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IV tigecycline scores as alternative C. difficile treatment
AMSTERDAM – Intravenous tigecycline was significantly more effective than standard therapy at curing refractory Clostridium difficile infections, according to a case-control study presented at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
Tigecycline effected a 76% clinical cure rate, compared with 53% for the combination regimen of intravenous metronidazole and oral vancomycin, Dr. Baltin Gergely Szabo reported. And despite the fact that those who took tigecycline had more clinically severe disease, no colectomies were required in that group, while two patients in the standard treatment arm did need the procedure.
However, tigecycline didn’t significantly improve relapse rates or mortality, noted Dr. Szabo of the St. Stephan and St. Ladislaus Hospital-Clinic, Budapest, Hungary.
He presented the results of a matched case-control study of 90 patients with severe C. difficile infections, who were treated with either of the protocols. Patients who took tigecycline were more likely to have a recurrent infection (38% vs. 29%). Thus, they were also more likely to have previously been treated with metronidazole (38% vs. 24%) and vancomycin (24% vs. 7%). Prior tigecycline use was very rare in both groups (2% vs. 0%).
Those who took tigecycline were significantly younger as well (72 vs. 78 years), and more often men (56% vs. 30%). They were more likely to be hypertensive, have chronic obstructive pulmonary disease, have cancers, be immunosuppressed, and be chronic users of corticosteroids.
However, the Charlson comorbidity index was similar between the tigecycline and standard therapy groups (4.6 vs. 5). They were also matched for ATLAS scores (mean 7.8 in each group).
Significantly more patients taking tigecycline had acquired their infections during hospitalization (64% vs. 30%). They also had a longer duration of symptoms (17 vs. 10 days).
Imaging showed more severe disease in the tigecycline group with significantly more colonic distension, mural thickening, and ascites. Tigecycline patients had also undergone significantly more colonoscopies and blood cultures.
Tigecycline was given in the hospital for 7-10 days, with a 100-mg loading dose and subsequent 50-mg daily doses. The main duration of therapy was 10 days, but that varied widely, from 2 to 22 days. It was given only as first-line treatment to 15% of patients; the rest received tigecycline as an alternative treatment, often after the combination of metronidazole/vancomycin had failed. No adverse drug reactions occurred in the group.
Clinical cure was achieved in 76% of the tigecycline group and 53% of the standard protocol group – a significant difference. The drug was associated with a decreased rate of complicated disease course (29% vs. 53%) and significantly fewer colectomies (0 vs. 2).
Rates of toxic megacolon were equal (7% each group); ileus was more frequent in the tigecycline group (11% vs. 9%), but this difference was not statistically significant.
However, tigecycline had no impact on either in-hospital or 90-day relapse, or on in-hospital mortality (15 vs. 16 deaths). At 90 days, fewer patients taking the drug had died (17 vs. 21), but that difference was not statistically significant (P = 0.52).
A multivariate analysis identified several characteristics associated with a beneficial response to tigecycline:
• Male sex.
• Being immunosuppressed.
• Chronic steroid treatment.
• Malignancy.
• Longer duration of symptoms.
• Prior C. difficile infections.
• Nosocomial onset.
• Signs of severe infection on imaging.
Dr. Szabo said these characteristics can be used to create a profile of patients who might be good candidates for the drug.
He had no relevant financial declarations.
On Twitter @Alz_Gal
AMSTERDAM – Intravenous tigecycline was significantly more effective than standard therapy at curing refractory Clostridium difficile infections, according to a case-control study presented at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
Tigecycline effected a 76% clinical cure rate, compared with 53% for the combination regimen of intravenous metronidazole and oral vancomycin, Dr. Baltin Gergely Szabo reported. And despite the fact that those who took tigecycline had more clinically severe disease, no colectomies were required in that group, while two patients in the standard treatment arm did need the procedure.
However, tigecycline didn’t significantly improve relapse rates or mortality, noted Dr. Szabo of the St. Stephan and St. Ladislaus Hospital-Clinic, Budapest, Hungary.
He presented the results of a matched case-control study of 90 patients with severe C. difficile infections, who were treated with either of the protocols. Patients who took tigecycline were more likely to have a recurrent infection (38% vs. 29%). Thus, they were also more likely to have previously been treated with metronidazole (38% vs. 24%) and vancomycin (24% vs. 7%). Prior tigecycline use was very rare in both groups (2% vs. 0%).
Those who took tigecycline were significantly younger as well (72 vs. 78 years), and more often men (56% vs. 30%). They were more likely to be hypertensive, have chronic obstructive pulmonary disease, have cancers, be immunosuppressed, and be chronic users of corticosteroids.
However, the Charlson comorbidity index was similar between the tigecycline and standard therapy groups (4.6 vs. 5). They were also matched for ATLAS scores (mean 7.8 in each group).
Significantly more patients taking tigecycline had acquired their infections during hospitalization (64% vs. 30%). They also had a longer duration of symptoms (17 vs. 10 days).
Imaging showed more severe disease in the tigecycline group with significantly more colonic distension, mural thickening, and ascites. Tigecycline patients had also undergone significantly more colonoscopies and blood cultures.
Tigecycline was given in the hospital for 7-10 days, with a 100-mg loading dose and subsequent 50-mg daily doses. The main duration of therapy was 10 days, but that varied widely, from 2 to 22 days. It was given only as first-line treatment to 15% of patients; the rest received tigecycline as an alternative treatment, often after the combination of metronidazole/vancomycin had failed. No adverse drug reactions occurred in the group.
Clinical cure was achieved in 76% of the tigecycline group and 53% of the standard protocol group – a significant difference. The drug was associated with a decreased rate of complicated disease course (29% vs. 53%) and significantly fewer colectomies (0 vs. 2).
Rates of toxic megacolon were equal (7% each group); ileus was more frequent in the tigecycline group (11% vs. 9%), but this difference was not statistically significant.
However, tigecycline had no impact on either in-hospital or 90-day relapse, or on in-hospital mortality (15 vs. 16 deaths). At 90 days, fewer patients taking the drug had died (17 vs. 21), but that difference was not statistically significant (P = 0.52).
A multivariate analysis identified several characteristics associated with a beneficial response to tigecycline:
• Male sex.
• Being immunosuppressed.
• Chronic steroid treatment.
• Malignancy.
• Longer duration of symptoms.
• Prior C. difficile infections.
• Nosocomial onset.
• Signs of severe infection on imaging.
Dr. Szabo said these characteristics can be used to create a profile of patients who might be good candidates for the drug.
He had no relevant financial declarations.
On Twitter @Alz_Gal
AMSTERDAM – Intravenous tigecycline was significantly more effective than standard therapy at curing refractory Clostridium difficile infections, according to a case-control study presented at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
Tigecycline effected a 76% clinical cure rate, compared with 53% for the combination regimen of intravenous metronidazole and oral vancomycin, Dr. Baltin Gergely Szabo reported. And despite the fact that those who took tigecycline had more clinically severe disease, no colectomies were required in that group, while two patients in the standard treatment arm did need the procedure.
However, tigecycline didn’t significantly improve relapse rates or mortality, noted Dr. Szabo of the St. Stephan and St. Ladislaus Hospital-Clinic, Budapest, Hungary.
He presented the results of a matched case-control study of 90 patients with severe C. difficile infections, who were treated with either of the protocols. Patients who took tigecycline were more likely to have a recurrent infection (38% vs. 29%). Thus, they were also more likely to have previously been treated with metronidazole (38% vs. 24%) and vancomycin (24% vs. 7%). Prior tigecycline use was very rare in both groups (2% vs. 0%).
Those who took tigecycline were significantly younger as well (72 vs. 78 years), and more often men (56% vs. 30%). They were more likely to be hypertensive, have chronic obstructive pulmonary disease, have cancers, be immunosuppressed, and be chronic users of corticosteroids.
However, the Charlson comorbidity index was similar between the tigecycline and standard therapy groups (4.6 vs. 5). They were also matched for ATLAS scores (mean 7.8 in each group).
Significantly more patients taking tigecycline had acquired their infections during hospitalization (64% vs. 30%). They also had a longer duration of symptoms (17 vs. 10 days).
Imaging showed more severe disease in the tigecycline group with significantly more colonic distension, mural thickening, and ascites. Tigecycline patients had also undergone significantly more colonoscopies and blood cultures.
Tigecycline was given in the hospital for 7-10 days, with a 100-mg loading dose and subsequent 50-mg daily doses. The main duration of therapy was 10 days, but that varied widely, from 2 to 22 days. It was given only as first-line treatment to 15% of patients; the rest received tigecycline as an alternative treatment, often after the combination of metronidazole/vancomycin had failed. No adverse drug reactions occurred in the group.
Clinical cure was achieved in 76% of the tigecycline group and 53% of the standard protocol group – a significant difference. The drug was associated with a decreased rate of complicated disease course (29% vs. 53%) and significantly fewer colectomies (0 vs. 2).
Rates of toxic megacolon were equal (7% each group); ileus was more frequent in the tigecycline group (11% vs. 9%), but this difference was not statistically significant.
However, tigecycline had no impact on either in-hospital or 90-day relapse, or on in-hospital mortality (15 vs. 16 deaths). At 90 days, fewer patients taking the drug had died (17 vs. 21), but that difference was not statistically significant (P = 0.52).
A multivariate analysis identified several characteristics associated with a beneficial response to tigecycline:
• Male sex.
• Being immunosuppressed.
• Chronic steroid treatment.
• Malignancy.
• Longer duration of symptoms.
• Prior C. difficile infections.
• Nosocomial onset.
• Signs of severe infection on imaging.
Dr. Szabo said these characteristics can be used to create a profile of patients who might be good candidates for the drug.
He had no relevant financial declarations.
On Twitter @Alz_Gal
AT ACCMID 2016
Key clinical point: Tigecycline was an effective therapy for patients with severe C. difficile infections.
Major finding: The drug effected a clinical cure in 76% of patients, compared with a 53% cure rate in those taking metronidazole and vancomycin.
Data source: A retrospective case-control study involving 90 patients.
Disclosures: Dr. Szabo had no relevant financial disclosures.
C. difficile infections raise risk of death, long-term care for seniors
AMSTERDAM – Clostridium difficile infections are a major driver of death and nursing home placement in Americans older than 65 years, according to research presented at a major international conference on infectious diseases.
A Medicare database review of almost 1.6 million patients has determined that 36% of those with C. difficile died, compared with 25% of an age-matched control group – an 11% attributable mortality. The infections also doubled the risk of placement in a skilled care nursing facility and tripled the risk of nursing home admission, Dr. Erik Dubberke said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
Dr. Dubberke, an infectious disease specialist at Washington University, St. Louis, said these findings underscore not only the infection’s potential lethality, but its considerable impact on both short- and long-term quality of life.
His case-control study included 175,000 patients older than 65 years who were diagnosed with a C. difficile infection in 2011 – they were then matched with 1.45 million controls. This yielded 129,000 pairs matched for mortality, 105,000 matched for skilled nursing facility admission, and 93,500 matched for nursing home admission. The analysis controlled for age, gender, race, other infections, as well as health care utilization and a comprehensive group of acute and chronic conditions in the prior 12 months.
Overall, Dr. Dubberke found that 36% of cases and 25% of controls died during the year – a 44% increased risk of death and an 11% attributable mortality rate. During the same period, another 36% of the C. difficile cases were admitted to a skilled nursing facility, compared with 19% of controls – an 89% increased risk and 17% attributable admission rate.
C. difficile infections also exerted a significant impact on nursing home admissions: 15% of the cases in the study were admitted, compared with 5% of controls. This represented almost a tripling of risk (relative risk, 2.80), with an attributable admission rate of 10%, Dr. Dubberke said.
“These findings illustrate how C. difficile impacts quality of life, with short-term morbidity reflected in increasing admissions to skilled nursing facilities, and long-term morbidity by increasing admissions to nursing homes,” he said.
Dr. Dubberke had no financial disclosures.
On Twitter @Alz_Gal
AMSTERDAM – Clostridium difficile infections are a major driver of death and nursing home placement in Americans older than 65 years, according to research presented at a major international conference on infectious diseases.
A Medicare database review of almost 1.6 million patients has determined that 36% of those with C. difficile died, compared with 25% of an age-matched control group – an 11% attributable mortality. The infections also doubled the risk of placement in a skilled care nursing facility and tripled the risk of nursing home admission, Dr. Erik Dubberke said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
Dr. Dubberke, an infectious disease specialist at Washington University, St. Louis, said these findings underscore not only the infection’s potential lethality, but its considerable impact on both short- and long-term quality of life.
