The Skeptics Guide to Emergency Medicine

Date: September 16th, 2021 Reference: Sippola et al. Effect of Oral Moxifloxacin vs Intravenous Ertapenem Plus Oral Levofloxacin for Treatment of Uncomplicated Acute Appendicitis. The APPAC II Randomized Clinical Trial. JAMA 2021 Guest Skeptic: Dr. Rob Leeper is an assistant professor of surgery at Western University and the London Health Sciences Center.  His practice is in trauma, emergency general surgery, and critical care with an academic interest in ultrasound and medical simulation. Rules of SGEM Journal Club Case: A 23-year-old man with CT confirmed uncomplicated appendicitis, mild abdominal pain, stable clinical signs, and essentially normal laboratory investigations has just concluded his bedside consultation with the on-call general surgery team.  The patient and surgeons have had an evidence-informed discussion and have arrived at a mutually agreed upon decision to proceed with non-operative treatment of his appendicitis.  The patient is recommended to undergo admission to hospital for serial observation and intravenous antibiotics.  The patient asks; “gosh doc, if this disease is so mild why can’t I just go home and take antibiotics by mouth?”. Dr. Eric Walser Background: The appendix is a structure about as long as your pinkie finger that hangs off the beginning of the colon, in the right lower quadrant of your abdomen. There are lots of theories about subtle functions of the appendix, but its most prominent role is to become inflamed or infected in approximately 7% of people. Usually appendicitis occurs because the lumen, or inside, of the appendix is obstructed by something. Often that is a piece of stool called a fecalith, but other times it can be lymph tissue or another process we may never actually identify. This causes the pressure in the appendix to increase eventually obstructing venous outflow and then arterial inflow. We used to assume that this was an ordered progression that always leads to appendiceal rupture in a stepwise fashion, but we now think that there is more of a spectrum of severity based on individual anatomic and other factors. While the presentation of appendicitis can vary from patient to patient, as our emergency medicine colleagues know well, most patients are not diffusely peritonitic or systemically unwell. Before we had things like surgery or antibiotics, appendicitis carried up to a 50% case fatality rate. Luckily now, with these treatments the mortality rate is almost zero. For the last 135 years we have treated appendicitis with an appendectomy, which is now almost always performed in laparoscopic fashion. A laparoscopic appendectomy involves a general anesthetic, making three small incisions between 1 and 2 cm in length; and the operation usually takes somewhere between 30 to 60 minutes. Most patients go home the same day or the next morning, either with a short course of antibiotics or with none after surgery. Most patients who have this surgery are back to work and their usual routine at around the two-week mark. The chance of requiring additional procedures is quite low unless we find that the appendix has already perforated. It is a good, and generally very safe operation, with a high rate of patient satisfaction. Omar et al  published a study in 2008 showing just how safe laparoscopic appendectomies have become. They found in over 230,000 UK patients the death rate was less than half compared to the open procedure (0.64% vs 0.29%; p<0.001). Patrick Roy Nonoperative treatment of appendicitis (NOTA) was first described in the 1940s and moved into the public consciousness when Patrick Roy was treated with antibiotics alone during the 1994 Stanley Cup playoffs. In 2014, tennis star Rafael Nadal was diagnosed with acute appendicitis. He was participating in the Shanghai Masters Tennis Tournament at the time. Nadal opted to be treated with antibiotics and had his appendix removed via laparoscopic one month later. There have been several randomized trials like the APPAC trial and the CODA trial demonstrating that, in general, nonoperative management is safe, but that 25-60% of patients would go on to require an appendectomy during follow-up, which was usually around one year. The recent Eastern Association for the Surgery of Trauma (EAST) guidelines from 2019 on appendicitis could not provide a recommendation on the use of NOTA as first line treatment. Despite this, we know from database studies that appendectomy remains far more common in North America, with nonoperative management reserved for remote areas or extenuating circumstances. We have covered adult uncomplicated NOTA a couple of times on the SGEM. The first time was on SGEM#115 and we reviewed two SRMAs on the topic that came to opposite conclusions. The other time we looked at this issue was with Dr. Leeper on SGEM#256. We reviewed an observational study on NOTA. SGEM Bottom Line: Nonoperative management of acute uncomplicated appendicitis may be better than we thought in selected patients but comes with a cost of a small absolute increase in some complications. In that observational study by Sceats et al in JAMA 2019, all the patients were admitted to hospital for their antibiotic therapy or surgery. The study we are going to be looking at today compared outpatient vs. inpatient NOTA with antibiotics. Clinical Question: Is a course of oral, outpatient antibiotic treatment non-inferior to a course of initial in-patient, IV antibiotics followed by completion of oral, outpatient antibiotics? Reference: Sippola et al. Effect of Oral Moxifloxacin vs Intravenous Ertapenem Plus Oral Levofloxacin for Treatment of Uncomplicated Acute Appendicitis. The APPAC II Randomized Clinical Trial. JAMA 2021 Population: Healthy adult patients aged 18 to 60 with CT proven, uncomplicated appendicitis without appendicolith. They defined uncomplicated as having an appendiceal diameter larger than 6 mm with a thickened, contrast-enhanced wall along with periappendiceal edema and/or minor fluid collection and the absence of the criteria of complicated acute appendicitis. Complicated was defined as the  presence of appendicolith, perforation, abscess, or suspicion of tumor. Exclusions: They excluded those outside the age range, allergy to contrast media or iodine, allergy on contraindication to antibiotic therapy, kidney insufficiency or elevated serum creatinine level, type 2 diabetes, and use of metformin medication, severe systemic illness (eg, malignancy, medical condition requiring immunosuppressant medication), pregnancy or lactation. Intervention: Oral antibiotics for seven days (moxifloxacin 400mg daily) Comparison: Intravenous IV antibiotics for two days (ertapenem sodium 1 g once daily) followed by oral antibiotics for 5 days (levofloxacin 500 mg a day plus metronidazole 500 mg three times daily) Outcome: Primary Outcome: Success at one-year. This was defined as resolution of acute appendicitis resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during the 1-year follow-up. Secondary Outcomes: Postintervention adverse events related to antibiotics or appendectomy, abdominal symptoms, duration of hospital stay, pain, and length of sick leave. Authors’ Conclusions: “Among adults with uncomplicated acute appendicitis, treatment with 7 days of oral moxifloxacin compared with 2 days of intravenous ertapenem followed by 5 days of levofloxacin and metronidazole resulted in treatment success rates greater than 65% in both groups, but failed to demonstrate noninferiority for treatment success of oral antibiotics compared with intravenous followed by oral antibiotics.” 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 treated. No 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. 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. No The treatment effect was large enough and precise enough to be clinically significant. Yes Results: They randomized 599 patients, mean age was 36 years, and 44% were female. Key Result: Outpatient oral antibiotics failed to show non-inferiority compared to inpatient IV antibiotics followed by outpatient oral antibiotics. Primary Outcome: The treatment success rate at one year 70.2% outpatient oral vs 73.8% inpatient IV followed by outpatient oral −3.6% difference (1-sided 95% CI, −9.7% to ¥) p = 0.26 Secondary Outcomes: There were no statistical differences in any of the secondary outcomes measured. 1. Exclusions – They excluded pregnant and breastfeeding patients. This is a common exclusion and contributes to the lack of knowledge about how best to treat women (Women and Health Research IOM 1999). If there were concerns regarding lactation, potential participants could have been asked about bottle feeding temporarily during the study period. 2. Participation Rate – There were 1,036 patients eligible to be included in the trial. 433 declined to participate immediately (42%) and 16 more withdrew their consent after randomization. This means that 57% of patients agreed to NOTA. When using a script to explain the pros and cons of NOTA to patients, Minecci et al showed a real-life uptake of about 35% for NOTA in pediatric patients.

