The Skeptics Guide to Emergency Medicine

Date: April 24th, 2020 Reference: Watanabe et al. Is Use of Warning Lights and Sirens Associated With Increased Risk of Ambulance Crashes? A Contemporary Analysis Using National EMS Information System (NEMSIS) Data. Annals of Emergency Medicine. July 2019 Guest Skeptic: Dr. Robert Edmonds is an emergency physician in the US Air Force in Virginia.  This is Bob’s eleventh visit to 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 visiting with your father, a 64-year-old overweight man with hypertension.  He describes significant pain in his chest upon awakening and tells you to call an ambulance.  The EMS crew arrives and performs a 3 lead EKG that does not show an ST elevated myocardial infarction. They prepare to load your father into the ambulance, and since you’re his only child and he’s a talker, he mentions you’re an emergency physician.  The crew then asks if you want them to transport your father Code 3 with full lights and sirens. Background: The use of warning lights and sirens in ambulances is fairly widespread. Their use is associated with marginally faster response and transport times (7). Several studies have found ambulance crashes occurring while lights and sirens are used to have a higher injury rate, and a majority of fatal ambulance crashes involve their use (12-15). EMS agencies have varying guidelines on when to use lights and sirens, and the amount of time saved with lights and sirens is approximately 1-3 minutes (REF).  This means the intervention is likely unhelpful for the patient in many transports. Clinical Question: What is the association between warning lights and sirens use by EMS and crash-related delays? Reference: Watanabe et al. Is Use of Warning Lights and Sirens Associated With Increased Risk of Ambulance Crashes? A Contemporary Analysis Using National EMS Information System (NEMSIS) Data. Annals of Emergency Medicine. July 2019 Population: All dispatches of a transport-capable ground EMS vehicle to a 911 emergency scene from the 2016 National EMS Information System, both the response to the scene and the transport from the scene. Excluded: Interfacility transfers, intercepts, medical transports, and standbys; responses by nontransport or rescue vehicles, mutual aid activations, and supervisor responses; and events documented as responses or transports by rotor-wing or fixed-wing air-medical services. Intervention: Use of lights and sirens Comparison: No lights and sirens Outcome: Crash-related delay (proxy for EMS vehicle crash) Authors’ Conclusions: “Ambulance use of lights and sirens is associated with increased risk of ambulance crashes. The association is greatest during the transport phase. EMS providers should weigh these risks against any potential time savings associated with lights and sirens use.” 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/No Have the authors identified all-important confounding factors? Yes Was the follow up of subjects complete enough? Yes How precise are the results/estimate of risk? Adequate 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: The 2016 NEMSIS database contained 20.4 million 911 dispatches of ground EMS. There was a total of 2,539 crash-related delays. Key Result: There was a greater odds ratio of crashing with the use of lights and sirens. 1) Reporting Bias: The authors mention how the study is entirely dependent on crash related delays.  It is unknown how widespread reporting of crash-related delays is and since this is dependent on individual agencies self-reporting, there may be bias from the agencies to report this more commonly when lights and sirens are used, as this was already believed at the time of the study to induce additional risk.  Alternatively, as the authors point out, some upgrades to lights and sirens may occur after an ambulance crash has occurred, which would bias the results. 2) Association not Causation: It would not be correct to conclude that lights and sirens  cause crashes from this publication. This was a retrospective database study not a randomized controlled trial. There could have been unmeasured confounders responsible for the observed results. 3) Partial Lights and Sirens:The authors teased apart three scenarios-complete absence of lights and sirens, full use of lights and sirens, and partial use of lights and sirens. These partial use cases include both cases where there was initially no lights and sirens and then they upgraded to lights and sirens, as well as cases where the crew started with lights and sirens, and they downgraded, turning off the lights and sirens.  Due to the retrospective nature of this study, it’s not possible to discern at a systematic level how these upgrade and downgrade situations are determined and if there is a theme to these which would impact the results. Sam Peltzman 4) Peltzman Effect: This is a theory that proposes people will be more likely to engage in risky behavior when safety measures have been introduced. This change in behaviour will compensate for any benefit achieved by intervention. It is named after Sam Peltzman who in the 1970’s hypothesized that mandating seatbelts in cars would increase risky behaviour and results in more crashes/injuries. His proposal was controversial and the data from seatbelts ultimately demonstrated a net benefit. However, there are a number of examples of the Peltzman effect In medicine, there can also be unintended consequences of health care interventions (smoking cessation, electronic health records, rapid response teams, etc). When an intervention is introduced it can nudge behaviour of the physician and the patient resulting in compensatory responses that may have a net negative impact (Prasad and Jena 2014). Lights and siren use by EMS may give the paramedics a false sense of security. They may drive more aggressively that results in a greater number of crashes. 5) Lack of Patient Oriented Outcomes: Although the direct comparison of lights and sirens and crashes is important, it would have been interesting if data could be collected on patient important outcomes, such as mortality, injuries to the patients or EMS crews, or duration of delays. Comment on Authors’ Conclusion Compared to SGEM Conclusion: We agree with the authors that there is an associated increase in crashes with the use of lights and sirens, but this appears to be much less statistically compelling in the response phase. SGEM Bottom Line: The use of warning lights and sirens was associated with a significant increase in the risk of crashing in the transport phase. Case Resolution: You tell the EMS crew to use their best judgement, and they drive to the nearest emergency room without the use of lights and sirens. Your father is diagnosed with a pulmonary embolism and convalesces in the hospital for a few days until he is uneventfully discharged home on apixaban. Dr. Robert Edmonds Clinical Application: For clinicians involved in the decisions regarding EMS utilization, this study further focuses on the need for judicious use of lights and sirens.  As noted in the accompanying editorial by Tanaka in the same issue of Annals, “the Fire Department of the City of New York estimated a 32% reduction in crashes during their test period with updated lights and sirens protocols.” When this is coupled with the fairly minor reduction in transport time of only 1-3 minutes with the use of lights and sirens, it makes a strong case to limit the use of lights and sirens for only the patients with the direst need for timely emergency medical care. What Do I Tell My Patient? The ambulance crew will make a choice about whether it’s appropriate to use lights and sirens to transport you to the hospital.  Even if they don’t go with lights and sirens, they’re still going to get you to the hospital quickly, and there’s less risk of crashing. Keener Kontest: Last weeks’ winner was a repeat win for Jonathan Godfrey a paramedic from Asheville, NC. He knew the name of Dr. Boyles publication, in 1661, that bears directly on the SGEM is: "The Sceptical Chymist: or Chymico-Physical Doubts & Paradoxes". Listen to the SGEM podcast to hear this weeks’ question. Send your answer to TheSGEM@gmail.com with “keener” in the subject line. The first correct answer will receive a cool skeptical prize. Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.

