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Two ratios of plasma, platelets, and RBCs compared
Among profoundly injured trauma patients with major bleeding, both early (24 hour) and late (30 day) mortality were similar between those who received transfusions of plasma, platelets, and red blood cells in a 1:1:1 ratio and those who received them in a 1:1:2 ratio in a phase III clinical trial, which was reported online Feb. 3 in JAMA.
Transfusion protocols for such patients have been “predominantly guided by tradition rather than evidence from large, multicenter randomized trials.” Moreover, transfusion protocols have changed markedly during the past decade, with many clinicians changing over to the 1:1:1 ratio because it is more balanced and more closely replicates the ratio present in whole blood than the traditional 1:1:2 ratio, said Dr. John B. Holcomb of the Center for Translational Injury Research, University of Texas Health Science Center, Houston, and his associates in the PROPPR (Pragmatic, Randomized Optimal Platelet and Plasma Ratios) trial.
They described the study as the first multicenter randomized trial using approved blood products to compare these two transfusion ratios, using mortality as the primary end point. They enrolled 680 adults treated at 12 Level 1 trauma centers in North America for severe injury with major bleeding during a 16-month period.
Overall 24-hour mortality was not significantly different, at 12.7% in the 1:1:1 group and 17% in the 1:1:2 group, and 30-day mortality also was not significantly different (22.4% vs 26.1%). These results were confirmed in sensitivity analyses. However, exsanguination, the predominant cause of death within 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6%), and significantly more patients in the 1:1:1 group achieved anatomic homeostasis (86.1% vs 78.1%). Thus, clinicians “should consider using a 1:1:1 transfusion protocol,” Dr. Holcomb and his associates said (JAMA 2015 Feb. 3 [doi:10.10001/jama.2015.12]).
There also were no significant differences between the two study groups in 23 complications, including transfusion-related complications. And,“despite significant concerns that the 1:1:1 group would experience higher rates of multiple inflammatory-mediated complications, such as acute respiratory distress syndrome, multiple organ failure, infection, venous thromboembolism, and sepsis, no differences were detected between the two treatment groups,” they noted.
Among profoundly injured trauma patients with major bleeding, both early (24 hour) and late (30 day) mortality were similar between those who received transfusions of plasma, platelets, and red blood cells in a 1:1:1 ratio and those who received them in a 1:1:2 ratio in a phase III clinical trial, which was reported online Feb. 3 in JAMA.
Transfusion protocols for such patients have been “predominantly guided by tradition rather than evidence from large, multicenter randomized trials.” Moreover, transfusion protocols have changed markedly during the past decade, with many clinicians changing over to the 1:1:1 ratio because it is more balanced and more closely replicates the ratio present in whole blood than the traditional 1:1:2 ratio, said Dr. John B. Holcomb of the Center for Translational Injury Research, University of Texas Health Science Center, Houston, and his associates in the PROPPR (Pragmatic, Randomized Optimal Platelet and Plasma Ratios) trial.
They described the study as the first multicenter randomized trial using approved blood products to compare these two transfusion ratios, using mortality as the primary end point. They enrolled 680 adults treated at 12 Level 1 trauma centers in North America for severe injury with major bleeding during a 16-month period.
Overall 24-hour mortality was not significantly different, at 12.7% in the 1:1:1 group and 17% in the 1:1:2 group, and 30-day mortality also was not significantly different (22.4% vs 26.1%). These results were confirmed in sensitivity analyses. However, exsanguination, the predominant cause of death within 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6%), and significantly more patients in the 1:1:1 group achieved anatomic homeostasis (86.1% vs 78.1%). Thus, clinicians “should consider using a 1:1:1 transfusion protocol,” Dr. Holcomb and his associates said (JAMA 2015 Feb. 3 [doi:10.10001/jama.2015.12]).
There also were no significant differences between the two study groups in 23 complications, including transfusion-related complications. And,“despite significant concerns that the 1:1:1 group would experience higher rates of multiple inflammatory-mediated complications, such as acute respiratory distress syndrome, multiple organ failure, infection, venous thromboembolism, and sepsis, no differences were detected between the two treatment groups,” they noted.
Among profoundly injured trauma patients with major bleeding, both early (24 hour) and late (30 day) mortality were similar between those who received transfusions of plasma, platelets, and red blood cells in a 1:1:1 ratio and those who received them in a 1:1:2 ratio in a phase III clinical trial, which was reported online Feb. 3 in JAMA.
Transfusion protocols for such patients have been “predominantly guided by tradition rather than evidence from large, multicenter randomized trials.” Moreover, transfusion protocols have changed markedly during the past decade, with many clinicians changing over to the 1:1:1 ratio because it is more balanced and more closely replicates the ratio present in whole blood than the traditional 1:1:2 ratio, said Dr. John B. Holcomb of the Center for Translational Injury Research, University of Texas Health Science Center, Houston, and his associates in the PROPPR (Pragmatic, Randomized Optimal Platelet and Plasma Ratios) trial.
They described the study as the first multicenter randomized trial using approved blood products to compare these two transfusion ratios, using mortality as the primary end point. They enrolled 680 adults treated at 12 Level 1 trauma centers in North America for severe injury with major bleeding during a 16-month period.
Overall 24-hour mortality was not significantly different, at 12.7% in the 1:1:1 group and 17% in the 1:1:2 group, and 30-day mortality also was not significantly different (22.4% vs 26.1%). These results were confirmed in sensitivity analyses. However, exsanguination, the predominant cause of death within 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6%), and significantly more patients in the 1:1:1 group achieved anatomic homeostasis (86.1% vs 78.1%). Thus, clinicians “should consider using a 1:1:1 transfusion protocol,” Dr. Holcomb and his associates said (JAMA 2015 Feb. 3 [doi:10.10001/jama.2015.12]).
There also were no significant differences between the two study groups in 23 complications, including transfusion-related complications. And,“despite significant concerns that the 1:1:1 group would experience higher rates of multiple inflammatory-mediated complications, such as acute respiratory distress syndrome, multiple organ failure, infection, venous thromboembolism, and sepsis, no differences were detected between the two treatment groups,” they noted.
FROM JAMA
Key clinical point: Early and late mortality were similar between severe trauma patients given a 1:1:1 and those given a 1:1:2 ratio of plasma to platelets to RBCs.
Major finding: 24-hour mortality was not significantly different, at 12.7% in the 1:1:1 group and 17% in the 1:1:2 group, and 30-day mortality also was not significantly different (22.4% vs 26.1%).
Data source: A phase III multicenter partially blinded, randomized trial comparing two strategies for hemorrhage control in 680 profoundly injured adults treated during a 16-month period.
Disclosures: This study was supported by the U.S. National Heart, Lung, and Blood Institute, the U.S. Department of Defense, Defense Research and Development Canada, and the Canadian Institutes of Health Research-Institute of Circulatory and Respiratory Health. Dr. Holcomb reported having no financial disclosures; two associates reported ties to TEM International, CSL Behring, and Decision Health.
Half of patients elect head and neck surgery before meeting surgeon
CORONADO, CALIF. – About half of patients decide to undergo head and neck surgery even before meeting their surgeon, and concerns about cost of the procedure weigh heavily on their minds, results from a pilot study demonstrated.
In an effort to determine which factors influence patient decision making about elective surgery in otolaryngology, lead study author Dr. Maya G. Sardesai and her associates surveyed 48 consecutive adults who underwent head and neck surgery performed by one of six surgeons at Harborview Medical Center, Seattle, between March and September 2014.
The effort “rose from an observation in her clinical practice that, despite similar degrees of disease burden and similar counseling, patients sometimes show widely divergent degrees of enthusiasm for elective procedures,” Dr. Sardesai of the department of otolaryngology-head and neck surgery at the medical center said at the Triological Society’s Combined Sections Meeting. “This prompted the question: What information influences decision making in this setting?”
Current guidelines emphasize discussing the risks and benefits of surgery in the informed consent process, she continued, “but some studies of decision making in this setting have suggested that other factors might also influence decisions, such as family advice, social perception, and cost. There’s limited data in the otolaryngology literature about this, even though there’s a preponderance of quality-of-life surgery with low but potentially significant risks.”
With input from patients and surgeons, the researchers created a 35-question survey and administered it in the surgeon’s office, with questions that centered around the timing of the procedure, advice of others, sources of information, and their approach to decision making. More than half of patients (56%) were undergoing tonsillectomy, followed by a nasal procedure (48%), palate procedure (44%), midline glossectomy (35%), hyoid suspension (4%), genioglossus advancement (4%), laryngeal procedure (2%), and other (6%). (The numbers exceeded 100% because some patients underwent more than one procedure.)
Nearly half of subjects (49%) reported making their decision to pursue surgery even before their surgical consultation or meeting their surgeon. The researchers then divided the cohort into patients who had decided to pursue surgery before or after meeting their surgeon. Among those who made the decision before meeting the surgeon, 64% rated information they received from their primary care provider as very important, while 100% rated information they received from the surgeon as very important. These percentages were similar among patients who made the decision after meeting the surgeon (43% and 96%, respectively).
Patients who made their decision to pursue surgery after meeting their surgeon also were more likely to weigh information received from the Internet as more important, compared with patients who made their decision before meeting their surgeon (38% vs. 20%). “This difference was not statistically significant,” Dr. Sardesai said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “All patients felt that Internet information seemed important.”
Patients in both groups weighed concerns about symptoms as very important (in the range of 83%), which rated “highly if not more than concerns about the risks with or without surgery (70%).” Finally, she and her associates found that 49% of patients in both groups considered the cost of medical bills as very important, “which is an interesting finding, because our current consent process doesn’t include much discussion about monetary costs of treatment.”
Overall, the findings suggest that otolaryngologists and head and neck surgeons should reach out to referring providers “to ensure that they are well informed about the indications, benefits, limitation, and risks of head and neck surgeries,” Dr. Sardesai concluded. “This may also enhance opportunities for shared and collaborative decision making. If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether, and thus may be missing opportunities for better care. As otolaryngologists, we should also take an active role in providing and curating information from the Internet, since this is currently likely an increasingly important source of information for patients.”
She acknowledged certain limitations of the study, including its small sample size and the potential for recall bias. In addition, the survey “was administered in a surgeon’s office, which might bias patients to overemphasize the role of the surgeon,” she said. “Our future plans are to administer an enhanced version of the survey to broader [practice settings] to better understand these differences.”
Dr. Sardesai reported having no relevant financial conflicts.
On Twitter @dougbrunk
CORONADO, CALIF. – About half of patients decide to undergo head and neck surgery even before meeting their surgeon, and concerns about cost of the procedure weigh heavily on their minds, results from a pilot study demonstrated.
In an effort to determine which factors influence patient decision making about elective surgery in otolaryngology, lead study author Dr. Maya G. Sardesai and her associates surveyed 48 consecutive adults who underwent head and neck surgery performed by one of six surgeons at Harborview Medical Center, Seattle, between March and September 2014.
The effort “rose from an observation in her clinical practice that, despite similar degrees of disease burden and similar counseling, patients sometimes show widely divergent degrees of enthusiasm for elective procedures,” Dr. Sardesai of the department of otolaryngology-head and neck surgery at the medical center said at the Triological Society’s Combined Sections Meeting. “This prompted the question: What information influences decision making in this setting?”
Current guidelines emphasize discussing the risks and benefits of surgery in the informed consent process, she continued, “but some studies of decision making in this setting have suggested that other factors might also influence decisions, such as family advice, social perception, and cost. There’s limited data in the otolaryngology literature about this, even though there’s a preponderance of quality-of-life surgery with low but potentially significant risks.”
With input from patients and surgeons, the researchers created a 35-question survey and administered it in the surgeon’s office, with questions that centered around the timing of the procedure, advice of others, sources of information, and their approach to decision making. More than half of patients (56%) were undergoing tonsillectomy, followed by a nasal procedure (48%), palate procedure (44%), midline glossectomy (35%), hyoid suspension (4%), genioglossus advancement (4%), laryngeal procedure (2%), and other (6%). (The numbers exceeded 100% because some patients underwent more than one procedure.)
Nearly half of subjects (49%) reported making their decision to pursue surgery even before their surgical consultation or meeting their surgeon. The researchers then divided the cohort into patients who had decided to pursue surgery before or after meeting their surgeon. Among those who made the decision before meeting the surgeon, 64% rated information they received from their primary care provider as very important, while 100% rated information they received from the surgeon as very important. These percentages were similar among patients who made the decision after meeting the surgeon (43% and 96%, respectively).
