Sharon Worcester

SAN ANTONIO – Consumption of sugar-sweetened beverages was nearly eliminated among overweight and obese adolescents following a 1-year intervention involving biweekly home delivery of noncaloric beverages, and the increase in body mass index at 1 year was smaller among those adolescents than among controls.

The between-group differences for changes in body mass index and weight among the 224 participants randomized to the intervention group or to a control group were statistically significant at 1 year (–0.57 and –1.9 kg, respectively), Cara B. Ebbeling, Ph.D., reported at the annual meeting of the Obesity Society.

JJAVA/Fotolia.com

The difference between the groups with respect to the primary outcome measure of change in mean BMI at 2 years did not reach statistical significance, but this finding may reflect increasing consumption of sugar-sweetened beverages in the intervention group after 1 year, decreasing intake in the control group at 1 year (perhaps due to "a secular trend resulting from efforts to eliminate these beverages from schools"), or both, said Dr. Ebbeling of Boston Children’s Hospital.

Her presentation of the findings coincided with their publication online in the Sept. 21 issue of the New England Journal of Medicine (N. Engl. J. Med. 2012 Sept. 21 [doi: 10.1056/NEJMoa1203388]).

Study participants were 9th- and 10th-grade students with an average age of 15 years and a BMI at or above the 85th percentile for sex and age (average BMI of 30). The 124 boys and 100 girls in the study had similar baseline levels of reported consumption of sugar-sweetened beverages (1.7 servings per day). Those in the experimental group received home delivery of bottled water and diet beverages every 2 weeks, and had three 20-minute check-in visits for assessment of results. Additionally, parents of the participants agreed to monthly 30-minute motivational phone calls aimed at encouraging role-modeling and removing sugar-sweetened beverages from the home, and intervention messages with instructions to drink the delivered beverages – and to not buy or drink sugar-sweetened beverages – were mailed to participants.

Control group participants received $50 supermarket gift cards at 4 and 8 months as a retention strategy, but were not instructed on what to purchase with the cards, Dr. Ebbeling said.

At 1-year follow-up, consumption of sugar-sweetened beverages in the experimental group declined to almost zero, and remained significantly lower than in the control group at 2 years, she noted.

The consumption of unsweetened beverages was significantly higher in the intervention group than in the control group at 2 years.

The investigators also found that Hispanic ethnic group was a significant effect modifier for between-group differences in the change in BMI.

"Among Hispanics, there were significant intervention effects on the change in BMI at 1 year (–1.79) and at 2 years (–2.35) and on the change in body weight at 1 year (–6.4 kg) and at 2 years (–8.8kg)," they wrote, noting that the findings, which were corroborated by a reanalysis of data from a prior 19-month prospective observational study involving 548 middle school students, should nonetheless be interpreted with caution given the small size of the Hispanic subgroup of study participants.

Strengths of the current study include a focus on a single dietary behavior in the home environment, a diverse sample, excellent retention rates of 97% at 1 year and 93% at 2 years, collection of data on dietary process measures, and assessment of physical activity and television screen time. Limitations include a small sample size relative to multisite studies and reliance on self-reporting of diet and activity information, but given that nationally representative data suggest that overweight and obese adolescents obtain about 15% of their total daily energy intake – about 300 kcal per day – from sugar-sweetened beverages, the findings, especially when considered in the context of prior studies in other age groups, provide support for public health guidelines that recommend limiting consumption of sugar-sweetened beverages, Dr. Ebbeling and her colleagues concluded.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, the Harvard Catalyst Clinical and Translational Science Center, and the New Balance Foundation. The observational study reanalyzed by the investigators was funded by the National Institute of Child Health and Human Development, the Centers for Disease Control and Prevention, and the Robert Wood Johnson Foundation. Author disclosures are available with the full text of the article at www.nejm.org.

SAN ANTONIO – Consumption of sugar-sweetened beverages was nearly eliminated among overweight and obese adolescents following a 1-year intervention involving biweekly home delivery of noncaloric beverages, and the increase in body mass index at 1 year was smaller among those adolescents than among controls.

The between-group differences for changes in body mass index and weight among the 224 participants randomized to the intervention group or to a control group were statistically significant at 1 year (–0.57 and –1.9 kg, respectively), Cara B. Ebbeling, Ph.D., reported at the annual meeting of the Obesity Society.

JJAVA/Fotolia.com

The difference between the groups with respect to the primary outcome measure of change in mean BMI at 2 years did not reach statistical significance, but this finding may reflect increasing consumption of sugar-sweetened beverages in the intervention group after 1 year, decreasing intake in the control group at 1 year (perhaps due to "a secular trend resulting from efforts to eliminate these beverages from schools"), or both, said Dr. Ebbeling of Boston Children’s Hospital.

Her presentation of the findings coincided with their publication online in the Sept. 21 issue of the New England Journal of Medicine (N. Engl. J. Med. 2012 Sept. 21 [doi: 10.1056/NEJMoa1203388]).

Study participants were 9th- and 10th-grade students with an average age of 15 years and a BMI at or above the 85th percentile for sex and age (average BMI of 30). The 124 boys and 100 girls in the study had similar baseline levels of reported consumption of sugar-sweetened beverages (1.7 servings per day). Those in the experimental group received home delivery of bottled water and diet beverages every 2 weeks, and had three 20-minute check-in visits for assessment of results. Additionally, parents of the participants agreed to monthly 30-minute motivational phone calls aimed at encouraging role-modeling and removing sugar-sweetened beverages from the home, and intervention messages with instructions to drink the delivered beverages – and to not buy or drink sugar-sweetened beverages – were mailed to participants.

Control group participants received $50 supermarket gift cards at 4 and 8 months as a retention strategy, but were not instructed on what to purchase with the cards, Dr. Ebbeling said.

At 1-year follow-up, consumption of sugar-sweetened beverages in the experimental group declined to almost zero, and remained significantly lower than in the control group at 2 years, she noted.

The consumption of unsweetened beverages was significantly higher in the intervention group than in the control group at 2 years.

The investigators also found that Hispanic ethnic group was a significant effect modifier for between-group differences in the change in BMI.

"Among Hispanics, there were significant intervention effects on the change in BMI at 1 year (–1.79) and at 2 years (–2.35) and on the change in body weight at 1 year (–6.4 kg) and at 2 years (–8.8kg)," they wrote, noting that the findings, which were corroborated by a reanalysis of data from a prior 19-month prospective observational study involving 548 middle school students, should nonetheless be interpreted with caution given the small size of the Hispanic subgroup of study participants.

Strengths of the current study include a focus on a single dietary behavior in the home environment, a diverse sample, excellent retention rates of 97% at 1 year and 93% at 2 years, collection of data on dietary process measures, and assessment of physical activity and television screen time. Limitations include a small sample size relative to multisite studies and reliance on self-reporting of diet and activity information, but given that nationally representative data suggest that overweight and obese adolescents obtain about 15% of their total daily energy intake – about 300 kcal per day – from sugar-sweetened beverages, the findings, especially when considered in the context of prior studies in other age groups, provide support for public health guidelines that recommend limiting consumption of sugar-sweetened beverages, Dr. Ebbeling and her colleagues concluded.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, the Harvard Catalyst Clinical and Translational Science Center, and the New Balance Foundation. The observational study reanalyzed by the investigators was funded by the National Institute of Child Health and Human Development, the Centers for Disease Control and Prevention, and the Robert Wood Johnson Foundation. Author disclosures are available with the full text of the article at www.nejm.org.

SAN ANTONIO – Consumption of sugar-sweetened beverages was nearly eliminated among overweight and obese adolescents following a 1-year intervention involving biweekly home delivery of noncaloric beverages, and the increase in body mass index at 1 year was smaller among those adolescents than among controls.

The between-group differences for changes in body mass index and weight among the 224 participants randomized to the intervention group or to a control group were statistically significant at 1 year (–0.57 and –1.9 kg, respectively), Cara B. Ebbeling, Ph.D., reported at the annual meeting of the Obesity Society.

JJAVA/Fotolia.com

The difference between the groups with respect to the primary outcome measure of change in mean BMI at 2 years did not reach statistical significance, but this finding may reflect increasing consumption of sugar-sweetened beverages in the intervention group after 1 year, decreasing intake in the control group at 1 year (perhaps due to "a secular trend resulting from efforts to eliminate these beverages from schools"), or both, said Dr. Ebbeling of Boston Children’s Hospital.

Her presentation of the findings coincided with their publication online in the Sept. 21 issue of the New England Journal of Medicine (N. Engl. J. Med. 2012 Sept. 21 [doi: 10.1056/NEJMoa1203388]).

Study participants were 9th- and 10th-grade students with an average age of 15 years and a BMI at or above the 85th percentile for sex and age (average BMI of 30). The 124 boys and 100 girls in the study had similar baseline levels of reported consumption of sugar-sweetened beverages (1.7 servings per day). Those in the experimental group received home delivery of bottled water and diet beverages every 2 weeks, and had three 20-minute check-in visits for assessment of results. Additionally, parents of the participants agreed to monthly 30-minute motivational phone calls aimed at encouraging role-modeling and removing sugar-sweetened beverages from the home, and intervention messages with instructions to drink the delivered beverages – and to not buy or drink sugar-sweetened beverages – were mailed to participants.

Control group participants received $50 supermarket gift cards at 4 and 8 months as a retention strategy, but were not instructed on what to purchase with the cards, Dr. Ebbeling said.

At 1-year follow-up, consumption of sugar-sweetened beverages in the experimental group declined to almost zero, and remained significantly lower than in the control group at 2 years, she noted.

The consumption of unsweetened beverages was significantly higher in the intervention group than in the control group at 2 years.

The investigators also found that Hispanic ethnic group was a significant effect modifier for between-group differences in the change in BMI.

"Among Hispanics, there were significant intervention effects on the change in BMI at 1 year (–1.79) and at 2 years (–2.35) and on the change in body weight at 1 year (–6.4 kg) and at 2 years (–8.8kg)," they wrote, noting that the findings, which were corroborated by a reanalysis of data from a prior 19-month prospective observational study involving 548 middle school students, should nonetheless be interpreted with caution given the small size of the Hispanic subgroup of study participants.

Strengths of the current study include a focus on a single dietary behavior in the home environment, a diverse sample, excellent retention rates of 97% at 1 year and 93% at 2 years, collection of data on dietary process measures, and assessment of physical activity and television screen time. Limitations include a small sample size relative to multisite studies and reliance on self-reporting of diet and activity information, but given that nationally representative data suggest that overweight and obese adolescents obtain about 15% of their total daily energy intake – about 300 kcal per day – from sugar-sweetened beverages, the findings, especially when considered in the context of prior studies in other age groups, provide support for public health guidelines that recommend limiting consumption of sugar-sweetened beverages, Dr. Ebbeling and her colleagues concluded.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Research Resources, the Harvard Catalyst Clinical and Translational Science Center, and the New Balance Foundation. The observational study reanalyzed by the investigators was funded by the National Institute of Child Health and Human Development, the Centers for Disease Control and Prevention, and the Robert Wood Johnson Foundation. Author disclosures are available with the full text of the article at www.nejm.org.

Recent negative events and recent nonsuicidal self-injurious behavior are the strongest predictors of suicide-related behaviors among patients undergoing treatment for first-episode psychosis, an Australian study of 72 patients and 108 matched controls has shown.

The findings have important implications for the management of first-episode psychosis patients, and suggest a need for psychosocial interventions that could help reduce the high rates of suicide attempts and suicides in this population, Izabela E. Fedyszyn, a doctoral candidate at La Trobe University, Victoria, Australia, and her colleagues reported in the September issue of Schizophrenia Research.

About 12% of patients attempt suicide within 2 years of treatment for first-episode psychosis, and about 25% of those make multiple suicide attempts; about 1.5% of first-episode patients die from suicide within 18 months of presenting to psychiatric services. However, little is known about recent risk factors for these behaviors or about the relative importance of baseline, past, and recent variables to the prediction of suicide-related acts, the investigators said.

To determine the predictive power of these variables and to identify the most influential recent factors that could be targeted for intervention, the investigators performed a case-control study of 180 patients, aged 15-24 years, and found that having experienced negative events in the prior 3 months increased the likelihood of suicide-related behaviors nearly twofold, and having engaged in nonsuicidal self-injurious behaviors in the prior 3 months increased the likelihood by 73 times (Schizophr. Res. 2012;140:17-24).

The investigators noted, however, that the confidence interval for the latter finding is quite wide because of a small number of controls displaying nonsuicidal self-harm.

Other factors initially found to be associated with suicide-related behaviors included baseline depressive symptoms, baseline suicidal ideation/intent, past negative events, past nonsuicidal self-injurious behaviors, and recent depressive symptoms. However, in a hierarchical logistic regression model, only recent negative events and recent self-injurious behavior remained significant predictors of suicidal behavior (adjusted odds ratios, 1.90 and 72.96).

The association between nonsuicidal self-injurious behaviors and suicide-related behaviors within 3 months remained significant after the investigators controlled for the 10.6% of the study population with comorbid bipolar disorder, a subset of the study population that was significantly more likely than those without bipolar disorder to engage in suicide-related behaviors during treatment.

The final model, which took into account baseline, past, and recent characteristics of patients, correctly classified 75.5% of cases and 89.2% of controls with respect to suicide attempt status, the investigators said, noting that the findings suggest steps could be taken to prevent suicidal behaviors in these patients.

Targeting nonsuicidal self-injurious behavior could help reduce the incidence of suicidal behaviors, as could placing greater emphasis on psychosocial interventions to improve coping mechanisms among those with recent negative life events.

"A previous investigation of the characteristics of suicide attempts in first-episode patients indicated that interpersonal issues were the most common antecedents. Extending individuals’ range of coping skills, such as interpersonal effectiveness, affect regulation, stress management, and problem solving, could strengthen protective processes and reduce the rates of suicide-related acts," the investigators wrote.

Data for this study were obtained from an audit of medical records for patients treated between December 2002 and November 2005 at the Early Psychosis Prevention and Intervention Center in Melbourne. Cases were patients who had made at least one suicide attempt; controls were randomly selected patients who had not made a suicide attempt.

Though limited by factors such as the retrospective design and missing data in some cases, this study involved a multidiagnostic sample selected from an epidemiologically representative cohort of first-episode psychosis patients and a retrospective field audit methodology that avoided potential response biases. Another strength was the use of staged data analysis, enabling a range of variables to be examined without diminishing the power of the final model, the investigators noted.

"Given the role of recent negative events and nonsuicidal self-injurious behavior in increasing the likelihood of suicide-related behaviors, incorporating psychosocial interventions addressing affect regulation, interpersonal effectiveness, stress management and problem-solving skills, alongside case management and pharmacotherapy, may help to reduce the prevalence of suicide attempts and suicide in this population," they wrote.

The investigators reported having no relevant financial conflicts.

Recent negative events and recent nonsuicidal self-injurious behavior are the strongest predictors of suicide-related behaviors among patients undergoing treatment for first-episode psychosis, an Australian study of 72 patients and 108 matched controls has shown.

The findings have important implications for the management of first-episode psychosis patients, and suggest a need for psychosocial interventions that could help reduce the high rates of suicide attempts and suicides in this population, Izabela E. Fedyszyn, a doctoral candidate at La Trobe University, Victoria, Australia, and her colleagues reported in the September issue of Schizophrenia Research.

About 12% of patients attempt suicide within 2 years of treatment for first-episode psychosis, and about 25% of those make multiple suicide attempts; about 1.5% of first-episode patients die from suicide within 18 months of presenting to psychiatric services. However, little is known about recent risk factors for these behaviors or about the relative importance of baseline, past, and recent variables to the prediction of suicide-related acts, the investigators said.

To determine the predictive power of these variables and to identify the most influential recent factors that could be targeted for intervention, the investigators performed a case-control study of 180 patients, aged 15-24 years, and found that having experienced negative events in the prior 3 months increased the likelihood of suicide-related behaviors nearly twofold, and having engaged in nonsuicidal self-injurious behaviors in the prior 3 months increased the likelihood by 73 times (Schizophr. Res. 2012;140:17-24).

The investigators noted, however, that the confidence interval for the latter finding is quite wide because of a small number of controls displaying nonsuicidal self-harm.

Other factors initially found to be associated with suicide-related behaviors included baseline depressive symptoms, baseline suicidal ideation/intent, past negative events, past nonsuicidal self-injurious behaviors, and recent depressive symptoms. However, in a hierarchical logistic regression model, only recent negative events and recent self-injurious behavior remained significant predictors of suicidal behavior (adjusted odds ratios, 1.90 and 72.96).

The association between nonsuicidal self-injurious behaviors and suicide-related behaviors within 3 months remained significant after the investigators controlled for the 10.6% of the study population with comorbid bipolar disorder, a subset of the study population that was significantly more likely than those without bipolar disorder to engage in suicide-related behaviors during treatment.

The final model, which took into account baseline, past, and recent characteristics of patients, correctly classified 75.5% of cases and 89.2% of controls with respect to suicide attempt status, the investigators said, noting that the findings suggest steps could be taken to prevent suicidal behaviors in these patients.

Targeting nonsuicidal self-injurious behavior could help reduce the incidence of suicidal behaviors, as could placing greater emphasis on psychosocial interventions to improve coping mechanisms among those with recent negative life events.

"A previous investigation of the characteristics of suicide attempts in first-episode patients indicated that interpersonal issues were the most common antecedents. Extending individuals’ range of coping skills, such as interpersonal effectiveness, affect regulation, stress management, and problem solving, could strengthen protective processes and reduce the rates of suicide-related acts," the investigators wrote.

Data for this study were obtained from an audit of medical records for patients treated between December 2002 and November 2005 at the Early Psychosis Prevention and Intervention Center in Melbourne. Cases were patients who had made at least one suicide attempt; controls were randomly selected patients who had not made a suicide attempt.

Though limited by factors such as the retrospective design and missing data in some cases, this study involved a multidiagnostic sample selected from an epidemiologically representative cohort of first-episode psychosis patients and a retrospective field audit methodology that avoided potential response biases. Another strength was the use of staged data analysis, enabling a range of variables to be examined without diminishing the power of the final model, the investigators noted.

"Given the role of recent negative events and nonsuicidal self-injurious behavior in increasing the likelihood of suicide-related behaviors, incorporating psychosocial interventions addressing affect regulation, interpersonal effectiveness, stress management and problem-solving skills, alongside case management and pharmacotherapy, may help to reduce the prevalence of suicide attempts and suicide in this population," they wrote.

The investigators reported having no relevant financial conflicts.

Recent negative events and recent nonsuicidal self-injurious behavior are the strongest predictors of suicide-related behaviors among patients undergoing treatment for first-episode psychosis, an Australian study of 72 patients and 108 matched controls has shown.

The findings have important implications for the management of first-episode psychosis patients, and suggest a need for psychosocial interventions that could help reduce the high rates of suicide attempts and suicides in this population, Izabela E. Fedyszyn, a doctoral candidate at La Trobe University, Victoria, Australia, and her colleagues reported in the September issue of Schizophrenia Research.

About 12% of patients attempt suicide within 2 years of treatment for first-episode psychosis, and about 25% of those make multiple suicide attempts; about 1.5% of first-episode patients die from suicide within 18 months of presenting to psychiatric services. However, little is known about recent risk factors for these behaviors or about the relative importance of baseline, past, and recent variables to the prediction of suicide-related acts, the investigators said.

To determine the predictive power of these variables and to identify the most influential recent factors that could be targeted for intervention, the investigators performed a case-control study of 180 patients, aged 15-24 years, and found that having experienced negative events in the prior 3 months increased the likelihood of suicide-related behaviors nearly twofold, and having engaged in nonsuicidal self-injurious behaviors in the prior 3 months increased the likelihood by 73 times (Schizophr. Res. 2012;140:17-24).

The investigators noted, however, that the confidence interval for the latter finding is quite wide because of a small number of controls displaying nonsuicidal self-harm.

Other factors initially found to be associated with suicide-related behaviors included baseline depressive symptoms, baseline suicidal ideation/intent, past negative events, past nonsuicidal self-injurious behaviors, and recent depressive symptoms. However, in a hierarchical logistic regression model, only recent negative events and recent self-injurious behavior remained significant predictors of suicidal behavior (adjusted odds ratios, 1.90 and 72.96).