Date: April 21st, 2020 Reference: Juergens et al. Effectiveness of emergency physician determinations of the need for thrombolytic therapy in acute stroke. Proc Baylor Univ Med Center Oct 2019 Guest Skeptic: Dr. Chuck Sheppard is an attending Emergency Department Physician at Mercy Hospital in Springfield, Missouri and the medical director for Mercy Life Line air medical service.  He has been practicing in Emergency Medicine for over 40 years and involved in EMS services for over 30 years. Case: 56-year-old female with sudden onset of left arm and leg weakness with slurred speech presents to the emergency department (ED). She was last seen well two hours prior. Her past medical history includes hypertension and type II diabetes. She is not on any anticoagulation except ASA. There is no previous history of stroke. The neurology led stroke team is not available and you wonder if that will affect her outcome. Background: Treatment for acute ischemic stroke has been debated between neurologists and emergency physicians for years now. A recent PRO/CON debate on the subject was published in CJEM April 2020 with Dr. Eddy Lang and myself. It was the legend of emergency medicine, Dr. Jerome Hoffman that really raised the concern about the lack of evidence for using thrombolytics in acute ischemic stroke. He was interviewed on an SGEM Xtra segment called No Retreat, No Surrender. We have covered acute ischemic stroke many times on the SGEM. SGEM#29: Stroke Me, Stroke Me SGEM#70: The Secret of NINDS SGEM Xtra:Thrombolysis for Acute Stroke SGEM Xtra: Walk of Life SGEM#269: Pre-Hospital Nitroglycerin for Acute Stroke Patients? Clinical Question: Does the presence of a neurologist led stroke team affect the likelihood of receiving tPA and does that improve a patient-oriented outcome? Reference: Juergens et al. Effectiveness of emergency physician determinations of the need for thrombolytic therapy in acute stroke. Proc Baylor Univ Med Center Oct 2019 Population: All patients presenting to the ED meeting stroke activation criteria Intervention: Neurologist led stroke team Comparison: No neurologist led stroke team Outcomes: Primary Outcome: Rate of tPA administration Secondary Outcomes: Door-to-needle times, modified Rankin Scale (mRS) at discharge, change in National Institutes of Health Stroke Scale (NIHSS), and discharge disposition Authors’ Conclusions: “Emergency physicians administered significantly less thrombolytics than did neurologists. No significant difference was observed in outcomes, including mRS and admission-to-discharge change in NIHSS. 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? Precise Do you believe the results? Yes Can the results be applied to the local population? Unsure Do the results of this study fit with other available evidence? Yes Results: There were 415 stroke activations during the study period (Jan 1, 2015 to June 30, 2016). Of those activations, 153 (37%) were managed by the neurologist led team and 262 (63%) were treated by emergency physicians. The median age was early 60’s with slightly more female patients in the cohort. Three-quarters arrived by EMS and the median NIHSS score was 7 for the EM physicians and 6 for the neurologists. The diagnosis was hemorrhagic stroke (~10%), ischemic stroke (~70%), neurological/psychiatric (~15%) and other (~5%). Key Result: Neurologists gave tPA 13% more often than EM physicians Primary Outcome: Rate of tPA administration 26.3% EM physicians and 39.2% neurologists (p=0.006) Secondary Outcomes: No statistical difference in mRS score at discharge 1. Single Center: This was a single center study that may have a unique practice pattern limiting its external validity to other practice environments. As someone who practices in a rural environment, we transport our stroke patients “code stroke” to a higher level of care or use telemedicine with a neurologist who decides on tPA administration. 2. Retrospective Study: This was a retrospective single-center study and results demonstrate association not causation. There could be unmeasured confounders responsible for the observed differences in the results. 3. When Thrombolysed: The neurologists led the team Monday to Friday during business hours. There could be differences that were not measured on nights, weekends and holidays. The baseline NIHSS score was one-point different at baseline between the two cohorts. We know that the severity of the stroke at presentation has a strong influence on the final outcome. We also don’t know if the radiology coverage after hours and on weekends was different. 4. Time to Thrombolysis and Mimics:  tPA was administered statistically earlier in the neurologist led stroke team. Previous studies have shown time is not brain and it is possible they were thromoblysing more TIAs or stroke mimics as mentioned by Dr. Hoffman on his SGEM Xtra episode. This could bias the study toward benefit of tPA. Despite this potential bias there was no statistical difference in mRS score at discharge. 5. Harms: Limited data was captured with regards to harm. There were more deaths (mRS 6) and mortality at discharge with neurologist led teams but this was not statistically significant. They provided no information on intracranial hemorrhage, symptomatic intracranial hemorrhages or other bleeds. It is hard to evaluate the net patient efficacy without this information on adverse events. Even if there was a small signal of benefit with neurologists led teams it could be offset by an increase in harms/adverse events. Given the data provided we do not know what the net impact was in this retrospective, single-center study. Comment on Authors’ Conclusion Compared to SGEM Conclusion: We generally agree with the authors' conclusions. SGEM Bottom Line: Neurologists led stroke teams give tPA more often but it did not result in statistically significant better patient-oriented outcomes in this study. Case Resolution: Based on this study you can reassure the patient that the lack of a neurologist led stroke team may decrease her chances of getting thrombolysis (clot busting drug) but that will probably not affect her outcome. Dr. Chuck Shepard Clinical Application: It appears that while a “neurologist led stroke team” may be important for other reasons, it appears that in the absence of one only decreases the chance of getting tPA but doesn’t affect the outcome. It is unsure how a neurologist led stroke team would impact outcomes in the new era of endovascular treatment (EVT). What Do I Tell My Patient? You appear to be having a stroke and we have a system in place to treat your stroke even though the neurologist is not here at this moment.  We will take good care of you and the evidence is that your outcomes will be just as good as if the stroke team was led by a neurologist in our hospital. Keener Kontest: Last weeks’ winner was Dr. Cindy Bitter an Assistant Professor of Emergency Medicine from Washington, University in St. Louis. She knew dogs have 300 million olfactory receptors in their nose. Listen to the SGEM podcast to hear this weeks’ question. Send your answer to TheSGEM@gmail.com with “keener” in the subject line. The first correct answer will receive a cool skeptical prize. Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.

Date: April 9th, 2020 Reference: Kline et al. Randomized trial of therapy dogs versus deliberative coloring (art therapy) to reduce stress in emergency medicine providers. AEM April 2020 Guest Skeptic: Dr. Justin Morgenstern is an emergency physician and the creator of the excellent #FOAMed project called First10EM.com Case: It has been a hard shift. You wish you could say “uncharacteristically”, but recently all your shifts in the emergency department have felt a little hard. The increased workload due to COVID-19 hasn’t been helping. You sit down to chart after a difficult resuscitation, and the charge nurse, seeing that you look a little stressed, asks if you would like to take a break to play with a dog. Background: Medicine is an incredibly rewarding profession. However, it is undeniably marked by significant levels of stress. Reports of burnout are high across medicine, and even higher in emergency medicine (1,2). A study of USA physicians showed that they had more than  50% with at least one symptom of burnout. Emergency physicians reported the highest prevalence of burnout at around 70% (3). Burnout is associated with a loss of empathy and compassion towards patients, decreased job satisfaction, and shorter careers in medicine (4,5). It has also been associated with negative impacts on patient care including self-perceived medical error (6), risk of medical errors (7), and quality of care (8,9). We have covered burnout a few times on the SGEM including my own personal experience of being on the edge of burnout: Five Tips: To Avoid Emergency Medicine Burnout SGEM#178:Mindfulness – It’s not Better to Burnout than it is to Rust SGEM Xtra: On the Edge of Burnout ACEM18 SGEM Xtra: CAEP Wellness Week 2019 YouTube: Being on the Edge of Burnout One Year Later There is some prior literature that exposure to animals decreases stress (10,11). Theoretically, time spent deliberately coloring as a mindfulness practice could also decrease stress (12). Therefore, these authors designed a prospective, randomized trial comparing the effects of dog therapy, deliberate coloring, and control on stress levels for emergency department providers (13). Clinical Question: Does dog therapy result in lower perceived stress than deliberate coloring or control when applied as a break