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Clinical question

In pediatric postoperative spinal fusion/adolescent idiopathic scoliosis patients, do alternatives to traditional opioid-based analgesic pain regimens lead to improved clinical outcomes?

Background

Traditional care for pediatric postoperative spinal fusion (PSF) patients has included late mobilization most often because of significant pain that requires significant opioid administration. This has led to side effects of heavy opioid use, primarily nausea/vomiting and sleepiness.

In the United States, prescribers have become more aware of the pitfalls of opioid use given that more people now die of opioid misuse than breast cancer. An approach of multimodal analgesia with early mobilization has been shown to have decreased length of stay (LOS) and improve patient satisfaction, but data on clinical outcomes have been lacking.

Study design

Single-center quality improvement (QI) project.

Setting

Urban, 527-bed, quaternary care, free-standing children’s hospital.

Synopsis

Based on the recognition that multiple “standards” of care were utilized in the postoperative management of PSF patients, a QI project was undertaken. The primary outcome measured was functional recovery, as measured by average LOS and pain scores at the first 6:00 am after surgery then on postoperative days 1, 2, and 3.

Process measures were: use of multimodal agents (gabapentin and ketorolac) and discontinuation of patient-controlled analgesia (PCA) before postoperative day 3. Balancing measures were 30-day readmissions or ED revisit. Patients were divided into three groups by analyzing outcomes in three consecutive time periods: conventional management (n = 134), transition period (n = 104), and rapid recovery pathway (n = 84). In the conventional management time period, patients received intraoperative methadone and postoperative morphine/hydromorphone PCA. During the transition period, plan-do-study-act (PDSA) cycles with ketorolac and gabapentin pilots were instituted and assessed. Finally, a rapid recovery pathway (RRP) was designed and published as a web-based algorithm. Standardized entry order sets were developed to maintain compliance and consistency among health care professionals, and a transition period was allowed to reach the highest possible percentage of patients adhering to multimodal analgesia regimen.

Adherence to the multimodal regimen led to 90% of patients receiving ketorolac on postoperative day 1, 100% receiving gabapentin on night of surgery, 86% off of IV PCA by postoperative day 3, and 100% order set adherence after full implementation of the RRP. LOS decreased from 5.7 to 4 days after RRP implementation. Pain scores also showed significant improvement on postoperative day 0 (average pain score, 3.8 vs. 4.9) and postoperative day 1 (3.8 vs. 5). Balancing measures of 30-day readmissions or ED visits after discharge was 2.9% and rose to 3.6% after full implementation.

Bottom line

Multimodal analgesia – including preoperative gabapentin and acetaminophen, intraoperative methadone and acetaminophen, and postoperative PCA diazepam, gabapentin, acetaminophen, and ketorolac – results in decreased length of stay and improved self-reported daily pain scores.

Citation

Muhly WT et al. Rapid recovery pathway after spinal fusion for idiopathic scoliosis. Pediatrics. 2016 Apr;137(4):e20151568.

Dr. Giordano is a pediatric neurosurgery hospitalist and assistant professor in pediatrics at Columbia University Irving Medical Center in New York.

Clinical question

In pediatric postoperative spinal fusion/adolescent idiopathic scoliosis patients, do alternatives to traditional opioid-based analgesic pain regimens lead to improved clinical outcomes?

Background

Traditional care for pediatric postoperative spinal fusion (PSF) patients has included late mobilization most often because of significant pain that requires significant opioid administration. This has led to side effects of heavy opioid use, primarily nausea/vomiting and sleepiness.

In the United States, prescribers have become more aware of the pitfalls of opioid use given that more people now die of opioid misuse than breast cancer. An approach of multimodal analgesia with early mobilization has been shown to have decreased length of stay (LOS) and improve patient satisfaction, but data on clinical outcomes have been lacking.

Study design

Single-center quality improvement (QI) project.

Setting

Urban, 527-bed, quaternary care, free-standing children’s hospital.

Synopsis

Based on the recognition that multiple “standards” of care were utilized in the postoperative management of PSF patients, a QI project was undertaken. The primary outcome measured was functional recovery, as measured by average LOS and pain scores at the first 6:00 am after surgery then on postoperative days 1, 2, and 3.

Process measures were: use of multimodal agents (gabapentin and ketorolac) and discontinuation of patient-controlled analgesia (PCA) before postoperative day 3. Balancing measures were 30-day readmissions or ED revisit. Patients were divided into three groups by analyzing outcomes in three consecutive time periods: conventional management (n = 134), transition period (n = 104), and rapid recovery pathway (n = 84). In the conventional management time period, patients received intraoperative methadone and postoperative morphine/hydromorphone PCA. During the transition period, plan-do-study-act (PDSA) cycles with ketorolac and gabapentin pilots were instituted and assessed. Finally, a rapid recovery pathway (RRP) was designed and published as a web-based algorithm. Standardized entry order sets were developed to maintain compliance and consistency among health care professionals, and a transition period was allowed to reach the highest possible percentage of patients adhering to multimodal analgesia regimen.

Adherence to the multimodal regimen led to 90% of patients receiving ketorolac on postoperative day 1, 100% receiving gabapentin on night of surgery, 86% off of IV PCA by postoperative day 3, and 100% order set adherence after full implementation of the RRP. LOS decreased from 5.7 to 4 days after RRP implementation. Pain scores also showed significant improvement on postoperative day 0 (average pain score, 3.8 vs. 4.9) and postoperative day 1 (3.8 vs. 5). Balancing measures of 30-day readmissions or ED visits after discharge was 2.9% and rose to 3.6% after full implementation.

Bottom line

Multimodal analgesia – including preoperative gabapentin and acetaminophen, intraoperative methadone and acetaminophen, and postoperative PCA diazepam, gabapentin, acetaminophen, and ketorolac – results in decreased length of stay and improved self-reported daily pain scores.

Citation

Muhly WT et al. Rapid recovery pathway after spinal fusion for idiopathic scoliosis. Pediatrics. 2016 Apr;137(4):e20151568.

Dr. Giordano is a pediatric neurosurgery hospitalist and assistant professor in pediatrics at Columbia University Irving Medical Center in New York.

Clinical question

In pediatric postoperative spinal fusion/adolescent idiopathic scoliosis patients, do alternatives to traditional opioid-based analgesic pain regimens lead to improved clinical outcomes?

Background

Traditional care for pediatric postoperative spinal fusion (PSF) patients has included late mobilization most often because of significant pain that requires significant opioid administration. This has led to side effects of heavy opioid use, primarily nausea/vomiting and sleepiness.

In the United States, prescribers have become more aware of the pitfalls of opioid use given that more people now die of opioid misuse than breast cancer. An approach of multimodal analgesia with early mobilization has been shown to have decreased length of stay (LOS) and improve patient satisfaction, but data on clinical outcomes have been lacking.

Study design

Single-center quality improvement (QI) project.

Setting

Urban, 527-bed, quaternary care, free-standing children’s hospital.

Synopsis

Based on the recognition that multiple “standards” of care were utilized in the postoperative management of PSF patients, a QI project was undertaken. The primary outcome measured was functional recovery, as measured by average LOS and pain scores at the first 6:00 am after surgery then on postoperative days 1, 2, and 3.

Process measures were: use of multimodal agents (gabapentin and ketorolac) and discontinuation of patient-controlled analgesia (PCA) before postoperative day 3. Balancing measures were 30-day readmissions or ED revisit. Patients were divided into three groups by analyzing outcomes in three consecutive time periods: conventional management (n = 134), transition period (n = 104), and rapid recovery pathway (n = 84). In the conventional management time period, patients received intraoperative methadone and postoperative morphine/hydromorphone PCA. During the transition period, plan-do-study-act (PDSA) cycles with ketorolac and gabapentin pilots were instituted and assessed. Finally, a rapid recovery pathway (RRP) was designed and published as a web-based algorithm. Standardized entry order sets were developed to maintain compliance and consistency among health care professionals, and a transition period was allowed to reach the highest possible percentage of patients adhering to multimodal analgesia regimen.

Adherence to the multimodal regimen led to 90% of patients receiving ketorolac on postoperative day 1, 100% receiving gabapentin on night of surgery, 86% off of IV PCA by postoperative day 3, and 100% order set adherence after full implementation of the RRP. LOS decreased from 5.7 to 4 days after RRP implementation. Pain scores also showed significant improvement on postoperative day 0 (average pain score, 3.8 vs. 4.9) and postoperative day 1 (3.8 vs. 5). Balancing measures of 30-day readmissions or ED visits after discharge was 2.9% and rose to 3.6% after full implementation.

Bottom line

Multimodal analgesia – including preoperative gabapentin and acetaminophen, intraoperative methadone and acetaminophen, and postoperative PCA diazepam, gabapentin, acetaminophen, and ketorolac – results in decreased length of stay and improved self-reported daily pain scores.

Citation

Muhly WT et al. Rapid recovery pathway after spinal fusion for idiopathic scoliosis. Pediatrics. 2016 Apr;137(4):e20151568.

Dr. Giordano is a pediatric neurosurgery hospitalist and assistant professor in pediatrics at Columbia University Irving Medical Center in New York.

Clinical question: Is the combination of aspirin and clopidogrel effective in reducing stroke recurrence?

Background: The risk of recurrent stroke varies from 3% to 15% in the 3 months after a minor ischemic stroke (NIH Stroke Scale score of 3 or less) or high-risk transient ischemic attack (ABCD2 score of 4 or less). Dual-antiplatelet therapy with aspirin and clopidogrel reduces recurrent coronary syndrome; therefore, this strategy can prevent recurrent stroke.

Study design: Prospective, randomized, double-blind, multicenter, placebo-controlled trial.

Setting: 269 sites in 10 countries, mostly in the United States, from May 28, 2010, to Dec. 19, 2017.

Synopsis: The POINT (­Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) trial enrolled 4,881 patients older than 18 years of age randomized to a loading dose of 600 mg of clopidogrel followed by 75 mg per day or placebo, and aspirin 162 mg daily for 5 days followed by 81 mg daily. The primary outcome was the risk of major ischemic events, including ischemic stroke, myocardial infarction, or death from ischemic vascular causes. Major ischemic events were observed in 5.0% receiving dual therapy and in 6.5% of those receiving aspirin alone (hazard ratio, 0.75; 95% confidence interval, 0.59-0.95; P = .02) with most occurring within a week after the initial stroke. Major hemorrhage occurred in only 23 patients (0.9%), most of which were extracranial and nonfatal. One of the main limitations is the difficulty in objectively diagnosing TIAs, accounting for 43% of the patients in the study.

