Mary Ann Moon

Online access to medical records and clinicians prompted the patients in a large health maintenance organization to increase rather than decrease their in-person and telephone contacts for clinical services, according to a report.

Of particular concern was the finding that those who used electronic patient portals also showed increased utilization of hospitals and emergency services, not just office contacts, according to Dr. Ted E. Palen of the Institute for Health Research, Kaiser Permanente Colorado, and his associates.

Proponents of online patient access have argued that if patients could "look up ... their test results, request prescription refills, schedule appointments, and send secure emails to clinicians, then their use of clinical in-person and telephone calls [would] decrease." But the results of this retrospective study of more than 88,000 adult patients argue the opposite, the investigators reported.

Dr. Palen and his colleagues assessed the use of clinical services among 44,321 patients who signed up for online access and a matched control group of 44,321 patients who did not during a 5-year period before and after the introduction of the patient portals.

Contrary to the researchers’ expectations, portal users had significantly more in-person and telephone contacts with their clinicians in the year after the patient portal program was introduced than they had in the preceding year. The rate of office visits rose by 3.2 per HMO member per year, and the rate of telephone contacts rose by 4.2 per member per year.

Patients who used online access also had significantly more in-person and telephone contacts with their clinicians than did those in the control group, the researchers said (JAMA 2012;308:2012-9).

Even more surprising, the rates of after-hours clinic visits, emergency department visits, and hospitalizations also increased significantly for portal users compared with nonusers. Rates of after-hours visits were higher by 18.7/1,000 HMO members per year, rates of ED visits were higher by 11.2/1,000, and hospitalizations were higher by 19.9/1,000.

This pattern of health care utilization persisted when the data were analyzed according to patient age, with both younger patients (under age 50) and older patients (over age 50) increasing their rate of in-person and telephone contact with clinicians after beginning online access.

Patient portals are thought to be especially beneficial for patients with chronic illnesses; the assumption being that such patients could monitor their condition and communicate with clinicians electronically, reducing their need for in-person visits.

However, in this study, patients with asthma, diabetes, and congestive heart failure who used the patient portal all increased their in-person and telephone contacts with their clinicians, compared with nonusers who had these chronic illnesses.

The researchers noted that any large study can identify differences between groups that are statistically but not clinically significant. "However, the magnitude of differences in utilization that we identified appears to be clinically significant.

"For example, in a health system with 100,000 adult members with online access, if the rate of office visits increases by 0.5 visits per member per year, concomitant with an increase in telephone encounters by 0.3 per member per year, over the course of a year clinicians . . . would need to provide 50,000 more clinic visits and respond to 30,000 more telephone calls.

"If this also holds true for the small group practice, a primary care physician with 1,000 adult patients who has online access would need to provide for almost 10 more clinic visits per week and over 5.5 more telephone calls per week," they noted.

This study was not designed to examine why patients might change their patterns of contact with clinicians, but the investigators suggested that patients who are already more likely to use health care services may selectively sign up for online access, "and then use this technology to gain even more frequent access rather than view it as a substitute for contact with the health care system."

This study was supported by the Kaiser Permanente Colorado Regional Initiative Committee Fund. There were no conflicts reported.

Online access to medical records and clinicians prompted the patients in a large health maintenance organization to increase rather than decrease their in-person and telephone contacts for clinical services, according to a report.

Of particular concern was the finding that those who used electronic patient portals also showed increased utilization of hospitals and emergency services, not just office contacts, according to Dr. Ted E. Palen of the Institute for Health Research, Kaiser Permanente Colorado, and his associates.

Proponents of online patient access have argued that if patients could "look up ... their test results, request prescription refills, schedule appointments, and send secure emails to clinicians, then their use of clinical in-person and telephone calls [would] decrease." But the results of this retrospective study of more than 88,000 adult patients argue the opposite, the investigators reported.

Dr. Palen and his colleagues assessed the use of clinical services among 44,321 patients who signed up for online access and a matched control group of 44,321 patients who did not during a 5-year period before and after the introduction of the patient portals.

Contrary to the researchers’ expectations, portal users had significantly more in-person and telephone contacts with their clinicians in the year after the patient portal program was introduced than they had in the preceding year. The rate of office visits rose by 3.2 per HMO member per year, and the rate of telephone contacts rose by 4.2 per member per year.

Patients who used online access also had significantly more in-person and telephone contacts with their clinicians than did those in the control group, the researchers said (JAMA 2012;308:2012-9).

Even more surprising, the rates of after-hours clinic visits, emergency department visits, and hospitalizations also increased significantly for portal users compared with nonusers. Rates of after-hours visits were higher by 18.7/1,000 HMO members per year, rates of ED visits were higher by 11.2/1,000, and hospitalizations were higher by 19.9/1,000.

This pattern of health care utilization persisted when the data were analyzed according to patient age, with both younger patients (under age 50) and older patients (over age 50) increasing their rate of in-person and telephone contact with clinicians after beginning online access.

Patient portals are thought to be especially beneficial for patients with chronic illnesses; the assumption being that such patients could monitor their condition and communicate with clinicians electronically, reducing their need for in-person visits.

However, in this study, patients with asthma, diabetes, and congestive heart failure who used the patient portal all increased their in-person and telephone contacts with their clinicians, compared with nonusers who had these chronic illnesses.

The researchers noted that any large study can identify differences between groups that are statistically but not clinically significant. "However, the magnitude of differences in utilization that we identified appears to be clinically significant.

"For example, in a health system with 100,000 adult members with online access, if the rate of office visits increases by 0.5 visits per member per year, concomitant with an increase in telephone encounters by 0.3 per member per year, over the course of a year clinicians . . . would need to provide 50,000 more clinic visits and respond to 30,000 more telephone calls.

"If this also holds true for the small group practice, a primary care physician with 1,000 adult patients who has online access would need to provide for almost 10 more clinic visits per week and over 5.5 more telephone calls per week," they noted.

This study was not designed to examine why patients might change their patterns of contact with clinicians, but the investigators suggested that patients who are already more likely to use health care services may selectively sign up for online access, "and then use this technology to gain even more frequent access rather than view it as a substitute for contact with the health care system."

This study was supported by the Kaiser Permanente Colorado Regional Initiative Committee Fund. There were no conflicts reported.

Online access to medical records and clinicians prompted the patients in a large health maintenance organization to increase rather than decrease their in-person and telephone contacts for clinical services, according to a report.

Of particular concern was the finding that those who used electronic patient portals also showed increased utilization of hospitals and emergency services, not just office contacts, according to Dr. Ted E. Palen of the Institute for Health Research, Kaiser Permanente Colorado, and his associates.

Proponents of online patient access have argued that if patients could "look up ... their test results, request prescription refills, schedule appointments, and send secure emails to clinicians, then their use of clinical in-person and telephone calls [would] decrease." But the results of this retrospective study of more than 88,000 adult patients argue the opposite, the investigators reported.

Dr. Palen and his colleagues assessed the use of clinical services among 44,321 patients who signed up for online access and a matched control group of 44,321 patients who did not during a 5-year period before and after the introduction of the patient portals.

Contrary to the researchers’ expectations, portal users had significantly more in-person and telephone contacts with their clinicians in the year after the patient portal program was introduced than they had in the preceding year. The rate of office visits rose by 3.2 per HMO member per year, and the rate of telephone contacts rose by 4.2 per member per year.

Patients who used online access also had significantly more in-person and telephone contacts with their clinicians than did those in the control group, the researchers said (JAMA 2012;308:2012-9).

Even more surprising, the rates of after-hours clinic visits, emergency department visits, and hospitalizations also increased significantly for portal users compared with nonusers. Rates of after-hours visits were higher by 18.7/1,000 HMO members per year, rates of ED visits were higher by 11.2/1,000, and hospitalizations were higher by 19.9/1,000.

This pattern of health care utilization persisted when the data were analyzed according to patient age, with both younger patients (under age 50) and older patients (over age 50) increasing their rate of in-person and telephone contact with clinicians after beginning online access.

Patient portals are thought to be especially beneficial for patients with chronic illnesses; the assumption being that such patients could monitor their condition and communicate with clinicians electronically, reducing their need for in-person visits.

However, in this study, patients with asthma, diabetes, and congestive heart failure who used the patient portal all increased their in-person and telephone contacts with their clinicians, compared with nonusers who had these chronic illnesses.

The researchers noted that any large study can identify differences between groups that are statistically but not clinically significant. "However, the magnitude of differences in utilization that we identified appears to be clinically significant.

"For example, in a health system with 100,000 adult members with online access, if the rate of office visits increases by 0.5 visits per member per year, concomitant with an increase in telephone encounters by 0.3 per member per year, over the course of a year clinicians . . . would need to provide 50,000 more clinic visits and respond to 30,000 more telephone calls.

"If this also holds true for the small group practice, a primary care physician with 1,000 adult patients who has online access would need to provide for almost 10 more clinic visits per week and over 5.5 more telephone calls per week," they noted.

This study was not designed to examine why patients might change their patterns of contact with clinicians, but the investigators suggested that patients who are already more likely to use health care services may selectively sign up for online access, "and then use this technology to gain even more frequent access rather than view it as a substitute for contact with the health care system."

This study was supported by the Kaiser Permanente Colorado Regional Initiative Committee Fund. There were no conflicts reported.

Among adults discharged from the hospital, visits to the emergency department within 30 days are nearly as frequent as are readmissions, according to a report in the Jan. 23/30 issue of JAMA.

In a population-based study of 30-day outcomes after hospital discharge, treat-and-release visits to the ED accounted for approximately 40% of all hospital-based acute care given in the immediate postdischarge period, said Dr. Anita A. Vashi of the Robert Wood Johnson Foundation Clinical Scholars Program and the department of emergency medicine, Yale University, New Haven, Conn., and her associates.

Readmission rates are seen as a marker of hospitals’ quality of care. Rates of ED visits following discharge also are important, but aren’t as well understood. Studies done to date "have tended to focus on the experience at a single institution, with a single payer, or with a specific condition," the investigators said.

"The use of hospital readmissions as a lone metric for postdischarge health care quality may be incomplete without considering the role of the ED," they noted.

The researchers studied the issue using data from three geographically distant states that participate in the Healthcare Cost and Utilization Project state inpatient and ED databases, using a sample of 5,032,254 discharges during a 1-year period from medical centers in California, Florida, and Nebraska. All together these states account for approximately 17% of all hospitalizations in the United States annually.

All the study subjects were adults, with a mean age of 53.4 years; 29.2% were aged 65 years and older. Slightly more than half were women, and slightly less than half were white. Most of the patients had some form of medical coverage, including private insurance (32%) and Medicare (30%). These patients were discharged after hospitalization for 470 unique conditions, 65.2% medical, 34.8% surgical. The researchers defined the ED visits as treat-and-release to separate them from visits to the ED that resulted in readmission, as about 57% of the readmissions were through the ED.

Overall, 17.9% of all discharges were followed by at least one acute-care visit to a hospital within 30 days. About one-third of all such visits – 35% of ED visits and 31% of readmissions – occurred within 7 days of discharge. A total of 7.5% of discharges were followed by at least one ED visit, and another 12.3% by a readmission. There were 97.5 ED visits and 147.6 readmissions for every 1,000 discharges.

ED visits accounted for 39.8% of the 1,233,402 postdischarge visits for acute care (JAMA 2013;309:364-71).

"Focusing solely on readmissions would have missed nearly half a million ED treat-and-release encounters in these three states and substantially underestimated acute care use following medical and surgical inpatient discharges," Dr. Vashi and her colleagues noted.