The association between nonsuicidal self-injurious behaviors and suicide-related behaviors within 3 months remained significant after the investigators controlled for the 10.6% of the study population with comorbid bipolar disorder, a subset of the study population that was significantly more likely than those without bipolar disorder to engage in suicide-related behaviors during treatment.

The final model, which took into account baseline, past, and recent characteristics of patients, correctly classified 75.5% of cases and 89.2% of controls with respect to suicide attempt status, the investigators said, noting that the findings suggest steps could be taken to prevent suicidal behaviors in these patients.

Targeting nonsuicidal self-injurious behavior could help reduce the incidence of suicidal behaviors, as could placing greater emphasis on psychosocial interventions to improve coping mechanisms among those with recent negative life events.

"A previous investigation of the characteristics of suicide attempts in first-episode patients indicated that interpersonal issues were the most common antecedents. Extending individuals’ range of coping skills, such as interpersonal effectiveness, affect regulation, stress management, and problem solving, could strengthen protective processes and reduce the rates of suicide-related acts," the investigators wrote.

Data for this study were obtained from an audit of medical records for patients treated between December 2002 and November 2005 at the Early Psychosis Prevention and Intervention Center in Melbourne. Cases were patients who had made at least one suicide attempt; controls were randomly selected patients who had not made a suicide attempt.

Though limited by factors such as the retrospective design and missing data in some cases, this study involved a multidiagnostic sample selected from an epidemiologically representative cohort of first-episode psychosis patients and a retrospective field audit methodology that avoided potential response biases. Another strength was the use of staged data analysis, enabling a range of variables to be examined without diminishing the power of the final model, the investigators noted.

"Given the role of recent negative events and nonsuicidal self-injurious behavior in increasing the likelihood of suicide-related behaviors, incorporating psychosocial interventions addressing affect regulation, interpersonal effectiveness, stress management and problem-solving skills, alongside case management and pharmacotherapy, may help to reduce the prevalence of suicide attempts and suicide in this population," they wrote.

The investigators reported having no relevant financial conflicts.

Adding everolimus to exemestane for the treatment of estrogen receptor–positive advanced breast cancer that is refractory to nonsteroidal aromatase inhibitors has beneficial effects on bone turnover and breast cancer progression in bone, according to an exploratory analysis of data from the BOLERO-2 trial.

Additional exploratory analyses demonstrate that everolimus (Afinitor) is well tolerated among postmenopausal women – including the elderly.

Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), which has been implicated in resistance to standard endocrine therapy for estrogen receptor–positive breast cancer. Previously reported data from the double-blind, placebo-controlled phase III BOLERO-2 trial showed a significant clinical benefit with respect to the primary end point of progression-free survival when everolimus was added to the steroidal aromatase inhibitor exemestane (Aromasin).

The new findings were presented during poster sessions at the American Society of Clinical Oncology’s 2012 Breast Cancer Symposium.

To evaluate the bone-related effects of everolimus, investigators analyzed bone turnover marker levels and breast cancer progression in bone in BOLERO-2 patients who had bone metastases at baseline, including 184 patients who received placebo and 370 who received exemestane.

They found that active treatment with everolimus and exemestane was associated with improved levels of bone-specific alkaline phosphatase, amino-terminal propeptide of type 1 collagen, and C-terminal cross-linking telopeptide of type 1 collagen at 6- and 12-week follow-up.

The levels of each of these markers had increased at both time points in those receiving placebo, but had decreased in those receiving everolimus, Dr. Lowell L. Hart, a hematologist/oncologist in group practice in Fort Myers, Fla., and his colleagues reported (J. Clin. Oncol. 2012;30[suppl. 27; abstr. 102]).

Also, the cumulative incidence rate of breast cancer progressive disease in bone was lower in those who received everolimus, compared with those who received placebo (3.03% vs. 6.16% at day 60), they said, noting that this trend continued beyond 6 months.

Bone-related adverse events among the patients included in this analysis were grade 1/2, and occurred at a similar frequency in both groups (2.9% for the placebo group and 3.8% for the treatment group).

The safety and tolerability of everolimus were also evaluated in two additional exploratory analyses. In one, everolimus treatment was shown at a median of 12.5 months’ follow-up to be generally well tolerated among 492 postmenopausal women in the treatment group for the study.

Notable adverse events of all grades in those patients, compared with the 238 patients in the placebo group, included stomatitis (59% vs. 12%), rash (39% vs. 7%), pneumonitis (16% vs. 0%), and hyperglycemia (14% vs. less than 1%). Notable grade 3/4 events were stomatitis (8% vs. less than 1%), anemia (7% vs. less than 1%), hyperglycemia (5% vs. less than 1%), pneumonitis (3% vs. 0), and rash (1% vs. 0), reported Dr. Alejandra T. Perez, director of the breast cancer center at Memorial Cancer Institute in Hollywood, Fla.

The adverse events were manageable when patients were treated appropriately, Dr. Perez said (J. Clin. Oncol. 2012;30[suppl. 27; abstr. 103]).

For example, the study protocol permitted dose reduction or interruptions for the management of adverse events, and a look at the antitumor effects of treatment showed that results were consistent in those who received time-averaged doses less than 7.5 mg/day and those who received time-averaged doses greater than 7.5 mg/day (hazard ratios, 0.4 vs. 0.45, respectively). Those who developed stomatitis were treated with topical corticosteroids and/or mouthwashes containing nonsteroidal anti-inflammatories or anesthetics, and those with noninfectious pneumonitis were treated using a combination of radiographic imaging, oral corticosteroids, and temporary cessation of treatment.

Among the subset of study participants aged 65 years and older, the incidences of adverse events were similar or marginally lower than in the entire population, according to Dr. Hope S. Rugo of the University of California, San Francisco, and her colleagues.

For example, stomatitis occurred in 52% of those aged 65 and older who received everolimus, rash occurred in 32%, pneumonitis occurred in 15%, and hyperglycemia occurred in 13%. Grade 3/4 adverse events among those aged 70 years or older and reported only in those receiving everolimus included fatigue in 10%, anemia in 10%, hyperglycemia in 9%, stomatitis in 8%, dyspnea in 7%, pneumonitis in 5%, neutropenia in 3%, and hypertension in 3% (J. Clin. Oncol. 2012;30[suppl. 27; abstr. 104]).

Adding everolimus to exemestane was well tolerated both in the overall population and among elderly patients, and grade 3/4 adverse events were uncommon and manageable, Dr. Rugo noted. No new safety signals emerged.

Dr. Perez added that knowledge of adverse event management strategies is essential for optimizing tolerability and patient outcomes.

BOLERO-2 trial participants were postmenopausal women with estrogen receptor–positive breast cancer who relapsed or progressed on a nonsteroidal aromatase inhibitor. They were randomized to receive a 10-mg oral daily dose of everolimus plus 25 mg of exemestane once daily, or placebo and 25 mg of exemestane daily; treatment with everolimus conferred a median 4.2-month progression-free survival advantage, more than doubling the median progression-free survival from 3.2 months in the placebo group to 7.8 months in the treatment group. Based on these findings, the U.S. Food and Drug Administration approved the drug for this indication in July, making it the first mTOR inhibitor approved for advanced hormone receptor–positive breast cancer.

BOLERO-2 was sponsored by Novartis Pharmaceuticals. Dr. Rugo reported receiving research funding from Merck, Novartis, and Pfizer. Dr. Hart and Dr. Perez reported having no relevant financial disclosures.

Adding everolimus to exemestane for the treatment of estrogen receptor–positive advanced breast cancer that is refractory to nonsteroidal aromatase inhibitors has beneficial effects on bone turnover and breast cancer progression in bone, according to an exploratory analysis of data from the BOLERO-2 trial.

Additional exploratory analyses demonstrate that everolimus (Afinitor) is well tolerated among postmenopausal women – including the elderly.

Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), which has been implicated in resistance to standard endocrine therapy for estrogen receptor–positive breast cancer. Previously reported data from the double-blind, placebo-controlled phase III BOLERO-2 trial showed a significant clinical benefit with respect to the primary end point of progression-free survival when everolimus was added to the steroidal aromatase inhibitor exemestane (Aromasin).

The new findings were presented during poster sessions at the American Society of Clinical Oncology’s 2012 Breast Cancer Symposium.

To evaluate the bone-related effects of everolimus, investigators analyzed bone turnover marker levels and breast cancer progression in bone in BOLERO-2 patients who had bone metastases at baseline, including 184 patients who received placebo and 370 who received exemestane.

They found that active treatment with everolimus and exemestane was associated with improved levels of bone-specific alkaline phosphatase, amino-terminal propeptide of type 1 collagen, and C-terminal cross-linking telopeptide of type 1 collagen at 6- and 12-week follow-up.

The levels of each of these markers had increased at both time points in those receiving placebo, but had decreased in those receiving everolimus, Dr. Lowell L. Hart, a hematologist/oncologist in group practice in Fort Myers, Fla., and his colleagues reported (J. Clin. Oncol. 2012;30[suppl. 27; abstr. 102]).

Also, the cumulative incidence rate of breast cancer progressive disease in bone was lower in those who received everolimus, compared with those who received placebo (3.03% vs. 6.16% at day 60), they said, noting that this trend continued beyond 6 months.

Bone-related adverse events among the patients included in this analysis were grade 1/2, and occurred at a similar frequency in both groups (2.9% for the placebo group and 3.8% for the treatment group).

The safety and tolerability of everolimus were also evaluated in two additional exploratory analyses. In one, everolimus treatment was shown at a median of 12.5 months’ follow-up to be generally well tolerated among 492 postmenopausal women in the treatment group for the study.

Notable adverse events of all grades in those patients, compared with the 238 patients in the placebo group, included stomatitis (59% vs. 12%), rash (39% vs. 7%), pneumonitis (16% vs. 0%), and hyperglycemia (14% vs. less than 1%). Notable grade 3/4 events were stomatitis (8% vs. less than 1%), anemia (7% vs. less than 1%), hyperglycemia (5% vs. less than 1%), pneumonitis (3% vs. 0), and rash (1% vs. 0), reported Dr. Alejandra T. Perez, director of the breast cancer center at Memorial Cancer Institute in Hollywood, Fla.

The adverse events were manageable when patients were treated appropriately, Dr. Perez said (J. Clin. Oncol. 2012;30[suppl. 27; abstr. 103]).

For example, the study protocol permitted dose reduction or interruptions for the management of adverse events, and a look at the antitumor effects of treatment showed that results were consistent in those who received time-averaged doses less than 7.5 mg/day and those who received time-averaged doses greater than 7.5 mg/day (hazard ratios, 0.4 vs. 0.45, respectively). Those who developed stomatitis were treated with topical corticosteroids and/or mouthwashes containing nonsteroidal anti-inflammatories or anesthetics, and those with noninfectious pneumonitis were treated using a combination of radiographic imaging, oral corticosteroids, and temporary cessation of treatment.

Among the subset of study participants aged 65 years and older, the incidences of adverse events were similar or marginally lower than in the entire population, according to Dr. Hope S. Rugo of the University of California, San Francisco, and her colleagues.

For example, stomatitis occurred in 52% of those aged 65 and older who received everolimus, rash occurred in 32%, pneumonitis occurred in 15%, and hyperglycemia occurred in 13%. Grade 3/4 adverse events among those aged 70 years or older and reported only in those receiving everolimus included fatigue in 10%, anemia in 10%, hyperglycemia in 9%, stomatitis in 8%, dyspnea in 7%, pneumonitis in 5%, neutropenia in 3%, and hypertension in 3% (J. Clin. Oncol. 2012;30[suppl. 27; abstr. 104]).

Adding everolimus to exemestane was well tolerated both in the overall population and among elderly patients, and grade 3/4 adverse events were uncommon and manageable, Dr. Rugo noted. No new safety signals emerged.

Dr. Perez added that knowledge of adverse event management strategies is essential for optimizing tolerability and patient outcomes.

BOLERO-2 trial participants were postmenopausal women with estrogen receptor–positive breast cancer who relapsed or progressed on a nonsteroidal aromatase inhibitor. They were randomized to receive a 10-mg oral daily dose of everolimus plus 25 mg of exemestane once daily, or placebo and 25 mg of exemestane daily; treatment with everolimus conferred a median 4.2-month progression-free survival advantage, more than doubling the median progression-free survival from 3.2 months in the placebo group to 7.8 months in the treatment group. Based on these findings, the U.S. Food and Drug Administration approved the drug for this indication in July, making it the first mTOR inhibitor approved for advanced hormone receptor–positive breast cancer.

BOLERO-2 was sponsored by Novartis Pharmaceuticals. Dr. Rugo reported receiving research funding from Merck, Novartis, and Pfizer. Dr. Hart and Dr. Perez reported having no relevant financial disclosures.

Adding everolimus to exemestane for the treatment of estrogen receptor–positive advanced breast cancer that is refractory to nonsteroidal aromatase inhibitors has beneficial effects on bone turnover and breast cancer progression in bone, according to an exploratory analysis of data from the BOLERO-2 trial.

Additional exploratory analyses demonstrate that everolimus (Afinitor) is well tolerated among postmenopausal women – including the elderly.

Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), which has been implicated in resistance to standard endocrine therapy for estrogen receptor–positive breast cancer. Previously reported data from the double-blind, placebo-controlled phase III BOLERO-2 trial showed a significant clinical benefit with respect to the primary end point of progression-free survival when everolimus was added to the steroidal aromatase inhibitor exemestane (Aromasin).

The new findings were presented during poster sessions at the American Society of Clinical Oncology’s 2012 Breast Cancer Symposium.

To evaluate the bone-related effects of everolimus, investigators analyzed bone turnover marker levels and breast cancer progression in bone in BOLERO-2 patients who had bone metastases at baseline, including 184 patients who received placebo and 370 who received exemestane.

They found that active treatment with everolimus and exemestane was associated with improved levels of bone-specific alkaline phosphatase, amino-terminal propeptide of type 1 collagen, and C-terminal cross-linking telopeptide of type 1 collagen at 6- and 12-week follow-up.

The levels of each of these markers had increased at both time points in those receiving placebo, but had decreased in those receiving everolimus, Dr. Lowell L. Hart, a hematologist/oncologist in group practice in Fort Myers, Fla., and his colleagues reported (J. Clin. Oncol. 2012;30[suppl. 27; abstr. 102]).

Also, the cumulative incidence rate of breast cancer progressive disease in bone was lower in those who received everolimus, compared with those who received placebo (3.03% vs. 6.16% at day 60), they said, noting that this trend continued beyond 6 months.

Bone-related adverse events among the patients included in this analysis were grade 1/2, and occurred at a similar frequency in both groups (2.9% for the placebo group and 3.8% for the treatment group).

The safety and tolerability of everolimus were also evaluated in two additional exploratory analyses. In one, everolimus treatment was shown at a median of 12.5 months’ follow-up to be generally well tolerated among 492 postmenopausal women in the treatment group for the study.

Notable adverse events of all grades in those patients, compared with the 238 patients in the placebo group, included stomatitis (59% vs. 12%), rash (39% vs. 7%), pneumonitis (16% vs. 0%), and hyperglycemia (14% vs. less than 1%). Notable grade 3/4 events were stomatitis (8% vs. less than 1%), anemia (7% vs. less than 1%), hyperglycemia (5% vs. less than 1%), pneumonitis (3% vs. 0), and rash (1% vs. 0), reported Dr. Alejandra T. Perez, director of the breast cancer center at Memorial Cancer Institute in Hollywood, Fla.

The adverse events were manageable when patients were treated appropriately, Dr. Perez said (J. Clin. Oncol. 2012;30[suppl. 27; abstr. 103]).

For example, the study protocol permitted dose reduction or interruptions for the management of adverse events, and a look at the antitumor effects of treatment showed that results were consistent in those who received time-averaged doses less than 7.5 mg/day and those who received time-averaged doses greater than 7.5 mg/day (hazard ratios, 0.4 vs. 0.45, respectively). Those who developed stomatitis were treated with topical corticosteroids and/or mouthwashes containing nonsteroidal anti-inflammatories or anesthetics, and those with noninfectious pneumonitis were treated using a combination of radiographic imaging, oral corticosteroids, and temporary cessation of treatment.

Among the subset of study participants aged 65 years and older, the incidences of adverse events were similar or marginally lower than in the entire population, according to Dr. Hope S. Rugo of the University of California, San Francisco, and her colleagues.

For example, stomatitis occurred in 52% of those aged 65 and older who received everolimus, rash occurred in 32%, pneumonitis occurred in 15%, and hyperglycemia occurred in 13%. Grade 3/4 adverse events among those aged 70 years or older and reported only in those receiving everolimus included fatigue in 10%, anemia in 10%, hyperglycemia in 9%, stomatitis in 8%, dyspnea in 7%, pneumonitis in 5%, neutropenia in 3%, and hypertension in 3% (J. Clin. Oncol. 2012;30[suppl. 27; abstr. 104]).

Adding everolimus to exemestane was well tolerated both in the overall population and among elderly patients, and grade 3/4 adverse events were uncommon and manageable, Dr. Rugo noted. No new safety signals emerged.

Dr. Perez added that knowledge of adverse event management strategies is essential for optimizing tolerability and patient outcomes.

BOLERO-2 trial participants were postmenopausal women with estrogen receptor–positive breast cancer who relapsed or progressed on a nonsteroidal aromatase inhibitor. They were randomized to receive a 10-mg oral daily dose of everolimus plus 25 mg of exemestane once daily, or placebo and 25 mg of exemestane daily; treatment with everolimus conferred a median 4.2-month progression-free survival advantage, more than doubling the median progression-free survival from 3.2 months in the placebo group to 7.8 months in the treatment group. Based on these findings, the U.S. Food and Drug Administration approved the drug for this indication in July, making it the first mTOR inhibitor approved for advanced hormone receptor–positive breast cancer.

BOLERO-2 was sponsored by Novartis Pharmaceuticals. Dr. Rugo reported receiving research funding from Merck, Novartis, and Pfizer. Dr. Hart and Dr. Perez reported having no relevant financial disclosures.

The investigational drug trastuzumab emtansine, or T-DM1, was well tolerated and was associated with significantly prolonged progression-free survival compared with combination capecitabine/lapatinib (XL) treatment in 978 patients with HER2-positive metastatic breast cancer.

The antibody-drug conjugate, which combines the antitumor activity of the monoclonal antibody trastuzumab with the cytotoxic effects of the maytansine derivative DM1, also improved overall survival.

The median progression-free survival among those randomized to receive T-DM1 was 9.6 months, compared with 6.4 months for those treated with XL (stratified hazard ratio, 0.65) – a difference that was both statistically significant (P less than .0001) and clinically meaningful, said Dr. Mark D. Pegram of Stanford (Calif.) University’s Stanford Cancer Institute.

The findings were noted in the first planned interim analysis of the randomized, open-label, phase III EMILIA study. Overall survival at 1 year was 84.7% and 77% in the T-DM1 and XL groups, respectively, and overall survival at 2 years was 65.4% and 47.5% for the groups, respectively (J. Clin. Oncol. 30, 2012 [suppl 27 abstr 98]). The objective response rate was 43.6% vs. 30.8%, and the duration of response among those with an objective response was a median of 12.6 months vs. 6.5 months, Dr. Pegram said.

The findings were presented at the American Society of Clinical Oncology’s 2012 Breast Cancer Symposium.

The findings with respect to overall survival, based on this analysis, showed a trend in favor of T-DM1 (stratified hazard ratio, 0.621; P less than .0005), but the difference between the two treatment groups did not technically achieve statistical significance, Dr. Pegram said.

However, the overall survival analysis was recently updated, and the latest findings did demonstrate a statistically significant overall survival advantage with T-DM1 treatment, he noted.

The detailed findings from that latest analysis will be reported publicly for the first time at the European Society for Medical Oncology 2012 Congress to be held Oct. 1. Roche/Genentech Inc., maker of T-DM1, resubmitted to the Food and Drug Administration an application for accelerated approval of the agent. The company has said it plans to provide the FDA, which refused to file the initial application for accelerated approval submitted in 2010, with the updated overall survival analysis data when the agency reviews the application.

EMILIA participants were women with confirmed HER2-positive metastatic breast cancer who had been treated previously with trastuzumab and a taxane. They were randomized to receive 3.6 mg/kg of intravenous T-DMI every 3 weeks, or combination therapy with an oral twice-daily dose of 1,000 mg/m² of capecitabine on days 1-4 every 3 weeks and an oral dose once daily of 1,240 mg of lapatinib; the XL combination treatment is currently the only approved combination treatment for trastuzumab-refractory HER2-positive metastatic breast cancer.

