IBD & Intestinal Disorders

SAN DIEGO – Fecal microbiota transplantation (FMT) is now first-line therapy for Clostridium difficile infection (CDI) in much of Scandinavia. At an annual conference on infectious diseases, two specialists debated whether that should be the case in the United States, too.

The epidemiology of CDI has changed greatly in the past decade, as other researchers have noted (Infect Drug Resist. 2014;7:63-72). Incidence, severity, and case-fatality rates have risen substantially, and individuals who lack the usual risk factors for CDI are now acquiring it in community settings. Moreover, CDI adds about 5-6 days to a patient’s average hospital stay, and almost one in three affected patients is rehospitalized (Am J Infect Control. 2015 Apr 1;43[4]:314-7.) – most often within a week of discharge, said Dr. Thomas Moore, who is at the University of Kansas, Wichita.

“Should FMT be used as first-line therapy? Not just yes, but hell, yes! It has superior efficacy,” Dr. Moore said.

Courtesy CDC/Dr. Gilda Jones

He pointed to the recent landmark study (N Engl J Med. 2013;368:407-15) of CDI in which duodenal infusions of donor feces more than tripled the rates of relapse-free cure, compared with vancomycin monotherapy or vancomycin with bowel lavage (P less than .001 for both comparisons). Moreover, diarrhea resolved for 81% of patients after the first fecal infusion, and the observed superiority over the vancomycin regimens was so marked that investigators stopped the study after the interim analysis.

Evidence suggests FMT is safe as well as effective, said Dr. Moore. Centers in Norway, Sweden, Denmark, Finland, and Holland have treated at least 900 patients with no reported adverse effects and with cure rates of about 90%, he noted. Of more than 1,000 published FMT studies worldwide, there has been one only report of peritonitis after colonoscopy, one case of irritable bowel syndrome, three reports of mild enteritis, one case of upper gastrointestinal bleeding, one death from sepsis from a dislodged gastrostomy tube, and one case of new-onset obesity, which occurred after a patient received fecal microbiota donated by an obese relative, he added (Open Forum Infect Dis. 2015 Feb 1. doi: 10.1093/ofid/ofv004). Patients now receive fecal microbiota donations from normal-weight individuals, he noted (http://www.openbiome.org/stool-donation/).

“Fecal microbiota transplantation could save lives,” Dr. Moore concluded. Donor material is “cheap and unlimited, the procedure is cost-effective, easy to perform, can even be done at home, and patient satisfaction is very high.”

But Dr. Johan S. Bakken, an infectious disease specialist at St. Luke’s Hospital in Duluth, Minn., argued that FMT is not ready for first-line use for CDI in the United States. “There are no published FMT practice guidelines for initial therapy, even in Scandinavia, and no randomized controlled trials of FMT conducted anywhere,” said Dr. Bakken. He noted that because the Food and Drug Administration has not approved FMT for first-line use in CDI, utilization could require an approved Investigational New Drug application, leading to “unavoidable” treatment delays.

Clinicians also should not gloss over concerns about adverse effects with FMT, Dr. Bakken said. In addition to the case of new-onset obesity, there are risks of aspirating fecal material or perforating hollow viscera. Furthermore, the potential long-term adverse consequences of FMT are unknown, he said.

In contrast, the rate of resolution of initial CDI with per oral vancomycin or fidaxomicin is more than 80%, Dr. Bakken said. Moreover, liquid vancomycin at an appropriate dose and frequency for CDI costs about $4.25 per day in Duluth, he added. “No comparative outcomes data are available for FMT, but it is more costly than vancomycin, may not be locally available, and requires several days or weeks of planning,” he emphasized.

Cost-reimbursement issues with third-party payers are also likely with FMT, according to Dr. Bakken. “There also are potential or perceived medicolegal issues with FMT,” he said. “Keep in mind that about 80% of the world’s lawyers work and practice in the U.S.A.”

Dr. Moore had no disclosures. Dr. Bakken reported being an advisory board member of Rebiotix, which is developing a biologic drug to treat recurrent CDI.

SAN DIEGO – Fecal microbiota transplantation (FMT) is now first-line therapy for Clostridium difficile infection (CDI) in much of Scandinavia. At an annual conference on infectious diseases, two specialists debated whether that should be the case in the United States, too.

The epidemiology of CDI has changed greatly in the past decade, as other researchers have noted (Infect Drug Resist. 2014;7:63-72). Incidence, severity, and case-fatality rates have risen substantially, and individuals who lack the usual risk factors for CDI are now acquiring it in community settings. Moreover, CDI adds about 5-6 days to a patient’s average hospital stay, and almost one in three affected patients is rehospitalized (Am J Infect Control. 2015 Apr 1;43[4]:314-7.) – most often within a week of discharge, said Dr. Thomas Moore, who is at the University of Kansas, Wichita.

“Should FMT be used as first-line therapy? Not just yes, but hell, yes! It has superior efficacy,” Dr. Moore said.

Courtesy CDC/Dr. Gilda Jones

He pointed to the recent landmark study (N Engl J Med. 2013;368:407-15) of CDI in which duodenal infusions of donor feces more than tripled the rates of relapse-free cure, compared with vancomycin monotherapy or vancomycin with bowel lavage (P less than .001 for both comparisons). Moreover, diarrhea resolved for 81% of patients after the first fecal infusion, and the observed superiority over the vancomycin regimens was so marked that investigators stopped the study after the interim analysis.

Evidence suggests FMT is safe as well as effective, said Dr. Moore. Centers in Norway, Sweden, Denmark, Finland, and Holland have treated at least 900 patients with no reported adverse effects and with cure rates of about 90%, he noted. Of more than 1,000 published FMT studies worldwide, there has been one only report of peritonitis after colonoscopy, one case of irritable bowel syndrome, three reports of mild enteritis, one case of upper gastrointestinal bleeding, one death from sepsis from a dislodged gastrostomy tube, and one case of new-onset obesity, which occurred after a patient received fecal microbiota donated by an obese relative, he added (Open Forum Infect Dis. 2015 Feb 1. doi: 10.1093/ofid/ofv004). Patients now receive fecal microbiota donations from normal-weight individuals, he noted (http://www.openbiome.org/stool-donation/).

“Fecal microbiota transplantation could save lives,” Dr. Moore concluded. Donor material is “cheap and unlimited, the procedure is cost-effective, easy to perform, can even be done at home, and patient satisfaction is very high.”

But Dr. Johan S. Bakken, an infectious disease specialist at St. Luke’s Hospital in Duluth, Minn., argued that FMT is not ready for first-line use for CDI in the United States. “There are no published FMT practice guidelines for initial therapy, even in Scandinavia, and no randomized controlled trials of FMT conducted anywhere,” said Dr. Bakken. He noted that because the Food and Drug Administration has not approved FMT for first-line use in CDI, utilization could require an approved Investigational New Drug application, leading to “unavoidable” treatment delays.

Clinicians also should not gloss over concerns about adverse effects with FMT, Dr. Bakken said. In addition to the case of new-onset obesity, there are risks of aspirating fecal material or perforating hollow viscera. Furthermore, the potential long-term adverse consequences of FMT are unknown, he said.

In contrast, the rate of resolution of initial CDI with per oral vancomycin or fidaxomicin is more than 80%, Dr. Bakken said. Moreover, liquid vancomycin at an appropriate dose and frequency for CDI costs about $4.25 per day in Duluth, he added. “No comparative outcomes data are available for FMT, but it is more costly than vancomycin, may not be locally available, and requires several days or weeks of planning,” he emphasized.

Cost-reimbursement issues with third-party payers are also likely with FMT, according to Dr. Bakken. “There also are potential or perceived medicolegal issues with FMT,” he said. “Keep in mind that about 80% of the world’s lawyers work and practice in the U.S.A.”

Dr. Moore had no disclosures. Dr. Bakken reported being an advisory board member of Rebiotix, which is developing a biologic drug to treat recurrent CDI.

SAN DIEGO – Fecal microbiota transplantation (FMT) is now first-line therapy for Clostridium difficile infection (CDI) in much of Scandinavia. At an annual conference on infectious diseases, two specialists debated whether that should be the case in the United States, too.

