The Hospitalist

ORLANDO – It’s inevitable that hospitalists will soon be caring for patients who come in on insulin pumps, continuous glucose monitors, and even closed loop systems, if they haven’t done so already.

A third or more of patients with type 1 diabetes mellitus and growing numbers of patients with insulin-dependent type 2 diabetes mellitus patients are using pumps and sensor technology. The American Diabetes Association advocates allowing patients who are physically and mentally able to continue to use their pumps when hospitalized, and there’s general consensus that continuous glucose monitors (CGM) can be used in the hospital.

All in all, it’s a good thing, according to Guillermo E. Umpierrez, MD, professor of endocrinology at Emory University and chief of endocrinology at Grady Memorial Hospital, both in Atlanta.

In a talk at the annual scientific sessions of the American Diabetes Association, Dr. Umpierrez reviewed a number of studies showing that glycemic control with the new technology is no worse in the hospital – and sometimes even better – than with traditional point-of-care glucose testing and insulin administration. There is a lack of randomized, controlled trials to prove the point definitively, but what evidence does exist is promising.

“This technology is rapidly advancing, and I am very optimistic that we are going to see more and more of these devices in the hospital. If patients can manage themselves, allow them to use CGM, allow them to use their pumps,” he said.

As for closed loop systems – automated glucose sensing and insulin administration – emerging evidence suggests they “allow you to have very good glucose control and less glycemic variability,” both inside and outside of the ICU, he said. “I am very hopeful before I retire that there will be management of a significant number of patients with closed loop systems.”

To keep up, training for hospital providers on the new technology is now “mandatory at all levels,” Dr. Umpierrez said, and if they haven’t done so already, hospitals need to put policies and procedures in place for when, and when not, to allow patients to use their diabetes equipment, and how to integrate it into care.

Among many things to consider, patients must be well enough to use their pumps and monitors, be able to demonstrate their functions, and also want to participate in their own care.

Contraindications to inpatient pump use include impaired consciousness, critical illness, and hyperglycemic crises because insulin requirements change too rapidly and dramatically for pumps. Lack of trained providers and supplies is another hurdle. Pumps also need to come off for MRIs.

CGM, meanwhile, has been shown to improve glycemic control, detecting both hyperglycemia and hypoglycemia more readily than point-of-care testing. It’s good at picking up trends in glucose levels, and Dr. Umpierrez anticipates a time when readings will be transmitted to nurses’ stations automatically to track blood glucose trends. “I think that’s the future,” he said.

But, as with insulin pumps, there are caveats. Among them, it’s unclear how well CGM works during hypoxia, hypothermia, and hypotension. Thrombus formation and infections have been reported with intravascular monitors, and a number of agents can throw off some CGM devices, including acetaminophen, heparin, and dopamine.

Dr. Umpierrez disclosed relationships with AstraZeneca, Merck, Novo Nordisk, Sanofi, and other companies.

[email protected]

ORLANDO – It’s inevitable that hospitalists will soon be caring for patients who come in on insulin pumps, continuous glucose monitors, and even closed loop systems, if they haven’t done so already.

A third or more of patients with type 1 diabetes mellitus and growing numbers of patients with insulin-dependent type 2 diabetes mellitus patients are using pumps and sensor technology. The American Diabetes Association advocates allowing patients who are physically and mentally able to continue to use their pumps when hospitalized, and there’s general consensus that continuous glucose monitors (CGM) can be used in the hospital.

All in all, it’s a good thing, according to Guillermo E. Umpierrez, MD, professor of endocrinology at Emory University and chief of endocrinology at Grady Memorial Hospital, both in Atlanta.

In a talk at the annual scientific sessions of the American Diabetes Association, Dr. Umpierrez reviewed a number of studies showing that glycemic control with the new technology is no worse in the hospital – and sometimes even better – than with traditional point-of-care glucose testing and insulin administration. There is a lack of randomized, controlled trials to prove the point definitively, but what evidence does exist is promising.

“This technology is rapidly advancing, and I am very optimistic that we are going to see more and more of these devices in the hospital. If patients can manage themselves, allow them to use CGM, allow them to use their pumps,” he said.

As for closed loop systems – automated glucose sensing and insulin administration – emerging evidence suggests they “allow you to have very good glucose control and less glycemic variability,” both inside and outside of the ICU, he said. “I am very hopeful before I retire that there will be management of a significant number of patients with closed loop systems.”

To keep up, training for hospital providers on the new technology is now “mandatory at all levels,” Dr. Umpierrez said, and if they haven’t done so already, hospitals need to put policies and procedures in place for when, and when not, to allow patients to use their diabetes equipment, and how to integrate it into care.

Among many things to consider, patients must be well enough to use their pumps and monitors, be able to demonstrate their functions, and also want to participate in their own care.

Contraindications to inpatient pump use include impaired consciousness, critical illness, and hyperglycemic crises because insulin requirements change too rapidly and dramatically for pumps. Lack of trained providers and supplies is another hurdle. Pumps also need to come off for MRIs.

CGM, meanwhile, has been shown to improve glycemic control, detecting both hyperglycemia and hypoglycemia more readily than point-of-care testing. It’s good at picking up trends in glucose levels, and Dr. Umpierrez anticipates a time when readings will be transmitted to nurses’ stations automatically to track blood glucose trends. “I think that’s the future,” he said.

But, as with insulin pumps, there are caveats. Among them, it’s unclear how well CGM works during hypoxia, hypothermia, and hypotension. Thrombus formation and infections have been reported with intravascular monitors, and a number of agents can throw off some CGM devices, including acetaminophen, heparin, and dopamine.

Dr. Umpierrez disclosed relationships with AstraZeneca, Merck, Novo Nordisk, Sanofi, and other companies.

[email protected]

ORLANDO – It’s inevitable that hospitalists will soon be caring for patients who come in on insulin pumps, continuous glucose monitors, and even closed loop systems, if they haven’t done so already.

A third or more of patients with type 1 diabetes mellitus and growing numbers of patients with insulin-dependent type 2 diabetes mellitus patients are using pumps and sensor technology. The American Diabetes Association advocates allowing patients who are physically and mentally able to continue to use their pumps when hospitalized, and there’s general consensus that continuous glucose monitors (CGM) can be used in the hospital.

All in all, it’s a good thing, according to Guillermo E. Umpierrez, MD, professor of endocrinology at Emory University and chief of endocrinology at Grady Memorial Hospital, both in Atlanta.

In a talk at the annual scientific sessions of the American Diabetes Association, Dr. Umpierrez reviewed a number of studies showing that glycemic control with the new technology is no worse in the hospital – and sometimes even better – than with traditional point-of-care glucose testing and insulin administration. There is a lack of randomized, controlled trials to prove the point definitively, but what evidence does exist is promising.

“This technology is rapidly advancing, and I am very optimistic that we are going to see more and more of these devices in the hospital. If patients can manage themselves, allow them to use CGM, allow them to use their pumps,” he said.

