Robert Finn

Major Finding: Between April 2009 and Dec. 12, 2009, there were an estimated 55 million cases of H1N1 influenza in the United States; between 7,880 and 16,460 of those infected have died. By Jan. 2, 2010, 61 million Americans had been vaccinated, including 38% of individuals in the limited vaccine subset of the initial target groups.

Data Source: Centers for Disease Control and Prevention.

Disclosures: None reported.

Between 39 million and 80 million individuals in the United States contracted 2009 influenza H1N1 between April 2009 and Dec. 12, 2009, according to data collected by the Centers for Disease Control and Prevention.

The midlevel of the estimated range is 55 million individuals.

Of those infected with H1N1 influenza, an estimated 173,000-362,000 have been hospitalized, and between 7,880 and 16,460 have died, the CDC reported.

About 18 million children 0-17 years of age contracted the virus. Adults 18-64 years of age accounted for another 32 million cases, and there were 5 million cases among individuals 65 years of age and older.

According to the results of two surveys, an estimated 61 million persons (20% of the U.S. population) had received the monovalent H1N1 vaccine by Jan. 2, 2010, including 29% of children and 22% of health care personnel (MMWR 2010;59:1-5).

About 28% of the people in the initial target groups and 38% of those in the limited vaccine subset received at least one dose of the vaccine. The initial target groups included:

▸ pregnant women

▸ persons who live with or care for infants less than 6 months of age

▸ young adults aged 6 months to 24 years, and

▸ persons aged 25-64 years with certain medical conditions.

The limited vaccine subset included:

▸ pregnant women,

▸ persons who live with or care for infants less than 6 months of age,

▸ health care and emergency services personnel,

▸ children aged 6 months to 4 years, and

▸ children aged 5-18 years with certain medical conditions.

The data came from two telephone surveys: the National 2009 H1N1 Flu Survey (NHFS) and the Behavioral Risk Factor Surveillance System (BRFSS).

At an estimated 33%, the vaccination rate was highest among children 6 months to 4 years of age. The lowest rate, 11%, was found among adults 65 years of age and older.

“The results in this report show that nearly 90% of adults aged [less than] 65 years with medical conditions that increase their risk for influenza-related complications remain unvaccinated,” wrote J. A. Singleton and colleagues at the CDC. “Given the increased supply of vaccine, efforts to encourage 2009 H1N1 vaccination among persons at increased risk for … complications should be strengthened.”

Pregnant women have been hit hard by H1N1 flu, both in terms of hospitalization rates and mortality, as reported elsewhere.

The 38% H1N1 vaccination coverage among pregnant women in this report was higher than the typical rate of 15%-25% seen with seasonal flu vaccination, but the confidence interval of 24%-52% is large.

A separate data collection system, the Pregnancy Risk Assessment Monitoring System (PRAMS), involving approximately 30,000 women with live births in 31 states, will provide more precise estimates in the future, the investigators said.

The surveys also revealed lower vaccination coverage among blacks than whites, similar to the disparities seen in seasonal vaccine coverage.

“The finding of lower 2009 H1N1 coverage among black heath care workers suggests that access to care is not the only barrier to influenza vaccination and highlights a role for targeted outreach efforts,” they wrote.

Major Finding: Between April 2009 and Dec. 12, 2009, there were an estimated 55 million cases of H1N1 influenza in the United States; between 7,880 and 16,460 of those infected have died. By Jan. 2, 2010, 61 million Americans had been vaccinated, including 38% of individuals in the limited vaccine subset of the initial target groups.

Data Source: Centers for Disease Control and Prevention.

Disclosures: None reported.

Between 39 million and 80 million individuals in the United States contracted 2009 influenza H1N1 between April 2009 and Dec. 12, 2009, according to data collected by the Centers for Disease Control and Prevention.

The midlevel of the estimated range is 55 million individuals.

Of those infected with H1N1 influenza, an estimated 173,000-362,000 have been hospitalized, and between 7,880 and 16,460 have died, the CDC reported.

About 18 million children 0-17 years of age contracted the virus. Adults 18-64 years of age accounted for another 32 million cases, and there were 5 million cases among individuals 65 years of age and older.

According to the results of two surveys, an estimated 61 million persons (20% of the U.S. population) had received the monovalent H1N1 vaccine by Jan. 2, 2010, including 29% of children and 22% of health care personnel (MMWR 2010;59:1-5).

About 28% of the people in the initial target groups and 38% of those in the limited vaccine subset received at least one dose of the vaccine. The initial target groups included:

▸ pregnant women

▸ persons who live with or care for infants less than 6 months of age

▸ young adults aged 6 months to 24 years, and

▸ persons aged 25-64 years with certain medical conditions.

The limited vaccine subset included:

▸ pregnant women,

▸ persons who live with or care for infants less than 6 months of age,

▸ health care and emergency services personnel,

▸ children aged 6 months to 4 years, and

▸ children aged 5-18 years with certain medical conditions.

The data came from two telephone surveys: the National 2009 H1N1 Flu Survey (NHFS) and the Behavioral Risk Factor Surveillance System (BRFSS).

At an estimated 33%, the vaccination rate was highest among children 6 months to 4 years of age. The lowest rate, 11%, was found among adults 65 years of age and older.

“The results in this report show that nearly 90% of adults aged [less than] 65 years with medical conditions that increase their risk for influenza-related complications remain unvaccinated,” wrote J. A. Singleton and colleagues at the CDC. “Given the increased supply of vaccine, efforts to encourage 2009 H1N1 vaccination among persons at increased risk for … complications should be strengthened.”

Pregnant women have been hit hard by H1N1 flu, both in terms of hospitalization rates and mortality, as reported elsewhere.

The 38% H1N1 vaccination coverage among pregnant women in this report was higher than the typical rate of 15%-25% seen with seasonal flu vaccination, but the confidence interval of 24%-52% is large.

A separate data collection system, the Pregnancy Risk Assessment Monitoring System (PRAMS), involving approximately 30,000 women with live births in 31 states, will provide more precise estimates in the future, the investigators said.

The surveys also revealed lower vaccination coverage among blacks than whites, similar to the disparities seen in seasonal vaccine coverage.

“The finding of lower 2009 H1N1 coverage among black heath care workers suggests that access to care is not the only barrier to influenza vaccination and highlights a role for targeted outreach efforts,” they wrote.

Major Finding: Between April 2009 and Dec. 12, 2009, there were an estimated 55 million cases of H1N1 influenza in the United States; between 7,880 and 16,460 of those infected have died. By Jan. 2, 2010, 61 million Americans had been vaccinated, including 38% of individuals in the limited vaccine subset of the initial target groups.

Data Source: Centers for Disease Control and Prevention.

Disclosures: None reported.

Between 39 million and 80 million individuals in the United States contracted 2009 influenza H1N1 between April 2009 and Dec. 12, 2009, according to data collected by the Centers for Disease Control and Prevention.

The midlevel of the estimated range is 55 million individuals.

Of those infected with H1N1 influenza, an estimated 173,000-362,000 have been hospitalized, and between 7,880 and 16,460 have died, the CDC reported.

About 18 million children 0-17 years of age contracted the virus. Adults 18-64 years of age accounted for another 32 million cases, and there were 5 million cases among individuals 65 years of age and older.

According to the results of two surveys, an estimated 61 million persons (20% of the U.S. population) had received the monovalent H1N1 vaccine by Jan. 2, 2010, including 29% of children and 22% of health care personnel (MMWR 2010;59:1-5).

About 28% of the people in the initial target groups and 38% of those in the limited vaccine subset received at least one dose of the vaccine. The initial target groups included:

▸ pregnant women

▸ persons who live with or care for infants less than 6 months of age

▸ young adults aged 6 months to 24 years, and

▸ persons aged 25-64 years with certain medical conditions.

The limited vaccine subset included:

▸ pregnant women,

▸ persons who live with or care for infants less than 6 months of age,

▸ health care and emergency services personnel,

▸ children aged 6 months to 4 years, and

▸ children aged 5-18 years with certain medical conditions.

The data came from two telephone surveys: the National 2009 H1N1 Flu Survey (NHFS) and the Behavioral Risk Factor Surveillance System (BRFSS).

At an estimated 33%, the vaccination rate was highest among children 6 months to 4 years of age. The lowest rate, 11%, was found among adults 65 years of age and older.

“The results in this report show that nearly 90% of adults aged [less than] 65 years with medical conditions that increase their risk for influenza-related complications remain unvaccinated,” wrote J. A. Singleton and colleagues at the CDC. “Given the increased supply of vaccine, efforts to encourage 2009 H1N1 vaccination among persons at increased risk for … complications should be strengthened.”

Pregnant women have been hit hard by H1N1 flu, both in terms of hospitalization rates and mortality, as reported elsewhere.

The 38% H1N1 vaccination coverage among pregnant women in this report was higher than the typical rate of 15%-25% seen with seasonal flu vaccination, but the confidence interval of 24%-52% is large.

A separate data collection system, the Pregnancy Risk Assessment Monitoring System (PRAMS), involving approximately 30,000 women with live births in 31 states, will provide more precise estimates in the future, the investigators said.

The surveys also revealed lower vaccination coverage among blacks than whites, similar to the disparities seen in seasonal vaccine coverage.

“The finding of lower 2009 H1N1 coverage among black heath care workers suggests that access to care is not the only barrier to influenza vaccination and highlights a role for targeted outreach efforts,” they wrote.

Major Finding: There has been no increase in the prevalence of overweight and obesity among most subgroups in the United States.

Data Source: CDC study of 2007–2008 NHANES data.

Disclosures: None

Increases in obesity rates among American children and adults may have reached a plateau, according to two studies.

Examined by the Centers for Disease Control and Prevention, data from the comprehensive National Health and Nutrition Examination Survey (NHANES) for 2007–2008 show few changes in the prevalence of obesity since a similar survey in 1999–2000.

While most subcategories of Americans saw no statistically significant increase in the prevalence of overweight and obesity, there were some exceptions.

The prevalence of high weight in boys 6–19 years of age whose body mass index (BMI) was at the 97th percentile or above rose from less than 10% in 1999–2000 to 15.1% in 2007–2008.

Similarly, the prevalence of adult males classified as obese (BMI more than 30 kg/m

But for infants and toddlers of both sexes, boys 2–5 years of age, and girls and women of all ages, the rates of overweight and obesity appear to have stabilized over the last decade, after increasing greatly in prior years.

In an accompanying editorial, Dr. J. Michael Gaziano of Brigham and Women's Hospital, Boston, wrote that the studies, “offer a glimmer of hope that in the United States, at least, the steady, decades-long increases in overweight and obesity may have slowed or perhaps reached a plateau.”

The 2007–2008 survey on children and adolescents involved a representative sample of 719 infants and toddlers and 3,281 children and adolescents 2–19 years of age. Cynthia L. Ogden, Ph.D., and colleagues from the CDC authored that study (JAMA 2010;303:(doi:10.1001/jama.2009.2012

The 2007–2008 survey on adults involved a representative sample of 5,555 men and women 20 years of age and above.

Katherine M. Flegal, Ph.D. and colleagues from the CDC authored that study (JAMA 2010;303:(doi:10.1001/jama.2009.2014

In the most recent survey, 11.9% of children 2–19 years of age had BMIs at the 97th percentile and above, 16.9% had BMIs at the 95th percentile and above, and 31.7% had BMIs in the 85th percentile and above.

Among adults, 33.9% had BMIs of 30 and above (classified as obese), and 68.3% had BMIs of 25 and above (classified as overweight). In addition, 14.3% of adults had BMIs of 35 or above (Grade 2 obesity), and 5.7% had BMIs of 40 or above (Grade 3 obesity).

Dr. Gaziano continued in his editorial, “Even if these trends can be maintained, 68% of U.S. adults are overweight or obese, and almost 32% of school-aged U.S. children and adolescents are at or above the 85th percentile of BMI for age.

Given the risk of obesity-related major health problems, a massive public-health campaign to raise awareness about the effects of overweight and obesity is necessary.

“The longer the delay in taking aggressive action, the higher the likelihood that the significant progress achieved in decreasing chronic disease rates during the last 40 years will be negated, possibly even with a decrease in life expectancy,” he said (JAMA 2010;303: (doi:10.1001/jama.2009.2025

The CDC sponsored both studies, and the investigators reported no financial disclosures.

