

The Skeptics Guide to Emergency Medicine
Dr. Ken Milne
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Dec 13, 2025 • 34min
SGEM#496: Hangin’ Tough after a Nerve Block for Pediatric Femur Fractures
Reference: Binder ZW et al. “Ultrasound-Guided Nerve Block for Pediatric Femur Fractures in the Emergency Department: A Prospective Multi-Center Study.” Academic Emergency Medicine, 2025.
Date: November 24, 2025
Dr. Lauren Westafer
Guest Skeptic: Dr. Lauren Westafer is an Associate Professor in the Department of Emergency Medicine at the University of Massachusetts Medical School, Baystate. She is the co-founder of FOAMcast and a researcher in pulmonary embolism and implementation science. Dr. Westafer serves as the research methodology editor for Annals of Emergency Medicine.
Case: A 9-year-old boy presents to the emergency department after a trampoline injury. He was at a party with his friends and they were all bouncing together and competing to see who could bounce the highest. The boy fell down on his right leg and a friend accidentally landed on it. On your exam, the boy is in significant pain and has a deformity of his right leg. You do not note any additional injuries. X-rays confirm a mid-shaft femur fracture. You administer some IV morphine, but the boy is still whimpering in pain. One of the other attending physicians on shift who happens to be an ultrasound enthusiast, suggests using an ultrasound-guided nerve block as a way to manage the boy's pain. The boy’s parents ask “What is that?”
Background: Femur fractures are one of the most painful injuries in pediatric patients and frequently require hospital admission for definitive treatment, often with long ED stays prior to operative management. Traditional pain management for these injuries relies heavily on IV opioids, which have well-documented side effects including nausea, respiratory depression, and sedation. Increasing public awareness of the opioid crisis has also led to growing parental concern over opioid exposure in children. There is growing interest in opioid-sparing pain control methods.
The fascia iliaca compartment nerve block (FICNB) is a regional anesthesia technique that targets the femoral nerve and adjacent sensory nerves to provide localized pain relief. While landmark-based FICNB techniques have been used successfully in adult patients, recent studies suggest that ultrasound guidance improves the accuracy and safety of these procedures. However, evidence on the effectiveness and safety of ultrasound-guided FICNB in pediatric patients, particularly when performed by emergency physicians in real-world ED settings, remains limited.
Clinical Question: In children with femur fractures, is ultrasound-guided FICNB more effective at reducing pain compared to systemic analgesia?
Reference: Binder ZW et al. “Ultrasound-Guided Nerve Block for Pediatric Femur Fractures in the Emergency Department: A Prospective Multi-Center Study.” Academic Emergency Medicine, 2025.
Population: Children aged 4–17 years presenting to the ED with isolated, acute femur fractures.
Excluded: Patient with neurovascular compromise, multi-trauma, GCS ≤13, bilateral fractures, allergy to anesthetics, prisoners, pregnancy.
Intervention: Ultrasound-guided fascia iliaca compartment nerve block (FICNB) performed with ropivacaine or bupivacaine
Comparison: Systemic analgesia administered at discretion of ED treating team
Outcome:
Primary Outcome: Reduction in pain intensity at 60 minutes using the Faces Pain Scale–Revised (FPS-R).
Secondary Outcomes: Reduction in pain at 240 minutes, opioid consumption (oral morphine equivalents per hour), occurrence of adverse events, and emergency department (ED) length of stay.
Trial: Prospective multi-center observational study conducted at 12 pediatric emergency departments in the US and Australia. Some sites performed FICNB. Other sites did not.
Dr. Zachary Binder
Guest Author: Dr. Zachary Binder is a pediatric emergency medicine attending physician at UMass Memorial Health and Associate Professor at UMass Chan Medical School. He is the Director of Point-of-Care Ultrasound for the Department of Pediatrics and the medical school.
Authors’ Conclusions: Children who received FICNB had greater reductions in pain intensity and required less opioid medication than those who did not. This is the largest prospective study evaluating the ultrasound-guided FICNB performed on children in the ED, and its findings support the procedure’s use for pediatric femur fracture pain management.
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? Yes
Was the follow up of subjects complete enough? Yes.
How precise are the results? Fairly precise
Do you believe the results? Yes
Can the results be applied to the local population? Unsure
Do the results of this study fit with other available evidence? Yes.
Funding of the Study: No financial conflicts of interest
Results:
They included a total of 114 participants (54 in the FICNB group and 60 in the non-FICNB group). The mean age was ~10 years old, with ~20% female. Fractures were mostly displaced (91% vs 83%), while open fractures were rare (~2%). Most had received opioids before enrollment (96% vs 88%). FICNBs were performed by attendings (37%), fellows (33%), or residents (30%) under supervision. Half were performed or supervised by attendings with advanced POCUS training.
