Tool Boosts Power to Predict Delirium in Adult ICU

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Tool Boosts Power to Predict Delirium in Adult ICU

A recently developed tool could help doctors stay ahead of the game in preventing delirium in intensive care patients.

Dutch researchers say their delirium prediction model, known as PRE-DELIRIC, was significantly more successful than doctors and nurses at predicting delirium in hospitalized adults.

Preventive measures for delirium can limit its incidence, severity, and duration. While several assessment tools exist for other segments of hospitalized patients, "no evidence-based prediction model for general intensive care patients is available," Mark van den Boogaard, Ph.D., of Radboud University Nijmegen (Netherlands) Medical Centre and his colleagues said (BMJ 2012;344:e420 [doi: 10.1136/bmj.e420]).

General preventive measures in all ICU patients are time consuming, and may expose many patients to unnecessary risks such as adverse events related to drug prophylaxis, the researchers explained.

For PRE-DELIRIC (Prediction of Delirium in ICU Patients), Dr. van den Boogaard and his colleagues defined 10 risk factors that can be easily assessed within 24 hours of admission to the ICU: age, APACHE II (Acute Physiology and Chronic Health Evaluation II) score, admission category, coma, infection, metabolic acidosis, morphine use, sedative use, urea concentration, and urgent admission.

"The use of the PRE-DELERIC model to identify and consequently preventively treat high-risk patients could offer an important contribution to intensive care practice and ensure efficient use of research resources to study only high-risk patients," the researchers said.

Clinically, the model may improve the use of nondrug measures to prevent delirium in high-risk patients, the researchers added. Such measures include improvement of orientation, cognitive stimulation, early mobilization, and listening to music, they said.

In noncritical patients, nondrug preventive measures have been shown to reduce delirium incidence and duration, and haloperidol treatment has lessened severity, duration, and associated length of stay. But for ICU patients, data are hard to come by. PRE-DELIRIC could inform the choice to use prophylactic haloperidol in these patients, the authors said. Existing research (Lancet 2009;373:1874-82) does show that "early mobilisation of mechanically ventilated patients in intensive care, besides other significant effects, resulted in a reduced duration of delirium," Dr. van den Boogaard and his coauthors wrote.

After testing their model for temporal validation, the researchers conducted an external validation study of data from intensive care patients admitted to four Dutch hospitals between Jan. 1 and Sept. 1, 2009. The pooled data included information from 3,056 patients aged 18 years and older, yielding an area under the receiver operating characteristics curve (AUROC) of 0.85. The patients were divided into four risk groups: low, moderate, high, and very high. The sensitivity and specificity were, respectively, 81% and 75% for the group with low-risk group; 62% and 89% for the moderate-risk group; 46% and 95% for the high-risk group; and 30% and 98% for the group with very high risk.

The researchers compared the predictions of patient delirium made by their model to predictions made by doctors and nurses in the hospital, using a convenience sample of 124 patients.

The AUROC for the PRE-DELIRIC model (0.87) was significantly higher than that of the doctors and nurses (0.59).

No significant differences appeared in the predictions of intensive care nurses compared with student intensive care nurses or among intensivists, fellow-intensivists, and residents, the researchers said.

The PRE-DELIRIC model is being used in daily practice in the hospital where the model was developed, the researchers said. "Intensive care patients with a high risk of delirium (at least a 50% PRE-DELIRIC score), and patients with dementia or alcohol misuse, receive preventive measures. The optimal cut-off point of the PRE-DELIRIC model and the most effective delirium preventive interventions for intensive care patients need to be studied in the near future."

The findings were limited by the static nature of the model, which does not account for changes in health status that might affect the odds of developing delirium, the researchers noted.

The researchers reported having no financial conflicts of interest.

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A recently developed tool could help doctors stay ahead of the game in preventing delirium in intensive care patients.

Dutch researchers say their delirium prediction model, known as PRE-DELIRIC, was significantly more successful than doctors and nurses at predicting delirium in hospitalized adults.

Preventive measures for delirium can limit its incidence, severity, and duration. While several assessment tools exist for other segments of hospitalized patients, "no evidence-based prediction model for general intensive care patients is available," Mark van den Boogaard, Ph.D., of Radboud University Nijmegen (Netherlands) Medical Centre and his colleagues said (BMJ 2012;344:e420 [doi: 10.1136/bmj.e420]).

General preventive measures in all ICU patients are time consuming, and may expose many patients to unnecessary risks such as adverse events related to drug prophylaxis, the researchers explained.

For PRE-DELIRIC (Prediction of Delirium in ICU Patients), Dr. van den Boogaard and his colleagues defined 10 risk factors that can be easily assessed within 24 hours of admission to the ICU: age, APACHE II (Acute Physiology and Chronic Health Evaluation II) score, admission category, coma, infection, metabolic acidosis, morphine use, sedative use, urea concentration, and urgent admission.

"The use of the PRE-DELERIC model to identify and consequently preventively treat high-risk patients could offer an important contribution to intensive care practice and ensure efficient use of research resources to study only high-risk patients," the researchers said.

Clinically, the model may improve the use of nondrug measures to prevent delirium in high-risk patients, the researchers added. Such measures include improvement of orientation, cognitive stimulation, early mobilization, and listening to music, they said.

In noncritical patients, nondrug preventive measures have been shown to reduce delirium incidence and duration, and haloperidol treatment has lessened severity, duration, and associated length of stay. But for ICU patients, data are hard to come by. PRE-DELIRIC could inform the choice to use prophylactic haloperidol in these patients, the authors said. Existing research (Lancet 2009;373:1874-82) does show that "early mobilisation of mechanically ventilated patients in intensive care, besides other significant effects, resulted in a reduced duration of delirium," Dr. van den Boogaard and his coauthors wrote.

After testing their model for temporal validation, the researchers conducted an external validation study of data from intensive care patients admitted to four Dutch hospitals between Jan. 1 and Sept. 1, 2009. The pooled data included information from 3,056 patients aged 18 years and older, yielding an area under the receiver operating characteristics curve (AUROC) of 0.85. The patients were divided into four risk groups: low, moderate, high, and very high. The sensitivity and specificity were, respectively, 81% and 75% for the group with low-risk group; 62% and 89% for the moderate-risk group; 46% and 95% for the high-risk group; and 30% and 98% for the group with very high risk.

The researchers compared the predictions of patient delirium made by their model to predictions made by doctors and nurses in the hospital, using a convenience sample of 124 patients.

The AUROC for the PRE-DELIRIC model (0.87) was significantly higher than that of the doctors and nurses (0.59).

No significant differences appeared in the predictions of intensive care nurses compared with student intensive care nurses or among intensivists, fellow-intensivists, and residents, the researchers said.

The PRE-DELIRIC model is being used in daily practice in the hospital where the model was developed, the researchers said. "Intensive care patients with a high risk of delirium (at least a 50% PRE-DELIRIC score), and patients with dementia or alcohol misuse, receive preventive measures. The optimal cut-off point of the PRE-DELIRIC model and the most effective delirium preventive interventions for intensive care patients need to be studied in the near future."

The findings were limited by the static nature of the model, which does not account for changes in health status that might affect the odds of developing delirium, the researchers noted.

The researchers reported having no financial conflicts of interest.

A recently developed tool could help doctors stay ahead of the game in preventing delirium in intensive care patients.

Dutch researchers say their delirium prediction model, known as PRE-DELIRIC, was significantly more successful than doctors and nurses at predicting delirium in hospitalized adults.

Preventive measures for delirium can limit its incidence, severity, and duration. While several assessment tools exist for other segments of hospitalized patients, "no evidence-based prediction model for general intensive care patients is available," Mark van den Boogaard, Ph.D., of Radboud University Nijmegen (Netherlands) Medical Centre and his colleagues said (BMJ 2012;344:e420 [doi: 10.1136/bmj.e420]).

General preventive measures in all ICU patients are time consuming, and may expose many patients to unnecessary risks such as adverse events related to drug prophylaxis, the researchers explained.

For PRE-DELIRIC (Prediction of Delirium in ICU Patients), Dr. van den Boogaard and his colleagues defined 10 risk factors that can be easily assessed within 24 hours of admission to the ICU: age, APACHE II (Acute Physiology and Chronic Health Evaluation II) score, admission category, coma, infection, metabolic acidosis, morphine use, sedative use, urea concentration, and urgent admission.

"The use of the PRE-DELERIC model to identify and consequently preventively treat high-risk patients could offer an important contribution to intensive care practice and ensure efficient use of research resources to study only high-risk patients," the researchers said.

Clinically, the model may improve the use of nondrug measures to prevent delirium in high-risk patients, the researchers added. Such measures include improvement of orientation, cognitive stimulation, early mobilization, and listening to music, they said.

In noncritical patients, nondrug preventive measures have been shown to reduce delirium incidence and duration, and haloperidol treatment has lessened severity, duration, and associated length of stay. But for ICU patients, data are hard to come by. PRE-DELIRIC could inform the choice to use prophylactic haloperidol in these patients, the authors said. Existing research (Lancet 2009;373:1874-82) does show that "early mobilisation of mechanically ventilated patients in intensive care, besides other significant effects, resulted in a reduced duration of delirium," Dr. van den Boogaard and his coauthors wrote.

After testing their model for temporal validation, the researchers conducted an external validation study of data from intensive care patients admitted to four Dutch hospitals between Jan. 1 and Sept. 1, 2009. The pooled data included information from 3,056 patients aged 18 years and older, yielding an area under the receiver operating characteristics curve (AUROC) of 0.85. The patients were divided into four risk groups: low, moderate, high, and very high. The sensitivity and specificity were, respectively, 81% and 75% for the group with low-risk group; 62% and 89% for the moderate-risk group; 46% and 95% for the high-risk group; and 30% and 98% for the group with very high risk.

The researchers compared the predictions of patient delirium made by their model to predictions made by doctors and nurses in the hospital, using a convenience sample of 124 patients.

The AUROC for the PRE-DELIRIC model (0.87) was significantly higher than that of the doctors and nurses (0.59).

No significant differences appeared in the predictions of intensive care nurses compared with student intensive care nurses or among intensivists, fellow-intensivists, and residents, the researchers said.

The PRE-DELIRIC model is being used in daily practice in the hospital where the model was developed, the researchers said. "Intensive care patients with a high risk of delirium (at least a 50% PRE-DELIRIC score), and patients with dementia or alcohol misuse, receive preventive measures. The optimal cut-off point of the PRE-DELIRIC model and the most effective delirium preventive interventions for intensive care patients need to be studied in the near future."

The findings were limited by the static nature of the model, which does not account for changes in health status that might affect the odds of developing delirium, the researchers noted.

The researchers reported having no financial conflicts of interest.

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Tool Boosts Power to Predict Delirium in Adult ICU
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Tool Boosts Power to Predict Delirium in Adult ICU
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preventing delirium, intensive care, Dutch researchers, delirium prediction model, PRE-DELRIC, Preventive measures for delirium, Mark van den Boogaard, Ph.D., Prediction of Delirium in ICU Patients, Dr. van den Boogaard, APACHE II, Acute Physiology and Chronic Health Evaluation II score,
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FROM THE BRITISH MEDICAL JOURNAL

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Risk Factors Keyed to Complications After Colorectal Surgery

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Risk Factors Keyed to Complications After Colorectal Surgery

Operating room time, body mass index, and the surgeon performing the procedure were the top three factors affecting readmission rates, transfusion rates, and surgical site infections after colorectal surgery in a single-center prospective study of more than 3,000 patients.