It is crucial to include such ED visits in assessments of hospitals’ quality of care because they contribute substantially to fragmentation of care with its attendant duplication of services, conflicting care recommendations, medication errors, patient distress, and higher costs, they added.

Among medical discharges, 30-day rates of ED visits were highest for digestive disorders (140.7 visits per 1,000 discharges) and psychosis (219.4 visits per 1,000 discharges). Visits for heart failure also were common.

Among surgical conditions, ED visits were most common for complicated laparoscopic cholecystectomy (84.5 visits per 1,000 discharges) and complicated cesarean deliveries (84.6 visits per 1,000 discharges). Visits following PCI with drug-eluting stent placement, for major cardiac diagnoses, and for complicated hip and femur procedures also were common.

Among the 470 unique conditions in this study, those with the highest rates of ED visits were related to mental health problems and drug and alcohol abuse.

"Anticipating patient needs and developing an appropriate care plan prior to hospital discharge may help prevent some of these likely low-acuity visits," Dr. Vashi and her associates said.

For example, "given that patients hospitalized for reasons related to mental illness and drug and alcohol abuse had especially high rates of return to the ED, there must be consideration of how acute care can be best delivered and targeted to this population outside of hospitals," they said.

The investigators cautioned that their findings underestimate the number of hospital discharges that are immediately followed by emergency care visits, because they could not include in this study patients who died before making it to the ED, went to urgent-care centers, or presented at walk-in clinics.

This study was supported in part by the Agency for Healthcare Research and Quality, the National Institute on Aging, and the American Federation for Aging Research. Dr. Vashi reported no financial conflicts of interest, and one of her associates reported ties to Medtronic.

Among adults discharged from the hospital, visits to the emergency department within 30 days are nearly as frequent as are readmissions, according to a report in the Jan. 23/30 issue of JAMA.

In a population-based study of 30-day outcomes after hospital discharge, treat-and-release visits to the ED accounted for approximately 40% of all hospital-based acute care given in the immediate postdischarge period, said Dr. Anita A. Vashi of the Robert Wood Johnson Foundation Clinical Scholars Program and the department of emergency medicine, Yale University, New Haven, Conn., and her associates.

Readmission rates are seen as a marker of hospitals’ quality of care. Rates of ED visits following discharge also are important, but aren’t as well understood. Studies done to date "have tended to focus on the experience at a single institution, with a single payer, or with a specific condition," the investigators said.

"The use of hospital readmissions as a lone metric for postdischarge health care quality may be incomplete without considering the role of the ED," they noted.

The researchers studied the issue using data from three geographically distant states that participate in the Healthcare Cost and Utilization Project state inpatient and ED databases, using a sample of 5,032,254 discharges during a 1-year period from medical centers in California, Florida, and Nebraska. All together these states account for approximately 17% of all hospitalizations in the United States annually.

All the study subjects were adults, with a mean age of 53.4 years; 29.2% were aged 65 years and older. Slightly more than half were women, and slightly less than half were white. Most of the patients had some form of medical coverage, including private insurance (32%) and Medicare (30%). These patients were discharged after hospitalization for 470 unique conditions, 65.2% medical, 34.8% surgical. The researchers defined the ED visits as treat-and-release to separate them from visits to the ED that resulted in readmission, as about 57% of the readmissions were through the ED.

Overall, 17.9% of all discharges were followed by at least one acute-care visit to a hospital within 30 days. About one-third of all such visits – 35% of ED visits and 31% of readmissions – occurred within 7 days of discharge. A total of 7.5% of discharges were followed by at least one ED visit, and another 12.3% by a readmission. There were 97.5 ED visits and 147.6 readmissions for every 1,000 discharges.

ED visits accounted for 39.8% of the 1,233,402 postdischarge visits for acute care (JAMA 2013;309:364-71).

"Focusing solely on readmissions would have missed nearly half a million ED treat-and-release encounters in these three states and substantially underestimated acute care use following medical and surgical inpatient discharges," Dr. Vashi and her colleagues noted.

It is crucial to include such ED visits in assessments of hospitals’ quality of care because they contribute substantially to fragmentation of care with its attendant duplication of services, conflicting care recommendations, medication errors, patient distress, and higher costs, they added.

Among medical discharges, 30-day rates of ED visits were highest for digestive disorders (140.7 visits per 1,000 discharges) and psychosis (219.4 visits per 1,000 discharges). Visits for heart failure also were common.

Among surgical conditions, ED visits were most common for complicated laparoscopic cholecystectomy (84.5 visits per 1,000 discharges) and complicated cesarean deliveries (84.6 visits per 1,000 discharges). Visits following PCI with drug-eluting stent placement, for major cardiac diagnoses, and for complicated hip and femur procedures also were common.

Among the 470 unique conditions in this study, those with the highest rates of ED visits were related to mental health problems and drug and alcohol abuse.

"Anticipating patient needs and developing an appropriate care plan prior to hospital discharge may help prevent some of these likely low-acuity visits," Dr. Vashi and her associates said.

For example, "given that patients hospitalized for reasons related to mental illness and drug and alcohol abuse had especially high rates of return to the ED, there must be consideration of how acute care can be best delivered and targeted to this population outside of hospitals," they said.

The investigators cautioned that their findings underestimate the number of hospital discharges that are immediately followed by emergency care visits, because they could not include in this study patients who died before making it to the ED, went to urgent-care centers, or presented at walk-in clinics.

This study was supported in part by the Agency for Healthcare Research and Quality, the National Institute on Aging, and the American Federation for Aging Research. Dr. Vashi reported no financial conflicts of interest, and one of her associates reported ties to Medtronic.

Among adults discharged from the hospital, visits to the emergency department within 30 days are nearly as frequent as are readmissions, according to a report in the Jan. 23/30 issue of JAMA.

In a population-based study of 30-day outcomes after hospital discharge, treat-and-release visits to the ED accounted for approximately 40% of all hospital-based acute care given in the immediate postdischarge period, said Dr. Anita A. Vashi of the Robert Wood Johnson Foundation Clinical Scholars Program and the department of emergency medicine, Yale University, New Haven, Conn., and her associates.

Readmission rates are seen as a marker of hospitals’ quality of care. Rates of ED visits following discharge also are important, but aren’t as well understood. Studies done to date "have tended to focus on the experience at a single institution, with a single payer, or with a specific condition," the investigators said.

"The use of hospital readmissions as a lone metric for postdischarge health care quality may be incomplete without considering the role of the ED," they noted.

The researchers studied the issue using data from three geographically distant states that participate in the Healthcare Cost and Utilization Project state inpatient and ED databases, using a sample of 5,032,254 discharges during a 1-year period from medical centers in California, Florida, and Nebraska. All together these states account for approximately 17% of all hospitalizations in the United States annually.

All the study subjects were adults, with a mean age of 53.4 years; 29.2% were aged 65 years and older. Slightly more than half were women, and slightly less than half were white. Most of the patients had some form of medical coverage, including private insurance (32%) and Medicare (30%). These patients were discharged after hospitalization for 470 unique conditions, 65.2% medical, 34.8% surgical. The researchers defined the ED visits as treat-and-release to separate them from visits to the ED that resulted in readmission, as about 57% of the readmissions were through the ED.

Overall, 17.9% of all discharges were followed by at least one acute-care visit to a hospital within 30 days. About one-third of all such visits – 35% of ED visits and 31% of readmissions – occurred within 7 days of discharge. A total of 7.5% of discharges were followed by at least one ED visit, and another 12.3% by a readmission. There were 97.5 ED visits and 147.6 readmissions for every 1,000 discharges.

ED visits accounted for 39.8% of the 1,233,402 postdischarge visits for acute care (JAMA 2013;309:364-71).

"Focusing solely on readmissions would have missed nearly half a million ED treat-and-release encounters in these three states and substantially underestimated acute care use following medical and surgical inpatient discharges," Dr. Vashi and her colleagues noted.

It is crucial to include such ED visits in assessments of hospitals’ quality of care because they contribute substantially to fragmentation of care with its attendant duplication of services, conflicting care recommendations, medication errors, patient distress, and higher costs, they added.

Among medical discharges, 30-day rates of ED visits were highest for digestive disorders (140.7 visits per 1,000 discharges) and psychosis (219.4 visits per 1,000 discharges). Visits for heart failure also were common.

Among surgical conditions, ED visits were most common for complicated laparoscopic cholecystectomy (84.5 visits per 1,000 discharges) and complicated cesarean deliveries (84.6 visits per 1,000 discharges). Visits following PCI with drug-eluting stent placement, for major cardiac diagnoses, and for complicated hip and femur procedures also were common.

Among the 470 unique conditions in this study, those with the highest rates of ED visits were related to mental health problems and drug and alcohol abuse.

"Anticipating patient needs and developing an appropriate care plan prior to hospital discharge may help prevent some of these likely low-acuity visits," Dr. Vashi and her associates said.

For example, "given that patients hospitalized for reasons related to mental illness and drug and alcohol abuse had especially high rates of return to the ED, there must be consideration of how acute care can be best delivered and targeted to this population outside of hospitals," they said.

The investigators cautioned that their findings underestimate the number of hospital discharges that are immediately followed by emergency care visits, because they could not include in this study patients who died before making it to the ED, went to urgent-care centers, or presented at walk-in clinics.

This study was supported in part by the Agency for Healthcare Research and Quality, the National Institute on Aging, and the American Federation for Aging Research. Dr. Vashi reported no financial conflicts of interest, and one of her associates reported ties to Medtronic.

The use of aspirin therapy approximately doubled the risk that age-related macular degeneration would develop over a period of 10-15 years in a secondary analysis of data in the Blue Mountain Eye Study, which was published online Jan. 21 in JAMA Internal Medicine.

The regular use of aspirin was significantly associated with an increased incidence of neovascular (wet) age-related macular degeneration (AMD), with an odds ratio of 2.37, independently of cardiovascular disease (CVD), smoking status, and numerous potentially confounding factors. However, "this potential risk appears to be small (3.7% after 15 years) and should be balanced with the significant morbidity and mortality of suboptimally treated CVD," said Gerald Liew, Ph.D., of the center for vision research, department of ophthalmology, University of Sydney, and his associates.

"Given the widespread use of aspirin, any increased risk of disabling conditions and morbidity will be significant and affect many people," they noted.

Several previous studies have examined the relationship between aspirin therapy and AMD, but the findings have been inconsistent. Dr. Liew and his colleagues performed a prospective study using the largest cohort and the longest follow-up to date. Their study subjects were 2,389 participants in the Blue Mountain Eye Study, a population-based cohort study of eye disease in urban Australians aged 49 years or older.

Aspirin use was determined from the subjects’ responses to a detailed questionnaire at baseline. "Although we did not collect information on aspirin dosage, most aspirin use in Australia is prescribed at 150 mg daily," the researchers said.

A total of 257 subjects (10.8%) used aspirin therapy.

At 15-year follow-up, 63 subjects had developed neovascular AMD.

Among subjects taking aspirin therapy, the cumulative rate of neovascular AMD was 1.9% at 5 years, 7% at 10 years, and 9.3% at 15 years. In comparison, these rates were 0.8% at 5 years, 1.6% at 10 years, and 3.7% at 15 years among subjects who did not take aspirin regularly.

The increase in risk became significant only after 10-15 years, "suggesting that cumulative dosage is important in pathogenesis" of neovascular AMD, the investigators said.

This long lead time also may explain why several previous studies that had shorter follow-up failed to detect the association, they added.