Date: September 8th, 2021 Reference: Desch et al. The TOMAHAWK Investigators. Angiography after Out-of-Hospital Cardiac Arrest without ST-Segment Elevation. NEJM 2021. Guest Skeptic: Dr. Stephen Meigher is the EM Chief Resident training with the Jacobi and Montefiore Emergency Medicine Residency Training Program. He heads curriculum and conference for the academic year and is passionate about resident education on- and off-shift, from procedural to evidence-analytical.  Dr. Kaushal Khambhati is also a fourth-year resident training with the Jacobi and Montefiore Emergency Medicine Residency Training Program.  He is interested and experienced in healthcare informatics, previously worked with ED-directed EMR design, and is involved in the New York City Health and Hospitals Healthcare Administration Scholars Program (HASP). Five Rules of the SGEM Journal Club Case: A 70-year-old woman is found unresponsive and apneic at home by her partner.  EMS arrives and finds the patient in monomorphic ventricular tachycardic (VT) cardiac arrest. She has a history of hypertension and non-insulin dependent diabetes mellitus. The paramedics achieve return of spontaneous circulation (ROSC) after CPR, advanced cardiac life support (ALCS), and Intubation.  She arrives in the emergency department (ED) with decreased level of consciousness and shock.  The EKG shows sinus tachycardia with nonspecific changes and no ST segment elevations, Q waves, or hyperacute T waves.  Her point-of-care ultrasound (POCUS) shows appropriate-appearing global ejection fraction and no marked wall motion abnormalities.  Cardiology has been consulted and asks for a neurology consultation given her mental status. Background: The American Heart Association estimates there are approximately 350,000 EMS-assessed out-of-hospital cardiac arrests (OHCAs) in the United States per year. Half of these arrests are witnessed with the other half being un-witnessed. Many of these OHCAs are due to ventricular fibrillation or pulseless VT. Defibrillation is the treatment of choice in these cases but does not often result in sustained ROSC (Kudenchuk et al 2006). Acute coronary syndrome (ACS) is responsible for the majority (60%) of all OHCAs in patients. There is evidence that taking those patients with ROSC and EKG showing STEMI directly for angiography +/- angioplasty is associated with positive patient-oriented outcomes. The AHA has a statement with recommendations based on the available data. They suggest to perform catheterization and reperfusion for post-arrest patients with ST-segment elevation, even if the patient is comatose  However, there is no consensus if this strategy should be employed in patients without ST-segment elevation (Yannopoulos et al, Circulation 2019). The 2015 AHA Guidelines make the following recommendations: Coronary angiography should be performed emergently (rather than later in the hospital stay or not at all) for OHCA patients with suspected cardiac etiology of arrest and ST elevation on ECG (Class I, LOE B-NR). Emergency coronary angiography is reasonable for select (eg, electrically or hemodynamically unstable) adult patients who are comatose after OHCA of suspected cardiac origin but without ST elevation on ECG (Class IIa, LOE B-NR). Lemke et al 2019 published a multicentre RCT done in the Netherlands looking at patients without ST segment elevation in OHCA with ROSC.  Patients were randomized to receive immediate coronary angiography or delayed coronary angiography performed after neurologic recovery. They found no superiority to the immediate strategy for their primary outcome of survival at 90 days. One of the limitations of the COACT trial is they only included patients who had an intra-arrest shockable rhythm which only accounts for 60% of OHCA patients. Clinical Question: Does early coronary artery angiography following resuscitation of Out-of-Hospital Cardiac Arrest benefit patient outcomes in patients without ST Segment elevation patterns on their post-ROSC EKG? Reference: Desch et al the TOMAHAWK Investigators. Angiography after Out-of-Hospital Cardiac Arrest without ST-Segment Elevation. NEJM 2021. Population: Adults aged 30 years and older with shockable or non-shockable OHCA, ROSC and no ST segment elevation EKG pattern. Exclusions: ST-segment elevation or left bundle branch block, no ROSC, severe hemodynamic or electrical instability requiring immediate coronary angiography/intervention (delay clinically not acceptable), life-threatening arrhythmia possibly caused by acute myocardial ischemia, cardiogenic shock (defined by clinical and hemodynamic criteria), obvious extra-cardiac etiology such as traumatic brain injury, primary metabolic or electrolyte disorders, intoxication, overt hemorrhage, respiratory failure due to known lung disease, suffocation, drowning, IHCA and known or likely pregnancy Intervention: Immediate angiography as soon as possible after hospital admission Comparison: Delayed or selective angiography after being transferred to the intensive care unit (ICU) for further evaluation of the cause of the cardiac arrest and for treatment Outcome: Primary Outcome: All-cause mortality at 30 days Secondary Outcomes: They had 13 secondary endpoints of which only 7 of the 13 were reported in the published manuscript. Reported: MI at 30 days, severe neurologic injury (Cerebral Performance Category of 3-5) at 30 days, composite of death from any cause at 30 days or severe neurologic deficit at 30 days, ICU length of stay (LOS), serialized values for the Simplified Acute Physiology Score (SAPS) II, rehospitalization for CHF within 30 days, and peak values of myocardial biomarkers. Not Reported: MI at 6 and 12 months, severe neurologic injury at 6 and 12 months, all-cause mortality at 6 and 12 months, rehospitalization for CHF at 6 and 12 months, LOS in hospital, and quality of life at 6 and 12 months Adverse Events: Moderate or severe bleeding (Types 2-5 on Bleeding Academic Research Consortium), stroke at 30 days, and acute kidney failure requiring hemodialysis at 30 days Authors’ Conclusions: “In this randomized, international trial, we found that among patients with successfully resuscitated out-of-hospital cardiac arrest and no ST- segment elevation, a strategy of immediate unselected coronary angiography provided no benefit over a delayed and selective approach with respect to the primary end point of death from any cause.”  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 large enough and precise enough to be clinically significant. No Results: There were 554 patients recruited and available for analysis in this trial. The median age was 70 years, 70% were male and more than 1/3 (37.6%) had known coronary artery disease. Many patients had comorbidities with the most common being hypertension (68%), dyslipidemia (38%) and diabetes (29%). The median time to ROSC was 15 minutes. Most patients (55%) had a shockable arrest rhythm. The median Glasgow Coma Scale (GCS) score was 3. Angiography was performed in 96% of patients in the immediate group (median time 2.9 hours) and 62% in the delayed/selective group (median time 46.9 hours). Key Result: No statistical difference in all-cause mortality at 30 days  Primary Outcome: All-cause mortality at 30 days 54% immediate group vs 46% delayed/selective group Hazard ratio 1.28 (95% CI; 1.00 to 1.63) Secondary Outcomes:  No statistical difference in incidence of MI, severe neurologic deficit, ICU LOS, SAPS II score, rehospitalization for CHF or peak laboratory results (troponin or creatinine) Composite outcome of all-cause mortality or severe neurologic deficit was greater in the immediate group RR 1.16 (95% CI; 1.00 to 1.34) Adverse Events: No statistical difference in moderate or severe bleeding, stroke or acute kidney failure leading to renal replacement 1. Selection Bias – There could have been some selection bias introduced into the recruitment of patients. Specifically, some of the exclusion criteria required clinical judgement. Examples of this include severe hemodynamic or electrical instability requiring immediate coronary angiography/intervention (delay clinically not acceptable), life-threatening arrhythmia possibly caused by acute myocardial ischemia, and cardiogenic shock (defined by clinical and hemodynamic criteria). It is unclear if this would have had a material impact on the results. One group that was explicitly excluded was those patients known or likely to be pregnant. This sex bias was discussed on a recent SGEM Xtra: Unbreak My Heart. We provided evidence that cardiovascular disease among women is understudied, under-recognized, underdiagnosed, undertreated and women are under-represented in clinical trials. 2. Non-Blinded - This was an open-label study because of the overt nature of coronary angiography. Clinicians would have known which group each patient was assigned. The patient would not be aware of group allocation because they were unconscious with a median GCS score of 3.

Date: August 31st, 2021 Reference: McLean et al. Interphysician weight bias: A cross-sectional observational survey study to guide implicit bias training in the medical workplace. AEM Sept 2021 Guest Skeptic: Dr. Corey Heitz is an emergency physician in Roanoke, Virginia. He is also the CME editor for Academic Emergency Medicine. Case: You are working in the emergency department (ED) with the new resident, one of whom is overweight. You overhear his colleagues wonder where he went, chuckling, and one of them comments that “he probably went for second breakfast.” Realizing that these residents are making fun of their colleague’s weight, you decide to address the issue. Background: We have talked about biases many times on the SGEM. Usually when we use the term bias it is in the context of something that systematically moves us away from the “truth”. Science does not make truth claims and the term is used as a shorthand for the best point estimate of an observed effect size. An example in the medical literature would be selection bias. This is when subjects for a research study are not randomly selected. This can skew the results and impact the conclusions.  Another example would be publication bias. Studies with “positive” results are more likely to be published while those with “negative” results are more likely to end up in the bottom of the file drawer. There are many other types of bias in the practice of medicine. Some of my favourite ones are anchoring bias, base-rate neglect, and hindsight bias. For a description of these and many more check out Dr. Pat Croskerry list of 50 cognitive biases in medicine. You can also click on the codex for an extensive list of different biases. This SGEM episode focuses on a kind of bias as defined by the common English language as “a particular tendency, trend, inclination, feeling, or opinion, especially one that is preconceived or unreasoned”. It is a sense of prejudice or stereotyping and the formation of a foregone conclusion independent of current evidence. There are many biases in the house of medicine. We have discussed some of them on  the SGEM. They include things like age, gender, socioeconomic status, race, and other factors. The gender pay gap is one of the topics that has been spoken about most on the SGEM. A paper by Wiler et al AEM 2019 showed females in academic emergency medicine were paid ~$12,000/year less than their male colleagues (SGEM#248). The September 2021 issue of AEM is a special issue focusing on biases in emergency medicine. It includes articles on racial, ethnic and gender disparities. One specific topic jumped out as something that has not received much attention, weight bias. There is literature on physicians’ weight biases towards patients and patients’ weight bias towards physicians. However, there is limited information on physician-to-physician weight bias. Clinical Question: What is the prevalence of interphysician implicit, explicit, and professional weight bias? Reference: McLean et al. Interphysician weight bias: A cross-sectional observational survey study to guide implicit bias training in the medical workplace. AEM Sept 2021 Population: Practicing physicians and physicians-in-training in North America Excluded: Those who did not consent; did not identify as physicians or physicians-in-training; or were not currently residing in North America. Intervention: Survey instruments measuring implicit weight bias (IWB), explicit weight bias (EWB), and professional weight bias (PWB) Comparison: None Outcome: Descriptive analyses along with correlative models Dr. Mary McLean This is an SGEMHOP episode which means we have the lead author on the show. Dr. Mary McLean is an Assistant Program Director at St. John’s Riverside Hospital Emergency Medicine Residency in Yonkers, New York. She is the New York ACEP liaison for the Research and Education Committee and is a past ALL NYC EM Resident Education Fellow. Dr. McLean was the guest skeptic on the SGEM#310 reviewing an article showing EM physicians are not great at performing the HINTS exam. Implicit Bias: Implicit bias is unconscious and often subtle type of bias that is hard to pinpoint in ourselves and notoriously hard to measure. Implicit weight bias (IWB) was measured using the Implicit Association Test (IAT) based on work from Project Implicit which is a Harvard-based research organization. The weight bias IAT has been previously validated for the general population. This was adapted by adding the theme of physicians in the medical workplace. Project Implicit’s silhouette images of people with obesity was modified to add stethoscopes and clipboards, and adjust clothing to look like scrubs, white coats, or professional clothing. The good and bad layperson descriptor