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Beta-blockers curb death risk in patients with primary prevention ICD
ROME – Beta-blocker therapy reduces the risks of all-cause mortality as well as cardiac death in patients with a left ventricular ejection fraction below 35% who get an implantable cardioverter-defibrillator for primary prevention, Laurent Fauchier, MD, PhD, reported at the annual congress of the European Society of Cardiology.
Some physicians have recently urged reconsideration of current guidelines recommending routine use of beta-blockers for prevention of cardiovascular events in certain groups of patients with coronary artery disease, including those with chronic heart failure who have received an ICD for primary prevention of sudden death. And indeed it’s true that the now–relatively old randomized trials of ICDs for primary prevention in patients with chronic heart failure don’t provide any real evidence that beta-blockers reduce mortality in this setting. In fact, the guideline recommendation for beta-blockade has been based upon expert opinion. This was the impetus for Dr. Fauchier and coinvestigators to conduct a large retrospective observational study in a contemporary cohort of heart failure patients who received an ICD for primary prevention during a recent 10-year period at the 12 largest centers in France.
Fifteen percent of the 3,975 French ICD recipients did not receive a beta-blocker. They differed from those who did in that they were on average 2 years older, had an absolute 5% lower ejection fraction, and were more likely to also receive cardiac resynchronization therapy. Propensity score matching based on these and 19 other baseline characteristics enabled investigators to assemble a cohort of 541 closely matched patient pairs, explained Dr. Fauchier, professor of cardiology at Francois Rabelais University in Tours, France.
During a mean follow-up of 3.2 years, the risk of all-cause mortality in ICD recipients not on a beta-blocker was 34% higher than in those who were. Moreover, their risk of cardiac death was 50% greater.
In contrast, beta-blocker therapy had no effect on the risks of sudden death or of appropriate or inappropriate shocks.
The finding that beta-blocker therapy doesn’t prevent sudden death in patients with an ICD for primary prevention has not previously been reported. However, it makes sense. The device prevents such events so effectively that a beta-blocker adds nothing further in that regard, according to Dr. Fauchier.
“Beta-blockers should continue to be used widely, as currently recommended, for heart failure in the specific setting of patients with prophylactic ICD implantation. You do not have the benefit for prevention of sudden death, but you still have all the benefit from preventing cardiac death,” the electrophysiologist concluded.
This study was supported by French governmental research grants. Dr. Fauchier reported serving as a consultant to Bayer, Pfizer, Boehringer Ingelheim, Medtronic, and Novartis.
ROME – Beta-blocker therapy reduces the risks of all-cause mortality as well as cardiac death in patients with a left ventricular ejection fraction below 35% who get an implantable cardioverter-defibrillator for primary prevention, Laurent Fauchier, MD, PhD, reported at the annual congress of the European Society of Cardiology.
Some physicians have recently urged reconsideration of current guidelines recommending routine use of beta-blockers for prevention of cardiovascular events in certain groups of patients with coronary artery disease, including those with chronic heart failure who have received an ICD for primary prevention of sudden death. And indeed it’s true that the now–relatively old randomized trials of ICDs for primary prevention in patients with chronic heart failure don’t provide any real evidence that beta-blockers reduce mortality in this setting. In fact, the guideline recommendation for beta-blockade has been based upon expert opinion. This was the impetus for Dr. Fauchier and coinvestigators to conduct a large retrospective observational study in a contemporary cohort of heart failure patients who received an ICD for primary prevention during a recent 10-year period at the 12 largest centers in France.
Fifteen percent of the 3,975 French ICD recipients did not receive a beta-blocker. They differed from those who did in that they were on average 2 years older, had an absolute 5% lower ejection fraction, and were more likely to also receive cardiac resynchronization therapy. Propensity score matching based on these and 19 other baseline characteristics enabled investigators to assemble a cohort of 541 closely matched patient pairs, explained Dr. Fauchier, professor of cardiology at Francois Rabelais University in Tours, France.
During a mean follow-up of 3.2 years, the risk of all-cause mortality in ICD recipients not on a beta-blocker was 34% higher than in those who were. Moreover, their risk of cardiac death was 50% greater.
In contrast, beta-blocker therapy had no effect on the risks of sudden death or of appropriate or inappropriate shocks.
The finding that beta-blocker therapy doesn’t prevent sudden death in patients with an ICD for primary prevention has not previously been reported. However, it makes sense. The device prevents such events so effectively that a beta-blocker adds nothing further in that regard, according to Dr. Fauchier.
“Beta-blockers should continue to be used widely, as currently recommended, for heart failure in the specific setting of patients with prophylactic ICD implantation. You do not have the benefit for prevention of sudden death, but you still have all the benefit from preventing cardiac death,” the electrophysiologist concluded.
This study was supported by French governmental research grants. Dr. Fauchier reported serving as a consultant to Bayer, Pfizer, Boehringer Ingelheim, Medtronic, and Novartis.
ROME – Beta-blocker therapy reduces the risks of all-cause mortality as well as cardiac death in patients with a left ventricular ejection fraction below 35% who get an implantable cardioverter-defibrillator for primary prevention, Laurent Fauchier, MD, PhD, reported at the annual congress of the European Society of Cardiology.
Some physicians have recently urged reconsideration of current guidelines recommending routine use of beta-blockers for prevention of cardiovascular events in certain groups of patients with coronary artery disease, including those with chronic heart failure who have received an ICD for primary prevention of sudden death. And indeed it’s true that the now–relatively old randomized trials of ICDs for primary prevention in patients with chronic heart failure don’t provide any real evidence that beta-blockers reduce mortality in this setting. In fact, the guideline recommendation for beta-blockade has been based upon expert opinion. This was the impetus for Dr. Fauchier and coinvestigators to conduct a large retrospective observational study in a contemporary cohort of heart failure patients who received an ICD for primary prevention during a recent 10-year period at the 12 largest centers in France.
Fifteen percent of the 3,975 French ICD recipients did not receive a beta-blocker. They differed from those who did in that they were on average 2 years older, had an absolute 5% lower ejection fraction, and were more likely to also receive cardiac resynchronization therapy. Propensity score matching based on these and 19 other baseline characteristics enabled investigators to assemble a cohort of 541 closely matched patient pairs, explained Dr. Fauchier, professor of cardiology at Francois Rabelais University in Tours, France.
During a mean follow-up of 3.2 years, the risk of all-cause mortality in ICD recipients not on a beta-blocker was 34% higher than in those who were. Moreover, their risk of cardiac death was 50% greater.
In contrast, beta-blocker therapy had no effect on the risks of sudden death or of appropriate or inappropriate shocks.
The finding that beta-blocker therapy doesn’t prevent sudden death in patients with an ICD for primary prevention has not previously been reported. However, it makes sense. The device prevents such events so effectively that a beta-blocker adds nothing further in that regard, according to Dr. Fauchier.
“Beta-blockers should continue to be used widely, as currently recommended, for heart failure in the specific setting of patients with prophylactic ICD implantation. You do not have the benefit for prevention of sudden death, but you still have all the benefit from preventing cardiac death,” the electrophysiologist concluded.
This study was supported by French governmental research grants. Dr. Fauchier reported serving as a consultant to Bayer, Pfizer, Boehringer Ingelheim, Medtronic, and Novartis.
AT THE ESC CONGRESS 2016
Key clinical point:
Major finding: Patients with heart failure with reduced ejection fraction who received an ICD for primary prevention and were not on a beta-blocker were at an adjusted 50% increased risk for cardiac death and 34% increased risk for all-cause mortality during 3.2 years of follow-up, but they were at no increased risk for sudden death.
Data source: A retrospective observational study of all of the nearly 4,000 patients who received a primary prevention ICD at the 12 largest French centers during a recent 10-year period.
Disclosures: This study was supported by French governmental research funds. The presenter reported serving as a consultant to Bayer, Pfizer, Boehringer Ingelheim, Medtronic, and Novartis.
High-risk deliveries much more likely to be C-sections
Cesarean section rates for low-risk deliveries are 4.7 times lower than for deliveries that had a medical indication for the procedure listed in the record, according to the Agency for Healthcare Research and Quality.
The C-section rate for non–low-risk deliveries (deliveries with a medical indication that excluded them from the low-risk category) was 76.1% in 2013, compared with 16.2% for low-risk deliveries. Conversely, 23.9% of non–low-risk deliveries that year were performed vaginally, compared with 83.8% of low-risk deliveries, the AHRQ reported.