Patients who made their decision to pursue surgery after meeting their surgeon also were more likely to weigh information received from the Internet as more important, compared with patients who made their decision before meeting their surgeon (38% vs. 20%). “This difference was not statistically significant,” Dr. Sardesai said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “All patients felt that Internet information seemed important.”
Patients in both groups weighed concerns about symptoms as very important (in the range of 83%), which rated “highly if not more than concerns about the risks with or without surgery (70%).” Finally, she and her associates found that 49% of patients in both groups considered the cost of medical bills as very important, “which is an interesting finding, because our current consent process doesn’t include much discussion about monetary costs of treatment.”
Overall, the findings suggest that otolaryngologists and head and neck surgeons should reach out to referring providers “to ensure that they are well informed about the indications, benefits, limitation, and risks of head and neck surgeries,” Dr. Sardesai concluded. “This may also enhance opportunities for shared and collaborative decision making. If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether, and thus may be missing opportunities for better care. As otolaryngologists, we should also take an active role in providing and curating information from the Internet, since this is currently likely an increasingly important source of information for patients.”
She acknowledged certain limitations of the study, including its small sample size and the potential for recall bias. In addition, the survey “was administered in a surgeon’s office, which might bias patients to overemphasize the role of the surgeon,” she said. “Our future plans are to administer an enhanced version of the survey to broader [practice settings] to better understand these differences.”
Dr. Sardesai reported having no relevant financial conflicts.
On Twitter @dougbrunk
CORONADO, CALIF. – About half of patients decide to undergo head and neck surgery even before meeting their surgeon, and concerns about cost of the procedure weigh heavily on their minds, results from a pilot study demonstrated.
In an effort to determine which factors influence patient decision making about elective surgery in otolaryngology, lead study author Dr. Maya G. Sardesai and her associates surveyed 48 consecutive adults who underwent head and neck surgery performed by one of six surgeons at Harborview Medical Center, Seattle, between March and September 2014.
The effort “rose from an observation in her clinical practice that, despite similar degrees of disease burden and similar counseling, patients sometimes show widely divergent degrees of enthusiasm for elective procedures,” Dr. Sardesai of the department of otolaryngology-head and neck surgery at the medical center said at the Triological Society’s Combined Sections Meeting. “This prompted the question: What information influences decision making in this setting?”
Current guidelines emphasize discussing the risks and benefits of surgery in the informed consent process, she continued, “but some studies of decision making in this setting have suggested that other factors might also influence decisions, such as family advice, social perception, and cost. There’s limited data in the otolaryngology literature about this, even though there’s a preponderance of quality-of-life surgery with low but potentially significant risks.”
With input from patients and surgeons, the researchers created a 35-question survey and administered it in the surgeon’s office, with questions that centered around the timing of the procedure, advice of others, sources of information, and their approach to decision making. More than half of patients (56%) were undergoing tonsillectomy, followed by a nasal procedure (48%), palate procedure (44%), midline glossectomy (35%), hyoid suspension (4%), genioglossus advancement (4%), laryngeal procedure (2%), and other (6%). (The numbers exceeded 100% because some patients underwent more than one procedure.)
Nearly half of subjects (49%) reported making their decision to pursue surgery even before their surgical consultation or meeting their surgeon. The researchers then divided the cohort into patients who had decided to pursue surgery before or after meeting their surgeon. Among those who made the decision before meeting the surgeon, 64% rated information they received from their primary care provider as very important, while 100% rated information they received from the surgeon as very important. These percentages were similar among patients who made the decision after meeting the surgeon (43% and 96%, respectively).
Patients who made their decision to pursue surgery after meeting their surgeon also were more likely to weigh information received from the Internet as more important, compared with patients who made their decision before meeting their surgeon (38% vs. 20%). “This difference was not statistically significant,” Dr. Sardesai said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “All patients felt that Internet information seemed important.”
Patients in both groups weighed concerns about symptoms as very important (in the range of 83%), which rated “highly if not more than concerns about the risks with or without surgery (70%).” Finally, she and her associates found that 49% of patients in both groups considered the cost of medical bills as very important, “which is an interesting finding, because our current consent process doesn’t include much discussion about monetary costs of treatment.”
Overall, the findings suggest that otolaryngologists and head and neck surgeons should reach out to referring providers “to ensure that they are well informed about the indications, benefits, limitation, and risks of head and neck surgeries,” Dr. Sardesai concluded. “This may also enhance opportunities for shared and collaborative decision making. If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether, and thus may be missing opportunities for better care. As otolaryngologists, we should also take an active role in providing and curating information from the Internet, since this is currently likely an increasingly important source of information for patients.”
She acknowledged certain limitations of the study, including its small sample size and the potential for recall bias. In addition, the survey “was administered in a surgeon’s office, which might bias patients to overemphasize the role of the surgeon,” she said. “Our future plans are to administer an enhanced version of the survey to broader [practice settings] to better understand these differences.”
Dr. Sardesai reported having no relevant financial conflicts.
On Twitter @dougbrunk
AT THE COMBINED SECTIONS WINTER MEETING
Key clinical point: Otolaryngologists and head and neck surgeons should ensure that primary and referring providers are well educated about elective head and neck procedures.
Major finding: Nearly half of patients opted for elective head and neck surgery even before meeting their surgeon.
Data source: A survey of 48 consecutive adults who underwent elective head and neck surgery between March and September 2014.
Disclosures: Dr. Sardesai reported having no financial disclosures.
NMBAs not linked to longer LOS after pediatric tracheostomy
CORONADO, CALIF. – The use of neuromuscular blockade agents in pediatric patients after tracheostomy was not an independent predictor of longer hospital length of stay, results from a 3-year, single-center study suggest. Factors which portended a longer length of stay including having a longer preoperative length of stay and being cared for in the neonatal intensive care unit.
“Across the country there are widespread initiatives to improve quality of care,” study coauthor Eric Bauer said at the Triological Society’s Combined Sections Meeting.
“Tracheostomy has been identified as a contributor to prolonged length of stay. Additionally, it’s a procedure associated with increased rates of pediatric otolaryngology infections and major adverse events including accidental decannulation. However, the factors which increase prolonged hospital stay have not been determined.”
Mr. Bauer, a fourth-year medical student at the Ohio State University, Columbus, noted that some published studies in the medical literature that focus on the use of neuromuscular blockade agents (NMBAs) following pediatric single-stage laryngeal or tracheal reconstruction suggest that these medications may prolong hospital stay and increase complication risk. “Therefore, the goal of our study was to determine if the use of NMBAs in pediatric patients following tracheostomy is associated with a prolonged length of stay,” he said at the meeting jointly sponsored by the Triological Society and the American College of Surgeons..
Mr. Bauer and his fellow researchers performed a retrospective chart review from 2010 to 2013 for all tracheostomies performed and cared for in the neonatal and pediatric intensive care units of Nationwide Children’s Hospital, Columbus. In all, 114 patients were included, 26 of whom received neuromuscular blockade agents in the postoperative period. Patients cared for in the cardiothoracic ICU were excluded from the analysis.
After collecting demographic, clinical, and 30-day outcome characteristics for all patients, the researchers observed no significant differences between those who received NMBAs and those who did not with respect to patient median age, gender, and baseline medical condition differences. “Patients who received NMBAs did have more cardiac illness (50% vs. 22% among those who did not receive NMBAs; P = .005), while patients who did not receive NMBAs had more neurologic disease (81% vs. 54%; P = .006),” Mr. Bauer said. “Overall, it was a medically complex patient group with a vast array of illnesses.”
Upper-airway obstruction was the most common indication for surgery, followed by cardiopulmonary and neurologic conditions. The researchers found that patients who did not receive NMBAs had more neurologic indications for tracheostomy, compared with their counterparts who did receive the agents (38% vs. 8%; P = .003), while patients who ultimately received NMBA had more cardiopulmonary indications for surgery (54% vs. 18%; P< .001).
In an analysis of preoperative factors, patients who ultimately received NMBA, compared with those who did not, had longer preoperative length of stay (LOS) (28-93 days vs. 59-224 days; P = .002), more respiratory failure 3 days prior to surgery (96% vs. 74%; P = .014), and prolonged intubation periods prior to surgery (0-24 days vs. 6-45 days; P = .009). However, location of care (NICU vs. PICU) was similar throughout. In addition, the physiologic status on the day of surgery as indicated by the Pediatric Risk of Mortality score was similar in both groups.
Mr. Bauer went on to report that preoperative interventions including 30-day use of glucocorticoids, inotropes, and aminoglycosides were similar between the two groups, as was the use of blood transfusions 48 hours prior to surgery. As for postoperative sedation, opioid use and pediatric daily dosing was similar between groups. However, the rate of dexmedetomidine use was twice as high in patients who ultimately received NMBAs, compared with those who did not (46% vs. 26%; P = .026).
In terms of outcomes, the rate of pressure ulcers, pneumonia, urinary tract infections, and other complications did not differ between the two groups, while the rate of mortality at the time of data collection was also similar (12% among those who received NMBAs and 15% among those who did not). This “mirrors the national average of 13%-20%,” Mr. Bauer said. “In addition, there were no mortalities related to the procedure itself.”
On univariate analysis, postoperative LOS was a median of 10 days longer in patients who received NMBAs, compared with those who did not (23 vs. 33 days, respectively; P = .043). After multivariate analysis, however, that association was no longer significant (P = .91). Multivariable analysis also found that patients with traumatic indications for tracheostomy placement had a 44% shorter LOS (P = .002), while those with upper-airway obstruction indications for tracheostomy placement had a 27% shorter LOS (P = .02). A similar association was observed in patients who tolerated oral nutrition prior to surgery, as compared with enteral nutrition (a 48% reduction in LOS; P< .001).
Factors which portended a longer postoperative LOS were preoperative lengths of stay that lasted 10 days or more (P less than .001) and being cared for in the neonatal vs. the pediatric ICU (P = .002).
“The use of paralytic agents in this complex cohort was not an independent predictor of longer LOS,” Mr. Bauer concluded. “Instead, factors such as preoperative LOS along with [certain] indications ultimately affected the LOS. Finally, the ideal sedative protocol following tracheostomy has not been determined and requires additional investigation.”
Mr. Bauer reported that neither he nor his associates had relevant financial conflicts to disclose.
On Twitter @dougbrunk
CORONADO, CALIF. – The use of neuromuscular blockade agents in pediatric patients after tracheostomy was not an independent predictor of longer hospital length of stay, results from a 3-year, single-center study suggest. Factors which portended a longer length of stay including having a longer preoperative length of stay and being cared for in the neonatal intensive care unit.
“Across the country there are widespread initiatives to improve quality of care,” study coauthor Eric Bauer said at the Triological Society’s Combined Sections Meeting.
“Tracheostomy has been identified as a contributor to prolonged length of stay. Additionally, it’s a procedure associated with increased rates of pediatric otolaryngology infections and major adverse events including accidental decannulation. However, the factors which increase prolonged hospital stay have not been determined.”
Mr. Bauer, a fourth-year medical student at the Ohio State University, Columbus, noted that some published studies in the medical literature that focus on the use of neuromuscular blockade agents (NMBAs) following pediatric single-stage laryngeal or tracheal reconstruction suggest that these medications may prolong hospital stay and increase complication risk. “Therefore, the goal of our study was to determine if the use of NMBAs in pediatric patients following tracheostomy is associated with a prolonged length of stay,” he said at the meeting jointly sponsored by the Triological Society and the American College of Surgeons..
Mr. Bauer and his fellow researchers performed a retrospective chart review from 2010 to 2013 for all tracheostomies performed and cared for in the neonatal and pediatric intensive care units of Nationwide Children’s Hospital, Columbus. In all, 114 patients were included, 26 of whom received neuromuscular blockade agents in the postoperative period. Patients cared for in the cardiothoracic ICU were excluded from the analysis.
After collecting demographic, clinical, and 30-day outcome characteristics for all patients, the researchers observed no significant differences between those who received NMBAs and those who did not with respect to patient median age, gender, and baseline medical condition differences. “Patients who received NMBAs did have more cardiac illness (50% vs. 22% among those who did not receive NMBAs; P = .005), while patients who did not receive NMBAs had more neurologic disease (81% vs. 54%; P = .006),” Mr. Bauer said. “Overall, it was a medically complex patient group with a vast array of illnesses.”
Upper-airway obstruction was the most common indication for surgery, followed by cardiopulmonary and neurologic conditions. The researchers found that patients who did not receive NMBAs had more neurologic indications for tracheostomy, compared with their counterparts who did receive the agents (38% vs. 8%; P = .003), while patients who ultimately received NMBA had more cardiopulmonary indications for surgery (54% vs. 18%; P< .001).
