Jennie Smith

SAN DIEGO – Ketamine sedates violent and highly agitated patients in the emergency department faster than other widely used agents and with a similar rate of adverse events, based on the results of a small observational study presented at the annual meeting of the Society for Academic Emergency Medicine.

Dr. Jeffrey Riddell and his colleagues at the University of California San Francisco, Fresno, reported results from a prospective cohort of 83 patients, 18-65 years old, who presented with acute agitation requiring sedation at a single urban ED.

Ketamine was given to 21 patients at a median dose of 70 mg IV or 250 mg IM. Another 9 patients received haloperidol (5 mg IM), 39 got lorazepam or midazolam (2 mg IV or IM), and 14 were treated with a combination of haloperidol, diphenhydramine, and lorazepam.

Ketamine proved the fastest acting, with a median time to sedation of 3 minutes. Median time to sedation was 8 minutes for haloperidol alone, 10 minutes for the benzodiazepines, and 17.5 minutes for the combination of sedative agents. Patient selection may have been at play in the longer time seen with the combination therapy, a result of clinicians selecting this option for the most agitated patients, Dr. Riddell said in an interview.

Adverse events measured in the study were dystonia, hypotension, hypoxia, and intubation. One of the 9 patients in the haloperidol group had an adverse event, as did 2 of 14 given the combination, 3 of 39 given benzodiazepines, and 3 of 21 given ketamine. “The study wasn’t powered to detect a clinically significant difference in side effects, but in this small subset [the rate of adverse events] looked similar,” Dr. Riddell said.

Ketamine’s onset of action, compared with the other agents, was all the more remarkable, he said, because physicians did not separate intramuscular and intravenous delivery forms. Intramuscular delivery is generally slower, therefore, intravenous sedation with ketamine could be even faster than 3 minutes.

Dr. Riddell said his team hoped that the observational study will form the basis for a randomized controlled trial with clinicians blinded to treatment allocation. “Only the ED pharmacist will be aware of the medication type,” he said.

The preliminary data on ketamine’s speed and safety “bore out what our experience was with it in the ED,” he said. “There’s still not a lot of good data about it for agitated patients in the ED, though there’s tons of data for procedural sedation. Extrapolating from that, we’re trying to show that it also works in the ED population that needs a medication for sedation.”

The study was funded by the National Institutes of Health through a grant from the University of California San Francisco Clinical and Translational Science Institute. The investigators declared no conflicts of interest.

SAN DIEGO – Ketamine sedates violent and highly agitated patients in the emergency department faster than other widely used agents and with a similar rate of adverse events, based on the results of a small observational study presented at the annual meeting of the Society for Academic Emergency Medicine.

Dr. Jeffrey Riddell and his colleagues at the University of California San Francisco, Fresno, reported results from a prospective cohort of 83 patients, 18-65 years old, who presented with acute agitation requiring sedation at a single urban ED.

Ketamine was given to 21 patients at a median dose of 70 mg IV or 250 mg IM. Another 9 patients received haloperidol (5 mg IM), 39 got lorazepam or midazolam (2 mg IV or IM), and 14 were treated with a combination of haloperidol, diphenhydramine, and lorazepam.

Ketamine proved the fastest acting, with a median time to sedation of 3 minutes. Median time to sedation was 8 minutes for haloperidol alone, 10 minutes for the benzodiazepines, and 17.5 minutes for the combination of sedative agents. Patient selection may have been at play in the longer time seen with the combination therapy, a result of clinicians selecting this option for the most agitated patients, Dr. Riddell said in an interview.

Adverse events measured in the study were dystonia, hypotension, hypoxia, and intubation. One of the 9 patients in the haloperidol group had an adverse event, as did 2 of 14 given the combination, 3 of 39 given benzodiazepines, and 3 of 21 given ketamine. “The study wasn’t powered to detect a clinically significant difference in side effects, but in this small subset [the rate of adverse events] looked similar,” Dr. Riddell said.

Ketamine’s onset of action, compared with the other agents, was all the more remarkable, he said, because physicians did not separate intramuscular and intravenous delivery forms. Intramuscular delivery is generally slower, therefore, intravenous sedation with ketamine could be even faster than 3 minutes.

Dr. Riddell said his team hoped that the observational study will form the basis for a randomized controlled trial with clinicians blinded to treatment allocation. “Only the ED pharmacist will be aware of the medication type,” he said.

The preliminary data on ketamine’s speed and safety “bore out what our experience was with it in the ED,” he said. “There’s still not a lot of good data about it for agitated patients in the ED, though there’s tons of data for procedural sedation. Extrapolating from that, we’re trying to show that it also works in the ED population that needs a medication for sedation.”

The study was funded by the National Institutes of Health through a grant from the University of California San Francisco Clinical and Translational Science Institute. The investigators declared no conflicts of interest.

SAN DIEGO – Ketamine sedates violent and highly agitated patients in the emergency department faster than other widely used agents and with a similar rate of adverse events, based on the results of a small observational study presented at the annual meeting of the Society for Academic Emergency Medicine.

Dr. Jeffrey Riddell and his colleagues at the University of California San Francisco, Fresno, reported results from a prospective cohort of 83 patients, 18-65 years old, who presented with acute agitation requiring sedation at a single urban ED.

Ketamine was given to 21 patients at a median dose of 70 mg IV or 250 mg IM. Another 9 patients received haloperidol (5 mg IM), 39 got lorazepam or midazolam (2 mg IV or IM), and 14 were treated with a combination of haloperidol, diphenhydramine, and lorazepam.

Ketamine proved the fastest acting, with a median time to sedation of 3 minutes. Median time to sedation was 8 minutes for haloperidol alone, 10 minutes for the benzodiazepines, and 17.5 minutes for the combination of sedative agents. Patient selection may have been at play in the longer time seen with the combination therapy, a result of clinicians selecting this option for the most agitated patients, Dr. Riddell said in an interview.

Adverse events measured in the study were dystonia, hypotension, hypoxia, and intubation. One of the 9 patients in the haloperidol group had an adverse event, as did 2 of 14 given the combination, 3 of 39 given benzodiazepines, and 3 of 21 given ketamine. “The study wasn’t powered to detect a clinically significant difference in side effects, but in this small subset [the rate of adverse events] looked similar,” Dr. Riddell said.

Ketamine’s onset of action, compared with the other agents, was all the more remarkable, he said, because physicians did not separate intramuscular and intravenous delivery forms. Intramuscular delivery is generally slower, therefore, intravenous sedation with ketamine could be even faster than 3 minutes.

Dr. Riddell said his team hoped that the observational study will form the basis for a randomized controlled trial with clinicians blinded to treatment allocation. “Only the ED pharmacist will be aware of the medication type,” he said.

The preliminary data on ketamine’s speed and safety “bore out what our experience was with it in the ED,” he said. “There’s still not a lot of good data about it for agitated patients in the ED, though there’s tons of data for procedural sedation. Extrapolating from that, we’re trying to show that it also works in the ED population that needs a medication for sedation.”

The study was funded by the National Institutes of Health through a grant from the University of California San Francisco Clinical and Translational Science Institute. The investigators declared no conflicts of interest.

BOSTON – Findings presented at the annual scientific sessions of the American Diabetes Association showed that one widely used glucose-lowering agent, sitagliptin, was not associated with an increase in major atherosclerotic cardiovascular events or hospitalizations for heart failure, compared with placebo.

Results from TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) were reassuring to clinicians who consider sitagliptin (Januvia), like other dipeptidyl peptidase-4 (DPP-4) inhibitors, to be a well-tolerated, effective drug not associated with weight gain or hypoglycemia in patients with type 2 diabetes.

The TECOS findings, however, did raise questions about whether sitagliptin was different than other DPP-4 inhibitors in people with known cardiovascular disease.

A randomized controlled trial of saxagliptin (Onglyza) found a 27% increased risk of hospitalization for heart failure, compared with placebo.

A trial of alogliptin (Nesina) saw a numerical imbalance in hospitalizations for heart failure that did not reach statistical significance.

Speaking at the conference after the presentation of the TECOS findings, Dr. Allison B. Goldfine, head of the section of clinical, behavioral, and outcomes research at the Joslin Diabetes Center and of Harvard Medical School, both in Boston, who was not an investigator on any of the three trials, suggested several potential reasons that the signal for heart failure hospitalizations was inconsistent across the trials.

Dr. Goldfine pointed to important differences in trial design and duration. Patients in the alogliptin trial had acute coronary syndrome at baseline and hemoglobin A_1c levels of between 6.5% and 11%, and they were followed up a median of 18 months.

Patients in the saxagliptin trial had either established cardiovascular disease or multiple risk factors for vascular disease, HbA_1c of 6.5%-12%, and were followed 2 years. TECOS patients had a history of coronary artery disease, ischemic cerebrovascular disease, or atherosclerotic peripheral arterial disease, and had an HbA_1c between 6.5% and 8%. They were followed for 3 years.

Dr. Goldfine also noted the potential for differences in activity among the individual agents. “There are some different specificities and the potential for on- and off-target effects across these drugs,” she said, though these remain poorly understood.

“Is it a class effect? Maybe not, as there was no hospitalization for heart failure increase in TECOS,” Dr. Goldfine said. “But I want you to be very cautious in using this interpretation. These were not head-to-head studies, and there were differences in the patient illnesses and severities, comorbidities and concomitant therapies, sample sizes, duration of follow up, and a potential for altered attentiveness and therapeutic practices due to these baseline differences.”