during an emergency medicine shift? Reference: Kline et al. Randomized trial of therapy dogs versus deliberative coloring (art therapy) to reduce stress in emergency medicine providers. AEM April 2020 Population: Emergency care providers, including nurses, residents, and physicians, from a single center emergency department. Exclusions: Dislike, allergy, fear, or other reason not to interact with a therapy dog. Intervention: There were two interventions, which occurred approximately midway through the provider’s shift. Dog therapy consisted of an interaction with a therapy dog, which providers could pet or touch if they wished. The coloring group was provided with three mandalas to choose to color and a complete set of coloring pencils. Both of these activities occurred in a quiet room, physically separated from the clinical care area, with no electronic devices, telephone, window, or overhead speaker. Comparison: A convenience sample of providers that were not offered any break. Outcomes: Primary Outcomes: There were two primary outcomes. The first was a self-assessment of stress using a visual analogue scale. The second was a 10-item validated perceived stress scores, altered to focus providers on the past several hours rather than months, as it was originally designed. These were both measured at the beginning of the shift, about 30 minutes after the intervention, and near the end of the shift. Secondary Outcomes: They looked also looked at a FACES scales as a measure of stress, and provider cortisol levels. Dr. Jeff Kline This is an SGEMHOP episode which means we have the lead author on the show.  Dr. Jeff Kline (@klinelab) is the Vice Chair of Research in Emergency Medicine and a professor of physiology, Indiana University School of Medicine. He is the editor in chief of AEM, creator of Pulmonary Embolism Rule-out Criteria (PERC) Rule and has published extensively in the area of pulmonary emboli. Authors’ Conclusions: "This randomized, controlled clinical trial demonstrates preliminary evidence that a five minute therapy dog interaction while on shift can reduce provider stress in Emergency Department physicians and nurses.”  Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. Yes The patients were adequately randomized. No The randomization process was concealed. Unsure 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. Yes The treatment effect was large enough and precise enough to be clinically significant. Unsure Key Results: They enrolled 127 providers, but five withdrew because they thought their shift was too busy to participate. 47% were resident physicians, 23% were attending physicians, and 30% were nurses. They were most frequently (60%) enrolled during an evening shift. The coloring intervention took a median of five minutes and 26 seconds. In the dog group, providers spent a median of five minutes and 49 seconds with the dogs and had significant interaction with both the dog and the dog’s handler. Primary Outcome: Stress based on the VAS was the same in all three groups at the beginning of the shift (18mm) but rose in the coloring group and fell in the dog group. Stress based on the validated stress score rose in the control group, but otherwise was not statistically significant. Secondary Outcomes: In all three groups, cortisol levels were highest at the beginning of the shift and decrease over time. The cortisol level fell more in both intervention groups. We asked Jeff ten questions to get a greater understand of his publication. Listen to the SGEMHOP podcast to hear all of his answers. 1) Allocation Concealment: Allocation concealment is one of those EBM terms that gets thrown around a lot but isn’t often discussed. It’s really important, because if you can guess what group you are going to be in, it might affect your decision to join the study. For example, in this study, if I thought I was going to be in the dog group, I would definitely say yes, but I have no interest in coloring, so probably would have said no. Can you comment on your allocation concealment procedures and whether you think they are adequate? 2) Nocebo / Convenience Sample: First, the idea of nocebo is fascinating, and it would be great if you could explain your logic for not randomizing the control group to the listeners. Second, I worry about the convenience sample as a source of bias. The study’s objective was not blinded, so it is possible that the convenience sample could have been selected on particularly stressful days or particularly not stressful days, which would impact the results.  3) Two Primary Outcomes: This paper had two co-primary outcomes, but as we frequently say on the SGEM, “there can only be one.” Perhaps as the editor in chief of Academic Emergency Medicine, you can settle this one for us.  Are you really allowed to have more than one primary outcome? 4) Statistical vs Clinical Significance: Overall, the results suggest a statistical decrease in stress in the group exposed to dogs. However, it is unclear whether the magnitude of change was large enough to be noticeable. Do you think the results are clinically significant? 5) Blinding: Obviously, it is essentially impossible to blind a study like this, but the lack of blinding does make it harder to interpret the subjective feelings of stress. It is possible that people just like dogs (who doesn't), and the lower scores don’t really reflect stress. 6) Short vs Long Term Outcomes: You focused on same-day stress, but presumably for burnout, long term outcomes might be more important. Do you think these results will extrapolate to longer term benefits? 7) Language: I noticed that one of the coloring options had crude language. I found the message funny, and it would have lifted my spirits on shift, but I can imagine problems if the completed picture accidentally found its way into a patient’s hands. They might not understand the emergency provider’s darker humour. 8) Harms from Dogs: Did you consider potential harms from the interventions? For example, you let participants opt out if they had dislike, fear, or had allergies to dogs. Personally, I love dogs, but I am also incredibly allergic. I can imagine ignoring my allergies to play with the dog mid shift, but then regretting that choice and having increased stress as I trying to manage my remaining patients with incredibly itchy eyes and an endlessly runny nose. Puppies PRN and Dogs on Demand 9) Scheduling the Intervention vs Stress Relief on Demand: In this study, the intervention was scheduled for a specific time during the shift. Emergency shifts aren’t very amenable to strict schedules. In fact, when someone tries to schedule something at a specific time during one of my shifts, it tends to increase stress. I wonder whether interventions like this would be more effective if they were available when the provider felt they needed them – such as after a stressful resuscitation.

Date: April 4th, 2020 It has been just over a year since Dr. Salim Razaie (REBEL EM) and I stepped into the ring for a boxing matched theme debate in Sydney, Australia. It was the EBM rumble down under for SMACC 2019. How the world has changed with COVID19. You can see the original SGEM Xtra post from March 2019. It has more details about each issue we discussed and our slides. This is being posted now because a high-definition video is available on YOUTUBE for those who could not attend or for those who want to watch this epic match again.  It is an example of mixing education and entertainment for some great knowledge translation. You can also listen to an edited version on the SGEM iTunes feed. We went four rounds punching and counter punching arguments about critical care controversies. The REBEL took the fight to the Skeptic. He supported his position with a flurry of publications.. The skeptic responded with his own citations. As with boxing, the champion must be beat, the challenger cannot win with a draw and there were no knockouts in the match. The skeptic fell back on the burden of proof and asserted he had not been convinced to accept any of the REBELs claims. The ultimate winner was the patient. We both agree that the patient deserves the best care, based on the best evidence. Four Critical Care Controversies: Round#1: Mechanical CPR - SGEM#136 Round#2: Epinephrine in Out-of-Hospital Cardiac Arrest (OHCA) - SGEM#238 Round#3: Stroke Ambulances with CT Scanners Round#4: Bougie for First Pass Intubation - SGEM#271 Conclusion/Winner - Use EBM and the winner is the patient We appreciate Dr. Justin Morgenstern (First10EM) being the impartial referee for this contest.  He ensured it was a good clean fight about the evidence and did not allow us to punch each other below the belt (in the p-value). We encourage you to read the primary literature yourself. There are multiple links provided to the relevant studies in the original post. The literature should guide your care but it should not dictate your care. You will still need to apply your good clinical judgment and ask the patient what they value and prefer. Thank you to all the students who supported me in the skeptical corner of the ring. I hope it encouraged their critical thinking skills. Not just to accept anything because their supervisor/attending told them. They also made sure I had plenty of maple syrup between the rounds. 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 is for patients get the best care, based on the best evidence.  REMEMBER TO BE SKEPTICAL ABOUT ANYTHING YOU LEARN, EVEN IF YOU HEARD IT ON THE SKEPTICS’ GUIDE TO EMERGENCY MEDICINE.

