The Skeptics Guide to Emergency Medicine

Date: January 16th, 2022 Reference: Matchett, G. et al. Etomidate versus ketamine for emergency endotracheal intubation: a randomized clinical trial. Intensive Care Med 2021 Guest Skeptic: Missy Carter, former City of Bremerton Firefighter/Paramedic, currently a professor of Emergency Medical Services at Tacoma Community College’s paramedic program. Missy is currently working in a community emergency department as a physician assistant and recently accepted a critical care position in Tacoma Washington. Case: You respond to a rapid response on the floor for a 58-year-old woman in septic shock who is requiring emergent rapid sequence intubation (RSI). As you prepare to intubate the pharmacist asks if you would prefer ketamine or etomidate for induction in this patient. Background: We have covered the issue of intubation multiple times on the SGEM. This has included looking at supraglottic airways for out-of-hospital cardiac arrests (SGEM#247), video vs. direct laryngoscopy (SGEM#95), tracheal intubation for in-hospital cardiac arrests (SGEM#197), apneic oxygenation (SGEM#186) and confirming intubation with POCUS (SGEM#249). One thing we have not covered is the choice of induction agent for intubation. There has been much debate regarding the use of etomidate verses ketamine for induction in the critically ill [1-4]. A 2009 randomized control trial conducted in French ICUs supported the use of ketamine in this patient population [5]. Both agents are considered hemodynamically stable, but any induction agent may precipitate shock in the critically ill. There is some conflicting evidence as to which agent is preferred for patients who are at high risk of peri intubation complications. Historically there has been concern about adrenal insufficiency caused by etomidate being harmful for patients with sepsis but this has not been shown to cause increased mortality in the literature [6, 7]. Ketamine has emerged as a reasonable alternative but in recent years there has been concern about increased cardiovascular collapse with ketamine especially in those with sepsis or a high shock index [1, 8].    Clinical Question: Which induction agent has a better day 7 survival for critically ill patients requiring emergency endotracheal intubation, ketamine or etomidate? Reference: Matchett, G. et al. Etomidate versus ketamine for emergency endotracheal intubation: a randomized clinical trial. Intensive Care Med 2021 Population: Adults 18 years of age and older in need of emergency endotracheal (ET) intubation Exclusions: Children, pregnant patients, patients needing ET intubation without sedation or allergic to one of the agents being used Intervention: Ketamine 1-2mg/kg IV Comparison: Etomidate 0.2-0.3mg/kg IV Outcome: Primary Outcome: 7-day survival Secondary Outcomes: 28-day survival, duration of mechanical ventilation, ICU length of stay, need for vasopressor use, SOFA scores and an assessment of a new diagnosis of adrenal insufficiency by the treating critical care teams. Trial: Prospective, randomized, parallel-assignment, open-label, single-center trial (NCT02643381) Authors’ Conclusions: While the primary outcome of Day 7 survival was greater in patients randomized to ketamine, there was no significant difference in survival by Day 28.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. No The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). Unsure The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No All groups were treated equally except for the intervention. Yes Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Unsure The treatment effect was large enough and precise enough to be clinically significant. Unsure Lack of conflicts of interest. No Results: The cohort consisted of 801 critically ill patients that required ET. The mean age was 55 years, 38% female, 69% were in the MICU, and 51% had diagnosis of sepsis. Key Result: Day 7 survival was statistically higher in the ketamine arm compared to the etomidate arm Primary Outcome: 7-day survival favored Ketamine (85.1%) vs etomidate (77.3%), difference − 7.8, (95% CI; − 13 to − 2.4) p = 0.005 Secondary Outcomes: There was no statistical difference in 28-day survival between groups (ketamine 66.8% vs etomidate 64.1%) 1. Selection Bias: These were not consecutive patients. The manuscript says physicians were “encouraged to consider screening and enrolling patients whenever clinical circumstances reasonably permitted but were under no obligation to do so.” When you look at the number of patients excluded due to “clinical circumstances, clinician preference for usual care” in each arm of trial they were similar (n =396 for etomidate, and n = 398 for Ketamine). The reasons for these exclusions are unclear and may have biased the results towards whichever medication the physician favored. How these exclusions would ultimately impact the over-all results is also unclear. 2. Blinding: This was an open label trial. The authors said: “After extensive discussions with hospital and community stakeholders, we were unable to arrive at a satisfactory plan for masking.” This lack of blinding could have been responsible for the reported higher level of adrenal insufficiency was found in the etomidate arm. Having knowledge of group allocation may have led clinicians to more testing for adrenal insufficiency in the etomidate arm verses the ketamine arm. 3. Outcome Measure: The authors recognize that selecting 7 day survival is an unconventional outcome measure in an RCT of critically ill patients. They chose one Constantine unit (7 days) as the outcome because of their quality improvement data and to have the endpoint close to randomization. While the 7 day mortality was statistically better in the ketamine group compared to the etomidate group, there was not statistical difference reported at 28 days. Also, a more patient oriented outcome would be survival with good neurologic status. 4. External Validity: This trial was a single center trial including largely ICU patients who were intubated by an anesthesia lead airway team. This airway team uses the Montpellier Intubation protocol which includes the presence of two skilled operators, head-up positioning, deliberate preoxygenation, routine use of neuromuscular blocking agents and intubating stylets and frequent use of VL. They use EtCO2 detection for tube confirmation and are focused on prompt treatment of post intubation hypotension with vasopressors and IVF. This practice produced a 91% first pass success rate and likely contributed to standardized care in each group. The practice may not be generalizable to other centers who do not use such standardized protocols. 5. Hypothesis Generating: There were some interesting secondary outcomes regarding hemodynamics and cardiovascular collapse that are thought provoking and hypothesis generating. Ketamine had higher rates of vasopressors use, more frequent post intubation CPR, and higher incidence of post induction cardiovascular collapse compared to etomidate. This is very interesting given the 7-day mortality was better with ketamine. It may be that the airway team was so aggressive about post intubation management that they were able to overcome these complications. This circles back to nerdy point #4 and raises another question about generalizability. If these complications are encountered in other practice settings, such as the pre-hospital setting where there are less resources, would the patient receive the same aggressive post intubation management for these complications and might that change the outcomes. Comment on Authors’ Conclusion Compared to SGEM Conclusion: We agree with the authors conclusion. SGEM Bottom Line: It likely does not make a patient-oriented difference whether you use ketamine or etomidate for emergency endotracheal induction in most critically ill patients. Case Resolution: You tell your pharmacist you would like to use etomidate at a half dose but prior to intubation. First you would like to optimize hemodynamics and oxygenation and have a vasopressor ready in case you encounter post intubation hypotension. Missy Carter Clinical Application: Both ketamine and etomidate have similar hemodynamic stability, but both should be used with caution in the critically ill patient. There may be certain patient populations who might benefit from one medication over the other, but more research is needed on this topic. Regardless of which agent used there should be a focus on optimizing patient physiology by aggressively resuscitating before you intubate. Considering lower dosing for either induction agent in the critically ill may be further protective. What Do I Tell the Patient? You tell the patients family she is requiring a breathing tube to keep her safe while we manage her illness. She will be given medications to make them comfortable during and after the procedure. Although complications are possible, we will be doing everything we can to reduce her risk and keep her safe and comfortable. Keener Kontest: Last weeks’ winner was Dr. Paul Ehlers a PGY4 from UCSF. He knew the Rak Su singer who suffered a hemothorax was Myles Stephenson. Listen to the SGEM podcast for this weeks’ question.  If you know, then send an email to thesgem@gmail.com with “keener” in the subject line.

