The Skeptics Guide to Emergency Medicine

Date: April 7th, 2022 Reference: Wong et al. Sensitivity of diffusion-weighted magnetic resonance imaging in transient global amnesia as a function of time from symptom onset. AEM April 2022 Guest Skeptic: Dr. Chris Bond is an emergency medicine physician and assistant Professor at the University of Calgary. Case: A 65-year-old man presents to your emergency department with his wife. She tells you that he woke up normally this morning, but after breakfast he began asking the same questions repetitively and was amnestic to the answer, seemingly unable to form new memories. He remained completely awake and alert and otherwise appeared well.  There was no history of recent trauma, infectious symptoms, or any other illness.  Background: Transient global amnesia (TGA) is an idiopathic acute neurological disorder that presents with sudden onset anterograde memory loss. It was first described as a syndrome in 1956 by Courjon and Guyotat and also by Bender [1,2].  Fisher and Adams formally described as TGA in 1964 [3]. The usual presentation is a patient between 50 and 70 years of age who are cognitively and neurologically intact but asking repetitive questions, unable to form new memory. Symptoms do not last very long and resolve within 24 hours. The incidence has been reported as 23.5 per 100,000 people per year [4] and is more common in people who get migraine headaches [5]. TGA is often precipitated by physical or emotional stressors, pain, the Valsalva maneuver, hot or cold-water immersion or sexual intercourse [6] Diagnosing TGA combines items put forward by Hodges and Warlow and Caplan [7-9]. This results in seven diagnostic criteria for TGA. Diagnostic Criteria for Transient Global Amnesia Attack is witnessed Clear-cut anterograde amnesia during the attack No neurologic symptoms or signs during the attack other than amnesia (no clouding of consciousness or loss of personal identity) No neurologic physical examination findings others than anterograde amnesia Memory loss is transient (resolution within 24 h) No epileptic features and no active epilepsy (defined as no seizure within 2 years or on antiepileptic medication) No recent head injury A diagnostic algorithm has been published for patients with sudden onset of anterograde amnesia [6]. Included in this differential is transient epileptic amnesia, transient ischemic attack, stroke, metabolic disorders, psychogenic disorders, and post traumatic amnesia. The workup can include laboratory testing, EEGs, ECGs, echocardiogram and advanced neuroimaging. Clinical Question: What is the sensitivity of diffusion-weighted magnetic resonance imaging (DW-MRI) as a function of time from symptom onset compared to clinical diagnosis of TGA? Reference: Wong et al. Sensitivity of diffusion-weighted magnetic resonance imaging in transient global amnesia as a function of time from symptom onset. AEM April 2022 Population: Adult patients 16 years of age and older with a diagnosis of TGA based on the existing clinical criteria Intervention: Evaluation with DW-MRI at varying time intervals post symptom onset Comparison: No comparison as no studies of patients without DW-MRI were included Outcome: Sensitivity of DW-MRI in diagnosis of TGA Dr. Matt Wong This is a back-to-back SGEMHOP episode. We did the March episode at the end of last month and the April episode is the first week of this month. We are pleased to have the lead author on the show. Dr. Matthew Wong is an emergency physician and educator at Beth Israel Deaconess Medical Center, and an Assistant Professor at Harvard Medical School. Authors’ Conclusions: “DW-MRI lesions are uncommon in patients with TGA early after symptom onset, but the sensitivity (i.e., positivity rate) of DW-MRI increases with time. Despite the limited quality of existing evidence, obtaining an early DW-MRI in patients with clinical diagnosis of TGA in the acute setting is likely a low-yield test.” Quality Checklist for Systematic Review Diagnostic Studies: The diagnostic question is clinically relevant with an established criterion standard. Yes The search for studies was detailed and exhaustive. Yes The methodological quality of primary studies were assessed for common forms of diagnostic research bias. Yes The assessment of studies were reproducible. Yes There was low heterogeneity for estimates of sensitivity or specificity. No The summary diagnostic accuracy is sufficiently precise to improve upon existing clinical decision-making models. No Results: They identified 23 studies in their search with a total of 1,688 patients who met inclusion criteria. All studies were case series of adult patients clinically diagnosed with TGA who underwent DW-MRI. Key Result: The sensitivity of DW-MRI in diagnosing TGA increases with time. In the first 12 hours from symptom onset, sensitivity of DW-MRI is 15.6%. It improves thereafter to sensitivities between 66 and 83%, with very wide confidence intervals for all point estimates. There is also significant heterogeneity between studies. Listen to the SGEM podcast to hear Matt answer our ten nerdy questions. 1. Number of Studies: It’s unfortunate that there was a paucity of data to inform our care on TGA. While you identified 23 studies with almost 1,700 patients there were only 2 studies for some time frames with a few dozen patients. The largest time frame only had 10 studies containing 539 patients. 2. Observational Studies: All the studies were observational in nature. There were no randomized trials allocating patients to any time frame (early or late). This limits conclusions to time being associated with better sensitivity for diagnosis TGA with DW-MRI. There could have been reasons why some patients go an MRI sooner while others receive an MRI later. 3. Heterogeneity: The heterogeneity measured by the I2 test was very high (72%-96%) for all time points besides 36-48 hours and 60-72 hours. Why did you decide to meta-analyze the data rather than just providing a narrative report? 4. Table 3: This has 0-12, 0-24 and 12-24 hour groups for time interval from onset. Why did you use three-time groupings here? 5. Partial Verification Bias (Referral Bias, Work-up Bias) – This happens when only a certain set of patients who underwent the index test is verified by the reference standard. Only those who met the clinical criteria for TGA got a DW-MRI. What about all those patients who did not meet clinical criteria and therefore did not get an MRI? This could increase sensitivity. Spectrum Bias 6. Spectrum Bias – Sensitivity depends on the spectrum of disease, while specificity depends on the spectrum of non-disease. So, you can falsely raise sensitivity if the clinical practice has lots of people with TGA. Do you know what the prevalence of TGA was in the included studies? Responds 7. Imperfect Gold Standard Bias (Copper Standard Bias): This is what can happen if the “gold’ standard is not that good of a test. False positives and false negatives can really mess up results. What is the diagnostic accuracy of the clinical criteria for diagnosing TGA? Responds 8. Serial MRIs: Some of the studies included in the SRMA used serial MRIs. Can you comment if the results were aligned with the entire group within the meta-analysis? 9. Future Studies: You know this area well after having looked at all these studies. How would you design a study using DW-MRI to evaluate for TGA based upon what you know now? 10. Open Question: Is there anything else you would like the SGEMer to know about TGA in general or your study specifically? Comment on Authors’ Conclusion Compared to SGEM Conclusion: We generally agree with the authors conclusions. SGEM Bottom Line: Urgent DW-MRI for patients meeting standard diagnostic criteria for TGA is a low yield intervention. Case Resolution: You perform a good history, followed by a directed physical examination. You then observe him over a period of hours in the emergency department and he slowly begins to form new memories. You perform an unenhanced CT head and basic bloodwork which is normal. He is discharged home with his wife and will follow up with a neurologist as an outpatient. Dr. Chris Bond Clinical Application: We do not need to request an urgent DW-MRIs in patients who meet clinical diagnostic criteria for TGA. What Do I Tell the Patient? You have something called transient global amnesia or TGA. This condition is not a stroke or seizure or other dangerous disease and will mostly likely resolve over 24 hours. You should have no long-lasting effects from this. You also explain this to the patient’s caregiver and provide a written handout from the Mayo Clinic explaining the same. Should you develop any other neurologic symptoms such as weakness, sensory changes, speech abnormalities or confusion, or are worried you should return to the emergency department immediately. Keener Kontest: Last weeks’ winner was Dr. Steven Stelts from NZ. Man is he quick with the answers. He knew Morton Heilig submitted a patent for the first head-mounted virtual reality display in 1957 . Listen to the SGEM podcast for this weeks’ question.  If you know, then send an email to thesgem@gmail.com with “keener” in the subject line. The first correct answer will receive a cool skeptical prize. SGEMHOP: Now it is your turn SGEMers. What do you think of this episode on the DW-MRI in diagnosing TGA? Tweet your comments using #SGEMHOP.  What questions do you have Matt and his team Ask them on the SGEM blog? The best social media feedback will be published in AEM. Don’t forget (unless you have TGA) those of you who are subscribers to Academic Emergency Medicine can head over to the AEM home page to get CME credit for this podcast and article. Remember to be skeptical of anything you learn,