Date: March 27th, 2020 Reference: Secko et al. Musculoskeletal Ultrasonography to Diagnose Dislocated Shoulders: A ProspectiveCohort. Ann Emerg Med Feb 2020 Guest Skeptic: Dr. Tony Zitek is an Emergency Medicine physician in Miami, Florida. He is an Assistant Professor of Emergency Medicine for Florida International University and Nova Southeastern University, and Tony is the Research Director for the Emergency Medicine residency program at Kendall Regional Medical Center. DISCLAIMER: THIS IS NOT AN EPISODE ON COVID19 Here are five websites to get up-to-date information about COVID19: Centre for Disease Control and Prevention Health Canada Public Health Ontario World Health Organization Food and Drug Administration Case: An 18-year-old, previously healthy male presents to the emergency department after sustaining an injury to his right shoulder after colliding with another player during a football game.  On examination, there is a loss of the normal rounded appearance of the shoulder.  You suspect the patient may have a shoulder dislocation.  He has no history of shoulder dislocations in the past.  Will you order an x-ray or perform a point-of-care ultrasound to confirm the diagnosis? Background: Despite shoulder dislocations being a very common injury presenting to the ED, it has only been covered once on SGEM#121. This episode tried to answer whether it was better for the shoulder to be immobilized in an external or internal rotation post-reduction. We still don’t know if one position is superior to another. Emergency physicians frequently perform pre- and post-reduction x-rays for patients with shoulder dislocations.  However, some prior studies suggest that the routine performance of these x-rays may not be necessary, especially in patients with recurrent dislocations who have not sustained any direct trauma [1-2]. Point-of-care ultrasound (POCUS) has previously been studied for the use of the diagnosis of shoulder dislocations with most prior data suggesting that POCUS is highly sensitive and specific for the diagnosis of shoulder dislocations [3-4]. As with other applications of POCUS, the use of ultrasound for shoulder dislocations has the potential to reduce the time to diagnosis, reduce radiation exposure, and lower cost.  However, prior studies about the use of POCUS for shoulder dislocations have used a variety of scanning techniques and some have utilized as few as 2 sonographers [4].  One study found only a 54% sensitivity for identifying persistent dislocation after a reduction attempt [5]. Clinical Question: What is the diagnostic accuracy of point-of-care ultrasound for the diagnosis of shoulder dislocations as compared with x-ray? Reference: Secko et al. Musculoskeletal Ultrasonography to Diagnose Dislocated Shoulders: A Prospective Cohort. Ann Emerg Med Feb 2020 Population: Adult patients with suspected shoulder dislocations who presented to one of two EDs when a study investigator was present. Exclusion: Patients with multiple traumatic injuries, decreased level of consciousness, or hemodynamic instability. Intervention: Pre- and post-reduction POCUS utilizing a posterior approach in which they traced the scapular spine towards the glenohumeral joint. The POCUS technique they used is basically as follows --- the sonographer palpates the spine of the scapula, and then places the ultrasound probe directly over the scapular spine. The study protocol allowed the sonographer to choose either a linear or curvilinear probe. The sonographer then follows the scapular spine laterally until the glenoid and humerus are identified. Using this technique, the glenoid and humeral head both look like hyperechoic semicircles. They should be very close to each other, and if not, that indicates a shoulder dislocation. After assessing for dislocation, the sonographer can assess for fracture by fanning the probe from a cephalic to caudal direction. A fracture appears as a disruption in the normal contour of the hyperechoic humerus. (shown below in Figure 1 from the manuscript). Figure 1. A, Proper probe placement on the patient and the 3-step sequence to examine the shoulder from the posterior approach. The blue dot above the probe corresponds to the probe indicator. B, The corresponding ultrasonographic images to the probe placement in A at the level of the scapular spine (1), the glenohumeral joint (2), and the humerus (3). Comparison: Pre- and post-reduction x-rays. Outcomes:   Primary Outcome: The diagnostic accuracy of POCUS for shoulder dislocations. Secondary Outcomes: Presence or absence of fracture, time from triage to POCUS exam as compared to x-ray, time from POCUS exam initiation to diagnosis, determination of glenohumeral distance of non-dislocated and dislocated shoulders, and sonographer confidence in diagnosis (from 0-10). Authors’ Conclusions: “A posterior approach point-of-care ultrasonographic study is a quick and accurate tool to diagnose dislocated shoulders. Ultrasonography was also able to accurately identify humeral fractures and significantly reduce the time to diagnosis from triage compared with standard radiography.” Quality Checklist forObservational 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? No Was the exposure accurately measured to minimize bias? N/A Was the outcome accurately measured to minimize bias? Yes/No 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 confidence intervals around the point estimate of sensitivity and specificity for dislocation identification and even wider for fracture identification. 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 Key Results: They enrolled 65 patients in the study. The median age was 40 years, 58% being male, 49% had a dislocation (29 anterior, 2 posterior and 1 inferior) and 32% had a history of dislocation. POCUS had a 100% sensitivity, specificity, PPV and NPV for diagnosing shoulder dislocation. Primary Outcome: Sensitivity 100% (95% CI; 87-100) Specificity 100% (95% CI; 87-100) PPV 100% (95% CI; 87-100) NPV 100% (95% CI; 87-100) Secondary Outcomes: 25/65 (38%) had fractures with 13 being Hill-Sachs/Bankart’s Non-Hill-Sachs/Bankart’s Fracture:Sensitivity 92% (95% CI; 60-99.6), specificity 100% (95% CI; 92-100), PPV 100% (95% CI; 68-100) and NPV of 98% (95% CI; 89- 99.9). POCUS was 43 minutes faster from exam to diagnosis compared to x-ray. The median glenohumeral distance was –1.83 cm (IQR –1.98 to –1.41 cm) in anterior dislocations, 0.22 cm (IQR 0.10 to 0.35 cm) on non-dislocated shoulders, and 3.30 cm (IQR 2.59 to 4.00 cm) in posterior dislocations Sonographers’ confidence in their POCUS diagnosis was 9.1 of 10 in non-dislocated cases and 9.4 of 10 in dislocated cases. 1) Accuracy of POCUS to Confirm Shoulder Dislocation: The data suggests that POCUS is highly sensitive and specific for the diagnosis of shoulder dislocation. However, this study utilized a convenience sample of patients that were all ultra sounded by one of six sonographers who were either ultrasound fellows or ultrasound fellowship-trained attendings. That being said, there is some evidence that less-skilled sonographers can use this technique with high accuracy.  In fact, the authors cited a study by my friend Shadi Lahham from UC Irvine, in which novice sonographers had a 100% sensitivity and specificity using a posterior approach POCUS examination [6].  Overall, given the study at hand and the previous studies assessing POCUS for shoulder dislocations, we can say pretty confidently that POCUS, especially the posterior approach, has very high sensitivity and specificity for the diagnosis of shoulder dislocations. The sonographers were very confident in their diagnoses (9.1/10). This was not surprising given the small group of skilled sonographers performed all the ultrasounds. It is unclear if POCUS would have the same diagnostic accuracy in the hands of a community emergency physician. Additionally, while the study was technically “multicenter” in that two facilities were involved, one of the two sites enrolled only 5 patients.  Therefore, this was mostly a single center study. For these reasons, we question the external validity of the study, and I’m not sure that if the ultrasounds were performed by typical community emergency physicians that you would achieve such impressive results. 2) Accuracy of POCUS to Confirm Shoulder Reduction: In the study at hand, 27 of 32 subjects with dislocations had post-reduction POCUS exams performed to confirm adequate reduction.  Per the study protocol, all 32 were supposed to have had a post-reduction POCUS performed, but there were five cases where this did not happen. The manuscript says it was because the study sonographer was unavailable after the reduction for various reasons without further explanation. This could have introduced some bias and increases our skepticism of the results. 3) Accuracy of POCUS for Shoulder Fracture Diagnosis: Of the 65 patients, there were 25 (38%) with fractures.  POCUS identified only 52% of those fractures. However, all but one of the missed fractures was a Hill-Sach’s deformity or a Bankart lesion.  There were 12 non-Hill Sach’s/Bankart’s fractures in this study, and POCUS identified 11 of those 12. The one missed fracture was a surgical neck fracture.  Overall, POCUS was 92% sensitive (95% CI; 60% to 99.6%) and 100% specific (95% CI; 92% to 100%) for non–Hill-Sachs/Bankart’s fractures.

