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Most Children Who Died From Flu Weren't Vaccinated
Nearly half the flu-related deaths in children last year occurred in those younger than 5 years, and only 23% of eligible children had been vaccinated, according to data from the Centers for Disease Control and Prevention.
The CDC released data on influenza-associated pediatric deaths between September 2010 and August 2011 in the Morbidity and Mortality Weekly Report, published online Sept. 16 (MMWR 2011;60:1233-38).
A total of 115 flu-related deaths in children younger than age 18 years were reported to the CDC during the study period. Of these, 56 (49%) had no known high-risk medical conditions as defined by the CDC’s Advisory Committee on Immunization Practices. Only 17 children (23%) had been fully vaccinated, based on data from the 74 children aged 6 months and older for whom vaccination information was available.
The median age of the patients who died was 6 years, and 53 deaths (46%) occurred in children younger than 5 years.
Overall, 71 cases (62%) were associated with influenza A viruses, and 44 (38%) were associated with influenza B viruses.
"Influenza B was identified in a disproportionate number of pediatric influenza-associated deaths," although only 26% of the circulating viruses during the 2010-2011 flu season were influenza B, the researchers noted. In previous seasons, the percentage of influenza B viruses in flu-related pediatric deaths has been equal or greater than the percentage of influenza B circulating virus for that season, they said.
The data are subject to the limitations of the current surveillance system, the researchers noted. But the report emphasizes the need for continued surveillance. The CDC continues to recommend annual flu vaccinations for all children aged 6 months and older.
The MMWR also included a report on flu activity in the United States and worldwide from May 22, 2011 through Sept. 3, 2011 (MMWR 2011;60:1239-41). In the U.S., 122 respiratory specimens were positive for influenza, including 87 cases of influenza A and 35 of influenza B. Flu viruses were reported in 26 states during this period, and they were different from the currently circulating H3N2 virus.
Worldwide, the 2009 H1N1 virus was the dominant circulating virus in Australia, while influenza B viruses dominated New Zealand. The 2009 H1N1 virus also dominated cases in southern Africa, while the influenza A H3N2 was the dominant virus in Asia during this period.
Nearly half the flu-related deaths in children last year occurred in those younger than 5 years, and only 23% of eligible children had been vaccinated, according to data from the Centers for Disease Control and Prevention.
The CDC released data on influenza-associated pediatric deaths between September 2010 and August 2011 in the Morbidity and Mortality Weekly Report, published online Sept. 16 (MMWR 2011;60:1233-38).
A total of 115 flu-related deaths in children younger than age 18 years were reported to the CDC during the study period. Of these, 56 (49%) had no known high-risk medical conditions as defined by the CDC’s Advisory Committee on Immunization Practices. Only 17 children (23%) had been fully vaccinated, based on data from the 74 children aged 6 months and older for whom vaccination information was available.
The median age of the patients who died was 6 years, and 53 deaths (46%) occurred in children younger than 5 years.
Overall, 71 cases (62%) were associated with influenza A viruses, and 44 (38%) were associated with influenza B viruses.
"Influenza B was identified in a disproportionate number of pediatric influenza-associated deaths," although only 26% of the circulating viruses during the 2010-2011 flu season were influenza B, the researchers noted. In previous seasons, the percentage of influenza B viruses in flu-related pediatric deaths has been equal or greater than the percentage of influenza B circulating virus for that season, they said.
The data are subject to the limitations of the current surveillance system, the researchers noted. But the report emphasizes the need for continued surveillance. The CDC continues to recommend annual flu vaccinations for all children aged 6 months and older.
The MMWR also included a report on flu activity in the United States and worldwide from May 22, 2011 through Sept. 3, 2011 (MMWR 2011;60:1239-41). In the U.S., 122 respiratory specimens were positive for influenza, including 87 cases of influenza A and 35 of influenza B. Flu viruses were reported in 26 states during this period, and they were different from the currently circulating H3N2 virus.
Worldwide, the 2009 H1N1 virus was the dominant circulating virus in Australia, while influenza B viruses dominated New Zealand. The 2009 H1N1 virus also dominated cases in southern Africa, while the influenza A H3N2 was the dominant virus in Asia during this period.
Nearly half the flu-related deaths in children last year occurred in those younger than 5 years, and only 23% of eligible children had been vaccinated, according to data from the Centers for Disease Control and Prevention.
The CDC released data on influenza-associated pediatric deaths between September 2010 and August 2011 in the Morbidity and Mortality Weekly Report, published online Sept. 16 (MMWR 2011;60:1233-38).
A total of 115 flu-related deaths in children younger than age 18 years were reported to the CDC during the study period. Of these, 56 (49%) had no known high-risk medical conditions as defined by the CDC’s Advisory Committee on Immunization Practices. Only 17 children (23%) had been fully vaccinated, based on data from the 74 children aged 6 months and older for whom vaccination information was available.
The median age of the patients who died was 6 years, and 53 deaths (46%) occurred in children younger than 5 years.
Overall, 71 cases (62%) were associated with influenza A viruses, and 44 (38%) were associated with influenza B viruses.
"Influenza B was identified in a disproportionate number of pediatric influenza-associated deaths," although only 26% of the circulating viruses during the 2010-2011 flu season were influenza B, the researchers noted. In previous seasons, the percentage of influenza B viruses in flu-related pediatric deaths has been equal or greater than the percentage of influenza B circulating virus for that season, they said.
The data are subject to the limitations of the current surveillance system, the researchers noted. But the report emphasizes the need for continued surveillance. The CDC continues to recommend annual flu vaccinations for all children aged 6 months and older.
The MMWR also included a report on flu activity in the United States and worldwide from May 22, 2011 through Sept. 3, 2011 (MMWR 2011;60:1239-41). In the U.S., 122 respiratory specimens were positive for influenza, including 87 cases of influenza A and 35 of influenza B. Flu viruses were reported in 26 states during this period, and they were different from the currently circulating H3N2 virus.
Worldwide, the 2009 H1N1 virus was the dominant circulating virus in Australia, while influenza B viruses dominated New Zealand. The 2009 H1N1 virus also dominated cases in southern Africa, while the influenza A H3N2 was the dominant virus in Asia during this period.
FROM THE CDC MORBIDITY AND MORTALITY WEEKLY REPORT
Major Finding: During the 2010-2011 season, 53 deaths (46%) occurred in children younger than 5 years; 23% of the pediatric deaths from the flu occurred in fully vaccinated children.
Data Source: An analysis by the Centers for Disease Control and Prevention of influenza-associated pediatric deaths between September 2010 and August 2011.
Disclosures: None.
Antipsychotics Linked to Metabolic Syndrome Spike in Children
PARIS – The percentage of children and adolescents who developed metabolic syndrome while taking antipsychotics more than doubled from 3% after 3 months of use to 7% after 12 months, according to data from a longitudinal study of 235 children and adolescents, Jessica Merchán-Naranjo reported at the Annual Congress of the European College of Neuropsychopharmacology.
Data from previous studies have shown the development of metabolic adverse effects as a result of antipsychotics, but the nature of the impact on children has not been well studied, said Ms. Merchán-Naranjo of the Hospital General Universitario Gregorio Marañón in Madrid.
At baseline, 116 children had no prior antipsychotic treatment and 119 had fewer than 30 days of exposure to antipsychotics. The patients were assessed at baseline and again after 3, 6, and 12 months of antipsychotic use. The mean age of the children was 14 years, 141 were male, and 89% were white.
The diagnoses were divided into three groups: schizophrenia or other disorders with psychotic symptoms (93 patients), bipolar disorder (38 patients), and other disorders (104 patients). The majority of the children were treated with risperidone (146 patients). The most common additional medications were olanzapine (39 patients), and quetiapine (38 patients). The remaining patients were treated with clozapine, haloperidol, pimozide, or aripiprazole.
The percentage of children who met criteria for metabolic syndrome at 3, 6, and 12 months was 3%, 6%, and 7%, respectively. Metabolic syndrome was defined as at least three of the following conditions: body mass index in the 95th percentile or higher, triglycerides greater than 110 mg/dL, HDL cholesterol less than 40 mg/dL, and glucose of 110 mg/dL or higher.
The percentage of children who were considered at risk for metabolic syndrome at 3, 6, and 12 months was 22%, 24%, and 33%, respectively. The researchers defined "at risk" as either a body mass index in the 95th percentile or higher, or a BMI in the 85th percentile or higher plus the presence of hypertension, dyslipidemia, or hyperglycemia.
The results confirm that adverse events should be monitored in children and adolescents taking antipsychotics throughout the entire treatment period, she added.
The study was funded by Spain’s Ministry of Science and Innovation and by an independent investigator award from the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM). Ms. Merchán-Naranjo reported no conflict of interest.
PARIS – The percentage of children and adolescents who developed metabolic syndrome while taking antipsychotics more than doubled from 3% after 3 months of use to 7% after 12 months, according to data from a longitudinal study of 235 children and adolescents, Jessica Merchán-Naranjo reported at the Annual Congress of the European College of Neuropsychopharmacology.
Data from previous studies have shown the development of metabolic adverse effects as a result of antipsychotics, but the nature of the impact on children has not been well studied, said Ms. Merchán-Naranjo of the Hospital General Universitario Gregorio Marañón in Madrid.
At baseline, 116 children had no prior antipsychotic treatment and 119 had fewer than 30 days of exposure to antipsychotics. The patients were assessed at baseline and again after 3, 6, and 12 months of antipsychotic use. The mean age of the children was 14 years, 141 were male, and 89% were white.
The diagnoses were divided into three groups: schizophrenia or other disorders with psychotic symptoms (93 patients), bipolar disorder (38 patients), and other disorders (104 patients). The majority of the children were treated with risperidone (146 patients). The most common additional medications were olanzapine (39 patients), and quetiapine (38 patients). The remaining patients were treated with clozapine, haloperidol, pimozide, or aripiprazole.
The percentage of children who met criteria for metabolic syndrome at 3, 6, and 12 months was 3%, 6%, and 7%, respectively. Metabolic syndrome was defined as at least three of the following conditions: body mass index in the 95th percentile or higher, triglycerides greater than 110 mg/dL, HDL cholesterol less than 40 mg/dL, and glucose of 110 mg/dL or higher.
The percentage of children who were considered at risk for metabolic syndrome at 3, 6, and 12 months was 22%, 24%, and 33%, respectively. The researchers defined "at risk" as either a body mass index in the 95th percentile or higher, or a BMI in the 85th percentile or higher plus the presence of hypertension, dyslipidemia, or hyperglycemia.
The results confirm that adverse events should be monitored in children and adolescents taking antipsychotics throughout the entire treatment period, she added.
The study was funded by Spain’s Ministry of Science and Innovation and by an independent investigator award from the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM). Ms. Merchán-Naranjo reported no conflict of interest.