Many previous studies have addressed risk factors and surgical outcomes, but "little is known about the relative contribution of various risk factors to specific outcomes," said Elena Manilich, Ph.D., of the Cleveland Clinic. She presented the findings at the annual meeting of the American Society of Colon and Rectal Surgeons.

She and her colleagues analyzed outcomes from 3,552 patients who underwent colorectal surgery. Their average age at the time of surgery was 51 years, and approximately half were women. Cancer was the most common indication for surgery (16%).

Overall, the length of surgery was significantly associated with increased complication rates, Dr. Manilich said. In particular, the adjusted odds ratios for procedures lasting more than 200 minutes vs. those lasting less than 200 minutes were 2.79 for transfusion, 2.11 for surgical site infection and abscess, and 2.09 for wound infection.

Surgeons who performed fewer than 20 procedures were significant predictors of surgical site infections, abscesses, reoperation, and anastomotic leaks in their patients, Dr. Manilich said.

Increased patient body mass index was independently associated with wound infection, surgical site infection, and portal and deep vein thrombosis, she added.

In addition, a patient age older than 75 years was independently associated with transfusion and reoperation.

The outcomes that were most influenced by complications were hospital readmission, transfusion, surgical site infection, wound infections, and abscesses. Complications were defined as outcomes that occurred prior to hospital discharge or within 30 days of the initial surgery.

The findings were limited by the use of data from a single hospital and by the inability to adjust for patient histories (such as prior abdominal procedures) that might have affected the outcomes, Dr. Manilich said. But the study is unique in its use of a logistic regression analysis to identify which variables predict which outcomes, she added.

"An understanding of these results may be useful to colorectal surgeons who are making an effort to understand and improve their surgical outcomes," she said.

Dr. Manilich had no financial conflicts to disclose.

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Operating room time, body mass index, and the surgeon performing the procedure were the top three factors affecting readmission rates, transfusion rates, and surgical site infections after colorectal surgery in a single-center prospective study of more than 3,000 patients.

Many previous studies have addressed risk factors and surgical outcomes, but "little is known about the relative contribution of various risk factors to specific outcomes," said Elena Manilich, Ph.D., of the Cleveland Clinic. She presented the findings at the annual meeting of the American Society of Colon and Rectal Surgeons.

She and her colleagues analyzed outcomes from 3,552 patients who underwent colorectal surgery. Their average age at the time of surgery was 51 years, and approximately half were women. Cancer was the most common indication for surgery (16%).

Overall, the length of surgery was significantly associated with increased complication rates, Dr. Manilich said. In particular, the adjusted odds ratios for procedures lasting more than 200 minutes vs. those lasting less than 200 minutes were 2.79 for transfusion, 2.11 for surgical site infection and abscess, and 2.09 for wound infection.

Surgeons who performed fewer than 20 procedures were significant predictors of surgical site infections, abscesses, reoperation, and anastomotic leaks in their patients, Dr. Manilich said.

Increased patient body mass index was independently associated with wound infection, surgical site infection, and portal and deep vein thrombosis, she added.

In addition, a patient age older than 75 years was independently associated with transfusion and reoperation.

The outcomes that were most influenced by complications were hospital readmission, transfusion, surgical site infection, wound infections, and abscesses. Complications were defined as outcomes that occurred prior to hospital discharge or within 30 days of the initial surgery.

The findings were limited by the use of data from a single hospital and by the inability to adjust for patient histories (such as prior abdominal procedures) that might have affected the outcomes, Dr. Manilich said. But the study is unique in its use of a logistic regression analysis to identify which variables predict which outcomes, she added.

"An understanding of these results may be useful to colorectal surgeons who are making an effort to understand and improve their surgical outcomes," she said.

Dr. Manilich had no financial conflicts to disclose.

Operating room time, body mass index, and the surgeon performing the procedure were the top three factors affecting readmission rates, transfusion rates, and surgical site infections after colorectal surgery in a single-center prospective study of more than 3,000 patients.

Many previous studies have addressed risk factors and surgical outcomes, but "little is known about the relative contribution of various risk factors to specific outcomes," said Elena Manilich, Ph.D., of the Cleveland Clinic. She presented the findings at the annual meeting of the American Society of Colon and Rectal Surgeons.

She and her colleagues analyzed outcomes from 3,552 patients who underwent colorectal surgery. Their average age at the time of surgery was 51 years, and approximately half were women. Cancer was the most common indication for surgery (16%).

Overall, the length of surgery was significantly associated with increased complication rates, Dr. Manilich said. In particular, the adjusted odds ratios for procedures lasting more than 200 minutes vs. those lasting less than 200 minutes were 2.79 for transfusion, 2.11 for surgical site infection and abscess, and 2.09 for wound infection.

Surgeons who performed fewer than 20 procedures were significant predictors of surgical site infections, abscesses, reoperation, and anastomotic leaks in their patients, Dr. Manilich said.

Increased patient body mass index was independently associated with wound infection, surgical site infection, and portal and deep vein thrombosis, she added.

In addition, a patient age older than 75 years was independently associated with transfusion and reoperation.

The outcomes that were most influenced by complications were hospital readmission, transfusion, surgical site infection, wound infections, and abscesses. Complications were defined as outcomes that occurred prior to hospital discharge or within 30 days of the initial surgery.

The findings were limited by the use of data from a single hospital and by the inability to adjust for patient histories (such as prior abdominal procedures) that might have affected the outcomes, Dr. Manilich said. But the study is unique in its use of a logistic regression analysis to identify which variables predict which outcomes, she added.

"An understanding of these results may be useful to colorectal surgeons who are making an effort to understand and improve their surgical outcomes," she said.

Dr. Manilich had no financial conflicts to disclose.

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Risk Factors Keyed to Complications After Colorectal Surgery
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Major Finding: Operating time had a significant impact on the outcomes of colorectal procedures. The adjusted odds ratio for procedures lasting more than 200 minutes, compared with those lasting less than 200 minutes, was 2.79 for transfusion, 2.11 for surgical site infection and abscess, and 2.09 for wound infection.

Data Source: The data come from an outcomes database of adults who underwent colorectal surgery in 2010 and 2011.

Disclosures: Dr. Manilich had no financial conflicts to disclose.

No Extra Concerns for Stroke Treatment in Warfarin Users

Supports TPA Use in Eligible Patients
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No Extra Concerns for Stroke Treatment in Warfarin Users

Thrombolysis with intravenous tissue plasminogen activator for the treatment of acute ischemic stroke does not increase the risk of brain hemorrhage in patients who are also taking warfarin, based on data from an observational study of more than 23,000 patients.

The patients in the study had an international normalized ratio (INR) of 1.7 or lower, which is the same population of warfarin-treated patients for whom intravenous tissue plasminogen activator (TPA) is recommended in the current American Heart Association/American Stroke Association guidelines.

Dr. Ying Xian

Symptomatic intracranial hemorrhage (sICH) is an adverse event associated with intravenous TPA that may occur more often in patients receiving warfarin, according to Dr. Ying Xian, who was lead investigator on the study, published June 26 in JAMA. But "the true absolute risk of sICH in this population remains a matter of significant debate," and previous studies of bleeding risk associated with warfarin have been small, with inconsistent results, wrote Dr. Xian of the Duke Clinical Research Institute in Durham, N.C. and his colleagues.

The investigators reviewed data from 23,437 adults in the American Heart Association’s Get With the Guidelines - Stroke Registry. The study participants were treated with intravenous TPA at 1,203 registry hospitals between April 2009 and June 2011 (JAMA 2012;307:2600-8).

A total of 1,802 (8%) of the patients were receiving warfarin at the time of treatment with TPA. A total of 1,107 patients (5%) developed sICH after TPA.

Although the unadjusted rate of hemorrhage was significantly higher in warfarin-treated patients, compared with non-warfarin patients (6% vs. 5%, P less than .001), there was no significant difference in hemorrhage rates after risk adjustment (adjusted odds ratio, 1.01). The results were similar regardless of whether or not the patients’ scores on the National Institutes of Health Stroke Scale (NIHSS) were excluded from the risk adjustment, the researchers noted.

Similarly, there was no significant difference in the rates of life-threatening or serious systemic hemorrhage between the warfarin and non-warfarin groups (0.9% for both) and no significant differences between the two groups in TPA complications (11% vs. 8%, respectively) or in-hospital mortality (11% vs. 8%, respectively).

"We found the potential for substantial undertreatment, because up to 50% of warfarin-treated patients who might have been eligible for reperfusion therapy did not receive intravenous TPA," the researchers wrote.

The results also indicated that there was no significant relationship between warfarin use and sICH in a subgroup analysis of patients with INRs between 1.5 and 1.7 or in an exploratory analysis of patients with INRs of 2.0 or lower.

The higher unadjusted incidence of sICH in warfarin patients may be a result of the differences in risk profiles between the warfarin and non-warfarin patients, because those receiving warfarin were significantly older and had higher NIHSS scores, the researchers noted.

The study was limited by several factors, including its retrospective design and a lack of NIHSS information for all patients. More research is needed to explore the effectiveness of intravenous TPA for patients with INRs outside of the range recommended by the guidelines, they added.

The study was supported in part by the American Heart Association – Pharmaceutical Roundtable and from David and Stevie Spina. Dr. Xian had no financial conflicts to disclose. Several coauthors disclosed financial relationships with multiple companies, including Boehringer Ingelheim, Merck, Bristol-Myers Squibb, and Sanofi-aventis, which have supported the Get With the Guidelines – Stroke Program in the past, and Janssen Pharmaceutical Companies of Johnson & Johnson, which currently supports it. Boehringer Ingelheim markets TPA in the United States as Activase.

Body

"These results are surprising, yet reassuring, because patients receiving warfarin were in general older and more likely to have atrial fibrillation and overall had more risk factors for intracranial hemorrhage," Dr. Mark J. Alberts wrote in an accompanying editorial.

The study was limited in part by the fact that the majority of the patients had INRs lower than 1.5. "The overall suggestion of slightly higher rates of intracranial hemorrhage among patients with higher INRs warrants further monitoring," he noted.

The findings, however, support the use of TPA for eligible patients, Dr. Alberts said. "The real risk is in not treating otherwise eligible patients, who may then have prolonged morbidity from their stroke."

Dr. Alberts is with the stroke program at Northwestern University in Chicago. He reported serving as a consultant for and receiving honoraria from Genentech and Boehringer Ingelheim, and serving as a consultant for Janssen and the Joint Commission. His comments are derived from an editorial accompanying the warfarin-TPA study (JAMA 2012;307:2637-8).

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Body

"These results are surprising, yet reassuring, because patients receiving warfarin were in general older and more likely to have atrial fibrillation and overall had more risk factors for intracranial hemorrhage," Dr. Mark J. Alberts wrote in an accompanying editorial.

The study was limited in part by the fact that the majority of the patients had INRs lower than 1.5. "The overall suggestion of slightly higher rates of intracranial hemorrhage among patients with higher INRs warrants further monitoring," he noted.

The findings, however, support the use of TPA for eligible patients, Dr. Alberts said. "The real risk is in not treating otherwise eligible patients, who may then have prolonged morbidity from their stroke."

Dr. Alberts is with the stroke program at Northwestern University in Chicago. He reported serving as a consultant for and receiving honoraria from Genentech and Boehringer Ingelheim, and serving as a consultant for Janssen and the Joint Commission. His comments are derived from an editorial accompanying the warfarin-TPA study (JAMA 2012;307:2637-8).

Body

"These results are surprising, yet reassuring, because patients receiving warfarin were in general older and more likely to have atrial fibrillation and overall had more risk factors for intracranial hemorrhage," Dr. Mark J. Alberts wrote in an accompanying editorial.