Date: March 31st, 2022 Reference: Butt et al. Take-Pause: Efficacy of mindfulness-based virtual reality as an intervention in the pediatric emergency department. AEM March 2022 Guest Skeptic: Dr. Lauren Westafer is an Assistant Professor in the Department of Emergency Medicine at the University of Massachusetts Medical School – Baystate. She is the cofounder of FOAMcast and is a pulmonary embolism and implementation science researcher. Lauren won the 2021 SAEM FOAMed Excellence in Education Award. Case: A 15-year-old male presents to the pediatric emergency department (ED) with right ankle pain sustained while twisting his ankle during dance practice. The right ankle is swollen and tender. He rates his pain a 5 on the FACES scale and is awaiting examination by the treating clinician. Background: Pediatric emergency department (ED) visits and related procedures can invoke pain and anxiety among children. Patients who experience adequate pain relief during their ED stay have significant reductions in distress, improved rapport with their physician, improved intent to comply with discharge instructions and higher levels of personal and caregiver satisfaction. Children represent one group of patients that are less likely to receive adequate analgesia (Brown et al, Selbst and Clark). This phenomenon is known as oligoanalgesia or poor pain management through the underuse of analgesia. Dr. Anthony Crocco We have covered pediatric pain with PEM super hero Dr. Anthony Crocco on SGEM#78 who did a RANThony on this issue. Dr. Samina Ali is a PEM super (s)hero who was on SGEM#242 looking at intranasal (IN) ketamine vs fentanyl on pain reduction for extremity injuries in children. The bottom line from that trial was IN ketamine appears to be non-inferior to IN fentanyl for efficacy, but with more adverse events. Many clinicians utilize distraction techniques to reduce pain and anxiety in children during their ED visits [4]. However, there are no prospective randomized trials using virtual reality (VR) as a distraction technique while awaiting physician evaluation. Clinical Question: Does a 5-minute virtual reality program reduce situational anxiety in the pediatric ED? Reference: Butt et al. Take-Pause: Efficacy of mindfulness-based virtual reality as an intervention in the pediatric emergency department. AEM March 2022 Population: Patients ages 13-17 years who presented to the pediatric ED with mild to moderate acute pain (pain score 2-6 on FACES pain scale) Exclusions: Patients with developmental delays, inability to speak English, prone to motion sickness, significant visual/hearing impairment, pregnancy, parental refusal, received analgesic ≤4 hours prior to ED arrival, or inability to use the pain scale. Intervention: Virtual reality “Take Pause” program for 5 minutes Comparison: Passive distraction technique with hospital-owned iPad with pre-downloaded age-appropriate games for 5 minutes Outcome: Primary Outcome: Difference in the change in situational anxiety level between groups 15 minutes after intervention using the Spielberger State – Trait Anxiety Inventory (STAI: Y-6 item) Secondary Outcomes: Mean difference in pain score on the FACES scale, heart rate, respiration rate from baseline to 15 minutes after intervention Trial: Prospective, randomized, single-blind trial Mahlaqa Butt This is an SGEMHOP episode which means we have the lead author on the show. Mahlaqa Butt, MPH is a third-year medical student at New York Institute of Technology-College of Osteopathic Medicine and a clinical research associate at the Department of Emergency Medicine at Maimonides Medical Center, Brooklyn NY. She has co-authored 11 peer-reviewed emergency medicine research publications primarily focused on opioid-free pain management in the ED. She will be pursuing a residency in emergency medicine this fall. Authors’ Conclusions: “Take-Pause, offering an active and immersive distraction technique, is more effective than a passive distraction approach to lower anxiety levels in adolescent ED patients.” 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. Unsure 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. Unsure Financial conflicts of interest. The authors stated they had no potential conflicts to disclose. Results: They enrolled 110 teenagers into the trial with 55 participants in each group. The mean age was 15 years, 60% were male and the mean pain score was 4.1/10. Key Result: Anxiety levels were reported lower in the intervention group compared to the comparison group. Primary Outcome: Mean anxiety score on the Spielberger State – Trait Anxiety Inventory (STAI: Y-6 item) VR group improved by 10 points vs. 6 points in the iPad group (95% CI: 0.44 to 7.6) p < 0.001 Secondary Outcomes: At 15 minutes, there was no difference in mean pain scores (3.6 vs 3.6), heart rate (intervention 81 bpm vs control 83 bpm), or respiratory rate (intervention 18 vs control 20) Listen to the SGEM podcast to hear Mahlaqa answer our five nerdy questions. 1. Patient Characteristics – Very little information is given regarding patient characteristics. For example, we have no information on traumatic vs nontraumatic pain, location of pain, race/ethnicity, or other potentially important variables. Although randomization should theoretically balance out any differences, it is helpful to have patient characteristics reported so we can gauge – are these patients like my patients? 2. Virtual Reality (VR) for Mindfulness – We have looked at mindfulness to help relieve the stress of interns on their EM rotation on SGEM#178. In this other small study, it seemed to be effective. However, that study had 10 weeks of mindfulness training sessions as the intervention. Can you describe this Take Pause VR immersion tool in more detail? 3. Effect Size - Effect size is a quantitative measurement of the magnitude of the difference between groups. In this study, the authors set out to find a difference of ≥3 on the STAI Y-6 from baseline to post-intervention. They felt this would be statistically significant as a 1999 study that looked at music before bronchoscopy had a 3.6 reduction on the anxiety score (but did not meet the arbitrary 5 points set out by those authors). It often takes more participants to detect a smaller effect size. 4. Comparison Group – You compared the VR Take Pause immersion tool to standard distraction techniques using an iPad. This could have introduced a bias towards lower anxiety because some teenagers desire to use some cool new technology. Why not use another VR headset intervention? Patients knew they were going to be randomized into the VR or iPad group. You mentioned in your publication this could have led to optimism bias. Could you explain that type of bias further? Did you consider other techniques not involving technology like animal therapy? On SGEM#289 we looked at having a dog to play with to relieve stress on the staff. The intervention looked promising, and I wonder how it would have compared to using a VR device. 5. Statistical Significance vs Clinical Significance - The mean baseline anxiety score (STAI Y-6 score) placed nearly the same proportion of patients in the mild anxiety group (score 20-40) ~82-94% and in the moderate anxiety group (score 41-60) – 16% of patients in both groups. The virtual reality arm had a 10-point reduction from baseline while the iPad group had a 6-point reduction. However, the post-intervention score was only 2.9 points different between groups. Overall, it’s not clear that the statistically significant difference between groups is clinically significant. Comment on Authors’ Conclusion Compared to SGEM Conclusion: We disagree with the authors conclusion and believe that this trial shows both Take-Pause and passive distraction with an iPad reduce self-reported anxiety levels in adolescent ED patients. SGEM Bottom Line: The virtual reality "Take Pause" immersion tool is another possible non-pharmaceutical intervention to reduce anxiety of paediatric patients in the ED. Case Resolution: The patient is offered either a mindfulness-based virtual reality program or an iPad with preprogrammed games while awaiting clinician evaluation. Dr. Lauren Westafer Clinical Application: Reducing anxiety is important in the emergency department. There are several non-pharmacologic techniques that can be used. This small study suggests the VR Take Pause immersion tool can be one of those techniques. What Do I Tell My Patient?  There are several ways to reduce anxiety in the pediatric emergency department. Both a mindfulness based virtual reality program and playing games on an iPad may help reduce your anxiety. Keener Kontest: Last weeks’ winner was Danny Driskill from the Kentucky College of Osteopathic Medicine. He knew IBM Simon Personal Communicator was the first “smart phone”.  It was released August 16, 1994. Listen to the SGEM podcast for this weeks’ question.  If you know, then send an email to thesgem@gmail.com with “keener” in the subject line.