In an analysis of preoperative factors, patients who ultimately received NMBA, compared with those who did not, had longer preoperative length of stay (LOS) (28-93 days vs. 59-224 days; P = .002), more respiratory failure 3 days prior to surgery (96% vs. 74%; P = .014), and prolonged intubation periods prior to surgery (0-24 days vs. 6-45 days; P = .009). However, location of care (NICU vs. PICU) was similar throughout. In addition, the physiologic status on the day of surgery as indicated by the Pediatric Risk of Mortality score was similar in both groups.
Mr. Bauer went on to report that preoperative interventions including 30-day use of glucocorticoids, inotropes, and aminoglycosides were similar between the two groups, as was the use of blood transfusions 48 hours prior to surgery. As for postoperative sedation, opioid use and pediatric daily dosing was similar between groups. However, the rate of dexmedetomidine use was twice as high in patients who ultimately received NMBAs, compared with those who did not (46% vs. 26%; P = .026).
In terms of outcomes, the rate of pressure ulcers, pneumonia, urinary tract infections, and other complications did not differ between the two groups, while the rate of mortality at the time of data collection was also similar (12% among those who received NMBAs and 15% among those who did not). This “mirrors the national average of 13%-20%,” Mr. Bauer said. “In addition, there were no mortalities related to the procedure itself.”
On univariate analysis, postoperative LOS was a median of 10 days longer in patients who received NMBAs, compared with those who did not (23 vs. 33 days, respectively; P = .043). After multivariate analysis, however, that association was no longer significant (P = .91). Multivariable analysis also found that patients with traumatic indications for tracheostomy placement had a 44% shorter LOS (P = .002), while those with upper-airway obstruction indications for tracheostomy placement had a 27% shorter LOS (P = .02). A similar association was observed in patients who tolerated oral nutrition prior to surgery, as compared with enteral nutrition (a 48% reduction in LOS; P< .001).
Factors which portended a longer postoperative LOS were preoperative lengths of stay that lasted 10 days or more (P less than .001) and being cared for in the neonatal vs. the pediatric ICU (P = .002).
“The use of paralytic agents in this complex cohort was not an independent predictor of longer LOS,” Mr. Bauer concluded. “Instead, factors such as preoperative LOS along with [certain] indications ultimately affected the LOS. Finally, the ideal sedative protocol following tracheostomy has not been determined and requires additional investigation.”
Mr. Bauer reported that neither he nor his associates had relevant financial conflicts to disclose.
On Twitter @dougbrunk
CORONADO, CALIF. – The use of neuromuscular blockade agents in pediatric patients after tracheostomy was not an independent predictor of longer hospital length of stay, results from a 3-year, single-center study suggest. Factors which portended a longer length of stay including having a longer preoperative length of stay and being cared for in the neonatal intensive care unit.
“Across the country there are widespread initiatives to improve quality of care,” study coauthor Eric Bauer said at the Triological Society’s Combined Sections Meeting.
“Tracheostomy has been identified as a contributor to prolonged length of stay. Additionally, it’s a procedure associated with increased rates of pediatric otolaryngology infections and major adverse events including accidental decannulation. However, the factors which increase prolonged hospital stay have not been determined.”
Mr. Bauer, a fourth-year medical student at the Ohio State University, Columbus, noted that some published studies in the medical literature that focus on the use of neuromuscular blockade agents (NMBAs) following pediatric single-stage laryngeal or tracheal reconstruction suggest that these medications may prolong hospital stay and increase complication risk. “Therefore, the goal of our study was to determine if the use of NMBAs in pediatric patients following tracheostomy is associated with a prolonged length of stay,” he said at the meeting jointly sponsored by the Triological Society and the American College of Surgeons..
Mr. Bauer and his fellow researchers performed a retrospective chart review from 2010 to 2013 for all tracheostomies performed and cared for in the neonatal and pediatric intensive care units of Nationwide Children’s Hospital, Columbus. In all, 114 patients were included, 26 of whom received neuromuscular blockade agents in the postoperative period. Patients cared for in the cardiothoracic ICU were excluded from the analysis.
After collecting demographic, clinical, and 30-day outcome characteristics for all patients, the researchers observed no significant differences between those who received NMBAs and those who did not with respect to patient median age, gender, and baseline medical condition differences. “Patients who received NMBAs did have more cardiac illness (50% vs. 22% among those who did not receive NMBAs; P = .005), while patients who did not receive NMBAs had more neurologic disease (81% vs. 54%; P = .006),” Mr. Bauer said. “Overall, it was a medically complex patient group with a vast array of illnesses.”
Upper-airway obstruction was the most common indication for surgery, followed by cardiopulmonary and neurologic conditions. The researchers found that patients who did not receive NMBAs had more neurologic indications for tracheostomy, compared with their counterparts who did receive the agents (38% vs. 8%; P = .003), while patients who ultimately received NMBA had more cardiopulmonary indications for surgery (54% vs. 18%; P< .001).
In an analysis of preoperative factors, patients who ultimately received NMBA, compared with those who did not, had longer preoperative length of stay (LOS) (28-93 days vs. 59-224 days; P = .002), more respiratory failure 3 days prior to surgery (96% vs. 74%; P = .014), and prolonged intubation periods prior to surgery (0-24 days vs. 6-45 days; P = .009). However, location of care (NICU vs. PICU) was similar throughout. In addition, the physiologic status on the day of surgery as indicated by the Pediatric Risk of Mortality score was similar in both groups.
Mr. Bauer went on to report that preoperative interventions including 30-day use of glucocorticoids, inotropes, and aminoglycosides were similar between the two groups, as was the use of blood transfusions 48 hours prior to surgery. As for postoperative sedation, opioid use and pediatric daily dosing was similar between groups. However, the rate of dexmedetomidine use was twice as high in patients who ultimately received NMBAs, compared with those who did not (46% vs. 26%; P = .026).
In terms of outcomes, the rate of pressure ulcers, pneumonia, urinary tract infections, and other complications did not differ between the two groups, while the rate of mortality at the time of data collection was also similar (12% among those who received NMBAs and 15% among those who did not). This “mirrors the national average of 13%-20%,” Mr. Bauer said. “In addition, there were no mortalities related to the procedure itself.”
On univariate analysis, postoperative LOS was a median of 10 days longer in patients who received NMBAs, compared with those who did not (23 vs. 33 days, respectively; P = .043). After multivariate analysis, however, that association was no longer significant (P = .91). Multivariable analysis also found that patients with traumatic indications for tracheostomy placement had a 44% shorter LOS (P = .002), while those with upper-airway obstruction indications for tracheostomy placement had a 27% shorter LOS (P = .02). A similar association was observed in patients who tolerated oral nutrition prior to surgery, as compared with enteral nutrition (a 48% reduction in LOS; P< .001).
Factors which portended a longer postoperative LOS were preoperative lengths of stay that lasted 10 days or more (P less than .001) and being cared for in the neonatal vs. the pediatric ICU (P = .002).
“The use of paralytic agents in this complex cohort was not an independent predictor of longer LOS,” Mr. Bauer concluded. “Instead, factors such as preoperative LOS along with [certain] indications ultimately affected the LOS. Finally, the ideal sedative protocol following tracheostomy has not been determined and requires additional investigation.”
Mr. Bauer reported that neither he nor his associates had relevant financial conflicts to disclose.
On Twitter @dougbrunk
AT THE COMBINED SECTIONS WINTER MEETING
Key clinical point: The use of paralytic agents in pediatric patients after undergoing tracheostomy was not an independent predictor of longer postoperative hospital length of stay.
Major finding: Patients who ultimately received neuromuscular blockade agents, compared with those who did not, had longer preoperative LOS (28-93 days vs. 59-224 days; P = .002) and more respiratory failure three days prior to surgery (96% vs. 74%; P = .014).
Data source: A retrospective chart review of 114 tracheostomies performed and cared for in the neonatal and pediatric intensive care units of Nationwide Children’s Hospital from 2010 to 2013.
Disclosures: Mr. Bauer reported that neither he nor his associates had relevant financial conflicts to disclose.
President’s budget would extend Medicaid pay bump, repeal SGR
President Barack Obama’s 2016 budget calls for extending the Medicaid pay bump for primary care physicians, improving access to health providers, and installing a permanent fix to Medicare’s Sustainable Growth Rate reimbursement formula.
The president outlined his nearly $4 trillion budget in a summary released Feb. 2 by the White House. The proposal includes extending increased payments for primary care services delivered by physicians who accept Medicaid through 2016, with modifications to expand provider eligibility. The president also wants to enhance training of primary care practitioners and other physicians in high-need specialties by providing $5.25 billion over 10 years to support 13,000 new medical school graduate residents through a new graduate medical education program.
In addition, the president is seeking the end of sequestration, the broad federal cuts triggered by the Budget Control Act of 2011. During a Feb. 2 news conference, the president stressed that the deficit reduction achieved during his presidency – a reported cut of two-thirds – makes his budget proposals possible.
“We can afford to make these investments, while remaining fiscally responsible,” President Obama said during the conference. “In fact, we would be making a critical error if we avoided making these investments.”
The president’s budget includes a number of recommendations that would cut billions in Medicare funding over the next 10 years.
The budget would reduce the projected growth of Medicare payments for graduate medical education by $16 billion, while saving more than $100 billion by reducing inflation updates for providers who treat Medicare beneficiaries after they leave the hospital. Meanwhile, improving payment accuracy for the Medicare Advantage program would result in $43 billion in savings over 10 years, according to the plan.
The proposal also seeks to extend funding for the Children’s Health Insurance Program (CHIP) through 2019 and give states the option to streamline eligibility determinations for children in Medicaid and CHIP.
The president said he wants to accelerate physician participation in high-quality and efficient health care delivery systems by repealing the SGR and reforming Medicare physician payments consistent with recent bipartisan legislation. Obama also suggested extending increased Medicaid payments to primary care physicians through 2016 at a cost of $6.3 billion.
Other medical and public health care proposals include:
• Directing more than $100 million to reduce abuse of prescription opioids and $4.2 billion to the Health Center Program to expand services to an additional 1 million patients.
• Funding increases for every state to expand existing prescription drug monitoring programs, and funding increases for the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Agency for Healthcare Research and Quality to decrease the rates of inappropriate prescription drug abuse.
• An increase of more than $550 million above 2015 enacted levels across the federal government to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria.
• More than $500 million to enhance the advanced development of next-generation medical countermeasures against chemical, biologic, radiologic, and nuclear threats.
• A 6% spending increase in medical research and development to fuel programs such as the Precision Medicine Initiative and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.
• Increased access to generic drugs by stopping companies from entering into anticompetitive deals intended to block consumer access to generics.
The administration contends the budget will trim the deficit by $1.8 trillion over the next decade, primarily because of health, tax, and immigration reforms. That includes $400 billion in health savings that would grow over time – raising about $1 trillion in the second decade and extending the Medicare hospital insurance trust fund solvency by about 5 years, the president said.
Republican lawmakers criticized the budget proposal, calling it a repeat of past failures.
“Today President Obama laid out a plan for more taxes, more spending, and more of the Washington gridlock that has failed middle-class families,” House Speaker John Boehner (R-Ohio) said in a statement. “It may be Groundhog Day, but the American people can’t afford a repeat of the same old top-down policies of the past. Like the president’s previous budgets, this plan never balances – ever.”
Liberal groups, such as the Center for American Progress, praised the budget proposal.
“President Obama’s budget lays out a detailed agenda to create good jobs, raise wages, and help working families achieve middle-class security,” Carmel Martin, the center’s executive vice president, said in a statement. “Rather than stumbling through a series of unnecessary manufactured crises or clinging to failed austerity measures such as sequestration, Congress has an opportunity to work with President Obama to build an economy that works for everyone, not just the wealthy few.”
On Twitter @legal_med
President Barack Obama’s 2016 budget calls for extending the Medicaid pay bump for primary care physicians, improving access to health providers, and installing a permanent fix to Medicare’s Sustainable Growth Rate reimbursement formula.
The president outlined his nearly $4 trillion budget in a summary released Feb. 2 by the White House. The proposal includes extending increased payments for primary care services delivered by physicians who accept Medicaid through 2016, with modifications to expand provider eligibility. The president also wants to enhance training of primary care practitioners and other physicians in high-need specialties by providing $5.25 billion over 10 years to support 13,000 new medical school graduate residents through a new graduate medical education program.