After the data were adjusted to account for subject age, sex, and smoking status, aspirin therapy was significantly associated with an increased incidence of neovascular AMD, with an odds ratio of 2.37. This association remained unchanged after further adjustment for history of CVD, BMI, and blood pressure.

Aspirin therapy was not associated with the risk of geographic (dry) AMD.

The rate of neovascular AMD rose with increasing use of aspirin, from 2.2% among people who never took aspirin to 2.9% among occasional users to 5.8% among regular users, Dr. Liew and his associates said (JAMA Intern. Med. 2013 Jan. 21 [doi:10.1001/jamainternmed.2013.1583]).

The correlation between aspirin therapy and neovascular AMD remained robust in a further analysis of the data that adjusted for numerous risk factors and protective factors, such as white blood cell count, dietary factors, cholesterol levels, and the presence or absence of diabetes. The odds ratio was 2.05 in this analysis.

"Because aspirin use is strongly associated with painful conditions and CVD, we examined whether other medications associated with these conditions had a similar association with neovascular AMD," the investigators wrote. Acetaminophen, beta-blockers, and other drugs showed no significant associations with AMD.

"Although aspirin is one of the most effective CVD treatments and reduces recurrent CVD events by one-fifth, some meta-analyses have called into question the efficacy of aspirin use in CVD primary prevention and highlighted the significant adverse effects, such as increased gastrointestinal, intracerebral, and extracranial hemorrhage. Our study now raises the possibility that the risk of neovascular AMD may also need to be considered," Dr. Liew and his associates wrote.

At this time "there is insufficient evidence to recommend changing clinical practice, except perhaps in patients" who have strong risk factors for AMD, they added.

This study was supported by the National Health and Medical Research Council Australia. No financial conflicts of interest were reported.

The use of aspirin therapy approximately doubled the risk that age-related macular degeneration would develop over a period of 10-15 years in a secondary analysis of data in the Blue Mountain Eye Study, which was published online Jan. 21 in JAMA Internal Medicine.

The regular use of aspirin was significantly associated with an increased incidence of neovascular (wet) age-related macular degeneration (AMD), with an odds ratio of 2.37, independently of cardiovascular disease (CVD), smoking status, and numerous potentially confounding factors. However, "this potential risk appears to be small (3.7% after 15 years) and should be balanced with the significant morbidity and mortality of suboptimally treated CVD," said Gerald Liew, Ph.D., of the center for vision research, department of ophthalmology, University of Sydney, and his associates.

"Given the widespread use of aspirin, any increased risk of disabling conditions and morbidity will be significant and affect many people," they noted.

Several previous studies have examined the relationship between aspirin therapy and AMD, but the findings have been inconsistent. Dr. Liew and his colleagues performed a prospective study using the largest cohort and the longest follow-up to date. Their study subjects were 2,389 participants in the Blue Mountain Eye Study, a population-based cohort study of eye disease in urban Australians aged 49 years or older.

Aspirin use was determined from the subjects’ responses to a detailed questionnaire at baseline. "Although we did not collect information on aspirin dosage, most aspirin use in Australia is prescribed at 150 mg daily," the researchers said.

A total of 257 subjects (10.8%) used aspirin therapy.

At 15-year follow-up, 63 subjects had developed neovascular AMD.

Among subjects taking aspirin therapy, the cumulative rate of neovascular AMD was 1.9% at 5 years, 7% at 10 years, and 9.3% at 15 years. In comparison, these rates were 0.8% at 5 years, 1.6% at 10 years, and 3.7% at 15 years among subjects who did not take aspirin regularly.

The increase in risk became significant only after 10-15 years, "suggesting that cumulative dosage is important in pathogenesis" of neovascular AMD, the investigators said.

This long lead time also may explain why several previous studies that had shorter follow-up failed to detect the association, they added.

After the data were adjusted to account for subject age, sex, and smoking status, aspirin therapy was significantly associated with an increased incidence of neovascular AMD, with an odds ratio of 2.37. This association remained unchanged after further adjustment for history of CVD, BMI, and blood pressure.

Aspirin therapy was not associated with the risk of geographic (dry) AMD.

The rate of neovascular AMD rose with increasing use of aspirin, from 2.2% among people who never took aspirin to 2.9% among occasional users to 5.8% among regular users, Dr. Liew and his associates said (JAMA Intern. Med. 2013 Jan. 21 [doi:10.1001/jamainternmed.2013.1583]).

The correlation between aspirin therapy and neovascular AMD remained robust in a further analysis of the data that adjusted for numerous risk factors and protective factors, such as white blood cell count, dietary factors, cholesterol levels, and the presence or absence of diabetes. The odds ratio was 2.05 in this analysis.

"Because aspirin use is strongly associated with painful conditions and CVD, we examined whether other medications associated with these conditions had a similar association with neovascular AMD," the investigators wrote. Acetaminophen, beta-blockers, and other drugs showed no significant associations with AMD.

"Although aspirin is one of the most effective CVD treatments and reduces recurrent CVD events by one-fifth, some meta-analyses have called into question the efficacy of aspirin use in CVD primary prevention and highlighted the significant adverse effects, such as increased gastrointestinal, intracerebral, and extracranial hemorrhage. Our study now raises the possibility that the risk of neovascular AMD may also need to be considered," Dr. Liew and his associates wrote.

At this time "there is insufficient evidence to recommend changing clinical practice, except perhaps in patients" who have strong risk factors for AMD, they added.

This study was supported by the National Health and Medical Research Council Australia. No financial conflicts of interest were reported.

The use of aspirin therapy approximately doubled the risk that age-related macular degeneration would develop over a period of 10-15 years in a secondary analysis of data in the Blue Mountain Eye Study, which was published online Jan. 21 in JAMA Internal Medicine.

The regular use of aspirin was significantly associated with an increased incidence of neovascular (wet) age-related macular degeneration (AMD), with an odds ratio of 2.37, independently of cardiovascular disease (CVD), smoking status, and numerous potentially confounding factors. However, "this potential risk appears to be small (3.7% after 15 years) and should be balanced with the significant morbidity and mortality of suboptimally treated CVD," said Gerald Liew, Ph.D., of the center for vision research, department of ophthalmology, University of Sydney, and his associates.

"Given the widespread use of aspirin, any increased risk of disabling conditions and morbidity will be significant and affect many people," they noted.

Several previous studies have examined the relationship between aspirin therapy and AMD, but the findings have been inconsistent. Dr. Liew and his colleagues performed a prospective study using the largest cohort and the longest follow-up to date. Their study subjects were 2,389 participants in the Blue Mountain Eye Study, a population-based cohort study of eye disease in urban Australians aged 49 years or older.

Aspirin use was determined from the subjects’ responses to a detailed questionnaire at baseline. "Although we did not collect information on aspirin dosage, most aspirin use in Australia is prescribed at 150 mg daily," the researchers said.

A total of 257 subjects (10.8%) used aspirin therapy.

At 15-year follow-up, 63 subjects had developed neovascular AMD.

Among subjects taking aspirin therapy, the cumulative rate of neovascular AMD was 1.9% at 5 years, 7% at 10 years, and 9.3% at 15 years. In comparison, these rates were 0.8% at 5 years, 1.6% at 10 years, and 3.7% at 15 years among subjects who did not take aspirin regularly.

The increase in risk became significant only after 10-15 years, "suggesting that cumulative dosage is important in pathogenesis" of neovascular AMD, the investigators said.

This long lead time also may explain why several previous studies that had shorter follow-up failed to detect the association, they added.

After the data were adjusted to account for subject age, sex, and smoking status, aspirin therapy was significantly associated with an increased incidence of neovascular AMD, with an odds ratio of 2.37. This association remained unchanged after further adjustment for history of CVD, BMI, and blood pressure.

Aspirin therapy was not associated with the risk of geographic (dry) AMD.

The rate of neovascular AMD rose with increasing use of aspirin, from 2.2% among people who never took aspirin to 2.9% among occasional users to 5.8% among regular users, Dr. Liew and his associates said (JAMA Intern. Med. 2013 Jan. 21 [doi:10.1001/jamainternmed.2013.1583]).

The correlation between aspirin therapy and neovascular AMD remained robust in a further analysis of the data that adjusted for numerous risk factors and protective factors, such as white blood cell count, dietary factors, cholesterol levels, and the presence or absence of diabetes. The odds ratio was 2.05 in this analysis.

"Because aspirin use is strongly associated with painful conditions and CVD, we examined whether other medications associated with these conditions had a similar association with neovascular AMD," the investigators wrote. Acetaminophen, beta-blockers, and other drugs showed no significant associations with AMD.

"Although aspirin is one of the most effective CVD treatments and reduces recurrent CVD events by one-fifth, some meta-analyses have called into question the efficacy of aspirin use in CVD primary prevention and highlighted the significant adverse effects, such as increased gastrointestinal, intracerebral, and extracranial hemorrhage. Our study now raises the possibility that the risk of neovascular AMD may also need to be considered," Dr. Liew and his associates wrote.

At this time "there is insufficient evidence to recommend changing clinical practice, except perhaps in patients" who have strong risk factors for AMD, they added.

This study was supported by the National Health and Medical Research Council Australia. No financial conflicts of interest were reported.

Nearly 9% of all routine outpatient colonoscopies that were performed in 1 year in a nationally representative sample of Medicare beneficiaries used anesthesia assistance – an anesthesiologist or nurse-anesthetist – to administer deep sedation using propofol.

The American Society for Gastrointestinal Endoscopy recommends against anesthesia assistance for such average-risk patients because it isn’t warranted and is cost-prohibitive. Nevertheless, in this retrospective cohort study using a nationally representative sample of 328,177 Medicare patients who underwent routine outpatient colonoscopy during 2003, anesthesia assistance was used in 8.7% of the procedures. This included 8.2% of procedures done in patients who had no comorbidities (Gastroenterology 2012 Oct. 29 [doi: 10.1053/j.gastro.2012.10.038]).

The researchers, led by Dr. Jason A. Dominitz of the VA Puget Sound Health Care System in Seattle, found that the use of anesthesia assistance varied dramatically by geographic location and by the endoscopist’s specialty. A very small proportion of the endoscopists in this study, 4.5%, accounted for more than 40% of the procedures performed using anesthesia assistance.

"Those endoscopists with very high rates of anesthesia assistance overwhelmingly practiced in an urban setting (95%) and were disproportionately represented by gastroenterologists (76%) and colorectal surgeons (10%)," as compared with general surgeons, internists, family physicians, or others.

"This practice has enormous economic implications for society, as the use of an anesthesia provider adds a considerable cost to each procedure and is at variance with recommendations from professional societies. In 2003, charges to Medicare for sedation by anesthesia professionals during colonoscopy were nearly $80 million," said Dr. Dominitz, who is also with the division of gastroenterology at the University of Washington, Seattle, and his associates.

"If the projected growth in the use of anesthesia assistance does reach 53% by 2015, the total national expenditure for this service could range from approximately $800 million to $3.8 billion annually," they noted.

The investigators studied this issue because the use of propofol for deep sedation during routine colonoscopies has increased markedly.

The study sample included only colonoscopies performed in hospital outpatient clinics, ambulatory surgery centers, private offices, and other outpatient settings by 18,578 physicians.

Among the study’s findings:

• Use of anesthesia assistance didn’t alter the rate of detection of colonic polyps or the rate of complications such as GI bleeding, perforation, and hospital/ED visits within 30 days.

• Use of anesthesia assistance varied widely among the states, and even between states that bordered each other. The lowest rates of use were in Montana (0.1%) and South Dakota (0.2%); the highest were in New Jersey (48.1%), New York (27.9%), and Nevada (26.0%). "This variation is most likely attributable to variation in reimbursement practices by different carriers," Dr. Dominitz and his associates said.

