The Skeptics Guide to Emergency Medicine

Date: May 19th, 2020 Reference: Yang P et al. Endovascular thrombectomy with or without intravenous alteplase in acute stroke. NJEM 2020. Guest Skeptic: Dr. Anand Swaminathan is an Assistant Professor of Emergency Medicine at St. Joseph’s Regional Medical Center in Paterson, NJ. Managing editor of EM:RAP and Associate Editor at REBEL EM. Case: A 53-year-old previously healthy man presents with 1.5 hours of right sided weakness as well as slurred speech. A rapid bedside assessment gives you a National Institute of Health Stroke Score/Scale (NIHSS) of 9 and you are concerned about a large vessel occlusion (LVO) based on the high NIHSS as well as the presence of both an upper extremity drift and the speech abnormality. A non-contrast CT shows no evidence of intracranial hemorrhage. A CT angiogram plus CT perfusion demonstrate a clot in the left proximal middle cerebral artery (MCA) with a small infarcted area and a large penumbra. Based on your institution’s current guidelines, the patient is a candidate for endovascular therapy, but they are also within the current window for the administration of alteplase. You wonder if you should give the alteplase while waiting for your neurointerventional team? Background: The issue of thrombolytics for stroke has been debated since at least 1995. This is the year that the famous NINDS trial was published. We cover this as an SGEM classic that all EM physicians should know about on SGEM#70. Our bottom line was that we were skeptical thrombolysis has a net patient-oriented benefit for acute ischemic strokes. We have covered this issue of thrombolysis for acute ischemic stroke a number of times on the SGEM SGEM#29: Stroke Me, Stroke Me SGEM Xtra:Thrombolysis for Acute Stroke SGEM#290: Neurologist Led Stroke Teams – Working 9 to 5 You also had the Legend of Emergency Medicine, Dr. Jerome Hoffman on to reflect upon the last 25 years and the thrombolysis for acute ischemic stroke debate (No Retreat, No Surrender) I also invited my EBM friend, Dr. Eddy Lang onto the SGEM to discuss his perspective on the issue (SGEM Xtra). This led to a pro/con publication in the Canadian Journal of Emergency Medicine (CJEM) tPA should be the initial treatment in eligible patients presenting with an acute ischemic stroke (Milne et al CJEM April 2020). The publication of the MR CLEAN trial in January 2015 changed the face of ischemic stroke care. This was the first study demonstrating a benefit to endovascular treatment of a specific subset of ischemic stroke patients: those with LVOpresenting within sixhours of symptom onset. MR CLEAN was followed by a flurry of publications seeking to replicate and refine treatment as well as expand the window for treatment. The REBEL EM team reviewed this literature back in 2018 and, with the help of Dr. Evie Marcolini, created the below workflow: One major component of LVO management is the use of systemic thrombolytics in patients presenting within the current thrombolytic treatment window prior to endovascular intervention. However, it’s unclear if systemic thrombolytic administration results in better outcomes or if it simply exposes the patient to increased risks at a higher cost. Limited evidence questions the utility of the current approach with thrombolytics plus endovascular therapy (Phan 2017, Rai 2018). There is a clear need for further research into systemic thrombolytics dosing and use. Clinical Question: Is endovascular therapy alone non-inferior to endovascular therapy plus systemic thrombolytics in the treatment of patients with large vessel occlusion strokes presenting within 4.5 hours of onset? Reference: Yang P et al. Endovascular thrombectomy with or without intravenous alteplase in acute stroke. NJEM 2020. Population: Adult patients (18 years of age or older) presenting within 4.5 hours of ischemic stroke symptom onset and with cerebral vascular occlusion on CT angiography of the intracranial internal carotid artery or middle cerebral artery (first and/or second segments) and an NIHSS > 1 and if endovascular thrombectomy was intended to be performed. Exclusions: Disability from a previous stroke or contraindication to IV alteplase and any contra-indication for thrombolysis according to American Heart Association (AHA) guidelines. Intervention: Endovascular thrombectomy alone Comparison: Endovascular thrombectomy + systemic alteplase 0.9 mg/kg Outcomes: Primary Outcome: Modified Rankin Scale (mRS) score assessed at 90 days after randomization looking for non-inferiority (defined as a lower end of the odds ratio > 0.80) Secondary Outcomes: Death from any cause at 90 days, successful