The epidemiology of CDI has changed greatly in the past decade, as other researchers have noted (Infect Drug Resist. 2014;7:63-72). Incidence, severity, and case-fatality rates have risen substantially, and individuals who lack the usual risk factors for CDI are now acquiring it in community settings. Moreover, CDI adds about 5-6 days to a patient’s average hospital stay, and almost one in three affected patients is rehospitalized (Am J Infect Control. 2015 Apr 1;43[4]:314-7.) – most often within a week of discharge, said Dr. Thomas Moore, who is at the University of Kansas, Wichita.

“Should FMT be used as first-line therapy? Not just yes, but hell, yes! It has superior efficacy,” Dr. Moore said.

Courtesy CDC/Dr. Gilda Jones

He pointed to the recent landmark study (N Engl J Med. 2013;368:407-15) of CDI in which duodenal infusions of donor feces more than tripled the rates of relapse-free cure, compared with vancomycin monotherapy or vancomycin with bowel lavage (P less than .001 for both comparisons). Moreover, diarrhea resolved for 81% of patients after the first fecal infusion, and the observed superiority over the vancomycin regimens was so marked that investigators stopped the study after the interim analysis.

Evidence suggests FMT is safe as well as effective, said Dr. Moore. Centers in Norway, Sweden, Denmark, Finland, and Holland have treated at least 900 patients with no reported adverse effects and with cure rates of about 90%, he noted. Of more than 1,000 published FMT studies worldwide, there has been one only report of peritonitis after colonoscopy, one case of irritable bowel syndrome, three reports of mild enteritis, one case of upper gastrointestinal bleeding, one death from sepsis from a dislodged gastrostomy tube, and one case of new-onset obesity, which occurred after a patient received fecal microbiota donated by an obese relative, he added (Open Forum Infect Dis. 2015 Feb 1. doi: 10.1093/ofid/ofv004). Patients now receive fecal microbiota donations from normal-weight individuals, he noted (http://www.openbiome.org/stool-donation/).

“Fecal microbiota transplantation could save lives,” Dr. Moore concluded. Donor material is “cheap and unlimited, the procedure is cost-effective, easy to perform, can even be done at home, and patient satisfaction is very high.”

But Dr. Johan S. Bakken, an infectious disease specialist at St. Luke’s Hospital in Duluth, Minn., argued that FMT is not ready for first-line use for CDI in the United States. “There are no published FMT practice guidelines for initial therapy, even in Scandinavia, and no randomized controlled trials of FMT conducted anywhere,” said Dr. Bakken. He noted that because the Food and Drug Administration has not approved FMT for first-line use in CDI, utilization could require an approved Investigational New Drug application, leading to “unavoidable” treatment delays.

Clinicians also should not gloss over concerns about adverse effects with FMT, Dr. Bakken said. In addition to the case of new-onset obesity, there are risks of aspirating fecal material or perforating hollow viscera. Furthermore, the potential long-term adverse consequences of FMT are unknown, he said.

In contrast, the rate of resolution of initial CDI with per oral vancomycin or fidaxomicin is more than 80%, Dr. Bakken said. Moreover, liquid vancomycin at an appropriate dose and frequency for CDI costs about $4.25 per day in Duluth, he added. “No comparative outcomes data are available for FMT, but it is more costly than vancomycin, may not be locally available, and requires several days or weeks of planning,” he emphasized.

Cost-reimbursement issues with third-party payers are also likely with FMT, according to Dr. Bakken. “There also are potential or perceived medicolegal issues with FMT,” he said. “Keep in mind that about 80% of the world’s lawyers work and practice in the U.S.A.”

Dr. Moore had no disclosures. Dr. Bakken reported being an advisory board member of Rebiotix, which is developing a biologic drug to treat recurrent CDI.

Researchers have created a risk score to help identify patients at high risk for Clostridium difficile infection after hospitalization, for future use in vaccine trials, according to a new study.

C. difficile is the most common pathogen type in health care–associated infections and the leading cause of enterocolitis-associated deaths. Identification of patients who are at high risk for C. difficile is important in the development of future vaccines.

©luiscar/Thinkstockphotos.com

Dr. James Baggs, epidemiologist at the Centers for Disease Control and Prevention, and his colleagues conducted a retrospective cohort study to identify groups at high risk for C. difficile infection (CDI) for future vaccine trials. Their results were published in Vaccine online Oct. 9.

Data on medications and discharge were obtained from two large academic medical centers in Connecticut and New York. This information was linked to surveillance data from the Emerging Infections Program on active population-based CDIs. Participants were included if they had a hospital stay without a history of CDI with a primary outcome of infection 28 days or more after discharge.

To identify predictors of CDI after discharge, the investigators used a backward elimination employing a Cox proportional hazards model. They then created a CDI risk index based on the predictors.

During the study period, a total of 35,186 index hospitalizations were identified in Connecticut and New York. CDI diagnosis 28 days or more after discharge was observed in 288 patients (0.82%).

Initial models did not perform well in cross-site validation; however, a combined model that included age, past hospitalizations, use of 3rd/4th generation cephalosporin, clindamycin, or fluoroquinolone antibiotics was developed. This validation cohort resulted in a risk score that was predictive (P less than .001).

Finally, the study participants were divided into high-risk and low-risk groups based on the distribution of scores in the cohort. The low-risk group experienced CDI diagnosis 28 days or more after hospitalization at a rate of 0.3% versus 1.6% in the high-risk group.

“Our study identified specific parameters for a risk index that can be applied at hospital discharge to identify a patient population with increased risk of CDI [greater than or equal to] 28 days after discharge that could be targeted for vaccine trials,” Dr. Braggs and his coauthors wrote.

The authors noted several limitations to the study. For example, they indicated that data was obtained from two hospitals which may not represent some minority populations. Therefore, data from other hospitals may be able to help identify if the risk index is generalizable.

No conflicts of interest were reported. The study was partially funded by GlaxoSmithKline through the CDC Foundation, and GSK had the opportunity to review the preliminary manuscript.

Researchers have created a risk score to help identify patients at high risk for Clostridium difficile infection after hospitalization, for future use in vaccine trials, according to a new study.

C. difficile is the most common pathogen type in health care–associated infections and the leading cause of enterocolitis-associated deaths. Identification of patients who are at high risk for C. difficile is important in the development of future vaccines.

©luiscar/Thinkstockphotos.com

Dr. James Baggs, epidemiologist at the Centers for Disease Control and Prevention, and his colleagues conducted a retrospective cohort study to identify groups at high risk for C. difficile infection (CDI) for future vaccine trials. Their results were published in Vaccine online Oct. 9.

Data on medications and discharge were obtained from two large academic medical centers in Connecticut and New York. This information was linked to surveillance data from the Emerging Infections Program on active population-based CDIs. Participants were included if they had a hospital stay without a history of CDI with a primary outcome of infection 28 days or more after discharge.

To identify predictors of CDI after discharge, the investigators used a backward elimination employing a Cox proportional hazards model. They then created a CDI risk index based on the predictors.

During the study period, a total of 35,186 index hospitalizations were identified in Connecticut and New York. CDI diagnosis 28 days or more after discharge was observed in 288 patients (0.82%).

Initial models did not perform well in cross-site validation; however, a combined model that included age, past hospitalizations, use of 3rd/4th generation cephalosporin, clindamycin, or fluoroquinolone antibiotics was developed. This validation cohort resulted in a risk score that was predictive (P less than .001).

Finally, the study participants were divided into high-risk and low-risk groups based on the distribution of scores in the cohort. The low-risk group experienced CDI diagnosis 28 days or more after hospitalization at a rate of 0.3% versus 1.6% in the high-risk group.

“Our study identified specific parameters for a risk index that can be applied at hospital discharge to identify a patient population with increased risk of CDI [greater than or equal to] 28 days after discharge that could be targeted for vaccine trials,” Dr. Braggs and his coauthors wrote.

The authors noted several limitations to the study. For example, they indicated that data was obtained from two hospitals which may not represent some minority populations. Therefore, data from other hospitals may be able to help identify if the risk index is generalizable.

No conflicts of interest were reported. The study was partially funded by GlaxoSmithKline through the CDC Foundation, and GSK had the opportunity to review the preliminary manuscript.

Researchers have created a risk score to help identify patients at high risk for Clostridium difficile infection after hospitalization, for future use in vaccine trials, according to a new study.

C. difficile is the most common pathogen type in health care–associated infections and the leading cause of enterocolitis-associated deaths. Identification of patients who are at high risk for C. difficile is important in the development of future vaccines.