PARIS – The percentage of children and adolescents who developed metabolic syndrome while taking antipsychotics more than doubled from 3% after 3 months of use to 7% after 12 months, according to data from a longitudinal study of 235 children and adolescents, Jessica Merchán-Naranjo reported at the Annual Congress of the European College of Neuropsychopharmacology.
Data from previous studies have shown the development of metabolic adverse effects as a result of antipsychotics, but the nature of the impact on children has not been well studied, said Ms. Merchán-Naranjo of the Hospital General Universitario Gregorio Marañón in Madrid.
At baseline, 116 children had no prior antipsychotic treatment and 119 had fewer than 30 days of exposure to antipsychotics. The patients were assessed at baseline and again after 3, 6, and 12 months of antipsychotic use. The mean age of the children was 14 years, 141 were male, and 89% were white.
The diagnoses were divided into three groups: schizophrenia or other disorders with psychotic symptoms (93 patients), bipolar disorder (38 patients), and other disorders (104 patients). The majority of the children were treated with risperidone (146 patients). The most common additional medications were olanzapine (39 patients), and quetiapine (38 patients). The remaining patients were treated with clozapine, haloperidol, pimozide, or aripiprazole.
The percentage of children who met criteria for metabolic syndrome at 3, 6, and 12 months was 3%, 6%, and 7%, respectively. Metabolic syndrome was defined as at least three of the following conditions: body mass index in the 95th percentile or higher, triglycerides greater than 110 mg/dL, HDL cholesterol less than 40 mg/dL, and glucose of 110 mg/dL or higher.
The percentage of children who were considered at risk for metabolic syndrome at 3, 6, and 12 months was 22%, 24%, and 33%, respectively. The researchers defined "at risk" as either a body mass index in the 95th percentile or higher, or a BMI in the 85th percentile or higher plus the presence of hypertension, dyslipidemia, or hyperglycemia.
The results confirm that adverse events should be monitored in children and adolescents taking antipsychotics throughout the entire treatment period, she added.
The study was funded by Spain’s Ministry of Science and Innovation and by an independent investigator award from the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM). Ms. Merchán-Naranjo reported no conflict of interest.
FROM THE ANNUAL CONGRESS OF THE EUROPEAN COLLEGE OF NEUROPSYCHO-
PHARMACOLOGY
Major Finding: The risk for the developing metabolic syndrome in children and adolescents increases sharply between 3-12 months of antipsychotic treatment.
Data Source: A longitudinal study of 235 children and adolescents with schizophrenia or other disorders or psychotic symptoms, bipolar disorders, and other disorders.
Disclosures: The study was funded by the Spanish Ministry of Science and Innovation and by an independent investigator award from the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM). Ms. Merchán-Naranjo reported no conflict of interest.
Make Clinical Trials Shorter and Sexier, Study Suggests
PARIS – Clinical trials can show meaningful results after 5 weeks, and many trials should include more women, according to findings from the NEWMEDS program.
NEWMEDS, which is short for Novel Methods Leading to New Medications in Depression and Schizophrenia, is a consortium of scientists from around the world. The consortium is funded by the Innovative Medicines Initiative, a large-scale partnership between the European Union (represented by the European Commission) and the pharmaceutical industry (represented by the European Federation of Pharmaceutical Industries and Associations), according to the NEWMEDS website.
A primary goal of NEWMEDS is to look at ways of addressing the bottleneck that often slows drug development, said Jonathan Rabinowitz, Ph.D., who presented results of NEWMEDS research at the annual congress of the European College of Neuropsychopharmacology.
To date, the NEWMEDS repository of data from randomized controlled trials of antipsychotics in patients with schizophrenia includes 60 studies: 59 industry-sponsored studies from 5 drug companies and 1 from the National Institute of Mental Health (NIMH). The industry-sponsored studies included 29 placebo-controlled trials and 30 active comparator trials for a total of 23,401 patients. The NIMH trial added an additional 1,493 patients, reported Dr. Rabinowitz of Bar Ilan University in Ramat Gan, Israel.
The NEWMEDS team has reviewed 29 of these studies (including 6,971 patients on active treatment and 2,200 on placebo), with the goal of addressing four questions:
• Can clinical trials be shorter?
• What outcomes might predict treatment success?
• Do clinical trials have an overrepresentation of "eligibility creepers," meaning patients who don’t quite meet eligibility criteria?
• Do eligibility creepers have treatment responses that are different from those of patients who fall within the eligibility criteria?
The studies included in the review were sponsored by AstraZeneca, Janssen, Lilly, Lundbeck, and Pfizer.
In 37% of the studies lasting 6 weeks or longer, the effects of the week 5 results were larger than those at week 6, based on the LOCF (last observation carried forward) differences in Positive and Negative Syndrome Scale (PANSS) scores between the placebo and active patients. And in about half of the studies, at least 80% of week 6 effects were detectable at week 3, Dr. Rabinowitz said.
To determine whether certain subgroups of patients would show a stronger active treatment response, the NEWMEDS team examined variables, including sex, age, race, body mass index, age at disease onset, number of previous psychiatric hospitalizations, and the region where patients lived.
A review of study demographics showed that, on average, 71% of the participants in schizophrenia clinical trials were male, Dr. Rabinowitz said. However, "females had considerably less placebo response and slightly more treatment response than males," based on PANSS scores, he said.
Also of interest was the finding that patients in Eastern Europe showed a 19% greater active treatment response than did those in North America, Dr. Rabinowitz said. However, the reasons for this difference remain unclear and require further study, he added.
In addition, "people aged 30 years and older with 4 or more years of illness showed considerably better treatment response," Dr. Rabinowitz said.
A total of 20 of the 29 studies reviewed had specific eligibility criteria, and these were analyzed for eligibility creep, which was defined as patients who were within 6 points of the minimum eligibility criteria at the time of initial screening (for example, if a minimum PANSS score was 70, patients with scores of 70-75 could be eligibility creepers).
The researchers found that eligibility creepers were not overrepresented in the studies they reviewed, although there was an 18% less difference in active treatment response in this group, compared with the rest of the study cohort, Dr. Rabinowitz said.
Based on the findings, he presented three recommendations:
• Efforts should be made to dramatically increase the number of women in studies. Assuming a standard deviation of 19, a study that is 50% women would require 85 patients per treatment arm.
• Placebo-controlled efficacy trials could be shortened by 1 to 2 weeks.
• Sensitivity analysis should be included in a statistical analysis to reanalyze data after removing patients who fall within 6 points of the inclusion criteria.
The next step in the process would be a trial simulator including these elements, he said.
Dr. Rabinowitz has received research grant support and/or travel support and/or speaker fees and/or consultancy fees from Janssen, Johnson & Johnson, Lilly, Pfizer, BiolineRx, F. Hoffmann-La Roche, and Newron Pharmaceuticals.
PARIS – Clinical trials can show meaningful results after 5 weeks, and many trials should include more women, according to findings from the NEWMEDS program.
NEWMEDS, which is short for Novel Methods Leading to New Medications in Depression and Schizophrenia, is a consortium of scientists from around the world. The consortium is funded by the Innovative Medicines Initiative, a large-scale partnership between the European Union (represented by the European Commission) and the pharmaceutical industry (represented by the European Federation of Pharmaceutical Industries and Associations), according to the NEWMEDS website.
A primary goal of NEWMEDS is to look at ways of addressing the bottleneck that often slows drug development, said Jonathan Rabinowitz, Ph.D., who presented results of NEWMEDS research at the annual congress of the European College of Neuropsychopharmacology.
To date, the NEWMEDS repository of data from randomized controlled trials of antipsychotics in patients with schizophrenia includes 60 studies: 59 industry-sponsored studies from 5 drug companies and 1 from the National Institute of Mental Health (NIMH). The industry-sponsored studies included 29 placebo-controlled trials and 30 active comparator trials for a total of 23,401 patients. The NIMH trial added an additional 1,493 patients, reported Dr. Rabinowitz of Bar Ilan University in Ramat Gan, Israel.
The NEWMEDS team has reviewed 29 of these studies (including 6,971 patients on active treatment and 2,200 on placebo), with the goal of addressing four questions:
• Can clinical trials be shorter?
• What outcomes might predict treatment success?
• Do clinical trials have an overrepresentation of "eligibility creepers," meaning patients who don’t quite meet eligibility criteria?
• Do eligibility creepers have treatment responses that are different from those of patients who fall within the eligibility criteria?
The studies included in the review were sponsored by AstraZeneca, Janssen, Lilly, Lundbeck, and Pfizer.
In 37% of the studies lasting 6 weeks or longer, the effects of the week 5 results were larger than those at week 6, based on the LOCF (last observation carried forward) differences in Positive and Negative Syndrome Scale (PANSS) scores between the placebo and active patients. And in about half of the studies, at least 80% of week 6 effects were detectable at week 3, Dr. Rabinowitz said.
To determine whether certain subgroups of patients would show a stronger active treatment response, the NEWMEDS team examined variables, including sex, age, race, body mass index, age at disease onset, number of previous psychiatric hospitalizations, and the region where patients lived.
A review of study demographics showed that, on average, 71% of the participants in schizophrenia clinical trials were male, Dr. Rabinowitz said. However, "females had considerably less placebo response and slightly more treatment response than males," based on PANSS scores, he said.
Also of interest was the finding that patients in Eastern Europe showed a 19% greater active treatment response than did those in North America, Dr. Rabinowitz said. However, the reasons for this difference remain unclear and require further study, he added.
In addition, "people aged 30 years and older with 4 or more years of illness showed considerably better treatment response," Dr. Rabinowitz said.
A total of 20 of the 29 studies reviewed had specific eligibility criteria, and these were analyzed for eligibility creep, which was defined as patients who were within 6 points of the minimum eligibility criteria at the time of initial screening (for example, if a minimum PANSS score was 70, patients with scores of 70-75 could be eligibility creepers).
The researchers found that eligibility creepers were not overrepresented in the studies they reviewed, although there was an 18% less difference in active treatment response in this group, compared with the rest of the study cohort, Dr. Rabinowitz said.
Based on the findings, he presented three recommendations:
• Efforts should be made to dramatically increase the number of women in studies. Assuming a standard deviation of 19, a study that is 50% women would require 85 patients per treatment arm.
• Placebo-controlled efficacy trials could be shortened by 1 to 2 weeks.
• Sensitivity analysis should be included in a statistical analysis to reanalyze data after removing patients who fall within 6 points of the inclusion criteria.
The next step in the process would be a trial simulator including these elements, he said.
Dr. Rabinowitz has received research grant support and/or travel support and/or speaker fees and/or consultancy fees from Janssen, Johnson & Johnson, Lilly, Pfizer, BiolineRx, F. Hoffmann-La Roche, and Newron Pharmaceuticals.
PARIS – Clinical trials can show meaningful results after 5 weeks, and many trials should include more women, according to findings from the NEWMEDS program.