Bottom line: Dual-antiplatelet therapy with aspirin and clopidogrel is beneficial, mainly in the first week after a minor stroke or high-risk TIA with low risk of major bleeding.

Citation: Johnston SC et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379:215-25.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver.

Clinical question: Is the combination of aspirin and clopidogrel effective in reducing stroke recurrence?

Background: The risk of recurrent stroke varies from 3% to 15% in the 3 months after a minor ischemic stroke (NIH Stroke Scale score of 3 or less) or high-risk transient ischemic attack (ABCD2 score of 4 or less). Dual-antiplatelet therapy with aspirin and clopidogrel reduces recurrent coronary syndrome; therefore, this strategy can prevent recurrent stroke.

Study design: Prospective, randomized, double-blind, multicenter, placebo-controlled trial.

Setting: 269 sites in 10 countries, mostly in the United States, from May 28, 2010, to Dec. 19, 2017.

Synopsis: The POINT (­Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) trial enrolled 4,881 patients older than 18 years of age randomized to a loading dose of 600 mg of clopidogrel followed by 75 mg per day or placebo, and aspirin 162 mg daily for 5 days followed by 81 mg daily. The primary outcome was the risk of major ischemic events, including ischemic stroke, myocardial infarction, or death from ischemic vascular causes. Major ischemic events were observed in 5.0% receiving dual therapy and in 6.5% of those receiving aspirin alone (hazard ratio, 0.75; 95% confidence interval, 0.59-0.95; P = .02) with most occurring within a week after the initial stroke. Major hemorrhage occurred in only 23 patients (0.9%), most of which were extracranial and nonfatal. One of the main limitations is the difficulty in objectively diagnosing TIAs, accounting for 43% of the patients in the study.

Bottom line: Dual-antiplatelet therapy with aspirin and clopidogrel is beneficial, mainly in the first week after a minor stroke or high-risk TIA with low risk of major bleeding.

Citation: Johnston SC et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379:215-25.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver.

Clinical question: Is the combination of aspirin and clopidogrel effective in reducing stroke recurrence?

Background: The risk of recurrent stroke varies from 3% to 15% in the 3 months after a minor ischemic stroke (NIH Stroke Scale score of 3 or less) or high-risk transient ischemic attack (ABCD2 score of 4 or less). Dual-antiplatelet therapy with aspirin and clopidogrel reduces recurrent coronary syndrome; therefore, this strategy can prevent recurrent stroke.

Study design: Prospective, randomized, double-blind, multicenter, placebo-controlled trial.

Setting: 269 sites in 10 countries, mostly in the United States, from May 28, 2010, to Dec. 19, 2017.

Synopsis: The POINT (­Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) trial enrolled 4,881 patients older than 18 years of age randomized to a loading dose of 600 mg of clopidogrel followed by 75 mg per day or placebo, and aspirin 162 mg daily for 5 days followed by 81 mg daily. The primary outcome was the risk of major ischemic events, including ischemic stroke, myocardial infarction, or death from ischemic vascular causes. Major ischemic events were observed in 5.0% receiving dual therapy and in 6.5% of those receiving aspirin alone (hazard ratio, 0.75; 95% confidence interval, 0.59-0.95; P = .02) with most occurring within a week after the initial stroke. Major hemorrhage occurred in only 23 patients (0.9%), most of which were extracranial and nonfatal. One of the main limitations is the difficulty in objectively diagnosing TIAs, accounting for 43% of the patients in the study.

Bottom line: Dual-antiplatelet therapy with aspirin and clopidogrel is beneficial, mainly in the first week after a minor stroke or high-risk TIA with low risk of major bleeding.

Citation: Johnston SC et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379:215-25.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver.

Clinical question: Does rivaroxaban prevent recurrent ischemic stroke in patients with embolic stroke from undetermined source?

Background: Embolic stroke of undetermined source (ESUS) represents approximately 20% of ischemic strokes. Rivaroxaban inhibits factor Xa and is shown to be effective for secondary stroke prevention in patients with nonvalvular atrial fibrillation. Strategies to prevent cryptogenic stroke caused by mechanisms other than cardioembolic sources are lacking.

Study design: International, double-blind, event-­driven, randomized, phase III trial.

Recurrent stroke was observed in 158 in the rivaroxaban group and 156 in the aspirin group, mostly ischemic. The trial was terminated early because of a higher incidence of intracranial hemorrhage and major bleeding among patients assigned to rivaroxaban at an annual rate of 1.8%, compared with 0.7% (hazard ratio, 2.72; 95% confidence interval, 1.68-4.39; P less than .001). Although the study utilized strict criteria to define ESUS, it is feasible that the lack of benefit may be due to heterogeneous arterial, cardiogenic, and paradoxical emboli with diverse composition and poor response to rivaroxaban.

Bottom line: Rivaroxaban does not confer protection from recurrent stroke in patients with embolic stroke of unknown origin and increases risk for intracranial hemorrhage and major bleeding.

Citation: Hart RG et al. Rivaroxaban for stroke prevention after embolic stroke of undetermined source. N Engl J Med. 2018;378(23):2191-201.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver

Clinical question: Does rivaroxaban prevent recurrent ischemic stroke in patients with embolic stroke from undetermined source?

Background: Embolic stroke of undetermined source (ESUS) represents approximately 20% of ischemic strokes. Rivaroxaban inhibits factor Xa and is shown to be effective for secondary stroke prevention in patients with nonvalvular atrial fibrillation. Strategies to prevent cryptogenic stroke caused by mechanisms other than cardioembolic sources are lacking.

Study design: International, double-blind, event-­driven, randomized, phase III trial.

Recurrent stroke was observed in 158 in the rivaroxaban group and 156 in the aspirin group, mostly ischemic. The trial was terminated early because of a higher incidence of intracranial hemorrhage and major bleeding among patients assigned to rivaroxaban at an annual rate of 1.8%, compared with 0.7% (hazard ratio, 2.72; 95% confidence interval, 1.68-4.39; P less than .001). Although the study utilized strict criteria to define ESUS, it is feasible that the lack of benefit may be due to heterogeneous arterial, cardiogenic, and paradoxical emboli with diverse composition and poor response to rivaroxaban.

Bottom line: Rivaroxaban does not confer protection from recurrent stroke in patients with embolic stroke of unknown origin and increases risk for intracranial hemorrhage and major bleeding.

Citation: Hart RG et al. Rivaroxaban for stroke prevention after embolic stroke of undetermined source. N Engl J Med. 2018;378(23):2191-201.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver

Clinical question: Does rivaroxaban prevent recurrent ischemic stroke in patients with embolic stroke from undetermined source?

Background: Embolic stroke of undetermined source (ESUS) represents approximately 20% of ischemic strokes. Rivaroxaban inhibits factor Xa and is shown to be effective for secondary stroke prevention in patients with nonvalvular atrial fibrillation. Strategies to prevent cryptogenic stroke caused by mechanisms other than cardioembolic sources are lacking.

Study design: International, double-blind, event-­driven, randomized, phase III trial.

Recurrent stroke was observed in 158 in the rivaroxaban group and 156 in the aspirin group, mostly ischemic. The trial was terminated early because of a higher incidence of intracranial hemorrhage and major bleeding among patients assigned to rivaroxaban at an annual rate of 1.8%, compared with 0.7% (hazard ratio, 2.72; 95% confidence interval, 1.68-4.39; P less than .001). Although the study utilized strict criteria to define ESUS, it is feasible that the lack of benefit may be due to heterogeneous arterial, cardiogenic, and paradoxical emboli with diverse composition and poor response to rivaroxaban.

Bottom line: Rivaroxaban does not confer protection from recurrent stroke in patients with embolic stroke of unknown origin and increases risk for intracranial hemorrhage and major bleeding.

Citation: Hart RG et al. Rivaroxaban for stroke prevention after embolic stroke of undetermined source. N Engl J Med. 2018;378(23):2191-201.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver

BERLIN – A dry-powder nasal formulation of glucagon was as good as intramuscular delivery for the reversal of severe hypoglycemia in patients with type 1 diabetes mellitus (T1DM) in a randomized controlled trial.

Sara Freeman/MDedge News

A 100% treatment success rate (n = 66) was seen for both nasal glucagon and intramuscular glucagon, defined as an increase in plasma glucose to 70 mg/dL (3.9 mmol/L or greater) or more or an increase of 20 mg/L (1.1 mmol/L) or more from the glucose nadir within 30 minutes of administration.

Furthermore, slightly more than 97% of patients achieved treatment success within 15 minutes in both treatment groups, with mean times of 11.4 minutes for the nasal formulation and 9.8 minutes for intramuscular administration.

Similar glucose responses were observed within 40 minutes of glucagon administration, study investigator Leona Plum-Mörschel, MD, PhD, reported at the annual meeting of the European Association for the Study of Diabetes. Dr. Plum-Mörschel is the CEO of the clinical research organization Profil Mainz (Germany), which helped Eli Lilly conduct the trial.

“We are all aware and fully agree that severe hypoglycemia is a serious and potentially life-threatening complication of diabetes treatment with insulin and the sulfonylureas,” said Dr. Plum-Mörschel. At least one in three patients with diabetes reports one hypoglycemic episode per year, she added. While this is quite prevalent in patients with T1DM, it’s not uncommon for those with type 2 diabetes mellitus (T2DM) to experience hypoglycemic episodes.

“Outside of a hospital or emergency room setting, injectable glucagon is currently the only option to treat severe hypoglycemia,” Dr. Plum-Mörschel reminded delegates. “Thankfully, the available injectable glucagon emergency kits are highly effective for the treatment of hypoglycemic events,” she added.

However, for untrained caregivers they can be “really challenging to use,” according to Dr. Plum-Mörschel. This is because the available kits involve multiple steps, including reconstitution, before being ready to inject. A severe hypoglycemic event is stressful enough without them worrying about getting things right, she suggested.

This is where a nasal formulation would be advantageous, and it is something that’s been touted to be on the horizon for a few years. Studies have previously shown that nasal glucagon is comparable to intramuscular glucagon in both adult and pediatric populations. Turning the formulation used in those studies into a commercial product however, has meant more clinical testing before being licensed by the regulatory authorities.

