Post–liver transplant results similar in acute alcoholic hepatitis, stage 1a

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– Patients with acute alcoholic hepatitis (AAH) have similar early post–liver transplant outcomes to those listed with fulminant hepatic failure, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.

Patients with severe AAH have high mortality, but many are unable to survive the 6 months of sobriety required to be accepted as liver transplant candidates, said George Cholankeril, MD, of the gastroenterology and hepatology department at Stanford (Calif.) University.

He and his associates studied wait-list mortality and post–liver transplant survival among 1,912 patients listed for either AAH or fulminant hepatic failure on the United Network for Organ Sharing (UNOS) registry between 2011 and 2016.

A total of 193 patients were listed with AAH, 314 were listed with drug-induced liver injury including acetaminophen (DILI-APAP), and 1,405 were listed as non-DILI patients.

One-year post–liver transplant survival among AAH patients was 93.3%, compared with 87.75% for DILI-APAP patients and 88.4% among non-DILI patients (P less than .001). Survival remained the same among AAH patients 3 years following transplantation, but rates dropped for both the DILI-APAP group (80.8%) and the non-DILI group (81.4%), Dr. Cholankeril reported.

Patients were a median age of 45, 33, and 46 years among the AAH, DILI-APAP, and non-DILI, groups respectively. Patients were majority white among all three groups, with a significantly larger female population among the DILI-APAP group (80.6%) than the AAH (34.7%) or non-DILI (59.4%) groups. Patients in the AAH group had a median Model for End-Stage Liver Disease (MELD) score of 32, compared with 34 for DILI-APAP and 21 for non-DILI.

AAH patients could potentially see significant improvement with a liver transplant, according to investigators; however, the current standards for candidacy have created treatment barriers.

“Patients with AAH have comparable early post-transplant outcomes to those with hepatic liver failure,” said Dr. Cholankeril. “However, there is no consensus or national guidelines for liver transplantation within this patient population.”

Wait-list trends have already started to shift toward more AAH patient acceptance. The number of AAH patients added to the transplant wait lists increased from 14 in 2011 to 58 in 2016. Investigators also found that the number of liver transplant centers accepting AAH patients to their transplant lists increased from 3 to 26.

Investigators were limited by the variations in protocols for each transplant center, as well as by the inconsistency of pre–liver transplant psychosocial metrics. The diagnostic criteria of AAH through UNOS was also a limitation for investigators, according to Dr. Cholankeril.

Although liver transplantation may be able to help some patients, it is only a small fix for a much larger problem. “This is only a solution for a minority of patients with the rising epidemic of alcoholic intoxication in the U.S.,” he said. “As the increasing mortality trends show alcohol-related mortality, and alcoholic liver disease is a contributor to it, we must recognize alcoholic liver disease remains an orphan disease and there is still an unmet need.”

Dr. Cholankeril reported no relevant financial disclosures.

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Transplanting patients with alcohol induced liver disease has been controversial since the earliest days of liver transplantation. Initially some programs were reluctant to transplant patients with a disease that was “self-inflicted” based on an ethical concern about using a scarce resource to save the lives of those whose disease was their own fault, while other patients may die waiting. There was also a concern that transplanting alcoholics would be bad publicity for organ donation and reduce the public’s willingness to donate organs.  The highly publicized transplantation of baseball legend and known alcoholic Mickey Mantle in 1995 intensified this debate.

Over time it became clear that the concerns regarding transplanting alcoholics were unfounded. The outcomes were equal or better than for other diseases. Liver transplantation was termed “the ultimate eye opening experience” as serious recidivism turned out to be very uncommon. It was realized that a large percentage of all reasons for seeking medical care can be attributed to self-inflicted harm when one considers cigarette induced malignancy and cardiovascular disease and dietary indiscretion leading to obesity and diabetes.  It also became clear that from a practical standpoint prohibiting transplantation of alcoholics simply drove patients to programs that would accept such patients, or caused them and their family to withhold disclosure of alcohol use.

While transplantation of patients with chronic liver disease due to alcohol use has become standard of care, transplanting patients with acute alcoholic hepatitis remains controversial and relatively uncommon. Many programs require a period of abstinence, which is impossible in the setting of acute alcoholic hepatitis. The concern is that it is impossible to discern among actively drinking candidates which ones will be able to achieve sobriety after the transplant. The report by Cholankeril and colleagues documents that the tide is changing. There are increasing numbers of patients being transplanted for acute alcoholic hepatitis, and outcomes are acceptable.  However, as the authors point out, the numbers are small and represent a highly selected group of patients. Nevertheless, the pressure on programs to modify rigid abstinence criteria is likely to grow as the evidence accumulates showing selected patients with acute alcoholic hepatitis can do well.

Jeffrey Punch, MD, FACS, is transplant specialist at the University of Michigan in Ann Arbor, and on the Editorial Advisory Board of ACS Surgery News.

 

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Transplanting patients with alcohol induced liver disease has been controversial since the earliest days of liver transplantation. Initially some programs were reluctant to transplant patients with a disease that was “self-inflicted” based on an ethical concern about using a scarce resource to save the lives of those whose disease was their own fault, while other patients may die waiting. There was also a concern that transplanting alcoholics would be bad publicity for organ donation and reduce the public’s willingness to donate organs.  The highly publicized transplantation of baseball legend and known alcoholic Mickey Mantle in 1995 intensified this debate.

Over time it became clear that the concerns regarding transplanting alcoholics were unfounded. The outcomes were equal or better than for other diseases. Liver transplantation was termed “the ultimate eye opening experience” as serious recidivism turned out to be very uncommon. It was realized that a large percentage of all reasons for seeking medical care can be attributed to self-inflicted harm when one considers cigarette induced malignancy and cardiovascular disease and dietary indiscretion leading to obesity and diabetes.  It also became clear that from a practical standpoint prohibiting transplantation of alcoholics simply drove patients to programs that would accept such patients, or caused them and their family to withhold disclosure of alcohol use.

While transplantation of patients with chronic liver disease due to alcohol use has become standard of care, transplanting patients with acute alcoholic hepatitis remains controversial and relatively uncommon. Many programs require a period of abstinence, which is impossible in the setting of acute alcoholic hepatitis. The concern is that it is impossible to discern among actively drinking candidates which ones will be able to achieve sobriety after the transplant. The report by Cholankeril and colleagues documents that the tide is changing. There are increasing numbers of patients being transplanted for acute alcoholic hepatitis, and outcomes are acceptable.  However, as the authors point out, the numbers are small and represent a highly selected group of patients. Nevertheless, the pressure on programs to modify rigid abstinence criteria is likely to grow as the evidence accumulates showing selected patients with acute alcoholic hepatitis can do well.

Jeffrey Punch, MD, FACS, is transplant specialist at the University of Michigan in Ann Arbor, and on the Editorial Advisory Board of ACS Surgery News.

 

Body

Transplanting patients with alcohol induced liver disease has been controversial since the earliest days of liver transplantation. Initially some programs were reluctant to transplant patients with a disease that was “self-inflicted” based on an ethical concern about using a scarce resource to save the lives of those whose disease was their own fault, while other patients may die waiting. There was also a concern that transplanting alcoholics would be bad publicity for organ donation and reduce the public’s willingness to donate organs.  The highly publicized transplantation of baseball legend and known alcoholic Mickey Mantle in 1995 intensified this debate.

Over time it became clear that the concerns regarding transplanting alcoholics were unfounded. The outcomes were equal or better than for other diseases. Liver transplantation was termed “the ultimate eye opening experience” as serious recidivism turned out to be very uncommon. It was realized that a large percentage of all reasons for seeking medical care can be attributed to self-inflicted harm when one considers cigarette induced malignancy and cardiovascular disease and dietary indiscretion leading to obesity and diabetes.  It also became clear that from a practical standpoint prohibiting transplantation of alcoholics simply drove patients to programs that would accept such patients, or caused them and their family to withhold disclosure of alcohol use.

While transplantation of patients with chronic liver disease due to alcohol use has become standard of care, transplanting patients with acute alcoholic hepatitis remains controversial and relatively uncommon. Many programs require a period of abstinence, which is impossible in the setting of acute alcoholic hepatitis. The concern is that it is impossible to discern among actively drinking candidates which ones will be able to achieve sobriety after the transplant. The report by Cholankeril and colleagues documents that the tide is changing. There are increasing numbers of patients being transplanted for acute alcoholic hepatitis, and outcomes are acceptable.  However, as the authors point out, the numbers are small and represent a highly selected group of patients. Nevertheless, the pressure on programs to modify rigid abstinence criteria is likely to grow as the evidence accumulates showing selected patients with acute alcoholic hepatitis can do well.

Jeffrey Punch, MD, FACS, is transplant specialist at the University of Michigan in Ann Arbor, and on the Editorial Advisory Board of ACS Surgery News.

 

 

– Patients with acute alcoholic hepatitis (AAH) have similar early post–liver transplant outcomes to those listed with fulminant hepatic failure, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.

Patients with severe AAH have high mortality, but many are unable to survive the 6 months of sobriety required to be accepted as liver transplant candidates, said George Cholankeril, MD, of the gastroenterology and hepatology department at Stanford (Calif.) University.

He and his associates studied wait-list mortality and post–liver transplant survival among 1,912 patients listed for either AAH or fulminant hepatic failure on the United Network for Organ Sharing (UNOS) registry between 2011 and 2016.

A total of 193 patients were listed with AAH, 314 were listed with drug-induced liver injury including acetaminophen (DILI-APAP), and 1,405 were listed as non-DILI patients.

One-year post–liver transplant survival among AAH patients was 93.3%, compared with 87.75% for DILI-APAP patients and 88.4% among non-DILI patients (P less than .001). Survival remained the same among AAH patients 3 years following transplantation, but rates dropped for both the DILI-APAP group (80.8%) and the non-DILI group (81.4%), Dr. Cholankeril reported.

Patients were a median age of 45, 33, and 46 years among the AAH, DILI-APAP, and non-DILI, groups respectively. Patients were majority white among all three groups, with a significantly larger female population among the DILI-APAP group (80.6%) than the AAH (34.7%) or non-DILI (59.4%) groups. Patients in the AAH group had a median Model for End-Stage Liver Disease (MELD) score of 32, compared with 34 for DILI-APAP and 21 for non-DILI.

AAH patients could potentially see significant improvement with a liver transplant, according to investigators; however, the current standards for candidacy have created treatment barriers.

“Patients with AAH have comparable early post-transplant outcomes to those with hepatic liver failure,” said Dr. Cholankeril. “However, there is no consensus or national guidelines for liver transplantation within this patient population.”

Wait-list trends have already started to shift toward more AAH patient acceptance. The number of AAH patients added to the transplant wait lists increased from 14 in 2011 to 58 in 2016. Investigators also found that the number of liver transplant centers accepting AAH patients to their transplant lists increased from 3 to 26.

Investigators were limited by the variations in protocols for each transplant center, as well as by the inconsistency of pre–liver transplant psychosocial metrics. The diagnostic criteria of AAH through UNOS was also a limitation for investigators, according to Dr. Cholankeril.

Although liver transplantation may be able to help some patients, it is only a small fix for a much larger problem. “This is only a solution for a minority of patients with the rising epidemic of alcoholic intoxication in the U.S.,” he said. “As the increasing mortality trends show alcohol-related mortality, and alcoholic liver disease is a contributor to it, we must recognize alcoholic liver disease remains an orphan disease and there is still an unmet need.”

Dr. Cholankeril reported no relevant financial disclosures.

 

– Patients with acute alcoholic hepatitis (AAH) have similar early post–liver transplant outcomes to those listed with fulminant hepatic failure, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.

Patients with severe AAH have high mortality, but many are unable to survive the 6 months of sobriety required to be accepted as liver transplant candidates, said George Cholankeril, MD, of the gastroenterology and hepatology department at Stanford (Calif.) University.

He and his associates studied wait-list mortality and post–liver transplant survival among 1,912 patients listed for either AAH or fulminant hepatic failure on the United Network for Organ Sharing (UNOS) registry between 2011 and 2016.

A total of 193 patients were listed with AAH, 314 were listed with drug-induced liver injury including acetaminophen (DILI-APAP), and 1,405 were listed as non-DILI patients.

One-year post–liver transplant survival among AAH patients was 93.3%, compared with 87.75% for DILI-APAP patients and 88.4% among non-DILI patients (P less than .001). Survival remained the same among AAH patients 3 years following transplantation, but rates dropped for both the DILI-APAP group (80.8%) and the non-DILI group (81.4%), Dr. Cholankeril reported.

Patients were a median age of 45, 33, and 46 years among the AAH, DILI-APAP, and non-DILI, groups respectively. Patients were majority white among all three groups, with a significantly larger female population among the DILI-APAP group (80.6%) than the AAH (34.7%) or non-DILI (59.4%) groups. Patients in the AAH group had a median Model for End-Stage Liver Disease (MELD) score of 32, compared with 34 for DILI-APAP and 21 for non-DILI.