His case-control study included 175,000 patients older than 65 years who were diagnosed with a C. difficile infection in 2011 – they were then matched with 1.45 million controls. This yielded 129,000 pairs matched for mortality, 105,000 matched for skilled nursing facility admission, and 93,500 matched for nursing home admission. The analysis controlled for age, gender, race, other infections, as well as health care utilization and a comprehensive group of acute and chronic conditions in the prior 12 months.
Overall, Dr. Dubberke found that 36% of cases and 25% of controls died during the year – a 44% increased risk of death and an 11% attributable mortality rate. During the same period, another 36% of the C. difficile cases were admitted to a skilled nursing facility, compared with 19% of controls – an 89% increased risk and 17% attributable admission rate.
C. difficile infections also exerted a significant impact on nursing home admissions: 15% of the cases in the study were admitted, compared with 5% of controls. This represented almost a tripling of risk (relative risk, 2.80), with an attributable admission rate of 10%, Dr. Dubberke said.
“These findings illustrate how C. difficile impacts quality of life, with short-term morbidity reflected in increasing admissions to skilled nursing facilities, and long-term morbidity by increasing admissions to nursing homes,” he said.
Dr. Dubberke had no financial disclosures.
On Twitter @Alz_Gal
AMSTERDAM – Clostridium difficile infections are a major driver of death and nursing home placement in Americans older than 65 years, according to research presented at a major international conference on infectious diseases.
A Medicare database review of almost 1.6 million patients has determined that 36% of those with C. difficile died, compared with 25% of an age-matched control group – an 11% attributable mortality. The infections also doubled the risk of placement in a skilled care nursing facility and tripled the risk of nursing home admission, Dr. Erik Dubberke said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
Dr. Dubberke, an infectious disease specialist at Washington University, St. Louis, said these findings underscore not only the infection’s potential lethality, but its considerable impact on both short- and long-term quality of life.
His case-control study included 175,000 patients older than 65 years who were diagnosed with a C. difficile infection in 2011 – they were then matched with 1.45 million controls. This yielded 129,000 pairs matched for mortality, 105,000 matched for skilled nursing facility admission, and 93,500 matched for nursing home admission. The analysis controlled for age, gender, race, other infections, as well as health care utilization and a comprehensive group of acute and chronic conditions in the prior 12 months.
Overall, Dr. Dubberke found that 36% of cases and 25% of controls died during the year – a 44% increased risk of death and an 11% attributable mortality rate. During the same period, another 36% of the C. difficile cases were admitted to a skilled nursing facility, compared with 19% of controls – an 89% increased risk and 17% attributable admission rate.
C. difficile infections also exerted a significant impact on nursing home admissions: 15% of the cases in the study were admitted, compared with 5% of controls. This represented almost a tripling of risk (relative risk, 2.80), with an attributable admission rate of 10%, Dr. Dubberke said.
“These findings illustrate how C. difficile impacts quality of life, with short-term morbidity reflected in increasing admissions to skilled nursing facilities, and long-term morbidity by increasing admissions to nursing homes,” he said.
Dr. Dubberke had no financial disclosures.
On Twitter @Alz_Gal
AT ECCMID 2016
Key clinical point: Clostridium difficile infections are key drivers of death and long-term care placement among U.S. senior citizens.
Major finding: In 2011, 36% of older patients with C. difficile died, compared with 25% of an age-matched control group – an 11% attributable mortality.
Data source: A case-control study involving over 1.5 million Medicare recipients.
Disclosures: Dr. Dubberke had no financial disclosures.
The perils of hospital air
Hospital air is a potential route of transmission of beta-lactam–resistant bacteria (BLRB), which are important causative agents of nosocomial infections, according to research published in the American Journal of Infection Control.
Dr. Mahnaz Nikaeen of the department of environmental health engineering at Isfahan (Iran) University of Medical Sciences, and his coauthors collected and tested 64 air samples from four hospital wards to determine the prevalence of airborne BLRB in different teaching hospitals, to evaluate the frequency of five common beta-lactamase–encoding genes in isolated resistant bacteria, and to identify the most predominant BLRB by 16s rRNA gene sequencing. The sampling locations in each hospital included operating rooms, ICUs, surgery wards, and internal medicine wards.
The investigators detected airborne bacteria by using culture plates with and without beta-lactams.
The prevalence of BLRB in the air samples ranged between 3% and 34%, Dr. Nikaeen said. Oxacillin-resistant bacteria had the highest prevalence, followed by ceftazidime- and cefazolin-resistant bacteria. Acinetobacter spp, Acinetobacter baumannii, and Staphylococcus spp were the most predominant BLRB.
Gene sequencing revealed that the frequency of beta-lactamase–encoding genes in isolated BLRB ranged between 0% and 47%, with the highest and lowest detection for OXA-23, commonly found in Acinetobacter spp, and CTX-m-32, a gene prevalent in extended-spectrum beta-lactamase–producing Enterobacteriaceae, respectively. MecA, a genetic element found in methicillin-resistant Staphylococcus spp, had a relatively high frequency in surgery wards and operating rooms, whereas the frequency of blaTEM, another common extended-spectrum beta-lactamase produced by Enterobacteriaceae, was higher in intensive care units and internal medicine wards. OXA-51, a chromosomally located intrinsic gene in A. baumannii, was detected in four wards.
“Isolation of beta-lactam–resistant Staphylococcus spp and A. baumannii as the most predominant BLRB indicated the potential role of airborne bacteria in dissemination of nosocomial infections,” Dr. Nikaeen and his coauthors said. “The results confirm the necessity for application of effective control measures that significantly decrease the exposure of high-risk patients to potentially airborne nosocomial infections.”
The authors reported having no conflicts.
Read the complete study in the American Journal of Infection Control (doi:10.1016/j.ajic.2016.01.041).
On Twitter @richpizzi
Hospital air is a potential route of transmission of beta-lactam–resistant bacteria (BLRB), which are important causative agents of nosocomial infections, according to research published in the American Journal of Infection Control.
Dr. Mahnaz Nikaeen of the department of environmental health engineering at Isfahan (Iran) University of Medical Sciences, and his coauthors collected and tested 64 air samples from four hospital wards to determine the prevalence of airborne BLRB in different teaching hospitals, to evaluate the frequency of five common beta-lactamase–encoding genes in isolated resistant bacteria, and to identify the most predominant BLRB by 16s rRNA gene sequencing. The sampling locations in each hospital included operating rooms, ICUs, surgery wards, and internal medicine wards.
The investigators detected airborne bacteria by using culture plates with and without beta-lactams.
The prevalence of BLRB in the air samples ranged between 3% and 34%, Dr. Nikaeen said. Oxacillin-resistant bacteria had the highest prevalence, followed by ceftazidime- and cefazolin-resistant bacteria. Acinetobacter spp, Acinetobacter baumannii, and Staphylococcus spp were the most predominant BLRB.
Gene sequencing revealed that the frequency of beta-lactamase–encoding genes in isolated BLRB ranged between 0% and 47%, with the highest and lowest detection for OXA-23, commonly found in Acinetobacter spp, and CTX-m-32, a gene prevalent in extended-spectrum beta-lactamase–producing Enterobacteriaceae, respectively. MecA, a genetic element found in methicillin-resistant Staphylococcus spp, had a relatively high frequency in surgery wards and operating rooms, whereas the frequency of blaTEM, another common extended-spectrum beta-lactamase produced by Enterobacteriaceae, was higher in intensive care units and internal medicine wards. OXA-51, a chromosomally located intrinsic gene in A. baumannii, was detected in four wards.
“Isolation of beta-lactam–resistant Staphylococcus spp and A. baumannii as the most predominant BLRB indicated the potential role of airborne bacteria in dissemination of nosocomial infections,” Dr. Nikaeen and his coauthors said. “The results confirm the necessity for application of effective control measures that significantly decrease the exposure of high-risk patients to potentially airborne nosocomial infections.”
The authors reported having no conflicts.
Read the complete study in the American Journal of Infection Control (doi:10.1016/j.ajic.2016.01.041).
On Twitter @richpizzi
Hospital air is a potential route of transmission of beta-lactam–resistant bacteria (BLRB), which are important causative agents of nosocomial infections, according to research published in the American Journal of Infection Control.
Dr. Mahnaz Nikaeen of the department of environmental health engineering at Isfahan (Iran) University of Medical Sciences, and his coauthors collected and tested 64 air samples from four hospital wards to determine the prevalence of airborne BLRB in different teaching hospitals, to evaluate the frequency of five common beta-lactamase–encoding genes in isolated resistant bacteria, and to identify the most predominant BLRB by 16s rRNA gene sequencing. The sampling locations in each hospital included operating rooms, ICUs, surgery wards, and internal medicine wards.
The investigators detected airborne bacteria by using culture plates with and without beta-lactams.
The prevalence of BLRB in the air samples ranged between 3% and 34%, Dr. Nikaeen said. Oxacillin-resistant bacteria had the highest prevalence, followed by ceftazidime- and cefazolin-resistant bacteria. Acinetobacter spp, Acinetobacter baumannii, and Staphylococcus spp were the most predominant BLRB.
Gene sequencing revealed that the frequency of beta-lactamase–encoding genes in isolated BLRB ranged between 0% and 47%, with the highest and lowest detection for OXA-23, commonly found in Acinetobacter spp, and CTX-m-32, a gene prevalent in extended-spectrum beta-lactamase–producing Enterobacteriaceae, respectively. MecA, a genetic element found in methicillin-resistant Staphylococcus spp, had a relatively high frequency in surgery wards and operating rooms, whereas the frequency of blaTEM, another common extended-spectrum beta-lactamase produced by Enterobacteriaceae, was higher in intensive care units and internal medicine wards. OXA-51, a chromosomally located intrinsic gene in A. baumannii, was detected in four wards.
“Isolation of beta-lactam–resistant Staphylococcus spp and A. baumannii as the most predominant BLRB indicated the potential role of airborne bacteria in dissemination of nosocomial infections,” Dr. Nikaeen and his coauthors said. “The results confirm the necessity for application of effective control measures that significantly decrease the exposure of high-risk patients to potentially airborne nosocomial infections.”
The authors reported having no conflicts.
Read the complete study in the American Journal of Infection Control (doi:10.1016/j.ajic.2016.01.041).
On Twitter @richpizzi
FROM AMERICAN JOURNAL OF INFECTION CONTROL
Isolating asymptomatic C. diff carriers slashes hospital-acquired infections
Screening asymptomatic patients admitted through the emergency department for occult Clostridium difficile infection, then isolating those found to be carriers throughout their hospital stay, substantially reduced the incidence of hospital-acquired C. difficile infection in a tertiary acute-care hospital, according to a report published online April 25 in JAMA Internal Medicine.
In what investigators described as the first study to assess the benefit of such an intervention, the Quebec Heart and Lung Institute (QHLI) in Quebec City went from being endemic for C. difficile infection to having the lowest incidence among 22 academic hospitals across the province of Quebec. “If confirmed in subsequent studies, isolating asymptomatic carriers could potentially prevent thousands of cases of hospital-acquired C. difficile infection every year in North America,” said Dr. Yves Longtin of the infection prevention and control unit at Jewish General Hospital, Montreal, and his associates.
The QHLI implemented the screen-and-isolate program because, despite robust infection-control efforts, it continued to exceed the government-imposed target level of 9.0 C. difficile infections per 10,000 patient-days. The program, which involved 7,599 patients admitted to the facility through its ED during a 17-month period, called for rectal sampling with a sterile swab, using a polymerase chain reaction (PCR) assay to detect the tcdB gene, obtaining the results within 24 hours, and isolating any carriers for the remainder of their stay. A total of 368 asymptomatic patients (4.8%) were found to be carriers.
Before the intervention, the hospital’s monthly incidence averaged 8.2 cases per 10,000 patient-days, with a high of 28.6 cases per 10,000 patient-days during an epidemic. After the intervention was implemented, the monthly incidence dropped to 3.0 per 10,000 patient-days. The hospital exceeded target levels of cases in 24.4% of the months preceding the intervention, compared with none of the months afterward. The investigators calculated that only 121 patients needed to be screened and 6 asymptomatic carriers needed to be isolated to prevent 1 case of hospital-acquired C. difficile infection.