The nasal formulation consists of a dry power containing 3 mg glucagon that is provided in a single-use, compact, and thus, portable, device. It’s been designed to be stored at room temperature and is ready to use immediately. Pressing the plunger on the device releases the fine powder that does not require inhalation to work, which means it can be given easily to an unconscious patient with severe hypoglycemia.

“The aim of the present study was to compare the efficacy and safety of commercially manufactured nasal glucagon with intramuscular glucagon for the treatment of insulin-induced hypoglycemia in adults with type 1 diabetes,” Dr. Plum-Mörschel said.

It was a randomized, single-dose, crossover study involving 70 adult patients with T1DM with hypoglycemia artificially induced by an intravenous insulin infusion during the two dosing visits. Five minutes after stopping insulin, nasal glucagon (3 mg) or intramuscular (1 mg) was given, with multiple plasma glucose measurements taken for up to 90 minutes.

The mean age of participants was 41.7 years old, 61% were male, the mean duration of diabetes was 19.8 years, with a baseline glycated hemoglobin (HbA_1c) of 7.3%.

As for safety, Dr. Plum-Mörschel noted that nasal glucagon had a safety profile that was acceptable for emergency treatment. There was no difference between the nasal or intramuscular glucagon treatment groups in the percentages of patients experiencing treatment-emergent adverse events (at least 5% frequency): nausea was seen in 22% and 29%, vomiting in 10% and 12%, and headache in 12% and 7%, respectively.

Asking patients who had been treated with nasal glucagon about specific symptoms related to nasal administration showed around 63% had watery eyes, 49% nasal itching, 39% nasal congestion, 37% a runny nose, 24% sneezing, 20% itchy eyes, and 12.9% itchy throat. “All of these events were transient, generally mild or moderate in nature, and none were serious. Indeed, there were no deaths in the study and no other serious AEs [adverse events] occurred.”

Dr. Plum-Mörschel concluded: “These results support nasal glucagon as a viable alternative to intramuscular glucagon for the treatment of severe hypoglycemia.

“I personally would expect that, due to its simplicity of use, nasal glucagon will create a greater community who can render quick aid in a rescue situation.”

The study was funded by Eli Lilly. Dr. Plum-Mörschel is an employee of Profil Mainz and has received travel grants and speaker honoraria from Eli Lilly and Novo Nordisk.
 

SOURCE: Suico J et al. EASD 2018, Abstract 150.

BERLIN – A dry-powder nasal formulation of glucagon was as good as intramuscular delivery for the reversal of severe hypoglycemia in patients with type 1 diabetes mellitus (T1DM) in a randomized controlled trial.

Sara Freeman/MDedge News

A 100% treatment success rate (n = 66) was seen for both nasal glucagon and intramuscular glucagon, defined as an increase in plasma glucose to 70 mg/dL (3.9 mmol/L or greater) or more or an increase of 20 mg/L (1.1 mmol/L) or more from the glucose nadir within 30 minutes of administration.

Furthermore, slightly more than 97% of patients achieved treatment success within 15 minutes in both treatment groups, with mean times of 11.4 minutes for the nasal formulation and 9.8 minutes for intramuscular administration.

Similar glucose responses were observed within 40 minutes of glucagon administration, study investigator Leona Plum-Mörschel, MD, PhD, reported at the annual meeting of the European Association for the Study of Diabetes. Dr. Plum-Mörschel is the CEO of the clinical research organization Profil Mainz (Germany), which helped Eli Lilly conduct the trial.

“We are all aware and fully agree that severe hypoglycemia is a serious and potentially life-threatening complication of diabetes treatment with insulin and the sulfonylureas,” said Dr. Plum-Mörschel. At least one in three patients with diabetes reports one hypoglycemic episode per year, she added. While this is quite prevalent in patients with T1DM, it’s not uncommon for those with type 2 diabetes mellitus (T2DM) to experience hypoglycemic episodes.

“Outside of a hospital or emergency room setting, injectable glucagon is currently the only option to treat severe hypoglycemia,” Dr. Plum-Mörschel reminded delegates. “Thankfully, the available injectable glucagon emergency kits are highly effective for the treatment of hypoglycemic events,” she added.

However, for untrained caregivers they can be “really challenging to use,” according to Dr. Plum-Mörschel. This is because the available kits involve multiple steps, including reconstitution, before being ready to inject. A severe hypoglycemic event is stressful enough without them worrying about getting things right, she suggested.

This is where a nasal formulation would be advantageous, and it is something that’s been touted to be on the horizon for a few years. Studies have previously shown that nasal glucagon is comparable to intramuscular glucagon in both adult and pediatric populations. Turning the formulation used in those studies into a commercial product however, has meant more clinical testing before being licensed by the regulatory authorities.

The nasal formulation consists of a dry power containing 3 mg glucagon that is provided in a single-use, compact, and thus, portable, device. It’s been designed to be stored at room temperature and is ready to use immediately. Pressing the plunger on the device releases the fine powder that does not require inhalation to work, which means it can be given easily to an unconscious patient with severe hypoglycemia.

“The aim of the present study was to compare the efficacy and safety of commercially manufactured nasal glucagon with intramuscular glucagon for the treatment of insulin-induced hypoglycemia in adults with type 1 diabetes,” Dr. Plum-Mörschel said.

It was a randomized, single-dose, crossover study involving 70 adult patients with T1DM with hypoglycemia artificially induced by an intravenous insulin infusion during the two dosing visits. Five minutes after stopping insulin, nasal glucagon (3 mg) or intramuscular (1 mg) was given, with multiple plasma glucose measurements taken for up to 90 minutes.

The mean age of participants was 41.7 years old, 61% were male, the mean duration of diabetes was 19.8 years, with a baseline glycated hemoglobin (HbA_1c) of 7.3%.

As for safety, Dr. Plum-Mörschel noted that nasal glucagon had a safety profile that was acceptable for emergency treatment. There was no difference between the nasal or intramuscular glucagon treatment groups in the percentages of patients experiencing treatment-emergent adverse events (at least 5% frequency): nausea was seen in 22% and 29%, vomiting in 10% and 12%, and headache in 12% and 7%, respectively.

Asking patients who had been treated with nasal glucagon about specific symptoms related to nasal administration showed around 63% had watery eyes, 49% nasal itching, 39% nasal congestion, 37% a runny nose, 24% sneezing, 20% itchy eyes, and 12.9% itchy throat. “All of these events were transient, generally mild or moderate in nature, and none were serious. Indeed, there were no deaths in the study and no other serious AEs [adverse events] occurred.”

Dr. Plum-Mörschel concluded: “These results support nasal glucagon as a viable alternative to intramuscular glucagon for the treatment of severe hypoglycemia.

“I personally would expect that, due to its simplicity of use, nasal glucagon will create a greater community who can render quick aid in a rescue situation.”

The study was funded by Eli Lilly. Dr. Plum-Mörschel is an employee of Profil Mainz and has received travel grants and speaker honoraria from Eli Lilly and Novo Nordisk.
 

SOURCE: Suico J et al. EASD 2018, Abstract 150.

BERLIN – A dry-powder nasal formulation of glucagon was as good as intramuscular delivery for the reversal of severe hypoglycemia in patients with type 1 diabetes mellitus (T1DM) in a randomized controlled trial.

Sara Freeman/MDedge News

A 100% treatment success rate (n = 66) was seen for both nasal glucagon and intramuscular glucagon, defined as an increase in plasma glucose to 70 mg/dL (3.9 mmol/L or greater) or more or an increase of 20 mg/L (1.1 mmol/L) or more from the glucose nadir within 30 minutes of administration.

Furthermore, slightly more than 97% of patients achieved treatment success within 15 minutes in both treatment groups, with mean times of 11.4 minutes for the nasal formulation and 9.8 minutes for intramuscular administration.

Similar glucose responses were observed within 40 minutes of glucagon administration, study investigator Leona Plum-Mörschel, MD, PhD, reported at the annual meeting of the European Association for the Study of Diabetes. Dr. Plum-Mörschel is the CEO of the clinical research organization Profil Mainz (Germany), which helped Eli Lilly conduct the trial.

“We are all aware and fully agree that severe hypoglycemia is a serious and potentially life-threatening complication of diabetes treatment with insulin and the sulfonylureas,” said Dr. Plum-Mörschel. At least one in three patients with diabetes reports one hypoglycemic episode per year, she added. While this is quite prevalent in patients with T1DM, it’s not uncommon for those with type 2 diabetes mellitus (T2DM) to experience hypoglycemic episodes.

“Outside of a hospital or emergency room setting, injectable glucagon is currently the only option to treat severe hypoglycemia,” Dr. Plum-Mörschel reminded delegates. “Thankfully, the available injectable glucagon emergency kits are highly effective for the treatment of hypoglycemic events,” she added.

However, for untrained caregivers they can be “really challenging to use,” according to Dr. Plum-Mörschel. This is because the available kits involve multiple steps, including reconstitution, before being ready to inject. A severe hypoglycemic event is stressful enough without them worrying about getting things right, she suggested.

This is where a nasal formulation would be advantageous, and it is something that’s been touted to be on the horizon for a few years. Studies have previously shown that nasal glucagon is comparable to intramuscular glucagon in both adult and pediatric populations. Turning the formulation used in those studies into a commercial product however, has meant more clinical testing before being licensed by the regulatory authorities.

The nasal formulation consists of a dry power containing 3 mg glucagon that is provided in a single-use, compact, and thus, portable, device. It’s been designed to be stored at room temperature and is ready to use immediately. Pressing the plunger on the device releases the fine powder that does not require inhalation to work, which means it can be given easily to an unconscious patient with severe hypoglycemia.

“The aim of the present study was to compare the efficacy and safety of commercially manufactured nasal glucagon with intramuscular glucagon for the treatment of insulin-induced hypoglycemia in adults with type 1 diabetes,” Dr. Plum-Mörschel said.

It was a randomized, single-dose, crossover study involving 70 adult patients with T1DM with hypoglycemia artificially induced by an intravenous insulin infusion during the two dosing visits. Five minutes after stopping insulin, nasal glucagon (3 mg) or intramuscular (1 mg) was given, with multiple plasma glucose measurements taken for up to 90 minutes.