NEWMEDS, which is short for Novel Methods Leading to New Medications in Depression and Schizophrenia, is a consortium of scientists from around the world. The consortium is funded by the Innovative Medicines Initiative, a large-scale partnership between the European Union (represented by the European Commission) and the pharmaceutical industry (represented by the European Federation of Pharmaceutical Industries and Associations), according to the NEWMEDS website.
A primary goal of NEWMEDS is to look at ways of addressing the bottleneck that often slows drug development, said Jonathan Rabinowitz, Ph.D., who presented results of NEWMEDS research at the annual congress of the European College of Neuropsychopharmacology.
To date, the NEWMEDS repository of data from randomized controlled trials of antipsychotics in patients with schizophrenia includes 60 studies: 59 industry-sponsored studies from 5 drug companies and 1 from the National Institute of Mental Health (NIMH). The industry-sponsored studies included 29 placebo-controlled trials and 30 active comparator trials for a total of 23,401 patients. The NIMH trial added an additional 1,493 patients, reported Dr. Rabinowitz of Bar Ilan University in Ramat Gan, Israel.
The NEWMEDS team has reviewed 29 of these studies (including 6,971 patients on active treatment and 2,200 on placebo), with the goal of addressing four questions:
• Can clinical trials be shorter?
• What outcomes might predict treatment success?
• Do clinical trials have an overrepresentation of "eligibility creepers," meaning patients who don’t quite meet eligibility criteria?
• Do eligibility creepers have treatment responses that are different from those of patients who fall within the eligibility criteria?
The studies included in the review were sponsored by AstraZeneca, Janssen, Lilly, Lundbeck, and Pfizer.
In 37% of the studies lasting 6 weeks or longer, the effects of the week 5 results were larger than those at week 6, based on the LOCF (last observation carried forward) differences in Positive and Negative Syndrome Scale (PANSS) scores between the placebo and active patients. And in about half of the studies, at least 80% of week 6 effects were detectable at week 3, Dr. Rabinowitz said.
To determine whether certain subgroups of patients would show a stronger active treatment response, the NEWMEDS team examined variables, including sex, age, race, body mass index, age at disease onset, number of previous psychiatric hospitalizations, and the region where patients lived.
A review of study demographics showed that, on average, 71% of the participants in schizophrenia clinical trials were male, Dr. Rabinowitz said. However, "females had considerably less placebo response and slightly more treatment response than males," based on PANSS scores, he said.
Also of interest was the finding that patients in Eastern Europe showed a 19% greater active treatment response than did those in North America, Dr. Rabinowitz said. However, the reasons for this difference remain unclear and require further study, he added.
In addition, "people aged 30 years and older with 4 or more years of illness showed considerably better treatment response," Dr. Rabinowitz said.
A total of 20 of the 29 studies reviewed had specific eligibility criteria, and these were analyzed for eligibility creep, which was defined as patients who were within 6 points of the minimum eligibility criteria at the time of initial screening (for example, if a minimum PANSS score was 70, patients with scores of 70-75 could be eligibility creepers).
The researchers found that eligibility creepers were not overrepresented in the studies they reviewed, although there was an 18% less difference in active treatment response in this group, compared with the rest of the study cohort, Dr. Rabinowitz said.
Based on the findings, he presented three recommendations:
• Efforts should be made to dramatically increase the number of women in studies. Assuming a standard deviation of 19, a study that is 50% women would require 85 patients per treatment arm.
• Placebo-controlled efficacy trials could be shortened by 1 to 2 weeks.
• Sensitivity analysis should be included in a statistical analysis to reanalyze data after removing patients who fall within 6 points of the inclusion criteria.
The next step in the process would be a trial simulator including these elements, he said.
Dr. Rabinowitz has received research grant support and/or travel support and/or speaker fees and/or consultancy fees from Janssen, Johnson & Johnson, Lilly, Pfizer, BiolineRx, F. Hoffmann-La Roche, and Newron Pharmaceuticals.
FROM THE ANNUAL CONGRESS OF THE EUROPEAN COLLEGE OF NEUROPSYCHO-PHARMACOLOGY
Short Course of Escitalopram Reduces Fear in Depression
PARIS – A 7-day treatment of escitalopram significantly decreased the response of the amygdala to fearful stimuli in adults with major depression, Dr. Beata Godlewska reported at the Annual Congress of the European College of Neuropsychopharmacology.
Previous studies in healthy volunteers using functional magnetic resonance imaging (fMRI) have shown that antidepressant treatment reduces emotional responses to negative stimuli.
"Major depression is characterized by negative biases in emotion processing," said Dr. Godlewska, of the department of psychiatry at the University of Oxford (England). "It has been proposed that this change in processing could mediate the therapeutic effect of antidepressants."
Dr. Godlewska and colleagues randomized 42 depressed adults and 17 healthy volunteers to 10 mg/day of escitalopram or a placebo for 7 days. The researchers collected fMRI image information at a magnetic field strength of 3T on the last day of the study, focusing on activity in predetermined regions of interest for the bilateral amygdala. The imaging data consisted of neural responses to presentations happy or fearful faces, but the participants did not know what responses were being measured.
After 7 days, depressed patients treated with escitalopram showed significantly decreased activation in the right amygdala when presented with fearful faces, compared to depressed patients treated with a placebo. "There was no difference in amygdala activation between the escitalopram-treated patients and the healthy controls," Dr. Godlewska said.
Importantly, no clinically significant changes in mood were observed among the different groups during the 7-day study period, Dr. Godlewska noted.
Therefore, the findings suggest that antidepressants improve a depressed patient’s negative affective bias first, and then mood improves, Dr. Godlewska said. This represents a complete change from the currently accepted thinking. "Now people think that improvement in mood is the first stage, and only then the biases change," she said.
This early improvement in negative affective bias could help depressed patients relearn positive emotional associations in a more supportive environment, Dr. Godlewska noted.
More research is needed to determine the clinical implications of the findings, and Dr. Godlewska and colleagues are currently designing a study that would incorporate long-term follow-up data.
The study was funded by the Medical Research Council. Dr. Godlewska had no financial conflicts to disclose.
PARIS – A 7-day treatment of escitalopram significantly decreased the response of the amygdala to fearful stimuli in adults with major depression, Dr. Beata Godlewska reported at the Annual Congress of the European College of Neuropsychopharmacology.
Previous studies in healthy volunteers using functional magnetic resonance imaging (fMRI) have shown that antidepressant treatment reduces emotional responses to negative stimuli.
"Major depression is characterized by negative biases in emotion processing," said Dr. Godlewska, of the department of psychiatry at the University of Oxford (England). "It has been proposed that this change in processing could mediate the therapeutic effect of antidepressants."
Dr. Godlewska and colleagues randomized 42 depressed adults and 17 healthy volunteers to 10 mg/day of escitalopram or a placebo for 7 days. The researchers collected fMRI image information at a magnetic field strength of 3T on the last day of the study, focusing on activity in predetermined regions of interest for the bilateral amygdala. The imaging data consisted of neural responses to presentations happy or fearful faces, but the participants did not know what responses were being measured.
After 7 days, depressed patients treated with escitalopram showed significantly decreased activation in the right amygdala when presented with fearful faces, compared to depressed patients treated with a placebo. "There was no difference in amygdala activation between the escitalopram-treated patients and the healthy controls," Dr. Godlewska said.
Importantly, no clinically significant changes in mood were observed among the different groups during the 7-day study period, Dr. Godlewska noted.
Therefore, the findings suggest that antidepressants improve a depressed patient’s negative affective bias first, and then mood improves, Dr. Godlewska said. This represents a complete change from the currently accepted thinking. "Now people think that improvement in mood is the first stage, and only then the biases change," she said.
This early improvement in negative affective bias could help depressed patients relearn positive emotional associations in a more supportive environment, Dr. Godlewska noted.
More research is needed to determine the clinical implications of the findings, and Dr. Godlewska and colleagues are currently designing a study that would incorporate long-term follow-up data.
The study was funded by the Medical Research Council. Dr. Godlewska had no financial conflicts to disclose.
PARIS – A 7-day treatment of escitalopram significantly decreased the response of the amygdala to fearful stimuli in adults with major depression, Dr. Beata Godlewska reported at the Annual Congress of the European College of Neuropsychopharmacology.
Previous studies in healthy volunteers using functional magnetic resonance imaging (fMRI) have shown that antidepressant treatment reduces emotional responses to negative stimuli.
"Major depression is characterized by negative biases in emotion processing," said Dr. Godlewska, of the department of psychiatry at the University of Oxford (England). "It has been proposed that this change in processing could mediate the therapeutic effect of antidepressants."
Dr. Godlewska and colleagues randomized 42 depressed adults and 17 healthy volunteers to 10 mg/day of escitalopram or a placebo for 7 days. The researchers collected fMRI image information at a magnetic field strength of 3T on the last day of the study, focusing on activity in predetermined regions of interest for the bilateral amygdala. The imaging data consisted of neural responses to presentations happy or fearful faces, but the participants did not know what responses were being measured.
After 7 days, depressed patients treated with escitalopram showed significantly decreased activation in the right amygdala when presented with fearful faces, compared to depressed patients treated with a placebo. "There was no difference in amygdala activation between the escitalopram-treated patients and the healthy controls," Dr. Godlewska said.
Importantly, no clinically significant changes in mood were observed among the different groups during the 7-day study period, Dr. Godlewska noted.
Therefore, the findings suggest that antidepressants improve a depressed patient’s negative affective bias first, and then mood improves, Dr. Godlewska said. This represents a complete change from the currently accepted thinking. "Now people think that improvement in mood is the first stage, and only then the biases change," she said.
This early improvement in negative affective bias could help depressed patients relearn positive emotional associations in a more supportive environment, Dr. Godlewska noted.
More research is needed to determine the clinical implications of the findings, and Dr. Godlewska and colleagues are currently designing a study that would incorporate long-term follow-up data.
The study was funded by the Medical Research Council. Dr. Godlewska had no financial conflicts to disclose.
FROM THE ANNUAL MEETING OF THE EUROPEAN COLLEGE OF NEUROPSYCHO-
PHARMACOLOGY
Major Finding: Depressed patients treated with escitalopram showed significantly
decreased activation in the right amygdala when presented with fearful
faces, compared to depressed patients treated with a placebo. No changes in mood were observed.
Data Source: A randomized study of 42 depressed adults and 17 healthy volunteers to 10 mg/day of escitalopram or a placebo for 7 days.
Disclosures: The study was funded by the Medical Research Council. Dr. Godlewska had no financial conflicts to disclose.
Judge OKs Federal Funding for Embryonic Stem Cell Research
A federal judge in Washington dismissed a lawsuit that sought to block federal funding for medical studies using human embryonic stem cells.
A previous court opinion filed in 1999 concluded that the National Institutes of Health could legally use federal funds for embryonic stem cell research, according to the court opinion filed July 27 and posted on the NIH website.