Clinicians considering use of the DPP4 inhibitors “need to realize that there’s some uncertainty when evaluating the risk and benefit of any of our drugs,” she noted.

The TECOS findings will not be the last word on DPP-4 inhibitors and the mixed signals on heart failure seen to date, Dr. Goldfine said. “I think a lot of effort will go on in the very near future to try to understand these better to see if there’s an explanation.”

Dr. Goldfine disclosed past research support from Amneal, LifeScan, Nestle, Novo, and Nordisk.

BOSTON – Findings presented at the annual scientific sessions of the American Diabetes Association showed that one widely used glucose-lowering agent, sitagliptin, was not associated with an increase in major atherosclerotic cardiovascular events or hospitalizations for heart failure, compared with placebo.

Results from TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) were reassuring to clinicians who consider sitagliptin (Januvia), like other dipeptidyl peptidase-4 (DPP-4) inhibitors, to be a well-tolerated, effective drug not associated with weight gain or hypoglycemia in patients with type 2 diabetes.

The TECOS findings, however, did raise questions about whether sitagliptin was different than other DPP-4 inhibitors in people with known cardiovascular disease.

A randomized controlled trial of saxagliptin (Onglyza) found a 27% increased risk of hospitalization for heart failure, compared with placebo.

A trial of alogliptin (Nesina) saw a numerical imbalance in hospitalizations for heart failure that did not reach statistical significance.

Speaking at the conference after the presentation of the TECOS findings, Dr. Allison B. Goldfine, head of the section of clinical, behavioral, and outcomes research at the Joslin Diabetes Center and of Harvard Medical School, both in Boston, who was not an investigator on any of the three trials, suggested several potential reasons that the signal for heart failure hospitalizations was inconsistent across the trials.

Dr. Goldfine pointed to important differences in trial design and duration. Patients in the alogliptin trial had acute coronary syndrome at baseline and hemoglobin A_1c levels of between 6.5% and 11%, and they were followed up a median of 18 months.

Patients in the saxagliptin trial had either established cardiovascular disease or multiple risk factors for vascular disease, HbA_1c of 6.5%-12%, and were followed 2 years. TECOS patients had a history of coronary artery disease, ischemic cerebrovascular disease, or atherosclerotic peripheral arterial disease, and had an HbA_1c between 6.5% and 8%. They were followed for 3 years.

Dr. Goldfine also noted the potential for differences in activity among the individual agents. “There are some different specificities and the potential for on- and off-target effects across these drugs,” she said, though these remain poorly understood.

“Is it a class effect? Maybe not, as there was no hospitalization for heart failure increase in TECOS,” Dr. Goldfine said. “But I want you to be very cautious in using this interpretation. These were not head-to-head studies, and there were differences in the patient illnesses and severities, comorbidities and concomitant therapies, sample sizes, duration of follow up, and a potential for altered attentiveness and therapeutic practices due to these baseline differences.”

Clinicians considering use of the DPP4 inhibitors “need to realize that there’s some uncertainty when evaluating the risk and benefit of any of our drugs,” she noted.

The TECOS findings will not be the last word on DPP-4 inhibitors and the mixed signals on heart failure seen to date, Dr. Goldfine said. “I think a lot of effort will go on in the very near future to try to understand these better to see if there’s an explanation.”

Dr. Goldfine disclosed past research support from Amneal, LifeScan, Nestle, Novo, and Nordisk.

BOSTON – Findings presented at the annual scientific sessions of the American Diabetes Association showed that one widely used glucose-lowering agent, sitagliptin, was not associated with an increase in major atherosclerotic cardiovascular events or hospitalizations for heart failure, compared with placebo.

Results from TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) were reassuring to clinicians who consider sitagliptin (Januvia), like other dipeptidyl peptidase-4 (DPP-4) inhibitors, to be a well-tolerated, effective drug not associated with weight gain or hypoglycemia in patients with type 2 diabetes.

The TECOS findings, however, did raise questions about whether sitagliptin was different than other DPP-4 inhibitors in people with known cardiovascular disease.

A randomized controlled trial of saxagliptin (Onglyza) found a 27% increased risk of hospitalization for heart failure, compared with placebo.

A trial of alogliptin (Nesina) saw a numerical imbalance in hospitalizations for heart failure that did not reach statistical significance.

Speaking at the conference after the presentation of the TECOS findings, Dr. Allison B. Goldfine, head of the section of clinical, behavioral, and outcomes research at the Joslin Diabetes Center and of Harvard Medical School, both in Boston, who was not an investigator on any of the three trials, suggested several potential reasons that the signal for heart failure hospitalizations was inconsistent across the trials.

Dr. Goldfine pointed to important differences in trial design and duration. Patients in the alogliptin trial had acute coronary syndrome at baseline and hemoglobin A_1c levels of between 6.5% and 11%, and they were followed up a median of 18 months.

Patients in the saxagliptin trial had either established cardiovascular disease or multiple risk factors for vascular disease, HbA_1c of 6.5%-12%, and were followed 2 years. TECOS patients had a history of coronary artery disease, ischemic cerebrovascular disease, or atherosclerotic peripheral arterial disease, and had an HbA_1c between 6.5% and 8%. They were followed for 3 years.

Dr. Goldfine also noted the potential for differences in activity among the individual agents. “There are some different specificities and the potential for on- and off-target effects across these drugs,” she said, though these remain poorly understood.

“Is it a class effect? Maybe not, as there was no hospitalization for heart failure increase in TECOS,” Dr. Goldfine said. “But I want you to be very cautious in using this interpretation. These were not head-to-head studies, and there were differences in the patient illnesses and severities, comorbidities and concomitant therapies, sample sizes, duration of follow up, and a potential for altered attentiveness and therapeutic practices due to these baseline differences.”

Clinicians considering use of the DPP4 inhibitors “need to realize that there’s some uncertainty when evaluating the risk and benefit of any of our drugs,” she noted.

The TECOS findings will not be the last word on DPP-4 inhibitors and the mixed signals on heart failure seen to date, Dr. Goldfine said. “I think a lot of effort will go on in the very near future to try to understand these better to see if there’s an explanation.”

Dr. Goldfine disclosed past research support from Amneal, LifeScan, Nestle, Novo, and Nordisk.

SAN DIEGO – Children who have suffered blunt trauma are routinely screened in emergency departments for intra-abdominal injury via computed tomography of the abdomen and pelvis.

But concerns about excess exposure to CT radiation, particularly to the gonads, led one group of researchers to question whether it’s necessary to scan the entire abdominopelvic region in all of these patients to identify intra-abdominal injury (IAI).

Dr. Stacy Reynolds and her colleagues at the Carolinas Medical Center in Charlotte, N.C., hypothesized that CT limited to the radiographic abdomen – the region between the dome of the diaphragm to the top of the iliac crest – can capture the vast majority of IAIs in this population.

At the Society for Academic Emergency Medicine annual meeting, Dr. Reynolds presented results from a retrospective cohort study enrolling 313 hemodynamically stable pediatric patients (median age 14 years, 64% male) presenting to 12 EDs after blunt trauma. Patients with known pelvic fractures or hip dislocation were excluded, as they would have had a clear indication for a full abdominopelvic CT.

All subjects underwent axial abdominopelvic CT imaging. Researchers created matched pairs of images comprising the original scans and those that had been altered with software that truncated the pelvic portion of the study to create CT abdomen-only studies. Study radiologists were blinded to the results of the original scans.

Twenty-six IAI’s were diagnosed in 24 patients: 8 hepatic injuries, 12 splenic injuries, 5 renal injuries, and 1 retroperitoneal hemorrhage. Abdominal CT alone was 85% sensitive (95% confidence interval, 65%-96%) and 99% specific (95% CI, 97%-100%) in identifying IAIs. The four missed injuries were solid organ injuries within the radiographic abdomen. False positives occurred in two of the complete scans, both involving free fluid prompting suspicion of small bowel injury later ruled out by clinical observation.

Dr. Reynolds said in an interview said that the findings, while promising, were limited by the study’s small numbers, and its use of axial images alone, when sagittal images also would be required for the most accurate diagnoses. Also, physician suspicion of IAI prior to imaging was not captured because of the study’s retrospective design, she said. “The real key to whether or not this hypothesis is valuable is if physicians are able to target the right population of patients for application.”

Dr. Reynolds cautioned that the findings would need to be validated in a larger trial before any changes could be made to clinical practice. “Some of the outcomes that we need to make sure whether we’re missing are still rare,” she said. “You couldn’t feel confident that this is the right way to go with a study this small, but it establishes that we can safely and ethically pursue a multicenter trial that would examine the issue with bigger numbers.”

Other groups of investigators, including members of the Pediatric Emergency Care Applied Research Network (PECARN), also have taken up the question of identifying children at low risk of IAI who may not need CT screening after blunt trauma. In 2013, PECARN published a prediction rule using only patient history and physical examination findings intended to obviate use of CT in the lowest-risk patients (Ann. Emerg. Med. 2013;62:107-16.e2).

Dr. Reynolds said that while overuse of CT was a worrisome trend that could have long-term implications for patients, and that it was important to identify ways it might be limited, there is a reason it remains the go-to technology in the ED for detecting IAI. “It’s got very high sensitivity and specificity. If you’re a busy trauma surgeon who’s admitting 20 injured patients in a night, there’s no faster or more efficient way to determine whether the patient in front of you is injured.”

The study was funded by the Carolinas Trauma Network Research Center of Excellence. None of the investigators disclosed conflicts of interest.