The mean age of participants was 41.7 years old, 61% were male, the mean duration of diabetes was 19.8 years, with a baseline glycated hemoglobin (HbA_1c) of 7.3%.

As for safety, Dr. Plum-Mörschel noted that nasal glucagon had a safety profile that was acceptable for emergency treatment. There was no difference between the nasal or intramuscular glucagon treatment groups in the percentages of patients experiencing treatment-emergent adverse events (at least 5% frequency): nausea was seen in 22% and 29%, vomiting in 10% and 12%, and headache in 12% and 7%, respectively.

Asking patients who had been treated with nasal glucagon about specific symptoms related to nasal administration showed around 63% had watery eyes, 49% nasal itching, 39% nasal congestion, 37% a runny nose, 24% sneezing, 20% itchy eyes, and 12.9% itchy throat. “All of these events were transient, generally mild or moderate in nature, and none were serious. Indeed, there were no deaths in the study and no other serious AEs [adverse events] occurred.”

Dr. Plum-Mörschel concluded: “These results support nasal glucagon as a viable alternative to intramuscular glucagon for the treatment of severe hypoglycemia.

“I personally would expect that, due to its simplicity of use, nasal glucagon will create a greater community who can render quick aid in a rescue situation.”

The study was funded by Eli Lilly. Dr. Plum-Mörschel is an employee of Profil Mainz and has received travel grants and speaker honoraria from Eli Lilly and Novo Nordisk.
 

SOURCE: Suico J et al. EASD 2018, Abstract 150.

Recurrence risk is significant among all patients with venous thromboembolism (VTE), though recurrence is most frequent in patients with cancer-related VTE, according to a nationwide Danish study.

Ida Ehlers Albertsen, MD, of Aalborg (Denmark) University Hospital and her coauthors followed 73,993 patients who were diagnosed with incident VTE during January 2000–December 2015. The patients’ VTEs were classified as either cancer-related, unprovoked (occurring in patients without any provoking factors), or provoked (occurring in patients with one or more provoking factors, such as recent major surgery, recent fracture/trauma, obesity, or hormone replacement therapy).

The researchers found similar risks of recurrence among patients with unprovoked and provoked VTE at 6-month follow-up, with rates per 100 person-years of 6.80 and 6.92, respectively. By comparison, the recurrence rate for cancer-related VTE at 6 months was 9.06. The findings were reported in the American Journal of Medicine.

However, at 10-year follow-up the rates were 3.70 for cancer-related VTE, 2.84 for unprovoked VTE, and 2.22 for provoked VTE, which reinforces the belief that “unprovoked venous thromboembolism is associated with long-term higher risk of recurrence than provoked venous thromboembolism.”

Additionally, at 10-year follow-up, the absolute recurrence risk of cancer-related VTE and unprovoked VTE were both at approximately 20%, with recurrence risk of provoked VTE at just above 15%. Compared with the recurrence risk of provoked VTE at 10-year follow-up, the hazard ratios of cancer-related VTE and unprovoked VTE recurrence risk were 1.23 (95% confidence interval, 1.13-1.33) and 1.18 (95% CI, 1.13-1.24), respectively.

The coauthors observed several challenges in comparing their study to previous analyses on recurrent risk, noting that the definition of provoked VTE “varies throughout the literature” and that the majority of VTE studies “provide cumulative incidence proportions and not the actual rates.” They also stated that indefinite or extended therapy for all VTE patients comes with its own potential complications, even with the improved safety of non–vitamin K antagonist oral anticoagulants, writing that “treatment should be given to patients where the benefits outweigh the risks.”

Despite the differences in recurrence rates at 6-month and 10-year follow-up, the coauthors suggested that enough risk was present in all types to warrant additional studies and reconsider how VTE patients are categorized.

“A high recurrence risk in all types of venous thromboembolism indicates that further research is needed to optimize risk stratification for venous thromboembolism patients,” they wrote.

The study was partially funded by a grant from the Obel Family Foundation. Some authors reported financial disclosures related to Janssen, Bayer, Roche, and others.

SOURCE: Albertsen IE et al. Am J Med. 2018 Sep;131(9):1067-74.e4.

Recurrence risk is significant among all patients with venous thromboembolism (VTE), though recurrence is most frequent in patients with cancer-related VTE, according to a nationwide Danish study.

Ida Ehlers Albertsen, MD, of Aalborg (Denmark) University Hospital and her coauthors followed 73,993 patients who were diagnosed with incident VTE during January 2000–December 2015. The patients’ VTEs were classified as either cancer-related, unprovoked (occurring in patients without any provoking factors), or provoked (occurring in patients with one or more provoking factors, such as recent major surgery, recent fracture/trauma, obesity, or hormone replacement therapy).

The researchers found similar risks of recurrence among patients with unprovoked and provoked VTE at 6-month follow-up, with rates per 100 person-years of 6.80 and 6.92, respectively. By comparison, the recurrence rate for cancer-related VTE at 6 months was 9.06. The findings were reported in the American Journal of Medicine.

However, at 10-year follow-up the rates were 3.70 for cancer-related VTE, 2.84 for unprovoked VTE, and 2.22 for provoked VTE, which reinforces the belief that “unprovoked venous thromboembolism is associated with long-term higher risk of recurrence than provoked venous thromboembolism.”

Additionally, at 10-year follow-up, the absolute recurrence risk of cancer-related VTE and unprovoked VTE were both at approximately 20%, with recurrence risk of provoked VTE at just above 15%. Compared with the recurrence risk of provoked VTE at 10-year follow-up, the hazard ratios of cancer-related VTE and unprovoked VTE recurrence risk were 1.23 (95% confidence interval, 1.13-1.33) and 1.18 (95% CI, 1.13-1.24), respectively.

The coauthors observed several challenges in comparing their study to previous analyses on recurrent risk, noting that the definition of provoked VTE “varies throughout the literature” and that the majority of VTE studies “provide cumulative incidence proportions and not the actual rates.” They also stated that indefinite or extended therapy for all VTE patients comes with its own potential complications, even with the improved safety of non–vitamin K antagonist oral anticoagulants, writing that “treatment should be given to patients where the benefits outweigh the risks.”

Despite the differences in recurrence rates at 6-month and 10-year follow-up, the coauthors suggested that enough risk was present in all types to warrant additional studies and reconsider how VTE patients are categorized.

“A high recurrence risk in all types of venous thromboembolism indicates that further research is needed to optimize risk stratification for venous thromboembolism patients,” they wrote.

The study was partially funded by a grant from the Obel Family Foundation. Some authors reported financial disclosures related to Janssen, Bayer, Roche, and others.

SOURCE: Albertsen IE et al. Am J Med. 2018 Sep;131(9):1067-74.e4.

Recurrence risk is significant among all patients with venous thromboembolism (VTE), though recurrence is most frequent in patients with cancer-related VTE, according to a nationwide Danish study.

Ida Ehlers Albertsen, MD, of Aalborg (Denmark) University Hospital and her coauthors followed 73,993 patients who were diagnosed with incident VTE during January 2000–December 2015. The patients’ VTEs were classified as either cancer-related, unprovoked (occurring in patients without any provoking factors), or provoked (occurring in patients with one or more provoking factors, such as recent major surgery, recent fracture/trauma, obesity, or hormone replacement therapy).

The researchers found similar risks of recurrence among patients with unprovoked and provoked VTE at 6-month follow-up, with rates per 100 person-years of 6.80 and 6.92, respectively. By comparison, the recurrence rate for cancer-related VTE at 6 months was 9.06. The findings were reported in the American Journal of Medicine.

However, at 10-year follow-up the rates were 3.70 for cancer-related VTE, 2.84 for unprovoked VTE, and 2.22 for provoked VTE, which reinforces the belief that “unprovoked venous thromboembolism is associated with long-term higher risk of recurrence than provoked venous thromboembolism.”

Additionally, at 10-year follow-up, the absolute recurrence risk of cancer-related VTE and unprovoked VTE were both at approximately 20%, with recurrence risk of provoked VTE at just above 15%. Compared with the recurrence risk of provoked VTE at 10-year follow-up, the hazard ratios of cancer-related VTE and unprovoked VTE recurrence risk were 1.23 (95% confidence interval, 1.13-1.33) and 1.18 (95% CI, 1.13-1.24), respectively.

The coauthors observed several challenges in comparing their study to previous analyses on recurrent risk, noting that the definition of provoked VTE “varies throughout the literature” and that the majority of VTE studies “provide cumulative incidence proportions and not the actual rates.” They also stated that indefinite or extended therapy for all VTE patients comes with its own potential complications, even with the improved safety of non–vitamin K antagonist oral anticoagulants, writing that “treatment should be given to patients where the benefits outweigh the risks.”

Despite the differences in recurrence rates at 6-month and 10-year follow-up, the coauthors suggested that enough risk was present in all types to warrant additional studies and reconsider how VTE patients are categorized.

“A high recurrence risk in all types of venous thromboembolism indicates that further research is needed to optimize risk stratification for venous thromboembolism patients,” they wrote.

The study was partially funded by a grant from the Obel Family Foundation. Some authors reported financial disclosures related to Janssen, Bayer, Roche, and others.

SOURCE: Albertsen IE et al. Am J Med. 2018 Sep;131(9):1067-74.e4.

The Hospitalist recently sat down with Nancy J. Rennert, MD, FACE, FACP, CPHQ, chief of endocrinology and diabetes at Norwalk (Conn.) Hospital, Western Connecticut Health Network, to discuss her institution’s glycemic control initiatives.

Tell us a bit about your program:

Norwalk Hospital is a 366-bed community teaching hospital founded 125 years ago, now part of the growing Western Connecticut Health Network. Our residency and fellowship training programs are affiliated with Yale University, New Haven, Conn., and we are a branch campus of the University of Vermont, Burlington.

With leadership support, we created our Glycemic Care Team (GCT) 4 years ago to focus on improving the quality of care for persons with diabetes who were admitted to our hospital (often for another primary medical reason). Our hospitalists – 8 on the teaching service and 11 on the nonteaching service – are key players in our efforts as they care for the majority of medical inpatients. GCT is interdisciplinary and includes stakeholders at all levels, including quality, pharmacy, nutrition, hospital medicine, diabetes education, administrative leadership, endocrinology, information technology, point-of-care testing/pathology, surgery and more. We meet monthly with an agenda that includes safety events, glucometrics, and discussion of policies and protocols. Subgroups complete tasks in between the monthly meetings, and we bring in other clinical specialties as indicated based on the issues at hand.
 