In 2009, President Obama expanded the potential for embryonic stem cell research by opening federal funding to new stem cell lines, in addition to existing lines.
However, later in 2009, a group including two scientists whose research work involves adult stem cells, filed a lawsuit against NIH.
The suit alleged that the NIH's plans for federal funding of embryonic stem cell research violated the Dickey-Wicker Amendment, a 1996 law preventing the NIH from funding research in which human embryos were created specifically for medical studies, or research in which embryos were destroyed or subjected to risks beyond those allowed for fetuses in utero, according to the court documents.
The dismissal of the lawsuit is good news for medical researchers and patients seeking more options, Stephanie Cutter, Assistant to the President and Deputy Senior White House Adviser, wrote in a White House blog post.
“While we don't know exactly what stem cell research will yield, scientists believe this research could treat or cure diseases that affect millions of Americans every year,” Ms. Cutter wrote.
“We are pleased with today's ruling. Responsible stem cell research has the potential to develop new treatments and ultimately save lives. This ruling will help ensure this groundbreaking research can continue to move forward,” NIH director Francis S. Collins said in a statement.
Others, however, disagreed.
“The Christian Medical and Dental Associations supported the funding ban and is disappointed with this ruling,” Dr. Gene Rudd, senior vice president of the organization, said in an interview.
“CMDA supports ongoing adult stem cell research,” Dr. Rudd said.
“The problem with embryonic stem cell research is that acquisition of these stem cells results in death to early human life. That makes their use ethically unacceptable,” he said.
“And the latest science indicates that acquisition of embryonic stem cells is not necessary.
“Adult stem cells can be induced to become pluripotent, just as embryonic stem cells. Further research in this area is both promising and ethical,” Dr. Rudd added.
A federal judge in Washington dismissed a lawsuit that sought to block federal funding for medical studies using human embryonic stem cells.
A previous court opinion filed in 1999 concluded that the National Institutes of Health could legally use federal funds for embryonic stem cell research, according to the court opinion filed July 27 and posted on the NIH website.
In 2009, President Obama expanded the potential for embryonic stem cell research by opening federal funding to new stem cell lines, in addition to existing lines.
However, later in 2009, a group including two scientists whose research work involves adult stem cells, filed a lawsuit against NIH.
The suit alleged that the NIH's plans for federal funding of embryonic stem cell research violated the Dickey-Wicker Amendment, a 1996 law preventing the NIH from funding research in which human embryos were created specifically for medical studies, or research in which embryos were destroyed or subjected to risks beyond those allowed for fetuses in utero, according to the court documents.
The dismissal of the lawsuit is good news for medical researchers and patients seeking more options, Stephanie Cutter, Assistant to the President and Deputy Senior White House Adviser, wrote in a White House blog post.
“While we don't know exactly what stem cell research will yield, scientists believe this research could treat or cure diseases that affect millions of Americans every year,” Ms. Cutter wrote.
“We are pleased with today's ruling. Responsible stem cell research has the potential to develop new treatments and ultimately save lives. This ruling will help ensure this groundbreaking research can continue to move forward,” NIH director Francis S. Collins said in a statement.
Others, however, disagreed.
“The Christian Medical and Dental Associations supported the funding ban and is disappointed with this ruling,” Dr. Gene Rudd, senior vice president of the organization, said in an interview.
“CMDA supports ongoing adult stem cell research,” Dr. Rudd said.
“The problem with embryonic stem cell research is that acquisition of these stem cells results in death to early human life. That makes their use ethically unacceptable,” he said.
“And the latest science indicates that acquisition of embryonic stem cells is not necessary.
“Adult stem cells can be induced to become pluripotent, just as embryonic stem cells. Further research in this area is both promising and ethical,” Dr. Rudd added.
A federal judge in Washington dismissed a lawsuit that sought to block federal funding for medical studies using human embryonic stem cells.
A previous court opinion filed in 1999 concluded that the National Institutes of Health could legally use federal funds for embryonic stem cell research, according to the court opinion filed July 27 and posted on the NIH website.
In 2009, President Obama expanded the potential for embryonic stem cell research by opening federal funding to new stem cell lines, in addition to existing lines.
However, later in 2009, a group including two scientists whose research work involves adult stem cells, filed a lawsuit against NIH.
The suit alleged that the NIH's plans for federal funding of embryonic stem cell research violated the Dickey-Wicker Amendment, a 1996 law preventing the NIH from funding research in which human embryos were created specifically for medical studies, or research in which embryos were destroyed or subjected to risks beyond those allowed for fetuses in utero, according to the court documents.
The dismissal of the lawsuit is good news for medical researchers and patients seeking more options, Stephanie Cutter, Assistant to the President and Deputy Senior White House Adviser, wrote in a White House blog post.
“While we don't know exactly what stem cell research will yield, scientists believe this research could treat or cure diseases that affect millions of Americans every year,” Ms. Cutter wrote.
“We are pleased with today's ruling. Responsible stem cell research has the potential to develop new treatments and ultimately save lives. This ruling will help ensure this groundbreaking research can continue to move forward,” NIH director Francis S. Collins said in a statement.
Others, however, disagreed.
“The Christian Medical and Dental Associations supported the funding ban and is disappointed with this ruling,” Dr. Gene Rudd, senior vice president of the organization, said in an interview.
“CMDA supports ongoing adult stem cell research,” Dr. Rudd said.
“The problem with embryonic stem cell research is that acquisition of these stem cells results in death to early human life. That makes their use ethically unacceptable,” he said.
“And the latest science indicates that acquisition of embryonic stem cells is not necessary.
“Adult stem cells can be induced to become pluripotent, just as embryonic stem cells. Further research in this area is both promising and ethical,” Dr. Rudd added.
Rise in Postpartum Strokes Linked to Heart Disease, HT
Major Finding: Pregnancy-related hospitalizations for stroke in the United States increased by 54% from 1994-1995 to 2006-2007.
Data Source: A review of ICD-9 code data from 64,023,525 women nationwide.
Disclosures: Dr. Kuklina and her associates said they had no relevant financial disclosures.
The rate of any type of pregnancy-related hospitalization for stroke in the United States increased from approximately 4,000 in 1994-1995 to about 6,000 in 2006-2007, based on data from a nationwide sample of more than 64 million pregnant women.
This 54% increase can be explained largely by postpartum hospitalizations in women with heart disease or hypertensive disorders, said Dr. Elena V. Kuklina and her associates at the Centers for Disease Control and Prevention in Atlanta.
The researchers compared ICD-9 code data from 1994 to 1995 with data from 2006 to 2007. Types of stroke included cerebral venous thrombosis, hemorrhagic, ischemic, subarachnoid, transient ischemic attack, and unspecified (Stroke 2011 J [doi:10.1161/strokeaha.110. 610592]). Overall, hypertensive disorders were present in 11%, 23%, and 28% of prenatal, delivery, and postpartum hospitalizations, respectively, in 1994-1995, and these numbers increased to 17%, 29%, and 41% in 2006-2007. Only the increase in postpartum hospitalizations for stroke was statistically significant.
Heart disease was a complication in pregnancy-related hospitalizations for stroke in 16% of prenatal hospitalizations, 8% of delivery hospitalizations, and 9% of postpartum hospitalizations in 1994-1995, whereas that was the case in 16%, 8%, and 12% of the hospitalizations, respectively, in 2006-2007.
The rate of any stroke per 1,000 deliveries increased significantly for prenatal hospitalizations and postpartum hospitalizations between the two time periods (from 0.15 to 0.22 and from 0.12 to 0.22, respectively). However, the rate of any stroke during delivery hospitalizations remained unchanged at 0.27.
After adjustiment for confounding variables, patients who were hospitalized with hypertensive disorders during pregnancy, during delivery, and post partum were 1.8, 5.6, and 3.5 times more likely, respectively, to have indications of stroke, compared with patients without hypertensive disorders, the researchers noted.
In addition, patients who were hospitalized with heart disease during the prenatal period and the delivery period were, respectively, 9.4 times as likely and 5.4 times as likely to have indications of stroke.
The current recommendations from the American Heart Association and the American Stroke Association for managing pregnant women with a history of noncardioembolic stroke or at risk of cardioembolic stroke include treatment with anticoagulant therapy in the form of unfractionated heparin or low-molecular-weight heparin until week 13, followed by low dose aspirin for the rest of the pregnancy (Stroke 2011;42:227-76).
Major Finding: Pregnancy-related hospitalizations for stroke in the United States increased by 54% from 1994-1995 to 2006-2007.
Data Source: A review of ICD-9 code data from 64,023,525 women nationwide.
Disclosures: Dr. Kuklina and her associates said they had no relevant financial disclosures.
The rate of any type of pregnancy-related hospitalization for stroke in the United States increased from approximately 4,000 in 1994-1995 to about 6,000 in 2006-2007, based on data from a nationwide sample of more than 64 million pregnant women.
This 54% increase can be explained largely by postpartum hospitalizations in women with heart disease or hypertensive disorders, said Dr. Elena V. Kuklina and her associates at the Centers for Disease Control and Prevention in Atlanta.
The researchers compared ICD-9 code data from 1994 to 1995 with data from 2006 to 2007. Types of stroke included cerebral venous thrombosis, hemorrhagic, ischemic, subarachnoid, transient ischemic attack, and unspecified (Stroke 2011 J [doi:10.1161/strokeaha.110. 610592]). Overall, hypertensive disorders were present in 11%, 23%, and 28% of prenatal, delivery, and postpartum hospitalizations, respectively, in 1994-1995, and these numbers increased to 17%, 29%, and 41% in 2006-2007. Only the increase in postpartum hospitalizations for stroke was statistically significant.
Heart disease was a complication in pregnancy-related hospitalizations for stroke in 16% of prenatal hospitalizations, 8% of delivery hospitalizations, and 9% of postpartum hospitalizations in 1994-1995, whereas that was the case in 16%, 8%, and 12% of the hospitalizations, respectively, in 2006-2007.
The rate of any stroke per 1,000 deliveries increased significantly for prenatal hospitalizations and postpartum hospitalizations between the two time periods (from 0.15 to 0.22 and from 0.12 to 0.22, respectively). However, the rate of any stroke during delivery hospitalizations remained unchanged at 0.27.
After adjustiment for confounding variables, patients who were hospitalized with hypertensive disorders during pregnancy, during delivery, and post partum were 1.8, 5.6, and 3.5 times more likely, respectively, to have indications of stroke, compared with patients without hypertensive disorders, the researchers noted.
In addition, patients who were hospitalized with heart disease during the prenatal period and the delivery period were, respectively, 9.4 times as likely and 5.4 times as likely to have indications of stroke.
The current recommendations from the American Heart Association and the American Stroke Association for managing pregnant women with a history of noncardioembolic stroke or at risk of cardioembolic stroke include treatment with anticoagulant therapy in the form of unfractionated heparin or low-molecular-weight heparin until week 13, followed by low dose aspirin for the rest of the pregnancy (Stroke 2011;42:227-76).