SAN DIEGO – Children who have suffered blunt trauma are routinely screened in emergency departments for intra-abdominal injury via computed tomography of the abdomen and pelvis.

But concerns about excess exposure to CT radiation, particularly to the gonads, led one group of researchers to question whether it’s necessary to scan the entire abdominopelvic region in all of these patients to identify intra-abdominal injury (IAI).

Dr. Stacy Reynolds and her colleagues at the Carolinas Medical Center in Charlotte, N.C., hypothesized that CT limited to the radiographic abdomen – the region between the dome of the diaphragm to the top of the iliac crest – can capture the vast majority of IAIs in this population.

At the Society for Academic Emergency Medicine annual meeting, Dr. Reynolds presented results from a retrospective cohort study enrolling 313 hemodynamically stable pediatric patients (median age 14 years, 64% male) presenting to 12 EDs after blunt trauma. Patients with known pelvic fractures or hip dislocation were excluded, as they would have had a clear indication for a full abdominopelvic CT.

All subjects underwent axial abdominopelvic CT imaging. Researchers created matched pairs of images comprising the original scans and those that had been altered with software that truncated the pelvic portion of the study to create CT abdomen-only studies. Study radiologists were blinded to the results of the original scans.

Twenty-six IAI’s were diagnosed in 24 patients: 8 hepatic injuries, 12 splenic injuries, 5 renal injuries, and 1 retroperitoneal hemorrhage. Abdominal CT alone was 85% sensitive (95% confidence interval, 65%-96%) and 99% specific (95% CI, 97%-100%) in identifying IAIs. The four missed injuries were solid organ injuries within the radiographic abdomen. False positives occurred in two of the complete scans, both involving free fluid prompting suspicion of small bowel injury later ruled out by clinical observation.

Dr. Reynolds said in an interview said that the findings, while promising, were limited by the study’s small numbers, and its use of axial images alone, when sagittal images also would be required for the most accurate diagnoses. Also, physician suspicion of IAI prior to imaging was not captured because of the study’s retrospective design, she said. “The real key to whether or not this hypothesis is valuable is if physicians are able to target the right population of patients for application.”

Dr. Reynolds cautioned that the findings would need to be validated in a larger trial before any changes could be made to clinical practice. “Some of the outcomes that we need to make sure whether we’re missing are still rare,” she said. “You couldn’t feel confident that this is the right way to go with a study this small, but it establishes that we can safely and ethically pursue a multicenter trial that would examine the issue with bigger numbers.”

Other groups of investigators, including members of the Pediatric Emergency Care Applied Research Network (PECARN), also have taken up the question of identifying children at low risk of IAI who may not need CT screening after blunt trauma. In 2013, PECARN published a prediction rule using only patient history and physical examination findings intended to obviate use of CT in the lowest-risk patients (Ann. Emerg. Med. 2013;62:107-16.e2).

Dr. Reynolds said that while overuse of CT was a worrisome trend that could have long-term implications for patients, and that it was important to identify ways it might be limited, there is a reason it remains the go-to technology in the ED for detecting IAI. “It’s got very high sensitivity and specificity. If you’re a busy trauma surgeon who’s admitting 20 injured patients in a night, there’s no faster or more efficient way to determine whether the patient in front of you is injured.”

The study was funded by the Carolinas Trauma Network Research Center of Excellence. None of the investigators disclosed conflicts of interest.

SAN DIEGO – Children who have suffered blunt trauma are routinely screened in emergency departments for intra-abdominal injury via computed tomography of the abdomen and pelvis.

But concerns about excess exposure to CT radiation, particularly to the gonads, led one group of researchers to question whether it’s necessary to scan the entire abdominopelvic region in all of these patients to identify intra-abdominal injury (IAI).

Dr. Stacy Reynolds and her colleagues at the Carolinas Medical Center in Charlotte, N.C., hypothesized that CT limited to the radiographic abdomen – the region between the dome of the diaphragm to the top of the iliac crest – can capture the vast majority of IAIs in this population.

At the Society for Academic Emergency Medicine annual meeting, Dr. Reynolds presented results from a retrospective cohort study enrolling 313 hemodynamically stable pediatric patients (median age 14 years, 64% male) presenting to 12 EDs after blunt trauma. Patients with known pelvic fractures or hip dislocation were excluded, as they would have had a clear indication for a full abdominopelvic CT.

All subjects underwent axial abdominopelvic CT imaging. Researchers created matched pairs of images comprising the original scans and those that had been altered with software that truncated the pelvic portion of the study to create CT abdomen-only studies. Study radiologists were blinded to the results of the original scans.

Twenty-six IAI’s were diagnosed in 24 patients: 8 hepatic injuries, 12 splenic injuries, 5 renal injuries, and 1 retroperitoneal hemorrhage. Abdominal CT alone was 85% sensitive (95% confidence interval, 65%-96%) and 99% specific (95% CI, 97%-100%) in identifying IAIs. The four missed injuries were solid organ injuries within the radiographic abdomen. False positives occurred in two of the complete scans, both involving free fluid prompting suspicion of small bowel injury later ruled out by clinical observation.

Dr. Reynolds said in an interview said that the findings, while promising, were limited by the study’s small numbers, and its use of axial images alone, when sagittal images also would be required for the most accurate diagnoses. Also, physician suspicion of IAI prior to imaging was not captured because of the study’s retrospective design, she said. “The real key to whether or not this hypothesis is valuable is if physicians are able to target the right population of patients for application.”

Dr. Reynolds cautioned that the findings would need to be validated in a larger trial before any changes could be made to clinical practice. “Some of the outcomes that we need to make sure whether we’re missing are still rare,” she said. “You couldn’t feel confident that this is the right way to go with a study this small, but it establishes that we can safely and ethically pursue a multicenter trial that would examine the issue with bigger numbers.”

Other groups of investigators, including members of the Pediatric Emergency Care Applied Research Network (PECARN), also have taken up the question of identifying children at low risk of IAI who may not need CT screening after blunt trauma. In 2013, PECARN published a prediction rule using only patient history and physical examination findings intended to obviate use of CT in the lowest-risk patients (Ann. Emerg. Med. 2013;62:107-16.e2).

Dr. Reynolds said that while overuse of CT was a worrisome trend that could have long-term implications for patients, and that it was important to identify ways it might be limited, there is a reason it remains the go-to technology in the ED for detecting IAI. “It’s got very high sensitivity and specificity. If you’re a busy trauma surgeon who’s admitting 20 injured patients in a night, there’s no faster or more efficient way to determine whether the patient in front of you is injured.”

The study was funded by the Carolinas Trauma Network Research Center of Excellence. None of the investigators disclosed conflicts of interest.

BOSTON – The glucose-lowering drug sitagliptin, part of a class of drugs whose cardiovascular safety has been cast into doubt based on findings in trials of similar agents, was shown not to increase the risk of heart failure or other adverse cardiovascular outcomes in a large randomized trial.

Results presented June 8 at the annual scientific sessions of the American Diabetes Association and published simultaneously in the New England Journal of Medicine (doi:10.1056/NEJMoa1501352) revealed “no evidence of harm one way or another” for cardiovascular events or heart failure, Dr. Rury F. Holman, professor of diabetic medicine and diabetes trials unit director at the Oxford (England) Centre for Diabetes, Endocrinology & Metabolism, the study’s corresponding author, said at a press conference.

Though the manufacturer announced the main cardiovascular findings on sitagliptin (Januvia), earlier this year, the details of this trial – driven by concerns about a signal for increased risk of heart failure in two earlier trials of dipeptidyl peptidase 4 (DPP-4) inhibitors – were presented for the first time.

TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) enrolled 14,671 patients with type 2 diabetes in combination with cardiovascular disease who were age 50 years or older. Patients were recruited in 38 countries and randomized to add-on therapy with

sitagliptin or placebo in addition to other antihyperglycemic therapies used openly at physician discretion. At mean 3 years’ follow-up, sitagliptin was noninferior to placebo for a combined cardiovascular endpoint comprising first time to CV death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina (hazard ratio, 0.98; 95% confidence interval, 0.88-1.09, P < .001).

Hospitalizations for heart failure did not differ between the placebo and sitagliptin arms (HR, 1.0; 95% CI, 0.83-1.20, P = .98), and no significant differences were seen in rates of pancreatitis or pancreatic cancer.

All patients in both the control and intervention arms were treated to similar glucose targets by their physicians. Levels of glycated hemoglobin between the groups were close throughout the study period, with a difference of –0.29 for the sitagliptin arm (95% CI, –0.32 to –0.27). “That’s important because we didn’t want a glucose difference that might have influenced the cardiovascular outcomes one way or another,” Dr. Holman commented.

Dr. Eric D. Peterson, executive director of the Duke Clinical Research Institute as well as professor in the departments of medicine and cardiology and the Fred Cobb, MD, Distinguished Professor of Medicine of Duke University, Durham, N.C., who was a coauthor on the study, commented on its heart failure finding. TECOS had been prompted by unexpected

heart-failure signals seen in two earlier trials of DPP-4 inhibitors, saxagliptin and alogliptin.

“Given the size of our study, and the longer duration of follow-up, as well as the higher risk of our population, we feel that this puts to bed the question – at least with sitagliptin – that there’s any risk for heart failure increases,” Dr. Peterson said.

The investigators were careful to assert that few conclusions could be drawn for the class of drugs as a whole based on the TECOS findings but suggested chance could have played a role in the earlier studies.