AAH patients could potentially see significant improvement with a liver transplant, according to investigators; however, the current standards for candidacy have created treatment barriers.

“Patients with AAH have comparable early post-transplant outcomes to those with hepatic liver failure,” said Dr. Cholankeril. “However, there is no consensus or national guidelines for liver transplantation within this patient population.”

Wait-list trends have already started to shift toward more AAH patient acceptance. The number of AAH patients added to the transplant wait lists increased from 14 in 2011 to 58 in 2016. Investigators also found that the number of liver transplant centers accepting AAH patients to their transplant lists increased from 3 to 26.

Investigators were limited by the variations in protocols for each transplant center, as well as by the inconsistency of pre–liver transplant psychosocial metrics. The diagnostic criteria of AAH through UNOS was also a limitation for investigators, according to Dr. Cholankeril.

Although liver transplantation may be able to help some patients, it is only a small fix for a much larger problem. “This is only a solution for a minority of patients with the rising epidemic of alcoholic intoxication in the U.S.,” he said. “As the increasing mortality trends show alcohol-related mortality, and alcoholic liver disease is a contributor to it, we must recognize alcoholic liver disease remains an orphan disease and there is still an unmet need.”

Dr. Cholankeril reported no relevant financial disclosures.

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Key clinical point: Acute alcoholic hepatitis (AAH) patients have similar post-transplant results to fulminant hepatic failure patients.

Major finding: Survival 1 and 3 years after liver transplant was comparable in patients with drug-induced liver injury including acetaminophen (P = .10) and significantly higher than other chronic alcoholic liver disease patients (P less that .001).

Data source: Retrospective study of 1,912 liver transplant patients listed for either AAH or status 1A registered on the UNOS registry between 2011 and 2016.

Disclosures: Presenter reported no relevant financial disclosures.

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VIDEO: Fibrosis biomarkers show promise to replace liver biopsy

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– The concentrations of three biomarkers successfully identified the severity of fibrosis in patients with nonalcoholic steatohepatitis (NASH), according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.

This noninvasive diagnostic method could replace liver biopsy, the current standard used to diagnose patients with NASH.

Liver biopsies are associated with high cost, high rates of complications like infection, and minimal association with morbidity and mortality, Manal Abdelmalek, MD, a hepatologist and liver transplant specialist at Duke University, Durham, N.C., said in a video interview.

Investigators measured serum concentrations of a2-macroglobulin, hyaluronic acid, and metalloproteinase-1 collected from 792 patients with NASH on the same day as patients’ liver biopsies.

Dr. Abdelmalek and her fellow investigators randomly assigned half of the samples to a training group and half the samples to a validation group.

Investigators found that samples in the training group showed a sensitivity of 84.4% (95% confidence interval, 75.5%-91.0%), compared with 81.1% (95% CI, 71.7%-88.4%) in the validation group. Among patients with liver fibrosis, the biomarker test correctly diagnosed 76.5%-100% of patients, with variations depending on placement in the four classifications based on severity.

Investigators feel optimistic that, with more testing, this biomarker test can be used in collaboration with imaging or used independently, minimizing possible patient complications.

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– The concentrations of three biomarkers successfully identified the severity of fibrosis in patients with nonalcoholic steatohepatitis (NASH), according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.

This noninvasive diagnostic method could replace liver biopsy, the current standard used to diagnose patients with NASH.

Liver biopsies are associated with high cost, high rates of complications like infection, and minimal association with morbidity and mortality, Manal Abdelmalek, MD, a hepatologist and liver transplant specialist at Duke University, Durham, N.C., said in a video interview.

Investigators measured serum concentrations of a2-macroglobulin, hyaluronic acid, and metalloproteinase-1 collected from 792 patients with NASH on the same day as patients’ liver biopsies.

Dr. Abdelmalek and her fellow investigators randomly assigned half of the samples to a training group and half the samples to a validation group.

Investigators found that samples in the training group showed a sensitivity of 84.4% (95% confidence interval, 75.5%-91.0%), compared with 81.1% (95% CI, 71.7%-88.4%) in the validation group. Among patients with liver fibrosis, the biomarker test correctly diagnosed 76.5%-100% of patients, with variations depending on placement in the four classifications based on severity.

Investigators feel optimistic that, with more testing, this biomarker test can be used in collaboration with imaging or used independently, minimizing possible patient complications.

– The concentrations of three biomarkers successfully identified the severity of fibrosis in patients with nonalcoholic steatohepatitis (NASH), according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.

This noninvasive diagnostic method could replace liver biopsy, the current standard used to diagnose patients with NASH.

Liver biopsies are associated with high cost, high rates of complications like infection, and minimal association with morbidity and mortality, Manal Abdelmalek, MD, a hepatologist and liver transplant specialist at Duke University, Durham, N.C., said in a video interview.

Investigators measured serum concentrations of a2-macroglobulin, hyaluronic acid, and metalloproteinase-1 collected from 792 patients with NASH on the same day as patients’ liver biopsies.

Dr. Abdelmalek and her fellow investigators randomly assigned half of the samples to a training group and half the samples to a validation group.

Investigators found that samples in the training group showed a sensitivity of 84.4% (95% confidence interval, 75.5%-91.0%), compared with 81.1% (95% CI, 71.7%-88.4%) in the validation group. Among patients with liver fibrosis, the biomarker test correctly diagnosed 76.5%-100% of patients, with variations depending on placement in the four classifications based on severity.

Investigators feel optimistic that, with more testing, this biomarker test can be used in collaboration with imaging or used independently, minimizing possible patient complications.

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Public health intervention helps stem tuberculosis transmission

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– Using an on-site multi-disciplinary team to approach patients who are unwilling to receive tuberculosis treatment can improve patient cooperation, according to a case study presented ID Week 2017, an infectious disease meeting.

Such public health interventions may be able to improve disease control and interrupt the transmission cycle among patients who are not adhering to treatment, according to Aisha Haynie, MD, MPA.

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The first patient Dr. Haynie and her colleagues interacted with as a team was a young female adult diagnosed with active TB, who had been going back and forth from the hospital over the course of 10 months, according to Dr. Haynie.

“We started the patient on treatment and she actually decided to move into a motel,” said Dr. Haynie. “After that, she moved back into the family home and said she wasn’t having any contact [with residents], which we didn’t really believe.”

While the patient did reluctantly give Dr. Haynie and her team a list of five family members to test, the patient told Dr. Haynie that she and her team were not allowed into the patient’s home.

When the five members were tested, the new patients showed similar signs of reluctance and mistrust of the health system.

“The family members came to our clinic and two of them were TB positive,” recounted Dr. Haynie. “So they came back, but while they were sitting in the waiting room, they signed papers and they left.”

Despite continuous attempts to reach the family and address the growing concern from health professionals of the danger of TB transmission to other members of the family, patients continue not to adhere to procedures beyond pharmaceutical intervention.

In an attempt to directly contact the patient’s family, Dr. Haynie lead a team consisting of a local health authority physician, a TB nurse practitioner, a TB contact analyst, a nurse case manager, a county attorney, and an interpreter for unscheduled visits to family members individually.

“We had specific requests [including] keeping appointments, getting labs, and we added a deadline,” said Dr. Haynie, Chief of Disease Control and Medical Epidemiology for the Harris County Public Health & Environmental Services. “By the next Friday [we told them that] we were filing court papers with or without the information and we [would] be contacting child protective services as well.”

Following the intervention, the patient and her family adhered to testing procedures. This revealed an infant with active TB and 8 other family members with TB Infection. Isolation breaches were also discovered. Most importantly, the TB transmission cycle was interrupted, according to Dr. Haynie.

A key aspect of the team’s successful approach was to address cultural and economic barriers that hindered successful interaction with the family, TB misconceptions corrected in order for a trusting relationship to develop.

The investigators developed this intervention in Harris County, Tx, which at 4.3 million residents is the 3rd most populous U.S. county, and has reported a TB case rate of 7.6 cases per 100,000, which is approximately double that of the U.S. average, according to Dr. Haynie. Of those cases in Harris County, 73% are foreign-born, compared with the average rate of 59% in Texas.

Dr. Haynie and fellow investigators asserted part of the reason patients were so reluctant to receive treatment from the Harris County Public Health department was a combination of mistrust in the system and a number of false ideas patients have regarding TB, a sign of further educational tools being needed.

Since the first use of the intervention, Dr. Haynie and her team have implemented this approach with other non-adherent patients with relative success.

“This is something that we now do and we have not been back to court [to enforce compliance] since,” said Dr. Haynie.

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– Using an on-site multi-disciplinary team to approach patients who are unwilling to receive tuberculosis treatment can improve patient cooperation, according to a case study presented ID Week 2017, an infectious disease meeting.

Such public health interventions may be able to improve disease control and interrupt the transmission cycle among patients who are not adhering to treatment, according to Aisha Haynie, MD, MPA.

Zerbor/Thinkstock
The first patient Dr. Haynie and her colleagues interacted with as a team was a young female adult diagnosed with active TB, who had been going back and forth from the hospital over the course of 10 months, according to Dr. Haynie.

“We started the patient on treatment and she actually decided to move into a motel,” said Dr. Haynie. “After that, she moved back into the family home and said she wasn’t having any contact [with residents], which we didn’t really believe.”

While the patient did reluctantly give Dr. Haynie and her team a list of five family members to test, the patient told Dr. Haynie that she and her team were not allowed into the patient’s home.

When the five members were tested, the new patients showed similar signs of reluctance and mistrust of the health system.

“The family members came to our clinic and two of them were TB positive,” recounted Dr. Haynie. “So they came back, but while they were sitting in the waiting room, they signed papers and they left.”

Despite continuous attempts to reach the family and address the growing concern from health professionals of the danger of TB transmission to other members of the family, patients continue not to adhere to procedures beyond pharmaceutical intervention.

In an attempt to directly contact the patient’s family, Dr. Haynie lead a team consisting of a local health authority physician, a TB nurse practitioner, a TB contact analyst, a nurse case manager, a county attorney, and an interpreter for unscheduled visits to family members individually.

“We had specific requests [including] keeping appointments, getting labs, and we added a deadline,” said Dr. Haynie, Chief of Disease Control and Medical Epidemiology for the Harris County Public Health & Environmental Services. “By the next Friday [we told them that] we were filing court papers with or without the information and we [would] be contacting child protective services as well.”

Following the intervention, the patient and her family adhered to testing procedures. This revealed an infant with active TB and 8 other family members with TB Infection. Isolation breaches were also discovered. Most importantly, the TB transmission cycle was interrupted, according to Dr. Haynie.

A key aspect of the team’s successful approach was to address cultural and economic barriers that hindered successful interaction with the family, TB misconceptions corrected in order for a trusting relationship to develop.

The investigators developed this intervention in Harris County, Tx, which at 4.3 million residents is the 3rd most populous U.S. county, and has reported a TB case rate of 7.6 cases per 100,000, which is approximately double that of the U.S. average, according to Dr. Haynie. Of those cases in Harris County, 73% are foreign-born, compared with the average rate of 59% in Texas.

Dr. Haynie and fellow investigators asserted part of the reason patients were so reluctant to receive treatment from the Harris County Public Health department was a combination of mistrust in the system and a number of false ideas patients have regarding TB, a sign of further educational tools being needed.

Since the first use of the intervention, Dr. Haynie and her team have implemented this approach with other non-adherent patients with relative success.

“This is something that we now do and we have not been back to court [to enforce compliance] since,” said Dr. Haynie.

 

– Using an on-site multi-disciplinary team to approach patients who are unwilling to receive tuberculosis treatment can improve patient cooperation, according to a case study presented ID Week 2017, an infectious disease meeting.

Such public health interventions may be able to improve disease control and interrupt the transmission cycle among patients who are not adhering to treatment, according to Aisha Haynie, MD, MPA.

Zerbor/Thinkstock
The first patient Dr. Haynie and her colleagues interacted with as a team was a young female adult diagnosed with active TB, who had been going back and forth from the hospital over the course of 10 months, according to Dr. Haynie.

“We started the patient on treatment and she actually decided to move into a motel,” said Dr. Haynie. “After that, she moved back into the family home and said she wasn’t having any contact [with residents], which we didn’t really believe.”

While the patient did reluctantly give Dr. Haynie and her team a list of five family members to test, the patient told Dr. Haynie that she and her team were not allowed into the patient’s home.

When the five members were tested, the new patients showed similar signs of reluctance and mistrust of the health system.

“The family members came to our clinic and two of them were TB positive,” recounted Dr. Haynie. “So they came back, but while they were sitting in the waiting room, they signed papers and they left.”