Date: March 18th, 2020 Reference: Ebell et al. Accuracy of Biomarkers for the Diagnosis of Adult Community-Acquired Pneumonia: A Meta-analysis. AEM March 2020 Guest Skeptic: Dr. Chris Bond is an emergency medicine physician and assistant Professor at the University of Calgary. He is also an avid FOAM supporter/producer through various online outlets including TheSGEM. Disclaimer: This is Not an Episode on COVID19 Things are changing quickly with the COVID19 pandemic.  Here are five basic things you can do to help flatten the curve as of this blogpost: Wash your hands well and often (at least 20 seconds with soap and water) Try not to touch your face Physically isolate yourself from large gatherings but stay socially connected electronically Cough into your elbow or use a tissue, throw the tissue out and go to #1 Disinfect objects or surfaces with a regular household cleaning wipe or spray If you are unsure of what to do or for more information, here are five websites to get up-to-date information about COVID19: COVID19 Centre for Disease Control and Prevention Health Canada Public Health Ontario World Health Organization Food and Drug Administration   Case: A 47-year-old healthy, non-smoker, presents to the emergency department (ED) with a productive cough, fever and says it has been difficult to breathe for the past four days. He appears well, with a temperature of 38.7 Celsius, heart rate of 90 beats per minute, respiratory rate of 20 breaths per minute and room air oxygen saturation of 91%. On auscultation you hear some fine crackles at the bases. You wonder if there is value in ordering any bloodwork, particularly a biomarker such as C-reactive protein (CRP), procalcitonin (PCT) or a complete blood count for white blood cell count (WBC) in addition to doing a chest x-ray (CXR). Background: Community-acquired pneumonia (CAP) is a significant source of morbidity and mortality in adults (1,2).  We have covered this issue a couple of times on the SGEM. One episode looked at β-Lactam monotherapy vs. β-Lactam plus macrolide combination therapy in adult patients admitted to hospital with moderately severe CAP (SGEM#120). This study supported the combination therapy in these patients. More recently, we looked at the question of whether steroids improve morbidity and mortality in patients admitted to hospital with CAP (SGEM#216). The bottom line was that corticosteroids appear to improve mortality and/or morbidity in patients admitted to hospital with CAP. There is evidence that an accurate diagnosis of CAP may lead to earlier treatment while avoiding unnecessary antibiotics for patients who do not have CAP. Pervious research has demonstrated that individual signs and symptoms have limited accuracy in the diagnosis of CAP. The diagnosis of CAP is usually based on an abnormal chest x-ray in a patient with signs and symptoms of a lower respiratory tract infection (3,4). White blood cell count (WBC), C-reactive protein (CRP), and procalcitonin are biomarkers associated with an increased likelihood of CAP. There are also clinical prediction rules that include CRP for the diagnosis of CAP (5,6). Procalcitonin is another potential biomarker that may help in the diagnosis of bacterial pneumonia (7).  Guidelines such as the National Institute for Health and Care Excellence (NICE) recommend the use of CRP at the point of care to reduce inappropriate antibiotic when diagnosing CAP (8) These various biomarkers are readily available in the ED setting in the US, as well as in the primary care setting in other countries in Europe. The study we are reviewing on this SGEM episode performs an updated systematic review and meta-analysis (SRMA) of the diagnostic accuracy of biomarkers for CAP. Clinical Question: What is the accuracy of biomarkers for the diagnosis of community acquired pneumonia? Reference: Ebell et al. Accuracy of Biomarkers for the Diagnosis of Adult Community-Acquired Pneumonia: A Meta-analysis. AEM March 2020 Population: Adult patients presenting with symptoms of acute respiratory infection and patients with clinically suspected pneumonia based on physician order of a chest radiograph, reporting sufficient information to calculate sensitivity and specificity for the diagnosis of CAP for at least one biomarker. Exclusions: Studies of dyspnea or sepsis rather than suspected CAP. Studies limited to patients with chronic lung disease, patients in skilled nursing facilities, or immunosuppressed/HIV patients. Ventilator or hospital acquired pneumonia. Studies of the diagnosis of a specific pathogen (i.e. mycoplasma or legionella). Studies that did not use a cohort design (i.e. recruited patients with known CAP and healthy controls). Intervention: C-reactive protein (CRP), procalcitonin or white blood cell (WBC) count Comparison: Chest imaging with CXR or CT scan Outcome: Diagnosis accuracy of biomarkers for pneumonia This is an SGEMHOP episode which means we have the lead author on the show.  Dr. Mark Ebell is a Family Physician and Professor at the University of Georgia in Athens. He is a co-founder of POEMs, editor-in-chief of Essential Evidence, deputy editor of American Family Physician, and co-host of the podcast Primary Care Update.   Dr. Mark Ebell Authors’ Conclusions: Biomarkers can be useful for the diagnosis of community-acquired pneumonia. The cutoff chosen will determine whether the test is most useful for ruling out pneumonia (CRP < 10 or 20 mg/L) or for ruling in pneumonia (e.g., CRP > 50 or 100 mg/L). CRP is the most accurate of the three studied biomarkers that are currently being used to assist in the diagnosis of community acquired pneumonia. We note that CRP is inexpensive and readily available in many settings and may be easily integrated into the clinical workflow for diagnosis of community acquired pneumonia in appropriate patients. 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. Yes The methodological quality of primary studies were assessed for bias. Yes The assessment of studies were reproducible. Yes The outcomes were clinically relevant. Yes There was low heterogeneity for estimates of sensitivity or specificity. No There was low statistical heterogeneity for the primary outcomes. No  The treatment effect was large enough and precise enough to be clinically significant. Yes Key Results: They screened 829 studies and found 14 that met inclusion and exclusion criteria with a total number of 6,599 patients. The study time periods ranged from 1986 to 2016, with 12 studies being performed in Europe, and one in each of the United States and Chile. Half of the studies were performed in ED patients and the other half in primary care settings. CRP was studied in 13 of the 14 studies, PCT in seven and leukocytosis in five. One study used the combination of CRP and PCT. Eight studies were felt to be at low risk of bias using the QUADAS-2 tool while six studies were felt to be at moderate risk of bias. None of the studies appeared to have been industry funded. Key Result: Diagnostic accuracy for community acquired pneumonia  was greatest with CRP. All of these biomarkers have a threshold effect, meaning that sensitivity increases as specificity decreases. As a result, summary estimates of sensitivity, specificity and likelihood ratio are shown for different cutoffs for each test. Primary Outcome: Diagnostic accuracy of community acquired pneumonia C-Reactive Protein: A CRP cutoff of 10 mg/L had the highest sensitivity at 90% and lowest negative likelihood ratio of 0.27. CRP > 20 mg/L CRP > 50 mg/L and CRP > 100 mg/L had positive likelihood ratios of 2.08, 3.68 and 5.79 respectively, with poor negative likelihood ratios. Procalcitonin: PCT > 0.25 mcg/L and PCT > 0.50 mcg/L had good positive likelihood ratios (5.43 and 8.25 respectively), negative likelihood ratios were worse than for CRP Leukocytosis: This was defined as a white blood cell count (WBC) > 9.5 to 10.5 x 10^9 cells/L had modest accuracy (LR+ 3.15, LR- 0.54) with good homogeneity around this estimate. We asked Mark five questions to get a greater understand of his publication. Listen to the SGEMHOP podcast to hear all of his answers. 1) External Validity: Less than 1/3 of patients came from the ED setting. This limits the application of these results to this clinical setting. The NICE guideline recommends the use of CRP in the primary care setting, presumably as a point of care test to help decide whether or not to order a CXR. Is this a rational use of resources in an ED setting where a CXR could be done as the initial test? 2) Point Estimates and 95% Confidence Intervals: There have been some conventional cut offs for likelihood ratios. None of the positive likelihood ratios were >10 to confidently rule in pneumonia and none of the negative likelihood rations were <0.1 to confidently rule out pneumonia. There were generally wide confidence intervals around the point estimates. 3) Post-Hoc Cut Offs: It is not clear in some of the studies used a post-hoc cutoff. We have discussed this before on the SGEM of potentially overfitting the data. How do you think this could affect your results and the interpretation? 4) Imperfect Gold Standard Bias (Copper Standard Bias):The biomarkers were compared to CXR in 13 of the 14 studies. We know that CXRs is less accurate in diagnosing CAP than a CT scan. How do you think that could have impacted the results? 5) Clinically Significant: A positive CXR does not mean a patient has a bacterial pneumonia.