The study was funded by sitagliptin’s manufacturer, Merck Sharp & Dohme. Dr. Holman disclosed a financial relationship with the study sponsor. Dr. Peterson disclosed financial relationships with other manufacturers.

BOSTON – The glucose-lowering drug sitagliptin, part of a class of drugs whose cardiovascular safety has been cast into doubt based on findings in trials of similar agents, was shown not to increase the risk of heart failure or other adverse cardiovascular outcomes in a large randomized trial.

Results presented June 8 at the annual scientific sessions of the American Diabetes Association and published simultaneously in the New England Journal of Medicine (doi:10.1056/NEJMoa1501352) revealed “no evidence of harm one way or another” for cardiovascular events or heart failure, Dr. Rury F. Holman, professor of diabetic medicine and diabetes trials unit director at the Oxford (England) Centre for Diabetes, Endocrinology & Metabolism, the study’s corresponding author, said at a press conference.

Though the manufacturer announced the main cardiovascular findings on sitagliptin (Januvia), earlier this year, the details of this trial – driven by concerns about a signal for increased risk of heart failure in two earlier trials of dipeptidyl peptidase 4 (DPP-4) inhibitors – were presented for the first time.

TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) enrolled 14,671 patients with type 2 diabetes in combination with cardiovascular disease who were age 50 years or older. Patients were recruited in 38 countries and randomized to add-on therapy with

sitagliptin or placebo in addition to other antihyperglycemic therapies used openly at physician discretion. At mean 3 years’ follow-up, sitagliptin was noninferior to placebo for a combined cardiovascular endpoint comprising first time to CV death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina (hazard ratio, 0.98; 95% confidence interval, 0.88-1.09, P < .001).

Hospitalizations for heart failure did not differ between the placebo and sitagliptin arms (HR, 1.0; 95% CI, 0.83-1.20, P = .98), and no significant differences were seen in rates of pancreatitis or pancreatic cancer.

All patients in both the control and intervention arms were treated to similar glucose targets by their physicians. Levels of glycated hemoglobin between the groups were close throughout the study period, with a difference of –0.29 for the sitagliptin arm (95% CI, –0.32 to –0.27). “That’s important because we didn’t want a glucose difference that might have influenced the cardiovascular outcomes one way or another,” Dr. Holman commented.

Dr. Eric D. Peterson, executive director of the Duke Clinical Research Institute as well as professor in the departments of medicine and cardiology and the Fred Cobb, MD, Distinguished Professor of Medicine of Duke University, Durham, N.C., who was a coauthor on the study, commented on its heart failure finding. TECOS had been prompted by unexpected

heart-failure signals seen in two earlier trials of DPP-4 inhibitors, saxagliptin and alogliptin.

“Given the size of our study, and the longer duration of follow-up, as well as the higher risk of our population, we feel that this puts to bed the question – at least with sitagliptin – that there’s any risk for heart failure increases,” Dr. Peterson said.

The investigators were careful to assert that few conclusions could be drawn for the class of drugs as a whole based on the TECOS findings but suggested chance could have played a role in the earlier studies.

The study was funded by sitagliptin’s manufacturer, Merck Sharp & Dohme. Dr. Holman disclosed a financial relationship with the study sponsor. Dr. Peterson disclosed financial relationships with other manufacturers.

BOSTON – The glucose-lowering drug sitagliptin, part of a class of drugs whose cardiovascular safety has been cast into doubt based on findings in trials of similar agents, was shown not to increase the risk of heart failure or other adverse cardiovascular outcomes in a large randomized trial.

Results presented June 8 at the annual scientific sessions of the American Diabetes Association and published simultaneously in the New England Journal of Medicine (doi:10.1056/NEJMoa1501352) revealed “no evidence of harm one way or another” for cardiovascular events or heart failure, Dr. Rury F. Holman, professor of diabetic medicine and diabetes trials unit director at the Oxford (England) Centre for Diabetes, Endocrinology & Metabolism, the study’s corresponding author, said at a press conference.

Though the manufacturer announced the main cardiovascular findings on sitagliptin (Januvia), earlier this year, the details of this trial – driven by concerns about a signal for increased risk of heart failure in two earlier trials of dipeptidyl peptidase 4 (DPP-4) inhibitors – were presented for the first time.

TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) enrolled 14,671 patients with type 2 diabetes in combination with cardiovascular disease who were age 50 years or older. Patients were recruited in 38 countries and randomized to add-on therapy with

sitagliptin or placebo in addition to other antihyperglycemic therapies used openly at physician discretion. At mean 3 years’ follow-up, sitagliptin was noninferior to placebo for a combined cardiovascular endpoint comprising first time to CV death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina (hazard ratio, 0.98; 95% confidence interval, 0.88-1.09, P < .001).

Hospitalizations for heart failure did not differ between the placebo and sitagliptin arms (HR, 1.0; 95% CI, 0.83-1.20, P = .98), and no significant differences were seen in rates of pancreatitis or pancreatic cancer.

All patients in both the control and intervention arms were treated to similar glucose targets by their physicians. Levels of glycated hemoglobin between the groups were close throughout the study period, with a difference of –0.29 for the sitagliptin arm (95% CI, –0.32 to –0.27). “That’s important because we didn’t want a glucose difference that might have influenced the cardiovascular outcomes one way or another,” Dr. Holman commented.

Dr. Eric D. Peterson, executive director of the Duke Clinical Research Institute as well as professor in the departments of medicine and cardiology and the Fred Cobb, MD, Distinguished Professor of Medicine of Duke University, Durham, N.C., who was a coauthor on the study, commented on its heart failure finding. TECOS had been prompted by unexpected

heart-failure signals seen in two earlier trials of DPP-4 inhibitors, saxagliptin and alogliptin.

“Given the size of our study, and the longer duration of follow-up, as well as the higher risk of our population, we feel that this puts to bed the question – at least with sitagliptin – that there’s any risk for heart failure increases,” Dr. Peterson said.

The investigators were careful to assert that few conclusions could be drawn for the class of drugs as a whole based on the TECOS findings but suggested chance could have played a role in the earlier studies.

The study was funded by sitagliptin’s manufacturer, Merck Sharp & Dohme. Dr. Holman disclosed a financial relationship with the study sponsor. Dr. Peterson disclosed financial relationships with other manufacturers.

BOSTON – Maternal obesity and increased weight gain during pregnancy are associated with changes to newborns’ cardiometabolic markers, and these associations are largely independent of infant adiposity, according to new research findings.

Maternal obesity and weight gain during pregnancy are established risk factors for childhood obesity, but the reasons for this remain little understood.

thinkstockphotos.com

In utero programming of infant metabolism may be occurring, providing reasons beyond fetal growth and fat accretion for the differences in lipid and hormonal profiles among infants, judging from the findings reported at the annual scientific sessions of the American Diabetes Association.

Presenting data from a cohort of 753 mother-infant pairs, Dominick J. Lemas, Ph.D., of the University of Colorado, Denver, said that samples of cord blood revealed “striking” associations.

Dr. Lemas and his colleagues found higher levels of cord blood glucose (P = .03), and leptin (P < .001) in newborns among mothers who gained more weight during pregnancy. Infants of women with higher body mass index when they became pregnant saw higher levels of leptin (P < .001) in cord blood and lower levels of HDL cholesterol (P = .05), even after adjusting for infant adiposity.

The leptin finding was particularly surprising, Dr. Lemas said. Leptin, a hormone that regulates food intake, energy output, and other functions, is synthesized by fatty tissues and therefore expected to be found in higher levels among infants with fatter body composition.

In this study, however, “the association actually became stronger when we adjusted for the adiposity of the infant,” he said.

The investigators looked carefully at cord blood lipids, including total and high-density lipoprotein (HDL) cholesterol, triglycerides, and free fatty acids. The finding that prepregnancy BMI was negatively associated with HDL cholesterol “was something very interesting for our group,” Dr. Lemas said at the conference. “In adults, abnormal lipid patterns are a very strong predictor of cardiovascular disease.”

The findings raise two main concerns, Dr. Lemas said. First, “what factors beyond maternal BMI and gestational weight gain contribute to the changes to these cardiometabolic biomarkers at delivery?” And second, he said, it remains to be seen if these markers persist or result in clinically meaningful differences: “It’s possible cord-blood biomarkers don’t predict the metabolic risk of these individuals a few years down the road.”

The investigators used data from Healthy Start, a cohort study funded by the National Institute of Diabetes and Digestive and Kidney Diseases. They disclosed no conflicts of interest, and the full paper on their findings will be published in the International Journal of Obesity.

BOSTON – Maternal obesity and increased weight gain during pregnancy are associated with changes to newborns’ cardiometabolic markers, and these associations are largely independent of infant adiposity, according to new research findings.

Maternal obesity and weight gain during pregnancy are established risk factors for childhood obesity, but the reasons for this remain little understood.

thinkstockphotos.com

In utero programming of infant metabolism may be occurring, providing reasons beyond fetal growth and fat accretion for the differences in lipid and hormonal profiles among infants, judging from the findings reported at the annual scientific sessions of the American Diabetes Association.

Presenting data from a cohort of 753 mother-infant pairs, Dominick J. Lemas, Ph.D., of the University of Colorado, Denver, said that samples of cord blood revealed “striking” associations.

Dr. Lemas and his colleagues found higher levels of cord blood glucose (P = .03), and leptin (P < .001) in newborns among mothers who gained more weight during pregnancy. Infants of women with higher body mass index when they became pregnant saw higher levels of leptin (P < .001) in cord blood and lower levels of HDL cholesterol (P = .05), even after adjusting for infant adiposity.