Despite continuous attempts to reach the family and address the growing concern from health professionals of the danger of TB transmission to other members of the family, patients continue not to adhere to procedures beyond pharmaceutical intervention.

In an attempt to directly contact the patient’s family, Dr. Haynie lead a team consisting of a local health authority physician, a TB nurse practitioner, a TB contact analyst, a nurse case manager, a county attorney, and an interpreter for unscheduled visits to family members individually.

“We had specific requests [including] keeping appointments, getting labs, and we added a deadline,” said Dr. Haynie, Chief of Disease Control and Medical Epidemiology for the Harris County Public Health & Environmental Services. “By the next Friday [we told them that] we were filing court papers with or without the information and we [would] be contacting child protective services as well.”

Following the intervention, the patient and her family adhered to testing procedures. This revealed an infant with active TB and 8 other family members with TB Infection. Isolation breaches were also discovered. Most importantly, the TB transmission cycle was interrupted, according to Dr. Haynie.

A key aspect of the team’s successful approach was to address cultural and economic barriers that hindered successful interaction with the family, TB misconceptions corrected in order for a trusting relationship to develop.

The investigators developed this intervention in Harris County, Tx, which at 4.3 million residents is the 3rd most populous U.S. county, and has reported a TB case rate of 7.6 cases per 100,000, which is approximately double that of the U.S. average, according to Dr. Haynie. Of those cases in Harris County, 73% are foreign-born, compared with the average rate of 59% in Texas.

Dr. Haynie and fellow investigators asserted part of the reason patients were so reluctant to receive treatment from the Harris County Public Health department was a combination of mistrust in the system and a number of false ideas patients have regarding TB, a sign of further educational tools being needed.

Since the first use of the intervention, Dr. Haynie and her team have implemented this approach with other non-adherent patients with relative success.

“This is something that we now do and we have not been back to court [to enforce compliance] since,” said Dr. Haynie.

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Study: Macrolide treatment lowers risk of failure in pediatric CAP patients

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– Macrolide use showed lower treatment failure rates than did amoxicillin or beta-lactam treatment for pediatric community acquired pneumonia (CAP) patients, according to a study presented at an annual scientific meeting on infectious diseases.

While guidelines recommend amoxicillin as the first-line therapy against CAP, investigators have noticed an increase in macrolide prescriptions to pediatric outpatients, despite reported shortcomings in its use against atypical pneumonia.

“Macrolides are probably prescribed out of proportion to the presence of atypical pneumonia in that practice setting,” said Lori Handy, MD, of Children’s Hospital of Philadelphia. This could be an issue, according to Dr. Handy: “We also know that depending on the study, up to 40% of Streptococcus pneumoniae is resistant to macrolides, meaning there are children out there who may have S. pneumoniae who are receiving therapy not targeted at their disease pathogen.”

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To examine the possible impact of an increase in macrolide prescriptions, the investigators conducted a retrospective cohort study of 10,470 CAP pediatric patients across 31 primary care practices in the Children’s Hospital of Philadelphia network who were diagnosed between January 2009 and December 2013.

The studied cohort was split into three groups based on treatment options: amoxicillin monotherapy (4,252, 40.6%), macrolide monotherapy (4,459, 42.6%), and broad-spectrum beta-lactams (1,759, 16.8%).

Patient age ranged from 3 months to 18 years, the majority were white, with a roughly equal number of each sex. Of the children studied, 634 (6.1%) experienced treatment failure, defined as a change in antibiotics, an emergency department visit for related symptoms, or hospitalization for pneumonia, all of which had to occur more than 24 hours after a pediatric visit, according to Dr. Handy.

Of the children who failed treatment, 341 (54%) were in the amoxicillin group, 145 (23%) were in the macrolide group, and 147 (23%) were in the broad-spectrum group.

Patients younger than 5 years old who received macrolide therapy were half as likely to experience treatment failure compared with those given amoxicillin (odds ratio [OR] .52 [95% confidence interval (CI), 0.34-0.78]).

“What this translates to in practice is that about 32 children would need to treated with macrolides to prevent one failure in the amoxicillin group,” said Dr. Handy.

Patients 5 years and older showed even lower odds of treatment failure, at approximately one-third the rate of amoxicillin treated patients (OR .31 [95% CI, 0.23-0.92]).

Dr. Handy stated that the retrospective nature of the study and the possibility of changes in the epidemiology of CAP occurring since 2013 should be considered when evaluating the findings.

In addition, she pointed out, CAP is a clinical diagnosis, and there is generally no microbiological data associated with it in order to determine the etiology of the infection.

Overall, in healthy children with CAP, it would be better to use macrolide antibiotics compared with amoxicillin, Dr. Handy concluded. However, without the microbiological data, a more randomized, controlled trial would be needed to determine how to best treat these patients, she added.

During discussion, members of the audience asked about the appropriateness of measuring a change in antibiotics as an endpoint, especially in children with viral pneumonia, who may have had parents request stronger medication when their children did not improve quickly enough.

The 47 patients who were hospitalized would not have provided enough control to properly test the results, Dr. Handy replied, although she did acknowledge the potential issue of viral infections.

She stated the need for further study to assess its possible impact, saying she didn’t know whether viral infections may have skewed their results. “Either they’ve done nothing because they’re equally distributed among the groups or they’ve pushed them one way or the other way,” she said.

Dr. Handy and her colleagues reported having no relevant financial disclosures. The event was the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

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– Macrolide use showed lower treatment failure rates than did amoxicillin or beta-lactam treatment for pediatric community acquired pneumonia (CAP) patients, according to a study presented at an annual scientific meeting on infectious diseases.

While guidelines recommend amoxicillin as the first-line therapy against CAP, investigators have noticed an increase in macrolide prescriptions to pediatric outpatients, despite reported shortcomings in its use against atypical pneumonia.

“Macrolides are probably prescribed out of proportion to the presence of atypical pneumonia in that practice setting,” said Lori Handy, MD, of Children’s Hospital of Philadelphia. This could be an issue, according to Dr. Handy: “We also know that depending on the study, up to 40% of Streptococcus pneumoniae is resistant to macrolides, meaning there are children out there who may have S. pneumoniae who are receiving therapy not targeted at their disease pathogen.”

copyright stockdevil/Thinkstock


To examine the possible impact of an increase in macrolide prescriptions, the investigators conducted a retrospective cohort study of 10,470 CAP pediatric patients across 31 primary care practices in the Children’s Hospital of Philadelphia network who were diagnosed between January 2009 and December 2013.

The studied cohort was split into three groups based on treatment options: amoxicillin monotherapy (4,252, 40.6%), macrolide monotherapy (4,459, 42.6%), and broad-spectrum beta-lactams (1,759, 16.8%).

Patient age ranged from 3 months to 18 years, the majority were white, with a roughly equal number of each sex. Of the children studied, 634 (6.1%) experienced treatment failure, defined as a change in antibiotics, an emergency department visit for related symptoms, or hospitalization for pneumonia, all of which had to occur more than 24 hours after a pediatric visit, according to Dr. Handy.

Of the children who failed treatment, 341 (54%) were in the amoxicillin group, 145 (23%) were in the macrolide group, and 147 (23%) were in the broad-spectrum group.

Patients younger than 5 years old who received macrolide therapy were half as likely to experience treatment failure compared with those given amoxicillin (odds ratio [OR] .52 [95% confidence interval (CI), 0.34-0.78]).

“What this translates to in practice is that about 32 children would need to treated with macrolides to prevent one failure in the amoxicillin group,” said Dr. Handy.

Patients 5 years and older showed even lower odds of treatment failure, at approximately one-third the rate of amoxicillin treated patients (OR .31 [95% CI, 0.23-0.92]).

Dr. Handy stated that the retrospective nature of the study and the possibility of changes in the epidemiology of CAP occurring since 2013 should be considered when evaluating the findings.

In addition, she pointed out, CAP is a clinical diagnosis, and there is generally no microbiological data associated with it in order to determine the etiology of the infection.

Overall, in healthy children with CAP, it would be better to use macrolide antibiotics compared with amoxicillin, Dr. Handy concluded. However, without the microbiological data, a more randomized, controlled trial would be needed to determine how to best treat these patients, she added.

During discussion, members of the audience asked about the appropriateness of measuring a change in antibiotics as an endpoint, especially in children with viral pneumonia, who may have had parents request stronger medication when their children did not improve quickly enough.

The 47 patients who were hospitalized would not have provided enough control to properly test the results, Dr. Handy replied, although she did acknowledge the potential issue of viral infections.

She stated the need for further study to assess its possible impact, saying she didn’t know whether viral infections may have skewed their results. “Either they’ve done nothing because they’re equally distributed among the groups or they’ve pushed them one way or the other way,” she said.

Dr. Handy and her colleagues reported having no relevant financial disclosures. The event was the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

 

– Macrolide use showed lower treatment failure rates than did amoxicillin or beta-lactam treatment for pediatric community acquired pneumonia (CAP) patients, according to a study presented at an annual scientific meeting on infectious diseases.

While guidelines recommend amoxicillin as the first-line therapy against CAP, investigators have noticed an increase in macrolide prescriptions to pediatric outpatients, despite reported shortcomings in its use against atypical pneumonia.

“Macrolides are probably prescribed out of proportion to the presence of atypical pneumonia in that practice setting,” said Lori Handy, MD, of Children’s Hospital of Philadelphia. This could be an issue, according to Dr. Handy: “We also know that depending on the study, up to 40% of Streptococcus pneumoniae is resistant to macrolides, meaning there are children out there who may have S. pneumoniae who are receiving therapy not targeted at their disease pathogen.”

copyright stockdevil/Thinkstock


To examine the possible impact of an increase in macrolide prescriptions, the investigators conducted a retrospective cohort study of 10,470 CAP pediatric patients across 31 primary care practices in the Children’s Hospital of Philadelphia network who were diagnosed between January 2009 and December 2013.

The studied cohort was split into three groups based on treatment options: amoxicillin monotherapy (4,252, 40.6%), macrolide monotherapy (4,459, 42.6%), and broad-spectrum beta-lactams (1,759, 16.8%).

Patient age ranged from 3 months to 18 years, the majority were white, with a roughly equal number of each sex. Of the children studied, 634 (6.1%) experienced treatment failure, defined as a change in antibiotics, an emergency department visit for related symptoms, or hospitalization for pneumonia, all of which had to occur more than 24 hours after a pediatric visit, according to Dr. Handy.

Of the children who failed treatment, 341 (54%) were in the amoxicillin group, 145 (23%) were in the macrolide group, and 147 (23%) were in the broad-spectrum group.

Patients younger than 5 years old who received macrolide therapy were half as likely to experience treatment failure compared with those given amoxicillin (odds ratio [OR] .52 [95% confidence interval (CI), 0.34-0.78]).

“What this translates to in practice is that about 32 children would need to treated with macrolides to prevent one failure in the amoxicillin group,” said Dr. Handy.

Patients 5 years and older showed even lower odds of treatment failure, at approximately one-third the rate of amoxicillin treated patients (OR .31 [95% CI, 0.23-0.92]).

Dr. Handy stated that the retrospective nature of the study and the possibility of changes in the epidemiology of CAP occurring since 2013 should be considered when evaluating the findings.

In addition, she pointed out, CAP is a clinical diagnosis, and there is generally no microbiological data associated with it in order to determine the etiology of the infection.

Overall, in healthy children with CAP, it would be better to use macrolide antibiotics compared with amoxicillin, Dr. Handy concluded. However, without the microbiological data, a more randomized, controlled trial would be needed to determine how to best treat these patients, she added.

During discussion, members of the audience asked about the appropriateness of measuring a change in antibiotics as an endpoint, especially in children with viral pneumonia, who may have had parents request stronger medication when their children did not improve quickly enough.

The 47 patients who were hospitalized would not have provided enough control to properly test the results, Dr. Handy replied, although she did acknowledge the potential issue of viral infections.

She stated the need for further study to assess its possible impact, saying she didn’t know whether viral infections may have skewed their results. “Either they’ve done nothing because they’re equally distributed among the groups or they’ve pushed them one way or the other way,” she said.

Dr. Handy and her colleagues reported having no relevant financial disclosures. The event was the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

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Key clinical point: Macrolide treatment correlated with lower rates of treatment failure in pediatric community acquire pneumonia patients.

Major finding: Macrolide treatment was associated with treatment failure OR of .52 in patients younger than 5 years and .31 among patients older than 5 years.

Data source: Retrospective study of 10,460 pediatric patients receiving antibiotics for community acquired pneumonia during 2009-2013.

Disclosures: Dr. Handy and her colleagues reported having no relevant financial disclosures.