Key Results: Children who received FICNB had greater reduction in pain compared to those who did not, without more adverse events or longer ED LOS.
Primary Outcome (Pain reduction at 60 min)
There was a mean decrease of 3.8 points (95% CI, 3.1 to 4.6) in the FICNB group compared to a decrease of 0.8 points in the non-FICNB group (95% CI, -0.2 to 1.9).
That was a difference of 3.0 (95% CI, 1.7 to 4.3).
Secondary Outcomes
When it came to pain reduction at 240 min, there was a mean decrease of 3.6 points (95% CI, 2.6 to 4.5) in the FICNB group vs. 1.7 points (95% CI, 0.7 to 2.7) in the non-FICNB group. That was a difference of 1.9; (95% CI, 0.5 to 3.2).
The FICBN also received less opioids after enrollment measured as oral morphine equivalents per hour (OME/hr). This was 0.3 in the FICBN group vs. 1.1 in the non-FICBN group). This was a difference of 0.8 (95% CI, 0.4 to 1.1).
ED length of stay in both groups was 6.1 hours with overlapping 95% CI.
There was not much difference in adverse events between the two groups (5.6% FICNB vs 8.3% non-FICNB), with no serious complications attributable to FICNB. One patient in the FICNB group had apnea but had also received ketamine, fentanyl and midazolam.
Listen to the SGEM podcast to hear Zack respond to our five nerdy points.
Selection Bias
Twelve sites were included. The proportion of physicians able to perform the nerve block ranged from 25-100% of the faculty. There were four sites that did not routinely perform FICNB. For the sites that did perform the nerve block, it was only performed when someone trained to do it was on shift (which makes sense). Patients may also have been missed for other reasons such as maybe it was too busy on shift or there was a fast disposition from ED to the operating room. However, this also means that there is a group of eligible kids that may have been missed with this convenience sampling.
How do you think this selection bias may have impacted the results of the study?
Performing FICNB
We can’t imagine that a young child is going to be thrilled seeing a long needle being introduced to the leg that is already broken.
How do you do this practically? Are you having to give any additional medications for anxiolysis prior to this? Are you worried about the patient moving during this process?
Any tips on how to fit this into the workflow of a busy ED shift?
One other thing that we were looking for was whether or not all of these blocks were successfully placed on the first attempt or did some require multiple attempts?
Ultrasound Training and Competencies
We were impressed that in this study, the nerve block was performed by a mix of attending physicians (37%) and fellows and residents under supervision.
What does it take to train someone to perform this nerve block? How do you determine they are capable enough to be credentialed?
Generalizability
It’s mentioned in the paper that four of the 12 sites involved in this project did not routinely perform FICNB. It’s also mentioned that at some of these sites, not performing FICNB would be considered substandard care. This is quite a variation even amongst academic children’s hospitals which may make this practice less generalizable to the community or rural settings.
What do you think are some of the biggest barriers and challenges in having this practice be adopted more widely? Is it the lack of trained staff? Buy-in from orthopedic colleagues?
Patient and Family Experience
While the primary outcome of pain reduction was very patient-oriented, we can’t help but wonder, did you collect any additional data about the experience of patients or families? Were they overall satisfied with the care they received nerve block or not? Did any express preference for nerve block or systemic analgesia?
Comment on Authors’ Conclusion Compared to SGEM Conclusion: We agree with the authors’ conclusion.
SGEM Bottom Line: Ultrasound-guided fascia iliaca compartment nerve blocks were associated with clinically meaningful pain reduction and less opioid use for pediatric femur fractures in the ED without prolonging length of stay.

Dec 6, 2025 • 25min
SGEM#495: Tell Me Lies, Tell Me Sweet Little Lies – Reporting of Noninferiority Margins on ClinicalTrials.gov.
Date: December 4, 2025
Guest Skeptic: Dr. Jestin Carlson – Long-time listener, second-time guest.
Reference: Reinaud et al. Reporting of Noninferiority Margins on ClinicalTrials.gov: A Systematic Review. JAMA Netw Open. 2025
Case: You are working with a resident who asks you about a new thrombolytic they heard about on the SGEM for acute ischemic stroke. This new treatment was found not to be inferior to the existing thrombolytic, but they are not sure how the paper reached that conclusion. You start to discuss noninferiority margins when the resident asks you, “Are the noninferiority margins reported on ClinicalTrials.gov consistent with the final publications?”