Date: March 12th, 2020 Dr. Jonathan Stea Guest Skeptic: Dr. Jonathan Stea (@Jonathanstea) is a PhD Clinical Psychologist working at the Foothills Medical Centre in Calgary, Alberta. He is also an Adjunct Assistant Professor, Department of Psychology, University of Calgary. This SGEM Xtra is based on a tweet from about a month ago on The 10 Commandments of helping distinguish between science from pseudoscience for psychology students. It was written by Scott O. Lilienfeld (Association for Psychological Science 2005). This seemed like a good time to discuss pseudoscience because of the legitimate concerns about COVID19. These high anxiety situations regarding health seem to bring out those looking to sell fraudulent products. The FDA has even had to issue warning letters to firms with claims to “prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19).” Dr. Nina Shapiro has written a couple of articles in Forbes about this issue of “miracle cures” and FDA warnings. There was also an article by Timothy Caulfield (@CaulfieldTIm). In that piece he specifically mentioned a Calgary naturopathy who made some unsupported claims about COVID19. Fears Of The COVID-19 Coronavirus Provide More Opportunity For Misinformation About Miracle Cures (March 1, 2020) FDA Issues Warnings To Companies Selling Fraudulent COVID-19 Coronavirus Therapies (March 9, 2020) Misinformation, alternative medicine and the coronavirus (March 12, 2020) We also need to be careful not to paint with too broad of a brush. There are bad people out there making false claims. It does not mean all practitioners are bad and all practices are fraudulent. Massage therapy and Reiki may relieve some peoples’ anxiety over COVID19. In contrast, there is no high-quality evidence that homeopathy and chiropractic care can cure COVID19. We should try to focus on the claims that people are making and hold those who are making incorrect claims accountable. Even the Canadian Association of Naturopathic Doctors (CAND) said that the Calgary naturopath had made: “false and misleading statements” and there “are no proven methods for the prevention or treatment of COVID-19 — claims otherwise made by any health professionals are invalid and should be reported immediately to applicable regulators.” We should apply the same level of skepticism and science to all claims. These include claims made by all health care providers including psychologists, physicians, nurses, chiropractors, naturopaths, acupuncturists, etc. It is not just about COVID19 claims but about any therapeutic claims. Patients deserve the best care, based on the best evidence. COVID19 The COVID19 story is evolving quickly and could be out of date when this episode is published. Here are some basic things that you could do to try and stay healthy: Wash your hands well (at least 20 seconds with soap and water) and try not to touch your face Avoid people who are sick and limit your social gatherings Stay home if you are feeling ill Cough into a tissue and throw it out immediately or cough into your elbow and disinfect objects or surfaces with a regular household cleaning wipe or spray People who are feeling ill should wear a facemask but other people who are feeling fine and not caring for a sick person do not need to wear a mask If you are unsure of what to do, please contact your local health authority. There are some official websites to get the latest update on the COVID19 situation: Centre for Disease Control and Prevention Health Canada Public Health Ontario World Health Organization Food and Drug Administration A Rough Guide To Spotting Bad Science Science is very exciting and does not need to be made more sensational. As a science communicator, it is disappointing when research is hyped up in the media. A recent example of this would be the CRASH#3 trial. This was a well-designed randomized control trial asking an important question. The research group successfully completed and published their trial in a high impact journal. The primary outcome was “negative” but that in no way negates the science or its importance. It was unfortunate to see the spin that came out on CRASH#3 (SGEM#270). The 10 Commandments of EBM The 10 Commandments of Helping Students Distinguish Science from Pseudoscience in Psychology. There are a number of definitions of science and here is one: “Science is the study of the nature and behaviour of natural things and the knowledge that we obtain about them.” Collins Dictionary. American Psychological Association Dictionary of Psychology has a definition for Pseudoscience: "a system of theories and methods that has some resemblance to a genuine science but that cannot be considered such. Examples include astrology, numerology, and esoteric magic. Various criteria for distinguishing pseudosciences from true sciences have been proposed, one of the most influential being that of falsifiability." Using these definitions, here is the list of the 10 Commandments from Dr. Scott O. Lilienfeld: 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 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.

Date: March 4th, 2020 Reference: Radonovich et al. N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel. A Randomized Clinical Trial. JAMA 2019 The Respiratory Protection Effectiveness Clinical Trial (ResPECT) Guest Skeptics: Dr. Christopher Patey is an Assistant Professor with Memorial University Medical School in St. John’s, Newfoundland Canada. Over the past seventeen years he has practiced as a rural emergency and family physician and Clinical Chief of Emergency at Carbonear Hospital. Paul Norman is a registered nurse working as a frontline emergency nurse in Eastern Health, Newfoundland, Canada. Paul has greater than ten years of experience working in Emergency Nursing and Critical Care. His focus is implementation of LEAN strategies, quality and process improvement. Paul's work has been extended to reach emergency services throughout Canada and he has contributed on many platforms including local, regional, provincial and national speaking engagements. Disclaimers: This episode is about influenza not coronavirus (Covid-19) Dr. Patey's Disclaimer: I am not an expert on PPE (Personal Protective Equipment), Influenza/HINI/Coronavirus, Journal Reviews or Emergency Department management of pandemics. Paul Norman's Disclaimer: We (Dr. Patey and I) are experts on asking questions on the frontline of a Rural Emergency Department to ensure quality, and most importantly, effective patient care. Dr. Ken Milne's Disclaimer: I am an expert on critical appraisal but do not know what mask (if any) is best for preventing the Covid-19 virus. I think we can all agree on a few general recommendation: Get a flu shot if possible, wash your hands well (at least 20 seconds with soap and water), try not to touch your face, avoid people who are sick, stay home if you are feeling ill, cough into a tissue and throw it out immediately or cough into your elbow, disinfect objects or surfaces with a regular household cleaning wipe or spray, people who are well do not need to wear a facemask, people who are feeling ill should wear a facemask, and reach out to your local health authority if you think you might have the COVID-19. Covid-19 Information: This story is evolving quickly, and people should go to official websites to get the latest update on the Cover-19 situation: Centre for Disease Control and Prevention Health Canada Public Health Ontario World Health Organization Food and Drug Administration Case: With the potential global impact of the coronavirus (COVID-19) and our rural emergency departments (ED) having an extremely low compliance rate for N95 mask fit testing, our ED administration sends an urgent request for everyone to have N95 mask testing as soon as possible (ASAP). The urgent email also request shaving facial hair. You wonder about the evidence supporting the initiative and if there is any recent evidence surrounding N95 masks usage for preventing health care workers getting acute respiratory illnesses. Background: Many hospitals had their health care workers fitted with N95 masks in response to the 2009 H1N1 pandemic. The N95 masks were known to prevent small particles and therefore thought to be more effective. What was not known is whether or not this better effectiveness would translate into less viral respiratory infections acquired in hospital compared to regular disposable surgical medical masks. In other words, would N95 masks have a healthcare provider-oriented outcome. When it appeared that the transmission of the pandemic H1N1 was not different from seasonal influenza the recommendation for medical masks in most settings was reinstated. With the potential for an epidemic/pandemic outbreak of coronovirus, there is the demand for increased vigilance in preventive measures to prevent and contain the outbreak of this communicable disease. There have been a number of other studies discussing masks in preventing influenza spread: Loeb et al 2009 did a non-inferiority trial of surgical masks vs. N95 respirator masks for preventing flu in Ontario nurses working at tertiary care hospitals. They concluded surgical masks were non-inferior. MacIntyre et al 2009 did a cluster RCT on the use of face masks to control for respiratory virus transmission in households. They found face masks were unlikely to be an effective policy for seasonal respiratory diseases. This was in part because <50% of participants had mask adherence. Those who wore the mask did have a statistically significant reduction in clinical infection. MacIntyre et al 2011 published another study in the same year comparing efficacy non-face masks to fit tested and non-fit tested N95 respiratory mask in preventing respiratory infections in hospital workers in China. The results showed a significant decrease in respiratory illnesses including influenza. The authors did cautioned readers that the trial may have been underpowered. Smith et al CMAJ 2016 did a systematic review and meta-analysis on this topic. The authors concluded: "Although N95 respirators appeared to have a protective advantage over surgical masks in laboratory settings, our meta-analysis showed that there were insufficient data to determine definitively whether N95 respirators are superior to surgical masks in protecting health care workers against transmissible acute respiratory infections in clinical settings.” Clinical Question: Are N95 masks superior in preventing flu or flu like illnesses in hospital workers compared to medical masks? Reference: Radonovich et al. N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel. A Randomized Clinical Trial. JAMA 2019 The Respiratory Protection Effectiveness Clinical Trial (ResPECT) Population: Full-time hospital employees defined as providing at least 24hrs of direct patient care a week. Participants were instructed to wear their assigned protective devices during a 12-week period (intervention period) during which the incidence of viral respiratory illness was expected to be highest that year developed by the ALERT algorithm. This was for 48 weeks of intervention spanning four consecutive viral respiratory seasons. Intervention: N95 respirator mask. Employees were told to wear their masks when six feet (two meters) from a person suspected or confirmed of having a respiratory illness. Control: Medical mask Outcomes: Primary Outcome: Incidence of laboratory-confirmed influenza. Secondary Outcomes: Incidence of acute respiratory illness, laboratory-detected respiratory infections, laboratory-confirmed respiratory illness, and influenza like illness. Adherence to interventions was also assessed. Authors’ Conclusions: “Among outpatient healthcare personnel, N95 respirators vs medical masks as worn by participants in this trial resulted in no significant difference in the incidence of laboratory-confirmed influenza. Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. No The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). Yes The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No All groups were treated equally except for the intervention. Yes Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Unsure The treatment effect was large enough and precise enough to be clinically significant. No Key Results: This study was conducted at seven medical centers and 137 outpatient sites over four years (2011-2015) during the 3-month flu season. They enrolled 2,862 full time employees with a mean age of 43 years and 84% female. Nurses made up 41% of the cohort and less than 10% were physicians. No statistical difference in the laboratory-confirmed influenza between an N95 mask and a medical mask. Primary Outcome: Laboratory-confirmed influenza 8.2% N95 respirator group and 7.2% medical mask group (difference, 1.0%, [95% CI: −0.5% to 2.5%]; P = 0.18) Adjusted odds ratio (OR) was 1.18 (95% CI: 0.95 to 1.45) Secondary Outcomes: No statistical difference in any of the secondary outcomes using an intention-to-treat (ITT) or per-protocol (PP) analysis. Self-reported wearing of the mask “always” or “sometimes” was about 90% in both groups. Self-Reporting: Health care workers self-reported any illness. This could have resulted in under or over reporting of being sick. Adherence to mask use was also self-reported. Of those reporting, 90% said they wore the mask always or sometimes. However, almost one-third in each group did not even report adherence. This further limits the interpretation of the results. Lack of Physicians: Less than 10% of the cohort were physicians. This means we have much less data on this group of individuals. I also suspect physicians were less likely to follow mask recommendations. Unfortunately, the supplemental material did not break down how many physicians were in the physician, physician trainees or advanced practitioners’ cohort. Outside of Work: Participants were not required to use the masks outside of their work setting. Employees had to have at least 24 hours/week of direct patient care to be included in the study. However, more time would have been spent out of the hospital/clinic setting. These outside influences/exposures could have an impact on the results. Patient-Oriented Outcome: This study was focused on the employees.

