Reuters Staff

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) - Sanofi SA said on Monday the U.S. Department of Health and Human Services (HHS) approved $43.18 million in funding to accelerate the development of a Zika vaccine, as efforts to prevent the infection gather momentum.

The funding from the HHS' Biomedical Advanced Research and Development Authority (BARDA) will be used for mid-stage trials, expected to begin in the first half of 2018, and for manufacturing, the French drugmaker said.

The contract runs through June 2022, but if the data is positive, the contract includes an option for up to additional $130.45 million for late-stage trials necessary for eventual approval.

Work on the vaccine began in March as a collaborative effort between the U.S. Department Of Defense's Walter Reed Army Institute of Research (WRAIR), BARDA and the National Institutes of Health. Sanofi in July teamed up with WRAIR to co-develop the vaccine.

Earlier this month, BARDA gave Japanese drugmaker Takeda Pharmaceutical Co nearly $20 million in initial funding to develop a Zika vaccine.

Sanofi is one of the many companies around the world looking to develop a vaccine against the virus that has spread rapidly since the current outbreak was first detected last year in Brazil.

Hundreds of thousands of people are estimated to have been infected with Zika in the Americas and parts of Asia. Most have no symptoms or experience only a mild illness.

The virus can penetrate the womb in pregnant women, causing a rare but crippling birth defect known as microcephaly. In adults, it has been linked to Guillain-Barre syndrome, a form of temporary paralysis.

Zika, a member of the flavivirus species that includes dengue, yellow fever and West Nile virus, is typically spread by the bite of the Aedes aegypti mosquito.

It can be also passed on through sex, a unique characteristic among mosquito-borne viruses.

Sanofi Pasteur, the vaccine unit of Sanofi, already has several vaccines approved for others flaviviruses, such as yellow fever, dengue and Japanese encephalitis.

As of September, the HHS has awarded at least $433 million in repurposed funds to support Zika response and preparedness activities.

(Reuters) - Sanofi SA said on Monday the U.S. Department of Health and Human Services (HHS) approved $43.18 million in funding to accelerate the development of a Zika vaccine, as efforts to prevent the infection gather momentum.

The funding from the HHS' Biomedical Advanced Research and Development Authority (BARDA) will be used for mid-stage trials, expected to begin in the first half of 2018, and for manufacturing, the French drugmaker said.

The contract runs through June 2022, but if the data is positive, the contract includes an option for up to additional $130.45 million for late-stage trials necessary for eventual approval.

Work on the vaccine began in March as a collaborative effort between the U.S. Department Of Defense's Walter Reed Army Institute of Research (WRAIR), BARDA and the National Institutes of Health. Sanofi in July teamed up with WRAIR to co-develop the vaccine.

Earlier this month, BARDA gave Japanese drugmaker Takeda Pharmaceutical Co nearly $20 million in initial funding to develop a Zika vaccine.

Sanofi is one of the many companies around the world looking to develop a vaccine against the virus that has spread rapidly since the current outbreak was first detected last year in Brazil.

Hundreds of thousands of people are estimated to have been infected with Zika in the Americas and parts of Asia. Most have no symptoms or experience only a mild illness.

The virus can penetrate the womb in pregnant women, causing a rare but crippling birth defect known as microcephaly. In adults, it has been linked to Guillain-Barre syndrome, a form of temporary paralysis.

Zika, a member of the flavivirus species that includes dengue, yellow fever and West Nile virus, is typically spread by the bite of the Aedes aegypti mosquito.

It can be also passed on through sex, a unique characteristic among mosquito-borne viruses.

Sanofi Pasteur, the vaccine unit of Sanofi, already has several vaccines approved for others flaviviruses, such as yellow fever, dengue and Japanese encephalitis.

As of September, the HHS has awarded at least $433 million in repurposed funds to support Zika response and preparedness activities.

(Reuters) - Sanofi SA said on Monday the U.S. Department of Health and Human Services (HHS) approved $43.18 million in funding to accelerate the development of a Zika vaccine, as efforts to prevent the infection gather momentum.

The funding from the HHS' Biomedical Advanced Research and Development Authority (BARDA) will be used for mid-stage trials, expected to begin in the first half of 2018, and for manufacturing, the French drugmaker said.

The contract runs through June 2022, but if the data is positive, the contract includes an option for up to additional $130.45 million for late-stage trials necessary for eventual approval.

Work on the vaccine began in March as a collaborative effort between the U.S. Department Of Defense's Walter Reed Army Institute of Research (WRAIR), BARDA and the National Institutes of Health. Sanofi in July teamed up with WRAIR to co-develop the vaccine.

Earlier this month, BARDA gave Japanese drugmaker Takeda Pharmaceutical Co nearly $20 million in initial funding to develop a Zika vaccine.

Sanofi is one of the many companies around the world looking to develop a vaccine against the virus that has spread rapidly since the current outbreak was first detected last year in Brazil.

Hundreds of thousands of people are estimated to have been infected with Zika in the Americas and parts of Asia. Most have no symptoms or experience only a mild illness.

The virus can penetrate the womb in pregnant women, causing a rare but crippling birth defect known as microcephaly. In adults, it has been linked to Guillain-Barre syndrome, a form of temporary paralysis.

Zika, a member of the flavivirus species that includes dengue, yellow fever and West Nile virus, is typically spread by the bite of the Aedes aegypti mosquito.

It can be also passed on through sex, a unique characteristic among mosquito-borne viruses.

Sanofi Pasteur, the vaccine unit of Sanofi, already has several vaccines approved for others flaviviruses, such as yellow fever, dengue and Japanese encephalitis.

As of September, the HHS has awarded at least $433 million in repurposed funds to support Zika response and preparedness activities.

NEW YORK (Reuters Health) - The American Academy of Pediatrics (AAP) today released six clinical reports and one policy statement covering a range of timely topics relevant to the health and care of children. Here is a snapshot.

1) Evaluation and Management of Children and Adolescents With Acute Mental Health or Behavioral Problems. Part I: Common Clinical Challenges of Patients With Mental Health and/or Behavioral Emergencies. 

This report focuses on the issues relevant to children and adolescents presenting to the emergency department (ED) or primary care clinic with a mental health condition or emergency and covers the following topics: medical clearance of pediatric psychiatric patients; suicidal ideation and suicide attempts; involuntary hospitalization; restraint of the agitated patient (verbal restraint, chemical restraint and physical restraint); coordination with the medical home.

2) Evaluation and Management of Children With Acute Mental Health or Behavioral Problems. Part II: Recognition of Clinically Challenging Mental Health Related Conditions Presenting With Medical or Uncertain Symptoms. 

This clinical report focuses on the challenges a pediatrician may face when evaluating patients with a mental health condition, which may be contributing to or complicating a medical or indeterminate clinical presentation. Topics include somatic symptom and related disorders; adverse effects of psychiatric medications (antipsychotic adverse effects, neuroleptic malignant syndrome, serotonin syndrome); children with special needs in the ED (autism spectrum and developmental disorders); mental health screening in the ED.

Both reports are from the AAP Committee on Pediatric Emergency Medicine and the American College of Emergency Physicians Pediatric Emergency Medicine Committee and include an executive summary.

3) Mind-Body Therapies in Children and Youth

From the AAP Section on Integrative Medicine, this report notes that a "growing body of evidence supports the effectiveness and safety of mind-body therapies in pediatrics. This clinical report outlines popular mind-body therapies for children and youth and examines the best-available evidence for a variety of mind-body therapies and practices, including biofeedback, clinical hypnosis, guided imagery, meditation, and yoga. The report is intended to help health care professionals guide their patients to nonpharmacologic approaches to improve concentration, help decrease pain, control discomfort, or ease anxiety."

4) Preventing Obesity and Eating Disorders in Adolescents 

This report, from the AAP Committee on Nutrition, Committee on Adolescence, Section on Obesity, notes that "messages from pediatricians addressing obesity and reviewing constructive ways to manage weight can be safely and supportively incorporated into health care visits. Avoiding certain weight-based language and using motivational interviewing (MI) techniques may improve communication and promote successful outcomes when providing weight-management counseling. This clinical report addresses the interaction between obesity prevention and eating disorders (EDs) in teenagers, provides the pediatrician with evidence-informed tools to identify behaviors that predispose to both obesity and EDs, and provides guidance about obesity and ED prevention messages. The focus should be on a healthy lifestyle rather than on weight. Evidence suggests that obesity prevention and treatment, if conducted correctly, do not predispose to EDs."