The AHRQ analysis combined a new definition of low-risk delivery developed by the Society for Maternal-Fetal Medicine (Am J Obstet Gynecol. 2016;214[2]:153-63) with data from the State Inpatient Databases of 43 states and the District of Columbia. This approach allowed AHRQ researchers to apply the new definition to actual counts of deliveries from 2,719 hospitals – representing 95% of the population – instead of national estimates based on a much smaller sample.
Cesarean section rates for low-risk deliveries are 4.7 times lower than for deliveries that had a medical indication for the procedure listed in the record, according to the Agency for Healthcare Research and Quality.
The C-section rate for non–low-risk deliveries (deliveries with a medical indication that excluded them from the low-risk category) was 76.1% in 2013, compared with 16.2% for low-risk deliveries. Conversely, 23.9% of non–low-risk deliveries that year were performed vaginally, compared with 83.8% of low-risk deliveries, the AHRQ reported.
The AHRQ analysis combined a new definition of low-risk delivery developed by the Society for Maternal-Fetal Medicine (Am J Obstet Gynecol. 2016;214[2]:153-63) with data from the State Inpatient Databases of 43 states and the District of Columbia. This approach allowed AHRQ researchers to apply the new definition to actual counts of deliveries from 2,719 hospitals – representing 95% of the population – instead of national estimates based on a much smaller sample.
Cesarean section rates for low-risk deliveries are 4.7 times lower than for deliveries that had a medical indication for the procedure listed in the record, according to the Agency for Healthcare Research and Quality.
The C-section rate for non–low-risk deliveries (deliveries with a medical indication that excluded them from the low-risk category) was 76.1% in 2013, compared with 16.2% for low-risk deliveries. Conversely, 23.9% of non–low-risk deliveries that year were performed vaginally, compared with 83.8% of low-risk deliveries, the AHRQ reported.
The AHRQ analysis combined a new definition of low-risk delivery developed by the Society for Maternal-Fetal Medicine (Am J Obstet Gynecol. 2016;214[2]:153-63) with data from the State Inpatient Databases of 43 states and the District of Columbia. This approach allowed AHRQ researchers to apply the new definition to actual counts of deliveries from 2,719 hospitals – representing 95% of the population – instead of national estimates based on a much smaller sample.
Health care workers at risk for mild MERS-CoV infections
Health care workers directly caring for patients with Middle East respiratory syndrome coronavirus (MERS-CoV) are more highly predisposed to contracting the virus, but in a milder form than that of their patients, thus making it difficult to diagnose and treat.
In a study published in Emerging Infectious Diseases, health care professionals (HCP) from the King Faisal Specialist Hospital and Research Centre in Riyadh, Saudi Arabia, were examined to determine their likelihood for getting MERS-CoV based on their proximity to patients who already had it. 
“Healthcare settings are important amplifiers of transmission,” explained the investigators, led by Basem M. Alraddadi, MD. “Current MERS-CoV infection control recommendations are based on experience with other viruses rather than on a complete understanding of the epidemiology of MERS-CoV transmission.”
Dr. Alraddadi and his coinvestigators identified 363 HCP, all of whom would be placed into one of three cohorts based on the department in which they worked most extensively: the Medical Intensive Care Unit (MICU), the emergency department (ED), and the neurology unit. A total of 292 HCP were ultimately enrolled in the study: 131 in MICU, 127 in ED, and 34 in neurology. After 9 subjects were excluded because of unavailability of serum specimens, 128 MICU, 122 ED, and 33 neurology unit workers remained.
While none of the neurology unit workers contracted the virus, 15 MICU workers (11.7%) and 5 ED workers (4.1%) did, for a total of 20 out of the 250 subjects in those two cohorts (8%). Radiology technicians were the most susceptible, as 5 of 17 (29.4%) got the virus, followed by 13 of 138 nurses (9.4%), 1 of 31 respiratory therapists (3.2%), and 1 of 41 physicians (2.4%).
“HCP who reported always covering their nose and mouth with either a medical mask or N95 respirator had lower risk for infection than did HCP reporting not always or never doing so, [while] those who reported always using N95 respirators for direct patient contact were less likely to be seropositive, a trend that approached statistical significance (P = .07),” the authors noted.
The most frequent symptoms reported by those surveyed were muscle pain, fevers, headaches, dry cough, and shortness of breath. In the 20-case HCP sample, however, 12 subjects (60%) only had mild illness while 3 (15%) were asymptomatic, making it very hard to diagnose and treat their infection. Three subjects (15%) had severe illness, while another two (10%) had moderate illness, meaning they were admitted to hospital but did not require any mechanical ventilation.
“Our study did not identify strong associations with underlying chronic illnesses, most likely because the prevalence of such conditions was low ([less than] 10%) in this population, [but] HCPs with a history of smoking had a risk for infection almost 3 times that of nonsmokers,” the authors wrote (Emerg Infect Dis. 2016 Nov. doi: 10.3201/eid2211.160920).
The Ministry of Health of Saudi Arabia and the Centers for Disease Control and Prevention funded the study. Dr. Alraddadi and his coauthors did not report any disclosures.
Health care workers directly caring for patients with Middle East respiratory syndrome coronavirus (MERS-CoV) are more highly predisposed to contracting the virus, but in a milder form than that of their patients, thus making it difficult to diagnose and treat.
In a study published in Emerging Infectious Diseases, health care professionals (HCP) from the King Faisal Specialist Hospital and Research Centre in Riyadh, Saudi Arabia, were examined to determine their likelihood for getting MERS-CoV based on their proximity to patients who already had it.
“Healthcare settings are important amplifiers of transmission,” explained the investigators, led by Basem M. Alraddadi, MD. “Current MERS-CoV infection control recommendations are based on experience with other viruses rather than on a complete understanding of the epidemiology of MERS-CoV transmission.”
Dr. Alraddadi and his coinvestigators identified 363 HCP, all of whom would be placed into one of three cohorts based on the department in which they worked most extensively: the Medical Intensive Care Unit (MICU), the emergency department (ED), and the neurology unit. A total of 292 HCP were ultimately enrolled in the study: 131 in MICU, 127 in ED, and 34 in neurology. After 9 subjects were excluded because of unavailability of serum specimens, 128 MICU, 122 ED, and 33 neurology unit workers remained.
While none of the neurology unit workers contracted the virus, 15 MICU workers (11.7%) and 5 ED workers (4.1%) did, for a total of 20 out of the 250 subjects in those two cohorts (8%). Radiology technicians were the most susceptible, as 5 of 17 (29.4%) got the virus, followed by 13 of 138 nurses (9.4%), 1 of 31 respiratory therapists (3.2%), and 1 of 41 physicians (2.4%).
“HCP who reported always covering their nose and mouth with either a medical mask or N95 respirator had lower risk for infection than did HCP reporting not always or never doing so, [while] those who reported always using N95 respirators for direct patient contact were less likely to be seropositive, a trend that approached statistical significance (P = .07),” the authors noted.
The most frequent symptoms reported by those surveyed were muscle pain, fevers, headaches, dry cough, and shortness of breath. In the 20-case HCP sample, however, 12 subjects (60%) only had mild illness while 3 (15%) were asymptomatic, making it very hard to diagnose and treat their infection. Three subjects (15%) had severe illness, while another two (10%) had moderate illness, meaning they were admitted to hospital but did not require any mechanical ventilation.
“Our study did not identify strong associations with underlying chronic illnesses, most likely because the prevalence of such conditions was low ([less than] 10%) in this population, [but] HCPs with a history of smoking had a risk for infection almost 3 times that of nonsmokers,” the authors wrote (Emerg Infect Dis. 2016 Nov. doi: 10.3201/eid2211.160920).
The Ministry of Health of Saudi Arabia and the Centers for Disease Control and Prevention funded the study. Dr. Alraddadi and his coauthors did not report any disclosures.
Health care workers directly caring for patients with Middle East respiratory syndrome coronavirus (MERS-CoV) are more highly predisposed to contracting the virus, but in a milder form than that of their patients, thus making it difficult to diagnose and treat.
In a study published in Emerging Infectious Diseases, health care professionals (HCP) from the King Faisal Specialist Hospital and Research Centre in Riyadh, Saudi Arabia, were examined to determine their likelihood for getting MERS-CoV based on their proximity to patients who already had it.
“Healthcare settings are important amplifiers of transmission,” explained the investigators, led by Basem M. Alraddadi, MD. “Current MERS-CoV infection control recommendations are based on experience with other viruses rather than on a complete understanding of the epidemiology of MERS-CoV transmission.”
Dr. Alraddadi and his coinvestigators identified 363 HCP, all of whom would be placed into one of three cohorts based on the department in which they worked most extensively: the Medical Intensive Care Unit (MICU), the emergency department (ED), and the neurology unit. A total of 292 HCP were ultimately enrolled in the study: 131 in MICU, 127 in ED, and 34 in neurology. After 9 subjects were excluded because of unavailability of serum specimens, 128 MICU, 122 ED, and 33 neurology unit workers remained.