During the same time period, rates of C. difficile infection remained stable at other hospitals across the province, Dr. Longtin and his associates said (JAMA Intern Med. 2016 Apr 25. doi: 10.1001/jamainternmed.2016.0177).
“The intervention may be effective not only by preventing direct patient-to-patient transmission but also by limiting contamination of the hospital environment,” they noted.
The study was supported by the Quebec Heart and Lung Institute, the Quebec Ministry of Health and Social Services, and the Quebec Foundation for Health Research. Dr. Longtin reported being a coapplicant on a patent for methods, reagents, and kits for the assessment of bacterial infections. His associates reported ties to Sanofi Pasteur, Merck, and Otsuka.
Until now, there were no data to determine whether interventions targeting asymptomatic carriers could reduce hospital-acquired C. difficile infection, so these findings are particularly encouraging. But the feasibility of expanding such programs on a larger scale must be carefully considered.
None of the commercially available PCR assays for diagnosing C. difficile has been approved by the Food and Drug Administration for detection in asymptomatic carriers. In addition, screening all patients admitted through the ED is labor and resource intensive, particularly in view of the high cost of PCR assays, and private rooms for isolation may not be available. Moreover, isolation can cause patients anxiety and depression, especially if it is long-term.
Perhaps targeting the highest-risk patients for screening and isolation would be helpful. Patients at high risk for shedding C. difficile spores (such as those who have a history of the infection or who have recently used antibiotics) and patients admitted to high-risk wards such as the ICU may be a good starting point.
Dr. Alice Y. Guh and Dr. L. Clifford McDonald are with the division of healthcare quality promotion at the U.S. Centers for Disease Control and Prevention, Atlanta. They reported having no relevant financial disclosures. Dr. Guh and Dr. McDonald made these remarks in an invited commentary (JAMA Intern Med. 2016 Apr 25. doi: 10.1001/jamainternmed.2016.1118) accompanying Dr. Longtin’s report.
Until now, there were no data to determine whether interventions targeting asymptomatic carriers could reduce hospital-acquired C. difficile infection, so these findings are particularly encouraging. But the feasibility of expanding such programs on a larger scale must be carefully considered.
None of the commercially available PCR assays for diagnosing C. difficile has been approved by the Food and Drug Administration for detection in asymptomatic carriers. In addition, screening all patients admitted through the ED is labor and resource intensive, particularly in view of the high cost of PCR assays, and private rooms for isolation may not be available. Moreover, isolation can cause patients anxiety and depression, especially if it is long-term.
Perhaps targeting the highest-risk patients for screening and isolation would be helpful. Patients at high risk for shedding C. difficile spores (such as those who have a history of the infection or who have recently used antibiotics) and patients admitted to high-risk wards such as the ICU may be a good starting point.
Dr. Alice Y. Guh and Dr. L. Clifford McDonald are with the division of healthcare quality promotion at the U.S. Centers for Disease Control and Prevention, Atlanta. They reported having no relevant financial disclosures. Dr. Guh and Dr. McDonald made these remarks in an invited commentary (JAMA Intern Med. 2016 Apr 25. doi: 10.1001/jamainternmed.2016.1118) accompanying Dr. Longtin’s report.
Until now, there were no data to determine whether interventions targeting asymptomatic carriers could reduce hospital-acquired C. difficile infection, so these findings are particularly encouraging. But the feasibility of expanding such programs on a larger scale must be carefully considered.
None of the commercially available PCR assays for diagnosing C. difficile has been approved by the Food and Drug Administration for detection in asymptomatic carriers. In addition, screening all patients admitted through the ED is labor and resource intensive, particularly in view of the high cost of PCR assays, and private rooms for isolation may not be available. Moreover, isolation can cause patients anxiety and depression, especially if it is long-term.
Perhaps targeting the highest-risk patients for screening and isolation would be helpful. Patients at high risk for shedding C. difficile spores (such as those who have a history of the infection or who have recently used antibiotics) and patients admitted to high-risk wards such as the ICU may be a good starting point.
Dr. Alice Y. Guh and Dr. L. Clifford McDonald are with the division of healthcare quality promotion at the U.S. Centers for Disease Control and Prevention, Atlanta. They reported having no relevant financial disclosures. Dr. Guh and Dr. McDonald made these remarks in an invited commentary (JAMA Intern Med. 2016 Apr 25. doi: 10.1001/jamainternmed.2016.1118) accompanying Dr. Longtin’s report.
Screening asymptomatic patients admitted through the emergency department for occult Clostridium difficile infection, then isolating those found to be carriers throughout their hospital stay, substantially reduced the incidence of hospital-acquired C. difficile infection in a tertiary acute-care hospital, according to a report published online April 25 in JAMA Internal Medicine.
In what investigators described as the first study to assess the benefit of such an intervention, the Quebec Heart and Lung Institute (QHLI) in Quebec City went from being endemic for C. difficile infection to having the lowest incidence among 22 academic hospitals across the province of Quebec. “If confirmed in subsequent studies, isolating asymptomatic carriers could potentially prevent thousands of cases of hospital-acquired C. difficile infection every year in North America,” said Dr. Yves Longtin of the infection prevention and control unit at Jewish General Hospital, Montreal, and his associates.
The QHLI implemented the screen-and-isolate program because, despite robust infection-control efforts, it continued to exceed the government-imposed target level of 9.0 C. difficile infections per 10,000 patient-days. The program, which involved 7,599 patients admitted to the facility through its ED during a 17-month period, called for rectal sampling with a sterile swab, using a polymerase chain reaction (PCR) assay to detect the tcdB gene, obtaining the results within 24 hours, and isolating any carriers for the remainder of their stay. A total of 368 asymptomatic patients (4.8%) were found to be carriers.
Before the intervention, the hospital’s monthly incidence averaged 8.2 cases per 10,000 patient-days, with a high of 28.6 cases per 10,000 patient-days during an epidemic. After the intervention was implemented, the monthly incidence dropped to 3.0 per 10,000 patient-days. The hospital exceeded target levels of cases in 24.4% of the months preceding the intervention, compared with none of the months afterward. The investigators calculated that only 121 patients needed to be screened and 6 asymptomatic carriers needed to be isolated to prevent 1 case of hospital-acquired C. difficile infection.
During the same time period, rates of C. difficile infection remained stable at other hospitals across the province, Dr. Longtin and his associates said (JAMA Intern Med. 2016 Apr 25. doi: 10.1001/jamainternmed.2016.0177).
“The intervention may be effective not only by preventing direct patient-to-patient transmission but also by limiting contamination of the hospital environment,” they noted.
The study was supported by the Quebec Heart and Lung Institute, the Quebec Ministry of Health and Social Services, and the Quebec Foundation for Health Research. Dr. Longtin reported being a coapplicant on a patent for methods, reagents, and kits for the assessment of bacterial infections. His associates reported ties to Sanofi Pasteur, Merck, and Otsuka.
Screening asymptomatic patients admitted through the emergency department for occult Clostridium difficile infection, then isolating those found to be carriers throughout their hospital stay, substantially reduced the incidence of hospital-acquired C. difficile infection in a tertiary acute-care hospital, according to a report published online April 25 in JAMA Internal Medicine.
In what investigators described as the first study to assess the benefit of such an intervention, the Quebec Heart and Lung Institute (QHLI) in Quebec City went from being endemic for C. difficile infection to having the lowest incidence among 22 academic hospitals across the province of Quebec. “If confirmed in subsequent studies, isolating asymptomatic carriers could potentially prevent thousands of cases of hospital-acquired C. difficile infection every year in North America,” said Dr. Yves Longtin of the infection prevention and control unit at Jewish General Hospital, Montreal, and his associates.
The QHLI implemented the screen-and-isolate program because, despite robust infection-control efforts, it continued to exceed the government-imposed target level of 9.0 C. difficile infections per 10,000 patient-days. The program, which involved 7,599 patients admitted to the facility through its ED during a 17-month period, called for rectal sampling with a sterile swab, using a polymerase chain reaction (PCR) assay to detect the tcdB gene, obtaining the results within 24 hours, and isolating any carriers for the remainder of their stay. A total of 368 asymptomatic patients (4.8%) were found to be carriers.
Before the intervention, the hospital’s monthly incidence averaged 8.2 cases per 10,000 patient-days, with a high of 28.6 cases per 10,000 patient-days during an epidemic. After the intervention was implemented, the monthly incidence dropped to 3.0 per 10,000 patient-days. The hospital exceeded target levels of cases in 24.4% of the months preceding the intervention, compared with none of the months afterward. The investigators calculated that only 121 patients needed to be screened and 6 asymptomatic carriers needed to be isolated to prevent 1 case of hospital-acquired C. difficile infection.
During the same time period, rates of C. difficile infection remained stable at other hospitals across the province, Dr. Longtin and his associates said (JAMA Intern Med. 2016 Apr 25. doi: 10.1001/jamainternmed.2016.0177).
“The intervention may be effective not only by preventing direct patient-to-patient transmission but also by limiting contamination of the hospital environment,” they noted.
The study was supported by the Quebec Heart and Lung Institute, the Quebec Ministry of Health and Social Services, and the Quebec Foundation for Health Research. Dr. Longtin reported being a coapplicant on a patent for methods, reagents, and kits for the assessment of bacterial infections. His associates reported ties to Sanofi Pasteur, Merck, and Otsuka.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Screening asymptomatic patients admitted through the ED for occult C. difficile infection and isolating them throughout their hospital stay substantially reduced the incidence of hospital-acquired C. difficile.
Major finding: 121 patients needed to be screened and 6 asymptomatic carriers needed to be isolated to prevent 1 case of hospital-acquired C. difficile infection.
Data source: A controlled quasi-experimental study comparing rates of C. difficile infection at a single hospital during a 1.5-year period before and after an infection-control program was implemented.
Disclosures: This study was supported by the Quebec Heart and Lung Institute, the Quebec Ministry of Health and Social Services, and the Quebec Foundation for Health Research. Dr. Longtin reported being a coapplicant on a patent for methods, reagents, and kits for the assessment of bacterial infections. His associates reported ties to Sanofi Pasteur, Merck, and Otsuka.
Chlorhexidine-alcohol skin prep reduced SSIs after abdominal hysterectomy
INDIAN WELLS, CALIF. – Using chlorhexidine-alcohol preoperative skin antisepsis at the time of abdominal hysterectomy is associated with a lower incidence of surgical site infections (SSIs), compared with using povidone-iodine antiseptic solution, a large retrospective study showed.
“Surgical site infections have been linked to longer hospital stays, higher readmission rates, and overall increased healthcare costs,” Ali Bazzi, the lead study author, said at the annual scientific meeting of the Society of Gynecologic Surgeons. “Preoperative topical skin antiseptics have decreased the rate of SSIs over the years and have led to improved patient outcomes. Current published guidelines for skin preparations, specifically abdominal hysterectomies, do not routinely specify a choice of antiseptic. With greater than 500,000 hysterectomies performed each year in the United States, and about half done via laparotomy, this can have significant clinical implications.”
In an effort to determine whether the choice of preoperative topical antisepsis independently affects SSIs, Mr. Bazzi, a fourth-year medical student at the University of Michigan, Ann Arbor, and his associates in the university’s department of gynecologic oncology evaluated chlorhexidine-gluconate in alcohol versus povidone-iodine in aqueous solution. The second objective focused on determining certain patient factors and operative predictors of SSIs.
The researchers used the Michigan Surgical Quality Collaborative database to perform a retrospective cohort analysis of patients who underwent abdominal hysterectomy from July 2012 to February 2015. The primary outcome was diagnosis of a superficial, deep, or organ space SSI within 30 days of surgery, while the primary predictor was whether the individual cases received either the chlorhexidine-alcohol or the povidone-iodine antiseptic solution.
The researchers excluded cases with missing data, preoperative sepsis or emergent operative cases, and patients on chronic steroids due to immunosuppression, since these cases were associated with a higher than baseline risk of developing SSIs. Other types of skin preparation agents did not meet a large enough sample size and thus were underpowered. These cases were not included in the final analysis. Multivariate logistic regression models estimated the independent effect of skin antiseptic choice on the rate of SSI.