Patients in the T-DM1 and XL groups were followed for a median of 12.9 and 12.4 months, respectively, and progression-free survival was determined by independent review.

T-DM1 was well tolerated; no unexpected safety signals emerged. The most common grade 3 or higher adverse events in the T-DM1 patients were thrombocytopenia (12.9% vs. 0.2% of T-DMI vs. XL patients), increased AST (4.3% vs. 0.8%), and increased ALT (2.9% vs. 1.4%). The most common adverse events in the XL patients were diarrhea (20.7% vs. 1.6% of the XL vs. T-DM1 patients), palmar plantar erythrodysesthesia (16.4% vs. 0), and vomiting (4.5% vs. 0.8%).

Dose reductions were required in 16.3% of T-DM1 patients, whereas lapatinib doses were reduced in 27.3% of the XL patients, and capecitabine doses were reduced in 53.4% of the XL patients.

The EMILIA trial is sponsored by Genentech. Dr. Pegram reported serving as a consultant or adviser for Takeda, receiving honoraria from AstraZeneca and GlaxoSmithKline, receiving research funding from Sanofi, providing expert testimony for Novartis, and receiving other remuneration from Bristol-Myers Squibb, Pfizer, and Roche/Genentech.

The investigational drug trastuzumab emtansine, or T-DM1, was well tolerated and was associated with significantly prolonged progression-free survival compared with combination capecitabine/lapatinib (XL) treatment in 978 patients with HER2-positive metastatic breast cancer.

The antibody-drug conjugate, which combines the antitumor activity of the monoclonal antibody trastuzumab with the cytotoxic effects of the maytansine derivative DM1, also improved overall survival.

The median progression-free survival among those randomized to receive T-DM1 was 9.6 months, compared with 6.4 months for those treated with XL (stratified hazard ratio, 0.65) – a difference that was both statistically significant (P less than .0001) and clinically meaningful, said Dr. Mark D. Pegram of Stanford (Calif.) University’s Stanford Cancer Institute.

The findings were noted in the first planned interim analysis of the randomized, open-label, phase III EMILIA study. Overall survival at 1 year was 84.7% and 77% in the T-DM1 and XL groups, respectively, and overall survival at 2 years was 65.4% and 47.5% for the groups, respectively (J. Clin. Oncol. 30, 2012 [suppl 27 abstr 98]). The objective response rate was 43.6% vs. 30.8%, and the duration of response among those with an objective response was a median of 12.6 months vs. 6.5 months, Dr. Pegram said.

The findings were presented at the American Society of Clinical Oncology’s 2012 Breast Cancer Symposium.

The findings with respect to overall survival, based on this analysis, showed a trend in favor of T-DM1 (stratified hazard ratio, 0.621; P less than .0005), but the difference between the two treatment groups did not technically achieve statistical significance, Dr. Pegram said.

However, the overall survival analysis was recently updated, and the latest findings did demonstrate a statistically significant overall survival advantage with T-DM1 treatment, he noted.

The detailed findings from that latest analysis will be reported publicly for the first time at the European Society for Medical Oncology 2012 Congress to be held Oct. 1. Roche/Genentech Inc., maker of T-DM1, resubmitted to the Food and Drug Administration an application for accelerated approval of the agent. The company has said it plans to provide the FDA, which refused to file the initial application for accelerated approval submitted in 2010, with the updated overall survival analysis data when the agency reviews the application.

EMILIA participants were women with confirmed HER2-positive metastatic breast cancer who had been treated previously with trastuzumab and a taxane. They were randomized to receive 3.6 mg/kg of intravenous T-DMI every 3 weeks, or combination therapy with an oral twice-daily dose of 1,000 mg/m² of capecitabine on days 1-4 every 3 weeks and an oral dose once daily of 1,240 mg of lapatinib; the XL combination treatment is currently the only approved combination treatment for trastuzumab-refractory HER2-positive metastatic breast cancer.

Patients in the T-DM1 and XL groups were followed for a median of 12.9 and 12.4 months, respectively, and progression-free survival was determined by independent review.

T-DM1 was well tolerated; no unexpected safety signals emerged. The most common grade 3 or higher adverse events in the T-DM1 patients were thrombocytopenia (12.9% vs. 0.2% of T-DMI vs. XL patients), increased AST (4.3% vs. 0.8%), and increased ALT (2.9% vs. 1.4%). The most common adverse events in the XL patients were diarrhea (20.7% vs. 1.6% of the XL vs. T-DM1 patients), palmar plantar erythrodysesthesia (16.4% vs. 0), and vomiting (4.5% vs. 0.8%).

Dose reductions were required in 16.3% of T-DM1 patients, whereas lapatinib doses were reduced in 27.3% of the XL patients, and capecitabine doses were reduced in 53.4% of the XL patients.

The EMILIA trial is sponsored by Genentech. Dr. Pegram reported serving as a consultant or adviser for Takeda, receiving honoraria from AstraZeneca and GlaxoSmithKline, receiving research funding from Sanofi, providing expert testimony for Novartis, and receiving other remuneration from Bristol-Myers Squibb, Pfizer, and Roche/Genentech.

The investigational drug trastuzumab emtansine, or T-DM1, was well tolerated and was associated with significantly prolonged progression-free survival compared with combination capecitabine/lapatinib (XL) treatment in 978 patients with HER2-positive metastatic breast cancer.

The antibody-drug conjugate, which combines the antitumor activity of the monoclonal antibody trastuzumab with the cytotoxic effects of the maytansine derivative DM1, also improved overall survival.

The median progression-free survival among those randomized to receive T-DM1 was 9.6 months, compared with 6.4 months for those treated with XL (stratified hazard ratio, 0.65) – a difference that was both statistically significant (P less than .0001) and clinically meaningful, said Dr. Mark D. Pegram of Stanford (Calif.) University’s Stanford Cancer Institute.

The findings were noted in the first planned interim analysis of the randomized, open-label, phase III EMILIA study. Overall survival at 1 year was 84.7% and 77% in the T-DM1 and XL groups, respectively, and overall survival at 2 years was 65.4% and 47.5% for the groups, respectively (J. Clin. Oncol. 30, 2012 [suppl 27 abstr 98]). The objective response rate was 43.6% vs. 30.8%, and the duration of response among those with an objective response was a median of 12.6 months vs. 6.5 months, Dr. Pegram said.

The findings were presented at the American Society of Clinical Oncology’s 2012 Breast Cancer Symposium.

The findings with respect to overall survival, based on this analysis, showed a trend in favor of T-DM1 (stratified hazard ratio, 0.621; P less than .0005), but the difference between the two treatment groups did not technically achieve statistical significance, Dr. Pegram said.

However, the overall survival analysis was recently updated, and the latest findings did demonstrate a statistically significant overall survival advantage with T-DM1 treatment, he noted.

The detailed findings from that latest analysis will be reported publicly for the first time at the European Society for Medical Oncology 2012 Congress to be held Oct. 1. Roche/Genentech Inc., maker of T-DM1, resubmitted to the Food and Drug Administration an application for accelerated approval of the agent. The company has said it plans to provide the FDA, which refused to file the initial application for accelerated approval submitted in 2010, with the updated overall survival analysis data when the agency reviews the application.

EMILIA participants were women with confirmed HER2-positive metastatic breast cancer who had been treated previously with trastuzumab and a taxane. They were randomized to receive 3.6 mg/kg of intravenous T-DMI every 3 weeks, or combination therapy with an oral twice-daily dose of 1,000 mg/m² of capecitabine on days 1-4 every 3 weeks and an oral dose once daily of 1,240 mg of lapatinib; the XL combination treatment is currently the only approved combination treatment for trastuzumab-refractory HER2-positive metastatic breast cancer.

Patients in the T-DM1 and XL groups were followed for a median of 12.9 and 12.4 months, respectively, and progression-free survival was determined by independent review.

T-DM1 was well tolerated; no unexpected safety signals emerged. The most common grade 3 or higher adverse events in the T-DM1 patients were thrombocytopenia (12.9% vs. 0.2% of T-DMI vs. XL patients), increased AST (4.3% vs. 0.8%), and increased ALT (2.9% vs. 1.4%). The most common adverse events in the XL patients were diarrhea (20.7% vs. 1.6% of the XL vs. T-DM1 patients), palmar plantar erythrodysesthesia (16.4% vs. 0), and vomiting (4.5% vs. 0.8%).

Dose reductions were required in 16.3% of T-DM1 patients, whereas lapatinib doses were reduced in 27.3% of the XL patients, and capecitabine doses were reduced in 53.4% of the XL patients.

The EMILIA trial is sponsored by Genentech. Dr. Pegram reported serving as a consultant or adviser for Takeda, receiving honoraria from AstraZeneca and GlaxoSmithKline, receiving research funding from Sanofi, providing expert testimony for Novartis, and receiving other remuneration from Bristol-Myers Squibb, Pfizer, and Roche/Genentech.

Trauma associated with the loss of a child might contribute to the onset of psychosis, according to an analysis of data from the National Comorbidity Survey Replication.

Findings from this cross-sectional survey that suggest the trauma of losing a child could be an etiologic factor in the onset of psychosis are a significantly later age of onset of psychosis among those experiencing the loss of a child, onset within a year of the trauma in many subjects, and the specificity of the association with psychosis compared with the specificity of the association for other psychiatric conditions. These findings build on the increasing evidence of an association between various types of trauma exposure and psychosis, Jordan E. DeVylder of Columbia University, New York, and his colleagues reported online in the Aug. 29 issue of Psychiatry Research.

For example, in the National Comorbidity Survey, childhood physical abuse significantly predicted psychosis, and cumulative trauma exposure was found to increase the likelihood of psychosis in a dose-response fashion – a finding that was replicated in subsequent studies.

In the current study, 409 of 6,458 participants in the National Comorbidity Survey Replication (NCS-R) reported the loss of a child, and 251 reported a lifetime psychotic experience.

There was a statistical trend toward a higher incidence of psychosis among those who had lost a child, with 18/409 of those who had lost a child also having a psychotic experience (odds ratio = 1.52), the investigators said (Psychiatry Res. 2012 Aug. 29 [doi:10/1016/j.psychres.2012.08.008]).

Child loss significantly predicted the age of onset of psychosis (age of onset was 36.4 and 27.2 years for those experiencing and not experiencing child loss). After demographic factors, number of children, and co-occurring diagnoses were controlled for, a main effect of child loss was seen, as was an interaction between child loss and gender; the effect of bereavement on age of psychosis onset was greater for men than for women, the investigators noted.

Also, psychosis onset followed child loss in nearly 60% of participants (4 of 4 males, and 6 of 13 females), and in 60% of those subjects, psychosis onset was within 1 year of child loss.

The specificity of the association between child loss and psychosis was evaluated using additional regression models. After investigators controlled for confounding variables such as number of living children, age, female gender, nonwhite race, foreign birth, and other psychiatric conditions, child loss was not shown to have a significant effect on age of onset for six other conditions, including posttraumatic stress disorder, major depression, substance abuse, generalized anxiety disorder, mania, and social phobia.

"The presented results together demonstrate that, in some individuals, child loss may contribute specifically to the onset of psychotic experience, but not other psychiatric conditions, even when controlling for confounding factors," the investigators wrote.

Participants in the NCS-R were U.S. adults aged 18 years or older who were surveyed between February 2001 and April 2003. The investigators "examined the relationship between child loss and age of psychosis onset, building on prior population-based studies by using a measure of trauma exposure that is less likely to be underreported or subject to recall bias, by examining psychosis onset rather than prevalence, and by controlling for co-occurring conditions," they said.

The main finding of this study is that child loss is associated with a later age of onset of psychosis among a large sample of people with a lifetime psychotic experience. However, it is of particular interest that psychosis onset occurred within 1 year of the loss of a child in a large proportion of those who experienced child loss (35.3% of the total sample), the investigators said.

This demonstrates a very close temporal relationship between child loss and psychosis in some individuals, confirming findings from a prior study of patients undergoing psychiatric hospitalization in the year after the loss of a child and extending those findings to nonhospitalized parents who experienced psychosis.

Furthermore, the lack of an effect of child loss on six other psychiatric conditions suggests that the relationship may be specific to psychosis and "not reflective of a broader influence of child loss on global mental health," although it is possible that child loss influences these conditions through mechanisms other than those represented by the models used in this study, they noted.

The fact that the overall increase in the odds of developing psychosis among those who experienced child loss did not reach statistical significance was not surprising, given the unlikelihood that most people with psychosis experience child loss – and that most people experiencing child loss develop psychosis.

"Trauma is only one of the many contributing factors in psychosis onset, and child loss is one particular trauma – therefore its singular influence was expected to be present but not overwhelming," they explained.

As for the mechanisms by which child loss may spur the onset of psychotic experiences, biologic diatheses-stress models suggest that the stress of child loss may contribute to dysregulation of the hypothalamic-pituitary-adrenal axis in vulnerable individuals. This, in turn, can elicit hyperresponsive subcortical dopamine activity that may manifest as psychotic symptoms in some individuals.

Though limited by the small number of bereaved parents in the group reporting a lifetime psychotic experience, and the failure of nearly one-third of those who answered the survey to respond to the child loss item, the findings are important for numerous reasons. The data provide evidence of an association between trauma and psychosis that occurs after the typical age of onset, and they are clinically relevant with respect to planning treatment for adults who have lost a child, the investigators concluded.

Future prospective studies that focus on other later-life traumatic events to further evaluate associations between trauma exposure and psychosis onset across the life course and across forms of trauma exposure would be valuable, the investigators added.

Dr. DeVylder reported having no relevant financial disclosures.

Trauma associated with the loss of a child might contribute to the onset of psychosis, according to an analysis of data from the National Comorbidity Survey Replication.

Findings from this cross-sectional survey that suggest the trauma of losing a child could be an etiologic factor in the onset of psychosis are a significantly later age of onset of psychosis among those experiencing the loss of a child, onset within a year of the trauma in many subjects, and the specificity of the association with psychosis compared with the specificity of the association for other psychiatric conditions. These findings build on the increasing evidence of an association between various types of trauma exposure and psychosis, Jordan E. DeVylder of Columbia University, New York, and his colleagues reported online in the Aug. 29 issue of Psychiatry Research.

For example, in the National Comorbidity Survey, childhood physical abuse significantly predicted psychosis, and cumulative trauma exposure was found to increase the likelihood of psychosis in a dose-response fashion – a finding that was replicated in subsequent studies.

In the current study, 409 of 6,458 participants in the National Comorbidity Survey Replication (NCS-R) reported the loss of a child, and 251 reported a lifetime psychotic experience.

There was a statistical trend toward a higher incidence of psychosis among those who had lost a child, with 18/409 of those who had lost a child also having a psychotic experience (odds ratio = 1.52), the investigators said (Psychiatry Res. 2012 Aug. 29 [doi:10/1016/j.psychres.2012.08.008]).

Child loss significantly predicted the age of onset of psychosis (age of onset was 36.4 and 27.2 years for those experiencing and not experiencing child loss). After demographic factors, number of children, and co-occurring diagnoses were controlled for, a main effect of child loss was seen, as was an interaction between child loss and gender; the effect of bereavement on age of psychosis onset was greater for men than for women, the investigators noted.

Also, psychosis onset followed child loss in nearly 60% of participants (4 of 4 males, and 6 of 13 females), and in 60% of those subjects, psychosis onset was within 1 year of child loss.

The specificity of the association between child loss and psychosis was evaluated using additional regression models. After investigators controlled for confounding variables such as number of living children, age, female gender, nonwhite race, foreign birth, and other psychiatric conditions, child loss was not shown to have a significant effect on age of onset for six other conditions, including posttraumatic stress disorder, major depression, substance abuse, generalized anxiety disorder, mania, and social phobia.

"The presented results together demonstrate that, in some individuals, child loss may contribute specifically to the onset of psychotic experience, but not other psychiatric conditions, even when controlling for confounding factors," the investigators wrote.

Participants in the NCS-R were U.S. adults aged 18 years or older who were surveyed between February 2001 and April 2003. The investigators "examined the relationship between child loss and age of psychosis onset, building on prior population-based studies by using a measure of trauma exposure that is less likely to be underreported or subject to recall bias, by examining psychosis onset rather than prevalence, and by controlling for co-occurring conditions," they said.

The main finding of this study is that child loss is associated with a later age of onset of psychosis among a large sample of people with a lifetime psychotic experience. However, it is of particular interest that psychosis onset occurred within 1 year of the loss of a child in a large proportion of those who experienced child loss (35.3% of the total sample), the investigators said.

This demonstrates a very close temporal relationship between child loss and psychosis in some individuals, confirming findings from a prior study of patients undergoing psychiatric hospitalization in the year after the loss of a child and extending those findings to nonhospitalized parents who experienced psychosis.

Furthermore, the lack of an effect of child loss on six other psychiatric conditions suggests that the relationship may be specific to psychosis and "not reflective of a broader influence of child loss on global mental health," although it is possible that child loss influences these conditions through mechanisms other than those represented by the models used in this study, they noted.

The fact that the overall increase in the odds of developing psychosis among those who experienced child loss did not reach statistical significance was not surprising, given the unlikelihood that most people with psychosis experience child loss – and that most people experiencing child loss develop psychosis.

"Trauma is only one of the many contributing factors in psychosis onset, and child loss is one particular trauma – therefore its singular influence was expected to be present but not overwhelming," they explained.

As for the mechanisms by which child loss may spur the onset of psychotic experiences, biologic diatheses-stress models suggest that the stress of child loss may contribute to dysregulation of the hypothalamic-pituitary-adrenal axis in vulnerable individuals. This, in turn, can elicit hyperresponsive subcortical dopamine activity that may manifest as psychotic symptoms in some individuals.

Though limited by the small number of bereaved parents in the group reporting a lifetime psychotic experience, and the failure of nearly one-third of those who answered the survey to respond to the child loss item, the findings are important for numerous reasons. The data provide evidence of an association between trauma and psychosis that occurs after the typical age of onset, and they are clinically relevant with respect to planning treatment for adults who have lost a child, the investigators concluded.

Future prospective studies that focus on other later-life traumatic events to further evaluate associations between trauma exposure and psychosis onset across the life course and across forms of trauma exposure would be valuable, the investigators added.

Dr. DeVylder reported having no relevant financial disclosures.

Trauma associated with the loss of a child might contribute to the onset of psychosis, according to an analysis of data from the National Comorbidity Survey Replication.

Findings from this cross-sectional survey that suggest the trauma of losing a child could be an etiologic factor in the onset of psychosis are a significantly later age of onset of psychosis among those experiencing the loss of a child, onset within a year of the trauma in many subjects, and the specificity of the association with psychosis compared with the specificity of the association for other psychiatric conditions. These findings build on the increasing evidence of an association between various types of trauma exposure and psychosis, Jordan E. DeVylder of Columbia University, New York, and his colleagues reported online in the Aug. 29 issue of Psychiatry Research.

For example, in the National Comorbidity Survey, childhood physical abuse significantly predicted psychosis, and cumulative trauma exposure was found to increase the likelihood of psychosis in a dose-response fashion – a finding that was replicated in subsequent studies.

In the current study, 409 of 6,458 participants in the National Comorbidity Survey Replication (NCS-R) reported the loss of a child, and 251 reported a lifetime psychotic experience.

There was a statistical trend toward a higher incidence of psychosis among those who had lost a child, with 18/409 of those who had lost a child also having a psychotic experience (odds ratio = 1.52), the investigators said (Psychiatry Res. 2012 Aug. 29 [doi:10/1016/j.psychres.2012.08.008]).

Child loss significantly predicted the age of onset of psychosis (age of onset was 36.4 and 27.2 years for those experiencing and not experiencing child loss). After demographic factors, number of children, and co-occurring diagnoses were controlled for, a main effect of child loss was seen, as was an interaction between child loss and gender; the effect of bereavement on age of psychosis onset was greater for men than for women, the investigators noted.

Also, psychosis onset followed child loss in nearly 60% of participants (4 of 4 males, and 6 of 13 females), and in 60% of those subjects, psychosis onset was within 1 year of child loss.