Date: December 28th, 2021 Reference: Kulvatunyou et al. The small (14 Fr) percutaneous catheter (P-CAT) versus large (28–32 Fr) open chest tube for traumatic hemothorax: A multicenter randomized clinical trial. J Trauma and Acute Care Surgery. November 2021. Guest Skeptic: Dr. Chris Root is a second-year resident physician in the Department of Emergency Medicine at the University of New Mexico Health Sciences Center in Albuquerque, NM. He is also a resident flight physician with UNM’s aeromedical service, UNM Lifeguard. Prior to earning his MD, he worked as a paramedic in the New York City 911 system. Case: A 43-year-old male presents to your emergency department (ED) the day after being involved in an all-terrain vehicle (ATV) accident. He reports he was riding his ATV along an embankment when it rolled, landing on top of him briefly. He did not seek medical attention at the time of the incident, but he has had persistent chest wall pain and worsening shortness of breath since yesterday evening. He is hemodynamically stable, oxygen saturation is 91% on room air, physical exam reveals ecchymosis and tenderness over the right chest wall with diminished right sided lung sounds. CT scans reveal multiple right sided rib fractures and a hemothorax estimated to measure 500cc with no additional injuries. Background:  We have discussed chest tubes a couple of times on the SGEM. This is usually with the master himself, Dr. Richard (Thoracic Rick) Malthaner. The first time was looking at a study about where to put the chest tube in a trauma patient. It turns out location (high or low) does not matter. The most important thing is placing the chest tube in the triangle of safety in the plural space (SGEM#129). The other episode on chest tubes looked at conservative vs interventional treatment for spontaneous pneumothorax (SGEM#300). This randomized controlled trial demonstrated that conservative management was non-inferior to placing a chest tube in a patient with a large first-time spontaneous pneumothorax. Another SGEM episode we did looked at the location of needle decompression for tension pneumothorax (SGEM#339). This was done with our good friend and frequent guest skeptic Dr. Robert Edmonds. This observational study did not support the claim that the second intercostal space-midclavicular line is thicker than the fourth/fifth intercostal space-anterior axillary line. This new SGEM episode looks at the size of chest tubes needed to successfully treat a traumatic hemothorax. Traditionally, these are treated by inserting a large bore chest tube (LBCT). There is increasing evidence supporting the use of smaller, percutaneously inserted chest tubes or pigtail catheter (PC) for the drainage of pleural effusions and pneumothoraces as well as some evidence of their efficacy for hemothorax. Clinical Question: Are small (14fr) pigtail catheters as effective as large (28-32 fr) chest tubes for the treatment of hemodynamcially stable patients with traumatic hemothorax? Reference: Kulvatunyou et al. The small (14 Fr) percutaneous catheter (P-CAT) versus large (28–32 Fr) open chest tube for traumatic hemothorax: A multicenter randomized clinical trial. J Trauma and Acute Care Surgery. November 2021. Population: Hemodynamically stable adult patients 18 years or older suffering traumatic hemothorax or hemopneumothorax requiring drainage at the discretion of the treating physician. Exclusions: Emergent indication, hemodynamic instability, patient refuses to participate, prisoner or pregnancy Intervention: Placement of small (14 fr PC) chest tube using a percutaneous seldinger technique Comparison: Placement of a large (28-32 fr LBCT) chest tube using a traditional surgical thoracostomy Outcome: Primary Outcome: Failure rate defined as radiographically apparent hemothorax after tube placement requiring an additional intervention such as second tube placement, thrombolysis or video-assisted thorascopic surgery Secondary Outcomes: Insertion complication rate; drainage output (30 minutes, 24-hour, 48-hour, and 72-hour); hospital course outcome up to 30 days (total tube days, ICU LOS, hospital LOS, and ventilator days); and insertion perception experience (IPE) score (1-5 score subjective score,1 - it was okay to 5 - it was the worst experience of my life). Trial: Multicenter, non-inferior, unblinded, randomized, parallel assignment comparison trial Authors’ Conclusions: “Small caliber 14-Fr PCs are equally as effective as 28- to 32-Fr chest tubes in their ability to drain traumatic HTX with no difference in complications. Patients reported better IPE scores with PCs over chest tubes, suggesting that PCs are better tolerated.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. Yes The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). Unsure The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No All groups were treated equally except for the intervention. Unsure Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Yes The treatment effect was precise enough to be clinically significant. Yes Financial conflicts of interest. Yes Results: There were 222 eligible patients identified over five years. The final cohort consisted of 119 patients (56 PC and 63 LBCT). The mean age was 55 years, 82% were male, 81% blunt trauma and median time to tube placement was 1 to 2 days from injury. Key Result: Small percutaneous catheters were non-inferior to large open chest tube for traumatic hemothorax Primary Outcome: Failure rate between PC and LBCT for the drainage of traumatic hemothorax 11% vs 13% (p=0.74). Secondary Outcomes: There were two insertion-related complications one from each group (bleeding from PC necessitated a thoracotomy and extra pleural position from chest tube placement required another tube placement). There were two deaths, one from each group (PC group had a PE on postinjury day 10 and the tube had already been removed and chest tube group had a nontrauma-related death at an outside institution). No statistical difference between PC and LBCT in terms of drainage tube output except at 30 minutes. No statistical difference in hospital course (tube days, ICU LOS, total hospital LOS or ventilatory days). Patients reported better IPE scores in the PC group compared to the LBCT group. 1. Selection Bias: There was no explicit statement that patients were consecutively recruited into the trial. They identified 222 eligible patients over five years. There were 102 excluded with 27 for “MD preference”.This means 27/102 (26%) of exclusions were for a subjective reason. This could have introduced some selection bias into the trial. 2. Exclusion of Hemodynamically Unstable Patients: Hemodynamically unstable trauma patients were excluded from study enrollment. Open thoracostomy and the placement of a LBCT is still considered by many to be the primary treatment for the evacuation of hemothorax in the hemodynamcailly unstable trauma patient. The authors did not seek to deviate from that idea in this study. However, they do allude to anecdotal experience placing PCs in hemodynamically unstable patients, and the output from PCs in the first hour was greater than that from LBCT in their trial, but further studies are needed to investigate the utility of PCs in hemodynamically unstable trauma patients. The exclusion of hemodynamically unstable patients could also explain the lower than anticipated failure rate which will be discussed later. 3. Patient Oriented Outcome: Tube failure rate is a simple, dichotomous, and clinically important primary outcome. However, the IPE score is a critical patient-oriented outcome (POO) that should be considered when managing these patients. The lead author, Dr. Kulvatanyou, alludes to having had friends and family members who have undergone LBCT placement express how horrible it was. Although the IPE scale developed by the investigators was not externally validated it is a straightforward and effective means of comparing the subjective experience of patients receiving either intervention. If you had a traumatic hemothorax, would you like the big tube or the small tube? 4. Low Overall Failure Rates: This study reports failure rates of 11% and 13% for PCs and LBCT respectively. These figures are significantly lower than a rate of 28.7% reported in a recent multi-institutional study from the Eastern Association for the Surgery of Trauma (EAST). The authors comment that this may be because their study excluded patients in extremis who may have additional injuries or require a level of procedural urgency that predisposes them to complications, however it is interesting to note that the study population in this trail had a mean hemothorax volume of 612mL vs 191 mL is the EAST study indicating that volume of blood did not appear to influence rate of failure compared to what has been published elsewhere (Prakash et al 2020). 5. Stopped Early: This is a multi-center RCT building on this groups previously published single center experience using PCs for the treatment of traumatic hemothorax (Kulvatunyou JTACS 2012). Despite enrolling at four sites for five years, they only enrolled 119 total patients. The authors initially estimated that they would have had to enroll 95 patients in each arm to have adequate power to detect a 15% absolute difference in efficacy between PCs and LBCTs.

Date: December 21st, 2021 Guest Skeptic: Dr. Howard “Howie” Mell began his career as a firefighter / paramedic in Chicago. He became double board certified in Emergency Medicine (EM) and Emergency Medical Services (EMS). Howie also has a Master of Public Health. Reference: Grotta JC et al. Prospective, multicenter, controlled trial of mobile stroke units. NEJM 2021 Case: The Mayor of your community consults you as an expert in public health, EMS and as an EM physician on whether they should purchase a mobile stroke unit (MSU) ambulance. Background: No one who has listened to the SGEM will be surprised we are covering another paper looking at stroke. We have often discussed the use of thrombolysis for acute ischemic stroke (AIS) with or without endovascular therapy (EVT). However, the SGEM has also looked at secondary stroke prevention on previous episodes (SGEM#24, SGEM#303). The SGEM has looked at pre-hospital stroke care using early administration of nitroglycerin by paramedics to see if it would improve neurologic outcome in patients with a presumed acute stroke (SGEM#269). The results from the RIGHT-2 trial reported no statistical difference in functional outcome as measured by the modified Rankin Scale (mRS) score at 90 days. The SGEM bottom line was that very early application of transdermal nitroglycerin by paramedics in the pre-hospital setting cannot be recommended at this time in patients with a suspected stroke. Mobile Stroke Unit The issue of having a MSU has also been discussed on  SGEM#330. A systematic review and meta-analysis which included seven randomized controlled trials and four observational studies including 21,297 patients was critically appraised.  The primary outcomes reported better neurologic outcome at seven days but not at one day post treatment by a MSU compared to conventional care (Fatima et al Int J Stroke 2020). The SGEM bottom line from that episode was we cannot recommend the use of MSU based on the available evidence. Clinical Question: Should mobile stroke units be purchased and deployed in your community? Reference: Grotta JC et al. Prospective, multicenter, controlled trial of mobile stroke units. NEJM 2021 Population: Patients calling EMS with a history and physical/neurological examination consistent with acute stroke who is last seen normal (LSN) possibly within 4 hours and 30 minutes and who had no definite tPA exclusions per guidelines, prior to CT scan or baseline labs. Daytime hours and mostly weekdays. Intervention: Care by a mobile stroke unit (MSU) Comparison: Care by traditional EMS referred to as standard management (SM) Outcome: Primary Outcome: Score on the utility-weighted modified Rankin scale (uw-mRS) at 90 days in patients who were adjudicated to be eligible to receive tPA on the basis of subsequent blinded review Secondary Outcomes: There were twelve secondary endpoints in their final protocol listed in hierarchical sequence of importance Agreement between on-board vascular neurologists (VN) and the remote VN Exploratory cost-effectiveness analysis (CEA) Outcomes comparing patients found eligible for tPA on MSU weeks compared to patients on SM weeks Ordinal (shift) analysis of mRS at 90 days, and Proportion of patients achieving 90 day mRS 0,1 vs 2-6 30% improvement from baseline to 24hr NIHSS Outcomes comparing all patients treated with tPA (whether or not adjudicated as tPA eligible) on MSU weeks compared to patients on SM weeks. Uw-mRS at 90 days Ordinal (shift) analysis of mRS at 90 days, and Proportion of patients achieving 90 day mRS 0,1 vs 2-630% Improvement from baseline to 24hr NIHSS Outcomes of those treated within 60 min LSN compared to those treated from 61 to 270 minutes Change in uw-mRS from baseline at 90 days Ordinal shift analysis of MRS at 90 days Proportion of patients achieving 90 day mRS 0,1 vs 2-6 30% improvement from baseline to 24hr NIHSS Outcomes all patients treated with IAT (separate analyses for those adjudicated as tPA eligible, all tPA treated, or all IAT with or without tPA) on MSU weeks compared to patients on SM weeks. Uw-mRS at 90 days Ordinal (shift) analysis of mRS at 90 days, and Proportion of patients achieving 90 day mRS 0,1 vs 2-6 30% improvement from baseline to 24hr NIHSS The time from LSN to tPA treatment on all patients treated within 4.5 hours of LSN on MSU weeks compared to similarly eligible patients on SM weeks Proportion of patients treated within 60 minutes of LSN on MSU weeks vs SM weeks. The time from LSN and from ED arrival to start of