While none of the neurology unit workers contracted the virus, 15 MICU workers (11.7%) and 5 ED workers (4.1%) did, for a total of 20 out of the 250 subjects in those two cohorts (8%). Radiology technicians were the most susceptible, as 5 of 17 (29.4%) got the virus, followed by 13 of 138 nurses (9.4%), 1 of 31 respiratory therapists (3.2%), and 1 of 41 physicians (2.4%).
“HCP who reported always covering their nose and mouth with either a medical mask or N95 respirator had lower risk for infection than did HCP reporting not always or never doing so, [while] those who reported always using N95 respirators for direct patient contact were less likely to be seropositive, a trend that approached statistical significance (P = .07),” the authors noted.
The most frequent symptoms reported by those surveyed were muscle pain, fevers, headaches, dry cough, and shortness of breath. In the 20-case HCP sample, however, 12 subjects (60%) only had mild illness while 3 (15%) were asymptomatic, making it very hard to diagnose and treat their infection. Three subjects (15%) had severe illness, while another two (10%) had moderate illness, meaning they were admitted to hospital but did not require any mechanical ventilation.
“Our study did not identify strong associations with underlying chronic illnesses, most likely because the prevalence of such conditions was low ([less than] 10%) in this population, [but] HCPs with a history of smoking had a risk for infection almost 3 times that of nonsmokers,” the authors wrote (Emerg Infect Dis. 2016 Nov. doi: 10.3201/eid2211.160920).
The Ministry of Health of Saudi Arabia and the Centers for Disease Control and Prevention funded the study. Dr. Alraddadi and his coauthors did not report any disclosures.
Key clinical point:
Major finding: Among workers who actually treated MERS-CoV patients, 20 out of 250 (8%) contracted the virus, while none of the clerical staff or patient transporters did.
Data source: Retrospective, single-center study of 363 health care personnel during May-June 2014.
Disclosures: The Ministry of Health of Saudi Arabia and the Centers for Disease Control and Prevention funded the study. The authors reported no financial disclosures.
Special Edition: Focus on ADHD
FALCON airs PFS edge for fulvestrant in ER+ breast cancer
COPENHAGEN – Fulvestrant continues to show superiority over anastrozole in treatment of hormone receptor-positive breast cancer, particularly in women with lower-volume disease, reported investigators in the phase III FALCON trial.
At a median follow-up of 25 months, median progression-free survival (PFS) for women assigned to receive the selective estrogen-receptor degrader fulvestrant (Faslodex) was 16.6 months, compared with 13.8 months for women assigned to receive the aromatase inhibitor anastrozole (Arimidex), reported Matthew J. Ellis, PhD, of the Lester and Sue Smith Breast Center at Baylor College of Medicine in Houston.
“These results are consistent with data from the FIRST study and confirm that fulvestrant is more efficacious than anastrozole in postmenopausal women with hormone receptor–positive locally advanced or metastatic breast cancer who have not received prior endocrine therapy,” he said at the European Society for Medical Oncology Congress.
The benefit of fulvestrant appeared to be only among patients who did not have visceral metastases, however.
In the FIRST study, results of which were reported at the San Antonio Breast Cancer Symposium in 2014, median overall survival at a median follow-up of 48.8 months was 54.1 months in patients on fulvestrant, vs. 48.4 months with anastrozole (hazard ratio [HR] 0.70, P = .04). The median PFS durations were 23.4 months vs. 13.1 months, respectively (HR 0.66, P = .01).
The FALCON (Fulvestrant and Anastrozole Compared in Hormonal Therapy-Naive Advanced Breast Cancer) trial was a phase III study designed to confirm the PFS benefit seen with fulvestrant in the earlier trial.
Postmenopausal women with locally advanced or metastatic breast cancer positive for the estrogen and/or progesterone receptor and negative for HER2 who had not previously received endocrine therapy were enrolled. They were randomly assigned to receive fulvestrant 500 mg intramuscularly on days 0, 14, and 28 then every 28 days plus an anastrozole placebo (232 patients), or oral anastrozole 1 mg daily plus fulvestrant placebo (230 patients).
Women with life-threatening visceral metastases, systemic estrogen-containing hormone replacement therapy within 6 months of randomization, or prior systemic treatment for breast cancer other than one line of chemotherapy or radiotherapy within 28 days of randomization (except radiation for control of bone pain) were excluded.
As noted, the primary endpoint of PFS was 16.6 months in the fulvestrant arm vs. 13.8 months in the anastrozole arm, translating into an HR for progression on fulvestrant of 0.797 (P = .0486).
Among the 208 patients with no visceral disease, median PFS with fulvestrant was 22.3 months, vs. 13.8 months (HR 0.59, P less than .01). In contrast, among the 254 patients with visceral disease, the respective median PFS durations were 13.8 and 15.9 months (nonsignificant).
For the secondary endpoint of overall survival, at 31% maturity (longest follow-up out to 39 months), there was no significant difference between the study arms.
There were also no significant differences in the secondary endpoints of overall response rate (among patients with measurable disease at baseline), clinical benefit rate, median duration of response, median duration of clinical benefit, or median time to deterioration of total score on the Functional Assessment of Cancer Therapy–Breast (FACT-B) patient-reported outcomes instrument.
Only estimated duration of response (11.4 vs. 7.5 months) and estimated duration of clinical benefit (21.9 vs. 17.5 months) were significantly better with fulvestrant (P less than .001 for each).
Grade 3 or greater adverse events occurred in 22.4% vs. 17.7%. Deaths from adverse events occurred in six patients on fulvestrant vs. seven on anastrozole. None of these deaths were considered to be related.
The FALCON results, which showed a benefit for fulvestrant only for those patients without visceral disease, point to a need for investigating whether patients with visceral metastases should receive other therapies, but this observation is hypothesis-generating only, said invited discussant Peter Schmid, MD, PhD, of Barts Cancer Institute at St. Bartholomew’s Hospital at Queen Mary University of London.
COPENHAGEN – Fulvestrant continues to show superiority over anastrozole in treatment of hormone receptor-positive breast cancer, particularly in women with lower-volume disease, reported investigators in the phase III FALCON trial.
At a median follow-up of 25 months, median progression-free survival (PFS) for women assigned to receive the selective estrogen-receptor degrader fulvestrant (Faslodex) was 16.6 months, compared with 13.8 months for women assigned to receive the aromatase inhibitor anastrozole (Arimidex), reported Matthew J. Ellis, PhD, of the Lester and Sue Smith Breast Center at Baylor College of Medicine in Houston.
“These results are consistent with data from the FIRST study and confirm that fulvestrant is more efficacious than anastrozole in postmenopausal women with hormone receptor–positive locally advanced or metastatic breast cancer who have not received prior endocrine therapy,” he said at the European Society for Medical Oncology Congress.
The benefit of fulvestrant appeared to be only among patients who did not have visceral metastases, however.
In the FIRST study, results of which were reported at the San Antonio Breast Cancer Symposium in 2014, median overall survival at a median follow-up of 48.8 months was 54.1 months in patients on fulvestrant, vs. 48.4 months with anastrozole (hazard ratio [HR] 0.70, P = .04). The median PFS durations were 23.4 months vs. 13.1 months, respectively (HR 0.66, P = .01).
The FALCON (Fulvestrant and Anastrozole Compared in Hormonal Therapy-Naive Advanced Breast Cancer) trial was a phase III study designed to confirm the PFS benefit seen with fulvestrant in the earlier trial.
Postmenopausal women with locally advanced or metastatic breast cancer positive for the estrogen and/or progesterone receptor and negative for HER2 who had not previously received endocrine therapy were enrolled. They were randomly assigned to receive fulvestrant 500 mg intramuscularly on days 0, 14, and 28 then every 28 days plus an anastrozole placebo (232 patients), or oral anastrozole 1 mg daily plus fulvestrant placebo (230 patients).
Women with life-threatening visceral metastases, systemic estrogen-containing hormone replacement therapy within 6 months of randomization, or prior systemic treatment for breast cancer other than one line of chemotherapy or radiotherapy within 28 days of randomization (except radiation for control of bone pain) were excluded.
As noted, the primary endpoint of PFS was 16.6 months in the fulvestrant arm vs. 13.8 months in the anastrozole arm, translating into an HR for progression on fulvestrant of 0.797 (P = .0486).