5) Parental Presence During Treatment of Ebola or Other Highly Consequential Infection 

From the AAP Committee on Infectious Diseases, this report offers "guidance to health care providers and hospitals on options to consider regarding parental presence at the bedside while caring for a child with suspected or proven Ebola virus disease (Ebola) or other highly consequential infection. Options are presented to help meet the needs of the patient and the family while also posing the least risk to providers and health care organizations."

6) Safe Sleep and Skin-to-Skin Care in the Neonatal Period for Healthy Term Newborns 

This report, from the Committee on Fetus and Newborn, Task Force on Sudden Infant Death Syndrome, notes that skin-to-skin care (SSC) and rooming-in are now common in the newborn period for healthy newborns with the implementation of maternity care practices that support breastfeeding as outlined in the World Health Organization's "Ten Steps to Successful Breastfeeding." The evidence indicates that implementation of these practices "increases overall and exclusive breastfeeding, safer and healthier transitions, and improved maternal-infant bonding. In some cases, however, the practice of SSC and rooming-in may pose safety concerns, particularly with regard to sleep. This clinical report is intended for birthing centers and delivery hospitals caring for healthy newborns to assist in the establishment of appropriate SSC and safe sleep policies."

The policy statement - Medication-Assisted Treatment of Adolescents With Opioid Use Disorders - is from the Committee on Substance Use and Prevention. It notes that opioid use disorder is "a leading cause of morbidity and mortality among US youth. Effective treatments, both medications and substance use disorder counseling, are available but underused, and access to developmentally appropriate treatment is severely restricted for adolescents and young adults. Resources to disseminate available therapies and to develop new treatments specifically for this age group are needed to save and improve lives of youth with opioid addiction."

"The AAP recommends that pediatricians consider offering medication-assisted treatment to their adolescent and young adult patients with severe opioid use disorders or discuss referrals to other providers for this service," the statement advises.

The six clinical reports and one policy statement are published in the September issue of Pediatrics and were released online August 22.

SOURCE: http://bit.ly/2bfNEj8

Pediatrics 2016.

(c) Copyright Thomson Reuters 2016.

NEW YORK (Reuters Health) - The American Academy of Pediatrics (AAP) today released six clinical reports and one policy statement covering a range of timely topics relevant to the health and care of children. Here is a snapshot.

1) Evaluation and Management of Children and Adolescents With Acute Mental Health or Behavioral Problems. Part I: Common Clinical Challenges of Patients With Mental Health and/or Behavioral Emergencies. 

This report focuses on the issues relevant to children and adolescents presenting to the emergency department (ED) or primary care clinic with a mental health condition or emergency and covers the following topics: medical clearance of pediatric psychiatric patients; suicidal ideation and suicide attempts; involuntary hospitalization; restraint of the agitated patient (verbal restraint, chemical restraint and physical restraint); coordination with the medical home.

2) Evaluation and Management of Children With Acute Mental Health or Behavioral Problems. Part II: Recognition of Clinically Challenging Mental Health Related Conditions Presenting With Medical or Uncertain Symptoms. 

This clinical report focuses on the challenges a pediatrician may face when evaluating patients with a mental health condition, which may be contributing to or complicating a medical or indeterminate clinical presentation. Topics include somatic symptom and related disorders; adverse effects of psychiatric medications (antipsychotic adverse effects, neuroleptic malignant syndrome, serotonin syndrome); children with special needs in the ED (autism spectrum and developmental disorders); mental health screening in the ED.

Both reports are from the AAP Committee on Pediatric Emergency Medicine and the American College of Emergency Physicians Pediatric Emergency Medicine Committee and include an executive summary.

3) Mind-Body Therapies in Children and Youth

From the AAP Section on Integrative Medicine, this report notes that a "growing body of evidence supports the effectiveness and safety of mind-body therapies in pediatrics. This clinical report outlines popular mind-body therapies for children and youth and examines the best-available evidence for a variety of mind-body therapies and practices, including biofeedback, clinical hypnosis, guided imagery, meditation, and yoga. The report is intended to help health care professionals guide their patients to nonpharmacologic approaches to improve concentration, help decrease pain, control discomfort, or ease anxiety."

4) Preventing Obesity and Eating Disorders in Adolescents 

This report, from the AAP Committee on Nutrition, Committee on Adolescence, Section on Obesity, notes that "messages from pediatricians addressing obesity and reviewing constructive ways to manage weight can be safely and supportively incorporated into health care visits. Avoiding certain weight-based language and using motivational interviewing (MI) techniques may improve communication and promote successful outcomes when providing weight-management counseling. This clinical report addresses the interaction between obesity prevention and eating disorders (EDs) in teenagers, provides the pediatrician with evidence-informed tools to identify behaviors that predispose to both obesity and EDs, and provides guidance about obesity and ED prevention messages. The focus should be on a healthy lifestyle rather than on weight. Evidence suggests that obesity prevention and treatment, if conducted correctly, do not predispose to EDs."

5) Parental Presence During Treatment of Ebola or Other Highly Consequential Infection 

From the AAP Committee on Infectious Diseases, this report offers "guidance to health care providers and hospitals on options to consider regarding parental presence at the bedside while caring for a child with suspected or proven Ebola virus disease (Ebola) or other highly consequential infection. Options are presented to help meet the needs of the patient and the family while also posing the least risk to providers and health care organizations."

6) Safe Sleep and Skin-to-Skin Care in the Neonatal Period for Healthy Term Newborns 

This report, from the Committee on Fetus and Newborn, Task Force on Sudden Infant Death Syndrome, notes that skin-to-skin care (SSC) and rooming-in are now common in the newborn period for healthy newborns with the implementation of maternity care practices that support breastfeeding as outlined in the World Health Organization's "Ten Steps to Successful Breastfeeding." The evidence indicates that implementation of these practices "increases overall and exclusive breastfeeding, safer and healthier transitions, and improved maternal-infant bonding. In some cases, however, the practice of SSC and rooming-in may pose safety concerns, particularly with regard to sleep. This clinical report is intended for birthing centers and delivery hospitals caring for healthy newborns to assist in the establishment of appropriate SSC and safe sleep policies."

The policy statement - Medication-Assisted Treatment of Adolescents With Opioid Use Disorders - is from the Committee on Substance Use and Prevention. It notes that opioid use disorder is "a leading cause of morbidity and mortality among US youth. Effective treatments, both medications and substance use disorder counseling, are available but underused, and access to developmentally appropriate treatment is severely restricted for adolescents and young adults. Resources to disseminate available therapies and to develop new treatments specifically for this age group are needed to save and improve lives of youth with opioid addiction."

"The AAP recommends that pediatricians consider offering medication-assisted treatment to their adolescent and young adult patients with severe opioid use disorders or discuss referrals to other providers for this service," the statement advises.

The six clinical reports and one policy statement are published in the September issue of Pediatrics and were released online August 22.

SOURCE: http://bit.ly/2bfNEj8

Pediatrics 2016.

(c) Copyright Thomson Reuters 2016.

NEW YORK (Reuters Health) - The American Academy of Pediatrics (AAP) today released six clinical reports and one policy statement covering a range of timely topics relevant to the health and care of children. Here is a snapshot.

1) Evaluation and Management of Children and Adolescents With Acute Mental Health or Behavioral Problems. Part I: Common Clinical Challenges of Patients With Mental Health and/or Behavioral Emergencies. 

This report focuses on the issues relevant to children and adolescents presenting to the emergency department (ED) or primary care clinic with a mental health condition or emergency and covers the following topics: medical clearance of pediatric psychiatric patients; suicidal ideation and suicide attempts; involuntary hospitalization; restraint of the agitated patient (verbal restraint, chemical restraint and physical restraint); coordination with the medical home.

2) Evaluation and Management of Children With Acute Mental Health or Behavioral Problems. Part II: Recognition of Clinically Challenging Mental Health Related Conditions Presenting With Medical or Uncertain Symptoms. 