Date: March 26th, 2022 Guest Skeptic: Professor Melanie Trecek-King Associate professor of biology at Massasoit Community College in Massachusetts. Founder and creator of Thinking Is Power. Reference: Trecek-King M.A Life Preserver for Staying Afloat in a Sea of Misinformation.  Skeptical Inquirer March/April 2022 Prof Trecek-King This is an SGEM Xtra episode. I met Melanie through our online interactions on Twitter. She posts excellent tweets about critical thinking. I then discovered her amazing website called Thinking is Power. We also discovered through our social media interactions that were were both Feynman fans. I asked Melanie to come on the show and discuss her recent article in Skeptical Inquirer and explain the acronym she created called FLOATER. Melanie explains that FLOATER grew out of James Lett’s “A Field Guide to Critical Thinking” (Lett J. Skeptical Inquirer 1990), in which he summarized the scientific method with the acronym FiLCHeRS (Falsifiability, Logic, Comprehensiveness of evidence, Honesty, Replicability, and Sufficiency of evidence). The FLOATER acronym stands for Falsifiability, Logic, Objectivity Alternative explanation, Tentative conclusion, Evidence, and Replicability. This was the basis for her article in Skeptical Inquirer. Melanie published her first article in the January/February edition called "Teach Skills, Not Facts". Listen to the SGEM Xtra podcast to hear Melanie explains each of the seven tools/rules that make up the FLOATER acronym. Tool 1: Falsifiability It must be possible to think of evidence that would prove the claim false. It seems counterintuitive, but the first step in determining if a claim is true is to determine if you can prove it wrong. Tool 2: Logic Arguments for the claim must be logical. They can be deductive or  inductive arguments. We should try and not commit logical fallacies when arguing positions. Tool 3: Objectivity The evidence for a claim must be evaluated honestly. Tool 4: Alternative Explanations Other ways of explaining the observation must be considered.  Tool 5: Tentative Conclusions In science, any conclusion can change based on new evidence. Tool 6: Evidence The evidence for a claim must be reliable, comprehensive, and sufficient. Tool 7: Replicability Evidence for a claim should be able to be repeated. We have a reproducibility crisis in science.  We ended this SGEM Xtra show with a quote from Marie Curie. I think Melanie is an amazing skeptic and educator. It was an absolute pleasure to have her on the show as the guest skeptic. 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. So, patients get the best care, based on the best evidence. Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine Additional Readings: Kahan et al. Science Curiosity and Political Information Processing. Political Psychology. January 2017 Kahan DM. Why Smart People Are Vulnerable to Putting Tribe Before Truth. Scientific America. December 2018 Trecek-King M. Teach Skills, Not Facts. Skeptical Inquirer. January/February 2022

Date: March 3rd, 2022 Reference: Macnow et al. Effect of Screen Time on Recovery From Concussion: A Randomized Clinical Trial. JAMA Pediatrics 2021 Guest Skeptic: Dr. Catherine Varner is an Assistant Professor and Clinician Investigator in the Department of Family and Community Medicine at the University of Toronto. She is an emergency physician at Mount Sinai Hospital and a Clinician Scientist and the Deputy Director of the Schwartz-Reisman Emergency Medicine Institute. Dr. Varner's research interests are in concussion and pregnancy care in the ED. Case: An 18-year-old female presents to the emergency department (ED) after falling off a moving snowmobile and hitting her head on the ground. It was a witnessed fall; she was wearing a helmet at the time and there was no loss of consciousness. There were no other injuries reported and she is found to have a GCS score of 15 after the injury. The Acute Concussion Evaluation–Emergency Department (ACE-ED) Tool is used, and she scores a 2 for headache and feeling foggy. She knows about taking it easy physically for the next couple of days but wonders if she must stay off her computer as well? Background: Concussions or mild traumatic brain injury (mTBI) are commonly diagnosed in the Emergency Department (ED). Most patients recover within the first week; however, 15-30% of patients develop persistent post-concussive symptoms. An issue that often comes up with minor head injuries is do we need to get advanced imaging. A paper by Dr. Ian Stiell and his group gave us a tool to help us decide who to scan with the now infamous clinical decision instrument called the Canadian CT Head Rule [1]. This classic paper was published in Lancet 2001 and reviewed on SGEM#106. Another issue that comes up is whether children need strict rest after a concussion. SGEM#112 reviewed a small study by Thomas et al published in Pediatrics 2015 asking if there was a benefit to recommending strict rest after a child has a concussion [2]. The bottom line from that episode was that in children with concussion, two days of rest followed by a gradual return to activity is preferred over five days of rest followed by a gradual return to activity. The longer strict rest period appears to cause more post-concussive symptoms. Our episode together looked at the impact of light exercise in adults with mild concussions on the likelihood of developing persistent symptoms up to 30 days following their injury (SGEM#331). We found there was not a statistical difference between light activities like walking and 48 hours of rest with gradual return to activity as tolerated. Our conclusions were that early light exercise may be encouraged as tolerated at ED discharge following mTBI, but this guidance is not sufficient to prevent persistent concussion symptoms [3]. The Acute Concussion Evaluation–Emergency Department (ACE-ED) tool is an instrument used by ED clinicians to diagnose a concussion and identify risk factors for prolonged recovery. It is both helpful for diagnosis and future management of symptoms. When a patient is recovering from a concussion, whether you are using ACE or another symptom scoring tool like the Postconcussion Symptom Scale or the Rivermead Post-concussion Symptom Questionnaire, future health care providers caring for the concussion patient may refer to the quantitative assessment of the patient’s symptoms in the acute phase of the injury. Clinical Question: Does screen time in the first 48 hours after concussion have an impact on the duration of concussive symptoms? Reference: Macnow et al. Effect of Screen Time on Recovery From Concussion: A Randomized Clinical Trial. JAMA Pediatrics 2021 Population: Patients aged 12 to 25 years presenting to the emergency department within 24 hours of sustaining a concussion according to the Acute Concussion Evaluation–Emergency Department (ACE-ED) tool (Giola et al 2008) Exclusions: Attending physician declined participation; their guardian was not present; the patient was younger than 18 years, or they (or their parent or guardian) were not fluent in English; intoxication; had a GCS score < 15; had intracranial abnormalities identified on imaging; had pre-existing intellectual disability, severe psychiatric illness, severe neurological conditions, or substantial previous neurological surgery; or required neurosurgical intervention, intubation, or hospital admission. Intervention: Patients were asked to abstain from screen time for 48 hours after injury. This was the screen time abstinent group. Comparison: Patients were permitted to engage in screen time in the first 48 hours after injury. This was the screen time permitted group. Outcome: Primary Outcome: Number of days until functional resolution of concussive symptoms, which was defined as the first day with a total score of three points or lower on the Post-Concussive Symptom Scale (PCSS) Secondary Outcomes: Amount of screen and sleep time during the intervention period, the day of return to school or work after the intervention period, the day of return to exercise after the intervention period, and daily PCSS scores. Trial: Single-centre, unblinded, randomized clinical trial Authors’ Conclusions: “The findings of this study indicated that avoiding screen time during acute concussion recovery may shorten the duration of symptoms. A multicenter study would help to further assess the effect of screen time exposure.” 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. 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). No All patient-important outcomes were considered. Unsure The treatment effect was large enough and precise enough to be clinically significant. No Funding. The stated conflicts of interests by the authors would not likely influence the conclusions of this trial. Results: They enrolled 125 patients into the study. The mean age was 17 years and 49% were female. Key Results: Patients with concussions who abstained from screen time recovered quicker than those permitted screen time. Primary Outcome: Median number of days until functional resolution of concussive symptoms, which was defined as the first day with a total score of 3 points or lower on the Post-Concussive Symptom Scale (PCSS) Abstained 3.5 days vs permitted 8.0 days Hazard ratio [HR], 0.51 (95% CI; 0.29-0.90) Secondary Outcomes:  Sensitivity analysis using different PCSS thresholds for recovery 1. Recruitment of Patients – This was a convenience sample when study staff was available. It is very difficult to enroll consecutive patients in the ED 24/7/365. However, we would have liked to know how many people were not approached, why and their characteristics. This would help us know if the patient population included is similar to those being seen at our own centres (tertiary, community or rural). Patients could also be excluded if the physician did not wish to participate. These factors could have introduced an element of selection bias. 2. Who Were These Patients - Let’s talk about generalizability? This study took place in a large volume, tertiary care level 1 trauma centre. They enrolled patients ages 12 to 25 years old, so a population in whom concussions are common. In that regard, this study can be generalized to many of the centres where we work and many of the patients whom we commonly see. However, just like in nerdy point #1, I want to know more about the clinical characteristics of the included patients. What happened to them in the ED? Did they undergo head CT? Did they need analgesics or antiemetics? Were they at risk of prolonged symptoms based on their pre-injury risk factors such as having anxiety or depression? These are some aspects of generalizability that I can’t answer when I read this trial. Our group completed a randomized trial in 241 patients with mild traumatic brain injury, published in Academic Emergency Medicine last year, and when we did a secondary analysis to identify risk factors associated with prolonged symptoms, we found, having a history of anxiety or depression increased the risk of persistent symptoms. Consistently studies looking at predictors of persistent symptoms have identified pre-injury depression or anxiety as risk factors. It would have been helpful to know what proportion of participants in this trial previously identified pre-injury risk factors for prolonged symptoms. 3. Blinding – This is an important aspect of RCTs but not always possible. Patients knew what group they were assigned. Were they aware of the hypothesis and did they have pre-conceived notion of the impact of screen time on concussions? This is important because they self-reported their amount of screen. This reporting could have been biased in the intervention control group. It is unclear if this would have biased the results towards or away from the null hypothesis. 4, Primary Outcome - Ensuring the primary outcome and a priori sample size calculation reflect what has already been published in the preceding literature is, in my opinion, the most important aspect to designing a randomized trial. I found this undertaking a bit confusing.