In addition, the president is seeking the end of sequestration, the broad federal cuts triggered by the Budget Control Act of 2011. During a Feb. 2 news conference, the president stressed that the deficit reduction achieved during his presidency – a reported cut of two-thirds – makes his budget proposals possible.
“We can afford to make these investments, while remaining fiscally responsible,” President Obama said during the conference. “In fact, we would be making a critical error if we avoided making these investments.”
The president’s budget includes a number of recommendations that would cut billions in Medicare funding over the next 10 years.
The budget would reduce the projected growth of Medicare payments for graduate medical education by $16 billion, while saving more than $100 billion by reducing inflation updates for providers who treat Medicare beneficiaries after they leave the hospital. Meanwhile, improving payment accuracy for the Medicare Advantage program would result in $43 billion in savings over 10 years, according to the plan.
The proposal also seeks to extend funding for the Children’s Health Insurance Program (CHIP) through 2019 and give states the option to streamline eligibility determinations for children in Medicaid and CHIP.
The president said he wants to accelerate physician participation in high-quality and efficient health care delivery systems by repealing the SGR and reforming Medicare physician payments consistent with recent bipartisan legislation. Obama also suggested extending increased Medicaid payments to primary care physicians through 2016 at a cost of $6.3 billion.
Other medical and public health care proposals include:
• Directing more than $100 million to reduce abuse of prescription opioids and $4.2 billion to the Health Center Program to expand services to an additional 1 million patients.
• Funding increases for every state to expand existing prescription drug monitoring programs, and funding increases for the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Agency for Healthcare Research and Quality to decrease the rates of inappropriate prescription drug abuse.
• An increase of more than $550 million above 2015 enacted levels across the federal government to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria.
• More than $500 million to enhance the advanced development of next-generation medical countermeasures against chemical, biologic, radiologic, and nuclear threats.
• A 6% spending increase in medical research and development to fuel programs such as the Precision Medicine Initiative and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.
• Increased access to generic drugs by stopping companies from entering into anticompetitive deals intended to block consumer access to generics.
The administration contends the budget will trim the deficit by $1.8 trillion over the next decade, primarily because of health, tax, and immigration reforms. That includes $400 billion in health savings that would grow over time – raising about $1 trillion in the second decade and extending the Medicare hospital insurance trust fund solvency by about 5 years, the president said.
Republican lawmakers criticized the budget proposal, calling it a repeat of past failures.
“Today President Obama laid out a plan for more taxes, more spending, and more of the Washington gridlock that has failed middle-class families,” House Speaker John Boehner (R-Ohio) said in a statement. “It may be Groundhog Day, but the American people can’t afford a repeat of the same old top-down policies of the past. Like the president’s previous budgets, this plan never balances – ever.”
Liberal groups, such as the Center for American Progress, praised the budget proposal.
“President Obama’s budget lays out a detailed agenda to create good jobs, raise wages, and help working families achieve middle-class security,” Carmel Martin, the center’s executive vice president, said in a statement. “Rather than stumbling through a series of unnecessary manufactured crises or clinging to failed austerity measures such as sequestration, Congress has an opportunity to work with President Obama to build an economy that works for everyone, not just the wealthy few.”
On Twitter @legal_med
President Barack Obama’s 2016 budget calls for extending the Medicaid pay bump for primary care physicians, improving access to health providers, and installing a permanent fix to Medicare’s Sustainable Growth Rate reimbursement formula.
The president outlined his nearly $4 trillion budget in a summary released Feb. 2 by the White House. The proposal includes extending increased payments for primary care services delivered by physicians who accept Medicaid through 2016, with modifications to expand provider eligibility. The president also wants to enhance training of primary care practitioners and other physicians in high-need specialties by providing $5.25 billion over 10 years to support 13,000 new medical school graduate residents through a new graduate medical education program.
In addition, the president is seeking the end of sequestration, the broad federal cuts triggered by the Budget Control Act of 2011. During a Feb. 2 news conference, the president stressed that the deficit reduction achieved during his presidency – a reported cut of two-thirds – makes his budget proposals possible.
“We can afford to make these investments, while remaining fiscally responsible,” President Obama said during the conference. “In fact, we would be making a critical error if we avoided making these investments.”
The president’s budget includes a number of recommendations that would cut billions in Medicare funding over the next 10 years.
The budget would reduce the projected growth of Medicare payments for graduate medical education by $16 billion, while saving more than $100 billion by reducing inflation updates for providers who treat Medicare beneficiaries after they leave the hospital. Meanwhile, improving payment accuracy for the Medicare Advantage program would result in $43 billion in savings over 10 years, according to the plan.
The proposal also seeks to extend funding for the Children’s Health Insurance Program (CHIP) through 2019 and give states the option to streamline eligibility determinations for children in Medicaid and CHIP.
The president said he wants to accelerate physician participation in high-quality and efficient health care delivery systems by repealing the SGR and reforming Medicare physician payments consistent with recent bipartisan legislation. Obama also suggested extending increased Medicaid payments to primary care physicians through 2016 at a cost of $6.3 billion.
Other medical and public health care proposals include:
• Directing more than $100 million to reduce abuse of prescription opioids and $4.2 billion to the Health Center Program to expand services to an additional 1 million patients.
• Funding increases for every state to expand existing prescription drug monitoring programs, and funding increases for the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Agency for Healthcare Research and Quality to decrease the rates of inappropriate prescription drug abuse.
• An increase of more than $550 million above 2015 enacted levels across the federal government to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria.
• More than $500 million to enhance the advanced development of next-generation medical countermeasures against chemical, biologic, radiologic, and nuclear threats.
• A 6% spending increase in medical research and development to fuel programs such as the Precision Medicine Initiative and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.
• Increased access to generic drugs by stopping companies from entering into anticompetitive deals intended to block consumer access to generics.
The administration contends the budget will trim the deficit by $1.8 trillion over the next decade, primarily because of health, tax, and immigration reforms. That includes $400 billion in health savings that would grow over time – raising about $1 trillion in the second decade and extending the Medicare hospital insurance trust fund solvency by about 5 years, the president said.
Republican lawmakers criticized the budget proposal, calling it a repeat of past failures.
“Today President Obama laid out a plan for more taxes, more spending, and more of the Washington gridlock that has failed middle-class families,” House Speaker John Boehner (R-Ohio) said in a statement. “It may be Groundhog Day, but the American people can’t afford a repeat of the same old top-down policies of the past. Like the president’s previous budgets, this plan never balances – ever.”
Liberal groups, such as the Center for American Progress, praised the budget proposal.
“President Obama’s budget lays out a detailed agenda to create good jobs, raise wages, and help working families achieve middle-class security,” Carmel Martin, the center’s executive vice president, said in a statement. “Rather than stumbling through a series of unnecessary manufactured crises or clinging to failed austerity measures such as sequestration, Congress has an opportunity to work with President Obama to build an economy that works for everyone, not just the wealthy few.”
On Twitter @legal_med
Regionalized trauma care trims 30-day mortality
LAKE BUENA VISTA, FLA. – Regionalized trauma care significantly reduces long-term mortality and maintains similar functional outcomes in patients with severe traumatic brain injury, a study showed.
Regionalization of trauma care is a health care strategy that attempts to improve outcomes for trauma patients by setting up a tiered, integrated system that aims to match the injured patient with the appropriate health care facility in a timely fashion. The Northern Ohio Trauma System (NOTS) was created in 2010 to manage trauma patients using the regionalization model.
In this study of outcomes in NOTS patients, longer-term follow-up of 3,496 severe traumatic brain injury (TBI) admissions showed 30-day mortality fell from 21% to 16% after regionalization (24% relative reduction; P value < .0001) and 6-month mortality declined from 24% to 20% (17% relative reduction; P = .004).
Multivariable logistic regression only strengthened the effect of regionalization on the primary outcome, lead study author Dr. Michael Kelly said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).
The odds ratio for 30-day mortality was 0.74, representing a 26% relative mortality reduction, and 0.82 for 6-month mortality, representing an 18% relative reduction.
At last year’s EAST meeting, Dr. Kelly and his colleagues reported that hospital mortality declined from 19% (262/1,359 patients) to 14% (302/2,137) in patients with severe TBI after the creation of the NOTS in 2010.
Despite bucking the current trend of rising mortality in hospitalized TBI patients, particularly those with severe brain injuries, their previous results were criticized by some as incomplete because hospital mortality was used without functional status measures or long-term mortality, he said.
To bridge the knowledge gap, the investigators identified all TBI patients older than 14 years with a Head Abbreviated Injury Scale (AIS) ≥ 3 from 2008 to 2012 in the NOTS database and matched them to the Ohio death index and the regional TBI rehabilitation database. Overall Functional Independence Measure (FIM) scores and FIM score gains were compared in 414 patients who were discharged to the regional TBI rehabilitation unit.
As a general rule of thumb, an overall FIM score of 60 is equivalent to 4 hours of personal care assistance in a nursing facility–type setting, a score of 80 equals 2 hours of personalized care in a nursing facility, more than 80 means the patient is able to receive family care at home, and ≥ 100 means minimal burdens in personal care, said Dr. Kelly of the MetroHealth Medical Center, Cleveland, and Cleveland Clinic.
A gain of 22 points is considered a minimal clinically important difference (MCID) for the overall FIM score. The MCID is 17 points for a FIM motor subscale gain, 3 for a FIM cognitive subscale gain, and has not been established for the FIM social subscale.
Overall FIM scores were similar before and after regionalization of trauma care (RT) at admission (54 vs. 48; P = .2) and at discharge (92 vs. 89; P = .1), he said.
FIM scores were similar in both groups at admission and discharge on the cognitive and social subscale domains, but were significantly lower post RT on the motor subscale at admission (38 vs. 31; P = .02) and discharge (68 vs. 65; P = .03). These differences were not clinically significant, according to Dr. Kelly and senior study author Dr. Jeffrey Claridge, NOTS medical director.
Pre- and post-RT patients had similar overall FIM score gains (37 vs. 36; P = .6), motor subscale gains (both groups 29), and social subscale gains (both groups 1). FIM cognitive subscale gains were significantly lower post RT (6 vs. 5; P = .01), but this difference was also not clinically significant.
Notably, discharges to regional TBI rehabilitation increased from 9% before RT to 14% after RT, Dr. Kelly said. The percentage of patients who were discharged to a skilled nurse facility or long-term care facility remained stable at about 30%, as did the percentage discharged home at about 40%.
“Regionalization improves long-term survival and maintains similar functional outcomes for patients with severe traumatic brain injury,” he concluded.
Discussant Dr. Jeffrey Coughenour of the University of Missouri Health System in Columbia said it appears regionalization is working, but added, “While we are saving more lives, what kind of lives are we saving? A question that has ever increasing implications for patients and payers evaluating the care we provide.”
He praised the investigators for using the FIM scale rather than the Glasgow Outcome Scale to try and answer this question, but said more information is needed on whether FIM scores improved in more challenging patients such as those with an AIS score of 4 or 5 or those entering rehabilitation after discharge to a skilled nursing or long-term care facility.
Data were not broken down for these more challenging subsets, Dr. Kelly said. The question of quality of life post regionalization was asked after the first study and that functional status was shown to be maintained in TBI patients in the follow-up study.
“Since no major changes in the hospital-based care or rehabilitation care of these TBI patients occurred, we weren’t surprised to see that functional outcomes did not improve,” he said in an interview. “The regionalization protocols were designed primarily to improve survival.”
During a discussion of the results, audience members questioned whether the investigators could be certain the results could be attributed to regionalization and not improvements in treatment of concurrent injuries or improvements in TBI treatment already underway at the time of policy change.
For the most part, these patients had isolated TBIs and no major changes in personnel or TBI care occurred during the study period, Dr. Kelly said.
Under NOTS, region-wide initiatives included use of the Centers for Disease Control and Prevention guidelines for field triage, a transfer line and transfer protocols, and a research database shared between two large hospital systems comprising the level I MetroHealth Medical Center trauma center, two level II trauma centers, and 12 nontrauma hospitals.
Dr. Kelly, his coauthors, and Dr. Coughenour reported no financial disclosures.
LAKE BUENA VISTA, FLA. – Regionalized trauma care significantly reduces long-term mortality and maintains similar functional outcomes in patients with severe traumatic brain injury, a study showed.
Regionalization of trauma care is a health care strategy that attempts to improve outcomes for trauma patients by setting up a tiered, integrated system that aims to match the injured patient with the appropriate health care facility in a timely fashion. The Northern Ohio Trauma System (NOTS) was created in 2010 to manage trauma patients using the regionalization model.