This clinical report focuses on the challenges a pediatrician may face when evaluating patients with a mental health condition, which may be contributing to or complicating a medical or indeterminate clinical presentation. Topics include somatic symptom and related disorders; adverse effects of psychiatric medications (antipsychotic adverse effects, neuroleptic malignant syndrome, serotonin syndrome); children with special needs in the ED (autism spectrum and developmental disorders); mental health screening in the ED.

Both reports are from the AAP Committee on Pediatric Emergency Medicine and the American College of Emergency Physicians Pediatric Emergency Medicine Committee and include an executive summary.

3) Mind-Body Therapies in Children and Youth

From the AAP Section on Integrative Medicine, this report notes that a "growing body of evidence supports the effectiveness and safety of mind-body therapies in pediatrics. This clinical report outlines popular mind-body therapies for children and youth and examines the best-available evidence for a variety of mind-body therapies and practices, including biofeedback, clinical hypnosis, guided imagery, meditation, and yoga. The report is intended to help health care professionals guide their patients to nonpharmacologic approaches to improve concentration, help decrease pain, control discomfort, or ease anxiety."

4) Preventing Obesity and Eating Disorders in Adolescents 

This report, from the AAP Committee on Nutrition, Committee on Adolescence, Section on Obesity, notes that "messages from pediatricians addressing obesity and reviewing constructive ways to manage weight can be safely and supportively incorporated into health care visits. Avoiding certain weight-based language and using motivational interviewing (MI) techniques may improve communication and promote successful outcomes when providing weight-management counseling. This clinical report addresses the interaction between obesity prevention and eating disorders (EDs) in teenagers, provides the pediatrician with evidence-informed tools to identify behaviors that predispose to both obesity and EDs, and provides guidance about obesity and ED prevention messages. The focus should be on a healthy lifestyle rather than on weight. Evidence suggests that obesity prevention and treatment, if conducted correctly, do not predispose to EDs."

5) Parental Presence During Treatment of Ebola or Other Highly Consequential Infection 

From the AAP Committee on Infectious Diseases, this report offers "guidance to health care providers and hospitals on options to consider regarding parental presence at the bedside while caring for a child with suspected or proven Ebola virus disease (Ebola) or other highly consequential infection. Options are presented to help meet the needs of the patient and the family while also posing the least risk to providers and health care organizations."

6) Safe Sleep and Skin-to-Skin Care in the Neonatal Period for Healthy Term Newborns 

This report, from the Committee on Fetus and Newborn, Task Force on Sudden Infant Death Syndrome, notes that skin-to-skin care (SSC) and rooming-in are now common in the newborn period for healthy newborns with the implementation of maternity care practices that support breastfeeding as outlined in the World Health Organization's "Ten Steps to Successful Breastfeeding." The evidence indicates that implementation of these practices "increases overall and exclusive breastfeeding, safer and healthier transitions, and improved maternal-infant bonding. In some cases, however, the practice of SSC and rooming-in may pose safety concerns, particularly with regard to sleep. This clinical report is intended for birthing centers and delivery hospitals caring for healthy newborns to assist in the establishment of appropriate SSC and safe sleep policies."

The policy statement - Medication-Assisted Treatment of Adolescents With Opioid Use Disorders - is from the Committee on Substance Use and Prevention. It notes that opioid use disorder is "a leading cause of morbidity and mortality among US youth. Effective treatments, both medications and substance use disorder counseling, are available but underused, and access to developmentally appropriate treatment is severely restricted for adolescents and young adults. Resources to disseminate available therapies and to develop new treatments specifically for this age group are needed to save and improve lives of youth with opioid addiction."

"The AAP recommends that pediatricians consider offering medication-assisted treatment to their adolescent and young adult patients with severe opioid use disorders or discuss referrals to other providers for this service," the statement advises.

The six clinical reports and one policy statement are published in the September issue of Pediatrics and were released online August 22.

SOURCE: http://bit.ly/2bfNEj8

Pediatrics 2016.

(c) Copyright Thomson Reuters 2016.

NEW YORK - After a decade of follow-up in the Prostate Cancer Research International Active Surveillance (PRIAS) study, researchers have confirmed that active surveillance is a safe treatment option for men with low-risk prostate cancer.

"However," they say, "some changes could be made to the follow-up protocol to safely increase the number of men who remain on active surveillance."

Dr. Leonard P. Bokhorst of Erasmus University Medical Center in Rotterdam, the Netherlands, and colleagues analyzed data on more than 5,000 men in 18 countries followed in PRIAS, including 622 who were followed more than five years and 107 were followed more than 7.5 years.

The median age at diagnosis was 65.9 years.

Original inclusion criteria included Gleason score 3+3 or lower, stage cT2c or lower, and prostate-specific antigen (PSA) 10 ng/ml or lower. PSA tests were scheduled every three months and digital rectal examinations were scheduled every six months during the first two years of study, then less often later. Criteria to recommend starting active treatment include Gleason score higher than 3+3, more than two positive cores, and stage higher than cT2.

Median PSA for the study population was 5.7 ng/ml. Most men (69%) had one positive biopsy core, with Gleason score of 3+3 (99%) and a clinical stage of T1c (88%).

Almost 3,400 men received at least one repeat biopsy during follow-up and some received up to five biopsies.

Overall, 1,768 men discontinued active surveillance during follow-up, 1,102 due to protocol-based reclassification. Other reasons for discontinuations included anxiety, switch to watchful waiting, death, and loss to follow-up. Two-thirds (67%) of the men were treated with either radical prostatectomy or radiation therapy after discontinuation. Only 3% received hormonal therapy.

Almost half (48%) of the patients were still on active surveillance after five years and 27% were on active surveillance at 10 years, the researchers reported online June 19 in European Urology.

The team had pathology data on 360 men who had radical prostatectomy. Of the men who switched to treatment because of protocol-based reclassification, 82 (30%) had favorable pathological outcomes, 85 (34%) had intermediate outcomes, and 100 (36%) had unfavorable outcomes.

Mortality from prostate cancer was less than 1% during follow-up.

Because of the higher rate of unfavorable treatment outcomes, the researchers recommended a change in the PRIAS protocol.

"Instead of an immediate switch to active treatment if more than two cores are positive, men should receive further investigation to confirm higher risk disease," the researchers write. They recommend examination by magnetic resonance imaging because its negative predictive value for Gleason upgrading is near 100%.

They concluded, "Criteria used to recommend a switch to active treatment do not seem selective enough to avoid unnecessary switches to active treatment."

Dr. Bokhorst did not respond to a request for comment.

The Prostate Cancer Research Foundation, Rotterdam, supports the PRIAS study. The authors made no disclosures.

SOURCE: http://bit.ly/28Q5Cd3

Eur Urol 2016.

NEW YORK - After a decade of follow-up in the Prostate Cancer Research International Active Surveillance (PRIAS) study, researchers have confirmed that active surveillance is a safe treatment option for men with low-risk prostate cancer.

"However," they say, "some changes could be made to the follow-up protocol to safely increase the number of men who remain on active surveillance."

Dr. Leonard P. Bokhorst of Erasmus University Medical Center in Rotterdam, the Netherlands, and colleagues analyzed data on more than 5,000 men in 18 countries followed in PRIAS, including 622 who were followed more than five years and 107 were followed more than 7.5 years.

The median age at diagnosis was 65.9 years.

Original inclusion criteria included Gleason score 3+3 or lower, stage cT2c or lower, and prostate-specific antigen (PSA) 10 ng/ml or lower. PSA tests were scheduled every three months and digital rectal examinations were scheduled every six months during the first two years of study, then less often later. Criteria to recommend starting active treatment include Gleason score higher than 3+3, more than two positive cores, and stage higher than cT2.

Median PSA for the study population was 5.7 ng/ml. Most men (69%) had one positive biopsy core, with Gleason score of 3+3 (99%) and a clinical stage of T1c (88%).

Almost 3,400 men received at least one repeat biopsy during follow-up and some received up to five biopsies.

Overall, 1,768 men discontinued active surveillance during follow-up, 1,102 due to protocol-based reclassification. Other reasons for discontinuations included anxiety, switch to watchful waiting, death, and loss to follow-up. Two-thirds (67%) of the men were treated with either radical prostatectomy or radiation therapy after discontinuation. Only 3% received hormonal therapy.

Almost half (48%) of the patients were still on active surveillance after five years and 27% were on active surveillance at 10 years, the researchers reported online June 19 in European Urology.