Dr. Gaziano reported receiving research funding from the National Institutes of Health, the Veterans Administration, and Veroscience; receiving pills and packaging for a research study from BASF, DSM, and Wyeth; serving as a consultant to Bayer; and serving as a medical expert for Merck.

Major Finding: There has been no increase in the prevalence of overweight and obesity among most subgroups in the United States.

Data Source: CDC study of 2007–2008 NHANES data.

Disclosures: None

Increases in obesity rates among American children and adults may have reached a plateau, according to two studies.

Examined by the Centers for Disease Control and Prevention, data from the comprehensive National Health and Nutrition Examination Survey (NHANES) for 2007–2008 show few changes in the prevalence of obesity since a similar survey in 1999–2000.

While most subcategories of Americans saw no statistically significant increase in the prevalence of overweight and obesity, there were some exceptions.

The prevalence of high weight in boys 6–19 years of age whose body mass index (BMI) was at the 97th percentile or above rose from less than 10% in 1999–2000 to 15.1% in 2007–2008.

Similarly, the prevalence of adult males classified as obese (BMI more than 30 kg/m

But for infants and toddlers of both sexes, boys 2–5 years of age, and girls and women of all ages, the rates of overweight and obesity appear to have stabilized over the last decade, after increasing greatly in prior years.

In an accompanying editorial, Dr. J. Michael Gaziano of Brigham and Women's Hospital, Boston, wrote that the studies, “offer a glimmer of hope that in the United States, at least, the steady, decades-long increases in overweight and obesity may have slowed or perhaps reached a plateau.”

The 2007–2008 survey on children and adolescents involved a representative sample of 719 infants and toddlers and 3,281 children and adolescents 2–19 years of age. Cynthia L. Ogden, Ph.D., and colleagues from the CDC authored that study (JAMA 2010;303:(doi:10.1001/jama.2009.2012

The 2007–2008 survey on adults involved a representative sample of 5,555 men and women 20 years of age and above.

Katherine M. Flegal, Ph.D. and colleagues from the CDC authored that study (JAMA 2010;303:(doi:10.1001/jama.2009.2014

In the most recent survey, 11.9% of children 2–19 years of age had BMIs at the 97th percentile and above, 16.9% had BMIs at the 95th percentile and above, and 31.7% had BMIs in the 85th percentile and above.

Among adults, 33.9% had BMIs of 30 and above (classified as obese), and 68.3% had BMIs of 25 and above (classified as overweight). In addition, 14.3% of adults had BMIs of 35 or above (Grade 2 obesity), and 5.7% had BMIs of 40 or above (Grade 3 obesity).

Dr. Gaziano continued in his editorial, “Even if these trends can be maintained, 68% of U.S. adults are overweight or obese, and almost 32% of school-aged U.S. children and adolescents are at or above the 85th percentile of BMI for age.

Given the risk of obesity-related major health problems, a massive public-health campaign to raise awareness about the effects of overweight and obesity is necessary.

“The longer the delay in taking aggressive action, the higher the likelihood that the significant progress achieved in decreasing chronic disease rates during the last 40 years will be negated, possibly even with a decrease in life expectancy,” he said (JAMA 2010;303: (doi:10.1001/jama.2009.2025

The CDC sponsored both studies, and the investigators reported no financial disclosures.

Dr. Gaziano reported receiving research funding from the National Institutes of Health, the Veterans Administration, and Veroscience; receiving pills and packaging for a research study from BASF, DSM, and Wyeth; serving as a consultant to Bayer; and serving as a medical expert for Merck.

Major Finding: There has been no increase in the prevalence of overweight and obesity among most subgroups in the United States.

Data Source: CDC study of 2007–2008 NHANES data.

Disclosures: None

Increases in obesity rates among American children and adults may have reached a plateau, according to two studies.

Examined by the Centers for Disease Control and Prevention, data from the comprehensive National Health and Nutrition Examination Survey (NHANES) for 2007–2008 show few changes in the prevalence of obesity since a similar survey in 1999–2000.

While most subcategories of Americans saw no statistically significant increase in the prevalence of overweight and obesity, there were some exceptions.

The prevalence of high weight in boys 6–19 years of age whose body mass index (BMI) was at the 97th percentile or above rose from less than 10% in 1999–2000 to 15.1% in 2007–2008.

Similarly, the prevalence of adult males classified as obese (BMI more than 30 kg/m

But for infants and toddlers of both sexes, boys 2–5 years of age, and girls and women of all ages, the rates of overweight and obesity appear to have stabilized over the last decade, after increasing greatly in prior years.

In an accompanying editorial, Dr. J. Michael Gaziano of Brigham and Women's Hospital, Boston, wrote that the studies, “offer a glimmer of hope that in the United States, at least, the steady, decades-long increases in overweight and obesity may have slowed or perhaps reached a plateau.”

The 2007–2008 survey on children and adolescents involved a representative sample of 719 infants and toddlers and 3,281 children and adolescents 2–19 years of age. Cynthia L. Ogden, Ph.D., and colleagues from the CDC authored that study (JAMA 2010;303:(doi:10.1001/jama.2009.2012

The 2007–2008 survey on adults involved a representative sample of 5,555 men and women 20 years of age and above.

Katherine M. Flegal, Ph.D. and colleagues from the CDC authored that study (JAMA 2010;303:(doi:10.1001/jama.2009.2014

In the most recent survey, 11.9% of children 2–19 years of age had BMIs at the 97th percentile and above, 16.9% had BMIs at the 95th percentile and above, and 31.7% had BMIs in the 85th percentile and above.

Among adults, 33.9% had BMIs of 30 and above (classified as obese), and 68.3% had BMIs of 25 and above (classified as overweight). In addition, 14.3% of adults had BMIs of 35 or above (Grade 2 obesity), and 5.7% had BMIs of 40 or above (Grade 3 obesity).

Dr. Gaziano continued in his editorial, “Even if these trends can be maintained, 68% of U.S. adults are overweight or obese, and almost 32% of school-aged U.S. children and adolescents are at or above the 85th percentile of BMI for age.

Given the risk of obesity-related major health problems, a massive public-health campaign to raise awareness about the effects of overweight and obesity is necessary.

“The longer the delay in taking aggressive action, the higher the likelihood that the significant progress achieved in decreasing chronic disease rates during the last 40 years will be negated, possibly even with a decrease in life expectancy,” he said (JAMA 2010;303: (doi:10.1001/jama.2009.2025

The CDC sponsored both studies, and the investigators reported no financial disclosures.

Dr. Gaziano reported receiving research funding from the National Institutes of Health, the Veterans Administration, and Veroscience; receiving pills and packaging for a research study from BASF, DSM, and Wyeth; serving as a consultant to Bayer; and serving as a medical expert for Merck.

Major Finding: Children with autism spectrum disorders need careful GI evaluations, but there's no good evidence that they have unique gastrointestinal problems or benefit from restricted diets.

Data Source: Literature review and the consensus of an interdisciplinary expert panel

Disclosures: The Autism Forum convened the panel and provided honoraria to its 14 members. One panel member reported relationships with a number of pharmaceutical companies. Another chairs an academic department that derives revenue from genetic laboratory testing.

There's no good evidence that children with autism have unique gastrointestinal disorders, nor is there convincing evidence that gluten-free or casein-free diets help these children, according to an expert panel.

The panel, which was convened by the Autism Forum, reached consensus on 23 statements regarding the evaluation, diagnosis, and treatment of gastrointestinal disorders in children with autism spectrum disorders (ASDs) (Pediatrics 2010;125:S1-S18).

One key recommendation was that children with ASDs need to be evaluated carefully for GI problems because many such children are nonverbal, and even those who are verbal may have difficulty describing their symptoms, such as abdominal pain.

In particular, the panel noted that children with ASDs often respond to GI symptoms by exhibiting problem behaviors such as agitation, aggression, and sleep disturbances.

The panel included experts in child psychiatry, developmental pediatrics, epidemiology, medical genetics, immunology, nursing, pediatric allergy, pediatric gastroenterology, pediatric pain, pediatric neurology, pediatric nutrition, and psychology. Dr. Timothy Buie of Harvard Medical School, Boston, was the paper's lead author.

The recommendations were based on a literature review, but without a formal meta-analysis.

“Because of the absence, in general, of high-quality clinical research data, evidence-based recommendations are not possible at the present time,” the panelists wrote. “However, the panel agreed on a number of statements based on expert opinion that arose from a review of existing evidence. It is acknowledged that, in many areas, evidence is generally confined to case reports, observational or descriptive studies, and poorly controlled or uncontrolled studies.”

Among the other conclusions were:

▸ Children with ASDs are subject to the same common GI disorders as neurotypical children and should be evaluated thoroughly. In particular, clinicians should be sure that these children receive a complete medical evaluation for GI disorders when they present with problem behaviors. Behavioral treatment may complement medical treatment in children with both ASDs and GI disorders, but behavioral treatment alone is not enough.

▸ The existence of “autistic enterocolitis” or other gastrointestinal disturbances unique to children with ASDs has not been established, and the evidence for abnormal gastrointestinal permeability (“leaky gut”) is limited. More research is needed in these areas, the panel said.

▸ Pediatricians and other primary care providers should be alert to nutritional problems in children with ASDs. Some of these children have narrow food preferences, and some parents may put their children on highly restrictive diets that are intended to be therapeutic but result in malnutrition.

In particular, pediatricians should evaluate the child's anthropometry, looking for evidence of wasting, stunting, or changes in growth rate. Children with ASDs should also be evaluated for food intolerance and food allergy, although there is no compelling evidence that these disorders are more prevalent in children with ASDs than in neurotypical children, the panelists reported.

Major Finding: Children with autism spectrum disorders need careful GI evaluations, but there's no good evidence that they have unique gastrointestinal problems or benefit from restricted diets.

Data Source: Literature review and the consensus of an interdisciplinary expert panel

Disclosures: The Autism Forum convened the panel and provided honoraria to its 14 members. One panel member reported relationships with a number of pharmaceutical companies. Another chairs an academic department that derives revenue from genetic laboratory testing.

There's no good evidence that children with autism have unique gastrointestinal disorders, nor is there convincing evidence that gluten-free or casein-free diets help these children, according to an expert panel.

The panel, which was convened by the Autism Forum, reached consensus on 23 statements regarding the evaluation, diagnosis, and treatment of gastrointestinal disorders in children with autism spectrum disorders (ASDs) (Pediatrics 2010;125:S1-S18).

One key recommendation was that children with ASDs need to be evaluated carefully for GI problems because many such children are nonverbal, and even those who are verbal may have difficulty describing their symptoms, such as abdominal pain.

In particular, the panel noted that children with ASDs often respond to GI symptoms by exhibiting problem behaviors such as agitation, aggression, and sleep disturbances.

The panel included experts in child psychiatry, developmental pediatrics, epidemiology, medical genetics, immunology, nursing, pediatric allergy, pediatric gastroenterology, pediatric pain, pediatric neurology, pediatric nutrition, and psychology. Dr. Timothy Buie of Harvard Medical School, Boston, was the paper's lead author.

The recommendations were based on a literature review, but without a formal meta-analysis.

“Because of the absence, in general, of high-quality clinical research data, evidence-based recommendations are not possible at the present time,” the panelists wrote. “However, the panel agreed on a number of statements based on expert opinion that arose from a review of existing evidence. It is acknowledged that, in many areas, evidence is generally confined to case reports, observational or descriptive studies, and poorly controlled or uncontrolled studies.”

Among the other conclusions were:

▸ Children with ASDs are subject to the same common GI disorders as neurotypical children and should be evaluated thoroughly. In particular, clinicians should be sure that these children receive a complete medical evaluation for GI disorders when they present with problem behaviors. Behavioral treatment may complement medical treatment in children with both ASDs and GI disorders, but behavioral treatment alone is not enough.

▸ The existence of “autistic enterocolitis” or other gastrointestinal disturbances unique to children with ASDs has not been established, and the evidence for abnormal gastrointestinal permeability (“leaky gut”) is limited. More research is needed in these areas, the panel said.

▸ Pediatricians and other primary care providers should be alert to nutritional problems in children with ASDs. Some of these children have narrow food preferences, and some parents may put their children on highly restrictive diets that are intended to be therapeutic but result in malnutrition.