endovascular procedure on MSU vs SM weeks Proportion of all tPA-eligible patients having EVT on MSU vs SM weeks The median/mean time from LSN to tPA therapy decision on all patients considered for treatment within 4.5 hours of LSN on MSU weeks compared to SM weeks Time between 911 call and onset of etiology-specific BP management on MSU vs SM weeks. Safety Endpoints: Incidence of symptomatic intracranial hemorrhage (sICH) in enrolled tPA treated patients on MSU weeks compared to SM weeks. sICH was defined as any intracranial blood accumulation associated with a clinical deterioration of 4 points of the NIHSS for which the hemorrhage has been identified as the dominating cause of the neurologic deterioration) Mortality up to one year Incidence of stroke mimics and transient ischemic attacks (TIAs) in tPA treated patients on MSU weeks compared to SM weeks. Trial: Prospective cohort study with cluster randomized deployment weeks and blinded assessment of both trial entry and clinical outcomes. Cluster randomization can have both strengths and weaknesses just like any study design. For those less familiar with this methodology Taljaard and Grimshaw wrote a good article the topic in 2014. Authors’ Conclusions: "In patients with acute stroke who were eligible for t-PA, utility-weighted disability outcomes at 90 days were better with MSUs than with EMS." Quality Checklist for Observational Studies: Did the study address a clearly focused issue? Yes Did the authors use an appropriate method to answer their question? No Was the cohort recruited in an acceptable way? No Was the exposure accurately measured to minimize bias? Yes Was the outcome accurately measured to minimize bias? No Have the authors identified all-important confounding factors? No Was the follow up of subjects complete enough? Yes How precise are the results? Unsure Do you believe the results? No Can the results be applied to the local population? No Do the results of this study fit with other available evidence? Yes Did the study have no conflicts of interest. No Key Results: This prospective observational study screened 10,443 patients and enrolled 1,515 patients (58.5% MSU vs 41.5% SM). Fourteen percent overall were not eligible for tPA due to intracranial blood seen on CT scan. Two-thirds in both groups (1,047 total) were decided post-hoc to be eligible for tPA. Of the tPA eligible patients, 97% in the MSU group received tPA compared to 79.5% in the SM group. This results section was a real struggle. It was unclear which primary and secondary outcomes we should highlight in the review. Should it be those published in the NEJM or do we discuss the original ClinicalTrials.gov outcomes, the current ClinicalTrials.gov outcomes or pre-specified published protocol outcomes (Yamal et al Int J Stroke 2018)? At the end of the day, we decided to provide the published primary outcome, mention the secondary outcomes and give a few of the safety outcomes. Key Result: Patients treated with a mobile stroke unit had better 90 day outcomes. Primary Outcome (NEJM): Score on the uw-mRS at 90 days in patients who were adjudicated to be eligible to receive tPA on the basis of subsequent (post-hoc) blinded review 0.72 in the MSU group and 0.66 in the SM group Adjusted Odds Ratio (aOR) ≥0.91, 2.43 (95% CI, 1.75 to 3.36; P<0.001). Secondary Outcomes: Among the patients eligible for tPA, 55.0% in the MSU group and 44.4% in the SM group had a score of 0 or 1 on the mRS at 90 days. Among all enrolled patients, the mean score on the uw-mRS at discharge was 0.57 in the MSU group and 0.51 in the SM group (aOR for a score of ≥0.91, 1.82; 95% CI, 1.39 to 2.37; P<0.001). For more secondary outcomes see the NEJM publication. Safety Endpoints: sICH in ~2% of patients who received tPA in each group and none of the patients considered to be stroke mimics. Mortality at 90 days was 8.9% in the MSU group vs 11.9% SM group. 1. Houston, We Have a Problem: They changed their protocol at least four times over the course of the study. These changes were described in the PDF of their protocol. Sometimes the changes were minor and other times they were major. You can also see how their primary outcomes changed on ClinicalTrials.gov, in their pre-published protocol and through to their published manuscript in the NEJM. We were unable to find the any data in the manuscript or supplemental material on the other three “original” or “current” primary outcomes. This included the kappa value for the agreement between on scene vascular neurologist and remote vascular neurologist, cost effectiveness or the change in uw-mRS from baseline at 90 days. We have reached out to the lead author Dr. Grotta and will update the blog if this information becomes available. UPDATE: The Cohen kappa was published by Wu et al in 2017 with a value of 0.73 which is considered moderate inter rater reliability according to McHugh 2012.

Date: December 21st, 2021 Guest Skeptic: Dr. Spencer Greaves is an Emergency Medicine resident at Florida Atlantic University. He received his Bachelors in Biomedical Engineering from Marquette University and his Masters in Public Health from Dartmouth College.  Spencer completed his medical doctorate at the Medical College of Wisconsin. He and his wife live in Boynton Beach, FL where they recently celebrated the birth of their first child. Disclaimer: "While I am proud to be attending this institution, my opinions expressed here are mine alone and do not represent my residency program, hospitals I work at, or any other affiliated organizations." Reference: Vallentin et al. Effect of Intravenous or Intraosseous Calcium vs Saline on Return of Spontaneous Circulation in Adults With Out-of-Hospital Cardiac Arrest - A Randomized Clinical Trial. JAMA 2021 This was an SGEM Journal Club and all the slides from the presentation can be downloaded using this LINK. As a reminder, here are the five rules for SGEM JC. Case: An EMS crew arrives at the home of a 68-year-old suffering from a witnessed out-of-hospital cardiac arrest (OHCA). They have a history of hypertension, elevated cholesterol, and smoked cigarettes for 50+ years. Bystander CPR is being performed. The monitor is hooked up. The paramedics performed high-quality CPR and follow their ACLS protocol. Intraosseous access is quickly obtained, and a dose of epinephrine is provided. CPR is continued while a supraglottic airway is placed successfully. The patient is transported to the emergency department with vital signs absent (VSA). Background: We have covered adult OHCA multiple times on the SGEM. This has included the following issues: Calcium has a theoretical benefit on patients with cardiac arrest as it has inotropic and vasopressor effects. Previous small, randomized control trials (RCTs) have shown no superiority to calcium for return of spontaneous circulation (ROSC). However, the point estimated did favor calcium. Clinical Question: Does administration of calcium during out-of-hospital cardiac arrest improve sustained return of spontaneous circulation? Reference: Vallentin et al. Effect of Intravenous or Intraosseous Calcium vs Saline on Return of Spontaneous Circulation in Adults With Out-of-Hospital Cardiac Arrest - A Randomized Clinical Trial. JAMA 2021 Population: Adults 18 years of age and older with OHCA in the central Denmark region from January 2020 to April 2021 who received at least one dose of epinephrine Exclusions: Traumatic cardiac arrest, known or strongly suspected pregnancy, prior enrollment in the trial, receipt of epinephrine outside the trial, or a clinical indication for calcium administration during the cardiac arrest. Intervention: Calcium chloride 5 mmol given IV or IO immediately after first dose of ACLS epinephrine up to two doses Comparison: Saline placebo given IV or IO immediately after first dose of ACLS epinephrine up to two doses Outcome: Primary Outcome: Sustained ROSC defined as no further need for chest compressions for at least 20 minutes Secondary Outcomes: Survival, favorable neurological outcome, and quality of life assessment at 30 and 90 days Trial: Double-blind, placebo-controlled, parallel group, superiority, randomized clinical trial Authors’ Conclusions: “Among adults with out-of-hospital cardiac arrest, treatment with intravenous or intraosseous calcium compared with saline did not significantly improve sustained return of spontaneous circulation. These results do not support the administration of calcium during out-of-hospital cardiac arrest in adults.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. No The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). Yes The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Yes All groups were treated equally except for the intervention. Yes Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Yes The treatment effect was large enough and precise enough to be clinically significant. No Financial Conflicts of Interest. Yes Results: There were 1,221 OHCAs during the trial period. They excluded 824 for a variety of reasons with the most common reason (69%) because they did not receive any epinephrine. The mean age was 68 years, 71% male, more than 80% arrested at home, 85% received bystander CPR and half were in asystole. Key Result: No statistical difference in ROSC Primary Outcome: ROSC 19% in the calcium group vs 27% in the saline group Risk ratio (RR) 0.72 (95% CI; 0.49 to 1.03) Risk Difference, −7.6% (95% CI; −16% to 0.8%); P = 0.09) Secondary Outcomes:  No statistically significant differences in 30-day survival, 30-day survival with a favorable neurological outcome or 90-day survival Survival at 90-days with favorable neurological outcome was statistical better in the placebo group. Quality of life assessment assessed by the patient was not statistically different at 30-days but was at 90-days favoring calcium 1. Outcomes: It would be great if there was consistency in reporting outcomes. The trial was registered with ClinicalTrials.gov. Primary outcome was the same in the registration, protocol, and published manuscript. However, there was no quality-of-life assessment registered as an outcome, it was called a tertiary outcome in the protocol, categorized as a secondary outcome on the Table 2 of the manuscript and a tertiary outcome in the text of the manuscript. Same thing for the 90-day outcome which was not mentioned in the trial registry, was considered a tertiary outcome in the protocol but elevated to a secondary outcome in Table 2 and tertiary outcome in the body of the text. 2. External Validity: This trial was conducted in Denmark. They have a two-tiered EMS service that has an ambulance and a mobile emergency care unit with a physician. This is different from most places in north America that do not have physicians in the pre-hospital setting. In addition, the latest statistics from the American Heart Association on cardiac arrests in the USA are different than the cohort included in this trial. The biggest difference was bystander CPR was 39% in the USA vs 85% in this Danish trial. These and other differences could limit the external validity to your own community. 3. Dose of Calcium: It is possible but not likely that a different dose of calcium may have made a difference. Proving a negative is harder than proving a positive. We start with a null hypothesis of no superiority. In this case, the null hypothesis is that calcium is not superior to placebo. The results did not support the alternative hypothesis of superiority, so we accept the null hypothesis. It would be a separate claim to say that calcium does not work for OHCAs. The more accurate statement would be there is no high-quality evidence to support the routine use of calcium in OHCAs. 4. OHCA: This data directly applies to OHCAs and not necessarily IHCA. There are longer times to drug administration in the pre-hospital setting. Time to drug administration was a median of 17 minutes. It could be hypothesized that early time to treatment could provide a patient-oriented outcome of benefit. However, that would need to be demonstrated. 5. Stopping Early: We have discussed the problem of stopping trials early before on the SGEM. It can introduce bias and increase uncertainty of the results. Stopping trials early over-estimates the effect size if there is a regression to the mean. Also, including trials that are stopped early can introduce bias into SRMA making them more difficult to interpret (Bassler et al JAMA 2010). Comment on Authors’ Conclusion Compared to SGEM Conclusion: We agree with the authors’ conclusions. SGEM Bottom Line: The routine use of calcium in an OHCA is not supported by the available evidence. Case Resolution: Three rounds of epinephrine are eventually provided without ever achieving ROSC. ECG shows no electrical activity, pupils are fixed and dilated, and POCUS shows no cardiac activity. The patient is pronounced deceased in the ED. Dr. Spencer Greaves Clinical Application: We have not and will continue to not routinely give calcium to adult patients with OHCAs. What Do I Tell the Patient?  You tell the patients family that they had a cardiac arrest. The paramedics did great CPR, put in an airway to help breathing and gave epinephrine to try and restart the heart. Despite everyone’s efforts we were not able to get their heart going again and they have died. Keener Kontest: Last weeks’ winner was Josh McGough at third year medical student from Stony Brook University. He knew Dr. Pam Bensen was the first EM resident in North America in 1971. Listen to the SGEM podcast for this weeks’ question. If you know, then send an email to thesgem@gmail.com with keener in the subject line. The first correct answer will receive a cool skeptical prize. Other FOAMed: First10EM: Calcium for OHCA - The COCA Trial The Bottom Line: COCA Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.

