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 [email protected].

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 [email protected].

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 [email protected].

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 [email protected] 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 [email protected] 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 [email protected] 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.

NEW YORK – Assessing nonresponsiveness to attention-deficit/hyperactivity disorder treatment requires a bit of detective work, according to Dr. Laurence L. Greenhill.

The reason can be as simple as a little kid not being able to swallow a big pill, or as complex as a dysfunctional family dynamic that interferes with medication adherence. But once the problem is rooted out and addressed, most refractory patients can experience a good response, Dr. Greenhill said at a psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

Since primary care physicians usually continue to manage children who respond to ADHD medications, psychiatrists are usually the ones who see nonresponders, said Dr. Greenhill, a child and adolescent psychiatrist at the New York Psychiatric Institute.

Medication nonadherence, the most common cause of a failure to improve, can arise from numerous situations.

Michele G. Sullivan/Frontline Medical News

On the simple side, it might be a matter of finding the right form of medication; a liquid or sprinkle capsule might be much easier for a child to take than a pill. And not all pills are created equally easy to take.

"For example, [the osmotic controlled release oral delivery system methylphenidate] just went off patent, and generics are now available. But some of these generics are much bigger. In fact, one of the 18-mg pills is twice as large as the patent medicine, and lots of kids can’t swallow it," he said.

The ADHD medication guide published by Long Island Jewish Hospital can be a helpful tool when working with parents on this issue. It lists all the Food and Drug Administration–approved medications for ADHD, with full-size photographs of each capsule, tablet, or pill.

Some generics are not pharmacokinetically or pharmacodynamically identical to the original formulation, Dr. Greenhill noted. Although the drug has to be molecularly identical and dose identical, "the ascending dose curve and duration of action need not be matched." Some generic formulations do fall into this problematic category. "For this reason, I try to encourage parents to get the brand," said Dr. Greenhill, adding that he has no financial interest in any of the drugs.

Medication nonadherence also can be attributable to uncomfortable or even intolerable side effects. These can include gastrointestinal issues, trouble sleeping, lack of appetite, restlessness, irritability, and "feeling fidgety."

Dosage adjustments or a medication change might be in order. For appetite issues, recommend giving the medication after meals, and reassure parents it’s OK to let a child eat later in the evening, when hunger may return.

It’s important to get the child’s growth records from the pediatrician, and plot height and weight curves every 6 months. If there’s a consistent fall-off, consider lowering the dose or changing to another drug.

Contrary to widely held belief, stimulants don’t pose significant cardiac risks to most children. A baseline electrocardiogram is really only necessary for a child who has a family history of sudden cardiac death or a personal history of syncope or cardiac abnormalities. Blood pressure and pulse should be monitored at every visit.

Melatonin is worth a try for youngsters whose ADHD meds interfere with good sleep, Dr. Greenhill said.

"I would start at 1 mg/night and work up," he said. "Starting at a high dose can actually shut off the naturally occurring melatonin. Plasma levels peak about an hour after taking it, so timing is important. I usually start with it about 3 hours before the scheduled sleeping time and then adjust."

Family dynamics also can play a big role in medication nonadherence. "ADHD families are often poor at scheduling activities, sometimes to the extent that parents are the ones who forget to give the medication. They also might not have a clear idea of how to give it, and just leave it on the kitchen table, making it the child’s responsibility to take it every day.

"If this is a child who can’t remember to bring homework back from school, then how is he going to remember to stay on schedule with medication?"

If it’s clear that parents are having difficulty in this area, the simplest thing to do is send the medicine to school and ask the nurse to administer it. Switching to a long-acting form might help, too, since it’s just easier to remember to take one pill than to take two.

The ADHD Parents Medication Guide is a great resource that can be used to get parents actively involved with the child’s drug therapy, Dr. Greenhill said. Developed by the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, the online guide is designed to help families and physicians work together to make the best decisions about a child’s care.

Dr. Greenhill is on the advisory board of Quotient, which manufactures an ADHD testing system, and is a consultant for the Health Information Technology Lab.

[email protected]

NEW YORK – Assessing nonresponsiveness to attention-deficit/hyperactivity disorder treatment requires a bit of detective work, according to Dr. Laurence L. Greenhill.

The reason can be as simple as a little kid not being able to swallow a big pill, or as complex as a dysfunctional family dynamic that interferes with medication adherence. But once the problem is rooted out and addressed, most refractory patients can experience a good response, Dr. Greenhill said at a psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

Since primary care physicians usually continue to manage children who respond to ADHD medications, psychiatrists are usually the ones who see nonresponders, said Dr. Greenhill, a child and adolescent psychiatrist at the New York Psychiatric Institute.

Medication nonadherence, the most common cause of a failure to improve, can arise from numerous situations.

Michele G. Sullivan/Frontline Medical News

On the simple side, it might be a matter of finding the right form of medication; a liquid or sprinkle capsule might be much easier for a child to take than a pill. And not all pills are created equally easy to take.

"For example, [the osmotic controlled release oral delivery system methylphenidate] just went off patent, and generics are now available. But some of these generics are much bigger. In fact, one of the 18-mg pills is twice as large as the patent medicine, and lots of kids can’t swallow it," he said.

The ADHD medication guide published by Long Island Jewish Hospital can be a helpful tool when working with parents on this issue. It lists all the Food and Drug Administration–approved medications for ADHD, with full-size photographs of each capsule, tablet, or pill.

