- Email: [email protected]
10 Emergency Medicine Clinical Practice Guidelines: Evidence Based or Expert Consensus?
Research Forum Abstracts predictor of those needing urgent endoscopy. All of these data highlight the need to identify those with UGIB who do not need urgent endoscopy or even further inpatient evaluation. We sought to determine if the addition of nasogastric lavage results would augment risk assessment achieved by non-invasive means with scoring systems like GBS and AIMS65 in acute UGIB. Methods: Sensitivity and specificity for NG lavage was obtained from several comparable studies on non-variceal UGIB. Due to the wide range of data, sensitivity and specificity for NG lavage was divided into low and high range and likelihood ratio (LR) were calculated. Percentage risk used as pretest probability and LR for NG lavage were inserted into the Bayesian nomogram to obtain posttest probabilities. Absolute (ADG) and relative diagnostic gains (RDG) were then calculated. ANOVA was used to evaluate strength of association with a P value set at .05. Results: Sensitivity of 0.42 and specificity of .54 for low range with a LR+ of 0.91 and 0.84 and 0.91, LR + 9.33 for high range respectively. Using low range values for NG lavange and AIMS 65 low risk resulted in a post test probability of 3%, ADG and RDG of 0%. Low range NG lavage and GBS low risk population resulted in a post test probability of 5% with 0% ABDG and RDG. High range values for NG lavage and AIMS 65 low risk pretest probability yielded a post test probability of 22%, ADG of 19% and RDG of 633.3%. For high range NG lavage and low risk GBS post test probability was 33%, ADG of 28% and RDG 560%. ANOVA for low range NG lavage P ¼ 1.0; for high range P ¼ .95. Conclusion: After combining the LRs for NG lavage from several comparable studies on non-variceal UGIB and using the low end LR (0.91) with both the GBS and AIM65 scores, there was zero absolute or relative gain in post-test probability for those with lowrisk as determined by the non-invasive scoring systems. On ANOVA analysis, there was no incremental benefit of NG lavage to non-invasive scoring systems for low-risk patients even when using the high end of LR (9.33). For patients with low-risk of need for endoscopic intervention or mortality based on the GBS or AIMS65 scoring systems, nasogastric lavage provides no additional yield in predicting these poor outcomes. In patients with a low score on GBS or AIMS65, nasogastric lavage should not be performed.
10
Emergency Medicine Clinical Practice Guidelines: Evidence Based or Expert Consensus?
Savage DF, Sandefur B, Bernard K, Schuur JD, Venkatesh AK/Yale-New Haven Hospital, New Haven, CT; Mayo Clinic, Rochester, MN; Brigham and Women’s Hospital-Massachusetts General Hospital-Harvard Affiliated Emergency Medicine Residency, Boston, MA; Brigham and Women’s Hospital, Boston, MA
Background: The Institute of Medicine’s 2011 report, Clinical Guidelines We Can Trust, noted substantial variability in the strength of evidence used to support clinical practice guidelines. These guidelines are increasingly being used as the foundation for evidence-based practice and national quality metrics; however, recent work in cardiology, obstetrics, and infectious diseases has shown that the majority of guidelines are based on expert consensus. To date the strength of evidence used to support recommendations found in the emergency medicine clinical practice guidelines is not known. Study Objectives: To describe the level of recommendations, and the strength of evidence on which these recommendations are made, in emergency medicine clinical practice guidelines. Methods: Systematic review of clinical practice guidelines published by the American College of Emergency Physicians (ACEP) from March 1993 to January 2015. A standardized data collection instrument was used to abstract the number and level of recommendations, the reported class of evidence, and the year of publication for each guideline. The primary outcomes were the proportion of Class III equivalent evidence and Level C equivalent recommendations. Because the evidence and recommendation