In this study of outcomes in NOTS patients, longer-term follow-up of 3,496 severe traumatic brain injury (TBI) admissions showed 30-day mortality fell from 21% to 16% after regionalization (24% relative reduction; P value < .0001) and 6-month mortality declined from 24% to 20% (17% relative reduction; P = .004).
Multivariable logistic regression only strengthened the effect of regionalization on the primary outcome, lead study author Dr. Michael Kelly said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).
The odds ratio for 30-day mortality was 0.74, representing a 26% relative mortality reduction, and 0.82 for 6-month mortality, representing an 18% relative reduction.
At last year’s EAST meeting, Dr. Kelly and his colleagues reported that hospital mortality declined from 19% (262/1,359 patients) to 14% (302/2,137) in patients with severe TBI after the creation of the NOTS in 2010.
Despite bucking the current trend of rising mortality in hospitalized TBI patients, particularly those with severe brain injuries, their previous results were criticized by some as incomplete because hospital mortality was used without functional status measures or long-term mortality, he said.
To bridge the knowledge gap, the investigators identified all TBI patients older than 14 years with a Head Abbreviated Injury Scale (AIS) ≥ 3 from 2008 to 2012 in the NOTS database and matched them to the Ohio death index and the regional TBI rehabilitation database. Overall Functional Independence Measure (FIM) scores and FIM score gains were compared in 414 patients who were discharged to the regional TBI rehabilitation unit.
As a general rule of thumb, an overall FIM score of 60 is equivalent to 4 hours of personal care assistance in a nursing facility–type setting, a score of 80 equals 2 hours of personalized care in a nursing facility, more than 80 means the patient is able to receive family care at home, and ≥ 100 means minimal burdens in personal care, said Dr. Kelly of the MetroHealth Medical Center, Cleveland, and Cleveland Clinic.
A gain of 22 points is considered a minimal clinically important difference (MCID) for the overall FIM score. The MCID is 17 points for a FIM motor subscale gain, 3 for a FIM cognitive subscale gain, and has not been established for the FIM social subscale.
Overall FIM scores were similar before and after regionalization of trauma care (RT) at admission (54 vs. 48; P = .2) and at discharge (92 vs. 89; P = .1), he said.
FIM scores were similar in both groups at admission and discharge on the cognitive and social subscale domains, but were significantly lower post RT on the motor subscale at admission (38 vs. 31; P = .02) and discharge (68 vs. 65; P = .03). These differences were not clinically significant, according to Dr. Kelly and senior study author Dr. Jeffrey Claridge, NOTS medical director.
Pre- and post-RT patients had similar overall FIM score gains (37 vs. 36; P = .6), motor subscale gains (both groups 29), and social subscale gains (both groups 1). FIM cognitive subscale gains were significantly lower post RT (6 vs. 5; P = .01), but this difference was also not clinically significant.
Notably, discharges to regional TBI rehabilitation increased from 9% before RT to 14% after RT, Dr. Kelly said. The percentage of patients who were discharged to a skilled nurse facility or long-term care facility remained stable at about 30%, as did the percentage discharged home at about 40%.
“Regionalization improves long-term survival and maintains similar functional outcomes for patients with severe traumatic brain injury,” he concluded.
Discussant Dr. Jeffrey Coughenour of the University of Missouri Health System in Columbia said it appears regionalization is working, but added, “While we are saving more lives, what kind of lives are we saving? A question that has ever increasing implications for patients and payers evaluating the care we provide.”
He praised the investigators for using the FIM scale rather than the Glasgow Outcome Scale to try and answer this question, but said more information is needed on whether FIM scores improved in more challenging patients such as those with an AIS score of 4 or 5 or those entering rehabilitation after discharge to a skilled nursing or long-term care facility.
Data were not broken down for these more challenging subsets, Dr. Kelly said. The question of quality of life post regionalization was asked after the first study and that functional status was shown to be maintained in TBI patients in the follow-up study.
“Since no major changes in the hospital-based care or rehabilitation care of these TBI patients occurred, we weren’t surprised to see that functional outcomes did not improve,” he said in an interview. “The regionalization protocols were designed primarily to improve survival.”
During a discussion of the results, audience members questioned whether the investigators could be certain the results could be attributed to regionalization and not improvements in treatment of concurrent injuries or improvements in TBI treatment already underway at the time of policy change.
For the most part, these patients had isolated TBIs and no major changes in personnel or TBI care occurred during the study period, Dr. Kelly said.
Under NOTS, region-wide initiatives included use of the Centers for Disease Control and Prevention guidelines for field triage, a transfer line and transfer protocols, and a research database shared between two large hospital systems comprising the level I MetroHealth Medical Center trauma center, two level II trauma centers, and 12 nontrauma hospitals.
Dr. Kelly, his coauthors, and Dr. Coughenour reported no financial disclosures.
LAKE BUENA VISTA, FLA. – Regionalized trauma care significantly reduces long-term mortality and maintains similar functional outcomes in patients with severe traumatic brain injury, a study showed.
Regionalization of trauma care is a health care strategy that attempts to improve outcomes for trauma patients by setting up a tiered, integrated system that aims to match the injured patient with the appropriate health care facility in a timely fashion. The Northern Ohio Trauma System (NOTS) was created in 2010 to manage trauma patients using the regionalization model.
In this study of outcomes in NOTS patients, longer-term follow-up of 3,496 severe traumatic brain injury (TBI) admissions showed 30-day mortality fell from 21% to 16% after regionalization (24% relative reduction; P value < .0001) and 6-month mortality declined from 24% to 20% (17% relative reduction; P = .004).
Multivariable logistic regression only strengthened the effect of regionalization on the primary outcome, lead study author Dr. Michael Kelly said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).
The odds ratio for 30-day mortality was 0.74, representing a 26% relative mortality reduction, and 0.82 for 6-month mortality, representing an 18% relative reduction.
At last year’s EAST meeting, Dr. Kelly and his colleagues reported that hospital mortality declined from 19% (262/1,359 patients) to 14% (302/2,137) in patients with severe TBI after the creation of the NOTS in 2010.
Despite bucking the current trend of rising mortality in hospitalized TBI patients, particularly those with severe brain injuries, their previous results were criticized by some as incomplete because hospital mortality was used without functional status measures or long-term mortality, he said.
To bridge the knowledge gap, the investigators identified all TBI patients older than 14 years with a Head Abbreviated Injury Scale (AIS) ≥ 3 from 2008 to 2012 in the NOTS database and matched them to the Ohio death index and the regional TBI rehabilitation database. Overall Functional Independence Measure (FIM) scores and FIM score gains were compared in 414 patients who were discharged to the regional TBI rehabilitation unit.
As a general rule of thumb, an overall FIM score of 60 is equivalent to 4 hours of personal care assistance in a nursing facility–type setting, a score of 80 equals 2 hours of personalized care in a nursing facility, more than 80 means the patient is able to receive family care at home, and ≥ 100 means minimal burdens in personal care, said Dr. Kelly of the MetroHealth Medical Center, Cleveland, and Cleveland Clinic.
A gain of 22 points is considered a minimal clinically important difference (MCID) for the overall FIM score. The MCID is 17 points for a FIM motor subscale gain, 3 for a FIM cognitive subscale gain, and has not been established for the FIM social subscale.
Overall FIM scores were similar before and after regionalization of trauma care (RT) at admission (54 vs. 48; P = .2) and at discharge (92 vs. 89; P = .1), he said.
FIM scores were similar in both groups at admission and discharge on the cognitive and social subscale domains, but were significantly lower post RT on the motor subscale at admission (38 vs. 31; P = .02) and discharge (68 vs. 65; P = .03). These differences were not clinically significant, according to Dr. Kelly and senior study author Dr. Jeffrey Claridge, NOTS medical director.
Pre- and post-RT patients had similar overall FIM score gains (37 vs. 36; P = .6), motor subscale gains (both groups 29), and social subscale gains (both groups 1). FIM cognitive subscale gains were significantly lower post RT (6 vs. 5; P = .01), but this difference was also not clinically significant.
Notably, discharges to regional TBI rehabilitation increased from 9% before RT to 14% after RT, Dr. Kelly said. The percentage of patients who were discharged to a skilled nurse facility or long-term care facility remained stable at about 30%, as did the percentage discharged home at about 40%.
“Regionalization improves long-term survival and maintains similar functional outcomes for patients with severe traumatic brain injury,” he concluded.
Discussant Dr. Jeffrey Coughenour of the University of Missouri Health System in Columbia said it appears regionalization is working, but added, “While we are saving more lives, what kind of lives are we saving? A question that has ever increasing implications for patients and payers evaluating the care we provide.”
He praised the investigators for using the FIM scale rather than the Glasgow Outcome Scale to try and answer this question, but said more information is needed on whether FIM scores improved in more challenging patients such as those with an AIS score of 4 or 5 or those entering rehabilitation after discharge to a skilled nursing or long-term care facility.
Data were not broken down for these more challenging subsets, Dr. Kelly said. The question of quality of life post regionalization was asked after the first study and that functional status was shown to be maintained in TBI patients in the follow-up study.
“Since no major changes in the hospital-based care or rehabilitation care of these TBI patients occurred, we weren’t surprised to see that functional outcomes did not improve,” he said in an interview. “The regionalization protocols were designed primarily to improve survival.”
During a discussion of the results, audience members questioned whether the investigators could be certain the results could be attributed to regionalization and not improvements in treatment of concurrent injuries or improvements in TBI treatment already underway at the time of policy change.
For the most part, these patients had isolated TBIs and no major changes in personnel or TBI care occurred during the study period, Dr. Kelly said.
Under NOTS, region-wide initiatives included use of the Centers for Disease Control and Prevention guidelines for field triage, a transfer line and transfer protocols, and a research database shared between two large hospital systems comprising the level I MetroHealth Medical Center trauma center, two level II trauma centers, and 12 nontrauma hospitals.
Dr. Kelly, his coauthors, and Dr. Coughenour reported no financial disclosures.
AT THE EAST SCIENTIFIC ASSEMBLY
Key clinical point: Regionalized trauma care reduces long-term mortality and maintains functional outcomes in patients with severe TBI.
Major finding: RT reduced 30-day mortality from 21% to 16% (P < .0001) and 6-month mortality from 24% to 20% (P = .004).
Data source: Analysis of 3,496 patients with severe TBI.
Disclosures: Dr. Kelly, his coauthors, and Dr. Coughenour reported no financial disclosures.
Ultrasound after neoadjuvant chemo can guide axillary surgery decisions
After neoadjuvant chemotherapy, axial ultrasound helps identify residual nodal disease – information that can guide the decision to pursue lymph node surgery, according to a report published online Feb. 2 in the Journal of Clinical Oncology.
This strategy of performing axial ultrasound to guide axillary surgery can reduce the number of both false-negative and false-positive results, thus improving both the rate of undertreating residual breast cancer and the rate of overtreating lymph nodes that have been cleared of the disease, said Dr. Judy C. Boughey of the Mayo Clinic, Rochester, Minn., and her associates.
They investigated two secondary end points of the American College of Surgeons Oncology Group Z1071 phase II clinical trial, which addressed sentinel lymph node surgery in women with initially node-positive breast cancer. The two end points were whether a normal appearance on ultrasound of sentinel lymph nodes after neoadjuvant chemotherapy denoted a decreased risk of residual cancer and whether an abnormal appearance of sentinel lymph nodes on ultrasound after neoadjuvant chemotherapy denoted an increased risk of residual cancer.
For this analysis of the ACSOG Z1071 data, Dr. Boughey and her associates assessed 611 study participants who initially had node-positive (stage T0-4, N1-2, M0) breast cancer treated at 136 medical centers, had completed neoadjuvant chemotherapy, had undergone axial ultrasound with archiving of the images, and had undergone sentinel lymph node surgery and axial dissection. A total of 70.4% of these patients had lymph nodes classified as normal on ultrasound and 29.6% had suspicious lymph nodes.
A total of 56.5% of patients with normal-appearing lymph nodes on ultrasound proved to have positive nodes on final pathology. In contrast, 71.8% – significantly more – of patients who had suspicious-looking lymph nodes on ultrasound proved to have positive nodes on final pathology (P less than .001). Women with suspicious nodal status on ultrasound also were more likely to have a higher number of positive nodes (34.5% vs 21.0%) and a larger median size of nodal metastases, representing a greater nodal disease burden, than those with normal appearance on ultrasound.
The investigators recommended a strategy in which patients with normal-appearing lymph nodes following adjuvant chemotherapy could undergo sentinel lymph node surgery. “If any of the sentinel lymph nodes were positive, the patient would undergo an axillary lymph node dissection, and if the sentinel lymph nodes were negative, then no further axillary surgery would be needed,” they wrote.