Date: December 13th, 2021 Reference: Lee et al. Addressing gender inequities: Creation of a multi-institutional consortium of women physicians in academic emergency medicine. AEM December 2021 Guest Skeptic: Dr. Justin Morgenstern is an emergency physician and the creator of the #FOAMed project called First10EM.com Case: At the completion of her 1-month elective in your rural emergency department (ED), you are discussing career plans with a medical student. She says that she is very interested in emergency medicine, but she isn’t sure if it is the right choice for her. She has worked in five EDs so far, and a man has filled almost every leadership position. She also just got back from an emergency medicine conference, and more than 90% of the speakers were white males. She loves the clinical work in emergency medicine, but she is worried that these apparent gender inequities will limit her career opportunities. Background: Gender equity is something we have spoken about often on the SGEM. Some listeners are happy we cover this topic while others have expressed concern. We recognize this can be an emotional issue. Our position is gender inequity exists in the house of medicine and it should be an issue everyone is interested in addressing. Here are some of the previous SGEM episodes that discussed gender equity: SGEM Xtra: From EBM to FBM – Gender Equity in the House of Medicine SGEM Xtra: Unbreak My Heart – Women and Cardiovascular Disease SGEM#248: She Works Hard for the Money – Time’s Up in Healthcare SGEM Xtra: Money, Money, Money It’s A Rich Man’s World – In the House of Medicine SGEM Xtra: I’m in a FIX State of Mind It is hard to believe some people deny the significant gender inequities that currently exist in medicine. Women are under-represented in leadership positions [1-3]. Women are less likely to be given senior academic promotions [4]. There are fewer women in editor positions in our academic journals [5]. Women receive less grant funding [6-7]. Women are paid less than men, even after accounting for potential confounders [2, 8-10]. Yet a recent twitter poll had more than 1/3 of respondents saying they did not think a physician gender pay gap existed in their emergency department. It is hard to move forward and address a problem when a significant portion of physicians do not even recognize that there is a problem. The literature describes many factors that contribute to gender inequity. Institutional policies related to promotion or advancement may inherently disadvantage women and are likely exacerbated by implicit bias and stereotyping. There are an insufficient number of women in current leadership positions, resulting in fewer mentors and role models for women earlier in their career. Policies around parental leave, emergency child-care, and breast-feeding support affect women disproportionately. Unfortunately, sexual harassment is also still widely documented in emergency medicine and has a major impact on career advancement and attrition [11-13]. The reasons for the gender gap are complex, and likely not completely understood. Existing gender balance within specialties, among other aspects of the "hidden curriculum", likely influence career decisions, with women trainees more likely to enter lower paying specialties. Current leadership positions are dominated by males, who may consciously or not be more supportive of other males for future promotions. Furthermore, there are numerous gender differences, both internal and external, that influence salary expectations and negotiations [14]. Female physicians are more likely to have female patients, and medical pay structures are often inherently biased. For example, in Ontario, where we both work, a biopsy of the penis pays almost 50% more than a biopsy of the vulva. Similarly, incision and drainage of a scrotal abscess pays twice as much as incision and drainage of a vulvar abscess [14]. There is data that suggests that practice patterns vary between women and men. Women in primary care are more likely to address multiple issues during a single appointment. They are more likely to provide emotional support and address psychosocial issues, and less likely to perform procedures. Although these are features most of us would want in a physician, unfortunately they result in lower remuneration in more medical payment models [14]. And of course, all of this occurs in the larger societal context in which women perform far more unpaid labour outside of medicine, resulting in much larger overall workloads, most of which is often overlooked. For a wonderful book on the topic, considering reading Invisible Women by Caroline Criado Perez. Too often, women are blamed for the gender pay gap. It is true that women, on average, work fewer hours, and are more likely to work part time. However, this difference in work is not enough alone to explain the pay gap. For example, one study found that women earned 36% less than their male colleagues, despite only working three hours less per week [14]. It is also not true that women earn less because they are less efficient. Data from Ontario revealed that female surgeons earn 24% less per hour spent operating, despite completing procedures in the same amount of time as men. The difference seems to derive from women performing less lucrative procedures [15]. We clearly have a problem in medicine. There is no denying the current state of gender inequity. Solutions, while in some cases glaringly obvious, are probably rather complex. Solutions are unlikely to be "one size fits all". The needs and desires of individual women will obviously be far more varied and far more complex than the "average woman", and we should always be wary of unintended consequences when implementing social policy. However, those are not excuses. The data speaks for itself. More action is needed, and it is needed now. The first step is to acknowledge the current problem widely and openly. This would be aided with transparent reporting on physicians’ payment, stratified by gender. It is worth noting that gender is not the only source of inequality in medicine, and this same data should be used to examine other factors such as race or disability. We need better training about bias in medicine, especially for those in leadership positions. We need to consider more egalitarian interview processes, where leadership are blinded to characteristics like gender or race. We need to consider the impacts of systemic discrimination and recognize that simply being fair in a single hiring decision is unlikely to be good enough, as it doesn’t account for the incredibly different paths that candidates took to reach the same point. We need to fix the biased billing codes and referral patterns. We need better parental benefits, and systems to ensure career advancement can continue even when one is taking time to raise children. So clearly there is a lot that needs to be done on this topic. But neither of us are experts on the topic, so I think we had better get into the meat of the episode and start talking to our guest who is an expert. Clinical Question: What can be done about gender inequity in emergency medicine? Reference: Lee et al. Addressing gender inequities: Creation of a multi-institutional consortium of women physicians in academic emergency medicine. AEM December 2021 There is no real PICO statement for this publication. We also normally do a quality check list to probe the publication for its validity. No such check list exists for this type of study seems to exist. it is still worth thinking critically about their methodology to consider the intrinsic and extrinsic validity of their discussion. When considering whether to develop a similar program, there are three major questions to consider: Does this program accomplish its intended goals? Will the results here extrapolate to other settings? What are the costs and alternative options? Methods: This article describes the creation of a multi-institutional consortium of women faculty in emergency medicine to promote career advancement and address issues of gender inequity. The consortium brought together female faculty from four hospitals associated with Harvard Medical School. Dr. Lois Lee This is an SGEMHOP episode which means we have the lead author on the show, and we can hear about this program directly from the author. Dr. Lois Lee is a pediatric emergency medicine physician at Boston Children’s Hospital and an Associate Professor of Pediatrics and Emergency Medicine at Harvard Medical School. Neither Ken nor I have experienced these issues firsthand. Is there anything else you think is important to add to the background material we provided? Thank you for continuing to highlight gender inequities in medicine and also for working to figure out some solutions to this complex problem. Although there are some things as an individual that can be done, many—if not most—of the solutions really need to be at the departmental leadership, institutional, and systemic level. What is the history behind this project and why did you think there was a need for this program? Under our medical school there are five different institutions with separate emergency departments—four adult or general EDs and one pediatric specific. And it turns out over the last 5-10 years four of them had either formally or informally developed women faculty groups for career support. Then in 2018 several women from the different institutions came together and they formed the Harvard Medical School Women in EM Consortium.  Although we all have academic affiliations under the same medical school, we otherwise had no formal connections through our EDs. Can you briefly describe the consortium and curriculum you developed? Site champions—at least two from each site

Date: December 10th, 2021 Guest Skeptic: Dr. Carly Eastin is an Associate Professor, Division of Research and Evidence Based Medicine, Department of Emergency Medicine, University of Arkansas for Medical Sciences. She is also the Chair of the SAEM Evidence Based Healthcare and Implementation (EBHI) Interest Group. Carly was a guest skeptic on the SGEM two years ago. That was in the BC Times- (Before Covid). We had the pleasure of recording a live episode of the SGEM at the University of Arkansas.  Back in 2019 we were talking about Vitamin C for sepsis (SGEM#268). SGEM Bottom Line: “There is not enough evidence to support the routine use of vitamin C in critically ill patients.” Not much has changed over the last two years. There have been at least two randomized control trials published that do not support the use of Vitamin C in sepsis. Fujii et al (VITAMINS RCT) JAMA 2020: n=216 patients with septic shock. No statistical difference in their primary outcome for duration of time alive and free of vasopressor administration up to day 7 or the secondary outcome of 90-day mortality. Moskowits et al (ACTS RCT) JAMA 2020: n=205 patients with septic shock. no statistical difference in primary outcome of SOFA scores at 72 hours or the secondary outcome of 30-day mortality. It was Dr. Paul Marik who has been a big advocate for Vitamin C sepsis. We did an SGEM episode on his before-after study (SGEM#174: Don’t Believe the Hype) with a dozen skeptics expressing their concern the results were too good to be true. Dr. Marik has also been promoting the use of Vitamin C for COVID19. However, there is insufficient evidence to support the routine use of Vitamin C in the treatment of critically ill or non-critically ill COVID19 patients (NIH COVID19 Treatment Guidelines and Thomas et al JAMA 2021). There is also no high-quality evidence that Vitamin C can prevent COVID19. There is a Phase II interventional randomized placebo-controlled trial testing whether treatment with Vitamin C can prevent symptoms of COVID19 (ClinicalTrials.gov). This SGEM Xtra episode is not to talk about Vitamin C, COVID19 or even do a structured critical appraisal of a recent publication. This is an SGEM Xtra episode to pay tribute to a friend and champion of the EBM community, Dr. Rakesh Engineer. Dr. Rakesh Engineer Rakesh died suddenly in 2019 and the Society of Academic Emergency Medicine (SAEM) reflected upon how best to honour him. SAEM decided to name an award after Rakesh, focusing on his passion for implementation science. Dr. Chris Carpenter knew Rakesh well and was asked to give a brief introduction to those who did not know him. You can listen to his introduction at this LINK. Chris Carpenter: "[Rakesh] was a devoted husband and dedicated father to three sons.  