The specificity of the association between child loss and psychosis was evaluated using additional regression models. After investigators controlled for confounding variables such as number of living children, age, female gender, nonwhite race, foreign birth, and other psychiatric conditions, child loss was not shown to have a significant effect on age of onset for six other conditions, including posttraumatic stress disorder, major depression, substance abuse, generalized anxiety disorder, mania, and social phobia.

"The presented results together demonstrate that, in some individuals, child loss may contribute specifically to the onset of psychotic experience, but not other psychiatric conditions, even when controlling for confounding factors," the investigators wrote.

Participants in the NCS-R were U.S. adults aged 18 years or older who were surveyed between February 2001 and April 2003. The investigators "examined the relationship between child loss and age of psychosis onset, building on prior population-based studies by using a measure of trauma exposure that is less likely to be underreported or subject to recall bias, by examining psychosis onset rather than prevalence, and by controlling for co-occurring conditions," they said.

The main finding of this study is that child loss is associated with a later age of onset of psychosis among a large sample of people with a lifetime psychotic experience. However, it is of particular interest that psychosis onset occurred within 1 year of the loss of a child in a large proportion of those who experienced child loss (35.3% of the total sample), the investigators said.

This demonstrates a very close temporal relationship between child loss and psychosis in some individuals, confirming findings from a prior study of patients undergoing psychiatric hospitalization in the year after the loss of a child and extending those findings to nonhospitalized parents who experienced psychosis.

Furthermore, the lack of an effect of child loss on six other psychiatric conditions suggests that the relationship may be specific to psychosis and "not reflective of a broader influence of child loss on global mental health," although it is possible that child loss influences these conditions through mechanisms other than those represented by the models used in this study, they noted.

The fact that the overall increase in the odds of developing psychosis among those who experienced child loss did not reach statistical significance was not surprising, given the unlikelihood that most people with psychosis experience child loss – and that most people experiencing child loss develop psychosis.

"Trauma is only one of the many contributing factors in psychosis onset, and child loss is one particular trauma – therefore its singular influence was expected to be present but not overwhelming," they explained.

As for the mechanisms by which child loss may spur the onset of psychotic experiences, biologic diatheses-stress models suggest that the stress of child loss may contribute to dysregulation of the hypothalamic-pituitary-adrenal axis in vulnerable individuals. This, in turn, can elicit hyperresponsive subcortical dopamine activity that may manifest as psychotic symptoms in some individuals.

Though limited by the small number of bereaved parents in the group reporting a lifetime psychotic experience, and the failure of nearly one-third of those who answered the survey to respond to the child loss item, the findings are important for numerous reasons. The data provide evidence of an association between trauma and psychosis that occurs after the typical age of onset, and they are clinically relevant with respect to planning treatment for adults who have lost a child, the investigators concluded.

Future prospective studies that focus on other later-life traumatic events to further evaluate associations between trauma exposure and psychosis onset across the life course and across forms of trauma exposure would be valuable, the investigators added.

Dr. DeVylder reported having no relevant financial disclosures.

How willing are dermatologists to embrace new technologies and incorporate them into their practice?

"As in all areas, there are individuals that are comfortable in their ways and don’t feel the need to add ‘complexity’ to their practice since they have a system that ‘already works,’ " said Dr. Ashish Bhatia of the department of clinical dermatology at Northwestern University, Chicago.

Courtesy The Dermatology Institute, Naperville

But dermatologists are a "creative group, often seeking out new ways to utilize technology to improve their patient care," said Dr. Bhatia in an interview. Interestingly, it’s not just the "younger, tech-savvy, recent graduates" who embrace new technologies.

As for which technologies are most popular, he noted that tablet computers have become ubiquitous.

"If you are not using one to share information with your patients, you are missing out on a great opportunity. Even elderly patients love flipping through before and after pictures that help them understand an upcoming procedure. Most patients find it easy to use, and it often sparks conversation about other procedures," Dr. Bhatia said.

He was a guest editor of the September issue of Seminars in Cutaneous Medicine and Surgery, which focused on "Information Technology in Dermatology and Dermatologic Surgery." He and his colleagues delved into technologies that can help modernize today’s practice.

YouTube

"If a picture is worth 1,000 words, a video is worth 100,000 or more," wrote Dr. Bhatia and his colleagues. YouTube and other video resources provide an invaluable and revolutionary tool for educating students.

"Thousands of videos scattered on the Internet depict everything from drawing blood to performing an appendectomy, and students can access these videos to better prepare themselves for reality, that is, standing at a patient’s bedside or performing in the operating room," they noted.

Online videos, along with textbook reviews and discussions of procedural steps, have become a "routine and important tool in preparing a student," and studies have demonstrated the value of online learning (Sem. Cut. Med. Surg. 2012;31:163-7).

Advantages of this type of online learning include convenience, freedom of navigation, the option of repeated practice or viewing, and access to high-quality videos and images. This Internet resource, which allows for storage and retrieval of vast amounts of information, can greatly enhance the learning experience of both students and medical professionals if used properly.

The use of video-based online learning is increasing in dermatologic surgery, but the field remains "behind the times," – compared with gynecology and plastic surgery – in terms of the volume of high-quality videos and associated blog posts found online, they noted.

Nonetheless, there are a number of available video resources, in addition to YouTube. Keep in mind that there is a link between quality and price, they warned.

"Sites that are free to users are unregulated, content is posted in a haphazard and disorganized fashion, and [the sites] leave it up to the user to search for desired information," wrote Dr. Bhatia and his colleagues, noting that paid sites tend to have a clear focus on education, while the goal of free user-generated sites tends to be unclear.

Still, YouTube is the leading source of videographic information, including surgical videos. Surgery posts from physicians, patients, surgical equipment manufacturers, and dermatologic societies such as the American Society for Dermatologic Surgery and the American College of Mohs Surgery, can be found there.

And while YouTube serves as a new medium for education and awareness, it appears that its primary use by physicians is for advertising. "Several individual and/or group practices are leveraging the new channel to reach customers and educate them about their services. Marketing-savvy physicians are also posting patient testimonials and videos of patients discussing procedures they have undergone, such as surgical excision and Mohs surgery/reconstruction," the authors noted. Comment threads for videos indicate that patients are also using YouTube as a forum to discuss fears about upcoming procedures and to share experiences and obtain information.

"The Internet serves as a paradigm shift in how we access and share information in written form. YouTube has the potential to add to this paradigm shift in terms of visual information. However academic institutions, especially in the field of medicine and surgery, have not yet harnessed this potential," they wrote, adding that organizations with readily available educational videos, and thought leaders in dermatologic surgery could be making material available online to help self-learning physicians enhance their skill set.

Surgical Video Sources

• YouTube (Google)

• Virtual Dermsurg (Derm Education Foundation)

• Procedures Consult (Elsevier)

• MedClip (Medical Videos)

• ORLive (BroadcastMed)

• AccessSurgery (McGraw Hill)

• MedlinePlus (U.S. National Library of Medicine and National Institutes of Health)

• Medical Videos (Bliss)

Dr. Ashish Bhatia and one of his coauthors, Mr. Kyle Bhatia, are unpaid authors and editors for video content on www.VirtualDermSurg.com.

Decision Support Tools

Clinical decision support (CDS) tools have come a long way in recent years, and with increasing use and acceptance of electronic resources and mobile devices, the growing number of CDS systems can be of great benefit, according to Dr. Art Papier.

"CDS systems have the potential to increase a physician’s cognitive awareness, help them recognize their knowledge limitations, and assist with problem solving and decision making in a specific patient context," wrote Dr. Papier, of the University of Rochester, N.Y.

Specific areas of diagnostic CDS addressed by Dr. Papier include those that relate to medication reactions, geographic relationships, and allergic contact dermatitis (Sem. Cut. Med. Surg. 2012;31:153-9).

• Medication reactions. Clinicians too often fail to promptly identify, classify, and diagnose a problem, and many available CDS systems provide too little information to help. However, two CDS systems that provide fuller differentials for possible adverse drug reactions are Litt’s DERM (Drug Eruption Reference Manual) Database and the drug eruption module in VisualDx.

• Geographic relationships. There are two designed CDS systems that search by state or country for infectious disease relationships: GIDEON (Global Infectious Diseases and Epidemiology Online Network) and VisualDx. "GIDEON is a diagnostic Web application covering the relationships of more than 340 infectious diseases and 231 countries. The database is searchable by country, symptom, exposure, or medication," wrote Dr. Papier. VisualDx is similar, and also covers infectious diseases that present with cutaneous findings, and allows users to search by lesion type, endemic country, exposures, medications, laboratory findings, and body location. The systems can be especially useful for recalling the relationships between foreign travel and infectious disease exposure.

• Allergic contact dermatitis. Dr. Papier recommended the American Contact Dermatitis Society’s CARD (Contact Allergen Replacement Database), which is part of the Society’s CAMP (Contact Allergen Management Program) database. This CDS has "great potential to guide the patient history, assessment, and eventual patient recommendations" in these cases, he said.

Technology has much to offer dermatology practices.

"As we are still at the beginning of this digital revolution in health care, a future with further innovation is certain. This future will certainly lead to new approaches and care delivery methods that will make our dermatology practices safer, more reliable, and consistent in care delivery," he wrote. "Our patients will wonder what took us so long."

Dr. Papier is the chief medical information officer for Logical Images, developer of VisualDx.

Smart Phone Apps

The number of available applications for smart phones and tablet computers has increased by more than 500% since 2009, according to Dr. Suneel Chikukuri of Baylor College of Medicine, Houston, and his colleague.

Determining which mobile applications provide the most benefit can be an overwhelming task. However, they narrowed it down, and recommended several apps most relevant for the dermatologist (Sem. Cut. Med. Surg. 2012;31:174-82).

IMNG Medical Media

The "textbook" apps Dr. Chikukuri and his colleague recommended included Fitzpatrick’s Color Atlas & Synopsis of Clinical Dermatology ($74.99), Derm Atlas ($7.99), A2Z of Dermatology ($3.99 iPhone and $2.99 iPad), and Color Atlas of Pediatric Dermatology ($129.99).

Among the continuing medical education apps they recommend are iMCQs in Dermatology ($2.99) and Dermatology In-Review Kodachrome Flashcard Series (free).

The authors also reviewed a number of diagnostic apps, specifically recommending Pocket Derm ($0.99), iRash ($2.99), Visual Dx Mobile ($150 per year), and Derm 101 (free with http://derm101.com subscription);

As for resource apps for patients, they recommended UV Index ($0.99), Skin of Mine (free), Skin Advocate (free), and CARD (free).

And lastly, for journal and news apps, they recommended Skin & Allergy News (free) and Skin Therapy Letter (free).

"Mobile platforms are revolutionizing the practice of medicine by providing convenient access to information. The aforementioned apps will help the practitioner improve their diagnostic resources without cumbersome textbooks. Patients will appreciate the up-to-date information, and the ability to better understand their diagnosis and treatments without access to a medical library," they concluded.

Dr. Chikukuri and his colleague reported having no conflicts of interest.

The iPad

The use of portable tablet computers, such as the iPad, is expanding in the clinical setting, with the devices serving as both a reference and patient education tool, reported Dr. Jeffrey T.S. Hsu of the department of dermatology at Dartmouth Medical School, Hanover, N.H, and his colleagues.

Whether the devices are used for sharing before and after photographs of cosmetic procedures, allowing patients to watch informational videos about specific procedures, or offering them the opportunity to watch a movie while waiting for topical anesthetic to take effect, tablets have the potential to increase patient satisfaction, optimize patient education, increase clinic efficiency, and enhance the overall patient experience (Sem. Cut. Med. Surg. 2012;31:200-2).

"Patients coming into the clinic for cosmetic procedures have questions, such as, ‘What will I look like after the procedure?’ and ‘Will there be scarring?’ Instead of describing the result and fueling their imagination, we give them an iPad to browse through numerous before and after photographs that serve as examples of patients who have had the same procedure," Dr. Hsu and his colleagues reported. Choosing a representative set of before and after pictures sets realistic expectations.

Among the "pros" of using the iPad is its ease of use. The device is lightweight and well suited for patients to hold one-handed while standing, sitting, or lying down. The touch screen allows for easy scrolling and zooming while viewing images. "It also simplifies categorization of photographs, allowing patients to review different examples of procedures based on location, size, gender, and ethnicity," the authors noted.

Disadvantages include the price, which is higher than many traditional notebook computers that can also be used to display pictures. Some users also find the virtual keyboard of the iPad to be cumbersome. The device can be damaged more easily than traditional notebooks, but a protective case can reduce the risk.

Optimal use of the iPad requires proper set-up with separate folders for each procedure and perhaps additional folders based on gender and ethnicity. Privacy and security are also paramount.

"Regardless of the method used to display the pictures, informed consent for using a patient’s pictures for educational purposes must be obtained prior to displaying the pictures," they wrote, noting that the device should be password protected in case it is lost or stolen.

The authors noted positive feedback from patients regarding the addition of the tablet computer during consultations. They reported having no conflicts of interest.

Digital Clinical Photography

The use of clinical photography in dermatologic practice is nothing new, and in fact has been accepted for decades as a standard means for documenting dermatologic conditions and as an adjunct to treatment. However, the emergence of high-quality, low-cost, digital imaging systems is making quality imaging more accessible to practitioners, and expanding its applications, according to William K. Witmer, director of DermaTrak Skin Imaging Centers in Fairfield, N.J., and his colleague.

Not only is clinical photography useful for documenting conditions and treatment, it is also valuable for monitoring at-risk patients and for professional and business development (Sem. Cut. Med. Surg. 2012;31:191-9).

Mr. Witmer and his colleague provided a number of tips for optimizing use, including how to select the right equipment for a particular practice – a special purpose system such as a dermatoscopic or a 3-D system may be useful for certain highly specialized practices, for example.

As for lighting systems, they recommended purchasing a camera-mounted flash for close-up photos and external studio lighting if space permits. Also, consider special purpose systems, such as ultraviolet systems, for imaging subsurface pigmentation.

"Because the outcomes of dermatology treatments typically result in a visible change to the patient’s appearance, photography is a natural adjunct to these procedures. For almost any procedure, you’ll want pictures before the treatment to establish a baseline, during the treatment to monitor progress, and at completion to document the results. Over time, these photographs will comprise a valuable professional resource," they wrote. They will also form an important part of the patient records and enable clear evidence-based communications.

Mr. Witmer’s colleague, Peter J. Lebovitz, is marketing manager at Canfield Imaging Systems in Fairfield. Mr. Witmer disclosed receiving payment for lectures from the Nevus Outreach Program.

Social Media

Patients’ use of social media for accessing medical information has accelerated, and dermatologists would do well to keep pace, according to Dr. Robin Travers.

Dr. Travers, in private practice in Chestnut Hill, Mass., provided a five-step plan for active engagement in social media applications.

Step 1: Identify audience and goals. Step 2: Research and test the waters. Step 3: Identify staff members and patients who are social media enthusiasts and enlist their help in developing social media programs. Step 4: Assess resources and select one or two platforms to focus on. Step 5: Define what success will look like and monitor progress (Sem. Cut. Med. Surg. 2012;31:168-173).

"Social Media has the potential to empower, engage, and educate patients and physicians alike. The environment has evolved beyond the simple information-retrieval capabilities of ‘Web 1.0’ to the newer ‘Web 2.0’ concept, which allows users of these social media platforms to expand certain aspects of the doctor-patient relationship well beyond the exam-room door," she wrote.

Practice strategies should facilitate awareness and management of online reputation. Professional and privacy concerns should be heeded.

Dr. Travers reported having no conflicts of interest.

Finding the Right EHR System

Electronic health records are among the hottest of hot-button issues when it comes to incorporating the latest technology into practice.

"Few issues in dermatology practice management evoke as much emotion as the topic of the use of electronic health records (EHRs)," according to Dr. Mark D. Kaufmann of the department of dermatology at Mount Sinai School of Medicine in New York, and his coauthor.

EHR systems were originally developed for primary care physicians, but the unique aspects of dermatology require a specialty-specific system.

The American Recovery and Reinvestment Act of 2009 has created incentives for adoption of EHRs. To meet the Centers for Medicare and Medicaid definition of "meaningful use," EHRS must include documentation of problem lists and active diagnoses, e-prescribing, and order entry with drug-drug interaction checks to help facilitate their use (Sem. Cut. Med. Surg. 2012;31:160-2).

"Regardless of these interventions, many practitioners are still hesitant to implement the programs. To be useful, additional dermatology-specific ER criteria must be met. This is because of the field’s broad coverage of both surgical and medical care, heavy reliance on clinical photos and diagrams, and close interaction with other specialists," they wrote.

"Consequently, EHRs that include a drawing tool function, the capability to upload and annotate files and photos, and easily interface with specialists would be most beneficial," they added.

In the long run, the advantage of a complete EHR system will outweigh the disadvantages – as long as the EHR system being used is the right one.

In addition to the basic templates and functions of a standard program, some other important EHR features for dermatologists are:

• Anatomic drawing templates – rather than typed, lengthy descriptions of anatomic locations – with full anterior and posterior views along with a close-up of the face (with anterior and lateral views), hands (with dorsal and palmar views), feet (with dorsal and plantar views), and the ear.

• Easy and accurate accessibility to biopsy results. For private dermatologists who outsource biopsies to stand-alone companies, an EHR system that provides results electronically is of great benefit.

• The ability to upload, de-identify, annotate, and attach clinical images to a patient’s record, with accessibility to the images by any physician at the institution. For specialists not in the same center, the ability to print or securely e-mail the images and annotated anatomic templates also would be helpful for correctly identifying sites of interest and for aiding in diagnosis.

• The ability to include information about distinct data, such as skin cancer type, location, size, pathology reports, date of biopsy, number of layers, and closure types. A system that collects and incorporates this data into the patient’s medical record is integral to practice efficiency.

An effective EHR system would be easy to use by all staff members and effortlessly annotated. With new tablet technology that can be easily transported to and from patient rooms, a system should allow for direct download.

With the new tablet technology, the Apple iPad and Samsung Galaxy (among others) can be integrated ino the office. EHRs can be downloaded directly onto the tablets, which can be easily transported to and from patient rooms," they wrote.

Given the current incentives – and looming disincentives – now is the time to make the switch from paper-based practices to EHRs, according to the authors. "Although initial adoption may be slow, practices will more than likely increase their efficiency in the long run," they noted.

Dr. Kaufmann reported receiving stock options from Modernizing Medicine as a member of its medical advisory board. He is chairman of the American Academy of Dermatology’s EHR Implementation Task Force, for which he receives no compensation. His colleague, Dr. Shraddha Desai, reported having no disclosures.

How willing are dermatologists to embrace new technologies and incorporate them into their practice?

"As in all areas, there are individuals that are comfortable in their ways and don’t feel the need to add ‘complexity’ to their practice since they have a system that ‘already works,’ " said Dr. Ashish Bhatia of the department of clinical dermatology at Northwestern University, Chicago.

Courtesy The Dermatology Institute, Naperville

But dermatologists are a "creative group, often seeking out new ways to utilize technology to improve their patient care," said Dr. Bhatia in an interview. Interestingly, it’s not just the "younger, tech-savvy, recent graduates" who embrace new technologies.

As for which technologies are most popular, he noted that tablet computers have become ubiquitous.

"If you are not using one to share information with your patients, you are missing out on a great opportunity. Even elderly patients love flipping through before and after pictures that help them understand an upcoming procedure. Most patients find it easy to use, and it often sparks conversation about other procedures," Dr. Bhatia said.

He was a guest editor of the September issue of Seminars in Cutaneous Medicine and Surgery, which focused on "Information Technology in Dermatology and Dermatologic Surgery." He and his colleagues delved into technologies that can help modernize today’s practice.

YouTube

"If a picture is worth 1,000 words, a video is worth 100,000 or more," wrote Dr. Bhatia and his colleagues. YouTube and other video resources provide an invaluable and revolutionary tool for educating students.

"Thousands of videos scattered on the Internet depict everything from drawing blood to performing an appendectomy, and students can access these videos to better prepare themselves for reality, that is, standing at a patient’s bedside or performing in the operating room," they noted.

Online videos, along with textbook reviews and discussions of procedural steps, have become a "routine and important tool in preparing a student," and studies have demonstrated the value of online learning (Sem. Cut. Med. Surg. 2012;31:163-7).

Advantages of this type of online learning include convenience, freedom of navigation, the option of repeated practice or viewing, and access to high-quality videos and images. This Internet resource, which allows for storage and retrieval of vast amounts of information, can greatly enhance the learning experience of both students and medical professionals if used properly.