Some generics are not pharmacokinetically or pharmacodynamically identical to the original formulation, Dr. Greenhill noted. Although the drug has to be molecularly identical and dose identical, "the ascending dose curve and duration of action need not be matched." Some generic formulations do fall into this problematic category. "For this reason, I try to encourage parents to get the brand," said Dr. Greenhill, adding that he has no financial interest in any of the drugs.

Medication nonadherence also can be attributable to uncomfortable or even intolerable side effects. These can include gastrointestinal issues, trouble sleeping, lack of appetite, restlessness, irritability, and "feeling fidgety."

Dosage adjustments or a medication change might be in order. For appetite issues, recommend giving the medication after meals, and reassure parents it’s OK to let a child eat later in the evening, when hunger may return.

It’s important to get the child’s growth records from the pediatrician, and plot height and weight curves every 6 months. If there’s a consistent fall-off, consider lowering the dose or changing to another drug.

Contrary to widely held belief, stimulants don’t pose significant cardiac risks to most children. A baseline electrocardiogram is really only necessary for a child who has a family history of sudden cardiac death or a personal history of syncope or cardiac abnormalities. Blood pressure and pulse should be monitored at every visit.

Melatonin is worth a try for youngsters whose ADHD meds interfere with good sleep, Dr. Greenhill said.

"I would start at 1 mg/night and work up," he said. "Starting at a high dose can actually shut off the naturally occurring melatonin. Plasma levels peak about an hour after taking it, so timing is important. I usually start with it about 3 hours before the scheduled sleeping time and then adjust."

Family dynamics also can play a big role in medication nonadherence. "ADHD families are often poor at scheduling activities, sometimes to the extent that parents are the ones who forget to give the medication. They also might not have a clear idea of how to give it, and just leave it on the kitchen table, making it the child’s responsibility to take it every day.

"If this is a child who can’t remember to bring homework back from school, then how is he going to remember to stay on schedule with medication?"

If it’s clear that parents are having difficulty in this area, the simplest thing to do is send the medicine to school and ask the nurse to administer it. Switching to a long-acting form might help, too, since it’s just easier to remember to take one pill than to take two.

The ADHD Parents Medication Guide is a great resource that can be used to get parents actively involved with the child’s drug therapy, Dr. Greenhill said. Developed by the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, the online guide is designed to help families and physicians work together to make the best decisions about a child’s care.

Dr. Greenhill is on the advisory board of Quotient, which manufactures an ADHD testing system, and is a consultant for the Health Information Technology Lab.

[email protected]

NEW YORK – Assessing nonresponsiveness to attention-deficit/hyperactivity disorder treatment requires a bit of detective work, according to Dr. Laurence L. Greenhill.

The reason can be as simple as a little kid not being able to swallow a big pill, or as complex as a dysfunctional family dynamic that interferes with medication adherence. But once the problem is rooted out and addressed, most refractory patients can experience a good response, Dr. Greenhill said at a psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

Since primary care physicians usually continue to manage children who respond to ADHD medications, psychiatrists are usually the ones who see nonresponders, said Dr. Greenhill, a child and adolescent psychiatrist at the New York Psychiatric Institute.

Medication nonadherence, the most common cause of a failure to improve, can arise from numerous situations.

Michele G. Sullivan/Frontline Medical News

On the simple side, it might be a matter of finding the right form of medication; a liquid or sprinkle capsule might be much easier for a child to take than a pill. And not all pills are created equally easy to take.

"For example, [the osmotic controlled release oral delivery system methylphenidate] just went off patent, and generics are now available. But some of these generics are much bigger. In fact, one of the 18-mg pills is twice as large as the patent medicine, and lots of kids can’t swallow it," he said.

The ADHD medication guide published by Long Island Jewish Hospital can be a helpful tool when working with parents on this issue. It lists all the Food and Drug Administration–approved medications for ADHD, with full-size photographs of each capsule, tablet, or pill.

Some generics are not pharmacokinetically or pharmacodynamically identical to the original formulation, Dr. Greenhill noted. Although the drug has to be molecularly identical and dose identical, "the ascending dose curve and duration of action need not be matched." Some generic formulations do fall into this problematic category. "For this reason, I try to encourage parents to get the brand," said Dr. Greenhill, adding that he has no financial interest in any of the drugs.

Medication nonadherence also can be attributable to uncomfortable or even intolerable side effects. These can include gastrointestinal issues, trouble sleeping, lack of appetite, restlessness, irritability, and "feeling fidgety."

Dosage adjustments or a medication change might be in order. For appetite issues, recommend giving the medication after meals, and reassure parents it’s OK to let a child eat later in the evening, when hunger may return.

It’s important to get the child’s growth records from the pediatrician, and plot height and weight curves every 6 months. If there’s a consistent fall-off, consider lowering the dose or changing to another drug.

Contrary to widely held belief, stimulants don’t pose significant cardiac risks to most children. A baseline electrocardiogram is really only necessary for a child who has a family history of sudden cardiac death or a personal history of syncope or cardiac abnormalities. Blood pressure and pulse should be monitored at every visit.

Melatonin is worth a try for youngsters whose ADHD meds interfere with good sleep, Dr. Greenhill said.

"I would start at 1 mg/night and work up," he said. "Starting at a high dose can actually shut off the naturally occurring melatonin. Plasma levels peak about an hour after taking it, so timing is important. I usually start with it about 3 hours before the scheduled sleeping time and then adjust."