He was born in Cleveland, Ohio and attended Ohio State University where he earned both his Bachelors and MD. After his internship at Barnes Jewish Hospital at Washington University St. Louis. He trained in Emergency Medicine at Spectrum Health in Grand Rapid Michigan. After that, he joined the Cleveland Clinic to be with his family, to educate the next generation of emergency physicians and launch his own clinical research career. Rakesh's vision epitomized implementation science, in which knowing is not enough: we must apply. As an emergency medicine clnical researcher, Rakesh thrived at the interface between published evidence and pragmatic application at the bedside.  He was a friend and I miss him dearly." Carly: "I did not have the privilege of knowing Rakesh personally very well, but was following him because I was a member of the SAEM Evidence-Based Healthcare and Implementation group when he was active and I was still trying to find my way in the EBM world. He was such a good speaker and was really funny. I also remember that it was Rakesh that gave me my first real understanding of implementation science, and I’ve been hooked ever since." Ken: "I remember running into Rakesh at an SAEM meeting in Indiana. To be more accurate, he almost ran into Chris and me outside the hotel. We were heading out to get something to eat or something and Rakesh pulled up in a big sedan. I want to remember that it was a convertible. We pretended to be almost run over by him. Rakesh quickly jumped out of the car, usual big smile on his face and we had a quick nerdy chat. That is the last memory I have of Rakesh. Chris sent me a goofy picture of Rakesh". Carly: "It’s hard to look at that picture without smiling. I can’t tell you how many stories just like yours I’ve heard about his laughter and fun personality. He was clearly highly respected and loved by many." Rakesh published a lot of peer reviewed articles during his career. This included biomarkers, gun safety and diagnostic imaging studies. Rakesh had just been elected Chair of the Evidence Based Healthcare and Implementation (EBHI) Interest Group for SAEM. He had been an active member of the interest group for many years. The mission of the EBHI Interest Group is the applied concept of merging healthcare professional expertise, research, and patient priorities and circumstances through a defined process of finding, appraising, and employing clinical science at the bedside. This mission aligns with the three pillars of EBM. There is the literature which informs our care, our clinical judgment and the patients’ preferences and values. This is what Dr. Davide Sackett said EBM is and what it isn't (BMJ 1996). Rakesh believed in integrating these three important aspects of EBM into practice. The EBHI Interest Group provides a network of expertise from the emergency medicine resident to the seasoned investigator, which serves as a forum for research, education, and clinical practice. Objectives of the EBHI Interest Group Engage the membership regularly and broaden the active core group through mentorship and collaboration for junior members. Increase use of social media and internet platforms to improve the visibility of the interest group and its members as well as to disseminate best practices. Continue focus on inter-institutional collaboration on journal clubs and scholarly projects, including original research or systematic reviews. Sponsor high-quality didactic submissions to the SAEM annual meeting. The Rakesh Engineer Award The Dr. Rakesh Engineer award will be given to an outstanding presentation related to Implementation Science at the SAEM annual meeting. Quality improvement projects can be considered if the implementation methods, effectiveness, and outcomes are reported. De-implementation studies are also eligible. More information on the Rakesh Engineer Award can be found at this LINK. If you are interested in nominating someone or yourself for this award you can click on this LINK. You can also click on the QR Code. The award will be given out for the first time at the conclusion of SAEM 2022 which will be held in New Orleans, May 10-13. The award committee will consider abstracts accepted to SAEM’s annual meeting and grade them based a list of criteria related to knowledge translation. The top three abstracts will be judged live at the meeting,  a winner chosen and the Rakesh Engineer Award presented. Implementation Science The journal Implementation Science defines this as “the scientific study of methods to promote the uptake of research findings into routine healthcare in clinical, organizational, and policy contexts.” In other words, implementation science programs use the available evidence to achieve measurable improvements in the quality of clinical care. It is easy to think that once something is determined to be the standard of care, people will just start doing it. But there are a lot of factors that influence the success of implementing a new practice to improve care or removing an old, outdated practice that might be harmful. Implementation science methods allow you to move through this process in a way that will be effective, sustainable over time, and lead to your desired outcomes. For those who would like to learn more, we suggest you read the manuscript titled, “Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science,” by Laura Damschroder and her colleagues published in Implementation Science 2009. You can also find a wealth of information at the NIH’s Implementation Science website. For those in academic or university settings, you may have an implementation science group locally who can provide additional resources. We would suggest exploring your institution’s website for implementation science experts. The SGEM will be back next episode doing a structured critical appraisal of a recent publication. Trying to cut the KT window down from over ten years to less than one year using the power of social media. So, patients get the best care, based on the best evidence. Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.

Date: November 16th, 2021 Reference:  Hammouda et al. Moving the Needle on Fall Prevention: A Geriatric Emergency Care Applied Research (GEAR) Network Scoping Review and Consensus Statement. AEM November 2021 Guest Skeptic: Dr. Kirsty Challen (@KirstyChallen) is a Consultant in Emergency Medicine and Emergency Medicine Research Lead at Lancashire Teaching Hospitals Trust (North West England). She is Chair of the Royal College of Emergency Medicine Women in Emergency Medicine group and involved with the RCEM Public Health and Informatics groups. Kirsty is also the creator of the wonderful infographics called #PaperinaPic.  Case: Mid-shift, you realise that the next patient you are about to see is the third in a row aged over 70 who has fallen at home, and that this is her third attendance for a fall in the last two months. You wonder if any emergency department (ED)-based interventions would help her and people like her be safe. Background: We looked at geriatric falls on an SGEM Xtra in 2015. Back then we found that at one academic site older adults attending ED with falls didn't receive guideline-based assessment, risk stratification or management. Dr. Chris Carpenter In 2014 the SGEM looked at a systematic review by Dr. Chris Carpenter, which concluded that there wasn't a good tool to help us predict which ED patients are at risk of recurrent falls (SGEM #89). Close to three million adults aged 65 and over visit American EDs annually after a fall [1]. Falling is the most common cause of traumatic injury resulting in older adults presenting to the ED [2]. Approximately 20% of falls result in injuries, and falls are the leading cause of traumatic mortality in this age group [3-5]. The SAEM Geriatric Emergency Medicine Task Force recognized fall prevention as a priority over 10 years ago. There is the Geriatric Emergency care Applied Research (GEAR) network, which is trying to improve the emergency care of older adults and those with dementia and other cognitive impairments. GEAR looks to identify research gaps in geriatric emergency care support research and evaluation of these areas. GEAR 2.0 has recently been launched with funding opportunity in conjunction with EMF. There are three other GEAR 1.0 manuscripts which have been published: Delirium Prevention, Detection, and Treatment in Emergency Medicine Settings AEM 2020 Care Transitions and Social Needs AEM 2021 Research Priorities for Elder Abuse Screening and Intervention J Elder Abuse Negl 2021 Clinical Question: In older patients presenting to ED with falls do risk stratification or fall prevention interventions influence patient-centered or operational outcomes? Reference:  Hammouda et al. Moving the Needle on Fall Prevention: A Geriatric Emergency Care Applied Research (GEAR) Network Scoping Review and Consensus Statement. AEM November 2021 This publication presents two related but different scoping reviews so there are  two PICOs. PICO #1 Population: Systematic search that found 32 studies of fall prevention interventions for patients aged 60 or over who presented to ED with a fall. Exclusions: Abstracts repeating data already included in full, not original research. Intervention: Fall prevention interventions including multifactorial risk reduction, medication review, exercise training, models of care like Hospital-at-Home. Comparison: Standard of Care. Outcomes: Quality of care ED metrics, ED operational outcomes like length of stay, patient-centered outcomes like ED returns, further falls, fear of falling, functional decline, institutionalization. PICO #2 Population: Systematic search that found 17 studies of risk stratification and falls care plans in patients aged 60 or over in ED or pre-ED settings. Exclusions: As review 1. Intervention: Risk stratification and falls care plan. Comparison: No risk stratification and falls care plan. Outcomes: ED referral (from pre-ED setting), quality of care ED metrics, ED operational outcomes, patient-centered outcomes. This is an SGEMHOP episode which means we have the honour of having the lead author, Dr. Elizabeth (Liz) Goldberg, on the show. She is an Associate Professor of Emergency Medicine and Health Services, Policy and Practice at Brown University. Her specific areas of interest include improving care for older adults and public health interventions to enhance longevity and healthy aging. Dr. Elizabeth Goldberg Authors’ Conclusions: “Harmonizing definitions, research methods, and outcomes is needed for direct comparison of studies. The need to identify ED-appropriate fall risk assessment tools and role of emergency medical services (EMS) personnel persists. Multifactorial interventions, especially involving exercise, are more efficacious in reducing recurrent falls, but more studies are needed to compare appropriate bundle combinations. GEAR prioritizes five research priorities: (1) EMS role in improving fall-related outcomes, (2) identifying optimal ED fall assessment tools, (3) clarifying patient-prioritized fall interventions and outcomes, (4) standardizing uniform fall ascertainment and measured outcomes, and (5) exploring ideal intervention components.” Quality Checklist for Scoping Systematic Reviews: Did they provide a structured summary that includes (as applicable): background, objectives, eligibility criteria, sources of evidence, charting methods, results, and conclusions that relate to the review questions and objectives? Yes Was a rationale for the review in the context of what is already known provided? Yes Was there an explicit statement of the questions and objectives being addressed with reference to their key elements? Yes Was their protocol pre-published and the study registered? No Characteristics of the sources of evidence used as eligibility criteria was specified? Yes All information sources in the search were described? Yes The presented the full electronic search strategy for at least one database, including any limits used, such that it could be repeated. Yes The process for selecting sources of evidence (i.e., screening and eligibility) was included in the scoping review. Yes Methods of charting data from the included sources of evidence was described. Yes There was a list of all variables and definitions for which data were