The study was limited in part by the fact that the majority of the patients had INRs lower than 1.5. "The overall suggestion of slightly higher rates of intracranial hemorrhage among patients with higher INRs warrants further monitoring," he noted.

The findings, however, support the use of TPA for eligible patients, Dr. Alberts said. "The real risk is in not treating otherwise eligible patients, who may then have prolonged morbidity from their stroke."

Dr. Alberts is with the stroke program at Northwestern University in Chicago. He reported serving as a consultant for and receiving honoraria from Genentech and Boehringer Ingelheim, and serving as a consultant for Janssen and the Joint Commission. His comments are derived from an editorial accompanying the warfarin-TPA study (JAMA 2012;307:2637-8).

Title
Supports TPA Use in Eligible Patients
Supports TPA Use in Eligible Patients

Thrombolysis with intravenous tissue plasminogen activator for the treatment of acute ischemic stroke does not increase the risk of brain hemorrhage in patients who are also taking warfarin, based on data from an observational study of more than 23,000 patients.

The patients in the study had an international normalized ratio (INR) of 1.7 or lower, which is the same population of warfarin-treated patients for whom intravenous tissue plasminogen activator (TPA) is recommended in the current American Heart Association/American Stroke Association guidelines.

Dr. Ying Xian

Symptomatic intracranial hemorrhage (sICH) is an adverse event associated with intravenous TPA that may occur more often in patients receiving warfarin, according to Dr. Ying Xian, who was lead investigator on the study, published June 26 in JAMA. But "the true absolute risk of sICH in this population remains a matter of significant debate," and previous studies of bleeding risk associated with warfarin have been small, with inconsistent results, wrote Dr. Xian of the Duke Clinical Research Institute in Durham, N.C. and his colleagues.

The investigators reviewed data from 23,437 adults in the American Heart Association’s Get With the Guidelines - Stroke Registry. The study participants were treated with intravenous TPA at 1,203 registry hospitals between April 2009 and June 2011 (JAMA 2012;307:2600-8).

A total of 1,802 (8%) of the patients were receiving warfarin at the time of treatment with TPA. A total of 1,107 patients (5%) developed sICH after TPA.

Although the unadjusted rate of hemorrhage was significantly higher in warfarin-treated patients, compared with non-warfarin patients (6% vs. 5%, P less than .001), there was no significant difference in hemorrhage rates after risk adjustment (adjusted odds ratio, 1.01). The results were similar regardless of whether or not the patients’ scores on the National Institutes of Health Stroke Scale (NIHSS) were excluded from the risk adjustment, the researchers noted.

Similarly, there was no significant difference in the rates of life-threatening or serious systemic hemorrhage between the warfarin and non-warfarin groups (0.9% for both) and no significant differences between the two groups in TPA complications (11% vs. 8%, respectively) or in-hospital mortality (11% vs. 8%, respectively).

"We found the potential for substantial undertreatment, because up to 50% of warfarin-treated patients who might have been eligible for reperfusion therapy did not receive intravenous TPA," the researchers wrote.

The results also indicated that there was no significant relationship between warfarin use and sICH in a subgroup analysis of patients with INRs between 1.5 and 1.7 or in an exploratory analysis of patients with INRs of 2.0 or lower.

The higher unadjusted incidence of sICH in warfarin patients may be a result of the differences in risk profiles between the warfarin and non-warfarin patients, because those receiving warfarin were significantly older and had higher NIHSS scores, the researchers noted.

The study was limited by several factors, including its retrospective design and a lack of NIHSS information for all patients. More research is needed to explore the effectiveness of intravenous TPA for patients with INRs outside of the range recommended by the guidelines, they added.

The study was supported in part by the American Heart Association – Pharmaceutical Roundtable and from David and Stevie Spina. Dr. Xian had no financial conflicts to disclose. Several coauthors disclosed financial relationships with multiple companies, including Boehringer Ingelheim, Merck, Bristol-Myers Squibb, and Sanofi-aventis, which have supported the Get With the Guidelines – Stroke Program in the past, and Janssen Pharmaceutical Companies of Johnson & Johnson, which currently supports it. Boehringer Ingelheim markets TPA in the United States as Activase.

Thrombolysis with intravenous tissue plasminogen activator for the treatment of acute ischemic stroke does not increase the risk of brain hemorrhage in patients who are also taking warfarin, based on data from an observational study of more than 23,000 patients.

The patients in the study had an international normalized ratio (INR) of 1.7 or lower, which is the same population of warfarin-treated patients for whom intravenous tissue plasminogen activator (TPA) is recommended in the current American Heart Association/American Stroke Association guidelines.

Dr. Ying Xian

Symptomatic intracranial hemorrhage (sICH) is an adverse event associated with intravenous TPA that may occur more often in patients receiving warfarin, according to Dr. Ying Xian, who was lead investigator on the study, published June 26 in JAMA. But "the true absolute risk of sICH in this population remains a matter of significant debate," and previous studies of bleeding risk associated with warfarin have been small, with inconsistent results, wrote Dr. Xian of the Duke Clinical Research Institute in Durham, N.C. and his colleagues.

The investigators reviewed data from 23,437 adults in the American Heart Association’s Get With the Guidelines - Stroke Registry. The study participants were treated with intravenous TPA at 1,203 registry hospitals between April 2009 and June 2011 (JAMA 2012;307:2600-8).

A total of 1,802 (8%) of the patients were receiving warfarin at the time of treatment with TPA. A total of 1,107 patients (5%) developed sICH after TPA.

Although the unadjusted rate of hemorrhage was significantly higher in warfarin-treated patients, compared with non-warfarin patients (6% vs. 5%, P less than .001), there was no significant difference in hemorrhage rates after risk adjustment (adjusted odds ratio, 1.01). The results were similar regardless of whether or not the patients’ scores on the National Institutes of Health Stroke Scale (NIHSS) were excluded from the risk adjustment, the researchers noted.

Similarly, there was no significant difference in the rates of life-threatening or serious systemic hemorrhage between the warfarin and non-warfarin groups (0.9% for both) and no significant differences between the two groups in TPA complications (11% vs. 8%, respectively) or in-hospital mortality (11% vs. 8%, respectively).

"We found the potential for substantial undertreatment, because up to 50% of warfarin-treated patients who might have been eligible for reperfusion therapy did not receive intravenous TPA," the researchers wrote.

The results also indicated that there was no significant relationship between warfarin use and sICH in a subgroup analysis of patients with INRs between 1.5 and 1.7 or in an exploratory analysis of patients with INRs of 2.0 or lower.

The higher unadjusted incidence of sICH in warfarin patients may be a result of the differences in risk profiles between the warfarin and non-warfarin patients, because those receiving warfarin were significantly older and had higher NIHSS scores, the researchers noted.

The study was limited by several factors, including its retrospective design and a lack of NIHSS information for all patients. More research is needed to explore the effectiveness of intravenous TPA for patients with INRs outside of the range recommended by the guidelines, they added.

The study was supported in part by the American Heart Association – Pharmaceutical Roundtable and from David and Stevie Spina. Dr. Xian had no financial conflicts to disclose. Several coauthors disclosed financial relationships with multiple companies, including Boehringer Ingelheim, Merck, Bristol-Myers Squibb, and Sanofi-aventis, which have supported the Get With the Guidelines – Stroke Program in the past, and Janssen Pharmaceutical Companies of Johnson & Johnson, which currently supports it. Boehringer Ingelheim markets TPA in the United States as Activase.

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Major Finding: There was no significant difference in hemorrhage rates after intravenous TPA between stroke patients taking warfarin and those not taking warfarin (6% vs. 5%, respectively, P less than .001).

Data Source: The data come from a review of 23,437 adults in the American Heart Association’s Get With the Guidelines – Stroke Registry.

Disclosures: The study was supported in part by the American Heart Association – Pharmaceutical Roundtable and from David and Stevie Spina. Dr. Xian had no financial conflicts to disclose. Several coauthors disclosed financial relationships with multiple companies, including Boehringer Ingelheim, Merck, Bristol-Myers Squibb, and Sanofi-aventis, which have supported the Get With the Guidelines – Stroke Program in the past, and Janssen Pharmaceutical Companies of Johnson & Johnson, which currently supports it. Boehringer Ingelheim markets TPA in the United States as Activase.

Got Dengue? Find Out Fast

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A new test for the early detection of dengue fever will be available for distribution on July 2, according to a written statement from the Centers for Disease Control and Prevention.

The new molecular test identifies the dengue virus itself rather than detecting antibodies, and it uses the same equipment and supplies that most public health laboratories already use to diagnose influenza, according to the CDC.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License
A new test for dengue fever, transmitted by Aedes mosquitoes (above), will help clinicians detect the disease earlier.

The test, called the CDC DENV-1-4 Real Time PCR Assay, is designed for use during the first 7 days after dengue symptoms appear, which may be too early for antibody detection.

The ability to diagnose early will give clinicians and public health officials a more complete picture of dengue fever, which is now a reportable disease in the United States, said Jorge L. Muñoz-Jordán, Ph.D., chief of molecular diagnostics and research at the Dengue branch of the CDC, said in the statement.

"The availability of state-of-the-art dengue diagnostics will improve patient management and the public health response to dengue," he said.

Dengue fever is transmitted by Aedes mosquitoes and is a major cause of illness in Puerto Rico and the U.S. Virgin Islands, as well as some parts of the United States in which the mosquitoes are found. U.S. travelers returning home from Latin America, the Caribbean, and Asia are also at risk, the CDC stated.

Symptoms of dengue fever include a high fever; rash or bleeding of the nose and gums; headache, joint, muscle, or bone pain; severe pain behind the eyes; and easy bruising.

The test has been approved by the Food and Drug Administration, and it will be available to labs in the United States and internationally, according to the statement. For more details, visit the CDC website.

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A new test for the early detection of dengue fever will be available for distribution on July 2, according to a written statement from the Centers for Disease Control and Prevention.

The new molecular test identifies the dengue virus itself rather than detecting antibodies, and it uses the same equipment and supplies that most public health laboratories already use to diagnose influenza, according to the CDC.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License
A new test for dengue fever, transmitted by Aedes mosquitoes (above), will help clinicians detect the disease earlier.

The test, called the CDC DENV-1-4 Real Time PCR Assay, is designed for use during the first 7 days after dengue symptoms appear, which may be too early for antibody detection.

The ability to diagnose early will give clinicians and public health officials a more complete picture of dengue fever, which is now a reportable disease in the United States, said Jorge L. Muñoz-Jordán, Ph.D., chief of molecular diagnostics and research at the Dengue branch of the CDC, said in the statement.

"The availability of state-of-the-art dengue diagnostics will improve patient management and the public health response to dengue," he said.

Dengue fever is transmitted by Aedes mosquitoes and is a major cause of illness in Puerto Rico and the U.S. Virgin Islands, as well as some parts of the United States in which the mosquitoes are found. U.S. travelers returning home from Latin America, the Caribbean, and Asia are also at risk, the CDC stated.

Symptoms of dengue fever include a high fever; rash or bleeding of the nose and gums; headache, joint, muscle, or bone pain; severe pain behind the eyes; and easy bruising.

The test has been approved by the Food and Drug Administration, and it will be available to labs in the United States and internationally, according to the statement. For more details, visit the CDC website.

A new test for the early detection of dengue fever will be available for distribution on July 2, according to a written statement from the Centers for Disease Control and Prevention.