words were also replaced with words used to describe good and bad doctors, based on Stern's medical professionalism framework Explicit Bias: Explicit bias is a more outward bias expressed in words or actions, that’s easier for us to pinpoint in other people and in ourselves The Anti-fat Attitudes Questionnaire (Crandall et al 1994), which was originally validated for the general population was the tool used to assess explicit weight bias (EWB). It was adapted to focus on interphysician views and practices. The adapted items were kept as similar as possible to the validated original - for example, only changing the word “person” to the word “doctor” and leaving the remainder of the item unchanged, unless another tweak was absolutely necessary. NOTE: The word “fat” as a descriptor is used in the questionnaire and to investigate explicit and professional weight bias. This word can be inflammatory, but it’s used with purpose. It’s meant to evoke an emotional response from subjects, which is necessary for this kind of research. Physicians were asked 13 questions on a 7-point Likert scale (1- strongly agree, 2- agree, 3- somewhat agree, 4- neither agree or disagree, 5- somewhat disagree, 6- disagree and 7- strongly disagree). Professional Bias: Professional bias was defined as the reduced willingness to collaborate with, seek advice from, and foster mutually beneficial professional relationships with physician colleagues with obesity. To assess professional weight bias (PWB) a new scale of explicit questions that applied specifically to the medical workplace and nuances of physician careers was created. Subjects were asked to used the same Likert scale to rate their agreement with several items. Each item was meant to capture participants’ views on physicians with obesity regarding collaboration, hiring, promotion, leadership opportunities, and other classic measures of professional success determined by group consensus within our team. Authors’ Conclusions: “Our findings highlight the prevalence of interphysician implicit WB; the strong correlations between implicit, explicit, and professional WB; and the potential disparities faced by physicians with obesity. These results may be used to guide implicit bias training for a more inclusive medical workplace.” Quality Checklist for Observational Study: Did the study address a clearly focused issue? Unsure Did the authors use an appropriate method to answer their question? Unsure 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 accurate 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: Surveys were electronically sent to individuals of which 1,198 opened the document. There were 620 participants who completed the survey. The mean age was 44 years, 58% identified as female, mean BMI was 26, 73% were Caucasian, 78% emergency physicians and 72% were attending physicians. Key Result: A high percentage of participants indicated IWB against other physicians while other results suggested some EWB and PWB does exist. Implicit Weight Bias (IWB): 87% of participants had a D-score above 0, indicating implicit weight bias against other physicians(34% demonstrated severe anti-fat weight bias and 31% moderate) Male and increased age were both positively correlated with anti-fat weight bias Explicit Weight Bias (EWB) and Professional Weight Bias (PWB): Ranges and means on the rating scales showed levels of variability, suggested bias does exist Positive correlation was seen with IWB (r=0.24 for EWB, r=0.16 for PWB) r=0.73 correlating EWB to PWB Male sex positively correlated with both EWB and PWB 1. Correlative Measurements: A lot of correlative measurements were used. Can you explain some of the differences between a D score, r value, B value, and β values? The D-score is a standardized difference calculated from IAT response time data. It ranges from (-1) to (+1), with 0 representing neutrality. In simple terms, a positive D score means you sorted faster when pictures of physicians with obesity were paired with negative words, and slower when physicians with obesity were paired with positive words. This is interpreted as representing implicit bias, with a (+1) indicating maximal anti-fat bias. The opposite is true for negative D scores, with (-1) indicating maximal anti-thin bias. The r value represents strength of correlations. It also ranges from (-1) to (+1), with 0 representing no association, (-1) representing maximal negative association, and (+1) representing maximal positive association.

Date: August 27th, 2021 Reference: Gagnon et al. Direct-access physiotherapy to help manage patients with musculoskeletal disorders in an emergency department: Results of a randomized controlled trial. AEM 2021 Dagny Haas Guest Skeptic: Dagny Kane-Haas is a physiotherapist who also has a master’s degree in Clinical Science in Manipulative Therapy. Case: A forty-year-old woman presents to the emergency department (ED) with a sore lower back after moving some boxes at home over the weekend. She tried acetaminophen with limited relief. Her pain is eight out of ten on the zero-to-ten-point numeric pain rating scale (NPRS). She has no red flags (TUNA FISH) and is diagnosed as having mechanical back pain without imaging as per ACEP Choosing Wisely. You know mechanical low back pain is difficult to treat effectively and are trying to set expectations. While preparing her for discharge you wonder if seeing a physiotherapist before going home from the ED would improve her outcome. Background: Acute and chronic back pain has been covered many times on the SGEM. There is no high-quality evidence that acetaminophen, NSAIDS, steroids, diazepam, muscle relaxants or combinations of pharmacologic modalities provide much relief. SGEM#87:Let Your Back Bone Slide (Paracetamol for Low-Back Pain) SGEM#173: Diazepam Won’t Get Back Pain Down SGEM#240: I Can’t Get No Satisfaction for My Chronic Non-Cancer Pain SGEM#304: Treating Acute Low Back Pain – It’s Tricky, Tricky, Tricky We do know that opioids are very effective at reducing many types of pain including muscular skeletal pain. However, opioids have many side effects and concerns about substance misused. The ACEP 2020 clinical policy on the use of opioids states: “Preferentially prescribe nonopioid analgesic therapies (nonpharmacologic and pharmacologic) rather than opioids as the initial treatment of acute pain in patients discharged from the emergency department. For cases in which opioid medications are deemed necessary, prescribe the lowest effective dose of a short-acting opioid for the shortest time indicated.” (Level C Recommendation) There are several non-pharmaceutical treatments that have also been tried to treat low back pain. They include: Cognitive Behavioural Therapy and mindfulness (Cherkin et al JAMA 2016), chiropractic (Paige et al JAMA 2017), physical therapy (Paolucci et al J Pain Research 2018) and acupuncture (Colquhoun and Novella Anesthesia and Analgesia 2013). None of these other treatments has high-quality evidence supporting their use. We have covered a randomized control trial looking at acupuncture to treat painful conditions presenting to the ED, including acute back pain, on SGEM#187. That trial reported no difference in clinical or statistical relevant reduction of pain at one hour between groups (acupuncture only, acupuncture plus pharmacotherapy or pharmacotherapy alone). However, we have not done a structured critical appraisal of an RCT looking at physiotherapy for this clinical condition. Clinical Question: Does access to a physiotherapist in ED help patients who present with minor musculoskeletal disorders (MSKD)? Reference: Gagnon et al. Direct-access physiotherapy to help manage patients with musculoskeletal disorders in an emergency department: Results of a randomized controlled trial. AEM 2021 Population: Adult patients 18-80 years of age presenting to the ED with suspected minor MSKD, traumatic or not. Minor was defined using the Canadian Triage and Acuity Scale (CTAS) score of 3, 4 or 5. Excluded: Non-minor MSKD (ex: open fractures or open wounds), red flags, clinically unstable, hospitalized patients, or those in long-term care facilities. Intervention: Physiotherapist evaluated the patient post triage in the ED. They would recommend interventions based on their clinical assessment. This could include advice, technical aids, imaging, prescribed or over-the-counter medication, and consults with other health care professionals. However, there was no follow-up by the physiotherapist. Comparison: Usual care Outcome: Primary Outcome: Pain and function at one and three months. Pain was assessed using a NPRS. Function was evaluated using the Pain inventory subscale of the short version of the Brief Pain Inventory (BPI). The BPI scores ten activities of daily living (e.g., general activity, mood, walking, work, sleep) on a zero-to-ten-point scale (0 - no interference with function and 10- completely interferes with function) Secondary Outcomes: Utilization of resources at ED discharge, interventions utilized, medications, healthcare professionals consulted, return ED visits and imaging received. Authors’ Conclusions: “Patients presenting with a MSKD to the ED with direct access to a PT had better clinical outcomes and used less services and resources than those in the usual care group after ED discharge and up to 3 months after discharge.” 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). No The patients in both groups were similar with respect to prognostic factors. No 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). No All patient-important outcomes were considered. No The treatment effect was large enough and precise enough to be clinically significant. No Results: They recruited 78 patients into the trial. The mean age was 40 years and 56% were male. Key Result: Lower pain scores and better function in the physiotherapy group compared to usual care at both one and three months. Primary Outcome: Pain (NPRS) and function (BPI) Secondary Outcomes: Control Compared to Physical Therapy (PT). Not applicable (NA), not statistically different (NSD) and over the counter (OTC) medications 1. Consecutive Patients: This was a consecutive recruitment of a convenience sample. The recruitment was only 13 hours per week between the hours of 1pm and 9pm Monday to Friday depending on the physiotherapists schedule. In contrast, emergency medicine is 24/7/365. This selective recruitment could introduce bias and impact external validity to those patients who present on nights, weekends, and holidays. 2. Differences in Groups: Those in the control group were older, more often male and had a higher initial pain score. These differences could have been a result of the block randomization process used to balance area of body affected and not age or sex. The authors did try to control for these factors in their analysis. 3. Lack of Blinding: They did not describe the extent of blinding in the trial. The participants would have known they were seeing a physiotherapist. It is unclear if they were familiar with the hypothesis. It is also not reported if the clinicians were blinded. This lack of blinding could have introduced bias. Getting more attention during the initial visit from another health care professional could have impacted their initial pain and function scores and possibly those at one and three months. If the clinicians knew about the trial they could have altered their usual care. 4. Small Sample Size with Large Loss to Follow-Up: The a priori sample size was calculated on the minimum clinically important difference (MCID) of the BPI estimated to be 1.00. This required a total of 90 patients to be recruited into the trial. The final cohort consisted of 78 patients. They did not reach their target number of patients due to a lack of funds. A quality metric we look for is less than 20% loss to follow-up. They had about 20% loss to follow-up at the 1-month and 3-month outcome. There were differences in those who sex, age and initial pain scores in those that were lost to follow-up and those who were not. This makes me more skeptical of the results. 5. Outcomes:  They had four primary outcomes with pain and function being assessed at one and three months. This increases the chance of a Type I error where the null hypothesis is falsely rejected (false positive). The point estimate of effect size difference between groups was statistically significant. However, the 95% confidence interval for minimally important clinical difference was crossed for both pain and function at one and three months. Given the multiple other threats to validity (small convenience sample, baseline difference, lack of blinding and loss to follow-up) makes us more skeptical that there is a meaningful clinical difference. Comment on Authors’ Conclusion Compared to SGEM Conclusion: While the conclusions are correct, we think they are incomplete. It would have been better to put in a caution statement about the small sample size, lack of blinding and loss to follow-up to put the conclusions in context. SGEM Bottom Line: Physiotherapy looks promising as a potential intervention for patients with mild MSKD presenting to the ED, but we need better trials to confirm these preliminary findings with clinically significant outcomes before recommending their implementation. Case Resolution: You recommend ibuprofen 400mg to see if that works better than the acetaminophen and try to set reasonable expectations. Clinical Application: It is nice to see an RCT done looking at PT in ED and getting a positive outcome. However, these results need to demonstrate a clinically meaningful outcome and confirmed before applying clinically. Dr. Ken Milne What Do I Tell the Patient?