• Younger endoscopists and those with fewer years in practice were more likely than older endoscopists and those with more years in practice to use anesthesia assistance.

• The volume of patients seen by the endoscopist did not correlate with use of anesthesia assistance.

• More than 80% of general surgeons, internists, and family physicians performed no colonoscopies with anesthesia assistance.

• Anesthesia assistance was more frequently used in black than in white patients, perhaps because of the very high rates of use in urban settings, where there is more racial diversity. Urban patients were more than twice as likely to receive anesthesia assistance as rural patients.

In a sensitivity analysis excluding patients with comorbidities, the findings confirmed those of the main analysis.

This study was not designed to determine the reasons for these variations in the use of anesthesia assistance. However, the researchers speculated that because propofol has a faster onset and more rapid recovery time than opiates and benzodiazepines, it improves practice efficiency, allowing more procedures to be performed per day.

In addition, employing anesthesia providers can generate an extra income stream for endoscopy practices. And if endoscopists who practice outside of hospitals already employ anesthesia providers for higher-risk or hard-to-sedate patients, "it may be prudent business practice to utilize these providers for more routine cases as well," Dr. Dominitz and his colleagues said.

This study was supported by the American College of Gastroenterology, the American Society for Gastrointestinal Endoscopy, and the VA Puget Sound Health Care System. No financial conflicts of interest were reported.

Nearly 9% of all routine outpatient colonoscopies that were performed in 1 year in a nationally representative sample of Medicare beneficiaries used anesthesia assistance – an anesthesiologist or nurse-anesthetist – to administer deep sedation using propofol.

The American Society for Gastrointestinal Endoscopy recommends against anesthesia assistance for such average-risk patients because it isn’t warranted and is cost-prohibitive. Nevertheless, in this retrospective cohort study using a nationally representative sample of 328,177 Medicare patients who underwent routine outpatient colonoscopy during 2003, anesthesia assistance was used in 8.7% of the procedures. This included 8.2% of procedures done in patients who had no comorbidities (Gastroenterology 2012 Oct. 29 [doi: 10.1053/j.gastro.2012.10.038]).

The researchers, led by Dr. Jason A. Dominitz of the VA Puget Sound Health Care System in Seattle, found that the use of anesthesia assistance varied dramatically by geographic location and by the endoscopist’s specialty. A very small proportion of the endoscopists in this study, 4.5%, accounted for more than 40% of the procedures performed using anesthesia assistance.

"Those endoscopists with very high rates of anesthesia assistance overwhelmingly practiced in an urban setting (95%) and were disproportionately represented by gastroenterologists (76%) and colorectal surgeons (10%)," as compared with general surgeons, internists, family physicians, or others.

"This practice has enormous economic implications for society, as the use of an anesthesia provider adds a considerable cost to each procedure and is at variance with recommendations from professional societies. In 2003, charges to Medicare for sedation by anesthesia professionals during colonoscopy were nearly $80 million," said Dr. Dominitz, who is also with the division of gastroenterology at the University of Washington, Seattle, and his associates.

"If the projected growth in the use of anesthesia assistance does reach 53% by 2015, the total national expenditure for this service could range from approximately $800 million to $3.8 billion annually," they noted.

The investigators studied this issue because the use of propofol for deep sedation during routine colonoscopies has increased markedly.

The study sample included only colonoscopies performed in hospital outpatient clinics, ambulatory surgery centers, private offices, and other outpatient settings by 18,578 physicians.

Among the study’s findings:

• Use of anesthesia assistance didn’t alter the rate of detection of colonic polyps or the rate of complications such as GI bleeding, perforation, and hospital/ED visits within 30 days.

• Use of anesthesia assistance varied widely among the states, and even between states that bordered each other. The lowest rates of use were in Montana (0.1%) and South Dakota (0.2%); the highest were in New Jersey (48.1%), New York (27.9%), and Nevada (26.0%). "This variation is most likely attributable to variation in reimbursement practices by different carriers," Dr. Dominitz and his associates said.

• Younger endoscopists and those with fewer years in practice were more likely than older endoscopists and those with more years in practice to use anesthesia assistance.

• The volume of patients seen by the endoscopist did not correlate with use of anesthesia assistance.

• More than 80% of general surgeons, internists, and family physicians performed no colonoscopies with anesthesia assistance.

• Anesthesia assistance was more frequently used in black than in white patients, perhaps because of the very high rates of use in urban settings, where there is more racial diversity. Urban patients were more than twice as likely to receive anesthesia assistance as rural patients.

In a sensitivity analysis excluding patients with comorbidities, the findings confirmed those of the main analysis.

This study was not designed to determine the reasons for these variations in the use of anesthesia assistance. However, the researchers speculated that because propofol has a faster onset and more rapid recovery time than opiates and benzodiazepines, it improves practice efficiency, allowing more procedures to be performed per day.

In addition, employing anesthesia providers can generate an extra income stream for endoscopy practices. And if endoscopists who practice outside of hospitals already employ anesthesia providers for higher-risk or hard-to-sedate patients, "it may be prudent business practice to utilize these providers for more routine cases as well," Dr. Dominitz and his colleagues said.

This study was supported by the American College of Gastroenterology, the American Society for Gastrointestinal Endoscopy, and the VA Puget Sound Health Care System. No financial conflicts of interest were reported.

Nearly 9% of all routine outpatient colonoscopies that were performed in 1 year in a nationally representative sample of Medicare beneficiaries used anesthesia assistance – an anesthesiologist or nurse-anesthetist – to administer deep sedation using propofol.

The American Society for Gastrointestinal Endoscopy recommends against anesthesia assistance for such average-risk patients because it isn’t warranted and is cost-prohibitive. Nevertheless, in this retrospective cohort study using a nationally representative sample of 328,177 Medicare patients who underwent routine outpatient colonoscopy during 2003, anesthesia assistance was used in 8.7% of the procedures. This included 8.2% of procedures done in patients who had no comorbidities (Gastroenterology 2012 Oct. 29 [doi: 10.1053/j.gastro.2012.10.038]).

The researchers, led by Dr. Jason A. Dominitz of the VA Puget Sound Health Care System in Seattle, found that the use of anesthesia assistance varied dramatically by geographic location and by the endoscopist’s specialty. A very small proportion of the endoscopists in this study, 4.5%, accounted for more than 40% of the procedures performed using anesthesia assistance.

"Those endoscopists with very high rates of anesthesia assistance overwhelmingly practiced in an urban setting (95%) and were disproportionately represented by gastroenterologists (76%) and colorectal surgeons (10%)," as compared with general surgeons, internists, family physicians, or others.

"This practice has enormous economic implications for society, as the use of an anesthesia provider adds a considerable cost to each procedure and is at variance with recommendations from professional societies. In 2003, charges to Medicare for sedation by anesthesia professionals during colonoscopy were nearly $80 million," said Dr. Dominitz, who is also with the division of gastroenterology at the University of Washington, Seattle, and his associates.

"If the projected growth in the use of anesthesia assistance does reach 53% by 2015, the total national expenditure for this service could range from approximately $800 million to $3.8 billion annually," they noted.

The investigators studied this issue because the use of propofol for deep sedation during routine colonoscopies has increased markedly.

The study sample included only colonoscopies performed in hospital outpatient clinics, ambulatory surgery centers, private offices, and other outpatient settings by 18,578 physicians.

Among the study’s findings:

• Use of anesthesia assistance didn’t alter the rate of detection of colonic polyps or the rate of complications such as GI bleeding, perforation, and hospital/ED visits within 30 days.

• Use of anesthesia assistance varied widely among the states, and even between states that bordered each other. The lowest rates of use were in Montana (0.1%) and South Dakota (0.2%); the highest were in New Jersey (48.1%), New York (27.9%), and Nevada (26.0%). "This variation is most likely attributable to variation in reimbursement practices by different carriers," Dr. Dominitz and his associates said.

• Younger endoscopists and those with fewer years in practice were more likely than older endoscopists and those with more years in practice to use anesthesia assistance.

• The volume of patients seen by the endoscopist did not correlate with use of anesthesia assistance.

• More than 80% of general surgeons, internists, and family physicians performed no colonoscopies with anesthesia assistance.

• Anesthesia assistance was more frequently used in black than in white patients, perhaps because of the very high rates of use in urban settings, where there is more racial diversity. Urban patients were more than twice as likely to receive anesthesia assistance as rural patients.

In a sensitivity analysis excluding patients with comorbidities, the findings confirmed those of the main analysis.

This study was not designed to determine the reasons for these variations in the use of anesthesia assistance. However, the researchers speculated that because propofol has a faster onset and more rapid recovery time than opiates and benzodiazepines, it improves practice efficiency, allowing more procedures to be performed per day.

In addition, employing anesthesia providers can generate an extra income stream for endoscopy practices. And if endoscopists who practice outside of hospitals already employ anesthesia providers for higher-risk or hard-to-sedate patients, "it may be prudent business practice to utilize these providers for more routine cases as well," Dr. Dominitz and his colleagues said.

This study was supported by the American College of Gastroenterology, the American Society for Gastrointestinal Endoscopy, and the VA Puget Sound Health Care System. No financial conflicts of interest were reported.

The H1N1 influenza vaccine did not raise the risk of fetal death when given to pregnant women, according to a report published online Jan. 16 in the New England Journal of Medicine.

In a study analyzing data from Norwegian national health registries following the 2009 pandemic, "we found no evidence that influenza vaccination of pregnant women increased the risk of fetal death. However, influenza virus itself posed a major risk; among pregnant women who received a clinical diagnosis of influenza, the risk of fetal death nearly doubled," said Dr. Siri E. Hâberg of the Norwegian Institute of Public Health, Oslo, and her associates.

©Micah Young/istockphoto.com

Moreover, "vaccination appeared to provide some protection against excess fetal mortality during the pandemic," they noted.

"Our study adds to growing evidence that vaccination of pregnant women during an influenza pandemic does not harm – and may benefit – the fetus."

At the time of the pandemic the vaccine was considered safe and was recommended for pregnant women, who were at particular risk from H1N1. Early anecdotal reports of fetal losses in pregnant women, however, including 30 cases in Norway, raised concerns.

Dr. Hâberg and her colleagues used data from nationwide health registries to examine the issue.

There were 113,331 singleton births among women who became pregnant in Norway during the 2009-2010 flu season. A total of 492 fetal deaths occurred, for an overall rate of 4.3 fetal deaths per 1,000 births. Among 99,539 women who delivered outside the pandemic window, there were 410 fetal deaths, for a rate of 4.1 deaths per 1,000 births.

Just over half (54%) of women pregnant during the pandemic received the flu vaccine. As expected, vaccination substantially reduced the risk that they would contract influenza, they said.

There were 78 fetal deaths among the 25,976 (0.3%) women who were vaccinated during pregnancy and 414 among the 87,335 (0.5%) who were unvaccinated.

Compared with the reference group of women who were pregnant either before or after the pandemic, those who were pregnant during the pandemic and acquired influenza showed a markedly increased risk of fetal death, with an adjusted hazard ratio of 1.91. In contrast, the risk of fetal death was slightly lower in women who were pregnant during the pandemic and were vaccinated, with an adjusted HR of 0.88, the investigators said (N. Engl. J. Med. 2013 Jan. 16 [doi:10.1056/NEJMoa1207210]).