The leptin finding was particularly surprising, Dr. Lemas said. Leptin, a hormone that regulates food intake, energy output, and other functions, is synthesized by fatty tissues and therefore expected to be found in higher levels among infants with fatter body composition.

In this study, however, “the association actually became stronger when we adjusted for the adiposity of the infant,” he said.

The investigators looked carefully at cord blood lipids, including total and high-density lipoprotein (HDL) cholesterol, triglycerides, and free fatty acids. The finding that prepregnancy BMI was negatively associated with HDL cholesterol “was something very interesting for our group,” Dr. Lemas said at the conference. “In adults, abnormal lipid patterns are a very strong predictor of cardiovascular disease.”

The findings raise two main concerns, Dr. Lemas said. First, “what factors beyond maternal BMI and gestational weight gain contribute to the changes to these cardiometabolic biomarkers at delivery?” And second, he said, it remains to be seen if these markers persist or result in clinically meaningful differences: “It’s possible cord-blood biomarkers don’t predict the metabolic risk of these individuals a few years down the road.”

The investigators used data from Healthy Start, a cohort study funded by the National Institute of Diabetes and Digestive and Kidney Diseases. They disclosed no conflicts of interest, and the full paper on their findings will be published in the International Journal of Obesity.

BOSTON – Maternal obesity and increased weight gain during pregnancy are associated with changes to newborns’ cardiometabolic markers, and these associations are largely independent of infant adiposity, according to new research findings.

Maternal obesity and weight gain during pregnancy are established risk factors for childhood obesity, but the reasons for this remain little understood.

thinkstockphotos.com

In utero programming of infant metabolism may be occurring, providing reasons beyond fetal growth and fat accretion for the differences in lipid and hormonal profiles among infants, judging from the findings reported at the annual scientific sessions of the American Diabetes Association.

Presenting data from a cohort of 753 mother-infant pairs, Dominick J. Lemas, Ph.D., of the University of Colorado, Denver, said that samples of cord blood revealed “striking” associations.

Dr. Lemas and his colleagues found higher levels of cord blood glucose (P = .03), and leptin (P < .001) in newborns among mothers who gained more weight during pregnancy. Infants of women with higher body mass index when they became pregnant saw higher levels of leptin (P < .001) in cord blood and lower levels of HDL cholesterol (P = .05), even after adjusting for infant adiposity.

The leptin finding was particularly surprising, Dr. Lemas said. Leptin, a hormone that regulates food intake, energy output, and other functions, is synthesized by fatty tissues and therefore expected to be found in higher levels among infants with fatter body composition.

In this study, however, “the association actually became stronger when we adjusted for the adiposity of the infant,” he said.

The investigators looked carefully at cord blood lipids, including total and high-density lipoprotein (HDL) cholesterol, triglycerides, and free fatty acids. The finding that prepregnancy BMI was negatively associated with HDL cholesterol “was something very interesting for our group,” Dr. Lemas said at the conference. “In adults, abnormal lipid patterns are a very strong predictor of cardiovascular disease.”

The findings raise two main concerns, Dr. Lemas said. First, “what factors beyond maternal BMI and gestational weight gain contribute to the changes to these cardiometabolic biomarkers at delivery?” And second, he said, it remains to be seen if these markers persist or result in clinically meaningful differences: “It’s possible cord-blood biomarkers don’t predict the metabolic risk of these individuals a few years down the road.”

The investigators used data from Healthy Start, a cohort study funded by the National Institute of Diabetes and Digestive and Kidney Diseases. They disclosed no conflicts of interest, and the full paper on their findings will be published in the International Journal of Obesity.

BOSTON – A system to detect dropping blood glucose and suspend insulin delivery during sleep is safe and effective in children with type 1 diabetes as young as 4 years, according to results of a randomized controlled trial.

In a presentation to the annual scientific sessions of the American Diabetes Association, Dr. Bruce A. Buckingham of Stanford (Calif.) University showed that the system, which combines glucose monitoring with insulin pump connected wirelessly to a computer by the patient’s bedside, worked nearly as well in children as it had in a previous study enrolling adults (Diabetes Care 2014;37:1885-91).

Dr. Buckingham and his colleagues enrolled 36 children aged 4-10 years and 45 children aged 11-14 years. All the children had type 1 diabetes for a year or more and had been using an insulin pump at least 6 months. The youngsters had hemoglobin A_1c levels of 8% or lower, and the investigators confirmed the presence of nighttime hypoglycemia during 2 weeks of pretrial monitoring. The children were then randomized to the active or inactive system for 42 nights, of which 21 were active. Patients were not aware whether the system was active on any given night.

Insulin delivery was suspended when the computer predicted glucose would fall below 80 mg/dL within 30 minutes, to anticipate and prevent further drops to levels of 60 mg/dL or lower that could, if prolonged, trigger a seizure.

Unlike other systems for continuous glucose monitoring that alert patients of dropping glucose, this one used alarms only when levels dropped below 60 mg/dL. More often than not, Dr. Buckingham said, “people do not awaken to alarms.” The idea “is for the system to work in the background – a good night’s sleep without a seizure.”

Dr. Buckingham and his colleagues found that among about 1,900 nights recorded in the 11- to 14-year-old subgroup, the active system reduced the number of nights children’s glucose fell below 60 mg/dL for 2 hours or more from 8% in the control group to 3% in the active system (P < .001). Among about 1,600 nights monitored in the 4- to 10-year-olds, prolonged hypoglycemia was reduced from 5% of nights in the control group to 1% in the active group (P < .001).

Although younger children have a higher risk of fasting ketonemia that can be increased with insulin pump shut-offs, no episodes of ketosis occurred during the study, and there were no seizures.

The National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Buckingham disclosed advisory or consulting relationships with Medtronic, Sanofi, Novo Nordisk, Tandem, and ConvaTec.

BOSTON – A system to detect dropping blood glucose and suspend insulin delivery during sleep is safe and effective in children with type 1 diabetes as young as 4 years, according to results of a randomized controlled trial.

In a presentation to the annual scientific sessions of the American Diabetes Association, Dr. Bruce A. Buckingham of Stanford (Calif.) University showed that the system, which combines glucose monitoring with insulin pump connected wirelessly to a computer by the patient’s bedside, worked nearly as well in children as it had in a previous study enrolling adults (Diabetes Care 2014;37:1885-91).

Dr. Buckingham and his colleagues enrolled 36 children aged 4-10 years and 45 children aged 11-14 years. All the children had type 1 diabetes for a year or more and had been using an insulin pump at least 6 months. The youngsters had hemoglobin A_1c levels of 8% or lower, and the investigators confirmed the presence of nighttime hypoglycemia during 2 weeks of pretrial monitoring. The children were then randomized to the active or inactive system for 42 nights, of which 21 were active. Patients were not aware whether the system was active on any given night.

Insulin delivery was suspended when the computer predicted glucose would fall below 80 mg/dL within 30 minutes, to anticipate and prevent further drops to levels of 60 mg/dL or lower that could, if prolonged, trigger a seizure.

Unlike other systems for continuous glucose monitoring that alert patients of dropping glucose, this one used alarms only when levels dropped below 60 mg/dL. More often than not, Dr. Buckingham said, “people do not awaken to alarms.” The idea “is for the system to work in the background – a good night’s sleep without a seizure.”

Dr. Buckingham and his colleagues found that among about 1,900 nights recorded in the 11- to 14-year-old subgroup, the active system reduced the number of nights children’s glucose fell below 60 mg/dL for 2 hours or more from 8% in the control group to 3% in the active system (P < .001). Among about 1,600 nights monitored in the 4- to 10-year-olds, prolonged hypoglycemia was reduced from 5% of nights in the control group to 1% in the active group (P < .001).

Although younger children have a higher risk of fasting ketonemia that can be increased with insulin pump shut-offs, no episodes of ketosis occurred during the study, and there were no seizures.

The National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Buckingham disclosed advisory or consulting relationships with Medtronic, Sanofi, Novo Nordisk, Tandem, and ConvaTec.

BOSTON – A system to detect dropping blood glucose and suspend insulin delivery during sleep is safe and effective in children with type 1 diabetes as young as 4 years, according to results of a randomized controlled trial.

In a presentation to the annual scientific sessions of the American Diabetes Association, Dr. Bruce A. Buckingham of Stanford (Calif.) University showed that the system, which combines glucose monitoring with insulin pump connected wirelessly to a computer by the patient’s bedside, worked nearly as well in children as it had in a previous study enrolling adults (Diabetes Care 2014;37:1885-91).

Dr. Buckingham and his colleagues enrolled 36 children aged 4-10 years and 45 children aged 11-14 years. All the children had type 1 diabetes for a year or more and had been using an insulin pump at least 6 months. The youngsters had hemoglobin A_1c levels of 8% or lower, and the investigators confirmed the presence of nighttime hypoglycemia during 2 weeks of pretrial monitoring. The children were then randomized to the active or inactive system for 42 nights, of which 21 were active. Patients were not aware whether the system was active on any given night.

Insulin delivery was suspended when the computer predicted glucose would fall below 80 mg/dL within 30 minutes, to anticipate and prevent further drops to levels of 60 mg/dL or lower that could, if prolonged, trigger a seizure.

Unlike other systems for continuous glucose monitoring that alert patients of dropping glucose, this one used alarms only when levels dropped below 60 mg/dL. More often than not, Dr. Buckingham said, “people do not awaken to alarms.” The idea “is for the system to work in the background – a good night’s sleep without a seizure.”