Mr. Bazzi reported results from 5,074 abdominal hysterectomies. Compared with patients in the povidone-iodine group, those in the chlorhexidine-alcohol group had several medical comorbidities, demographic and perioperative factors associated with the development of SSIs, including being more likely to have a BMI of 30 kg/m2 or greater; American Society of Anesthesiology Class of 3 or greater; dependent functional status; malignancy as a preoperative indication for surgery; estimated blood loss of greater than 250 cc; and surgery lasting longer than 3 hours.
The overall rate of any SSI was 3.6%. The unadjusted SSI rates based on antiseptic choice were 3.5% in the chlorhexidine-alcohol group and 3.8% in the povidone-iodine group. After using multivariate logistic regression adjusted for population differences, the researchers determined that chlorhexidine-alcohol was associated with a 30% lower odds of developing SSIs, compared with those in the povidone-iodine group (odds ratio, 0.71; 95% confidence interval, 0.51-0.98; P = .037).
Mr. Bazzi, who begins an ob.gyn. residency at St. John Hospital and Medical Center in Detroit in July 2016, acknowledged that other qualitative factors not included in the analysis could affect the incidence of SSIs, such as operative experience, surgical technique, resident exposure, type of ligature used, and excessive use of electrosurgical devices.
He noted that future randomized, controlled trials of skin antiseptic preparations given prior to abdominal hysterectomy would be helpful. For now, “we believe that future guidelines should specify the choice of antisepsis prior to abdominal hysterectomy,” he said at the meeting, which is jointly sponsored by the American College of Surgeons.
Mr. Bazzi reported having no financial disclosures.
INDIAN WELLS, CALIF. – Using chlorhexidine-alcohol preoperative skin antisepsis at the time of abdominal hysterectomy is associated with a lower incidence of surgical site infections (SSIs), compared with using povidone-iodine antiseptic solution, a large retrospective study showed.
“Surgical site infections have been linked to longer hospital stays, higher readmission rates, and overall increased healthcare costs,” Ali Bazzi, the lead study author, said at the annual scientific meeting of the Society of Gynecologic Surgeons. “Preoperative topical skin antiseptics have decreased the rate of SSIs over the years and have led to improved patient outcomes. Current published guidelines for skin preparations, specifically abdominal hysterectomies, do not routinely specify a choice of antiseptic. With greater than 500,000 hysterectomies performed each year in the United States, and about half done via laparotomy, this can have significant clinical implications.”
In an effort to determine whether the choice of preoperative topical antisepsis independently affects SSIs, Mr. Bazzi, a fourth-year medical student at the University of Michigan, Ann Arbor, and his associates in the university’s department of gynecologic oncology evaluated chlorhexidine-gluconate in alcohol versus povidone-iodine in aqueous solution. The second objective focused on determining certain patient factors and operative predictors of SSIs.
The researchers used the Michigan Surgical Quality Collaborative database to perform a retrospective cohort analysis of patients who underwent abdominal hysterectomy from July 2012 to February 2015. The primary outcome was diagnosis of a superficial, deep, or organ space SSI within 30 days of surgery, while the primary predictor was whether the individual cases received either the chlorhexidine-alcohol or the povidone-iodine antiseptic solution.
The researchers excluded cases with missing data, preoperative sepsis or emergent operative cases, and patients on chronic steroids due to immunosuppression, since these cases were associated with a higher than baseline risk of developing SSIs. Other types of skin preparation agents did not meet a large enough sample size and thus were underpowered. These cases were not included in the final analysis. Multivariate logistic regression models estimated the independent effect of skin antiseptic choice on the rate of SSI.
Mr. Bazzi reported results from 5,074 abdominal hysterectomies. Compared with patients in the povidone-iodine group, those in the chlorhexidine-alcohol group had several medical comorbidities, demographic and perioperative factors associated with the development of SSIs, including being more likely to have a BMI of 30 kg/m2 or greater; American Society of Anesthesiology Class of 3 or greater; dependent functional status; malignancy as a preoperative indication for surgery; estimated blood loss of greater than 250 cc; and surgery lasting longer than 3 hours.
The overall rate of any SSI was 3.6%. The unadjusted SSI rates based on antiseptic choice were 3.5% in the chlorhexidine-alcohol group and 3.8% in the povidone-iodine group. After using multivariate logistic regression adjusted for population differences, the researchers determined that chlorhexidine-alcohol was associated with a 30% lower odds of developing SSIs, compared with those in the povidone-iodine group (odds ratio, 0.71; 95% confidence interval, 0.51-0.98; P = .037).
Mr. Bazzi, who begins an ob.gyn. residency at St. John Hospital and Medical Center in Detroit in July 2016, acknowledged that other qualitative factors not included in the analysis could affect the incidence of SSIs, such as operative experience, surgical technique, resident exposure, type of ligature used, and excessive use of electrosurgical devices.
He noted that future randomized, controlled trials of skin antiseptic preparations given prior to abdominal hysterectomy would be helpful. For now, “we believe that future guidelines should specify the choice of antisepsis prior to abdominal hysterectomy,” he said at the meeting, which is jointly sponsored by the American College of Surgeons.
Mr. Bazzi reported having no financial disclosures.
INDIAN WELLS, CALIF. – Using chlorhexidine-alcohol preoperative skin antisepsis at the time of abdominal hysterectomy is associated with a lower incidence of surgical site infections (SSIs), compared with using povidone-iodine antiseptic solution, a large retrospective study showed.
“Surgical site infections have been linked to longer hospital stays, higher readmission rates, and overall increased healthcare costs,” Ali Bazzi, the lead study author, said at the annual scientific meeting of the Society of Gynecologic Surgeons. “Preoperative topical skin antiseptics have decreased the rate of SSIs over the years and have led to improved patient outcomes. Current published guidelines for skin preparations, specifically abdominal hysterectomies, do not routinely specify a choice of antiseptic. With greater than 500,000 hysterectomies performed each year in the United States, and about half done via laparotomy, this can have significant clinical implications.”
In an effort to determine whether the choice of preoperative topical antisepsis independently affects SSIs, Mr. Bazzi, a fourth-year medical student at the University of Michigan, Ann Arbor, and his associates in the university’s department of gynecologic oncology evaluated chlorhexidine-gluconate in alcohol versus povidone-iodine in aqueous solution. The second objective focused on determining certain patient factors and operative predictors of SSIs.
The researchers used the Michigan Surgical Quality Collaborative database to perform a retrospective cohort analysis of patients who underwent abdominal hysterectomy from July 2012 to February 2015. The primary outcome was diagnosis of a superficial, deep, or organ space SSI within 30 days of surgery, while the primary predictor was whether the individual cases received either the chlorhexidine-alcohol or the povidone-iodine antiseptic solution.
The researchers excluded cases with missing data, preoperative sepsis or emergent operative cases, and patients on chronic steroids due to immunosuppression, since these cases were associated with a higher than baseline risk of developing SSIs. Other types of skin preparation agents did not meet a large enough sample size and thus were underpowered. These cases were not included in the final analysis. Multivariate logistic regression models estimated the independent effect of skin antiseptic choice on the rate of SSI.
Mr. Bazzi reported results from 5,074 abdominal hysterectomies. Compared with patients in the povidone-iodine group, those in the chlorhexidine-alcohol group had several medical comorbidities, demographic and perioperative factors associated with the development of SSIs, including being more likely to have a BMI of 30 kg/m2 or greater; American Society of Anesthesiology Class of 3 or greater; dependent functional status; malignancy as a preoperative indication for surgery; estimated blood loss of greater than 250 cc; and surgery lasting longer than 3 hours.
The overall rate of any SSI was 3.6%. The unadjusted SSI rates based on antiseptic choice were 3.5% in the chlorhexidine-alcohol group and 3.8% in the povidone-iodine group. After using multivariate logistic regression adjusted for population differences, the researchers determined that chlorhexidine-alcohol was associated with a 30% lower odds of developing SSIs, compared with those in the povidone-iodine group (odds ratio, 0.71; 95% confidence interval, 0.51-0.98; P = .037).
Mr. Bazzi, who begins an ob.gyn. residency at St. John Hospital and Medical Center in Detroit in July 2016, acknowledged that other qualitative factors not included in the analysis could affect the incidence of SSIs, such as operative experience, surgical technique, resident exposure, type of ligature used, and excessive use of electrosurgical devices.
He noted that future randomized, controlled trials of skin antiseptic preparations given prior to abdominal hysterectomy would be helpful. For now, “we believe that future guidelines should specify the choice of antisepsis prior to abdominal hysterectomy,” he said at the meeting, which is jointly sponsored by the American College of Surgeons.
Mr. Bazzi reported having no financial disclosures.
AT SGS 2016
Key clinical point: Chlorhexidine-alcohol preoperative skin antisepsis at the time of abdominal hysterectomy was superior to povidone-iodine antiseptic solution in reducing SSIs.
Major finding: The use of chlorhexidine-alcohol preoperative skin antisepsis at the time of abdominal hysterectomy was associated with about a 30% lower odds of developing SSIs, compared with using povidone-iodine antiseptic solution (odds ratio, 0.71).
Data source: A retrospective cohort analysis of 5,074 patients who underwent abdominal hysterectomy from July 2012 to February 2015.
Disclosures: Mr. Bazzi reported having no financial disclosures.
C. difficile transmission linked to antibiotic use in long-term care facilities
Antibiotic use may drive Clostridium difficile transmission within long-term care facilities, according to the results of a recent study published in Annals of Internal Medicine.
Dr. Kevin A. Brown of Public Health Ontario in Toronto, and his coauthors, assessed long-term care–onset C. difficile infection in the largest and most comprehensive study of its kind to date. The retrospective study included 86 Veterans Health Administration health care regions and examined long-term care residents from January 2006 through December 2012. Study results indicated large variations in regional rates of C. difficile infection, regional antibiotic use, and importation of cases of acute care C. difficile infection (Ann Intern Med. 2016 Apr 19. doi: 10.7326/M15-1754).
The total study population included 6,012 cases with a C. difficile infection incidence of 3.7 cases per 10,000 resident days. The regional variability in the incidence of long-term care–onset C. difficile infection was found to be attributable in large part (75%) to antibiotic use and importation from acute care facilities. The data also showed that regional differences in both the prescription of antibiotics and the individual receipt of antibiotics contributed to resident risk, suggesting increased risk for both acquiring and spreading C. difficile.
A potential mechanism offered by the authors for the transmission of C. difficile in facilities with high antibiotic use may be the increased prevalence of residents with asymptomatic C. difficile colonization who become more effective at shedding C. difficile spores when exposed to antibiotics.
Dr. Brown and his colleagues said that efforts designed to reduce C. difficile infection in long-term care should focus on the reduction of total antibiotic use, and that infection control teams may need to take special measures in long-term care facilities that receive residents from hospitals with elevated rates of C. difficile infection.
This study was funded by the U.S. Department of Veterans Affairs and the Centers for Disease Control and Prevention. Dr. Brown reported grants from AstraZeneca outside the submitted work, and another coauthor disclosed grant support from the funding source during the conduct of the study. The remaining coauthors disclosed no conflicts of interest.
Antibiotic use may drive Clostridium difficile transmission within long-term care facilities, according to the results of a recent study published in Annals of Internal Medicine.
Dr. Kevin A. Brown of Public Health Ontario in Toronto, and his coauthors, assessed long-term care–onset C. difficile infection in the largest and most comprehensive study of its kind to date. The retrospective study included 86 Veterans Health Administration health care regions and examined long-term care residents from January 2006 through December 2012. Study results indicated large variations in regional rates of C. difficile infection, regional antibiotic use, and importation of cases of acute care C. difficile infection (Ann Intern Med. 2016 Apr 19. doi: 10.7326/M15-1754).
The total study population included 6,012 cases with a C. difficile infection incidence of 3.7 cases per 10,000 resident days. The regional variability in the incidence of long-term care–onset C. difficile infection was found to be attributable in large part (75%) to antibiotic use and importation from acute care facilities. The data also showed that regional differences in both the prescription of antibiotics and the individual receipt of antibiotics contributed to resident risk, suggesting increased risk for both acquiring and spreading C. difficile.
A potential mechanism offered by the authors for the transmission of C. difficile in facilities with high antibiotic use may be the increased prevalence of residents with asymptomatic C. difficile colonization who become more effective at shedding C. difficile spores when exposed to antibiotics.
Dr. Brown and his colleagues said that efforts designed to reduce C. difficile infection in long-term care should focus on the reduction of total antibiotic use, and that infection control teams may need to take special measures in long-term care facilities that receive residents from hospitals with elevated rates of C. difficile infection.