Date: August 19th, 2021 Reference: Pantell et al. Evaluation and management of well-appearing febrile infants 8 to 60 days old. Pediatrics 2021 Guest Skeptic: Dr. Dennis Ren is a pediatric emergency medicine fellow at Children’s National Hospital in Washington, DC. Case: A 25-day-old, full-term boy presents to the emergency department with fever. His parents report that he felt warm that evening, and they found that he had a rectal temperature of 38.2°C (100.8°F). He has an older sister at home with a cough and rhinorrhea. Overall, he has no symptoms and appears well. He has continued to feed normally and produce wet diapers. The parents ask you, “Do you really think he needs any additional testing? He probably caught something from his sister, right?” Background: Parents often bring their infants to the ED with concerns about fever. They can develop a real “fever fear” or “feverphobia” and often need reassurance that fever alone is not dangerous. We have talked about pediatric fever and fever fear with Dr. Anthony Crocco from Sketchy EBM back on SGEM#95 and made a “Ranthony” video on the topic. The American Academy of Pediatrics says that “…fever, in and of itself, is not known to endanger a generally healthy child.  In contrast, fever may actually be of benefit; thus, the real goal of antipyretic therapy is not simply to normalize body temperature but to improve the overall comfort and well-being of the child.”  However, fever without source in infants less than three months of age represents a significant diagnostic dilemma for clinicians. Several clinical decision instruments had been developed previously, including the Rochester (Jaskiewicz et al 1994), Boston (Baskin et al 1992) and Philadelphia (Baker et al 1993) criteria to help clinicians stratify the risk of significant bacterial infections. A new clinical decision instrument called the Step-by-Step approach was reviewed on SGEM#171. SGEM#171 Bottom Line: If you have availability of serum procalcitonin measurement in a clinically relevant time frame, the Step-by-Step approach to fever without source in infants 90 days old or younger is better than using the Rochester criteria or Lab-score methods. With the caveat that you should be careful with infants between 22-28 days old or those who present within two hours of fever onset. We have been trying to optimize our approach to evaluating and managing febrile infants for more than four decades.  Our goal is to identify the febrile infants with urinary tract infection, bacteremia, and bacterial meningitis (or what was referred to as serious bacterial infections) while simultaneously trying to spare them from invasive and potentially unnecessary procedures like lumbar punctures or the possible iatrogenic consequences of empiric antibiotics or hospitalization. Several risk stratification tools have been published over the years. These clinical decision instruments included subjective clinical criteria along with pre-determined thresholds for lab criteria like white blood cell count (WBC) and immature to total neutrophil ratio. Unfortunately, these criteria may not be appropriate in the current era. In fact, the Modified Boston and Philadelphia Criteria for invasive bacterial infections may misclassify almost one-third of infants with bacterial meningitis. With routine screening of pregnant women, improvements in food safety, and conjugate pneumococcal vaccines, we have seen a decrease in Group B streptococcus, Listeria, and Streptococcus pneumoniae infections in infants. Instead, there has been a shift to Gram-negative organisms being the most common culprits in bacterial infections in infants. Simultaneously, our ability to test for infection has advanced with the use of inflammatory markers (IM) like procalcitonin and C-reactive protein (CRP) as well as polymerase chain reaction (PCR) testing for rapid identification of multiple viruses and bacteria. Clinical Question: What are recommendations for evaluating and managing well-appearing, term infants, 8 to 60 days of age with fever ≥38°C? Reference: Pantell et al. Evaluation and management of well-appearing febrile infants 8 to 60 days old. Pediatrics 2021 Authors’ Conclusion: “Three algorithms summarize the recommendations for infants 8 to 21 days of age, 22 to 28 days of age, and 29 to 60 days of age. The recommendations in this guideline do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.” Quality Checklist for A Guideline: The study population included or focused on those in the emergency department? No An explicit and sensible process was used to identify, select and combine evidence? Yes The quality of the evidence was explicitly assessed using a validated instrument? Yes An explicit and sensible process was used to the relative value of different outcomes? Yes The guideline thoughtfully balances desirable and undesirable effects? Yes The guideline accounts for important recent developments Yes/Unsure The guidelines has been peer-reviewed and tested? Yes/No Practical, actionable, and clinically important recommendations are made? Yes The guideline authors’ conflicts of interest are fully reported, transparent and unlikely to sway the recommendations of the guidelines? Yes Key Recommendations: There are four key components to considered in evaluating the well-appearing febrile infant and three algorithms based on the age of the infant. Four Key Components of Evaluation: Urine Blood culture Inflammatory Markers (IM) Procalcitonin >0.5 ng/mL Absolute neutrophil count (ANC) > 4,000 mm3 or >5,200 mm3 (There are two ANC cutoffs included based on the PECARN study and Febrile Young Infant Research Collaborativestudy) CRP >20 mg/L Temperature > 38.5°C Cerebrospinal Fluid (CSF) from lumbar puncture (LP) Algorithms At a Glance: There are three age groups (8-21d, 22-28d and 29-60d). All age groups get urine and blood cultures. Inflammatory markers are considered optional for the youngest group. The youngest group gets an LP, antibiotics and admitted while the older two groups may get an LP and antibiotics and may be discharged home. Infants 8 to 21 Days of Age This is a straightforward group and not a big change from previous practice. We should still be conservative with this group. These infants are all getting a full work up including urine, blood, and CSF. They are being treated with empiric antibiotics and staying in the hospital. Dr. Archie Cochrane The inflammatory markers are optional (Grade B, Weak Recommendation) as they do not really change decision to administer antimicrobials or disposition. This follows Archie Cochrane’s approach to testing: “Before ordering a test, decide what you will do if it is (1) positive or (2) negative. If both answers are the same, don’t take the test”. We should be also cautious regarding herpes simplex virus (HSV) infection in this age group and may also consider adding acyclovir coverage in addition to empiric antibiotics. Infants 22 to 28 Days of Age This is where there is some nuance and room for shared decision making. We are still going to obtain urine and blood. This is where the inflammatory markers can be used to guide further management. If any IM is abnormal, these guidelines recommend performing an LP and obtaining CSF (Grade C, Moderate Recommendation). However, even if all IMs are normal, the clinician can still choose to perform a LP. If the decision is made to defer LP, these patients will need to stay in the hospital. The choice of administering empiric antimicrobials in a situation where an LP is not performed is dependent on a discussion of the potential harms and potential benefits between clinician and family. While the risk of meningitis is lower in this age group, empiric treatment without CSF may result in partially treated meningitis. A key thing to remember for this algorithm and age group is that we should not send these patients home without obtaining an interpretable CSF. If the urine studies are normal, IM are normal, CSF is normal or enterovirus positive, these patients can be discharged home after receiving a dose of parenteral antibiotics (Grade C, Moderate Recommendation) with proper anticipatory guidance and return precautions and follow up in 24 hours. Infants 29 to 60 Days of Age This algorithm has the potential to really decrease the number of LPs and allow us to send more infants home based on the IMs. We are still going to start by obtaining urine, blood culture, and IMs. Circumcised boys may be exempted from urine studies given their risk of urinary tract infection is <1%. In the setting of having normal IMs, LP may be deferred (Grade B, Moderate Recommendation) even with a positive urinalysis. Patients with positive urinalysis and normal IMs can be discharged home on oral antibiotics with close follow up in 12 to 24 hours. If urinalysis is negative and the IMs are normal, these patients may be sent home without a lumbar puncture and without antimicrobial therapy. They should be closely observed, provided with strict return precautions, and have follow up arranged within 24 to 36 hours. If the IMs are elevated, things get a bit tricky. The guidelines state that a LP may be performed (Grade C, Weak Recommendation). This is different from the previous age group where the recommendation was that LP should be performed in the setting of abnormal IMs. If CSF is negative with positive or negative urinalysis, you may give them a dose of antimicrobial and still send them home. If CSF is not obtained or uninterpretable, you should give a dose of IV antimicrobial and observe in the hospital or discharge home.