What prior challenges did you encounter that led you to enroll in the Glycemic Control (GC) eQUIPS Program?

In order to know if our GCT was making a positive difference, we needed to first measure our baseline metrics and then identify our goals and develop our processes. We wanted actionable data analysis and the ability to differentiate areas of our hospital such as individual clinical units. After researching the options, we chose SHM’s GC eQUIPS Program, which we found to be user friendly. The national benchmarking was an important aspect for us as well. As a kick-off event, I invited Greg Maynard, MD, MHM, a hospitalist and the chief quality officer, UC Davis Medical Center, to speak on inpatient diabetes and was thrilled when he accepted my invitation. This provided an exciting start to our journey with SHM’s eQUIPS data management program.

As we began to obtain baseline measurements of glucose control, we needed a standardized, validated tool. The point-of-care glucose meters generated an enormous amount of data, but we were unable to sort this and analyze it in a meaningful and potentially actionable way. We were especially concerned about hypoglycemia. Our first task was to develop a prescriber ordered and nurse driven hypoglycemia protocol. How would we measure the overall effectiveness and success of the stepwise components of the protocol? The eQUIPS hypoglycemia management report was ideal in that it detailed metrics in stepwise fashion as it related to our protocol. For example, we were able to see the time from detection of hypoglycemia to the next point-of-care glucose check and to resolution of the event.

In addition, we wanted some comparative benchmarking data. The GC eQUIPS Program has a robust database of U.S. hospitals, which helped us define our ultimate goal – to be in the upper quartile of all measures. And we did it! Because of the amazing teamwork and leadership support, we were able to achieve national distinction from SHM as a “Top Performer” hospital for glycemic care.
 

How did the program help you and the team design your initiatives?

Data are powerful and convincing. We post and report our eQUIPS Glucometrics to our clinical staff monthly by unit, and through this process, we obtain the necessary “buy-ins” as well as participation to design clinical protocols and order sets. For example, we noted that many patients would be placed on “sliding scale”/coverage insulin alone at the time of hospital admission. This often would not be adjusted during the hospital stay. Our data showed that this practice was associated with more glucose fluctuations and hypoglycemia. When we reviewed this with our hospitalists, we achieved consensus and developed basal/bolus correction insulin protocols, which are embedded in the admission care sets. Following use of these order sets, we noted less hypoglycemia (decreased from 5.9% and remains less than 3.6%) and lower glucose variability. With the help of the eQUIPS metrics and benchmarking, we now have more than 20 protocols and safety rules built into our EHR system.

What were the key benefits that the GC eQUIPS Program provided that you were unable to find elsewhere?

The unique features we found most useful are the national benchmarking and “real-world” data presentation. National benchmarking allows us to compare ourselves with other hospitals (we can sort for like hospitals or all hospitals) and to periodically evaluate our processes and reexamine our goals. As part of this program, we can communicate with leaders of other high-performing hospitals and share strategies and challenges as well as discuss successes and failures. The quarterly benchmark webinar is another opportunity to be part of this professional community and we often pick up helpful information.

We particularly like the hyperglycemia/hypoglycemia scatter plots, which demonstrate the practical and important impact of glycemic control. Often there is a see-saw effect in which, if one parameter goes up, the other goes down; finding the sweet spot between hyperglycemia and hypoglycemia is key and clinically important.
 

Do you have any other comments to share related to your institution’s participation in the program?

We are fortunate to have many successes driven by our participation with the GC eQUIPS Program:

• Coordination of capillary blood glucose (CBG) testing, insulin administration and meal delivery: Use of rapid-acting insulin premeal is standard of care and requires that CBG testing, insulin, and meal delivery be precisely coordinated for optimal insulin action. We developed a process in which the catering associate calls the nurse using a voice-activated pager when the meal tray leaves the kitchen. Then, the nurse checks the CBG and gives insulin when the tray arrives. The tray contains a card to empower the patient to wait for the nurse to administer insulin prior to eating. This also provides an opportunity for nutritional education and carbohydrate awareness. Implementation of this process increased the percentage of patients who had a CBG and insulin administration within 15 minutes before a meal from less than 10% to more than 60%.
• Patient education regarding insulin use: In many cases, hospital patients may be started on insulin and their oral agents may be discontinued. This can be confusing and frightening to patients who often do not know if they will need to be on insulin long term. Our GCT created a script for the staff nurse to inform and reassure patients that this is standard practice and does not mean that they will need to remain on insulin after hospital discharge. The clinical team will communicate with the patient and together they will review treatment options. We have received many positive reviews from patients and staff for improving communication around this aspect of insulin therapy.
• Clinician and leader education: When our data revealed an uptick in hypoglycemia in our critical care units, we engaged the physicians, nurses, and staff and reviewed patient charts to identify potential process changes. To keep hypoglycemia in the spotlight, our director of critical care added hypoglycemia to the ICU checklist, which is discussed on all team clinical rounds. We are also developing an electronic metric (24-hour glucose maximum and minimum values) that can be quickly reviewed by the clinical team daily.
• Hypoglycemia and hyperkalemia: Analysis of our hypoglycemia data revealed a higher-than-expected rate in the ED in patients who did not have a diabetes diagnosis. Further review showed that this was associated with insulin treatment of hyperkalemia. Subsequently, we engaged our resident trainees and other team members in a study to characterize this hypoglycemia-hyperkalemia, and we have recently submitted a manuscript for publication detailing our findings and recommendations for glucose monitoring in these patients.
• Guideline for medical consultation on nonmedical services: Based on review of glucometrics on the nonmedical units and discussions with our hospitalist teams, we designed a guideline that includes recommendations for Medical Consultation in Nonmedical Admissions. Comanagement by a medical consultant will be requested earlier, and we will monitor if this influences glucometrics, patient and hospitalist satisfaction, etc.
• Medical student and house staff education: Two of our GCT hospitalists organize a monthly patient safety conference. After the students and trainees are asked to propose actionable solutions, the hospitalists discuss proposals generated at our GCT meetings. The students and trainees have the opportunity to participate in quality improvement, and we get great ideas from them as well.

Perhaps our biggest success is our Glycemic Care Team itself. We now receive questions and items to review from all departments and are seen as the hospital’s expert team on diabetes and hyperglycemia. It is truly a pleasure to lead this group of extremely high functioning and dedicated professionals. It is said that “team work makes the dream work.” Moving forward, I hope to expand our Glycemic Care Team to all the hospitals in our network.

The Hospitalist recently sat down with Nancy J. Rennert, MD, FACE, FACP, CPHQ, chief of endocrinology and diabetes at Norwalk (Conn.) Hospital, Western Connecticut Health Network, to discuss her institution’s glycemic control initiatives.

Tell us a bit about your program:

Norwalk Hospital is a 366-bed community teaching hospital founded 125 years ago, now part of the growing Western Connecticut Health Network. Our residency and fellowship training programs are affiliated with Yale University, New Haven, Conn., and we are a branch campus of the University of Vermont, Burlington.

With leadership support, we created our Glycemic Care Team (GCT) 4 years ago to focus on improving the quality of care for persons with diabetes who were admitted to our hospital (often for another primary medical reason). Our hospitalists – 8 on the teaching service and 11 on the nonteaching service – are key players in our efforts as they care for the majority of medical inpatients. GCT is interdisciplinary and includes stakeholders at all levels, including quality, pharmacy, nutrition, hospital medicine, diabetes education, administrative leadership, endocrinology, information technology, point-of-care testing/pathology, surgery and more. We meet monthly with an agenda that includes safety events, glucometrics, and discussion of policies and protocols. Subgroups complete tasks in between the monthly meetings, and we bring in other clinical specialties as indicated based on the issues at hand.
 

What prior challenges did you encounter that led you to enroll in the Glycemic Control (GC) eQUIPS Program?

In order to know if our GCT was making a positive difference, we needed to first measure our baseline metrics and then identify our goals and develop our processes. We wanted actionable data analysis and the ability to differentiate areas of our hospital such as individual clinical units. After researching the options, we chose SHM’s GC eQUIPS Program, which we found to be user friendly. The national benchmarking was an important aspect for us as well. As a kick-off event, I invited Greg Maynard, MD, MHM, a hospitalist and the chief quality officer, UC Davis Medical Center, to speak on inpatient diabetes and was thrilled when he accepted my invitation. This provided an exciting start to our journey with SHM’s eQUIPS data management program.

As we began to obtain baseline measurements of glucose control, we needed a standardized, validated tool. The point-of-care glucose meters generated an enormous amount of data, but we were unable to sort this and analyze it in a meaningful and potentially actionable way. We were especially concerned about hypoglycemia. Our first task was to develop a prescriber ordered and nurse driven hypoglycemia protocol. How would we measure the overall effectiveness and success of the stepwise components of the protocol? The eQUIPS hypoglycemia management report was ideal in that it detailed metrics in stepwise fashion as it related to our protocol. For example, we were able to see the time from detection of hypoglycemia to the next point-of-care glucose check and to resolution of the event.

In addition, we wanted some comparative benchmarking data. The GC eQUIPS Program has a robust database of U.S. hospitals, which helped us define our ultimate goal – to be in the upper quartile of all measures. And we did it! Because of the amazing teamwork and leadership support, we were able to achieve national distinction from SHM as a “Top Performer” hospital for glycemic care.
 

How did the program help you and the team design your initiatives?

Data are powerful and convincing. We post and report our eQUIPS Glucometrics to our clinical staff monthly by unit, and through this process, we obtain the necessary “buy-ins” as well as participation to design clinical protocols and order sets. For example, we noted that many patients would be placed on “sliding scale”/coverage insulin alone at the time of hospital admission. This often would not be adjusted during the hospital stay. Our data showed that this practice was associated with more glucose fluctuations and hypoglycemia. When we reviewed this with our hospitalists, we achieved consensus and developed basal/bolus correction insulin protocols, which are embedded in the admission care sets. Following use of these order sets, we noted less hypoglycemia (decreased from 5.9% and remains less than 3.6%) and lower glucose variability. With the help of the eQUIPS metrics and benchmarking, we now have more than 20 protocols and safety rules built into our EHR system.

What were the key benefits that the GC eQUIPS Program provided that you were unable to find elsewhere?