This study was funded by the U.S. Department of Veterans Affairs and the Centers for Disease Control and Prevention. Dr. Brown reported grants from AstraZeneca outside the submitted work, and another coauthor disclosed grant support from the funding source during the conduct of the study. The remaining coauthors disclosed no conflicts of interest.
Antibiotic use may drive Clostridium difficile transmission within long-term care facilities, according to the results of a recent study published in Annals of Internal Medicine.
Dr. Kevin A. Brown of Public Health Ontario in Toronto, and his coauthors, assessed long-term care–onset C. difficile infection in the largest and most comprehensive study of its kind to date. The retrospective study included 86 Veterans Health Administration health care regions and examined long-term care residents from January 2006 through December 2012. Study results indicated large variations in regional rates of C. difficile infection, regional antibiotic use, and importation of cases of acute care C. difficile infection (Ann Intern Med. 2016 Apr 19. doi: 10.7326/M15-1754).
The total study population included 6,012 cases with a C. difficile infection incidence of 3.7 cases per 10,000 resident days. The regional variability in the incidence of long-term care–onset C. difficile infection was found to be attributable in large part (75%) to antibiotic use and importation from acute care facilities. The data also showed that regional differences in both the prescription of antibiotics and the individual receipt of antibiotics contributed to resident risk, suggesting increased risk for both acquiring and spreading C. difficile.
A potential mechanism offered by the authors for the transmission of C. difficile in facilities with high antibiotic use may be the increased prevalence of residents with asymptomatic C. difficile colonization who become more effective at shedding C. difficile spores when exposed to antibiotics.
Dr. Brown and his colleagues said that efforts designed to reduce C. difficile infection in long-term care should focus on the reduction of total antibiotic use, and that infection control teams may need to take special measures in long-term care facilities that receive residents from hospitals with elevated rates of C. difficile infection.
This study was funded by the U.S. Department of Veterans Affairs and the Centers for Disease Control and Prevention. Dr. Brown reported grants from AstraZeneca outside the submitted work, and another coauthor disclosed grant support from the funding source during the conduct of the study. The remaining coauthors disclosed no conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point:C. difficile transmission may be driven by antibiotic use in long-term care facilities.
Major finding: The majority (75%) of the regional variability in the incidence of long-term care–onset C. difficile infection was attributable to antibiotic use and importation.
Data sources: Retrospective study of long-term care residents from 86 Veterans Health Administration health care regions examined from January 2006 through December 2012.
Disclosures: This study was funded by the U.S. Department of Veterans Affairs and the Centers for Disease Control and Prevention. Dr. Brown reported grants from AstraZeneca outside the submitted work, and another coauthor disclosed grant support from the funding source during the conduct of the study. The remaining coauthors disclosed no conflicts of interest.
U.S. sepsis-related mortality rates differ based on data source
Despite challenges in estimating sepsis-related mortality in the U.S. because of its complex clinical nature and variety of underlying causes, estimates based on administrative claims data may be more accurate than those derived from death certificates, according to a report published April 8 in the Morbidity and Mortality Weekly Report.
Dr. Lauren Epstein of the division of healthcare quality promotion at the National Center for Emerging and Zoonotic Infectious Diseases, and her colleagues, compared U.S. sepsis-related mortality estimates from different sources. Deaths attributable to diagnoses corresponding to ICD-10 diagnosis codes A40 (streptococcal septicemia) and A41 (other septicemia) from 1999 to 2014 were extracted from the CDC WONDER (Wide-ranging Online Data for Epidemiologic Research) database. Administrative claims data using various combinations of the ICD-9-CM administrative codes for primary or secondary infection and organ dysfunction to identify severe sepsis from 2004 to 2009 were extracted from the largest all-payer, publicly available inpatient database in the United States, the Nationwide Inpatient Sample. (MMWR. 2016 Apr 8;65[13]:342-5).
Of the roughly 2.5 million death certificates listing sepsis as a cause of death, 22% identified sepsis as the underlying cause of death during the time period assessed. The results of the comparison demonstrated that the estimated range of sepsis-related mortality based on death certificate data was lower than that obtained using administrative claims data (ranges, 146,000-159,000 and 168,000-381,000, respectively). These results indicate that the annual estimate based on administrative claims data during the time period assessed was 15%-140% higher than the estimate based on death certificate data.
To explain the difference between the estimated sepsis-related mortality ranges, the authors said that while both death certificate and administrative claims data are important sources of public health information, they are each associated with limitations that can affect such estimates. For example, the authors said that death certificate certifiers may be more prone to record sepsis as an immediate cause of death, resulting in lower estimates of sepsis-related mortality based on underlying causes of death. Regarding administrative claims data, the authors said that such data cannot be all inclusive, as only those sepsis-related deaths occurring in health care facilities are captured.
The authors said that their results highlight the need for a better defined and more reliable sepsis surveillance system that should be based on objective clinical data. This approach would allow for increased accuracy in the tracking of sepsis trends in the United States, as well as an improved system for gauging the impact of sepsis awareness and prevention efforts.
No funding sources or conflicts of interest were reported.
Despite challenges in estimating sepsis-related mortality in the U.S. because of its complex clinical nature and variety of underlying causes, estimates based on administrative claims data may be more accurate than those derived from death certificates, according to a report published April 8 in the Morbidity and Mortality Weekly Report.
Dr. Lauren Epstein of the division of healthcare quality promotion at the National Center for Emerging and Zoonotic Infectious Diseases, and her colleagues, compared U.S. sepsis-related mortality estimates from different sources. Deaths attributable to diagnoses corresponding to ICD-10 diagnosis codes A40 (streptococcal septicemia) and A41 (other septicemia) from 1999 to 2014 were extracted from the CDC WONDER (Wide-ranging Online Data for Epidemiologic Research) database. Administrative claims data using various combinations of the ICD-9-CM administrative codes for primary or secondary infection and organ dysfunction to identify severe sepsis from 2004 to 2009 were extracted from the largest all-payer, publicly available inpatient database in the United States, the Nationwide Inpatient Sample. (MMWR. 2016 Apr 8;65[13]:342-5).
Of the roughly 2.5 million death certificates listing sepsis as a cause of death, 22% identified sepsis as the underlying cause of death during the time period assessed. The results of the comparison demonstrated that the estimated range of sepsis-related mortality based on death certificate data was lower than that obtained using administrative claims data (ranges, 146,000-159,000 and 168,000-381,000, respectively). These results indicate that the annual estimate based on administrative claims data during the time period assessed was 15%-140% higher than the estimate based on death certificate data.
To explain the difference between the estimated sepsis-related mortality ranges, the authors said that while both death certificate and administrative claims data are important sources of public health information, they are each associated with limitations that can affect such estimates. For example, the authors said that death certificate certifiers may be more prone to record sepsis as an immediate cause of death, resulting in lower estimates of sepsis-related mortality based on underlying causes of death. Regarding administrative claims data, the authors said that such data cannot be all inclusive, as only those sepsis-related deaths occurring in health care facilities are captured.
The authors said that their results highlight the need for a better defined and more reliable sepsis surveillance system that should be based on objective clinical data. This approach would allow for increased accuracy in the tracking of sepsis trends in the United States, as well as an improved system for gauging the impact of sepsis awareness and prevention efforts.
No funding sources or conflicts of interest were reported.
Despite challenges in estimating sepsis-related mortality in the U.S. because of its complex clinical nature and variety of underlying causes, estimates based on administrative claims data may be more accurate than those derived from death certificates, according to a report published April 8 in the Morbidity and Mortality Weekly Report.
Dr. Lauren Epstein of the division of healthcare quality promotion at the National Center for Emerging and Zoonotic Infectious Diseases, and her colleagues, compared U.S. sepsis-related mortality estimates from different sources. Deaths attributable to diagnoses corresponding to ICD-10 diagnosis codes A40 (streptococcal septicemia) and A41 (other septicemia) from 1999 to 2014 were extracted from the CDC WONDER (Wide-ranging Online Data for Epidemiologic Research) database. Administrative claims data using various combinations of the ICD-9-CM administrative codes for primary or secondary infection and organ dysfunction to identify severe sepsis from 2004 to 2009 were extracted from the largest all-payer, publicly available inpatient database in the United States, the Nationwide Inpatient Sample. (MMWR. 2016 Apr 8;65[13]:342-5).
Of the roughly 2.5 million death certificates listing sepsis as a cause of death, 22% identified sepsis as the underlying cause of death during the time period assessed. The results of the comparison demonstrated that the estimated range of sepsis-related mortality based on death certificate data was lower than that obtained using administrative claims data (ranges, 146,000-159,000 and 168,000-381,000, respectively). These results indicate that the annual estimate based on administrative claims data during the time period assessed was 15%-140% higher than the estimate based on death certificate data.
To explain the difference between the estimated sepsis-related mortality ranges, the authors said that while both death certificate and administrative claims data are important sources of public health information, they are each associated with limitations that can affect such estimates. For example, the authors said that death certificate certifiers may be more prone to record sepsis as an immediate cause of death, resulting in lower estimates of sepsis-related mortality based on underlying causes of death. Regarding administrative claims data, the authors said that such data cannot be all inclusive, as only those sepsis-related deaths occurring in health care facilities are captured.
The authors said that their results highlight the need for a better defined and more reliable sepsis surveillance system that should be based on objective clinical data. This approach would allow for increased accuracy in the tracking of sepsis trends in the United States, as well as an improved system for gauging the impact of sepsis awareness and prevention efforts.
No funding sources or conflicts of interest were reported.
FROM MMWR
Key clinical point: Sepsis surveillance should be based on objective clinical data rather than on data obtained from death certificates.
Major finding: Using administrative codes, the U.S. sepsis-related mortality estimate from 2004 to 2009 was 15%-140% higher than the estimate derived from the use of death certificates (ranges; 168,000-381,000 and 146,000-159,000, respectively).
Data source: Death certificate data from the CDC WONDER database and administrative claims data from a previously published report of sepsis mortality estimates based on the Nationwide Inpatient Sample, Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality.
Disclosures: No funding sources or conflicts of interest were reported.
Clostridium difficile management guidance updated by AHRQ
Clinical trial data support the use of vancomycin over metronidazole for those with initial Clostridium difficile infection (CDI), and fidaxomicin over vancomycin for the prevention of recurrent infection, according to a newly-released update of the 2011 Agency for Healthcare Research and Quality Comparative Effectiveness Review.
In contrast, data were considered to be weak though consistent in their pattern of efficacy regarding the use of fecal microbiota transplantation and lactobacillus probiotics to restore the biodiversity of the gut microbiota and improve patient resistance to CDI or its recurrence, according to Mary Butler, Ph.D., of the division of health policy and management, University of Minnesota School of Public Health, and her associates.
Since publication of the original review, data have been reported supporting the effectiveness of new diagnostic tests, as well as the comparative efficacy of particular agents over others in different stages of the illness. Dr. Butler and six additional experts in the fields of health policy and management and infectious disease reviewed published literature from 2010 through 2015 focusing on a limited number of quality improvement opportunities identified as most important to improve patient care, adding seven new findings and updating six findings from the original review.
To update the 2011 review, the authors conducted a literature review covering the years 2010 through 2015. Of the 7,416 individual citations identified using this search methodology, 252 were selected for further scrutiny. Of these, 37 diagnostic studies and 56 studies evaluating prevention or treatment interventions were identified and assessed from a pool of 252 eligible studies selected from 7,416 citations regarding early diagnosis, prevention, and treatment of Clostridium difficile.
Dr. Butler and her colleagues noted that the four years between the original review and the update were marked by an overall increase in research regarding both diagnosis and interventions. Aside from the aforementioned interventional updates, four diagnostic methodologies without recommendations in the original review (nucleic acid amplification tests, enzyme tests for toxins A/B, assay tests for glutamate dehydrogenase, and test algorithms) are all included in the update, with high, moderate, and low levels of evidence, respectively.
Regarding preventive strategies, the design and reporting of new studies published since the release of the original review were considered to have shown improvement; however, only weak evidence was found for effectiveness in reducing the incidence of CDI.
The updated management review has been published online at www.effectivehealthcare.ahrq.gov/reports/final.cfm (AHRQ Publication No. 16-EHC012-EF. March 2016).
The Agency for Healthcare Research and Quality funded the update. None of the investigators reported any affiliations or financial involvements that would have conflicted with the material presented in this report.