Among the 208 patients with no visceral disease, median PFS with fulvestrant was 22.3 months, vs. 13.8 months (HR 0.59, P less than .01). In contrast, among the 254 patients with visceral disease, the respective median PFS durations were 13.8 and 15.9 months (nonsignificant).
For the secondary endpoint of overall survival, at 31% maturity (longest follow-up out to 39 months), there was no significant difference between the study arms.
There were also no significant differences in the secondary endpoints of overall response rate (among patients with measurable disease at baseline), clinical benefit rate, median duration of response, median duration of clinical benefit, or median time to deterioration of total score on the Functional Assessment of Cancer Therapy–Breast (FACT-B) patient-reported outcomes instrument.
Only estimated duration of response (11.4 vs. 7.5 months) and estimated duration of clinical benefit (21.9 vs. 17.5 months) were significantly better with fulvestrant (P less than .001 for each).
Grade 3 or greater adverse events occurred in 22.4% vs. 17.7%. Deaths from adverse events occurred in six patients on fulvestrant vs. seven on anastrozole. None of these deaths were considered to be related.
The FALCON results, which showed a benefit for fulvestrant only for those patients without visceral disease, point to a need for investigating whether patients with visceral metastases should receive other therapies, but this observation is hypothesis-generating only, said invited discussant Peter Schmid, MD, PhD, of Barts Cancer Institute at St. Bartholomew’s Hospital at Queen Mary University of London.
COPENHAGEN – Fulvestrant continues to show superiority over anastrozole in treatment of hormone receptor-positive breast cancer, particularly in women with lower-volume disease, reported investigators in the phase III FALCON trial.
At a median follow-up of 25 months, median progression-free survival (PFS) for women assigned to receive the selective estrogen-receptor degrader fulvestrant (Faslodex) was 16.6 months, compared with 13.8 months for women assigned to receive the aromatase inhibitor anastrozole (Arimidex), reported Matthew J. Ellis, PhD, of the Lester and Sue Smith Breast Center at Baylor College of Medicine in Houston.
“These results are consistent with data from the FIRST study and confirm that fulvestrant is more efficacious than anastrozole in postmenopausal women with hormone receptor–positive locally advanced or metastatic breast cancer who have not received prior endocrine therapy,” he said at the European Society for Medical Oncology Congress.
The benefit of fulvestrant appeared to be only among patients who did not have visceral metastases, however.
In the FIRST study, results of which were reported at the San Antonio Breast Cancer Symposium in 2014, median overall survival at a median follow-up of 48.8 months was 54.1 months in patients on fulvestrant, vs. 48.4 months with anastrozole (hazard ratio [HR] 0.70, P = .04). The median PFS durations were 23.4 months vs. 13.1 months, respectively (HR 0.66, P = .01).
The FALCON (Fulvestrant and Anastrozole Compared in Hormonal Therapy-Naive Advanced Breast Cancer) trial was a phase III study designed to confirm the PFS benefit seen with fulvestrant in the earlier trial.
Postmenopausal women with locally advanced or metastatic breast cancer positive for the estrogen and/or progesterone receptor and negative for HER2 who had not previously received endocrine therapy were enrolled. They were randomly assigned to receive fulvestrant 500 mg intramuscularly on days 0, 14, and 28 then every 28 days plus an anastrozole placebo (232 patients), or oral anastrozole 1 mg daily plus fulvestrant placebo (230 patients).
Women with life-threatening visceral metastases, systemic estrogen-containing hormone replacement therapy within 6 months of randomization, or prior systemic treatment for breast cancer other than one line of chemotherapy or radiotherapy within 28 days of randomization (except radiation for control of bone pain) were excluded.
As noted, the primary endpoint of PFS was 16.6 months in the fulvestrant arm vs. 13.8 months in the anastrozole arm, translating into an HR for progression on fulvestrant of 0.797 (P = .0486).
Among the 208 patients with no visceral disease, median PFS with fulvestrant was 22.3 months, vs. 13.8 months (HR 0.59, P less than .01). In contrast, among the 254 patients with visceral disease, the respective median PFS durations were 13.8 and 15.9 months (nonsignificant).
For the secondary endpoint of overall survival, at 31% maturity (longest follow-up out to 39 months), there was no significant difference between the study arms.
There were also no significant differences in the secondary endpoints of overall response rate (among patients with measurable disease at baseline), clinical benefit rate, median duration of response, median duration of clinical benefit, or median time to deterioration of total score on the Functional Assessment of Cancer Therapy–Breast (FACT-B) patient-reported outcomes instrument.
Only estimated duration of response (11.4 vs. 7.5 months) and estimated duration of clinical benefit (21.9 vs. 17.5 months) were significantly better with fulvestrant (P less than .001 for each).
Grade 3 or greater adverse events occurred in 22.4% vs. 17.7%. Deaths from adverse events occurred in six patients on fulvestrant vs. seven on anastrozole. None of these deaths were considered to be related.
The FALCON results, which showed a benefit for fulvestrant only for those patients without visceral disease, point to a need for investigating whether patients with visceral metastases should receive other therapies, but this observation is hypothesis-generating only, said invited discussant Peter Schmid, MD, PhD, of Barts Cancer Institute at St. Bartholomew’s Hospital at Queen Mary University of London.
AT ESMO 2016
Key clinical point: The selective estrogen receptor degrader fulvestrant continues to offer improved progression-free survival (PFS) compared with the aromatase inhibitor anastrozole.
Major finding: At a median 25 months’ follow-up, median PFS was 16.6 months for fulvestrant vs. 13.8 months for anastrozole.
Data source: Randomized phase III trial of 462 women with endocrine therapy–naive locally advanced metastatic hormone receptor–positive breast cancer.
Disclosures: FALCON was sponsored by AstraZeneca. Dr. Ellis reported consulting for AstraZeneca, and Dr. Schmid reported honoraria or consultation fees from the company.
Missed Adult Vaccines Cost U.S. Nearly $9 Billion in 2015
Just how important are adult vaccines? According to a new study from Health Affairs missed vaccines cost the U.S. economy $8.95 billion in 2015. “This review not only estimated the direct costs and productivity losses due to inpatient and outpatient visits associated with vaccine-preventable diseases…but [it also] examined this across all vaccines recommended for US adults,” authors Sachiko Ozawa, Allison Portnoy, Hiwote Getaneh, Samantha Clark, Maria Knoll, David Bishai, H. Keri Yang, and Pallavi D. Patwardhan explained.
“Low rates of vaccine uptake lead to costs to individuals and society in terms of deaths and disabilities, which are avoidable, and they create economic losses from doctor visits, hospitalizations, and lost income,” the authors argued. “To identify the magnitude of this problem, we calculated the current economic burden that is attributable to vaccine-preventable diseases among US adults.
Not surprisingly, preventable influenza exacted the highest cost, estimated to be $5.8 billion. Pneumococcal disease was second, with an estimated cost of $1.9 billion, followed by herpes zoster ($782 million), human papillomavirus, and hepatitis B ($173 million).
Researchers were from University of North Carolina at Chapel Hill, Harvard T. H. Chan School of Public Health, in Boston, Massachusetts, MRDC in New York City, Johns Hopkins Bloomberg School of Public Health, in Baltimore, Maryland, and Merck. This study was funded by Merck. The study “highlights the need for US adults to better appreciate the value of vaccines to prevent economic burden,” they said.
Just how important are adult vaccines? According to a new study from Health Affairs missed vaccines cost the U.S. economy $8.95 billion in 2015. “This review not only estimated the direct costs and productivity losses due to inpatient and outpatient visits associated with vaccine-preventable diseases…but [it also] examined this across all vaccines recommended for US adults,” authors Sachiko Ozawa, Allison Portnoy, Hiwote Getaneh, Samantha Clark, Maria Knoll, David Bishai, H. Keri Yang, and Pallavi D. Patwardhan explained.
“Low rates of vaccine uptake lead to costs to individuals and society in terms of deaths and disabilities, which are avoidable, and they create economic losses from doctor visits, hospitalizations, and lost income,” the authors argued. “To identify the magnitude of this problem, we calculated the current economic burden that is attributable to vaccine-preventable diseases among US adults.
Not surprisingly, preventable influenza exacted the highest cost, estimated to be $5.8 billion. Pneumococcal disease was second, with an estimated cost of $1.9 billion, followed by herpes zoster ($782 million), human papillomavirus, and hepatitis B ($173 million).
Researchers were from University of North Carolina at Chapel Hill, Harvard T. H. Chan School of Public Health, in Boston, Massachusetts, MRDC in New York City, Johns Hopkins Bloomberg School of Public Health, in Baltimore, Maryland, and Merck. This study was funded by Merck. The study “highlights the need for US adults to better appreciate the value of vaccines to prevent economic burden,” they said.