The new molecular test identifies the dengue virus itself rather than detecting antibodies, and it uses the same equipment and supplies that most public health laboratories already use to diagnose influenza, according to the CDC.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License
A new test for dengue fever, transmitted by Aedes mosquitoes (above), will help clinicians detect the disease earlier.

The test, called the CDC DENV-1-4 Real Time PCR Assay, is designed for use during the first 7 days after dengue symptoms appear, which may be too early for antibody detection.

The ability to diagnose early will give clinicians and public health officials a more complete picture of dengue fever, which is now a reportable disease in the United States, said Jorge L. Muñoz-Jordán, Ph.D., chief of molecular diagnostics and research at the Dengue branch of the CDC, said in the statement.

"The availability of state-of-the-art dengue diagnostics will improve patient management and the public health response to dengue," he said.

Dengue fever is transmitted by Aedes mosquitoes and is a major cause of illness in Puerto Rico and the U.S. Virgin Islands, as well as some parts of the United States in which the mosquitoes are found. U.S. travelers returning home from Latin America, the Caribbean, and Asia are also at risk, the CDC stated.

Symptoms of dengue fever include a high fever; rash or bleeding of the nose and gums; headache, joint, muscle, or bone pain; severe pain behind the eyes; and easy bruising.

The test has been approved by the Food and Drug Administration, and it will be available to labs in the United States and internationally, according to the statement. For more details, visit the CDC website.

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Noninvasive Prenatal DNA Test Detects Trisomy 18 and 21

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Noninvasive Prenatal DNA Test Detects Trisomy 18 and 21

A noninvasive DNA screening test effectively detected chromosome abnormalities in fetuses of women with singleton pregnancies, based on data from approximately 3,000 women published online in June in the American Journal of Obstetrics and Gynecology.

Data from previous case-control studies have shown that the Digital Analysis of Selected Regions (DANSR) assay can identify chromosome abnormalities by evaluating specific fragments of maternal cell-free DNA (cfDNA), said Dr. Mary E. Norton of Stanford (Calif.) University and her colleagues.

In this multicenter, prospective cohort study, the researchers included pregnant women aged 18-50 years with singleton pregnancies who were planning to undergo invasive prenatal diagnostic testing for any reason. Women with multiples, those with known chromosome abnormalities, or those who had already undergone an invasive prenatal test in the current pregnancy were excluded. The final analysis included samples from 3,228 women with a mean maternal age of 34 years and a mean gestational age of 17 weeks (Am. J. Obstet. Gynecol. 2012 [doi:10.1016/j.ajog.2012.05.021]).

The sensitivity of the test was 100% for trisomy 21 malformations. A total of 81 cases of trisomy 21 were identified and all were classified as high risk, with one false positive out of 2,888 normal cases, for a false positive rate of 0.3% (specificity 99.97%). Similarly, the sensitivity was 97% for trisomy 18. A total of 38 cases of trisomy 18 were identified, and 37 were classified as high-risk, with 2 false positives for a false positive rate of 0.07% (specificity 99.93%).

The positive predictive values for trisomy 21 and trisomy 18 were 98.8% and 94.9%, respectively. The negative predictive values for trisomy 21 and trisomy 18 were 100% and 99.96%, respectively.

Another 73 cases of other chromosomal abnormalities were identified, but they did not affect the analysis of risk for trisomy 18 or 21, Dr. Norton and her associates noted.

The test involved collecting 20 mL of blood from each patient before she underwent any invasive diagnostic testing procedure. DNA samples were classified as high risk or low risk based on a predefined cutoff value of 1% based on previous analyses. Results from the DANSR assay were compared with results from invasive tests as a reference.

"With the methods reported here, the higher throughput and lower cost make this technique potentially scalable for population screening," Dr. Norton and her associates wrote. However, even the high detection rates achieved in the study do not compare with those obtained with invasive diagnoses and may not provide much in the way of additional information for women who then have invasive tests, they noted.

"Further experience in larger populations of average-risk women is needed to clarify the role and utility of cfDNA in clinical practice," they said.

Dr. Norton said she had no relevant financial disclosures. The study was funded by Ariosa Diagnostics, which makes the test used in the study. Several of her coauthors are employees, consultants, or board members of Ariosa Diagnostics.

Body

Current methods of screening for common chromosomal abnormalities require multiple steps with ultrasound and blood work. This complex algorithm gives a risk for trisomy 21 that provides a sensitivity of only 88%-95%, with a 5% false-positive rate for Down syndrome. As families face the decision to choose invasive testing and the risk of fetal loss associated with these procedures, a screening test that provides more reliable results might allow parents to feel more comfortable with their decision to choose or not choose invasive testing.

Dr. Norton and her colleagues present their multicenter trial for the detection of fetal chromosomal abnormalities using analysis of cell-free DNA within maternal serum. They report a sensitivity for detection of Down syndrome of 100% for high-risk cases and 99.97% in the low risk group (with a false positive rate of 0.03%). The prediction of trisomy 18 was less sensitive, with a sensitivity of 97.4%. These tests, however, are done on women already undergoing amniocentesis for a specific reason.

Effective, low-cost screening methods are ideal in screening for chromosomal abnormalities. And this type of testing may be promising for the detection of chromosomal abnormalities other than trisomy 21 and trisomy 18. We must be reminded that this testing remains a screening test. The only way to definitively determine the karyotype is through invasive prenatal diagnosis. And is another screening test the right answer?

As we consider this testing modality, it must be studied in routine populations for low-risk patients who are not undergoing invasive testing – the clinical setting in which most of our patients would be. Although cell-free DNA testing modalities offer promise for screening, they are not yet ready to replace invasive testing for definitive diagnosis of karyotypic abnormalities.

Kristin Atkins, M.D., is in the department of obstetrics, gynecology, and reproductive sciences, and the division of maternal/fetal medicine, at the University of Maryland, Baltimore. She said she had no relevant financial disclosures.

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Body

Current methods of screening for common chromosomal abnormalities require multiple steps with ultrasound and blood work. This complex algorithm gives a risk for trisomy 21 that provides a sensitivity of only 88%-95%, with a 5% false-positive rate for Down syndrome. As families face the decision to choose invasive testing and the risk of fetal loss associated with these procedures, a screening test that provides more reliable results might allow parents to feel more comfortable with their decision to choose or not choose invasive testing.

Dr. Norton and her colleagues present their multicenter trial for the detection of fetal chromosomal abnormalities using analysis of cell-free DNA within maternal serum. They report a sensitivity for detection of Down syndrome of 100% for high-risk cases and 99.97% in the low risk group (with a false positive rate of 0.03%). The prediction of trisomy 18 was less sensitive, with a sensitivity of 97.4%. These tests, however, are done on women already undergoing amniocentesis for a specific reason.

Effective, low-cost screening methods are ideal in screening for chromosomal abnormalities. And this type of testing may be promising for the detection of chromosomal abnormalities other than trisomy 21 and trisomy 18. We must be reminded that this testing remains a screening test. The only way to definitively determine the karyotype is through invasive prenatal diagnosis. And is another screening test the right answer?

As we consider this testing modality, it must be studied in routine populations for low-risk patients who are not undergoing invasive testing – the clinical setting in which most of our patients would be. Although cell-free DNA testing modalities offer promise for screening, they are not yet ready to replace invasive testing for definitive diagnosis of karyotypic abnormalities.

Kristin Atkins, M.D., is in the department of obstetrics, gynecology, and reproductive sciences, and the division of maternal/fetal medicine, at the University of Maryland, Baltimore. She said she had no relevant financial disclosures.

Body

Current methods of screening for common chromosomal abnormalities require multiple steps with ultrasound and blood work. This complex algorithm gives a risk for trisomy 21 that provides a sensitivity of only 88%-95%, with a 5% false-positive rate for Down syndrome. As families face the decision to choose invasive testing and the risk of fetal loss associated with these procedures, a screening test that provides more reliable results might allow parents to feel more comfortable with their decision to choose or not choose invasive testing.

Dr. Norton and her colleagues present their multicenter trial for the detection of fetal chromosomal abnormalities using analysis of cell-free DNA within maternal serum. They report a sensitivity for detection of Down syndrome of 100% for high-risk cases and 99.97% in the low risk group (with a false positive rate of 0.03%). The prediction of trisomy 18 was less sensitive, with a sensitivity of 97.4%. These tests, however, are done on women already undergoing amniocentesis for a specific reason.

Effective, low-cost screening methods are ideal in screening for chromosomal abnormalities. And this type of testing may be promising for the detection of chromosomal abnormalities other than trisomy 21 and trisomy 18. We must be reminded that this testing remains a screening test. The only way to definitively determine the karyotype is through invasive prenatal diagnosis. And is another screening test the right answer?

As we consider this testing modality, it must be studied in routine populations for low-risk patients who are not undergoing invasive testing – the clinical setting in which most of our patients would be. Although cell-free DNA testing modalities offer promise for screening, they are not yet ready to replace invasive testing for definitive diagnosis of karyotypic abnormalities.

Kristin Atkins, M.D., is in the department of obstetrics, gynecology, and reproductive sciences, and the division of maternal/fetal medicine, at the University of Maryland, Baltimore. She said she had no relevant financial disclosures.

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Not Yet Ready for Prime Time

A noninvasive DNA screening test effectively detected chromosome abnormalities in fetuses of women with singleton pregnancies, based on data from approximately 3,000 women published online in June in the American Journal of Obstetrics and Gynecology.

Data from previous case-control studies have shown that the Digital Analysis of Selected Regions (DANSR) assay can identify chromosome abnormalities by evaluating specific fragments of maternal cell-free DNA (cfDNA), said Dr. Mary E. Norton of Stanford (Calif.) University and her colleagues.

In this multicenter, prospective cohort study, the researchers included pregnant women aged 18-50 years with singleton pregnancies who were planning to undergo invasive prenatal diagnostic testing for any reason. Women with multiples, those with known chromosome abnormalities, or those who had already undergone an invasive prenatal test in the current pregnancy were excluded. The final analysis included samples from 3,228 women with a mean maternal age of 34 years and a mean gestational age of 17 weeks (Am. J. Obstet. Gynecol. 2012 [doi:10.1016/j.ajog.2012.05.021]).

The sensitivity of the test was 100% for trisomy 21 malformations. A total of 81 cases of trisomy 21 were identified and all were classified as high risk, with one false positive out of 2,888 normal cases, for a false positive rate of 0.3% (specificity 99.97%). Similarly, the sensitivity was 97% for trisomy 18. A total of 38 cases of trisomy 18 were identified, and 37 were classified as high-risk, with 2 false positives for a false positive rate of 0.07% (specificity 99.93%).

The positive predictive values for trisomy 21 and trisomy 18 were 98.8% and 94.9%, respectively. The negative predictive values for trisomy 21 and trisomy 18 were 100% and 99.96%, respectively.

Another 73 cases of other chromosomal abnormalities were identified, but they did not affect the analysis of risk for trisomy 18 or 21, Dr. Norton and her associates noted.

The test involved collecting 20 mL of blood from each patient before she underwent any invasive diagnostic testing procedure. DNA samples were classified as high risk or low risk based on a predefined cutoff value of 1% based on previous analyses. Results from the DANSR assay were compared with results from invasive tests as a reference.

"With the methods reported here, the higher throughput and lower cost make this technique potentially scalable for population screening," Dr. Norton and her associates wrote. However, even the high detection rates achieved in the study do not compare with those obtained with invasive diagnoses and may not provide much in the way of additional information for women who then have invasive tests, they noted.

"Further experience in larger populations of average-risk women is needed to clarify the role and utility of cfDNA in clinical practice," they said.