Family dynamics also can play a big role in medication nonadherence. "ADHD families are often poor at scheduling activities, sometimes to the extent that parents are the ones who forget to give the medication. They also might not have a clear idea of how to give it, and just leave it on the kitchen table, making it the child’s responsibility to take it every day.

"If this is a child who can’t remember to bring homework back from school, then how is he going to remember to stay on schedule with medication?"

If it’s clear that parents are having difficulty in this area, the simplest thing to do is send the medicine to school and ask the nurse to administer it. Switching to a long-acting form might help, too, since it’s just easier to remember to take one pill than to take two.

The ADHD Parents Medication Guide is a great resource that can be used to get parents actively involved with the child’s drug therapy, Dr. Greenhill said. Developed by the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, the online guide is designed to help families and physicians work together to make the best decisions about a child’s care.

Dr. Greenhill is on the advisory board of Quotient, which manufactures an ADHD testing system, and is a consultant for the Health Information Technology Lab.

[email protected]

Prescription drugs

Credit: CDC

A new report suggests that many health plans in the insurance exchanges mandated by the Affordable Care Act (ACA) will impose high out-of-pocket costs for patients with hematologic malignancies and provide limited access to specialty treatment centers.

Furthermore, although the plans analyzed appear to provide adequate coverage of hematology/oncology drugs, most require prior authorization.

In other words, the insurer must be notified and may not approve the purchase of a drug based on medical evidence or other criteria.

This report, “2014 Individual Exchange Policies in Four States: An Early Look for Patients with Blood Cancers,” was commissioned by the Leukemia & Lymphoma Society and prepared by Milliman, Inc.

It provides a look at the 2014 individual benefit designs, coverage benefits, and premiums for policies sold on 4 state health insurance exchanges—California, New York, Florida, and Texas—with a focus on items of interest for patients with hematologic malignancies.

“[W]hile many new rules under ACA make obtaining insurance easier for people with blood cancers, such as prohibiting companies from turning away patients with pre-existing conditions and eliminating lifetime coverage limitations, the Milliman report identifies several areas of concern that we want cancer patients to be aware of and policymakers to address,” said Mark Velleca, MD, PhD, chief policy and advocacy officer of the Leukemia & Lymphoma Society.

Premium costs

To compare monthly premium rates, the report’s authors captured rates for a 50-year-old non-smoker with an annual income of $90,000 residing in Houston, Los Angeles, Miami, or New York City.

They found considerable variation according to plan type and location, but overall, plans were cheapest in Houston. Monthly premiums for Houston ranged from $234 to $520. The range was $274 to $566 for Los Angeles, $277 to $635 for Miami, and $307 to $896 for New York.

The ranges reflect the costs according to plan type. Each insurer offers 4 different health plans: Platinum (about 10% cost-sharing), Gold (roughly 20%), Silver (roughly 30%), and Bronze (roughly 40%).

Cost-sharing

The authors noted that the lower-tier Bronze and Silver plans require significant cost-sharing for patients. The report revealed high deductibles in the health plans, sometimes nearly as high as the out-of-pocket ceiling.

Deductibles for the Silver and Bronze plans are often at least $2000 and $4000, respectively, for individuals. The maximum out-of-pocket limits set for 2014 are $6350 for an individual policy and $12,799 for a family policy.

Some insurers offer plans in some states with lower out-of-pocket limits. However, the out-of-pocket limit does not apply to non-covered drugs or treatment centers.

Drug coverage

When analyzing drug coverage, the authors decided to look at 3 drugs used to treat chronic myeloid leukemia—imatinib (Gleevec), nilotinib (Tasigna), and dasatinib (Sprycel)—and 5 drugs used to treat multiple myeloma—thalidomide (Thalomid), lenalidomide (Revlimid), pomalidomide (Pomalyst), cyclophosphamide (Cytoxan), and melphalan (Alkeran).

Most of the insurers require prior authorization for these drugs, but most of them cover all 3 chronic myeloid leukemia drugs and a majority of the myeloma drugs. Pomalyst and Cytoxan are often not covered, although most insurers do cover generic cyclophosphamide.

Network adequacy

Most of the insurers studied do not cover all NCI-designated cancer and transplant centers, and a few do not cover any of these centers. The authors said this could discourage patient enrollment in these plans or mean that a patient’s recommended treatment is not covered.

And since it is unlikely that any out-of-network expenses will count toward a patient’s out-of-pocket maximum, cancer patients could accumulate thousands of dollars of medical expenses and never reach their out-of-pocket maximum.

The authors did note, however, that satisfactory cancer care can be provided outside of NCI-designated cancer and transplant centers.

For more details, see the full report.

Prescription drugs

Credit: CDC

A new report suggests that many health plans in the insurance exchanges mandated by the Affordable Care Act (ACA) will impose high out-of-pocket costs for patients with hematologic malignancies and provide limited access to specialty treatment centers.

Furthermore, although the plans analyzed appear to provide adequate coverage of hematology/oncology drugs, most require prior authorization.

In other words, the insurer must be notified and may not approve the purchase of a drug based on medical evidence or other criteria.

This report, “2014 Individual Exchange Policies in Four States: An Early Look for Patients with Blood Cancers,” was commissioned by the Leukemia & Lymphoma Society and prepared by Milliman, Inc.

It provides a look at the 2014 individual benefit designs, coverage benefits, and premiums for policies sold on 4 state health insurance exchanges—California, New York, Florida, and Texas—with a focus on items of interest for patients with hematologic malignancies.