Just how important are adult vaccines? According to a new study from Health Affairs missed vaccines cost the U.S. economy $8.95 billion in 2015. “This review not only estimated the direct costs and productivity losses due to inpatient and outpatient visits associated with vaccine-preventable diseases…but [it also] examined this across all vaccines recommended for US adults,” authors Sachiko Ozawa, Allison Portnoy, Hiwote Getaneh, Samantha Clark, Maria Knoll, David Bishai, H. Keri Yang, and Pallavi D. Patwardhan explained.
“Low rates of vaccine uptake lead to costs to individuals and society in terms of deaths and disabilities, which are avoidable, and they create economic losses from doctor visits, hospitalizations, and lost income,” the authors argued. “To identify the magnitude of this problem, we calculated the current economic burden that is attributable to vaccine-preventable diseases among US adults.
Not surprisingly, preventable influenza exacted the highest cost, estimated to be $5.8 billion. Pneumococcal disease was second, with an estimated cost of $1.9 billion, followed by herpes zoster ($782 million), human papillomavirus, and hepatitis B ($173 million).
Researchers were from University of North Carolina at Chapel Hill, Harvard T. H. Chan School of Public Health, in Boston, Massachusetts, MRDC in New York City, Johns Hopkins Bloomberg School of Public Health, in Baltimore, Maryland, and Merck. This study was funded by Merck. The study “highlights the need for US adults to better appreciate the value of vaccines to prevent economic burden,” they said.
Earlier ischemic stroke presentation may sometimes mean delayed tPA
BALTIMORE – Going to the hospital soon after the development of symptoms of acute ischemic stroke may not guarantee quick treatment.
A study of 1,865 patients treated within the past decade at a large urban comprehensive stroke center has revealed delayed treatment with tissue plasminogen activator, compared with patients who came to the emergency room hours after symptom development, Dr. Kyle C. Rossi said at the annual meeting of the American Neurological Association.
Treatment with tissue plasminogen activator (tPA) within 3 hours after the first symptoms of acute ischemic stroke definitely improves long-term outcomes, but meeting this target time remains a challenge. Patients who present to the emergency room soon after symptom development would seemingly have an advantage, yet Dr. Rossi’s preliminary scrutiny of patient records at Mount Sinai raised doubts about this and prompted the present study.
The hypothesis was that cases with a shorter time between symptom development and diagnosis of stroke (last known well-to-stroke code time, or LKW-to-code) will have a longer time between diagnosis and tPA administration (code-to-tPA), “possibly due to the perception on the part of evaluating physicians of sufficient remaining time before the end of the tPA window.”
The researchers examined patient records from the American Heart Association/American Stroke Association’s “Get with the Guidelines” stroke program, a voluntary observational registry for patients with acute stroke. Of the 1,865 ischemic stroke patients treated during 2009-2015, 122 who received intravenous tPA were allocated to three LKW-to-code groups: within an hour (38 patients), within the next hour (49 patients), or 2 hours or more (35 patients).
The patients tended to be in their late 60s. Just over half were female, and about 40% were white.
Overall, the average LKW-to-code time was 91 ± 48 minutes and the average code-to-tPA time was 67 ± 26 minutes.
Average code-to-tPA times were 80, 67, and 52 minutes, respectively, for the three groups (P less than .0001). On average, it took 28 minutes longer to give tPA to patients who presented within an hour than to patients presenting 2 hours or longer after their first stroke symptom. There was an increase in code-to-tPA time of 1 minute for every decrease in LKW-to-code time of 4 minutes (P less than .0001).
The delay in the time to treat patients who arrive sooner after development of stroke symptoms may result from a decision made by the evaluating neurologist to conduct additional testing prior to administering tPA. Sometimes other staff may be unaware of the decision to delay treatment, according to Dr. Rossi and his colleagues.
“Absolutely, folks coming in soon after symptoms develop should be treated early. But treatment needs to balance rapid delivery with adequate testing. Sometimes, when there is some time to spare before the optimum treatment window closes we can do a more thorough examination and address lingering questions,” Dr. Rossi said.
The decision to get more information about the patient’s condition reflects the goal to give tPA as soon as safely possible to the right patients. While laudable, the study highlights that the timing of treatment can be improved.
Dr. Rossi reported having no financial disclosures.
BALTIMORE – Going to the hospital soon after the development of symptoms of acute ischemic stroke may not guarantee quick treatment.
A study of 1,865 patients treated within the past decade at a large urban comprehensive stroke center has revealed delayed treatment with tissue plasminogen activator, compared with patients who came to the emergency room hours after symptom development, Dr. Kyle C. Rossi said at the annual meeting of the American Neurological Association.
Treatment with tissue plasminogen activator (tPA) within 3 hours after the first symptoms of acute ischemic stroke definitely improves long-term outcomes, but meeting this target time remains a challenge. Patients who present to the emergency room soon after symptom development would seemingly have an advantage, yet Dr. Rossi’s preliminary scrutiny of patient records at Mount Sinai raised doubts about this and prompted the present study.
The hypothesis was that cases with a shorter time between symptom development and diagnosis of stroke (last known well-to-stroke code time, or LKW-to-code) will have a longer time between diagnosis and tPA administration (code-to-tPA), “possibly due to the perception on the part of evaluating physicians of sufficient remaining time before the end of the tPA window.”
The researchers examined patient records from the American Heart Association/American Stroke Association’s “Get with the Guidelines” stroke program, a voluntary observational registry for patients with acute stroke. Of the 1,865 ischemic stroke patients treated during 2009-2015, 122 who received intravenous tPA were allocated to three LKW-to-code groups: within an hour (38 patients), within the next hour (49 patients), or 2 hours or more (35 patients).
The patients tended to be in their late 60s. Just over half were female, and about 40% were white.
Overall, the average LKW-to-code time was 91 ± 48 minutes and the average code-to-tPA time was 67 ± 26 minutes.
Average code-to-tPA times were 80, 67, and 52 minutes, respectively, for the three groups (P less than .0001). On average, it took 28 minutes longer to give tPA to patients who presented within an hour than to patients presenting 2 hours or longer after their first stroke symptom. There was an increase in code-to-tPA time of 1 minute for every decrease in LKW-to-code time of 4 minutes (P less than .0001).
The delay in the time to treat patients who arrive sooner after development of stroke symptoms may result from a decision made by the evaluating neurologist to conduct additional testing prior to administering tPA. Sometimes other staff may be unaware of the decision to delay treatment, according to Dr. Rossi and his colleagues.
“Absolutely, folks coming in soon after symptoms develop should be treated early. But treatment needs to balance rapid delivery with adequate testing. Sometimes, when there is some time to spare before the optimum treatment window closes we can do a more thorough examination and address lingering questions,” Dr. Rossi said.
The decision to get more information about the patient’s condition reflects the goal to give tPA as soon as safely possible to the right patients. While laudable, the study highlights that the timing of treatment can be improved.
Dr. Rossi reported having no financial disclosures.
BALTIMORE – Going to the hospital soon after the development of symptoms of acute ischemic stroke may not guarantee quick treatment.
A study of 1,865 patients treated within the past decade at a large urban comprehensive stroke center has revealed delayed treatment with tissue plasminogen activator, compared with patients who came to the emergency room hours after symptom development, Dr. Kyle C. Rossi said at the annual meeting of the American Neurological Association.
Treatment with tissue plasminogen activator (tPA) within 3 hours after the first symptoms of acute ischemic stroke definitely improves long-term outcomes, but meeting this target time remains a challenge. Patients who present to the emergency room soon after symptom development would seemingly have an advantage, yet Dr. Rossi’s preliminary scrutiny of patient records at Mount Sinai raised doubts about this and prompted the present study.
The hypothesis was that cases with a shorter time between symptom development and diagnosis of stroke (last known well-to-stroke code time, or LKW-to-code) will have a longer time between diagnosis and tPA administration (code-to-tPA), “possibly due to the perception on the part of evaluating physicians of sufficient remaining time before the end of the tPA window.”
The researchers examined patient records from the American Heart Association/American Stroke Association’s “Get with the Guidelines” stroke program, a voluntary observational registry for patients with acute stroke. Of the 1,865 ischemic stroke patients treated during 2009-2015, 122 who received intravenous tPA were allocated to three LKW-to-code groups: within an hour (38 patients), within the next hour (49 patients), or 2 hours or more (35 patients).
The patients tended to be in their late 60s. Just over half were female, and about 40% were white.
Overall, the average LKW-to-code time was 91 ± 48 minutes and the average code-to-tPA time was 67 ± 26 minutes.