Major Finding: Pregnancy-related hospitalizations for stroke in the United States increased by 54% from 1994-1995 to 2006-2007.
Data Source: A review of ICD-9 code data from 64,023,525 women nationwide.
Disclosures: Dr. Kuklina and her associates said they had no relevant financial disclosures.
The rate of any type of pregnancy-related hospitalization for stroke in the United States increased from approximately 4,000 in 1994-1995 to about 6,000 in 2006-2007, based on data from a nationwide sample of more than 64 million pregnant women.
This 54% increase can be explained largely by postpartum hospitalizations in women with heart disease or hypertensive disorders, said Dr. Elena V. Kuklina and her associates at the Centers for Disease Control and Prevention in Atlanta.
The researchers compared ICD-9 code data from 1994 to 1995 with data from 2006 to 2007. Types of stroke included cerebral venous thrombosis, hemorrhagic, ischemic, subarachnoid, transient ischemic attack, and unspecified (Stroke 2011 J [doi:10.1161/strokeaha.110. 610592]). Overall, hypertensive disorders were present in 11%, 23%, and 28% of prenatal, delivery, and postpartum hospitalizations, respectively, in 1994-1995, and these numbers increased to 17%, 29%, and 41% in 2006-2007. Only the increase in postpartum hospitalizations for stroke was statistically significant.
Heart disease was a complication in pregnancy-related hospitalizations for stroke in 16% of prenatal hospitalizations, 8% of delivery hospitalizations, and 9% of postpartum hospitalizations in 1994-1995, whereas that was the case in 16%, 8%, and 12% of the hospitalizations, respectively, in 2006-2007.
The rate of any stroke per 1,000 deliveries increased significantly for prenatal hospitalizations and postpartum hospitalizations between the two time periods (from 0.15 to 0.22 and from 0.12 to 0.22, respectively). However, the rate of any stroke during delivery hospitalizations remained unchanged at 0.27.
After adjustiment for confounding variables, patients who were hospitalized with hypertensive disorders during pregnancy, during delivery, and post partum were 1.8, 5.6, and 3.5 times more likely, respectively, to have indications of stroke, compared with patients without hypertensive disorders, the researchers noted.
In addition, patients who were hospitalized with heart disease during the prenatal period and the delivery period were, respectively, 9.4 times as likely and 5.4 times as likely to have indications of stroke.
The current recommendations from the American Heart Association and the American Stroke Association for managing pregnant women with a history of noncardioembolic stroke or at risk of cardioembolic stroke include treatment with anticoagulant therapy in the form of unfractionated heparin or low-molecular-weight heparin until week 13, followed by low dose aspirin for the rest of the pregnancy (Stroke 2011;42:227-76).
From Stroke
Add Trichomonas vaginalis to STD Screen : Left untreated, T. vaginalis can increase the risk of HIV acquisition and transmission.
Major Finding: The prevalence of T. vaginalis (8.7%) was higher than that of chlamydia (6.7%) and gonorrhea (1.7%).
Data Source: Samples from 7,593 women aged 18-89 years from 30 labs in 21 states.
Disclosures: Dr. Ginocchio said that she had no financial conflicts to disclose.
QUEBEC CITY – When screening women for gonorrhea and chlamydia, screen them for Trichomonas vaginalis, too.
If left untreated, T. vaginalis (TV) can increase a woman's risk for acquiring HIV from a sexual partner, or transmitting HIV to a sexual partner, according to the Centers for Disease Control and Prevention.
To determine the rates of coinfection for TV in women who are being screened for other STDs, Christine C. Ginocchio, Ph.D., of North Shore–Long Island Jewish Health System Laboratories in Lake Success, N.Y., and her colleagues collected samples from 7,593 women aged 18-89 years who were undergoing routine screening for chlamydia and gonorrhea. In all, 7,590 results were obtained from 30 labs in 21 states.
Overall, the prevalence of TV was 8.7%, compared with 6.7% for chlamydia and 1.7% for gonorrhea. TV was the most common of the three infections among women aged 30-39 years (8%), 40-49 years (11%), and 50 years and older (13%). The median age of the women who were positive for TV was slightly older (26 years), compared with that of the women who were positive for chlamydia and gonorrhea (22 years), according to the findings presented at the meeting.
The prevalence of TV (8.5%) fell between that of chlamydia (14%) and gonorrhea (3.3%) in women aged 18-19 years, and was 8.3% in women aged 20–29 years, compared with 8% for chlamydia and 2% for gonorrhea.
The prevalence of TV as a coinfection with chlamydia and/or gonorrhea was relatively low across all age groups, but it occurred most often in younger women. TV and chlamydia coinfection occurred in approximately 2% of women aged 18-19 years. Other TV coinfections occurred in 1% or fewer of any age group.
When data were broken down by race, the prevalence of all three infections was greatest among black women. TV was the most prevalent (20%), compared with chlamydia (12%) and gonorrhea (4%) in these women. The prevalence of TV in other races was 11% in American Indians/Alaskan Natives, 7% in Native Hawaiians/Pacific Islanders, 6% in whites, 5% in Hispanics, 4% in Asians, and 7% in other or unknown races.
The women were seen in a range of settings including family practices, emergency departments, hospital inpatient settings, STD clinics, and jails. Prevalence data based on collection site showed that the prevalence of TV was highest in jail settings (22%) and emergency departments (17%). TV was the most common infection in all but family practice and internal medicine settings, where the prevalence was approximately 6%, compared with 7% for gonorrhea and 2% for chlamydia.
The findings support data from previous studies and indicate that the prevalence of TV varies widely based on the population being studied. The findings also support data from previous studies of racial disparity in TV.
However, “the high TV prevalence in all age groups suggests that all women being screened for chlamydia and gonorrhea should also be screened for TV,” Dr. Ginocchio said.
Major Finding: The prevalence of T. vaginalis (8.7%) was higher than that of chlamydia (6.7%) and gonorrhea (1.7%).
Data Source: Samples from 7,593 women aged 18-89 years from 30 labs in 21 states.
Disclosures: Dr. Ginocchio said that she had no financial conflicts to disclose.
QUEBEC CITY – When screening women for gonorrhea and chlamydia, screen them for Trichomonas vaginalis, too.
If left untreated, T. vaginalis (TV) can increase a woman's risk for acquiring HIV from a sexual partner, or transmitting HIV to a sexual partner, according to the Centers for Disease Control and Prevention.
To determine the rates of coinfection for TV in women who are being screened for other STDs, Christine C. Ginocchio, Ph.D., of North Shore–Long Island Jewish Health System Laboratories in Lake Success, N.Y., and her colleagues collected samples from 7,593 women aged 18-89 years who were undergoing routine screening for chlamydia and gonorrhea. In all, 7,590 results were obtained from 30 labs in 21 states.
Overall, the prevalence of TV was 8.7%, compared with 6.7% for chlamydia and 1.7% for gonorrhea. TV was the most common of the three infections among women aged 30-39 years (8%), 40-49 years (11%), and 50 years and older (13%). The median age of the women who were positive for TV was slightly older (26 years), compared with that of the women who were positive for chlamydia and gonorrhea (22 years), according to the findings presented at the meeting.
The prevalence of TV (8.5%) fell between that of chlamydia (14%) and gonorrhea (3.3%) in women aged 18-19 years, and was 8.3% in women aged 20–29 years, compared with 8% for chlamydia and 2% for gonorrhea.
The prevalence of TV as a coinfection with chlamydia and/or gonorrhea was relatively low across all age groups, but it occurred most often in younger women. TV and chlamydia coinfection occurred in approximately 2% of women aged 18-19 years. Other TV coinfections occurred in 1% or fewer of any age group.
When data were broken down by race, the prevalence of all three infections was greatest among black women. TV was the most prevalent (20%), compared with chlamydia (12%) and gonorrhea (4%) in these women. The prevalence of TV in other races was 11% in American Indians/Alaskan Natives, 7% in Native Hawaiians/Pacific Islanders, 6% in whites, 5% in Hispanics, 4% in Asians, and 7% in other or unknown races.
The women were seen in a range of settings including family practices, emergency departments, hospital inpatient settings, STD clinics, and jails. Prevalence data based on collection site showed that the prevalence of TV was highest in jail settings (22%) and emergency departments (17%). TV was the most common infection in all but family practice and internal medicine settings, where the prevalence was approximately 6%, compared with 7% for gonorrhea and 2% for chlamydia.
The findings support data from previous studies and indicate that the prevalence of TV varies widely based on the population being studied. The findings also support data from previous studies of racial disparity in TV.
However, “the high TV prevalence in all age groups suggests that all women being screened for chlamydia and gonorrhea should also be screened for TV,” Dr. Ginocchio said.
Major Finding: The prevalence of T. vaginalis (8.7%) was higher than that of chlamydia (6.7%) and gonorrhea (1.7%).
Data Source: Samples from 7,593 women aged 18-89 years from 30 labs in 21 states.
Disclosures: Dr. Ginocchio said that she had no financial conflicts to disclose.
QUEBEC CITY – When screening women for gonorrhea and chlamydia, screen them for Trichomonas vaginalis, too.
If left untreated, T. vaginalis (TV) can increase a woman's risk for acquiring HIV from a sexual partner, or transmitting HIV to a sexual partner, according to the Centers for Disease Control and Prevention.
To determine the rates of coinfection for TV in women who are being screened for other STDs, Christine C. Ginocchio, Ph.D., of North Shore–Long Island Jewish Health System Laboratories in Lake Success, N.Y., and her colleagues collected samples from 7,593 women aged 18-89 years who were undergoing routine screening for chlamydia and gonorrhea. In all, 7,590 results were obtained from 30 labs in 21 states.
Overall, the prevalence of TV was 8.7%, compared with 6.7% for chlamydia and 1.7% for gonorrhea. TV was the most common of the three infections among women aged 30-39 years (8%), 40-49 years (11%), and 50 years and older (13%). The median age of the women who were positive for TV was slightly older (26 years), compared with that of the women who were positive for chlamydia and gonorrhea (22 years), according to the findings presented at the meeting.
The prevalence of TV (8.5%) fell between that of chlamydia (14%) and gonorrhea (3.3%) in women aged 18-19 years, and was 8.3% in women aged 20–29 years, compared with 8% for chlamydia and 2% for gonorrhea.
The prevalence of TV as a coinfection with chlamydia and/or gonorrhea was relatively low across all age groups, but it occurred most often in younger women. TV and chlamydia coinfection occurred in approximately 2% of women aged 18-19 years. Other TV coinfections occurred in 1% or fewer of any age group.