©luiscar/Thinkstockphotos.com

Dr. James Baggs, epidemiologist at the Centers for Disease Control and Prevention, and his colleagues conducted a retrospective cohort study to identify groups at high risk for C. difficile infection (CDI) for future vaccine trials. Their results were published in Vaccine online Oct. 9.

Data on medications and discharge were obtained from two large academic medical centers in Connecticut and New York. This information was linked to surveillance data from the Emerging Infections Program on active population-based CDIs. Participants were included if they had a hospital stay without a history of CDI with a primary outcome of infection 28 days or more after discharge.

To identify predictors of CDI after discharge, the investigators used a backward elimination employing a Cox proportional hazards model. They then created a CDI risk index based on the predictors.

During the study period, a total of 35,186 index hospitalizations were identified in Connecticut and New York. CDI diagnosis 28 days or more after discharge was observed in 288 patients (0.82%).

Initial models did not perform well in cross-site validation; however, a combined model that included age, past hospitalizations, use of 3rd/4th generation cephalosporin, clindamycin, or fluoroquinolone antibiotics was developed. This validation cohort resulted in a risk score that was predictive (P less than .001).

Finally, the study participants were divided into high-risk and low-risk groups based on the distribution of scores in the cohort. The low-risk group experienced CDI diagnosis 28 days or more after hospitalization at a rate of 0.3% versus 1.6% in the high-risk group.

“Our study identified specific parameters for a risk index that can be applied at hospital discharge to identify a patient population with increased risk of CDI [greater than or equal to] 28 days after discharge that could be targeted for vaccine trials,” Dr. Braggs and his coauthors wrote.

The authors noted several limitations to the study. For example, they indicated that data was obtained from two hospitals which may not represent some minority populations. Therefore, data from other hospitals may be able to help identify if the risk index is generalizable.

No conflicts of interest were reported. The study was partially funded by GlaxoSmithKline through the CDC Foundation, and GSK had the opportunity to review the preliminary manuscript.

SAN DIEGO – Delays in laboratory testing led a hospital to misclassify the origin of nearly a quarter of Clostridium difficile infections, Dr. Christopher Polage said at an annual scientific meeting on infectious diseases.

“Many patients with symptoms and risk factors are not being tested within 3 days of admission, leading to overreporting of hospital-onset [Clostridium difficile infections] and underreporting of community-onset CDI,” said Dr. Polage of the UC Davis (Calif.) Health System. By testing patients who have diarrhea and risk factors for CDI sooner after admission, hospitals can prevent outbreaks and improve their standardized infection ratio for CDI, he added.

CDC/D. Holdeman

Clostridium difficile is implicated in about 29,000 deaths every year in the United States. The vast majority of such cases are classified as hospital onset, based on the “3-day rule,” meaning that patients were tested more than 3 days after admission. “This is the preventable hospital outcome that we’re all trying to bring down,” Dr. Polage said.

As part of that effort, he and his colleagues studied 11 hospital units that were considered high risk for CDI. To identify toxigenic C. difficile, they performed culture and polymerase chain reaction testing on perianal swabs collected from all adult patients admitted to these units. They also analyzed toxin immunoassays of stool samples when physicians requested them for patients with diarrhea.

“The question was, how often was misclassification happening?” said Dr. Polage. Among 48 cases that the laboratory reported as hospital onset, based on the “3-day rule,” close to half (44%) actually had CD-positive perianal swabs when admitted, he said. And half of these swab-positive patients waited more than 3 days for a CD stool test even though they had current or recent diarrhea, he added. In fact, swab-positive patients with diarrhea went a median of 6 days without a CD stool test, and some went untested for 10 days, Dr. Polage said.

“Anyone who has tried to determine if a hospitalized patient is having diarrhea knows that this can be very hard to pin down,” Dr. Polage noted. But some patients with positive swabs on admission met three different definitions for diarrhea, “making it pretty clear that they had community-onset CDI,” he said. This most conservative approach found that 23% of “hospital-onset” cases were actually community onset, he said.

Thus far, UC Davis Health System seems not to have had an increase in antibiotic prescriptions in response to greater detection of community-onset CDI, Dr. Polage said. “This is not something we take lightly,” he added. “We put together a lot of educational materials for patients, physicians, and providers, and work with our antibiotic stewardship team. We found that we might be able to focus on patients who had CDI at time of admission, and intervene with them individually to more carefully monitor what antibiotic they were using.”

Dr. Polage reported these findings at IDWeek, the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The Gordon and Betty Moore Foundation helped fund the study. Dr. Polage reported having received research materials or honoraria from Cepheid, TechLab, Alere, Meridian, and ACEA Biosciences.

SAN DIEGO – Delays in laboratory testing led a hospital to misclassify the origin of nearly a quarter of Clostridium difficile infections, Dr. Christopher Polage said at an annual scientific meeting on infectious diseases.

“Many patients with symptoms and risk factors are not being tested within 3 days of admission, leading to overreporting of hospital-onset [Clostridium difficile infections] and underreporting of community-onset CDI,” said Dr. Polage of the UC Davis (Calif.) Health System. By testing patients who have diarrhea and risk factors for CDI sooner after admission, hospitals can prevent outbreaks and improve their standardized infection ratio for CDI, he added.

CDC/D. Holdeman

Clostridium difficile is implicated in about 29,000 deaths every year in the United States. The vast majority of such cases are classified as hospital onset, based on the “3-day rule,” meaning that patients were tested more than 3 days after admission. “This is the preventable hospital outcome that we’re all trying to bring down,” Dr. Polage said.

As part of that effort, he and his colleagues studied 11 hospital units that were considered high risk for CDI. To identify toxigenic C. difficile, they performed culture and polymerase chain reaction testing on perianal swabs collected from all adult patients admitted to these units. They also analyzed toxin immunoassays of stool samples when physicians requested them for patients with diarrhea.

“The question was, how often was misclassification happening?” said Dr. Polage. Among 48 cases that the laboratory reported as hospital onset, based on the “3-day rule,” close to half (44%) actually had CD-positive perianal swabs when admitted, he said. And half of these swab-positive patients waited more than 3 days for a CD stool test even though they had current or recent diarrhea, he added. In fact, swab-positive patients with diarrhea went a median of 6 days without a CD stool test, and some went untested for 10 days, Dr. Polage said.

“Anyone who has tried to determine if a hospitalized patient is having diarrhea knows that this can be very hard to pin down,” Dr. Polage noted. But some patients with positive swabs on admission met three different definitions for diarrhea, “making it pretty clear that they had community-onset CDI,” he said. This most conservative approach found that 23% of “hospital-onset” cases were actually community onset, he said.

Thus far, UC Davis Health System seems not to have had an increase in antibiotic prescriptions in response to greater detection of community-onset CDI, Dr. Polage said. “This is not something we take lightly,” he added. “We put together a lot of educational materials for patients, physicians, and providers, and work with our antibiotic stewardship team. We found that we might be able to focus on patients who had CDI at time of admission, and intervene with them individually to more carefully monitor what antibiotic they were using.”

Dr. Polage reported these findings at IDWeek, the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The Gordon and Betty Moore Foundation helped fund the study. Dr. Polage reported having received research materials or honoraria from Cepheid, TechLab, Alere, Meridian, and ACEA Biosciences.

SAN DIEGO – Delays in laboratory testing led a hospital to misclassify the origin of nearly a quarter of Clostridium difficile infections, Dr. Christopher Polage said at an annual scientific meeting on infectious diseases.

“Many patients with symptoms and risk factors are not being tested within 3 days of admission, leading to overreporting of hospital-onset [Clostridium difficile infections] and underreporting of community-onset CDI,” said Dr. Polage of the UC Davis (Calif.) Health System. By testing patients who have diarrhea and risk factors for CDI sooner after admission, hospitals can prevent outbreaks and improve their standardized infection ratio for CDI, he added.

CDC/D. Holdeman

Clostridium difficile is implicated in about 29,000 deaths every year in the United States. The vast majority of such cases are classified as hospital onset, based on the “3-day rule,” meaning that patients were tested more than 3 days after admission. “This is the preventable hospital outcome that we’re all trying to bring down,” Dr. Polage said.

As part of that effort, he and his colleagues studied 11 hospital units that were considered high risk for CDI. To identify toxigenic C. difficile, they performed culture and polymerase chain reaction testing on perianal swabs collected from all adult patients admitted to these units. They also analyzed toxin immunoassays of stool samples when physicians requested them for patients with diarrhea.