The team had pathology data on 360 men who had radical prostatectomy. Of the men who switched to treatment because of protocol-based reclassification, 82 (30%) had favorable pathological outcomes, 85 (34%) had intermediate outcomes, and 100 (36%) had unfavorable outcomes.

Mortality from prostate cancer was less than 1% during follow-up.

Because of the higher rate of unfavorable treatment outcomes, the researchers recommended a change in the PRIAS protocol.

"Instead of an immediate switch to active treatment if more than two cores are positive, men should receive further investigation to confirm higher risk disease," the researchers write. They recommend examination by magnetic resonance imaging because its negative predictive value for Gleason upgrading is near 100%.

They concluded, "Criteria used to recommend a switch to active treatment do not seem selective enough to avoid unnecessary switches to active treatment."

Dr. Bokhorst did not respond to a request for comment.

The Prostate Cancer Research Foundation, Rotterdam, supports the PRIAS study. The authors made no disclosures.

SOURCE: http://bit.ly/28Q5Cd3

Eur Urol 2016.

NEW YORK - After a decade of follow-up in the Prostate Cancer Research International Active Surveillance (PRIAS) study, researchers have confirmed that active surveillance is a safe treatment option for men with low-risk prostate cancer.

"However," they say, "some changes could be made to the follow-up protocol to safely increase the number of men who remain on active surveillance."

Dr. Leonard P. Bokhorst of Erasmus University Medical Center in Rotterdam, the Netherlands, and colleagues analyzed data on more than 5,000 men in 18 countries followed in PRIAS, including 622 who were followed more than five years and 107 were followed more than 7.5 years.

The median age at diagnosis was 65.9 years.

Original inclusion criteria included Gleason score 3+3 or lower, stage cT2c or lower, and prostate-specific antigen (PSA) 10 ng/ml or lower. PSA tests were scheduled every three months and digital rectal examinations were scheduled every six months during the first two years of study, then less often later. Criteria to recommend starting active treatment include Gleason score higher than 3+3, more than two positive cores, and stage higher than cT2.

Median PSA for the study population was 5.7 ng/ml. Most men (69%) had one positive biopsy core, with Gleason score of 3+3 (99%) and a clinical stage of T1c (88%).

Almost 3,400 men received at least one repeat biopsy during follow-up and some received up to five biopsies.

Overall, 1,768 men discontinued active surveillance during follow-up, 1,102 due to protocol-based reclassification. Other reasons for discontinuations included anxiety, switch to watchful waiting, death, and loss to follow-up. Two-thirds (67%) of the men were treated with either radical prostatectomy or radiation therapy after discontinuation. Only 3% received hormonal therapy.

Almost half (48%) of the patients were still on active surveillance after five years and 27% were on active surveillance at 10 years, the researchers reported online June 19 in European Urology.

The team had pathology data on 360 men who had radical prostatectomy. Of the men who switched to treatment because of protocol-based reclassification, 82 (30%) had favorable pathological outcomes, 85 (34%) had intermediate outcomes, and 100 (36%) had unfavorable outcomes.

Mortality from prostate cancer was less than 1% during follow-up.

Because of the higher rate of unfavorable treatment outcomes, the researchers recommended a change in the PRIAS protocol.

"Instead of an immediate switch to active treatment if more than two cores are positive, men should receive further investigation to confirm higher risk disease," the researchers write. They recommend examination by magnetic resonance imaging because its negative predictive value for Gleason upgrading is near 100%.

They concluded, "Criteria used to recommend a switch to active treatment do not seem selective enough to avoid unnecessary switches to active treatment."

Dr. Bokhorst did not respond to a request for comment.

The Prostate Cancer Research Foundation, Rotterdam, supports the PRIAS study. The authors made no disclosures.

SOURCE: http://bit.ly/28Q5Cd3

Eur Urol 2016.

WASHINGTON - U.S. House of Representatives Speaker Paul Ryan unveiled a Republican healthcare agenda on Wednesday that would repeal Obamacare but keep some of its more popular provisions.

The proposal is part of Ryan's blueprint, titled "A Better Way," which offers a Republican alternative to the Democratic Party on policy issues ahead of the Nov. 8 election.

Earlier this month, Ryan, the country's highest-ranking elected Republican, released initiatives on national security and combating poverty. Proposals on regulation, tax reform and constitutional authority are expected in the coming weeks.

Republicans have challenged President Barack Obama's signature healthcare law, the Affordable Care Act, since it was enacted in 2010 after a bitter fight in Congress.

"Obamacare has limited choices for patients, driven up costs for consumers, and buried employers and health care providers under thousands of new regulations," a draft of the Ryan plan said. "This law cannot be fixed."

But Ryan's proposal would keep some popular aspects of the law, including not allowing people with pre-existing conditions to be denied coverage and permitting children to stay on their parents' coverage until age 26.

The Obama administration says some 20 million Americans have become insured as a result of the Affordable Care Act.

The Ryan plan recycles long-held Republican proposals like allowing consumers to buy health insurance across state lines, expanding the use of health savings accounts and giving states block grants to run the Medicaid program for the poor.

For people who do not get insurance through their jobs, the Republican plan would establish a refundable tax credit. Obamacare, by contrast, provides subsidies to some lower-income people to buy insurance if they do not qualify for Medicaid.

The Republican proposal would gradually increase the Medicare eligibility age, which currently is 65, to match that of the Social Security pension plan, which is 67 for people born in 1960 or later.

Like Obamacare's so-called Cadillac tax on expensive healthcare plans offered by employers, the Republican proposal would cap the tax deductibility of employer-based plans.

The Republican plan includes medical liability reform that would put a cap on non-economic damages awarded in lawsuits, a measure aimed at cutting overall healthcare costs.

Under Obamacare, many states expanded the number of people eligible for Medicaid. The Republican plan would allow states that decided to expand Medicaid before this year to keep the expansion, while preventing any new states from doing so.

WASHINGTON - U.S. House of Representatives Speaker Paul Ryan unveiled a Republican healthcare agenda on Wednesday that would repeal Obamacare but keep some of its more popular provisions.

The proposal is part of Ryan's blueprint, titled "A Better Way," which offers a Republican alternative to the Democratic Party on policy issues ahead of the Nov. 8 election.

Earlier this month, Ryan, the country's highest-ranking elected Republican, released initiatives on national security and combating poverty. Proposals on regulation, tax reform and constitutional authority are expected in the coming weeks.

Republicans have challenged President Barack Obama's signature healthcare law, the Affordable Care Act, since it was enacted in 2010 after a bitter fight in Congress.

"Obamacare has limited choices for patients, driven up costs for consumers, and buried employers and health care providers under thousands of new regulations," a draft of the Ryan plan said. "This law cannot be fixed."

But Ryan's proposal would keep some popular aspects of the law, including not allowing people with pre-existing conditions to be denied coverage and permitting children to stay on their parents' coverage until age 26.

The Obama administration says some 20 million Americans have become insured as a result of the Affordable Care Act.

The Ryan plan recycles long-held Republican proposals like allowing consumers to buy health insurance across state lines, expanding the use of health savings accounts and giving states block grants to run the Medicaid program for the poor.

For people who do not get insurance through their jobs, the Republican plan would establish a refundable tax credit. Obamacare, by contrast, provides subsidies to some lower-income people to buy insurance if they do not qualify for Medicaid.

The Republican proposal would gradually increase the Medicare eligibility age, which currently is 65, to match that of the Social Security pension plan, which is 67 for people born in 1960 or later.

Like Obamacare's so-called Cadillac tax on expensive healthcare plans offered by employers, the Republican proposal would cap the tax deductibility of employer-based plans.

The Republican plan includes medical liability reform that would put a cap on non-economic damages awarded in lawsuits, a measure aimed at cutting overall healthcare costs.

Under Obamacare, many states expanded the number of people eligible for Medicaid. The Republican plan would allow states that decided to expand Medicaid before this year to keep the expansion, while preventing any new states from doing so.

WASHINGTON - U.S. House of Representatives Speaker Paul Ryan unveiled a Republican healthcare agenda on Wednesday that would repeal Obamacare but keep some of its more popular provisions.

The proposal is part of Ryan's blueprint, titled "A Better Way," which offers a Republican alternative to the Democratic Party on policy issues ahead of the Nov. 8 election.

