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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
Take-Home Chlamydia Test Raised Rescreening Rates
QUEBEC CITY – Women with a history of chlamydia were significantly more likely to get retested if they could collect samples at home rather than having to visit a clinic, based on data from 404 women.
Women with recurrent chlamydia infections can be at increased risk for long-term complications, but few women comply with the Centers for Disease Control and Prevention recommendation for chlamydia rescreening 3 months after an initial treatment, Dr. Fujie Xu of the CDC said during a presentation of the findings at a congress of the International Society for Sexually Transmitted Diseases Research.
"The need for a clinic visit and a vaginal speculum examination likely contribute to poor compliance with the rescreening recommendation," she said.
Dr. Xu and her colleagues surmised that offering women at-home testing instead of a clinic visit might increase rescreening rates.
They were right. The study’s primary end point was the rescreening rate during a 7-week window from 1 week before to 6 weeks after a date of 3 months past the patient’s initial treatment. A total of 80 of 196 women (41%) randomized to perform a home test were rescreened, compared with 43 of 208 women (21%) randomized to a follow-up clinic visit. The difference was statistically significant.
Women in the take-home group also were significantly more likely to be rescreened at any point during the study, compared with the clinic group (49% vs. 28%).
The women were recruited from Jackson, Miss., New Orleans, and St. Louis. The average age of the women was 21 years; 85% of the home test group and 88% of the clinic test group were black. The education levels were similar between the two groups. All study participants had previously tested positive for chlamydia.
When the researchers analyzed the findings by demographic factors, women in the at-home test group who had a high school eduction or less were significantly more likely to be rescreened than were similarly educated women in the clinic group. For women who had some college education, there was no significant difference in screening rates between the at-home test and clinic test groups.
At the rescreening visits, 93 specimens from home test patients and 55 from clinic test patients were tested. The percentage of positive tests upon rescreening was similar between the groups: 13% in the home group and 15% in the clinic group.
Overall, rescreening rates were almost twice as high in the at-home test group as in the clinic group, Dr. Xu said. In several study subgroups, rescreening rates were consistently higher among women who used home tests, compared with clinic tests, she added.
Home testing for chlamydia represents a new tool, "but not the magic bullet," Dr. Xu said. More research is needed to identify better ways to remind patients to get rescreened for chlamydia, and more support is needed for FDA-approved tests for home specimen collection, she said.
Additional data from this study were published online in the August issue of Obstetrics & Gynecology (2011 August;118:231-239 [doi: 10.1097/AOG.0b013e3182246a83]).
Dr. Xu said that she had no financial conflicts to disclose.
QUEBEC CITY – Women with a history of chlamydia were significantly more likely to get retested if they could collect samples at home rather than having to visit a clinic, based on data from 404 women.
Women with recurrent chlamydia infections can be at increased risk for long-term complications, but few women comply with the Centers for Disease Control and Prevention recommendation for chlamydia rescreening 3 months after an initial treatment, Dr. Fujie Xu of the CDC said during a presentation of the findings at a congress of the International Society for Sexually Transmitted Diseases Research.
"The need for a clinic visit and a vaginal speculum examination likely contribute to poor compliance with the rescreening recommendation," she said.
Dr. Xu and her colleagues surmised that offering women at-home testing instead of a clinic visit might increase rescreening rates.
They were right. The study’s primary end point was the rescreening rate during a 7-week window from 1 week before to 6 weeks after a date of 3 months past the patient’s initial treatment. A total of 80 of 196 women (41%) randomized to perform a home test were rescreened, compared with 43 of 208 women (21%) randomized to a follow-up clinic visit. The difference was statistically significant.
Women in the take-home group also were significantly more likely to be rescreened at any point during the study, compared with the clinic group (49% vs. 28%).
The women were recruited from Jackson, Miss., New Orleans, and St. Louis. The average age of the women was 21 years; 85% of the home test group and 88% of the clinic test group were black. The education levels were similar between the two groups. All study participants had previously tested positive for chlamydia.
When the researchers analyzed the findings by demographic factors, women in the at-home test group who had a high school eduction or less were significantly more likely to be rescreened than were similarly educated women in the clinic group. For women who had some college education, there was no significant difference in screening rates between the at-home test and clinic test groups.