grading scheme was changed slightly in 2001, we developed standard definitions for evidence and recommendation grading for this study. Class III equivalent evidence was defined as reports of descriptive cross-sectional studies, observational studies including case reports or case studies, or consensus statements. Level C equivalent recommendations were defined as those based on preliminary or inconclusive evidence, committee consensus, or limited-research-based evidence. We defined current guidelines as those published on the ACEP Web site for dissemination and use as of April 1, 2015, which included 19 guidelines. The oldest current guideline was published in 2003. We report descriptive statistics, and chi-square test for trend was used to assess changes in the proportion of Level C equivalent recommendations over time. Results: A total of 51 guidelines including 436 recommendations, with an average of 8.5 recommendations per guidelines (range: 0-55), were identified. The median number of guidelines published per year was 2 (range 2-4). A total of 2571 references were classified within all clinical guidelines of which 261 (10.2%) were Class I equivalent, 1071 (41.6%) Class II equivalent, and 1239 (48.2%) Class III equivalent. Of all recommendations, 37 (8.5%) of recommendations were Level A equivalent, 192
Volume 66, no. 4s : October 2015
(44.0%) were level B equivalent, and 207 (47.5%) were Level C equivalent. Between 1997 and 2015, years in which complete recommendation data exist, there was no statistical trend in the proportion of recommendations with Level A (P ¼ .051), B (P ¼ .312) or C equivalent ratings (p¼0.864). For the ACEP guidelines published as current (n¼19), 67 recommendations (48.91%) were Class C equivalent, and 417 Class III references (60.97%) were used in these guidelines. Conclusion: Emergency medicine clinical practice guidelines are largely based on lower classes of evidence and a majority of recommendations are consensus based. These findings demonstrate an evidence gap that the emergency care research agenda should address.
11
The Use of a GlideScope Video Laryngoscope is Associated With a Higher First Pass Success than a Direct Laryngoscope in the Presence of a Bloody Airway
Corn GJ, Hollinger P, Patanwala AE, Sakles JC/University of Arizona, Tucson, AZ
Study Objectives: The objective of this study was to compare the effectiveness of the GlideScope video laryngoscope (GVL) to the direct laryngoscope (DL) in patients with an airway contaminated with blood in the emergency department (ED). Methods: Over a 7-year 9-month period, between July 1, 2007 and March 31, 2015, all intubations performed in an academic ED were recorded in a continuous quality improvement (CQI) database by the operators. The CQI form included information such as patient demographics, operator level of training, device(s) used, number of attempts, and outcome of each attempt. In addition, operators performed a difficult airway assessment and noted the presence or absence of difficult airway characteristics including the presence of blood in the airway. Patients 18 years of age, who underwent rapid sequence intubation (RSI) in the ED with a standard GVL or DL were included in the analysis. The primary outcome was first pass success (FPS), which was defined as a successful intubation with a single laryngoscope insertion. A multivariate regression model was developed to control for confounders and to determine the effect of a bloody airway on FPS when using a GVL or a DL. Results: A total of 345 adult RSIs were performed during the study period on patients with a bloody airway using a GVL (n¼158) or a DL (n¼187). The FPS of the GVL in these patients was 77.9% (95% CI: 70.7%-83.7%) and the FPS of the DL was 62.6% (95% CI: 55.4%-69.2%). In the multivariate regression analysis, the GVL was associated with a higher odds of FPS than the DL (aOR 3.1; 95% CI: 1.8-5.3). Conclusion: In this cohort of patients with a bloody airway undergoing RSI in the ED, the GVL had a higher FPS than the DL. The GVL is recommended as the primary intubating device in the ED in patients with a blood contaminated airway.