Date: February 24th, 2022 Reference: Parish et al. An umbrella review of effect size, bias, and power across meta-analyses in emergency medicine. AEM 2021 Guest Skeptic: Professor Daniel Fatovich is an emergency physician and clinical researcher based at Royal Perth Hospital, Western Australia. He is Head of the Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research; Professor of Emergency Medicine, University of Western Australia; and Director of Research for East Metropolitan Health Service. Case: A resident has been following the literature over their four years of training. They have already seen several things come into fashion and go out of fashion during this short time. This includes therapeutic hypothermia for out-of-hospital cardiac arrest (OHCA), tranexamic acid (TXA) for epistaxis and electrolyte solutions for mild pediatric gastroenteritis. They wonder how strong the evidence is for much of what we do in emergency medicine. Background: There are many things in medicine that could be considered myth or dogma. We have covered some of these over the 10 years. Topical anesthetic uses of 24-48 hours for mild cornea abrasions will cause blindness- No (SGEM# 315) Epinephrine for adult out-of-hospital cardiac arrests (OHCAs) results in better neurologic outcomes – No (SGEM#238) TXA for intracranial hemorrhage, isolated traumatic brain injury, post-partum hemorrhage or gastrointestinal bleed results in better primary outcomes - No (SGEM#236, SGEM#270, SGEM#214, and SGEM#301) Therapeutic hypothermia in adult OHCA saves lives – No (SGEM#336) Electrolyte solutions are needed in mild pediatric gastroenteritis - No (SGEM#158) A lot of medical practice is based on low quality research. Tricoci et al. JAMA Feb 2009 looked at the ACC/AHA guidelines from 1984 to 2008. They found 53 guidelines with 7,196 recommendations. The results were only 11% of recommendations were considered Level A, 39% were Level B and 50% were Level C. The definitions used for each level of evidence are as follows: An update was published by Fanaroff et al in JAMA 2019. The level of high-quality evidence had not changed much when looking at the ACC/AHA guidelines from 2008-2018. There were 26 guidelines with 2,930 recommendations. Now Level A recommendations were down to 9%, Level B 50% and Level C 41%. This lack of evidence is not isolated to cardiology. A recent study looked at the top ten elective orthopaedic procedures. It was an umbrella review of meta-analyses of randomized control trials (RTCs) or other study designs if no RCTs existed (Blom et al BMJ 2021). The comparison was the clinical efficacy of the most common orthopaedic procedures with no treatment, placebo, or non-operative care. The primary outcome was the quality of the evidence for each procedure. Only two out of ten common procedures, carpal tunnel decompression and total knee replacement, showed superiority over non-operative care. Clinical Question: What is the effect of faults such as underpowered studies, flawed studies (i.e. methodologic and statistical errors, poorly designed studies) and biases in the field of therapeutic interventions in the emergency medicine literature? Reference: Parish et al. An umbrella review of effect size, bias, and power across meta-analyses in emergency medicine. AEM 2021 Population: SRMAs 1990-2020 in the top 20 journals under the google scholar subcategory: emergency medicine; emergency medicine meta-analyses from JAMA, NEJM, BMJ, The Lancet, and the Cochrane Database of Systematic Reviews; emergency medicine topics across all PubMed journals; and an extraction of all studies from the Annals of Emergency Medicine Systematic Review Snapshots (SRS) series. Exclusions: Articles were excluded if they did not include a quantitative synthesis (meta-analysis); did not contain at least two summarized studies; did not make a comparison between two groups to assess an effect size; did not report an effect size as at least one of mean difference or standardized mean difference (SMD; Cohen's d), odds ratio (OR), risk ratio (RR), hazard ratio (HR), or transformations of these effect sizes; were meta-analyses of diagnostic accuracy studies; or were not related to the practice of emergency medicine. Intervention: Data supplement 1 lists all 431 MAs derived from 332 published SRMAs. Comparison: Includes placebo, usual care, nothing. Outcomes: Identify broad patterns in study parameters (effect size, power, mortality benefit and potential bias). Dr. Austin Parish We are fortunate to have the lead author on this episode even though it is not an SGEMHOP. Dr. Austin Parish is the Chief Resident in Emergency Medicine at the Lincoln Medical Center, Bronx NY. He is also a researcher for the Meta Research Innovation Center at Stanford (METRICS) Authors’ Conclusions: “Few interventions studied within SRMAs relevant to emergency medicine seem to have strong and unbiased evidence for improving outcomes. The field would benefit from more optimally powered trials.” Quality Checklist for Therapeutic Systematic Reviews: The clinical question is sensible and answerable. Yes The search for studies was detailed and exhaustive. Yes The primary studies were of high methodological quality. No The assessment of studies were reproducible. Yes The outcomes were clinically relevant. Yes There was low statistical heterogeneity for the primary outcomes. No The treatment effect was large enough and precise enough to be clinically significant. Sometimes Results: The systematic review identified 431 eligible meta-analyses (MAs) relevant to emergency medicine. The MAs included a total of 3,129 individual study outcomes of which 2,593 (83%) were from randomized controlled trials. Key Result: A minority of interventions published in SRMA and relevant to emergency medicine have unbiased and strong evidence for improved outcomes. Primary Outcome: Broad patterns in study parameters Effect Size: The median Odds Ratio (OR) across all studies was 0.70. Within each MA, the earliest study effect on average demonstrated larger benefit compared to the overall summary effect. Only 57 of 431 meta-analyses (13%) both favored the experimental intervention and did not show any signal of small study effects or excess significance. Power: Only 12 of 431 MAs had at least one study with 80% or higher power to detect an OR of 0.70 Mortality: Zero out of 431 MAs reported the interventions significantly decreased mortality in well-powered trials. Although the power of studies increased somewhat over time, most studies were underpowered. Biases: 92 of the SRMAs included 10 or more studies that could be analyzed with a funnel plot for asymmetry. 25% (23/92) showed evidence of asymmetry suggesting excess significance. 85 (20%) of the SRMAs reported statistical significance in favor of the intervention. Of these, 1/3 showed a signal of small study effect and/or excess significance while 2/3 (57/85) did not. Of the 57, only 36 (63%) had a GRADE assessment reported. Half were rated as low-quality evidence and only 11% rated as high-quality evidence. 1. How Good is the Evidence? I’ve often posed the question: what proportion of our EM clinical practice is backed up by high level evidence? After speaking with thought leaders the answer I got to was less than 10%. This umbrella review quantifies the answer in more detail: 12/431 = 2.8%. There is not a large amount of high-level evidence supporting most EM practices. The results demonstrate that very few interventions meet the highest evidence standards, and most of the SRMAs are significantly flawed and may overstate true treatment effects. So, we need to advance our knowledge and practice through never ending questioning of it, via a research culture, whereby clinical trials and clinical research are a routine part of everyday EM work, research that engages clinicians and patients with clinically useful questions – to be a learning health system. What is the proportion of our EM clinical practice is backed up by high level evidence? 2. The Best Evidence: Table 1 in the paper lists the 12 MAs in EM that have statistically significant results (p < 0.05 by random effects), based on data with no signal for small study effects or excess significance and at least one RCT and at least one study with 80% power to detect a small effect (d = 0.2). The biggest effect of an intervention was the rate of haemolysis using straight needle venepuncture vs an IV; OR 0.11(95%CI; 0.05-0.23). Of the 12 MAs, only another three had a 95% confidence intervals that did not cross 1 (the line of no statistical difference), for well powered studies (fixed effect): senior doctor vs no senior doctor in triage for preventing patient left without being seen (OR 0.74, 95% CI; 0.70-0.77); clopidogrel pre-treatment vs no clopidogrel pre-treatment in acute coronary syndrome patients to receive percutaneous intervention (OR 0.79, 95% CI; 0.73-0.85) for a major coronary event; glucocorticoids and usual care vs usual care for croup (OR 0.44, 95% CI; 0.27-0.72) on rate of return visits. While there were no mortality benefits listed under fixed effect, well powered studies, under the heading of random effects, all studies – there were some mortality benefits for mechanical CPR, transfer for angioplasty, thrombolysis for PE and vasopressin + catecholamines. The details will be listed in the blog. Mechanical CPR vs manual CPR for OHCA on mortality by arrival to hospital (OR 0.80, 95% CI; 0.68-0.94); Transfer for angioplasty vs on site thrombolysis for ST elevated myocardial infarction on 30-day mortality (OR 0.78, 95% CI; 0.61-0.99); Thrombolysis vs conventional anticoagulation for pulmonary embolism (OR 0.42, 95% CI; 0.19-0.93);