“[W]hile many new rules under ACA make obtaining insurance easier for people with blood cancers, such as prohibiting companies from turning away patients with pre-existing conditions and eliminating lifetime coverage limitations, the Milliman report identifies several areas of concern that we want cancer patients to be aware of and policymakers to address,” said Mark Velleca, MD, PhD, chief policy and advocacy officer of the Leukemia & Lymphoma Society.

Premium costs

To compare monthly premium rates, the report’s authors captured rates for a 50-year-old non-smoker with an annual income of $90,000 residing in Houston, Los Angeles, Miami, or New York City.

They found considerable variation according to plan type and location, but overall, plans were cheapest in Houston. Monthly premiums for Houston ranged from $234 to $520. The range was $274 to $566 for Los Angeles, $277 to $635 for Miami, and $307 to $896 for New York.

The ranges reflect the costs according to plan type. Each insurer offers 4 different health plans: Platinum (about 10% cost-sharing), Gold (roughly 20%), Silver (roughly 30%), and Bronze (roughly 40%).

Cost-sharing

The authors noted that the lower-tier Bronze and Silver plans require significant cost-sharing for patients. The report revealed high deductibles in the health plans, sometimes nearly as high as the out-of-pocket ceiling.

Deductibles for the Silver and Bronze plans are often at least $2000 and $4000, respectively, for individuals. The maximum out-of-pocket limits set for 2014 are $6350 for an individual policy and $12,799 for a family policy.

Some insurers offer plans in some states with lower out-of-pocket limits. However, the out-of-pocket limit does not apply to non-covered drugs or treatment centers.

Drug coverage

When analyzing drug coverage, the authors decided to look at 3 drugs used to treat chronic myeloid leukemia—imatinib (Gleevec), nilotinib (Tasigna), and dasatinib (Sprycel)—and 5 drugs used to treat multiple myeloma—thalidomide (Thalomid), lenalidomide (Revlimid), pomalidomide (Pomalyst), cyclophosphamide (Cytoxan), and melphalan (Alkeran).

Most of the insurers require prior authorization for these drugs, but most of them cover all 3 chronic myeloid leukemia drugs and a majority of the myeloma drugs. Pomalyst and Cytoxan are often not covered, although most insurers do cover generic cyclophosphamide.

Network adequacy

Most of the insurers studied do not cover all NCI-designated cancer and transplant centers, and a few do not cover any of these centers. The authors said this could discourage patient enrollment in these plans or mean that a patient’s recommended treatment is not covered.

And since it is unlikely that any out-of-network expenses will count toward a patient’s out-of-pocket maximum, cancer patients could accumulate thousands of dollars of medical expenses and never reach their out-of-pocket maximum.

The authors did note, however, that satisfactory cancer care can be provided outside of NCI-designated cancer and transplant centers.

For more details, see the full report.

Prescription drugs

Credit: CDC

A new report suggests that many health plans in the insurance exchanges mandated by the Affordable Care Act (ACA) will impose high out-of-pocket costs for patients with hematologic malignancies and provide limited access to specialty treatment centers.

Furthermore, although the plans analyzed appear to provide adequate coverage of hematology/oncology drugs, most require prior authorization.

In other words, the insurer must be notified and may not approve the purchase of a drug based on medical evidence or other criteria.

This report, “2014 Individual Exchange Policies in Four States: An Early Look for Patients with Blood Cancers,” was commissioned by the Leukemia & Lymphoma Society and prepared by Milliman, Inc.

It provides a look at the 2014 individual benefit designs, coverage benefits, and premiums for policies sold on 4 state health insurance exchanges—California, New York, Florida, and Texas—with a focus on items of interest for patients with hematologic malignancies.

“[W]hile many new rules under ACA make obtaining insurance easier for people with blood cancers, such as prohibiting companies from turning away patients with pre-existing conditions and eliminating lifetime coverage limitations, the Milliman report identifies several areas of concern that we want cancer patients to be aware of and policymakers to address,” said Mark Velleca, MD, PhD, chief policy and advocacy officer of the Leukemia & Lymphoma Society.

Premium costs

To compare monthly premium rates, the report’s authors captured rates for a 50-year-old non-smoker with an annual income of $90,000 residing in Houston, Los Angeles, Miami, or New York City.

They found considerable variation according to plan type and location, but overall, plans were cheapest in Houston. Monthly premiums for Houston ranged from $234 to $520. The range was $274 to $566 for Los Angeles, $277 to $635 for Miami, and $307 to $896 for New York.

The ranges reflect the costs according to plan type. Each insurer offers 4 different health plans: Platinum (about 10% cost-sharing), Gold (roughly 20%), Silver (roughly 30%), and Bronze (roughly 40%).

Cost-sharing

The authors noted that the lower-tier Bronze and Silver plans require significant cost-sharing for patients. The report revealed high deductibles in the health plans, sometimes nearly as high as the out-of-pocket ceiling.

Deductibles for the Silver and Bronze plans are often at least $2000 and $4000, respectively, for individuals. The maximum out-of-pocket limits set for 2014 are $6350 for an individual policy and $12,799 for a family policy.

Some insurers offer plans in some states with lower out-of-pocket limits. However, the out-of-pocket limit does not apply to non-covered drugs or treatment centers.