“The question was, how often was misclassification happening?” said Dr. Polage. Among 48 cases that the laboratory reported as hospital onset, based on the “3-day rule,” close to half (44%) actually had CD-positive perianal swabs when admitted, he said. And half of these swab-positive patients waited more than 3 days for a CD stool test even though they had current or recent diarrhea, he added. In fact, swab-positive patients with diarrhea went a median of 6 days without a CD stool test, and some went untested for 10 days, Dr. Polage said.

“Anyone who has tried to determine if a hospitalized patient is having diarrhea knows that this can be very hard to pin down,” Dr. Polage noted. But some patients with positive swabs on admission met three different definitions for diarrhea, “making it pretty clear that they had community-onset CDI,” he said. This most conservative approach found that 23% of “hospital-onset” cases were actually community onset, he said.

Thus far, UC Davis Health System seems not to have had an increase in antibiotic prescriptions in response to greater detection of community-onset CDI, Dr. Polage said. “This is not something we take lightly,” he added. “We put together a lot of educational materials for patients, physicians, and providers, and work with our antibiotic stewardship team. We found that we might be able to focus on patients who had CDI at time of admission, and intervene with them individually to more carefully monitor what antibiotic they were using.”

Dr. Polage reported these findings at IDWeek, the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The Gordon and Betty Moore Foundation helped fund the study. Dr. Polage reported having received research materials or honoraria from Cepheid, TechLab, Alere, Meridian, and ACEA Biosciences.

For the first time, an oral vaccine against Helicobacter pylori infection proved effective and safe in a phase III trial involving nearly 4,500 children in China, according to a report published in the Oct. 10 issue of the Lancet.

The vaccine’s efficacy waned somewhat after the first year but still significantly reduced H. pylori infection in approximately 1,000 of the recipients followed for the entire 3-year study period. This suggests that it could substantially reduce the rates of gastritis, peptic ulcer, gastric adenocarcinoma, and lymphoma associated with the infection, which currently affects more than half the world’s population, including more than 600 million in China, said Ming Zeng, Ph.D., of the Chinese National Institute for Food and Drug Control, Beijing, and associates.

©sgame/thinkstockphotos.com

Researchers at Third Military Medical University, Chongqing and Chongqing Kangwei Biotechnology, both in China, developed the new vaccine using DNA recombination technology to fuse urease B subunit proteins (gene derived from H. pylori) with heat-labile enterotoxin B subunit proteins (gene derived from E. coli). The vaccine was designed to be administered in three oral doses given 2 weeks apart, after study subjects fasted for at least 2 hours and then drank an 80-mL buffer solution containing sodium bicarbonate and sodium citrate.

Dr. Zeng and associates compared the vaccine (2,232 participants) against an identical placebo (2,232 participants) in the single-center, double-blind, randomized trial, which involved children aged 6-15 years recruited from 12 schools in Ganyu County in eastern China. All the study participants were healthy and tested negative for past or present H. pylori infection at baseline.

The primary endpoint – the development of H. pylori infection within the first year after vaccination – occurred in 14 children who received the vaccine, which was significantly fewer than the 50 children who received placebo. This yielded a vaccine efficacy rate of 71.8% at 1 year. During extended follow-up of a subset of 3,014 participants at 2 years, 10 H. pylori infections developed in the vaccine group and 22 in the placebo group, for a vaccine efficacy of 55.0%. Similarly, at 3-year follow-up of 1,946 participants, vaccine efficacy was 55.8%, the investigators said (Lancet 2015 Oct 10;386:1457-64).

“The event rate of the placebo group varied from 2.4 to 1.4 per 100 person-years, whereas that of the vaccine group remained around 0.7/100 person-years” throughout the 3-year study period, they added.

The vaccine elicited a significantly greater immune response than did the placebo, as measured in serum IgG and salivary IgA. The geometric mean titer was 389.4 in vaccine recipients, compared with only 72.2 in the placebo group, and the seroconversion rate was 86.1% for the vaccine, compared with 4.6% for placebo. The “mild” waning trend in vaccine-elicited antibodies suggests that a booster dose may be necessary in later years, Dr. Zeng and associates wrote.

The incidence of adverse reactions to the vaccine was identical in the two study groups, at 7%. All adverse reactions were mild and resolved within 24 hours. The most frequent was vomiting, followed by fever and headache. No serious adverse events were considered to be related to the study drug. “However, the number of participants in this study might not be enough to identify rare vaccine-related adverse events. Longer-term follow-up is needed in much larger populations” and in more ethnically and demographically diverse groups to identify such rare reactions, they noted.

For the first time, an oral vaccine against Helicobacter pylori infection proved effective and safe in a phase III trial involving nearly 4,500 children in China, according to a report published in the Oct. 10 issue of the Lancet.

The vaccine’s efficacy waned somewhat after the first year but still significantly reduced H. pylori infection in approximately 1,000 of the recipients followed for the entire 3-year study period. This suggests that it could substantially reduce the rates of gastritis, peptic ulcer, gastric adenocarcinoma, and lymphoma associated with the infection, which currently affects more than half the world’s population, including more than 600 million in China, said Ming Zeng, Ph.D., of the Chinese National Institute for Food and Drug Control, Beijing, and associates.

©sgame/thinkstockphotos.com

Researchers at Third Military Medical University, Chongqing and Chongqing Kangwei Biotechnology, both in China, developed the new vaccine using DNA recombination technology to fuse urease B subunit proteins (gene derived from H. pylori) with heat-labile enterotoxin B subunit proteins (gene derived from E. coli). The vaccine was designed to be administered in three oral doses given 2 weeks apart, after study subjects fasted for at least 2 hours and then drank an 80-mL buffer solution containing sodium bicarbonate and sodium citrate.

Dr. Zeng and associates compared the vaccine (2,232 participants) against an identical placebo (2,232 participants) in the single-center, double-blind, randomized trial, which involved children aged 6-15 years recruited from 12 schools in Ganyu County in eastern China. All the study participants were healthy and tested negative for past or present H. pylori infection at baseline.

The primary endpoint – the development of H. pylori infection within the first year after vaccination – occurred in 14 children who received the vaccine, which was significantly fewer than the 50 children who received placebo. This yielded a vaccine efficacy rate of 71.8% at 1 year. During extended follow-up of a subset of 3,014 participants at 2 years, 10 H. pylori infections developed in the vaccine group and 22 in the placebo group, for a vaccine efficacy of 55.0%. Similarly, at 3-year follow-up of 1,946 participants, vaccine efficacy was 55.8%, the investigators said (Lancet 2015 Oct 10;386:1457-64).

“The event rate of the placebo group varied from 2.4 to 1.4 per 100 person-years, whereas that of the vaccine group remained around 0.7/100 person-years” throughout the 3-year study period, they added.

The vaccine elicited a significantly greater immune response than did the placebo, as measured in serum IgG and salivary IgA. The geometric mean titer was 389.4 in vaccine recipients, compared with only 72.2 in the placebo group, and the seroconversion rate was 86.1% for the vaccine, compared with 4.6% for placebo. The “mild” waning trend in vaccine-elicited antibodies suggests that a booster dose may be necessary in later years, Dr. Zeng and associates wrote.

The incidence of adverse reactions to the vaccine was identical in the two study groups, at 7%. All adverse reactions were mild and resolved within 24 hours. The most frequent was vomiting, followed by fever and headache. No serious adverse events were considered to be related to the study drug. “However, the number of participants in this study might not be enough to identify rare vaccine-related adverse events. Longer-term follow-up is needed in much larger populations” and in more ethnically and demographically diverse groups to identify such rare reactions, they noted.

For the first time, an oral vaccine against Helicobacter pylori infection proved effective and safe in a phase III trial involving nearly 4,500 children in China, according to a report published in the Oct. 10 issue of the Lancet.

The vaccine’s efficacy waned somewhat after the first year but still significantly reduced H. pylori infection in approximately 1,000 of the recipients followed for the entire 3-year study period. This suggests that it could substantially reduce the rates of gastritis, peptic ulcer, gastric adenocarcinoma, and lymphoma associated with the infection, which currently affects more than half the world’s population, including more than 600 million in China, said Ming Zeng, Ph.D., of the Chinese National Institute for Food and Drug Control, Beijing, and associates.