Average code-to-tPA times were 80, 67, and 52 minutes, respectively, for the three groups (P less than .0001). On average, it took 28 minutes longer to give tPA to patients who presented within an hour than to patients presenting 2 hours or longer after their first stroke symptom. There was an increase in code-to-tPA time of 1 minute for every decrease in LKW-to-code time of 4 minutes (P less than .0001).
The delay in the time to treat patients who arrive sooner after development of stroke symptoms may result from a decision made by the evaluating neurologist to conduct additional testing prior to administering tPA. Sometimes other staff may be unaware of the decision to delay treatment, according to Dr. Rossi and his colleagues.
“Absolutely, folks coming in soon after symptoms develop should be treated early. But treatment needs to balance rapid delivery with adequate testing. Sometimes, when there is some time to spare before the optimum treatment window closes we can do a more thorough examination and address lingering questions,” Dr. Rossi said.
The decision to get more information about the patient’s condition reflects the goal to give tPA as soon as safely possible to the right patients. While laudable, the study highlights that the timing of treatment can be improved.
Dr. Rossi reported having no financial disclosures.
AT ANA 2016
Key clinical point:
Major finding: TPA was delivered 28 minutes longer on average for patients presenting less than 1 hour after stroke symptoms, compared with patients presenting more than 2 hours after.
Data source: Analysis of 1,865 patients with acute ischemic stroke in the American Heart Association/American Stroke Association’s “Get with the Guidelines” stroke program who were diagnosed at Mount Sinai Hospital in New York.
Disclosures: Dr. Rossi reported having no financial disclosures.
Novel Messenger RNA Vaccine in Development for Zika
A novel anti-Zika vaccine based on messenger RNA (mRNA) technology received financial backing from HHS. Moderna Therapeutics, Cambridge, Massachusetts, will get $8.2 million to accelerate the development of the vaccine.
Messenger RNA carries specific genetic codes to parts of the cell. The vaccine uses mRNA containing the genetic sequence of the Zika virus to generate an immune response.
This technology produces vaccine faster than other methods, which require the growth and purification of an attenuated or inactivated virus, HHS says. Moderna also is designing the vaccine to be easy to administer by not requiring any specialized delivery devices.
Under the initial 4-year agreement, HHS’ Biomedical Advanced Research and Development Authority (BARDA) will support a phase 1 clinical trial, toxicology studies, vaccine formulation, and manufacturing. If additional funding is identified the agreement could be extended to 5 years, with a total of $125.5 million to cover phase 2 and 3 clinical trials and large-scale manufacturing.
The funding is part of an obligated $85 million BARDA “reprogrammed” for Zika work. The funds are also being used to develop other Zika vaccines, blood screening tests, and pathogen reduction technologies.
A novel anti-Zika vaccine based on messenger RNA (mRNA) technology received financial backing from HHS. Moderna Therapeutics, Cambridge, Massachusetts, will get $8.2 million to accelerate the development of the vaccine.
Messenger RNA carries specific genetic codes to parts of the cell. The vaccine uses mRNA containing the genetic sequence of the Zika virus to generate an immune response.
This technology produces vaccine faster than other methods, which require the growth and purification of an attenuated or inactivated virus, HHS says. Moderna also is designing the vaccine to be easy to administer by not requiring any specialized delivery devices.
Under the initial 4-year agreement, HHS’ Biomedical Advanced Research and Development Authority (BARDA) will support a phase 1 clinical trial, toxicology studies, vaccine formulation, and manufacturing. If additional funding is identified the agreement could be extended to 5 years, with a total of $125.5 million to cover phase 2 and 3 clinical trials and large-scale manufacturing.
The funding is part of an obligated $85 million BARDA “reprogrammed” for Zika work. The funds are also being used to develop other Zika vaccines, blood screening tests, and pathogen reduction technologies.
A novel anti-Zika vaccine based on messenger RNA (mRNA) technology received financial backing from HHS. Moderna Therapeutics, Cambridge, Massachusetts, will get $8.2 million to accelerate the development of the vaccine.
Messenger RNA carries specific genetic codes to parts of the cell. The vaccine uses mRNA containing the genetic sequence of the Zika virus to generate an immune response.
This technology produces vaccine faster than other methods, which require the growth and purification of an attenuated or inactivated virus, HHS says. Moderna also is designing the vaccine to be easy to administer by not requiring any specialized delivery devices.
Under the initial 4-year agreement, HHS’ Biomedical Advanced Research and Development Authority (BARDA) will support a phase 1 clinical trial, toxicology studies, vaccine formulation, and manufacturing. If additional funding is identified the agreement could be extended to 5 years, with a total of $125.5 million to cover phase 2 and 3 clinical trials and large-scale manufacturing.
The funding is part of an obligated $85 million BARDA “reprogrammed” for Zika work. The funds are also being used to develop other Zika vaccines, blood screening tests, and pathogen reduction technologies.
Psychiatric patients face inordinately long wait times in emergency departments
Individuals with psychiatric conditions are facing increasingly longer wait times in emergency departments across the country, including children, according to a pair of studies presented by the American College of Emergency Physicians.
“I really started doing this research because of my clinical experience,” explained Suzanne Catherine Lippert, MD, of Stanford (Calif.) University and the lead author of both studies during an Oct. 17 conference call, saying that seeing patients sit in the ED for days prompted her to finally look into this issue.
Patients with bipolar disorder had the highest likelihood of waiting more than 24 hours in the ED, with an odds ratio of 3.7 (95% confidence interval, 1.5-9.4). This was followed by patients with a diagnosis of psychosis, a dual diagnosis of psychiatric disorders, multiple psychiatric diagnoses, or depression. The most common diagnoses were substance abuse, anxiety, and depression, which constituted 41%, 26%, and 23% of the diagnoses, respectively. Patients with psychosis were admitted 34% of the time and transferred 24% of the time; those who self-harmed were admitted 33% of the time and transferred 29% of the time; and patients with bipolar disorder were admitted 29% of the time and transferred 40% of the time. Patients who had either two or three diagnoses were admitted 9% and 10% of the time, respectively.
“Further investigation of the systems affecting these patients, including placement of involuntary holds, availability of ED psychiatric consultants, or outpatient resources would delineate potential intervention points for the care of these vulnerable patients,” Dr. Lippert and her coauthors wrote.
The second study looked at the differences in waiting for care at EDs between psychiatric patients and medical patients. Length of stay was defined the same way it was in the previous study, with disposition meaning either “discharge, admission to medical or psychiatric bed, [or] transfer to any acute facility.” Length of stay was divided into the same three categories as the previous study, too.
Psychiatric patients were more likely than were medical patients to wait more than 6 hours for disposition, regardless of what the disposition itself ended up being, by a rate of 23% vs. 10%. Similarly, 7% of psychiatric patients vs. just 2.3% of medical patients had to wait longer than 12 hours in the ED, while 1.3% of psychiatric had to wait longer than 24 hours, compared with only 0.5% of medical patients. The average length of stay was significantly longer for psychiatric patients: 194 minutes vs. 138 minutes for medical patients (P less than .01).
Additionally, psychiatric patients were more likely to be uninsured, with 22% not having insurance, compared with 15% of medical patients being uninsured. Furthermore, 4.6% of the psychiatric patients’ previous visit to the ED had been within the prior 72 hours, compared with 3.6% of medical patients. A total of 21% of psychiatric patients required admittance, compared with 13% of medical patients, while 11% of psychiatric patients were transferred, compared with just 1.4% of medical patients.
“These results compel us to further investigate the potential causes of prolonged length of stay in psychiatric patients and to further characterize the population of psychiatric patients most at risk of prolonged stays,” Dr. Lippert and her coinvestigators concluded.
ACEP President Rebecca B. Parker, MD, chimed in during the conference call, explaining that a survey of more than 1,700 emergency physicians revealed some “troubling” findings about the state of emergency departments over the last year.
The nation’s dwindling mental health resources are having a direct impact on patients having psychiatric emergencies, including children,” Dr. Parker explained. “These patients are waiting longer for care, especially those patients who require hospitalization.”
Findings of the survey indicate that 48% of ED physicians witness psychiatric patients being “boarded” in their EDs at least once a day while they wait for a bed. Additionally, less than 17% of respondents said their ED has a psychiatrist on call to respond to psychiatric emergencies, with 11.7% responding that they have no psychiatrist on call to deal with such emergencies. And 52% of respondents said the mental health system in their community has gotten noticeably worse in just the last year.
In a separate statement, Dr. Parker voiced outrage about the situation. “Psychiatric patients wait in the emergency department for hours and even days for a bed, which delays the psychiatric care they so desperately need,” she said. “It also leads to delays in care and diminished resources for other emergency patients. The emergency department has become the dumping ground for these vulnerable patients who have been abandoned by every other part of the health care system.”