Background: A non-inferiority (NI) trial asks whether a new strategy is “not unacceptably worse” than an established, effective strategy by more than a pre-specified amount. The non-inferiority margin (Δ) or delta is the largest loss of effectiveness we would tolerate in exchange for another advantage (lower cost, easier logistics, fewer adverse effects). Regulators and methods groups emphasize that Δ must be clinically justified, pre-specified, and not chosen after seeing the data. The Δ is then tested using a one-sided hypothesis procedure or, equivalently, by checking whether the confidence interval for the treatment difference stays within Δ.
For example, a new medicine to treat hypertension lowers patients’ systolic blood pressure by 1 point more than the standard treatment but causes gastrointestinal (GI) upset in 50% of patients. That difference may be statistically significant, but clinically it doesn’t result in a net benefit for the patients since so many of them get GI upset. Ideally, the noninferiority margins should be set up before the trial is conducted to minimize bias.
Many modern ED trials rely on NI logic (TNK vs tPA for stroke, non-operative treatment of appendicitis, Simple Aspiration versus Drainage for Complete Pneumothorax, etc). However, prior work suggested poor reporting of noninferiority margins with reporting rates as low as 2.6% for studies published between 2012 and 2014. That was over 10 years ago...hopefully we have improved since then.
Clinical Question: What proportion of registered noninferiority randomized trials report the noninferiority margin at registration, and how consistent are margins between ClinicalTrials.gov and corresponding publications?
Reference: Reinaud et al. Reporting of Noninferiority Margins on ClinicalTrials.gov: A Systematic Review. JAMA Netw Open. 2025
Population: All registered non‑inferiority trials on ClinicalTrials.gov with primary completion 2010–2015 (Stage 1) and all first‑posted 2022–2023 (Stage 2).
Excluded: Nonrandomized, single-arm, phase 1–2/2–3, diagnostic/screening trials where noninferiority was only a secondary outcome.
Exposure: Presence of a prespecified noninferiority margin reported on ClinicalTrials.gov (at registration / during enrollment / after primary completion / in posted results).
Comparison: Descriptive contrasts across timepoints and between the registry and corresponding publications (consistency).
Outcome:
Primary Outcome: Proportion reporting the noninferiority margin at registration on ClinicalTrials.gov.
Secondary Outcomes: Timing of first reporting (registration, during enrollment, after completion, or in posted results); proportion reporting margin in posted results; proportion reporting margin in the corresponding publication; justification of margin; consistency between registry and publication; reporting of primary analysis population and Type I Error.
Type of Study: A systematic review of registered randomized trials’ methods reporting.
Authors’ Conclusions: “Reporting of the noninferiority margin on ClinicalTrials.gov was low (3.0% in 2010–2015 sample, 9.2% in 2022-2023 sample). Because margins are central to design and interpretation, mandatory reporting of trial design and the noninferiority margin at registration would improve transparency and reliability of noninferiority trial results.”
Quality Checklist for Systematic Review:
Was the main question clearly stated? Yes
Was the search detailed and exhaustive? Yes
Were the inclusion criteria appropriate? Yes
Included studies sufficiently valid? Yes
Results similar from study to study? Yes
Any financial conflicts of interest? Authors do not report any financial conflicts of interest.
Results: In the 2010 to 2015 cohort (n=266), 60% were industry‑funded; most evaluated drugs/biologics (~67%); parallel‑arm designs predominated (94%); open‑label was common (49%); adults‑only accounted for 74%; and the median planned sample size was 304 (IQR 63 to 545). The 2022 to 2023 cohort (n=327) showed similar patterns with more adult-only studies (83%) and a median planned sample size 228 (IQR 50 to 406).
Key Result: Very few trials pre-specified a Δ at registration, a super majority reported a Δ in their publication and registry‑to‑publication consistency could only be evaluated in a handful of studies.
2010 to 2015 sample (n=266)
Only 8 trials (3%) reported the planned noninferiority margin at registration.
31 trials (11.7%) first reported a margin after registration (11 during enrollment; 20 after primary completion).
Of 132 trials with results posted on ClinicalTrials.gov, 79 (59.8%) reported the noninferiority margin in the posted results.
Corresponding publications were found for 208 trials (2010–2015 sample); 196/208 (94.2%) publications reported the noninferiority margin, and 86/196 (41.3%) justified it.
2022 to 2023 sample (n=327)
30 trials (9%) reported the margin at registration (a modest improvement but still low); only 6 of these justified.
When margins were reported in both the registry and the publication, they were identical in the 5 trials that reported margins at registration and in publication; margins in posted results and publications were consistent for all but 1 of 63 trials.
Registry Transparency: ClinicalTirals.gov lacks a mandatory, structured field for trial design type and noninferiority margin. The authors suggest mandatory fields to prevent untraceable post-hoc margin changes. Building and maintaining trust in the scientific literature depends on ensuring we are honest and transparent in the scientific process. This includes transparency in registration.