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Expanding treatment options to deal with antibiotic resistance

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Sat, 12/08/2018 - 14:30

– In an era of rising antibiotic resistance, new potential treatment options and policy changes took the stage at the start of an annual scientific meeting on infectious diseases.

Presenters covered emerging topics addressing infectious diseases, with a strong focus on HIV. A common emphasis, among all presentations, was the pressing need to update availability of newer and more effective drugs.

“There’s always something hot in ID, and often it’s transient. But what isn’t transient is the overwhelming problem of antibiotic resistance,” said Stan Deresinski, MD, infectious disease specialist from Stanford (Calif.) University. He added that: “A fear come true is the merger of antibiotic resistance and increased virulence.”

MacXever/Thinkstock
This convergence of multidrug-resistant diseases (MDR) and hypervirulence has added emphasis to a need for action, Dr. Deresinski said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. One example is a recent study conducted in Hangzhou, China, examining patients with carbapenem-resistant Klebsiella pneumoniae. In the survey of 387 patients with clinical ST11 carbapenem-resistant K. pneumoniae, investigators found 11 (3%) of the patients carried a virulence plasmid, and 5 of these 11 died, showing a deadly association between virulence and antibiotic resistance, according to Dr. Deresinski.

While long-term solutions are needed, a short-term answer is the increase in the kinds of antibiotics available, Dr. Deresinski said.

“As we look at this sort of event, we begin to look at ourselves in the near future as plague doctors,” warned Dr. Deresinski. “We need to deal with this, and the thing that can be done in the short term is the development of new antibiotics.”

The Food and Drug Administration has several avenues that could be used to provide for expedited antibiotics approval, such as fast tracking and priority approval of drugs. An additional program called Generating Antibiotic Incentives Now (GAIN) that allows the FDA to designate an antibiotic as an anti-infectious disease product, making it eligible for fast tracking and priority approval, as well as the addition of 5 years of market exclusivity, may be used to incentivize the development of newer drugs.

In addition, Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Antibacterial Resistance Leadership Group (ARLG) are two groups that will be essential for accelerating antibiotic development, Dr. Deresinski said.

CARB-X, which is a public-private partnership created by a White House executive order in 2014, focuses on preclinical discovery and development, and ARLG works under the mission statement, “prioritize, design, and execute clinical research that will reduce public health threat of antibacterial resistance.”

Among the hot topics in HIV, presenters described a series of studies conducted throughout the year assessing prexposure prophylaxis (PrEP), and how interventions, such as the use of the drug tenofovir, can increase efficacy of oral prophylaxis in preventing HIV-1 transmission.

In a test of antiretroviral therapy, the use of long-acting intramuscular injectable therapy every 4 and 8 weeks had huge improvement in patient approval, 88% and 89% respectively, compared with the 43% approval rate that oral HIV-1 medications received, said Wendy Armstrong, MD, of Emory University, Atlanta.

“[This] therapy is really getting to the point that we dreamed of 25 years ago, when our goals were finding an effective agent: to have simple agents, less frequent dosing schemes, limited adverse effects, and limited drug-to-drug interaction,” said Dr. Armstrong.

Among other topics to be addressed at the conference, Dr. Deresinski noted that the recent drop in Zika infections, as well as an uptick seen in hepatitis A outbreaks among the homeless and drug-user populations, would be discussed later in the week.
 

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– In an era of rising antibiotic resistance, new potential treatment options and policy changes took the stage at the start of an annual scientific meeting on infectious diseases.

Presenters covered emerging topics addressing infectious diseases, with a strong focus on HIV. A common emphasis, among all presentations, was the pressing need to update availability of newer and more effective drugs.

“There’s always something hot in ID, and often it’s transient. But what isn’t transient is the overwhelming problem of antibiotic resistance,” said Stan Deresinski, MD, infectious disease specialist from Stanford (Calif.) University. He added that: “A fear come true is the merger of antibiotic resistance and increased virulence.”

MacXever/Thinkstock
This convergence of multidrug-resistant diseases (MDR) and hypervirulence has added emphasis to a need for action, Dr. Deresinski said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. One example is a recent study conducted in Hangzhou, China, examining patients with carbapenem-resistant Klebsiella pneumoniae. In the survey of 387 patients with clinical ST11 carbapenem-resistant K. pneumoniae, investigators found 11 (3%) of the patients carried a virulence plasmid, and 5 of these 11 died, showing a deadly association between virulence and antibiotic resistance, according to Dr. Deresinski.

While long-term solutions are needed, a short-term answer is the increase in the kinds of antibiotics available, Dr. Deresinski said.

“As we look at this sort of event, we begin to look at ourselves in the near future as plague doctors,” warned Dr. Deresinski. “We need to deal with this, and the thing that can be done in the short term is the development of new antibiotics.”

The Food and Drug Administration has several avenues that could be used to provide for expedited antibiotics approval, such as fast tracking and priority approval of drugs. An additional program called Generating Antibiotic Incentives Now (GAIN) that allows the FDA to designate an antibiotic as an anti-infectious disease product, making it eligible for fast tracking and priority approval, as well as the addition of 5 years of market exclusivity, may be used to incentivize the development of newer drugs.

In addition, Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Antibacterial Resistance Leadership Group (ARLG) are two groups that will be essential for accelerating antibiotic development, Dr. Deresinski said.

CARB-X, which is a public-private partnership created by a White House executive order in 2014, focuses on preclinical discovery and development, and ARLG works under the mission statement, “prioritize, design, and execute clinical research that will reduce public health threat of antibacterial resistance.”

Among the hot topics in HIV, presenters described a series of studies conducted throughout the year assessing prexposure prophylaxis (PrEP), and how interventions, such as the use of the drug tenofovir, can increase efficacy of oral prophylaxis in preventing HIV-1 transmission.

In a test of antiretroviral therapy, the use of long-acting intramuscular injectable therapy every 4 and 8 weeks had huge improvement in patient approval, 88% and 89% respectively, compared with the 43% approval rate that oral HIV-1 medications received, said Wendy Armstrong, MD, of Emory University, Atlanta.

“[This] therapy is really getting to the point that we dreamed of 25 years ago, when our goals were finding an effective agent: to have simple agents, less frequent dosing schemes, limited adverse effects, and limited drug-to-drug interaction,” said Dr. Armstrong.

Among other topics to be addressed at the conference, Dr. Deresinski noted that the recent drop in Zika infections, as well as an uptick seen in hepatitis A outbreaks among the homeless and drug-user populations, would be discussed later in the week.
 

– In an era of rising antibiotic resistance, new potential treatment options and policy changes took the stage at the start of an annual scientific meeting on infectious diseases.

Presenters covered emerging topics addressing infectious diseases, with a strong focus on HIV. A common emphasis, among all presentations, was the pressing need to update availability of newer and more effective drugs.

“There’s always something hot in ID, and often it’s transient. But what isn’t transient is the overwhelming problem of antibiotic resistance,” said Stan Deresinski, MD, infectious disease specialist from Stanford (Calif.) University. He added that: “A fear come true is the merger of antibiotic resistance and increased virulence.”

MacXever/Thinkstock
This convergence of multidrug-resistant diseases (MDR) and hypervirulence has added emphasis to a need for action, Dr. Deresinski said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. One example is a recent study conducted in Hangzhou, China, examining patients with carbapenem-resistant Klebsiella pneumoniae. In the survey of 387 patients with clinical ST11 carbapenem-resistant K. pneumoniae, investigators found 11 (3%) of the patients carried a virulence plasmid, and 5 of these 11 died, showing a deadly association between virulence and antibiotic resistance, according to Dr. Deresinski.

While long-term solutions are needed, a short-term answer is the increase in the kinds of antibiotics available, Dr. Deresinski said.

“As we look at this sort of event, we begin to look at ourselves in the near future as plague doctors,” warned Dr. Deresinski. “We need to deal with this, and the thing that can be done in the short term is the development of new antibiotics.”

The Food and Drug Administration has several avenues that could be used to provide for expedited antibiotics approval, such as fast tracking and priority approval of drugs. An additional program called Generating Antibiotic Incentives Now (GAIN) that allows the FDA to designate an antibiotic as an anti-infectious disease product, making it eligible for fast tracking and priority approval, as well as the addition of 5 years of market exclusivity, may be used to incentivize the development of newer drugs.

In addition, Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Antibacterial Resistance Leadership Group (ARLG) are two groups that will be essential for accelerating antibiotic development, Dr. Deresinski said.

CARB-X, which is a public-private partnership created by a White House executive order in 2014, focuses on preclinical discovery and development, and ARLG works under the mission statement, “prioritize, design, and execute clinical research that will reduce public health threat of antibacterial resistance.”

Among the hot topics in HIV, presenters described a series of studies conducted throughout the year assessing prexposure prophylaxis (PrEP), and how interventions, such as the use of the drug tenofovir, can increase efficacy of oral prophylaxis in preventing HIV-1 transmission.

In a test of antiretroviral therapy, the use of long-acting intramuscular injectable therapy every 4 and 8 weeks had huge improvement in patient approval, 88% and 89% respectively, compared with the 43% approval rate that oral HIV-1 medications received, said Wendy Armstrong, MD, of Emory University, Atlanta.

“[This] therapy is really getting to the point that we dreamed of 25 years ago, when our goals were finding an effective agent: to have simple agents, less frequent dosing schemes, limited adverse effects, and limited drug-to-drug interaction,” said Dr. Armstrong.

Among other topics to be addressed at the conference, Dr. Deresinski noted that the recent drop in Zika infections, as well as an uptick seen in hepatitis A outbreaks among the homeless and drug-user populations, would be discussed later in the week.
 

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Hospital mortality for emergency bowel resection linked to failure to rescue

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Wed, 01/02/2019 - 09:59

– The variation among hospitals in mortality for emergent bowel resection may be explained in part by failure-to-rescue (FTR) rates, according to a study presented at the American Association for Surgery of Trauma annual meeting.

Ambar Mehta, a medical student at Johns Hopkins University School of Medicine in Baltimore, and a team of colleagues reviewed case data on 105,925 bowel resections that occurred between 2010 and 2013 using the Agency for Healthcare Research and Quality Nationwide Inpatient Sample.

Hospitals included were ranked by mortality for emergency bowel resection with the top quintile representing lowest mortality (1.5%) and bottom quintile representing the highest (14.9%).

Failure to rescue was defined as death after a major postoperative complication, according to Mr. Mehta. Overall failure-to-rescue rates were 9.8-fold higher in the bottom quintile hospitals, compared with those in the top quintile (33.4% vs. 3.4%). Patients studied were majority white (78.9%), female (53.9%), and younger than 65 years (52%).

Although FTR rates were significantly higher in the bottom quintile hospitals, complication rates were comparable (41.6% for bottom vs. 33.3% for top), suggesting that it was not complications per se that drove mortality but other postop factors.

Complications measured were acute renal failure, pulmonary failure, pneumonia, hemorrhage, gastrointestinal bleeding, pulmonary embolism, surgical site infections, and myocardial infarction.

Risk ratios for failure to rescue showed a similar increasing trend in correlation with mortality, with the hospitals in the lowest quintile showing a risk of 13 (P less than .01), compared with a risk of 3.2 (P less than .01) among hospitals in the highest quintile.

Correlation between failure to rescue and mortality was still evident when investigators adjusted analysis to compare hospitals that conducted more than 10 resections annually, causing investigators to suggest a need for changes in resection procedures.

“Our data suggest rates of failure to rescue correlate to rates of hospital mortality and we believe that system-level initiatives such as focusing on teamwork and team culture can reduce nationwide variations in mortality,” said Mr. Mehta.

Discussant Andrew Peitzman, MD, FACS, vice president for Trauma and Surgical Services at the University of Pittsburgh, acknowledged the link between mortality and failure to rescue among bowel resection patients and brought up the question of how to avoid such issues in the first place.

“This study validates the principle that a patient will generally tolerate an operation but not the first complication,” said Dr. Peitzman. “How do we avoid the first complication [and] what do you recommend in our acute care surgery practices and hospital structures to rescue our patients?”

Understanding why the complications happen at all is the first step to preventing them, Mr. Mehta said. Emergency general surgery–specific programs or mentorship programs may be a good start to cutting down on the inherent risk increase of emergent procedures.

Having greater than 20 beds designated to the intensive care unit and having a greater ratio of nursing staff to patients may be other viable solutions, according to a study Mr. Mehta cited; however, he asserted, focusing on team protocols seems to be the most successful course.

When asked by audience members about the idea of regionalizing care, Dr. Mehta said more data would be needed. “Regionalization has definitely shown benefits in a trauma setting,” said Mr. Mehta. “Copying a model of that idea for nontrauma [emergency general surgery] procedures may work, but it would require studies in a multicenter program.”

The study was limited by the use of administrative claims data, including being unable to determine if deaths were caused by a failure to rescue or whether families determined to end care after an initial complication. Investigators were also unable to identify which surgical diagnoses led to the procedure, nor could they adjust for varying hospital resources.