In particular, pediatricians should evaluate the child's anthropometry, looking for evidence of wasting, stunting, or changes in growth rate. Children with ASDs should also be evaluated for food intolerance and food allergy, although there is no compelling evidence that these disorders are more prevalent in children with ASDs than in neurotypical children, the panelists reported.

Major Finding: Children with autism spectrum disorders need careful GI evaluations, but there's no good evidence that they have unique gastrointestinal problems or benefit from restricted diets.

Data Source: Literature review and the consensus of an interdisciplinary expert panel

Disclosures: The Autism Forum convened the panel and provided honoraria to its 14 members. One panel member reported relationships with a number of pharmaceutical companies. Another chairs an academic department that derives revenue from genetic laboratory testing.

There's no good evidence that children with autism have unique gastrointestinal disorders, nor is there convincing evidence that gluten-free or casein-free diets help these children, according to an expert panel.

The panel, which was convened by the Autism Forum, reached consensus on 23 statements regarding the evaluation, diagnosis, and treatment of gastrointestinal disorders in children with autism spectrum disorders (ASDs) (Pediatrics 2010;125:S1-S18).

One key recommendation was that children with ASDs need to be evaluated carefully for GI problems because many such children are nonverbal, and even those who are verbal may have difficulty describing their symptoms, such as abdominal pain.

In particular, the panel noted that children with ASDs often respond to GI symptoms by exhibiting problem behaviors such as agitation, aggression, and sleep disturbances.

The panel included experts in child psychiatry, developmental pediatrics, epidemiology, medical genetics, immunology, nursing, pediatric allergy, pediatric gastroenterology, pediatric pain, pediatric neurology, pediatric nutrition, and psychology. Dr. Timothy Buie of Harvard Medical School, Boston, was the paper's lead author.

The recommendations were based on a literature review, but without a formal meta-analysis.

“Because of the absence, in general, of high-quality clinical research data, evidence-based recommendations are not possible at the present time,” the panelists wrote. “However, the panel agreed on a number of statements based on expert opinion that arose from a review of existing evidence. It is acknowledged that, in many areas, evidence is generally confined to case reports, observational or descriptive studies, and poorly controlled or uncontrolled studies.”

Among the other conclusions were:

▸ Children with ASDs are subject to the same common GI disorders as neurotypical children and should be evaluated thoroughly. In particular, clinicians should be sure that these children receive a complete medical evaluation for GI disorders when they present with problem behaviors. Behavioral treatment may complement medical treatment in children with both ASDs and GI disorders, but behavioral treatment alone is not enough.

▸ The existence of “autistic enterocolitis” or other gastrointestinal disturbances unique to children with ASDs has not been established, and the evidence for abnormal gastrointestinal permeability (“leaky gut”) is limited. More research is needed in these areas, the panel said.

▸ Pediatricians and other primary care providers should be alert to nutritional problems in children with ASDs. Some of these children have narrow food preferences, and some parents may put their children on highly restrictive diets that are intended to be therapeutic but result in malnutrition.

In particular, pediatricians should evaluate the child's anthropometry, looking for evidence of wasting, stunting, or changes in growth rate. Children with ASDs should also be evaluated for food intolerance and food allergy, although there is no compelling evidence that these disorders are more prevalent in children with ASDs than in neurotypical children, the panelists reported.

Major Findings: Patients' mean heart rate increased significantly from 82 beats per minute at baseline to around 86 beats per minute at week 6 and at 6 months of using the OROS methylphenidate.

Source of Data: An open-label trial of 114 adolescents with ADHD.

Disclosures: The study was sponsored by McNeil, which markets OROS methylphenidate under the brand name Concerta. Dr. Hammerness acknowledged serving as a speaker for, receiving research funds from, or participating in CME activities or professional talks supported by several pharmaceutical companies, including McNeil.

HONOLULU – High-dose OROS methylphenidate was associated with small but statistically significant increases in systolic blood pressure and heart rate in a 6-month, open-label study in adolescents.

The study found that there were no significant long-term increases in diastolic blood pressure or in electrocardiographic measures, Dr. Paul Hammerness said at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

The findings are consistent with other studies involving younger children and lower doses, said Dr. Hammerness of Massachusetts General Hospital and Harvard Medical School, Boston. Because of concerns about possible associations between stimulant medications for attention-deficit/hyperactivity disorder (ADHD) and cardiovascular complications–including sudden cardiac death–the Food and Drug Administration recommended in June 2009 that physicians pay special attention to a child's cardiovascular system when prescribing stimulants.

The study involved 114 adolescents with a mean age of 14 years at baseline (range, 12 to 18 years). All of the subjects were healthy, and all had a diagnosis of ADHD based on full DSM-IV criteria. The trial was intended to evaluate the use of OROS methylphenidate for the prevention of cigarette smoking (J. Pediatr. 2009;155:84–9).

Participants were excluded if they had a history of cardiovascular disease or had untreated mood or anxiety disorders, eating disorders, psychosis, or substance use disorders. Participants who were on stable regimens of benzodiazepines or antidepressants (other than monoamine oxidase inhibitors) could be admitted into the study.

The beginning dose of OROS methylphenidate was 0.5–0.75 mg/kg per day, and that was titrated to a maximum of 1.5 mg/kg per day by week 3. At week 6, the mean total daily dose was 63 mg, and 50% of the participants were taking 72 mg or more.

As expected, OROS methylphenidate was highly effective in treating the participants' ADHD. Their Rating Scale scores declined from a mean of 26.9 at baseline to 9.7 at week 6.

Of the 114 participants who entered the study, 73% were male, and their mean body mass index was 22.6 kg/m

Mean systolic blood pressure at baseline was 113 mm Hg, and that increased to 117 mm Hg at 6 months, a significant increase. Mean diastolic blood pressure began at 63 mm Hg, increased significantly to 65 mm Hg at week 6, but then returned to 64 mm Hg at 6 months. Mean heart rate began at 82 beats per minute, increased significantly to 86 beats per minute at week 6, and remained at about that rate at 6 months.

The investigators found no statistically significant or clinically meaningful changes in ECG variables, including PR, QRS, or QTC.

Reasoning that any adverse cardiovascular effects of OROS methylphenidate might be restricted to certain subsets of adolescents, the investigators separately analyzed those 16 participants who met criteria for prehypertension or hypertension at baseline, based on at least one blood pressure reading above the 90th or 95th percentile. The investigators found no impact of abnormal premedication blood pressure readings on blood pressure changes during treatment.

None of the participants experienced serious adverse events or serious cardiovascular adverse events during the study. Ten of the 114 subjects reported one or more subjective cardiovascular complaints, including palpitations, chest pain, and fast or racing heartbeat. Of those, six had a lifetime diagnosis of comorbid anxiety disorder.

One participant discontinued treatment because of recurrent palpitations. She had a lifetime history of comorbid generalized anxiety disorder and migraines. But she showed no change from baseline in any cardiovascular measurement, and her primary care physician did not find her complaints to be consistent with cardiac disease. She later used a different stimulant medication with no subsequent cardiovascular symptoms.

“The FDA continues to review and still concludes that the overall risk-benefit ratio supports the use of stimulant medications for ADHD,” Dr. Hammerness said. But he did recommend that clinicians carefully evaluate a child's cardiovascular symptoms and family history before prescribing stimulants.

Major Findings: Patients' mean heart rate increased significantly from 82 beats per minute at baseline to around 86 beats per minute at week 6 and at 6 months of using the OROS methylphenidate.

Source of Data: An open-label trial of 114 adolescents with ADHD.

Disclosures: The study was sponsored by McNeil, which markets OROS methylphenidate under the brand name Concerta. Dr. Hammerness acknowledged serving as a speaker for, receiving research funds from, or participating in CME activities or professional talks supported by several pharmaceutical companies, including McNeil.

HONOLULU – High-dose OROS methylphenidate was associated with small but statistically significant increases in systolic blood pressure and heart rate in a 6-month, open-label study in adolescents.

The study found that there were no significant long-term increases in diastolic blood pressure or in electrocardiographic measures, Dr. Paul Hammerness said at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

The findings are consistent with other studies involving younger children and lower doses, said Dr. Hammerness of Massachusetts General Hospital and Harvard Medical School, Boston. Because of concerns about possible associations between stimulant medications for attention-deficit/hyperactivity disorder (ADHD) and cardiovascular complications–including sudden cardiac death–the Food and Drug Administration recommended in June 2009 that physicians pay special attention to a child's cardiovascular system when prescribing stimulants.

The study involved 114 adolescents with a mean age of 14 years at baseline (range, 12 to 18 years). All of the subjects were healthy, and all had a diagnosis of ADHD based on full DSM-IV criteria. The trial was intended to evaluate the use of OROS methylphenidate for the prevention of cigarette smoking (J. Pediatr. 2009;155:84–9).

Participants were excluded if they had a history of cardiovascular disease or had untreated mood or anxiety disorders, eating disorders, psychosis, or substance use disorders. Participants who were on stable regimens of benzodiazepines or antidepressants (other than monoamine oxidase inhibitors) could be admitted into the study.

The beginning dose of OROS methylphenidate was 0.5–0.75 mg/kg per day, and that was titrated to a maximum of 1.5 mg/kg per day by week 3. At week 6, the mean total daily dose was 63 mg, and 50% of the participants were taking 72 mg or more.

As expected, OROS methylphenidate was highly effective in treating the participants' ADHD. Their Rating Scale scores declined from a mean of 26.9 at baseline to 9.7 at week 6.

Of the 114 participants who entered the study, 73% were male, and their mean body mass index was 22.6 kg/m

Mean systolic blood pressure at baseline was 113 mm Hg, and that increased to 117 mm Hg at 6 months, a significant increase. Mean diastolic blood pressure began at 63 mm Hg, increased significantly to 65 mm Hg at week 6, but then returned to 64 mm Hg at 6 months. Mean heart rate began at 82 beats per minute, increased significantly to 86 beats per minute at week 6, and remained at about that rate at 6 months.

The investigators found no statistically significant or clinically meaningful changes in ECG variables, including PR, QRS, or QTC.

Reasoning that any adverse cardiovascular effects of OROS methylphenidate might be restricted to certain subsets of adolescents, the investigators separately analyzed those 16 participants who met criteria for prehypertension or hypertension at baseline, based on at least one blood pressure reading above the 90th or 95th percentile. The investigators found no impact of abnormal premedication blood pressure readings on blood pressure changes during treatment.

None of the participants experienced serious adverse events or serious cardiovascular adverse events during the study. Ten of the 114 subjects reported one or more subjective cardiovascular complaints, including palpitations, chest pain, and fast or racing heartbeat. Of those, six had a lifetime diagnosis of comorbid anxiety disorder.

One participant discontinued treatment because of recurrent palpitations. She had a lifetime history of comorbid generalized anxiety disorder and migraines. But she showed no change from baseline in any cardiovascular measurement, and her primary care physician did not find her complaints to be consistent with cardiac disease. She later used a different stimulant medication with no subsequent cardiovascular symptoms.

“The FDA continues to review and still concludes that the overall risk-benefit ratio supports the use of stimulant medications for ADHD,” Dr. Hammerness said. But he did recommend that clinicians carefully evaluate a child's cardiovascular symptoms and family history before prescribing stimulants.

Major Findings: Patients' mean heart rate increased significantly from 82 beats per minute at baseline to around 86 beats per minute at week 6 and at 6 months of using the OROS methylphenidate.

Source of Data: An open-label trial of 114 adolescents with ADHD.

Disclosures: The study was sponsored by McNeil, which markets OROS methylphenidate under the brand name Concerta. Dr. Hammerness acknowledged serving as a speaker for, receiving research funds from, or participating in CME activities or professional talks supported by several pharmaceutical companies, including McNeil.

HONOLULU – High-dose OROS methylphenidate was associated with small but statistically significant increases in systolic blood pressure and heart rate in a 6-month, open-label study in adolescents.

The study found that there were no significant long-term increases in diastolic blood pressure or in electrocardiographic measures, Dr. Paul Hammerness said at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

The findings are consistent with other studies involving younger children and lower doses, said Dr. Hammerness of Massachusetts General Hospital and Harvard Medical School, Boston. Because of concerns about possible associations between stimulant medications for attention-deficit/hyperactivity disorder (ADHD) and cardiovascular complications–including sudden cardiac death–the Food and Drug Administration recommended in June 2009 that physicians pay special attention to a child's cardiovascular system when prescribing stimulants.