These findings remained robust in several further analyses, including a substudy that included women with multiple births; another that excluded cases in which the vaccine was administered during the first trimester; and another analysis that adjusted for variables such as maternal diabetes, chronic illness, body mass index, and smoking status.

"We also considered nonfatal birth outcomes (preterm delivery, low birth weight at term, and low Apgar score at term) and found no evidence of an association between vaccination and these outcomes," Dr. Hâberg and her associates wrote.

"We found no basis for withholding influenza vaccination from pregnant women in their second or third trimester – an important group, given that these women can be particularly vulnerable to the severe effects of influenza virus infection," they said.

Recent studies in Denmark and Canada "have likewise shown no evidence that influenza vaccination during the 2009 pandemic increased the risk of stillbirth or other adverse birth outcomes," the researchers added.

This study was supported by the Norwegian Institute of Public Health and the U.S. National Institute of Environmental Health Sciences. Disclosures for Dr. Hâberg and her associates were not available. The makers of the vaccines assessed in this study had no role in the study design, implementation, or funding.

The H1N1 influenza vaccine did not raise the risk of fetal death when given to pregnant women, according to a report published online Jan. 16 in the New England Journal of Medicine.

In a study analyzing data from Norwegian national health registries following the 2009 pandemic, "we found no evidence that influenza vaccination of pregnant women increased the risk of fetal death. However, influenza virus itself posed a major risk; among pregnant women who received a clinical diagnosis of influenza, the risk of fetal death nearly doubled," said Dr. Siri E. Hâberg of the Norwegian Institute of Public Health, Oslo, and her associates.

©Micah Young/istockphoto.com

Moreover, "vaccination appeared to provide some protection against excess fetal mortality during the pandemic," they noted.

"Our study adds to growing evidence that vaccination of pregnant women during an influenza pandemic does not harm – and may benefit – the fetus."

At the time of the pandemic the vaccine was considered safe and was recommended for pregnant women, who were at particular risk from H1N1. Early anecdotal reports of fetal losses in pregnant women, however, including 30 cases in Norway, raised concerns.

Dr. Hâberg and her colleagues used data from nationwide health registries to examine the issue.

There were 113,331 singleton births among women who became pregnant in Norway during the 2009-2010 flu season. A total of 492 fetal deaths occurred, for an overall rate of 4.3 fetal deaths per 1,000 births. Among 99,539 women who delivered outside the pandemic window, there were 410 fetal deaths, for a rate of 4.1 deaths per 1,000 births.

Just over half (54%) of women pregnant during the pandemic received the flu vaccine. As expected, vaccination substantially reduced the risk that they would contract influenza, they said.

There were 78 fetal deaths among the 25,976 (0.3%) women who were vaccinated during pregnancy and 414 among the 87,335 (0.5%) who were unvaccinated.

Compared with the reference group of women who were pregnant either before or after the pandemic, those who were pregnant during the pandemic and acquired influenza showed a markedly increased risk of fetal death, with an adjusted hazard ratio of 1.91. In contrast, the risk of fetal death was slightly lower in women who were pregnant during the pandemic and were vaccinated, with an adjusted HR of 0.88, the investigators said (N. Engl. J. Med. 2013 Jan. 16 [doi:10.1056/NEJMoa1207210]).

These findings remained robust in several further analyses, including a substudy that included women with multiple births; another that excluded cases in which the vaccine was administered during the first trimester; and another analysis that adjusted for variables such as maternal diabetes, chronic illness, body mass index, and smoking status.

"We also considered nonfatal birth outcomes (preterm delivery, low birth weight at term, and low Apgar score at term) and found no evidence of an association between vaccination and these outcomes," Dr. Hâberg and her associates wrote.

"We found no basis for withholding influenza vaccination from pregnant women in their second or third trimester – an important group, given that these women can be particularly vulnerable to the severe effects of influenza virus infection," they said.

Recent studies in Denmark and Canada "have likewise shown no evidence that influenza vaccination during the 2009 pandemic increased the risk of stillbirth or other adverse birth outcomes," the researchers added.

This study was supported by the Norwegian Institute of Public Health and the U.S. National Institute of Environmental Health Sciences. Disclosures for Dr. Hâberg and her associates were not available. The makers of the vaccines assessed in this study had no role in the study design, implementation, or funding.

The H1N1 influenza vaccine did not raise the risk of fetal death when given to pregnant women, according to a report published online Jan. 16 in the New England Journal of Medicine.

In a study analyzing data from Norwegian national health registries following the 2009 pandemic, "we found no evidence that influenza vaccination of pregnant women increased the risk of fetal death. However, influenza virus itself posed a major risk; among pregnant women who received a clinical diagnosis of influenza, the risk of fetal death nearly doubled," said Dr. Siri E. Hâberg of the Norwegian Institute of Public Health, Oslo, and her associates.

©Micah Young/istockphoto.com

Moreover, "vaccination appeared to provide some protection against excess fetal mortality during the pandemic," they noted.

"Our study adds to growing evidence that vaccination of pregnant women during an influenza pandemic does not harm – and may benefit – the fetus."

At the time of the pandemic the vaccine was considered safe and was recommended for pregnant women, who were at particular risk from H1N1. Early anecdotal reports of fetal losses in pregnant women, however, including 30 cases in Norway, raised concerns.

Dr. Hâberg and her colleagues used data from nationwide health registries to examine the issue.

There were 113,331 singleton births among women who became pregnant in Norway during the 2009-2010 flu season. A total of 492 fetal deaths occurred, for an overall rate of 4.3 fetal deaths per 1,000 births. Among 99,539 women who delivered outside the pandemic window, there were 410 fetal deaths, for a rate of 4.1 deaths per 1,000 births.

Just over half (54%) of women pregnant during the pandemic received the flu vaccine. As expected, vaccination substantially reduced the risk that they would contract influenza, they said.

There were 78 fetal deaths among the 25,976 (0.3%) women who were vaccinated during pregnancy and 414 among the 87,335 (0.5%) who were unvaccinated.

Compared with the reference group of women who were pregnant either before or after the pandemic, those who were pregnant during the pandemic and acquired influenza showed a markedly increased risk of fetal death, with an adjusted hazard ratio of 1.91. In contrast, the risk of fetal death was slightly lower in women who were pregnant during the pandemic and were vaccinated, with an adjusted HR of 0.88, the investigators said (N. Engl. J. Med. 2013 Jan. 16 [doi:10.1056/NEJMoa1207210]).

These findings remained robust in several further analyses, including a substudy that included women with multiple births; another that excluded cases in which the vaccine was administered during the first trimester; and another analysis that adjusted for variables such as maternal diabetes, chronic illness, body mass index, and smoking status.

"We also considered nonfatal birth outcomes (preterm delivery, low birth weight at term, and low Apgar score at term) and found no evidence of an association between vaccination and these outcomes," Dr. Hâberg and her associates wrote.

"We found no basis for withholding influenza vaccination from pregnant women in their second or third trimester – an important group, given that these women can be particularly vulnerable to the severe effects of influenza virus infection," they said.

Recent studies in Denmark and Canada "have likewise shown no evidence that influenza vaccination during the 2009 pandemic increased the risk of stillbirth or other adverse birth outcomes," the researchers added.

This study was supported by the Norwegian Institute of Public Health and the U.S. National Institute of Environmental Health Sciences. Disclosures for Dr. Hâberg and her associates were not available. The makers of the vaccines assessed in this study had no role in the study design, implementation, or funding.

Among critically ill adults requiring mechanical ventilation and receiving early enteral nutrition, it may not be necessary to routinely monitor residual gastric volume as a means of averting vomiting and thus preventing aspiration and the development of ventilator-associated pneumonia, according to a report in the Jan. 16 issue of JAMA.

In a multicenter randomized trial involving 449 such patients, forgoing routine monitoring of residual gastric volume was found "noninferior" at preventing ventilator-associated pneumonia to the standard practice of performing this monitoring every 6 hours. Moreover, patients who were not monitored actually were more likely to achieve their nutritional targets, while showing equivalent mortality, infection rates, lengths of hospital stay, lengths of ICU stay, and organ failure scores, said Dr. Jean Reignier of Centre Hospitalier Departemental de la Vendee, La Roche-sur Yon (France), and his associates.

"Residual gastric volume monitoring leads to unnecessary interruption of enteral nutrition delivery with subsequent inadequate feeding, and should be removed from the standard care of critically ill patients receiving invasive mechanical ventilation and early enteral nutrition," the investigators said.

It is thought that higher gastric volume causes intolerance of enteral feeding, with its attendant gastroesophageal reflux and vomiting. Monitoring of residual gastric volume involves periodically aspirating the stomach through the nasogastric tube with a 50-mL syringe. If the volume exceeds a cutoff – usually 250 mL – enteral nutrition is stopped or decreased to minimize the risk of vomiting, aspiration, and subsequent development of ventilator-associated pneumonia.

However, it has never been definitively established that increased gastric volume does lead to vomiting (or exactly what the cutoff amount should be), that this vomiting does lead to ventilator-associated pneumonia, or that the monitoring procedure actually reduces the risk of pneumonia. And monitoring has been linked to decreased calorie delivery and its associated morbidity.

Dr. Reignier and his colleagues found in a preliminary study at a single ICU that forgoing the monitoring procedure did not raise the rate of ventilator-associated pneumonia. They then performed this noninferiority study to test the theory that residual gastric volume monitoring may not be necessary for this purpose.

Adult patients who were expected to require more than 48 hours of mechanical ventilation at nine ICUs were enrolled over a 1-year period. Three of the ICUs were medical and six were medical-surgical. Three were in university hospitals and six were in general hospitals affiliated with a university.

The study subjects were randomly assigned to receive either standard care, which included monitoring of residual gastric volume every 6 hours or the "intervention" of no monitoring.

The primary outcome was the rate of ventilator-associated pneumonia. In the intention-to-treat analysis, this rate was 15.8% in the control group (222 patients) and 16.7% in the "intervention" group (227 patients), a nonsignificant difference. In the per-protocol analysis, this rate was 16.3% in the control group (215 patients) and 17.8% in the intervention group (208 patients), also a nonsignificant difference.

Thus, forgoing routine monitoring of residual gastric volume was noninferior to performing such monitoring at preventing this form of pneumonia, the researchers said (JAMA 2013;309:249-56).

In further analyses, the cumulative incidences of ventilator-associated pneumonia also were not significantly different between the two study groups. Microbiologic testing showed that the organisms causing pneumonia were the same between the two groups, as were the proportions of infections caused by Staphylococcus aureus, Streptococcus species, Enterobacteriaceae, and Pseudomonadaceae.

The two study groups also did not differ in short- or long-term mortality; rates of other ICU-acquired infections; scores on measures of organ failure; or the duration of ventilation, ICU stay, or hospital stay.

It was interesting that the proportion of patients who vomited was significantly higher in the unmonitored than in the monitored group, and that the number of vomiting episodes also was significantly higher in the unmonitored group, yet the rate of pneumonia was not significantly different, Dr. Reignier and his associates noted.

Despite higher rates of vomiting, more patients in the unmonitored group achieved their calorie targets on enteral nutrition.

The investigators proposed several explanations for their findings.

In several previous studies, residual gastric volumes did not correlate with vomiting or aspiration rates. Volumes lower than 250 mL did not correlate with decreased complications, and values as high as 500 mL did not correlate with increased rates of pneumonia.

Second, the measurement of residual gastric volume has never been standardized or validated. And the accuracy of gastric aspiration through the nasogastric tube may vary according to tube position, tube diameter, the number of tube openings in the stomach, the level of aspiration in the stomach, and the clinician’s experience, the investigators said.