Dr. Norton said she had no relevant financial disclosures. The study was funded by Ariosa Diagnostics, which makes the test used in the study. Several of her coauthors are employees, consultants, or board members of Ariosa Diagnostics.

A noninvasive DNA screening test effectively detected chromosome abnormalities in fetuses of women with singleton pregnancies, based on data from approximately 3,000 women published online in June in the American Journal of Obstetrics and Gynecology.

Data from previous case-control studies have shown that the Digital Analysis of Selected Regions (DANSR) assay can identify chromosome abnormalities by evaluating specific fragments of maternal cell-free DNA (cfDNA), said Dr. Mary E. Norton of Stanford (Calif.) University and her colleagues.

In this multicenter, prospective cohort study, the researchers included pregnant women aged 18-50 years with singleton pregnancies who were planning to undergo invasive prenatal diagnostic testing for any reason. Women with multiples, those with known chromosome abnormalities, or those who had already undergone an invasive prenatal test in the current pregnancy were excluded. The final analysis included samples from 3,228 women with a mean maternal age of 34 years and a mean gestational age of 17 weeks (Am. J. Obstet. Gynecol. 2012 [doi:10.1016/j.ajog.2012.05.021]).

The sensitivity of the test was 100% for trisomy 21 malformations. A total of 81 cases of trisomy 21 were identified and all were classified as high risk, with one false positive out of 2,888 normal cases, for a false positive rate of 0.3% (specificity 99.97%). Similarly, the sensitivity was 97% for trisomy 18. A total of 38 cases of trisomy 18 were identified, and 37 were classified as high-risk, with 2 false positives for a false positive rate of 0.07% (specificity 99.93%).

The positive predictive values for trisomy 21 and trisomy 18 were 98.8% and 94.9%, respectively. The negative predictive values for trisomy 21 and trisomy 18 were 100% and 99.96%, respectively.

Another 73 cases of other chromosomal abnormalities were identified, but they did not affect the analysis of risk for trisomy 18 or 21, Dr. Norton and her associates noted.

The test involved collecting 20 mL of blood from each patient before she underwent any invasive diagnostic testing procedure. DNA samples were classified as high risk or low risk based on a predefined cutoff value of 1% based on previous analyses. Results from the DANSR assay were compared with results from invasive tests as a reference.

"With the methods reported here, the higher throughput and lower cost make this technique potentially scalable for population screening," Dr. Norton and her associates wrote. However, even the high detection rates achieved in the study do not compare with those obtained with invasive diagnoses and may not provide much in the way of additional information for women who then have invasive tests, they noted.

"Further experience in larger populations of average-risk women is needed to clarify the role and utility of cfDNA in clinical practice," they said.

Dr. Norton said she had no relevant financial disclosures. The study was funded by Ariosa Diagnostics, which makes the test used in the study. Several of her coauthors are employees, consultants, or board members of Ariosa Diagnostics.

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Delirium Hits Hard in Hospitalized Alzheimer's Patients

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Approximately one in eight Alzheimer’s disease patients who develop delirium while hospitalized will suffer at least one adverse outcome, based on data from 771 adults. The findings were published in Annals of Internal Medicine on June 18.

Previous studies have shown that delirium can increase the rate of cognitive decline in AD patients, but the impact of hospitalization and delirium has not been well studied, said Dr. Tamara G. Fong of the Aging Brain Center, Boston, and her colleagues. Adults with Alzheimer’s disease (AD) are three times more likely to be hospitalized than are those without AD, the researchers noted.

To assess the adverse outcomes of death, institutionalization, and cognitive decline associated with hospitalization and delirium, Dr. Fong and her colleagues followed 771 community-dwelling adults aged 65 years and older with a clinical diagnosis of AD. The mean follow-up was 2 years, and outcomes were assessed at 1 year after an initial hospitalization. A total of 367 individuals (48%) were hospitalized, and 194 of these patients (25%) developed delirium while hospitalized (Ann. Intern. Med. 2012;156:848-56).

At least one adverse outcome occurred in 32% of nonhospitalized patients, 55% of hospitalized patients without delirium, and 79% of hospitalized patients with delirium.

In the hospitalized patients, 6% of deaths, 15% of institutionalizations, and 21% of cases of cognitive decline were associated with delirium, the researchers said.

Death occurred in 15% of hospitalized patients with delirium, compared with 9% of hospitalized patients without delirium and 2% of nonhospitalized patients.

The hospitalized patients with delirium had an increased risk for death, institutionalization, and cognitive decline, compared with the other groups, with adjusted risk ratios of 5.4, 9.3, and 1.6, respectively. Hospitalized patients with no delirium had a slightly smaller increase in the risk of death (adjusted risk ratio 4.7) and institutionalization (adjusted risk ratio 6.9).

The mean age of the patients was 77 years, 57% were women, and 95% were white.

The results were limited by several factors, including the observational nature of the study and the incomplete data on the cognitive outcome and functional status of some patients, the researchers wrote. But the findings show "the important and incremental associations of hospitalization and delirium with 1-year outcomes," they said.

Additional research is needed to determine whether preventing hospitalization and delirium in AD patients can reduce their risk for death, institutionalization, and cognitive decline, they noted.

Dr. Fong had no financial conflicts to disclose. The study was funded by the National Institute on Aging and the Massachusetts Alzheimer’s Disease Research Center.

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Approximately one in eight Alzheimer’s disease patients who develop delirium while hospitalized will suffer at least one adverse outcome, based on data from 771 adults. The findings were published in Annals of Internal Medicine on June 18.

Previous studies have shown that delirium can increase the rate of cognitive decline in AD patients, but the impact of hospitalization and delirium has not been well studied, said Dr. Tamara G. Fong of the Aging Brain Center, Boston, and her colleagues. Adults with Alzheimer’s disease (AD) are three times more likely to be hospitalized than are those without AD, the researchers noted.

To assess the adverse outcomes of death, institutionalization, and cognitive decline associated with hospitalization and delirium, Dr. Fong and her colleagues followed 771 community-dwelling adults aged 65 years and older with a clinical diagnosis of AD. The mean follow-up was 2 years, and outcomes were assessed at 1 year after an initial hospitalization. A total of 367 individuals (48%) were hospitalized, and 194 of these patients (25%) developed delirium while hospitalized (Ann. Intern. Med. 2012;156:848-56).

At least one adverse outcome occurred in 32% of nonhospitalized patients, 55% of hospitalized patients without delirium, and 79% of hospitalized patients with delirium.

In the hospitalized patients, 6% of deaths, 15% of institutionalizations, and 21% of cases of cognitive decline were associated with delirium, the researchers said.

Death occurred in 15% of hospitalized patients with delirium, compared with 9% of hospitalized patients without delirium and 2% of nonhospitalized patients.

The hospitalized patients with delirium had an increased risk for death, institutionalization, and cognitive decline, compared with the other groups, with adjusted risk ratios of 5.4, 9.3, and 1.6, respectively. Hospitalized patients with no delirium had a slightly smaller increase in the risk of death (adjusted risk ratio 4.7) and institutionalization (adjusted risk ratio 6.9).

The mean age of the patients was 77 years, 57% were women, and 95% were white.

The results were limited by several factors, including the observational nature of the study and the incomplete data on the cognitive outcome and functional status of some patients, the researchers wrote. But the findings show "the important and incremental associations of hospitalization and delirium with 1-year outcomes," they said.

Additional research is needed to determine whether preventing hospitalization and delirium in AD patients can reduce their risk for death, institutionalization, and cognitive decline, they noted.

Dr. Fong had no financial conflicts to disclose. The study was funded by the National Institute on Aging and the Massachusetts Alzheimer’s Disease Research Center.

Approximately one in eight Alzheimer’s disease patients who develop delirium while hospitalized will suffer at least one adverse outcome, based on data from 771 adults. The findings were published in Annals of Internal Medicine on June 18.

Previous studies have shown that delirium can increase the rate of cognitive decline in AD patients, but the impact of hospitalization and delirium has not been well studied, said Dr. Tamara G. Fong of the Aging Brain Center, Boston, and her colleagues. Adults with Alzheimer’s disease (AD) are three times more likely to be hospitalized than are those without AD, the researchers noted.

To assess the adverse outcomes of death, institutionalization, and cognitive decline associated with hospitalization and delirium, Dr. Fong and her colleagues followed 771 community-dwelling adults aged 65 years and older with a clinical diagnosis of AD. The mean follow-up was 2 years, and outcomes were assessed at 1 year after an initial hospitalization. A total of 367 individuals (48%) were hospitalized, and 194 of these patients (25%) developed delirium while hospitalized (Ann. Intern. Med. 2012;156:848-56).

At least one adverse outcome occurred in 32% of nonhospitalized patients, 55% of hospitalized patients without delirium, and 79% of hospitalized patients with delirium.

In the hospitalized patients, 6% of deaths, 15% of institutionalizations, and 21% of cases of cognitive decline were associated with delirium, the researchers said.

Death occurred in 15% of hospitalized patients with delirium, compared with 9% of hospitalized patients without delirium and 2% of nonhospitalized patients.

The hospitalized patients with delirium had an increased risk for death, institutionalization, and cognitive decline, compared with the other groups, with adjusted risk ratios of 5.4, 9.3, and 1.6, respectively. Hospitalized patients with no delirium had a slightly smaller increase in the risk of death (adjusted risk ratio 4.7) and institutionalization (adjusted risk ratio 6.9).

The mean age of the patients was 77 years, 57% were women, and 95% were white.

The results were limited by several factors, including the observational nature of the study and the incomplete data on the cognitive outcome and functional status of some patients, the researchers wrote. But the findings show "the important and incremental associations of hospitalization and delirium with 1-year outcomes," they said.

Additional research is needed to determine whether preventing hospitalization and delirium in AD patients can reduce their risk for death, institutionalization, and cognitive decline, they noted.

Dr. Fong had no financial conflicts to disclose. The study was funded by the National Institute on Aging and the Massachusetts Alzheimer’s Disease Research Center.

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Major Finding: Death occurred in 15% of hospitalized older Alzheimer’s patients with delirium, compared with hospitalized patients without delirium and 2% of nonhospitalized patients.

Data Source: The data come from a prospective cohort study of 771 adults aged 65 years and older with a clinical diagnosis of Alzheimer’s disease.

Disclosures: Dr. Fong had no financial conflicts to disclose. The study was funded by the National Institute on Aging and the Massachusetts Alzheimer’s Disease Research Center.

Telepsychiatry for Children Improved Symptoms, Halved ED Visits

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Telepsychiatry for Children Improved Symptoms, Halved ED Visits

A pilot telepsychiatry program for children significantly improved symptoms and cut emergency department visits in half, based on data from more than 8,000 patients over 2 years.

Health care costs will continue to rise, so new mechanisms are needed to combat the shortfalls in primary care medicine – including the limited number of child psychiatrists, said Alexander Vo, Ph.D., who presented the results in a webinar June 12.

"Telemedicine is the use of technology to deliver health care from a distance," said Dr. Vo of the University of Texas Medical Branch at Galveston. Faced with a shortage of pediatric psychiatrists in Texas and given a mandate to provide access to quality mental health and medical care, the University of Texas received a grant to develop pediatric psychiatry clinics for telemedicine.

"The goal of the project was to increase access to mental health care," Dr. Vo said. "Over a 2-year period we served approximately 8,000 patients with approximately 12,000 clinical appointments."

Then after the 2-year period, Dr. Vo and his colleagues surveyed 530 parents whose children were involved in the telemedicine program. Overall, 89% of the parents said the program made it easier for their children to receive services from a specialist, and more than 60% of parents reported dramatic improvements in their children’s functional behavior or symptoms.