Clinical trial data support the use of vancomycin over metronidazole for those with initial Clostridium difficile infection (CDI), and fidaxomicin over vancomycin for the prevention of recurrent infection, according to a newly-released update of the 2011 Agency for Healthcare Research and Quality Comparative Effectiveness Review.
In contrast, data were considered to be weak though consistent in their pattern of efficacy regarding the use of fecal microbiota transplantation and lactobacillus probiotics to restore the biodiversity of the gut microbiota and improve patient resistance to CDI or its recurrence, according to Mary Butler, Ph.D., of the division of health policy and management, University of Minnesota School of Public Health, and her associates.
Since publication of the original review, data have been reported supporting the effectiveness of new diagnostic tests, as well as the comparative efficacy of particular agents over others in different stages of the illness. Dr. Butler and six additional experts in the fields of health policy and management and infectious disease reviewed published literature from 2010 through 2015 focusing on a limited number of quality improvement opportunities identified as most important to improve patient care, adding seven new findings and updating six findings from the original review.
To update the 2011 review, the authors conducted a literature review covering the years 2010 through 2015. Of the 7,416 individual citations identified using this search methodology, 252 were selected for further scrutiny. Of these, 37 diagnostic studies and 56 studies evaluating prevention or treatment interventions were identified and assessed from a pool of 252 eligible studies selected from 7,416 citations regarding early diagnosis, prevention, and treatment of Clostridium difficile.
Dr. Butler and her colleagues noted that the four years between the original review and the update were marked by an overall increase in research regarding both diagnosis and interventions. Aside from the aforementioned interventional updates, four diagnostic methodologies without recommendations in the original review (nucleic acid amplification tests, enzyme tests for toxins A/B, assay tests for glutamate dehydrogenase, and test algorithms) are all included in the update, with high, moderate, and low levels of evidence, respectively.
Regarding preventive strategies, the design and reporting of new studies published since the release of the original review were considered to have shown improvement; however, only weak evidence was found for effectiveness in reducing the incidence of CDI.
The updated management review has been published online at www.effectivehealthcare.ahrq.gov/reports/final.cfm (AHRQ Publication No. 16-EHC012-EF. March 2016).
The Agency for Healthcare Research and Quality funded the update. None of the investigators reported any affiliations or financial involvements that would have conflicted with the material presented in this report.
Clinical trial data support the use of vancomycin over metronidazole for those with initial Clostridium difficile infection (CDI), and fidaxomicin over vancomycin for the prevention of recurrent infection, according to a newly-released update of the 2011 Agency for Healthcare Research and Quality Comparative Effectiveness Review.
In contrast, data were considered to be weak though consistent in their pattern of efficacy regarding the use of fecal microbiota transplantation and lactobacillus probiotics to restore the biodiversity of the gut microbiota and improve patient resistance to CDI or its recurrence, according to Mary Butler, Ph.D., of the division of health policy and management, University of Minnesota School of Public Health, and her associates.
Since publication of the original review, data have been reported supporting the effectiveness of new diagnostic tests, as well as the comparative efficacy of particular agents over others in different stages of the illness. Dr. Butler and six additional experts in the fields of health policy and management and infectious disease reviewed published literature from 2010 through 2015 focusing on a limited number of quality improvement opportunities identified as most important to improve patient care, adding seven new findings and updating six findings from the original review.
To update the 2011 review, the authors conducted a literature review covering the years 2010 through 2015. Of the 7,416 individual citations identified using this search methodology, 252 were selected for further scrutiny. Of these, 37 diagnostic studies and 56 studies evaluating prevention or treatment interventions were identified and assessed from a pool of 252 eligible studies selected from 7,416 citations regarding early diagnosis, prevention, and treatment of Clostridium difficile.
Dr. Butler and her colleagues noted that the four years between the original review and the update were marked by an overall increase in research regarding both diagnosis and interventions. Aside from the aforementioned interventional updates, four diagnostic methodologies without recommendations in the original review (nucleic acid amplification tests, enzyme tests for toxins A/B, assay tests for glutamate dehydrogenase, and test algorithms) are all included in the update, with high, moderate, and low levels of evidence, respectively.
Regarding preventive strategies, the design and reporting of new studies published since the release of the original review were considered to have shown improvement; however, only weak evidence was found for effectiveness in reducing the incidence of CDI.
The updated management review has been published online at www.effectivehealthcare.ahrq.gov/reports/final.cfm (AHRQ Publication No. 16-EHC012-EF. March 2016).
The Agency for Healthcare Research and Quality funded the update. None of the investigators reported any affiliations or financial involvements that would have conflicted with the material presented in this report.
Device maker Olympus hiked prices for scopes as superbug infections spread
Soon after doctors at UCLA’s Ronald Reagan Medical Center traced deadly infections to tainted medical scopes last year, they pressed the device maker to lend them replacements.
But Olympus Corp. refused. Instead, the Tokyo company offered to sell UCLA 35 new scopes for $1.2 million – a 28% increase in price from what it charged the university just months earlier, according to university emails obtained from a public-records request.
Olympus sales manager Vincent Hernandez told UCLA that the company’s previous discounts no longer applied. “Supplies are already low, where demand is high with all academic institutions expanding their inventories,” Mr. Hernandez wrote to the medical center.
The emails show how Olympus continued to push sales even as the devices it previously sold to UCLA and other medical institutions were linked to illnesses and deaths.
The messages also mark a sharp departure from what had been a close, mutually beneficial relationship between the giant device manufacturer and one of the country’s most prestigious academic medical centers.
Once the outbreak was confirmed in late January 2015, UCLA urgently needed replacement scopes to safely perform gastrointestinal procedures, in which the duodenoscopes were snaked down a patient’s throat.
In response to the outbreaks and government warnings last year, many medical centers rushed to adopt new cleaning measures. That left them with fewer of the reusable scopes on hand, so they felt compelled to buy more.
Ultimately, three UCLA patients died and five more were sickened from October 2014 to January 2015 by drug-resistant bacteria trapped inside the Olympus scopes. Only in January of this year did the company agree to recall its duodenoscopes and repair them over the coming months to cut the risk of bacteria passing to the next patient.
Previously, the emails show, UCLA and Olympus collaborated closely: At least one top doctor at UCLA asked for money from the company to hold a medical conference. The company’s employees were allowed to observe medical procedures.
On Jan. 7, 2015, 3 weeks before the outbreak at UCLA was confirmed, Dr. Raman Muthusamy, the director of endoscopy at UCLA, asked Olympus to contribute more money for an upcoming medical conference at a Beverly Hills hotel: “Quick question: Who do I speak to about sponsorship from Olympus to the Mellinkoff symposium,” Dr. Muthusamy wrote to Mr. Hernandez and another Olympus employee. “Last year, Olympus gave $18,000 – this year only $10K. Given our increasing collaborations thought it should at least stay the same.”
Later, on Jan. 23, 2015, Olympus salesman Richard Ramirez sent an email thanking a UCLA doctor for allowing him and another company representative “to sit in on a few of your cases yesterday.”
At the doctor’s request, Mr. Ramirez provided some “special contracted pricing information” on scope-related accessories.
The outbreak was confirmed Jan. 28, and the solicitousness appeared to end on both sides. Rebuffed in their request for replacement scopes, UCLA officials struggled to grasp Olympus’ sharp increase in price.
“Last February [2014] when we were acquiring the 7 new TJF‐Q180V scopes we have today, the price was $26,200.98 and our new quote is $33,470.15 [per] scope which is an increase of 28 percent,” Randi Hissom, a business operations director at UCLA Health System, wrote to Mr. Hernandez in a Feb. 10, 2015, email.
Mr. Hernandez advised her that the university could earn a discount if it ordered more scopes. He also warned that “with the number of scopes being requested, it is possible that we could go on a back order.”
On Feb. 23, 4 days after the Food and Drug Administration issued a safety alert about the scopes to all U.S. hospitals, Mr. Hernandez chastised two UCLA doctors for failing to purchase the amount of equipment specified in their contract with Olympus.
The company’s salespeople “continued to run into a wall with acquiring orders … I would like to arrange a meeting with you soon to further review and discuss the compliance of the contract,” Mr. Hernandez wrote in a Feb. 23, 2015, email.
The sudden demand for gastrointestinal scopes triggered an unexpected windfall for Olympus, the leading supplier in the United States and worldwide.
Olympus executives boasted in February about the company’s “record-breaking” performance, driven by a 13% increase in scope sales for the 9 months that ended Dec. 31. The company’s profit soared 34% to $352 million for the same period.
Rep. Ted Lieu (D-Calif.) said the emails with UCLA show that Olympus sought to profit from a crisis that it created. In a letter to the company last year, he asked Olympus to donate scopes to hospitals or forgo profits from the sale of additional devices.
“What Olympus did was outrageous,” Rep. Lieu said in a recent interview. “They jacked up the prices and made even more money off their defective scopes and then bragged about it. Have they no shame?”
Olympus spokesman Mark Miller said the emails with UCLA “represent standard business discussions within Olympus and between company personnel and customers.”
He attributed Olympus’ recent financial gains to the overall strength of the business.
“Olympus launched several new products for medical and surgical specialties during the last 12 months that were all well-received by the market and contribute to our results,” he said.
UCLA’s Dr. Muthusamy didn’t respond to a request for comment. Nor did Olympus salesmen Mr. Hernandez and Mr. Ramirez.
UCLA continues to use Olympus equipment. But after the company’s response to the outbreak it eventually turned to a rival manufacturer, Pentax Medical, for more scopes.
“Ronald Reagan UCLA Medical Center ordered additional scopes from Pentax in order to ensure that we had sufficient scopes to perform the necessary procedures for our patients,” said Enrique Rivero, a university spokesman. “Pentax was able to quickly provide a sufficient quantity of scopes in a timely manner, allowing us to clear our backlog of patients.”
Mr. Rivero said Dr. Muthusamy’s request for more symposium support, and Olympus’ $10,000 donation to the March 2015 gastroenterology conference, were in keeping with university policy.
Olympus recently ran afoul of federal law in regard to its sales practices companywide. This month, the device manufacturer agreed to pay a record $646-million settlement to end federal government investigations into illegal kickbacks and bribery in the United States and Latin America.
The company had courted prominent doctors and hospitals for years with millions of dollars of free equipment, cash payments, trips, and entertainment such as winery tours and balloon rides in violation of U.S. law, according to federal prosecutors. No specific institutions or hospitals were named in the federal criminal complaint filed March 1, and the practices were not confined to scopes.
“Olympus leadership acknowledges the company’s responsibility for the past conduct, which does not represent the values of Olympus or its employees,” Nacho Abia, chief executive of the Olympus Corp. of the Americas unit in Center Valley, Pa., said in a statement this month after the settlement.
Meanwhile, the deterioration in the company’s relationship with UCLA continues. Several UCLA patients or their families have sued Olympus over the infections there. Olympus responded to one of the first wrongful death cases by blaming UCLA for the outbreak.
In a Feb. 1 filing in Los Angeles federal court, Olympus said UCLA failed to clean its scopes according to the company’s protocols and to obtain available training from Olympus.
In interviews, UCLA doctors have said Olympus employees didn’t raise those concerns when they visited the hospital after the outbreak was discovered. The FDA has said infections occurred even when hospitals followed the manufacturer’s instructions.
UCLA and Olympus said they won’t comment on the pending litigation.
A recent Senate investigation linked Olympus to 19 superbug outbreaks in the U.S. and Europe from 2012 to 2015, including at UCLA and Cedars-Sinai Medical Center. The report also criticized the company for failing to alert U.S. regulators and hospitals sooner about the risk of infection from its scope design.
Federal prosecutors are investigating Olympus and two other device manufacturers – Pentax and Fujifilm – over their role in the outbreaks.
This article was originally published by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Melody Petersen is a staff writer at the Los Angeles Times. Her email address is [email protected].
Soon after doctors at UCLA’s Ronald Reagan Medical Center traced deadly infections to tainted medical scopes last year, they pressed the device maker to lend them replacements.
But Olympus Corp. refused. Instead, the Tokyo company offered to sell UCLA 35 new scopes for $1.2 million – a 28% increase in price from what it charged the university just months earlier, according to university emails obtained from a public-records request.
Olympus sales manager Vincent Hernandez told UCLA that the company’s previous discounts no longer applied. “Supplies are already low, where demand is high with all academic institutions expanding their inventories,” Mr. Hernandez wrote to the medical center.