Third, and perhaps most important, many studies have challenged the role of gastric aspiration in the development of ventilator-associated pneumonia. The oral cavity, not the stomach, may be the significant reservoir of pathogens that cause this form of pneumonia, they said.

Eliminating the routine monitoring of residual gastric volume would be advantageous in that it would significantly reduce the workload of nurses and other clinicians, allowing them to focus on other interventions that have proved their value, Dr. Reignier and his colleagues added.

The study was sponsored by Centre Hospitalier Departmental de la Vendee. No financial conflicts of interest were reported.

Among critically ill adults requiring mechanical ventilation and receiving early enteral nutrition, it may not be necessary to routinely monitor residual gastric volume as a means of averting vomiting and thus preventing aspiration and the development of ventilator-associated pneumonia, according to a report in the Jan. 16 issue of JAMA.

In a multicenter randomized trial involving 449 such patients, forgoing routine monitoring of residual gastric volume was found "noninferior" at preventing ventilator-associated pneumonia to the standard practice of performing this monitoring every 6 hours. Moreover, patients who were not monitored actually were more likely to achieve their nutritional targets, while showing equivalent mortality, infection rates, lengths of hospital stay, lengths of ICU stay, and organ failure scores, said Dr. Jean Reignier of Centre Hospitalier Departemental de la Vendee, La Roche-sur Yon (France), and his associates.

"Residual gastric volume monitoring leads to unnecessary interruption of enteral nutrition delivery with subsequent inadequate feeding, and should be removed from the standard care of critically ill patients receiving invasive mechanical ventilation and early enteral nutrition," the investigators said.

It is thought that higher gastric volume causes intolerance of enteral feeding, with its attendant gastroesophageal reflux and vomiting. Monitoring of residual gastric volume involves periodically aspirating the stomach through the nasogastric tube with a 50-mL syringe. If the volume exceeds a cutoff – usually 250 mL – enteral nutrition is stopped or decreased to minimize the risk of vomiting, aspiration, and subsequent development of ventilator-associated pneumonia.

However, it has never been definitively established that increased gastric volume does lead to vomiting (or exactly what the cutoff amount should be), that this vomiting does lead to ventilator-associated pneumonia, or that the monitoring procedure actually reduces the risk of pneumonia. And monitoring has been linked to decreased calorie delivery and its associated morbidity.

Dr. Reignier and his colleagues found in a preliminary study at a single ICU that forgoing the monitoring procedure did not raise the rate of ventilator-associated pneumonia. They then performed this noninferiority study to test the theory that residual gastric volume monitoring may not be necessary for this purpose.

Adult patients who were expected to require more than 48 hours of mechanical ventilation at nine ICUs were enrolled over a 1-year period. Three of the ICUs were medical and six were medical-surgical. Three were in university hospitals and six were in general hospitals affiliated with a university.

The study subjects were randomly assigned to receive either standard care, which included monitoring of residual gastric volume every 6 hours or the "intervention" of no monitoring.

The primary outcome was the rate of ventilator-associated pneumonia. In the intention-to-treat analysis, this rate was 15.8% in the control group (222 patients) and 16.7% in the "intervention" group (227 patients), a nonsignificant difference. In the per-protocol analysis, this rate was 16.3% in the control group (215 patients) and 17.8% in the intervention group (208 patients), also a nonsignificant difference.

Thus, forgoing routine monitoring of residual gastric volume was noninferior to performing such monitoring at preventing this form of pneumonia, the researchers said (JAMA 2013;309:249-56).

In further analyses, the cumulative incidences of ventilator-associated pneumonia also were not significantly different between the two study groups. Microbiologic testing showed that the organisms causing pneumonia were the same between the two groups, as were the proportions of infections caused by Staphylococcus aureus, Streptococcus species, Enterobacteriaceae, and Pseudomonadaceae.

The two study groups also did not differ in short- or long-term mortality; rates of other ICU-acquired infections; scores on measures of organ failure; or the duration of ventilation, ICU stay, or hospital stay.

It was interesting that the proportion of patients who vomited was significantly higher in the unmonitored than in the monitored group, and that the number of vomiting episodes also was significantly higher in the unmonitored group, yet the rate of pneumonia was not significantly different, Dr. Reignier and his associates noted.

Despite higher rates of vomiting, more patients in the unmonitored group achieved their calorie targets on enteral nutrition.

The investigators proposed several explanations for their findings.

In several previous studies, residual gastric volumes did not correlate with vomiting or aspiration rates. Volumes lower than 250 mL did not correlate with decreased complications, and values as high as 500 mL did not correlate with increased rates of pneumonia.

Second, the measurement of residual gastric volume has never been standardized or validated. And the accuracy of gastric aspiration through the nasogastric tube may vary according to tube position, tube diameter, the number of tube openings in the stomach, the level of aspiration in the stomach, and the clinician’s experience, the investigators said.

Third, and perhaps most important, many studies have challenged the role of gastric aspiration in the development of ventilator-associated pneumonia. The oral cavity, not the stomach, may be the significant reservoir of pathogens that cause this form of pneumonia, they said.

Eliminating the routine monitoring of residual gastric volume would be advantageous in that it would significantly reduce the workload of nurses and other clinicians, allowing them to focus on other interventions that have proved their value, Dr. Reignier and his colleagues added.

The study was sponsored by Centre Hospitalier Departmental de la Vendee. No financial conflicts of interest were reported.

Among critically ill adults requiring mechanical ventilation and receiving early enteral nutrition, it may not be necessary to routinely monitor residual gastric volume as a means of averting vomiting and thus preventing aspiration and the development of ventilator-associated pneumonia, according to a report in the Jan. 16 issue of JAMA.

In a multicenter randomized trial involving 449 such patients, forgoing routine monitoring of residual gastric volume was found "noninferior" at preventing ventilator-associated pneumonia to the standard practice of performing this monitoring every 6 hours. Moreover, patients who were not monitored actually were more likely to achieve their nutritional targets, while showing equivalent mortality, infection rates, lengths of hospital stay, lengths of ICU stay, and organ failure scores, said Dr. Jean Reignier of Centre Hospitalier Departemental de la Vendee, La Roche-sur Yon (France), and his associates.

"Residual gastric volume monitoring leads to unnecessary interruption of enteral nutrition delivery with subsequent inadequate feeding, and should be removed from the standard care of critically ill patients receiving invasive mechanical ventilation and early enteral nutrition," the investigators said.

It is thought that higher gastric volume causes intolerance of enteral feeding, with its attendant gastroesophageal reflux and vomiting. Monitoring of residual gastric volume involves periodically aspirating the stomach through the nasogastric tube with a 50-mL syringe. If the volume exceeds a cutoff – usually 250 mL – enteral nutrition is stopped or decreased to minimize the risk of vomiting, aspiration, and subsequent development of ventilator-associated pneumonia.

However, it has never been definitively established that increased gastric volume does lead to vomiting (or exactly what the cutoff amount should be), that this vomiting does lead to ventilator-associated pneumonia, or that the monitoring procedure actually reduces the risk of pneumonia. And monitoring has been linked to decreased calorie delivery and its associated morbidity.

Dr. Reignier and his colleagues found in a preliminary study at a single ICU that forgoing the monitoring procedure did not raise the rate of ventilator-associated pneumonia. They then performed this noninferiority study to test the theory that residual gastric volume monitoring may not be necessary for this purpose.

Adult patients who were expected to require more than 48 hours of mechanical ventilation at nine ICUs were enrolled over a 1-year period. Three of the ICUs were medical and six were medical-surgical. Three were in university hospitals and six were in general hospitals affiliated with a university.

The study subjects were randomly assigned to receive either standard care, which included monitoring of residual gastric volume every 6 hours or the "intervention" of no monitoring.

The primary outcome was the rate of ventilator-associated pneumonia. In the intention-to-treat analysis, this rate was 15.8% in the control group (222 patients) and 16.7% in the "intervention" group (227 patients), a nonsignificant difference. In the per-protocol analysis, this rate was 16.3% in the control group (215 patients) and 17.8% in the intervention group (208 patients), also a nonsignificant difference.

Thus, forgoing routine monitoring of residual gastric volume was noninferior to performing such monitoring at preventing this form of pneumonia, the researchers said (JAMA 2013;309:249-56).

In further analyses, the cumulative incidences of ventilator-associated pneumonia also were not significantly different between the two study groups. Microbiologic testing showed that the organisms causing pneumonia were the same between the two groups, as were the proportions of infections caused by Staphylococcus aureus, Streptococcus species, Enterobacteriaceae, and Pseudomonadaceae.

The two study groups also did not differ in short- or long-term mortality; rates of other ICU-acquired infections; scores on measures of organ failure; or the duration of ventilation, ICU stay, or hospital stay.

It was interesting that the proportion of patients who vomited was significantly higher in the unmonitored than in the monitored group, and that the number of vomiting episodes also was significantly higher in the unmonitored group, yet the rate of pneumonia was not significantly different, Dr. Reignier and his associates noted.

Despite higher rates of vomiting, more patients in the unmonitored group achieved their calorie targets on enteral nutrition.

The investigators proposed several explanations for their findings.

In several previous studies, residual gastric volumes did not correlate with vomiting or aspiration rates. Volumes lower than 250 mL did not correlate with decreased complications, and values as high as 500 mL did not correlate with increased rates of pneumonia.

Second, the measurement of residual gastric volume has never been standardized or validated. And the accuracy of gastric aspiration through the nasogastric tube may vary according to tube position, tube diameter, the number of tube openings in the stomach, the level of aspiration in the stomach, and the clinician’s experience, the investigators said.

Third, and perhaps most important, many studies have challenged the role of gastric aspiration in the development of ventilator-associated pneumonia. The oral cavity, not the stomach, may be the significant reservoir of pathogens that cause this form of pneumonia, they said.

Eliminating the routine monitoring of residual gastric volume would be advantageous in that it would significantly reduce the workload of nurses and other clinicians, allowing them to focus on other interventions that have proved their value, Dr. Reignier and his colleagues added.

The study was sponsored by Centre Hospitalier Departmental de la Vendee. No financial conflicts of interest were reported.

Seizures that occur in patients admitted to the hospital for nonseizure reasons are likely to recur during the hospital stay, usually carry a high risk of mortality and morbidity, and often are not treated optimally, according to a report published online Jan. 14 in JAMA Neurology.

In a retrospective study of 218 patients who developed seizures when they were inpatients at medical, surgical, or emergency departments at two New York hospitals, the overall rate of death or discharge to hospice care was 14%, said Dr. Madeline C. Fields of the department of neurology at Mount Sinai School of Medicine, New York, and her associates.

The investigators undertook this study to describe the epidemiology of hospital-onset seizures because until now, no studies in the United States have done so. No management guidelines are available for clinicians, and even the usefulness of antiepileptic drugs (AEDs) is uncertain. "This is surprising considering that hospital-onset seizures are dramatic events that often lead to increased intensity of medical care, consultations, and prolonged hospital stays," they noted.

The Agency for Healthcare Research and Quality estimates that seizures develop during approximately 1.4 million hospitalizations each year, or about 4% of all annual hospitalizations. When they develop in people with no history of seizure, it is usually because of stroke, infection, or metabolic disturbances. When they develop in people with a history of seizure, it is thought to be because stress, medication, sleep deprivation, fever, or other factors related to the hospitalization exacerbate the underlying seizure disorder.

Dr. Fields and her colleagues reviewed 1 year of medical records from a large nonprofit and a large municipal hospital affiliated with New York University, identifying 218 cases in which adults admitted for nonseizure indications developed hospital-onset seizures. Most of these cases (64%) occurred in patients without a history of seizures.