Date: February 21st 2022 Reference: Kim et al. Emergency psychiatric assessment, treatment, and healing (EmPATH) unit decreases hospital admission for patients presenting with suicidal ideation in rural America. AEM February 2022. Guest Skeptic: Dr. Kirsty Challen (@KirstyChallen) is a Consultant in Emergency Medicine and Emergency Medicine Research Lead at Lancashire Teaching Hospitals Trust (North West England). She is Chair of the Royal College of Emergency Medicine Women in Emergency Medicine group and involved with the RCEM Public Health and Informatics groups. Kirsty is also the creator of the wonderful infographics called #PaperinaPic. Case: You are in discussion with your emergency department (ED) manager about the number of patients boarding for hours to days and you are both aware that many of these patients are attending with mental health crises. You wonder whether a model of care involving a specifically designed unit would improve their patient experience and ED boarding times. Background: We have covered mental health issues only a few times on the SGEM. The latest SGEM Xtra was a very powerful episode with Dr. Tim Graham sharing his story of burnout, anxiety, and depression. This was based upon his article published in the Canadian Medical Association Journal (CMAJ). We also had Dr. Tyler Black on that episode to provide his expertise as a suicidologist.  ED visits in the US for mental health conditions has increased by 44% from 2006 to 2014. Inadequately resourced provision for emergency mental health care is familiar to health care professionals in multiple jurisdictions and patients can spend days in the ED waiting for inpatient admission. We've talked about mental health issues in SGEM #252 in 2019. In that episode we concluded that clinician gestalt was likely to be as accurate and efficient in screening for suicidality as a specific tool (Convergent Functional Information for Suicidality screening tool). Also, in SGEM #313 we recognised that three or more ED attendances for alcohol-related issues was associated with a 1-year mortality risk of over 6%. Clinical Question: Does the implementation of a dedicated interdisciplinary unit for mental health patients presenting to an ED with suicidal ideation or a suicide attempt reduce inpatient admissions and ED boarding time? Reference: Kim et al. Emergency psychiatric assessment, treatment, and healing (EmPATH) unit decreases hospital admission for patients presenting with suicidal ideation in rural America. AEM February 2022. Population: Adults presenting to a single academic tertiary referral ED in Iowa with suicidal ideation or after a suicide attempt – determined using administrative data.. Excluded: Patients that were medically unstable, needed co-management of a medical condition, were incarcerated, actively violent or judged by the provider to be intoxicated. Also, patients with mental health conditions other than suicidal ideation or attempt. Intervention: Post-establishment of EmPATH unit Nov 2018 – May 2019. Comparison: Pre-establishment of EmPATH unit Nov 2017 – May 2018. Outcome: Primary Outcome: Proportion of patients admitted to inpatient psychiatric unit (direct from ED, via EmPATH Unit or by transfer). Secondary Outcomes: Any admission including psychiatry, intensive care, or medicine; complete vs incomplete psychiatric admission; hospital length of stay in those with a bed requested; ED length of stay; use of restraints in ED, scheduled follow-up, 30-day ED return; restraint use; code green Dr. Allie Kim This is an SGEMHOP episode which means we have the lead author on the show (Dr. Kim). And as a special treat we also have the senior author (Dr. Lee). Dr. Allie Kim graduated from emergency medicine residency at the University of Iowa last July and now works as an attending physician at Unity Point Health hospitals in Des Moines, Iowa. We also have senior author Dr. Sangil Lee who is a Clinical Associate Professor of Emergency Medicine at the University of Iowa. The state of Iowa has only a handful of inpatient psychiatric units. The University of Iowa, where the EmPATH unit was implemented, is one of them. We see patients from all over the state, plus even out of state, and with the increase in numbers of mental health presenting to our emergency department, the sheer percentage of our patients needing inpatient psychiatric care was high. And, as many of us have seen, patients may wait in their ER bed for days until an inpatient bed became available. This “boarding” of patients delayed their psychiatric care and left less room for us to see other patients. Dr. Sangil Lee The EmPATH program we created, in conjunction with the Department of Psychiatry, is an open concept unit with the capacity to treat 12 adults. Patients must be medically cleared first in the ED, and also be behaviorally appropriate, to enter the EmPATH unit. Once in the unit, there are psychiatrists, nurses, and social workers to help patients. Average stay is about two days and most patients go home after stabilization there; however, if they need additional time, they can be transferred to the inpatient psychiatry unit. Authors’ Conclusions: “The introduction of the EmPATH unit has improved management of patients presenting to the ED with suicidal attempts/ideation by reducing ED boarding and unnecessary admissions and establishing post-ED follow-up care.” 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? No Was the follow up of subjects complete enough? Yes How precise are the results? Fairly precise for the primary outcome 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 Funding of the Study: Department seed grant Results: There were 435 patients included in the pre-EmPATH stage and 527 patients included in the post-EmPATH stage. This gives a total cohort size of 962 patients presenting to the ED with suicidality. The median age was 32 years, it was close to a 50/50 male/female split, almost two-thirds arrived as walk-ins with the rest being by EMS or police, and 13% were identified as homeless. Key Result: Psychiatric admissions were reduced significantly after the introduction of the EmPATH Primary Outcome: Proportion of patients admitted to inpatient psychiatric unit (direct from ED, via EmPath Unit or by transfer). 57.1% in the pre-EmPATH stage vs 27.3% in the post-EmPATH stage Absolute difference of 29.8% and RR = 0.48 (95% CI = 0.40 to 0.56) Secondary Outcomes: ED boarding time was reduced from a mean of 16 hours to a mean of 5 hours We asked Allie and Sangil 10 nerdy questions to better understand their research. Listen to the SGEM podcast to hear their responses. Retrospective Observational Study – You acknowledge this as your first limitation. Why do you think it is important to caution readers about this type of study design? Administrative Data – You used administrative data (admitting diagnosis) to identify the patients to include in this study. Particularly with patients presenting after suicide attempt, who may have a diagnosis involving injury or poisoning, how sure are you that you can capture all these? Before and After Study – This was an uncontrolled before and after observational study. An editorial in the EBM_BMJ by Goodacre cautions against these types of studies. Stepped Wedge Design – One way to address this limitation of uncontrolled before and after study design would be to perform a stepped wedge design. A multi-centred cluster RCT would provide more robust information. Have you considered this as a future project? Single Centre – That is a great Segway into another nerdy point. This was a single center study. How representative is your center of US EDs in general and academic EDs in particular? Confounders - We mentioned in the quality checklist that you haven't presented rates of substance misuse or previous psychiatric diagnosis in the paper. Do you think they have changed or might have had an effect on the EmPATH unit? Washout - You had a washout period from May – Nov 2018. Can you explain to listeners why this was important for your study design and what was happening in the ED and EmPATH units during that time? Length of Stay – In the United Kingdom they have a goal to try to disposition emergency department patients within 4 hours. The decrease ED length of stay (LOS) decreased from 16 hours down to 5 hours. If confirmed, this could make a significant impact on ED flow. However, the total hospital LOS for patients who had a psychiatric bed request placed did not change with the implementation of EmPATH. Might you just be shifting the boarding problem from the ED to EmPATH, or do you think patients still benefit from the wider scope of care provided in the EmPATH unit? Long-Term Data – Why did you not follow-up on the long-term patient outcome such as suicide related using national data as you had done in previous studies? Anything Else – Is there anything else you would want the SGEM listeners to know about your research that we have not asked or was not published in the manuscript? Comment on Authors’ Conclusion Compared to SGEM Conclusion: We agree that in this case the EmPATH unit has been associated with a reduction in psychiatric admissions and ED boarding times.