©sgame/thinkstockphotos.com

Researchers at Third Military Medical University, Chongqing and Chongqing Kangwei Biotechnology, both in China, developed the new vaccine using DNA recombination technology to fuse urease B subunit proteins (gene derived from H. pylori) with heat-labile enterotoxin B subunit proteins (gene derived from E. coli). The vaccine was designed to be administered in three oral doses given 2 weeks apart, after study subjects fasted for at least 2 hours and then drank an 80-mL buffer solution containing sodium bicarbonate and sodium citrate.

Dr. Zeng and associates compared the vaccine (2,232 participants) against an identical placebo (2,232 participants) in the single-center, double-blind, randomized trial, which involved children aged 6-15 years recruited from 12 schools in Ganyu County in eastern China. All the study participants were healthy and tested negative for past or present H. pylori infection at baseline.

The primary endpoint – the development of H. pylori infection within the first year after vaccination – occurred in 14 children who received the vaccine, which was significantly fewer than the 50 children who received placebo. This yielded a vaccine efficacy rate of 71.8% at 1 year. During extended follow-up of a subset of 3,014 participants at 2 years, 10 H. pylori infections developed in the vaccine group and 22 in the placebo group, for a vaccine efficacy of 55.0%. Similarly, at 3-year follow-up of 1,946 participants, vaccine efficacy was 55.8%, the investigators said (Lancet 2015 Oct 10;386:1457-64).

“The event rate of the placebo group varied from 2.4 to 1.4 per 100 person-years, whereas that of the vaccine group remained around 0.7/100 person-years” throughout the 3-year study period, they added.

The vaccine elicited a significantly greater immune response than did the placebo, as measured in serum IgG and salivary IgA. The geometric mean titer was 389.4 in vaccine recipients, compared with only 72.2 in the placebo group, and the seroconversion rate was 86.1% for the vaccine, compared with 4.6% for placebo. The “mild” waning trend in vaccine-elicited antibodies suggests that a booster dose may be necessary in later years, Dr. Zeng and associates wrote.

The incidence of adverse reactions to the vaccine was identical in the two study groups, at 7%. All adverse reactions were mild and resolved within 24 hours. The most frequent was vomiting, followed by fever and headache. No serious adverse events were considered to be related to the study drug. “However, the number of participants in this study might not be enough to identify rare vaccine-related adverse events. Longer-term follow-up is needed in much larger populations” and in more ethnically and demographically diverse groups to identify such rare reactions, they noted.

A Chinese herbal medicine preparation may offer relief from constipation symptoms in individuals with irritable bowel syndrome.

A randomized, placebo-controlled trial in 125 individuals with constipation-predominant irritable bowel syndrome (IBS-C) showed the preparation was associated with significant improvements, compared with placebo.

©Courtesy Wikimedia Commons/ Ulf Eliasson/Creative commons SA 3.0

In the per-protocol analysis, 68% of patients given the herbal medicine reported achieving adequate relief from their symptoms, compared with 43% of the placebo group (P = .10), according to a paper published online in Clinical Gastroenterology and Hepatology.

Patients were randomized to receive either a standardized extract of seven Chinese herbal medicine ingredients in capsule form – five capsules taken twice daily – or a taste- and color-matched placebo for 8 weeks, with further follow-up at 16 weeks.

The herbal ingredients included extracts of Chinese peony (Paeonia lactiflora), Seville orange (Citrus aurantium), Magnolia officinalis, and Chinese licorice (Glycyrrhiza uralensis), which were used for their antispasmodic effects, as intestinal muscle relaxants, and as myorelaxants.

The authors commented that while there are recent advances in the treatment of irritable bowel syndrome – such as the serotonergic agent prucalopride, chloride channel activator lubiprostone, and guanylate cyclase–C activator linaclotide – there is not yet a single drug regimen that shows efficacy for the many symptoms of IBS or addresses the high rate of symptom return.

In the study, patients treated with the herbal preparation showed improved bowel habits at the end of treatment, including significantly lower IBS Symptom Severity Scale scores, reduced straining during defecation, a decrease in hard, lumpy stools, and increased stool consistency.

“Although there were significant results for participants in the treatment group, to gain adequate benefit they needed to remain on treatment,” wrote Dr. Alan Bensoussan of the National Institute of Complementary Medicine at the University of Western Sydney (Australia) and his coauthors.

However, the study did not find any statistically significant differences between the intervention and placebo arm in overall IBS-related quality of life, abdominal pain, or bloating at the end of treatment (Clin. Gastroenterol. Hepatol. 2015 Jun 29. doi:10.1016/j.cgh.2015.06.022).

“Thus, IBS-C participants appeared to interpret more normal bowel functions as a significant improvement in the condition, but [quality of life] may only improve when pain and bloating are also substantially ameliorated,” the authors wrote.

Researchers said this finding supports recently published data suggesting that improving bowel movements is a higher priority for patients with IBS-C than pain relief.

Although patients were asked to discontinue related treatment such as anticholinergic agents, opioid analgesics, and regular laxatives, they were allowed some rescue medication.

There was a nonsignificantly greater use of bulking agents in the Chinese herbal medicine group, and stimulant laxative use in the placebo group.

The study medication was generally well tolerated, although there were twice as many gastrointestinal adverse events reported in the intervention group as in the control group.

Overall, there were 19 withdrawals from the study, 6 of which were potentially associated with the study drug; the reasons included diarrhea, blood in the urine, increased bloating, and dizziness.

The study was supported by the National Health and Medical Research Council, and there were no conflicts of interest reported.

A Chinese herbal medicine preparation may offer relief from constipation symptoms in individuals with irritable bowel syndrome.

A randomized, placebo-controlled trial in 125 individuals with constipation-predominant irritable bowel syndrome (IBS-C) showed the preparation was associated with significant improvements, compared with placebo.

©Courtesy Wikimedia Commons/ Ulf Eliasson/Creative commons SA 3.0

In the per-protocol analysis, 68% of patients given the herbal medicine reported achieving adequate relief from their symptoms, compared with 43% of the placebo group (P = .10), according to a paper published online in Clinical Gastroenterology and Hepatology.

Patients were randomized to receive either a standardized extract of seven Chinese herbal medicine ingredients in capsule form – five capsules taken twice daily – or a taste- and color-matched placebo for 8 weeks, with further follow-up at 16 weeks.

The herbal ingredients included extracts of Chinese peony (Paeonia lactiflora), Seville orange (Citrus aurantium), Magnolia officinalis, and Chinese licorice (Glycyrrhiza uralensis), which were used for their antispasmodic effects, as intestinal muscle relaxants, and as myorelaxants.

The authors commented that while there are recent advances in the treatment of irritable bowel syndrome – such as the serotonergic agent prucalopride, chloride channel activator lubiprostone, and guanylate cyclase–C activator linaclotide – there is not yet a single drug regimen that shows efficacy for the many symptoms of IBS or addresses the high rate of symptom return.

In the study, patients treated with the herbal preparation showed improved bowel habits at the end of treatment, including significantly lower IBS Symptom Severity Scale scores, reduced straining during defecation, a decrease in hard, lumpy stools, and increased stool consistency.

“Although there were significant results for participants in the treatment group, to gain adequate benefit they needed to remain on treatment,” wrote Dr. Alan Bensoussan of the National Institute of Complementary Medicine at the University of Western Sydney (Australia) and his coauthors.

However, the study did not find any statistically significant differences between the intervention and placebo arm in overall IBS-related quality of life, abdominal pain, or bloating at the end of treatment (Clin. Gastroenterol. Hepatol. 2015 Jun 29. doi:10.1016/j.cgh.2015.06.022).

“Thus, IBS-C participants appeared to interpret more normal bowel functions as a significant improvement in the condition, but [quality of life] may only improve when pain and bloating are also substantially ameliorated,” the authors wrote.

Researchers said this finding supports recently published data suggesting that improving bowel movements is a higher priority for patients with IBS-C than pain relief.

Although patients were asked to discontinue related treatment such as anticholinergic agents, opioid analgesics, and regular laxatives, they were allowed some rescue medication.

There was a nonsignificantly greater use of bulking agents in the Chinese herbal medicine group, and stimulant laxative use in the placebo group.

The study medication was generally well tolerated, although there were twice as many gastrointestinal adverse events reported in the intervention group as in the control group.

Overall, there were 19 withdrawals from the study, 6 of which were potentially associated with the study drug; the reasons included diarrhea, blood in the urine, increased bloating, and dizziness.

The study was supported by the National Health and Medical Research Council, and there were no conflicts of interest reported.