The study involved 114 adolescents with a mean age of 14 years at baseline (range, 12 to 18 years). All of the subjects were healthy, and all had a diagnosis of ADHD based on full DSM-IV criteria. The trial was intended to evaluate the use of OROS methylphenidate for the prevention of cigarette smoking (J. Pediatr. 2009;155:84–9).

Participants were excluded if they had a history of cardiovascular disease or had untreated mood or anxiety disorders, eating disorders, psychosis, or substance use disorders. Participants who were on stable regimens of benzodiazepines or antidepressants (other than monoamine oxidase inhibitors) could be admitted into the study.

The beginning dose of OROS methylphenidate was 0.5–0.75 mg/kg per day, and that was titrated to a maximum of 1.5 mg/kg per day by week 3. At week 6, the mean total daily dose was 63 mg, and 50% of the participants were taking 72 mg or more.

As expected, OROS methylphenidate was highly effective in treating the participants' ADHD. Their Rating Scale scores declined from a mean of 26.9 at baseline to 9.7 at week 6.

Of the 114 participants who entered the study, 73% were male, and their mean body mass index was 22.6 kg/m

Mean systolic blood pressure at baseline was 113 mm Hg, and that increased to 117 mm Hg at 6 months, a significant increase. Mean diastolic blood pressure began at 63 mm Hg, increased significantly to 65 mm Hg at week 6, but then returned to 64 mm Hg at 6 months. Mean heart rate began at 82 beats per minute, increased significantly to 86 beats per minute at week 6, and remained at about that rate at 6 months.

The investigators found no statistically significant or clinically meaningful changes in ECG variables, including PR, QRS, or QTC.

Reasoning that any adverse cardiovascular effects of OROS methylphenidate might be restricted to certain subsets of adolescents, the investigators separately analyzed those 16 participants who met criteria for prehypertension or hypertension at baseline, based on at least one blood pressure reading above the 90th or 95th percentile. The investigators found no impact of abnormal premedication blood pressure readings on blood pressure changes during treatment.

None of the participants experienced serious adverse events or serious cardiovascular adverse events during the study. Ten of the 114 subjects reported one or more subjective cardiovascular complaints, including palpitations, chest pain, and fast or racing heartbeat. Of those, six had a lifetime diagnosis of comorbid anxiety disorder.

One participant discontinued treatment because of recurrent palpitations. She had a lifetime history of comorbid generalized anxiety disorder and migraines. But she showed no change from baseline in any cardiovascular measurement, and her primary care physician did not find her complaints to be consistent with cardiac disease. She later used a different stimulant medication with no subsequent cardiovascular symptoms.

“The FDA continues to review and still concludes that the overall risk-benefit ratio supports the use of stimulant medications for ADHD,” Dr. Hammerness said. But he did recommend that clinicians carefully evaluate a child's cardiovascular symptoms and family history before prescribing stimulants.

Medical evacuations of patients critically injured in Haiti's devastating earthquake to hospitals in the United States resumed on Feb. 1, following a 5-day interruption.

The exact cause of the interruption appears to be under dispute. According to published reports, some sources said the issue involved how hospitals would be reimbursed for caring for these patients. Other sources cited a lack of capacity at hospitals in Florida, where most of the patients had been sent.

White House spokesman Tommy Vietor said that logistical problems had caused the interruption. He pointed to difficulties in locating appropriate medical facilities that were close to airports capable of handling large military transport planes.

Whatever the cause, the flights resumed the day after Kathleen Sebelius, Secretary of the Department of Health and Human Services, activated components of the National Disaster Medical System (NDMS). With this announcement, hospitals that are part of the NDMS could be assured that the federal government would pay them for the patients' care at 110% of the Medicare reimbursement rate.

The flights were halted on Jan. 27, shortly after Florida Governor Charlie Crist wrote a letter to Secretary Sebelius stating that medical facilities in Florida were “quickly reaching saturation, especially in the area of high-level trauma care.”

In that letter, Governor Crist also pointed to a “lack of coordination by federal authorities” overseeing the evacuations. He noted that 436 patients had been admitted to Florida hospitals, with more than 90% suffering from multiple traumas.

“Recently, we learned that federal planning is underway to move between 30–50 critically ill patients per day for an indefinite period of time,” Governor Crist's letter continued. “Florida does not have the capacity to support such an operation.”

The U.S. Agency for International Development (USAID) is coordinating the government's response to the earthquake. In a statement announcing the activation of the NDMS, USAID administrator Dr. Rajiv Shah stated, “Medical evacuations have only been used in limited instances where patients had medical needs that could not be met in Haiti. We are committed to working with the Haitian people and the Government of Haiti to create long-term care facilities in-country. Continued medical assistance is critical to these efforts.”

In a Feb. 1 statement responding to the NDMS activation, Governor Crist said that “Florida is grateful to our federal partners for taking steps to activate the National Disaster Medical System. The quick response to my letter last week to Secretary Sebelius will ensure that critically injured survivors of the Haiti earthquake will continue to receive the medical care they so desperately need.”

Governor Crist noted that Florida had committed to welcoming 19,000 people from Haiti including, as of that date, 526 patients who were receiving critical medical care.

“Florida's hospitals, doctors, nurses and medical teams are at the forefront of caring for survivors, both here in Florida and in Haiti,” he continued. “For their tireless efforts, I commend their dedication to promptly and compassionately serving those in need.”

The day following the NDMS announcement, medical evacuation flights resumed, arriving in Tampa and Atlanta. Hospitals in New York, Boston, Philadelphia, and Lyons, N.J., were also alerted that patients might be sent to those facilities.

Medical evacuations of patients critically injured in Haiti's devastating earthquake to hospitals in the United States resumed on Feb. 1, following a 5-day interruption.

The exact cause of the interruption appears to be under dispute. According to published reports, some sources said the issue involved how hospitals would be reimbursed for caring for these patients. Other sources cited a lack of capacity at hospitals in Florida, where most of the patients had been sent.

White House spokesman Tommy Vietor said that logistical problems had caused the interruption. He pointed to difficulties in locating appropriate medical facilities that were close to airports capable of handling large military transport planes.

Whatever the cause, the flights resumed the day after Kathleen Sebelius, Secretary of the Department of Health and Human Services, activated components of the National Disaster Medical System (NDMS). With this announcement, hospitals that are part of the NDMS could be assured that the federal government would pay them for the patients' care at 110% of the Medicare reimbursement rate.

The flights were halted on Jan. 27, shortly after Florida Governor Charlie Crist wrote a letter to Secretary Sebelius stating that medical facilities in Florida were “quickly reaching saturation, especially in the area of high-level trauma care.”

In that letter, Governor Crist also pointed to a “lack of coordination by federal authorities” overseeing the evacuations. He noted that 436 patients had been admitted to Florida hospitals, with more than 90% suffering from multiple traumas.

“Recently, we learned that federal planning is underway to move between 30–50 critically ill patients per day for an indefinite period of time,” Governor Crist's letter continued. “Florida does not have the capacity to support such an operation.”

The U.S. Agency for International Development (USAID) is coordinating the government's response to the earthquake. In a statement announcing the activation of the NDMS, USAID administrator Dr. Rajiv Shah stated, “Medical evacuations have only been used in limited instances where patients had medical needs that could not be met in Haiti. We are committed to working with the Haitian people and the Government of Haiti to create long-term care facilities in-country. Continued medical assistance is critical to these efforts.”

In a Feb. 1 statement responding to the NDMS activation, Governor Crist said that “Florida is grateful to our federal partners for taking steps to activate the National Disaster Medical System. The quick response to my letter last week to Secretary Sebelius will ensure that critically injured survivors of the Haiti earthquake will continue to receive the medical care they so desperately need.”

Governor Crist noted that Florida had committed to welcoming 19,000 people from Haiti including, as of that date, 526 patients who were receiving critical medical care.

“Florida's hospitals, doctors, nurses and medical teams are at the forefront of caring for survivors, both here in Florida and in Haiti,” he continued. “For their tireless efforts, I commend their dedication to promptly and compassionately serving those in need.”

The day following the NDMS announcement, medical evacuation flights resumed, arriving in Tampa and Atlanta. Hospitals in New York, Boston, Philadelphia, and Lyons, N.J., were also alerted that patients might be sent to those facilities.

Medical evacuations of patients critically injured in Haiti's devastating earthquake to hospitals in the United States resumed on Feb. 1, following a 5-day interruption.

The exact cause of the interruption appears to be under dispute. According to published reports, some sources said the issue involved how hospitals would be reimbursed for caring for these patients. Other sources cited a lack of capacity at hospitals in Florida, where most of the patients had been sent.

White House spokesman Tommy Vietor said that logistical problems had caused the interruption. He pointed to difficulties in locating appropriate medical facilities that were close to airports capable of handling large military transport planes.

Whatever the cause, the flights resumed the day after Kathleen Sebelius, Secretary of the Department of Health and Human Services, activated components of the National Disaster Medical System (NDMS). With this announcement, hospitals that are part of the NDMS could be assured that the federal government would pay them for the patients' care at 110% of the Medicare reimbursement rate.

The flights were halted on Jan. 27, shortly after Florida Governor Charlie Crist wrote a letter to Secretary Sebelius stating that medical facilities in Florida were “quickly reaching saturation, especially in the area of high-level trauma care.”

In that letter, Governor Crist also pointed to a “lack of coordination by federal authorities” overseeing the evacuations. He noted that 436 patients had been admitted to Florida hospitals, with more than 90% suffering from multiple traumas.

“Recently, we learned that federal planning is underway to move between 30–50 critically ill patients per day for an indefinite period of time,” Governor Crist's letter continued. “Florida does not have the capacity to support such an operation.”

The U.S. Agency for International Development (USAID) is coordinating the government's response to the earthquake. In a statement announcing the activation of the NDMS, USAID administrator Dr. Rajiv Shah stated, “Medical evacuations have only been used in limited instances where patients had medical needs that could not be met in Haiti. We are committed to working with the Haitian people and the Government of Haiti to create long-term care facilities in-country. Continued medical assistance is critical to these efforts.”

In a Feb. 1 statement responding to the NDMS activation, Governor Crist said that “Florida is grateful to our federal partners for taking steps to activate the National Disaster Medical System. The quick response to my letter last week to Secretary Sebelius will ensure that critically injured survivors of the Haiti earthquake will continue to receive the medical care they so desperately need.”

Governor Crist noted that Florida had committed to welcoming 19,000 people from Haiti including, as of that date, 526 patients who were receiving critical medical care.

“Florida's hospitals, doctors, nurses and medical teams are at the forefront of caring for survivors, both here in Florida and in Haiti,” he continued. “For their tireless efforts, I commend their dedication to promptly and compassionately serving those in need.”

The day following the NDMS announcement, medical evacuation flights resumed, arriving in Tampa and Atlanta. Hospitals in New York, Boston, Philadelphia, and Lyons, N.J., were also alerted that patients might be sent to those facilities.

When Dr. Lisa V. Luly-Rivera admitted the 14-year-old girl to the University of Miami's tent hospital at the airport in Port-au-Prince, the girl's leg was edematous and she had some hyperpigmentation. But between one day and the next, her leg became warm, and the warmth started moving up toward her thigh. The leg was clearly infected.

The surgeons, fearing necrotizing fasciitis, wanted to amputate. Dr. Luly-Rivera, a hospitalist at the University of Miami who was in Haiti to help earthquake victims, found herself arguing with the surgeons.

“No, that's not what you do and you know it,” she recalls saying. “You don't just have to preemptively amputate.”

She pointed out that the girl could still move her leg, and it had some range of motion. She knew she had some good antibiotics—Rocephin, Flagyl, and Clindal—to provide multiorganism coverage. So she insisted that the surgeons do a fasciotomy. Then she treated the girl with IV antibiotics and hoped the infection would abate. It did, and the girl kept her leg.

Dr. Luly-Rivera arrived in Haiti just 8 days after the devastating earthquake on Jan. 12, 2010. A Haitian-American who was born in Queens, N.Y., Dr. Luly-Rivera has many friends and relatives still living in that poverty-stricken country, and fortunately none was seriously hurt. But she knew that her skills as a hospitalist—and the fact that she spoke fluent Creole—could be put to good use during her 5-day visit.