The use of video-based online learning is increasing in dermatologic surgery, but the field remains "behind the times," – compared with gynecology and plastic surgery – in terms of the volume of high-quality videos and associated blog posts found online, they noted.

Nonetheless, there are a number of available video resources, in addition to YouTube. Keep in mind that there is a link between quality and price, they warned.

"Sites that are free to users are unregulated, content is posted in a haphazard and disorganized fashion, and [the sites] leave it up to the user to search for desired information," wrote Dr. Bhatia and his colleagues, noting that paid sites tend to have a clear focus on education, while the goal of free user-generated sites tends to be unclear.

Still, YouTube is the leading source of videographic information, including surgical videos. Surgery posts from physicians, patients, surgical equipment manufacturers, and dermatologic societies such as the American Society for Dermatologic Surgery and the American College of Mohs Surgery, can be found there.

And while YouTube serves as a new medium for education and awareness, it appears that its primary use by physicians is for advertising. "Several individual and/or group practices are leveraging the new channel to reach customers and educate them about their services. Marketing-savvy physicians are also posting patient testimonials and videos of patients discussing procedures they have undergone, such as surgical excision and Mohs surgery/reconstruction," the authors noted. Comment threads for videos indicate that patients are also using YouTube as a forum to discuss fears about upcoming procedures and to share experiences and obtain information.

"The Internet serves as a paradigm shift in how we access and share information in written form. YouTube has the potential to add to this paradigm shift in terms of visual information. However academic institutions, especially in the field of medicine and surgery, have not yet harnessed this potential," they wrote, adding that organizations with readily available educational videos, and thought leaders in dermatologic surgery could be making material available online to help self-learning physicians enhance their skill set.

Surgical Video Sources

• YouTube (Google)

• Virtual Dermsurg (Derm Education Foundation)

• Procedures Consult (Elsevier)

• MedClip (Medical Videos)

• ORLive (BroadcastMed)

• AccessSurgery (McGraw Hill)

• MedlinePlus (U.S. National Library of Medicine and National Institutes of Health)

• Medical Videos (Bliss)

Dr. Ashish Bhatia and one of his coauthors, Mr. Kyle Bhatia, are unpaid authors and editors for video content on www.VirtualDermSurg.com.

Decision Support Tools

Clinical decision support (CDS) tools have come a long way in recent years, and with increasing use and acceptance of electronic resources and mobile devices, the growing number of CDS systems can be of great benefit, according to Dr. Art Papier.

"CDS systems have the potential to increase a physician’s cognitive awareness, help them recognize their knowledge limitations, and assist with problem solving and decision making in a specific patient context," wrote Dr. Papier, of the University of Rochester, N.Y.

Specific areas of diagnostic CDS addressed by Dr. Papier include those that relate to medication reactions, geographic relationships, and allergic contact dermatitis (Sem. Cut. Med. Surg. 2012;31:153-9).

• Medication reactions. Clinicians too often fail to promptly identify, classify, and diagnose a problem, and many available CDS systems provide too little information to help. However, two CDS systems that provide fuller differentials for possible adverse drug reactions are Litt’s DERM (Drug Eruption Reference Manual) Database and the drug eruption module in VisualDx.

• Geographic relationships. There are two designed CDS systems that search by state or country for infectious disease relationships: GIDEON (Global Infectious Diseases and Epidemiology Online Network) and VisualDx. "GIDEON is a diagnostic Web application covering the relationships of more than 340 infectious diseases and 231 countries. The database is searchable by country, symptom, exposure, or medication," wrote Dr. Papier. VisualDx is similar, and also covers infectious diseases that present with cutaneous findings, and allows users to search by lesion type, endemic country, exposures, medications, laboratory findings, and body location. The systems can be especially useful for recalling the relationships between foreign travel and infectious disease exposure.

• Allergic contact dermatitis. Dr. Papier recommended the American Contact Dermatitis Society’s CARD (Contact Allergen Replacement Database), which is part of the Society’s CAMP (Contact Allergen Management Program) database. This CDS has "great potential to guide the patient history, assessment, and eventual patient recommendations" in these cases, he said.

Technology has much to offer dermatology practices.

"As we are still at the beginning of this digital revolution in health care, a future with further innovation is certain. This future will certainly lead to new approaches and care delivery methods that will make our dermatology practices safer, more reliable, and consistent in care delivery," he wrote. "Our patients will wonder what took us so long."

Dr. Papier is the chief medical information officer for Logical Images, developer of VisualDx.

Smart Phone Apps

The number of available applications for smart phones and tablet computers has increased by more than 500% since 2009, according to Dr. Suneel Chikukuri of Baylor College of Medicine, Houston, and his colleague.

Determining which mobile applications provide the most benefit can be an overwhelming task. However, they narrowed it down, and recommended several apps most relevant for the dermatologist (Sem. Cut. Med. Surg. 2012;31:174-82).

IMNG Medical Media

The "textbook" apps Dr. Chikukuri and his colleague recommended included Fitzpatrick’s Color Atlas & Synopsis of Clinical Dermatology ($74.99), Derm Atlas ($7.99), A2Z of Dermatology ($3.99 iPhone and $2.99 iPad), and Color Atlas of Pediatric Dermatology ($129.99).

Among the continuing medical education apps they recommend are iMCQs in Dermatology ($2.99) and Dermatology In-Review Kodachrome Flashcard Series (free).

The authors also reviewed a number of diagnostic apps, specifically recommending Pocket Derm ($0.99), iRash ($2.99), Visual Dx Mobile ($150 per year), and Derm 101 (free with http://derm101.com subscription);

As for resource apps for patients, they recommended UV Index ($0.99), Skin of Mine (free), Skin Advocate (free), and CARD (free).

And lastly, for journal and news apps, they recommended Skin & Allergy News (free) and Skin Therapy Letter (free).

"Mobile platforms are revolutionizing the practice of medicine by providing convenient access to information. The aforementioned apps will help the practitioner improve their diagnostic resources without cumbersome textbooks. Patients will appreciate the up-to-date information, and the ability to better understand their diagnosis and treatments without access to a medical library," they concluded.

Dr. Chikukuri and his colleague reported having no conflicts of interest.

The iPad

The use of portable tablet computers, such as the iPad, is expanding in the clinical setting, with the devices serving as both a reference and patient education tool, reported Dr. Jeffrey T.S. Hsu of the department of dermatology at Dartmouth Medical School, Hanover, N.H, and his colleagues.

Whether the devices are used for sharing before and after photographs of cosmetic procedures, allowing patients to watch informational videos about specific procedures, or offering them the opportunity to watch a movie while waiting for topical anesthetic to take effect, tablets have the potential to increase patient satisfaction, optimize patient education, increase clinic efficiency, and enhance the overall patient experience (Sem. Cut. Med. Surg. 2012;31:200-2).

"Patients coming into the clinic for cosmetic procedures have questions, such as, ‘What will I look like after the procedure?’ and ‘Will there be scarring?’ Instead of describing the result and fueling their imagination, we give them an iPad to browse through numerous before and after photographs that serve as examples of patients who have had the same procedure," Dr. Hsu and his colleagues reported. Choosing a representative set of before and after pictures sets realistic expectations.

Among the "pros" of using the iPad is its ease of use. The device is lightweight and well suited for patients to hold one-handed while standing, sitting, or lying down. The touch screen allows for easy scrolling and zooming while viewing images. "It also simplifies categorization of photographs, allowing patients to review different examples of procedures based on location, size, gender, and ethnicity," the authors noted.

Disadvantages include the price, which is higher than many traditional notebook computers that can also be used to display pictures. Some users also find the virtual keyboard of the iPad to be cumbersome. The device can be damaged more easily than traditional notebooks, but a protective case can reduce the risk.

Optimal use of the iPad requires proper set-up with separate folders for each procedure and perhaps additional folders based on gender and ethnicity. Privacy and security are also paramount.

"Regardless of the method used to display the pictures, informed consent for using a patient’s pictures for educational purposes must be obtained prior to displaying the pictures," they wrote, noting that the device should be password protected in case it is lost or stolen.

The authors noted positive feedback from patients regarding the addition of the tablet computer during consultations. They reported having no conflicts of interest.

Digital Clinical Photography

The use of clinical photography in dermatologic practice is nothing new, and in fact has been accepted for decades as a standard means for documenting dermatologic conditions and as an adjunct to treatment. However, the emergence of high-quality, low-cost, digital imaging systems is making quality imaging more accessible to practitioners, and expanding its applications, according to William K. Witmer, director of DermaTrak Skin Imaging Centers in Fairfield, N.J., and his colleague.

Not only is clinical photography useful for documenting conditions and treatment, it is also valuable for monitoring at-risk patients and for professional and business development (Sem. Cut. Med. Surg. 2012;31:191-9).

Mr. Witmer and his colleague provided a number of tips for optimizing use, including how to select the right equipment for a particular practice – a special purpose system such as a dermatoscopic or a 3-D system may be useful for certain highly specialized practices, for example.

As for lighting systems, they recommended purchasing a camera-mounted flash for close-up photos and external studio lighting if space permits. Also, consider special purpose systems, such as ultraviolet systems, for imaging subsurface pigmentation.

"Because the outcomes of dermatology treatments typically result in a visible change to the patient’s appearance, photography is a natural adjunct to these procedures. For almost any procedure, you’ll want pictures before the treatment to establish a baseline, during the treatment to monitor progress, and at completion to document the results. Over time, these photographs will comprise a valuable professional resource," they wrote. They will also form an important part of the patient records and enable clear evidence-based communications.

Mr. Witmer’s colleague, Peter J. Lebovitz, is marketing manager at Canfield Imaging Systems in Fairfield. Mr. Witmer disclosed receiving payment for lectures from the Nevus Outreach Program.

Social Media

Patients’ use of social media for accessing medical information has accelerated, and dermatologists would do well to keep pace, according to Dr. Robin Travers.

Dr. Travers, in private practice in Chestnut Hill, Mass., provided a five-step plan for active engagement in social media applications.

Step 1: Identify audience and goals. Step 2: Research and test the waters. Step 3: Identify staff members and patients who are social media enthusiasts and enlist their help in developing social media programs. Step 4: Assess resources and select one or two platforms to focus on. Step 5: Define what success will look like and monitor progress (Sem. Cut. Med. Surg. 2012;31:168-173).

"Social Media has the potential to empower, engage, and educate patients and physicians alike. The environment has evolved beyond the simple information-retrieval capabilities of ‘Web 1.0’ to the newer ‘Web 2.0’ concept, which allows users of these social media platforms to expand certain aspects of the doctor-patient relationship well beyond the exam-room door," she wrote.

Practice strategies should facilitate awareness and management of online reputation. Professional and privacy concerns should be heeded.

Dr. Travers reported having no conflicts of interest.

Finding the Right EHR System

Electronic health records are among the hottest of hot-button issues when it comes to incorporating the latest technology into practice.

"Few issues in dermatology practice management evoke as much emotion as the topic of the use of electronic health records (EHRs)," according to Dr. Mark D. Kaufmann of the department of dermatology at Mount Sinai School of Medicine in New York, and his coauthor.

EHR systems were originally developed for primary care physicians, but the unique aspects of dermatology require a specialty-specific system.

The American Recovery and Reinvestment Act of 2009 has created incentives for adoption of EHRs. To meet the Centers for Medicare and Medicaid definition of "meaningful use," EHRS must include documentation of problem lists and active diagnoses, e-prescribing, and order entry with drug-drug interaction checks to help facilitate their use (Sem. Cut. Med. Surg. 2012;31:160-2).

"Regardless of these interventions, many practitioners are still hesitant to implement the programs. To be useful, additional dermatology-specific ER criteria must be met. This is because of the field’s broad coverage of both surgical and medical care, heavy reliance on clinical photos and diagrams, and close interaction with other specialists," they wrote.

"Consequently, EHRs that include a drawing tool function, the capability to upload and annotate files and photos, and easily interface with specialists would be most beneficial," they added.

In the long run, the advantage of a complete EHR system will outweigh the disadvantages – as long as the EHR system being used is the right one.

In addition to the basic templates and functions of a standard program, some other important EHR features for dermatologists are:

• Anatomic drawing templates – rather than typed, lengthy descriptions of anatomic locations – with full anterior and posterior views along with a close-up of the face (with anterior and lateral views), hands (with dorsal and palmar views), feet (with dorsal and plantar views), and the ear.

• Easy and accurate accessibility to biopsy results. For private dermatologists who outsource biopsies to stand-alone companies, an EHR system that provides results electronically is of great benefit.

• The ability to upload, de-identify, annotate, and attach clinical images to a patient’s record, with accessibility to the images by any physician at the institution. For specialists not in the same center, the ability to print or securely e-mail the images and annotated anatomic templates also would be helpful for correctly identifying sites of interest and for aiding in diagnosis.

• The ability to include information about distinct data, such as skin cancer type, location, size, pathology reports, date of biopsy, number of layers, and closure types. A system that collects and incorporates this data into the patient’s medical record is integral to practice efficiency.

An effective EHR system would be easy to use by all staff members and effortlessly annotated. With new tablet technology that can be easily transported to and from patient rooms, a system should allow for direct download.

With the new tablet technology, the Apple iPad and Samsung Galaxy (among others) can be integrated ino the office. EHRs can be downloaded directly onto the tablets, which can be easily transported to and from patient rooms," they wrote.

Given the current incentives – and looming disincentives – now is the time to make the switch from paper-based practices to EHRs, according to the authors. "Although initial adoption may be slow, practices will more than likely increase their efficiency in the long run," they noted.

Dr. Kaufmann reported receiving stock options from Modernizing Medicine as a member of its medical advisory board. He is chairman of the American Academy of Dermatology’s EHR Implementation Task Force, for which he receives no compensation. His colleague, Dr. Shraddha Desai, reported having no disclosures.

How willing are dermatologists to embrace new technologies and incorporate them into their practice?

"As in all areas, there are individuals that are comfortable in their ways and don’t feel the need to add ‘complexity’ to their practice since they have a system that ‘already works,’ " said Dr. Ashish Bhatia of the department of clinical dermatology at Northwestern University, Chicago.

Courtesy The Dermatology Institute, Naperville

But dermatologists are a "creative group, often seeking out new ways to utilize technology to improve their patient care," said Dr. Bhatia in an interview. Interestingly, it’s not just the "younger, tech-savvy, recent graduates" who embrace new technologies.

As for which technologies are most popular, he noted that tablet computers have become ubiquitous.

"If you are not using one to share information with your patients, you are missing out on a great opportunity. Even elderly patients love flipping through before and after pictures that help them understand an upcoming procedure. Most patients find it easy to use, and it often sparks conversation about other procedures," Dr. Bhatia said.

He was a guest editor of the September issue of Seminars in Cutaneous Medicine and Surgery, which focused on "Information Technology in Dermatology and Dermatologic Surgery." He and his colleagues delved into technologies that can help modernize today’s practice.

YouTube

"If a picture is worth 1,000 words, a video is worth 100,000 or more," wrote Dr. Bhatia and his colleagues. YouTube and other video resources provide an invaluable and revolutionary tool for educating students.

"Thousands of videos scattered on the Internet depict everything from drawing blood to performing an appendectomy, and students can access these videos to better prepare themselves for reality, that is, standing at a patient’s bedside or performing in the operating room," they noted.

Online videos, along with textbook reviews and discussions of procedural steps, have become a "routine and important tool in preparing a student," and studies have demonstrated the value of online learning (Sem. Cut. Med. Surg. 2012;31:163-7).

Advantages of this type of online learning include convenience, freedom of navigation, the option of repeated practice or viewing, and access to high-quality videos and images. This Internet resource, which allows for storage and retrieval of vast amounts of information, can greatly enhance the learning experience of both students and medical professionals if used properly.

The use of video-based online learning is increasing in dermatologic surgery, but the field remains "behind the times," – compared with gynecology and plastic surgery – in terms of the volume of high-quality videos and associated blog posts found online, they noted.

Nonetheless, there are a number of available video resources, in addition to YouTube. Keep in mind that there is a link between quality and price, they warned.

"Sites that are free to users are unregulated, content is posted in a haphazard and disorganized fashion, and [the sites] leave it up to the user to search for desired information," wrote Dr. Bhatia and his colleagues, noting that paid sites tend to have a clear focus on education, while the goal of free user-generated sites tends to be unclear.

Still, YouTube is the leading source of videographic information, including surgical videos. Surgery posts from physicians, patients, surgical equipment manufacturers, and dermatologic societies such as the American Society for Dermatologic Surgery and the American College of Mohs Surgery, can be found there.

And while YouTube serves as a new medium for education and awareness, it appears that its primary use by physicians is for advertising. "Several individual and/or group practices are leveraging the new channel to reach customers and educate them about their services. Marketing-savvy physicians are also posting patient testimonials and videos of patients discussing procedures they have undergone, such as surgical excision and Mohs surgery/reconstruction," the authors noted. Comment threads for videos indicate that patients are also using YouTube as a forum to discuss fears about upcoming procedures and to share experiences and obtain information.

"The Internet serves as a paradigm shift in how we access and share information in written form. YouTube has the potential to add to this paradigm shift in terms of visual information. However academic institutions, especially in the field of medicine and surgery, have not yet harnessed this potential," they wrote, adding that organizations with readily available educational videos, and thought leaders in dermatologic surgery could be making material available online to help self-learning physicians enhance their skill set.

Surgical Video Sources

• YouTube (Google)

• Virtual Dermsurg (Derm Education Foundation)

• Procedures Consult (Elsevier)

• MedClip (Medical Videos)

• ORLive (BroadcastMed)

• AccessSurgery (McGraw Hill)

• MedlinePlus (U.S. National Library of Medicine and National Institutes of Health)

• Medical Videos (Bliss)

Dr. Ashish Bhatia and one of his coauthors, Mr. Kyle Bhatia, are unpaid authors and editors for video content on www.VirtualDermSurg.com.

Decision Support Tools

Clinical decision support (CDS) tools have come a long way in recent years, and with increasing use and acceptance of electronic resources and mobile devices, the growing number of CDS systems can be of great benefit, according to Dr. Art Papier.

"CDS systems have the potential to increase a physician’s cognitive awareness, help them recognize their knowledge limitations, and assist with problem solving and decision making in a specific patient context," wrote Dr. Papier, of the University of Rochester, N.Y.

Specific areas of diagnostic CDS addressed by Dr. Papier include those that relate to medication reactions, geographic relationships, and allergic contact dermatitis (Sem. Cut. Med. Surg. 2012;31:153-9).

• Medication reactions. Clinicians too often fail to promptly identify, classify, and diagnose a problem, and many available CDS systems provide too little information to help. However, two CDS systems that provide fuller differentials for possible adverse drug reactions are Litt’s DERM (Drug Eruption Reference Manual) Database and the drug eruption module in VisualDx.

• Geographic relationships. There are two designed CDS systems that search by state or country for infectious disease relationships: GIDEON (Global Infectious Diseases and Epidemiology Online Network) and VisualDx. "GIDEON is a diagnostic Web application covering the relationships of more than 340 infectious diseases and 231 countries. The database is searchable by country, symptom, exposure, or medication," wrote Dr. Papier. VisualDx is similar, and also covers infectious diseases that present with cutaneous findings, and allows users to search by lesion type, endemic country, exposures, medications, laboratory findings, and body location. The systems can be especially useful for recalling the relationships between foreign travel and infectious disease exposure.

• Allergic contact dermatitis. Dr. Papier recommended the American Contact Dermatitis Society’s CARD (Contact Allergen Replacement Database), which is part of the Society’s CAMP (Contact Allergen Management Program) database. This CDS has "great potential to guide the patient history, assessment, and eventual patient recommendations" in these cases, he said.

Technology has much to offer dermatology practices.

"As we are still at the beginning of this digital revolution in health care, a future with further innovation is certain. This future will certainly lead to new approaches and care delivery methods that will make our dermatology practices safer, more reliable, and consistent in care delivery," he wrote. "Our patients will wonder what took us so long."

Dr. Papier is the chief medical information officer for Logical Images, developer of VisualDx.

Smart Phone Apps

The number of available applications for smart phones and tablet computers has increased by more than 500% since 2009, according to Dr. Suneel Chikukuri of Baylor College of Medicine, Houston, and his colleague.