Investigators reported no relevant financial disclosures.

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– The variation among hospitals in mortality for emergent bowel resection may be explained in part by failure-to-rescue (FTR) rates, according to a study presented at the American Association for Surgery of Trauma annual meeting.

Ambar Mehta, a medical student at Johns Hopkins University School of Medicine in Baltimore, and a team of colleagues reviewed case data on 105,925 bowel resections that occurred between 2010 and 2013 using the Agency for Healthcare Research and Quality Nationwide Inpatient Sample.

Hospitals included were ranked by mortality for emergency bowel resection with the top quintile representing lowest mortality (1.5%) and bottom quintile representing the highest (14.9%).

Failure to rescue was defined as death after a major postoperative complication, according to Mr. Mehta. Overall failure-to-rescue rates were 9.8-fold higher in the bottom quintile hospitals, compared with those in the top quintile (33.4% vs. 3.4%). Patients studied were majority white (78.9%), female (53.9%), and younger than 65 years (52%).

Although FTR rates were significantly higher in the bottom quintile hospitals, complication rates were comparable (41.6% for bottom vs. 33.3% for top), suggesting that it was not complications per se that drove mortality but other postop factors.

Complications measured were acute renal failure, pulmonary failure, pneumonia, hemorrhage, gastrointestinal bleeding, pulmonary embolism, surgical site infections, and myocardial infarction.

Risk ratios for failure to rescue showed a similar increasing trend in correlation with mortality, with the hospitals in the lowest quintile showing a risk of 13 (P less than .01), compared with a risk of 3.2 (P less than .01) among hospitals in the highest quintile.

Correlation between failure to rescue and mortality was still evident when investigators adjusted analysis to compare hospitals that conducted more than 10 resections annually, causing investigators to suggest a need for changes in resection procedures.

“Our data suggest rates of failure to rescue correlate to rates of hospital mortality and we believe that system-level initiatives such as focusing on teamwork and team culture can reduce nationwide variations in mortality,” said Mr. Mehta.

Discussant Andrew Peitzman, MD, FACS, vice president for Trauma and Surgical Services at the University of Pittsburgh, acknowledged the link between mortality and failure to rescue among bowel resection patients and brought up the question of how to avoid such issues in the first place.

“This study validates the principle that a patient will generally tolerate an operation but not the first complication,” said Dr. Peitzman. “How do we avoid the first complication [and] what do you recommend in our acute care surgery practices and hospital structures to rescue our patients?”

Understanding why the complications happen at all is the first step to preventing them, Mr. Mehta said. Emergency general surgery–specific programs or mentorship programs may be a good start to cutting down on the inherent risk increase of emergent procedures.

Having greater than 20 beds designated to the intensive care unit and having a greater ratio of nursing staff to patients may be other viable solutions, according to a study Mr. Mehta cited; however, he asserted, focusing on team protocols seems to be the most successful course.

When asked by audience members about the idea of regionalizing care, Dr. Mehta said more data would be needed. “Regionalization has definitely shown benefits in a trauma setting,” said Mr. Mehta. “Copying a model of that idea for nontrauma [emergency general surgery] procedures may work, but it would require studies in a multicenter program.”

The study was limited by the use of administrative claims data, including being unable to determine if deaths were caused by a failure to rescue or whether families determined to end care after an initial complication. Investigators were also unable to identify which surgical diagnoses led to the procedure, nor could they adjust for varying hospital resources.

Investigators reported no relevant financial disclosures.

– The variation among hospitals in mortality for emergent bowel resection may be explained in part by failure-to-rescue (FTR) rates, according to a study presented at the American Association for Surgery of Trauma annual meeting.

Ambar Mehta, a medical student at Johns Hopkins University School of Medicine in Baltimore, and a team of colleagues reviewed case data on 105,925 bowel resections that occurred between 2010 and 2013 using the Agency for Healthcare Research and Quality Nationwide Inpatient Sample.

Hospitals included were ranked by mortality for emergency bowel resection with the top quintile representing lowest mortality (1.5%) and bottom quintile representing the highest (14.9%).

Failure to rescue was defined as death after a major postoperative complication, according to Mr. Mehta. Overall failure-to-rescue rates were 9.8-fold higher in the bottom quintile hospitals, compared with those in the top quintile (33.4% vs. 3.4%). Patients studied were majority white (78.9%), female (53.9%), and younger than 65 years (52%).

Although FTR rates were significantly higher in the bottom quintile hospitals, complication rates were comparable (41.6% for bottom vs. 33.3% for top), suggesting that it was not complications per se that drove mortality but other postop factors.

Complications measured were acute renal failure, pulmonary failure, pneumonia, hemorrhage, gastrointestinal bleeding, pulmonary embolism, surgical site infections, and myocardial infarction.

Risk ratios for failure to rescue showed a similar increasing trend in correlation with mortality, with the hospitals in the lowest quintile showing a risk of 13 (P less than .01), compared with a risk of 3.2 (P less than .01) among hospitals in the highest quintile.

Correlation between failure to rescue and mortality was still evident when investigators adjusted analysis to compare hospitals that conducted more than 10 resections annually, causing investigators to suggest a need for changes in resection procedures.

“Our data suggest rates of failure to rescue correlate to rates of hospital mortality and we believe that system-level initiatives such as focusing on teamwork and team culture can reduce nationwide variations in mortality,” said Mr. Mehta.

Discussant Andrew Peitzman, MD, FACS, vice president for Trauma and Surgical Services at the University of Pittsburgh, acknowledged the link between mortality and failure to rescue among bowel resection patients and brought up the question of how to avoid such issues in the first place.

“This study validates the principle that a patient will generally tolerate an operation but not the first complication,” said Dr. Peitzman. “How do we avoid the first complication [and] what do you recommend in our acute care surgery practices and hospital structures to rescue our patients?”

Understanding why the complications happen at all is the first step to preventing them, Mr. Mehta said. Emergency general surgery–specific programs or mentorship programs may be a good start to cutting down on the inherent risk increase of emergent procedures.

Having greater than 20 beds designated to the intensive care unit and having a greater ratio of nursing staff to patients may be other viable solutions, according to a study Mr. Mehta cited; however, he asserted, focusing on team protocols seems to be the most successful course.

When asked by audience members about the idea of regionalizing care, Dr. Mehta said more data would be needed. “Regionalization has definitely shown benefits in a trauma setting,” said Mr. Mehta. “Copying a model of that idea for nontrauma [emergency general surgery] procedures may work, but it would require studies in a multicenter program.”

The study was limited by the use of administrative claims data, including being unable to determine if deaths were caused by a failure to rescue or whether families determined to end care after an initial complication. Investigators were also unable to identify which surgical diagnoses led to the procedure, nor could they adjust for varying hospital resources.

Investigators reported no relevant financial disclosures.

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Key clinical point: Hospital variation in mortality for emergency bowel resection may be explained by the variation in failure-to-rescue rates.

Major finding: Risk-adjusted failure-to-rescue rates were 9.8 times higher in hospitals with the highest mortality than in those with the lowest (33.4% vs. 3.1%).

Data source: Study of 105,925 bowel resections that occurred between 2010 and 2013 collected from the AHRQ Nationwide Inpatient Sample.

Disclosures: Investigators reported no relevant financial disclosures.

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Prehospital tourniquets in civilian settings significantly decreased mortality

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Wed, 01/02/2019 - 09:59

– Prehospital tourniquet use on injured civilians in trauma situations was associated with a nearly sixfold decrease in mortality, according to a study presented at the annual meeting of the American Association for Surgery of Trauma.

While tourniquets have been an effective tool in military settings, data on successful applications in civilian settings have been scarce.

Wikimedia Creative Commons License/INDNAM
“Our data support a more aggressive prehospital push to the application of extremity tourniquets in civilian trauma patients with severe hemorrhage and traumatic amputation,” said presenter Pedro G. Teixeira, MD, a vascular surgeon and associate trauma director at Seton Medical Center, Austin, Tex.

Dr. Teixeira and his coinvestigators conducted a multicenter, retrospective study of 1,026 peripheral–vascular injury patients admitted to level I trauma centers between January 2011 and December 2016. Among the patients studied, 181 (17.6%) received a tourniquet prior to hospital admission.

A majority of tourniquets were applied to the limbs, with the most common application sites on the arm (49%) and the thigh (29%).Tourniquets were held in place for an average 77 minutes.

Of the patients in the study, 98 (9.6%) underwent an amputation; 35 of these patients had received a tourniquet.

After adjusting for confounding factors, such as age and mechanism of injury, investigators found patients who received tourniquets were nearly six times more likely to survive than were their nontourniquet counterparts (odds ratio, 5.86; 95% confidence interval, 1.41-24.47; P = .015).

While the overall mortality rate among those with a tourniquet – compared with those without a tourniquet – was significantly lower, the comparative mortality rate among amputee patients was not significant, which investigators hypothesized could be because of the smaller number of patients in this subgroup.

Additionally, patients who did not receive a tourniquet had lower injury severity scores, had better vital signs, and needed less blood, according to investigators.

The findings of this study mirror what many military medical professionals have historically, and adamantly, supported, according to discussant Jay J. Doucet, MD, FACS, medical director for the surgical intensive care unit at the University of California San Diego Medical Center and a former combat surgeon.

“The medical lessons on our battlefields that hold such great promise have to be carefully relearned, brought home, and fearlessly applied here,” said Dr. Doucet. “I have yet to meet an employed military surgeon who does not believe the tourniquet is an indispensable tool.” While Dr. Doucet did acknowledge the benefit of tourniquets outside military use and addressed the need for increased implementation among civilian hospitals, he did pose a query about the mortality rate that investigators had found.

“The no-tourniquet group has an adjusted odds of death at a rate that is 5.86 times higher, yet they had better vitals, needed less blood, had lower [injury severity scores], had less head injury, fewer traumatic amputations, and fewer complications,” said Dr. Doucet. “So why do they die?”

Investigators were not able to pinpoint the cause of death among patients because of the limitations of their study; however, Dr. Teixeira and his colleagues were able to determine the presence of cardiac complications, pulmonary complications, and acute kidney injury, none of which had a significantly different presence between the two study groups.

The data gathered from this study are strong enough to support the use of tourniquets in civilian situations, asserted Dr. Teixeira, which means the next hurdle is to integrate it into the health system.

“What’s important from our perspective as leaders of this issue is what we are doing to increase the rate [of tourniquet use],” said Dr. Teixeira. “I think one of the important things is the Stop the Bleed program, [in which] we are actually teaching the Austin police department, and we are trying to increase the use of the tourniquet and demonstrate its importance.”

Investigators reported no relevant financial disclosures.

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– Prehospital tourniquet use on injured civilians in trauma situations was associated with a nearly sixfold decrease in mortality, according to a study presented at the annual meeting of the American Association for Surgery of Trauma.

While tourniquets have been an effective tool in military settings, data on successful applications in civilian settings have been scarce.

Wikimedia Creative Commons License/INDNAM
“Our data support a more aggressive prehospital push to the application of extremity tourniquets in civilian trauma patients with severe hemorrhage and traumatic amputation,” said presenter Pedro G. Teixeira, MD, a vascular surgeon and associate trauma director at Seton Medical Center, Austin, Tex.

Dr. Teixeira and his coinvestigators conducted a multicenter, retrospective study of 1,026 peripheral–vascular injury patients admitted to level I trauma centers between January 2011 and December 2016. Among the patients studied, 181 (17.6%) received a tourniquet prior to hospital admission.

A majority of tourniquets were applied to the limbs, with the most common application sites on the arm (49%) and the thigh (29%).Tourniquets were held in place for an average 77 minutes.

Of the patients in the study, 98 (9.6%) underwent an amputation; 35 of these patients had received a tourniquet.

After adjusting for confounding factors, such as age and mechanism of injury, investigators found patients who received tourniquets were nearly six times more likely to survive than were their nontourniquet counterparts (odds ratio, 5.86; 95% confidence interval, 1.41-24.47; P = .015).

While the overall mortality rate among those with a tourniquet – compared with those without a tourniquet – was significantly lower, the comparative mortality rate among amputee patients was not significant, which investigators hypothesized could be because of the smaller number of patients in this subgroup.

Additionally, patients who did not receive a tourniquet had lower injury severity scores, had better vital signs, and needed less blood, according to investigators.

The findings of this study mirror what many military medical professionals have historically, and adamantly, supported, according to discussant Jay J. Doucet, MD, FACS, medical director for the surgical intensive care unit at the University of California San Diego Medical Center and a former combat surgeon.