When data were broken down by race, the prevalence of all three infections was greatest among black women. TV was the most prevalent (20%), compared with chlamydia (12%) and gonorrhea (4%) in these women. The prevalence of TV in other races was 11% in American Indians/Alaskan Natives, 7% in Native Hawaiians/Pacific Islanders, 6% in whites, 5% in Hispanics, 4% in Asians, and 7% in other or unknown races.
The women were seen in a range of settings including family practices, emergency departments, hospital inpatient settings, STD clinics, and jails. Prevalence data based on collection site showed that the prevalence of TV was highest in jail settings (22%) and emergency departments (17%). TV was the most common infection in all but family practice and internal medicine settings, where the prevalence was approximately 6%, compared with 7% for gonorrhea and 2% for chlamydia.
The findings support data from previous studies and indicate that the prevalence of TV varies widely based on the population being studied. The findings also support data from previous studies of racial disparity in TV.
However, “the high TV prevalence in all age groups suggests that all women being screened for chlamydia and gonorrhea should also be screened for TV,” Dr. Ginocchio said.
From A Congress of the International Society for Sexually Tranmitted Diseases Research
Many Unvaccinated Women Deny Need for HPV Vaccine
QUEBEC CITY – More than half of women who denied getting the HPV vaccine also said that they had no intention of getting the vaccine in the coming year, according to a survey of women aged 15-24 years.
"Monitoring vaccine uptake can identify potential disparities in coverage and guide vaccine implementation efforts," said Nicole Liddon, Ph.D., a behavioral scientist at the Centers for Disease Control and Prevention.
Several national estimates of HPV vaccine uptake exist in the United States, but data are limited regarding vaccination status as it relates to sexual behavior and unvaccinated women’s intent to get vaccinated, Dr. Liddon said at a congress of the International Society for Sexually Transmitted Diseases Research.
She and her colleagues reviewed data from the National Survey of Family Growth – a nationally representative U.S. survey – that included questions about HPV vaccination for women younger than age 25 years.
The data included 1,243 vaccinated women and 955 unvaccinated women aged 15-24 years. Of the women who reported vaccination, 23% had received at least one dose of HPV vaccine. Vaccination rates were almost twice as high among 15- to 19-year-olds, compared with 20- to 24-year-olds (30% vs. 16%)
Among the unvaccinated women, 58% of 15- to 19-year-olds and 62% of 20- to 24-year-olds said they were unlikely to get vaccinated in the coming year.
A total of 546 of the unvaccinated women gave a main reason for not being vaccinated and not planning to be vaccinated in the next year. "Not at risk/don’t need it" was the response from 33% of these women. Another 15% said that their health care provider had not recommended HPV vaccination for them, 12% said they were concerned about the vaccine’s safety and side effects, and 10% cited cost or lack of insurance coverage.
A further review of demographic data from unvaccinated women showed that Hispanic women aged 20-24 years were more likely than were younger Hispanics to say they intended to get vaccinated, and 15- to 19- year-old non-Catholics were less likely to say they intended to get vaccinated, compared with older non-Catholics.
Additional disparities were noted among 15- to 24-year-olds based on insurance status; those with insurance were more than four times as likely to be vaccinated as the uninsured were.
Among women in both age groups who were not vaccinated, those who said they were likely to get vaccinated in the future were more than twice as likely to have ever had sex, compared with those who had never had sex, Dr. Liddon noted.
"Our data do not suggest that HPV vaccination results in more risky sexual behavior," Dr. Liddon noted. However, more data are needed on the timing of HPV vaccination as it relates to sexual initiation, she said.
Dr. Liddon stated that she had no financial conflicts of interest.
QUEBEC CITY – More than half of women who denied getting the HPV vaccine also said that they had no intention of getting the vaccine in the coming year, according to a survey of women aged 15-24 years.
"Monitoring vaccine uptake can identify potential disparities in coverage and guide vaccine implementation efforts," said Nicole Liddon, Ph.D., a behavioral scientist at the Centers for Disease Control and Prevention.
Several national estimates of HPV vaccine uptake exist in the United States, but data are limited regarding vaccination status as it relates to sexual behavior and unvaccinated women’s intent to get vaccinated, Dr. Liddon said at a congress of the International Society for Sexually Transmitted Diseases Research.
She and her colleagues reviewed data from the National Survey of Family Growth – a nationally representative U.S. survey – that included questions about HPV vaccination for women younger than age 25 years.
The data included 1,243 vaccinated women and 955 unvaccinated women aged 15-24 years. Of the women who reported vaccination, 23% had received at least one dose of HPV vaccine. Vaccination rates were almost twice as high among 15- to 19-year-olds, compared with 20- to 24-year-olds (30% vs. 16%)
Among the unvaccinated women, 58% of 15- to 19-year-olds and 62% of 20- to 24-year-olds said they were unlikely to get vaccinated in the coming year.
A total of 546 of the unvaccinated women gave a main reason for not being vaccinated and not planning to be vaccinated in the next year. "Not at risk/don’t need it" was the response from 33% of these women. Another 15% said that their health care provider had not recommended HPV vaccination for them, 12% said they were concerned about the vaccine’s safety and side effects, and 10% cited cost or lack of insurance coverage.
A further review of demographic data from unvaccinated women showed that Hispanic women aged 20-24 years were more likely than were younger Hispanics to say they intended to get vaccinated, and 15- to 19- year-old non-Catholics were less likely to say they intended to get vaccinated, compared with older non-Catholics.
Additional disparities were noted among 15- to 24-year-olds based on insurance status; those with insurance were more than four times as likely to be vaccinated as the uninsured were.
Among women in both age groups who were not vaccinated, those who said they were likely to get vaccinated in the future were more than twice as likely to have ever had sex, compared with those who had never had sex, Dr. Liddon noted.
"Our data do not suggest that HPV vaccination results in more risky sexual behavior," Dr. Liddon noted. However, more data are needed on the timing of HPV vaccination as it relates to sexual initiation, she said.
Dr. Liddon stated that she had no financial conflicts of interest.
QUEBEC CITY – More than half of women who denied getting the HPV vaccine also said that they had no intention of getting the vaccine in the coming year, according to a survey of women aged 15-24 years.
"Monitoring vaccine uptake can identify potential disparities in coverage and guide vaccine implementation efforts," said Nicole Liddon, Ph.D., a behavioral scientist at the Centers for Disease Control and Prevention.
Several national estimates of HPV vaccine uptake exist in the United States, but data are limited regarding vaccination status as it relates to sexual behavior and unvaccinated women’s intent to get vaccinated, Dr. Liddon said at a congress of the International Society for Sexually Transmitted Diseases Research.
She and her colleagues reviewed data from the National Survey of Family Growth – a nationally representative U.S. survey – that included questions about HPV vaccination for women younger than age 25 years.
The data included 1,243 vaccinated women and 955 unvaccinated women aged 15-24 years. Of the women who reported vaccination, 23% had received at least one dose of HPV vaccine. Vaccination rates were almost twice as high among 15- to 19-year-olds, compared with 20- to 24-year-olds (30% vs. 16%)
Among the unvaccinated women, 58% of 15- to 19-year-olds and 62% of 20- to 24-year-olds said they were unlikely to get vaccinated in the coming year.
A total of 546 of the unvaccinated women gave a main reason for not being vaccinated and not planning to be vaccinated in the next year. "Not at risk/don’t need it" was the response from 33% of these women. Another 15% said that their health care provider had not recommended HPV vaccination for them, 12% said they were concerned about the vaccine’s safety and side effects, and 10% cited cost or lack of insurance coverage.
A further review of demographic data from unvaccinated women showed that Hispanic women aged 20-24 years were more likely than were younger Hispanics to say they intended to get vaccinated, and 15- to 19- year-old non-Catholics were less likely to say they intended to get vaccinated, compared with older non-Catholics.
Additional disparities were noted among 15- to 24-year-olds based on insurance status; those with insurance were more than four times as likely to be vaccinated as the uninsured were.
Among women in both age groups who were not vaccinated, those who said they were likely to get vaccinated in the future were more than twice as likely to have ever had sex, compared with those who had never had sex, Dr. Liddon noted.
"Our data do not suggest that HPV vaccination results in more risky sexual behavior," Dr. Liddon noted. However, more data are needed on the timing of HPV vaccination as it relates to sexual initiation, she said.
Dr. Liddon stated that she had no financial conflicts of interest.
FROM A CONGRESS OF THE INTERNATIONAL SOCIETY FOR SEXUALLY TRANSMITTED DISEASES RESEARCH
Major Finding: In 2007-2008, 23% of women who self-reported vaccination status had received at least one dose of the HPV vaccine and at least 58% of unvaccinated women said that they did not plan to be vaccinated in the coming year.
Data Source: National Survey of Family Growth, 2007-2008.
Disclosures: Dr. Liddon said that she had no financial conflicts of interest.
Experts: Palliative Care Can Begin Before the End
BETHESDA, MD. – Palliative care, once limited to the last days before death, is ripe for research and essential to improving patient quality of life, according to speakers at a summit sponsored by the National Institute of Nursing Research and National Institutes of Health partners.
"We have to put the clinician back in the mix," Dr. Ira R. Byock, professor of anesthesiology and director of palliative medicine at Dartmouth Medical School in Hanover, N.H., said in the opening keynote address.
According to several speakers at the meeting, putting the clinician back in the mix may mean changing the thinking about palliative care from something that begins in the last days of life to something started as early as a patient’s first day of a cancer diagnosis, as well as making it easier for clinicians to explore palliative care strategies.
One route to improving palliative care is through rigorous research in both inpatient and outpatient settings to see what works, according to Dr. Jennifer S. Temel, clinical director of thoracic oncology at Massachusetts General Hospital in Boston.
Dr. Temel made the case for the value of palliative care research when she discussed her recent study of early palliative care for patients with advanced lung cancer (N. Engl. J. Med. 2010;363:733-42).
Chemotherapy can improve symptoms, "but the problem is that patients are trading off their cancer symptoms for chemotherapy-related symptoms (fatigue, nausea, neuropathy), so overall physical quality of life is not significantly changed," she said.
In a randomized, controlled trial of 151 adults with metastatic non–small cell lung cancer, patients who received palliative care soon after their diagnoses had significantly less depression and anxiety, compared with controls. Another significant finding: The median survival was longer among patients in the early palliative care group, compared with controls (11.6 months vs. 8.9 months; P = .02).
Patients with advanced illnesses suffer from both physical and psychological symptoms, Dr. Temel said.
Dr. Temel’s findings suggest that early palliative care can be used in conjunction with chemotherapy, and cancer patients could be managed jointly in an oncology and clinic setting. However, more research is needed to support and expand her findings.
To help promote and enhance additional research in the field of palliative care, Dr. Amy P. Abernethy, an oncologist at Duke University Medical Center in Durham, N.C., described the creation of the U.S. Palliative Care Research Cooperative (PCRC) group. Dr. Abernethy is the coprincipal investigator of the PCRC, which was established in 2010 and funded by the National Institute of Nursing Research. The PCRC is currently establishing research protocols and procedures through which palliative care researchers will be able to suggest topics and submit grant applications, said Dr. Abernethy. "We must focus our scope, choose studies carefully, and do them well," she said.