reperfusion before thrombectomy, recanalization at 24-72 hours (assessed by CTA), NIHSS score at 24 hours, and 5-7 days, final lesion volume on CT and mRS comparisons Safety Outcomes: All hemorrhages and symptomatic intracranial hemorrhages according to the Heidelberg criteria, occurrence of pseudoaneurysm and groin hematoma at the site of arterial puncture used for thrombectomy, cerebral infarction in a new vascular territory at five to seven days, and mortality within 90 days. Authors’ Conclusions: “In Chinese patients with acute ischemic stroke from large-vessel occlusion, endovascular thrombectomy alone was noninferior with regard to functional outcome, within a 20% margin of confidence, to endovascular thrombectomy preceded by intravenous alteplase administered within 4.5 hours after symptom onset.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. Unsure The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). Unsure The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No All groups were treated equally except for the intervention. Unsure Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Yes The treatment effect was large enough and precise enough to be clinically significant. No Key Results: They screened 1,586 patients for eligibility and 654 were included in the final analysis. The median age was 69 years and slightly more were male. The median NIHSS score was 17. Primary Outcome: Adjusted odds ratio for the mRS aOR = 1.07 (95% CI 0.81 TO 1.40) Demonstrates non-inferiority as lower limit of non-inferiority was set at 0.80 Secondary Outcomes:  1) Consecutive Patients and External Validity – The manuscript did not explicitly say patients were recruited consecutively. Without this information it is hard to comment on whether or not there was selection bias. We are also concerned about the external validity of a stroke trial conducted in China compared to the care provided in the USA. 2) Declined to Participate – Of eligible patients, 15% (240/1,586) declined to participate. There was no information provided on this group in the published paper or supplementary material. Patients deciding to participate could have been different from those who decided not to participate. This too could have introduced some selection bias. 3) Lack of Blinding: The treating physicians and study participants were not blinded to group allocation. This could have biased the study towards the EVT alone if that hypothesis was known to these two groups. 4) Intention-To-Treat (ITT): You will often hear us comment about whether or not the trial has used an ITT analysis. This is a quality indicator for superiority designs. However, for non-interiority trials a per-protocol analysis is the more conservative approach to minimize bias.Using an ITT can bias the results toward the null hypothesis. The per-protocol analysis could only be found in the supplemental appendix. A non-inferiority design seeks to establish a novel treatment is not worse than a standard treatment by more than a predetermined acceptable amount. The null hypothesis for a non-inferiority study states for a given outcome, treatment A (a novel treatment) is worse than treatment B (an accepted, validated treatment) by more than a non-inferiority margin called the delta (∆). In contrast, the alternate hypothesis states for a given outcome, treatment A is not worse than treatment B by more than ∆.This type of study design is often used when two circumstances are met:  a placebo trial would be unethical, due to the existence of a treatment proven superior to placebo, and the novel treatment offers other advantages (e.g., cost, ease of use, less invasiveness, fewer adverse effects, etc.). Setting the non-inferiority margin should be specified a priori. It can be set at a statistically significant difference or a clinically significant difference. Subjectivity can be introduced when determining what is considered clinically significant. A number of guidelines exist like the CONSORT extension statement to help researcher properly design non-inferiority trials. 5) Outcomes: Outcome data was obtained via interviews performed in person or by phone. Phone interviews are suboptimal for assessing functionality. This could add more statistical noise into the data and bias the results to finding non-inferiority. We could not find how many assessments were done in person and how many were done by phone. It would be interesting to see if there were any differences in outcome that could be attributed to the method of assessing the outcome. Comment on Authors’ Conclusion Compared to SGEM Conclusion: We generally agree with the authors’ conclusions.