Drug coverage

When analyzing drug coverage, the authors decided to look at 3 drugs used to treat chronic myeloid leukemia—imatinib (Gleevec), nilotinib (Tasigna), and dasatinib (Sprycel)—and 5 drugs used to treat multiple myeloma—thalidomide (Thalomid), lenalidomide (Revlimid), pomalidomide (Pomalyst), cyclophosphamide (Cytoxan), and melphalan (Alkeran).

Most of the insurers require prior authorization for these drugs, but most of them cover all 3 chronic myeloid leukemia drugs and a majority of the myeloma drugs. Pomalyst and Cytoxan are often not covered, although most insurers do cover generic cyclophosphamide.

Network adequacy

Most of the insurers studied do not cover all NCI-designated cancer and transplant centers, and a few do not cover any of these centers. The authors said this could discourage patient enrollment in these plans or mean that a patient’s recommended treatment is not covered.

And since it is unlikely that any out-of-network expenses will count toward a patient’s out-of-pocket maximum, cancer patients could accumulate thousands of dollars of medical expenses and never reach their out-of-pocket maximum.

The authors did note, however, that satisfactory cancer care can be provided outside of NCI-designated cancer and transplant centers.

For more details, see the full report.

A lot of mythology regarding the new Health Insurance Portability and Accountability Act rules (which I discussed in detail a few months ago) continues to circulate. One of the biggest myths is that e-mail communication with patients is now forbidden, so let’s debunk that one right now.

Here is a statement lifted verbatim from the official HIPAA web site (FAQ section):

"Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.

"If the provider feels the patient may not be aware of the possible risks of using unencrypted e-mail, or has concerns about potential liability, the provider can alert the patient of those risks, and let the patient decide whether to continue e-mail communications."

Okay, so it’s permissible – but is it a good idea? Aside from the obvious privacy issues, many physicians balk at taking on one more unreimbursed demand on their time. While no one denies that these concerns are real, there also are real benefits to be gained from properly managed online communication – among them increased practice efficiency, and increased quality of care and satisfaction for patients.

I started giving one of my e-mail addresses to selected patients several years ago as an experiment, hoping to take some pressure off of our overloaded telephone system. The patients were grateful for simplified and more direct access, and I appreciated the decrease in phone messages and interruptions while I was seeing patients. I also noticed a decrease in those frustrating, unnecessary office visits – you know, "The rash is completely gone, but you told me to come back ..."

In general, I have found that the advantages for everyone involved (not least my nurses and receptionists) far outweigh the problems. And now, newer technologies such as encryption, web-based messaging, and integrated online communication should go a long way toward assuaging privacy concerns.

Encryption software is now inexpensive, readily available, and easily added to most e-mail systems. Packages are available from companies such as EMC, Hilgraeve, Kryptiq, Proofpoint, Axway, and ZixCorp, among many others. (As always, I have no financial interest in any company mentioned in this column.)

Rather than simply encrypting their e-mail, increasing numbers of physicians are opting for the route taken by most online banking and shopping sites: a secure website. Patients sign onto it and send a message to your office. Physicians or staffers are notified in their regular e-mail of messages on the website, and then they post a reply to the patient on the site that can only be accessed by the patient. The patient is notified of the practice’s reply in his or her regular e-mail. Web-based messaging services can be incorporated into existing practice sites or can stand on their own. Medfusion, MyDocOnline, and RelayHealth are among the many vendors that offer secure cloud-based messaging services.

A big advantage of using such a service is that you’re partnering with a vendor who has to stay on top of HIPAA and other privacy requirements. Another is the option of using electronic forms, or templates. Templates ensure that patients’ messages include the information needed to process prescription refill requests, or to adequately describe their problems and provide some clinical assessment data for the physician or nurse. They also can be designed to triage messages to the front- and back-office staff, so that time is not wasted bouncing messages around the office until the proper responder is found.

Many electronic health record systems now allow you to integrate a web-based messaging system. Advantages here include the ability to view the patient’s medical record from home or anywhere else before answering the communication, and the fact that all messages automatically become a part of the patient’s record. Electronic health record vendors that provide this type of system include Allscripts, CompuGroup Medical, Cerner, Epic, GE Medical Systems, NextGen, McKesson, and Siemens.

As with any cloud-based service, insist on multiple layers of security, uninterruptible power sources, instant switchover to backup hardware in the event of a crash, and frequent, reliable backups.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is a clinical associate professor of dermatology at Seton Hall University School of Graduate Medical Education in South Orange, N.J. Dr. Eastern is a two-time past president of the Dermatological Society of New Jersey, and currently serves on its executive board. He holds teaching positions at several hospitals and has delivered more than 500 academic speaking presentations. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Skin & Allergy News.

A lot of mythology regarding the new Health Insurance Portability and Accountability Act rules (which I discussed in detail a few months ago) continues to circulate. One of the biggest myths is that e-mail communication with patients is now forbidden, so let’s debunk that one right now.

Here is a statement lifted verbatim from the official HIPAA web site (FAQ section):

"Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.

"If the provider feels the patient may not be aware of the possible risks of using unencrypted e-mail, or has concerns about potential liability, the provider can alert the patient of those risks, and let the patient decide whether to continue e-mail communications."

Okay, so it’s permissible – but is it a good idea? Aside from the obvious privacy issues, many physicians balk at taking on one more unreimbursed demand on their time. While no one denies that these concerns are real, there also are real benefits to be gained from properly managed online communication – among them increased practice efficiency, and increased quality of care and satisfaction for patients.