Date: February 28th, 2020 Reference: Rajendran et al. Randomised control trial of adult therapeutic colouring for the management of significant anxiety in the Emergency Department. AEM February 2020 Guest Skeptic: Dr. Corey Heitz is an emergency physician in Roanoke, Virginia. He is also the CME editor for Academic Emergency Medicine. Case: One night during an overnight shift, you are taking care of a patient who presented to the emergency department (ED) due to anxiety and vague suicidal ideation. The process for medical clearance and psychiatric evaluation can take quite a while, and you notice that this patient seems stressed and anxious. You wonder if there’s a way to assist them during the prolonged wait without resorting to sedative medication. Background: Psychological disorders are a common reason for presenting to the ED. Anxiety disorders are the most common (Marchesi et al EMJ 2004). However, we have only covered mental health issues a few times on the SGEM: SGEM#45: Vitamin H (Haloperidol for Psychosis) SGEM#178: Mindfulness – It’s not Better to Burnout than it is to Rust SGEM#218: Excited Delirium Syndrome SGEM#237: Screening Tool for Child Sex Trafficking SGEM#252: Blue Monday- Screening Adult ED Patients for Risk of Future Suicidality Patients with psychological disorders are often kept in the ED for a prolonged period of time. The ED itself can be a stressful environment and exacerbate anxiety. Emergency physicians have pharmaceutical options to treat anxiety. One of the most common medications to use is a benzodiazepine like lorazepam or diazepam. There is a need for non-pharmacological therapies to treat anxiety, and in some settings, art therapy has been studied. Specifically, adult coloring books have been used in the community and seem to function through cognitive easing (Rigby et al BMJ 2016 and Curry et al Art There 2005). Clinical Question: Can colouring decrease anxiety in adult patients presenting to the emergency department? Reference: Rajendran et al. Randomised control trial of adult therapeutic colouring for the management of significant anxiety in the Emergency Department. AEM February 2020 Population: Patients >15 years old with a score of >6 on the Hospital Anxiety and Depression Scale Anxiety (HADS-A). A score of >6 is considered moderate to severe anxiety. Intervention: Colouring pack (10 adult colouring pages and 36 pencil colours) Comparison: Placebo pack (10 plain sheets of paper, a Bic pen and instructions to draw or write freely) Outcome: Primary Outcome: Within-patient change in HADS-A score from baseline after two hours of therapy. Secondary Outcomes: Survey questions regarding value of therapy and level of engagement with treatment packs (length of time) Dr. Naveen Rajendran This is an SGEMHOP episode which means we have the lead author on the show. Dr. Naveen Rajendran is an intern at the Westmead Hospital in Sydney with a keen interest in emergency medicine and the investigation of novel therapies that could aid in alleviating the growing stress on modern emergency departments. This study was conducted when he was a medical student at the University of Sydney with Dr. Coggins (@coggi33) who was his research supervisor. Authors’ Conclusions: “Among ED patients, exposure to adult colouring books resulted in lower self-reported levels of anxiety at 2-hours compared to placebo.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. Yes The patients were adequately randomized. Unsure The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). Unsure The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No All groups were treated equally except for the intervention. Yes Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Yes The treatment effect was large enough and precise enough to be clinically significant. Yes Key Results: They screened 179 patients that were flagged as being anxious. The cohort included 53 participants with a mean age of 33 years and 73% were female. HADS-A decreased significantly more in the adult colouring group Primary Outcome: Intervention Group: Mean HADS-A decrease at two hours was 3.7 (95%CI 2.4 to 5.1, p<0.001) Control Group: Mean HADS-A decrease at two hours: 0.3 (95%CI -0.6 to 1.2, p=0.51) Secondary Outcomes:  For the question "would you recommend colouring" on a Likert Scale (1-5) the average satisfaction score was 4.2. We asked Naveen ten questions to get a greater understand of his publication. Listen to the SGEMHOP podcast to hear all of his answers. Single Centre: This was a relatively small sample size of 53 patients. However, you did recruit enough to meet your power calculation of 48 participants to find a 2.5-point decrease with 80% power. We were more concerned that this was conducted in a single center and raises question of external validity to other populations. Consecutive Patients: We are unsure if this was a consecutive sample. The methods section says; “all patients in the ED were potentially eligible for the study.”  However, patients needed to be flagged by residents, consultants, triage nurses or social workers as being “anxious”. People have unconscious biases and this method could have introduced some selection bias. Why not just ask patients if they were feeling anxious and then ask them to be included in the trial? Exclusions: A significant number of patients were excluded after initial screening. Can you discuss how this might affect real-world utility of something like this? Lack of Blinding: The patients would know if they were in the colouring pack vs. placebo pack. Could this have impacted the results? Blinding to Hypothesis: Were the patients, clinicians, and outcome assessors blinded to the research hypothesis? HADS-A Scoring: The HADS-A has been validated in various languages and groups of patients. You say this anxiety scoring system has been validated in the ED setting. We pulled that study and it was done in Saudi Arabia (Al Aseri et al BMC Emerg Med 2015). Has it been validated in any other countries like the USA or Canada? Placebo Control: There is a difference between a placebo control and an active control. Can you discuss how your placebo control group is a true placebo? It seemed to us more like an active control group. How is the activity such as coloring so different from having a pen and paper and being told to occupy yourself with them? Medication: You compared the colouring activity to the placebo pack (Bic Pen, plain paper and encouragement to draw). Why not comparing it to usual care such as a benzodiazepine? Magnitude of Effect: The intervention decreased the HADS-A score by 3.4 more than the control. While it was statistically significant is this observed decrease clinically significant. Duration of Effect: Your primary outcome was at two hours. Did you measure any anxiety outcomes after the activity has ended? Do we know how long it takes someone to return to a high anxiety level once art therapy is removed? Conflicts of Interest: Did you receive any funding or support from the adult colouring book industry? Comment on Authors’ Conclusion Compared to SGEM Conclusion:  We agree with the authors’ conclusions SGEM Bottom Line: Art therapy in the form of coloring may be a useful non-pharmacologic alternative treatment for ED patients with anxiety. Case Resolution: You provide your patient with an adult coloring book and coloring pencils. Two hours later, they seem calmer, and their ED visit is almost over. They thank you for providing them something to ease their mind during their stay. Dr. Corey Heitz Clinical Application: Adult coloring books are a low risk and potentially rewarding non-pharmacologic way to treat anxiety in the ED. What Do I Tell the Patient?  You seem anxious, and this visit may take some time. Some people have found that being able to spend some time colouring can help them cope with the stress of an ED visit. Would you like some supplies and try doing some colouring? Keener Kontest: Last weeks’ winner was Jonathan Godfrey. He knew PARACHUTE stood for: "PArticipation in RAndomized trials Compromised by widely Held beliefs aboUt lack of Treatment Equipoise". Listen to the SGEM podcast to hear this weeks’ question. Send your answer 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 about using adult colouring books to deal with patients’ anxiety in the ED? Tweet your comments using #SGEMHOP. What questions do you have for Naveen and Andrew and his team? Ask them on the SGEM blog. The best social media feedback will be published in AEM. Also, 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. We will put the process on the SGEM blog: Go to the Wiley Health Learningwebsite Register and create a log in Search for Academic Emergency Medicine – “February” Complete the five questions and submit your answers Please email Corey (coreyheitzmd@gmail.com) with any questions or difficulties. Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.