She wasn't alone. The University of Miami Leonard M. Miller School of Medicine has had a presence in Haiti since 1994 through Project Medishare, a program founded by Dr. Barth Green and Dr. Arthur Fournier. University physicians quickly organized into teams that would spend 5 days in Haiti providing emergency medical and surgical care.

At first they set up a hospital at a United Nations facility, but just a day after Dr. Luly-Rivera and her hospitalist colleague Dr. Amir K. Jaffer arrived, the university constructed a field hospital at the Port-au-Prince airport. The hospital, in four large tents with three operating rooms, was equipped to handle 250 patients.

Two days after the field hospital opened, the first radiology machine arrived. “Patients were already getting amputations in the operating room for injuries that were not likely to heal or that were leading to wound infections or compartment syndromes,” Dr. Jaffer recalled. “But those where the fractures were more occult, where they were not visible but they still had a lot of pain, they were splinted and stabilized. And then they started to get casts when we had an x-ray machine available on-site.”

Dr. Jaffer, who has special expertise in deep vein thrombosis (DVT), was glad to see that the hospital had heparin and low-molecular-weight heparin. Many patients had fractures of a long bone, so Dr. Jaffer started these high-risk patients on prophylaxis.

Dr. Jaffer and Dr. Luly-Rivera both said they did anything that needed doing, from starting IV lines to bringing food to patients. But they also used their training as hospitalists to comanage patients along with the surgeons. The hospitalists managed patients' fluids, pain, and antibiotics.

They worked in shifts that were nominally 12 hours long, but sometimes ended up lasting 15 or even 20 hours. During a night shift, Dr. Luly-Rivera noticed something strange about a 17-year-old boy she had admitted the day before. The boy had a hemopneumothorax, but no chest tubes were available, so the surgeons had improvised one with a Foley catheter and some surgical tubing.

That night Dr. Luly-Rivera noticed the boy was lethargic and unresponsive, although she recalled he had been able to follow commands earlier in the day. “I said to myself, 'OK, we don't have all of the resources here. We have to send him to the Israeli hospital [which was better equipped].' So I woke up the entire surgical team,” she said. “I said, 'This patient is going to crash tonight if we don't transfer him.' And everyone started arguing: 'We don't have security.' 'How are we going to transfer him over?' 'Well, he's not crashing right now.' And I said, 'He will die tonight if we don't do something.'”

Dr. Luly-Rivera found some of the EMTs who were there from Miami, who agreed to have the boy transferred to the Israeli hospital, where he got a proper chest tube. “He was so critical that they shipped him to the U.S.N.S. Comfort [the U.S. Navy's hospital ship docked at the waterfront]. I just got a report back on Tuesday. He's doing much better.”

Dr. Luly-Rivera expressed mixed emotions about her experience in Haiti. At first she said, “I enjoyed my time down there,” but a minute later she said, “It was extremely difficult to witness what was going on … and to see the suffering of the patients. It was difficult to see all the children being amputated, the adults. I just left there with the sense of, what's going to happen to this generation of people? It was very disheartening.”

Dr. Jaffer said that he was struck by how calm everyone at the hospital was. “I was amazed with how patient people were,” he said. “I did not ever see anybody in my 5 days there getting angry with anyone else. … I was amazed at how patient these Haitian people were with both each other and the help they were getting from people around them.”

On the other hand, “there was a lot of fear in these people's eyes and their body language. We would talk to them about what their fears were, but the truth of the matter is there was no systematic way to address that.” Addressing the posttraumatic stress disorder after such an event “is something we need to think about,” said Dr. Jaffer, adding that he saw no psychiatrists or other mental health professionals while he was there.

Dr. Luly-Rivera urged other hospitalists to spend a few days helping out in Haiti. “As hospitalists, a lot of people are scared to go there,” she said. “They don't know what to expect. You're not just doing hospitalist work. You're doing everything. You're just there to take care of patients in whatever way you can. The experience was so rewarding for me. I want to go back. But it does take a toll on you. You come back changed.”

Dr. Lisa V. Luly-Rivera of the University of Miami put her hospitalist skills to use during a 5-day visit during the second week following the earthquake in Haiti.

Source COURTESY AMIR K. JAFFER

Among the U.S. physicians responding to the crisis in Haiti were Dr. Mario Reyes, chief of hospital medicine at Miami Children's Hospital; Dr. Barth Green, chief of neurosurgery at the University of Miami and a founder of Project Medishare; and Dr. Amir K. Jaffer, chief of hospital medicine at the University of Miami.

Source COURTESY AMIR K. JAFFER

When Dr. Lisa V. Luly-Rivera admitted the 14-year-old girl to the University of Miami's tent hospital at the airport in Port-au-Prince, the girl's leg was edematous and she had some hyperpigmentation. But between one day and the next, her leg became warm, and the warmth started moving up toward her thigh. The leg was clearly infected.

The surgeons, fearing necrotizing fasciitis, wanted to amputate. Dr. Luly-Rivera, a hospitalist at the University of Miami who was in Haiti to help earthquake victims, found herself arguing with the surgeons.

“No, that's not what you do and you know it,” she recalls saying. “You don't just have to preemptively amputate.”

She pointed out that the girl could still move her leg, and it had some range of motion. She knew she had some good antibiotics—Rocephin, Flagyl, and Clindal—to provide multiorganism coverage. So she insisted that the surgeons do a fasciotomy. Then she treated the girl with IV antibiotics and hoped the infection would abate. It did, and the girl kept her leg.

Dr. Luly-Rivera arrived in Haiti just 8 days after the devastating earthquake on Jan. 12, 2010. A Haitian-American who was born in Queens, N.Y., Dr. Luly-Rivera has many friends and relatives still living in that poverty-stricken country, and fortunately none was seriously hurt. But she knew that her skills as a hospitalist—and the fact that she spoke fluent Creole—could be put to good use during her 5-day visit.

She wasn't alone. The University of Miami Leonard M. Miller School of Medicine has had a presence in Haiti since 1994 through Project Medishare, a program founded by Dr. Barth Green and Dr. Arthur Fournier. University physicians quickly organized into teams that would spend 5 days in Haiti providing emergency medical and surgical care.

At first they set up a hospital at a United Nations facility, but just a day after Dr. Luly-Rivera and her hospitalist colleague Dr. Amir K. Jaffer arrived, the university constructed a field hospital at the Port-au-Prince airport. The hospital, in four large tents with three operating rooms, was equipped to handle 250 patients.

Two days after the field hospital opened, the first radiology machine arrived. “Patients were already getting amputations in the operating room for injuries that were not likely to heal or that were leading to wound infections or compartment syndromes,” Dr. Jaffer recalled. “But those where the fractures were more occult, where they were not visible but they still had a lot of pain, they were splinted and stabilized. And then they started to get casts when we had an x-ray machine available on-site.”

Dr. Jaffer, who has special expertise in deep vein thrombosis (DVT), was glad to see that the hospital had heparin and low-molecular-weight heparin. Many patients had fractures of a long bone, so Dr. Jaffer started these high-risk patients on prophylaxis.

Dr. Jaffer and Dr. Luly-Rivera both said they did anything that needed doing, from starting IV lines to bringing food to patients. But they also used their training as hospitalists to comanage patients along with the surgeons. The hospitalists managed patients' fluids, pain, and antibiotics.

They worked in shifts that were nominally 12 hours long, but sometimes ended up lasting 15 or even 20 hours. During a night shift, Dr. Luly-Rivera noticed something strange about a 17-year-old boy she had admitted the day before. The boy had a hemopneumothorax, but no chest tubes were available, so the surgeons had improvised one with a Foley catheter and some surgical tubing.

That night Dr. Luly-Rivera noticed the boy was lethargic and unresponsive, although she recalled he had been able to follow commands earlier in the day. “I said to myself, 'OK, we don't have all of the resources here. We have to send him to the Israeli hospital [which was better equipped].' So I woke up the entire surgical team,” she said. “I said, 'This patient is going to crash tonight if we don't transfer him.' And everyone started arguing: 'We don't have security.' 'How are we going to transfer him over?' 'Well, he's not crashing right now.' And I said, 'He will die tonight if we don't do something.'”

Dr. Luly-Rivera found some of the EMTs who were there from Miami, who agreed to have the boy transferred to the Israeli hospital, where he got a proper chest tube. “He was so critical that they shipped him to the U.S.N.S. Comfort [the U.S. Navy's hospital ship docked at the waterfront]. I just got a report back on Tuesday. He's doing much better.”

Dr. Luly-Rivera expressed mixed emotions about her experience in Haiti. At first she said, “I enjoyed my time down there,” but a minute later she said, “It was extremely difficult to witness what was going on … and to see the suffering of the patients. It was difficult to see all the children being amputated, the adults. I just left there with the sense of, what's going to happen to this generation of people? It was very disheartening.”

Dr. Jaffer said that he was struck by how calm everyone at the hospital was. “I was amazed with how patient people were,” he said. “I did not ever see anybody in my 5 days there getting angry with anyone else. … I was amazed at how patient these Haitian people were with both each other and the help they were getting from people around them.”

On the other hand, “there was a lot of fear in these people's eyes and their body language. We would talk to them about what their fears were, but the truth of the matter is there was no systematic way to address that.” Addressing the posttraumatic stress disorder after such an event “is something we need to think about,” said Dr. Jaffer, adding that he saw no psychiatrists or other mental health professionals while he was there.

Dr. Luly-Rivera urged other hospitalists to spend a few days helping out in Haiti. “As hospitalists, a lot of people are scared to go there,” she said. “They don't know what to expect. You're not just doing hospitalist work. You're doing everything. You're just there to take care of patients in whatever way you can. The experience was so rewarding for me. I want to go back. But it does take a toll on you. You come back changed.”

Dr. Lisa V. Luly-Rivera of the University of Miami put her hospitalist skills to use during a 5-day visit during the second week following the earthquake in Haiti.

Source COURTESY AMIR K. JAFFER

Among the U.S. physicians responding to the crisis in Haiti were Dr. Mario Reyes, chief of hospital medicine at Miami Children's Hospital; Dr. Barth Green, chief of neurosurgery at the University of Miami and a founder of Project Medishare; and Dr. Amir K. Jaffer, chief of hospital medicine at the University of Miami.

Source COURTESY AMIR K. JAFFER

When Dr. Lisa V. Luly-Rivera admitted the 14-year-old girl to the University of Miami's tent hospital at the airport in Port-au-Prince, the girl's leg was edematous and she had some hyperpigmentation. But between one day and the next, her leg became warm, and the warmth started moving up toward her thigh. The leg was clearly infected.

The surgeons, fearing necrotizing fasciitis, wanted to amputate. Dr. Luly-Rivera, a hospitalist at the University of Miami who was in Haiti to help earthquake victims, found herself arguing with the surgeons.

“No, that's not what you do and you know it,” she recalls saying. “You don't just have to preemptively amputate.”

She pointed out that the girl could still move her leg, and it had some range of motion. She knew she had some good antibiotics—Rocephin, Flagyl, and Clindal—to provide multiorganism coverage. So she insisted that the surgeons do a fasciotomy. Then she treated the girl with IV antibiotics and hoped the infection would abate. It did, and the girl kept her leg.

Dr. Luly-Rivera arrived in Haiti just 8 days after the devastating earthquake on Jan. 12, 2010. A Haitian-American who was born in Queens, N.Y., Dr. Luly-Rivera has many friends and relatives still living in that poverty-stricken country, and fortunately none was seriously hurt. But she knew that her skills as a hospitalist—and the fact that she spoke fluent Creole—could be put to good use during her 5-day visit.

She wasn't alone. The University of Miami Leonard M. Miller School of Medicine has had a presence in Haiti since 1994 through Project Medishare, a program founded by Dr. Barth Green and Dr. Arthur Fournier. University physicians quickly organized into teams that would spend 5 days in Haiti providing emergency medical and surgical care.

At first they set up a hospital at a United Nations facility, but just a day after Dr. Luly-Rivera and her hospitalist colleague Dr. Amir K. Jaffer arrived, the university constructed a field hospital at the Port-au-Prince airport. The hospital, in four large tents with three operating rooms, was equipped to handle 250 patients.