Date: August 12th, 2021 Reference: Daya et al. Survival After Intravenous Versus Intraosseous Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Shock-Refractory Cardiac Arrest. Circulation 2020 Guest Skeptic: Missy Carter is a PA practicing in emergency medicine in the Seattle area and an adjunct faculty member with the Tacoma Community College paramedic program. Missy is also now the director for Difficult Airway EMS course in Washington State Case: An EMS crew arrives to your emergency department (ED) with a 58-year-old female who suffered a witnessed ventricular fibrillation (VF) out-of-hospital cardiac arrest (OHCA). They performed high-quality CPR and shocked the patient twice before giving amiodarone via intraosseous (IO). After giving hand off the medic tells you she had difficulty finding intravenous (IV) access and went straight to an IO. She wonders if she should have spent more time on scene trying to get the IV versus the tibial IO she has in place. Background: We have covered OHCA multiple times on the SGEM. This has included the classic paper from Legend of EM Dr. Ian Stiell on BLS vs. ACLS (SGEM#64), the use of mechanical CPR (SGEM#136), and pre-hospital hypothermia (SGEM#183). ALPS Trail The issue of amiodarone vs lidocaine has also been covered on SGEM#162. This was the ALPS randomized control trial published in NEJM 2016. The bottom line from that SGEM critical appraisal was that neither amiodarone or lidocaine were likely to provide a clinically important benefit in adult OHCA patients with refractory VF or pulseless ventricular tachycardia. We did do an episode on IO vs IV access for OHCA (SGEM#231). This was a critical appraisal of an observational study published in Annals of EM (Kawano et al 2018). The key result was that significantly fewer patients had a favorable neurologic outcome in the IO group compared to the IV group. However, we must be careful not to over-interpret observational data. There could have been unmeasured confounders that explained the difference between the two groups. In recent years there has been an effort to lower the cognitive load in the pre-hospital setting and focus resources on the interventions that positively effect patient outcomes. There has been a trend to place supraglottic devices over intubation with some evidence to support this move (SGEM#247).  Another trend is to use IO access over IV access to free up pre-hospital providers to focus on more meaningful interventions. Clinical Question: Does it matter if you give antiarrhythmic medications via IV or IO route in OHCA? Reference: Daya et al. Survival After Intravenous Versus Intraosseous Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Shock-Refractory Cardiac Arrest. Circulation 2020 Population: Adult patients with non-traumatic out-of-hospital cardiac arrest and shock refractory ventricular fibrillation or pulseless ventricular tachycardia after one or more shocks anytime during resuscitation. Excluded: Patients who had already received open-label intravenous lidocaine or amiodarone during resuscitation or had known hypersensitivity to these drugs Intervention: Amiodarone, Lidocaine or placebo given IO Comparison: Amiodarone, lidocaine or placebo given IV Outcome: Primary Outcome: Survival to hospital discharge Secondary Outcomes: Survival to hospital admission, survival with favorable neurologic outcome (modified Rankin Scale score of 3 or less) Authors’ Conclusions: We found no significant effect modification by drug administration route for amiodarone or lidocaine in comparison with placebo during out-of-hospital cardiac arrest. However, point estimates for the effects of both drugs in comparison with placebo were significantly greater for the intravenous than for the intraosseous route across virtually all outcomes and beneficial only for the intravenous route. Given that the study was underpowered to statistically assess interactions, these findings signal the potential importance of the drug administration route during resuscitation that merits further investigation. 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? There were wide 95% CI around the point estimate of risk ratios Do you believe the results? Yes Can the results be applied to the local population? Yes Do the results of this study fit with other available evidence? Yes Results: In the ALPS publication, there were 37,889 patients with non-traumatic out-of-hospital cardiac arrest of which 7,051 (18.6%) had shock-refractory ventricular fibrillation or pulseless ventricular tachycardia. The intention to treat (ITT) population was 4,653 and the per-protocol (PP) population was 3,026. There was no statistical difference between Amiodarone (24.4%), lidocaine (23.7%) and Placebo (21.0%) in the ALPS study. There was also no statistical difference in favourable neurologic function at discharge between groups. This was a pre-specified subgroup analysis of the 3,019 PP population. IV route was used 78% of the time and the IO route was used 22% of the time. The mean age of participates was 63 years, 80% were male, less than a 1/3 occurred in a public location, 60% had bystander-initiated CPR and a time to first arrival of EMS of 6 minutes. There were differences in sex, time-to-emergency medical services arrival, and some cardiopulmonary resuscitation characteristics between those in the IO cohort vs. the IV cohort but were similar in other aspects. Key Result: There was no significant effect modification by drug administration route (IV or IO) for amiodarone or lidocaine in comparison with placebo during adult OHCA. Primary Outcome: Survival to hospital discharge Only amiodarone vs. placebo IV was statistically significant (p=0.014) * Adjusted Risk Ratio was 1.26 [95% CI, 1.06–1.50] for IV amiodarone vs placebo No statistical difference for amiodarone or lidocaine compared to placebo when given IO   Secondary Outcomes: Survival to Hospital Admission: Greater if drugs were given by IV compared to placebo but not with IO Survival with Favorable Neurologic Outcome: Greater if drugs were given IV compared to placebo but not with IO 1) Observational Study: This is a subgroup analysis of the ALPS trial which makes it an observational study. The authors properly prespecified their subgroup and reported their data as unadjusted and adjusted which decrease the chance of finding spurious outcomes. However, prespecifying subgroups and adjusting the data cannot overcome the lack of randomizations. We can only conclude associations from this study and not attribute causation to any of the findings. 2) Subgroup Analysis: We should generally view subgroup analyses as hypothesis generating. Very few claims from RCT subgroups get tested in future trials. A study by Wallach et al found that of 117 subgroup claims from RCT only ten percent were tested in a future study. Of those subgroup claims that were tested, zero percent confirmed the original claim. “The overall trial result is usually a better guide to the direction of effect in subgroups than the apparent effect observed within a subgroup” (Yusuf et al JAMA 1991 3) Pharmacologic Characteristics: The authors posit that some differences between lidocaine and the more lipophilic amiodarone might decrease the efficacy of IO vs IV administration.While interesting, we should remember that it is easy to fool ourselves with these types of explanations. The body is very complicated and there is much we do not understand. Such a claim would need to be demonstrated with evidence. 4) Per-Protocol Analysis: The more conservative method of analyzing a superiority trial would have been to do an ITT analysis. Doing a PP analysis can increase the point estimate of effect size. Even with this bias the PP analysis did not demonstrate a statistical difference in primary outcome for the APLS trial. The ITT analysis for the ALPS trial can be found in their supplemental material. It reported no significant differences between the trial groups in the primary or the secondary outcomes. Unfortunately, they did not provide the data broken down by IV vs IO. 5) Site of the IO: In the study, 78% of the participants received an IV while 22% had an IO placed. The IO was predominantly tibial which may have biased the results. The authors hypothesize that a more proximal route (humeral or sternal) may have made a difference. We think this is unlikely given that there is no high-quality evidence that any ACLS drug for adult OHCA has been shown to make a patient-oriented benefit. Comment on Authors’ Conclusion Compared to SGEM Conclusion: We agree that there is no statistical difference in IV or IO administration of antiarrhythmic medications compared to placebo. A subgroup showed there may (or may not) be a benefit to giving amiodarone IV but that would need to be confirmed. SGEM Bottom Line: We suggest focusing on the treatments that have demonstrated to provide a patient-oriented benefit (high-quality CPR and defibrillation) in adult OHCA rather than those treatments that do not have high-quality evidence to support their use (type of airway, vascular access, vasopressors, or antiarrhythmic drugs).