Earlier this month, Ryan, the country's highest-ranking elected Republican, released initiatives on national security and combating poverty. Proposals on regulation, tax reform and constitutional authority are expected in the coming weeks.

Republicans have challenged President Barack Obama's signature healthcare law, the Affordable Care Act, since it was enacted in 2010 after a bitter fight in Congress.

"Obamacare has limited choices for patients, driven up costs for consumers, and buried employers and health care providers under thousands of new regulations," a draft of the Ryan plan said. "This law cannot be fixed."

But Ryan's proposal would keep some popular aspects of the law, including not allowing people with pre-existing conditions to be denied coverage and permitting children to stay on their parents' coverage until age 26.

The Obama administration says some 20 million Americans have become insured as a result of the Affordable Care Act.

The Ryan plan recycles long-held Republican proposals like allowing consumers to buy health insurance across state lines, expanding the use of health savings accounts and giving states block grants to run the Medicaid program for the poor.

For people who do not get insurance through their jobs, the Republican plan would establish a refundable tax credit. Obamacare, by contrast, provides subsidies to some lower-income people to buy insurance if they do not qualify for Medicaid.

The Republican proposal would gradually increase the Medicare eligibility age, which currently is 65, to match that of the Social Security pension plan, which is 67 for people born in 1960 or later.

Like Obamacare's so-called Cadillac tax on expensive healthcare plans offered by employers, the Republican proposal would cap the tax deductibility of employer-based plans.

The Republican plan includes medical liability reform that would put a cap on non-economic damages awarded in lawsuits, a measure aimed at cutting overall healthcare costs.

Under Obamacare, many states expanded the number of people eligible for Medicaid. The Republican plan would allow states that decided to expand Medicaid before this year to keep the expansion, while preventing any new states from doing so.

NEW YORK (Reuters Health) - Helicobacter pylori treatment containing clarithromycin is associated with a short-term increase in the risk of neuropsychiatric events, according to a study from Hong Kong.

Neuropsychiatric events following clarithromycin therapy have been reported previously, but no population-based study had assessed the neuropsychiatric risk associated with clarithromycin.

Dr. Esther W. Chan, from Li Ka Shing Faculty of Medicine, University of Hong Kong, and colleagues used data from the University of Hong Kong Clinical Data Analysis and Reporting System to investigate the association between H. pylori therapy containing clarithromycin and acute neuropsychiatric events.

Current use of clarithromycin as part of the H. pylori regimen was associated with a 4.12-fold increased risk of neuropsychiatric events, including a 5.42-fold increase in psychotic events and a 2.63-fold increase in cognitive impairment, compared with baseline.

These increased risks appear to be limited to days 2 to 14 since the prescription start date, according to the May 2 online report in JAMA Internal Medicine.

The crude absolute risks per 1000 prescriptions were 0.45 for neuropsychiatric events, 0.12 for psychotic events, and 0.12 for cognitive impairment during current use of therapy.

"Given the low absolute neuropsychiatric risk, an abrupt change in prescribing practice based on the observed increase in neuropsychiatric events is not suggested, particularly in the absence of better treatment alternatives," the researchers conclude.

"Such transient neuropsychiatric events will usually resolve spontaneously after treatment cessation and psychiatric interventions can be avoided," the authors note.

"Because we investigated H. pylori therapy as the exposure, we could not pinpoint which drug in the regimen contributed to the neuropsychiatric events in our study," they caution. "We hypothesized that clarithromycin is the most probable drug because very limited evidence suggested that neuropsychiatric

events are associated with amoxicillin or proton pump inhibitors."

Dr. Chan was unable to provide comments in time for publication.

The authors reported no funding or disclosures.

NEW YORK (Reuters Health) - Helicobacter pylori treatment containing clarithromycin is associated with a short-term increase in the risk of neuropsychiatric events, according to a study from Hong Kong.

Neuropsychiatric events following clarithromycin therapy have been reported previously, but no population-based study had assessed the neuropsychiatric risk associated with clarithromycin.

Dr. Esther W. Chan, from Li Ka Shing Faculty of Medicine, University of Hong Kong, and colleagues used data from the University of Hong Kong Clinical Data Analysis and Reporting System to investigate the association between H. pylori therapy containing clarithromycin and acute neuropsychiatric events.

Current use of clarithromycin as part of the H. pylori regimen was associated with a 4.12-fold increased risk of neuropsychiatric events, including a 5.42-fold increase in psychotic events and a 2.63-fold increase in cognitive impairment, compared with baseline.

These increased risks appear to be limited to days 2 to 14 since the prescription start date, according to the May 2 online report in JAMA Internal Medicine.

The crude absolute risks per 1000 prescriptions were 0.45 for neuropsychiatric events, 0.12 for psychotic events, and 0.12 for cognitive impairment during current use of therapy.

"Given the low absolute neuropsychiatric risk, an abrupt change in prescribing practice based on the observed increase in neuropsychiatric events is not suggested, particularly in the absence of better treatment alternatives," the researchers conclude.

"Such transient neuropsychiatric events will usually resolve spontaneously after treatment cessation and psychiatric interventions can be avoided," the authors note.

"Because we investigated H. pylori therapy as the exposure, we could not pinpoint which drug in the regimen contributed to the neuropsychiatric events in our study," they caution. "We hypothesized that clarithromycin is the most probable drug because very limited evidence suggested that neuropsychiatric

events are associated with amoxicillin or proton pump inhibitors."

Dr. Chan was unable to provide comments in time for publication.

The authors reported no funding or disclosures.

NEW YORK (Reuters Health) - Helicobacter pylori treatment containing clarithromycin is associated with a short-term increase in the risk of neuropsychiatric events, according to a study from Hong Kong.

Neuropsychiatric events following clarithromycin therapy have been reported previously, but no population-based study had assessed the neuropsychiatric risk associated with clarithromycin.

Dr. Esther W. Chan, from Li Ka Shing Faculty of Medicine, University of Hong Kong, and colleagues used data from the University of Hong Kong Clinical Data Analysis and Reporting System to investigate the association between H. pylori therapy containing clarithromycin and acute neuropsychiatric events.

Current use of clarithromycin as part of the H. pylori regimen was associated with a 4.12-fold increased risk of neuropsychiatric events, including a 5.42-fold increase in psychotic events and a 2.63-fold increase in cognitive impairment, compared with baseline.

These increased risks appear to be limited to days 2 to 14 since the prescription start date, according to the May 2 online report in JAMA Internal Medicine.

The crude absolute risks per 1000 prescriptions were 0.45 for neuropsychiatric events, 0.12 for psychotic events, and 0.12 for cognitive impairment during current use of therapy.

"Given the low absolute neuropsychiatric risk, an abrupt change in prescribing practice based on the observed increase in neuropsychiatric events is not suggested, particularly in the absence of better treatment alternatives," the researchers conclude.

"Such transient neuropsychiatric events will usually resolve spontaneously after treatment cessation and psychiatric interventions can be avoided," the authors note.

"Because we investigated H. pylori therapy as the exposure, we could not pinpoint which drug in the regimen contributed to the neuropsychiatric events in our study," they caution. "We hypothesized that clarithromycin is the most probable drug because very limited evidence suggested that neuropsychiatric

events are associated with amoxicillin or proton pump inhibitors."

Dr. Chan was unable to provide comments in time for publication.

The authors reported no funding or disclosures.

NEW YORK (Reuters Health) - The risk of cataracts increases after percutaneous coronary intervention (PCI), suggesting the need for eye protection in patients undergoing these procedures, researchers from Taiwan report.

Although previous studies have identified a link between occupational radiation exposure and excess risk of cataract formation, the research in patients has been more limited. Lead eyeglasses are currently recommended for interventionists, but there are no guidelines for patient eye protection.

Dr. Yu-Tung Huang, from Kaohsiung Medical University,Kaohsiung, Taiwan, and colleagues used data from Taiwan's National Health Insurance research database to evaluate the risk of cataract surgery in 13,807 patients exposed to PCI and 27,614 patients not exposed to PCI.

Patients who underwent PCI were 25% more likely than those not exposed to PCI to have cataract surgery, according to the April 4 JAMA Internal Medicine online report.

The risk of cataract surgery increased with increasing numbers of PCI procedures, from 23% increased risk with one procedure to 29% increased risk with two to four procedures to 43% increased risk with five or more procedures.