ACEP presented the findings during its annual meeting in Las Vegas. No funding sources for these studies were disclosed; Dr. Lippert did not report any financial disclosures.
Individuals with psychiatric conditions are facing increasingly longer wait times in emergency departments across the country, including children, according to a pair of studies presented by the American College of Emergency Physicians.
“I really started doing this research because of my clinical experience,” explained Suzanne Catherine Lippert, MD, of Stanford (Calif.) University and the lead author of both studies during an Oct. 17 conference call, saying that seeing patients sit in the ED for days prompted her to finally look into this issue.
Patients with bipolar disorder had the highest likelihood of waiting more than 24 hours in the ED, with an odds ratio of 3.7 (95% confidence interval, 1.5-9.4). This was followed by patients with a diagnosis of psychosis, a dual diagnosis of psychiatric disorders, multiple psychiatric diagnoses, or depression. The most common diagnoses were substance abuse, anxiety, and depression, which constituted 41%, 26%, and 23% of the diagnoses, respectively. Patients with psychosis were admitted 34% of the time and transferred 24% of the time; those who self-harmed were admitted 33% of the time and transferred 29% of the time; and patients with bipolar disorder were admitted 29% of the time and transferred 40% of the time. Patients who had either two or three diagnoses were admitted 9% and 10% of the time, respectively.
“Further investigation of the systems affecting these patients, including placement of involuntary holds, availability of ED psychiatric consultants, or outpatient resources would delineate potential intervention points for the care of these vulnerable patients,” Dr. Lippert and her coauthors wrote.
The second study looked at the differences in waiting for care at EDs between psychiatric patients and medical patients. Length of stay was defined the same way it was in the previous study, with disposition meaning either “discharge, admission to medical or psychiatric bed, [or] transfer to any acute facility.” Length of stay was divided into the same three categories as the previous study, too.
Psychiatric patients were more likely than were medical patients to wait more than 6 hours for disposition, regardless of what the disposition itself ended up being, by a rate of 23% vs. 10%. Similarly, 7% of psychiatric patients vs. just 2.3% of medical patients had to wait longer than 12 hours in the ED, while 1.3% of psychiatric had to wait longer than 24 hours, compared with only 0.5% of medical patients. The average length of stay was significantly longer for psychiatric patients: 194 minutes vs. 138 minutes for medical patients (P less than .01).
Additionally, psychiatric patients were more likely to be uninsured, with 22% not having insurance, compared with 15% of medical patients being uninsured. Furthermore, 4.6% of the psychiatric patients’ previous visit to the ED had been within the prior 72 hours, compared with 3.6% of medical patients. A total of 21% of psychiatric patients required admittance, compared with 13% of medical patients, while 11% of psychiatric patients were transferred, compared with just 1.4% of medical patients.
“These results compel us to further investigate the potential causes of prolonged length of stay in psychiatric patients and to further characterize the population of psychiatric patients most at risk of prolonged stays,” Dr. Lippert and her coinvestigators concluded.
ACEP President Rebecca B. Parker, MD, chimed in during the conference call, explaining that a survey of more than 1,700 emergency physicians revealed some “troubling” findings about the state of emergency departments over the last year.
The nation’s dwindling mental health resources are having a direct impact on patients having psychiatric emergencies, including children,” Dr. Parker explained. “These patients are waiting longer for care, especially those patients who require hospitalization.”
Findings of the survey indicate that 48% of ED physicians witness psychiatric patients being “boarded” in their EDs at least once a day while they wait for a bed. Additionally, less than 17% of respondents said their ED has a psychiatrist on call to respond to psychiatric emergencies, with 11.7% responding that they have no psychiatrist on call to deal with such emergencies. And 52% of respondents said the mental health system in their community has gotten noticeably worse in just the last year.
In a separate statement, Dr. Parker voiced outrage about the situation. “Psychiatric patients wait in the emergency department for hours and even days for a bed, which delays the psychiatric care they so desperately need,” she said. “It also leads to delays in care and diminished resources for other emergency patients. The emergency department has become the dumping ground for these vulnerable patients who have been abandoned by every other part of the health care system.”
ACEP presented the findings during its annual meeting in Las Vegas. No funding sources for these studies were disclosed; Dr. Lippert did not report any financial disclosures.
Individuals with psychiatric conditions are facing increasingly longer wait times in emergency departments across the country, including children, according to a pair of studies presented by the American College of Emergency Physicians.
“I really started doing this research because of my clinical experience,” explained Suzanne Catherine Lippert, MD, of Stanford (Calif.) University and the lead author of both studies during an Oct. 17 conference call, saying that seeing patients sit in the ED for days prompted her to finally look into this issue.
Patients with bipolar disorder had the highest likelihood of waiting more than 24 hours in the ED, with an odds ratio of 3.7 (95% confidence interval, 1.5-9.4). This was followed by patients with a diagnosis of psychosis, a dual diagnosis of psychiatric disorders, multiple psychiatric diagnoses, or depression. The most common diagnoses were substance abuse, anxiety, and depression, which constituted 41%, 26%, and 23% of the diagnoses, respectively. Patients with psychosis were admitted 34% of the time and transferred 24% of the time; those who self-harmed were admitted 33% of the time and transferred 29% of the time; and patients with bipolar disorder were admitted 29% of the time and transferred 40% of the time. Patients who had either two or three diagnoses were admitted 9% and 10% of the time, respectively.
“Further investigation of the systems affecting these patients, including placement of involuntary holds, availability of ED psychiatric consultants, or outpatient resources would delineate potential intervention points for the care of these vulnerable patients,” Dr. Lippert and her coauthors wrote.
The second study looked at the differences in waiting for care at EDs between psychiatric patients and medical patients. Length of stay was defined the same way it was in the previous study, with disposition meaning either “discharge, admission to medical or psychiatric bed, [or] transfer to any acute facility.” Length of stay was divided into the same three categories as the previous study, too.
Psychiatric patients were more likely than were medical patients to wait more than 6 hours for disposition, regardless of what the disposition itself ended up being, by a rate of 23% vs. 10%. Similarly, 7% of psychiatric patients vs. just 2.3% of medical patients had to wait longer than 12 hours in the ED, while 1.3% of psychiatric had to wait longer than 24 hours, compared with only 0.5% of medical patients. The average length of stay was significantly longer for psychiatric patients: 194 minutes vs. 138 minutes for medical patients (P less than .01).
Additionally, psychiatric patients were more likely to be uninsured, with 22% not having insurance, compared with 15% of medical patients being uninsured. Furthermore, 4.6% of the psychiatric patients’ previous visit to the ED had been within the prior 72 hours, compared with 3.6% of medical patients. A total of 21% of psychiatric patients required admittance, compared with 13% of medical patients, while 11% of psychiatric patients were transferred, compared with just 1.4% of medical patients.
“These results compel us to further investigate the potential causes of prolonged length of stay in psychiatric patients and to further characterize the population of psychiatric patients most at risk of prolonged stays,” Dr. Lippert and her coinvestigators concluded.
ACEP President Rebecca B. Parker, MD, chimed in during the conference call, explaining that a survey of more than 1,700 emergency physicians revealed some “troubling” findings about the state of emergency departments over the last year.
The nation’s dwindling mental health resources are having a direct impact on patients having psychiatric emergencies, including children,” Dr. Parker explained. “These patients are waiting longer for care, especially those patients who require hospitalization.”
Findings of the survey indicate that 48% of ED physicians witness psychiatric patients being “boarded” in their EDs at least once a day while they wait for a bed. Additionally, less than 17% of respondents said their ED has a psychiatrist on call to respond to psychiatric emergencies, with 11.7% responding that they have no psychiatrist on call to deal with such emergencies. And 52% of respondents said the mental health system in their community has gotten noticeably worse in just the last year.
In a separate statement, Dr. Parker voiced outrage about the situation. “Psychiatric patients wait in the emergency department for hours and even days for a bed, which delays the psychiatric care they so desperately need,” she said. “It also leads to delays in care and diminished resources for other emergency patients. The emergency department has become the dumping ground for these vulnerable patients who have been abandoned by every other part of the health care system.”
ACEP presented the findings during its annual meeting in Las Vegas. No funding sources for these studies were disclosed; Dr. Lippert did not report any financial disclosures.
FROM AN ACEP TELECONFERENCE
Key clinical point:
Major finding: Higher percentages of psychiatric patients have to wait more than a day before disposition, compared with medical patients.
Data source: Two retrospective reviews of more than 65 million ED visits in the NHAMCS database from 2001-2011.