Among the 79 (36%) patients with a history of seizures, 16 (20%) were not taking AEDs at hospitalization, 32 (41%) were taking a single AED, and 31 (39%) were taking two or more AEDs.

Most patients (61%) in the entire study population had multiple seizures during the hospital stay. A total of 39% had seizures on multiple days, while another 22% had multiple seizures during a single day. Close to half (43%) of the patients who had new-onset seizures had recurrences during the hospital stay, as did 32% of patients who had a history of seizure.

These high rates of seizure recurrence "have never been reported and may be important" for clinicians trying to manage such cases, the researchers said (JAMA Neurol. 2013 Jan. 14 [doi:10.1001/2013.jamaneurol.337]).

Status epilepticus occurred in 8% of patients overall and was the index seizure in 6% overall.

The most common types of seizure were generalized tonic-clonic convulsions (33%) and complex partial seizures (21%). This was true in both patients with no history of seizures and in those with known seizure disorders.

The most frequent identifiable reasons for the seizures, other than exacerbation of an existing seizure disorder, were stroke, metabolic derangement, and brain tumor. Stroke was the most common etiology in patients who had multiple seizures during a single day, whereas metabolic abnormalities were the most common etiology in patients who had isolated seizures on multiple days.

Death or discharge to hospice care was considered "common" in this study, occurring in 14% of patients overall. Among patients with no history of seizures, this rate was even higher at 19%. This outcome occurred more often in patients who had recurrences during their stay (21%) than in those who had only a single seizure while hospitalized (10%).

In other settings, newer AEDs are recommended for patients with comorbidities because they are less likely than are older agents to interact with other medications, less likely to provoke adverse reactions, and do not carry the risk of protein-binding abnormalities that older agents do. However, in this study, older AEDs were much more likely to be prescribed.

Phenytoin was the first-line choice in half of the patients who had no history of seizures, as well as in 28% of those who had a history of seizures.

Moreover, "phenytoin was not always used in a manner commensurate with current standards," Dr. Fields and her associates wrote.

The loading dose of IV phenytoin often was not individualized to the patient, resulting in a subtherapeutic dose in 21% of cases and a supratherapeutic dose in 9%. The loading dose was not checked in another 29% of cases.

In addition, 26% of the patients discharged from the hospital were given prescriptions for phenytoin at that time. It may be that selection of this hepatic-enzyme-inducing drug was "predicated on acute choice rather than consideration of the consequences of long-term therapy in what is most likely an ill population receiving concomitant medications whose metabolism could be affected by phenytoin," the researchers wrote.

Benzodiazepines were the first line choice of AEDs in 61% of patients, including 25% of those whose index seizure was status epilepticus. Levetiracetam was the first line choice in another 24% of patients who had no history of seizures.

"This study provides preliminary data that could be used to plan a randomized controlled trial. Seizure recurrence was common enough that it could be a primary outcome measure," the investigators added.

This study was funded by Pfizer under a paid consultant agreement with the New York University Comprehensive Epilepsy Center, through which the investigators conducted their research and wrote their report. Two of the authors were employees of the center at the time of the study. One author reported ties to the Milken Foundation, the Epilepsy Therapy Project, the Epilepsy Study Consortium, and the National Institute of Neurological Disorders and Stroke.

Seizures that occur in patients admitted to the hospital for nonseizure reasons are likely to recur during the hospital stay, usually carry a high risk of mortality and morbidity, and often are not treated optimally, according to a report published online Jan. 14 in JAMA Neurology.

In a retrospective study of 218 patients who developed seizures when they were inpatients at medical, surgical, or emergency departments at two New York hospitals, the overall rate of death or discharge to hospice care was 14%, said Dr. Madeline C. Fields of the department of neurology at Mount Sinai School of Medicine, New York, and her associates.

The investigators undertook this study to describe the epidemiology of hospital-onset seizures because until now, no studies in the United States have done so. No management guidelines are available for clinicians, and even the usefulness of antiepileptic drugs (AEDs) is uncertain. "This is surprising considering that hospital-onset seizures are dramatic events that often lead to increased intensity of medical care, consultations, and prolonged hospital stays," they noted.

The Agency for Healthcare Research and Quality estimates that seizures develop during approximately 1.4 million hospitalizations each year, or about 4% of all annual hospitalizations. When they develop in people with no history of seizure, it is usually because of stroke, infection, or metabolic disturbances. When they develop in people with a history of seizure, it is thought to be because stress, medication, sleep deprivation, fever, or other factors related to the hospitalization exacerbate the underlying seizure disorder.

Dr. Fields and her colleagues reviewed 1 year of medical records from a large nonprofit and a large municipal hospital affiliated with New York University, identifying 218 cases in which adults admitted for nonseizure indications developed hospital-onset seizures. Most of these cases (64%) occurred in patients without a history of seizures.

Among the 79 (36%) patients with a history of seizures, 16 (20%) were not taking AEDs at hospitalization, 32 (41%) were taking a single AED, and 31 (39%) were taking two or more AEDs.

Most patients (61%) in the entire study population had multiple seizures during the hospital stay. A total of 39% had seizures on multiple days, while another 22% had multiple seizures during a single day. Close to half (43%) of the patients who had new-onset seizures had recurrences during the hospital stay, as did 32% of patients who had a history of seizure.

These high rates of seizure recurrence "have never been reported and may be important" for clinicians trying to manage such cases, the researchers said (JAMA Neurol. 2013 Jan. 14 [doi:10.1001/2013.jamaneurol.337]).

Status epilepticus occurred in 8% of patients overall and was the index seizure in 6% overall.

The most common types of seizure were generalized tonic-clonic convulsions (33%) and complex partial seizures (21%). This was true in both patients with no history of seizures and in those with known seizure disorders.

The most frequent identifiable reasons for the seizures, other than exacerbation of an existing seizure disorder, were stroke, metabolic derangement, and brain tumor. Stroke was the most common etiology in patients who had multiple seizures during a single day, whereas metabolic abnormalities were the most common etiology in patients who had isolated seizures on multiple days.

Death or discharge to hospice care was considered "common" in this study, occurring in 14% of patients overall. Among patients with no history of seizures, this rate was even higher at 19%. This outcome occurred more often in patients who had recurrences during their stay (21%) than in those who had only a single seizure while hospitalized (10%).

In other settings, newer AEDs are recommended for patients with comorbidities because they are less likely than are older agents to interact with other medications, less likely to provoke adverse reactions, and do not carry the risk of protein-binding abnormalities that older agents do. However, in this study, older AEDs were much more likely to be prescribed.

Phenytoin was the first-line choice in half of the patients who had no history of seizures, as well as in 28% of those who had a history of seizures.

Moreover, "phenytoin was not always used in a manner commensurate with current standards," Dr. Fields and her associates wrote.

The loading dose of IV phenytoin often was not individualized to the patient, resulting in a subtherapeutic dose in 21% of cases and a supratherapeutic dose in 9%. The loading dose was not checked in another 29% of cases.

In addition, 26% of the patients discharged from the hospital were given prescriptions for phenytoin at that time. It may be that selection of this hepatic-enzyme-inducing drug was "predicated on acute choice rather than consideration of the consequences of long-term therapy in what is most likely an ill population receiving concomitant medications whose metabolism could be affected by phenytoin," the researchers wrote.

Benzodiazepines were the first line choice of AEDs in 61% of patients, including 25% of those whose index seizure was status epilepticus. Levetiracetam was the first line choice in another 24% of patients who had no history of seizures.

"This study provides preliminary data that could be used to plan a randomized controlled trial. Seizure recurrence was common enough that it could be a primary outcome measure," the investigators added.

This study was funded by Pfizer under a paid consultant agreement with the New York University Comprehensive Epilepsy Center, through which the investigators conducted their research and wrote their report. Two of the authors were employees of the center at the time of the study. One author reported ties to the Milken Foundation, the Epilepsy Therapy Project, the Epilepsy Study Consortium, and the National Institute of Neurological Disorders and Stroke.

Seizures that occur in patients admitted to the hospital for nonseizure reasons are likely to recur during the hospital stay, usually carry a high risk of mortality and morbidity, and often are not treated optimally, according to a report published online Jan. 14 in JAMA Neurology.

In a retrospective study of 218 patients who developed seizures when they were inpatients at medical, surgical, or emergency departments at two New York hospitals, the overall rate of death or discharge to hospice care was 14%, said Dr. Madeline C. Fields of the department of neurology at Mount Sinai School of Medicine, New York, and her associates.

The investigators undertook this study to describe the epidemiology of hospital-onset seizures because until now, no studies in the United States have done so. No management guidelines are available for clinicians, and even the usefulness of antiepileptic drugs (AEDs) is uncertain. "This is surprising considering that hospital-onset seizures are dramatic events that often lead to increased intensity of medical care, consultations, and prolonged hospital stays," they noted.

The Agency for Healthcare Research and Quality estimates that seizures develop during approximately 1.4 million hospitalizations each year, or about 4% of all annual hospitalizations. When they develop in people with no history of seizure, it is usually because of stroke, infection, or metabolic disturbances. When they develop in people with a history of seizure, it is thought to be because stress, medication, sleep deprivation, fever, or other factors related to the hospitalization exacerbate the underlying seizure disorder.

Dr. Fields and her colleagues reviewed 1 year of medical records from a large nonprofit and a large municipal hospital affiliated with New York University, identifying 218 cases in which adults admitted for nonseizure indications developed hospital-onset seizures. Most of these cases (64%) occurred in patients without a history of seizures.

Among the 79 (36%) patients with a history of seizures, 16 (20%) were not taking AEDs at hospitalization, 32 (41%) were taking a single AED, and 31 (39%) were taking two or more AEDs.

Most patients (61%) in the entire study population had multiple seizures during the hospital stay. A total of 39% had seizures on multiple days, while another 22% had multiple seizures during a single day. Close to half (43%) of the patients who had new-onset seizures had recurrences during the hospital stay, as did 32% of patients who had a history of seizure.

These high rates of seizure recurrence "have never been reported and may be important" for clinicians trying to manage such cases, the researchers said (JAMA Neurol. 2013 Jan. 14 [doi:10.1001/2013.jamaneurol.337]).

Status epilepticus occurred in 8% of patients overall and was the index seizure in 6% overall.

The most common types of seizure were generalized tonic-clonic convulsions (33%) and complex partial seizures (21%). This was true in both patients with no history of seizures and in those with known seizure disorders.

The most frequent identifiable reasons for the seizures, other than exacerbation of an existing seizure disorder, were stroke, metabolic derangement, and brain tumor. Stroke was the most common etiology in patients who had multiple seizures during a single day, whereas metabolic abnormalities were the most common etiology in patients who had isolated seizures on multiple days.

Death or discharge to hospice care was considered "common" in this study, occurring in 14% of patients overall. Among patients with no history of seizures, this rate was even higher at 19%. This outcome occurred more often in patients who had recurrences during their stay (21%) than in those who had only a single seizure while hospitalized (10%).

In other settings, newer AEDs are recommended for patients with comorbidities because they are less likely than are older agents to interact with other medications, less likely to provoke adverse reactions, and do not carry the risk of protein-binding abnormalities that older agents do. However, in this study, older AEDs were much more likely to be prescribed.

Phenytoin was the first-line choice in half of the patients who had no history of seizures, as well as in 28% of those who had a history of seizures.

Moreover, "phenytoin was not always used in a manner commensurate with current standards," Dr. Fields and her associates wrote.