A Chinese herbal medicine preparation may offer relief from constipation symptoms in individuals with irritable bowel syndrome.

A randomized, placebo-controlled trial in 125 individuals with constipation-predominant irritable bowel syndrome (IBS-C) showed the preparation was associated with significant improvements, compared with placebo.

©Courtesy Wikimedia Commons/ Ulf Eliasson/Creative commons SA 3.0

In the per-protocol analysis, 68% of patients given the herbal medicine reported achieving adequate relief from their symptoms, compared with 43% of the placebo group (P = .10), according to a paper published online in Clinical Gastroenterology and Hepatology.

Patients were randomized to receive either a standardized extract of seven Chinese herbal medicine ingredients in capsule form – five capsules taken twice daily – or a taste- and color-matched placebo for 8 weeks, with further follow-up at 16 weeks.

The herbal ingredients included extracts of Chinese peony (Paeonia lactiflora), Seville orange (Citrus aurantium), Magnolia officinalis, and Chinese licorice (Glycyrrhiza uralensis), which were used for their antispasmodic effects, as intestinal muscle relaxants, and as myorelaxants.

The authors commented that while there are recent advances in the treatment of irritable bowel syndrome – such as the serotonergic agent prucalopride, chloride channel activator lubiprostone, and guanylate cyclase–C activator linaclotide – there is not yet a single drug regimen that shows efficacy for the many symptoms of IBS or addresses the high rate of symptom return.

In the study, patients treated with the herbal preparation showed improved bowel habits at the end of treatment, including significantly lower IBS Symptom Severity Scale scores, reduced straining during defecation, a decrease in hard, lumpy stools, and increased stool consistency.

“Although there were significant results for participants in the treatment group, to gain adequate benefit they needed to remain on treatment,” wrote Dr. Alan Bensoussan of the National Institute of Complementary Medicine at the University of Western Sydney (Australia) and his coauthors.

However, the study did not find any statistically significant differences between the intervention and placebo arm in overall IBS-related quality of life, abdominal pain, or bloating at the end of treatment (Clin. Gastroenterol. Hepatol. 2015 Jun 29. doi:10.1016/j.cgh.2015.06.022).

“Thus, IBS-C participants appeared to interpret more normal bowel functions as a significant improvement in the condition, but [quality of life] may only improve when pain and bloating are also substantially ameliorated,” the authors wrote.

Researchers said this finding supports recently published data suggesting that improving bowel movements is a higher priority for patients with IBS-C than pain relief.

Although patients were asked to discontinue related treatment such as anticholinergic agents, opioid analgesics, and regular laxatives, they were allowed some rescue medication.

There was a nonsignificantly greater use of bulking agents in the Chinese herbal medicine group, and stimulant laxative use in the placebo group.

The study medication was generally well tolerated, although there were twice as many gastrointestinal adverse events reported in the intervention group as in the control group.

Overall, there were 19 withdrawals from the study, 6 of which were potentially associated with the study drug; the reasons included diarrhea, blood in the urine, increased bloating, and dizziness.

The study was supported by the National Health and Medical Research Council, and there were no conflicts of interest reported.

SAN DIEGO – Less than a third of hospitals reprocessed duodenoscopes adequately to prevent potential transmission of carbapenem-resistant Enterobacteriaceae (CRE) and other pathogens, investigators reported at an annual scientific meeting on infectious diseases.

Moreover, only a third of facilities had conducted active surveillance for multidrug-resistant infections related to use of their duodenoscopes in the past year, reported Susan Beekmann of the Emerging Infections Network of the Infectious Diseases Society of America. “These findings suggest that endemic bacterial transmission associated with duodenoscopy may occur and may go unrecognized,” said Ms. Beekmann, program coordinator for EIN at the University of Iowa Carver College of Medicine in Iowa City.

©CDC/James Archer

Duodenoscopes, which are used in endoscopic retrograde cholangiopancreatography (ERCP), became a hot topic earlier this year after causing outbreaks of fatal CRE infections in Los Angeles County. The Food and Drug Administration has acknowledged that the “complex design of the devices makes it difficult to remove contaminants compared to other types of endoscopes,” and both the CDC and the FDA have recommended specific reprocessing and surveillance steps to reduce the chances that the scopes transmit serious infections.

To understand how hospitals were actually reprocessing and culturing the scopes at the time CDC released its guidance, Ms. Beekmann and her colleagues electronically surveyed 740 hospital epidemiologists through IDSA-EIN. They received responses from 378 physicians (52%), of which half said their facilities used duodenoscopes, Ms. Beekmann reported at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Only 55 (29%) of these respondents said their facilities reprocessed duodenoscopes to an extent that the IDSA researchers defined as adequate – that is, manual reprocessing with high-level disinfection, either alone or in combination with other options, Ms. Beekmann said. Furthermore, only a third of facilities had cultured their duodenoscopes or done any other surveillance for bacterial transmission after duodenoscopy in the past year, even though most said they reviewed their reprocessing policies and procedures more often than once a year.

Respondents also described widely varying methodologies for sampling and culturing, Ms. Beekmann said. “Although we did not ask about them, ten respondents mentioned ATP bioluminescence assays,” she added. Based on the findings, better reprocessing technologies and consistent, real-time strategies to monitor the effectiveness of scope reprocessing are “urgent patient safety needs,” she and her colleagues concluded.

Ms. Beekmann and her associates reported no relevant financial disclosures.

SAN DIEGO – Less than a third of hospitals reprocessed duodenoscopes adequately to prevent potential transmission of carbapenem-resistant Enterobacteriaceae (CRE) and other pathogens, investigators reported at an annual scientific meeting on infectious diseases.

Moreover, only a third of facilities had conducted active surveillance for multidrug-resistant infections related to use of their duodenoscopes in the past year, reported Susan Beekmann of the Emerging Infections Network of the Infectious Diseases Society of America. “These findings suggest that endemic bacterial transmission associated with duodenoscopy may occur and may go unrecognized,” said Ms. Beekmann, program coordinator for EIN at the University of Iowa Carver College of Medicine in Iowa City.

©CDC/James Archer

Duodenoscopes, which are used in endoscopic retrograde cholangiopancreatography (ERCP), became a hot topic earlier this year after causing outbreaks of fatal CRE infections in Los Angeles County. The Food and Drug Administration has acknowledged that the “complex design of the devices makes it difficult to remove contaminants compared to other types of endoscopes,” and both the CDC and the FDA have recommended specific reprocessing and surveillance steps to reduce the chances that the scopes transmit serious infections.

To understand how hospitals were actually reprocessing and culturing the scopes at the time CDC released its guidance, Ms. Beekmann and her colleagues electronically surveyed 740 hospital epidemiologists through IDSA-EIN. They received responses from 378 physicians (52%), of which half said their facilities used duodenoscopes, Ms. Beekmann reported at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Only 55 (29%) of these respondents said their facilities reprocessed duodenoscopes to an extent that the IDSA researchers defined as adequate – that is, manual reprocessing with high-level disinfection, either alone or in combination with other options, Ms. Beekmann said. Furthermore, only a third of facilities had cultured their duodenoscopes or done any other surveillance for bacterial transmission after duodenoscopy in the past year, even though most said they reviewed their reprocessing policies and procedures more often than once a year.

Respondents also described widely varying methodologies for sampling and culturing, Ms. Beekmann said. “Although we did not ask about them, ten respondents mentioned ATP bioluminescence assays,” she added. Based on the findings, better reprocessing technologies and consistent, real-time strategies to monitor the effectiveness of scope reprocessing are “urgent patient safety needs,” she and her colleagues concluded.

Ms. Beekmann and her associates reported no relevant financial disclosures.

SAN DIEGO – Less than a third of hospitals reprocessed duodenoscopes adequately to prevent potential transmission of carbapenem-resistant Enterobacteriaceae (CRE) and other pathogens, investigators reported at an annual scientific meeting on infectious diseases.

Moreover, only a third of facilities had conducted active surveillance for multidrug-resistant infections related to use of their duodenoscopes in the past year, reported Susan Beekmann of the Emerging Infections Network of the Infectious Diseases Society of America. “These findings suggest that endemic bacterial transmission associated with duodenoscopy may occur and may go unrecognized,” said Ms. Beekmann, program coordinator for EIN at the University of Iowa Carver College of Medicine in Iowa City.