“The medical lessons on our battlefields that hold such great promise have to be carefully relearned, brought home, and fearlessly applied here,” said Dr. Doucet. “I have yet to meet an employed military surgeon who does not believe the tourniquet is an indispensable tool.” While Dr. Doucet did acknowledge the benefit of tourniquets outside military use and addressed the need for increased implementation among civilian hospitals, he did pose a query about the mortality rate that investigators had found.

“The no-tourniquet group has an adjusted odds of death at a rate that is 5.86 times higher, yet they had better vitals, needed less blood, had lower [injury severity scores], had less head injury, fewer traumatic amputations, and fewer complications,” said Dr. Doucet. “So why do they die?”

Investigators were not able to pinpoint the cause of death among patients because of the limitations of their study; however, Dr. Teixeira and his colleagues were able to determine the presence of cardiac complications, pulmonary complications, and acute kidney injury, none of which had a significantly different presence between the two study groups.

The data gathered from this study are strong enough to support the use of tourniquets in civilian situations, asserted Dr. Teixeira, which means the next hurdle is to integrate it into the health system.

“What’s important from our perspective as leaders of this issue is what we are doing to increase the rate [of tourniquet use],” said Dr. Teixeira. “I think one of the important things is the Stop the Bleed program, [in which] we are actually teaching the Austin police department, and we are trying to increase the use of the tourniquet and demonstrate its importance.”

Investigators reported no relevant financial disclosures.

– Prehospital tourniquet use on injured civilians in trauma situations was associated with a nearly sixfold decrease in mortality, according to a study presented at the annual meeting of the American Association for Surgery of Trauma.

While tourniquets have been an effective tool in military settings, data on successful applications in civilian settings have been scarce.

Wikimedia Creative Commons License/INDNAM
“Our data support a more aggressive prehospital push to the application of extremity tourniquets in civilian trauma patients with severe hemorrhage and traumatic amputation,” said presenter Pedro G. Teixeira, MD, a vascular surgeon and associate trauma director at Seton Medical Center, Austin, Tex.

Dr. Teixeira and his coinvestigators conducted a multicenter, retrospective study of 1,026 peripheral–vascular injury patients admitted to level I trauma centers between January 2011 and December 2016. Among the patients studied, 181 (17.6%) received a tourniquet prior to hospital admission.

A majority of tourniquets were applied to the limbs, with the most common application sites on the arm (49%) and the thigh (29%).Tourniquets were held in place for an average 77 minutes.

Of the patients in the study, 98 (9.6%) underwent an amputation; 35 of these patients had received a tourniquet.

After adjusting for confounding factors, such as age and mechanism of injury, investigators found patients who received tourniquets were nearly six times more likely to survive than were their nontourniquet counterparts (odds ratio, 5.86; 95% confidence interval, 1.41-24.47; P = .015).

While the overall mortality rate among those with a tourniquet – compared with those without a tourniquet – was significantly lower, the comparative mortality rate among amputee patients was not significant, which investigators hypothesized could be because of the smaller number of patients in this subgroup.

Additionally, patients who did not receive a tourniquet had lower injury severity scores, had better vital signs, and needed less blood, according to investigators.

The findings of this study mirror what many military medical professionals have historically, and adamantly, supported, according to discussant Jay J. Doucet, MD, FACS, medical director for the surgical intensive care unit at the University of California San Diego Medical Center and a former combat surgeon.

“The medical lessons on our battlefields that hold such great promise have to be carefully relearned, brought home, and fearlessly applied here,” said Dr. Doucet. “I have yet to meet an employed military surgeon who does not believe the tourniquet is an indispensable tool.” While Dr. Doucet did acknowledge the benefit of tourniquets outside military use and addressed the need for increased implementation among civilian hospitals, he did pose a query about the mortality rate that investigators had found.

“The no-tourniquet group has an adjusted odds of death at a rate that is 5.86 times higher, yet they had better vitals, needed less blood, had lower [injury severity scores], had less head injury, fewer traumatic amputations, and fewer complications,” said Dr. Doucet. “So why do they die?”

Investigators were not able to pinpoint the cause of death among patients because of the limitations of their study; however, Dr. Teixeira and his colleagues were able to determine the presence of cardiac complications, pulmonary complications, and acute kidney injury, none of which had a significantly different presence between the two study groups.

The data gathered from this study are strong enough to support the use of tourniquets in civilian situations, asserted Dr. Teixeira, which means the next hurdle is to integrate it into the health system.

“What’s important from our perspective as leaders of this issue is what we are doing to increase the rate [of tourniquet use],” said Dr. Teixeira. “I think one of the important things is the Stop the Bleed program, [in which] we are actually teaching the Austin police department, and we are trying to increase the use of the tourniquet and demonstrate its importance.”

Investigators reported no relevant financial disclosures.

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Key clinical point: Prehospital tourniquets are associated with dramatic decrease in peripheral–vascular injury mortality.

Major finding: Patients who were given a prehospital tourniquet were associated with a survival odds ratio nearly sixfold higher than those without (odds ratio, 5.86; 95% confidence interval, 1.41-24.47; P = .015).

Data source: Multicenter retrospective study of 1,026 patients with peripheral vascular injuries admitted to a level I trauma facility between January 2011 and December 2016.

Disclosures: Investigators reported no relevant financial disclosures.

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Early start to puberty increases likelihood of depression in girls

The stresses of maturing early
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Early puberty in girls can increase the likelihood of developing depression or antisocial behavior, a prospective study found

“Earlier pubertal timing in girls is often accompanied by distinct rises in the prevalence, severity, and onset of psychopathology,” wrote Jane Mendle, PhD, of Cornell University, Ithaca, N.Y., and her associates. “It is difficult to know whether, when, and on what processes to intervene if we cannot establish how much pubertal timing matters for well-being later in life.”

selensergen/Thinkstock
Investigators gathered 7,802 women from the National Longitudinal Study of Adolescent Health (Add Health) to participate in this study between 1994 and 2008. The Add Health study was known for a “high degree of racial, ethnic, and socioeconomic diversity,” the researchers said. The results were published in the journal Pediatrics.

Patients were evaluated in four waves, with average ages of 15.8 years, 16.1 years, 21.7 years, and 28.7 years for waves one through four, respectively.

Symptoms for depression and antisocial behavior were evaluated using the Center for Epidemiologic Studies Depression Scale, a self-reported survey, and a self-reported questionnaire on recent antisocial behaviors including theft, property damage, and selling drugs. The youngest girls also were asked about running away from home, lying to parents, shoplifting, and driving a car without the owner’s permission, while the oldest participants were asked about deliberately writing a bad check, using someone else’s debit card without permission, and buying or selling stolen property. Those participating were mostly white (66%) and on average experienced menarche at age 12 years.

Older age at menarche was significantly associated with lower levels of symptoms of depression (b = –0.87, P less than .05), when data were analyzed in a proximal influences model.

“To illustrate, a girl who reached menarche at age 10 years (approximately 2 years earlier than the mean) would have depressive symptoms 8% of 1 SD [standard deviation] greater in adolescence, whereas a girl who reached menarche at age 8 years would have depressive symptoms 25% of 1 SD greater,” the investigators wrote.

A linear and quadratic association between early menarche and depressive symptoms persisted as patients reached their 30s, suggesting girls who matured earlier are more likely to display symptoms of depression as an adult because they became depressed as teenagers and they remain vulnerable, Dr. Mendle and her colleagues reported.

Early maturation also was associated with a higher frequency of antisocial behavior in both proximal
(b = –.009, P less than .05) and lingering (b = –0.02, P less than .05) models.

Dr. Mendle and her colleagues found the gap in antisocial activity between those who matured early and those who did not was more pronounced in adulthood than adolescence, and the effects of antisocial behavior were smaller than the effects of depressive symptoms.

The investigators said they were limited by an incomplete understanding of why these longitudinal effects continue. Also, because they used age at menarche as an indicator of pubertal timing, the investigators said they could not capture the social, emotional, or hormonal processes present earlier in puberty.

“Results from the current study suggest that girls who experienced earlier menarche continued to report elevated psychopathology in early-to-middle adulthood even after accounting for demographic and contextual variables commonly associated with vulnerability for mental health. These findings align with the broad body of work linking early puberty with higher psychopathology during adolescence‍ as well as with the few studies showing longer-term associations with mental health in adulthood,” Dr. Mendle and her associates wrote.

“Understanding the longevity of these associations offers new challenges to researchers, [and] practical information for pediatricians and adolescent health care providers, and highlights that the emotional sequelae of puberty may endure well past the proximal period of adolescence,” they concluded. There also may be other disorders beyond depression and antisocial behavior associated with early puberty, which should be explored.

This study was funded by the National Institutes of Health. The investigators reported no relevant financial disclosures.

 

SOURCE: Mendle J et al. Pediatrics. 2017 Dec 26. doi: 10.1542/peds.2017-1703.

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Puberty is a complex time for teenagers, especially young girls, and biological factors and chronic stress such as early childhood abuse or neglect can lead to the early onset of puberty, and subsequently depression and antisocial behavior. A link between obesity and an early start to puberty has been established in previous studies as well.

Adding poor body image and possible bullying to the stresses of puberty can create an increased risk for mental health problems. There are also the added pressures of looking older physically, but socially not having matured enough; young girls may seek out friends who are older than them to fit in with peers who look like them, and then feel pressured to engage in risky activities to fit in.

It is important for us as pediatricians to intervene when these situations arise. Having a thorough history of trauma when counseling patients on their pubescent time line can be essential. Screen for depression and antisocial behavior in girls with early puberty, and refer to developmentally appropriate community and mental health resources for additional support if necessary. Talk with parents about close monitoring of friend groups and about encouraging their children to spend time with age-appropriate friends. Our mission is to guide children and adolescents into healthy adulthood.
 

Ellen Selkie, MD, MPH, is an adolescent medicine specialist at the University of Michigan, Ann Arbor. She commented on the article by Mendle et al. in an accompanying editorial (Pediatrics. 2017 Jan 1. doi: 10.1542/peds.2017-3460 .) She had no relevant financial disclosures.

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Puberty is a complex time for teenagers, especially young girls, and biological factors and chronic stress such as early childhood abuse or neglect can lead to the early onset of puberty, and subsequently depression and antisocial behavior. A link between obesity and an early start to puberty has been established in previous studies as well.

Adding poor body image and possible bullying to the stresses of puberty can create an increased risk for mental health problems. There are also the added pressures of looking older physically, but socially not having matured enough; young girls may seek out friends who are older than them to fit in with peers who look like them, and then feel pressured to engage in risky activities to fit in.

It is important for us as pediatricians to intervene when these situations arise. Having a thorough history of trauma when counseling patients on their pubescent time line can be essential. Screen for depression and antisocial behavior in girls with early puberty, and refer to developmentally appropriate community and mental health resources for additional support if necessary. Talk with parents about close monitoring of friend groups and about encouraging their children to spend time with age-appropriate friends. Our mission is to guide children and adolescents into healthy adulthood.
 

Ellen Selkie, MD, MPH, is an adolescent medicine specialist at the University of Michigan, Ann Arbor. She commented on the article by Mendle et al. in an accompanying editorial (Pediatrics. 2017 Jan 1. doi: 10.1542/peds.2017-3460 .) She had no relevant financial disclosures.

Body

 

Puberty is a complex time for teenagers, especially young girls, and biological factors and chronic stress such as early childhood abuse or neglect can lead to the early onset of puberty, and subsequently depression and antisocial behavior. A link between obesity and an early start to puberty has been established in previous studies as well.

Adding poor body image and possible bullying to the stresses of puberty can create an increased risk for mental health problems. There are also the added pressures of looking older physically, but socially not having matured enough; young girls may seek out friends who are older than them to fit in with peers who look like them, and then feel pressured to engage in risky activities to fit in.

It is important for us as pediatricians to intervene when these situations arise. Having a thorough history of trauma when counseling patients on their pubescent time line can be essential. Screen for depression and antisocial behavior in girls with early puberty, and refer to developmentally appropriate community and mental health resources for additional support if necessary. Talk with parents about close monitoring of friend groups and about encouraging their children to spend time with age-appropriate friends. Our mission is to guide children and adolescents into healthy adulthood.
 

Ellen Selkie, MD, MPH, is an adolescent medicine specialist at the University of Michigan, Ann Arbor. She commented on the article by Mendle et al. in an accompanying editorial (Pediatrics. 2017 Jan 1. doi: 10.1542/peds.2017-3460 .) She had no relevant financial disclosures.

Title
The stresses of maturing early
The stresses of maturing early

 

Early puberty in girls can increase the likelihood of developing depression or antisocial behavior, a prospective study found

“Earlier pubertal timing in girls is often accompanied by distinct rises in the prevalence, severity, and onset of psychopathology,” wrote Jane Mendle, PhD, of Cornell University, Ithaca, N.Y., and her associates. “It is difficult to know whether, when, and on what processes to intervene if we cannot establish how much pubertal timing matters for well-being later in life.”

selensergen/Thinkstock
Investigators gathered 7,802 women from the National Longitudinal Study of Adolescent Health (Add Health) to participate in this study between 1994 and 2008. The Add Health study was known for a “high degree of racial, ethnic, and socioeconomic diversity,” the researchers said. The results were published in the journal Pediatrics.