sought and any assumptions and simplifications made. Yes If done, a rationale for conducting a critical appraisal of included sources of evidence; describe the methods used and how this information was used in any data synthesis (if appropriate) was provided. No The methods of handling and summarizing the data that were charted was described. Yes Give numbers of sources of evidence screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally using a flow diagram. Yes For each source of evidence, present characteristics for which data were charted and provide the citations. Yes If done, present data on critical appraisal of included sources of evidence (see item 12). No For each included source of evidence, present the relevant data that were charted that relate to the review questions and objectives. Yes The authors summarized and/or present the charting results as they relate to the review questions and objectives. Yes The authors summarized the main results (including an overview of concepts, themes, and types of evidence available), link to the review questions and objectives, and consider the relevance to key groups. Yes They discuseds the limitations of the scoping review process. Yes The provided a general interpretation of the results with respect to the review questions and objectives, as well as potential implications and/or next steps. Yes The described sources of funding for the included sources of evidence, as well as sources of funding for the scoping review. Describe the role of the funders of the scoping review. Yes Results: 32 studies were included (3 meta-analyses and 23 RCTs) with a total of 571,071 patients to try to answer the first PICO question about falls prevention. Studies were from 11 countries, 1999-2019, with follow-up from 1 to 18 months. Interventions included falls risk assessment, physical rehabilitation sessions, preventive education, educational guidelines, follow-up with NP or PT, and alert devices. Most used recurrent falls as the outcome although anxiety over falls, functional ability and QALYs also featured. 17 studies were included (4 meta-analyses and 8 RCTs) with a total of at least 17,232 patients to address the second PICO question about risk stratification. Studies were from 9 countries, 2011-18, with follow-up from 6 to 12 months. 11 screening instruments were identified with interventions including educational, physical therapy, follow-up calls, discharge planning and home visits. Most used recurrent falls as the outcome. Key Result: The GEAR-Falls group identified five research priorities. EMS role in improving fall-related outcomes Identifying optimal ED fall assessment tools Clarifying patient-prioritized fall interventions and outcomes Standardizing uniform fall ascertainment and measured outcomes Exploring ideal intervention components We asked Liz five nerdy questions about her study.  Listen to the SGEM podcast to hear her responses. 1. Question Selection: Your group original had three PICO questions (the third was about specific risk factors for falls e.g. polypharmacy). How and why did you decide to address the two that you did? 2. Consensus Conference: You held a consensus conference of your multidisciplinary group with the initial findings of the scoping review to generate and vote on research priorities.

Date: November 10th, 2021 Reference: Andersen, et al: Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest. JAMA Sept 2021. Guest Skeptic: Dr. Neil Dasgupta is an emergency physician and ED intensivist from Long Island, NY, and currently an assistant clinical professor and Director of Emergency Critical Care at Nassau University Medical Center. Case: A code blue is called for a 71-year-old male in-patient that is boarding in the emergency department (ED). He had been admitted the night before for a new diagnosis of rapid atrial fibrillation. He has a history of hypertension, dyslipidemia, and type-2 diabetes. His medications include a beta-blocker, statin, angiotensin converting enzyme inhibitor (ACE-I), metformin, ASA and direct oral anticoagulant (DOAC). You arrive and see that the Advanced Cardiac Life Support (ACLS) algorithm is being followed for adult cardiac arrest patients with pulseless electrical activity (PEA). Cardiopulmonary resuscitation (CPR) is in progress. The monitor shows a non-shockable rhythm. Epinephrine is provided and you quickly place an advanced airway. A second dose of epinephrine is given, and you start to think about reversible causes and your next steps for in-hospital cardiac arrests (IHCA). SGEM#50: Under Pressure Background: We have looked an IHCA a couple of times on the SGEM. The first time we looked at this issue on (SGEM#50). This was also the first SGEM JC done where Dr. William Osler started the Journal Club initiative at McGill University. We reviewed a randomized, double-blind, placebo-controlled, parallel-group trial done in three Greek tertiary hospitals. This trial (n=268) reported increased return of spontaneous circulation (ROSC) and increased survival to hospital discharge with good neurologic function with a vasopressin, steroids, and epinephrine (VSE) protocol compared to epinephrine alone. We felt this was interesting but would need to be validated/replicated before changing our IHCA protocols. Corticosteroids have been suggested as a possible therapy in these cardiac arrest situations. A SRMA published in 2020 on the use of steroids after cardiac arrest reported an increase in ROSC and survival to discharge but was limited by the availability of adequately powered high-quality RCTs (Liu et al JIMR 2020). We covered another SRMA that was published in 2021 looking at the same issue of whether the use of corticosteroids impact neurologic outcomes and mortality in patients with a cardiac arrest (SGEM#329)? These authors reported a statistical increase in good neurologic outcome and survival to hospital discharge with steroids but not survival at one year or longer. This study provided weak evidence in support of using corticosteroids for IHCA as part of a VSE protocol. Answering clinical questions about cardiac arrest with clinical trials has always been fraught with difficulty. However, cardiac arrest is something we regularly treat in the emergency department, and we need more high-quality data to inform our care. Vasopressin had been included as a part of the American Heart Association (AHA) ACLS protocol for quite a while but was removed in favor of a vasopressor monotherapy strategy with epinephrine.  The tide now is shifting in resuscitation research to shift our focus from obtaining ROSC to measuring functionality and good neurologic outcomes.  In the context of questioning epinephrine’s role in ACLS after Paramedic2, we look at using the VSE protocol in cardiac arrest. Clinical Question: Does adding a combination of vasopressin and methylprednisolone increase the chance of achieving ROSC in cardiac arrest? Reference: Andersen, et al: Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest. JAMA Sept 2021. Population: Adult patients 18 years of age and older with an in-hospital cardiac arrest. Excluded: Out-of-hospital cardiac arrest (OHCA), valid do-not-resuscitate order, invasive mechanical circulatory support and known or suspected pregnancy at the time of the cardiac arrest. Intervention: Vasopressin 20 IU and methylprednisolone 40 mg given as soon as possible after first dose of epinephrine, followed by vasopressin 20 IU after each epinephrine up to four doses. Comparison: Placebo of normal saline Outcome: Primary Outcome: ROSC defined as no further need of chest compressions for at least 20 minutes Secondary Outcomes: 30-day survival and 30-day survival with favorable neurologic outcome (defined as a Cerebral Performance Category of 1 or 2) Trial Design: Multicenter, single nation, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial Authors’ Conclusions: “Among patients with in-hospital cardiac arrest, administration of vasopressin and methylprednisolone, compared with placebo, significantly increased the likelihood of return of spontaneous circulation. However, there is uncertainty whether this treatment results in benefit or harm for long-term survival.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. No The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). Yes The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Yes All groups were treated equally except for the intervention. Yes Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Yes The treatment effect was large enough and precise enough to be clinically significant. No Was the study without any financial conflicts of interest. No Results: They recruited and analyzed 501 patients with a mean age of 71 years, 64% were male and 2/3 were on a medical ward. Key Result: More ROSC was achieved with VSE compared to epinephrine alone, but this did not translate into better long term-survival or with favorable neurologic outcome. Primary Outcome: ROSC 42% intervention group vs 33% in control group. Absolute difference of 9.6% (95% CI, 1.1% to 18.0%). Risk ratio of 1.30 (95% CI, 1.03 to 1.63) p=0.03. Secondary Outcomes:No statistical difference between groups for both key secondary outcomes. Survival at 30 days: 9.7% vs 12%. Absolute difference −2.0% (95% CI, −7.5% to 3.5%) with risk ratio, 0.83 (95% CI, 0.50-1.37); P = 0.48). A favorable neurologic outcome at 30 days: 7.6% vs 7.6% with a risk ratio, 1.00 (95% CI, 0.55 to 1.83); P >0.99 1. ED Patients: These are not ED patients, but they are often emergency physicians’ responsibility. In many hospitals the only in-house physician at certain times is in the ED and will be responding to Code Blues. We need to be cautious not to over-interpret the data and directly apply it to patients who arrive in the ED and have an arrest. This data can help inform and guide our care, but it should not dictate our care. These might be more like our patients than we think. Digging into the demographics of the included patients they seem like a surprisingly healthy cohort for IHCA. RRT (11% vs 8%), mechanical ventilation (8% vs 11%) and on pressor support (5% vs 9). Only 10% vs 7% of patients in the ICU, and 8% vs 14% in the ED.  This may actually help us to better extract its applicability to the ED population and what gets brought in via EMS.  It also may be a result of the inclusion/exclusion criteria set up. 2. Enrollment: This was surprisingly low. From 2,362 screened patients to 512 randomized, and 501 ultimately included for analysis. There were a lot of exclusions despite a liberal inclusion criteria and limited exclusion criteria. Large numbers of patients were excluded for not receiving epinephrine, ROSC prior to getting the drug, and a whole series of clinical team dependent factors (forgot about the study/early termination/physician preference/logistics). While the authors claim this did not have an impact on the outcome, it’s hard to imagine it didn’t have any impact on the included cohort or introduced some selection bias. 3. Patient-Oriented Outcome: The endpoint of ROSC is patient-centered, and a prerequisite for a good neurologic function. However, it is not a net benefit to save more people who have a poor quality of life. This is what was demonstrated in the PARAMEDIC2 trial (SGEM#238). There was an increase in survivors with epinephrine for OHCA. Unfortunately, the increase was mainly for patients having severe neurologic impairment was more common among survivors in the epinephrine groups compared to the placebo group (31.0% vs. 17.8%). 4. Cerebral Performance Category (CPC) Score: Speaking of POO. The outcome measure for favorable neurologic outcome was the CPC score. Legend of EM, Dr. Ian Stiell from Ottawa published some data from the classic OPALS trail. They said that while the CPC can be an important outcome tool, it should not be considered a substitute for the Health Utilities Index (Annals EM 2009). The inter and intra-rater reliability of the CPC score has also been questioned. A cohort study of patients with OHCA reported poor kappa values for classifying favorable vs unfavorable neurologic status at hospital discharge (Ajam et al Scan J Trauma Resusc Emerg Med 2001) Another study looked about both OHCA and IHCA patients and the interrater reliability of the CPC score. They too found poor kappa values suggesting substantial variability in determining neurologic outcomes (Grossestreuer et al Resuscitation 2016).