As for closed loop systems – automated glucose sensing and insulin administration – emerging evidence suggests they “allow you to have very good glucose control and less glycemic variability,” both inside and outside of the ICU, he said. “I am very hopeful before I retire that there will be management of a significant number of patients with closed loop systems.”

To keep up, training for hospital providers on the new technology is now “mandatory at all levels,” Dr. Umpierrez said, and if they haven’t done so already, hospitals need to put policies and procedures in place for when, and when not, to allow patients to use their diabetes equipment, and how to integrate it into care.

Among many things to consider, patients must be well enough to use their pumps and monitors, be able to demonstrate their functions, and also want to participate in their own care.

Contraindications to inpatient pump use include impaired consciousness, critical illness, and hyperglycemic crises because insulin requirements change too rapidly and dramatically for pumps. Lack of trained providers and supplies is another hurdle. Pumps also need to come off for MRIs.

CGM, meanwhile, has been shown to improve glycemic control, detecting both hyperglycemia and hypoglycemia more readily than point-of-care testing. It’s good at picking up trends in glucose levels, and Dr. Umpierrez anticipates a time when readings will be transmitted to nurses’ stations automatically to track blood glucose trends. “I think that’s the future,” he said.

But, as with insulin pumps, there are caveats. Among them, it’s unclear how well CGM works during hypoxia, hypothermia, and hypotension. Thrombus formation and infections have been reported with intravascular monitors, and a number of agents can throw off some CGM devices, including acetaminophen, heparin, and dopamine.

Dr. Umpierrez disclosed relationships with AstraZeneca, Merck, Novo Nordisk, Sanofi, and other companies.

[email protected]

Some policy responses to the opioid epidemic have immediate, beneficial effects, while others lead to short-term harms that might be offset by long-term health benefits, according to researchers who have mathematically modeled the impact of 11 interventions.

Policies that expand addiction treatment or curb harmful effects of addiction such as overdose and infection were immediately beneficial in the model, with no negative effects on life years (LYs), quality-adjusted life years (QALYs), or addiction deaths, the researchers reported.

In contrast, policies that constrain prescription opioid supply resulted in some benefits, but also short-term harms because of inadequate pain control and users switching to heroin.

However, the modeling study also suggests those harms might be mitigated over the long term as new addictions are averted, according to Allison L. Pitt, a PhD candidate in the department of management science and engineering at Stanford (Calif.) University, and her coauthors.

Combining different interventions had additive benefits in the model, prompting Ms. Pitt and her coauthors to recommend a multifaceted policy approach to curb opioid abuse and reduce addiction deaths.

“No epidemic has ever been averted solely by treating single affected cases,” they wrote in the American Journal of Public Health. “Instead, portfolios of policies will likely be required, including those that prevent addiction, treat addiction, and mitigate its effects.”

In their study, Ms. Pitt and her colleagues projected the impact of 11 policies aimed at curbing opioid addiction and reducing addiction deaths. They used dynamic compartmental modeling, a technique commonly used for evaluating the spread of contagious disease.

This technique is appropriate for studying the opioid epidemic, because it allows for dynamic modeling of addiction incidence that reflects a changing number of prescription holders, the authors said in their report, which focused on projected outcomes of various interventions at 5 and 10 years.

None of the policies substantially reduced opioid-related deaths in 5-year outcomes projections, they found. Increasing availability of naloxone averted 4% of addiction deaths, the highest reduction of any intervention over that time period.

However, interventions focused on providing services for people with addictions did generally provide uniform benefits over the 5-year horizon: “Naloxone availability, needle exchange, medication-assisted treatment, and psychosocial treatment policies generate gains in LYs and QALYs and reduce deaths, without harming any group,” Ms. Pitt and her coauthors said.

Interventions that reduced opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, increased LYs and QALYs while decreasing total addiction deaths over 5 years. However, the investigators said, those benefits were partly offset by increases in heroin-related deaths.

Drug rescheduling was associated with a 45.6% increase in heroin-related deaths over 5 years in the model, the highest percentage increase of any intervention in the published data.

Over the 10-year horizon, addiction deaths continued to decrease proportionally for naloxone availability and needle-exchange policies, authors said. By comparison, policies focused on opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, averted substantially more deaths over 10 years than would be expected, compared with the 5-year results, investigators said.

Acute pain prescribing, which increased opioid-related deaths over 5 years in the model, was associated with a decrease in opioid-related deaths over 10 years, they added.

The report coauthors were Keith Humphreys, PhD, of Stanford’s department of psychiatry and behavioral sciences, and Margaret L. Brandeau, PhD, of the university’s department of management science and engineering.

The coauthors cited several limitations. One is that the opioid epidemic is changing in unpredictable ways. Therefore, numerous assumptions about the epidemic were made based on the opinions of clinicians and scientists.

The study was supported by a grant from the National Institute on Drug Abuse. Dr. Humphreys reported support through a Senior Career Research Scientist award from the VA Health Services Research and Development Service.

SOURCE: Pitt AL et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304590.

Some policy responses to the opioid epidemic have immediate, beneficial effects, while others lead to short-term harms that might be offset by long-term health benefits, according to researchers who have mathematically modeled the impact of 11 interventions.

Policies that expand addiction treatment or curb harmful effects of addiction such as overdose and infection were immediately beneficial in the model, with no negative effects on life years (LYs), quality-adjusted life years (QALYs), or addiction deaths, the researchers reported.

In contrast, policies that constrain prescription opioid supply resulted in some benefits, but also short-term harms because of inadequate pain control and users switching to heroin.

However, the modeling study also suggests those harms might be mitigated over the long term as new addictions are averted, according to Allison L. Pitt, a PhD candidate in the department of management science and engineering at Stanford (Calif.) University, and her coauthors.

Combining different interventions had additive benefits in the model, prompting Ms. Pitt and her coauthors to recommend a multifaceted policy approach to curb opioid abuse and reduce addiction deaths.

“No epidemic has ever been averted solely by treating single affected cases,” they wrote in the American Journal of Public Health. “Instead, portfolios of policies will likely be required, including those that prevent addiction, treat addiction, and mitigate its effects.”

In their study, Ms. Pitt and her colleagues projected the impact of 11 policies aimed at curbing opioid addiction and reducing addiction deaths. They used dynamic compartmental modeling, a technique commonly used for evaluating the spread of contagious disease.

This technique is appropriate for studying the opioid epidemic, because it allows for dynamic modeling of addiction incidence that reflects a changing number of prescription holders, the authors said in their report, which focused on projected outcomes of various interventions at 5 and 10 years.

None of the policies substantially reduced opioid-related deaths in 5-year outcomes projections, they found. Increasing availability of naloxone averted 4% of addiction deaths, the highest reduction of any intervention over that time period.

However, interventions focused on providing services for people with addictions did generally provide uniform benefits over the 5-year horizon: “Naloxone availability, needle exchange, medication-assisted treatment, and psychosocial treatment policies generate gains in LYs and QALYs and reduce deaths, without harming any group,” Ms. Pitt and her coauthors said.