One of the most striking findings was a 51% reduction in emergency department visits from baseline to the end of year 2, said Dr. Vo. "We effectively diverted these individuals from the [ED], and probably indicated that a lot of the [ED] use by this population was inappropriate," he said. "This is a very big finding for us."

In addition, 89% of the families said they would use telepsychiatry again in the future if it was available to them. "This speaks to the potential that using technology to deliver health care has; people want this kind of service if they are not able to go in person," he said.

Several factors crucial to the success of the project included establishing partnerships with existing community mental health centers where patients could go for their telemedicine visits. The project also involved establishing broadband internet access where needed. "That allowed us to have the ability to deliver quality care by providing expert guidance via real time consultation and monitoring," Dr. Vo said.

The program also involved the creation of a secure portal to share patient information among the different clinics, which had varying levels of technology for medical records, he said.

The take-home messages for clinicians are that telemedicine is a very viable medium for delivering care in psychiatry, it is accepted by patients, and it is effective for controlling costs, increasing access to care, and improving clinical outcomes, according to Dr. Vo.

"One of the hot topics is the use of in-home telemedicine," he added. Telemedicine from a patient’s home has the added advantages of convenience, privacy, and the avoidance of stigma, he said.

For providers who want to get into telemedicine, "this is an emerging market," he said. Potential barriers to expanding telepsychiatry include licensure and reimbursement issues. Specifically, providers may want to know whether they can still be paid at the same rate as an in-person visit, said Dr. Vo. Lack of broadband connectivity in some areas is a problem as well, he noted.

However, the findings from the University of Texas program suggest that telemedicine is here to stay. "Telemedicine transcends rural or geographic barriers," said Dr. Vo. In the future, telemedicine could expand to include telemonitoring of patients, especially those in urban areas who have mobile devices, he said.

The webinar was hosted by Internet Innovation Alliance (IIA) and Colorado Access, a nonprofit health plan that provides access to behavioral and physical health services. Dr. Vo had no financial conflicts to disclose.

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A pilot telepsychiatry program for children significantly improved symptoms and cut emergency department visits in half, based on data from more than 8,000 patients over 2 years.

Health care costs will continue to rise, so new mechanisms are needed to combat the shortfalls in primary care medicine – including the limited number of child psychiatrists, said Alexander Vo, Ph.D., who presented the results in a webinar June 12.

"Telemedicine is the use of technology to deliver health care from a distance," said Dr. Vo of the University of Texas Medical Branch at Galveston. Faced with a shortage of pediatric psychiatrists in Texas and given a mandate to provide access to quality mental health and medical care, the University of Texas received a grant to develop pediatric psychiatry clinics for telemedicine.

"The goal of the project was to increase access to mental health care," Dr. Vo said. "Over a 2-year period we served approximately 8,000 patients with approximately 12,000 clinical appointments."

Then after the 2-year period, Dr. Vo and his colleagues surveyed 530 parents whose children were involved in the telemedicine program. Overall, 89% of the parents said the program made it easier for their children to receive services from a specialist, and more than 60% of parents reported dramatic improvements in their children’s functional behavior or symptoms.

One of the most striking findings was a 51% reduction in emergency department visits from baseline to the end of year 2, said Dr. Vo. "We effectively diverted these individuals from the [ED], and probably indicated that a lot of the [ED] use by this population was inappropriate," he said. "This is a very big finding for us."

In addition, 89% of the families said they would use telepsychiatry again in the future if it was available to them. "This speaks to the potential that using technology to deliver health care has; people want this kind of service if they are not able to go in person," he said.

Several factors crucial to the success of the project included establishing partnerships with existing community mental health centers where patients could go for their telemedicine visits. The project also involved establishing broadband internet access where needed. "That allowed us to have the ability to deliver quality care by providing expert guidance via real time consultation and monitoring," Dr. Vo said.

The program also involved the creation of a secure portal to share patient information among the different clinics, which had varying levels of technology for medical records, he said.

The take-home messages for clinicians are that telemedicine is a very viable medium for delivering care in psychiatry, it is accepted by patients, and it is effective for controlling costs, increasing access to care, and improving clinical outcomes, according to Dr. Vo.

"One of the hot topics is the use of in-home telemedicine," he added. Telemedicine from a patient’s home has the added advantages of convenience, privacy, and the avoidance of stigma, he said.

For providers who want to get into telemedicine, "this is an emerging market," he said. Potential barriers to expanding telepsychiatry include licensure and reimbursement issues. Specifically, providers may want to know whether they can still be paid at the same rate as an in-person visit, said Dr. Vo. Lack of broadband connectivity in some areas is a problem as well, he noted.

However, the findings from the University of Texas program suggest that telemedicine is here to stay. "Telemedicine transcends rural or geographic barriers," said Dr. Vo. In the future, telemedicine could expand to include telemonitoring of patients, especially those in urban areas who have mobile devices, he said.

The webinar was hosted by Internet Innovation Alliance (IIA) and Colorado Access, a nonprofit health plan that provides access to behavioral and physical health services. Dr. Vo had no financial conflicts to disclose.

A pilot telepsychiatry program for children significantly improved symptoms and cut emergency department visits in half, based on data from more than 8,000 patients over 2 years.

Health care costs will continue to rise, so new mechanisms are needed to combat the shortfalls in primary care medicine – including the limited number of child psychiatrists, said Alexander Vo, Ph.D., who presented the results in a webinar June 12.

"Telemedicine is the use of technology to deliver health care from a distance," said Dr. Vo of the University of Texas Medical Branch at Galveston. Faced with a shortage of pediatric psychiatrists in Texas and given a mandate to provide access to quality mental health and medical care, the University of Texas received a grant to develop pediatric psychiatry clinics for telemedicine.

"The goal of the project was to increase access to mental health care," Dr. Vo said. "Over a 2-year period we served approximately 8,000 patients with approximately 12,000 clinical appointments."

Then after the 2-year period, Dr. Vo and his colleagues surveyed 530 parents whose children were involved in the telemedicine program. Overall, 89% of the parents said the program made it easier for their children to receive services from a specialist, and more than 60% of parents reported dramatic improvements in their children’s functional behavior or symptoms.

One of the most striking findings was a 51% reduction in emergency department visits from baseline to the end of year 2, said Dr. Vo. "We effectively diverted these individuals from the [ED], and probably indicated that a lot of the [ED] use by this population was inappropriate," he said. "This is a very big finding for us."

In addition, 89% of the families said they would use telepsychiatry again in the future if it was available to them. "This speaks to the potential that using technology to deliver health care has; people want this kind of service if they are not able to go in person," he said.

Several factors crucial to the success of the project included establishing partnerships with existing community mental health centers where patients could go for their telemedicine visits. The project also involved establishing broadband internet access where needed. "That allowed us to have the ability to deliver quality care by providing expert guidance via real time consultation and monitoring," Dr. Vo said.

The program also involved the creation of a secure portal to share patient information among the different clinics, which had varying levels of technology for medical records, he said.

The take-home messages for clinicians are that telemedicine is a very viable medium for delivering care in psychiatry, it is accepted by patients, and it is effective for controlling costs, increasing access to care, and improving clinical outcomes, according to Dr. Vo.

"One of the hot topics is the use of in-home telemedicine," he added. Telemedicine from a patient’s home has the added advantages of convenience, privacy, and the avoidance of stigma, he said.

For providers who want to get into telemedicine, "this is an emerging market," he said. Potential barriers to expanding telepsychiatry include licensure and reimbursement issues. Specifically, providers may want to know whether they can still be paid at the same rate as an in-person visit, said Dr. Vo. Lack of broadband connectivity in some areas is a problem as well, he noted.

However, the findings from the University of Texas program suggest that telemedicine is here to stay. "Telemedicine transcends rural or geographic barriers," said Dr. Vo. In the future, telemedicine could expand to include telemonitoring of patients, especially those in urban areas who have mobile devices, he said.

The webinar was hosted by Internet Innovation Alliance (IIA) and Colorado Access, a nonprofit health plan that provides access to behavioral and physical health services. Dr. Vo had no financial conflicts to disclose.

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Major Finding: Overall, 89% of the parents said the telepsychiatry program made it easier for their child to receive services from a specialist, and more than 60% reported dramatic improvements in the child’s functional behavior or symptoms.

Data Source: This study included more than 8,000 patients who had 12,000 appointments during a 2-year period; a total of 530 parents participated in a survey after their children received care.

Disclosures: The webinar was hosted by Internet Innovation Alliance and Colorado Access, a nonprofit health plan that provides access to behavioral and physical health services. Dr. Vo had no financial conflicts to disclose.

Pamphlet, Social Worker Phone Call Cut Postpartum Depression

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WASHINGTON – A two-part behavioral, educational intervention reduced rates of postpartum depression in black and Hispanic women by approximately one-third for up to 6 months, based on data from a randomized trial of 540 new mothers.

"The burden of postpartum depressive symptoms is especially high in low-income black and Latina women," Dr. Elizabeth Howell of Mount Sinai Medical Center in New York said.

Previous studies have suggested that factors such as poor social support, overload from the demands of daily life, and physical symptoms contribute to postpartum depression, she said at the annual meeting of the Society for Prevention Research.

In this study, Dr. Howell and her colleagues developed a behavioral, educational intervention to reduce postpartum depression in a high-risk population of minority women. The intervention included a 15-minute review of a patient-education booklet and partner summary sheet with a trained bilingual social worker before the women left the hospital. The second part of the intervention was a phone call from the social worker at 2 weeks post partum to assess the women’s symptoms, symptom management skills, and other issues. When needed, the social worker helped the 270 women in this group develop action plans to manage symptoms and access community resources. The findings also were published in the May issue of Obstetrics & Gynecology (2012;119:942-9).

"The burden of postpartum depressive symptoms is especially high in low-income black and Latina women," Dr. Elizabeth Howell said.

The educational pamphlet presented possible triggers of postpartum depression as normal elements of the postpartum experience, such as hair loss, bleeding, back pain, incision pain or episiotomy site pain, infant colic, and feeling sad or blue.

The 270 in the control group received a list of community resources instead of the detailed pamphlet, and a 2-week control phone call.

The study participants were evaluated for depression (defined as a score of 10 or greater on the Edinburgh Postnatal Depression Scale) before randomization and at 3 weeks, 3 months, and 6 months.

Overall, positive depression scores were significantly less common in the intervention group, compared with the controls, at 3 weeks (9% and 15%, respectively). Depression scores remained less common in the intervention group, compared with controls, at 3 months (8% vs. 13%) and 6 months (9% vs. 14%), although these differences did not reach statistical significance.

In an intent to treat analysis, mothers in the intervention group had a 33% reduced risk of screening positive for depression for up to 6 months post partum.

The mean age of the women was 28 years, 62% were Hispanic, and 41% were having their first child.

The study was limited by the relatively low rate of positive depressive symptoms, compared with data from other studies of high-risk minority women, the researchers noted. However, the results suggest that factors reported to contribute to postpartum depression can be addressed and modified.

"It is important to note that the effect during the first 6 months post partum would likely benefit the infant, mother, and family," they added.

Dr. Howell had no financial conflicts to disclose. The study was funded by the National Institutes of Health.

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WASHINGTON – A two-part behavioral, educational intervention reduced rates of postpartum depression in black and Hispanic women by approximately one-third for up to 6 months, based on data from a randomized trial of 540 new mothers.

"The burden of postpartum depressive symptoms is especially high in low-income black and Latina women," Dr. Elizabeth Howell of Mount Sinai Medical Center in New York said.