Date: August 7th, 2021 Dr. Susanne DeMeester Guest Skeptic: Dr. Susanne (Susy) DeMeester is an Emergency Physician practicing at St. Charles Medical Center in Bend, Oregon. She has been very involved with EMRAP's CorePendium as the cardiovascular section editor and has a chapter coming out soon on women and acute coronary syndrome. Dr. DeMeester was on SGEM#222 as part of the SGEMHOP series. She was the lead author of a study looked at whether an emergency department algorithm for atrial fibrillation management decrease the number of patients admitted to hospital. The SGEM Bottom Line: There are clearly patients with primary atrial fibrillation who can be managed safely as outpatients. There are no evidence-based criteria for identifying high-risk patients who require admission, so for now we will have to rely on clinical judgement. This SGEM Xtra episode is the result of some feedback I received from a listener following SGEM#337 episode on the GRACE-1 guidelines for recurrent low-risk chest pain. The person lamented that it would be nice if a cardiac case scenario was of a female patient. This made me review past SGEM episodes which confirmed there has been a gender bias. While there were a half-dozen episodes that did have female patients, they were the minority. So, I felt a good way to address the issue would be to invite an expert like Dr. DeMeester to discuss this gender bias. There is a difference between gender and sex. Despite having different meanings they are often used interchangeably. Gender refers to social constructs while sex refers to biological attributes. This is not the first SGEM episode that has addressed the gender gap in the house of medicine. I had the honour of presenting at the 2019 FeminEM conference called Female Idea Exchange (FIX19). My FIX19 talk was called from Evidence-Based Medicine to Feminist-Based Medicine. It looked at the three pillars of EBM: relevant scientific literature, clinicians, and patients. I realized that each of the three pillars contained biases against women. In the presentation, multiple references were provided to support the claim that a gender gap does exist. The conclusion from the FIX19 talk was that we should be moving from Evidence-Based Medicine (nerdy and male dominated) to Feminist-Based Medicine (recognizing the inequities in the house of medicine) to Gender-Based Medicine (acknowledging the spectrum of gender and sexuality) and ultimately to Humanist- Based Medicine. The SGEM did a regular critical appraisal of a recent publication with Dr. Ester Choo (SGEM#248). It covered the study published in AEM looking at the continuation of gender disparities among academic emergency physicians (Wiler et al AEM 2019). We also did an entire SGEM Xtra episode with Dr. Michelle Cohen on the broader issue of the gender pay gap (SGEM Xtra: Money, Money, Money It’s A Rich Man’s World – In the House of Medicine). This was based on the Canadian Medical Association Journal article focusing on closing the gender pay gap in Canada (Cohen and Kiren 2020). Five questions about gender disparities when it comes to cardiovascular disease. What is the burden of cardiovascular disease in females and is it the same as males? We know females are often excluded from being subjects in medical research. Are female represented proportionally in cardiovascular disease  clinical research? Are there differences between males and females with regards to cardiovascular disease risk factors? Do females who have a cardiovascular event present differently to the emergency department? Have any sex differences been identified in the treatment and outcomes of females with cardiovascular events? Please listen to the SGEM podcast to hear Dr. DeMeester's answers to these five questions. What can be done to address this gender gap? The Lancet gathered a group of international experts to answer this question. The commission published recommendations to reduce the global burden of cardiovascular disease in women by 2030 (Vogel et al). This Includes: Acknowledging the current burden of disease Raising awareness about the differences in presentations and sex-specific and under-recognized risk factors Increasing the number of women included in clinical trials The European Society of Cardiology supported this initiative. They published an article called: Cardiovascular Disease in Women - Reducing the gender gap in prevention, diagnosis and treatment of cardiovascular disease.  The Lancet also created a number of infographics to help with the knowledge translation of these recommendations. The SGEM will be back next episode doing a structured critical appraisal of a recent publication. Trying to cut the knowledge translation window down from over ten years to less than one year using the power of social media. The ultimate goal of the SGEM is for 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. Additional Reading: Davies RE, Rier JD. Gender Disparities in CAD: Women and Ischemic Heart Disease. Curr Atheroscler Rep. 2018 Sep 4;20(10):51. doi: 10.1007/s11883-018-0753-7. PMID: 30178384 Mehilli J, Presbitero P. Coronary artery disease and acute coronary syndrome in women. Heart 2020;106:487-492. Greenwood BN, Carnahan S, Huang L. Patient-physician gender concordance and increased mortality among female heart attack patients. Proc Natl Acad Sci U S A. 2018 Aug 21;115(34):8569-8574. doi: 10.1073/pnas.1800097115. Epub 2018 Aug 6. PMID: 30082406; PMCID: PMC6112736 Nguyen PK, Nag D, Wu JC. Sex differences in the diagnostic evaluation of coronary artery disease. J Nucl Cardiol. 2011;18(1):144-152. doi:10.1007/s12350-010-9315-2 Lichtman JH, Leifheit EC, Safdar B, Bao H, Krumholz HM, Lorenze NP, Daneshvar M, Spertus JA, D'Onofrio G. Sex Differences in the Presentation and Perception of Symptoms Among Young Patients With Myocardial Infarction: Evidence from the VIRGO Study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients). Circulation. 2018 Feb 20;137(8):781-790. doi: 10.1161/CIRCULATIONAHA.117.031650. PMID: 29459463; PMCID: PMC5822747 Mosca L, Benjamin EJ, Berra K, Bezanson JL, Dolor RJ, Lloyd- Jones DM, et al. Effectiveness-based guidelines for the prevention of cardiovascular disease in women–2011 update: a guideline from the American Heart Association. Circulation. 2011;123:1243–62 Canto JG, Rogers WJ, Goldberg RJ, et al. Association of age and sex with myocardial infarction symptom presentation and in- hospital mortality. JAMA Internal Medicine, American Medical Association, 22 Feb 2012, jamanetwork.com/journals/jama/ fullarticle/1355992 Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics—2012 update; a report from the American Heart Association http://Circ.ahajournals.org/Content/125/1/e2.Full, 3 Jan. 2012, circ.ahajournals.org/content/125/1/e2.full Alexander KP, Chen AY, Newby LK, Schwartz JB, Redberg RF, Hochman JS, et al. Sex differences in major bleeding with glyco-protein IIb/IIIa inhibitors: results from the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines) initiative. Circulation. 2006;114:1380–7 Regitz-Zagrosek V, Blomstrom LC, Borghi C, et al. ESC guidelines on the management of cardiovascular diseases during pregnancy: the Task Force on the Management of Cardiovascular Diseases during Pregnancy of the European Society of Cardiology (ESC). Eur Heart J. 2011;32:3147–97 Dey S, Flather MD, Devlin G, Brieger D, Gurfinkel EP, Steg PG, et al. Sex-related differences in the presentation, treatment and outcomes among patients with acute coronary syndromes: the Global Registry of Acute Coronary Events. Heart. 2009;95:20–6 Bank IEM, de Hoog VC, de Kleijn DPV, et al. Sex-Based Differences in the Performance of the HEART Score in Patients Presenting to the Emergency Department With Acute Chest Pain. J Am Heart Assoc. 2017;6(6):e005373. Published 2017 Jun 21. doi:10.1161/JAHA.116.005373

Date: July 29th, 2021 Reference: Azizi et al. Optimal anatomical location for needle decompression for tension pneumothorax: A multicenter prospective cohort study. Injury 2021 Guest Skeptic: Dr. Robert Edmonds is an emergency physician in the Air Force in Ohio.  This is Bob’s 14th episode cohosting the SGEM. DISCLAIMER: THE VIEWS AND OPINIONS OF THIS PODCAST DO NOT REPRESENT THE UNITED STATES GOVERNMENT OR THE US AIR FORCE. Case: You are driving home from a busy shift and see a car collision occur right in front of you.  The driver is a restrained self-extricated male who lost control of his vehicle into a light post and the vehicle’s airbags deployed.  After safely pulling over and having a bystander call 911, you evaluate the patient.  He is speaking in full sentences without confusion, has a strong, rapid pulse, significant pain in his chest and is having a very hard time breathing.  As you wait for EMS to arrive, you quickly dash back to your car to retrieve your stethoscope and an angiocatheter you have in your glovebox.  You notice a marked difference between breath sounds on the left side and decide the patient needs treatment for a tension pneumothorax.  After obtaining consent from the patient, you debate whether to decompress at the second intercostal space in the midclavicular line as you originally learned, or in the fourth/fifth intercostal space midaxillary line as per the current ATLS guidelines. Background: The latest ATLS guidelines were published in 2018. We covered them on the SGEM Xtra with Dr. Neil Parry. There were several changes to the new guidelines but one of them was changing the location for needled decompression for adult patients. Needle thoracostomy is subject to several complications compared to a tube thoracostomy primarily due to the shorter length of the needle as well as the smaller lumen, so site selection has focused on finding a short distance and a site unlikely to kink or get dislodged. Dr. Richard Malthaner We have covered chest tube thorocostomy a couple of times on the SGEM with Dr. Richard (Thoracic) Malthaner. SGEM#129 looked at where to put the chest tube on trauma patients and if a post-procedure chest Xray (CXR) was required. The conclusion from that episode was to put the tube on the correct side, within the triangle of safety, and within the pleural space. Continue to obtain a CXR post chest tube knowing it will probably not change management. Be more concerned if the patient is doing poorly or the tube is not draining. The other episode on chest tubes was SGEM#300. The clinical question was does everyone with a large first-time spontaneous pneumothorax need a chest tube? The answer from that episode was It is reasonable to provide conservative management (no chest tube) in a patient with large first-time spontaneous pneumothoraxes if you can ensure close follow-up. The changes in the ATLS guidelines were based in part on a small study (n=20) utilizing cadavers [1]. There were also studies using CT scans showing a preference for the fourth/fifth ICS AAL [2,3].  These studies were limited by heterogeneity (I2 83%-98%), possible publication bias, and not being randomized trials. These authors are adding to the literature by utilizing ultrasound on live patients. This could reduce some of the potential confounders in prior studies that were exclusively cadavers which may have differences in CWT due to post-mortem changes. The previous studies also focused on homogenous populations like military members and are therefore less generalizable to the general population. Additionally, by using ultrasound instead of CT, some of the confounders from arm placement during CT were reduced.  