Disclosures: No funding sources or disclosures were reported.
Addressing sex and gender inequality in biomedical research
in two general areas. Not only are biologic sex and gender insufficiently reported within research studies, but women are also underrepresented as basic and clinical researchers in academic medicine. While these issues may seem unrelated, addressing both will diversify knowledge and interdisciplinary research teams, as well as improve the value of the science produced and ultimately the quality of health care provided.
In 1986, the National Institutes of Health instituted a policy urging the inclusion of women as subjects in clinical trials. This policy became law when Congress passed the NIH Revitalization Act of 1993, which requires that NIH-supported clinical research include women and minorities as subjects “in approximately equal numbers of both sexes … unless different proportions are appropriate because of known prevalence, incidence, morbidity, mortality rates, or expected intervention effect.” Women of childbearing potential cannot be routinely excluded without a strong scientific rationale.
Despite these initiatives, evidence suggests that sex/gender is still not sufficiently considered as a biologic variable in federally funded research, and studies oftentimes fail to account for the cultural and societal influences of gender in health outcomes. Women comprise more than half of clinical trial participants, yet 75% of federally funded studies published in 2009 failed to report any outcomes by sex/gender. Recent events, such as the Food and Drug Administration’s updated Ambien dosage recommendation for men versus women, demonstrate the harmful effects of failing to account for sex as a biologic variable.
In recognition of the slow progress, the NIH required that research grants submitted after Jan. 25, 2016, address biologic sex within their research design and added reviewer criteria related to consideration of biologic sex in the research proposal. Ensuring enhanced inclusion, analysis, and reporting of sex and gender goes beyond NIH policy to include NIH enforcement of its own policies. In addition, journal editors should add review criteria related to sex and gender, and researchers themselves should examine potential sex/gender differences in their research.
The NIH and ORWH have implemented various programs to diversify the sciences; however, change has been less than desired. Studies indicate that females have lower publication rates throughout their careers, and are less likely to receive an R01 than men, despite reporting equal likelihood of applying for R01 awards. Additionally, the intraorganizational and network reach of female scientists is smaller than that of men, hindering opportunities for collaboration and publication. Even in the instance of equally qualified men and women conducting comparable work, investigators find differential pay between male and female researchers, as well as differential promotion to leadership positions. These factors, both in part caused by and exacerbated by unconscious or implicit interpersonal and institutional biases, lead to higher female attrition within the sciences and academia.
Addressing disparities and promoting greater inclusion includes unmasking unconscious bias and putting greater efforts toward mentoring and leadership initiatives for women. Only by partnering efforts to increase inclusion of sex/gender within research design with efforts to diversify the biomedical workforce can we adequately consider the role of sex and gender in biomedical research.
Dr. Geller is the G. William Arends Professor of Obstetrics and Gynecology at the University of Illinois College of Medicine, and the Director of the UIC Center for Research on Women and Gender. Ms. Koch is a senior research specialist at the Center for Research on Women and Gender. They reported having no financial disclosures.
in two general areas. Not only are biologic sex and gender insufficiently reported within research studies, but women are also underrepresented as basic and clinical researchers in academic medicine. While these issues may seem unrelated, addressing both will diversify knowledge and interdisciplinary research teams, as well as improve the value of the science produced and ultimately the quality of health care provided.
In 1986, the National Institutes of Health instituted a policy urging the inclusion of women as subjects in clinical trials. This policy became law when Congress passed the NIH Revitalization Act of 1993, which requires that NIH-supported clinical research include women and minorities as subjects “in approximately equal numbers of both sexes … unless different proportions are appropriate because of known prevalence, incidence, morbidity, mortality rates, or expected intervention effect.” Women of childbearing potential cannot be routinely excluded without a strong scientific rationale.
Despite these initiatives, evidence suggests that sex/gender is still not sufficiently considered as a biologic variable in federally funded research, and studies oftentimes fail to account for the cultural and societal influences of gender in health outcomes. Women comprise more than half of clinical trial participants, yet 75% of federally funded studies published in 2009 failed to report any outcomes by sex/gender. Recent events, such as the Food and Drug Administration’s updated Ambien dosage recommendation for men versus women, demonstrate the harmful effects of failing to account for sex as a biologic variable.
In recognition of the slow progress, the NIH required that research grants submitted after Jan. 25, 2016, address biologic sex within their research design and added reviewer criteria related to consideration of biologic sex in the research proposal. Ensuring enhanced inclusion, analysis, and reporting of sex and gender goes beyond NIH policy to include NIH enforcement of its own policies. In addition, journal editors should add review criteria related to sex and gender, and researchers themselves should examine potential sex/gender differences in their research.
The NIH and ORWH have implemented various programs to diversify the sciences; however, change has been less than desired. Studies indicate that females have lower publication rates throughout their careers, and are less likely to receive an R01 than men, despite reporting equal likelihood of applying for R01 awards. Additionally, the intraorganizational and network reach of female scientists is smaller than that of men, hindering opportunities for collaboration and publication. Even in the instance of equally qualified men and women conducting comparable work, investigators find differential pay between male and female researchers, as well as differential promotion to leadership positions. These factors, both in part caused by and exacerbated by unconscious or implicit interpersonal and institutional biases, lead to higher female attrition within the sciences and academia.
Addressing disparities and promoting greater inclusion includes unmasking unconscious bias and putting greater efforts toward mentoring and leadership initiatives for women. Only by partnering efforts to increase inclusion of sex/gender within research design with efforts to diversify the biomedical workforce can we adequately consider the role of sex and gender in biomedical research.
Dr. Geller is the G. William Arends Professor of Obstetrics and Gynecology at the University of Illinois College of Medicine, and the Director of the UIC Center for Research on Women and Gender. Ms. Koch is a senior research specialist at the Center for Research on Women and Gender. They reported having no financial disclosures.
in two general areas. Not only are biologic sex and gender insufficiently reported within research studies, but women are also underrepresented as basic and clinical researchers in academic medicine. While these issues may seem unrelated, addressing both will diversify knowledge and interdisciplinary research teams, as well as improve the value of the science produced and ultimately the quality of health care provided.
In 1986, the National Institutes of Health instituted a policy urging the inclusion of women as subjects in clinical trials. This policy became law when Congress passed the NIH Revitalization Act of 1993, which requires that NIH-supported clinical research include women and minorities as subjects “in approximately equal numbers of both sexes … unless different proportions are appropriate because of known prevalence, incidence, morbidity, mortality rates, or expected intervention effect.” Women of childbearing potential cannot be routinely excluded without a strong scientific rationale.
Despite these initiatives, evidence suggests that sex/gender is still not sufficiently considered as a biologic variable in federally funded research, and studies oftentimes fail to account for the cultural and societal influences of gender in health outcomes. Women comprise more than half of clinical trial participants, yet 75% of federally funded studies published in 2009 failed to report any outcomes by sex/gender. Recent events, such as the Food and Drug Administration’s updated Ambien dosage recommendation for men versus women, demonstrate the harmful effects of failing to account for sex as a biologic variable.
In recognition of the slow progress, the NIH required that research grants submitted after Jan. 25, 2016, address biologic sex within their research design and added reviewer criteria related to consideration of biologic sex in the research proposal. Ensuring enhanced inclusion, analysis, and reporting of sex and gender goes beyond NIH policy to include NIH enforcement of its own policies. In addition, journal editors should add review criteria related to sex and gender, and researchers themselves should examine potential sex/gender differences in their research.
The NIH and ORWH have implemented various programs to diversify the sciences; however, change has been less than desired. Studies indicate that females have lower publication rates throughout their careers, and are less likely to receive an R01 than men, despite reporting equal likelihood of applying for R01 awards. Additionally, the intraorganizational and network reach of female scientists is smaller than that of men, hindering opportunities for collaboration and publication. Even in the instance of equally qualified men and women conducting comparable work, investigators find differential pay between male and female researchers, as well as differential promotion to leadership positions. These factors, both in part caused by and exacerbated by unconscious or implicit interpersonal and institutional biases, lead to higher female attrition within the sciences and academia.
Addressing disparities and promoting greater inclusion includes unmasking unconscious bias and putting greater efforts toward mentoring and leadership initiatives for women. Only by partnering efforts to increase inclusion of sex/gender within research design with efforts to diversify the biomedical workforce can we adequately consider the role of sex and gender in biomedical research.
Dr. Geller is the G. William Arends Professor of Obstetrics and Gynecology at the University of Illinois College of Medicine, and the Director of the UIC Center for Research on Women and Gender. Ms. Koch is a senior research specialist at the Center for Research on Women and Gender. They reported having no financial disclosures.