Previous studies have suggested that factors such as poor social support, overload from the demands of daily life, and physical symptoms contribute to postpartum depression, she said at the annual meeting of the Society for Prevention Research.

In this study, Dr. Howell and her colleagues developed a behavioral, educational intervention to reduce postpartum depression in a high-risk population of minority women. The intervention included a 15-minute review of a patient-education booklet and partner summary sheet with a trained bilingual social worker before the women left the hospital. The second part of the intervention was a phone call from the social worker at 2 weeks post partum to assess the women’s symptoms, symptom management skills, and other issues. When needed, the social worker helped the 270 women in this group develop action plans to manage symptoms and access community resources. The findings also were published in the May issue of Obstetrics & Gynecology (2012;119:942-9).

"The burden of postpartum depressive symptoms is especially high in low-income black and Latina women," Dr. Elizabeth Howell said.

The educational pamphlet presented possible triggers of postpartum depression as normal elements of the postpartum experience, such as hair loss, bleeding, back pain, incision pain or episiotomy site pain, infant colic, and feeling sad or blue.

The 270 in the control group received a list of community resources instead of the detailed pamphlet, and a 2-week control phone call.

The study participants were evaluated for depression (defined as a score of 10 or greater on the Edinburgh Postnatal Depression Scale) before randomization and at 3 weeks, 3 months, and 6 months.

Overall, positive depression scores were significantly less common in the intervention group, compared with the controls, at 3 weeks (9% and 15%, respectively). Depression scores remained less common in the intervention group, compared with controls, at 3 months (8% vs. 13%) and 6 months (9% vs. 14%), although these differences did not reach statistical significance.

In an intent to treat analysis, mothers in the intervention group had a 33% reduced risk of screening positive for depression for up to 6 months post partum.

The mean age of the women was 28 years, 62% were Hispanic, and 41% were having their first child.

The study was limited by the relatively low rate of positive depressive symptoms, compared with data from other studies of high-risk minority women, the researchers noted. However, the results suggest that factors reported to contribute to postpartum depression can be addressed and modified.

"It is important to note that the effect during the first 6 months post partum would likely benefit the infant, mother, and family," they added.

Dr. Howell had no financial conflicts to disclose. The study was funded by the National Institutes of Health.

WASHINGTON – A two-part behavioral, educational intervention reduced rates of postpartum depression in black and Hispanic women by approximately one-third for up to 6 months, based on data from a randomized trial of 540 new mothers.

"The burden of postpartum depressive symptoms is especially high in low-income black and Latina women," Dr. Elizabeth Howell of Mount Sinai Medical Center in New York said.

Previous studies have suggested that factors such as poor social support, overload from the demands of daily life, and physical symptoms contribute to postpartum depression, she said at the annual meeting of the Society for Prevention Research.

In this study, Dr. Howell and her colleagues developed a behavioral, educational intervention to reduce postpartum depression in a high-risk population of minority women. The intervention included a 15-minute review of a patient-education booklet and partner summary sheet with a trained bilingual social worker before the women left the hospital. The second part of the intervention was a phone call from the social worker at 2 weeks post partum to assess the women’s symptoms, symptom management skills, and other issues. When needed, the social worker helped the 270 women in this group develop action plans to manage symptoms and access community resources. The findings also were published in the May issue of Obstetrics & Gynecology (2012;119:942-9).

"The burden of postpartum depressive symptoms is especially high in low-income black and Latina women," Dr. Elizabeth Howell said.

The educational pamphlet presented possible triggers of postpartum depression as normal elements of the postpartum experience, such as hair loss, bleeding, back pain, incision pain or episiotomy site pain, infant colic, and feeling sad or blue.

The 270 in the control group received a list of community resources instead of the detailed pamphlet, and a 2-week control phone call.

The study participants were evaluated for depression (defined as a score of 10 or greater on the Edinburgh Postnatal Depression Scale) before randomization and at 3 weeks, 3 months, and 6 months.

Overall, positive depression scores were significantly less common in the intervention group, compared with the controls, at 3 weeks (9% and 15%, respectively). Depression scores remained less common in the intervention group, compared with controls, at 3 months (8% vs. 13%) and 6 months (9% vs. 14%), although these differences did not reach statistical significance.

In an intent to treat analysis, mothers in the intervention group had a 33% reduced risk of screening positive for depression for up to 6 months post partum.

The mean age of the women was 28 years, 62% were Hispanic, and 41% were having their first child.

The study was limited by the relatively low rate of positive depressive symptoms, compared with data from other studies of high-risk minority women, the researchers noted. However, the results suggest that factors reported to contribute to postpartum depression can be addressed and modified.

"It is important to note that the effect during the first 6 months post partum would likely benefit the infant, mother, and family," they added.

Dr. Howell had no financial conflicts to disclose. The study was funded by the National Institutes of Health.

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FROM THE ANNUAL MEETING OF THE SOCIETY FOR PREVENTION RESEARCH

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Inside the Article

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Major Finding: Women who received a two-part behavioral intervention had a 33% reduced risk of screening positive for postpartum depression for up to 6 months, compared with a control group.

Data Source: The data come from a randomized trial of 540 black and Hispanic women in New York.

Disclosures: Dr. Howell had no financial conflicts to disclose. The study was funded by the National Institutes of Health.

Ustekinumab Beats Placebo for Psoriatic Arthritis

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Ustekinumab at 45-mg and 90-mg doses significantly improved arthritis symptoms, physical function, and inflammation in adults with psoriatic arthritis, compared with placebo, after 24 weeks of treatment, according to findings presented by Dr. Iain B. McInnes at the annual European Congress of Rheumatology.

These findings come from the PSUMMIT I study, a multicenter, randomized trial of 615 patients. Participants were patients whose psoriatic arthritis (PsA) remained persistent, despite treatment with NSAIDS or disease-modifying antirheumatic drugs (DMARDs). They were randomized to 45 mg of ustekinumab, 90 mg of ustekinumab, or a placebo. Patients who had been treated with anti–tumor necrosis factor (anti-TNF) agents were excluded from the study.

Dr. Iain B. McInnes

After 24 weeks, approximately half of the patients in the 45 mg–dose (42%) and 90 mg–dose (50%) groups achieved an ACR 20 response (that is, a 20% improvement based on certain parameters specified by the American College of Rheumatology); the percentages for both groups were significantly greater than that of the placebo group (23%).

"These findings are in line with our expectations from the original phase II trial published a short number of years ago and with the success already enjoyed in using this medicine in treating the skin component of the psoriasis/psoriatic arthritis spectrum," said Dr. McInnes, director of the Institute for Infection, Inflammation, and Immunity at the University of Glascow (Scotland). The findings are also gratifying, he added. "There has been some evidence elsewhere to suggest that the cytokines that are targeted by ustekinumab might be of importance in psoriasis and psoriatic arthritis pathogenesis – these clinical data are compatible with those ideas," he noted.

Significantly more patients in both ustekinumab groups achieved ACR 50 and ACR 70 responses, compared with the placebo patients. In addition, ustekinumab patients had clinically meaningful changes from baseline Health Assessment Questionnaire Disability Index scores (defined as a change greater than or equal to 0.3), compared with placebo patients. Approximately twice as many patients in the two treatment groups demonstrated this change, compared with the placebo patients (48% vs. 28%, respectively).

The median change in enthesitis scores were 43% in the 45-mg ustekinumab group and 50% in the 90-mg ustekinumab group, compared with no change in the placebo group.

So far, no substantial differences in adverse events between the treatment and placebo groups have emerged, Dr. McInnes said in an interview. However, "this is a small trial – in comparison to the larger phase III and postmarketing datasets for this agent in the psoriasis field – and as such we need to be conservative in our interpretation of adverse events," he emphasized. "Continued vigilance will be the key here, and follow-up is ongoing," he said.

If the findings are confirmed in other studies, "we may be able to offer this agent to provide a new mode of action for the treatment of psoriatic arthritis, a disease for which we currently have too few options available," said Dr. McInnes. However, "it is too early to determine at which stage in the patient journey such use would be optimally employed," he said.

"It seems self-evident that use of ustekinumab would be after conventional drugs have been tried, and then, most likely it would be used after a TNF inhibitor because that has been the order of discovery. This reflects the RA treatment paradigm.

"But this might not be the best course; in fact, we might get similar results with different modes of action. So without head-to-head data we would make our decision based on the extent of safety data available. There is considerable safety evidence for ustekinumab in the skin literature; however, right now there is a challenge to work out where this drug will be used if it is marketed" said Dr. McInnes.

Approximately half of the patients were using methotrexate at baseline, but this did not impact the effect of ustekinumab vs. placebo.

Dr. McInnes reported financial support from Janssen Research and Development.

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Ustekinumab at 45-mg and 90-mg doses significantly improved arthritis symptoms, physical function, and inflammation in adults with psoriatic arthritis, compared with placebo, after 24 weeks of treatment, according to findings presented by Dr. Iain B. McInnes at the annual European Congress of Rheumatology.

These findings come from the PSUMMIT I study, a multicenter, randomized trial of 615 patients. Participants were patients whose psoriatic arthritis (PsA) remained persistent, despite treatment with NSAIDS or disease-modifying antirheumatic drugs (DMARDs). They were randomized to 45 mg of ustekinumab, 90 mg of ustekinumab, or a placebo. Patients who had been treated with anti–tumor necrosis factor (anti-TNF) agents were excluded from the study.

Dr. Iain B. McInnes

After 24 weeks, approximately half of the patients in the 45 mg–dose (42%) and 90 mg–dose (50%) groups achieved an ACR 20 response (that is, a 20% improvement based on certain parameters specified by the American College of Rheumatology); the percentages for both groups were significantly greater than that of the placebo group (23%).

"These findings are in line with our expectations from the original phase II trial published a short number of years ago and with the success already enjoyed in using this medicine in treating the skin component of the psoriasis/psoriatic arthritis spectrum," said Dr. McInnes, director of the Institute for Infection, Inflammation, and Immunity at the University of Glascow (Scotland). The findings are also gratifying, he added. "There has been some evidence elsewhere to suggest that the cytokines that are targeted by ustekinumab might be of importance in psoriasis and psoriatic arthritis pathogenesis – these clinical data are compatible with those ideas," he noted.

Significantly more patients in both ustekinumab groups achieved ACR 50 and ACR 70 responses, compared with the placebo patients. In addition, ustekinumab patients had clinically meaningful changes from baseline Health Assessment Questionnaire Disability Index scores (defined as a change greater than or equal to 0.3), compared with placebo patients. Approximately twice as many patients in the two treatment groups demonstrated this change, compared with the placebo patients (48% vs. 28%, respectively).

The median change in enthesitis scores were 43% in the 45-mg ustekinumab group and 50% in the 90-mg ustekinumab group, compared with no change in the placebo group.

So far, no substantial differences in adverse events between the treatment and placebo groups have emerged, Dr. McInnes said in an interview. However, "this is a small trial – in comparison to the larger phase III and postmarketing datasets for this agent in the psoriasis field – and as such we need to be conservative in our interpretation of adverse events," he emphasized. "Continued vigilance will be the key here, and follow-up is ongoing," he said.

If the findings are confirmed in other studies, "we may be able to offer this agent to provide a new mode of action for the treatment of psoriatic arthritis, a disease for which we currently have too few options available," said Dr. McInnes. However, "it is too early to determine at which stage in the patient journey such use would be optimally employed," he said.

"It seems self-evident that use of ustekinumab would be after conventional drugs have been tried, and then, most likely it would be used after a TNF inhibitor because that has been the order of discovery. This reflects the RA treatment paradigm.