I started giving one of my e-mail addresses to selected patients several years ago as an experiment, hoping to take some pressure off of our overloaded telephone system. The patients were grateful for simplified and more direct access, and I appreciated the decrease in phone messages and interruptions while I was seeing patients. I also noticed a decrease in those frustrating, unnecessary office visits – you know, "The rash is completely gone, but you told me to come back ..."

In general, I have found that the advantages for everyone involved (not least my nurses and receptionists) far outweigh the problems. And now, newer technologies such as encryption, web-based messaging, and integrated online communication should go a long way toward assuaging privacy concerns.

Encryption software is now inexpensive, readily available, and easily added to most e-mail systems. Packages are available from companies such as EMC, Hilgraeve, Kryptiq, Proofpoint, Axway, and ZixCorp, among many others. (As always, I have no financial interest in any company mentioned in this column.)

Rather than simply encrypting their e-mail, increasing numbers of physicians are opting for the route taken by most online banking and shopping sites: a secure website. Patients sign onto it and send a message to your office. Physicians or staffers are notified in their regular e-mail of messages on the website, and then they post a reply to the patient on the site that can only be accessed by the patient. The patient is notified of the practice’s reply in his or her regular e-mail. Web-based messaging services can be incorporated into existing practice sites or can stand on their own. Medfusion, MyDocOnline, and RelayHealth are among the many vendors that offer secure cloud-based messaging services.

A big advantage of using such a service is that you’re partnering with a vendor who has to stay on top of HIPAA and other privacy requirements. Another is the option of using electronic forms, or templates. Templates ensure that patients’ messages include the information needed to process prescription refill requests, or to adequately describe their problems and provide some clinical assessment data for the physician or nurse. They also can be designed to triage messages to the front- and back-office staff, so that time is not wasted bouncing messages around the office until the proper responder is found.

Many electronic health record systems now allow you to integrate a web-based messaging system. Advantages here include the ability to view the patient’s medical record from home or anywhere else before answering the communication, and the fact that all messages automatically become a part of the patient’s record. Electronic health record vendors that provide this type of system include Allscripts, CompuGroup Medical, Cerner, Epic, GE Medical Systems, NextGen, McKesson, and Siemens.

As with any cloud-based service, insist on multiple layers of security, uninterruptible power sources, instant switchover to backup hardware in the event of a crash, and frequent, reliable backups.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is a clinical associate professor of dermatology at Seton Hall University School of Graduate Medical Education in South Orange, N.J. Dr. Eastern is a two-time past president of the Dermatological Society of New Jersey, and currently serves on its executive board. He holds teaching positions at several hospitals and has delivered more than 500 academic speaking presentations. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Skin & Allergy News.

A lot of mythology regarding the new Health Insurance Portability and Accountability Act rules (which I discussed in detail a few months ago) continues to circulate. One of the biggest myths is that e-mail communication with patients is now forbidden, so let’s debunk that one right now.

Here is a statement lifted verbatim from the official HIPAA web site (FAQ section):

"Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.

"If the provider feels the patient may not be aware of the possible risks of using unencrypted e-mail, or has concerns about potential liability, the provider can alert the patient of those risks, and let the patient decide whether to continue e-mail communications."

Okay, so it’s permissible – but is it a good idea? Aside from the obvious privacy issues, many physicians balk at taking on one more unreimbursed demand on their time. While no one denies that these concerns are real, there also are real benefits to be gained from properly managed online communication – among them increased practice efficiency, and increased quality of care and satisfaction for patients.

I started giving one of my e-mail addresses to selected patients several years ago as an experiment, hoping to take some pressure off of our overloaded telephone system. The patients were grateful for simplified and more direct access, and I appreciated the decrease in phone messages and interruptions while I was seeing patients. I also noticed a decrease in those frustrating, unnecessary office visits – you know, "The rash is completely gone, but you told me to come back ..."

In general, I have found that the advantages for everyone involved (not least my nurses and receptionists) far outweigh the problems. And now, newer technologies such as encryption, web-based messaging, and integrated online communication should go a long way toward assuaging privacy concerns.

Encryption software is now inexpensive, readily available, and easily added to most e-mail systems. Packages are available from companies such as EMC, Hilgraeve, Kryptiq, Proofpoint, Axway, and ZixCorp, among many others. (As always, I have no financial interest in any company mentioned in this column.)

Rather than simply encrypting their e-mail, increasing numbers of physicians are opting for the route taken by most online banking and shopping sites: a secure website. Patients sign onto it and send a message to your office. Physicians or staffers are notified in their regular e-mail of messages on the website, and then they post a reply to the patient on the site that can only be accessed by the patient. The patient is notified of the practice’s reply in his or her regular e-mail. Web-based messaging services can be incorporated into existing practice sites or can stand on their own. Medfusion, MyDocOnline, and RelayHealth are among the many vendors that offer secure cloud-based messaging services.

A big advantage of using such a service is that you’re partnering with a vendor who has to stay on top of HIPAA and other privacy requirements. Another is the option of using electronic forms, or templates. Templates ensure that patients’ messages include the information needed to process prescription refill requests, or to adequately describe their problems and provide some clinical assessment data for the physician or nurse. They also can be designed to triage messages to the front- and back-office staff, so that time is not wasted bouncing messages around the office until the proper responder is found.

Many electronic health record systems now allow you to integrate a web-based messaging system. Advantages here include the ability to view the patient’s medical record from home or anywhere else before answering the communication, and the fact that all messages automatically become a part of the patient’s record. Electronic health record vendors that provide this type of system include Allscripts, CompuGroup Medical, Cerner, Epic, GE Medical Systems, NextGen, McKesson, and Siemens.