Two days after the field hospital opened, the first radiology machine arrived. “Patients were already getting amputations in the operating room for injuries that were not likely to heal or that were leading to wound infections or compartment syndromes,” Dr. Jaffer recalled. “But those where the fractures were more occult, where they were not visible but they still had a lot of pain, they were splinted and stabilized. And then they started to get casts when we had an x-ray machine available on-site.”

Dr. Jaffer, who has special expertise in deep vein thrombosis (DVT), was glad to see that the hospital had heparin and low-molecular-weight heparin. Many patients had fractures of a long bone, so Dr. Jaffer started these high-risk patients on prophylaxis.

Dr. Jaffer and Dr. Luly-Rivera both said they did anything that needed doing, from starting IV lines to bringing food to patients. But they also used their training as hospitalists to comanage patients along with the surgeons. The hospitalists managed patients' fluids, pain, and antibiotics.

They worked in shifts that were nominally 12 hours long, but sometimes ended up lasting 15 or even 20 hours. During a night shift, Dr. Luly-Rivera noticed something strange about a 17-year-old boy she had admitted the day before. The boy had a hemopneumothorax, but no chest tubes were available, so the surgeons had improvised one with a Foley catheter and some surgical tubing.

That night Dr. Luly-Rivera noticed the boy was lethargic and unresponsive, although she recalled he had been able to follow commands earlier in the day. “I said to myself, 'OK, we don't have all of the resources here. We have to send him to the Israeli hospital [which was better equipped].' So I woke up the entire surgical team,” she said. “I said, 'This patient is going to crash tonight if we don't transfer him.' And everyone started arguing: 'We don't have security.' 'How are we going to transfer him over?' 'Well, he's not crashing right now.' And I said, 'He will die tonight if we don't do something.'”

Dr. Luly-Rivera found some of the EMTs who were there from Miami, who agreed to have the boy transferred to the Israeli hospital, where he got a proper chest tube. “He was so critical that they shipped him to the U.S.N.S. Comfort [the U.S. Navy's hospital ship docked at the waterfront]. I just got a report back on Tuesday. He's doing much better.”

Dr. Luly-Rivera expressed mixed emotions about her experience in Haiti. At first she said, “I enjoyed my time down there,” but a minute later she said, “It was extremely difficult to witness what was going on … and to see the suffering of the patients. It was difficult to see all the children being amputated, the adults. I just left there with the sense of, what's going to happen to this generation of people? It was very disheartening.”

Dr. Jaffer said that he was struck by how calm everyone at the hospital was. “I was amazed with how patient people were,” he said. “I did not ever see anybody in my 5 days there getting angry with anyone else. … I was amazed at how patient these Haitian people were with both each other and the help they were getting from people around them.”

On the other hand, “there was a lot of fear in these people's eyes and their body language. We would talk to them about what their fears were, but the truth of the matter is there was no systematic way to address that.” Addressing the posttraumatic stress disorder after such an event “is something we need to think about,” said Dr. Jaffer, adding that he saw no psychiatrists or other mental health professionals while he was there.

Dr. Luly-Rivera urged other hospitalists to spend a few days helping out in Haiti. “As hospitalists, a lot of people are scared to go there,” she said. “They don't know what to expect. You're not just doing hospitalist work. You're doing everything. You're just there to take care of patients in whatever way you can. The experience was so rewarding for me. I want to go back. But it does take a toll on you. You come back changed.”

Dr. Lisa V. Luly-Rivera of the University of Miami put her hospitalist skills to use during a 5-day visit during the second week following the earthquake in Haiti.

Source COURTESY AMIR K. JAFFER

Among the U.S. physicians responding to the crisis in Haiti were Dr. Mario Reyes, chief of hospital medicine at Miami Children's Hospital; Dr. Barth Green, chief of neurosurgery at the University of Miami and a founder of Project Medishare; and Dr. Amir K. Jaffer, chief of hospital medicine at the University of Miami.

Source COURTESY AMIR K. JAFFER

Patients with ventricular tachycardia or ventricular fibrillation do better if they undergo catheter ablation before receiving an implantable cardioverter defibrillator, according to a study of 107 patients.

Patients in the prospective, randomized controlled Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) study were included if they had previous myocardial infarction, stable ventricular tachycardia, and a left ventricular ejection fraction of 50% or less. The investigators, led by Dr. Karl-Heinz Kuck of the Asklepios Klinik St. Georg in Hamburg, Germany, compared 52 patients who underwent catheter ablation before receiving an implantable cardioverter defibrillator (ICD) with 55 patients who received the ICD alone (Lancet 2010;375:31-40).

Patients in the ICD-alone group had a recurrence of ventricular tachycardia or ventricular fibrillation after a median of 6 months, compared with 19 months in patients who underwent ablation before ICD implantation, a significant difference. Also, 47% of patients in the ablation group had no ventricular tachycardia or fibrillation episodes within 2 years of the procedure, compared with 29% of those in the ICD-only group.

In an editorial, Dr. William G. Stevenson and Dr. Usha Tedrow of Brigham and Women's Hospital, Boston, said ablation can be “considered early, in selected patients who are receiving an [ICD] for stable ventricular tachycardia, in whom recurrences of a ventricular tachycardia are likely.” They noted, however, that catheter ablation can be risky (Lancet 2010;375:4-6).

Two patients in the ablation group experienced serious complications during the procedure—one experienced transient ischemic ST segment elevation, and another experienced a transient cerebral ischemic event.

“Evidence of a positive effect on survival, subsequent hospital admissions, or quality of life is needed before this strategy can be recommended for routine use,” Dr. Stevenson and Dr. Tedrow wrote.

Disclosures: The study was funded by St. Jude Medical, which manufactured and supplied all of the ICDs used in the study. Dr. Kuck acknowledged relationships with Biosense Webster, St. Jude Medical, Boston Scientific, and Medtronic. Several of the coauthors also disclosed relationships with St. Jude Medical, Sanofi-Aventis, and Biosense Webster. The editorial authors reported no relevant conflicts of interest.

Patients with ventricular tachycardia or ventricular fibrillation do better if they undergo catheter ablation before receiving an implantable cardioverter defibrillator, according to a study of 107 patients.

Patients in the prospective, randomized controlled Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) study were included if they had previous myocardial infarction, stable ventricular tachycardia, and a left ventricular ejection fraction of 50% or less. The investigators, led by Dr. Karl-Heinz Kuck of the Asklepios Klinik St. Georg in Hamburg, Germany, compared 52 patients who underwent catheter ablation before receiving an implantable cardioverter defibrillator (ICD) with 55 patients who received the ICD alone (Lancet 2010;375:31-40).

Patients in the ICD-alone group had a recurrence of ventricular tachycardia or ventricular fibrillation after a median of 6 months, compared with 19 months in patients who underwent ablation before ICD implantation, a significant difference. Also, 47% of patients in the ablation group had no ventricular tachycardia or fibrillation episodes within 2 years of the procedure, compared with 29% of those in the ICD-only group.

In an editorial, Dr. William G. Stevenson and Dr. Usha Tedrow of Brigham and Women's Hospital, Boston, said ablation can be “considered early, in selected patients who are receiving an [ICD] for stable ventricular tachycardia, in whom recurrences of a ventricular tachycardia are likely.” They noted, however, that catheter ablation can be risky (Lancet 2010;375:4-6).

Two patients in the ablation group experienced serious complications during the procedure—one experienced transient ischemic ST segment elevation, and another experienced a transient cerebral ischemic event.

“Evidence of a positive effect on survival, subsequent hospital admissions, or quality of life is needed before this strategy can be recommended for routine use,” Dr. Stevenson and Dr. Tedrow wrote.

Disclosures: The study was funded by St. Jude Medical, which manufactured and supplied all of the ICDs used in the study. Dr. Kuck acknowledged relationships with Biosense Webster, St. Jude Medical, Boston Scientific, and Medtronic. Several of the coauthors also disclosed relationships with St. Jude Medical, Sanofi-Aventis, and Biosense Webster. The editorial authors reported no relevant conflicts of interest.

Patients with ventricular tachycardia or ventricular fibrillation do better if they undergo catheter ablation before receiving an implantable cardioverter defibrillator, according to a study of 107 patients.

Patients in the prospective, randomized controlled Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) study were included if they had previous myocardial infarction, stable ventricular tachycardia, and a left ventricular ejection fraction of 50% or less. The investigators, led by Dr. Karl-Heinz Kuck of the Asklepios Klinik St. Georg in Hamburg, Germany, compared 52 patients who underwent catheter ablation before receiving an implantable cardioverter defibrillator (ICD) with 55 patients who received the ICD alone (Lancet 2010;375:31-40).

Patients in the ICD-alone group had a recurrence of ventricular tachycardia or ventricular fibrillation after a median of 6 months, compared with 19 months in patients who underwent ablation before ICD implantation, a significant difference. Also, 47% of patients in the ablation group had no ventricular tachycardia or fibrillation episodes within 2 years of the procedure, compared with 29% of those in the ICD-only group.

In an editorial, Dr. William G. Stevenson and Dr. Usha Tedrow of Brigham and Women's Hospital, Boston, said ablation can be “considered early, in selected patients who are receiving an [ICD] for stable ventricular tachycardia, in whom recurrences of a ventricular tachycardia are likely.” They noted, however, that catheter ablation can be risky (Lancet 2010;375:4-6).

Two patients in the ablation group experienced serious complications during the procedure—one experienced transient ischemic ST segment elevation, and another experienced a transient cerebral ischemic event.

“Evidence of a positive effect on survival, subsequent hospital admissions, or quality of life is needed before this strategy can be recommended for routine use,” Dr. Stevenson and Dr. Tedrow wrote.

Disclosures: The study was funded by St. Jude Medical, which manufactured and supplied all of the ICDs used in the study. Dr. Kuck acknowledged relationships with Biosense Webster, St. Jude Medical, Boston Scientific, and Medtronic. Several of the coauthors also disclosed relationships with St. Jude Medical, Sanofi-Aventis, and Biosense Webster. The editorial authors reported no relevant conflicts of interest.

The efficacy of antidepressant treatment over placebo for major depressive disorder “varies considerably,” depending upon symptom severity, a recent meta-analysis showed.

Only patients whose depression is classified as “very severe” appear to have a greater benefit from antidepressants than from placebo pills, according to the study by Jay C. Fournier of the University of Pennsylvania, Philadelphia, and his colleagues (JAMA 2010;303:47-53).

Most placebo-controlled studies of antidepressants specifically exclude individuals who score below 23 on the Hamilton Depression Rating Scale (HDRS). HDRS scores of 8-13 indicate mild depression, scores of 14-18 indicate moderate depression, scores of 19-22 indicate severe depression, and scores of 23 or above indicate very severe depression.

In addition, many antidepressant studies include a “placebo washout period” in which all patients receive placebo pills for several days to 2 weeks before randomization. Often, patients who improve by 20% or more in the HDRS are excluded from the trial. Removing known placebo responders at the outset is thought to enhance the statistical power of the antidepressant-placebo comparison.

“This design feature severely limits the ability to generate accurate estimates of the placebo response rate,” wrote Mr. Fournier and his colleagues, noting that “the true rate of placebo response may be underestimated in trials that use this feature.”

To determine the true placebo response rate across the entire range of depression severity, the investigators combed the literature for randomized, controlled studies of minor depressive disorder that did not include a placebo washout period.

Of the 2,146 randomized, controlled trials of depressants published in English from January 1980 to March 2009, only 23 studies met those criteria. But only six of those studies could provide patient-level data to the investigators. It was those six studies, comprising 434 patients in antidepressant groups and 284 patients in placebo groups, that were the subject of the meta-analysis.

Actually, most meta-analyses include only group-level data. A study such as this one that includes patient-level data is called a “mega-analysis.” This approach allows investigators to conduct a more fine-grained multivariate analysis.

Three of the six studies used imipramine, a tricyclic antidepressant, and the other three used paroxetine, a selective serotonin reuptake inhibitor. The mean baseline HDRS score in the studies ranged from 14 to 24.

As expected, the higher the patient's baseline HDRS score, the more improvement was seen with both the active drug and the placebo. A difference of 3 points or more on the HDRS is considered clinically significant. It was only at HDRS baseline levels of 25 and above that active drug was both statistically and clinically better than placebo. This finding was the same for imipramine and paroxetine.