The need to engage patients and caregivers as partners in palliative care research was addressed in many talks, as was the need for better communication among clinicians, patients, and caregivers about palliative care. Dianne Gray, a parent advocate whose young son died of a rare genetic disease, spoke about the importance of communication between doctors and patients facing end-of-life issues and reminded clinicians that families want to work with doctors. But families also want honesty, even if the answer is "I don’t know," she emphasized.
In the summit’s closing keynote address, Dr. J. Randall Curtis, director of the Harborview/University of Washington End-of-Life Care Research Program, Seattle, discussed how changing attitudes toward palliative are getting clinicians back in the mix.
"Palliative care is much more broadly accepted as an important part of health care" in both inpatient and outpatient settings, he said in an interview.
Palliative care applies to all patients who face a life-limiting illness or a chronic illness that may shorten life, whether they are actively dying or only starting to manage an illness or think about end-of-life care, he said.
"Hospital-based physicians in particular have a very important role in providing palliative care," said Dr. Curtis. They have the opportunity to introduce discussions of palliative care when patients are hospitalized for exacerbation of symptoms, or when they are hospitalized in the last stages of life, he noted.
"I think there is a growing realization that all physicians caring for patients with life-limiting or life-threatening illnesses need to have basic palliative care skills," although specialists can and should be called in for difficult cases, Dr. Curtis said.
Dr. Temel said she had no financial conflicts to disclose. Dr. Curtis has received funding from the National Institutes of Health and the National Institute of Nursing Research. The summit was sponsored in part by the Foundation for the National Institutes of Health and by Pfizer.
BETHESDA, MD. – Palliative care, once limited to the last days before death, is ripe for research and essential to improving patient quality of life, according to speakers at a summit sponsored by the National Institute of Nursing Research and National Institutes of Health partners.
"We have to put the clinician back in the mix," Dr. Ira R. Byock, professor of anesthesiology and director of palliative medicine at Dartmouth Medical School in Hanover, N.H., said in the opening keynote address.
According to several speakers at the meeting, putting the clinician back in the mix may mean changing the thinking about palliative care from something that begins in the last days of life to something started as early as a patient’s first day of a cancer diagnosis, as well as making it easier for clinicians to explore palliative care strategies.
One route to improving palliative care is through rigorous research in both inpatient and outpatient settings to see what works, according to Dr. Jennifer S. Temel, clinical director of thoracic oncology at Massachusetts General Hospital in Boston.
Dr. Temel made the case for the value of palliative care research when she discussed her recent study of early palliative care for patients with advanced lung cancer (N. Engl. J. Med. 2010;363:733-42).
Chemotherapy can improve symptoms, "but the problem is that patients are trading off their cancer symptoms for chemotherapy-related symptoms (fatigue, nausea, neuropathy), so overall physical quality of life is not significantly changed," she said.
In a randomized, controlled trial of 151 adults with metastatic non–small cell lung cancer, patients who received palliative care soon after their diagnoses had significantly less depression and anxiety, compared with controls. Another significant finding: The median survival was longer among patients in the early palliative care group, compared with controls (11.6 months vs. 8.9 months; P = .02).
Patients with advanced illnesses suffer from both physical and psychological symptoms, Dr. Temel said.
Dr. Temel’s findings suggest that early palliative care can be used in conjunction with chemotherapy, and cancer patients could be managed jointly in an oncology and clinic setting. However, more research is needed to support and expand her findings.
To help promote and enhance additional research in the field of palliative care, Dr. Amy P. Abernethy, an oncologist at Duke University Medical Center in Durham, N.C., described the creation of the U.S. Palliative Care Research Cooperative (PCRC) group. Dr. Abernethy is the coprincipal investigator of the PCRC, which was established in 2010 and funded by the National Institute of Nursing Research. The PCRC is currently establishing research protocols and procedures through which palliative care researchers will be able to suggest topics and submit grant applications, said Dr. Abernethy. "We must focus our scope, choose studies carefully, and do them well," she said.
The need to engage patients and caregivers as partners in palliative care research was addressed in many talks, as was the need for better communication among clinicians, patients, and caregivers about palliative care. Dianne Gray, a parent advocate whose young son died of a rare genetic disease, spoke about the importance of communication between doctors and patients facing end-of-life issues and reminded clinicians that families want to work with doctors. But families also want honesty, even if the answer is "I don’t know," she emphasized.
In the summit’s closing keynote address, Dr. J. Randall Curtis, director of the Harborview/University of Washington End-of-Life Care Research Program, Seattle, discussed how changing attitudes toward palliative are getting clinicians back in the mix.
"Palliative care is much more broadly accepted as an important part of health care" in both inpatient and outpatient settings, he said in an interview.
Palliative care applies to all patients who face a life-limiting illness or a chronic illness that may shorten life, whether they are actively dying or only starting to manage an illness or think about end-of-life care, he said.
"Hospital-based physicians in particular have a very important role in providing palliative care," said Dr. Curtis. They have the opportunity to introduce discussions of palliative care when patients are hospitalized for exacerbation of symptoms, or when they are hospitalized in the last stages of life, he noted.
"I think there is a growing realization that all physicians caring for patients with life-limiting or life-threatening illnesses need to have basic palliative care skills," although specialists can and should be called in for difficult cases, Dr. Curtis said.
Dr. Temel said she had no financial conflicts to disclose. Dr. Curtis has received funding from the National Institutes of Health and the National Institute of Nursing Research. The summit was sponsored in part by the Foundation for the National Institutes of Health and by Pfizer.
BETHESDA, MD. – Palliative care, once limited to the last days before death, is ripe for research and essential to improving patient quality of life, according to speakers at a summit sponsored by the National Institute of Nursing Research and National Institutes of Health partners.
"We have to put the clinician back in the mix," Dr. Ira R. Byock, professor of anesthesiology and director of palliative medicine at Dartmouth Medical School in Hanover, N.H., said in the opening keynote address.
According to several speakers at the meeting, putting the clinician back in the mix may mean changing the thinking about palliative care from something that begins in the last days of life to something started as early as a patient’s first day of a cancer diagnosis, as well as making it easier for clinicians to explore palliative care strategies.
One route to improving palliative care is through rigorous research in both inpatient and outpatient settings to see what works, according to Dr. Jennifer S. Temel, clinical director of thoracic oncology at Massachusetts General Hospital in Boston.
Dr. Temel made the case for the value of palliative care research when she discussed her recent study of early palliative care for patients with advanced lung cancer (N. Engl. J. Med. 2010;363:733-42).
Chemotherapy can improve symptoms, "but the problem is that patients are trading off their cancer symptoms for chemotherapy-related symptoms (fatigue, nausea, neuropathy), so overall physical quality of life is not significantly changed," she said.
In a randomized, controlled trial of 151 adults with metastatic non–small cell lung cancer, patients who received palliative care soon after their diagnoses had significantly less depression and anxiety, compared with controls. Another significant finding: The median survival was longer among patients in the early palliative care group, compared with controls (11.6 months vs. 8.9 months; P = .02).
Patients with advanced illnesses suffer from both physical and psychological symptoms, Dr. Temel said.
Dr. Temel’s findings suggest that early palliative care can be used in conjunction with chemotherapy, and cancer patients could be managed jointly in an oncology and clinic setting. However, more research is needed to support and expand her findings.
To help promote and enhance additional research in the field of palliative care, Dr. Amy P. Abernethy, an oncologist at Duke University Medical Center in Durham, N.C., described the creation of the U.S. Palliative Care Research Cooperative (PCRC) group. Dr. Abernethy is the coprincipal investigator of the PCRC, which was established in 2010 and funded by the National Institute of Nursing Research. The PCRC is currently establishing research protocols and procedures through which palliative care researchers will be able to suggest topics and submit grant applications, said Dr. Abernethy. "We must focus our scope, choose studies carefully, and do them well," she said.
The need to engage patients and caregivers as partners in palliative care research was addressed in many talks, as was the need for better communication among clinicians, patients, and caregivers about palliative care. Dianne Gray, a parent advocate whose young son died of a rare genetic disease, spoke about the importance of communication between doctors and patients facing end-of-life issues and reminded clinicians that families want to work with doctors. But families also want honesty, even if the answer is "I don’t know," she emphasized.
In the summit’s closing keynote address, Dr. J. Randall Curtis, director of the Harborview/University of Washington End-of-Life Care Research Program, Seattle, discussed how changing attitudes toward palliative are getting clinicians back in the mix.
"Palliative care is much more broadly accepted as an important part of health care" in both inpatient and outpatient settings, he said in an interview.
Palliative care applies to all patients who face a life-limiting illness or a chronic illness that may shorten life, whether they are actively dying or only starting to manage an illness or think about end-of-life care, he said.
"Hospital-based physicians in particular have a very important role in providing palliative care," said Dr. Curtis. They have the opportunity to introduce discussions of palliative care when patients are hospitalized for exacerbation of symptoms, or when they are hospitalized in the last stages of life, he noted.
"I think there is a growing realization that all physicians caring for patients with life-limiting or life-threatening illnesses need to have basic palliative care skills," although specialists can and should be called in for difficult cases, Dr. Curtis said.
Dr. Temel said she had no financial conflicts to disclose. Dr. Curtis has received funding from the National Institutes of Health and the National Institute of Nursing Research. The summit was sponsored in part by the Foundation for the National Institutes of Health and by Pfizer.
EXPERT ANALYSIS FROM A PALLIATIVE CARE SUMMIT SPONSORED BY THE NATIONAL INSTITUTE OF NURSING RESEARCH AND NIH PARTNERS
Experts: Palliative Care Can Begin Before the End
BETHESDA, MD. – Palliative care, once limited to the last days before death, is ripe for research and essential to improving patient quality of life both in and out of the hospital, according to speakers at a summit sponsored by the National Institute of Nursing Research and National Institutes of Health partners.
"We have to put the clinician back in the mix," Dr. Ira R. Byock, professor of anesthesiology and director of palliative medicine at Dartmouth Medical School in Hanover, N.H., said in the opening keynote address.
According to several speakers at the meeting, putting the clinician back in the mix may mean changing the thinking about palliative care from something that begins in the last days of life to something started as early as a patient’s first day of a cancer diagnosis, as well as making it easier for clinicians to explore palliative care strategies.
One route to improving palliative care is through rigorous research in both inpatient and outpatient settings to see what works, according to Dr. Jennifer S. Temel, clinical director of thoracic oncology at Massachusetts General Hospital in Boston.
Dr. Temel made the case for the value of palliative care research when she discussed her recent study of early palliative care for patients with advanced lung cancer (N. Engl. J. Med. 2010;363:733-42).