Interventions that reduced opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, increased LYs and QALYs while decreasing total addiction deaths over 5 years. However, the investigators said, those benefits were partly offset by increases in heroin-related deaths.

Drug rescheduling was associated with a 45.6% increase in heroin-related deaths over 5 years in the model, the highest percentage increase of any intervention in the published data.

Over the 10-year horizon, addiction deaths continued to decrease proportionally for naloxone availability and needle-exchange policies, authors said. By comparison, policies focused on opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, averted substantially more deaths over 10 years than would be expected, compared with the 5-year results, investigators said.

Acute pain prescribing, which increased opioid-related deaths over 5 years in the model, was associated with a decrease in opioid-related deaths over 10 years, they added.

The report coauthors were Keith Humphreys, PhD, of Stanford’s department of psychiatry and behavioral sciences, and Margaret L. Brandeau, PhD, of the university’s department of management science and engineering.

The coauthors cited several limitations. One is that the opioid epidemic is changing in unpredictable ways. Therefore, numerous assumptions about the epidemic were made based on the opinions of clinicians and scientists.

The study was supported by a grant from the National Institute on Drug Abuse. Dr. Humphreys reported support through a Senior Career Research Scientist award from the VA Health Services Research and Development Service.

SOURCE: Pitt AL et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304590.

Some policy responses to the opioid epidemic have immediate, beneficial effects, while others lead to short-term harms that might be offset by long-term health benefits, according to researchers who have mathematically modeled the impact of 11 interventions.

Policies that expand addiction treatment or curb harmful effects of addiction such as overdose and infection were immediately beneficial in the model, with no negative effects on life years (LYs), quality-adjusted life years (QALYs), or addiction deaths, the researchers reported.

In contrast, policies that constrain prescription opioid supply resulted in some benefits, but also short-term harms because of inadequate pain control and users switching to heroin.

However, the modeling study also suggests those harms might be mitigated over the long term as new addictions are averted, according to Allison L. Pitt, a PhD candidate in the department of management science and engineering at Stanford (Calif.) University, and her coauthors.

Combining different interventions had additive benefits in the model, prompting Ms. Pitt and her coauthors to recommend a multifaceted policy approach to curb opioid abuse and reduce addiction deaths.

“No epidemic has ever been averted solely by treating single affected cases,” they wrote in the American Journal of Public Health. “Instead, portfolios of policies will likely be required, including those that prevent addiction, treat addiction, and mitigate its effects.”

In their study, Ms. Pitt and her colleagues projected the impact of 11 policies aimed at curbing opioid addiction and reducing addiction deaths. They used dynamic compartmental modeling, a technique commonly used for evaluating the spread of contagious disease.

This technique is appropriate for studying the opioid epidemic, because it allows for dynamic modeling of addiction incidence that reflects a changing number of prescription holders, the authors said in their report, which focused on projected outcomes of various interventions at 5 and 10 years.

None of the policies substantially reduced opioid-related deaths in 5-year outcomes projections, they found. Increasing availability of naloxone averted 4% of addiction deaths, the highest reduction of any intervention over that time period.

However, interventions focused on providing services for people with addictions did generally provide uniform benefits over the 5-year horizon: “Naloxone availability, needle exchange, medication-assisted treatment, and psychosocial treatment policies generate gains in LYs and QALYs and reduce deaths, without harming any group,” Ms. Pitt and her coauthors said.

Interventions that reduced opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, increased LYs and QALYs while decreasing total addiction deaths over 5 years. However, the investigators said, those benefits were partly offset by increases in heroin-related deaths.

Drug rescheduling was associated with a 45.6% increase in heroin-related deaths over 5 years in the model, the highest percentage increase of any intervention in the published data.

Over the 10-year horizon, addiction deaths continued to decrease proportionally for naloxone availability and needle-exchange policies, authors said. By comparison, policies focused on opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, averted substantially more deaths over 10 years than would be expected, compared with the 5-year results, investigators said.

Acute pain prescribing, which increased opioid-related deaths over 5 years in the model, was associated with a decrease in opioid-related deaths over 10 years, they added.

The report coauthors were Keith Humphreys, PhD, of Stanford’s department of psychiatry and behavioral sciences, and Margaret L. Brandeau, PhD, of the university’s department of management science and engineering.

The coauthors cited several limitations. One is that the opioid epidemic is changing in unpredictable ways. Therefore, numerous assumptions about the epidemic were made based on the opinions of clinicians and scientists.

The study was supported by a grant from the National Institute on Drug Abuse. Dr. Humphreys reported support through a Senior Career Research Scientist award from the VA Health Services Research and Development Service.

SOURCE: Pitt AL et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304590.

ATLANTA – In just 7 months, the University of North Carolina Children’s Hospital, Chapel Hill, dropped the length of stay for neonatal abstinence syndrome from about 11 days to 5 days by moving from scheduled to PRN morphine dosing and abandoning the Finnegan score, according to a report at the Pediatric Hospital Medicine meeting.

The use of morphine fell from 93% of infants transferred to the hospital’s inpatient floors for neonatal abstinence syndrome (NAS) to just 12%, with no downsides for infants or moms.

“Our results have been incredibly encouraging,” said lead investigator and pediatrics resident Thomas Blount, MD. The take-home message is to treat the infant, rather than relying on the Finnegan score.

UNC Children’s, which treats about 50 infants a year for NAS on its inpatient floors, had been using the traditional approach: babies were automatically scheduled for morphine and Finnegan scoring – a withdrawal symptom checklist – every 4 hours, regardless of need. Sometimes infants weren’t even assessed to see if they actually needed morphine before the next dose was given.

“Waking babies up every 4 hours just seemed crazy; of course, they were going to have heightened neurologic signs and symptoms.” Meanwhile, families and providers were frustrated that infants who were otherwise doing well were held for an extra week or more to wean them off morphine, Dr. Blount said at the meeting.

In Nov. 2017, the hospital switched to the eat/sleep/console (ESC) model for NAS on its inpatient floors. The model emphasizes what’s been shown to work in recent years: keeping the infant with the mother; encouraging breast feeding, skin-on-skin contact, and other comfort measures; and supplementing feeds to help with weight gain. Morphine is reserved for when those measures fail and given only with a needs assessment (Hosp Pediatr. 2018 Jan;8(1):1-6).

The hospital ditched Finnegan scoring on its inpatient floors. Nurses were asked instead to check if infants were feeding adequately, sleeping at least an hour between feedings, and able to be consoled within 10 minutes when upset. If the infants met all three of those ESC criteria, providers moved on. They left the baby swaddled, relied on ambient white noise of ocean waves, and checked back on them later. “They didn’t mess with them,” Dr. Blount said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Finnegan scoring “was causing so much anxiety. Staff and families became hypervigilant,” set off by every little twitch and yawn the baby made. It was a good thing when it was abandoned; everyone relaxed, he said.