The loading dose of IV phenytoin often was not individualized to the patient, resulting in a subtherapeutic dose in 21% of cases and a supratherapeutic dose in 9%. The loading dose was not checked in another 29% of cases.

In addition, 26% of the patients discharged from the hospital were given prescriptions for phenytoin at that time. It may be that selection of this hepatic-enzyme-inducing drug was "predicated on acute choice rather than consideration of the consequences of long-term therapy in what is most likely an ill population receiving concomitant medications whose metabolism could be affected by phenytoin," the researchers wrote.

Benzodiazepines were the first line choice of AEDs in 61% of patients, including 25% of those whose index seizure was status epilepticus. Levetiracetam was the first line choice in another 24% of patients who had no history of seizures.

"This study provides preliminary data that could be used to plan a randomized controlled trial. Seizure recurrence was common enough that it could be a primary outcome measure," the investigators added.

This study was funded by Pfizer under a paid consultant agreement with the New York University Comprehensive Epilepsy Center, through which the investigators conducted their research and wrote their report. Two of the authors were employees of the center at the time of the study. One author reported ties to the Milken Foundation, the Epilepsy Therapy Project, the Epilepsy Study Consortium, and the National Institute of Neurological Disorders and Stroke.

A decision-support algorithm to help primary care physicians assess adolescents and adults with uncomplicated acute bronchitis reduced unnecessary antibiotic use by about 10%, according to a report published online Jan. 14 in JAMA Internal Medicine.

Plus, printed and computer-assisted approaches alike decreased the overuse of antibiotic treatment in primary care practices, said Dr. Ralph Gonzales of the departments of medicine and epidemiology and biostatistics, University of California, San Francisco, and his associates (JAMA Intern. Med. 2013 Jan. 14 [doi:10.1001/jamainternmed.2013.1589]).

Reduced antibiotic use did not result in a significant increase in return visits to either the study’s primary care practices or a hospital, the researchers noted. So it appears that there was no appreciable increase in the adverse clinical consequences of withholding antibiotics, such as a rise in the incidence of pneumonia.

"In aggregate, these findings support the wider dissemination and use of this clinical algorithm to help reduce the overuse of antibiotics for acute bronchitis in primary care," the investigators said.

Dr. Gonzales and his colleagues tested the algorithm in a randomized, controlled trial involving 33 primary care practices from Geisinger Health System in rural and semirural central and northeastern Pennsylvania.

In addition to patient education materials, the decision-support algorithm included clinician education materials, such as:

– Prompts for taking an appropriate history and physical examination of all patients presenting with cough illness.

– A way to calculate a patient’s probability of having pneumonia.

– A list of relevant testing and treatment options for bronchitis.

– Feedback on the clinicians’ performance in appropriately prescribing antibiotics.

Eleven primary care practices were randomly assigned to use a printed version of the decision-support algorithm, 11 to use a computerized version, and 11 to serve as control practices where no decision-support algorithm was implemented.

The study included all of the practices’ board-certified internal medicine and family practice physicians, nurse practitioners, physician assistants, and registered nurses. The patient population comprised all adolescents and adults aged 13-64 years who presented with uncomplicated acute bronchitis during a single winter-season intervention period.

The data from these 6,242 patient cases were compared with those of 9,808 cases that occurred during the three winter seasons preceding implementation of the decision-support algorithm.

The number of visits for acute respiratory infections and the proportion diagnosed as uncomplicated acute bronchitis remained stable over time and across the study sites.

Compared with the preintervention period, the percentage of patients who were prescribed antibiotics during the intervention period decreased by 11.7% (from 80.0% to 68.3%) in practices using the print algorithm, and by 13.3% (from 74.0% to 60.7%) in practices using the computerized algorithm.

Those declines were significantly greater than the change in antibiotic prescribing seen in the control practices, where clinicians actually increased the use of antibiotics by 1.8%, from 72.5% to 74.3%, Dr. Gonzales and his associates said.

The percentage of patients who were not given antibiotics and who subsequently developed pneumonia requiring return visits remained "low" in all practices at all time periods, ranging from 0.5% to 1.5%.

The study results indicate that both conventional (printed) and computerized strategies for decision support are effective at reducing unwarranted use of antibiotics in uncomplicated acute bronchitis, the investigators said.

However, the findings may not be applicable in all settings, the researchers cautioned, because the study included only small- to medium-sized primary care practices within an integrated health care system in a rural and semirural region.

In addition, the study could not establish whether the declines in inappropriate prescription of antibiotics were due to the patient education component, the clinician education component, some other component, or simply to all clinicians’ knowledge that they were being monitored, the researchers said.

The Centers for Disease Control and Prevention supported the study. Dr. Gonzales reported ties to Phreesia, and an associate reported ties to Merck.

A decision-support algorithm to help primary care physicians assess adolescents and adults with uncomplicated acute bronchitis reduced unnecessary antibiotic use by about 10%, according to a report published online Jan. 14 in JAMA Internal Medicine.

Plus, printed and computer-assisted approaches alike decreased the overuse of antibiotic treatment in primary care practices, said Dr. Ralph Gonzales of the departments of medicine and epidemiology and biostatistics, University of California, San Francisco, and his associates (JAMA Intern. Med. 2013 Jan. 14 [doi:10.1001/jamainternmed.2013.1589]).

Reduced antibiotic use did not result in a significant increase in return visits to either the study’s primary care practices or a hospital, the researchers noted. So it appears that there was no appreciable increase in the adverse clinical consequences of withholding antibiotics, such as a rise in the incidence of pneumonia.

"In aggregate, these findings support the wider dissemination and use of this clinical algorithm to help reduce the overuse of antibiotics for acute bronchitis in primary care," the investigators said.

Dr. Gonzales and his colleagues tested the algorithm in a randomized, controlled trial involving 33 primary care practices from Geisinger Health System in rural and semirural central and northeastern Pennsylvania.

In addition to patient education materials, the decision-support algorithm included clinician education materials, such as:

– Prompts for taking an appropriate history and physical examination of all patients presenting with cough illness.

– A way to calculate a patient’s probability of having pneumonia.

– A list of relevant testing and treatment options for bronchitis.

– Feedback on the clinicians’ performance in appropriately prescribing antibiotics.

Eleven primary care practices were randomly assigned to use a printed version of the decision-support algorithm, 11 to use a computerized version, and 11 to serve as control practices where no decision-support algorithm was implemented.

The study included all of the practices’ board-certified internal medicine and family practice physicians, nurse practitioners, physician assistants, and registered nurses. The patient population comprised all adolescents and adults aged 13-64 years who presented with uncomplicated acute bronchitis during a single winter-season intervention period.

The data from these 6,242 patient cases were compared with those of 9,808 cases that occurred during the three winter seasons preceding implementation of the decision-support algorithm.

The number of visits for acute respiratory infections and the proportion diagnosed as uncomplicated acute bronchitis remained stable over time and across the study sites.

Compared with the preintervention period, the percentage of patients who were prescribed antibiotics during the intervention period decreased by 11.7% (from 80.0% to 68.3%) in practices using the print algorithm, and by 13.3% (from 74.0% to 60.7%) in practices using the computerized algorithm.

Those declines were significantly greater than the change in antibiotic prescribing seen in the control practices, where clinicians actually increased the use of antibiotics by 1.8%, from 72.5% to 74.3%, Dr. Gonzales and his associates said.

The percentage of patients who were not given antibiotics and who subsequently developed pneumonia requiring return visits remained "low" in all practices at all time periods, ranging from 0.5% to 1.5%.

The study results indicate that both conventional (printed) and computerized strategies for decision support are effective at reducing unwarranted use of antibiotics in uncomplicated acute bronchitis, the investigators said.

However, the findings may not be applicable in all settings, the researchers cautioned, because the study included only small- to medium-sized primary care practices within an integrated health care system in a rural and semirural region.

In addition, the study could not establish whether the declines in inappropriate prescription of antibiotics were due to the patient education component, the clinician education component, some other component, or simply to all clinicians’ knowledge that they were being monitored, the researchers said.

The Centers for Disease Control and Prevention supported the study. Dr. Gonzales reported ties to Phreesia, and an associate reported ties to Merck.

A decision-support algorithm to help primary care physicians assess adolescents and adults with uncomplicated acute bronchitis reduced unnecessary antibiotic use by about 10%, according to a report published online Jan. 14 in JAMA Internal Medicine.

Plus, printed and computer-assisted approaches alike decreased the overuse of antibiotic treatment in primary care practices, said Dr. Ralph Gonzales of the departments of medicine and epidemiology and biostatistics, University of California, San Francisco, and his associates (JAMA Intern. Med. 2013 Jan. 14 [doi:10.1001/jamainternmed.2013.1589]).

Reduced antibiotic use did not result in a significant increase in return visits to either the study’s primary care practices or a hospital, the researchers noted. So it appears that there was no appreciable increase in the adverse clinical consequences of withholding antibiotics, such as a rise in the incidence of pneumonia.

"In aggregate, these findings support the wider dissemination and use of this clinical algorithm to help reduce the overuse of antibiotics for acute bronchitis in primary care," the investigators said.

Dr. Gonzales and his colleagues tested the algorithm in a randomized, controlled trial involving 33 primary care practices from Geisinger Health System in rural and semirural central and northeastern Pennsylvania.

In addition to patient education materials, the decision-support algorithm included clinician education materials, such as:

– Prompts for taking an appropriate history and physical examination of all patients presenting with cough illness.

– A way to calculate a patient’s probability of having pneumonia.

– A list of relevant testing and treatment options for bronchitis.

– Feedback on the clinicians’ performance in appropriately prescribing antibiotics.

Eleven primary care practices were randomly assigned to use a printed version of the decision-support algorithm, 11 to use a computerized version, and 11 to serve as control practices where no decision-support algorithm was implemented.

The study included all of the practices’ board-certified internal medicine and family practice physicians, nurse practitioners, physician assistants, and registered nurses. The patient population comprised all adolescents and adults aged 13-64 years who presented with uncomplicated acute bronchitis during a single winter-season intervention period.

The data from these 6,242 patient cases were compared with those of 9,808 cases that occurred during the three winter seasons preceding implementation of the decision-support algorithm.

The number of visits for acute respiratory infections and the proportion diagnosed as uncomplicated acute bronchitis remained stable over time and across the study sites.

Compared with the preintervention period, the percentage of patients who were prescribed antibiotics during the intervention period decreased by 11.7% (from 80.0% to 68.3%) in practices using the print algorithm, and by 13.3% (from 74.0% to 60.7%) in practices using the computerized algorithm.

Those declines were significantly greater than the change in antibiotic prescribing seen in the control practices, where clinicians actually increased the use of antibiotics by 1.8%, from 72.5% to 74.3%, Dr. Gonzales and his associates said.

The percentage of patients who were not given antibiotics and who subsequently developed pneumonia requiring return visits remained "low" in all practices at all time periods, ranging from 0.5% to 1.5%.

The study results indicate that both conventional (printed) and computerized strategies for decision support are effective at reducing unwarranted use of antibiotics in uncomplicated acute bronchitis, the investigators said.

However, the findings may not be applicable in all settings, the researchers cautioned, because the study included only small- to medium-sized primary care practices within an integrated health care system in a rural and semirural region.

In addition, the study could not establish whether the declines in inappropriate prescription of antibiotics were due to the patient education component, the clinician education component, some other component, or simply to all clinicians’ knowledge that they were being monitored, the researchers said.

The Centers for Disease Control and Prevention supported the study. Dr. Gonzales reported ties to Phreesia, and an associate reported ties to Merck.