The investigators wrote that in marketing antidepressants, pharmaceutical manufacturers rarely mention that most efficacy studies specifically exclude patients who derive little benefit from their medications.

The authors concluded that “efforts should be made to clarify to clinicians and prospective patients that whereas [antidepressant medications] can have a substantial effect with more severe depressions, there is little evidence to suggest that they produce specific pharmacological benefit for the majority of patients with less severe acute depression.”

Commenting on the meta-analysis, Dr. Eric G. Tangalos emphasized that conclusions based on studies published as early as 1980 might not be relevant to current medical practice.

“Papers published in the 1980s took their data from clinical practice in the 1970s, and papers in the 1990s took their information from the 1980s. SSRIs, which are the current mainstay of therapy, did not emerge until the 1990s. Prior to the advent of SSRIs, physicians were reluctant to even identify depression because the available treatments (MAO inhibitors and, later, tricyclics) carried so many serious side effects,” said Dr. Tangalos, a professor of medicine at the Mayo Clinic in Rochester, Minn. He reported no relevant conflicts of interest.

Disclosures: The National Institute of Mental Health funded the study. Mr. Fournier stated that he had no relevant financial conflicts of interest. Several of the other investigators did report financial relationships with several pharmaceutical companies.

My Take

Findings Need Careful Assessment

This is an important study for internists, but I am cautious about its message. In view of the diagnostic variability of mild depression, we need to examine the findings carefully before we implement them wholesale.

I have treated many patients with mild chronic depression or dysthymic conditions who have had excellent (family member validated) short- and long-term results with antidepressant medications—so many patients, in fact, that the responses do not seem to reflect a placebo effect.

I would hope that formulary committees would not jump to blunt conclusions about the value of antidepressants without nuanced review of the study and substantiation of its findings.

WILLIAM E. GOLDEN, M.D., is professor of medicine and public health at the University of Arkansas, Little Rock. He reports no conflicts of interest.

The efficacy of antidepressant treatment over placebo for major depressive disorder “varies considerably,” depending upon symptom severity, a recent meta-analysis showed.

Only patients whose depression is classified as “very severe” appear to have a greater benefit from antidepressants than from placebo pills, according to the study by Jay C. Fournier of the University of Pennsylvania, Philadelphia, and his colleagues (JAMA 2010;303:47-53).

Most placebo-controlled studies of antidepressants specifically exclude individuals who score below 23 on the Hamilton Depression Rating Scale (HDRS). HDRS scores of 8-13 indicate mild depression, scores of 14-18 indicate moderate depression, scores of 19-22 indicate severe depression, and scores of 23 or above indicate very severe depression.

In addition, many antidepressant studies include a “placebo washout period” in which all patients receive placebo pills for several days to 2 weeks before randomization. Often, patients who improve by 20% or more in the HDRS are excluded from the trial. Removing known placebo responders at the outset is thought to enhance the statistical power of the antidepressant-placebo comparison.

“This design feature severely limits the ability to generate accurate estimates of the placebo response rate,” wrote Mr. Fournier and his colleagues, noting that “the true rate of placebo response may be underestimated in trials that use this feature.”

To determine the true placebo response rate across the entire range of depression severity, the investigators combed the literature for randomized, controlled studies of minor depressive disorder that did not include a placebo washout period.

Of the 2,146 randomized, controlled trials of depressants published in English from January 1980 to March 2009, only 23 studies met those criteria. But only six of those studies could provide patient-level data to the investigators. It was those six studies, comprising 434 patients in antidepressant groups and 284 patients in placebo groups, that were the subject of the meta-analysis.

Actually, most meta-analyses include only group-level data. A study such as this one that includes patient-level data is called a “mega-analysis.” This approach allows investigators to conduct a more fine-grained multivariate analysis.

Three of the six studies used imipramine, a tricyclic antidepressant, and the other three used paroxetine, a selective serotonin reuptake inhibitor. The mean baseline HDRS score in the studies ranged from 14 to 24.

As expected, the higher the patient's baseline HDRS score, the more improvement was seen with both the active drug and the placebo. A difference of 3 points or more on the HDRS is considered clinically significant. It was only at HDRS baseline levels of 25 and above that active drug was both statistically and clinically better than placebo. This finding was the same for imipramine and paroxetine.

The investigators wrote that in marketing antidepressants, pharmaceutical manufacturers rarely mention that most efficacy studies specifically exclude patients who derive little benefit from their medications.

The authors concluded that “efforts should be made to clarify to clinicians and prospective patients that whereas [antidepressant medications] can have a substantial effect with more severe depressions, there is little evidence to suggest that they produce specific pharmacological benefit for the majority of patients with less severe acute depression.”

Commenting on the meta-analysis, Dr. Eric G. Tangalos emphasized that conclusions based on studies published as early as 1980 might not be relevant to current medical practice.

“Papers published in the 1980s took their data from clinical practice in the 1970s, and papers in the 1990s took their information from the 1980s. SSRIs, which are the current mainstay of therapy, did not emerge until the 1990s. Prior to the advent of SSRIs, physicians were reluctant to even identify depression because the available treatments (MAO inhibitors and, later, tricyclics) carried so many serious side effects,” said Dr. Tangalos, a professor of medicine at the Mayo Clinic in Rochester, Minn. He reported no relevant conflicts of interest.

Disclosures: The National Institute of Mental Health funded the study. Mr. Fournier stated that he had no relevant financial conflicts of interest. Several of the other investigators did report financial relationships with several pharmaceutical companies.

My Take

Findings Need Careful Assessment

This is an important study for internists, but I am cautious about its message. In view of the diagnostic variability of mild depression, we need to examine the findings carefully before we implement them wholesale.

I have treated many patients with mild chronic depression or dysthymic conditions who have had excellent (family member validated) short- and long-term results with antidepressant medications—so many patients, in fact, that the responses do not seem to reflect a placebo effect.

I would hope that formulary committees would not jump to blunt conclusions about the value of antidepressants without nuanced review of the study and substantiation of its findings.

WILLIAM E. GOLDEN, M.D., is professor of medicine and public health at the University of Arkansas, Little Rock. He reports no conflicts of interest.

The efficacy of antidepressant treatment over placebo for major depressive disorder “varies considerably,” depending upon symptom severity, a recent meta-analysis showed.

Only patients whose depression is classified as “very severe” appear to have a greater benefit from antidepressants than from placebo pills, according to the study by Jay C. Fournier of the University of Pennsylvania, Philadelphia, and his colleagues (JAMA 2010;303:47-53).

Most placebo-controlled studies of antidepressants specifically exclude individuals who score below 23 on the Hamilton Depression Rating Scale (HDRS). HDRS scores of 8-13 indicate mild depression, scores of 14-18 indicate moderate depression, scores of 19-22 indicate severe depression, and scores of 23 or above indicate very severe depression.

In addition, many antidepressant studies include a “placebo washout period” in which all patients receive placebo pills for several days to 2 weeks before randomization. Often, patients who improve by 20% or more in the HDRS are excluded from the trial. Removing known placebo responders at the outset is thought to enhance the statistical power of the antidepressant-placebo comparison.

“This design feature severely limits the ability to generate accurate estimates of the placebo response rate,” wrote Mr. Fournier and his colleagues, noting that “the true rate of placebo response may be underestimated in trials that use this feature.”

To determine the true placebo response rate across the entire range of depression severity, the investigators combed the literature for randomized, controlled studies of minor depressive disorder that did not include a placebo washout period.

Of the 2,146 randomized, controlled trials of depressants published in English from January 1980 to March 2009, only 23 studies met those criteria. But only six of those studies could provide patient-level data to the investigators. It was those six studies, comprising 434 patients in antidepressant groups and 284 patients in placebo groups, that were the subject of the meta-analysis.

Actually, most meta-analyses include only group-level data. A study such as this one that includes patient-level data is called a “mega-analysis.” This approach allows investigators to conduct a more fine-grained multivariate analysis.

Three of the six studies used imipramine, a tricyclic antidepressant, and the other three used paroxetine, a selective serotonin reuptake inhibitor. The mean baseline HDRS score in the studies ranged from 14 to 24.

As expected, the higher the patient's baseline HDRS score, the more improvement was seen with both the active drug and the placebo. A difference of 3 points or more on the HDRS is considered clinically significant. It was only at HDRS baseline levels of 25 and above that active drug was both statistically and clinically better than placebo. This finding was the same for imipramine and paroxetine.

The investigators wrote that in marketing antidepressants, pharmaceutical manufacturers rarely mention that most efficacy studies specifically exclude patients who derive little benefit from their medications.

The authors concluded that “efforts should be made to clarify to clinicians and prospective patients that whereas [antidepressant medications] can have a substantial effect with more severe depressions, there is little evidence to suggest that they produce specific pharmacological benefit for the majority of patients with less severe acute depression.”

Commenting on the meta-analysis, Dr. Eric G. Tangalos emphasized that conclusions based on studies published as early as 1980 might not be relevant to current medical practice.

“Papers published in the 1980s took their data from clinical practice in the 1970s, and papers in the 1990s took their information from the 1980s. SSRIs, which are the current mainstay of therapy, did not emerge until the 1990s. Prior to the advent of SSRIs, physicians were reluctant to even identify depression because the available treatments (MAO inhibitors and, later, tricyclics) carried so many serious side effects,” said Dr. Tangalos, a professor of medicine at the Mayo Clinic in Rochester, Minn. He reported no relevant conflicts of interest.

Disclosures: The National Institute of Mental Health funded the study. Mr. Fournier stated that he had no relevant financial conflicts of interest. Several of the other investigators did report financial relationships with several pharmaceutical companies.

My Take

Findings Need Careful Assessment

This is an important study for internists, but I am cautious about its message. In view of the diagnostic variability of mild depression, we need to examine the findings carefully before we implement them wholesale.

I have treated many patients with mild chronic depression or dysthymic conditions who have had excellent (family member validated) short- and long-term results with antidepressant medications—so many patients, in fact, that the responses do not seem to reflect a placebo effect.

I would hope that formulary committees would not jump to blunt conclusions about the value of antidepressants without nuanced review of the study and substantiation of its findings.

WILLIAM E. GOLDEN, M.D., is professor of medicine and public health at the University of Arkansas, Little Rock. He reports no conflicts of interest.

The Food and Drug Administration has warned clinicians and patients to be vigilant for potentially life-threatening complications with the use of negative-pressure wound-therapy devices.

The agency issued the notification after receiving reports of 6 deaths and 77 injuries associated with NPWT devices. “Most of the deaths reported to FDA occurred at home or in a long-term care facility,” the FDA said.

Bleeding was the most serious complication; it was involved in 6 deaths and 17 injuries. Infections, which played a role in 27 reports, arose from the original open wound or dressing pieces retained in the wound. Overall, 32 injuries involved retention of foam dressing pieces; most of those patients required surgical procedures, wound debridement, and treatment of wound dehiscence, as well as additional hospitalization and antibiotic therapy.

The FDA notice listed wound types and conditions for which NPWT is contraindicated, as well as risk factors that should be considered before NPWT is used. (See boxes.)

NPWT is still useful “in the appropriate wounds and in the appropriate areas,” said Dr. Paul Y. Takahashi, an internist and expert in wound care at the Mayo Clinic, Rochester, Minn.

The device is FDA approved and “can help, particularly with preventing amputations. It can help in some situations in which a flap or a skin graft is not appropriate. And it certainly can still be beneficial for wounds that are not healing,” he said in an interview. But “you really have to be well trained in using the negative pressure device, and when you remove it … make sure it's well observed, make sure things are healing in nicely and that you're not having excess bleeding.”

Unlike standard wound dressings, which are changed at least daily, NPWT dressings may not be changed for 3 or 4 days, so complications can go unnoticed in NPWT-treated wounds, he noted.

Staff and patients should be alert for certain problem signs, Dr. Takahashi said. The edges of the wound should remain pink. It's time to become concerned when the edges start turning red or the area becomes painful. Other concerning symptoms include fevers, chills, and changes in blood pressure.