As with any cloud-based service, insist on multiple layers of security, uninterruptible power sources, instant switchover to backup hardware in the event of a crash, and frequent, reliable backups.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is a clinical associate professor of dermatology at Seton Hall University School of Graduate Medical Education in South Orange, N.J. Dr. Eastern is a two-time past president of the Dermatological Society of New Jersey, and currently serves on its executive board. He holds teaching positions at several hospitals and has delivered more than 500 academic speaking presentations. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Skin & Allergy News.

Hodgkin lymphoma

Cytotoxic T lymphocytes (CTLs) targeting Epstein-Barr virus (EBV) proteins appear to be a promising treatment option for patients with aggressive lymphomas.

Researchers tested the autologous CTLs in a cohort of 50 patients with Hodgkin or non-Hodgkin lymphoma.

The treatment produced responses in about 62% of patients with relapsed or refractory disease.

And it sustained remissions in roughly 93% of patients who were at a high risk of relapse.

Catherine Bollard, MD, of the Children’s National Medical Center in Washington, DC, and her colleagues reported these results in the Journal of Clinical Oncology.

The investigators noted that about 40% of lymphoma patients have tumor cells expressing the type II latency EBV antigens latent membrane protein 1 (LMP1) and LMP2. But T cells specific for these antigens are present in low numbers and may not “recognize” the tumors they should attack.

So Dr Bollard and her colleagues decided to test the effects of infusing LMP-directed CTLs into 50 patients with EBV-positive lymphomas.

The researchers used adenoviral vector-transduced dendritic cells and EBV-transformed B–lymphoblastoid cell lines as antigen-presenting cells to activate and expand LMP-specific T cells.

For some patients, the team used an adenoviral vector encoding the LMP2 antigen alone (n=17). And for others, they used a vector encoding both LMP1 and LMP2 (n=33).

Twenty-nine of the patients were in remission when they received CTL infusions, but they were at a high risk of relapse. The remaining 21 patients had relapsed or refractory disease at the time of CTL infusion.

Twenty-seven of the 29 patients who received CTLs as an adjuvant treatment remained in remission from their disease at 3.1 years after treatment.

However, the 2-year event-free survival rate was 82% for this group of patients. None of them died of lymphoma, but 9 died from complications associated with the chemotherapy and radiation they had received.

“That’s why this research is important,” Dr Bollard said. “Patients with lymphomas traditionally have a good cure rate with chemotherapy and radiation. What kills them is the side effects of those treatments—second cancers, lung, and heart disease.”

Of the 21 patients with relapsed or refractory disease, 13 responded to CTL infusions. And 11 patients achieved a complete response.

In this group, the 2-year event-free survival rate was about 50%, regardless of whether patients received CTLs directed against LMP1/2 or LMP2 alone.

The investigators found that responses were associated with effector and central memory LMP1-specific CTLs but not with the patient’s type of lymphoma or lymphopenic status.

Even those patients with limited in vivo expansion of LMP-directed CTLs achieved complete responses. And this effect was associated with epitope spreading.

“This is a targeted therapeutic approach that we hope can be used early in the disease to treat relapse,” Dr Bollard said. “We saw good outcomes here. Eventually, it could be a front-line therapy.”

The researchers noted that the difficulty of tailoring CTLs for each patient has been cited as a barrier to this type of treatment. But currently available treatments can be expensive and induce severe side effects that require hospitalization.

“Although we spend some time making the cells, patients go home with few side effects and few associated hospital costs,” said study author Cliona Rooney, PhD, of the Baylor College of Medicine in Houston, Texas. “It can be less costly than chemotherapy.”

In this study, the investigators did not see any toxicities attributable to CTL infusion. One patient did have CNS deterioration 2 weeks after infusion, but this was attributed to disease progression.

And another patient developed respiratory complications about 4 weeks after a second CTL infusion. But this was attributed to an intercurrent infection, and the patient made a complete recovery.

Hodgkin lymphoma

Cytotoxic T lymphocytes (CTLs) targeting Epstein-Barr virus (EBV) proteins appear to be a promising treatment option for patients with aggressive lymphomas.

Researchers tested the autologous CTLs in a cohort of 50 patients with Hodgkin or non-Hodgkin lymphoma.

The treatment produced responses in about 62% of patients with relapsed or refractory disease.

And it sustained remissions in roughly 93% of patients who were at a high risk of relapse.

Catherine Bollard, MD, of the Children’s National Medical Center in Washington, DC, and her colleagues reported these results in the Journal of Clinical Oncology.

The investigators noted that about 40% of lymphoma patients have tumor cells expressing the type II latency EBV antigens latent membrane protein 1 (LMP1) and LMP2. But T cells specific for these antigens are present in low numbers and may not “recognize” the tumors they should attack.

So Dr Bollard and her colleagues decided to test the effects of infusing LMP-directed CTLs into 50 patients with EBV-positive lymphomas.

The researchers used adenoviral vector-transduced dendritic cells and EBV-transformed B–lymphoblastoid cell lines as antigen-presenting cells to activate and expand LMP-specific T cells.

For some patients, the team used an adenoviral vector encoding the LMP2 antigen alone (n=17). And for others, they used a vector encoding both LMP1 and LMP2 (n=33).