The changes made a huge difference. The average number of morphine doses dropped from 39 per infant to just 7 total doses among 23 infants in the first 7 months of the ESC initiative. Currently, morphine is used in only about 1 of 10 cases. “We estimate that we’ve given over 900 fewer doses” since ESC was put in place, Dr. Blount said.

Courtesy UNC Children's Hospital

“We had a lot of pushback initially, mostly from nursing staff and residents wondering how this was going to work. It quickly went away,” Dr. Blount said.

His team is now considering rolling ESC out to the newborn nursery and NICU.

There was no industry funding for the work, and Dr. Blount didn’t have any disclosures.

[email protected]

ATLANTA – In just 7 months, the University of North Carolina Children’s Hospital, Chapel Hill, dropped the length of stay for neonatal abstinence syndrome from about 11 days to 5 days by moving from scheduled to PRN morphine dosing and abandoning the Finnegan score, according to a report at the Pediatric Hospital Medicine meeting.

The use of morphine fell from 93% of infants transferred to the hospital’s inpatient floors for neonatal abstinence syndrome (NAS) to just 12%, with no downsides for infants or moms.

“Our results have been incredibly encouraging,” said lead investigator and pediatrics resident Thomas Blount, MD. The take-home message is to treat the infant, rather than relying on the Finnegan score.

UNC Children’s, which treats about 50 infants a year for NAS on its inpatient floors, had been using the traditional approach: babies were automatically scheduled for morphine and Finnegan scoring – a withdrawal symptom checklist – every 4 hours, regardless of need. Sometimes infants weren’t even assessed to see if they actually needed morphine before the next dose was given.

“Waking babies up every 4 hours just seemed crazy; of course, they were going to have heightened neurologic signs and symptoms.” Meanwhile, families and providers were frustrated that infants who were otherwise doing well were held for an extra week or more to wean them off morphine, Dr. Blount said at the meeting.

In Nov. 2017, the hospital switched to the eat/sleep/console (ESC) model for NAS on its inpatient floors. The model emphasizes what’s been shown to work in recent years: keeping the infant with the mother; encouraging breast feeding, skin-on-skin contact, and other comfort measures; and supplementing feeds to help with weight gain. Morphine is reserved for when those measures fail and given only with a needs assessment (Hosp Pediatr. 2018 Jan;8(1):1-6).

The hospital ditched Finnegan scoring on its inpatient floors. Nurses were asked instead to check if infants were feeding adequately, sleeping at least an hour between feedings, and able to be consoled within 10 minutes when upset. If the infants met all three of those ESC criteria, providers moved on. They left the baby swaddled, relied on ambient white noise of ocean waves, and checked back on them later. “They didn’t mess with them,” Dr. Blount said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Finnegan scoring “was causing so much anxiety. Staff and families became hypervigilant,” set off by every little twitch and yawn the baby made. It was a good thing when it was abandoned; everyone relaxed, he said.

The changes made a huge difference. The average number of morphine doses dropped from 39 per infant to just 7 total doses among 23 infants in the first 7 months of the ESC initiative. Currently, morphine is used in only about 1 of 10 cases. “We estimate that we’ve given over 900 fewer doses” since ESC was put in place, Dr. Blount said.

Courtesy UNC Children's Hospital

“We had a lot of pushback initially, mostly from nursing staff and residents wondering how this was going to work. It quickly went away,” Dr. Blount said.

His team is now considering rolling ESC out to the newborn nursery and NICU.

There was no industry funding for the work, and Dr. Blount didn’t have any disclosures.

[email protected]

ATLANTA – In just 7 months, the University of North Carolina Children’s Hospital, Chapel Hill, dropped the length of stay for neonatal abstinence syndrome from about 11 days to 5 days by moving from scheduled to PRN morphine dosing and abandoning the Finnegan score, according to a report at the Pediatric Hospital Medicine meeting.

The use of morphine fell from 93% of infants transferred to the hospital’s inpatient floors for neonatal abstinence syndrome (NAS) to just 12%, with no downsides for infants or moms.

“Our results have been incredibly encouraging,” said lead investigator and pediatrics resident Thomas Blount, MD. The take-home message is to treat the infant, rather than relying on the Finnegan score.

UNC Children’s, which treats about 50 infants a year for NAS on its inpatient floors, had been using the traditional approach: babies were automatically scheduled for morphine and Finnegan scoring – a withdrawal symptom checklist – every 4 hours, regardless of need. Sometimes infants weren’t even assessed to see if they actually needed morphine before the next dose was given.

“Waking babies up every 4 hours just seemed crazy; of course, they were going to have heightened neurologic signs and symptoms.” Meanwhile, families and providers were frustrated that infants who were otherwise doing well were held for an extra week or more to wean them off morphine, Dr. Blount said at the meeting.

In Nov. 2017, the hospital switched to the eat/sleep/console (ESC) model for NAS on its inpatient floors. The model emphasizes what’s been shown to work in recent years: keeping the infant with the mother; encouraging breast feeding, skin-on-skin contact, and other comfort measures; and supplementing feeds to help with weight gain. Morphine is reserved for when those measures fail and given only with a needs assessment (Hosp Pediatr. 2018 Jan;8(1):1-6).

The hospital ditched Finnegan scoring on its inpatient floors. Nurses were asked instead to check if infants were feeding adequately, sleeping at least an hour between feedings, and able to be consoled within 10 minutes when upset. If the infants met all three of those ESC criteria, providers moved on. They left the baby swaddled, relied on ambient white noise of ocean waves, and checked back on them later. “They didn’t mess with them,” Dr. Blount said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Finnegan scoring “was causing so much anxiety. Staff and families became hypervigilant,” set off by every little twitch and yawn the baby made. It was a good thing when it was abandoned; everyone relaxed, he said.

The changes made a huge difference. The average number of morphine doses dropped from 39 per infant to just 7 total doses among 23 infants in the first 7 months of the ESC initiative. Currently, morphine is used in only about 1 of 10 cases. “We estimate that we’ve given over 900 fewer doses” since ESC was put in place, Dr. Blount said.

Courtesy UNC Children's Hospital

“We had a lot of pushback initially, mostly from nursing staff and residents wondering how this was going to work. It quickly went away,” Dr. Blount said.

His team is now considering rolling ESC out to the newborn nursery and NICU.

There was no industry funding for the work, and Dr. Blount didn’t have any disclosures.

[email protected]

Clinical question: Does a balanced crystalloid solution lead to better outcomes than does normal saline when used in critically sick adults?

Background: Balanced crystalloids are considered more physiological, with a composition closer to plasma. Observational studies have shown lower rates of hyperchloremic acidosis, renal failure, and death with use of balanced crystalloids. In spite of this, normal saline has been the most commonly used fluid. Differences in effects on important patient-related outcomes of safety and efficacy between these two interventions remain unknown.

Study design: Pragmatic, unblinded, cluster-randomized, multiple-crossover trial.

Setting: Vanderbilt University Health Center, Nashville, Tenn.