Patients were evaluated in four waves, with average ages of 15.8 years, 16.1 years, 21.7 years, and 28.7 years for waves one through four, respectively.

Symptoms for depression and antisocial behavior were evaluated using the Center for Epidemiologic Studies Depression Scale, a self-reported survey, and a self-reported questionnaire on recent antisocial behaviors including theft, property damage, and selling drugs. The youngest girls also were asked about running away from home, lying to parents, shoplifting, and driving a car without the owner’s permission, while the oldest participants were asked about deliberately writing a bad check, using someone else’s debit card without permission, and buying or selling stolen property. Those participating were mostly white (66%) and on average experienced menarche at age 12 years.

Older age at menarche was significantly associated with lower levels of symptoms of depression (b = –0.87, P less than .05), when data were analyzed in a proximal influences model.

“To illustrate, a girl who reached menarche at age 10 years (approximately 2 years earlier than the mean) would have depressive symptoms 8% of 1 SD [standard deviation] greater in adolescence, whereas a girl who reached menarche at age 8 years would have depressive symptoms 25% of 1 SD greater,” the investigators wrote.

A linear and quadratic association between early menarche and depressive symptoms persisted as patients reached their 30s, suggesting girls who matured earlier are more likely to display symptoms of depression as an adult because they became depressed as teenagers and they remain vulnerable, Dr. Mendle and her colleagues reported.

Early maturation also was associated with a higher frequency of antisocial behavior in both proximal
(b = –.009, P less than .05) and lingering (b = –0.02, P less than .05) models.

Dr. Mendle and her colleagues found the gap in antisocial activity between those who matured early and those who did not was more pronounced in adulthood than adolescence, and the effects of antisocial behavior were smaller than the effects of depressive symptoms.

The investigators said they were limited by an incomplete understanding of why these longitudinal effects continue. Also, because they used age at menarche as an indicator of pubertal timing, the investigators said they could not capture the social, emotional, or hormonal processes present earlier in puberty.

“Results from the current study suggest that girls who experienced earlier menarche continued to report elevated psychopathology in early-to-middle adulthood even after accounting for demographic and contextual variables commonly associated with vulnerability for mental health. These findings align with the broad body of work linking early puberty with higher psychopathology during adolescence‍ as well as with the few studies showing longer-term associations with mental health in adulthood,” Dr. Mendle and her associates wrote.

“Understanding the longevity of these associations offers new challenges to researchers, [and] practical information for pediatricians and adolescent health care providers, and highlights that the emotional sequelae of puberty may endure well past the proximal period of adolescence,” they concluded. There also may be other disorders beyond depression and antisocial behavior associated with early puberty, which should be explored.

This study was funded by the National Institutes of Health. The investigators reported no relevant financial disclosures.

 

SOURCE: Mendle J et al. Pediatrics. 2017 Dec 26. doi: 10.1542/peds.2017-1703.

 

Early puberty in girls can increase the likelihood of developing depression or antisocial behavior, a prospective study found

“Earlier pubertal timing in girls is often accompanied by distinct rises in the prevalence, severity, and onset of psychopathology,” wrote Jane Mendle, PhD, of Cornell University, Ithaca, N.Y., and her associates. “It is difficult to know whether, when, and on what processes to intervene if we cannot establish how much pubertal timing matters for well-being later in life.”

selensergen/Thinkstock
Investigators gathered 7,802 women from the National Longitudinal Study of Adolescent Health (Add Health) to participate in this study between 1994 and 2008. The Add Health study was known for a “high degree of racial, ethnic, and socioeconomic diversity,” the researchers said. The results were published in the journal Pediatrics.

Patients were evaluated in four waves, with average ages of 15.8 years, 16.1 years, 21.7 years, and 28.7 years for waves one through four, respectively.

Symptoms for depression and antisocial behavior were evaluated using the Center for Epidemiologic Studies Depression Scale, a self-reported survey, and a self-reported questionnaire on recent antisocial behaviors including theft, property damage, and selling drugs. The youngest girls also were asked about running away from home, lying to parents, shoplifting, and driving a car without the owner’s permission, while the oldest participants were asked about deliberately writing a bad check, using someone else’s debit card without permission, and buying or selling stolen property. Those participating were mostly white (66%) and on average experienced menarche at age 12 years.

Older age at menarche was significantly associated with lower levels of symptoms of depression (b = –0.87, P less than .05), when data were analyzed in a proximal influences model.

“To illustrate, a girl who reached menarche at age 10 years (approximately 2 years earlier than the mean) would have depressive symptoms 8% of 1 SD [standard deviation] greater in adolescence, whereas a girl who reached menarche at age 8 years would have depressive symptoms 25% of 1 SD greater,” the investigators wrote.

A linear and quadratic association between early menarche and depressive symptoms persisted as patients reached their 30s, suggesting girls who matured earlier are more likely to display symptoms of depression as an adult because they became depressed as teenagers and they remain vulnerable, Dr. Mendle and her colleagues reported.

Early maturation also was associated with a higher frequency of antisocial behavior in both proximal
(b = –.009, P less than .05) and lingering (b = –0.02, P less than .05) models.

Dr. Mendle and her colleagues found the gap in antisocial activity between those who matured early and those who did not was more pronounced in adulthood than adolescence, and the effects of antisocial behavior were smaller than the effects of depressive symptoms.

The investigators said they were limited by an incomplete understanding of why these longitudinal effects continue. Also, because they used age at menarche as an indicator of pubertal timing, the investigators said they could not capture the social, emotional, or hormonal processes present earlier in puberty.

“Results from the current study suggest that girls who experienced earlier menarche continued to report elevated psychopathology in early-to-middle adulthood even after accounting for demographic and contextual variables commonly associated with vulnerability for mental health. These findings align with the broad body of work linking early puberty with higher psychopathology during adolescence‍ as well as with the few studies showing longer-term associations with mental health in adulthood,” Dr. Mendle and her associates wrote.

“Understanding the longevity of these associations offers new challenges to researchers, [and] practical information for pediatricians and adolescent health care providers, and highlights that the emotional sequelae of puberty may endure well past the proximal period of adolescence,” they concluded. There also may be other disorders beyond depression and antisocial behavior associated with early puberty, which should be explored.

This study was funded by the National Institutes of Health. The investigators reported no relevant financial disclosures.

 

SOURCE: Mendle J et al. Pediatrics. 2017 Dec 26. doi: 10.1542/peds.2017-1703.

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Key clinical point: Girls who start puberty earlier are more likely to develop depression or antisocial behavior.

Major finding: Patients who reached menarche at 8 years of age showed depressive symptoms 25% of 1 standard deviation greater than those at 12 years of age.

Study details: A prospective study of 7,802 women gathered from the National Longitudinal Study of Adolescent Health between 1994 and 2008.

Disclosures: The investigators reported no relevant financial disclosures. This study was funded by the National Institutes of Health.Source: Mendle J et al. Pediatrics. 2017 Dec 26. doi: 10.1542/peds.2017-1703.
 

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Opioid management protocol lowered trauma patient pain medication use

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– A pain management protocol implemented in a trauma service reduced opioid intake in trauma patients while improving patient satisfaction, according to a retrospective study.

The opioid epidemic continues to grow every day, partly as a result of irresponsible overprescribing of opioid medication, according to Jessica Gross, MB BAO BCh, FACS, a trauma surgeon from Wake Forest (N.C.) Baptist Health at the American Association for the Surgery of Trauma annual meeting. Dr. Gross and her colleagues developed a pain management protocol (PMP) to provide adequate pain control while using fewer opioids in the postdischarge setting. They tested their PMP through a retrospective chart review of 498 patients admitted to the trauma service between January 2015 and December 2016, half of which were admitted before the PMP was initiated and half of which were admitted afterward.

The PMP involved a stepped approach to treating pain, with acetaminophen or ibuprofen as needed for mild pain, one 5-mg tablet of oxycodone/acetaminophen every 6 hours for moderate pain, two tablets for severe pain, and 50-100 mg of tramadol every 6 hours for breakthrough pain.

Counseling services for patients who were found to be in danger of substance use were provided in the hospital, and at discharge, patients received a weaning plan for their medication, according to Dr. Gross.

If the short-acting medications were found to be inadequate to control pain, patients were given slow-release pain medication as needed.

Average total medication, including at discharge and for refills, prescribed after PMP initiation was 1,242 morphine milligram equivalents (MME), compared with 2,421 MME prior to the protocol (P less than .0001).

After the protocol was implemented, Dr. Gross and her colleagues found the number of patients prescribed a refill dropped from 39.7% to 28.1%, with the size of those refills dropping from 1,032 MME to 213 MME on average.

“By having a comprehensive pain management protocol, we can reduce the amount of pain medications we prescribe for outpatient use, from discharge from the trauma service,” said Dr. Gross. “Additionally, we have shown that by having a protocol in place, we not only decreased the number of refills we were providing, but also the amount of pain medications that was prescribed within these refills.”

Through a Press Ganey survey analysis of patients during the month before and the month after the PMP implementation, investigators found a significant increase in patient satisfaction and overall pain management, according to Dr. Gross,

In addition, the main trauma floor where the PMP was implemented was recognized for the most improvement in overall hospital rating and pain management, compared with the previous year.

Discussant Oscar Guillamondegui MD,FACS, medical director of the trauma ICU at Vanderbilt University, Nashville, Tenn., acknowledged the importance of PMPs and the work investigators presented.

“I would consider this the next generation of ERAS [enhanced recovery after surgery], or ERAT [enhanced recovery after trauma] in pain perception modification,” said Dr. Guillamondegui. “Dr. Gross and the multidisciplinary group at Wake Forest have provided compelling evidence to help alleviate [the opioid epidemic].”

In a question-and-answer session following the presentation, attendees voiced concern over how a PMP would be used among patients who are more familiar with hospital systems, in particular concerning self-reported pain levels.

“Most of us employed at acute care centers are not working in utopia. Many of our patients are heroin addicts, are very bright, and know how to identify 10 on those silly smiley faces so that they get more medicine,” said Charles Lucas, MD, FACS, professor of surgeon at Wayne State University, Detroit. Dr. Lucas also pointed out that even when patients report false levels of pain, doctors still are required to put it into the electronic medical record for fear of repercussions,

In response, Dr. Gross said doctors on the floor reviewed patients to make sure they were receiving all doses of pain medications. If doctors felt the patient’s pain regimen was adequate, despite the patient reporting otherwise, no changes were made.

Certain limitations include not being able to confirm whether patients received prescription medication elsewhere, nor any concrete data on patient satisfaction after discharge other than an inference based on fewer refills and lower refill MME.

Investigators reported no relevant financial disclosures.

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– A pain management protocol implemented in a trauma service reduced opioid intake in trauma patients while improving patient satisfaction, according to a retrospective study.

The opioid epidemic continues to grow every day, partly as a result of irresponsible overprescribing of opioid medication, according to Jessica Gross, MB BAO BCh, FACS, a trauma surgeon from Wake Forest (N.C.) Baptist Health at the American Association for the Surgery of Trauma annual meeting. Dr. Gross and her colleagues developed a pain management protocol (PMP) to provide adequate pain control while using fewer opioids in the postdischarge setting. They tested their PMP through a retrospective chart review of 498 patients admitted to the trauma service between January 2015 and December 2016, half of which were admitted before the PMP was initiated and half of which were admitted afterward.

The PMP involved a stepped approach to treating pain, with acetaminophen or ibuprofen as needed for mild pain, one 5-mg tablet of oxycodone/acetaminophen every 6 hours for moderate pain, two tablets for severe pain, and 50-100 mg of tramadol every 6 hours for breakthrough pain.

Counseling services for patients who were found to be in danger of substance use were provided in the hospital, and at discharge, patients received a weaning plan for their medication, according to Dr. Gross.

If the short-acting medications were found to be inadequate to control pain, patients were given slow-release pain medication as needed.

Average total medication, including at discharge and for refills, prescribed after PMP initiation was 1,242 morphine milligram equivalents (MME), compared with 2,421 MME prior to the protocol (P less than .0001).

After the protocol was implemented, Dr. Gross and her colleagues found the number of patients prescribed a refill dropped from 39.7% to 28.1%, with the size of those refills dropping from 1,032 MME to 213 MME on average.

“By having a comprehensive pain management protocol, we can reduce the amount of pain medications we prescribe for outpatient use, from discharge from the trauma service,” said Dr. Gross. “Additionally, we have shown that by having a protocol in place, we not only decreased the number of refills we were providing, but also the amount of pain medications that was prescribed within these refills.”