©CDC/James Archer

Duodenoscopes, which are used in endoscopic retrograde cholangiopancreatography (ERCP), became a hot topic earlier this year after causing outbreaks of fatal CRE infections in Los Angeles County. The Food and Drug Administration has acknowledged that the “complex design of the devices makes it difficult to remove contaminants compared to other types of endoscopes,” and both the CDC and the FDA have recommended specific reprocessing and surveillance steps to reduce the chances that the scopes transmit serious infections.

To understand how hospitals were actually reprocessing and culturing the scopes at the time CDC released its guidance, Ms. Beekmann and her colleagues electronically surveyed 740 hospital epidemiologists through IDSA-EIN. They received responses from 378 physicians (52%), of which half said their facilities used duodenoscopes, Ms. Beekmann reported at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Only 55 (29%) of these respondents said their facilities reprocessed duodenoscopes to an extent that the IDSA researchers defined as adequate – that is, manual reprocessing with high-level disinfection, either alone or in combination with other options, Ms. Beekmann said. Furthermore, only a third of facilities had cultured their duodenoscopes or done any other surveillance for bacterial transmission after duodenoscopy in the past year, even though most said they reviewed their reprocessing policies and procedures more often than once a year.

Respondents also described widely varying methodologies for sampling and culturing, Ms. Beekmann said. “Although we did not ask about them, ten respondents mentioned ATP bioluminescence assays,” she added. Based on the findings, better reprocessing technologies and consistent, real-time strategies to monitor the effectiveness of scope reprocessing are “urgent patient safety needs,” she and her colleagues concluded.

Ms. Beekmann and her associates reported no relevant financial disclosures.

Cirrhosis nearly doubled among Veterans Affairs patients between 2001 and 2013, while cirrhosis-related mortality rose by about 50% and deaths from hepatocellular carcinoma almost tripled, investigators reported in the November issue of Gastroenterology.

Hepatitis C virus infection was “the overwhelming driver of these trends, with smaller contributions from alcoholic liver disease, nonalcoholic fatty liver disease, and other liver diseases,” said Dr. Lauren Beste of the University of Washington, Seattle, and her associates. Based on their data, the prevalence of cirrhosis in the United States will peak in 2021, they said. “In contrast, the incidence of HCC continues to increase, confirming worrisome predictions of rapid growth put forward by work (Gastroenterology. 2010;138[2]:513-21) conducted” in the early 2000s.

New HCV infections have dropped sharply in the United States since about 1990, but cases of HCV-related cirrhosis and HCC continue to rise as chronically infected patients age and their liver disease progresses. Although the burden of cirrhosis and HCC due to HCV infection is expected to peak in about the year 2020, the population-level effects of nonalcoholic fatty liver disease, alcoholic liver disease, and hepatitis B virus infection remained unclear, the investigators said. Therefore, they retrospectively studied underlying etiologies among a national cohort of almost 130,000 Veterans Affairs patients with cirrhosis and more than 21,000 patients with HCC between 2001 and 2013 (Gastroenterology 2015. doi: 10.1053/j.gastro.2015.07.056).

In 2013, the VA cared for more than 5.7 million patients, including about 1% with cirrhosis and 0.13% with HCC. Between 2001 and 2013, the prevalence of cirrhosis almost doubled, rising from 664 to 1,058 cases for every 100,000 patients. Deaths among cirrhotic patients also increased by about half, rising from 83 to 126 for every 100,000 patient-years. These liver-related deaths were mainly caused by HCC, whose incidence rose about 2.5 times from 17 to 45 per 100,000 patient-years, Dr. Beste and her associates reported.

Notably, deaths due to liver cancer rose threefold – from 13 to 37 per 100,000 patient-years between 2001 and 2013, “driven overwhelmingly by HCV with much smaller contributions from NAFLD and alcoholic liver disease,” said the researchers. By 2013, almost half of cirrhosis cases and related deaths occurred among HCV-infected patients, as did 67% of HCC cases and related deaths, they noted.

About 60% of patients with cirrhosis and HCV infection also had a longstanding history of alcohol use, the researchers noted. Addressing both factors, as well as diabetes, obesity, and other drivers of nonalcoholic fatty liver disease, could help ease the national burden of liver disease and liver-related mortality among U.S. veterans and other groups, they added. “The increasing burden of cirrhosis and HCC highlights the need for greater efforts to address their causes at a population level,” Dr. Beste and her associates wrote. “Health care systems will need to accommodate rising numbers of patients with cirrhosis and HCC.”

The Department of Veterans Affairs and the Veterans Health Administration funded the study. The investigators declared no competing interests.

Cirrhosis nearly doubled among Veterans Affairs patients between 2001 and 2013, while cirrhosis-related mortality rose by about 50% and deaths from hepatocellular carcinoma almost tripled, investigators reported in the November issue of Gastroenterology.

Hepatitis C virus infection was “the overwhelming driver of these trends, with smaller contributions from alcoholic liver disease, nonalcoholic fatty liver disease, and other liver diseases,” said Dr. Lauren Beste of the University of Washington, Seattle, and her associates. Based on their data, the prevalence of cirrhosis in the United States will peak in 2021, they said. “In contrast, the incidence of HCC continues to increase, confirming worrisome predictions of rapid growth put forward by work (Gastroenterology. 2010;138[2]:513-21) conducted” in the early 2000s.

New HCV infections have dropped sharply in the United States since about 1990, but cases of HCV-related cirrhosis and HCC continue to rise as chronically infected patients age and their liver disease progresses. Although the burden of cirrhosis and HCC due to HCV infection is expected to peak in about the year 2020, the population-level effects of nonalcoholic fatty liver disease, alcoholic liver disease, and hepatitis B virus infection remained unclear, the investigators said. Therefore, they retrospectively studied underlying etiologies among a national cohort of almost 130,000 Veterans Affairs patients with cirrhosis and more than 21,000 patients with HCC between 2001 and 2013 (Gastroenterology 2015. doi: 10.1053/j.gastro.2015.07.056).

In 2013, the VA cared for more than 5.7 million patients, including about 1% with cirrhosis and 0.13% with HCC. Between 2001 and 2013, the prevalence of cirrhosis almost doubled, rising from 664 to 1,058 cases for every 100,000 patients. Deaths among cirrhotic patients also increased by about half, rising from 83 to 126 for every 100,000 patient-years. These liver-related deaths were mainly caused by HCC, whose incidence rose about 2.5 times from 17 to 45 per 100,000 patient-years, Dr. Beste and her associates reported.

Notably, deaths due to liver cancer rose threefold – from 13 to 37 per 100,000 patient-years between 2001 and 2013, “driven overwhelmingly by HCV with much smaller contributions from NAFLD and alcoholic liver disease,” said the researchers. By 2013, almost half of cirrhosis cases and related deaths occurred among HCV-infected patients, as did 67% of HCC cases and related deaths, they noted.

About 60% of patients with cirrhosis and HCV infection also had a longstanding history of alcohol use, the researchers noted. Addressing both factors, as well as diabetes, obesity, and other drivers of nonalcoholic fatty liver disease, could help ease the national burden of liver disease and liver-related mortality among U.S. veterans and other groups, they added. “The increasing burden of cirrhosis and HCC highlights the need for greater efforts to address their causes at a population level,” Dr. Beste and her associates wrote. “Health care systems will need to accommodate rising numbers of patients with cirrhosis and HCC.”

The Department of Veterans Affairs and the Veterans Health Administration funded the study. The investigators declared no competing interests.

Cirrhosis nearly doubled among Veterans Affairs patients between 2001 and 2013, while cirrhosis-related mortality rose by about 50% and deaths from hepatocellular carcinoma almost tripled, investigators reported in the November issue of Gastroenterology.

Hepatitis C virus infection was “the overwhelming driver of these trends, with smaller contributions from alcoholic liver disease, nonalcoholic fatty liver disease, and other liver diseases,” said Dr. Lauren Beste of the University of Washington, Seattle, and her associates. Based on their data, the prevalence of cirrhosis in the United States will peak in 2021, they said. “In contrast, the incidence of HCC continues to increase, confirming worrisome predictions of rapid growth put forward by work (Gastroenterology. 2010;138[2]:513-21) conducted” in the early 2000s.