Synopsis: This study comprised 15,802 adults with mean age of 58 admitted to ICU who were cluster randomized to receive either balanced crystalloid or normal saline. Primary outcome was a composite of death from any cause, renal replacement therapy, or persistent renal dysfunction at 30 days and was observed less frequently in the balanced crystalloid group (adjusted odds ratio, 0.90; 95% confidence interval, 0.82-0.99; P = .04).

Since the trial was cluster randomized, prognostic imbalance between the groups caused by confounding factors was a big risk. Results could not be generalized because the study was done in a university health center. Mean fluid amount received was modest in both groups. Questions still remain about the efficacy and safety of balanced fluids, and hospitalists should weigh their decisions in light of this new information.

Bottom line: Balanced crystalloid solution decreased 30-day composite outcome of death, renal replacement therapy, or persistent renal dysfunction.

Citation: Semler MW et al. Balanced crystalloids versus saline in critically ill adults. N Engl J Med. 2018 Mar 1;378(9):829-39.
 

Dr. Parasramka is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Clinical question: Does a balanced crystalloid solution lead to better outcomes than does normal saline when used in critically sick adults?

Background: Balanced crystalloids are considered more physiological, with a composition closer to plasma. Observational studies have shown lower rates of hyperchloremic acidosis, renal failure, and death with use of balanced crystalloids. In spite of this, normal saline has been the most commonly used fluid. Differences in effects on important patient-related outcomes of safety and efficacy between these two interventions remain unknown.

Study design: Pragmatic, unblinded, cluster-randomized, multiple-crossover trial.

Setting: Vanderbilt University Health Center, Nashville, Tenn.

Synopsis: This study comprised 15,802 adults with mean age of 58 admitted to ICU who were cluster randomized to receive either balanced crystalloid or normal saline. Primary outcome was a composite of death from any cause, renal replacement therapy, or persistent renal dysfunction at 30 days and was observed less frequently in the balanced crystalloid group (adjusted odds ratio, 0.90; 95% confidence interval, 0.82-0.99; P = .04).

Since the trial was cluster randomized, prognostic imbalance between the groups caused by confounding factors was a big risk. Results could not be generalized because the study was done in a university health center. Mean fluid amount received was modest in both groups. Questions still remain about the efficacy and safety of balanced fluids, and hospitalists should weigh their decisions in light of this new information.

Bottom line: Balanced crystalloid solution decreased 30-day composite outcome of death, renal replacement therapy, or persistent renal dysfunction.

Citation: Semler MW et al. Balanced crystalloids versus saline in critically ill adults. N Engl J Med. 2018 Mar 1;378(9):829-39.
 

Dr. Parasramka is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Clinical question: Does a balanced crystalloid solution lead to better outcomes than does normal saline when used in critically sick adults?

Background: Balanced crystalloids are considered more physiological, with a composition closer to plasma. Observational studies have shown lower rates of hyperchloremic acidosis, renal failure, and death with use of balanced crystalloids. In spite of this, normal saline has been the most commonly used fluid. Differences in effects on important patient-related outcomes of safety and efficacy between these two interventions remain unknown.

Study design: Pragmatic, unblinded, cluster-randomized, multiple-crossover trial.

Setting: Vanderbilt University Health Center, Nashville, Tenn.

Synopsis: This study comprised 15,802 adults with mean age of 58 admitted to ICU who were cluster randomized to receive either balanced crystalloid or normal saline. Primary outcome was a composite of death from any cause, renal replacement therapy, or persistent renal dysfunction at 30 days and was observed less frequently in the balanced crystalloid group (adjusted odds ratio, 0.90; 95% confidence interval, 0.82-0.99; P = .04).

Since the trial was cluster randomized, prognostic imbalance between the groups caused by confounding factors was a big risk. Results could not be generalized because the study was done in a university health center. Mean fluid amount received was modest in both groups. Questions still remain about the efficacy and safety of balanced fluids, and hospitalists should weigh their decisions in light of this new information.

Bottom line: Balanced crystalloid solution decreased 30-day composite outcome of death, renal replacement therapy, or persistent renal dysfunction.

Citation: Semler MW et al. Balanced crystalloids versus saline in critically ill adults. N Engl J Med. 2018 Mar 1;378(9):829-39.
 

Dr. Parasramka is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Background: Pain is a very common cause for emergency room visits. Nonpharmacologic pain management is not well studied for adult patients visiting the ED.

Dr. Hasanein is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Background: Pain is a very common cause for emergency room visits. Nonpharmacologic pain management is not well studied for adult patients visiting the ED.

Dr. Hasanein is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Background: Pain is a very common cause for emergency room visits. Nonpharmacologic pain management is not well studied for adult patients visiting the ED.

Dr. Hasanein is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Clinical question: Does prophylactic use of haloperidol increase survival in critically ill adults with high risk of delirium?

Background: Delirium is common and associated with high mortality. Studies evaluating prophylactic use of haloperidol have been inconclusive.

Study design: Randomized, double-blind, placebo-controlled, multicenter, investigator-driven study.

Setting: ICUs at university hospitals and teaching and nonteaching hospitals in the Netherlands.

Synopsis: 1,789 adults with mean age 66.6 years were randomized to receive either 1 or 2 mg of haloperidol or placebo. The 1-mg haloperidol group was prematurely stopped because of futility.

There was no difference in the primary outcome of survival days within a 28-day period between the 2-mg haloperidol group and the placebo group (hazard ratio, 1.003; 95% confidence interval, 0.78-1.30; P = .93).

Secondary outcome of survival was also the same at 90 days. No significant difference was seen in the delirium incidence, delirium- and coma-free days, and the delirium-related outcome measures.

Patients were already undergoing nonpharmacologic interventions for delirium prevention, and this likely attenuated the effects of haloperidol. The dose and duration of haloperidol used might have also been too low and short to have an effect on the outcomes considering the severity of patient illness.

Bottom line: Haloperidol has no role in prophylactic use to increase survival among critically ill patients with a high risk of delirium.

Citation: van den Boogaard M et al. Effect of haloperidol on survival among critically ill adults with a high risk of delirium: The REDUCE randomized clinical trial. JAMA. 2018 Feb 20;319(7):680-90.

Dr. Chikkanna is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Clinical question: Does prophylactic use of haloperidol increase survival in critically ill adults with high risk of delirium?

Background: Delirium is common and associated with high mortality. Studies evaluating prophylactic use of haloperidol have been inconclusive.

Study design: Randomized, double-blind, placebo-controlled, multicenter, investigator-driven study.

Setting: ICUs at university hospitals and teaching and nonteaching hospitals in the Netherlands.

Synopsis: 1,789 adults with mean age 66.6 years were randomized to receive either 1 or 2 mg of haloperidol or placebo. The 1-mg haloperidol group was prematurely stopped because of futility.

There was no difference in the primary outcome of survival days within a 28-day period between the 2-mg haloperidol group and the placebo group (hazard ratio, 1.003; 95% confidence interval, 0.78-1.30; P = .93).