Date: May 18th, 2020 I was asked to participate in a debate regarding the issue of Masks4All in Canada by the people involved in the COVID Information for Canadian Physicians Facebook group. This is a private group ~22,000 physicians, residents, students and nurse practitioners from around the world. Dr. Joe Vipond I was reluctant to participate but was convinced after having a good conversation with the organizers and Dr. Vipond. They assured me it would be respectful, focus on the evidence and be an educational experience for the audience. These are stressful times and we all want the best recommendation for patients, based on the best evidence to ensure community well-being. Arguing for the affirmative position was Dr. Joe Vipond. He is an emergency physician at the Rockyview General Hospital and a clinical assistant professor at the University of Calgary. He has generously made available his notes from the debate that include links to more information. I argued against the resolution. This does not mean I am against wearing a cloth mask in public. Those who know my not so secret identity (BatDoc) know that I am often seen in public wearing a mask. This is not the type of mask Dr. Vipond and I were debating. We were not talking about wearing medical masks, surgical masks, N95 masks or respirators by healthcare providers on the front lines of COVID19. The debate also did not include symptomatic people or those caring for high-risk people. We were only debating the issue of universal cloth Masks4All in public. To be very clear, I am not anti-mask wearing in public. My position is "it all depends" as taught by my evidence-based medicine (EBM) mentor Dr. Andrew Worster from BEEM.  I am just not in favour of a mandatory universal Masks4All in public in Canada. You can watch the Mask4All debate on YouTube. Resolution: Be it resolved that a mandatory universal mask for all to prevent transmission of COVID19 be recommended for Canadians. Dr. Kashif Pirzada We were each given four minutes for an opening statement, three minutes for a rebuttal, four more minutes for a second affirmative statement and finished with three minutes for another rebuttal and closing statement. We had two moderators for this debate. Dr. Kashif Pirzada is an emergency physician in Toronto with an interest in startups and innovation.  He is also a co-founder of Conquer-Covid19, a charity that sources personal protection equipment for frontline health workers. Dr. Jennifer Kwan Dr. Jennifer Kwan is a family physician in Burlington, Ontario. She is known for COVID19 data visualizations on Twitter (@jkwan_md) along with the HowsMyFlattening team, and is an advocate for #Masks4Canada and personal protection equipment donations with Halton Regional Chinese Canadian Association. I am not against wearing a cloth mask in public. My position is that I am not convinced that a mandatory Masks4All in public by people that are practicing physical distancing will prevent transmission of clinical disease (COVID19). This is an important distinction. Dr. Samir Grover Questions on the Facebook feed were moderated by Dr. Samir Grover. He is an associate professor and program director for gastroenterology at the University of Toronto. Kashif and Samir have a podcast about COVID-19 called "The Medicine Club" which can be accessed on Twitter @TheMedClubTO It is important in any discussion to be clear on the terms being used. Mandatory: Required by a law or rule : OBLIGATORY. Universal: Including or covering all or a whole collectively or distributivity without limit or exception. Public: All public places (not to private places) Clinical Disease: There is a difference between a DOO (Disease Oriented Outcome- detection of COVID19 RNA) and a POO (Patient-Oriented Outcome - clinical disease). As a clinician, I am more interested in POOs and less interested in  DOOs. Epistemology: The study or a theory of the nature and grounds of knowledge especially with reference to its limits and validity I want to accept positions for good reasons not because it is someone’s opinion.  Just because someone is a gifted clinician and an excellent advocate for the environment does not mean they are an expert in clinical epidemiology, biostatistics and critical appraisal. This brings up the possibility of a Dunning-Kruger Effect. Here is a link to a great video made by Dr. Rohin Francis (@MedLifeCrisis). It is a satirical ad for Dunning-Kruger Alcohol and uses humour as a COVID19 coping strategy. “The Dunning-Kruger effect is a cognitive bias in which people wrongly overestimate their knowledge or ability in a specific area. This tends to occur because a lack of self-awareness prevents them from accurately assessing their skills.” My credentials included 37 years of medical research, Senior Editor of Academic Emergency Medicine (AEM), advance training in clinical epidemiology, biostatistics and critical appraisal.  I teach these skills and cognitive bias and logical fallacies to MSc and PhD students in the Department of Epidemiology. I have published dozens of critical appraisals which are considered a higher level of evidence than a randomized control trial on the EBM pyramid of evidence.  