At the rescreening visits, 93 specimens from home test patients and 55 from clinic test patients were tested. The percentage of positive tests upon rescreening was similar between the groups: 13% in the home group and 15% in the clinic group.
Overall, rescreening rates were almost twice as high in the at-home test group as in the clinic group, Dr. Xu said. In several study subgroups, rescreening rates were consistently higher among women who used home tests, compared with clinic tests, she added.
Home testing for chlamydia represents a new tool, "but not the magic bullet," Dr. Xu said. More research is needed to identify better ways to remind patients to get rescreened for chlamydia, and more support is needed for FDA-approved tests for home specimen collection, she said.
Additional data from this study were published online in the August issue of Obstetrics & Gynecology (2011 August;118:231-239 [doi: 10.1097/AOG.0b013e3182246a83]).
Dr. Xu said that she had no financial conflicts to disclose.
QUEBEC CITY – Women with a history of chlamydia were significantly more likely to get retested if they could collect samples at home rather than having to visit a clinic, based on data from 404 women.
Women with recurrent chlamydia infections can be at increased risk for long-term complications, but few women comply with the Centers for Disease Control and Prevention recommendation for chlamydia rescreening 3 months after an initial treatment, Dr. Fujie Xu of the CDC said during a presentation of the findings at a congress of the International Society for Sexually Transmitted Diseases Research.
"The need for a clinic visit and a vaginal speculum examination likely contribute to poor compliance with the rescreening recommendation," she said.
Dr. Xu and her colleagues surmised that offering women at-home testing instead of a clinic visit might increase rescreening rates.
They were right. The study’s primary end point was the rescreening rate during a 7-week window from 1 week before to 6 weeks after a date of 3 months past the patient’s initial treatment. A total of 80 of 196 women (41%) randomized to perform a home test were rescreened, compared with 43 of 208 women (21%) randomized to a follow-up clinic visit. The difference was statistically significant.
Women in the take-home group also were significantly more likely to be rescreened at any point during the study, compared with the clinic group (49% vs. 28%).
The women were recruited from Jackson, Miss., New Orleans, and St. Louis. The average age of the women was 21 years; 85% of the home test group and 88% of the clinic test group were black. The education levels were similar between the two groups. All study participants had previously tested positive for chlamydia.
When the researchers analyzed the findings by demographic factors, women in the at-home test group who had a high school eduction or less were significantly more likely to be rescreened than were similarly educated women in the clinic group. For women who had some college education, there was no significant difference in screening rates between the at-home test and clinic test groups.
At the rescreening visits, 93 specimens from home test patients and 55 from clinic test patients were tested. The percentage of positive tests upon rescreening was similar between the groups: 13% in the home group and 15% in the clinic group.
Overall, rescreening rates were almost twice as high in the at-home test group as in the clinic group, Dr. Xu said. In several study subgroups, rescreening rates were consistently higher among women who used home tests, compared with clinic tests, she added.
Home testing for chlamydia represents a new tool, "but not the magic bullet," Dr. Xu said. More research is needed to identify better ways to remind patients to get rescreened for chlamydia, and more support is needed for FDA-approved tests for home specimen collection, she said.
Additional data from this study were published online in the August issue of Obstetrics & Gynecology (2011 August;118:231-239 [doi: 10.1097/AOG.0b013e3182246a83]).
Dr. Xu said that she had no financial conflicts to disclose.
FROM A CONGRESS OF THE INTERNATIONAL SOCIETY FOR SEXUALLY TRANSMITTED DISEASES RESEARCH
Major Finding: Significantly more women with a history of chlamydia were rescreened if they used a take-home test instead of returning to a clinic (49% vs. 28%).
Data Source: A randomized, controlled trial of 404 women aged 16 years and older.
Disclosures: Dr. Xu said that she had no financial conflicts to disclose.
Add Trichomonas vaginalis to STD Screen
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 a congress of the International Society for Sexually Transmitted Diseases Research.
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.
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 a congress of the International Society for Sexually Transmitted Diseases Research.
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.
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 a congress of the International Society for Sexually Transmitted Diseases Research.
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.
Dr. Ginocchio said that she had no financial conflicts to disclose.
FROM A CONGRESS OF THE INTERNATIONAL SOCIETY FOR SEXUALLY TRANMITTED DISEASES RESEARCH
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.