Secondary outcome of survival was also the same at 90 days. No significant difference was seen in the delirium incidence, delirium- and coma-free days, and the delirium-related outcome measures.

Patients were already undergoing nonpharmacologic interventions for delirium prevention, and this likely attenuated the effects of haloperidol. The dose and duration of haloperidol used might have also been too low and short to have an effect on the outcomes considering the severity of patient illness.

Bottom line: Haloperidol has no role in prophylactic use to increase survival among critically ill patients with a high risk of delirium.

Citation: van den Boogaard M et al. Effect of haloperidol on survival among critically ill adults with a high risk of delirium: The REDUCE randomized clinical trial. JAMA. 2018 Feb 20;319(7):680-90.

Dr. Chikkanna is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Clinical question: Does prophylactic use of haloperidol increase survival in critically ill adults with high risk of delirium?

Background: Delirium is common and associated with high mortality. Studies evaluating prophylactic use of haloperidol have been inconclusive.

Study design: Randomized, double-blind, placebo-controlled, multicenter, investigator-driven study.

Setting: ICUs at university hospitals and teaching and nonteaching hospitals in the Netherlands.

Synopsis: 1,789 adults with mean age 66.6 years were randomized to receive either 1 or 2 mg of haloperidol or placebo. The 1-mg haloperidol group was prematurely stopped because of futility.

There was no difference in the primary outcome of survival days within a 28-day period between the 2-mg haloperidol group and the placebo group (hazard ratio, 1.003; 95% confidence interval, 0.78-1.30; P = .93).

Secondary outcome of survival was also the same at 90 days. No significant difference was seen in the delirium incidence, delirium- and coma-free days, and the delirium-related outcome measures.

Patients were already undergoing nonpharmacologic interventions for delirium prevention, and this likely attenuated the effects of haloperidol. The dose and duration of haloperidol used might have also been too low and short to have an effect on the outcomes considering the severity of patient illness.

Bottom line: Haloperidol has no role in prophylactic use to increase survival among critically ill patients with a high risk of delirium.

Citation: van den Boogaard M et al. Effect of haloperidol on survival among critically ill adults with a high risk of delirium: The REDUCE randomized clinical trial. JAMA. 2018 Feb 20;319(7):680-90.

Dr. Chikkanna is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Background: Delivery of high-quality, safe care is key to earning the trust and confidence of patients. Patients can be a valuable asset in determining and evaluating the quality and safety of the care they receive. Collectively analyzing patient perceptions remains a challenge.

One in 10 patients identified a PSI. There was variability in classifying incidents as PSIs in some categories. Of the concerns expressed by patients, 65% were not classified as PSI. Limitations included a focus on patient’s concerns rather than safety, PSI estimates based on patient’s feedback without clinical information, and lack of inter-rater reliability estimates.

Bottom line: Effective translation of patient experience can provide valuable insights about safety and quality of care in hospital.

Citation: O’Hara JK et al. What can patients tell us about the quality and safety of hospital care? Findings from a UK multicentre survey study. BMJ Qual Saf. 2018 Mar 15. doi: 10.1136/bmjqs-2017-006974.

Dr. Chikkanna is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Background: Delivery of high-quality, safe care is key to earning the trust and confidence of patients. Patients can be a valuable asset in determining and evaluating the quality and safety of the care they receive. Collectively analyzing patient perceptions remains a challenge.

One in 10 patients identified a PSI. There was variability in classifying incidents as PSIs in some categories. Of the concerns expressed by patients, 65% were not classified as PSI. Limitations included a focus on patient’s concerns rather than safety, PSI estimates based on patient’s feedback without clinical information, and lack of inter-rater reliability estimates.

Bottom line: Effective translation of patient experience can provide valuable insights about safety and quality of care in hospital.

Citation: O’Hara JK et al. What can patients tell us about the quality and safety of hospital care? Findings from a UK multicentre survey study. BMJ Qual Saf. 2018 Mar 15. doi: 10.1136/bmjqs-2017-006974.

Dr. Chikkanna is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Background: Delivery of high-quality, safe care is key to earning the trust and confidence of patients. Patients can be a valuable asset in determining and evaluating the quality and safety of the care they receive. Collectively analyzing patient perceptions remains a challenge.

One in 10 patients identified a PSI. There was variability in classifying incidents as PSIs in some categories. Of the concerns expressed by patients, 65% were not classified as PSI. Limitations included a focus on patient’s concerns rather than safety, PSI estimates based on patient’s feedback without clinical information, and lack of inter-rater reliability estimates.

Bottom line: Effective translation of patient experience can provide valuable insights about safety and quality of care in hospital.

Citation: O’Hara JK et al. What can patients tell us about the quality and safety of hospital care? Findings from a UK multicentre survey study. BMJ Qual Saf. 2018 Mar 15. doi: 10.1136/bmjqs-2017-006974.

Dr. Chikkanna is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Higher pretreatment drug concentrations close to a resistance breakpoint for susceptibility were associated with greater relapse risk in TB, based on data from 54 patients who relapsed and 63 who were treated and cured.

iLexx/Thinkstock

“We postulated that drug-susceptible Mycobacterium tuberculosis might have a graded spectrum of susceptibilities that could be used to determine the risk of relapse,” wrote Roberto Colangeli, PhD, of Rutgers University, Newark, N.J., and his colleagues.

In a study published in the New England Journal of Medicine, the researchers examined pretreatment bacterial isolates from adults with TB who had experienced relapse and those who were cured. Using these isolates, they identified the minimum inhibitory concentration (MIC) – the lowest concentration of the drug that prevents visible bacterial growth in culture – for isoniazid and rifampin.

Overall, after controlling for other potential relapse risk factors, higher pretreatment MIC values for both isoniazid and rifampin were associated with an increased relapse risk. For isoniazid, the average MIC below the breakpoint was 0.0334 mcg/mL for relapsed patients and 0.0286 mcg/mL for cured patients. For rifampin, the average MIC below the breakpoint was 0.0695 mcg/mL for relapsed patients and 0.0453 mcg/mL for cured patients. The higher values for the relapsed versus cured patients were represented by factors of 1.17 and 1.53 for isoniazid and rifampin, respectively.

The average age of the patients was 41 years; 83% were men, and 35% were non-Hispanic white.

The study findings were limited by several factors, including the small sample size, retrospective design, and inability to test MIC values from primary cultures versus subcultures, the researchers wrote. However, the results suggest an impact of MIC values on treatment outcomes, and “additional studies that are performed in larger, well-defined prospective cohorts and that include MIC testing of pretreatment culture isolates will be useful to better validate these findings,”

The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Colangeli reported no financial conflicts. Dr. Alland disclosed funding from Cepheid and several current and pending patents in the United States and Europe, with some royalties paid to Cepheid.

SOURCE: Colangeli R et al. N Engl J Med. 2018;379:823-33.