Dr. Buckingham and his colleagues found that among about 1,900 nights recorded in the 11- to 14-year-old subgroup, the active system reduced the number of nights children’s glucose fell below 60 mg/dL for 2 hours or more from 8% in the control group to 3% in the active system (P < .001). Among about 1,600 nights monitored in the 4- to 10-year-olds, prolonged hypoglycemia was reduced from 5% of nights in the control group to 1% in the active group (P < .001).

Although younger children have a higher risk of fasting ketonemia that can be increased with insulin pump shut-offs, no episodes of ketosis occurred during the study, and there were no seizures.

The National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Buckingham disclosed advisory or consulting relationships with Medtronic, Sanofi, Novo Nordisk, Tandem, and ConvaTec.

SAN DIEGO – A simple three-variable prediction rule can accurately predict which febrile infants younger than 2 months with fever who present to the emergency department have serious bacterial infections.

Bacterial meningitis, urinary tract infections, and bacteremia are considered serious bacterial infections; many young infants with these infections are difficult to identify, and current laboratory protocols for identifying them include urinalysis, white blood cell counts, band counts, and sometimes cerebrospinal fluid.

If validated in larger studies, the new prediction rule – which does not require cerebrospinal fluid – could limit lumbar punctures, antibiotic use, and unnecessary hospitalizations among infants at negligible risk of serious bacterial infections (SBI).

In a presentation at the annual meeting of the Society for Academic Emergency Medicine, Dr. Nathan Kuppermann of the University of California, Davis, demonstrated results from a large prospective cohort study of 1,821 febrile infants 60 days old and younger conducted at 21 emergency departments. Infants with underlying congenital anomalies or critical illness were excluded from the study.

The investigators evaluated eight variables as potential predictors: age, temperature, Yale Observation Scale score, and clinician suspicion of SBI, along with four laboratory variables (urinalysis, white blood cell count, absolute neutrophil count [ANC], and procalcitonin). Band counts were available at some, but not all of the study centers, and therefore were not evaluated.

Dr. Kuppermann and his colleagues found that positive urinalysis, ANC of 4.09 x 1,000/mm³ or higher, and serum procalcitonin of 1.71 ng/mL or higher were, taken together, 98%-99% sensitive and about 60% specific, in predicting SBI in the cohort. Negative predictive values approached 100%. The rate of SBI was 9.3% of the cohort, in keeping with expected rates.

“The SBI positive group was more likely to have higher clinician suspicion of SBI, and all of the lab markers were more elevated in the SBI positive group than the SBI negative group,” Dr. Kuppermann said at the meeting. However, after the researchers considered all of the predictors as a group, only the urinalysis, the ANC, and the procalcitonin remained important. Only 3 of 170 (1.76%)* infants with SBIs were missed when the three-variable prediction tool was used.

To make the prediction rule easier to remember and use, the investigators evaluated lower, more standard, and easier to remember thresholds for the three variables. They reanalyzed their data using a lower cutoff point for ANC of 4.00 x 1,000/mm³, and a lowered procalcitonin cutoff of 0.5 ng/mL. The rule performed almost identically as the original rule, and did not miss any more patients with SBIs beyond the original three.

Dr. Kuppermann described the three-variable rule as “simple, objective, and highly accurate” in predicting or ruling out SBI. Nonetheless, it requires external validation in a large cohort, he acknowledged. He said he would continue to routinely perform lumbar punctures in infants younger than 30 days with fever until the findings could be further validated.

“But personally, in that second month of life, I would use these data to decide who actually needs a lumbar puncture and hospitalization,” he said.

Dr. Kuppermann also noted as a limitation of the study that the cohort included few infants with bacterial meningitis.

The study was conducted in the Pediatric Emergency Care Applied Research Network (PECARN) and supported by grants from the Health Resources and Services Administration, the Maternal and Child Health Bureau, the Emergency Medical Services for Children program, and the National Institutes of Health. Dr. Kuppermann disclosed no relevant conflicts of interest.

*A correction was made to this article 6/24/15 

SAN DIEGO – A simple three-variable prediction rule can accurately predict which febrile infants younger than 2 months with fever who present to the emergency department have serious bacterial infections.

Bacterial meningitis, urinary tract infections, and bacteremia are considered serious bacterial infections; many young infants with these infections are difficult to identify, and current laboratory protocols for identifying them include urinalysis, white blood cell counts, band counts, and sometimes cerebrospinal fluid.

If validated in larger studies, the new prediction rule – which does not require cerebrospinal fluid – could limit lumbar punctures, antibiotic use, and unnecessary hospitalizations among infants at negligible risk of serious bacterial infections (SBI).

In a presentation at the annual meeting of the Society for Academic Emergency Medicine, Dr. Nathan Kuppermann of the University of California, Davis, demonstrated results from a large prospective cohort study of 1,821 febrile infants 60 days old and younger conducted at 21 emergency departments. Infants with underlying congenital anomalies or critical illness were excluded from the study.

The investigators evaluated eight variables as potential predictors: age, temperature, Yale Observation Scale score, and clinician suspicion of SBI, along with four laboratory variables (urinalysis, white blood cell count, absolute neutrophil count [ANC], and procalcitonin). Band counts were available at some, but not all of the study centers, and therefore were not evaluated.

Dr. Kuppermann and his colleagues found that positive urinalysis, ANC of 4.09 x 1,000/mm³ or higher, and serum procalcitonin of 1.71 ng/mL or higher were, taken together, 98%-99% sensitive and about 60% specific, in predicting SBI in the cohort. Negative predictive values approached 100%. The rate of SBI was 9.3% of the cohort, in keeping with expected rates.

“The SBI positive group was more likely to have higher clinician suspicion of SBI, and all of the lab markers were more elevated in the SBI positive group than the SBI negative group,” Dr. Kuppermann said at the meeting. However, after the researchers considered all of the predictors as a group, only the urinalysis, the ANC, and the procalcitonin remained important. Only 3 of 170 (1.76%)* infants with SBIs were missed when the three-variable prediction tool was used.

To make the prediction rule easier to remember and use, the investigators evaluated lower, more standard, and easier to remember thresholds for the three variables. They reanalyzed their data using a lower cutoff point for ANC of 4.00 x 1,000/mm³, and a lowered procalcitonin cutoff of 0.5 ng/mL. The rule performed almost identically as the original rule, and did not miss any more patients with SBIs beyond the original three.

Dr. Kuppermann described the three-variable rule as “simple, objective, and highly accurate” in predicting or ruling out SBI. Nonetheless, it requires external validation in a large cohort, he acknowledged. He said he would continue to routinely perform lumbar punctures in infants younger than 30 days with fever until the findings could be further validated.

“But personally, in that second month of life, I would use these data to decide who actually needs a lumbar puncture and hospitalization,” he said.

Dr. Kuppermann also noted as a limitation of the study that the cohort included few infants with bacterial meningitis.

The study was conducted in the Pediatric Emergency Care Applied Research Network (PECARN) and supported by grants from the Health Resources and Services Administration, the Maternal and Child Health Bureau, the Emergency Medical Services for Children program, and the National Institutes of Health. Dr. Kuppermann disclosed no relevant conflicts of interest.

*A correction was made to this article 6/24/15 

SAN DIEGO – A simple three-variable prediction rule can accurately predict which febrile infants younger than 2 months with fever who present to the emergency department have serious bacterial infections.

Bacterial meningitis, urinary tract infections, and bacteremia are considered serious bacterial infections; many young infants with these infections are difficult to identify, and current laboratory protocols for identifying them include urinalysis, white blood cell counts, band counts, and sometimes cerebrospinal fluid.

If validated in larger studies, the new prediction rule – which does not require cerebrospinal fluid – could limit lumbar punctures, antibiotic use, and unnecessary hospitalizations among infants at negligible risk of serious bacterial infections (SBI).

In a presentation at the annual meeting of the Society for Academic Emergency Medicine, Dr. Nathan Kuppermann of the University of California, Davis, demonstrated results from a large prospective cohort study of 1,821 febrile infants 60 days old and younger conducted at 21 emergency departments. Infants with underlying congenital anomalies or critical illness were excluded from the study.

The investigators evaluated eight variables as potential predictors: age, temperature, Yale Observation Scale score, and clinician suspicion of SBI, along with four laboratory variables (urinalysis, white blood cell count, absolute neutrophil count [ANC], and procalcitonin). Band counts were available at some, but not all of the study centers, and therefore were not evaluated.

Dr. Kuppermann and his colleagues found that positive urinalysis, ANC of 4.09 x 1,000/mm³ or higher, and serum procalcitonin of 1.71 ng/mL or higher were, taken together, 98%-99% sensitive and about 60% specific, in predicting SBI in the cohort. Negative predictive values approached 100%. The rate of SBI was 9.3% of the cohort, in keeping with expected rates.

“The SBI positive group was more likely to have higher clinician suspicion of SBI, and all of the lab markers were more elevated in the SBI positive group than the SBI negative group,” Dr. Kuppermann said at the meeting. However, after the researchers considered all of the predictors as a group, only the urinalysis, the ANC, and the procalcitonin remained important. Only 3 of 170 (1.76%)* infants with SBIs were missed when the three-variable prediction tool was used.

