you don’t have all that time." In fact, the WebBrain incorporates many chapters of the TSRA Cardiothoracic Review book, and the TSRA Clinical Scenarios were added to Moodle on Dec. 12.

One of the more common complaints had little to do with the content but more to do with delivery. At my own institution, most of our hospital computers run an outdated copy of Internet Explorer and have restricted access to update or install a new browser. The out-of-date or restricted software packages that are pervasive in institutional machines nullify many of the advantages of the WebBrain/Moodle format, as the majority of computers at Stanford Hospital cannot access the WebBrain. Furthermore, the WebBrain interface can be laggy and slow even with compatible software.

Others have complained that it is not always easy to find the readings, especially if a program does not follow one of the standardized curricula included with the rollout. First, one must find which content they are responsible for via departmental website or reference to the curricula. Next, the resident logs into the Moodle room, and the proper WebBrain course is launched, then each article for the week is selected and downloaded. Only after that can the content be read, saved, or printed. Using the tag function is helpful, but each time a tagged article is selected, the resident is taken away from the search and to the specific content area, away from the other material assigned for the week. Though it isn’t very difficult to navigate back to the search, all of the steps above make it a bit more of a process to access the material than is convenient for a resident trying to fit in readings between cases or while waiting to round. The new software is a definite improvement, yet still has not reached its full potential.

As Dr. Antonoff pointed out, one residency program has easily overcome this obstacle by consolidating and emailing the appropriate material every week. While the Moodle portion of the curriculum still sees limited functionality, this is probably the best solution to all of the problems. If the articles are in your mailbox, they are accessible anywhere, without the bother of logging in and navigating the Brain.

I discussed this with Dr. Jim Fann, who has been very involved in developing the curriculum, and he explained that direct delivery of the content to each resident had been part of the original goal. As mentioned before, however, publishers require that the delivery of the material is secure from unauthorized duplication. Within the context of an individual institution, those issues are less confining. While individual programs work to integrate the material into their own traditions, it may be worthwhile to designate a resident or office staff member to be in charge of distributing the week’s reading. One little-recognized feature of Moodle is the ability to upload calendars. Perhaps this area could be used by each program to keep the curricular and departmental calendars adjacent to the WebBrain link for easier access.

The recent changes in cardiothoracic surgical education have been myriad, and the rollout of the new curriculum is one of the most pervasive and visible signs of that change. The new curriculum has been designed and updated to reflect not only updates in medical knowledge and consensus, but also changes in the demographic of the cardiothoracic surgery resident and new paradigms in surgical education. The content and delivery systems, while not perfect, remain an ever improving work in progress, which aims to bring cardiothoracic surgical education into the collaborative, cloud based learning era while broadening its reach to both green cardiothoracic surgery interns and traditional fellows with a full general surgery residency behind them. All things considered, the rollout has been very successful, and as more functionality is added and bugs are worked out, things can only improve.