Date: February 15th, 2022 Guest Skeptic: Dr. Tim Graham is a Clinical Professor of emergency medicine at the University of Alberta, and Associate Chief Medical Information Officer, Edmonton Zone, of Alberta Health Services from Edmonton, Alberta. Reference: Graham T. Physician heal thyself. CMAJ 2021 TRIGGER WARNING: As a warning to those listening to the podcast or reading this blog post, there may be some things discussed that could be upsetting. The SGEM is a free open access project trying to cut the knowledge translation down to less than one year. It is intended for clinicians providing care to emergency patients, so they get the best care, based on the best evidence. Some of the material we are going to be talking about on this episode could trigger some strong emotions. If you are feeling upset by the content, then please stop listening to the podcast or reading the blog. There will be resources listed at the end of the blog for those looking for assistance. Dr. Tim Graham This is an SGEM Xtra episode. Tim approached me about an article he wrote and published in the Canadian Medical Association Journal (CMAJ). The title of the article was "Physician, heal thyself" and was in the humanities section of the October 2021 issue. This article resonated with many people and was the 6th most read CMAJ article of 2021. Tim thanked his wife, Dr. Samina Ali, in the CMAJ article and on the podcast. Samina has been a guest skeptic on the SGEM. She is the one who suggested Tim share his story to reach an even wider audience. In this SGEM Xtra episode, Tim tells his experience with burnout. This is a topic we have discussed many times on the SGEM and I have shared my personal experience with burnout. SGEM Xtra: The Water is Wide SGEM#289: I Want a Dog to Relieve My Stress in the Emergency Department SGEM Xtra: CAEP Wellness Week 2019 SGEM Xtra: On the Edge of Burnout SGEM Xtra: Don’t Give Up – The Power of Kindness SGEM#178: Mindfulness – It’s not Better to Burnout than it is to Rust SGEM Xtra: Five Tips to Avoid Emergency Medicine Burnout A 2015 study by Shanafelt et al of US physicians showed that more 50% had at least one symptom of burnout. The highest prevalence of burnout was reported by emergency physicians. COVID19 has been hard on the health care system. Medscape just published a 2021 survey of 13,000 physician from 29 specialties and emergency physicians were still #1 reporting the highest level of burnout.  People have made a distinction between burnout and moral injury. Journalist Diane Silver describes moral Injury as “a deep soul wound that pierces a person’s identity, sense of morality, and relationship to society.” It is something that tears us apart at the fabric of what it is to be a physician. Tim discusses how he started getting suicidal ideations and what he did to try and address these thoughts. This included seeking professional help, medication, and lifestyle changes. Some interventions helped more than others. Tim reports he is now in the best place mentally and physically than he has been in many years. Tim also gives some advice to prevent others from going through a similar experience. This includes a wellness tool kit that starts with a healthy diet, regular exercise and good sleep. Two things he found really helpful were meditation and yoga. Suicidologist: Dr. Tyler Black When preparing this SGEM Xtra episode, I suggested to Tim we get an expert in mental health to give us some more information on the topic. I'm not an expert in this area and reached out to Dr. Tyler Black. Tyler is a suicidologist, emergency psychiatrist and pharmacologist from Vancouver. Dr. Tyler Black Tyler provided a definition for suicidologist. He discussed burnout and the association with suicidal ideation in physicians (Menon et al JAMA 2020. Tyler gave some potential reasons why physicians do not seek mental health care (stigma, colleges/regulatory bodies, access to care, etc).  He  also described how we can help each other and ourselves stay mentally healthy. Tyler was also asked what he would do if given a blank cheque to address this problem of physician burnout. He would spend the money on research and getting scribes to interact with the EMR and not buy muffins for the break room. Tim was asked at the end of the podcast what he would tell his younger self. I challenge the SGEM audience to think about what you would say to your younger self. Here is what Tim would say: "I would tell young me that no matter how important I think work is, I am really just another cog in the never-ending gears of the health care system. Once internalized, this knowledge was liberating, and it gave me permission to prioritize myself and my well-being. In the end, if you die tomorrow, your employer will replace you, but your loved ones cannot." 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. So, patients get the best care, based on the best evidence. REMEMBER TO BE SKEPTICAL OF ANYTHING YOU LEARN, EVEN IF YOU HEARD IT ON THE SKEPTICS’ GUIDE TO EMERGENCY MEDICINE. Resources: Physician Wellness Resources Physician Health Program ACEM Member Wellbeing ACEP Wellness Section CAEP Resident Wellness EMRA Wellness Committee Meditation Apps Waking Up with Sam Harris Headspace Suicide Telephone and Websites Prevention Hotline 1-800-273-8255 (SAFE) USA Text HOME to 741741 Canada Text 686868 Suicide Prevention Life Line American Foundation for Suicide Preventio (AFSP) Suicide Prevention Resource Center AFSP for Professionals Podcasts Peter Attia Drive

Date: February 7th, 2022 Reference: Williams et al. Short- vs standard-course outpatient antibiotic therapy for community-acquired pneumonia in children: the scout-cap randomized clinical trial. JAMA Pediatrics 2022 Guest Skeptic: Dr. Dennis Ren is a pediatric emergency medicine fellow at Children’s National Hospital in Washington, DC. Case: A three-year-old boy presents to the emergency department (ED) with fever and cough. On exam, he is breathing a little fast and his oxygen saturation is 94% on room air but otherwise appears comfortable. You appreciate some decreased breath sounds and crackles on your lung exam. You make a clinical diagnosis of community-acquired pneumonia (CAP) and plan to send him home with a 10-day course of amoxicillin. His mother asks you, “Last time he took antibiotics for that long, he had terrible diarrhea. Do you think we can do fewer days of antibiotics and still treat the pneumonia?” Background: We have covered the topic of pediatric community-acquired pneumonia before on the SGEM #338 (Are Children with CAP Safe and Sound if Treated for 5 days rather than 10 days of antibiotics?) with Dr. Andrew Tagg on the Canadian SAFER Trial [1]. This trial suggested that a 5-day course of antibiotics was not non-inferior to the traditional 10-day course of antibiotics for children with CAP treated as outpatients. Things were much simpler when I started my pediatric training. I learned that a well-appearing child presenting to clinic with fever, slight tachypnea, and focal lung exam findings could be diagnosed with pneumonia by history and physical exam alone and go home with 10 days of amoxicillin BID. But now for some reason, this topic feels more complicated…maybe because there are so many different ways people go about diagnosing pneumonia and such variability in the reliability of physical exam findings [2,3]. Since we covered the SAFER trial, we have also had the CAP-IT [4] trial from the United Kingdom and Ireland which evaluated both high and low-dose amoxicillin for the treatment of CAP over three or seven days. They found that both a lower dose and a shorter duration of antibiotic therapy was non-inferior to higher dose, longer duration antibiotic therapy. They did find that cough persisted longer with the group that received a shorter duration of antibiotic therapy but overall adherence to medication was better in the group receiving a shorter duration of antibiotics. Why so many pneumonia studies? Ultimately, we want to find that balance of treating an infection but avoiding antibiotic-associated adverse effects and antibiotic resistance. So where is that sweet spot?  Clinical Question: Is a 5-day course of antibiotics superior to a 10-day course for the treatment of non-severe community-acquired pneumonia in children with respect to clinical outcomes, adverse effects, and antimicrobial resistance? Reference: Williams et al. Short- vs standard-course outpatient antibiotic therapy for community-acquired pneumonia in children: the scout-cap randomized clinical trial. JAMA Pediatrics 2022 Population: Children 6 to 71 months of age from 8 US cities diagnosed with uncomplicated CAP demonstrating early clinical improvement (no fever, tachypnea, severe cough) on day 3 to 6 of their initially prescribed oral beta-lactam therapy. Excluded: Severe pneumonia (Hospitalization, radiographic evidence of parapneumonic effusion, empyema, lung abscess, pneumatocele or Microbiologically confirmed Staph aureus or Strep pyogenes pneumonia. Parenteral or combination antibiotic therapy. Undergoing surgery or invasive airway procedures 7 days prior to diagnosis of CAP. Beta-lactam allergy. Concurrent bacterial infection necessitating >5 days of antibiotics. Aspiration pneumonia, bronchiolitis, bronchitis, acute asthma exacerbation. Chronic medical conditions. History of pneumonia within prior 6 months Intervention: Short 5 days course of previously prescribed antibiotic therapy (amoxicillin, amoxicillin with clavulanate, cefdinir) with 5 days of placebo Comparison: Standard course of 10 days of previously prescribed antibiotic therapy Outcomes: Primary Outcome: End of treatment response adjusted for duration of antibiotic risk (RADAR) at the first outcome assessment visit (OAV1) which occurred on study days 6 to 10. This was a 2-step process: Desirability of outcome ranking (DOOR) based on adequate clinical response, resolution of symptoms, presence, and severity of antibiotic-associated adverse effects. Ranked overall experience based on actual reported treatment duration Secondary Outcomes: RADAR at the second outcome assessment visit (OAV2) on study days 19 to 25. A portion of participants also consented to throat swab collection at the second outcome assessment visit to evaluate antibiotic resistance genes in oropharyngeal flora. Trial: Prospective, multicenter randomized double-blind placebo-controlled superiority clinical trial. Authors’ Conclusions: “In this study, among children responding to initial treatment for outpatient CAP, a 5-day antibiotic strategy was superior to a 10-day strategy. The shortened approach resulted in similar clinical response and antibiotic-associated adverse effects, while reducing antibiotic exposure and resistance.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. No The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. No selection bias). Unsure The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. 