This approach yielded a false-negative rate of just 9.8% when applied to the Z1071 study population, compared with a 12.6% false-negative rate when axial ultrasound was not used to select patients for surgery. Any false-negative rate under 10% was predetermined to be acceptable when the study was designed, Dr. Boughey and her associates said (J. Clin. Oncol. 2015 [doi:10.1200/JCO.2014.57.8401]).
Among patients who had a normal node appearance on ultrasound but positive findings on sentinel lymph node surgery, 63% proved to have no additional positive nodes in the axillary lymph node dissection. “Therefore, in patients with normal axial ultrasound, sentinel lymph node surgery could be used to identify patients who may be able to avoid axillary lymph node dissection. This is being evaluated in the Alliance A11202 trial, which is currently enrolling patients and comparing axillary radiation to axillary dissection for patients with positive sentinel lymph nodes after neoadjuvant chemotherapy,” they added.
The ACOSOG Z1071 trial was supported by National Cancer Institute grants to the American College of Surgeons Oncology Group, the Alliance for Clinical Trials in Oncology, and the Alliance Statistics and Data Center. Dr. Boughey reported having no financial disclosures; one of her associates reported receiving research funding from Galena Biopharma and Antigen Express.
After neoadjuvant chemotherapy, axial ultrasound helps identify residual nodal disease – information that can guide the decision to pursue lymph node surgery, according to a report published online Feb. 2 in the Journal of Clinical Oncology.
This strategy of performing axial ultrasound to guide axillary surgery can reduce the number of both false-negative and false-positive results, thus improving both the rate of undertreating residual breast cancer and the rate of overtreating lymph nodes that have been cleared of the disease, said Dr. Judy C. Boughey of the Mayo Clinic, Rochester, Minn., and her associates.
They investigated two secondary end points of the American College of Surgeons Oncology Group Z1071 phase II clinical trial, which addressed sentinel lymph node surgery in women with initially node-positive breast cancer. The two end points were whether a normal appearance on ultrasound of sentinel lymph nodes after neoadjuvant chemotherapy denoted a decreased risk of residual cancer and whether an abnormal appearance of sentinel lymph nodes on ultrasound after neoadjuvant chemotherapy denoted an increased risk of residual cancer.
For this analysis of the ACSOG Z1071 data, Dr. Boughey and her associates assessed 611 study participants who initially had node-positive (stage T0-4, N1-2, M0) breast cancer treated at 136 medical centers, had completed neoadjuvant chemotherapy, had undergone axial ultrasound with archiving of the images, and had undergone sentinel lymph node surgery and axial dissection. A total of 70.4% of these patients had lymph nodes classified as normal on ultrasound and 29.6% had suspicious lymph nodes.
A total of 56.5% of patients with normal-appearing lymph nodes on ultrasound proved to have positive nodes on final pathology. In contrast, 71.8% – significantly more – of patients who had suspicious-looking lymph nodes on ultrasound proved to have positive nodes on final pathology (P less than .001). Women with suspicious nodal status on ultrasound also were more likely to have a higher number of positive nodes (34.5% vs 21.0%) and a larger median size of nodal metastases, representing a greater nodal disease burden, than those with normal appearance on ultrasound.
The investigators recommended a strategy in which patients with normal-appearing lymph nodes following adjuvant chemotherapy could undergo sentinel lymph node surgery. “If any of the sentinel lymph nodes were positive, the patient would undergo an axillary lymph node dissection, and if the sentinel lymph nodes were negative, then no further axillary surgery would be needed,” they wrote.
This approach yielded a false-negative rate of just 9.8% when applied to the Z1071 study population, compared with a 12.6% false-negative rate when axial ultrasound was not used to select patients for surgery. Any false-negative rate under 10% was predetermined to be acceptable when the study was designed, Dr. Boughey and her associates said (J. Clin. Oncol. 2015 [doi:10.1200/JCO.2014.57.8401]).
Among patients who had a normal node appearance on ultrasound but positive findings on sentinel lymph node surgery, 63% proved to have no additional positive nodes in the axillary lymph node dissection. “Therefore, in patients with normal axial ultrasound, sentinel lymph node surgery could be used to identify patients who may be able to avoid axillary lymph node dissection. This is being evaluated in the Alliance A11202 trial, which is currently enrolling patients and comparing axillary radiation to axillary dissection for patients with positive sentinel lymph nodes after neoadjuvant chemotherapy,” they added.
The ACOSOG Z1071 trial was supported by National Cancer Institute grants to the American College of Surgeons Oncology Group, the Alliance for Clinical Trials in Oncology, and the Alliance Statistics and Data Center. Dr. Boughey reported having no financial disclosures; one of her associates reported receiving research funding from Galena Biopharma and Antigen Express.
After neoadjuvant chemotherapy, axial ultrasound helps identify residual nodal disease – information that can guide the decision to pursue lymph node surgery, according to a report published online Feb. 2 in the Journal of Clinical Oncology.
This strategy of performing axial ultrasound to guide axillary surgery can reduce the number of both false-negative and false-positive results, thus improving both the rate of undertreating residual breast cancer and the rate of overtreating lymph nodes that have been cleared of the disease, said Dr. Judy C. Boughey of the Mayo Clinic, Rochester, Minn., and her associates.
They investigated two secondary end points of the American College of Surgeons Oncology Group Z1071 phase II clinical trial, which addressed sentinel lymph node surgery in women with initially node-positive breast cancer. The two end points were whether a normal appearance on ultrasound of sentinel lymph nodes after neoadjuvant chemotherapy denoted a decreased risk of residual cancer and whether an abnormal appearance of sentinel lymph nodes on ultrasound after neoadjuvant chemotherapy denoted an increased risk of residual cancer.
For this analysis of the ACSOG Z1071 data, Dr. Boughey and her associates assessed 611 study participants who initially had node-positive (stage T0-4, N1-2, M0) breast cancer treated at 136 medical centers, had completed neoadjuvant chemotherapy, had undergone axial ultrasound with archiving of the images, and had undergone sentinel lymph node surgery and axial dissection. A total of 70.4% of these patients had lymph nodes classified as normal on ultrasound and 29.6% had suspicious lymph nodes.
A total of 56.5% of patients with normal-appearing lymph nodes on ultrasound proved to have positive nodes on final pathology. In contrast, 71.8% – significantly more – of patients who had suspicious-looking lymph nodes on ultrasound proved to have positive nodes on final pathology (P less than .001). Women with suspicious nodal status on ultrasound also were more likely to have a higher number of positive nodes (34.5% vs 21.0%) and a larger median size of nodal metastases, representing a greater nodal disease burden, than those with normal appearance on ultrasound.
The investigators recommended a strategy in which patients with normal-appearing lymph nodes following adjuvant chemotherapy could undergo sentinel lymph node surgery. “If any of the sentinel lymph nodes were positive, the patient would undergo an axillary lymph node dissection, and if the sentinel lymph nodes were negative, then no further axillary surgery would be needed,” they wrote.
This approach yielded a false-negative rate of just 9.8% when applied to the Z1071 study population, compared with a 12.6% false-negative rate when axial ultrasound was not used to select patients for surgery. Any false-negative rate under 10% was predetermined to be acceptable when the study was designed, Dr. Boughey and her associates said (J. Clin. Oncol. 2015 [doi:10.1200/JCO.2014.57.8401]).
Among patients who had a normal node appearance on ultrasound but positive findings on sentinel lymph node surgery, 63% proved to have no additional positive nodes in the axillary lymph node dissection. “Therefore, in patients with normal axial ultrasound, sentinel lymph node surgery could be used to identify patients who may be able to avoid axillary lymph node dissection. This is being evaluated in the Alliance A11202 trial, which is currently enrolling patients and comparing axillary radiation to axillary dissection for patients with positive sentinel lymph nodes after neoadjuvant chemotherapy,” they added.
The ACOSOG Z1071 trial was supported by National Cancer Institute grants to the American College of Surgeons Oncology Group, the Alliance for Clinical Trials in Oncology, and the Alliance Statistics and Data Center. Dr. Boughey reported having no financial disclosures; one of her associates reported receiving research funding from Galena Biopharma and Antigen Express.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Axial ultrasound following neoadjuvant chemotherapy can aid decision making on axillary surgery for breast cancer patients.
Major finding: Only 56.5% of patients with normal-appearing lymph nodes on ultrasound proved to have positive nodes on final pathology, compared with 71.8% of patients who had suspicious-looking lymph nodes on ultrasound (P less than .001).
Data source: An analysis of the secondary end points of the American College of Surgeons Oncology Group Z1071 phase II clinical trial, which involved 611 women with node-positive breast cancer planning to undergo sentinel lymph node surgery after completing neoadjuvant chemotherapy.
Disclosures: The ACOSOG Z1071 trial was supported by National Cancer Institute grants to the American College of Surgeons Oncology Group, the Alliance for Clinical Trials in Oncology, and the Alliance Statistics and Data Center. Dr. Boughey reported having no financial disclosures; one of her associates reported receiving research funding from Galena Biopharma and Antigen Express.
Abuse-deterrent formulation of extended-release hydrocodone approved
A new formulation of extended-release hydrocodone with abuse-deterrent properties has been approved by the Food and Drug Administration, the manufacturer, Zogenix, has announced.
The new formulation, marketed as Zohydro ER, contains extended-release hydrocodone with “pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to the Jan. 30 statement released by the company. The technology is called “BeadTek.”
The company expects to start transitioning from the currently available Zohydro ER product to the newly formulated product in the second quarter of 2015 for all the prescribed strengths of Zohydro ER, to avoid disrupting patients who are being treated with the product, the statement said.
Zohydro ER is an opioid agonist approved for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the prescribing information.
In the second half of this year, the company plans to submit the results of ongoing Human Abuse Liability studies, “which will further characterize the abuse-deterrent properties of the new formulation” and will support the addition of abuse-deterrent claims to the prescribing information, the company statement said. The statement refers to the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids, which describes the abuse-deterrent claims.
Zohydro ER was approved by the FDA in 2013.
A new formulation of extended-release hydrocodone with abuse-deterrent properties has been approved by the Food and Drug Administration, the manufacturer, Zogenix, has announced.
The new formulation, marketed as Zohydro ER, contains extended-release hydrocodone with “pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to the Jan. 30 statement released by the company. The technology is called “BeadTek.”
The company expects to start transitioning from the currently available Zohydro ER product to the newly formulated product in the second quarter of 2015 for all the prescribed strengths of Zohydro ER, to avoid disrupting patients who are being treated with the product, the statement said.
Zohydro ER is an opioid agonist approved for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the prescribing information.
In the second half of this year, the company plans to submit the results of ongoing Human Abuse Liability studies, “which will further characterize the abuse-deterrent properties of the new formulation” and will support the addition of abuse-deterrent claims to the prescribing information, the company statement said. The statement refers to the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids, which describes the abuse-deterrent claims.
Zohydro ER was approved by the FDA in 2013.
A new formulation of extended-release hydrocodone with abuse-deterrent properties has been approved by the Food and Drug Administration, the manufacturer, Zogenix, has announced.
The new formulation, marketed as Zohydro ER, contains extended-release hydrocodone with “pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to the Jan. 30 statement released by the company. The technology is called “BeadTek.”
The company expects to start transitioning from the currently available Zohydro ER product to the newly formulated product in the second quarter of 2015 for all the prescribed strengths of Zohydro ER, to avoid disrupting patients who are being treated with the product, the statement said.
Zohydro ER is an opioid agonist approved for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the prescribing information.
In the second half of this year, the company plans to submit the results of ongoing Human Abuse Liability studies, “which will further characterize the abuse-deterrent properties of the new formulation” and will support the addition of abuse-deterrent claims to the prescribing information, the company statement said. The statement refers to the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids, which describes the abuse-deterrent claims.
Zohydro ER was approved by the FDA in 2013.
Risk factors identified for the 1 in 500 likely to require postoperative CPR
PHOENIX – Pneumonia, dehydration, and septicemia topped the list of risk factors associated with the need for cardiopulmonary resuscitation during hospitalization for a major surgical procedure in 1 in 500 patients, a retrospective analysis found.
The large sample studied shows that having emergency rather than elective surgery, being older, being African American, and lacking health insurance were also associated with greater odds of needing CPR in this cohort, Dr. Ashima Das of Rainbow Children’s Hospital in Cleveland reported.