New HCV infections have dropped sharply in the United States since about 1990, but cases of HCV-related cirrhosis and HCC continue to rise as chronically infected patients age and their liver disease progresses. Although the burden of cirrhosis and HCC due to HCV infection is expected to peak in about the year 2020, the population-level effects of nonalcoholic fatty liver disease, alcoholic liver disease, and hepatitis B virus infection remained unclear, the investigators said. Therefore, they retrospectively studied underlying etiologies among a national cohort of almost 130,000 Veterans Affairs patients with cirrhosis and more than 21,000 patients with HCC between 2001 and 2013 (Gastroenterology 2015. doi: 10.1053/j.gastro.2015.07.056).

In 2013, the VA cared for more than 5.7 million patients, including about 1% with cirrhosis and 0.13% with HCC. Between 2001 and 2013, the prevalence of cirrhosis almost doubled, rising from 664 to 1,058 cases for every 100,000 patients. Deaths among cirrhotic patients also increased by about half, rising from 83 to 126 for every 100,000 patient-years. These liver-related deaths were mainly caused by HCC, whose incidence rose about 2.5 times from 17 to 45 per 100,000 patient-years, Dr. Beste and her associates reported.

Notably, deaths due to liver cancer rose threefold – from 13 to 37 per 100,000 patient-years between 2001 and 2013, “driven overwhelmingly by HCV with much smaller contributions from NAFLD and alcoholic liver disease,” said the researchers. By 2013, almost half of cirrhosis cases and related deaths occurred among HCV-infected patients, as did 67% of HCC cases and related deaths, they noted.

About 60% of patients with cirrhosis and HCV infection also had a longstanding history of alcohol use, the researchers noted. Addressing both factors, as well as diabetes, obesity, and other drivers of nonalcoholic fatty liver disease, could help ease the national burden of liver disease and liver-related mortality among U.S. veterans and other groups, they added. “The increasing burden of cirrhosis and HCC highlights the need for greater efforts to address their causes at a population level,” Dr. Beste and her associates wrote. “Health care systems will need to accommodate rising numbers of patients with cirrhosis and HCC.”

The Department of Veterans Affairs and the Veterans Health Administration funded the study. The investigators declared no competing interests.

Anti-TNF therapy for inflammatory bowel disease appears to double the relative risk of developing central demyelinating disease, though the absolute risk remains small, according to a preliminary report published online Oct. 5 in JAMA Internal Medicine.

Previous case reports have suggested a possible association between anti-TNF agents taken for IBD and later development of demyelinating diseases, but a definitive link has been difficult to establish because of the rarity of these disorders and the suspicion that there already may be an underlying association between IBD and demyelinating disease.

So researchers examined the issue by analyzing data from nationwide Danish health registries for IBD patients and medication exposure. They identified 4,504 patients treated during a 14-year period who had IBD and took anti-TNF agents, and 16,429 IBD patients matched for sex, age, and IBD duration who did not take the medications, according to Dr. Nynne Nyboe Andersen, of the department of epidemiology research, Statens Serum Institut, Copenhagen, and her associates.

Eleven patients in the exposed group had central demyelinating events: multiple sclerosis (2 patients), optic neuritis (5 patients), or other central demyelinating disease (4 patients). For exposed patients, there were 7.5 events per 10,000 person-years.

In comparison, 17 patients in the unexposed group had central demyelinating events: multiple sclerosis (5 patients), optic neuritis (6 patients), transverse myelitis (1 patient), or other central demyelinating disease (5 patients). In this group there were 3.3 events per 10,000 person-years.

The hazard ratio for developing central demyelinating disease after exposure to anti-TNF agents was 2.19, the investigators wrote (JAMA Intern Med. 2015 Oct 5, doi:10.1001/jamainternmed.2015.5396.).

These preliminary findings represent the first report of this association and must be confirmed in future studies, according to the researchers.

“If true, the observed association could either be attributed to the unmasking of a latent demyelinating disease or to the emergence of a de novo demyelinating disease,” Dr. Nyboe Andersen and her associates wrote in the research letter.

The study was supported by the Lundbeck Foundation, Women in Science, the Beckett Foundation, the Danish Colitis Crohn Association, and the Danish Council for Independent Research. Dr. Nyboe Andersen reported receiving travel and speaking fees from MSD and speaking fees from Ferring, and one of her associates reported receiving travel and speaking fees from AbbVie.

Anti-TNF therapy for inflammatory bowel disease appears to double the relative risk of developing central demyelinating disease, though the absolute risk remains small, according to a preliminary report published online Oct. 5 in JAMA Internal Medicine.

Previous case reports have suggested a possible association between anti-TNF agents taken for IBD and later development of demyelinating diseases, but a definitive link has been difficult to establish because of the rarity of these disorders and the suspicion that there already may be an underlying association between IBD and demyelinating disease.

So researchers examined the issue by analyzing data from nationwide Danish health registries for IBD patients and medication exposure. They identified 4,504 patients treated during a 14-year period who had IBD and took anti-TNF agents, and 16,429 IBD patients matched for sex, age, and IBD duration who did not take the medications, according to Dr. Nynne Nyboe Andersen, of the department of epidemiology research, Statens Serum Institut, Copenhagen, and her associates.

Eleven patients in the exposed group had central demyelinating events: multiple sclerosis (2 patients), optic neuritis (5 patients), or other central demyelinating disease (4 patients). For exposed patients, there were 7.5 events per 10,000 person-years.

In comparison, 17 patients in the unexposed group had central demyelinating events: multiple sclerosis (5 patients), optic neuritis (6 patients), transverse myelitis (1 patient), or other central demyelinating disease (5 patients). In this group there were 3.3 events per 10,000 person-years.

The hazard ratio for developing central demyelinating disease after exposure to anti-TNF agents was 2.19, the investigators wrote (JAMA Intern Med. 2015 Oct 5, doi:10.1001/jamainternmed.2015.5396.).

These preliminary findings represent the first report of this association and must be confirmed in future studies, according to the researchers.

“If true, the observed association could either be attributed to the unmasking of a latent demyelinating disease or to the emergence of a de novo demyelinating disease,” Dr. Nyboe Andersen and her associates wrote in the research letter.

The study was supported by the Lundbeck Foundation, Women in Science, the Beckett Foundation, the Danish Colitis Crohn Association, and the Danish Council for Independent Research. Dr. Nyboe Andersen reported receiving travel and speaking fees from MSD and speaking fees from Ferring, and one of her associates reported receiving travel and speaking fees from AbbVie.

Anti-TNF therapy for inflammatory bowel disease appears to double the relative risk of developing central demyelinating disease, though the absolute risk remains small, according to a preliminary report published online Oct. 5 in JAMA Internal Medicine.

Previous case reports have suggested a possible association between anti-TNF agents taken for IBD and later development of demyelinating diseases, but a definitive link has been difficult to establish because of the rarity of these disorders and the suspicion that there already may be an underlying association between IBD and demyelinating disease.

So researchers examined the issue by analyzing data from nationwide Danish health registries for IBD patients and medication exposure. They identified 4,504 patients treated during a 14-year period who had IBD and took anti-TNF agents, and 16,429 IBD patients matched for sex, age, and IBD duration who did not take the medications, according to Dr. Nynne Nyboe Andersen, of the department of epidemiology research, Statens Serum Institut, Copenhagen, and her associates.

Eleven patients in the exposed group had central demyelinating events: multiple sclerosis (2 patients), optic neuritis (5 patients), or other central demyelinating disease (4 patients). For exposed patients, there were 7.5 events per 10,000 person-years.

In comparison, 17 patients in the unexposed group had central demyelinating events: multiple sclerosis (5 patients), optic neuritis (6 patients), transverse myelitis (1 patient), or other central demyelinating disease (5 patients). In this group there were 3.3 events per 10,000 person-years.

The hazard ratio for developing central demyelinating disease after exposure to anti-TNF agents was 2.19, the investigators wrote (JAMA Intern Med. 2015 Oct 5, doi:10.1001/jamainternmed.2015.5396.).

These preliminary findings represent the first report of this association and must be confirmed in future studies, according to the researchers.

“If true, the observed association could either be attributed to the unmasking of a latent demyelinating disease or to the emergence of a de novo demyelinating disease,” Dr. Nyboe Andersen and her associates wrote in the research letter.

The study was supported by the Lundbeck Foundation, Women in Science, the Beckett Foundation, the Danish Colitis Crohn Association, and the Danish Council for Independent Research. Dr. Nyboe Andersen reported receiving travel and speaking fees from MSD and speaking fees from Ferring, and one of her associates reported receiving travel and speaking fees from AbbVie.