To make the prediction rule easier to remember and use, the investigators evaluated lower, more standard, and easier to remember thresholds for the three variables. They reanalyzed their data using a lower cutoff point for ANC of 4.00 x 1,000/mm³, and a lowered procalcitonin cutoff of 0.5 ng/mL. The rule performed almost identically as the original rule, and did not miss any more patients with SBIs beyond the original three.

Dr. Kuppermann described the three-variable rule as “simple, objective, and highly accurate” in predicting or ruling out SBI. Nonetheless, it requires external validation in a large cohort, he acknowledged. He said he would continue to routinely perform lumbar punctures in infants younger than 30 days with fever until the findings could be further validated.

“But personally, in that second month of life, I would use these data to decide who actually needs a lumbar puncture and hospitalization,” he said.

Dr. Kuppermann also noted as a limitation of the study that the cohort included few infants with bacterial meningitis.

The study was conducted in the Pediatric Emergency Care Applied Research Network (PECARN) and supported by grants from the Health Resources and Services Administration, the Maternal and Child Health Bureau, the Emergency Medical Services for Children program, and the National Institutes of Health. Dr. Kuppermann disclosed no relevant conflicts of interest.

*A correction was made to this article 6/24/15 

SAN DIEGO – More than 10% of geriatric patients presenting to emergency departments have signs of delirium, but not all delirium in the ED is equal, based on two presentations at the annual meeting of the Society for Academic Emergency Medicine.

For elderly patients in the emergency department, delirium is not merely present or absent. It is a heterogeneous syndrome, and certain subtypes likely indicate higher risk.

Dr. Jin Han, a researcher at Vanderbilt University in Nashville, Tenn., presented findings from a prospective, single-center observational study of 1,084 ED patients over age 65. Subjects were screened for delirium and their level of alertness. Of the 14% of patients with delirium, the researchers found the state of a patient’s arousal – decreased, normal, or increased – affected 6-month mortality.

In a separate study, Dr. Maura Kennedy of Harvard Medical School in Boston presented data suggesting that certain subtypes of delirium – particularly delirium with hypoactivity – are getting missed in the ED.

In Dr. Han’s study of 155 patients with delirium, a 4-point measurement called the Confusion Assessment Method for the Intensive Care Unit, (CAM-ICU) and the Richmond Agitation Sedation Scale (RASS) were used to measure delirium. Those with normal arousal as measured by RASS (n=15) had the highest 6-month mortality, at 40% (95% confidence interval, 20%-64%). In those with decreased arousal, the mortality rate was 27% (95% CI, 20%-35%); in those with increased arousal, mortality was 25%. The 6-month mortality rate in elderly ED patients without delirium was 11%.

Dr. Han acknowledged his study’s wide confidence intervals and the limitations of its single-site design and its screening tool, CAM-ICU, which has 70% sensitivity. Nonetheless, the findings imply that delirium needs to be looked at much more carefully in the ED. “Now if I see a patient with delirium and normal arousal, I want to make sure I rule out a potentially life-threatening illness,” he said in an interview.

Dr. Han’s research team is now collecting additional data, including etiology data and serum biomarkers, from ED patients with delirium in the hope of learning “why delirious patients with normal arousal do so poorly in terms of mortality.”

Dr. Kennedy presented a study from a cohort of 622 ED patients age 65 and older, who were screened using a tool called the Memorial Delirium Assessment Scale. The researchers compared their screening results to what doctors and nurses observed in the ED. Dr. Kennedy and her colleagues found that physicians were more likely to document delirium in a nonhypoactive patient, compared with a patient with hypoactive delirium (78% vs. 45%; P = .02).

“After all, an 88-year-old person screaming or hallucinating will get your attention, while in a busy ED, someone sleeping quietly in a bed at 2 pm might not,” Dr. Kennedy said in an interview.

Hypoactive delirium is easy to miss and is associated with poor outcomes. It needs to be screened for in the ED, as it could be dangerous to discharge some patients with delirium. Even if the patient is admitted, she added, delirium “is not necessarily going to be picked up upstairs” in the hospital.

More research needs to focus on “trying to identify the underlying cause [of delirium] in patients presenting to the ED,” Dr. Kennedy said. “And we need to start really looking at delirium as indicative of something else being wrong.”

Dr. Han’s study was funded by the National Institute on Aging and by the Emergency Medicine Foundation Center; he disclosed a consulting relationship with Bio-Signal Group. Dr. Kennedy’s studies were funded by the National Institute on Aging, and the Dennis W. Jahnigen Career Development Award. She disclosed no conflicts of interest.

SAN DIEGO – More than 10% of geriatric patients presenting to emergency departments have signs of delirium, but not all delirium in the ED is equal, based on two presentations at the annual meeting of the Society for Academic Emergency Medicine.

For elderly patients in the emergency department, delirium is not merely present or absent. It is a heterogeneous syndrome, and certain subtypes likely indicate higher risk.

Dr. Jin Han, a researcher at Vanderbilt University in Nashville, Tenn., presented findings from a prospective, single-center observational study of 1,084 ED patients over age 65. Subjects were screened for delirium and their level of alertness. Of the 14% of patients with delirium, the researchers found the state of a patient’s arousal – decreased, normal, or increased – affected 6-month mortality.

In a separate study, Dr. Maura Kennedy of Harvard Medical School in Boston presented data suggesting that certain subtypes of delirium – particularly delirium with hypoactivity – are getting missed in the ED.

In Dr. Han’s study of 155 patients with delirium, a 4-point measurement called the Confusion Assessment Method for the Intensive Care Unit, (CAM-ICU) and the Richmond Agitation Sedation Scale (RASS) were used to measure delirium. Those with normal arousal as measured by RASS (n=15) had the highest 6-month mortality, at 40% (95% confidence interval, 20%-64%). In those with decreased arousal, the mortality rate was 27% (95% CI, 20%-35%); in those with increased arousal, mortality was 25%. The 6-month mortality rate in elderly ED patients without delirium was 11%.

Dr. Han acknowledged his study’s wide confidence intervals and the limitations of its single-site design and its screening tool, CAM-ICU, which has 70% sensitivity. Nonetheless, the findings imply that delirium needs to be looked at much more carefully in the ED. “Now if I see a patient with delirium and normal arousal, I want to make sure I rule out a potentially life-threatening illness,” he said in an interview.

Dr. Han’s research team is now collecting additional data, including etiology data and serum biomarkers, from ED patients with delirium in the hope of learning “why delirious patients with normal arousal do so poorly in terms of mortality.”

Dr. Kennedy presented a study from a cohort of 622 ED patients age 65 and older, who were screened using a tool called the Memorial Delirium Assessment Scale. The researchers compared their screening results to what doctors and nurses observed in the ED. Dr. Kennedy and her colleagues found that physicians were more likely to document delirium in a nonhypoactive patient, compared with a patient with hypoactive delirium (78% vs. 45%; P = .02).

“After all, an 88-year-old person screaming or hallucinating will get your attention, while in a busy ED, someone sleeping quietly in a bed at 2 pm might not,” Dr. Kennedy said in an interview.

Hypoactive delirium is easy to miss and is associated with poor outcomes. It needs to be screened for in the ED, as it could be dangerous to discharge some patients with delirium. Even if the patient is admitted, she added, delirium “is not necessarily going to be picked up upstairs” in the hospital.

More research needs to focus on “trying to identify the underlying cause [of delirium] in patients presenting to the ED,” Dr. Kennedy said. “And we need to start really looking at delirium as indicative of something else being wrong.”

Dr. Han’s study was funded by the National Institute on Aging and by the Emergency Medicine Foundation Center; he disclosed a consulting relationship with Bio-Signal Group. Dr. Kennedy’s studies were funded by the National Institute on Aging, and the Dennis W. Jahnigen Career Development Award. She disclosed no conflicts of interest.

SAN DIEGO – More than 10% of geriatric patients presenting to emergency departments have signs of delirium, but not all delirium in the ED is equal, based on two presentations at the annual meeting of the Society for Academic Emergency Medicine.

For elderly patients in the emergency department, delirium is not merely present or absent. It is a heterogeneous syndrome, and certain subtypes likely indicate higher risk.

Dr. Jin Han, a researcher at Vanderbilt University in Nashville, Tenn., presented findings from a prospective, single-center observational study of 1,084 ED patients over age 65. Subjects were screened for delirium and their level of alertness. Of the 14% of patients with delirium, the researchers found the state of a patient’s arousal – decreased, normal, or increased – affected 6-month mortality.

In a separate study, Dr. Maura Kennedy of Harvard Medical School in Boston presented data suggesting that certain subtypes of delirium – particularly delirium with hypoactivity – are getting missed in the ED.

In Dr. Han’s study of 155 patients with delirium, a 4-point measurement called the Confusion Assessment Method for the Intensive Care Unit, (CAM-ICU) and the Richmond Agitation Sedation Scale (RASS) were used to measure delirium. Those with normal arousal as measured by RASS (n=15) had the highest 6-month mortality, at 40% (95% confidence interval, 20%-64%). In those with decreased arousal, the mortality rate was 27% (95% CI, 20%-35%); in those with increased arousal, mortality was 25%. The 6-month mortality rate in elderly ED patients without delirium was 11%.

Dr. Han acknowledged his study’s wide confidence intervals and the limitations of its single-site design and its screening tool, CAM-ICU, which has 70% sensitivity. Nonetheless, the findings imply that delirium needs to be looked at much more carefully in the ED. “Now if I see a patient with delirium and normal arousal, I want to make sure I rule out a potentially life-threatening illness,” he said in an interview.