"Because this was an observational study," they note, "we cannot establish causation, and there may be unmeasured confounders."

Nevertheless, the researchers conclude, "providing lead eyeglasses to protect patients' eyes, as is already done during cosmetic laser procedures, during the PCI procedures is recommended."

Dr. Huang did not respond to a request for comments.The authors reported no funding or disclosures.

NEW YORK (Reuters Health) - The risk of cataracts increases after percutaneous coronary intervention (PCI), suggesting the need for eye protection in patients undergoing these procedures, researchers from Taiwan report.

Although previous studies have identified a link between occupational radiation exposure and excess risk of cataract formation, the research in patients has been more limited. Lead eyeglasses are currently recommended for interventionists, but there are no guidelines for patient eye protection.

Dr. Yu-Tung Huang, from Kaohsiung Medical University,Kaohsiung, Taiwan, and colleagues used data from Taiwan's National Health Insurance research database to evaluate the risk of cataract surgery in 13,807 patients exposed to PCI and 27,614 patients not exposed to PCI.

Patients who underwent PCI were 25% more likely than those not exposed to PCI to have cataract surgery, according to the April 4 JAMA Internal Medicine online report.

The risk of cataract surgery increased with increasing numbers of PCI procedures, from 23% increased risk with one procedure to 29% increased risk with two to four procedures to 43% increased risk with five or more procedures.

"Because this was an observational study," they note, "we cannot establish causation, and there may be unmeasured confounders."

Nevertheless, the researchers conclude, "providing lead eyeglasses to protect patients' eyes, as is already done during cosmetic laser procedures, during the PCI procedures is recommended."

Dr. Huang did not respond to a request for comments.The authors reported no funding or disclosures.

NEW YORK (Reuters Health) - The risk of cataracts increases after percutaneous coronary intervention (PCI), suggesting the need for eye protection in patients undergoing these procedures, researchers from Taiwan report.

Although previous studies have identified a link between occupational radiation exposure and excess risk of cataract formation, the research in patients has been more limited. Lead eyeglasses are currently recommended for interventionists, but there are no guidelines for patient eye protection.

Dr. Yu-Tung Huang, from Kaohsiung Medical University,Kaohsiung, Taiwan, and colleagues used data from Taiwan's National Health Insurance research database to evaluate the risk of cataract surgery in 13,807 patients exposed to PCI and 27,614 patients not exposed to PCI.

Patients who underwent PCI were 25% more likely than those not exposed to PCI to have cataract surgery, according to the April 4 JAMA Internal Medicine online report.

The risk of cataract surgery increased with increasing numbers of PCI procedures, from 23% increased risk with one procedure to 29% increased risk with two to four procedures to 43% increased risk with five or more procedures.

"Because this was an observational study," they note, "we cannot establish causation, and there may be unmeasured confounders."

Nevertheless, the researchers conclude, "providing lead eyeglasses to protect patients' eyes, as is already done during cosmetic laser procedures, during the PCI procedures is recommended."

Dr. Huang did not respond to a request for comments.The authors reported no funding or disclosures.

NEW YORK (Reuters Health) - About one in 20 bariatric surgery patients are readmitted to the hospital within 30 days of having the procedure, according to new findings.

Readmissions are increasingly being used as a quality metric for surgical procedures, Dr. John Morton of Stanford University in California and colleagues note in their report, published online March 19 in the American Journal of Surgery.

"While (the Centers for Medicare and Medicaid Services) has not addressed bariatric surgery readmissions to date, other payors have made readmissions a priority," they add. "Data regarding bariatric surgery readmissions are critical to help better understand and drive quality improvement in this area.

"To investigate the prevalence, causes and risk factors for readmission following bariatric surgery, the researchers looked at data from the 2012 American College of Surgeons National Surgical Quality Improvement Program Public Use File dataset on nearly 18,300 bariatric patients, of whom 55% had laparoscopic Roux-en-Y gastric bypass (LRYGB), 10% had laparoscopic adjustable gastric banding (LAGB), and 35% had laparoscopic sleeve gastrectomy (LSG).

There were 955 readmissions (5.22%), most commonly for gastrointestinal causes (45%), dietary reasons (34%) and bleeding (7%). Readmission rates were nearly 7% for LRYGB; just under 2% for LAGB; and 4% for LSG.

The patients who were readmitted had a significantly longer average operating time (132 vs. 115 minutes) and length of stay (2.76 days vs. 2.23). Forty percent had a complication, versus 4% of patients who were not readmitted. Patients who were readmitted were also more likely to have a body mass index above 50, preoperative diabetes, chronic obstructive pulmonary disease, and hypertension.

Factors independently associated with readmission included African-American race (odds ratio, 1.53), complication (OR, 11.3) and resident involvement (OR, 0.53).

"Other studies have also demonstrated similar predictors of readmission and have also demonstrated that length of stay may also play a role in readmission rates," Dr. Morton and his team state. "This study helps demonstrate that bariatric surgery readmissions are prevalent and potentially preventable."

NEW YORK (Reuters Health) - About one in 20 bariatric surgery patients are readmitted to the hospital within 30 days of having the procedure, according to new findings.

Readmissions are increasingly being used as a quality metric for surgical procedures, Dr. John Morton of Stanford University in California and colleagues note in their report, published online March 19 in the American Journal of Surgery.

"While (the Centers for Medicare and Medicaid Services) has not addressed bariatric surgery readmissions to date, other payors have made readmissions a priority," they add. "Data regarding bariatric surgery readmissions are critical to help better understand and drive quality improvement in this area.

"To investigate the prevalence, causes and risk factors for readmission following bariatric surgery, the researchers looked at data from the 2012 American College of Surgeons National Surgical Quality Improvement Program Public Use File dataset on nearly 18,300 bariatric patients, of whom 55% had laparoscopic Roux-en-Y gastric bypass (LRYGB), 10% had laparoscopic adjustable gastric banding (LAGB), and 35% had laparoscopic sleeve gastrectomy (LSG).

There were 955 readmissions (5.22%), most commonly for gastrointestinal causes (45%), dietary reasons (34%) and bleeding (7%). Readmission rates were nearly 7% for LRYGB; just under 2% for LAGB; and 4% for LSG.

The patients who were readmitted had a significantly longer average operating time (132 vs. 115 minutes) and length of stay (2.76 days vs. 2.23). Forty percent had a complication, versus 4% of patients who were not readmitted. Patients who were readmitted were also more likely to have a body mass index above 50, preoperative diabetes, chronic obstructive pulmonary disease, and hypertension.

Factors independently associated with readmission included African-American race (odds ratio, 1.53), complication (OR, 11.3) and resident involvement (OR, 0.53).

"Other studies have also demonstrated similar predictors of readmission and have also demonstrated that length of stay may also play a role in readmission rates," Dr. Morton and his team state. "This study helps demonstrate that bariatric surgery readmissions are prevalent and potentially preventable."

NEW YORK (Reuters Health) - About one in 20 bariatric surgery patients are readmitted to the hospital within 30 days of having the procedure, according to new findings.

Readmissions are increasingly being used as a quality metric for surgical procedures, Dr. John Morton of Stanford University in California and colleagues note in their report, published online March 19 in the American Journal of Surgery.

"While (the Centers for Medicare and Medicaid Services) has not addressed bariatric surgery readmissions to date, other payors have made readmissions a priority," they add. "Data regarding bariatric surgery readmissions are critical to help better understand and drive quality improvement in this area.

"To investigate the prevalence, causes and risk factors for readmission following bariatric surgery, the researchers looked at data from the 2012 American College of Surgeons National Surgical Quality Improvement Program Public Use File dataset on nearly 18,300 bariatric patients, of whom 55% had laparoscopic Roux-en-Y gastric bypass (LRYGB), 10% had laparoscopic adjustable gastric banding (LAGB), and 35% had laparoscopic sleeve gastrectomy (LSG).

There were 955 readmissions (5.22%), most commonly for gastrointestinal causes (45%), dietary reasons (34%) and bleeding (7%). Readmission rates were nearly 7% for LRYGB; just under 2% for LAGB; and 4% for LSG.