Date: November 1st, 2021 Reference: Katsanos et al. Utility of Intravenous Alteplase Prior to Endovascular Stroke Treatment: A Systematic Review and Meta-analysis of RCTs. Neurology 2021 Guest Skeptic: Dr. Michal Krawczyk is in his fifth year of neurology residency at Western University in London, Ontario, Canada. He is interested in acute neurological illness, including cerebrovascular disease and epilepsy. Next year he will be beginning a Neurohospitalist fellowship at the University of Texas at Houston. Case: A 70-year-old male with a past medical history of hypertension and peripheral artery disease, last seen normal 1.5 hours ago, presenting with acute onset of aphasia and right sided face and arm weakness. He has a National Institute of Health Stroke Scale (NIHSS) score of 7. At 1am a CT angiogram is obtained that demonstrated a left M2 occlusion, and an Alberta Stroke Program Early CT Score (ASPECTS) of 10. Given the recent publications of trials assessing if mechanical thrombectomy alone is non-inferior to a bridging approach with tPA in addition to mechanical thrombectomy, you wonder whether these trials apply to your patient and what is the best course of action. Background: There are two treatments for acute ischemic stroke, systemic tPA and mechanical thrombectomy (MT). We have covered some studies looking at both treatment modalities on the SGEM. SGEM#29: Stroke Me, Stroke Me SGEM#70: The Secret of NINDS (Thrombolysis for Acute Stroke) SGEM#85: Won’t Get Fooled Again (tPA for AIS) SGEM#137: A Foggy Day – Endovascular Treatment for Acute Ischemic Stroke SGEM#292: With or Without You – Endovascular Treatment with or without tPA for Large Vessel Occlusions SGEM#297: tPA Advocates Be Like – Never Gonna Give You Up SGEM#333: Do you Gotta Be Starting Something – Like tPA before EVT? Mechanical thrombectomy is indicated only for patients with large vessel occlusions (LVOs) on imaging. There were a few earlier studies on MT that failed to demonstrate superiority, but it was the study MR CLEAN published in NEJM 2015 that really changed practice. It was a multicenter, randomized, unblinded trial treating 500 patients with an anterior circulation LVO within six hours of symptom onset. The primary outcome was mRS 0-2 at 90 days and it showed an absolute difference of 14% favoring MT. This gives a NNT of 7. Six RCTs have been published since MR CLEAN.  All supported MT and all were stopped early (SWIFT PRIME, EXTEND-IA, REVASCAT, ESCAPE, DAWN, and DEFUSE). For patients with LVOs it is unclear whether there is any additional benefit with administering tPA before thrombectomy, also known as a bridging approach, in contrast to skipping tPA and directly proceeding with MT. There are several theoretical advantages of a bridging approach. These potential advantages include thrombus debulking allowing easier clot retrieval, distal emboli lysis, recanalization prior to MT, and it may be beneficial in cases of unsuccessful MT. Conversely, a direct to MT approach may lead to fewer intracerebral hemorrhages (ICH) and quicker initiation of endovascular thrombectomy. Recently, three randomized control non-inferior trials on this topic have been published, two from China (DIRECT-MT, and DEVT) and one from Japan (SKIP). Two trials demonstrated non-inferiority while one trial failed to show that direct MT was non-inferior. Clinical Question: What is the best strategy for treating patients with an acute large vessel occlusion stroke, direct to mechanical thrombectomy or a bridging approach with tPa followed by mechanical thrombectomy? Reference: Katsanos et al. Utility of Intravenous Alteplase Prior to Endovascular Stroke Treatment: A Systematic Review and Meta-analysis of RCTs. Neurology 2021 Population: Randomized controlled trials of patients with acute large vessel occlusion stroke qualifying for MT Exclusions: Observational studies and non-randomized trials Intervention: MT alone Comparison: MT bridged with tPA Outcome: Primary Outcome: mRS score 0-2 at three months Secondary Outcomes: mRS 0-1 and ordinal shift at three months, successful recanalization before MT, successful recanalization after MT, randomization to puncture time, symptomatic intracranial hemorrhage (sICH), any ICH and all-cause mortality Authors’ Conclusions: “We detected no differences in functional outcomes of IV thrombolysis–eligible patients with an acute LVO receiving dEVT compared to BT. Because uncertainty for most endpoints remainslarge and the available data are not able to exclude the possibility of overall benefit or harm, further RCTs are needed.” Quality Checklist for Therapeutic Systematic Reviews: The clinical question is sensible and answerable.  Yes The search for studies was detailed and exhaustive. Yes The primary studies were of high methodological quality. No The assessment of studies were reproducible. Yes The outcomes were clinically relevant. Yes There was low statistical heterogeneity for the primary outcomes. Yes The treatment effect was large enough and precise enough to be clinically significant. No Results: The three RCTs included a total of 1,092 patients. Median age was in the early 70’s and 42% were female. Key Results: No statistical difference in good neurologic outcome Primary Outcome: mRS score 0-2 at three months OR 1.08 (95% CI 0.85 to 1.38) and adjusted OR 1.11 (95% CI 0.76 to 1.63) Secondary Outcomes: mRS score 0-1 at three months OR 1.10 (95% CI 0.84 to 1.43) and adjusted OR 1.16 (95% CI 0.84 to 1.61) Successful recanalization before EVT: OR 0.37 (0.18-0.77) Moderate certainty Successful recanalization after EVT: OR 0.77 (0.54-1.08) Low certainty sICH: OR 0.75 (0.45-1.25) Low certainty Any ICH: OR 0.67 (0.49-0.92) Moderate certainty All-cause mortality: OR 0.93 (0.68-1.29) Low certainty 1. External Validity: All three trials were from Asia and as such may not be directly applicable to North American populations and healthcare systems. In one of the trials, they used 0.6mg/kg of tPA (SKIP) instead of the standard 0.9mg/kg. This could bias the trial to finding non-inferiority. In addition, these studies were all conducted at stroke centres with MT availability and do not address a drip and ship model of care. 2. Non-Inferiority Margins: All three studies included in the SRMA were non-inferiority trial designs. They were asking if direct to MT was non-inferior to the standard bridging with tPA before MT. Two out of three trials (DIRECT-MT and DEVT) the non-inferiority was met, but the non-inferiority margin was set at ≤10% absolute clinical effect in DEVT, and 20% effect size in odds ratio in DIRECT-MT. Even if non-inferiority is demonstrated, it does not mean there is no clinical benefit from a bridging approach if the non-inferiority margin is too large, which may represent a clinically important difference. Many argue that the non-inferiority claim should only be reserved when a less conservative margin of 5% is utilized. None of the trials met this less conservative margin. 3. Performance Bias: We have discussed different forms of bias many times on the SGEM. This is the first time we have mentioned performance bias. This type of bias is defined by Cochrane Risk of Bias (RoB) Tool as the result of “systematic differences between groups in the care that is provided, or in exposure to factors other than the interventions of interest.” As highlighted in this SRMA, there was a performance bias in the DIRECT-MT trial with 9.4% of patients in the bridging group not receiving MT, while only 5.2% in the direct group did not receive MT. This 4.2% difference may have resulted in worse outcomes in the bridging group, favoring direct MT and a finding of non-inferiority. 3. Selection Bias: This is a type of bias we have discussed many times on the SGEM. The Cochrane RoB Tool defines selection bias as the result of “systematic differences between baseline characteristics of the groups that are compared.” Selection bias may affect the estimate of the per-protocol effect and/or the intention-to-treat effect. It depends on the definition that is used for the groups that are being compared. In the DEVT trial, an exclusion criterion was “arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel.”  This exclusion criterion may effectively ‘cherry-pick’ patients, excluding those where thrombectomy would have been difficult, potentially resulting in less favorable outcome in the direct MT group. It is unclear how many patients were excluded from the DEVT trial for this reason. In the DIRECT-MT trial approximately 5.8% (38/654) of patients intended to undergo thrombectomy did not due to technical reasons, highlighting that even in specialized academic centers thrombectomy remains technically challenging. 4. Timing of tPA: In the SKIP trial, 21% of patients in the bridging group had tPA started after groin puncture for MT. It is likely that in a significant proportion of these patients MT was completed even before the tPA infusion was finished. In the DIRECT-MT trial 87% of patients had a tPA infusion ongoing during MT, and 9% of patients in the bridging group did not receive the full dose of tPA. This could have biased the study towards finding non-inferiority for MT alone. 5. Subgroups: Certain subgroups that may benefit more from a bridging approach were underrepresented in the three trials. In the study design of the DEVT and SKIP trials they did not include patients with M2 occlusions. After final adjudication the percentage of M2 occlusions in the DEVT trail was 1.7%, SKIP 19%, and DIRECT-MT 10.1%. It is known that compared to M1/ICA occlusions, tPA is much more effective at lysing M2 clots. In the INTERRSeCT study,