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 Lack of conflicts of interest. No Results: They included 380 children (189 randomized to short course and 191 randomized to standard course). Mean age was 36 months, 51% male and 91% were treated with amoxicillin. Key Result: 5-day course of antibiotics for the treatment of outpatient CAP was superior to a 10-day course (similar efficacy, similar adverse events, while reducing antibiotic exposure and resistance). Primary Outcome: No significant difference in proportions of inadequate clinical response, persistent symptoms, or antibiotic-associated adverse effects between short-course vs standard-course groups. Short course therapy had 69% (95% CI, 63% to 75%) probability of more desirable RADAR outcome compared to standard course. This reflects the probability of a better DOOR (clinical response, resolution of symptoms, and antibiotic-associated adverse effects) for a randomly selected participant from the short course vs the standard course strategy. Secondary Outcomes: 1. Potential Selection Bias: They included 380 patients over a three-year study period. They do not remark on whether patients were enrolled consecutively, but I would assume there were probably quite a few more cases of pneumonia diagnosed across multiple institutions in that study period than were included in the final analysis. There was also some subjectivity in the enrollment. Patients could not have been included if they had a severe cough. Who decided whether the cough was severe and did they have some objective measure? They also used tachypnea to exclude patients. Measuring tachypnea is well known to be inaccurate and lack inter-rater reliability [5-7]. These factors may lead to some selection bias. 2. Included Patients: Patients included in this study were relatively healthy from 6 months to 71 months of age. We need to be cautious when extrapolating the results to children with underlying conditions or outside those age ranges. 3. Outcomes: We need to say a few things about the outcomes in this trial Complicated: Their primary outcome was a composite outcome which can make a fuzzier target. It was also a little hard to interpret. ClinicalTrials.gov Data - We should applaud the authors of this study for reporting the primary and secondary outcomes that they originally proposed. It is still surprising the number of published research trials in which the reported outcomes differ from the proposed outcomes. DOOR Score: The DOOR score evaluated patient-oriented outcomes, specifically clinical response, persistence of symptoms, and adverse effects from antibiotic therapy. We acknowledge that these have a degree of subjectivity including grading of cough severity and adverse effects of antibiotic therapy. Resistomes: A subgroup of the patients had throat swabs to assess for antibiotic resistance genes (ARGs) expressed as resistance genes per prokaryotic cell (RGPC). The authors reported that there were significantly lower RGPCs in the group that had short-course therapy in comparison to standard therapy. This is a lab-oriented outcome that brings up a few questions: Does this assessment of respiratory flora from a throat swab really correlate with what is happening in the lungs? What does a difference of 1.17 vs 1.33 mean clinically if anything? Is this going to be a persistent change? 4. Diagnosis of Pneumonia: All the patients included in this study were previously diagnosed with CAP in an outpatient clinic, urgent care centre, or emergency department. Unfortunately, we do not know how the diagnosis of pneumonia was made. Was it by clinical exam findings? Chest radiograph? Respiratory cultures? How accurate were these diagnoses? However,

Date: January 25th, 2022 Reference: Beyde et al. Efficacy of empiric antibiotic management of septic olecranon bursitis without bursal aspiration in emergency department patients. AEM January 2022 Guest Skeptic: Dr. Corey Heitz is an emergency physician in Roanoke, Virginia. He is also the CME editor for Academic Emergency Medicine. Case: You’re working in your busy freestanding emergency department (ED) getting absolutely crushed handing out COVID19 tests like candy and are relieved to see a patient with something different. A 27-year-old male construction worker building a local house presents with a tender, warm, erythematous olecranon and you diagnose him with septic olecranon bursitis. You offer to drain the bursa and get him back to work ASAP, and the patient looks very anxious and asks if you really must. Background: We have covered skin and soft tissue infections multiple times on the SGEM. The most recent time was with guest skeptic and SAEM FOAMed Excellence in Education Award winner Dr. Lauren Westafer (SGEM#348). We reviewed Dr. David Talan and colleagues’ study that was the October 2021 SGEM Hot Off the Press. That study investigated if a single-dose long-acting intravenous antibiotic could reduce hospitalization in patients with skin infections. The SGEM bottom line from that episode was in hospital systems with access to IV dalbavancin and the ability to establish expedited telephone and in-person follow up, this clinical pathway is associated with a decrease in hospitalizations for patients with moderately severe cellulitis. A couple of other SGEM episodes have looked at the management of cellulitis including SGEM#131 and SGEM#209. The treatment of abscesses has been covered four times on the SGEM (SGEM#13, SGEM#156, SGEM#164 and SGEM#311). The latest episode looked at the loop technique to drain uncomplicated abscesses. One topic we have not looked at is infected bursa. It’s estimated that about half of olecranon bursitis cases are septic[1]. Often, diagnostic aspiration is performed, but complications include fistula formation, further infection, and need for bursectomy [2-6]. Often the workup of septic bursitis is based upon anecdotal evidence [7]. This is likely due to the lack of high-quality evidence to direct our care. One area with limited information is the efficacy of empiric antibiotics without bursal aspiration. Clinical Question: What is the efficacy and outcomes associated with empiric antibiotic therapy, without aspiration, for septic olecranon bursitis? Reference: Beyde et al. Efficacy of empiric antibiotic management of septic olecranon bursitis without bursal aspiration in emergency department patients. AEM January 2022 Population: Adults >18 years old with olecranon bursitis Excluded: Declined authorization, underlying fracture, or surgery on the joint within 3 months Exposures: Antibiotics, aspiration, surgery or admission to hospital Comparison: None Outcome: Primary Outcome: Complicated versus uncomplicated bursitis resolution (Uncomplicated was defined as bursitis resolution without the need for bursal aspiration, surgery, or hospitalization) Secondary Outcome: Descriptive statistics of the cohort Study Design: Retrospective observational cohort study Dr. Ronna Campbell This is an SGEMHOP episode which means we have the senior author on the show. Dr. Ronna Campbell is an emergency physician practicing since 2007 in Rochester, MN. She enjoys mentoring medical students, residents and others in research. Authors’ Conclusions: “Eighty-eight percent of ED patients with suspected septic olecranon bursitis treated with empiric antibiotics without aspiration had resolution without need for subsequent bursal aspiration, hospitalization, or surgery. Our findings suggest that empiric antibiotics without bursal aspiration may be a reasonable initial approach to ED management of select patients with suspected septic olecranon bursitis.” Quality Checklist for Observational Study: Did the study address a clearly focused issue? Yes Did the authors use an appropriate method to answer their question? Yes Was the cohort recruited in an acceptable way? Yes Was the exposure accurately measured to minimize bias? Yes Was the outcome accurately measured to minimize bias? Yes Have the authors identified all-important confounding factors? Unsure Was the follow up of subjects complete enough? Yes How precise are the results? Fairly wide 95% CI around some of the point estimates 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 Funding of the Study? NCATS/NIH grant Results: 264 patients included in the study, 229 with three months of follow up, 220 with six months. The age ranged from 42-69 years with 85% male. The most common presenting symptoms were swelling (94%), erythema (77%), and pain (85%). Key Results: Most patients with suspected septic olecranon bursitis had an uncomplicated resolution of their bursitis. Primary Outcome: Complicated vs uncomplicated resolution 88.1% were uncomplicated (95% CI: 81.1%–92.8%) 6.0% had subsequent bursal aspiration (95% CI: 2.8%–11.8%) 6.7% were subsequently admitted to hospital for antibiotics (95% CI: 3.3%–12.7%) Secondary Outcomes: 1.5% (4) had ED aspiration with no known complications (one lost to follow-up) 15% (39) were admitted to hospital on the initial visit 56% (147) were discharged from the ED with antibiotics 8.8% (13) lost to follow up, 17.2% (27) 95% CI 11.4%-25.9% had subsequent bursitis-related visit, 88.1% (118) 95% CI 81.1-92.8% uncomplicated resolution and 8 (6.0%, 95% CI 2.8%-11.8%) underwent subsequent bursal aspiration 29% (76) were discharged from the ED without Antibiotics 12% (9) lost to follow up, 97% (65) 95% CI 89-99% resolved without antibiotics, 91% (61) 95% CI 81.96% had an uncomplicated resolution and 3% (2) 95% CI 1-11% received inpatient antibiotics in a subsequent hospitalization Listen to the SGEM podcast to hear Ronna answer our five nerdy questions about her study. 1. Study Design: You decided to perform a retrospective observational study. This really limits the strength of conclusions that can be made from the data. Can you comment on the decision not to perform a prospective observational study or a randomized control trial (CEBM)? 2. STROBE – You mentioned the STROBE guidelines (Strengthening the Reporting of Observational Studies in Epidemiology). Some of the SGEM listeners may not be familiar with these guidelines. Can you tell us a little about these guidelines and why it is important to follow them? 3. Lack of Blinding – The abstractors were not blinded to the study objectives. Do you think that could have impacted the results and what did you do to mitigate this potential bias? 4. Gold Standard - Was there any gold standard for the diagnosis of septic olecranon bursitis other than provider impression? 