The emails show how Olympus continued to push sales even as the devices it previously sold to UCLA and other medical institutions were linked to illnesses and deaths.
The messages also mark a sharp departure from what had been a close, mutually beneficial relationship between the giant device manufacturer and one of the country’s most prestigious academic medical centers.
Once the outbreak was confirmed in late January 2015, UCLA urgently needed replacement scopes to safely perform gastrointestinal procedures, in which the duodenoscopes were snaked down a patient’s throat.
In response to the outbreaks and government warnings last year, many medical centers rushed to adopt new cleaning measures. That left them with fewer of the reusable scopes on hand, so they felt compelled to buy more.
Ultimately, three UCLA patients died and five more were sickened from October 2014 to January 2015 by drug-resistant bacteria trapped inside the Olympus scopes. Only in January of this year did the company agree to recall its duodenoscopes and repair them over the coming months to cut the risk of bacteria passing to the next patient.
Previously, the emails show, UCLA and Olympus collaborated closely: At least one top doctor at UCLA asked for money from the company to hold a medical conference. The company’s employees were allowed to observe medical procedures.
On Jan. 7, 2015, 3 weeks before the outbreak at UCLA was confirmed, Dr. Raman Muthusamy, the director of endoscopy at UCLA, asked Olympus to contribute more money for an upcoming medical conference at a Beverly Hills hotel: “Quick question: Who do I speak to about sponsorship from Olympus to the Mellinkoff symposium,” Dr. Muthusamy wrote to Mr. Hernandez and another Olympus employee. “Last year, Olympus gave $18,000 – this year only $10K. Given our increasing collaborations thought it should at least stay the same.”
Later, on Jan. 23, 2015, Olympus salesman Richard Ramirez sent an email thanking a UCLA doctor for allowing him and another company representative “to sit in on a few of your cases yesterday.”
At the doctor’s request, Mr. Ramirez provided some “special contracted pricing information” on scope-related accessories.
The outbreak was confirmed Jan. 28, and the solicitousness appeared to end on both sides. Rebuffed in their request for replacement scopes, UCLA officials struggled to grasp Olympus’ sharp increase in price.
“Last February [2014] when we were acquiring the 7 new TJF‐Q180V scopes we have today, the price was $26,200.98 and our new quote is $33,470.15 [per] scope which is an increase of 28 percent,” Randi Hissom, a business operations director at UCLA Health System, wrote to Mr. Hernandez in a Feb. 10, 2015, email.
Mr. Hernandez advised her that the university could earn a discount if it ordered more scopes. He also warned that “with the number of scopes being requested, it is possible that we could go on a back order.”
On Feb. 23, 4 days after the Food and Drug Administration issued a safety alert about the scopes to all U.S. hospitals, Mr. Hernandez chastised two UCLA doctors for failing to purchase the amount of equipment specified in their contract with Olympus.
The company’s salespeople “continued to run into a wall with acquiring orders … I would like to arrange a meeting with you soon to further review and discuss the compliance of the contract,” Mr. Hernandez wrote in a Feb. 23, 2015, email.
The sudden demand for gastrointestinal scopes triggered an unexpected windfall for Olympus, the leading supplier in the United States and worldwide.
Olympus executives boasted in February about the company’s “record-breaking” performance, driven by a 13% increase in scope sales for the 9 months that ended Dec. 31. The company’s profit soared 34% to $352 million for the same period.
Rep. Ted Lieu (D-Calif.) said the emails with UCLA show that Olympus sought to profit from a crisis that it created. In a letter to the company last year, he asked Olympus to donate scopes to hospitals or forgo profits from the sale of additional devices.
“What Olympus did was outrageous,” Rep. Lieu said in a recent interview. “They jacked up the prices and made even more money off their defective scopes and then bragged about it. Have they no shame?”
Olympus spokesman Mark Miller said the emails with UCLA “represent standard business discussions within Olympus and between company personnel and customers.”
He attributed Olympus’ recent financial gains to the overall strength of the business.
“Olympus launched several new products for medical and surgical specialties during the last 12 months that were all well-received by the market and contribute to our results,” he said.
UCLA’s Dr. Muthusamy didn’t respond to a request for comment. Nor did Olympus salesmen Mr. Hernandez and Mr. Ramirez.
UCLA continues to use Olympus equipment. But after the company’s response to the outbreak it eventually turned to a rival manufacturer, Pentax Medical, for more scopes.
“Ronald Reagan UCLA Medical Center ordered additional scopes from Pentax in order to ensure that we had sufficient scopes to perform the necessary procedures for our patients,” said Enrique Rivero, a university spokesman. “Pentax was able to quickly provide a sufficient quantity of scopes in a timely manner, allowing us to clear our backlog of patients.”
Mr. Rivero said Dr. Muthusamy’s request for more symposium support, and Olympus’ $10,000 donation to the March 2015 gastroenterology conference, were in keeping with university policy.
Olympus recently ran afoul of federal law in regard to its sales practices companywide. This month, the device manufacturer agreed to pay a record $646-million settlement to end federal government investigations into illegal kickbacks and bribery in the United States and Latin America.
The company had courted prominent doctors and hospitals for years with millions of dollars of free equipment, cash payments, trips, and entertainment such as winery tours and balloon rides in violation of U.S. law, according to federal prosecutors. No specific institutions or hospitals were named in the federal criminal complaint filed March 1, and the practices were not confined to scopes.
“Olympus leadership acknowledges the company’s responsibility for the past conduct, which does not represent the values of Olympus or its employees,” Nacho Abia, chief executive of the Olympus Corp. of the Americas unit in Center Valley, Pa., said in a statement this month after the settlement.
Meanwhile, the deterioration in the company’s relationship with UCLA continues. Several UCLA patients or their families have sued Olympus over the infections there. Olympus responded to one of the first wrongful death cases by blaming UCLA for the outbreak.
In a Feb. 1 filing in Los Angeles federal court, Olympus said UCLA failed to clean its scopes according to the company’s protocols and to obtain available training from Olympus.
In interviews, UCLA doctors have said Olympus employees didn’t raise those concerns when they visited the hospital after the outbreak was discovered. The FDA has said infections occurred even when hospitals followed the manufacturer’s instructions.
UCLA and Olympus said they won’t comment on the pending litigation.
A recent Senate investigation linked Olympus to 19 superbug outbreaks in the U.S. and Europe from 2012 to 2015, including at UCLA and Cedars-Sinai Medical Center. The report also criticized the company for failing to alert U.S. regulators and hospitals sooner about the risk of infection from its scope design.
Federal prosecutors are investigating Olympus and two other device manufacturers – Pentax and Fujifilm – over their role in the outbreaks.
This article was originally published by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Melody Petersen is a staff writer at the Los Angeles Times. Her email address is [email protected].
Soon after doctors at UCLA’s Ronald Reagan Medical Center traced deadly infections to tainted medical scopes last year, they pressed the device maker to lend them replacements.
But Olympus Corp. refused. Instead, the Tokyo company offered to sell UCLA 35 new scopes for $1.2 million – a 28% increase in price from what it charged the university just months earlier, according to university emails obtained from a public-records request.
Olympus sales manager Vincent Hernandez told UCLA that the company’s previous discounts no longer applied. “Supplies are already low, where demand is high with all academic institutions expanding their inventories,” Mr. Hernandez wrote to the medical center.
The emails show how Olympus continued to push sales even as the devices it previously sold to UCLA and other medical institutions were linked to illnesses and deaths.
The messages also mark a sharp departure from what had been a close, mutually beneficial relationship between the giant device manufacturer and one of the country’s most prestigious academic medical centers.
Once the outbreak was confirmed in late January 2015, UCLA urgently needed replacement scopes to safely perform gastrointestinal procedures, in which the duodenoscopes were snaked down a patient’s throat.
In response to the outbreaks and government warnings last year, many medical centers rushed to adopt new cleaning measures. That left them with fewer of the reusable scopes on hand, so they felt compelled to buy more.
Ultimately, three UCLA patients died and five more were sickened from October 2014 to January 2015 by drug-resistant bacteria trapped inside the Olympus scopes. Only in January of this year did the company agree to recall its duodenoscopes and repair them over the coming months to cut the risk of bacteria passing to the next patient.
Previously, the emails show, UCLA and Olympus collaborated closely: At least one top doctor at UCLA asked for money from the company to hold a medical conference. The company’s employees were allowed to observe medical procedures.
On Jan. 7, 2015, 3 weeks before the outbreak at UCLA was confirmed, Dr. Raman Muthusamy, the director of endoscopy at UCLA, asked Olympus to contribute more money for an upcoming medical conference at a Beverly Hills hotel: “Quick question: Who do I speak to about sponsorship from Olympus to the Mellinkoff symposium,” Dr. Muthusamy wrote to Mr. Hernandez and another Olympus employee. “Last year, Olympus gave $18,000 – this year only $10K. Given our increasing collaborations thought it should at least stay the same.”
Later, on Jan. 23, 2015, Olympus salesman Richard Ramirez sent an email thanking a UCLA doctor for allowing him and another company representative “to sit in on a few of your cases yesterday.”
At the doctor’s request, Mr. Ramirez provided some “special contracted pricing information” on scope-related accessories.
The outbreak was confirmed Jan. 28, and the solicitousness appeared to end on both sides. Rebuffed in their request for replacement scopes, UCLA officials struggled to grasp Olympus’ sharp increase in price.
“Last February [2014] when we were acquiring the 7 new TJF‐Q180V scopes we have today, the price was $26,200.98 and our new quote is $33,470.15 [per] scope which is an increase of 28 percent,” Randi Hissom, a business operations director at UCLA Health System, wrote to Mr. Hernandez in a Feb. 10, 2015, email.
Mr. Hernandez advised her that the university could earn a discount if it ordered more scopes. He also warned that “with the number of scopes being requested, it is possible that we could go on a back order.”
On Feb. 23, 4 days after the Food and Drug Administration issued a safety alert about the scopes to all U.S. hospitals, Mr. Hernandez chastised two UCLA doctors for failing to purchase the amount of equipment specified in their contract with Olympus.
The company’s salespeople “continued to run into a wall with acquiring orders … I would like to arrange a meeting with you soon to further review and discuss the compliance of the contract,” Mr. Hernandez wrote in a Feb. 23, 2015, email.
The sudden demand for gastrointestinal scopes triggered an unexpected windfall for Olympus, the leading supplier in the United States and worldwide.
Olympus executives boasted in February about the company’s “record-breaking” performance, driven by a 13% increase in scope sales for the 9 months that ended Dec. 31. The company’s profit soared 34% to $352 million for the same period.
Rep. Ted Lieu (D-Calif.) said the emails with UCLA show that Olympus sought to profit from a crisis that it created. In a letter to the company last year, he asked Olympus to donate scopes to hospitals or forgo profits from the sale of additional devices.
“What Olympus did was outrageous,” Rep. Lieu said in a recent interview. “They jacked up the prices and made even more money off their defective scopes and then bragged about it. Have they no shame?”
Olympus spokesman Mark Miller said the emails with UCLA “represent standard business discussions within Olympus and between company personnel and customers.”
He attributed Olympus’ recent financial gains to the overall strength of the business.
“Olympus launched several new products for medical and surgical specialties during the last 12 months that were all well-received by the market and contribute to our results,” he said.
UCLA’s Dr. Muthusamy didn’t respond to a request for comment. Nor did Olympus salesmen Mr. Hernandez and Mr. Ramirez.
UCLA continues to use Olympus equipment. But after the company’s response to the outbreak it eventually turned to a rival manufacturer, Pentax Medical, for more scopes.
“Ronald Reagan UCLA Medical Center ordered additional scopes from Pentax in order to ensure that we had sufficient scopes to perform the necessary procedures for our patients,” said Enrique Rivero, a university spokesman. “Pentax was able to quickly provide a sufficient quantity of scopes in a timely manner, allowing us to clear our backlog of patients.”
Mr. Rivero said Dr. Muthusamy’s request for more symposium support, and Olympus’ $10,000 donation to the March 2015 gastroenterology conference, were in keeping with university policy.
Olympus recently ran afoul of federal law in regard to its sales practices companywide. This month, the device manufacturer agreed to pay a record $646-million settlement to end federal government investigations into illegal kickbacks and bribery in the United States and Latin America.