Dr. Han’s research team is now collecting additional data, including etiology data and serum biomarkers, from ED patients with delirium in the hope of learning “why delirious patients with normal arousal do so poorly in terms of mortality.”

Dr. Kennedy presented a study from a cohort of 622 ED patients age 65 and older, who were screened using a tool called the Memorial Delirium Assessment Scale. The researchers compared their screening results to what doctors and nurses observed in the ED. Dr. Kennedy and her colleagues found that physicians were more likely to document delirium in a nonhypoactive patient, compared with a patient with hypoactive delirium (78% vs. 45%; P = .02).

“After all, an 88-year-old person screaming or hallucinating will get your attention, while in a busy ED, someone sleeping quietly in a bed at 2 pm might not,” Dr. Kennedy said in an interview.

Hypoactive delirium is easy to miss and is associated with poor outcomes. It needs to be screened for in the ED, as it could be dangerous to discharge some patients with delirium. Even if the patient is admitted, she added, delirium “is not necessarily going to be picked up upstairs” in the hospital.

More research needs to focus on “trying to identify the underlying cause [of delirium] in patients presenting to the ED,” Dr. Kennedy said. “And we need to start really looking at delirium as indicative of something else being wrong.”

Dr. Han’s study was funded by the National Institute on Aging and by the Emergency Medicine Foundation Center; he disclosed a consulting relationship with Bio-Signal Group. Dr. Kennedy’s studies were funded by the National Institute on Aging, and the Dennis W. Jahnigen Career Development Award. She disclosed no conflicts of interest.

New guidelines on traumatic brain injury and neuroendocrine dysfunction ask clinicians to be mindful that hypopituitarism in TBI survivors can develop following injuries classified as mild and can be slow to develop.

The guidelines – published online May 7, 2015,in Endocrine Reviews (doi:10.1210/er.2014-1065) and based on a review of 16 studies conducted between 2014 and 2011 – emphasize early detection and treatment of hypopituitarism in adults with TBI; recognition can be difficult because symptoms can progress slowly and be nonspecific. Deficiencies in pituitary hormones have been linked to elevated cardiovascular, metabolic, and cognitive risks, though studies in TBI populations are scant.About 12% of people with TBI will show persistent neuroendocrine dysfunction on repeat testing, according to Dr. Fatih Tanriverdi of Erciyes University in Kayseri, Turkey, and his associates. Although growth hormone (GH) deficiencies are the most common type of hormone deficiency after TBI, adrenocorticotropic hormone (ACTH), gonadotropins (FSH and LH), and thyroid-stimulating hormone (TSH) can all be diminished.

Dr. Tanriverdi and his colleagues noted that much more research is needed to determine the precise pathways by which TBI can cause pituitary dysfunction and whether hormone replacement can bring about functional or cognitive improvement in TBI patients with deficiencies. In addition to severity of injury, genetic factors, inflammation, and autoimmunity appear to bear on the risk of hypopituitarism after TBI, they said.

The guidelines recommend routine screening and early treatment for people with complicated mild TBI – a Glasgow coma score of 13-15 with some abnormalities on CT or MRI, hospitalization longer than 24 hours, or acute pituitary hormonal changes after injury – and for moderate and severe TBI. People with uncomplicated mild TBI (GCS of 13-15 but no screening abnormalities) are considered at low risk of developing pituitary dysfunction and do not need to be followed.

Patients with complicated mild TBI should be screened for ACTH deficiency immediately after injury and at hospital discharge and treated if necessary. At 6 months they should be reassessed for ACTH, TSH, and FSH/LH deficiencies and treated with hormone replacement therapy as needed. At a year post injury, patients should be assessed for GH deficiency and treated for this as well, if necessary, with annual clinical and hormonal evaluations continuing 5 years.

If no hormone deficiencies are found at 12 months, patients should still be reassessed annually through the fif^th year for hypopituitarism, as hormone deficiencies can still develop.

Patients with moderate and severe TBI should be assessed and treated according to the same algorithm, the guidelines say, except that they do not require further screening beyond 1 year in the absence of symptoms. Patients should instead be coached to recognize symptoms of hypopituitarism and present for screening if symptoms appear.The guideline authors did not report outside funding and disclosed no conflicts of interest related to their recommendations.

New guidelines on traumatic brain injury and neuroendocrine dysfunction ask clinicians to be mindful that hypopituitarism in TBI survivors can develop following injuries classified as mild and can be slow to develop.

The guidelines – published online May 7, 2015,in Endocrine Reviews (doi:10.1210/er.2014-1065) and based on a review of 16 studies conducted between 2014 and 2011 – emphasize early detection and treatment of hypopituitarism in adults with TBI; recognition can be difficult because symptoms can progress slowly and be nonspecific. Deficiencies in pituitary hormones have been linked to elevated cardiovascular, metabolic, and cognitive risks, though studies in TBI populations are scant.About 12% of people with TBI will show persistent neuroendocrine dysfunction on repeat testing, according to Dr. Fatih Tanriverdi of Erciyes University in Kayseri, Turkey, and his associates. Although growth hormone (GH) deficiencies are the most common type of hormone deficiency after TBI, adrenocorticotropic hormone (ACTH), gonadotropins (FSH and LH), and thyroid-stimulating hormone (TSH) can all be diminished.

Dr. Tanriverdi and his colleagues noted that much more research is needed to determine the precise pathways by which TBI can cause pituitary dysfunction and whether hormone replacement can bring about functional or cognitive improvement in TBI patients with deficiencies. In addition to severity of injury, genetic factors, inflammation, and autoimmunity appear to bear on the risk of hypopituitarism after TBI, they said.

The guidelines recommend routine screening and early treatment for people with complicated mild TBI – a Glasgow coma score of 13-15 with some abnormalities on CT or MRI, hospitalization longer than 24 hours, or acute pituitary hormonal changes after injury – and for moderate and severe TBI. People with uncomplicated mild TBI (GCS of 13-15 but no screening abnormalities) are considered at low risk of developing pituitary dysfunction and do not need to be followed.

Patients with complicated mild TBI should be screened for ACTH deficiency immediately after injury and at hospital discharge and treated if necessary. At 6 months they should be reassessed for ACTH, TSH, and FSH/LH deficiencies and treated with hormone replacement therapy as needed. At a year post injury, patients should be assessed for GH deficiency and treated for this as well, if necessary, with annual clinical and hormonal evaluations continuing 5 years.

If no hormone deficiencies are found at 12 months, patients should still be reassessed annually through the fif^th year for hypopituitarism, as hormone deficiencies can still develop.

Patients with moderate and severe TBI should be assessed and treated according to the same algorithm, the guidelines say, except that they do not require further screening beyond 1 year in the absence of symptoms. Patients should instead be coached to recognize symptoms of hypopituitarism and present for screening if symptoms appear.The guideline authors did not report outside funding and disclosed no conflicts of interest related to their recommendations.

New guidelines on traumatic brain injury and neuroendocrine dysfunction ask clinicians to be mindful that hypopituitarism in TBI survivors can develop following injuries classified as mild and can be slow to develop.

The guidelines – published online May 7, 2015,in Endocrine Reviews (doi:10.1210/er.2014-1065) and based on a review of 16 studies conducted between 2014 and 2011 – emphasize early detection and treatment of hypopituitarism in adults with TBI; recognition can be difficult because symptoms can progress slowly and be nonspecific. Deficiencies in pituitary hormones have been linked to elevated cardiovascular, metabolic, and cognitive risks, though studies in TBI populations are scant.About 12% of people with TBI will show persistent neuroendocrine dysfunction on repeat testing, according to Dr. Fatih Tanriverdi of Erciyes University in Kayseri, Turkey, and his associates. Although growth hormone (GH) deficiencies are the most common type of hormone deficiency after TBI, adrenocorticotropic hormone (ACTH), gonadotropins (FSH and LH), and thyroid-stimulating hormone (TSH) can all be diminished.

Dr. Tanriverdi and his colleagues noted that much more research is needed to determine the precise pathways by which TBI can cause pituitary dysfunction and whether hormone replacement can bring about functional or cognitive improvement in TBI patients with deficiencies. In addition to severity of injury, genetic factors, inflammation, and autoimmunity appear to bear on the risk of hypopituitarism after TBI, they said.

The guidelines recommend routine screening and early treatment for people with complicated mild TBI – a Glasgow coma score of 13-15 with some abnormalities on CT or MRI, hospitalization longer than 24 hours, or acute pituitary hormonal changes after injury – and for moderate and severe TBI. People with uncomplicated mild TBI (GCS of 13-15 but no screening abnormalities) are considered at low risk of developing pituitary dysfunction and do not need to be followed.

Patients with complicated mild TBI should be screened for ACTH deficiency immediately after injury and at hospital discharge and treated if necessary. At 6 months they should be reassessed for ACTH, TSH, and FSH/LH deficiencies and treated with hormone replacement therapy as needed. At a year post injury, patients should be assessed for GH deficiency and treated for this as well, if necessary, with annual clinical and hormonal evaluations continuing 5 years.

If no hormone deficiencies are found at 12 months, patients should still be reassessed annually through the fif^th year for hypopituitarism, as hormone deficiencies can still develop.

Patients with moderate and severe TBI should be assessed and treated according to the same algorithm, the guidelines say, except that they do not require further screening beyond 1 year in the absence of symptoms. Patients should instead be coached to recognize symptoms of hypopituitarism and present for screening if symptoms appear.The guideline authors did not report outside funding and disclosed no conflicts of interest related to their recommendations.