Clinical Question: Is the chest wall thickness at the second intercostal space in the midclavicular line not thicker than the fourth/fifth intercostal space anterior axillary line? Reference: Azizi et al. Optimal anatomical location for needle decompression for tension pneumothorax: A multicenter prospective cohort study. Injury 2021 Population: A convenience sample of all adults presenting to one of the eight participating hospitals over a two-week period. (June 11-23, 2019) Excluded: Patients with pre-existing thoracic deformities, patients who were seriously ill requiring continuous urgent care, and patients who were unable to provide consent Intervention: Chest wall thickness at the second intercostal space in the midclavicular line Comparison: Chest wall thickness at the fourth/fifth intercostal space anterior axillary line Outcome: Primary Outcome: Median CWT in ICS2-MCL and ICS 4/5 AAL Secondary Outcomes: BMI 25-30 CWT, BMI 30+ CWT, hypothetical failure rates of needle decompression Authors’ Conclusions: “In overweight- and obese subjects, the chest wall is thicker in ICS 4/5-AAL than in ICS2-MCL and theoretical chances of successful needle decompression of a tension pneumothorax are significantly higher in ICS2-MCL compared to ICS 4/5-AAL.” 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? Unsure Was the cohort recruited in an acceptable way? Unsure Was the exposure accurately measured to minimize bias? Yes Was the outcome accurately measured to minimize bias? Yes/Unsure Have the authors identified all-important confounding factors? No Was the follow up of subjects complete enough? Yes How precise are the results? 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? No Results: There were 390 patients available for analysis in this study. Mean age was 51 years, 52% were male and the mean BMI was 25.5. Key Result – There was no statistical difference in mean chest wall thickness between the second ICS-MCL and the fourth/fifth ICS-AAL Primary Outcome: Median chest wall thickness (CWT) 26mm (IQR 21-32) ICS2-MCL vs 26mm (IQR 21-33) ICS 4/5 AAL (p<0.001) Secondary Outcomes: Median CWT BMI 25-30: Chest wall was thinner at ICS2-MCL 27mm vs ICS 4/5-AAL 29mm Median CWT BMI 30+: Chest wall was thinner at ICS 2-MCL 35 mm vs. ICS 4/5-AAL 39 mm Hypothetical Failure Rates of Needle Decompression 1. Convivence Sample - The authors state they used a convenience sample of patients presenting to the ED of eight hospitals during a two-week period June 11-23, 2019. The words “convenience” sample often refer to limited hours of enrollment (not nights/weekends and holidays usually). They did not explicitly state what they meant by convenience sample in the published manuscript. Selection bias could have been introduced using this methodology. 2. Angle of Attack - The authors mention the CWT and then use this to extrapolate the hypothetical rate of needle decompression failure for the two sites. This assumes the clinician performing the needle decompression enters the skin in a perpendicular approach and goes the shortest distance possible to the pleura. It is reasonable to suspect that the patient who is receiving needle decompression rather than a chest tube is further from definitive care or in a greater degree of extremis than a stable patient with a spontaneous pneumothorax who ambulated into the ED complaining of chest pain and difficulty breathing.  It’s likely that not all needles used for needle decompression are placed perfectly perpendicular to the site of choice, and it seems reasonable to conclude that there could be a significant difference in the actual angle of attack the needle takes when comparing the two sites.  This makes the authors’ hypothetical rate of ND failure based purely on CWT a little less definitive. 3. Site Selection – They evaluated the site previously recommended by ATLS (second ICS-MCL) but compared it to a different site than the new ATLS recommendation. These authors looked at fourth/fifth ICS-AAL instead of ATLS recommended fourth/fifth ICS-MAL). The Laan SRMA mentions how “…in our analysis of the CWT reported at different locations, we found that the mean CWT was smallest at ICS4/5-AAL, thicker at ICS4/5-MAL, and thickest at ICS2-MCL. Despite this observed tendency, the difference in CWT was not statistically significant (P=.08).” So, if the authors truly intended to support use of the second ICS-MCL over the more lateral and inferior sites, the better comparison would have been fourth/fifth ICS-MAL based on previous evidence. 4. Under Pressure - The authors used ultrasound to measure the CWT at both sites.  They state that the ultrasound probe was placed “without any compression” and exactly perpendicular to the chest wall.  Although every effort was likely made to reduce compression, these two sites do differ in how lateral they are, and it is possible that some compression of tissues did occur during measurement despite the best of efforts.  This challenges the accuracy of the measurements between the two sites. 5. Clinically Important – While this is an interesting study using POCUS to determine CWT and generate a hypothetical failure rate, a much better study would be a randomized trial. Randomize patients into getting the needle decompression at the second ICS-MCL or the fourth/fifth ICS-MAL as per the latest ATLS guidelines. The primary outcome could be successful decompression. If one site is superior to another then a further larger trial could be done looking at all-cause mortality as the primary outcome. Comment on Authors’ Conclusion Compared to SGEM Conclusion: We are hesitant to change practice based on a subgroup analysis and find insufficient evidence to reject the ATLS guidelines for needle thoracostomy placement site. This is recognizing that there is not strong data to support the ATLS guideline recommendation.

Date: July 24th, 2021 Guest Skeptic: Dr. Brain Goldman is an Emergency Medicine physician who works at Mount Sinai hospital in Toronto. He is the host of CBC radio show White Coat Black Art and the podcast The Dose. He is also the author of the bestselling books The Night Shift, Secret language of Doctors, and the Power of Kindness. This is a SGEM Xtra. Brain and I went on an away mission by shuttle craft to Ticonderoga, NY for the weekend. This was to join Mr. William Shatner to celebrate his 90th birthday. We took the opportunity during part of the road trip to record an SGEM episode about how Star Trek made us better physicians. Some of you may love this episode while others may not. William Shatner 90th Birthday Party Celebration Away Mission 2021 There were a number of challenges that needed to be overcome to make this epic trip happen. First, it was difficult to get VIP tickets to this sold out event hosted by James Cowley. James created the Star Trek: Original Series Set Tour. This is an amazing recreation of the sets from the original series. James is also an executive film producer, actor and famous Elvis impersonator. He graced us with a performance as Elvis as part of the birthday celebration weekend (link to video). After obtaining a couple of VIP tickets to the event, the next concern was: what colour of shirt to wear? There is the gold command tunic worn by Captain James T. Kirk, the blue science/medical tunic worn by Mr. Spock and Dr. McCoy, or the infamous red shirt. Please note that the red shirt characters were not statistically more likely die. Another challenge was traveling to the USA. The border restrictions were supposed to have been eased on July 21st to allow crossing by ground. However, it was announced on July 20th that the restrictions would remain in place until August 9th. People were allowed to cross by air if fully vaccinated and had negative COVID19 test within three days of departure. This allowed us to fly over the border, rent a car and drive to Ticonderoga. The final challenge was what to get Mr. Shatner for his 90th birthday. I called the Stratford Festival a few months before the event and asked for their assistance. They kindly searched their archives for the three seasons he was part of the company (1954-1956). There were no pictures that featured him on stage because he was not a famous actor at the time. They did find two photos of Mr. Shatner receiving the Festival’s Guthrie Award from Governor General Vincent Massey in 1956. There were also some newspaper clippings describing how Mr. Christopher Plummer was admitted to hospital for a kidney stone and his understudy, William Shatner, took over the lead role in Henry the V. The Stratford Festival Archivist did find one amazing photo of Mr. Shanter from 1954. It is a picture of him sitting in a chair surrounded by a few other individuals checking out the masks for the 1954 production of Oedipus Rex. It looked like he was getting ready to sit in the captain's chair aboard the USS Enterprise NCC 1701. It's this photo that I had printed, framed and presented to him as a birthday present. He was very gracious and appreciative of receiving this special birthday gift. For those of you not familiar with Star Trek it started with a TV series that had 79 episodes and was broadcasted over three seasons from 1966-1969. It is a science fiction franchise created by Gene Roddenberry. Star Trek The Original Series (TOS) launched many other TV series and movies. This SGEM Xtra will discuss some of the lessons learned from Star Trek and how it has applied to our practice of emergency medicine. Brian and I had a wonderful away mission. Some of the highlights included the private tour of the Enterprise by Mr. Shatner. I had the chutzpah to ask a question of during the bridge chat about what Mr. Shatner learned from his time at the Stratford festival that he applied to his career in TV and movies. His answer was he learned excellence from the best directors and actors in the world. It was also wonderful to go on a couple of hikes with Brian around Ticonderoga and see the natural beauty of this historic town. It is located in New York state on the north end of Lake George and a southern portion of Lake Champlain. There is also fort in Ticonderoga build by the French in the 18th century that played an important role during the American revolution. Mr. Daren Dochterman Another super experience was meeting the talented Mr. Daren Dochterman. He is a set designer who has worked on many movies. Daren won an award for his work on the visual effects for the movie Star Trek: The Motion Picture Director's Cut. He informed us that the Director's Cut is being remastered for 4K release and he is part of the team. Daren also co-hosts the best Star Trek podcast called the Inglorious Treksperts with Mark A. Altman. After Brian and I met him and discussed our love of Star Trek TOS he made us honorary treksperts. Our private tour of the Star Trek TOS set was fantastic. Seeing everything from the transporter room, sick bay, engineering, and Captain Kirk's quarters. The biggest thrill was to sit in the command chair on the bridge of the Enterprise. It was a surreal moment to be in such a detailed replica and is very hard to describe. If you are a Star Trek fan I would highly suggest you make the trip to Ticonderoga and sit in the Captain's chair yourself. Star Trek and Evidence-Based Medicine Listeners to the SGEM know this knowledge translation project promotes evidence-based medicine (EBM). The definition we use for EBM is the one provided by Dr. David Sackett in the BMJ 1996. "Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients." There are three components to EBM that can be represented in a Venn diagram: Relevant Scientific Evidence - The literature should inform our care as clinicians but not necessarily dictate our care. Many people make the mistake of thinking that EBM is just about the scientific literature. This is not true. It is important to know about the relevant scientific information and how to critically appraise the evidence. Patients' Values/Preferences - We need to ask patients what they value and prefer. This may be different that what we as clinicians think and we should not assume to know. Each patient will be an expert at their own personal experience. They have agency and we can engage with them on using a shared decision model. Clinical Judgment - Often the available evidence will not be very strong or will not specifically apply to the individual patient we are caring for in the emergency department. Also the patient