A review of 12,631,502 patient records found in the 2009 and 2010 National Inpatient Sample showed that 0.2% of all major surgery patients between 18 and 64 years went into cardiac arrest during their surgical hospitalization. Patients with postoperative pneumonia were at 3.05 (95% confidence interval = 2.75-3.39, P < .0001) times higher risk for needing CPR; meanwhile, major surgery patients with postoperative dehydration or other fluid and electrolyte disruptions faced an increased risk of 3.50 (95% CI = 3.18-3.85, P < .0001), Dr. Das reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
Septicemia posed a 2.60 greater risk (95% CI = 2.34-2.86, P < .0001). The odds ratio of needing CPR for patients with coagulopathy was 2.54 (95% CI = 2.30-2.81, P < .0001).
Dr. Das and her colleagues found that 80% of the 23,858 surgical procedures performed in patients who also needed CPR were emergent rather than elective. Patients’ risk of cardiac arrest increased by 1.02 ( 95% CI = 1.01-1.03, P < .0001) with every year of age, while African Americans had a slightly higher risk of needing CPR, compared with whites (OR, 1.51; 95% CI = 1.35-1.68; P < .0001), as did the uninsured, compared with the insured (P < .0001).
The authors of this study said they had no relevant financial disclosures.
On Twitter @whitneymcknight
PHOENIX – Pneumonia, dehydration, and septicemia topped the list of risk factors associated with the need for cardiopulmonary resuscitation during hospitalization for a major surgical procedure in 1 in 500 patients, a retrospective analysis found.
The large sample studied shows that having emergency rather than elective surgery, being older, being African American, and lacking health insurance were also associated with greater odds of needing CPR in this cohort, Dr. Ashima Das of Rainbow Children’s Hospital in Cleveland reported.
A review of 12,631,502 patient records found in the 2009 and 2010 National Inpatient Sample showed that 0.2% of all major surgery patients between 18 and 64 years went into cardiac arrest during their surgical hospitalization. Patients with postoperative pneumonia were at 3.05 (95% confidence interval = 2.75-3.39, P < .0001) times higher risk for needing CPR; meanwhile, major surgery patients with postoperative dehydration or other fluid and electrolyte disruptions faced an increased risk of 3.50 (95% CI = 3.18-3.85, P < .0001), Dr. Das reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
Septicemia posed a 2.60 greater risk (95% CI = 2.34-2.86, P < .0001). The odds ratio of needing CPR for patients with coagulopathy was 2.54 (95% CI = 2.30-2.81, P < .0001).
Dr. Das and her colleagues found that 80% of the 23,858 surgical procedures performed in patients who also needed CPR were emergent rather than elective. Patients’ risk of cardiac arrest increased by 1.02 ( 95% CI = 1.01-1.03, P < .0001) with every year of age, while African Americans had a slightly higher risk of needing CPR, compared with whites (OR, 1.51; 95% CI = 1.35-1.68; P < .0001), as did the uninsured, compared with the insured (P < .0001).
The authors of this study said they had no relevant financial disclosures.
On Twitter @whitneymcknight
PHOENIX – Pneumonia, dehydration, and septicemia topped the list of risk factors associated with the need for cardiopulmonary resuscitation during hospitalization for a major surgical procedure in 1 in 500 patients, a retrospective analysis found.
The large sample studied shows that having emergency rather than elective surgery, being older, being African American, and lacking health insurance were also associated with greater odds of needing CPR in this cohort, Dr. Ashima Das of Rainbow Children’s Hospital in Cleveland reported.
A review of 12,631,502 patient records found in the 2009 and 2010 National Inpatient Sample showed that 0.2% of all major surgery patients between 18 and 64 years went into cardiac arrest during their surgical hospitalization. Patients with postoperative pneumonia were at 3.05 (95% confidence interval = 2.75-3.39, P < .0001) times higher risk for needing CPR; meanwhile, major surgery patients with postoperative dehydration or other fluid and electrolyte disruptions faced an increased risk of 3.50 (95% CI = 3.18-3.85, P < .0001), Dr. Das reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
Septicemia posed a 2.60 greater risk (95% CI = 2.34-2.86, P < .0001). The odds ratio of needing CPR for patients with coagulopathy was 2.54 (95% CI = 2.30-2.81, P < .0001).
Dr. Das and her colleagues found that 80% of the 23,858 surgical procedures performed in patients who also needed CPR were emergent rather than elective. Patients’ risk of cardiac arrest increased by 1.02 ( 95% CI = 1.01-1.03, P < .0001) with every year of age, while African Americans had a slightly higher risk of needing CPR, compared with whites (OR, 1.51; 95% CI = 1.35-1.68; P < .0001), as did the uninsured, compared with the insured (P < .0001).
The authors of this study said they had no relevant financial disclosures.
On Twitter @whitneymcknight
AT THE CRITICAL CARE CONGRESS
Key clinical point: Risk modification for certain patient populations undergoing major surgical procedures may help reduce the rates of associated CPR.
Major finding: One in 500 patients who had a major surgical procedure required cardiopulmonary resuscitation.
Data source: A retrospective analysis of 12,631,502 patient records from the 2009-2010 Nationwide Inpatient Sample, identifying several risk factors for cardiac arrest occurring during a surgical hospitalization.
Disclosures: The authors of this study said they had no relevant financial disclosures.
Pregnancy outcomes similar in kidney transplant patients, despite age
Pregnancy outcomes were similar for women who underwent kidney transplants in childhood and those who received transplants as adults, according to findings published Feb. 2 in JAMA Pediatrics.
Live births occurred in 76% of pregnancies in women who received kidney transplants as children, compared with 77% of pregnancies among women who received transplants as adults, wrote Melanie L. Wyld and her colleagues from Sydney Medical School in Australia.
The study examined a total of 101 pregnancies in 66 women who received transplants before age 18 years, and 626 pregnancies in 401 women who were adults at the time of transplant.
Mean gestational age and prematurity incidence were also similar in the two groups, with child-transplant recipients having a mean gestational age of 35 weeks, and adult-transplant recipients having a mean gestational age of 36 weeks.
Incidence of prematurity was 45% in child-transplant mothers and 53% in adult-transplant mothers, the researchers reported.
“To our knowledge, this study is the first to look at pregnancy outcomes for women who received a kidney transplant as a child,” the researchers wrote. These results should “provide comfort to such mothers and their physicians that their early onset of kidney failure and longer period of posttransplant exposure to immunosuppression do not adversely affect their pregnancy outcomes,” they added.
Read the full article at: JAMA Pediatr. 2015;169(2):e143626. (doi:10.1001/jamapediatrics.2014.3626).
Pregnancy outcomes were similar for women who underwent kidney transplants in childhood and those who received transplants as adults, according to findings published Feb. 2 in JAMA Pediatrics.
Live births occurred in 76% of pregnancies in women who received kidney transplants as children, compared with 77% of pregnancies among women who received transplants as adults, wrote Melanie L. Wyld and her colleagues from Sydney Medical School in Australia.
The study examined a total of 101 pregnancies in 66 women who received transplants before age 18 years, and 626 pregnancies in 401 women who were adults at the time of transplant.
Mean gestational age and prematurity incidence were also similar in the two groups, with child-transplant recipients having a mean gestational age of 35 weeks, and adult-transplant recipients having a mean gestational age of 36 weeks.
Incidence of prematurity was 45% in child-transplant mothers and 53% in adult-transplant mothers, the researchers reported.
“To our knowledge, this study is the first to look at pregnancy outcomes for women who received a kidney transplant as a child,” the researchers wrote. These results should “provide comfort to such mothers and their physicians that their early onset of kidney failure and longer period of posttransplant exposure to immunosuppression do not adversely affect their pregnancy outcomes,” they added.
Read the full article at: JAMA Pediatr. 2015;169(2):e143626. (doi:10.1001/jamapediatrics.2014.3626).
Pregnancy outcomes were similar for women who underwent kidney transplants in childhood and those who received transplants as adults, according to findings published Feb. 2 in JAMA Pediatrics.
Live births occurred in 76% of pregnancies in women who received kidney transplants as children, compared with 77% of pregnancies among women who received transplants as adults, wrote Melanie L. Wyld and her colleagues from Sydney Medical School in Australia.
The study examined a total of 101 pregnancies in 66 women who received transplants before age 18 years, and 626 pregnancies in 401 women who were adults at the time of transplant.
Mean gestational age and prematurity incidence were also similar in the two groups, with child-transplant recipients having a mean gestational age of 35 weeks, and adult-transplant recipients having a mean gestational age of 36 weeks.
Incidence of prematurity was 45% in child-transplant mothers and 53% in adult-transplant mothers, the researchers reported.
“To our knowledge, this study is the first to look at pregnancy outcomes for women who received a kidney transplant as a child,” the researchers wrote. These results should “provide comfort to such mothers and their physicians that their early onset of kidney failure and longer period of posttransplant exposure to immunosuppression do not adversely affect their pregnancy outcomes,” they added.
Read the full article at: JAMA Pediatr. 2015;169(2):e143626. (doi:10.1001/jamapediatrics.2014.3626).
Checklist dramatically improves safety of bedside tracheostomy
LAKE BUENA VISTA, FLA. – Use of a multidisciplinary safety checklist prior to all bedside bronchoscopy-guided percutaneous tracheostomies was independently associated with a dramatic reduction in adverse procedural events, a study showed.
After adjustment for age, vitals, tracheostomy risk factors, and ICU duration after the procedure, multivariable logistic regression determined that no other factor – not age, baseline heart rate, baseline oxygen saturation, or difficult airway status – was significant against adverse procedural events except use of the checklist (odds ratio, 5.85; P = .022
Overall, in the postchecklist group, 3.2% experienced adverse events, compared with 14.7% in the prechecklist group.
“We feel this checklist could be used by other institutions with similar success and also could be modified for other invasive bedside procedures,” lead study author Dr. Joshua Hazelton said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).
Bedside bronchoscopy-guided percutaneous tracheostomies (BBPT) are safe, yet like many bedside procedures are seldom subject to the same safety checklists and timeout processes that have become standard in the operating room, he observed. When asked specifically how the checklist improved safety, Dr. Hazelton said the multidisciplinary aspect of the checklist distills a sense of ownership in every team member. A significant amount of evidence published on the benefits of World Health Organization checklists also shows checklists improve communication and empower members to speak up if something doesn’t feel right.
“Most of all, the checklist helped to focus the team on a procedure that really has very little margin of error,” he said. “As we do more of these procedures, I think the tendency for the entire team can be to look at these procedures as almost routine, and certainly with an airway procedure, I don’t think you should look at it as a routine thing.”
The safety checklist was created by a team of surgeons, critical care nurses, respiratory therapists, and trauma technicians at Cooper University Hospital in Camden, N.J., and focused on preprocedural setup, procedural steps, and a group timeout process.
In the equipment setup phase, the bedside nurse, respiratory therapist, and trauma technician must assemble and test all necessary equipment.
During the timeout process, team members are introduced, the nurse confirms the patient, the planned procedure, positioning of the patient, medications, and equipment, and the surgeon discusses any critical steps or steps that may be unique to the patient. Finally, each team member is given an opportunity to discuss any concerns or ask any questions prior to proceeding.
“The idea of this checklist is to bring the team together, so if there is one member of the team who doesn’t feel right about the procedure or has concerns, the procedure is stopped,” said Dr. Hazelton of the department of surgery at Cooper.
The last phase of the checklist is a postprocedural assessment to make sure the tracheostomy is properly secured and the patient is stable.
To assess its impact, the investigators prospectively analyzed all 63 patients who underwent bedside tracheostomy at the level I trauma center from checklist implementation July 1, 2013 to June 30, 2014 and compared them with 184 historical controls who underwent bedside tracheostomy without the checklist from July 1, 2011 to June 30, 2013. All tracheostomies were performed using the Blue Rhino Percutaneous Tracheostomy Kit (Cook Medical).
The pre- and postchecklist groups had similar numbers of patients with potentially difficult airways including those with cervical spine fracture (30 patients vs. 4 patients; P = .056), cervical ligamentous injury (3 vs. 0; not significant), occipital condyle fracture (3 vs. 0; NS), cervical spinal cord injury (4 vs. 2; NS), mandible fracture (8 vs. 2; NS), LeFort III fracture (5 vs. 1; NS), or oral cavity injury (5 vs. 1; NS).
Prechecklist patients were younger than postchecklist patients (48 years vs. 57 years; P = .001), but all other baseline characteristics were well matched including gender, body mass index, duration of mechanical ventilation, heart rate, mean arterial pressure, and oxygen saturation.