The company had courted prominent doctors and hospitals for years with millions of dollars of free equipment, cash payments, trips, and entertainment such as winery tours and balloon rides in violation of U.S. law, according to federal prosecutors. No specific institutions or hospitals were named in the federal criminal complaint filed March 1, and the practices were not confined to scopes.
“Olympus leadership acknowledges the company’s responsibility for the past conduct, which does not represent the values of Olympus or its employees,” Nacho Abia, chief executive of the Olympus Corp. of the Americas unit in Center Valley, Pa., said in a statement this month after the settlement.
Meanwhile, the deterioration in the company’s relationship with UCLA continues. Several UCLA patients or their families have sued Olympus over the infections there. Olympus responded to one of the first wrongful death cases by blaming UCLA for the outbreak.
In a Feb. 1 filing in Los Angeles federal court, Olympus said UCLA failed to clean its scopes according to the company’s protocols and to obtain available training from Olympus.
In interviews, UCLA doctors have said Olympus employees didn’t raise those concerns when they visited the hospital after the outbreak was discovered. The FDA has said infections occurred even when hospitals followed the manufacturer’s instructions.
UCLA and Olympus said they won’t comment on the pending litigation.
A recent Senate investigation linked Olympus to 19 superbug outbreaks in the U.S. and Europe from 2012 to 2015, including at UCLA and Cedars-Sinai Medical Center. The report also criticized the company for failing to alert U.S. regulators and hospitals sooner about the risk of infection from its scope design.
Federal prosecutors are investigating Olympus and two other device manufacturers – Pentax and Fujifilm – over their role in the outbreaks.
This article was originally published by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Melody Petersen is a staff writer at the Los Angeles Times. Her email address is [email protected].
Low phosphate linked to postop infection risk
BOSTON – Phosphate levels following colorectal surgery are predictive of risk for intra-abdominal infections, and can be helpful in identifying low-risk patients who may be suitable for early discharge after surgery, investigators say.
“The association between hypophosphatemia and intra-abdominal infections after colorectal resection is a novel finding,” said Dr. Eran Sadot, a visiting surgical oncology fellow at Memorial Sloan Kettering Cancer Center in New York City.
He described an intra-abdominal infection (IAI) risk-prediction tool at the annual Society of Surgical Oncology Cancer Symposium.
An estimated 5%-15% of patients who undergo colorectal surgery develop an IAI, largely from anastomotic leak, fistula, or intra-abdominal abscess. IAIs are associated with prolonged length of stay and higher costs, as well as an estimated 20% increase in short-term mortality, and reduced long-term survival, he said.
“These complications typically become clinically evident beyond postop day 5, and early identification of intra-abdominal infections can potentially lead to early intervention and limit sepsis, “ he said.
Several studies have shown that hypophosphatemia is associated with poor outcomes in various clinical settings – among hospitalized patients in general, in surgical and cardiac intensive care units, following open heart surgery, and after hepatic resections, he noted.
The investigators hypothesized that patients who develop IAIs have an intense acute-phase response accompanied by hypophosphatemia, and that early measurement of postoperative phosphate levels could serve as a marker for systemic response and early IAI. They conducted a retrospective study of data on patients who underwent first colorectal resection at their center from 2005 through 2015. They looked at postoperative hypophosphatemia, defined as serum levels less than 2.5 mg/dL, and they used logistic regression to create a risk model.
The sample included 7,423 patients with a median age of 61 years, including 42% who underwent resection for colon cancer, 26% for rectal cancer, and the remainder for various diagnoses.
In all, 399 patients (5%) developed IAIs, and two of these patients (0.5%) died.
The authors looked at the course of perioperative serum phosphate levels and saw that all patients had a slight rise in phosphate levels on the day of surgery, which then dropped rapidly to a nadir on postoperative day, and began to recover on day 3. They found that patients who did not have IAIs had more rapid recovery of phosphate levels than did patients who developed infections. In addition, they found that hypophosphatemia on postoperative day 3 was associated with a 50% increased risk of IAI (P = .001).
In a multivariable model of the cohort characteristics stratified by IAI, the researchers saw that risk factors independently associated with IAI included body mass index greater than 30 kg.m2 (odds ratio [OR] 1.4, P = .04), combined liver resection (OR 1.9, P less than .001), estimated blood loss greater than 400 mL (OR 1.7, P = .01), hypophosphatemia on postoperative day 3 (OR 1.4, P = .03), and abnormal white blood cell count on postoperative day 3 (OR 1.9, P less than .001).
They then created an IAI risk score assigning 1 point each to the risk factors just mentioned and tested it as a risk prediction tool. A score of 0 or 1 was associated with a low, 5% predicted risk of IAI, giving the score a negative predictive value of 95%. Scores of 2-3 were associated with moderate risk of IAI (9%-15%), and scores of 4 or 5 were associated with high risk (17%-21%) of infection.
The area under the receiver operating characteristic curve was 0.66 (95% confidence interval 0.61-0.7), indicating a test with a good mix of sensitivity and specificity.
“This model may be used in conjunction with the recently developed enhanced recovery or ERAS pathways to safely reduce the hospital stay,” Dr. Sadot concluded.
The study was internally supported. Dr. Sadot and colleagues reported no conflicts of interest.
BOSTON – Phosphate levels following colorectal surgery are predictive of risk for intra-abdominal infections, and can be helpful in identifying low-risk patients who may be suitable for early discharge after surgery, investigators say.
“The association between hypophosphatemia and intra-abdominal infections after colorectal resection is a novel finding,” said Dr. Eran Sadot, a visiting surgical oncology fellow at Memorial Sloan Kettering Cancer Center in New York City.
He described an intra-abdominal infection (IAI) risk-prediction tool at the annual Society of Surgical Oncology Cancer Symposium.
An estimated 5%-15% of patients who undergo colorectal surgery develop an IAI, largely from anastomotic leak, fistula, or intra-abdominal abscess. IAIs are associated with prolonged length of stay and higher costs, as well as an estimated 20% increase in short-term mortality, and reduced long-term survival, he said.
“These complications typically become clinically evident beyond postop day 5, and early identification of intra-abdominal infections can potentially lead to early intervention and limit sepsis, “ he said.
Several studies have shown that hypophosphatemia is associated with poor outcomes in various clinical settings – among hospitalized patients in general, in surgical and cardiac intensive care units, following open heart surgery, and after hepatic resections, he noted.
The investigators hypothesized that patients who develop IAIs have an intense acute-phase response accompanied by hypophosphatemia, and that early measurement of postoperative phosphate levels could serve as a marker for systemic response and early IAI. They conducted a retrospective study of data on patients who underwent first colorectal resection at their center from 2005 through 2015. They looked at postoperative hypophosphatemia, defined as serum levels less than 2.5 mg/dL, and they used logistic regression to create a risk model.
The sample included 7,423 patients with a median age of 61 years, including 42% who underwent resection for colon cancer, 26% for rectal cancer, and the remainder for various diagnoses.
In all, 399 patients (5%) developed IAIs, and two of these patients (0.5%) died.
The authors looked at the course of perioperative serum phosphate levels and saw that all patients had a slight rise in phosphate levels on the day of surgery, which then dropped rapidly to a nadir on postoperative day, and began to recover on day 3. They found that patients who did not have IAIs had more rapid recovery of phosphate levels than did patients who developed infections. In addition, they found that hypophosphatemia on postoperative day 3 was associated with a 50% increased risk of IAI (P = .001).
In a multivariable model of the cohort characteristics stratified by IAI, the researchers saw that risk factors independently associated with IAI included body mass index greater than 30 kg.m2 (odds ratio [OR] 1.4, P = .04), combined liver resection (OR 1.9, P less than .001), estimated blood loss greater than 400 mL (OR 1.7, P = .01), hypophosphatemia on postoperative day 3 (OR 1.4, P = .03), and abnormal white blood cell count on postoperative day 3 (OR 1.9, P less than .001).
They then created an IAI risk score assigning 1 point each to the risk factors just mentioned and tested it as a risk prediction tool. A score of 0 or 1 was associated with a low, 5% predicted risk of IAI, giving the score a negative predictive value of 95%. Scores of 2-3 were associated with moderate risk of IAI (9%-15%), and scores of 4 or 5 were associated with high risk (17%-21%) of infection.
The area under the receiver operating characteristic curve was 0.66 (95% confidence interval 0.61-0.7), indicating a test with a good mix of sensitivity and specificity.
“This model may be used in conjunction with the recently developed enhanced recovery or ERAS pathways to safely reduce the hospital stay,” Dr. Sadot concluded.
The study was internally supported. Dr. Sadot and colleagues reported no conflicts of interest.
BOSTON – Phosphate levels following colorectal surgery are predictive of risk for intra-abdominal infections, and can be helpful in identifying low-risk patients who may be suitable for early discharge after surgery, investigators say.
“The association between hypophosphatemia and intra-abdominal infections after colorectal resection is a novel finding,” said Dr. Eran Sadot, a visiting surgical oncology fellow at Memorial Sloan Kettering Cancer Center in New York City.
He described an intra-abdominal infection (IAI) risk-prediction tool at the annual Society of Surgical Oncology Cancer Symposium.
An estimated 5%-15% of patients who undergo colorectal surgery develop an IAI, largely from anastomotic leak, fistula, or intra-abdominal abscess. IAIs are associated with prolonged length of stay and higher costs, as well as an estimated 20% increase in short-term mortality, and reduced long-term survival, he said.
“These complications typically become clinically evident beyond postop day 5, and early identification of intra-abdominal infections can potentially lead to early intervention and limit sepsis, “ he said.
Several studies have shown that hypophosphatemia is associated with poor outcomes in various clinical settings – among hospitalized patients in general, in surgical and cardiac intensive care units, following open heart surgery, and after hepatic resections, he noted.
The investigators hypothesized that patients who develop IAIs have an intense acute-phase response accompanied by hypophosphatemia, and that early measurement of postoperative phosphate levels could serve as a marker for systemic response and early IAI. They conducted a retrospective study of data on patients who underwent first colorectal resection at their center from 2005 through 2015. They looked at postoperative hypophosphatemia, defined as serum levels less than 2.5 mg/dL, and they used logistic regression to create a risk model.
The sample included 7,423 patients with a median age of 61 years, including 42% who underwent resection for colon cancer, 26% for rectal cancer, and the remainder for various diagnoses.
In all, 399 patients (5%) developed IAIs, and two of these patients (0.5%) died.
The authors looked at the course of perioperative serum phosphate levels and saw that all patients had a slight rise in phosphate levels on the day of surgery, which then dropped rapidly to a nadir on postoperative day, and began to recover on day 3. They found that patients who did not have IAIs had more rapid recovery of phosphate levels than did patients who developed infections. In addition, they found that hypophosphatemia on postoperative day 3 was associated with a 50% increased risk of IAI (P = .001).
In a multivariable model of the cohort characteristics stratified by IAI, the researchers saw that risk factors independently associated with IAI included body mass index greater than 30 kg.m2 (odds ratio [OR] 1.4, P = .04), combined liver resection (OR 1.9, P less than .001), estimated blood loss greater than 400 mL (OR 1.7, P = .01), hypophosphatemia on postoperative day 3 (OR 1.4, P = .03), and abnormal white blood cell count on postoperative day 3 (OR 1.9, P less than .001).
They then created an IAI risk score assigning 1 point each to the risk factors just mentioned and tested it as a risk prediction tool. A score of 0 or 1 was associated with a low, 5% predicted risk of IAI, giving the score a negative predictive value of 95%. Scores of 2-3 were associated with moderate risk of IAI (9%-15%), and scores of 4 or 5 were associated with high risk (17%-21%) of infection.
The area under the receiver operating characteristic curve was 0.66 (95% confidence interval 0.61-0.7), indicating a test with a good mix of sensitivity and specificity.
“This model may be used in conjunction with the recently developed enhanced recovery or ERAS pathways to safely reduce the hospital stay,” Dr. Sadot concluded.
The study was internally supported. Dr. Sadot and colleagues reported no conflicts of interest.
Key clinical point: Hypophosphatemia may be a risk marker for intra-abdominal infections (IAI) following colorectal surgery.
Major finding: Hypophosphatemia on postoperative day 3 was associated with a 50% increased risk of IAI.
Data source: Retrospective review of data on 7,423 consecutive colorectal surgery patients.
Disclosures: The study was internally supported. Dr. Sadot and colleagues reported no conflicts of interest.