The patients who were readmitted had a significantly longer average operating time (132 vs. 115 minutes) and length of stay (2.76 days vs. 2.23). Forty percent had a complication, versus 4% of patients who were not readmitted. Patients who were readmitted were also more likely to have a body mass index above 50, preoperative diabetes, chronic obstructive pulmonary disease, and hypertension.

Factors independently associated with readmission included African-American race (odds ratio, 1.53), complication (OR, 11.3) and resident involvement (OR, 0.53).

"Other studies have also demonstrated similar predictors of readmission and have also demonstrated that length of stay may also play a role in readmission rates," Dr. Morton and his team state. "This study helps demonstrate that bariatric surgery readmissions are prevalent and potentially preventable."

NEW YORK (Reuters Health) - Clinical practice in management of early-onset sepsis (EOS) in newborns varies widely across Europe, North America and Asia, new survey results show.

National guidelines also disagree on when to start antibiotics in low-risk situations, and how to decide to stop therapy in high-risk scenarios, Dr. Wendy van Herk of Erasmus MC University Medical Center-Sophia Children's Hospital in Rotterdam, the Netherlands, and colleagues found."

A discussion leading to terms of a threshold to treat neonates with low infection risk, prospective studies ofstrategies regarding early discontinuation of unnecessary antibiotic therapy with safety endpoints acknowledging different backgrounds of health care systems, and clear and concise guidelines followed by research to study the impact are mandatory to improve management of term and late preterm infants at risk for EOS," they write in their report, online January 13 in The Pediatric Infectious Disease Journal.

Up to 15% of term and late-preterm neonates are evaluated for suspected EOS, and 10% receive intravenous antibiotics within the first three days of life, the researchers note. But the incidence of culture-proven EOS in term and late-preterm newborns is less than 0.1%, they add.

To investigate current management of suspected EOS, the researchers surveyed pediatricians and neonatologists and reviewed guidelines from Canada, the United States, the United Kingdom, Switzerland and Belgium. A total of 439 clinicians responded to the survey.

In response to a question about whether they would start antibiotic treatment in a scenario rated "low risk" for EOS, 29% of physicians said they would, 26% would not, and 45% said they would start treatment if the patients' laboratory markers were abnormal. Nearly all of the respondents (99%) said they would initiate antibiotics in a high-risk scenario.

In the low-risk situation, 89% said they would stop antibiotic treatment before 72 hours. In the high-risk scenario, 35% said they would stop antibiotics before 72 hours, 56% said they would continue treatment for five to seven days, and 9% said they would treat patients for more than seven days.

Overall, 31% of the survey respondents said they would base their decision to start antibiotic treatment on laboratory investigations, while 72% said they would do so when deciding to continue treatment. Most said they would use complete blood count (CBC) and C-reactive protein (CRP), while a small minority said they would use newer inflammation markers including procalcitonin (PCT) and interleukins.

While all the guidelines reviewed recommended treating newborns with clinical signs indicating infection, and re-evaluating whether patients needed more antibiotics at 36 to 48 hours, they did not provide specific advice on treatment when newborns had prolonged clinical signs of infection or high levels of infection markers. All guidelines recommended using CBC or CRP, while only one included PCT.

Dr. van Herk and colleagues also compared the guidelines for each country with the survey responses of physicians from that country, and found most followed national guidelines on when to start or discontinue antibiotics.

"The diversity with regards to duration of antibiotic therapy in higher risk situations raises the question, what are safe strategies to minimize duration of antibiotic therapy without under-treatment of truly septic neonates?" the authors write. "Currently, the duration of antibiotic therapy is controversial even for proven infection. Prospective, international, multicenter trials studying newer infection markers with a safety endpoint may be helpful in answering this question."

NEW YORK (Reuters Health) - Clinical practice in management of early-onset sepsis (EOS) in newborns varies widely across Europe, North America and Asia, new survey results show.

National guidelines also disagree on when to start antibiotics in low-risk situations, and how to decide to stop therapy in high-risk scenarios, Dr. Wendy van Herk of Erasmus MC University Medical Center-Sophia Children's Hospital in Rotterdam, the Netherlands, and colleagues found."

A discussion leading to terms of a threshold to treat neonates with low infection risk, prospective studies ofstrategies regarding early discontinuation of unnecessary antibiotic therapy with safety endpoints acknowledging different backgrounds of health care systems, and clear and concise guidelines followed by research to study the impact are mandatory to improve management of term and late preterm infants at risk for EOS," they write in their report, online January 13 in The Pediatric Infectious Disease Journal.

Up to 15% of term and late-preterm neonates are evaluated for suspected EOS, and 10% receive intravenous antibiotics within the first three days of life, the researchers note. But the incidence of culture-proven EOS in term and late-preterm newborns is less than 0.1%, they add.

To investigate current management of suspected EOS, the researchers surveyed pediatricians and neonatologists and reviewed guidelines from Canada, the United States, the United Kingdom, Switzerland and Belgium. A total of 439 clinicians responded to the survey.

In response to a question about whether they would start antibiotic treatment in a scenario rated "low risk" for EOS, 29% of physicians said they would, 26% would not, and 45% said they would start treatment if the patients' laboratory markers were abnormal. Nearly all of the respondents (99%) said they would initiate antibiotics in a high-risk scenario.

In the low-risk situation, 89% said they would stop antibiotic treatment before 72 hours. In the high-risk scenario, 35% said they would stop antibiotics before 72 hours, 56% said they would continue treatment for five to seven days, and 9% said they would treat patients for more than seven days.

Overall, 31% of the survey respondents said they would base their decision to start antibiotic treatment on laboratory investigations, while 72% said they would do so when deciding to continue treatment. Most said they would use complete blood count (CBC) and C-reactive protein (CRP), while a small minority said they would use newer inflammation markers including procalcitonin (PCT) and interleukins.

While all the guidelines reviewed recommended treating newborns with clinical signs indicating infection, and re-evaluating whether patients needed more antibiotics at 36 to 48 hours, they did not provide specific advice on treatment when newborns had prolonged clinical signs of infection or high levels of infection markers. All guidelines recommended using CBC or CRP, while only one included PCT.

Dr. van Herk and colleagues also compared the guidelines for each country with the survey responses of physicians from that country, and found most followed national guidelines on when to start or discontinue antibiotics.

"The diversity with regards to duration of antibiotic therapy in higher risk situations raises the question, what are safe strategies to minimize duration of antibiotic therapy without under-treatment of truly septic neonates?" the authors write. "Currently, the duration of antibiotic therapy is controversial even for proven infection. Prospective, international, multicenter trials studying newer infection markers with a safety endpoint may be helpful in answering this question."

NEW YORK (Reuters Health) - Clinical practice in management of early-onset sepsis (EOS) in newborns varies widely across Europe, North America and Asia, new survey results show.

National guidelines also disagree on when to start antibiotics in low-risk situations, and how to decide to stop therapy in high-risk scenarios, Dr. Wendy van Herk of Erasmus MC University Medical Center-Sophia Children's Hospital in Rotterdam, the Netherlands, and colleagues found."

A discussion leading to terms of a threshold to treat neonates with low infection risk, prospective studies ofstrategies regarding early discontinuation of unnecessary antibiotic therapy with safety endpoints acknowledging different backgrounds of health care systems, and clear and concise guidelines followed by research to study the impact are mandatory to improve management of term and late preterm infants at risk for EOS," they write in their report, online January 13 in The Pediatric Infectious Disease Journal.

Up to 15% of term and late-preterm neonates are evaluated for suspected EOS, and 10% receive intravenous antibiotics within the first three days of life, the researchers note. But the incidence of culture-proven EOS in term and late-preterm newborns is less than 0.1%, they add.

To investigate current management of suspected EOS, the researchers surveyed pediatricians and neonatologists and reviewed guidelines from Canada, the United States, the United Kingdom, Switzerland and Belgium. A total of 439 clinicians responded to the survey.

In response to a question about whether they would start antibiotic treatment in a scenario rated "low risk" for EOS, 29% of physicians said they would, 26% would not, and 45% said they would start treatment if the patients' laboratory markers were abnormal. Nearly all of the respondents (99%) said they would initiate antibiotics in a high-risk scenario.

In the low-risk situation, 89% said they would stop antibiotic treatment before 72 hours. In the high-risk scenario, 35% said they would stop antibiotics before 72 hours, 56% said they would continue treatment for five to seven days, and 9% said they would treat patients for more than seven days.