Twenty-nine of the patients were in remission when they received CTL infusions, but they were at a high risk of relapse. The remaining 21 patients had relapsed or refractory disease at the time of CTL infusion.

Twenty-seven of the 29 patients who received CTLs as an adjuvant treatment remained in remission from their disease at 3.1 years after treatment.

However, the 2-year event-free survival rate was 82% for this group of patients. None of them died of lymphoma, but 9 died from complications associated with the chemotherapy and radiation they had received.

“That’s why this research is important,” Dr Bollard said. “Patients with lymphomas traditionally have a good cure rate with chemotherapy and radiation. What kills them is the side effects of those treatments—second cancers, lung, and heart disease.”

Of the 21 patients with relapsed or refractory disease, 13 responded to CTL infusions. And 11 patients achieved a complete response.

In this group, the 2-year event-free survival rate was about 50%, regardless of whether patients received CTLs directed against LMP1/2 or LMP2 alone.

The investigators found that responses were associated with effector and central memory LMP1-specific CTLs but not with the patient’s type of lymphoma or lymphopenic status.

Even those patients with limited in vivo expansion of LMP-directed CTLs achieved complete responses. And this effect was associated with epitope spreading.

“This is a targeted therapeutic approach that we hope can be used early in the disease to treat relapse,” Dr Bollard said. “We saw good outcomes here. Eventually, it could be a front-line therapy.”

The researchers noted that the difficulty of tailoring CTLs for each patient has been cited as a barrier to this type of treatment. But currently available treatments can be expensive and induce severe side effects that require hospitalization.

“Although we spend some time making the cells, patients go home with few side effects and few associated hospital costs,” said study author Cliona Rooney, PhD, of the Baylor College of Medicine in Houston, Texas. “It can be less costly than chemotherapy.”

In this study, the investigators did not see any toxicities attributable to CTL infusion. One patient did have CNS deterioration 2 weeks after infusion, but this was attributed to disease progression.

And another patient developed respiratory complications about 4 weeks after a second CTL infusion. But this was attributed to an intercurrent infection, and the patient made a complete recovery.

Hodgkin lymphoma

Cytotoxic T lymphocytes (CTLs) targeting Epstein-Barr virus (EBV) proteins appear to be a promising treatment option for patients with aggressive lymphomas.

Researchers tested the autologous CTLs in a cohort of 50 patients with Hodgkin or non-Hodgkin lymphoma.

The treatment produced responses in about 62% of patients with relapsed or refractory disease.

And it sustained remissions in roughly 93% of patients who were at a high risk of relapse.

Catherine Bollard, MD, of the Children’s National Medical Center in Washington, DC, and her colleagues reported these results in the Journal of Clinical Oncology.

The investigators noted that about 40% of lymphoma patients have tumor cells expressing the type II latency EBV antigens latent membrane protein 1 (LMP1) and LMP2. But T cells specific for these antigens are present in low numbers and may not “recognize” the tumors they should attack.

So Dr Bollard and her colleagues decided to test the effects of infusing LMP-directed CTLs into 50 patients with EBV-positive lymphomas.

The researchers used adenoviral vector-transduced dendritic cells and EBV-transformed B–lymphoblastoid cell lines as antigen-presenting cells to activate and expand LMP-specific T cells.

For some patients, the team used an adenoviral vector encoding the LMP2 antigen alone (n=17). And for others, they used a vector encoding both LMP1 and LMP2 (n=33).

Twenty-nine of the patients were in remission when they received CTL infusions, but they were at a high risk of relapse. The remaining 21 patients had relapsed or refractory disease at the time of CTL infusion.

Twenty-seven of the 29 patients who received CTLs as an adjuvant treatment remained in remission from their disease at 3.1 years after treatment.

However, the 2-year event-free survival rate was 82% for this group of patients. None of them died of lymphoma, but 9 died from complications associated with the chemotherapy and radiation they had received.

“That’s why this research is important,” Dr Bollard said. “Patients with lymphomas traditionally have a good cure rate with chemotherapy and radiation. What kills them is the side effects of those treatments—second cancers, lung, and heart disease.”

Of the 21 patients with relapsed or refractory disease, 13 responded to CTL infusions. And 11 patients achieved a complete response.

In this group, the 2-year event-free survival rate was about 50%, regardless of whether patients received CTLs directed against LMP1/2 or LMP2 alone.

The investigators found that responses were associated with effector and central memory LMP1-specific CTLs but not with the patient’s type of lymphoma or lymphopenic status.

Even those patients with limited in vivo expansion of LMP-directed CTLs achieved complete responses. And this effect was associated with epitope spreading.

“This is a targeted therapeutic approach that we hope can be used early in the disease to treat relapse,” Dr Bollard said. “We saw good outcomes here. Eventually, it could be a front-line therapy.”

The researchers noted that the difficulty of tailoring CTLs for each patient has been cited as a barrier to this type of treatment. But currently available treatments can be expensive and induce severe side effects that require hospitalization.

“Although we spend some time making the cells, patients go home with few side effects and few associated hospital costs,” said study author Cliona Rooney, PhD, of the Baylor College of Medicine in Houston, Texas. “It can be less costly than chemotherapy.”

In this study, the investigators did not see any toxicities attributable to CTL infusion. One patient did have CNS deterioration 2 weeks after infusion, but this was attributed to disease progression.

And another patient developed respiratory complications about 4 weeks after a second CTL infusion. But this was attributed to an intercurrent infection, and the patient made a complete recovery.