Determining which mobile applications provide the most benefit can be an overwhelming task. However, they narrowed it down, and recommended several apps most relevant for the dermatologist (Sem. Cut. Med. Surg. 2012;31:174-82).

IMNG Medical Media

The "textbook" apps Dr. Chikukuri and his colleague recommended included Fitzpatrick’s Color Atlas & Synopsis of Clinical Dermatology ($74.99), Derm Atlas ($7.99), A2Z of Dermatology ($3.99 iPhone and $2.99 iPad), and Color Atlas of Pediatric Dermatology ($129.99).

Among the continuing medical education apps they recommend are iMCQs in Dermatology ($2.99) and Dermatology In-Review Kodachrome Flashcard Series (free).

The authors also reviewed a number of diagnostic apps, specifically recommending Pocket Derm ($0.99), iRash ($2.99), Visual Dx Mobile ($150 per year), and Derm 101 (free with http://derm101.com subscription);

As for resource apps for patients, they recommended UV Index ($0.99), Skin of Mine (free), Skin Advocate (free), and CARD (free).

And lastly, for journal and news apps, they recommended Skin & Allergy News (free) and Skin Therapy Letter (free).

"Mobile platforms are revolutionizing the practice of medicine by providing convenient access to information. The aforementioned apps will help the practitioner improve their diagnostic resources without cumbersome textbooks. Patients will appreciate the up-to-date information, and the ability to better understand their diagnosis and treatments without access to a medical library," they concluded.

Dr. Chikukuri and his colleague reported having no conflicts of interest.

The iPad

The use of portable tablet computers, such as the iPad, is expanding in the clinical setting, with the devices serving as both a reference and patient education tool, reported Dr. Jeffrey T.S. Hsu of the department of dermatology at Dartmouth Medical School, Hanover, N.H, and his colleagues.

Whether the devices are used for sharing before and after photographs of cosmetic procedures, allowing patients to watch informational videos about specific procedures, or offering them the opportunity to watch a movie while waiting for topical anesthetic to take effect, tablets have the potential to increase patient satisfaction, optimize patient education, increase clinic efficiency, and enhance the overall patient experience (Sem. Cut. Med. Surg. 2012;31:200-2).

"Patients coming into the clinic for cosmetic procedures have questions, such as, ‘What will I look like after the procedure?’ and ‘Will there be scarring?’ Instead of describing the result and fueling their imagination, we give them an iPad to browse through numerous before and after photographs that serve as examples of patients who have had the same procedure," Dr. Hsu and his colleagues reported. Choosing a representative set of before and after pictures sets realistic expectations.

Among the "pros" of using the iPad is its ease of use. The device is lightweight and well suited for patients to hold one-handed while standing, sitting, or lying down. The touch screen allows for easy scrolling and zooming while viewing images. "It also simplifies categorization of photographs, allowing patients to review different examples of procedures based on location, size, gender, and ethnicity," the authors noted.

Disadvantages include the price, which is higher than many traditional notebook computers that can also be used to display pictures. Some users also find the virtual keyboard of the iPad to be cumbersome. The device can be damaged more easily than traditional notebooks, but a protective case can reduce the risk.

Optimal use of the iPad requires proper set-up with separate folders for each procedure and perhaps additional folders based on gender and ethnicity. Privacy and security are also paramount.

"Regardless of the method used to display the pictures, informed consent for using a patient’s pictures for educational purposes must be obtained prior to displaying the pictures," they wrote, noting that the device should be password protected in case it is lost or stolen.

The authors noted positive feedback from patients regarding the addition of the tablet computer during consultations. They reported having no conflicts of interest.

Digital Clinical Photography

The use of clinical photography in dermatologic practice is nothing new, and in fact has been accepted for decades as a standard means for documenting dermatologic conditions and as an adjunct to treatment. However, the emergence of high-quality, low-cost, digital imaging systems is making quality imaging more accessible to practitioners, and expanding its applications, according to William K. Witmer, director of DermaTrak Skin Imaging Centers in Fairfield, N.J., and his colleague.

Not only is clinical photography useful for documenting conditions and treatment, it is also valuable for monitoring at-risk patients and for professional and business development (Sem. Cut. Med. Surg. 2012;31:191-9).

Mr. Witmer and his colleague provided a number of tips for optimizing use, including how to select the right equipment for a particular practice – a special purpose system such as a dermatoscopic or a 3-D system may be useful for certain highly specialized practices, for example.

As for lighting systems, they recommended purchasing a camera-mounted flash for close-up photos and external studio lighting if space permits. Also, consider special purpose systems, such as ultraviolet systems, for imaging subsurface pigmentation.

"Because the outcomes of dermatology treatments typically result in a visible change to the patient’s appearance, photography is a natural adjunct to these procedures. For almost any procedure, you’ll want pictures before the treatment to establish a baseline, during the treatment to monitor progress, and at completion to document the results. Over time, these photographs will comprise a valuable professional resource," they wrote. They will also form an important part of the patient records and enable clear evidence-based communications.

Mr. Witmer’s colleague, Peter J. Lebovitz, is marketing manager at Canfield Imaging Systems in Fairfield. Mr. Witmer disclosed receiving payment for lectures from the Nevus Outreach Program.

Social Media

Patients’ use of social media for accessing medical information has accelerated, and dermatologists would do well to keep pace, according to Dr. Robin Travers.

Dr. Travers, in private practice in Chestnut Hill, Mass., provided a five-step plan for active engagement in social media applications.

Step 1: Identify audience and goals. Step 2: Research and test the waters. Step 3: Identify staff members and patients who are social media enthusiasts and enlist their help in developing social media programs. Step 4: Assess resources and select one or two platforms to focus on. Step 5: Define what success will look like and monitor progress (Sem. Cut. Med. Surg. 2012;31:168-173).

"Social Media has the potential to empower, engage, and educate patients and physicians alike. The environment has evolved beyond the simple information-retrieval capabilities of ‘Web 1.0’ to the newer ‘Web 2.0’ concept, which allows users of these social media platforms to expand certain aspects of the doctor-patient relationship well beyond the exam-room door," she wrote.

Practice strategies should facilitate awareness and management of online reputation. Professional and privacy concerns should be heeded.

Dr. Travers reported having no conflicts of interest.

Finding the Right EHR System

Electronic health records are among the hottest of hot-button issues when it comes to incorporating the latest technology into practice.

"Few issues in dermatology practice management evoke as much emotion as the topic of the use of electronic health records (EHRs)," according to Dr. Mark D. Kaufmann of the department of dermatology at Mount Sinai School of Medicine in New York, and his coauthor.

EHR systems were originally developed for primary care physicians, but the unique aspects of dermatology require a specialty-specific system.

The American Recovery and Reinvestment Act of 2009 has created incentives for adoption of EHRs. To meet the Centers for Medicare and Medicaid definition of "meaningful use," EHRS must include documentation of problem lists and active diagnoses, e-prescribing, and order entry with drug-drug interaction checks to help facilitate their use (Sem. Cut. Med. Surg. 2012;31:160-2).

"Regardless of these interventions, many practitioners are still hesitant to implement the programs. To be useful, additional dermatology-specific ER criteria must be met. This is because of the field’s broad coverage of both surgical and medical care, heavy reliance on clinical photos and diagrams, and close interaction with other specialists," they wrote.

"Consequently, EHRs that include a drawing tool function, the capability to upload and annotate files and photos, and easily interface with specialists would be most beneficial," they added.

In the long run, the advantage of a complete EHR system will outweigh the disadvantages – as long as the EHR system being used is the right one.

In addition to the basic templates and functions of a standard program, some other important EHR features for dermatologists are:

• Anatomic drawing templates – rather than typed, lengthy descriptions of anatomic locations – with full anterior and posterior views along with a close-up of the face (with anterior and lateral views), hands (with dorsal and palmar views), feet (with dorsal and plantar views), and the ear.

• Easy and accurate accessibility to biopsy results. For private dermatologists who outsource biopsies to stand-alone companies, an EHR system that provides results electronically is of great benefit.

• The ability to upload, de-identify, annotate, and attach clinical images to a patient’s record, with accessibility to the images by any physician at the institution. For specialists not in the same center, the ability to print or securely e-mail the images and annotated anatomic templates also would be helpful for correctly identifying sites of interest and for aiding in diagnosis.

• The ability to include information about distinct data, such as skin cancer type, location, size, pathology reports, date of biopsy, number of layers, and closure types. A system that collects and incorporates this data into the patient’s medical record is integral to practice efficiency.

An effective EHR system would be easy to use by all staff members and effortlessly annotated. With new tablet technology that can be easily transported to and from patient rooms, a system should allow for direct download.

With the new tablet technology, the Apple iPad and Samsung Galaxy (among others) can be integrated ino the office. EHRs can be downloaded directly onto the tablets, which can be easily transported to and from patient rooms," they wrote.

Given the current incentives – and looming disincentives – now is the time to make the switch from paper-based practices to EHRs, according to the authors. "Although initial adoption may be slow, practices will more than likely increase their efficiency in the long run," they noted.

Dr. Kaufmann reported receiving stock options from Modernizing Medicine as a member of its medical advisory board. He is chairman of the American Academy of Dermatology’s EHR Implementation Task Force, for which he receives no compensation. His colleague, Dr. Shraddha Desai, reported having no disclosures.

The Agency for Healthcare Research and Quality’s Comprehensive Unit–Based Safety Program has proved effective for helping clinical teams tackle tough patient safety issues, and now the agency has introduced a tool kit to assist with implementation of the program nationwide.

The Comprehensive Unit–Based Safety Program, or CUSP, is a science-based change package initially conceived by Dr. Peter J. Pronovost of Johns Hopkins University, Baltimore, to help prevent potentially deadly central line-associated blood stream infections (CLABSIs) in hospital intensive care units, but with the help of the new tool kit developed with funding from the AHRQ, the program can be applied to any safety problem at the unit level. Numerous studies have demonstrated the effectiveness of the program for lowering infection rates, and preliminary results from a national study confirm those findings.

Implementation of CUSP at more than 1,100 adult intensive care units in 44 states over a 4-year period reduced the rate of CLABSIs by 40%, Dr. Carolyn M. Clancy, director of AHRQ, reported during a press conference held in conjunction with the AHRQ annual conference.

"This program offers hope for us about what’s possible when policy makers invest in the science of safety."

"That’s not just a number," she said, stressing that the 40% reduction equates to 500 lives saved, 2,000 CLABSIs prevented, and $34 million in health care costs avoided.

Some hospitals were able to achieve even better results, reducing the rate of CLABSIs to zero, she said.

One such hospital is Peterson Regional Medical Center in Kerrville, Tex., which has had zero CLABSIs in the entire hospital for more than 30 months since implementing CUSP.

"In my 32 years as a nurse, the CUSP program is the most powerful program I have ever seen," said Theresa Hickman, a nurse educator and the team leader for the 124-bed hospital’s participation in the national initiative.

Historically, those on the front lines in health care – such as nurses – have not been included in safety programs, but CUSP turns that model on its head, empowering frontline caregivers to make a difference, she said.

Indeed, CUSP combines clinical best practices with an understanding of the science of safety and improved patient safety culture to empower hospital teams to address identified safety issues, Dr. Clancy said.

The Society for Healthcare Epidemiology of America agreed. Within CUSP, "members of the health care team feel comfortable speaking up and learning as a team the lessons learned of each preventable infection. This demonstrated success shows culture change is possible by involving every member of the health care team in an effort that combines science with implementation," Dr. Jan Patterson, SHEA president, said in a statement. Dr. Patterson is director of the Center for Patient Safety and Health Policy at the University of Texas Health Science Center in San Antonio.

The tool kit is a multipronged quality improvement program developed by clinicians for clinicians. It is "modular, customizable, and self-paced," she said, noting that the package includes step-by-step instructor guides, presentation materials, implementation tools, and instructional videos, all of which can be used to address any patient safety issue.

Some of the hospitals that have successfully used the CUSP tool kit to reduce CLABSIs are now using it to fight other types of infections as well, such as urinary tract infections and ventilator-associated pneumonia, she said, noting that the tool kit can be modified to meet the unique needs of a specific unit, and that the concept of CUSP can be implemented facility-wide.

An important lesson from the dramatic results seen with CUSP is that health care–related infections should not be seen as an unfortunate but inevitable consequence of care.

"No one should become sicker due to the care they receive," she said, adding that results of the study have changed the idea of what is possible.

Rich Umbdenstock, president and chief executive officer of the American Hospital Association, which collaborated with AHRQ on promoting and implementing CUSP, agreed, saying that "by working together, we can achieve these positive results on a national level."

Already, hospitals are achieving infection rates previously believed impossible, Dr. Pronovost said, noting that "this could be health care’s ‘man on the moon’ moment."

"With these results, health care is taking a giant step forward ... this program offers hope for us about what’s possible when policy makers invest in the science of safety," he said.

The speakers reported having no relevant conflicts of interest.

The Agency for Healthcare Research and Quality’s Comprehensive Unit–Based Safety Program has proved effective for helping clinical teams tackle tough patient safety issues, and now the agency has introduced a tool kit to assist with implementation of the program nationwide.

The Comprehensive Unit–Based Safety Program, or CUSP, is a science-based change package initially conceived by Dr. Peter J. Pronovost of Johns Hopkins University, Baltimore, to help prevent potentially deadly central line-associated blood stream infections (CLABSIs) in hospital intensive care units, but with the help of the new tool kit developed with funding from the AHRQ, the program can be applied to any safety problem at the unit level. Numerous studies have demonstrated the effectiveness of the program for lowering infection rates, and preliminary results from a national study confirm those findings.

Implementation of CUSP at more than 1,100 adult intensive care units in 44 states over a 4-year period reduced the rate of CLABSIs by 40%, Dr. Carolyn M. Clancy, director of AHRQ, reported during a press conference held in conjunction with the AHRQ annual conference.

"This program offers hope for us about what’s possible when policy makers invest in the science of safety."

"That’s not just a number," she said, stressing that the 40% reduction equates to 500 lives saved, 2,000 CLABSIs prevented, and $34 million in health care costs avoided.

Some hospitals were able to achieve even better results, reducing the rate of CLABSIs to zero, she said.

One such hospital is Peterson Regional Medical Center in Kerrville, Tex., which has had zero CLABSIs in the entire hospital for more than 30 months since implementing CUSP.

"In my 32 years as a nurse, the CUSP program is the most powerful program I have ever seen," said Theresa Hickman, a nurse educator and the team leader for the 124-bed hospital’s participation in the national initiative.

Historically, those on the front lines in health care – such as nurses – have not been included in safety programs, but CUSP turns that model on its head, empowering frontline caregivers to make a difference, she said.

Indeed, CUSP combines clinical best practices with an understanding of the science of safety and improved patient safety culture to empower hospital teams to address identified safety issues, Dr. Clancy said.

The Society for Healthcare Epidemiology of America agreed. Within CUSP, "members of the health care team feel comfortable speaking up and learning as a team the lessons learned of each preventable infection. This demonstrated success shows culture change is possible by involving every member of the health care team in an effort that combines science with implementation," Dr. Jan Patterson, SHEA president, said in a statement. Dr. Patterson is director of the Center for Patient Safety and Health Policy at the University of Texas Health Science Center in San Antonio.

The tool kit is a multipronged quality improvement program developed by clinicians for clinicians. It is "modular, customizable, and self-paced," she said, noting that the package includes step-by-step instructor guides, presentation materials, implementation tools, and instructional videos, all of which can be used to address any patient safety issue.

Some of the hospitals that have successfully used the CUSP tool kit to reduce CLABSIs are now using it to fight other types of infections as well, such as urinary tract infections and ventilator-associated pneumonia, she said, noting that the tool kit can be modified to meet the unique needs of a specific unit, and that the concept of CUSP can be implemented facility-wide.

An important lesson from the dramatic results seen with CUSP is that health care–related infections should not be seen as an unfortunate but inevitable consequence of care.

"No one should become sicker due to the care they receive," she said, adding that results of the study have changed the idea of what is possible.

Rich Umbdenstock, president and chief executive officer of the American Hospital Association, which collaborated with AHRQ on promoting and implementing CUSP, agreed, saying that "by working together, we can achieve these positive results on a national level."

Already, hospitals are achieving infection rates previously believed impossible, Dr. Pronovost said, noting that "this could be health care’s ‘man on the moon’ moment."

"With these results, health care is taking a giant step forward ... this program offers hope for us about what’s possible when policy makers invest in the science of safety," he said.

The speakers reported having no relevant conflicts of interest.

The Agency for Healthcare Research and Quality’s Comprehensive Unit–Based Safety Program has proved effective for helping clinical teams tackle tough patient safety issues, and now the agency has introduced a tool kit to assist with implementation of the program nationwide.

The Comprehensive Unit–Based Safety Program, or CUSP, is a science-based change package initially conceived by Dr. Peter J. Pronovost of Johns Hopkins University, Baltimore, to help prevent potentially deadly central line-associated blood stream infections (CLABSIs) in hospital intensive care units, but with the help of the new tool kit developed with funding from the AHRQ, the program can be applied to any safety problem at the unit level. Numerous studies have demonstrated the effectiveness of the program for lowering infection rates, and preliminary results from a national study confirm those findings.

Implementation of CUSP at more than 1,100 adult intensive care units in 44 states over a 4-year period reduced the rate of CLABSIs by 40%, Dr. Carolyn M. Clancy, director of AHRQ, reported during a press conference held in conjunction with the AHRQ annual conference.

"This program offers hope for us about what’s possible when policy makers invest in the science of safety."

"That’s not just a number," she said, stressing that the 40% reduction equates to 500 lives saved, 2,000 CLABSIs prevented, and $34 million in health care costs avoided.

Some hospitals were able to achieve even better results, reducing the rate of CLABSIs to zero, she said.

One such hospital is Peterson Regional Medical Center in Kerrville, Tex., which has had zero CLABSIs in the entire hospital for more than 30 months since implementing CUSP.

"In my 32 years as a nurse, the CUSP program is the most powerful program I have ever seen," said Theresa Hickman, a nurse educator and the team leader for the 124-bed hospital’s participation in the national initiative.

Historically, those on the front lines in health care – such as nurses – have not been included in safety programs, but CUSP turns that model on its head, empowering frontline caregivers to make a difference, she said.

Indeed, CUSP combines clinical best practices with an understanding of the science of safety and improved patient safety culture to empower hospital teams to address identified safety issues, Dr. Clancy said.

The Society for Healthcare Epidemiology of America agreed. Within CUSP, "members of the health care team feel comfortable speaking up and learning as a team the lessons learned of each preventable infection. This demonstrated success shows culture change is possible by involving every member of the health care team in an effort that combines science with implementation," Dr. Jan Patterson, SHEA president, said in a statement. Dr. Patterson is director of the Center for Patient Safety and Health Policy at the University of Texas Health Science Center in San Antonio.

The tool kit is a multipronged quality improvement program developed by clinicians for clinicians. It is "modular, customizable, and self-paced," she said, noting that the package includes step-by-step instructor guides, presentation materials, implementation tools, and instructional videos, all of which can be used to address any patient safety issue.

Some of the hospitals that have successfully used the CUSP tool kit to reduce CLABSIs are now using it to fight other types of infections as well, such as urinary tract infections and ventilator-associated pneumonia, she said, noting that the tool kit can be modified to meet the unique needs of a specific unit, and that the concept of CUSP can be implemented facility-wide.

An important lesson from the dramatic results seen with CUSP is that health care–related infections should not be seen as an unfortunate but inevitable consequence of care.

"No one should become sicker due to the care they receive," she said, adding that results of the study have changed the idea of what is possible.

Rich Umbdenstock, president and chief executive officer of the American Hospital Association, which collaborated with AHRQ on promoting and implementing CUSP, agreed, saying that "by working together, we can achieve these positive results on a national level."

Already, hospitals are achieving infection rates previously believed impossible, Dr. Pronovost said, noting that "this could be health care’s ‘man on the moon’ moment."

"With these results, health care is taking a giant step forward ... this program offers hope for us about what’s possible when policy makers invest in the science of safety," he said.

The speakers reported having no relevant conflicts of interest.

Flat affect is common following first-episode psychosis, fluctuates more than the literature suggests, and is associated with poorer functioning.

The findings, noted in a 10-year Scandinavian follow-up study of more than 180 patients, also show that enduring flat affect, though relatively rare, is particularly associated with poorer social functioning, Dr. Julie Evensen of Oslo University Hospital and her colleagues reported in Schizophrenia Research.