12
Intraosseous Vascular Access Catheter Appears Safe During Extended Dwell: A Preliminary Report
Overbaugh R, Davlantes C, Miller L, Montez D, Puga T, Philbeck TE/ICON, San Antonio, TX; Teleflex Inc., Shavano Park, TX
Study Objectives: Despite relatively few documented complications associated with intraosseous (IO) vascular access, the US Food and Drug Administration (FDA) restricts catheter dwell time to 24 hours for IO devices. This may contribute to placement of central venous catheters for difficult vascular access patients in whom an IO placement would otherwise suffice, contributing to an increased risk for complications and costs. Many clinicians have requested that the IO catheter dwell time be extended to at least 48 hours. A study was designed to determine the safety of IO access when the catheter is left in place for up to 48 hours. Methods: The study protocol is being conducted under an Investigational Device Exemption granted by the FDA and was approved by IntegReview Ethical Review Board. Consenting adult volunteers (target N¼120) with renal impairment and/or diabetes were randomized to have an IO catheter (Arrow EZ-IO Intraosseous Vascular Access System,Teleflex Inc., Reading, PA) placed in the proximal humerus or proximal tibia by a trained physician. At the discretion of the investigator, subjects were administered midazolam and fentanyl to mitigate anxiety associated with IO insertion and the pain associated with the initial flush. With a slow continuous saline infusion administered by infusion pump, subjects remained in a secured early phase research unit for 48 hours. IO infusion pain was managed initially with IO lidocaine injections, then as needed with oral acetaminophen. For more severe pain, intravenous/ intramuscular Toradol or oral hydrocodone/acetaminophen were administered. After 48 hours, an IO aspirate sample was obtained from the in-situ catheter for culturing and an x-ray was taken of the IO insertion site after removal. After 30 days, subjects returned for physical examination and x-ray imaging of the insertion site. Results: As of April 2015, 24 subjects have completed the study with one subject in follow-up. There have been no serious adverse events or complications associated with the
Annals of Emergency Medicine S5
10
Emergency Medicine Clinical Practice Guidelines: Evidence Based or Expert Consensus?
Savage DF, Sandefur B, Bernard K, Schuur JD, Venkatesh AK/Yale-New Haven Hospital, New Haven, CT; Mayo Clinic, Rochester, MN; Brigham and Women’s Hospital-Massachusetts General Hospital-Harvard Affiliated Emergency Medicine Residency, Boston, MA; Brigham and Women’s Hospital, Boston, MA
Background: The Institute of Medicine’s 2011 report, Clinical Guidelines We Can Trust, noted substantial variability in the strength of evidence used to support clinical practice guidelines. These guidelines are increasingly being used as the foundation for evidence-based practice and national quality metrics; however, recent work in cardiology, obstetrics, and infectious diseases has shown that the majority of guidelines are based on expert consensus. To date the strength of evidence used to support recommendations found in the emergency medicine clinical practice guidelines is not known. Study Objectives: To describe the level of recommendations, and the strength of evidence on which these recommendations are made, in emergency medicine clinical practice guidelines. Methods: Systematic review of clinical practice guidelines published by the American College of Emergency Physicians (ACEP) from March 1993 to January 2015. A standardized data collection instrument was used to abstract the number and level of recommendations, the reported class of evidence, and the year of publication for each guideline. The primary outcomes were the proportion of Class III equivalent evidence and Level C equivalent recommendations. Because the evidence and recommendation grading scheme was changed slightly in 2001, we developed standard definitions for evidence and recommendation grading for this study. Class III equivalent evidence was defined as reports of descriptive cross-sectional studies, observational studies including case reports or case studies, or consensus statements. Level C equivalent recommendations were defined as those based on preliminary or inconclusive evidence, committee consensus, or limited-research-based evidence. We defined current guidelines as those published on the ACEP Web site for dissemination and use as of April 1, 2015, which included 19 guidelines. The oldest current guideline was published in 2003. We report descriptive statistics, and chi-square test for trend was used to assess changes in the proportion of Level C equivalent recommendations over time. Results: A total of 51 guidelines including 436 recommendations, with an average of 8.5 recommendations per guidelines (range: 0-55), were identified. The median number of guidelines published per year was 2 (range 2-4). A total of 2571 references were classified within all clinical guidelines of which 261 (10.2%) were Class I equivalent, 1071 (41.6%) Class II equivalent, and 1239 (48.2%) Class III equivalent. Of all recommendations, 37 (8.5%) of recommendations were Level A equivalent, 192
Volume 66, no. 4s : October 2015
(44.0%) were level B equivalent, and 207 (47.5%) were Level C equivalent. Between 1997 and 2015, years in which complete recommendation data exist, there was no statistical trend in the proportion of recommendations with Level A (P ¼ .051), B (P ¼ .312) or C equivalent ratings (p¼0.864). For the ACEP guidelines published as current (n¼19), 67 recommendations (48.91%) were Class C equivalent, and 417 Class III references (60.97%) were used in these guidelines. Conclusion: Emergency medicine clinical practice guidelines are largely based on lower classes of evidence and a majority of recommendations are consensus based. These findings demonstrate an evidence gap that the emergency care research agenda should address.