Higher pretreatment drug concentrations close to a resistance breakpoint for susceptibility were associated with greater relapse risk in TB, based on data from 54 patients who relapsed and 63 who were treated and cured.

iLexx/Thinkstock

“We postulated that drug-susceptible Mycobacterium tuberculosis might have a graded spectrum of susceptibilities that could be used to determine the risk of relapse,” wrote Roberto Colangeli, PhD, of Rutgers University, Newark, N.J., and his colleagues.

In a study published in the New England Journal of Medicine, the researchers examined pretreatment bacterial isolates from adults with TB who had experienced relapse and those who were cured. Using these isolates, they identified the minimum inhibitory concentration (MIC) – the lowest concentration of the drug that prevents visible bacterial growth in culture – for isoniazid and rifampin.

Overall, after controlling for other potential relapse risk factors, higher pretreatment MIC values for both isoniazid and rifampin were associated with an increased relapse risk. For isoniazid, the average MIC below the breakpoint was 0.0334 mcg/mL for relapsed patients and 0.0286 mcg/mL for cured patients. For rifampin, the average MIC below the breakpoint was 0.0695 mcg/mL for relapsed patients and 0.0453 mcg/mL for cured patients. The higher values for the relapsed versus cured patients were represented by factors of 1.17 and 1.53 for isoniazid and rifampin, respectively.

The average age of the patients was 41 years; 83% were men, and 35% were non-Hispanic white.

The study findings were limited by several factors, including the small sample size, retrospective design, and inability to test MIC values from primary cultures versus subcultures, the researchers wrote. However, the results suggest an impact of MIC values on treatment outcomes, and “additional studies that are performed in larger, well-defined prospective cohorts and that include MIC testing of pretreatment culture isolates will be useful to better validate these findings,”

The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Colangeli reported no financial conflicts. Dr. Alland disclosed funding from Cepheid and several current and pending patents in the United States and Europe, with some royalties paid to Cepheid.

SOURCE: Colangeli R et al. N Engl J Med. 2018;379:823-33.

Higher pretreatment drug concentrations close to a resistance breakpoint for susceptibility were associated with greater relapse risk in TB, based on data from 54 patients who relapsed and 63 who were treated and cured.

iLexx/Thinkstock

“We postulated that drug-susceptible Mycobacterium tuberculosis might have a graded spectrum of susceptibilities that could be used to determine the risk of relapse,” wrote Roberto Colangeli, PhD, of Rutgers University, Newark, N.J., and his colleagues.

In a study published in the New England Journal of Medicine, the researchers examined pretreatment bacterial isolates from adults with TB who had experienced relapse and those who were cured. Using these isolates, they identified the minimum inhibitory concentration (MIC) – the lowest concentration of the drug that prevents visible bacterial growth in culture – for isoniazid and rifampin.

Overall, after controlling for other potential relapse risk factors, higher pretreatment MIC values for both isoniazid and rifampin were associated with an increased relapse risk. For isoniazid, the average MIC below the breakpoint was 0.0334 mcg/mL for relapsed patients and 0.0286 mcg/mL for cured patients. For rifampin, the average MIC below the breakpoint was 0.0695 mcg/mL for relapsed patients and 0.0453 mcg/mL for cured patients. The higher values for the relapsed versus cured patients were represented by factors of 1.17 and 1.53 for isoniazid and rifampin, respectively.

The average age of the patients was 41 years; 83% were men, and 35% were non-Hispanic white.

The study findings were limited by several factors, including the small sample size, retrospective design, and inability to test MIC values from primary cultures versus subcultures, the researchers wrote. However, the results suggest an impact of MIC values on treatment outcomes, and “additional studies that are performed in larger, well-defined prospective cohorts and that include MIC testing of pretreatment culture isolates will be useful to better validate these findings,”

The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Colangeli reported no financial conflicts. Dr. Alland disclosed funding from Cepheid and several current and pending patents in the United States and Europe, with some royalties paid to Cepheid.

SOURCE: Colangeli R et al. N Engl J Med. 2018;379:823-33.

Both low-dose and full-dose rivaroxaban had superior benefit-risk profiles for extended venous thromboembolism (VTE) treatment compared with aspirin, according to results published in Thrombosis Research.

Sebastian Kaulitzki/Thinkstock

Incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower for patients treated with rivaroxaban at 20 mg and 10 mg, respectively, than for those treated with aspirin, reported Paolo Prandoni, MD, of the department of cardiothoracic and vascular sciences at the University of Padua, Italy, and his coauthors.

Investigators analyzed data from the EINSTEIN-CHOICE trial, a double-blind, randomized study of 3,365 patients aged 18 years or older with deep vein thrombosis or pulmonary embolism who had previously received anticoagulant treatment for 6-12 months. Patients were given either once-daily rivaroxaban at a low dose (10 mg), once-daily rivaroxaban at full dose (20 mg), or once- daily aspirin at a dose of 100 mg.

Benefit and risk were calculated using “excess numbers of events,” or the difference in cumulative incidences in a hypothetical population of 10,000 VTE patients treated for 1 year. Excess numbers of events were defined as the number of patients in this hypothetical population who would experience a particular event when treated with rivaroxaban (at either dose), minus that in the same population treated with aspirin.

The cumulative incidences of recurrent VTE in the full-dose rivaroxaban, low-dose rivaroxaban, and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively. The cumulative incidences of major bleeding in these groups were 0.7%, 0.4% and 0.5%, respectively.

In patients treated with 20 mg of rivaroxaban instead of aspirin, there would be 123 fewer episodes of pulmonary embolism (95% confidence interval, 21-226) and 198 fewer episodes of deep vein thrombosis (95% CI, 62-333).

In patients given 10 mg of rivaroxaban instead of aspirin, there would be 121 fewer episodes of pulmonary embolism (95% CI, 4-238) and 217 fewer episodes of deep vein thrombosis (95% CI, 92-342), Dr. Prandoni and his colleagues wrote.

Net clinical benefit was defined as the composite of symptomatic recurrent VTE and major bleeding events, and occurred in 23 patients in the full-dose rivaroxaban group, 17 patients in the low-dose rivaroxaban group, and 53 patients in the aspirin group.

For 10,000 patients treated for 1 year with rivaroxaban instead of aspirin, there would be 284 fewer net clinical benefit outcomes for the 20-mg dose (95% CI, 106-462) and 339 fewer (95% CI, 165-512) for the 10-mg dose. “Thus, compared with aspirin, one additional symptomatic recurrent VTE or major bleed would be avoided for every 36 or 30 patients treated with rivaroxaban 20 mg or 10 mg, respectively,” the investigators wrote.

The findings indicate that there is “no longer a place” for extended VTE treatment with aspirin, the investigators said.

“Extended anticoagulation with once daily rivaroxaban ... provides a clinically important benefit in terms of reduction in recurrent VTE,” they wrote. “Regardless of which dose is chosen ... rivaroxaban has a favourable benefit-risk profile relative to aspirin.”

Bayer AG funded the study. Dr. Prandoni reported financial relationships with Bayer, Sanofi, Daiichi Sankyo, and Pfizer.