Of 301 patients enrolled between 1997 and 2000 in the Early Treatment and Intervention in First-Episode Psychosis (TIPS) trial, a longitudinal study of consecutively admitted patients, 184 completed a 10-year follow-up. Of these, 66% displayed flat affect and had either improvement (10%), deterioration (16%), or fluctuation (40%) of their flat affect. At 10 years, 41% had clinically significant flat affect, but only 5% had enduring flat affect across the entire follow-up period, the investigators reported (Schizophr. Res. 2012;139:99-104).

The group of patients who never displayed flat affect achieved the best scores on most clinical and functional variables, and the group with enduring flat affect had the poorest scores.

This trend was most pronounced for social function scores on the Premorbid Assessment of Functioning Scale, or PAS (scores of 1.12 and 3.17, respectively), and for negative symptoms assessed using the Positive and Negative Syndrome Scale, or PANSS (negative symptom scores of 16.0 and 30.4, respectively), they said, noting that the differences in these instances were statistically significant.

The strongest predictor of enduring flat affect was PAS social last score (odds ratio, 1.9).

As for differences between the groups at 10 years, PANSS symptom component scores showed that the group of patients who never displayed flat affect scored significantly lower than both the deteriorating and fluctuating groups on both positive and cognitive components.

"On the general negative component, the never-present and the improving groups scored statistically significantly lower than the remaining groups. No statistically significant differences were found on the depressive or excitative components. In the enduring group, all patients fulfilled criteria for schizophrenia spectrum disorders at 10-year follow-up," they noted.

In addition, the fluctuating, deteriorating, and enduring groups were psychotic for statistically significantly longer during the follow-up period, and fewer were in remission or recovery after 10 years, the investigators said, noting that these groups also had poorer function as determined based on employment status, reduced ability to live independently, and lower Global Assessment of Functioning general function (GAF-F) scores. Objective measures of social function during follow-up demonstrated statistically significant differences between the enduring group and the other groups at all assessments.

Even after all analyses were repeated on schizophrenia spectrum patients, little change was seen in group distribution, and only small differences were seen with respect to baseline variables and outcome measures at 10 years compared with analyses of the full sample, they noted.

"Social premorbid function remained the most important predictor of enduring flat affect, and social function from baseline to 10 years remained significantly poorer in the enduring flat affect group compared to the other groups," they wrote.

Study participants were adults aged 18-65 years from four Scandinavian catchment sites. First-episode psychosis was defined by a PANSS score of 4 or more on one or more positive subscale items 1, 3, 5, or 6, or on general subscale 9 for at least 7 days. They also met DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic episode, delusional disorder, affective psychosis with mood-incongruent psychotic features or psychotic disorder not otherwise specified, and an IQ of at least 70. Assessments were conducted at baseline, at 3 months, and at 1, 2, 5, and 10 years.

The findings contrast with those from prior, smaller studies, in that the current study shows greater instability with respect to flat affect, and the results underscore the importance of early identification of patients with flat affect as these patients appear particularly vulnerable, the investigators noted.

"We found that the enduring group was similar to the remaining patients on most baseline variables, but differed significantly in premorbid social functioning. Reduced display of affect has been found in the children who later developed schizophrenia compared to their siblings who did not develop schizophrenia. The combination of flat affect and poor social functioning could potentially be present from early stages in the life of a child vulnerable to psychotic illness," they explained.

Though limited by the use of a single-item measure of flat affect, the study is unique in that it "explores a large and representative group of first-episode psychosis patients 10 years after their first psychotic episode with a particular focus on different flat affect trajectories." Another strength of the TIPS study is its strict focus on reliability testing throughout the follow-up period, the investigators noted, concluding that the findings – particularly the finding that flat affect, especially when enduring, is related to poorer functioning and poorer social functioning – pose a challenge to clinicians to "target, track, and engage those particularly vulnerable groups within a first-episode psychosis sample."

This study was supported by several entities, including Health West, Norway; the Norwegian National Research Council; Lundbeck Pharma; Eli Lilly; the U.S. National Alliance for Research on Schizophrenia and Depression; and the U.S. National Institute of Mental Health. The authors reported having no relevant conflicts of interest.

Flat affect is common following first-episode psychosis, fluctuates more than the literature suggests, and is associated with poorer functioning.

The findings, noted in a 10-year Scandinavian follow-up study of more than 180 patients, also show that enduring flat affect, though relatively rare, is particularly associated with poorer social functioning, Dr. Julie Evensen of Oslo University Hospital and her colleagues reported in Schizophrenia Research.

Of 301 patients enrolled between 1997 and 2000 in the Early Treatment and Intervention in First-Episode Psychosis (TIPS) trial, a longitudinal study of consecutively admitted patients, 184 completed a 10-year follow-up. Of these, 66% displayed flat affect and had either improvement (10%), deterioration (16%), or fluctuation (40%) of their flat affect. At 10 years, 41% had clinically significant flat affect, but only 5% had enduring flat affect across the entire follow-up period, the investigators reported (Schizophr. Res. 2012;139:99-104).

The group of patients who never displayed flat affect achieved the best scores on most clinical and functional variables, and the group with enduring flat affect had the poorest scores.

This trend was most pronounced for social function scores on the Premorbid Assessment of Functioning Scale, or PAS (scores of 1.12 and 3.17, respectively), and for negative symptoms assessed using the Positive and Negative Syndrome Scale, or PANSS (negative symptom scores of 16.0 and 30.4, respectively), they said, noting that the differences in these instances were statistically significant.

The strongest predictor of enduring flat affect was PAS social last score (odds ratio, 1.9).

As for differences between the groups at 10 years, PANSS symptom component scores showed that the group of patients who never displayed flat affect scored significantly lower than both the deteriorating and fluctuating groups on both positive and cognitive components.

"On the general negative component, the never-present and the improving groups scored statistically significantly lower than the remaining groups. No statistically significant differences were found on the depressive or excitative components. In the enduring group, all patients fulfilled criteria for schizophrenia spectrum disorders at 10-year follow-up," they noted.

In addition, the fluctuating, deteriorating, and enduring groups were psychotic for statistically significantly longer during the follow-up period, and fewer were in remission or recovery after 10 years, the investigators said, noting that these groups also had poorer function as determined based on employment status, reduced ability to live independently, and lower Global Assessment of Functioning general function (GAF-F) scores. Objective measures of social function during follow-up demonstrated statistically significant differences between the enduring group and the other groups at all assessments.

Even after all analyses were repeated on schizophrenia spectrum patients, little change was seen in group distribution, and only small differences were seen with respect to baseline variables and outcome measures at 10 years compared with analyses of the full sample, they noted.

"Social premorbid function remained the most important predictor of enduring flat affect, and social function from baseline to 10 years remained significantly poorer in the enduring flat affect group compared to the other groups," they wrote.

Study participants were adults aged 18-65 years from four Scandinavian catchment sites. First-episode psychosis was defined by a PANSS score of 4 or more on one or more positive subscale items 1, 3, 5, or 6, or on general subscale 9 for at least 7 days. They also met DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic episode, delusional disorder, affective psychosis with mood-incongruent psychotic features or psychotic disorder not otherwise specified, and an IQ of at least 70. Assessments were conducted at baseline, at 3 months, and at 1, 2, 5, and 10 years.

The findings contrast with those from prior, smaller studies, in that the current study shows greater instability with respect to flat affect, and the results underscore the importance of early identification of patients with flat affect as these patients appear particularly vulnerable, the investigators noted.

"We found that the enduring group was similar to the remaining patients on most baseline variables, but differed significantly in premorbid social functioning. Reduced display of affect has been found in the children who later developed schizophrenia compared to their siblings who did not develop schizophrenia. The combination of flat affect and poor social functioning could potentially be present from early stages in the life of a child vulnerable to psychotic illness," they explained.

Though limited by the use of a single-item measure of flat affect, the study is unique in that it "explores a large and representative group of first-episode psychosis patients 10 years after their first psychotic episode with a particular focus on different flat affect trajectories." Another strength of the TIPS study is its strict focus on reliability testing throughout the follow-up period, the investigators noted, concluding that the findings – particularly the finding that flat affect, especially when enduring, is related to poorer functioning and poorer social functioning – pose a challenge to clinicians to "target, track, and engage those particularly vulnerable groups within a first-episode psychosis sample."

This study was supported by several entities, including Health West, Norway; the Norwegian National Research Council; Lundbeck Pharma; Eli Lilly; the U.S. National Alliance for Research on Schizophrenia and Depression; and the U.S. National Institute of Mental Health. The authors reported having no relevant conflicts of interest.

Flat affect is common following first-episode psychosis, fluctuates more than the literature suggests, and is associated with poorer functioning.

The findings, noted in a 10-year Scandinavian follow-up study of more than 180 patients, also show that enduring flat affect, though relatively rare, is particularly associated with poorer social functioning, Dr. Julie Evensen of Oslo University Hospital and her colleagues reported in Schizophrenia Research.

Of 301 patients enrolled between 1997 and 2000 in the Early Treatment and Intervention in First-Episode Psychosis (TIPS) trial, a longitudinal study of consecutively admitted patients, 184 completed a 10-year follow-up. Of these, 66% displayed flat affect and had either improvement (10%), deterioration (16%), or fluctuation (40%) of their flat affect. At 10 years, 41% had clinically significant flat affect, but only 5% had enduring flat affect across the entire follow-up period, the investigators reported (Schizophr. Res. 2012;139:99-104).

The group of patients who never displayed flat affect achieved the best scores on most clinical and functional variables, and the group with enduring flat affect had the poorest scores.

This trend was most pronounced for social function scores on the Premorbid Assessment of Functioning Scale, or PAS (scores of 1.12 and 3.17, respectively), and for negative symptoms assessed using the Positive and Negative Syndrome Scale, or PANSS (negative symptom scores of 16.0 and 30.4, respectively), they said, noting that the differences in these instances were statistically significant.

The strongest predictor of enduring flat affect was PAS social last score (odds ratio, 1.9).

As for differences between the groups at 10 years, PANSS symptom component scores showed that the group of patients who never displayed flat affect scored significantly lower than both the deteriorating and fluctuating groups on both positive and cognitive components.

"On the general negative component, the never-present and the improving groups scored statistically significantly lower than the remaining groups. No statistically significant differences were found on the depressive or excitative components. In the enduring group, all patients fulfilled criteria for schizophrenia spectrum disorders at 10-year follow-up," they noted.

In addition, the fluctuating, deteriorating, and enduring groups were psychotic for statistically significantly longer during the follow-up period, and fewer were in remission or recovery after 10 years, the investigators said, noting that these groups also had poorer function as determined based on employment status, reduced ability to live independently, and lower Global Assessment of Functioning general function (GAF-F) scores. Objective measures of social function during follow-up demonstrated statistically significant differences between the enduring group and the other groups at all assessments.

Even after all analyses were repeated on schizophrenia spectrum patients, little change was seen in group distribution, and only small differences were seen with respect to baseline variables and outcome measures at 10 years compared with analyses of the full sample, they noted.

"Social premorbid function remained the most important predictor of enduring flat affect, and social function from baseline to 10 years remained significantly poorer in the enduring flat affect group compared to the other groups," they wrote.

Study participants were adults aged 18-65 years from four Scandinavian catchment sites. First-episode psychosis was defined by a PANSS score of 4 or more on one or more positive subscale items 1, 3, 5, or 6, or on general subscale 9 for at least 7 days. They also met DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic episode, delusional disorder, affective psychosis with mood-incongruent psychotic features or psychotic disorder not otherwise specified, and an IQ of at least 70. Assessments were conducted at baseline, at 3 months, and at 1, 2, 5, and 10 years.

The findings contrast with those from prior, smaller studies, in that the current study shows greater instability with respect to flat affect, and the results underscore the importance of early identification of patients with flat affect as these patients appear particularly vulnerable, the investigators noted.

"We found that the enduring group was similar to the remaining patients on most baseline variables, but differed significantly in premorbid social functioning. Reduced display of affect has been found in the children who later developed schizophrenia compared to their siblings who did not develop schizophrenia. The combination of flat affect and poor social functioning could potentially be present from early stages in the life of a child vulnerable to psychotic illness," they explained.

Though limited by the use of a single-item measure of flat affect, the study is unique in that it "explores a large and representative group of first-episode psychosis patients 10 years after their first psychotic episode with a particular focus on different flat affect trajectories." Another strength of the TIPS study is its strict focus on reliability testing throughout the follow-up period, the investigators noted, concluding that the findings – particularly the finding that flat affect, especially when enduring, is related to poorer functioning and poorer social functioning – pose a challenge to clinicians to "target, track, and engage those particularly vulnerable groups within a first-episode psychosis sample."

This study was supported by several entities, including Health West, Norway; the Norwegian National Research Council; Lundbeck Pharma; Eli Lilly; the U.S. National Alliance for Research on Schizophrenia and Depression; and the U.S. National Institute of Mental Health. The authors reported having no relevant conflicts of interest.

Two novel "next generation" mechanical flow restoration devices, or "clot retrievers," show promise for improving the treatment of stroke patients who fail or aren’t eligible for treatment with tissue plasminogen activator, according to findings from separate randomized controlled clinical trials.

In the SWIFT (Solitaire With the Intention of Thrombectomy) trial, the new Solitaire flow restoration device, a self-expanding stent retriever designed to restore blood flow in patients with ischemic stroke due to a large intracranial vessel occlusion, proved significantly more likely to successfully recanalize occlusions of the proximal cerebral arteries than did the Merci retriever, a first-generation mechanical thrombectomy device approved for use in 2004. The results showed that 58 patients treated with the Solitaire device had nearly fivefold greater odds of meeting the primary end point of a Thrombolysis in Myocardial Ischemia (TIMI) scale 2 or 3 flow in all treatable vessels than did 55 patients treated with the Merci retriever (61% vs. 24%; odds ratio, 4.87).

In another trial called TREVO 2, 88 patients treated with the new Trevo Retriever, a stentlike device similar to the Solitaire device, had greater than fourfold higher odds of successful revascularization than did 90 patients treated with the Merci retriever (86% vs. 60%; OR, 4.22). This trial used a slightly different definition of successful recanalization than did the SWIFT trial, defining it as a Thrombolysis in Cerebral Infarction (TICI) score of 2 or greater.

The findings of both trials were published Aug. 26 in the Lancet and were simultaneously presented at the annual congress of the European Society of Cardiology.

Dr. Jeffrey L. Saver of the University of California, Los Angeles, and his colleagues enrolled patients in the SWIFT trial at 18 sites between February 2010 and February 2011, if they had acute ischemic stroke with moderate to severe neurological deficits and angiographically confirmed occlusions of the proximal cerebral arteries, that were treatable by thrombectomy within 8 hours of symptom onset.

In addition to the greater likelihood of achieving the primary end point, the Solitaire patients were more likely to have good 90-day neurological outcomes (58% vs. 33%; OR, 2.78), and to require fewer passes with the device (mean of 1.7 vs. 2.2 passes), the investigators said (Lancet 2012 Aug. 26 [doi: 10.1016/S0140-6736(12)61384-1]).

Furthermore, the frequency of total device-related and procedure-related adverse events did not differ between the two groups, and the 90-day mortality rate was lower in the Solitaire group (OR, 0.29 after adjusting for age and time to treatment), the investigators said.

"On the basis of these results, when endovascular recanalization is done in patients with acute ischemic stroke, initial treatment with Solitaire might be a future treatment of choice," they concluded.

Dr. Raul G. Nogueira of Emory University in Atlanta and his colleagues enrolled patients in the TREVO 2 trial at 26 sites between February 2011 and December 2011, if they had acute onset of stroke symptoms leading to significant clinical deficits, angiographically proven occlusion of a proximal intracranial artery, and eligibility for endovascular therapy within 8 hours of symptom onset.

In addition to the greater likelihood of achieving the primary end point, the Trevo patients were less likely to require adjunctive treatment of any kind (18% vs. 31%; OR, 0.49), and after adjunctive interventions, the rate of TICI 2 or greater reperfusion was higher in the Trevo patients, the investigators said (Lancet 2012 Aug. 26 [doi: 10.1016/S0140-6736(12)61299-9]).

The Trevo patients also were more likely to have good 90-day functional outcomes (40% vs. 22%; OR, 2.39).

No significant differences were seen between the Trevo and Merci patients with respect to the primary safety end point (a composite of multiple device- and procedure-related events), although vessel perforations were 10 times more common with the Merci device, the investigators reported.

Mortality was also similar in both groups at 30 and 90 days.

The investigators noted that although the Trevo device was not compared with medical treatment alone in this study, the findings are encouraging when considered in the context of those from studies of the Trevo predecessor – PROACT II. In the current study, patients treated using the Trevo Retriever achieved the same rate of good clinical outcomes as reported in a pro-urokinase group in the PROACT II trial despite older age, higher baseline National Institutes of Health Stroke Scale score, more proximal occlusions, and more refractory occlusions.

"Our results are therefore encouraging and support the use of the Trevo Retriever in a prospective randomized trial of endovascular therapy against medical treatment alone," the investigators concluded.

As for how the Solitaire and Trevo devices compare with each other, no conclusions can be drawn from SWIFT and TREVO 2 because the two studies used different definitions of reperfusion and good neurological outcomes. However, the devices, both of which have been cleared for general use in the United States and Europe, appear to have a similar or better safety profile than the Merci retriever, and the results thus far suggest that "significant improvement could be forthcoming in stroke patients for whom drug treatment is ineffective," according to a Lancet press statement.

The SWIFT trial was funded by Covidien/ev3, the maker of the Solitaire device. TREVO 2 was funded by Stryker Neurological, the maker of Trevo. Many of the investigators disclosed conflicts of interest involving Covidien/ev3 Neurovascular or Stryker Neurological, as well as other manufacturers of endovascular therapies for stroke.

Two novel "next generation" mechanical flow restoration devices, or "clot retrievers," show promise for improving the treatment of stroke patients who fail or aren’t eligible for treatment with tissue plasminogen activator, according to findings from separate randomized controlled clinical trials.

In the SWIFT (Solitaire With the Intention of Thrombectomy) trial, the new Solitaire flow restoration device, a self-expanding stent retriever designed to restore blood flow in patients with ischemic stroke due to a large intracranial vessel occlusion, proved significantly more likely to successfully recanalize occlusions of the proximal cerebral arteries than did the Merci retriever, a first-generation mechanical thrombectomy device approved for use in 2004. The results showed that 58 patients treated with the Solitaire device had nearly fivefold greater odds of meeting the primary end point of a Thrombolysis in Myocardial Ischemia (TIMI) scale 2 or 3 flow in all treatable vessels than did 55 patients treated with the Merci retriever (61% vs. 24%; odds ratio, 4.87).

In another trial called TREVO 2, 88 patients treated with the new Trevo Retriever, a stentlike device similar to the Solitaire device, had greater than fourfold higher odds of successful revascularization than did 90 patients treated with the Merci retriever (86% vs. 60%; OR, 4.22). This trial used a slightly different definition of successful recanalization than did the SWIFT trial, defining it as a Thrombolysis in Cerebral Infarction (TICI) score of 2 or greater.

The findings of both trials were published Aug. 26 in the Lancet and were simultaneously presented at the annual congress of the European Society of Cardiology.

Dr. Jeffrey L. Saver of the University of California, Los Angeles, and his colleagues enrolled patients in the SWIFT trial at 18 sites between February 2010 and February 2011, if they had acute ischemic stroke with moderate to severe neurological deficits and angiographically confirmed occlusions of the proximal cerebral arteries, that were treatable by thrombectomy within 8 hours of symptom onset.

In addition to the greater likelihood of achieving the primary end point, the Solitaire patients were more likely to have good 90-day neurological outcomes (58% vs. 33%; OR, 2.78), and to require fewer passes with the device (mean of 1.7 vs. 2.2 passes), the investigators said (Lancet 2012 Aug. 26 [doi: 10.1016/S0140-6736(12)61384-1]).

Furthermore, the frequency of total device-related and procedure-related adverse events did not differ between the two groups, and the 90-day mortality rate was lower in the Solitaire group (OR, 0.29 after adjusting for age and time to treatment), the investigators said.

"On the basis of these results, when endovascular recanalization is done in patients with acute ischemic stroke, initial treatment with Solitaire might be a future treatment of choice," they concluded.