Date: January 27th, 2020 Guest Skeptics: Dr. Richelle Cooper is a Professor of Emergency Medicine at the UCLA Department of Emergency Medicine. Dr. Maia Dorsett is an Emergency and EMS Physician at the University of Rochester Medical Center. Reference: Dorsett et al. Bringing value, balance and humanity to the emergency department: The Right Care Top 10 for emergency medicine. Emerg Med J 2019 This is an SGEM Xtra based on a recent publication by Dr. Dorsett and her team. It is an article of ten recommendations on how we might provide a more balanced approach to healthcare tailored to the needs of the patients we see in the emergency department. One of the authors of the article was the Legend of Emergency Medicine, Dr. J. Hoffman. SGEMers have heard about over-testing, over-diagnosing and over-treating. These authors have some concerns about what they call the unmentioned "elephant in the room". "While specialty societies do undertake advocacy work to address the health needs of the public, they also have a fundamental duty to advocate for and protect the interests of their specialty. Furthermore, healthcare dollars that are ‘wasted’ are of course not actually thrown away but rather end up in someone’s pocket; thus, there is clearly a conflict of interest when specialty societies address the overuse of extremely lucrative medical procedures that provide substantial income to their members." Choosing Wisely is an initiative trying to address the issue of over-testing, over-diagnosing and over-treating. To be clear, these authors are not against Choosing Wisely. "Important to note that we are not against choosing wisely, however the issue is larger and more nuanced. It is not just about “low value” care and costs but about harms, harms from overuse of diagnostic tests and treatment and also from underuse in other cases. The right care alliance is concerned about the right care for the right patients at the right time, thus not just overused tests." The organization this group of authors are associated with is called the Right Care Alliance (RCA). How is it different from the Choosing Wisely Campaign? "The Right Care Alliance was formed in 2015 by the Lown Institute, a healthcare think tank. Many of us, such as myself, became involved with the work of the Lown because of our interest in reducing the harms of overtesting and overdiagnosis. But we quickly realized that talking about Right Care was actually a conversation about the Right amount of care and that this was more than just about too much care, it was also about underuse, health care access and a focus on treating the whole patient. It was this realization – that we cannot address overuse without talking about underuse - that lead to the formation of the RCA. The powerful part of the RCA is that it is a grassroots coalition of not just healthcare practitioners, but also patients and community members." Where does emergency medicine fit into the RCA initiative? "Nowhere in healthcare is the unfortunate dichotomy between overuse and underuse as apparent as in our emergency departments, which function simultaneously as centers of high acuity healthcare and healthcare safety nets. Organizationally, the RCA has a number of subcommittees or “councils”. The Emergency Medicine (EM) Council is one of these subgroups and is composed primarily of emergency physicians and nurses." "In May 2016, the RCA asked its specialty councils to create their own ‘top 10’ lists, The goal was to identify not merely interventions that are overused but also others that need to be used more widely, if we are to achieve both better and more equitable health outcomes and financial savings." What were the guiding principles put forward by the RCA to generate the top 10 list? Guiding Principles for Top 10 List: Patient-centred Holistic in approach Understandable to both healthcare professionals and non-health care professionals Meaningful to everyone who participates in the healthcare system Criteria Used to Select the Top 10 Items: Matter to patients Have high potential to harm or to benefit Be common (overuse) or rare (underuse) enough that avoiding or doing the item routinely would move the needle towards the right care Examine or illustrate how it ties to system failures. The committee was predominantly made up of emergency physicians, including residents, faculty and community physicians, and emergency medicine nurses. Patients were invited to participate on all the committees, and it was required that members of the Patient council review and provide input to all lists. The Emergency Medicine (EM) members of the RCA were all invited to participate, ultimately 125 gave input on potential items. They participated in each part of the scoring and ranking and in a smaller group for the discussion of the items. Similarly, Maia presented and received input from patients/patient advocates at a Lown conference. Two Overriding Principles of the EM Right Care Top 10 List: "The quixotic search for certainty’ describes the all too common attempt by clinicians to find the last few patients who may be in danger even though an evaluation has shown that risk is minimal. Along with this fear of missing even a single patient with a serious problem, most clinicians have been taught to believe (incorrectly) that ‘tests’ are more ‘objective’ than clinical judgement and, thus, that doing more is ‘safer’ and more ‘evidence based". "Medical care is not the sole, or even the most important, determinant of health outcomes. Social determinants—including, but not limited to, food insecurity, homelessness and addiction—are profoundly important to the health of a great many patients. These issues must be addressed as part of the larger healthcare system, but it is also critical that ED clinicians pay attention to and address social factors in their patients, individual by individual". EM Right Care Top 10 List: Listen to the SGEM podcast to hear Dr. Dorsett and Cooper expand on each of these items. Avoid further testing beyond history, physical exam, clinical gestalt and ECG in patients who are at minimal risk of an acute coronary syndrome (ACS). Avoid further testing beyond history, physical exam and clinical gestalt in patients who are at minimal risk of pulmonary embolus (PE). responds Be judicious with the use of imaging, especially advanced imaging, in trauma patients. Avoid routine laboratory testing. Consider non-medical reasons for a patient’s presentation to the ED. Tailor the intensity of care to the goals of the patient. Employ shared decision-making (SDM) where appropriate. When prescribing an intervention, make an effort to ensure that the patient is capable of accomplishing what is recommended. Tailor discharge instructions and follow-up recommendations to the individual patient. Be an advocate. Dr. Cooper Conclusion: "The RCA is working to change the conversation about American healthcare, advocating for access for all individuals to high-quality care without financial hardship, eliminating overuse and underuse, and championing the partnership between the patient and clinician. The EM Council’s top 10 list seeks to serve as a starting point to focus ED clinicians in achieving the goals of the RCA. While other lists exist, and we agree with many Choosing Wisely areas of focus, we seek to move the needle even further. In what is ultimately an impossible attempt never to miss a single case with a life-threatening diagnosis, we paradoxically cause a great deal of harm to the overall population through over-testing and contribute to the untenable rising cost of healthcare." Dr. Dorsett "When we fail to spend the time needed to understand the context of our patients’ lives outside of the ED, we miss the opportunity to improve the patient’s health. While some problems are big and may take decades to fix, micro-changes in our daily practice— listening more, ordering more thoughtfully—are possible today. One patient at a time, one shift at a time, one ED, one hospital and one community at a time, we as clinicians need to help drive the change. We do not need more research to show unnecessary testing is occurring; we need effective means to implement change and support clinicians in putting the best interests of their patients first." 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 10 years to less than 1 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.