Chemotherapy can improve symptoms, "but the problem is that patients are trading off their cancer symptoms for chemotherapy-related symptoms (fatigue, nausea, neuropathy), so overall physical quality of life is not significantly changed," she said.
In a randomized, controlled trial of 151 adults with metastatic non–small cell lung cancer, patients who received palliative care soon after their diagnoses had significantly less depression and anxiety, compared with controls. Another significant finding: The median survival was longer among patients in the early palliative care group, compared with controls (11.6 months vs. 8.9 months; P = .02).
Patients with advanced illnesses suffer from both physical and psychological symptoms, Dr. Temel said.
Dr. Temel’s findings suggest that early palliative care can be used in conjunction with chemotherapy, and cancer patients could be managed jointly in an oncology and clinic setting. However, more research is needed to support and expand her findings.
To help promote and enhance additional research in the field of palliative care, Dr. Amy P. Abernethy, an oncologist at Duke University Medical Center in Durham, N.C., described the creation of the U.S. Palliative Care Research Cooperative (PCRC) group. Dr. Abernethy is the coprincipal investigator of the PCRC, which was established in 2010 and funded by the National Institute of Nursing Research. The PCRC is currently establishing research protocols and procedures through which palliative care researchers will be able to suggest topics and submit grant applications, said Dr. Abernethy. "We must focus our scope, choose studies carefully, and do them well," she said.
The need to engage patients and caregivers as partners in palliative care research was addressed in many talks, as was the need for better communication among clinicians, patients, and caregivers about palliative care. Dianne Gray, a parent advocate whose young son died of a rare genetic disease, spoke about the importance of communication between doctors and patients facing end-of-life issues and reminded clinicians that families want to work with doctors. But families also want honesty, even if the answer is "I don’t know," she emphasized.
In the summit’s closing keynote address, Dr. J. Randall Curtis, director of the Harborview/University of Washington End-of-Life Care Research Program, Seattle, discussed how changing attitudes toward palliative are getting clinicians back in the mix.
"Palliative care is much more broadly accepted as an important part of health care" in both inpatient and outpatient settings, he said in an interview.
Palliative care applies to all patients who face a life-limiting illness or a chronic illness that may shorten life, whether they are actively dying or only starting to manage an illness or think about end-of-life care, he said.
"Hospital-based physicians in particular have a very important role in providing palliative care," said Dr. Curtis. They have the opportunity to introduce discussions of palliative care when patients are hospitalized for exacerbation of symptoms, or when they are hospitalized in the last stages of life, he noted.
"I think there is a growing realization that all physicians caring for patients with life-limiting or life-threatening illnesses need to have basic palliative care skills," although specialists can and should be called in for difficult cases, Dr. Curtis said.
Dr. Temel said she had no financial conflicts to disclose. Dr. Curtis has received funding from the National Institutes of Health and the National Institute of Nursing Research. The summit was sponsored in part by the Foundation for the National Institutes of Health and by Pfizer.
BETHESDA, MD. – Palliative care, once limited to the last days before death, is ripe for research and essential to improving patient quality of life both in and out of the hospital, according to speakers at a summit sponsored by the National Institute of Nursing Research and National Institutes of Health partners.
"We have to put the clinician back in the mix," Dr. Ira R. Byock, professor of anesthesiology and director of palliative medicine at Dartmouth Medical School in Hanover, N.H., said in the opening keynote address.
According to several speakers at the meeting, putting the clinician back in the mix may mean changing the thinking about palliative care from something that begins in the last days of life to something started as early as a patient’s first day of a cancer diagnosis, as well as making it easier for clinicians to explore palliative care strategies.
One route to improving palliative care is through rigorous research in both inpatient and outpatient settings to see what works, according to Dr. Jennifer S. Temel, clinical director of thoracic oncology at Massachusetts General Hospital in Boston.
Dr. Temel made the case for the value of palliative care research when she discussed her recent study of early palliative care for patients with advanced lung cancer (N. Engl. J. Med. 2010;363:733-42).
Chemotherapy can improve symptoms, "but the problem is that patients are trading off their cancer symptoms for chemotherapy-related symptoms (fatigue, nausea, neuropathy), so overall physical quality of life is not significantly changed," she said.
In a randomized, controlled trial of 151 adults with metastatic non–small cell lung cancer, patients who received palliative care soon after their diagnoses had significantly less depression and anxiety, compared with controls. Another significant finding: The median survival was longer among patients in the early palliative care group, compared with controls (11.6 months vs. 8.9 months; P = .02).
Patients with advanced illnesses suffer from both physical and psychological symptoms, Dr. Temel said.
Dr. Temel’s findings suggest that early palliative care can be used in conjunction with chemotherapy, and cancer patients could be managed jointly in an oncology and clinic setting. However, more research is needed to support and expand her findings.
To help promote and enhance additional research in the field of palliative care, Dr. Amy P. Abernethy, an oncologist at Duke University Medical Center in Durham, N.C., described the creation of the U.S. Palliative Care Research Cooperative (PCRC) group. Dr. Abernethy is the coprincipal investigator of the PCRC, which was established in 2010 and funded by the National Institute of Nursing Research. The PCRC is currently establishing research protocols and procedures through which palliative care researchers will be able to suggest topics and submit grant applications, said Dr. Abernethy. "We must focus our scope, choose studies carefully, and do them well," she said.
The need to engage patients and caregivers as partners in palliative care research was addressed in many talks, as was the need for better communication among clinicians, patients, and caregivers about palliative care. Dianne Gray, a parent advocate whose young son died of a rare genetic disease, spoke about the importance of communication between doctors and patients facing end-of-life issues and reminded clinicians that families want to work with doctors. But families also want honesty, even if the answer is "I don’t know," she emphasized.
In the summit’s closing keynote address, Dr. J. Randall Curtis, director of the Harborview/University of Washington End-of-Life Care Research Program, Seattle, discussed how changing attitudes toward palliative are getting clinicians back in the mix.
"Palliative care is much more broadly accepted as an important part of health care" in both inpatient and outpatient settings, he said in an interview.
Palliative care applies to all patients who face a life-limiting illness or a chronic illness that may shorten life, whether they are actively dying or only starting to manage an illness or think about end-of-life care, he said.
"Hospital-based physicians in particular have a very important role in providing palliative care," said Dr. Curtis. They have the opportunity to introduce discussions of palliative care when patients are hospitalized for exacerbation of symptoms, or when they are hospitalized in the last stages of life, he noted.
"I think there is a growing realization that all physicians caring for patients with life-limiting or life-threatening illnesses need to have basic palliative care skills," although specialists can and should be called in for difficult cases, Dr. Curtis said.
Dr. Temel said she had no financial conflicts to disclose. Dr. Curtis has received funding from the National Institutes of Health and the National Institute of Nursing Research. The summit was sponsored in part by the Foundation for the National Institutes of Health and by Pfizer.
BETHESDA, MD. – Palliative care, once limited to the last days before death, is ripe for research and essential to improving patient quality of life both in and out of the hospital, according to speakers at a summit sponsored by the National Institute of Nursing Research and National Institutes of Health partners.
"We have to put the clinician back in the mix," Dr. Ira R. Byock, professor of anesthesiology and director of palliative medicine at Dartmouth Medical School in Hanover, N.H., said in the opening keynote address.
According to several speakers at the meeting, putting the clinician back in the mix may mean changing the thinking about palliative care from something that begins in the last days of life to something started as early as a patient’s first day of a cancer diagnosis, as well as making it easier for clinicians to explore palliative care strategies.
One route to improving palliative care is through rigorous research in both inpatient and outpatient settings to see what works, according to Dr. Jennifer S. Temel, clinical director of thoracic oncology at Massachusetts General Hospital in Boston.
Dr. Temel made the case for the value of palliative care research when she discussed her recent study of early palliative care for patients with advanced lung cancer (N. Engl. J. Med. 2010;363:733-42).
Chemotherapy can improve symptoms, "but the problem is that patients are trading off their cancer symptoms for chemotherapy-related symptoms (fatigue, nausea, neuropathy), so overall physical quality of life is not significantly changed," she said.
In a randomized, controlled trial of 151 adults with metastatic non–small cell lung cancer, patients who received palliative care soon after their diagnoses had significantly less depression and anxiety, compared with controls. Another significant finding: The median survival was longer among patients in the early palliative care group, compared with controls (11.6 months vs. 8.9 months; P = .02).
Patients with advanced illnesses suffer from both physical and psychological symptoms, Dr. Temel said.
Dr. Temel’s findings suggest that early palliative care can be used in conjunction with chemotherapy, and cancer patients could be managed jointly in an oncology and clinic setting. However, more research is needed to support and expand her findings.
To help promote and enhance additional research in the field of palliative care, Dr. Amy P. Abernethy, an oncologist at Duke University Medical Center in Durham, N.C., described the creation of the U.S. Palliative Care Research Cooperative (PCRC) group. Dr. Abernethy is the coprincipal investigator of the PCRC, which was established in 2010 and funded by the National Institute of Nursing Research. The PCRC is currently establishing research protocols and procedures through which palliative care researchers will be able to suggest topics and submit grant applications, said Dr. Abernethy. "We must focus our scope, choose studies carefully, and do them well," she said.
The need to engage patients and caregivers as partners in palliative care research was addressed in many talks, as was the need for better communication among clinicians, patients, and caregivers about palliative care. Dianne Gray, a parent advocate whose young son died of a rare genetic disease, spoke about the importance of communication between doctors and patients facing end-of-life issues and reminded clinicians that families want to work with doctors. But families also want honesty, even if the answer is "I don’t know," she emphasized.
In the summit’s closing keynote address, Dr. J. Randall Curtis, director of the Harborview/University of Washington End-of-Life Care Research Program, Seattle, discussed how changing attitudes toward palliative are getting clinicians back in the mix.
"Palliative care is much more broadly accepted as an important part of health care" in both inpatient and outpatient settings, he said in an interview.
Palliative care applies to all patients who face a life-limiting illness or a chronic illness that may shorten life, whether they are actively dying or only starting to manage an illness or think about end-of-life care, he said.
"Hospital-based physicians in particular have a very important role in providing palliative care," said Dr. Curtis. They have the opportunity to introduce discussions of palliative care when patients are hospitalized for exacerbation of symptoms, or when they are hospitalized in the last stages of life, he noted.
"I think there is a growing realization that all physicians caring for patients with life-limiting or life-threatening illnesses need to have basic palliative care skills," although specialists can and should be called in for difficult cases, Dr. Curtis said.
Dr. Temel said she had no financial conflicts to disclose. Dr. Curtis has received funding from the National Institutes of Health and the National Institute of Nursing Research. The summit was sponsored in part by the Foundation for the National Institutes of Health and by Pfizer.
EXPERT ANALYSIS FROM A PALLIATIVE CARE SUMMIT SPONSORED BY THE NATIONAL INSTITUTE OF NURSING RESEARCH AND NIH PARTNERS