The unique features we found most useful are the national benchmarking and “real-world” data presentation. National benchmarking allows us to compare ourselves with other hospitals (we can sort for like hospitals or all hospitals) and to periodically evaluate our processes and reexamine our goals. As part of this program, we can communicate with leaders of other high-performing hospitals and share strategies and challenges as well as discuss successes and failures. The quarterly benchmark webinar is another opportunity to be part of this professional community and we often pick up helpful information.

We particularly like the hyperglycemia/hypoglycemia scatter plots, which demonstrate the practical and important impact of glycemic control. Often there is a see-saw effect in which, if one parameter goes up, the other goes down; finding the sweet spot between hyperglycemia and hypoglycemia is key and clinically important.
 

Do you have any other comments to share related to your institution’s participation in the program?

We are fortunate to have many successes driven by our participation with the GC eQUIPS Program:

• Coordination of capillary blood glucose (CBG) testing, insulin administration and meal delivery: Use of rapid-acting insulin premeal is standard of care and requires that CBG testing, insulin, and meal delivery be precisely coordinated for optimal insulin action. We developed a process in which the catering associate calls the nurse using a voice-activated pager when the meal tray leaves the kitchen. Then, the nurse checks the CBG and gives insulin when the tray arrives. The tray contains a card to empower the patient to wait for the nurse to administer insulin prior to eating. This also provides an opportunity for nutritional education and carbohydrate awareness. Implementation of this process increased the percentage of patients who had a CBG and insulin administration within 15 minutes before a meal from less than 10% to more than 60%.
• Patient education regarding insulin use: In many cases, hospital patients may be started on insulin and their oral agents may be discontinued. This can be confusing and frightening to patients who often do not know if they will need to be on insulin long term. Our GCT created a script for the staff nurse to inform and reassure patients that this is standard practice and does not mean that they will need to remain on insulin after hospital discharge. The clinical team will communicate with the patient and together they will review treatment options. We have received many positive reviews from patients and staff for improving communication around this aspect of insulin therapy.
• Clinician and leader education: When our data revealed an uptick in hypoglycemia in our critical care units, we engaged the physicians, nurses, and staff and reviewed patient charts to identify potential process changes. To keep hypoglycemia in the spotlight, our director of critical care added hypoglycemia to the ICU checklist, which is discussed on all team clinical rounds. We are also developing an electronic metric (24-hour glucose maximum and minimum values) that can be quickly reviewed by the clinical team daily.
• Hypoglycemia and hyperkalemia: Analysis of our hypoglycemia data revealed a higher-than-expected rate in the ED in patients who did not have a diabetes diagnosis. Further review showed that this was associated with insulin treatment of hyperkalemia. Subsequently, we engaged our resident trainees and other team members in a study to characterize this hypoglycemia-hyperkalemia, and we have recently submitted a manuscript for publication detailing our findings and recommendations for glucose monitoring in these patients.
• Guideline for medical consultation on nonmedical services: Based on review of glucometrics on the nonmedical units and discussions with our hospitalist teams, we designed a guideline that includes recommendations for Medical Consultation in Nonmedical Admissions. Comanagement by a medical consultant will be requested earlier, and we will monitor if this influences glucometrics, patient and hospitalist satisfaction, etc.
• Medical student and house staff education: Two of our GCT hospitalists organize a monthly patient safety conference. After the students and trainees are asked to propose actionable solutions, the hospitalists discuss proposals generated at our GCT meetings. The students and trainees have the opportunity to participate in quality improvement, and we get great ideas from them as well.

Perhaps our biggest success is our Glycemic Care Team itself. We now receive questions and items to review from all departments and are seen as the hospital’s expert team on diabetes and hyperglycemia. It is truly a pleasure to lead this group of extremely high functioning and dedicated professionals. It is said that “team work makes the dream work.” Moving forward, I hope to expand our Glycemic Care Team to all the hospitals in our network.

The Hospitalist recently sat down with Nancy J. Rennert, MD, FACE, FACP, CPHQ, chief of endocrinology and diabetes at Norwalk (Conn.) Hospital, Western Connecticut Health Network, to discuss her institution’s glycemic control initiatives.

Tell us a bit about your program:

Norwalk Hospital is a 366-bed community teaching hospital founded 125 years ago, now part of the growing Western Connecticut Health Network. Our residency and fellowship training programs are affiliated with Yale University, New Haven, Conn., and we are a branch campus of the University of Vermont, Burlington.

With leadership support, we created our Glycemic Care Team (GCT) 4 years ago to focus on improving the quality of care for persons with diabetes who were admitted to our hospital (often for another primary medical reason). Our hospitalists – 8 on the teaching service and 11 on the nonteaching service – are key players in our efforts as they care for the majority of medical inpatients. GCT is interdisciplinary and includes stakeholders at all levels, including quality, pharmacy, nutrition, hospital medicine, diabetes education, administrative leadership, endocrinology, information technology, point-of-care testing/pathology, surgery and more. We meet monthly with an agenda that includes safety events, glucometrics, and discussion of policies and protocols. Subgroups complete tasks in between the monthly meetings, and we bring in other clinical specialties as indicated based on the issues at hand.
 

What prior challenges did you encounter that led you to enroll in the Glycemic Control (GC) eQUIPS Program?

In order to know if our GCT was making a positive difference, we needed to first measure our baseline metrics and then identify our goals and develop our processes. We wanted actionable data analysis and the ability to differentiate areas of our hospital such as individual clinical units. After researching the options, we chose SHM’s GC eQUIPS Program, which we found to be user friendly. The national benchmarking was an important aspect for us as well. As a kick-off event, I invited Greg Maynard, MD, MHM, a hospitalist and the chief quality officer, UC Davis Medical Center, to speak on inpatient diabetes and was thrilled when he accepted my invitation. This provided an exciting start to our journey with SHM’s eQUIPS data management program.

As we began to obtain baseline measurements of glucose control, we needed a standardized, validated tool. The point-of-care glucose meters generated an enormous amount of data, but we were unable to sort this and analyze it in a meaningful and potentially actionable way. We were especially concerned about hypoglycemia. Our first task was to develop a prescriber ordered and nurse driven hypoglycemia protocol. How would we measure the overall effectiveness and success of the stepwise components of the protocol? The eQUIPS hypoglycemia management report was ideal in that it detailed metrics in stepwise fashion as it related to our protocol. For example, we were able to see the time from detection of hypoglycemia to the next point-of-care glucose check and to resolution of the event.

In addition, we wanted some comparative benchmarking data. The GC eQUIPS Program has a robust database of U.S. hospitals, which helped us define our ultimate goal – to be in the upper quartile of all measures. And we did it! Because of the amazing teamwork and leadership support, we were able to achieve national distinction from SHM as a “Top Performer” hospital for glycemic care.
 

How did the program help you and the team design your initiatives?

Data are powerful and convincing. We post and report our eQUIPS Glucometrics to our clinical staff monthly by unit, and through this process, we obtain the necessary “buy-ins” as well as participation to design clinical protocols and order sets. For example, we noted that many patients would be placed on “sliding scale”/coverage insulin alone at the time of hospital admission. This often would not be adjusted during the hospital stay. Our data showed that this practice was associated with more glucose fluctuations and hypoglycemia. When we reviewed this with our hospitalists, we achieved consensus and developed basal/bolus correction insulin protocols, which are embedded in the admission care sets. Following use of these order sets, we noted less hypoglycemia (decreased from 5.9% and remains less than 3.6%) and lower glucose variability. With the help of the eQUIPS metrics and benchmarking, we now have more than 20 protocols and safety rules built into our EHR system.

What were the key benefits that the GC eQUIPS Program provided that you were unable to find elsewhere?

The unique features we found most useful are the national benchmarking and “real-world” data presentation. National benchmarking allows us to compare ourselves with other hospitals (we can sort for like hospitals or all hospitals) and to periodically evaluate our processes and reexamine our goals. As part of this program, we can communicate with leaders of other high-performing hospitals and share strategies and challenges as well as discuss successes and failures. The quarterly benchmark webinar is another opportunity to be part of this professional community and we often pick up helpful information.

We particularly like the hyperglycemia/hypoglycemia scatter plots, which demonstrate the practical and important impact of glycemic control. Often there is a see-saw effect in which, if one parameter goes up, the other goes down; finding the sweet spot between hyperglycemia and hypoglycemia is key and clinically important.
 

Do you have any other comments to share related to your institution’s participation in the program?

We are fortunate to have many successes driven by our participation with the GC eQUIPS Program:

• Coordination of capillary blood glucose (CBG) testing, insulin administration and meal delivery: Use of rapid-acting insulin premeal is standard of care and requires that CBG testing, insulin, and meal delivery be precisely coordinated for optimal insulin action. We developed a process in which the catering associate calls the nurse using a voice-activated pager when the meal tray leaves the kitchen. Then, the nurse checks the CBG and gives insulin when the tray arrives. The tray contains a card to empower the patient to wait for the nurse to administer insulin prior to eating. This also provides an opportunity for nutritional education and carbohydrate awareness. Implementation of this process increased the percentage of patients who had a CBG and insulin administration within 15 minutes before a meal from less than 10% to more than 60%.
• Patient education regarding insulin use: In many cases, hospital patients may be started on insulin and their oral agents may be discontinued. This can be confusing and frightening to patients who often do not know if they will need to be on insulin long term. Our GCT created a script for the staff nurse to inform and reassure patients that this is standard practice and does not mean that they will need to remain on insulin after hospital discharge. The clinical team will communicate with the patient and together they will review treatment options. We have received many positive reviews from patients and staff for improving communication around this aspect of insulin therapy.
• Clinician and leader education: When our data revealed an uptick in hypoglycemia in our critical care units, we engaged the physicians, nurses, and staff and reviewed patient charts to identify potential process changes. To keep hypoglycemia in the spotlight, our director of critical care added hypoglycemia to the ICU checklist, which is discussed on all team clinical rounds. We are also developing an electronic metric (24-hour glucose maximum and minimum values) that can be quickly reviewed by the clinical team daily.
• Hypoglycemia and hyperkalemia: Analysis of our hypoglycemia data revealed a higher-than-expected rate in the ED in patients who did not have a diabetes diagnosis. Further review showed that this was associated with insulin treatment of hyperkalemia. Subsequently, we engaged our resident trainees and other team members in a study to characterize this hypoglycemia-hyperkalemia, and we have recently submitted a manuscript for publication detailing our findings and recommendations for glucose monitoring in these patients.
• Guideline for medical consultation on nonmedical services: Based on review of glucometrics on the nonmedical units and discussions with our hospitalist teams, we designed a guideline that includes recommendations for Medical Consultation in Nonmedical Admissions. Comanagement by a medical consultant will be requested earlier, and we will monitor if this influences glucometrics, patient and hospitalist satisfaction, etc.
• Medical student and house staff education: Two of our GCT hospitalists organize a monthly patient safety conference. After the students and trainees are asked to propose actionable solutions, the hospitalists discuss proposals generated at our GCT meetings. The students and trainees have the opportunity to participate in quality improvement, and we get great ideas from them as well.