Overall, 31% of the survey respondents said they would base their decision to start antibiotic treatment on laboratory investigations, while 72% said they would do so when deciding to continue treatment. Most said they would use complete blood count (CBC) and C-reactive protein (CRP), while a small minority said they would use newer inflammation markers including procalcitonin (PCT) and interleukins.

While all the guidelines reviewed recommended treating newborns with clinical signs indicating infection, and re-evaluating whether patients needed more antibiotics at 36 to 48 hours, they did not provide specific advice on treatment when newborns had prolonged clinical signs of infection or high levels of infection markers. All guidelines recommended using CBC or CRP, while only one included PCT.

Dr. van Herk and colleagues also compared the guidelines for each country with the survey responses of physicians from that country, and found most followed national guidelines on when to start or discontinue antibiotics.

"The diversity with regards to duration of antibiotic therapy in higher risk situations raises the question, what are safe strategies to minimize duration of antibiotic therapy without under-treatment of truly septic neonates?" the authors write. "Currently, the duration of antibiotic therapy is controversial even for proven infection. Prospective, international, multicenter trials studying newer infection markers with a safety endpoint may be helpful in answering this question."

NEW YORK - Intravascular ultrasound-guided (IVUS) stent implantation can lead to fewer adverse cardiac events compared with angiography-guided implantation, according to a new trial.

"Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at one year," Dr. Myeong-Ki Hong of Severance Cardiovascular Hospital and Yonsei University College of Medicine in Seoul, Korea, and colleagues report.

"These differences were primarily due to lower risk of target lesion revascularization," they note in an article online November 10 in JAMA. They presented their findings simultaneously at the American Heart Association Scientific Sessions in Orlando, Fla.

Dr. Hong and colleagues conducted a trial involving 1,400 patients with long coronary lesions between 2010 and 2014 at 20 centers in Korea. They randomized 700 patients to IVUS-guided stent implantation and 700 to angiography-guided stent implantation. They had one-year follow-up results on 94.5%.

Patient mean age was 64 and 69% were men. The mean stented target length was 39.3 mm.

The composite endpoint of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction (MI), or ischemia-driven target lesion revascularization, occurred in 19 (2.9%) patients who underwent IVUS implantation and 39 (5.8%) patients who underwent angiography-guided implantation (hazard ratio, 0.48; p=0.007).

Cardiac death and target-related MI were not significantly different between the two groups. However, ischemia-driven target lesion revascularization occurred in 17 (2.5%) IVUS

patients and 33 (5%) angiography patients (HR 0.51, p=0.02).

Clinicians performed post-stent balloon dilation more frequently in IVUS patients than in angiography patients (76% vs. 57%, p<0.001), and the mean final balloon size was larger in IVUS patients.

Patients who met IVUS criteria for stent optimization (363, 54%) had significantly greater mean post-intervention minimal lumen area at the stented segment compared with patients who did not meet IVUS criteria.

"The clinical benefit of IVUS-guided (drug-eluting stent) implantation may be attributed to the larger minimal lumen diameter followed by the more frequent adjunct postdilation with a large-sized balloon in the IVUS-guided group," the researchers write.

"To our knowledge, the current study is the first demonstration of the clinical benefit of IVUS guidance in second generation (drug-eluting stent) implantation in an adequately powered randomized clinical trial," they note.

However, even though recent guidelines recommend IVUS-guided implantation for some patients, evidence for improved outcomes based on adequately powered trials remains inadequate, they caution.

Dr. Hong did not respond to a request for comments. Abbott Vascular funded this research. The authors reported no conflicts of interest.

NEW YORK - Intravascular ultrasound-guided (IVUS) stent implantation can lead to fewer adverse cardiac events compared with angiography-guided implantation, according to a new trial.

"Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at one year," Dr. Myeong-Ki Hong of Severance Cardiovascular Hospital and Yonsei University College of Medicine in Seoul, Korea, and colleagues report.

"These differences were primarily due to lower risk of target lesion revascularization," they note in an article online November 10 in JAMA. They presented their findings simultaneously at the American Heart Association Scientific Sessions in Orlando, Fla.

Dr. Hong and colleagues conducted a trial involving 1,400 patients with long coronary lesions between 2010 and 2014 at 20 centers in Korea. They randomized 700 patients to IVUS-guided stent implantation and 700 to angiography-guided stent implantation. They had one-year follow-up results on 94.5%.

Patient mean age was 64 and 69% were men. The mean stented target length was 39.3 mm.

The composite endpoint of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction (MI), or ischemia-driven target lesion revascularization, occurred in 19 (2.9%) patients who underwent IVUS implantation and 39 (5.8%) patients who underwent angiography-guided implantation (hazard ratio, 0.48; p=0.007).

Cardiac death and target-related MI were not significantly different between the two groups. However, ischemia-driven target lesion revascularization occurred in 17 (2.5%) IVUS

patients and 33 (5%) angiography patients (HR 0.51, p=0.02).

Clinicians performed post-stent balloon dilation more frequently in IVUS patients than in angiography patients (76% vs. 57%, p<0.001), and the mean final balloon size was larger in IVUS patients.

Patients who met IVUS criteria for stent optimization (363, 54%) had significantly greater mean post-intervention minimal lumen area at the stented segment compared with patients who did not meet IVUS criteria.

"The clinical benefit of IVUS-guided (drug-eluting stent) implantation may be attributed to the larger minimal lumen diameter followed by the more frequent adjunct postdilation with a large-sized balloon in the IVUS-guided group," the researchers write.

"To our knowledge, the current study is the first demonstration of the clinical benefit of IVUS guidance in second generation (drug-eluting stent) implantation in an adequately powered randomized clinical trial," they note.

However, even though recent guidelines recommend IVUS-guided implantation for some patients, evidence for improved outcomes based on adequately powered trials remains inadequate, they caution.

Dr. Hong did not respond to a request for comments. Abbott Vascular funded this research. The authors reported no conflicts of interest.

NEW YORK - Intravascular ultrasound-guided (IVUS) stent implantation can lead to fewer adverse cardiac events compared with angiography-guided implantation, according to a new trial.

"Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at one year," Dr. Myeong-Ki Hong of Severance Cardiovascular Hospital and Yonsei University College of Medicine in Seoul, Korea, and colleagues report.

"These differences were primarily due to lower risk of target lesion revascularization," they note in an article online November 10 in JAMA. They presented their findings simultaneously at the American Heart Association Scientific Sessions in Orlando, Fla.

Dr. Hong and colleagues conducted a trial involving 1,400 patients with long coronary lesions between 2010 and 2014 at 20 centers in Korea. They randomized 700 patients to IVUS-guided stent implantation and 700 to angiography-guided stent implantation. They had one-year follow-up results on 94.5%.

Patient mean age was 64 and 69% were men. The mean stented target length was 39.3 mm.

The composite endpoint of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction (MI), or ischemia-driven target lesion revascularization, occurred in 19 (2.9%) patients who underwent IVUS implantation and 39 (5.8%) patients who underwent angiography-guided implantation (hazard ratio, 0.48; p=0.007).

Cardiac death and target-related MI were not significantly different between the two groups. However, ischemia-driven target lesion revascularization occurred in 17 (2.5%) IVUS

patients and 33 (5%) angiography patients (HR 0.51, p=0.02).

Clinicians performed post-stent balloon dilation more frequently in IVUS patients than in angiography patients (76% vs. 57%, p<0.001), and the mean final balloon size was larger in IVUS patients.

Patients who met IVUS criteria for stent optimization (363, 54%) had significantly greater mean post-intervention minimal lumen area at the stented segment compared with patients who did not meet IVUS criteria.

"The clinical benefit of IVUS-guided (drug-eluting stent) implantation may be attributed to the larger minimal lumen diameter followed by the more frequent adjunct postdilation with a large-sized balloon in the IVUS-guided group," the researchers write.

"To our knowledge, the current study is the first demonstration of the clinical benefit of IVUS guidance in second generation (drug-eluting stent) implantation in an adequately powered randomized clinical trial," they note.

However, even though recent guidelines recommend IVUS-guided implantation for some patients, evidence for improved outcomes based on adequately powered trials remains inadequate, they caution.

Dr. Hong did not respond to a request for comments. Abbott Vascular funded this research. The authors reported no conflicts of interest.