5. External Validity – This study was conducted at a single centre. In addition, it was the Mayo Clinic which is a quaternary care ED. Practice patterns of clinical staff (MD/DO/NP/PA) and management may be different here than at other quaternary EDs or community and rural EDs. Do you think your study has external validity to other practice environments? Comment on Authors’ Conclusion Compared to SGEM Conclusion: We generally agree with their conclusions SGEM Bottom Line: Antibiotics without aspiration seems safe and may be an effective method of treatment for suspected septic olecranon bursitis. Case Resolution: You discuss the options with the patient and using shared decision making, decide on an empiric antibiotic approach, without aspiration. The patient has a full and uncomplicated resolution. Clinical Application: The evidence base is weak and does not provide a clear answer. When deciding on a treatment plan, it is reasonable to not perform an aspiration for suspected septic olecranon bursitis. Dr. Corey Heitz What Do I Tell My Patient? You have what appears to be an infected elbow bursa. A bursa is a fluid-filled pad around our joints. We can either stick a needle in the bursa (aspirate) and try to get some fluid. This fluid can be tested for infection. Aspiration of a bursa can have complications such as bleeding, causing an infection or hitting a nerve. Another option is to not do the aspiration and treat you with antibiotics. If this does not work or you are getting worse, you can always return to the ED. Would you prefer aspiration plus antibiotics or no aspiration plus antibiotics? Keener Kontest: Last weeks’ winner was Ravin Debie. They knew budesonide was patented in 1973. Listen to the SGEM podcast for this weeks’ question.  If you know, then send an email to thesgem@gmail.com with “keener” in the subject line. The first correct answer will receive a cool skeptical prize. SGEMHOP: Now it is your turn SGEMers. What do you think of this episode on septic olecranon bursitis? Tweet your comments using #SGEMHOP.  What questions do you have for Ronna and her team? Ask them on the SGEM blog. The best social media feedback will be published in AEM. Don’t forget those of you who are subscribers to Academic Emergency Medicine can head over to the AEM home page to get CME credit for this podcast and article. Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine. References: Stell IM. Management of acute bursitis: outcome study of a structured approach. J R Soc Med. 1999;92:516-521. Lormeau C, Cormier G, Sigaux J, Arvieux C, Semerano L. Management of septic bursitis. Joint Bone Spine. 2019;86:583-588. Deal JB Jr, Vaslow AS, Bickley RJ, Verwiebe EG,

Date: January 22nd, 2022 Reference: Yu et al. Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial. Lancet 2021 Guest Skeptic: Dr. Justin Morgenstern is an emergency physician and the creator of the #FOAMed project called First10EM.com. Case: A 65-year-old woman with a history of diabetes, hypertension, and gastroesophageal reflux disease (GERD) presents with three days of fever, cough, and myalgias. She is fully vaccinated against COVID-19. Her husband tested positive for COVID-19 yesterday, and she used a home rapid test this morning that is also positive. Her vitals signs are all normal and she feels well enough to isolate at home. As you are preparing to discharge her, she asks if there is anything you can prescribe her to help. She thinks her friend might have been prescribed a puffer of some sort. Background: I’ve tried not to focus too much on COVID-19. There are many great FOAMed resources that have done a good job of covering the topic. The SGEM has only done a few shows over the two years including: Debate regarding a universal mandate for masks early in the pandemic with Dr. Joe Vipond (SGEM Xtra: Masks4All in Canada Debate) Skeptical review of the early therapeutics with Dr. Sean Moore for the Canadian Association of Emergency Physicians (CAEP) Town Hall (SGEM Xtra: COVID19 Treatments – Be Skeptical) Diagnostic accuracy of various tests for COVID19 with Dr. Chris Carpenter (SGEM#299: Learning to Test for COVID19) Structured critical appraisal of the DANMASK trial with Dr. Joe Vipond (SGEM#309: That’s All Joe Asks of You – Wear a Mask) The First10EM has done more than 30 blog posts about COVID-19 at this point, with a lot more to come. I know we all wish COVID-19 would just go away. But unfortunately, wishful thinking won’t help us, but hopefully science will. There is strong evidence that systemic steroids improve outcomes in patients with severe COVID-19 (First10EM: Steroids for COVID). This has raised the question of whether inhaled steroids might be helpful. After all, the infection is primarily in the lungs. Early in the pandemic, there was some observational data that concluded that inhaled steroids were associated with an increased mortality from COVID-19 in patients with asthma and COPD (Schultze Lancet Resp Med 2020). However, the most likely explanation was not causal. Sicker patients are prescribed steroids more often, and so the association is not surprising. The STOIC trial was an initial phase 2 open-label randomized control trial of inhaled budesonide for patients with mild symptoms of COVID-19 (Ramakrishnan et al Lancet Resp Med 2021). It did report positive results. Their primary outcome was a ‘COVID-19 related’ urgent care visit, emergency department assessment, or hospitalization, and was significantly reduced in the budesonide arm (15% vs 3%, p=0.009). However, the unblinded trial design, less relevant composite outcome, and fact that the trial was stopped early limit confidence in the results. That bring us to the PRINCIPLE trial. Clinical Question: Does inhaled budesonide improve clinical outcomes in high-risk outpatients with COVID-19? Reference: Yu et al. Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial. Lancet 2021 Population: Outpatients with symptomatic COVID-19 within 14 days of symptom onset who were considered high risk for adverse events. This included adults over 65 years of age, or over 50 years of age with co-morbidities. Exclusions: Known allergy or contraindication to inhaled budesonide, were unable to use an inhaler, or already using inhaled or systemic glucocorticoids. Intervention: Inhaled budesonide 800 ug BID for 14 days Comparison: Usual care (there was no placebo) Outcome: Primary Outcome: Composite outcome of COVID-19-related hospital admission or death within 28 days. However, partway through the trial they realized hospitalization was lower than normal, and so they added a second primary outcome: illness duration. Secondary Outcomes: Recovery by 14 days, daily symptoms rating, time to sustained alleviation of symptoms, time to initial reduction of symptoms, contact with health services, oxygen administration, ICU admission, mechanical ventilation and adherence to study medication Trial Design: Multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial Authors’ Conclusions: “Inhaled budesonide improves time to recovery, with a chance of also reducing hospital admissions or deaths (although our results did not meet the superiority threshold), in people with COVID-19 in the community who are at higher risk of complications.”  Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. No The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Unsure The study patients were recruited consecutively (i.e. no selection bias). No 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. No 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. Unsure Funding and Conflicts of Interest: This is primarily government funded. However, multiple authors declared COIs associated with AstraZeneca. Results: They recruited 1,959 into the trial for the primary analysis (833 budesonide and 1,126 usual care). Mean age was 64 years, 81% had comorbidities, 52% female, 11% had been vaccinated (1 or 2 shots), 5% were current smokers and median duration of illness was 6 days. Key Result: No statistical difference in hospitalization or death but quicker recovery reported in budesonide group. Primary Outcome: There was no statistical difference for the original primary outcome of hospital admission or death due to COVID-19: 6.8% with budesonide versus 8.8% with usual care (ARR 2.0%, 95% CI -0.2 to 4.5%) For the added primary outcome of time to first reported recovery, budesonide was better at 11.8 vs 14.7 days, absolute benefit 2.9 days (95% CI: 1.2-5.1 days) Secondary Outcomes:  No statistical difference in mortality (1% v 1%), mechanical ventilation (2% v 2%), need for supplemental oxygen (7% v 9%) or need for ICU (1% v 3%) There are a large number of symptom-based outcomes. In general, they demonstrate statistically less symptoms with budesonide, although the actual clinical difference seems small, and this is an unblinded study. We will discuss this further in the Talk Nerdy section. 1) Unblinded Trial: The biggest limitation in this study is its lack of blinding, especially considering they added a second primary outcome that was entirely symptom based. In any unblinded trial, we should expect that the treatment group will have fewer symptoms, so those results are unreliable here. However, even seemingly objective outcomes like hospitalizations can end up biased in unblinded trials. Imagine a patient who feels like ‘nothing is being done for them’, struggling with the cough and fatigue of COVID-19. They may not meet any formal admission criteria for COVID-19, but if it is there third ED visit, they might end up admitted anyway. (I have seen this happen many times.) Therefore, symptoms translate into hospitalizations, and so the unblinded nature of the trial even biases their original primary outcome. 2) Disease Specific Outcomes: For their original primary outcome, they looked at “COVID-19-related hospital admission or death” rather than just hospital admission or all death. This is an issue and can bias a trial from the outset. These outcomes fundamentally ignore harms of medications. If a patient is admitted to hospital because of a medication-related adverse event, then don’t get counted in this primary outcome. Luckily, adverse events are rare from inhaled budesonide, so this bias probably did not have a huge impact on these results. 3) Adding a Second Primary Outcome: The original primary outcome was a composite of COVID-19-related hospital admission or death within 28 days. This was changed to add a co-primary outcome of illness duration. The rationale was that the hospital admission rates in the UK were lower than the authors initially expected. Ethics approval was provided for this amendment and implemented before performing any interim analyses. The more objective primary outcome of hospitalization and death were not statistically different, but the subjective outcome of illness duration was better with budesonide. As mentioned in nerdy point #1 the lack of blinding likely impacted the additional primary outcome and may have impacted hospitalizations. 4) Extrapolation: Most of these patients were unvaccinated. Vaccinated patients have better outcomes after COVID-19 infection, and therefore are much less likely to benefit from treatment. Therefore, we shouldn’t expect to see the same degree of benefit in vaccinated populations. The same concern may apply to the shifting severity we see from new COVID-19 variants. 5) Threshold for Evidence During a Pandemic: This is a longer and more philosophical discussion. For any study, we will see a range of possible interpretations. During COVID-19, in particular, I have found myself disagreeing with some very smart evidence-based doctors who I usually agree with,