Perhaps our biggest success is our Glycemic Care Team itself. We now receive questions and items to review from all departments and are seen as the hospital’s expert team on diabetes and hyperglycemia. It is truly a pleasure to lead this group of extremely high functioning and dedicated professionals. It is said that “team work makes the dream work.” Moving forward, I hope to expand our Glycemic Care Team to all the hospitals in our network.

Clinical question: Is bacteremia from certain microbes associated with colorectal cancer?

Background: Streptococcus bovis bacteremia is classically associated with colorectal cancer. A number of other bacterial species have been found in colorectal cancer microbiota and may even exert oncogenic effects. However, it is not known whether bacteremia from these microbes is associated with ­colorectal cancer.

Study design: Retrospective cohort study.

Dr. Scarpato is clinical instructor in the division of hospital medicine, University of Colorado, Denver.

Clinical question: Is bacteremia from certain microbes associated with colorectal cancer?

Background: Streptococcus bovis bacteremia is classically associated with colorectal cancer. A number of other bacterial species have been found in colorectal cancer microbiota and may even exert oncogenic effects. However, it is not known whether bacteremia from these microbes is associated with ­colorectal cancer.

Study design: Retrospective cohort study.

Dr. Scarpato is clinical instructor in the division of hospital medicine, University of Colorado, Denver.

Clinical question: Is bacteremia from certain microbes associated with colorectal cancer?

Background: Streptococcus bovis bacteremia is classically associated with colorectal cancer. A number of other bacterial species have been found in colorectal cancer microbiota and may even exert oncogenic effects. However, it is not known whether bacteremia from these microbes is associated with ­colorectal cancer.

Study design: Retrospective cohort study.

Dr. Scarpato is clinical instructor in the division of hospital medicine, University of Colorado, Denver.

Frail older patients with acute myocardial infarction (AMI) may be at increased bleeding risk if managed with an invasive strategy, results of a large U.S. registry study suggest.

Ingram Pub.l

The increased bleeding risk was seen among frail older AMI patients who underwent cardiac catheterization, but it was not seen in those treated with more conservative medical management, according to study results.

That finding highlights the conundrum with invasive management strategies for frail patients with AMI, wrote John A. Dodson, MD, MPH, of New York University and study coinvestigators.

“Awareness of vulnerability and greater utilization of evidence-based strategies to reduce bleeding, including radial access and properly dose-adjusted anticoagulant therapies, may mitigate some bleeding events,” they wrote in JACC: Cardiovascular Interventions.

Results of this study, the first large U.S. registry analysis evaluating in-hospital bleeding risk in frail older adults with AMI, confirm findings from several previous small cohort studies linking frailty in AMI patients to in-hospital bleeding, investigators reported.

The analysis included a total of 129,330 AMI patients in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) registry who were aged at least 65 years in 2015 or 2016.

About one in six of these older patients were frail, as defined by a composite score based on impaired walking, cognition, and activities of daily living, investigators reported.

The bleeding rate was significantly higher among frail patients undergoing cardiac catheterization, at 9.4% for patients rated as having vulnerable/mild frailty and 9.9% for patients with moderate to severe frailty (P less than.001), compared with fit/well patients, whose rate was 6.5%, investigators wrote. By contrast, there was no significant difference in bleeding rates for frail versus nonfrail patients managed conservatively, they said.

After adjusting for bleeding risk factors, frailty was independently associated with increased risk of bleeding, compared with fit/well status, with odds ratios of 1.33 for vulnerable/mild frailty and 1.40 for moderate to severe frailty. Again, no association was found between frailty and bleeding risk in patients managed conservatively, according to investigators.

Frail patients in the ACTION registry were more often older and female and less likely to undergo cardiac catheterization when compared with fit or well patients, they added in the report.

Like the small cohort studies that preceded it, this large U.S. registry study shows that frailty is an “important additional risk factor” among older adults with AMI who are managed with an invasive strategy, investigators said.

“When applicable, estimation of bleeding risk in frail patients before invasive care may facilitate clinical decision making and the informed consent process,” they wrote.

The ACTION registry, an ongoing quality improvement initiative sponsored by the American College of Cardiology and the American Heart Association, started collecting frailty characteristics among hospitalized AMI patients in 2015, investigators noted.

Dr. Dodson reported support from the National Institutes of Health/National Institute on Aging and from the American Heart Association. Study coauthors provided disclosures related to Bayer, Janssen, Abbott Vascular, Jarvik Heart, LifeCuff Technologies, and Ancora Heart. JACC Cardiovasc Interv. 2018 Nov 26;11:2287-96

SOURCE: Dodson JA et al. JACC Cardiovasc Intv. 2018;11:2287-96.

Frail older patients with acute myocardial infarction (AMI) may be at increased bleeding risk if managed with an invasive strategy, results of a large U.S. registry study suggest.

Ingram Pub.l

The increased bleeding risk was seen among frail older AMI patients who underwent cardiac catheterization, but it was not seen in those treated with more conservative medical management, according to study results.

That finding highlights the conundrum with invasive management strategies for frail patients with AMI, wrote John A. Dodson, MD, MPH, of New York University and study coinvestigators.

“Awareness of vulnerability and greater utilization of evidence-based strategies to reduce bleeding, including radial access and properly dose-adjusted anticoagulant therapies, may mitigate some bleeding events,” they wrote in JACC: Cardiovascular Interventions.

Results of this study, the first large U.S. registry analysis evaluating in-hospital bleeding risk in frail older adults with AMI, confirm findings from several previous small cohort studies linking frailty in AMI patients to in-hospital bleeding, investigators reported.

The analysis included a total of 129,330 AMI patients in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) registry who were aged at least 65 years in 2015 or 2016.

About one in six of these older patients were frail, as defined by a composite score based on impaired walking, cognition, and activities of daily living, investigators reported.

The bleeding rate was significantly higher among frail patients undergoing cardiac catheterization, at 9.4% for patients rated as having vulnerable/mild frailty and 9.9% for patients with moderate to severe frailty (P less than.001), compared with fit/well patients, whose rate was 6.5%, investigators wrote. By contrast, there was no significant difference in bleeding rates for frail versus nonfrail patients managed conservatively, they said.

After adjusting for bleeding risk factors, frailty was independently associated with increased risk of bleeding, compared with fit/well status, with odds ratios of 1.33 for vulnerable/mild frailty and 1.40 for moderate to severe frailty. Again, no association was found between frailty and bleeding risk in patients managed conservatively, according to investigators.

Frail patients in the ACTION registry were more often older and female and less likely to undergo cardiac catheterization when compared with fit or well patients, they added in the report.

Like the small cohort studies that preceded it, this large U.S. registry study shows that frailty is an “important additional risk factor” among older adults with AMI who are managed with an invasive strategy, investigators said.

“When applicable, estimation of bleeding risk in frail patients before invasive care may facilitate clinical decision making and the informed consent process,” they wrote.

The ACTION registry, an ongoing quality improvement initiative sponsored by the American College of Cardiology and the American Heart Association, started collecting frailty characteristics among hospitalized AMI patients in 2015, investigators noted.

Dr. Dodson reported support from the National Institutes of Health/National Institute on Aging and from the American Heart Association. Study coauthors provided disclosures related to Bayer, Janssen, Abbott Vascular, Jarvik Heart, LifeCuff Technologies, and Ancora Heart. JACC Cardiovasc Interv. 2018 Nov 26;11:2287-96

SOURCE: Dodson JA et al. JACC Cardiovasc Intv. 2018;11:2287-96.

Frail older patients with acute myocardial infarction (AMI) may be at increased bleeding risk if managed with an invasive strategy, results of a large U.S. registry study suggest.

Ingram Pub.l

The increased bleeding risk was seen among frail older AMI patients who underwent cardiac catheterization, but it was not seen in those treated with more conservative medical management, according to study results.

That finding highlights the conundrum with invasive management strategies for frail patients with AMI, wrote John A. Dodson, MD, MPH, of New York University and study coinvestigators.

“Awareness of vulnerability and greater utilization of evidence-based strategies to reduce bleeding, including radial access and properly dose-adjusted anticoagulant therapies, may mitigate some bleeding events,” they wrote in JACC: Cardiovascular Interventions.

Results of this study, the first large U.S. registry analysis evaluating in-hospital bleeding risk in frail older adults with AMI, confirm findings from several previous small cohort studies linking frailty in AMI patients to in-hospital bleeding, investigators reported.

The analysis included a total of 129,330 AMI patients in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) registry who were aged at least 65 years in 2015 or 2016.

About one in six of these older patients were frail, as defined by a composite score based on impaired walking, cognition, and activities of daily living, investigators reported.

The bleeding rate was significantly higher among frail patients undergoing cardiac catheterization, at 9.4% for patients rated as having vulnerable/mild frailty and 9.9% for patients with moderate to severe frailty (P less than.001), compared with fit/well patients, whose rate was 6.5%, investigators wrote. By contrast, there was no significant difference in bleeding rates for frail versus nonfrail patients managed conservatively, they said.

After adjusting for bleeding risk factors, frailty was independently associated with increased risk of bleeding, compared with fit/well status, with odds ratios of 1.33 for vulnerable/mild frailty and 1.40 for moderate to severe frailty. Again, no association was found between frailty and bleeding risk in patients managed conservatively, according to investigators.

Frail patients in the ACTION registry were more often older and female and less likely to undergo cardiac catheterization when compared with fit or well patients, they added in the report.

Like the small cohort studies that preceded it, this large U.S. registry study shows that frailty is an “important additional risk factor” among older adults with AMI who are managed with an invasive strategy, investigators said.

“When applicable, estimation of bleeding risk in frail patients before invasive care may facilitate clinical decision making and the informed consent process,” they wrote.