"But this might not be the best course; in fact, we might get similar results with different modes of action. So without head-to-head data we would make our decision based on the extent of safety data available. There is considerable safety evidence for ustekinumab in the skin literature; however, right now there is a challenge to work out where this drug will be used if it is marketed" said Dr. McInnes.

Approximately half of the patients were using methotrexate at baseline, but this did not impact the effect of ustekinumab vs. placebo.

Dr. McInnes reported financial support from Janssen Research and Development.

Ustekinumab at 45-mg and 90-mg doses significantly improved arthritis symptoms, physical function, and inflammation in adults with psoriatic arthritis, compared with placebo, after 24 weeks of treatment, according to findings presented by Dr. Iain B. McInnes at the annual European Congress of Rheumatology.

These findings come from the PSUMMIT I study, a multicenter, randomized trial of 615 patients. Participants were patients whose psoriatic arthritis (PsA) remained persistent, despite treatment with NSAIDS or disease-modifying antirheumatic drugs (DMARDs). They were randomized to 45 mg of ustekinumab, 90 mg of ustekinumab, or a placebo. Patients who had been treated with anti–tumor necrosis factor (anti-TNF) agents were excluded from the study.

Dr. Iain B. McInnes

After 24 weeks, approximately half of the patients in the 45 mg–dose (42%) and 90 mg–dose (50%) groups achieved an ACR 20 response (that is, a 20% improvement based on certain parameters specified by the American College of Rheumatology); the percentages for both groups were significantly greater than that of the placebo group (23%).

"These findings are in line with our expectations from the original phase II trial published a short number of years ago and with the success already enjoyed in using this medicine in treating the skin component of the psoriasis/psoriatic arthritis spectrum," said Dr. McInnes, director of the Institute for Infection, Inflammation, and Immunity at the University of Glascow (Scotland). The findings are also gratifying, he added. "There has been some evidence elsewhere to suggest that the cytokines that are targeted by ustekinumab might be of importance in psoriasis and psoriatic arthritis pathogenesis – these clinical data are compatible with those ideas," he noted.

Significantly more patients in both ustekinumab groups achieved ACR 50 and ACR 70 responses, compared with the placebo patients. In addition, ustekinumab patients had clinically meaningful changes from baseline Health Assessment Questionnaire Disability Index scores (defined as a change greater than or equal to 0.3), compared with placebo patients. Approximately twice as many patients in the two treatment groups demonstrated this change, compared with the placebo patients (48% vs. 28%, respectively).

The median change in enthesitis scores were 43% in the 45-mg ustekinumab group and 50% in the 90-mg ustekinumab group, compared with no change in the placebo group.

So far, no substantial differences in adverse events between the treatment and placebo groups have emerged, Dr. McInnes said in an interview. However, "this is a small trial – in comparison to the larger phase III and postmarketing datasets for this agent in the psoriasis field – and as such we need to be conservative in our interpretation of adverse events," he emphasized. "Continued vigilance will be the key here, and follow-up is ongoing," he said.

If the findings are confirmed in other studies, "we may be able to offer this agent to provide a new mode of action for the treatment of psoriatic arthritis, a disease for which we currently have too few options available," said Dr. McInnes. However, "it is too early to determine at which stage in the patient journey such use would be optimally employed," he said.

"It seems self-evident that use of ustekinumab would be after conventional drugs have been tried, and then, most likely it would be used after a TNF inhibitor because that has been the order of discovery. This reflects the RA treatment paradigm.

"But this might not be the best course; in fact, we might get similar results with different modes of action. So without head-to-head data we would make our decision based on the extent of safety data available. There is considerable safety evidence for ustekinumab in the skin literature; however, right now there is a challenge to work out where this drug will be used if it is marketed" said Dr. McInnes.

Approximately half of the patients were using methotrexate at baseline, but this did not impact the effect of ustekinumab vs. placebo.

Dr. McInnes reported financial support from Janssen Research and Development.

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Ustekinumab Beats Placebo for Psoriatic Arthritis
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ustekinumab, psoriatic arthritis, Dr. Iain B. McInnes, EULAR, European Congress of Rheumatology, psa
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ustekinumab, psoriatic arthritis, Dr. Iain B. McInnes, EULAR, European Congress of Rheumatology, psa
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FROM THE ANNUAL EUROPEAN CONGRESS OF RHEUMATOLOGY

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Major Finding: Ustekinumab promoted an ACR 20 response in approximately half of psoriatic arthritis patients in the 45-mg (42%) and 90-mg (50%) treatment groups.

Data Source: The data come from the PSUMMIT I study, a randomized, double-blind, placebo-controlled, multicenter trial of 615 patients.

Disclosures: Dr. McInnes has received consulting fees from Janssen Research and Development LLC.

More Teens Wear Seat Belts, Yet Text While Driving

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More Teens Wear Seat Belts, Yet Text While Driving

Teen deaths due to car crashes dropped significantly over the past decade, owing to an improvement in risky behaviors such as not wearing a seat belt, according to data from the 2011 Youth Risk Behavior Surveillance System Survey.

"The most notable finding is this report is the significant reduction in the number of motor vehicle crashes, which are the leading cause of death among youth in the United States," Howell Wechsler, Ed.D., M.P.H., director of the Centers for Disease Control and Prevention’s Division of Adolescent and School Health, said in a telebriefing sponsored by the CDC on June 7.

In particular, the percentage of students who said they never or rarely wore seat belts dropped from 26% in 1991 to 8% in 2011, said Dr. Wechsler. In addition, the percentage of students who said they rode in a car with a drunk driver dropped from 40% to 24% between 1991 and 2011, and the percentage who said they had driven while drunk declined from 17% to 8% between 1997 and 2011.

"We would urge clinicians to ... give [their patients] good advice related to distracted driving and texting while driving."

Although these findings are encouraging, this year’s survey results also recognized the role of technology in creating new risky behaviors for teens by including questions about texting or emailing while driving, Dr. Wechsler said.

"For the first time, the use of technology is resulting in new risks," he said. Overall, 1 in 3 students said they had texted or emailed while driving within the past 30 days, and 1 in 6 students reported being the victims of cyberbullying during the past 12 months.

Texting or emailing while driving is especially dangerous, because it takes the drivers’ attention away from driving more often and for longer periods than other distractions, and inexperienced teen drivers are at increased risk for accidents resulting from inattention, Dr. Wechsler said.

"While we are pleased to see improvements in many behaviors related to motor vehicle crashes, naturally we are alarmed by some of the new findings, especially those involving distracted driving," Dr. Wechsler noted. The CDC is developing programs to improve and promote safe driving among teens, but health professionals have a role to play as well, he said.

"We would urge clinicians to counsel their patients and give them good advice related to distracted driving and texting while driving, and to also address the electronic bullying issue," he said.

Additional data from the survey showed no significant reduction in teen smoking and an increase in marijuana use since the last survey in 2009. Data for the Youth Risk Behavior Surveillance System Survey came from a nationally representative sample of more than 15,000 students in public and private high schools in the United States (MMWR 2012:61;SS-4).

Visit the CDC website for the complete report.

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Teen deaths due to car crashes dropped significantly over the past decade, owing to an improvement in risky behaviors such as not wearing a seat belt, according to data from the 2011 Youth Risk Behavior Surveillance System Survey.

"The most notable finding is this report is the significant reduction in the number of motor vehicle crashes, which are the leading cause of death among youth in the United States," Howell Wechsler, Ed.D., M.P.H., director of the Centers for Disease Control and Prevention’s Division of Adolescent and School Health, said in a telebriefing sponsored by the CDC on June 7.

In particular, the percentage of students who said they never or rarely wore seat belts dropped from 26% in 1991 to 8% in 2011, said Dr. Wechsler. In addition, the percentage of students who said they rode in a car with a drunk driver dropped from 40% to 24% between 1991 and 2011, and the percentage who said they had driven while drunk declined from 17% to 8% between 1997 and 2011.

"We would urge clinicians to ... give [their patients] good advice related to distracted driving and texting while driving."

Although these findings are encouraging, this year’s survey results also recognized the role of technology in creating new risky behaviors for teens by including questions about texting or emailing while driving, Dr. Wechsler said.

"For the first time, the use of technology is resulting in new risks," he said. Overall, 1 in 3 students said they had texted or emailed while driving within the past 30 days, and 1 in 6 students reported being the victims of cyberbullying during the past 12 months.

Texting or emailing while driving is especially dangerous, because it takes the drivers’ attention away from driving more often and for longer periods than other distractions, and inexperienced teen drivers are at increased risk for accidents resulting from inattention, Dr. Wechsler said.

"While we are pleased to see improvements in many behaviors related to motor vehicle crashes, naturally we are alarmed by some of the new findings, especially those involving distracted driving," Dr. Wechsler noted. The CDC is developing programs to improve and promote safe driving among teens, but health professionals have a role to play as well, he said.

"We would urge clinicians to counsel their patients and give them good advice related to distracted driving and texting while driving, and to also address the electronic bullying issue," he said.

Additional data from the survey showed no significant reduction in teen smoking and an increase in marijuana use since the last survey in 2009. Data for the Youth Risk Behavior Surveillance System Survey came from a nationally representative sample of more than 15,000 students in public and private high schools in the United States (MMWR 2012:61;SS-4).

Visit the CDC website for the complete report.

Teen deaths due to car crashes dropped significantly over the past decade, owing to an improvement in risky behaviors such as not wearing a seat belt, according to data from the 2011 Youth Risk Behavior Surveillance System Survey.

"The most notable finding is this report is the significant reduction in the number of motor vehicle crashes, which are the leading cause of death among youth in the United States," Howell Wechsler, Ed.D., M.P.H., director of the Centers for Disease Control and Prevention’s Division of Adolescent and School Health, said in a telebriefing sponsored by the CDC on June 7.

In particular, the percentage of students who said they never or rarely wore seat belts dropped from 26% in 1991 to 8% in 2011, said Dr. Wechsler. In addition, the percentage of students who said they rode in a car with a drunk driver dropped from 40% to 24% between 1991 and 2011, and the percentage who said they had driven while drunk declined from 17% to 8% between 1997 and 2011.

"We would urge clinicians to ... give [their patients] good advice related to distracted driving and texting while driving."

Although these findings are encouraging, this year’s survey results also recognized the role of technology in creating new risky behaviors for teens by including questions about texting or emailing while driving, Dr. Wechsler said.

"For the first time, the use of technology is resulting in new risks," he said. Overall, 1 in 3 students said they had texted or emailed while driving within the past 30 days, and 1 in 6 students reported being the victims of cyberbullying during the past 12 months.

Texting or emailing while driving is especially dangerous, because it takes the drivers’ attention away from driving more often and for longer periods than other distractions, and inexperienced teen drivers are at increased risk for accidents resulting from inattention, Dr. Wechsler said.

"While we are pleased to see improvements in many behaviors related to motor vehicle crashes, naturally we are alarmed by some of the new findings, especially those involving distracted driving," Dr. Wechsler noted. The CDC is developing programs to improve and promote safe driving among teens, but health professionals have a role to play as well, he said.

"We would urge clinicians to counsel their patients and give them good advice related to distracted driving and texting while driving, and to also address the electronic bullying issue," he said.

Additional data from the survey showed no significant reduction in teen smoking and an increase in marijuana use since the last survey in 2009. Data for the Youth Risk Behavior Surveillance System Survey came from a nationally representative sample of more than 15,000 students in public and private high schools in the United States (MMWR 2012:61;SS-4).

Visit the CDC website for the complete report.

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