SOURCE: Prandoni P et al. Thromb Res. 2018 Aug;168:121-9.

Both low-dose and full-dose rivaroxaban had superior benefit-risk profiles for extended venous thromboembolism (VTE) treatment compared with aspirin, according to results published in Thrombosis Research.

Sebastian Kaulitzki/Thinkstock

Incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower for patients treated with rivaroxaban at 20 mg and 10 mg, respectively, than for those treated with aspirin, reported Paolo Prandoni, MD, of the department of cardiothoracic and vascular sciences at the University of Padua, Italy, and his coauthors.

Investigators analyzed data from the EINSTEIN-CHOICE trial, a double-blind, randomized study of 3,365 patients aged 18 years or older with deep vein thrombosis or pulmonary embolism who had previously received anticoagulant treatment for 6-12 months. Patients were given either once-daily rivaroxaban at a low dose (10 mg), once-daily rivaroxaban at full dose (20 mg), or once- daily aspirin at a dose of 100 mg.

Benefit and risk were calculated using “excess numbers of events,” or the difference in cumulative incidences in a hypothetical population of 10,000 VTE patients treated for 1 year. Excess numbers of events were defined as the number of patients in this hypothetical population who would experience a particular event when treated with rivaroxaban (at either dose), minus that in the same population treated with aspirin.

The cumulative incidences of recurrent VTE in the full-dose rivaroxaban, low-dose rivaroxaban, and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively. The cumulative incidences of major bleeding in these groups were 0.7%, 0.4% and 0.5%, respectively.

In patients treated with 20 mg of rivaroxaban instead of aspirin, there would be 123 fewer episodes of pulmonary embolism (95% confidence interval, 21-226) and 198 fewer episodes of deep vein thrombosis (95% CI, 62-333).

In patients given 10 mg of rivaroxaban instead of aspirin, there would be 121 fewer episodes of pulmonary embolism (95% CI, 4-238) and 217 fewer episodes of deep vein thrombosis (95% CI, 92-342), Dr. Prandoni and his colleagues wrote.

Net clinical benefit was defined as the composite of symptomatic recurrent VTE and major bleeding events, and occurred in 23 patients in the full-dose rivaroxaban group, 17 patients in the low-dose rivaroxaban group, and 53 patients in the aspirin group.

For 10,000 patients treated for 1 year with rivaroxaban instead of aspirin, there would be 284 fewer net clinical benefit outcomes for the 20-mg dose (95% CI, 106-462) and 339 fewer (95% CI, 165-512) for the 10-mg dose. “Thus, compared with aspirin, one additional symptomatic recurrent VTE or major bleed would be avoided for every 36 or 30 patients treated with rivaroxaban 20 mg or 10 mg, respectively,” the investigators wrote.

The findings indicate that there is “no longer a place” for extended VTE treatment with aspirin, the investigators said.

“Extended anticoagulation with once daily rivaroxaban ... provides a clinically important benefit in terms of reduction in recurrent VTE,” they wrote. “Regardless of which dose is chosen ... rivaroxaban has a favourable benefit-risk profile relative to aspirin.”

Bayer AG funded the study. Dr. Prandoni reported financial relationships with Bayer, Sanofi, Daiichi Sankyo, and Pfizer.

SOURCE: Prandoni P et al. Thromb Res. 2018 Aug;168:121-9.

Both low-dose and full-dose rivaroxaban had superior benefit-risk profiles for extended venous thromboembolism (VTE) treatment compared with aspirin, according to results published in Thrombosis Research.

Sebastian Kaulitzki/Thinkstock

Incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower for patients treated with rivaroxaban at 20 mg and 10 mg, respectively, than for those treated with aspirin, reported Paolo Prandoni, MD, of the department of cardiothoracic and vascular sciences at the University of Padua, Italy, and his coauthors.

Investigators analyzed data from the EINSTEIN-CHOICE trial, a double-blind, randomized study of 3,365 patients aged 18 years or older with deep vein thrombosis or pulmonary embolism who had previously received anticoagulant treatment for 6-12 months. Patients were given either once-daily rivaroxaban at a low dose (10 mg), once-daily rivaroxaban at full dose (20 mg), or once- daily aspirin at a dose of 100 mg.

Benefit and risk were calculated using “excess numbers of events,” or the difference in cumulative incidences in a hypothetical population of 10,000 VTE patients treated for 1 year. Excess numbers of events were defined as the number of patients in this hypothetical population who would experience a particular event when treated with rivaroxaban (at either dose), minus that in the same population treated with aspirin.

The cumulative incidences of recurrent VTE in the full-dose rivaroxaban, low-dose rivaroxaban, and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively. The cumulative incidences of major bleeding in these groups were 0.7%, 0.4% and 0.5%, respectively.

In patients treated with 20 mg of rivaroxaban instead of aspirin, there would be 123 fewer episodes of pulmonary embolism (95% confidence interval, 21-226) and 198 fewer episodes of deep vein thrombosis (95% CI, 62-333).

In patients given 10 mg of rivaroxaban instead of aspirin, there would be 121 fewer episodes of pulmonary embolism (95% CI, 4-238) and 217 fewer episodes of deep vein thrombosis (95% CI, 92-342), Dr. Prandoni and his colleagues wrote.

Net clinical benefit was defined as the composite of symptomatic recurrent VTE and major bleeding events, and occurred in 23 patients in the full-dose rivaroxaban group, 17 patients in the low-dose rivaroxaban group, and 53 patients in the aspirin group.

For 10,000 patients treated for 1 year with rivaroxaban instead of aspirin, there would be 284 fewer net clinical benefit outcomes for the 20-mg dose (95% CI, 106-462) and 339 fewer (95% CI, 165-512) for the 10-mg dose. “Thus, compared with aspirin, one additional symptomatic recurrent VTE or major bleed would be avoided for every 36 or 30 patients treated with rivaroxaban 20 mg or 10 mg, respectively,” the investigators wrote.

The findings indicate that there is “no longer a place” for extended VTE treatment with aspirin, the investigators said.

“Extended anticoagulation with once daily rivaroxaban ... provides a clinically important benefit in terms of reduction in recurrent VTE,” they wrote. “Regardless of which dose is chosen ... rivaroxaban has a favourable benefit-risk profile relative to aspirin.”

Bayer AG funded the study. Dr. Prandoni reported financial relationships with Bayer, Sanofi, Daiichi Sankyo, and Pfizer.

SOURCE: Prandoni P et al. Thromb Res. 2018 Aug;168:121-9.

ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.

In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.

“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.

The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.

Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.

This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.

“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.

As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.

The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.

Dr. Sewell reported that he had no disclosures.

[email protected]

ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.

In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.

“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.

The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.

Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.

This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.

“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.

As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.

The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.

Dr. Sewell reported that he had no disclosures.

[email protected]

ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.

In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.

“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.

The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.

Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.

This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.

“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.

As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.

The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.

Dr. Sewell reported that he had no disclosures.

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