Dr. Raul G. Nogueira of Emory University in Atlanta and his colleagues enrolled patients in the TREVO 2 trial at 26 sites between February 2011 and December 2011, if they had acute onset of stroke symptoms leading to significant clinical deficits, angiographically proven occlusion of a proximal intracranial artery, and eligibility for endovascular therapy within 8 hours of symptom onset.

In addition to the greater likelihood of achieving the primary end point, the Trevo patients were less likely to require adjunctive treatment of any kind (18% vs. 31%; OR, 0.49), and after adjunctive interventions, the rate of TICI 2 or greater reperfusion was higher in the Trevo patients, the investigators said (Lancet 2012 Aug. 26 [doi: 10.1016/S0140-6736(12)61299-9]).

The Trevo patients also were more likely to have good 90-day functional outcomes (40% vs. 22%; OR, 2.39).

No significant differences were seen between the Trevo and Merci patients with respect to the primary safety end point (a composite of multiple device- and procedure-related events), although vessel perforations were 10 times more common with the Merci device, the investigators reported.

Mortality was also similar in both groups at 30 and 90 days.

The investigators noted that although the Trevo device was not compared with medical treatment alone in this study, the findings are encouraging when considered in the context of those from studies of the Trevo predecessor – PROACT II. In the current study, patients treated using the Trevo Retriever achieved the same rate of good clinical outcomes as reported in a pro-urokinase group in the PROACT II trial despite older age, higher baseline National Institutes of Health Stroke Scale score, more proximal occlusions, and more refractory occlusions.

"Our results are therefore encouraging and support the use of the Trevo Retriever in a prospective randomized trial of endovascular therapy against medical treatment alone," the investigators concluded.

As for how the Solitaire and Trevo devices compare with each other, no conclusions can be drawn from SWIFT and TREVO 2 because the two studies used different definitions of reperfusion and good neurological outcomes. However, the devices, both of which have been cleared for general use in the United States and Europe, appear to have a similar or better safety profile than the Merci retriever, and the results thus far suggest that "significant improvement could be forthcoming in stroke patients for whom drug treatment is ineffective," according to a Lancet press statement.

The SWIFT trial was funded by Covidien/ev3, the maker of the Solitaire device. TREVO 2 was funded by Stryker Neurological, the maker of Trevo. Many of the investigators disclosed conflicts of interest involving Covidien/ev3 Neurovascular or Stryker Neurological, as well as other manufacturers of endovascular therapies for stroke.

Two novel "next generation" mechanical flow restoration devices, or "clot retrievers," show promise for improving the treatment of stroke patients who fail or aren’t eligible for treatment with tissue plasminogen activator, according to findings from separate randomized controlled clinical trials.

In the SWIFT (Solitaire With the Intention of Thrombectomy) trial, the new Solitaire flow restoration device, a self-expanding stent retriever designed to restore blood flow in patients with ischemic stroke due to a large intracranial vessel occlusion, proved significantly more likely to successfully recanalize occlusions of the proximal cerebral arteries than did the Merci retriever, a first-generation mechanical thrombectomy device approved for use in 2004. The results showed that 58 patients treated with the Solitaire device had nearly fivefold greater odds of meeting the primary end point of a Thrombolysis in Myocardial Ischemia (TIMI) scale 2 or 3 flow in all treatable vessels than did 55 patients treated with the Merci retriever (61% vs. 24%; odds ratio, 4.87).

In another trial called TREVO 2, 88 patients treated with the new Trevo Retriever, a stentlike device similar to the Solitaire device, had greater than fourfold higher odds of successful revascularization than did 90 patients treated with the Merci retriever (86% vs. 60%; OR, 4.22). This trial used a slightly different definition of successful recanalization than did the SWIFT trial, defining it as a Thrombolysis in Cerebral Infarction (TICI) score of 2 or greater.

The findings of both trials were published Aug. 26 in the Lancet and were simultaneously presented at the annual congress of the European Society of Cardiology.

Dr. Jeffrey L. Saver of the University of California, Los Angeles, and his colleagues enrolled patients in the SWIFT trial at 18 sites between February 2010 and February 2011, if they had acute ischemic stroke with moderate to severe neurological deficits and angiographically confirmed occlusions of the proximal cerebral arteries, that were treatable by thrombectomy within 8 hours of symptom onset.

In addition to the greater likelihood of achieving the primary end point, the Solitaire patients were more likely to have good 90-day neurological outcomes (58% vs. 33%; OR, 2.78), and to require fewer passes with the device (mean of 1.7 vs. 2.2 passes), the investigators said (Lancet 2012 Aug. 26 [doi: 10.1016/S0140-6736(12)61384-1]).

Furthermore, the frequency of total device-related and procedure-related adverse events did not differ between the two groups, and the 90-day mortality rate was lower in the Solitaire group (OR, 0.29 after adjusting for age and time to treatment), the investigators said.

"On the basis of these results, when endovascular recanalization is done in patients with acute ischemic stroke, initial treatment with Solitaire might be a future treatment of choice," they concluded.

Dr. Raul G. Nogueira of Emory University in Atlanta and his colleagues enrolled patients in the TREVO 2 trial at 26 sites between February 2011 and December 2011, if they had acute onset of stroke symptoms leading to significant clinical deficits, angiographically proven occlusion of a proximal intracranial artery, and eligibility for endovascular therapy within 8 hours of symptom onset.

In addition to the greater likelihood of achieving the primary end point, the Trevo patients were less likely to require adjunctive treatment of any kind (18% vs. 31%; OR, 0.49), and after adjunctive interventions, the rate of TICI 2 or greater reperfusion was higher in the Trevo patients, the investigators said (Lancet 2012 Aug. 26 [doi: 10.1016/S0140-6736(12)61299-9]).

The Trevo patients also were more likely to have good 90-day functional outcomes (40% vs. 22%; OR, 2.39).

No significant differences were seen between the Trevo and Merci patients with respect to the primary safety end point (a composite of multiple device- and procedure-related events), although vessel perforations were 10 times more common with the Merci device, the investigators reported.

Mortality was also similar in both groups at 30 and 90 days.

The investigators noted that although the Trevo device was not compared with medical treatment alone in this study, the findings are encouraging when considered in the context of those from studies of the Trevo predecessor – PROACT II. In the current study, patients treated using the Trevo Retriever achieved the same rate of good clinical outcomes as reported in a pro-urokinase group in the PROACT II trial despite older age, higher baseline National Institutes of Health Stroke Scale score, more proximal occlusions, and more refractory occlusions.

"Our results are therefore encouraging and support the use of the Trevo Retriever in a prospective randomized trial of endovascular therapy against medical treatment alone," the investigators concluded.

As for how the Solitaire and Trevo devices compare with each other, no conclusions can be drawn from SWIFT and TREVO 2 because the two studies used different definitions of reperfusion and good neurological outcomes. However, the devices, both of which have been cleared for general use in the United States and Europe, appear to have a similar or better safety profile than the Merci retriever, and the results thus far suggest that "significant improvement could be forthcoming in stroke patients for whom drug treatment is ineffective," according to a Lancet press statement.

The SWIFT trial was funded by Covidien/ev3, the maker of the Solitaire device. TREVO 2 was funded by Stryker Neurological, the maker of Trevo. Many of the investigators disclosed conflicts of interest involving Covidien/ev3 Neurovascular or Stryker Neurological, as well as other manufacturers of endovascular therapies for stroke.

The investigational antiplatelet drug vorapaxar reduced the risk of cardiovascular death and ischemic events when it was added to standard antiplatelet treatment in a large, randomized, placebo-controlled trial of patients who had a previous myocardial infarction.

The findings, from a prespecified subgroup analysis of the TRA 2°P (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events)–TIMI 50 (Thrombolysis in Myocardial Infarction 50) trial, were most pronounced in patients younger than age 75 years with a body weight of at least 60 kg. Therefore, the benefits of treatment in this group may outweigh the risk of moderate or severe bleeding seen with treatment in this study, Dr. Benjamin M. Scirica of Harvard Medical School, Boston, and his colleagues from the TIMI Study Group reported Aug. 26 in the Lancet.

The study findings – the first to demonstrate the benefit of adding intense antiplatelet treatment to aspirin for long-term, secondary prevention of post-MI thrombotic events – were simultaneously presented at the annual congress of the European Society of Cardiology.

Of 26,449 patients in the TRA2°P–TIMI 50 trial, 17,769 experienced a qualifying MI and thus constituted the subgroup for the current analysis. These patients were randomized to receive treatment with 2.5 mg of a daily oral dose of either vorapaxar or placebo. In each group, 98% of patients concomitantly took aspirin, 78% took a thienopyridine, and 96% took a lipid-lowering agent. During a median follow-up of 2.5 years, cardiovascular death, MI, or stroke occurred in 610 of the 8,898 patients who received active treatment, compared with 750 of 8,881 patients who received placebo (3-year Kaplan-Meier estimates of 8.1% vs. 9.7%; hazard ratio, 0.80), the investigators said (Lancet 2012 Aug. 26 [doi:10.1016/S0140-6736(12)61269-0]).

However, the principal safety end point of moderate or severe bleeding, as defined by GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries), occurred significantly more often in the treatment group than in the placebo group, with 241 of 8,880 vorapaxar patients experiencing such bleeding, compared with 151 of 8,849 placebo patients (3-year Kaplan-Meier estimates of 3.4% vs. 2.1%; HR, 1.61).

Among those younger than age 75 years with no history of transient ischemic attack or stroke, and with a body weight of at least 60 kg (which represented 84% of the study subgroup), cardiovascular death, MI, or stroke occurred in 431 of 7,449 patients who received active treatment, compared with 570 of 7,640 who received placebo (3-year Kaplan Meier estimates of 6.8% vs. 8.6%; HR, 0.75), they noted.

"Moreover, cardiovascular death, myocardial infarction, stroke, urgent coronary revascularization, or GUSTO moderate or severe bleeding was less likely in the vorapaxar group than in the placebo group in these patients [HR, 0.86]. By contrast, for patients aged 75 years and older, with a history of transient ischemic attack or stroke, or patients weighing less than 60 kg, net clinical outcome was not significantly different with vorapaxar compared with placebo," the investigators wrote.

Patients in the multinational, double-blind TRA 2°P-TIMI 50 trial were adults with a history of atherothrombosis who were enrolled between September, 2007, and November, 2009. Those enrolled on the basis of MI had had a spontaneous MI in the 2 weeks to 12 months prior to enrollment.

Vorapaxar is a potent and selective antagonist of protease-activated receptor 1, which is the main receptor for thrombin on human platelets. The findings suggest that inhibiting this receptor "is a novel therapeutic target for long-term secondary prevention after myocardial infarction. The incremental benefit of vorapaxar existed even with high adherence to guidelines," the investigators wrote, noting that the findings add to existing evidence of a benefit of long-term antiplatelet treatment in addition to aspirin for reducing the risk of thrombotic events, and they also confirm the increased risk of bleeding with vorapaxar treatment.

"Identification of patients appropriate for treatment therefore depends on balance of the competing risks of ischemia and bleeding, which are largely based on the clinical setting, patient characteristics, concomitant anticoagulants, and drug dosing," they wrote.

Specifically, the findings of this and other studies indicate that clinical characteristics such as advanced age and low body weight are consistent predictor of increased bleeding risk with potent antithrombotic treatments.

"These simple clinical criteria seem to be useful for selection of patients with better potential for improved net clinical outcomes with vorapaxar," they wrote.

The TRA 2°P-TIMI 50 trial was supported by Merck. The TIMI Study Group and individual members of the group reported numerous disclosures with respect to grant funding, consulting work, and advisory board participation for various pharmaceutical companies. Details are available with the full text of the article at www.thelancet.com.

The investigational antiplatelet drug vorapaxar reduced the risk of cardiovascular death and ischemic events when it was added to standard antiplatelet treatment in a large, randomized, placebo-controlled trial of patients who had a previous myocardial infarction.

The findings, from a prespecified subgroup analysis of the TRA 2°P (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events)–TIMI 50 (Thrombolysis in Myocardial Infarction 50) trial, were most pronounced in patients younger than age 75 years with a body weight of at least 60 kg. Therefore, the benefits of treatment in this group may outweigh the risk of moderate or severe bleeding seen with treatment in this study, Dr. Benjamin M. Scirica of Harvard Medical School, Boston, and his colleagues from the TIMI Study Group reported Aug. 26 in the Lancet.

The study findings – the first to demonstrate the benefit of adding intense antiplatelet treatment to aspirin for long-term, secondary prevention of post-MI thrombotic events – were simultaneously presented at the annual congress of the European Society of Cardiology.

Of 26,449 patients in the TRA2°P–TIMI 50 trial, 17,769 experienced a qualifying MI and thus constituted the subgroup for the current analysis. These patients were randomized to receive treatment with 2.5 mg of a daily oral dose of either vorapaxar or placebo. In each group, 98% of patients concomitantly took aspirin, 78% took a thienopyridine, and 96% took a lipid-lowering agent. During a median follow-up of 2.5 years, cardiovascular death, MI, or stroke occurred in 610 of the 8,898 patients who received active treatment, compared with 750 of 8,881 patients who received placebo (3-year Kaplan-Meier estimates of 8.1% vs. 9.7%; hazard ratio, 0.80), the investigators said (Lancet 2012 Aug. 26 [doi:10.1016/S0140-6736(12)61269-0]).

However, the principal safety end point of moderate or severe bleeding, as defined by GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries), occurred significantly more often in the treatment group than in the placebo group, with 241 of 8,880 vorapaxar patients experiencing such bleeding, compared with 151 of 8,849 placebo patients (3-year Kaplan-Meier estimates of 3.4% vs. 2.1%; HR, 1.61).

Among those younger than age 75 years with no history of transient ischemic attack or stroke, and with a body weight of at least 60 kg (which represented 84% of the study subgroup), cardiovascular death, MI, or stroke occurred in 431 of 7,449 patients who received active treatment, compared with 570 of 7,640 who received placebo (3-year Kaplan Meier estimates of 6.8% vs. 8.6%; HR, 0.75), they noted.

"Moreover, cardiovascular death, myocardial infarction, stroke, urgent coronary revascularization, or GUSTO moderate or severe bleeding was less likely in the vorapaxar group than in the placebo group in these patients [HR, 0.86]. By contrast, for patients aged 75 years and older, with a history of transient ischemic attack or stroke, or patients weighing less than 60 kg, net clinical outcome was not significantly different with vorapaxar compared with placebo," the investigators wrote.

Patients in the multinational, double-blind TRA 2°P-TIMI 50 trial were adults with a history of atherothrombosis who were enrolled between September, 2007, and November, 2009. Those enrolled on the basis of MI had had a spontaneous MI in the 2 weeks to 12 months prior to enrollment.

Vorapaxar is a potent and selective antagonist of protease-activated receptor 1, which is the main receptor for thrombin on human platelets. The findings suggest that inhibiting this receptor "is a novel therapeutic target for long-term secondary prevention after myocardial infarction. The incremental benefit of vorapaxar existed even with high adherence to guidelines," the investigators wrote, noting that the findings add to existing evidence of a benefit of long-term antiplatelet treatment in addition to aspirin for reducing the risk of thrombotic events, and they also confirm the increased risk of bleeding with vorapaxar treatment.

"Identification of patients appropriate for treatment therefore depends on balance of the competing risks of ischemia and bleeding, which are largely based on the clinical setting, patient characteristics, concomitant anticoagulants, and drug dosing," they wrote.

Specifically, the findings of this and other studies indicate that clinical characteristics such as advanced age and low body weight are consistent predictor of increased bleeding risk with potent antithrombotic treatments.

"These simple clinical criteria seem to be useful for selection of patients with better potential for improved net clinical outcomes with vorapaxar," they wrote.

The TRA 2°P-TIMI 50 trial was supported by Merck. The TIMI Study Group and individual members of the group reported numerous disclosures with respect to grant funding, consulting work, and advisory board participation for various pharmaceutical companies. Details are available with the full text of the article at www.thelancet.com.

The investigational antiplatelet drug vorapaxar reduced the risk of cardiovascular death and ischemic events when it was added to standard antiplatelet treatment in a large, randomized, placebo-controlled trial of patients who had a previous myocardial infarction.

The findings, from a prespecified subgroup analysis of the TRA 2°P (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events)–TIMI 50 (Thrombolysis in Myocardial Infarction 50) trial, were most pronounced in patients younger than age 75 years with a body weight of at least 60 kg. Therefore, the benefits of treatment in this group may outweigh the risk of moderate or severe bleeding seen with treatment in this study, Dr. Benjamin M. Scirica of Harvard Medical School, Boston, and his colleagues from the TIMI Study Group reported Aug. 26 in the Lancet.

The study findings – the first to demonstrate the benefit of adding intense antiplatelet treatment to aspirin for long-term, secondary prevention of post-MI thrombotic events – were simultaneously presented at the annual congress of the European Society of Cardiology.

Of 26,449 patients in the TRA2°P–TIMI 50 trial, 17,769 experienced a qualifying MI and thus constituted the subgroup for the current analysis. These patients were randomized to receive treatment with 2.5 mg of a daily oral dose of either vorapaxar or placebo. In each group, 98% of patients concomitantly took aspirin, 78% took a thienopyridine, and 96% took a lipid-lowering agent. During a median follow-up of 2.5 years, cardiovascular death, MI, or stroke occurred in 610 of the 8,898 patients who received active treatment, compared with 750 of 8,881 patients who received placebo (3-year Kaplan-Meier estimates of 8.1% vs. 9.7%; hazard ratio, 0.80), the investigators said (Lancet 2012 Aug. 26 [doi:10.1016/S0140-6736(12)61269-0]).

However, the principal safety end point of moderate or severe bleeding, as defined by GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries), occurred significantly more often in the treatment group than in the placebo group, with 241 of 8,880 vorapaxar patients experiencing such bleeding, compared with 151 of 8,849 placebo patients (3-year Kaplan-Meier estimates of 3.4% vs. 2.1%; HR, 1.61).

Among those younger than age 75 years with no history of transient ischemic attack or stroke, and with a body weight of at least 60 kg (which represented 84% of the study subgroup), cardiovascular death, MI, or stroke occurred in 431 of 7,449 patients who received active treatment, compared with 570 of 7,640 who received placebo (3-year Kaplan Meier estimates of 6.8% vs. 8.6%; HR, 0.75), they noted.

"Moreover, cardiovascular death, myocardial infarction, stroke, urgent coronary revascularization, or GUSTO moderate or severe bleeding was less likely in the vorapaxar group than in the placebo group in these patients [HR, 0.86]. By contrast, for patients aged 75 years and older, with a history of transient ischemic attack or stroke, or patients weighing less than 60 kg, net clinical outcome was not significantly different with vorapaxar compared with placebo," the investigators wrote.

Patients in the multinational, double-blind TRA 2°P-TIMI 50 trial were adults with a history of atherothrombosis who were enrolled between September, 2007, and November, 2009. Those enrolled on the basis of MI had had a spontaneous MI in the 2 weeks to 12 months prior to enrollment.

Vorapaxar is a potent and selective antagonist of protease-activated receptor 1, which is the main receptor for thrombin on human platelets. The findings suggest that inhibiting this receptor "is a novel therapeutic target for long-term secondary prevention after myocardial infarction. The incremental benefit of vorapaxar existed even with high adherence to guidelines," the investigators wrote, noting that the findings add to existing evidence of a benefit of long-term antiplatelet treatment in addition to aspirin for reducing the risk of thrombotic events, and they also confirm the increased risk of bleeding with vorapaxar treatment.

"Identification of patients appropriate for treatment therefore depends on balance of the competing risks of ischemia and bleeding, which are largely based on the clinical setting, patient characteristics, concomitant anticoagulants, and drug dosing," they wrote.

Specifically, the findings of this and other studies indicate that clinical characteristics such as advanced age and low body weight are consistent predictor of increased bleeding risk with potent antithrombotic treatments.

"These simple clinical criteria seem to be useful for selection of patients with better potential for improved net clinical outcomes with vorapaxar," they wrote.

The TRA 2°P-TIMI 50 trial was supported by Merck. The TIMI Study Group and individual members of the group reported numerous disclosures with respect to grant funding, consulting work, and advisory board participation for various pharmaceutical companies. Details are available with the full text of the article at www.thelancet.com.