Date: October 20th, 2021 Reference: Talan et al. Pathway with single-dose long-acting intravenous antibiotic reduces emergency department hospitalizations of patients with skin infections. AEM October 2021 Guest Skeptic: Dr. Lauren Westafer an Assistant Professor in the Department of Emergency Medicine at the University of Massachusetts Medical School – Baystate. She is the cofounder of FOAMcast and a pulmonary embolism and implementation science researcher. Dr. Westafer serves as the Social Media Editor and research methodology editor for Annals of Emergency Medicine. Lauren also recently won the SAEM FOAMed Excellence in Education Award. Case: A 46-year-old male with a history of diabetes controlled on metformin presents with erythema and warmth to his right lower leg measuring 27 cm by 10 cm for the past four days. The patient is neurovascularly intact and there is no evidence of deep vein thrombosis (DVT) on ultrasound. He has no fever, and his white blood cell count is 12,500. Background: Emergency department visits for skin and soft tissue infections (SSTI) are common and increasing [1]. These types of infections include cellulitis and abscesses. The SGEM has a couple of episodes on the treatment of cellulitis with antibiotics (SGEM#131 and SGEM#209). The treatment of abscesses has been covered a few more times on the SGEM (SGEM#13, SGEM#156, SGEM#164 and SGEM#311). The latest episode looked at the loop technique to drain uncomplicated abscesses. The result was no statistical difference in failure rates between the loop and standard packing. Our conclusion was to consider using the loop technique on your next uncomplicated abscess. Most patients can be managed as outpatients. However, the average length of stay for inpatient care is one week and costs close to $5 billion dollars a year in the USA [2]. The mortality rate for hospitalized patients with SSTI is <0.05% [3, 4]. The only reason for in-patient management in 40% of patients was to provide parenteral antibiotics [5]. This has led to greater interest in long-acting parenteral antibiotics as a possible alternative to admission.  Clinical Question: Does the use of a clinical pathway, including a dose of intravenous dalbavancin, in emergency department patients with skin and soft tissue infections reduce hospitalizations? Reference: Talan et al. Pathway with single-dose long-acting intravenous antibiotic reduces emergency department hospitalizations of patients with skin infections. AEM October 2021 Population: Patients ≥18 years old with abscess, cellulitis, or wound infection believed or confirmed to be due to gram-positive bacteria and an area of infection of at least 75 cm2. Excluded: Unstable comorbidity (e.g. severe sepsis), immunosuppression, injection drug use and fever, pregnancy, breastfeeding, bilateral lower extremity involvement, severe neurologic disorder, allergy to glycopeptide antibiotics, suspected gram negative infection or infection likely to need more intensive care or broad spectrum antibiotics, suspected osteomyelitis, septic arthritis, or endocarditis. Intervention: Clinical pathway included a single dose of intravenous (IV) dalbavancin 1500 mg (creatinine clearance ≥30 mL/min) or 1,125 mg for creatinine clearance <30 mL/min not on dialysis Telephone follow up call 24 hours after the visit and a follow up appointment 48-72 hours after discharge Comparison: Usual care pre-implementation of the new clinical pathway Outcome: Primary Outcome: Hospitalization rate at the time of initial care in the population that received at least one antibiotic dose Secondary Outcomes: Hospitalizations through 44 days, health resource utilization (length of stay, level of care, major surgical interventions, ICU admissions), adverse events, and patient-related outcomes (satisfaction, work productivity, and quality of life surveys at 14 days) Trial Design: Before-and-after observational study at eleven US academic affiliated emergency departments (EDs). Dr. David Talan This is an SGEMHOP episode which means we have the lead author on the show. Dr. Talan is considered an authority in acute infections that result in severe morbidity and death. He is currently on the faculty of the Department of Emergency Medicine, and Department of Medicine, Division of Infectious Diseases at UCLA Medical Center. Dr. Talan also serves on the editorial board of the Annals of Emergency Medicine. Authors’ Conclusions: “Implementation of an ED SSTI clinical pathway for patient selection and follow-up that included use of a single-dose, long-acting IV antibiotic was associated with a significant reduction in hospitalization rate for stable patients with moderately severe infections.” Quality Checklist for Observational Study: Did the study address a clearly focused issue? Yes Did the authors use an appropriate method to answer their question? Yes Was the cohort recruited in an acceptable way? Yes Was the exposure accurately measured to minimize bias? Yes Was the outcome accurately measured to minimize bias? Yes Have the authors identified all-important confounding factors? Unsure Was the follow up of subjects complete enough? Yes How precise are the results? Fairly precise Do you believe the results? Yes Can the results be applied to the local population? Unsure Do the results of this study fit with other available evidence? Yes Results: Over 3,000 patients were screen in the before and in the after phase of this study. Only 5% were eligible for inclusion. The median age of participants was in the late 40’s, two-thirds were male, and over 80% had cellulitis. Key Result: Less patients were hospitalized after the implementation of the new clinical pathway that included a single-dose, long-acting IV antibiotic. Primary Outcome: Hospitalization rate at the time of initial care 38.5% usual care vs 17.6% new pathway Absolute Difference 20.8% (95% CI; 10.4% to 31.2%) Secondary Outcome: Hospitalizations through 44 days: Absolute Difference 16.1% (95% CI; 4.9% to 27.4%) Length of Stay: 3.0 days (IQR 2.0 to 5.0) vs 2.0 days (IQR 1.0 to 4.0) Infection-Related Surgery: 0.6% vs. 3.3% ICU Admissions: 1.9% vs 0.7% Mild, Moderate and Severe AE: Were all more common in the new pathway group Deaths: None Patient-Related Outcomes; These were detailed in the supplemental material We asked David five nerdy questions about his study.  Listen to the SGEM podcast to hear his responses. 1. Inclusion/Exclusion - The patient flow diagram, Figure 1, does not list reasons for exclusion, so it’s difficult to know why patients weren’t included and if they are different than those who were excluded. Do you have any data on the characteristics of the excluded patients, and could this have led to some selection bias? 2. Study Design – Your team used a before/after study design to investigate the association between a new clinical pathway and hospitalization for patients with SSTI. One drawback to this type of design is the possible contamination of treatment effect by confounders such as other system or local factors. For example, it’s not clear how much the protocol to ensure close outpatient follow up or education contributed to the lower hospitalization rates. 3. Hawthorne Effect – In this study, clinicians in the intervention period knew they were being studied. It is possible that some portion of the treatment effect was the result of the clinicians being aware that their management of skin and soft tissue infections was being evaluated and that discharge was encouraged. 4. Impact – The pathway demonstrated an absolute difference of 21% for the primary outcome of hospitalizations. As mentioned earlier, only 5% of those screened for eligibility were enrolled. That means most patients who present with SSTI the data does not directly apply to their management. Does this not limit the impact of this intervention significantly? 5. External validity – This study was conducted in 11 academic affiliated EDs in the US. The US has a much different healthcare system than other countries like Canada, UK and Australia. Do you think this data can be applied outside the US? The academic world is also different than community EDs. The clinical pathway included telephone follow up and an outpatient follow up visit within 48-72 hours. This may not be feasible in many community practice environments or certain patient populations. Comment on Authors’ Conclusion Compared to SGEM Conclusion: We generally agree with the authors’ conclusions. SGEM Bottom Line: In hospital systems with access to IV dalbavancin and the ability to establish expedited telephone and in-person follow up, this clinical pathway is associated with a decrease in hospitalizations for patients with moderately severe cellulitis. Case Resolution: You offer the man the new long-acting single-dose IV antibiotic and outpatient management. He is happy to not need to be admitted to hospital and is discharged home with follow-up instructions. Clinical Application: It all depends. This medication costs ~$5,000 for 1,500mg. It is unclear if this would be a cost effective strategy. There could also be a concern with indication creep leading to increased antibiotic resistance. Dr. Lauren Westafer What Do I Tell My Patient? You have a skin infection. Traditionally, people are often admitted to hospital for about one week to get IV antibiotics. We have a new medication that only requires one dose here in the ED. It is a long-acting antibiotic. You can go home today after the treatment. We will give you a call to make sure you are doing ok. You will also get an in-person follow-up in the next couple of days. Would you like to be admitted to hospital or be treated and sent home today?