11
The Use of a GlideScope Video Laryngoscope is Associated With a Higher First Pass Success than a Direct Laryngoscope in the Presence of a Bloody Airway
Corn GJ, Hollinger P, Patanwala AE, Sakles JC/University of Arizona, Tucson, AZ
Study Objectives: The objective of this study was to compare the effectiveness of the GlideScope video laryngoscope (GVL) to the direct laryngoscope (DL) in patients with an airway contaminated with blood in the emergency department (ED). Methods: Over a 7-year 9-month period, between July 1, 2007 and March 31, 2015, all intubations performed in an academic ED were recorded in a continuous quality improvement (CQI) database by the operators. The CQI form included information such as patient demographics, operator level of training, device(s) used, number of attempts, and outcome of each attempt. In addition, operators performed a difficult airway assessment and noted the presence or absence of difficult airway characteristics including the presence of blood in the airway. Patients 18 years of age, who underwent rapid sequence intubation (RSI) in the ED with a standard GVL or DL were included in the analysis. The primary outcome was first pass success (FPS), which was defined as a successful intubation with a single laryngoscope insertion. A multivariate regression model was developed to control for confounders and to determine the effect of a bloody airway on FPS when using a GVL or a DL. Results: A total of 345 adult RSIs were performed during the study period on patients with a bloody airway using a GVL (n¼158) or a DL (n¼187). The FPS of the GVL in these patients was 77.9% (95% CI: 70.7%-83.7%) and the FPS of the DL was 62.6% (95% CI: 55.4%-69.2%). In the multivariate regression analysis, the GVL was associated with a higher odds of FPS than the DL (aOR 3.1; 95% CI: 1.8-5.3). Conclusion: In this cohort of patients with a bloody airway undergoing RSI in the ED, the GVL had a higher FPS than the DL. The GVL is recommended as the primary intubating device in the ED in patients with a blood contaminated airway.
12
Intraosseous Vascular Access Catheter Appears Safe During Extended Dwell: A Preliminary Report
Overbaugh R, Davlantes C, Miller L, Montez D, Puga T, Philbeck TE/ICON, San Antonio, TX; Teleflex Inc., Shavano Park, TX
Study Objectives: Despite relatively few documented complications associated with intraosseous (IO) vascular access, the US Food and Drug Administration (FDA) restricts catheter dwell time to 24 hours for IO devices. This may contribute to placement of central venous catheters for difficult vascular access patients in whom an IO placement would otherwise suffice, contributing to an increased risk for complications and costs. Many clinicians have requested that the IO catheter dwell time be extended to at least 48 hours. A study was designed to determine the safety of IO access when the catheter is left in place for up to 48 hours. Methods: The study protocol is being conducted under an Investigational Device Exemption granted by the FDA and was approved by IntegReview Ethical Review Board. Consenting adult volunteers (target N¼120) with renal impairment and/or diabetes were randomized to have an IO catheter (Arrow EZ-IO Intraosseous Vascular Access System,Teleflex Inc., Reading, PA) placed in the proximal humerus or proximal tibia by a trained physician. At the discretion of the investigator, subjects were administered midazolam and fentanyl to mitigate anxiety associated with IO insertion and the pain associated with the initial flush. With a slow continuous saline infusion administered by infusion pump, subjects remained in a secured early phase research unit for 48 hours. IO infusion pain was managed initially with IO lidocaine injections, then as needed with oral acetaminophen. For more severe pain, intravenous/ intramuscular Toradol or oral hydrocodone/acetaminophen were administered. After 48 hours, an IO aspirate sample was obtained from the in-situ catheter for culturing and an x-ray was taken of the IO insertion site after removal. After 30 days, subjects returned for physical examination and x-ray imaging of the insertion site. Results: As of April 2015, 24 subjects have completed the study with one subject in follow-up. There have been no serious adverse events or complications associated with the
Annals of Emergency Medicine S5