The ACTION registry, an ongoing quality improvement initiative sponsored by the American College of Cardiology and the American Heart Association, started collecting frailty characteristics among hospitalized AMI patients in 2015, investigators noted.

Dr. Dodson reported support from the National Institutes of Health/National Institute on Aging and from the American Heart Association. Study coauthors provided disclosures related to Bayer, Janssen, Abbott Vascular, Jarvik Heart, LifeCuff Technologies, and Ancora Heart. JACC Cardiovasc Interv. 2018 Nov 26;11:2287-96

SOURCE: Dodson JA et al. JACC Cardiovasc Intv. 2018;11:2287-96.

Sepsis Campaign bundles shortened to 1 hour
In response to the 2016 Surviving Sepsis Campaign guidelines, the 3-hour and 6-hour bundles have been combined and shortened into a 1-hour bundle to emphasize the emergent nature of sepsis. Elements of the bundle remain to same: measuring lactate, obtaining blood cultures, administration of broad-spectrume antibiotics, administration of 30mL/kg crystalloid, and vasopressors when necessary.

Citation: Levy MM et al. The Surviving Sepsis Campaign bundle: 2018 update. Crit Care Med. 2018;46(6):997-1000

Sepsis Campaign bundles shortened to 1 hour
In response to the 2016 Surviving Sepsis Campaign guidelines, the 3-hour and 6-hour bundles have been combined and shortened into a 1-hour bundle to emphasize the emergent nature of sepsis. Elements of the bundle remain to same: measuring lactate, obtaining blood cultures, administration of broad-spectrume antibiotics, administration of 30mL/kg crystalloid, and vasopressors when necessary.

Citation: Levy MM et al. The Surviving Sepsis Campaign bundle: 2018 update. Crit Care Med. 2018;46(6):997-1000

Sepsis Campaign bundles shortened to 1 hour
In response to the 2016 Surviving Sepsis Campaign guidelines, the 3-hour and 6-hour bundles have been combined and shortened into a 1-hour bundle to emphasize the emergent nature of sepsis. Elements of the bundle remain to same: measuring lactate, obtaining blood cultures, administration of broad-spectrume antibiotics, administration of 30mL/kg crystalloid, and vasopressors when necessary.

Citation: Levy MM et al. The Surviving Sepsis Campaign bundle: 2018 update. Crit Care Med. 2018;46(6):997-1000

Risk stratification tools that omit lumbar puncture accurately classified most well-appearing febrile infants with invasive bacterial infections as being at low risk, results of a recent study show.

The modified Philadelphia criteria were highly sensitive for risk stratifying febrile infants, in a recent validation study based on a large, multicenter sample, investigators report. No infants with bacterial meningitis were classified as low risk using the modified criteria, which do not include routine testing of cerebrospinal fluid (CSF). Two infants with bacterial meningitis, both younger than 28 days old, were classified as low risk using the Rochester criteria, which also avoid routine lumbar puncture, investigators reported.

“Our findings support the use of the modified Philadelphia criteria without routine CSF testing for febrile infants in the second month of life,” the investigators said in their report, published in Pediatrics.

However, to confirm the safety of omitting CSF testing in low-risk febrile infants older than 28 days, a prospective study will be needed, cautioned the researchers, led by Paul L. Aronson, MD, of the department of pediatrics at Yale University in New Haven, Conn.

Nevertheless, some clinicians do not automatically perform CSF testing in infants older than 28 days because of the rarity of bacterial meningitis in that age group, they said in the report.

The study by Dr. Aronson and colleagues was based on data for infants younger than 60 days of age seen in the emergency departments of 9 hospitals between July 2011 and June 2016. The final sample included 135 infants with invasive bacterial infections, including 118 who had bacteremia without meningitis and 17 who had bacterial meningitis, along with 249 matched febrile infant controls.

A total of 25 infants with invasive bacterial infections were classified as low risk by the Rochester criteria, and 11 of those were low risk by the modified Philadelphia criteria, investigators said.

Compared with the modified Philadelphia criteria, the Rochester criteria had a lower sensitivity (81.5% vs. 91.9%; P = 0.01) and a higher specificity (59.8 vs. 34.5%; P less than 0.001).

Out of the 11 infants deemed low risk per the modified Philadelphia criteria, none were diagnosed with bacterial meningitis. By contrast, 2 of the 25 infants who were low risk per the Rochester criteria had bacterial meningitis, and both were younger than or equal to 28 days of age. “Both of these infants would have been classified as high risk per the modified Philadelphia criteria,” Dr. Aronson and his coauthors said.

Based on the findings of this study, caution should be exercised in applying low-risk criteria to infants 28 days of age or younger, according to the investigators.

“Febrile infants discharged from the emergency department without CSF testing should have close outpatient follow-up,” they wrote.

Dr. Aronson and his coauthors reported that they had no relevant disclosures. One coauthor reported serving as an expert witness in malpractice cases involving evaluation of febrile children.

SOURCE: Aronson PL et al. Pediatrics. 13 Nov 2018. doi: 10.1542/peds.2018-1879).

Risk stratification tools that omit lumbar puncture accurately classified most well-appearing febrile infants with invasive bacterial infections as being at low risk, results of a recent study show.

The modified Philadelphia criteria were highly sensitive for risk stratifying febrile infants, in a recent validation study based on a large, multicenter sample, investigators report. No infants with bacterial meningitis were classified as low risk using the modified criteria, which do not include routine testing of cerebrospinal fluid (CSF). Two infants with bacterial meningitis, both younger than 28 days old, were classified as low risk using the Rochester criteria, which also avoid routine lumbar puncture, investigators reported.

“Our findings support the use of the modified Philadelphia criteria without routine CSF testing for febrile infants in the second month of life,” the investigators said in their report, published in Pediatrics.

However, to confirm the safety of omitting CSF testing in low-risk febrile infants older than 28 days, a prospective study will be needed, cautioned the researchers, led by Paul L. Aronson, MD, of the department of pediatrics at Yale University in New Haven, Conn.

Nevertheless, some clinicians do not automatically perform CSF testing in infants older than 28 days because of the rarity of bacterial meningitis in that age group, they said in the report.

The study by Dr. Aronson and colleagues was based on data for infants younger than 60 days of age seen in the emergency departments of 9 hospitals between July 2011 and June 2016. The final sample included 135 infants with invasive bacterial infections, including 118 who had bacteremia without meningitis and 17 who had bacterial meningitis, along with 249 matched febrile infant controls.

A total of 25 infants with invasive bacterial infections were classified as low risk by the Rochester criteria, and 11 of those were low risk by the modified Philadelphia criteria, investigators said.

Compared with the modified Philadelphia criteria, the Rochester criteria had a lower sensitivity (81.5% vs. 91.9%; P = 0.01) and a higher specificity (59.8 vs. 34.5%; P less than 0.001).

Out of the 11 infants deemed low risk per the modified Philadelphia criteria, none were diagnosed with bacterial meningitis. By contrast, 2 of the 25 infants who were low risk per the Rochester criteria had bacterial meningitis, and both were younger than or equal to 28 days of age. “Both of these infants would have been classified as high risk per the modified Philadelphia criteria,” Dr. Aronson and his coauthors said.

Based on the findings of this study, caution should be exercised in applying low-risk criteria to infants 28 days of age or younger, according to the investigators.

“Febrile infants discharged from the emergency department without CSF testing should have close outpatient follow-up,” they wrote.

Dr. Aronson and his coauthors reported that they had no relevant disclosures. One coauthor reported serving as an expert witness in malpractice cases involving evaluation of febrile children.

SOURCE: Aronson PL et al. Pediatrics. 13 Nov 2018. doi: 10.1542/peds.2018-1879).

Risk stratification tools that omit lumbar puncture accurately classified most well-appearing febrile infants with invasive bacterial infections as being at low risk, results of a recent study show.

The modified Philadelphia criteria were highly sensitive for risk stratifying febrile infants, in a recent validation study based on a large, multicenter sample, investigators report. No infants with bacterial meningitis were classified as low risk using the modified criteria, which do not include routine testing of cerebrospinal fluid (CSF). Two infants with bacterial meningitis, both younger than 28 days old, were classified as low risk using the Rochester criteria, which also avoid routine lumbar puncture, investigators reported.

“Our findings support the use of the modified Philadelphia criteria without routine CSF testing for febrile infants in the second month of life,” the investigators said in their report, published in Pediatrics.

However, to confirm the safety of omitting CSF testing in low-risk febrile infants older than 28 days, a prospective study will be needed, cautioned the researchers, led by Paul L. Aronson, MD, of the department of pediatrics at Yale University in New Haven, Conn.

Nevertheless, some clinicians do not automatically perform CSF testing in infants older than 28 days because of the rarity of bacterial meningitis in that age group, they said in the report.

The study by Dr. Aronson and colleagues was based on data for infants younger than 60 days of age seen in the emergency departments of 9 hospitals between July 2011 and June 2016. The final sample included 135 infants with invasive bacterial infections, including 118 who had bacteremia without meningitis and 17 who had bacterial meningitis, along with 249 matched febrile infant controls.

A total of 25 infants with invasive bacterial infections were classified as low risk by the Rochester criteria, and 11 of those were low risk by the modified Philadelphia criteria, investigators said.

Compared with the modified Philadelphia criteria, the Rochester criteria had a lower sensitivity (81.5% vs. 91.9%; P = 0.01) and a higher specificity (59.8 vs. 34.5%; P less than 0.001).

Out of the 11 infants deemed low risk per the modified Philadelphia criteria, none were diagnosed with bacterial meningitis. By contrast, 2 of the 25 infants who were low risk per the Rochester criteria had bacterial meningitis, and both were younger than or equal to 28 days of age. “Both of these infants would have been classified as high risk per the modified Philadelphia criteria,” Dr. Aronson and his coauthors said.

Based on the findings of this study, caution should be exercised in applying low-risk criteria to infants 28 days of age or younger, according to the investigators.

“Febrile infants discharged from the emergency department without CSF testing should have close outpatient follow-up,” they wrote.

Dr. Aronson and his coauthors reported that they had no relevant disclosures. One coauthor reported serving as an expert witness in malpractice cases involving evaluation of febrile children.

SOURCE: Aronson PL et al. Pediatrics. 13 Nov 2018. doi: 10.1542/peds.2018-1879).