The pre- and postchecklist groups had the same occurrence of individual adverse procedural events including loss of airway (2 vs. 0; P = 1.0), deterioration in respiratory parameters during procedure (7 vs. 2; P = 1.0), hemodynamic compromise (19 vs. 2; P = .079), need for vasopressors or antiarrhythmics are (1 vs. 0; P = 1.0), and conversion to open procedure (5 vs. 0; P = .333). But overall, the postchecklist group experienced significantly fewer adverse events (3.2% vs. 14.7% prechecklist; P = .014), Dr. Hazelton said.
Discussant Dr. Bradley Dennis of Vanderbilt University Medical Center in Nashville, Tenn., said, “I don’t think we even need P values to identify this as a successful intervention, so I commend you for your excellent work.”
As bedside surgical procedures become more prevalent, it only stands to reason that the same patient safety measures used in the OR would be extended into the ICU, he said. Indeed, Vanderbilt has employed a preprocedure checklist for all procedures in the surgical trauma ICU since 2007, but unfortunately did not measure the outcomes prospectively.
Dr. Dennis went on to ask whether there were any patients in whom the checklist identified something that caused the team to abort the procedure.
Early in the process, there were several near-misses that were difficult to categorize, but typically revolved around not having a specific piece of rescue equipment in the room such as an airway box, Dr. Hazelton said. One particular case also raised concerns on the part of the respiratory therapist because of the patient’s large head, short neck, and body habitus, and after discussion, the procedure was halted.
“It was done in the operating room the next day and my colleague who performed that procedure told me it was somewhat challenging, a difficult cut down, a T-bar wing,” he said. “But certainly, that level of trust in your other colleagues, nursing, technicians, respiratory, is necessary for success of this kind of checklist.”
Dr. Hazelton and his coauthors reported having no financial disclosures.
LAKE BUENA VISTA, FLA. – Use of a multidisciplinary safety checklist prior to all bedside bronchoscopy-guided percutaneous tracheostomies was independently associated with a dramatic reduction in adverse procedural events, a study showed.
After adjustment for age, vitals, tracheostomy risk factors, and ICU duration after the procedure, multivariable logistic regression determined that no other factor – not age, baseline heart rate, baseline oxygen saturation, or difficult airway status – was significant against adverse procedural events except use of the checklist (odds ratio, 5.85; P = .022
Overall, in the postchecklist group, 3.2% experienced adverse events, compared with 14.7% in the prechecklist group.
“We feel this checklist could be used by other institutions with similar success and also could be modified for other invasive bedside procedures,” lead study author Dr. Joshua Hazelton said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).
Bedside bronchoscopy-guided percutaneous tracheostomies (BBPT) are safe, yet like many bedside procedures are seldom subject to the same safety checklists and timeout processes that have become standard in the operating room, he observed. When asked specifically how the checklist improved safety, Dr. Hazelton said the multidisciplinary aspect of the checklist distills a sense of ownership in every team member. A significant amount of evidence published on the benefits of World Health Organization checklists also shows checklists improve communication and empower members to speak up if something doesn’t feel right.
“Most of all, the checklist helped to focus the team on a procedure that really has very little margin of error,” he said. “As we do more of these procedures, I think the tendency for the entire team can be to look at these procedures as almost routine, and certainly with an airway procedure, I don’t think you should look at it as a routine thing.”
The safety checklist was created by a team of surgeons, critical care nurses, respiratory therapists, and trauma technicians at Cooper University Hospital in Camden, N.J., and focused on preprocedural setup, procedural steps, and a group timeout process.
In the equipment setup phase, the bedside nurse, respiratory therapist, and trauma technician must assemble and test all necessary equipment.
During the timeout process, team members are introduced, the nurse confirms the patient, the planned procedure, positioning of the patient, medications, and equipment, and the surgeon discusses any critical steps or steps that may be unique to the patient. Finally, each team member is given an opportunity to discuss any concerns or ask any questions prior to proceeding.
“The idea of this checklist is to bring the team together, so if there is one member of the team who doesn’t feel right about the procedure or has concerns, the procedure is stopped,” said Dr. Hazelton of the department of surgery at Cooper.
The last phase of the checklist is a postprocedural assessment to make sure the tracheostomy is properly secured and the patient is stable.
To assess its impact, the investigators prospectively analyzed all 63 patients who underwent bedside tracheostomy at the level I trauma center from checklist implementation July 1, 2013 to June 30, 2014 and compared them with 184 historical controls who underwent bedside tracheostomy without the checklist from July 1, 2011 to June 30, 2013. All tracheostomies were performed using the Blue Rhino Percutaneous Tracheostomy Kit (Cook Medical).
The pre- and postchecklist groups had similar numbers of patients with potentially difficult airways including those with cervical spine fracture (30 patients vs. 4 patients; P = .056), cervical ligamentous injury (3 vs. 0; not significant), occipital condyle fracture (3 vs. 0; NS), cervical spinal cord injury (4 vs. 2; NS), mandible fracture (8 vs. 2; NS), LeFort III fracture (5 vs. 1; NS), or oral cavity injury (5 vs. 1; NS).
Prechecklist patients were younger than postchecklist patients (48 years vs. 57 years; P = .001), but all other baseline characteristics were well matched including gender, body mass index, duration of mechanical ventilation, heart rate, mean arterial pressure, and oxygen saturation.
The pre- and postchecklist groups had the same occurrence of individual adverse procedural events including loss of airway (2 vs. 0; P = 1.0), deterioration in respiratory parameters during procedure (7 vs. 2; P = 1.0), hemodynamic compromise (19 vs. 2; P = .079), need for vasopressors or antiarrhythmics are (1 vs. 0; P = 1.0), and conversion to open procedure (5 vs. 0; P = .333). But overall, the postchecklist group experienced significantly fewer adverse events (3.2% vs. 14.7% prechecklist; P = .014), Dr. Hazelton said.
Discussant Dr. Bradley Dennis of Vanderbilt University Medical Center in Nashville, Tenn., said, “I don’t think we even need P values to identify this as a successful intervention, so I commend you for your excellent work.”
As bedside surgical procedures become more prevalent, it only stands to reason that the same patient safety measures used in the OR would be extended into the ICU, he said. Indeed, Vanderbilt has employed a preprocedure checklist for all procedures in the surgical trauma ICU since 2007, but unfortunately did not measure the outcomes prospectively.
Dr. Dennis went on to ask whether there were any patients in whom the checklist identified something that caused the team to abort the procedure.
Early in the process, there were several near-misses that were difficult to categorize, but typically revolved around not having a specific piece of rescue equipment in the room such as an airway box, Dr. Hazelton said. One particular case also raised concerns on the part of the respiratory therapist because of the patient’s large head, short neck, and body habitus, and after discussion, the procedure was halted.
“It was done in the operating room the next day and my colleague who performed that procedure told me it was somewhat challenging, a difficult cut down, a T-bar wing,” he said. “But certainly, that level of trust in your other colleagues, nursing, technicians, respiratory, is necessary for success of this kind of checklist.”
Dr. Hazelton and his coauthors reported having no financial disclosures.
LAKE BUENA VISTA, FLA. – Use of a multidisciplinary safety checklist prior to all bedside bronchoscopy-guided percutaneous tracheostomies was independently associated with a dramatic reduction in adverse procedural events, a study showed.
After adjustment for age, vitals, tracheostomy risk factors, and ICU duration after the procedure, multivariable logistic regression determined that no other factor – not age, baseline heart rate, baseline oxygen saturation, or difficult airway status – was significant against adverse procedural events except use of the checklist (odds ratio, 5.85; P = .022
Overall, in the postchecklist group, 3.2% experienced adverse events, compared with 14.7% in the prechecklist group.
“We feel this checklist could be used by other institutions with similar success and also could be modified for other invasive bedside procedures,” lead study author Dr. Joshua Hazelton said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).
Bedside bronchoscopy-guided percutaneous tracheostomies (BBPT) are safe, yet like many bedside procedures are seldom subject to the same safety checklists and timeout processes that have become standard in the operating room, he observed. When asked specifically how the checklist improved safety, Dr. Hazelton said the multidisciplinary aspect of the checklist distills a sense of ownership in every team member. A significant amount of evidence published on the benefits of World Health Organization checklists also shows checklists improve communication and empower members to speak up if something doesn’t feel right.
“Most of all, the checklist helped to focus the team on a procedure that really has very little margin of error,” he said. “As we do more of these procedures, I think the tendency for the entire team can be to look at these procedures as almost routine, and certainly with an airway procedure, I don’t think you should look at it as a routine thing.”
The safety checklist was created by a team of surgeons, critical care nurses, respiratory therapists, and trauma technicians at Cooper University Hospital in Camden, N.J., and focused on preprocedural setup, procedural steps, and a group timeout process.
In the equipment setup phase, the bedside nurse, respiratory therapist, and trauma technician must assemble and test all necessary equipment.
During the timeout process, team members are introduced, the nurse confirms the patient, the planned procedure, positioning of the patient, medications, and equipment, and the surgeon discusses any critical steps or steps that may be unique to the patient. Finally, each team member is given an opportunity to discuss any concerns or ask any questions prior to proceeding.
“The idea of this checklist is to bring the team together, so if there is one member of the team who doesn’t feel right about the procedure or has concerns, the procedure is stopped,” said Dr. Hazelton of the department of surgery at Cooper.
The last phase of the checklist is a postprocedural assessment to make sure the tracheostomy is properly secured and the patient is stable.
To assess its impact, the investigators prospectively analyzed all 63 patients who underwent bedside tracheostomy at the level I trauma center from checklist implementation July 1, 2013 to June 30, 2014 and compared them with 184 historical controls who underwent bedside tracheostomy without the checklist from July 1, 2011 to June 30, 2013. All tracheostomies were performed using the Blue Rhino Percutaneous Tracheostomy Kit (Cook Medical).
The pre- and postchecklist groups had similar numbers of patients with potentially difficult airways including those with cervical spine fracture (30 patients vs. 4 patients; P = .056), cervical ligamentous injury (3 vs. 0; not significant), occipital condyle fracture (3 vs. 0; NS), cervical spinal cord injury (4 vs. 2; NS), mandible fracture (8 vs. 2; NS), LeFort III fracture (5 vs. 1; NS), or oral cavity injury (5 vs. 1; NS).
Prechecklist patients were younger than postchecklist patients (48 years vs. 57 years; P = .001), but all other baseline characteristics were well matched including gender, body mass index, duration of mechanical ventilation, heart rate, mean arterial pressure, and oxygen saturation.
The pre- and postchecklist groups had the same occurrence of individual adverse procedural events including loss of airway (2 vs. 0; P = 1.0), deterioration in respiratory parameters during procedure (7 vs. 2; P = 1.0), hemodynamic compromise (19 vs. 2; P = .079), need for vasopressors or antiarrhythmics are (1 vs. 0; P = 1.0), and conversion to open procedure (5 vs. 0; P = .333). But overall, the postchecklist group experienced significantly fewer adverse events (3.2% vs. 14.7% prechecklist; P = .014), Dr. Hazelton said.
Discussant Dr. Bradley Dennis of Vanderbilt University Medical Center in Nashville, Tenn., said, “I don’t think we even need P values to identify this as a successful intervention, so I commend you for your excellent work.”
As bedside surgical procedures become more prevalent, it only stands to reason that the same patient safety measures used in the OR would be extended into the ICU, he said. Indeed, Vanderbilt has employed a preprocedure checklist for all procedures in the surgical trauma ICU since 2007, but unfortunately did not measure the outcomes prospectively.
Dr. Dennis went on to ask whether there were any patients in whom the checklist identified something that caused the team to abort the procedure.
Early in the process, there were several near-misses that were difficult to categorize, but typically revolved around not having a specific piece of rescue equipment in the room such as an airway box, Dr. Hazelton said. One particular case also raised concerns on the part of the respiratory therapist because of the patient’s large head, short neck, and body habitus, and after discussion, the procedure was halted.
“It was done in the operating room the next day and my colleague who performed that procedure told me it was somewhat challenging, a difficult cut down, a T-bar wing,” he said. “But certainly, that level of trust in your other colleagues, nursing, technicians, respiratory, is necessary for success of this kind of checklist.”
Dr. Hazelton and his coauthors reported having no financial disclosures.
AT THE EAST SCIENTIFIC ASSEMBLY
Key clinical point: A multidisciplinary checklist before percutaneous bedside tracheostomy can improve adverse event rates and overall safety.
Major finding: The overall adverse procedural event rate declined from 14.7% to 3.2% post checklist (P = .014).
Data source: Analysis of 247 patients who underwent percutaneous tracheostomy.
Disclosures: Dr. Hazelton and his coauthors reported having no financial disclosures.