Through a Press Ganey survey analysis of patients during the month before and the month after the PMP implementation, investigators found a significant increase in patient satisfaction and overall pain management, according to Dr. Gross,

In addition, the main trauma floor where the PMP was implemented was recognized for the most improvement in overall hospital rating and pain management, compared with the previous year.

Discussant Oscar Guillamondegui MD,FACS, medical director of the trauma ICU at Vanderbilt University, Nashville, Tenn., acknowledged the importance of PMPs and the work investigators presented.

“I would consider this the next generation of ERAS [enhanced recovery after surgery], or ERAT [enhanced recovery after trauma] in pain perception modification,” said Dr. Guillamondegui. “Dr. Gross and the multidisciplinary group at Wake Forest have provided compelling evidence to help alleviate [the opioid epidemic].”

In a question-and-answer session following the presentation, attendees voiced concern over how a PMP would be used among patients who are more familiar with hospital systems, in particular concerning self-reported pain levels.

“Most of us employed at acute care centers are not working in utopia. Many of our patients are heroin addicts, are very bright, and know how to identify 10 on those silly smiley faces so that they get more medicine,” said Charles Lucas, MD, FACS, professor of surgeon at Wayne State University, Detroit. Dr. Lucas also pointed out that even when patients report false levels of pain, doctors still are required to put it into the electronic medical record for fear of repercussions,

In response, Dr. Gross said doctors on the floor reviewed patients to make sure they were receiving all doses of pain medications. If doctors felt the patient’s pain regimen was adequate, despite the patient reporting otherwise, no changes were made.

Certain limitations include not being able to confirm whether patients received prescription medication elsewhere, nor any concrete data on patient satisfaction after discharge other than an inference based on fewer refills and lower refill MME.

Investigators reported no relevant financial disclosures.

 

– A pain management protocol implemented in a trauma service reduced opioid intake in trauma patients while improving patient satisfaction, according to a retrospective study.

The opioid epidemic continues to grow every day, partly as a result of irresponsible overprescribing of opioid medication, according to Jessica Gross, MB BAO BCh, FACS, a trauma surgeon from Wake Forest (N.C.) Baptist Health at the American Association for the Surgery of Trauma annual meeting. Dr. Gross and her colleagues developed a pain management protocol (PMP) to provide adequate pain control while using fewer opioids in the postdischarge setting. They tested their PMP through a retrospective chart review of 498 patients admitted to the trauma service between January 2015 and December 2016, half of which were admitted before the PMP was initiated and half of which were admitted afterward.

The PMP involved a stepped approach to treating pain, with acetaminophen or ibuprofen as needed for mild pain, one 5-mg tablet of oxycodone/acetaminophen every 6 hours for moderate pain, two tablets for severe pain, and 50-100 mg of tramadol every 6 hours for breakthrough pain.

Counseling services for patients who were found to be in danger of substance use were provided in the hospital, and at discharge, patients received a weaning plan for their medication, according to Dr. Gross.

If the short-acting medications were found to be inadequate to control pain, patients were given slow-release pain medication as needed.

Average total medication, including at discharge and for refills, prescribed after PMP initiation was 1,242 morphine milligram equivalents (MME), compared with 2,421 MME prior to the protocol (P less than .0001).

After the protocol was implemented, Dr. Gross and her colleagues found the number of patients prescribed a refill dropped from 39.7% to 28.1%, with the size of those refills dropping from 1,032 MME to 213 MME on average.

“By having a comprehensive pain management protocol, we can reduce the amount of pain medications we prescribe for outpatient use, from discharge from the trauma service,” said Dr. Gross. “Additionally, we have shown that by having a protocol in place, we not only decreased the number of refills we were providing, but also the amount of pain medications that was prescribed within these refills.”

Through a Press Ganey survey analysis of patients during the month before and the month after the PMP implementation, investigators found a significant increase in patient satisfaction and overall pain management, according to Dr. Gross,

In addition, the main trauma floor where the PMP was implemented was recognized for the most improvement in overall hospital rating and pain management, compared with the previous year.

Discussant Oscar Guillamondegui MD,FACS, medical director of the trauma ICU at Vanderbilt University, Nashville, Tenn., acknowledged the importance of PMPs and the work investigators presented.

“I would consider this the next generation of ERAS [enhanced recovery after surgery], or ERAT [enhanced recovery after trauma] in pain perception modification,” said Dr. Guillamondegui. “Dr. Gross and the multidisciplinary group at Wake Forest have provided compelling evidence to help alleviate [the opioid epidemic].”

In a question-and-answer session following the presentation, attendees voiced concern over how a PMP would be used among patients who are more familiar with hospital systems, in particular concerning self-reported pain levels.

“Most of us employed at acute care centers are not working in utopia. Many of our patients are heroin addicts, are very bright, and know how to identify 10 on those silly smiley faces so that they get more medicine,” said Charles Lucas, MD, FACS, professor of surgeon at Wayne State University, Detroit. Dr. Lucas also pointed out that even when patients report false levels of pain, doctors still are required to put it into the electronic medical record for fear of repercussions,

In response, Dr. Gross said doctors on the floor reviewed patients to make sure they were receiving all doses of pain medications. If doctors felt the patient’s pain regimen was adequate, despite the patient reporting otherwise, no changes were made.

Certain limitations include not being able to confirm whether patients received prescription medication elsewhere, nor any concrete data on patient satisfaction after discharge other than an inference based on fewer refills and lower refill MME.

Investigators reported no relevant financial disclosures.

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Key clinical point: A multidisciplinary pain management protocol (PMP) lowered pain medication use in trauma patients.

Major finding: Average prescription fell to 1,242 morphine milligram equivalents (MME) per prescription, compared with 2,421 MME per prescription prior to the protocol.

Data Source: Retrospective chart review of 498 trauma patients from Jan. 1, 2015, and Dec. 31, 2016.

Disclosures: Investigators reported no relevant financial disclosures.

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Bezlotoxumab may lower risk of C. difficile readmissions

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Bezlotoxumab may lower risk of C. difficile readmissions

 

Clostridium difficile infection (CDI) patients treated with bezlotoxumab were less likely to be readmitted for recurring symptoms within 30 days of discharge, according to a phase 3 trial funded by Merck.

Recurrent CDI is a burden on both patients and providers, increasing health risks with each recurrence and eating through hospital resources, according to Vimalanand S. Prabhu, PhD, associate principal scientist for Merck.

cjc2nd/Wikimedia Commons/CC ASA-3.0
“Approximately 25% of patients experience recurrent CDI. … After a first recurrence of CDI, the probability of a second recurrence is approximately 38%,” according to a study cited by Dr. Prabhu and colleagues (Clin Infect Dis. 2014 Aug 1;59[3]:345-54). “Recent model-based estimates place the 2014 economic cost of CDI at $5.4 billion in the United States, mostly attributable to hospitalization.”

In a randomized, double-blind, placebo-controlled, study of 1,050 CDI patients, a total of 27 (5%) of 530 of those given bezlotoxumab were re-hospitalized 30 days after discharge, compared with 58 (11%) of 520 patients in the placebo group (Clin Infect Dis. 2017 Aug 11. doi. 10.1093/cid/cix523).

Patients were gathered from 322 sites across 30 countries between November 2011 and May 2015.

When measuring CDI-related readmissions, the investigators found use of bezlotoxumab reduced rCDI hospitalizations by 6%, and by approximately 8% in high-risk patients, such as those over 65 years old or with severe CDI.

Bezlotoxumab works by binding to CDI toxin B, a primary cause of CDI symptoms, according to Dr. Prabhu and fellow investigators. The researchers suggested that bezlotoxumab could be a prevailing factor in fighting the rate of CDI infections, which accounted for 29,000 deaths in 2011 (N Engl J Med. 2015 Jun 11;372[24]:2368-9).

Investigators acknowledged that patients admitted for the study may be healthier than the real-world CDI population.

All investigators reported some financial involvement, whether being a full-time employee or acting as a consultant, for Merck, which funded the study. Individually, investigators reported financial ties to similar medical companies, such as Pfizer and AstraZeneca.

 

AGA offers patient education materials on C. diff that can help your patients better understand the infection. Learn more at http://www.gastro.org/patient-care/conditions-diseases/clostridium-difficile-infection.

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Clostridium difficile infection (CDI) patients treated with bezlotoxumab were less likely to be readmitted for recurring symptoms within 30 days of discharge, according to a phase 3 trial funded by Merck.

Recurrent CDI is a burden on both patients and providers, increasing health risks with each recurrence and eating through hospital resources, according to Vimalanand S. Prabhu, PhD, associate principal scientist for Merck.

cjc2nd/Wikimedia Commons/CC ASA-3.0
“Approximately 25% of patients experience recurrent CDI. … After a first recurrence of CDI, the probability of a second recurrence is approximately 38%,” according to a study cited by Dr. Prabhu and colleagues (Clin Infect Dis. 2014 Aug 1;59[3]:345-54). “Recent model-based estimates place the 2014 economic cost of CDI at $5.4 billion in the United States, mostly attributable to hospitalization.”

In a randomized, double-blind, placebo-controlled, study of 1,050 CDI patients, a total of 27 (5%) of 530 of those given bezlotoxumab were re-hospitalized 30 days after discharge, compared with 58 (11%) of 520 patients in the placebo group (Clin Infect Dis. 2017 Aug 11. doi. 10.1093/cid/cix523).

Patients were gathered from 322 sites across 30 countries between November 2011 and May 2015.

When measuring CDI-related readmissions, the investigators found use of bezlotoxumab reduced rCDI hospitalizations by 6%, and by approximately 8% in high-risk patients, such as those over 65 years old or with severe CDI.

Bezlotoxumab works by binding to CDI toxin B, a primary cause of CDI symptoms, according to Dr. Prabhu and fellow investigators. The researchers suggested that bezlotoxumab could be a prevailing factor in fighting the rate of CDI infections, which accounted for 29,000 deaths in 2011 (N Engl J Med. 2015 Jun 11;372[24]:2368-9).

Investigators acknowledged that patients admitted for the study may be healthier than the real-world CDI population.

All investigators reported some financial involvement, whether being a full-time employee or acting as a consultant, for Merck, which funded the study. Individually, investigators reported financial ties to similar medical companies, such as Pfizer and AstraZeneca.

 

AGA offers patient education materials on C. diff that can help your patients better understand the infection. Learn more at http://www.gastro.org/patient-care/conditions-diseases/clostridium-difficile-infection.

 

Clostridium difficile infection (CDI) patients treated with bezlotoxumab were less likely to be readmitted for recurring symptoms within 30 days of discharge, according to a phase 3 trial funded by Merck.

Recurrent CDI is a burden on both patients and providers, increasing health risks with each recurrence and eating through hospital resources, according to Vimalanand S. Prabhu, PhD, associate principal scientist for Merck.

cjc2nd/Wikimedia Commons/CC ASA-3.0
“Approximately 25% of patients experience recurrent CDI. … After a first recurrence of CDI, the probability of a second recurrence is approximately 38%,” according to a study cited by Dr. Prabhu and colleagues (Clin Infect Dis. 2014 Aug 1;59[3]:345-54). “Recent model-based estimates place the 2014 economic cost of CDI at $5.4 billion in the United States, mostly attributable to hospitalization.”

In a randomized, double-blind, placebo-controlled, study of 1,050 CDI patients, a total of 27 (5%) of 530 of those given bezlotoxumab were re-hospitalized 30 days after discharge, compared with 58 (11%) of 520 patients in the placebo group (Clin Infect Dis. 2017 Aug 11. doi. 10.1093/cid/cix523).

Patients were gathered from 322 sites across 30 countries between November 2011 and May 2015.

When measuring CDI-related readmissions, the investigators found use of bezlotoxumab reduced rCDI hospitalizations by 6%, and by approximately 8% in high-risk patients, such as those over 65 years old or with severe CDI.

Bezlotoxumab works by binding to CDI toxin B, a primary cause of CDI symptoms, according to Dr. Prabhu and fellow investigators. The researchers suggested that bezlotoxumab could be a prevailing factor in fighting the rate of CDI infections, which accounted for 29,000 deaths in 2011 (N Engl J Med. 2015 Jun 11;372[24]:2368-9).

Investigators acknowledged that patients admitted for the study may be healthier than the real-world CDI population.

All investigators reported some financial involvement, whether being a full-time employee or acting as a consultant, for Merck, which funded the study. Individually, investigators reported financial ties to similar medical companies, such as Pfizer and AstraZeneca.

 

AGA offers patient education materials on C. diff that can help your patients better understand the infection. Learn more at http://www.gastro.org/patient-care/conditions-diseases/clostridium-difficile-infection.

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