A patient handout and a link to the notification is at www.fda.gov/ForConsumers/ConsumerUpdates/ucm193277.htm

Risk Factors Relevant to NPWT Use

▸ Patients at high risk for bleeding and hemorrhage

▸ Patients on anticoagulants or platelet-aggregation inhibitors

▸ Patients with:

Friable vessels and infected blood vessels

Vascular anastomosis

Infected wounds

Osteomyelitis

Exposed organs, vessels, nerves, tendon, and ligaments

Sharp edges in the wound (e.g., bone fragments)

Spinal cord injury (stimulation of sympathetic nervous system)

Enteric fistulas

▸ Patients requiring:

MRI

Hyperbaric chamber

Defibrillation

▸ Patient size and weight

▸ Use near vagus nerve (bradycardia)

▸ Application of circumferential dressing

▸ Mode of therapy—intermittent versus continuous negative pressure

Source: Food and Drug Administration

Contraindications For NPWT

Necrotic tissue with eschar present

Untreated osteomyelitis

Nonenteric and unexplored fistulas

Malignancy in the wound

Exposed vasculature

Exposed nerves

Exposed anastomotic site

Exposed organs

Source: Food and Drug Administration

The Food and Drug Administration has warned clinicians and patients to be vigilant for potentially life-threatening complications with the use of negative-pressure wound-therapy devices.

The agency issued the notification after receiving reports of 6 deaths and 77 injuries associated with NPWT devices. “Most of the deaths reported to FDA occurred at home or in a long-term care facility,” the FDA said.

Bleeding was the most serious complication; it was involved in 6 deaths and 17 injuries. Infections, which played a role in 27 reports, arose from the original open wound or dressing pieces retained in the wound. Overall, 32 injuries involved retention of foam dressing pieces; most of those patients required surgical procedures, wound debridement, and treatment of wound dehiscence, as well as additional hospitalization and antibiotic therapy.

The FDA notice listed wound types and conditions for which NPWT is contraindicated, as well as risk factors that should be considered before NPWT is used. (See boxes.)

NPWT is still useful “in the appropriate wounds and in the appropriate areas,” said Dr. Paul Y. Takahashi, an internist and expert in wound care at the Mayo Clinic, Rochester, Minn.

The device is FDA approved and “can help, particularly with preventing amputations. It can help in some situations in which a flap or a skin graft is not appropriate. And it certainly can still be beneficial for wounds that are not healing,” he said in an interview. But “you really have to be well trained in using the negative pressure device, and when you remove it … make sure it's well observed, make sure things are healing in nicely and that you're not having excess bleeding.”

Unlike standard wound dressings, which are changed at least daily, NPWT dressings may not be changed for 3 or 4 days, so complications can go unnoticed in NPWT-treated wounds, he noted.

Staff and patients should be alert for certain problem signs, Dr. Takahashi said. The edges of the wound should remain pink. It's time to become concerned when the edges start turning red or the area becomes painful. Other concerning symptoms include fevers, chills, and changes in blood pressure.

A patient handout and a link to the notification is at www.fda.gov/ForConsumers/ConsumerUpdates/ucm193277.htm

Risk Factors Relevant to NPWT Use

▸ Patients at high risk for bleeding and hemorrhage

▸ Patients on anticoagulants or platelet-aggregation inhibitors

▸ Patients with:

Friable vessels and infected blood vessels

Vascular anastomosis

Infected wounds

Osteomyelitis

Exposed organs, vessels, nerves, tendon, and ligaments

Sharp edges in the wound (e.g., bone fragments)

Spinal cord injury (stimulation of sympathetic nervous system)

Enteric fistulas

▸ Patients requiring:

MRI

Hyperbaric chamber

Defibrillation

▸ Patient size and weight

▸ Use near vagus nerve (bradycardia)

▸ Application of circumferential dressing

▸ Mode of therapy—intermittent versus continuous negative pressure

Source: Food and Drug Administration

Contraindications For NPWT

Necrotic tissue with eschar present

Untreated osteomyelitis

Nonenteric and unexplored fistulas

Malignancy in the wound

Exposed vasculature

Exposed nerves

Exposed anastomotic site

Exposed organs

Source: Food and Drug Administration

The Food and Drug Administration has warned clinicians and patients to be vigilant for potentially life-threatening complications with the use of negative-pressure wound-therapy devices.

The agency issued the notification after receiving reports of 6 deaths and 77 injuries associated with NPWT devices. “Most of the deaths reported to FDA occurred at home or in a long-term care facility,” the FDA said.

Bleeding was the most serious complication; it was involved in 6 deaths and 17 injuries. Infections, which played a role in 27 reports, arose from the original open wound or dressing pieces retained in the wound. Overall, 32 injuries involved retention of foam dressing pieces; most of those patients required surgical procedures, wound debridement, and treatment of wound dehiscence, as well as additional hospitalization and antibiotic therapy.

The FDA notice listed wound types and conditions for which NPWT is contraindicated, as well as risk factors that should be considered before NPWT is used. (See boxes.)

NPWT is still useful “in the appropriate wounds and in the appropriate areas,” said Dr. Paul Y. Takahashi, an internist and expert in wound care at the Mayo Clinic, Rochester, Minn.

The device is FDA approved and “can help, particularly with preventing amputations. It can help in some situations in which a flap or a skin graft is not appropriate. And it certainly can still be beneficial for wounds that are not healing,” he said in an interview. But “you really have to be well trained in using the negative pressure device, and when you remove it … make sure it's well observed, make sure things are healing in nicely and that you're not having excess bleeding.”

Unlike standard wound dressings, which are changed at least daily, NPWT dressings may not be changed for 3 or 4 days, so complications can go unnoticed in NPWT-treated wounds, he noted.

Staff and patients should be alert for certain problem signs, Dr. Takahashi said. The edges of the wound should remain pink. It's time to become concerned when the edges start turning red or the area becomes painful. Other concerning symptoms include fevers, chills, and changes in blood pressure.

A patient handout and a link to the notification is at www.fda.gov/ForConsumers/ConsumerUpdates/ucm193277.htm

Risk Factors Relevant to NPWT Use

▸ Patients at high risk for bleeding and hemorrhage

▸ Patients on anticoagulants or platelet-aggregation inhibitors

▸ Patients with:

Friable vessels and infected blood vessels

Vascular anastomosis

Infected wounds

Osteomyelitis

Exposed organs, vessels, nerves, tendon, and ligaments

Sharp edges in the wound (e.g., bone fragments)

Spinal cord injury (stimulation of sympathetic nervous system)

Enteric fistulas

▸ Patients requiring:

MRI

Hyperbaric chamber

Defibrillation

▸ Patient size and weight

▸ Use near vagus nerve (bradycardia)

▸ Application of circumferential dressing

▸ Mode of therapy—intermittent versus continuous negative pressure

Source: Food and Drug Administration

Contraindications For NPWT

Necrotic tissue with eschar present

Untreated osteomyelitis

Nonenteric and unexplored fistulas

Malignancy in the wound

Exposed vasculature

Exposed nerves

Exposed anastomotic site

Exposed organs

Source: Food and Drug Administration

Disclosures: Dr. Lesham and associates reported no conflicts of interest.

SAN FRANCISCO — Infants most often acquire Staphylococcus aureus infections from their mothers horizontally after birth and not vertically during birth, based on a prospective, longitudinal study of 158 pregnant women and their offspring.

Of the participating women, 54 (34%) were S. aureus carriers, and 17 of the children born to them (31%) acquired S. aureus before discharge, Dr. Eyal Leshem and colleagues at Chaim Sheba Medical Center, Tel Hashomer, Israel, wrote in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, sponsored by the American Society for Microbiology.

By contrast, only 3% of the children born to noncarrier mothers acquired S. aureus. The investigators found that the mother's carriage status was a very strong predictor of the infant's status. Children born to carriers were 22 times more likely to acquire S. aureus than other children. The investigators controlled for the sex of the child, carriage status of the mother, breastfeeding, gestational age, antibiotic treatment, type of delivery, and smoking status. This increase in risk was highly statistically significant. The only other statistically significant predictor of mother-to-infant transmission was smoking status.

Of the 54 maternal carriers, 38 were nasal carriers, 9 were vaginal carriers, and 7 were both vaginal and nasal carriers. Among 11 of the newborns who acquired S. aureus from their carrier mothers, 9 had strains that were genetically identical to the mother's nasal strain, but only 2 had strains identical to the mother's vaginal strain. This suggests that the transmission was horizontal rather than vertical.

Two other pieces of evidence supported the hypothesis that most transmission was horizontal. Only 5% of newborns had acquired S. aureus by 1 hour after birth, but this figure increased to 8% at 24-48 hours and to 12% by 72-100 hours. Also, there were no significant differences in transmission rates between infants born vaginally and those born by cesarean section. If a vertical transmission were dominant, one would expect a greater rate of transmission in vaginal births.

Disclosures: Dr. Lesham and associates reported no conflicts of interest.

SAN FRANCISCO — Infants most often acquire Staphylococcus aureus infections from their mothers horizontally after birth and not vertically during birth, based on a prospective, longitudinal study of 158 pregnant women and their offspring.

Of the participating women, 54 (34%) were S. aureus carriers, and 17 of the children born to them (31%) acquired S. aureus before discharge, Dr. Eyal Leshem and colleagues at Chaim Sheba Medical Center, Tel Hashomer, Israel, wrote in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, sponsored by the American Society for Microbiology.

By contrast, only 3% of the children born to noncarrier mothers acquired S. aureus. The investigators found that the mother's carriage status was a very strong predictor of the infant's status. Children born to carriers were 22 times more likely to acquire S. aureus than other children. The investigators controlled for the sex of the child, carriage status of the mother, breastfeeding, gestational age, antibiotic treatment, type of delivery, and smoking status. This increase in risk was highly statistically significant. The only other statistically significant predictor of mother-to-infant transmission was smoking status.

Of the 54 maternal carriers, 38 were nasal carriers, 9 were vaginal carriers, and 7 were both vaginal and nasal carriers. Among 11 of the newborns who acquired S. aureus from their carrier mothers, 9 had strains that were genetically identical to the mother's nasal strain, but only 2 had strains identical to the mother's vaginal strain. This suggests that the transmission was horizontal rather than vertical.

Two other pieces of evidence supported the hypothesis that most transmission was horizontal. Only 5% of newborns had acquired S. aureus by 1 hour after birth, but this figure increased to 8% at 24-48 hours and to 12% by 72-100 hours. Also, there were no significant differences in transmission rates between infants born vaginally and those born by cesarean section. If a vertical transmission were dominant, one would expect a greater rate of transmission in vaginal births.

Disclosures: Dr. Lesham and associates reported no conflicts of interest.

SAN FRANCISCO — Infants most often acquire Staphylococcus aureus infections from their mothers horizontally after birth and not vertically during birth, based on a prospective, longitudinal study of 158 pregnant women and their offspring.

Of the participating women, 54 (34%) were S. aureus carriers, and 17 of the children born to them (31%) acquired S. aureus before discharge, Dr. Eyal Leshem and colleagues at Chaim Sheba Medical Center, Tel Hashomer, Israel, wrote in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, sponsored by the American Society for Microbiology.

By contrast, only 3% of the children born to noncarrier mothers acquired S. aureus. The investigators found that the mother's carriage status was a very strong predictor of the infant's status. Children born to carriers were 22 times more likely to acquire S. aureus than other children. The investigators controlled for the sex of the child, carriage status of the mother, breastfeeding, gestational age, antibiotic treatment, type of delivery, and smoking status. This increase in risk was highly statistically significant. The only other statistically significant predictor of mother-to-infant transmission was smoking status.

Of the 54 maternal carriers, 38 were nasal carriers, 9 were vaginal carriers, and 7 were both vaginal and nasal carriers. Among 11 of the newborns who acquired S. aureus from their carrier mothers, 9 had strains that were genetically identical to the mother's nasal strain, but only 2 had strains identical to the mother's vaginal strain. This suggests that the transmission was horizontal rather than vertical.

Two other pieces of evidence supported the hypothesis that most transmission was horizontal. Only 5% of newborns had acquired S. aureus by 1 hour after birth, but this figure increased to 8% at 24-48 hours and to 12% by 72-100 hours. Also, there were no significant differences in transmission rates between infants born vaginally and those born by cesarean section. If a vertical transmission were dominant, one would expect a greater rate of transmission in vaginal births.