may not be able or want to participate in the decision. We need to use our good clinical judgement to apply the best evidence while honouring what patients prefer. This model of EBM can be illustrated by the three main characters of Star Trek TOS. Mr. Spock - He represents logical thinking and provides evidence to the situation. However, decisions are made in a context and do not reduce to just numbers, p-values, or confidence intervals around a point estimate of an observed effect size. The evidence can inform our care and guide our care but it should not dictate our care. Dr. McCoy (Bones) - He represents the patients in the EBM Venn diagram. Dr. McCoy advocates for humanity in Star Trek. He speaks passionately about the emotional aspect of challenging situations faced. Captain James T. Kirk - He represents the clinical judgment. Captain Kirk listens to the logic and evidence that Mr. Spock provides and to the emotional arguments made by Dr. McCoy. This dialog helps him make decisions. These are often life and death decisions based on incomplete information and is similar to what emergency physicians must do in the emergency department. Lessons Learned from Star Trek that Apply to Emergency Medicine Brian and I discussed a number of things we learned from Star Trek that we think informs our practice of emergency medicine and makes us better physicians. Listen to the SGEM podcast to hear the details of this discussion. This was recorded while we drove from our hotel in Burlington, Vermont to Ticonderoga, NY. Risk Is Our Business: We risk stratify patients all the time considering potential benefits vs potential harms. This has been discussed multiple times on the SGEM. SGEM#118: I Hope you Had a Negative D-dimer (ADJUST PE Study) SGEM#282: It’s All ‘bout that Bayes, ‘Bout that Bayes- No Trouble – In Diagnosing Pulmonary Embolism SGEM#212: Holding Back the Years – Risk Factors for Adverse Outcomes in Older Adults with Blunt Chest Trauma SGEM#252: Blue Monday- Screening Adult ED Patients for Risk of Future Suicidality SGEM#170: Don’t Go Breaking My Heart – Ottawa Heart Failure Risk Scale Anyone, Anytime, for Anything: The emergency department is the light in the house of medicine that is on to assess and treat anyone, at anytime for anything. This includes people with substance use disorder and mental illness. It should not matter a patients gender, age, or race. SGEM#313: Here Comes A Regular to the ED SGEM#280: This Old Heart of Mine and Troponin Testing SGEM#266: Old Man Take a Look at the Canadian CT Head Rule I’m a Lot Like You Were SGEM#248: She Works Hard for the Money – Time’s Up in Healthcare SGEM Xtra: I’m in a FIX State of Mind No Win Scenario: Every patient who presents to the emergency department is an opportunity. We can have a number needed to treat (NNT) of one to help. It all depends on how we define "win". Even if we do everything correctly patients will die. However, how we deal with death is also important. The NNT concept has been discussed on the SGEM. SGEM Xtra: NNT – WET or DRI

Date: July 14th, 2021 Reference: Pernica et al. Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial. JAMA Pediatr. 2021. Guest Skeptic: Dr. Andrew (Andy) Tagg is an Emergency Physician with a special interest in education and lifelong learning. He is the co-founder of website lead of Don’t Forget the Bubbles (DFTB). When not drinking coffee and reading Batman comics he is playing with his children. Case: Six-year-old Morten comes into your emergency department (ED) with what looks like pneumonia.  He has been febrile with a temp of 39 degrees Celsius, he is mildly tachypneic but shows no real signs of respiratory distress and you can hear some crackles in the right mid-zone.  His chest X-ray (CXR) confirms your findings, but he is well enough to be treated as an outpatient. Background: It is hard to believe we have not covered the common condition of pediatric community acquired pneumonia (CAP) on the SGEM. Perhaps it is because there is limited evidence on this common condition. However, we have covered other pediatric infectious issues like: Honey for Cough SGEM#26 Fever Fear SGEM#95 Lumbar Punctures SGEM#296 Bronchiolitis SGEM#228 Invasive Bacterial Infection SGEM#334 We do have high-quality evidence that a CXR is not necessary to confirm the diagnosis of CAP in patients who are well enough to be managed as outpatients. There is also high-quality evidence that pre-school children do not routinely need antibiotics. This is because most  pneumonias in this age-group are caused by viral pathogens (Bradley et al 2011). Antibiotics are recommended for school age children diagnosed with CAP. However, how long should they be treated is an open question. The IDSA guidelines provide a strong recommendations based on moderate quality of evidence to guide our care. (Bradley et al 2011). Treatment courses of 10 days have been best studied, although shorter courses may be just as effective, particularly for more mild disease managed on an outpatient basis. (strong recommendation; moderate-quality evidence) There is an RCT reporting five days of amoxicillin (80mg/kg divided TID) was non-inferior to ten days for CAP in children six months to 59 months of age (Greenberg et al 2014). This was a relatively small study (n=115) from Israel. A short course (five days) has also been recommended by the American Thoracic Society and the IDSA for adults with CAP under certain conditions (Metlay et al 2019). We recommend that the duration of antibiotic therapy should be guided by a validated measure of clinical stability (resolution of vital sign abnormalities [heart rate, respiratory rate, blood pressure, oxygen saturation, and temperature], ability to eat, and normal mentation), and antibiotic therapy should be continued until the patient achieves stability and for no less than a total of 5 days (strong recommendation, moderate quality of evidence). Clinical Question: Is a five day course of antibiotic therapy non-inferior to a ten day course to achieve clinical cure for paediatric community-acquired pneumonia? Reference: Pernica et al. Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial. JAMA Pediatr. 2021 Population: Children aged six months to ten years of age diagnosed with community acquired pneumonia (CAP) who are well enough to be treated as an outpatient. CAP was defined as fever (rectal, oral or axillary in 48 hours before presentation), tachypnea (based on age, accessory muscle use or auscultation findings), CXR, or primary diagnosis by the ED physician. Exclusions: Empyema or necrotizing pneumonia, preexisting pulmonary disease, congenital heart disease, history of aspiration, malignant neoplasm, immunodeficiency, kidney disfunction, on beta-lactam antibiotics for >24hrs at presentation, 5-days of beta-lactam <72hours before presentation, IV cephalosporin or azithromycin in the ED, suspected mononucleosis, prolonged admission in the previous two months, CAP diagnosed in the previous month, lung abscess in the previous six months or an allergy to penicillin allergy. Intervention: Five days of high-dose amoxicillin (90mg/kg/d divided TID) followed by five days of placebo Comparison: Ten days of high-dose amoxicillin (90mg/kg/d divided TID) Outcome: Primary Outcome: Clinical cure at 14-21 days Secondary Outcomes: Days off school/childcare, missed work days for carers, adverse reactions and adherence Authors’ Conclusions: “Short-course antibiotic therapy appeared to be comparable to standard care for the treatment of previously healthy children with CAP not requiring hospitalization. Clinical practice guidelines should consider recommending 5 days of amoxicillin for pediatric pneumonia management in accordance with antimicrobial stewardship principles.” 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 in a per-protocol analysis for non-inferiority trials. 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. 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. Unsure Results: They recruited a total of 281 children to be included in the trial with a median age of 2.6 years and 57% male. Key Result: A 5-day course of antibiotics was not non-inferior   to a 10-day course of antibiotics in children with CAP. Primary Outcome: Clinical cure at 14-21 days after enrollment Per-Protocol Analysis: 88.6% in the intervention group 90.8% in the control group. Risk difference −0.016 (97.5% Confidence Limit −0.087) and cannot claim non-inferiority Intention-to-Treat Analysis: 85.7% in the intervention group and 84.1% in the control group. Risk difference 0.023 (97.5% Confidence Limit −0.061) Secondary Outcomes: Caregivers were off work two days instead of three in the intervention group. All other secondary outcomes were the same. 1. Included Children: Of the 5,406 children diagnosed with pneumonia over the duration of the trial only 281 were randomized. There were 3,215 possible patients missed suggesting they were not recruited consecutively. Only 5% of all possible patients made it into the trial. Are these 281 children typical of the cohort of all cases of pneumonia or different? 2. Chest X-Ray (CXR): Do you really need a CXR to diagnose mild pneumonia? It is actively discouraged in our Australian guidelines and PIDS and the IDSA also recommend not doing it. Certainly, if you are worried about an alternative diagnosis such as inhaled foreign body but in mild pneumonia that you are going to send home? Around one-quarter did not have a formal radiologist report of pneumonia. They state in the publication: “It is suboptimal that some study participants were not believed to have radiographic findings consistent with pneumonia by the attending radiologist” We have talked about CXR before for diagnosing pneumonia in adults (SGEM#287 and SGEM#298). It is an imperfect gold standard (Copper Standard Bias). Even if the CXR is “positive" it does not mean a child has a bacterial pneumonia. Prescribing antibiotics to patient with a viral pneumonia is unlikely to have a patient-oriented outcome (POO). They did do nasopharageal swabs on some of the children and found no significant differences in clinical cure rates among those with respiratory viruses or M pneumoniae detected compared with those without. 3. Clinical Cure: Their definition of clinical cure included subjective criteria. This could have introduced uncertainty into the data. They did use a definition that was similar to that used in other studies of 5-day CAP therapy in children (Harris et al 1998) and adults (Dunbar et al 2003) Their specific definition was children meeting all three of the following criteria: significant improvement in dyspnoea and increased work of breathing, and no recorded tachypnoea, at the day 14-21 follow-up visit; no more than 1 fever spike (as defined above) as a result of bacterial respiratory illness from day 4 up to and including the day 14-21 follow-up visit; and lack of a requirement for additional antibacterials or admission to hospital because of persistent/progressive lower respiratory illness during the 2 weeks after enrollment. You can see that different physicians could have different interpretations on what a “significant improvement” looked like clinically and if the child required additional antibiotics or hospital admission. 4. Non-Inferiority: This was non-inferiority trial and they correctly performed a per-protocol analysis. The non-inferiority margin was based on several assumptions. Because the 1-sided 97.5% confidence limit of the point estimate of 7.5% was exceeded, a formal conclusion of non-inferiority could not be made. However, this is a statistical outcome and may not be a clinically important difference. Physicians will need to interpret the finding for themselves and think about how to apply the data. Both groups had about a 90% clinical cure rate with only a 1.6% absolute risk difference. Will crossing the one-sided statistical barrier by 1.2% (7.5% vs 8.7%) make a difference in clinically apply this data? 5.