Basically, I am an uber nerd. This does NOT make my position of the evidence on cloth Masks4All correct or an argument from authority. The information is presented as evidence of my expertise and to support my claim that this is my lane. In the scientific method we start with the null hypothesis. The null would be that there is no statistical difference between universal/mandatory cloth masks4all and not wearing a cloth mask in public. The burden of proof is on those making the claim that cloth masks4all in public is superior in preventing transmission of clinical disease (POO) in those physically distancing. Without sufficient evidence we should not accept the claim. Therefore, we should accept the null hypothesis of no superiority. Everyone will have a different level of evidence required to accept a claim. I want patients to get the best recommendation, based on the best evidence. Without evidence people are providing an opinion. Christopher Hitchens famously said "that which can be asserted without evidence, can be dismissed without evidence." (Hitchens’ Razor) Peltzman Effect: Risk Compensation and Risk Homeostasis Prof Sam Peltzman Sam Peltzman was a professor who wrote a paper in 1975 about seatbelt regulations (The Effects of Automobile Safety Regulation, J Political Economy 1975). Professor Peltzman argued that the benefits of seatbelt would be offset by more pedestrian deaths and more nonfatal accidents because of “driving intensity”. This was driving faster and more recklessly with the security of the safety belt. His hypothesis was proven to be wrong and seatbelts were a net benefit but it did open a field of risk compensation. Bill Booth There are examples where an intervention did have a positive outcome (seat belts in cars and helmets when cycling) but there are other examples where the theoretical benefits did not materialize in the real world. This includes parachute equipment advancements to prevent morbidity and mortality from jumping out of a plane. Bill Booth was a person who designed safety equipment for parachutes. They should have decreased morbidity and mortality of jumping out of plane. The data showed it did not. There was risk compensation and it did not have the impact he hoped (Booth’s Second Law). "The safer skydiving gear becomes, the more chances skydivers will take, in order to keep the fatality rate constant."  Condoms Another example is condoms to prevent HIV virus transmission during that pandemic. The no glove, no love was thought to be a “no brainer”. It was widely felt that condoms could help prevent the spread of the HIV epidemic. However, the impact of condoms alone was mitigated during a global pandemic due to risk compensation/homeostasis. There are a significant portion of people who dislike using condoms, use is often irregular, and condoms seem to give a sense of security. This can lead to disinhibition, in which people may engage in risky sex with condoms (Shelton JD. Ten myths and one truth about generalized HIV epidemics, Lancet 2006). Risk compensation/homeostasis (Peltzman Effect) can also be seen in the unintended behavioral responses by patients and physicians to health care interventions. This may explain why certain health care interventions that seem logical and foolproof fail to demonstrate real-world benefits (Prasad and Jena Healthc Amst 2014). EHR and Burnout Electronic Health Records (EHRs) is just one newer example of the risk compensation hypothesis. One of the claimed benefits of introducing EHRs was to decrease medication errors. While they did demonstrate fewer of these errors they increased other errors. It is also unclear if the type of medication errors that were reduced had an important POO. EHRs also have been shown to negatively impact emergency department efficiency. They have been blamed for contributing to physician burnout. Burnout is associated with worse patient care. Gray A et al. The impact of computerized provider order entry on emergency department flow. CJEM 2016. Shanafelt et al Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015;90(12):1600-1613 West CP, Huschka MM, Novotny PJ, et al. Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study. JAMA. 2006; 296(9):1071-1078. Shanafelt TD, Balch CM, Bechamps G, et al. Burnout and medical errors among American surgeons. Ann Surg. 2010;251(6): 995-1000. Firth-Cozens J, Greenhalgh J. Doctors’ perceptions of the links between stress and lowered clinical care.

Date: May 9th, 2020 Guest Skeptic: Dr. Sean Moore is an Assistant Professor at the Northern Ontario School of Medicine (NOSM), Chief of Emergency Services at Lake of the Woods Hospital in Kenora, Medical director with Ornge, and Associate Medical Director with CritiCall Ontario. CAEP Town Hall We had the pleasure of presenting for the Canadian Association of Emergency Physicians (CAEP) COVID-19 Town Hall this week.  CAEP is the national voice of emergency medicine (EM) in Canada and provides continuing medical education, advocates on behalf of emergency physicians and their patients, supports research and strengthens the EM community. In co-operation with other specialties and committees, CAEP also plays a vital role in the development of national standards and clinical guidelines. Our CAEP COVID-19 Town Hall presentation is available to watch on the CAEP website. It has also been uploaded to CAEP's YouTube channel. All of the the CAEP COVID-19 Town Halls talks are available free open access. Copies of our slides can be downloaded at this link. Dr. Sean Moore Dr. Moore and I were asked to speak about the treatments being used for COVID-19. In this global pandemic, clinicians and researchers have been throwing multiple different treatments at this new corona virus hoping something will work. This includes things like: Azithromycin, Steroids, Famotidine, IL-6 inhibitors, Chloroquine, Hydroxychloroquine, Remdesivir, Vitamin C, and Zinc.   We narrowed our presentation down to five treatments and the evidence behind those treatments. These are listed below with links to the references mentioned in the presentation. Chloroquine / Hydroxychloroquine Dr. Didier Raoult Gautret et al. Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: A pilot observational study. Travel Med Infect Dis. April 11th, 2020 Tang et al. Hydroxychloroquine in patients with COVID-19: an open-label, randomized, controlled trial. MedRxIV April 14th, 2020 Chowdhury et al. A Rapid Systematic Review of Clinical Trials Utilizing  Chloroquine and Hydroxychloroquine as a Treatment for COVID‐19. AEM May 2020. We cannot recommend hydroxychloroquine or chloroquine based on the available evidence. Steroids Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 Mar 28. Steroids Wilson et al. COVID‐19: Interim Guidance on Management Pending Empirical Evidence. From an American Thoracic Society‐led International Task Force. Thoracic April 3rd, 2020 Villar et al. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial. Lancet Resp Med Feb 7th, 2020 Wu et al. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Int Med March 13th, 2020 We cannot recommend the use of steroids outside of an RCT. However, steroids should be considered when patients have other indications like COPD or asthma. Remdesivir Grein et al. Compassionate Use of Remdesivir for Patients with Severe Covid-19. NEJM April 10th, 2020 Wang et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. The Lancet April 29th, 2020 Fauchi A. Adaptive COVID-19 Treatment Trial (ACTT). Press Conference April 29th, 2020 We cannot recommend the routine use of remdesivir based on the available evidence. Convalescent Plasma Convalescent plasma is being investigated but there is very little information on this treatment modality. Currently the CONCOR Trial is underway in Canada using 200-500 ml of plasma. Researchers from across the country are involved including Drs. Donald Arnold, Philippe Begin and Jeannie Callum. Plasma collection was started in April. We cannot recommend the use of convalescent plasma outside of a research study. Vaccines Much work is being done on developing a COVID19 vaccine but that is a least months if not years away. My position on vaccines is that the evidence for potential benefit is much greater than the evidence for potential harm. Vaccines are safe and effective for the vast majority of people. SGEM#20 with guest skeptic Dr. Lauren Westafer (@LWestafer) from FOAMCast discussed the issue of flu shots for healthcare workers. We do not know how effective a vaccine will be, it's safety or how long the immunity would last at this time. George Santayana Dr. Moore and I continued the presentation with a reminder that we should remember our history. We have made mistakes in the past by adopting new technology or treatments too soon in medicine. There are examples of when the treatment was properly studied it was found not to work or even worse, increase mobility or mortality. It was George Santayana who said "those who cannot remember the past are condemned to repeat it".  An excellent article was written by Jeaane Lenzer and Shannon Brownlee and published in Issues in Science and Technology. It was titled Pandemic Science Out of Control: A toxic legacy of poor-quality research, media hype, lax regulatory oversight, and vicious partisanship has come home to roost in the search for effective treatments for COVID-19. I would encourage people to read at least the first paragraph. "On September 14, 1918, in the midst of the worst pandemic in modern history, an article in the New York Times quoted Dr. Rupert Blue, then surgeon general of the US Public Health Service. Blue reported that doctors in many countries were treating their influenza patients with digitalis and the antimalaria drug quinine. There was no evidence that the two drugs were any more effective than folk remedies being used by patients, including cinnamon, goose grease poultices, and salt stuffed up the nose, but doctors were desperate and willing to try just about anything. They would eventually abandon quinine and digitalis as treatments for flu when studies showed they were not only ineffective but caused serious and sometimes deadly side effects." Dr. Rob Leeper I took us back over 200 hundred years to give an example of why it is important to conduct randomized controlled trials rather than relying upon clinical experience and observational data. The study was conducted by Scottish medical student Alexander Hamilton who in 1809 challenged the standard of care, blood letting, for camp fever. He demonstrated that the number needed to treat for harm (NNT) was four. The primary outcome (harm) in this case was death. More details about blood letting and the importance of randomization can be found on the SGEM Xtra with Dr. Rob Leeper. The CAEP Town Hall on COVID-19 Treatments ended with an excellent article from the NEJM. It was a perspective piece written by Zagury-Orly and Schwartzstein called: A Reminder to Reason. I would highly suggest reading the entire article but the last paragraph gives a powerful statement. "We are living through an unprecedented biopsychosocial crisis; physicians must be the voice of reason and lead by example. We must reason critically and reflect on the biases that may influence our thinking processes, critically appraise evidence in deciding how to treat patients, and use anecdotal observations only to generate hypotheses for trials that can be conducted with clinical equipoise. We must act swiftly but carefully, with caution and reason." 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. Ultimately we want patients to 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. Other #FOAMed Resources on COVID19 First10EM with Dr. Justin Morgenstern PulmCrit with Dr. Josh Farkas EMCases with Dr. Anton Helman St. Emlyn's Dr. Simon Carley and the Team REBEL EM with Dr. Salim Rezaie and Team EMRAP with Dr. Mel Herber and Team

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.