Potential for Bias: Post-hoc or late specification of margins can bias conclusions. A margin change after seeing the data can turn a noninferior result from “fail” to “pass”. This would be like p-hacking or HARKing (hypothesizing after results are known).
Overinterpreting Non-inferiority Trials: The goal of non-inferiority trials is exactly that...to determine if one treatment is not inferior to another. It does not prove whether the treatment is effective. In addition, even if margins are pre-specified, they can be clinically meaningless. Readers still need to appraise whether the Δ represent something the patient would consider non-inferior.
Single Trial Registry: This study used a single registry (ClinicalTrials.gov) and did not search the study protocols. There are many registries where clinical trials can be registered, including the Australian New Zealand Clinical Trials Registry, the Chinese Clinical Trial Registry and EU Clinical Trials Register, to name a few. How these results generalize to other registries is unknown.
Ensuring Consistency with Reporting: FDA guidance and the CONSORT extension for noninferiority trials emphasize pre-specification and justification of margins. We should expect this in both registration and publication. In addition, journals, editors, and reviewers may insist that the author report not only the margins at the time of publication but also whether the margins were published at the time of registration.
Comment on the Authors’ Conclusion Compared to the SGEM Conclusion: We generally agree with the authors’ conclusions.
SGEM Bottom Line: Non-inferiority margins need to be pre-specified, justified, and clinically acceptable, and this new review shows we often can’t verify that from the trial registry alone.
Case Resolution: You tell the resident that when you read a noninferiority trial, check the publication for margin justification, when possible, verify pre-specification in the trial registry or protocol and reflect on whether the margin is clinically relevant. Treat noninferiority claims cautiously if the margin is not prospectively registered.
Clinical Application: Be skeptical when reading the results of a non-inferiority trial and cross-check them against what is reported on clinicaltrials.gov if it was registered there.
What Do I Tell the Patient? N/A
Keener Kontest: Last week’s winner was Brad Roney. He knew the pain was defined by the International Association for the Study of Pain (IASP) as: “An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.”
Listen to the SGEM podcast for this week’s question. If you know, then send an email to thesgem@gmail.com with “keener” in the subject line. The first correct answer will receive a shoutout on the next episode.
Other FOAMed:
First10EM - You Don't Understand Non-Inferiority Trials (and neither do I)
Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.
Additional Readings & Resources:
D'Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Stat Med. 2003 Jan 30;22(2):169-86. doi: 10.1002/sim.1425. PMID: 12520555.
Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med. 2006 Jul 4;145(1):62-9.

Nov 29, 2025 • 43min
SGEM#494: Another day for you and me in pain – Chronic Abdominal Pain and ED visits
Date: November 26, 2025
Reference: Ray et al. Emergency Department Visit Frequency Among Adults with Chronic Abdominal Pain: Findings From the 2023 US National Health Interview Survey. AEM November 2025.
Guest Skeptic: Dr. Kirsty Challen is a Consultant in Emergency Medicine in the UK and an evidence-based medicine advocate. She's a seasoned knowledge translator with her PaperinaPic infographics.
Case: You are mid-shift in what feels like the never-ending winter of emergency medicine, and you hear the sigh as your resident picks up the chart of the next patient to be seen. Wondering if the resident requires coffee or support, you ask what is wrong. “I’m good, it’s just this is the third patient with acute worsening of abdominal pain they’ve had for years that I’ve seen this week. What’s going on?”
Background: Abdominal pain is a frequent reason for presentation to the emergency department (ED), generating over 13 million visits in the US in 2022. As emergency care providers, we are taught to think of the worst-case diagnoses (aneurysmal, ischaemic, an ectopic pregnancy, appendicitis, etc). Once the “bad stuff” is excluded, it’s tempting to breathe a sigh of relief and “not my concern”.
However, there is an estimated population prevalence of chronic abdominal pain of around 22 per 1,000 person-years. According to the International Association for the Study of Pain, this is defined as abdominal pain without a clear diagnostic explanation that lasts for 3 months or more. Often, patients with these symptoms have been diagnosed with “functional” abdominal pain, although more recent terminology uses “Disorders of Gut-Brain Interaction”.
Managing patients with acute-on-chronic pain syndromes in the ED can be very challenging, particularly if continuity of care is lacking for their chronic condition. This has been addressed to some extent by the GRACE-2 guidance on managing recurrent low-risk abdominal pain, which de-emphasizes repeated routine imaging and recommends opioid-minimizing strategies for symptom management.
Clinical Question: Do people with chronic abdominal pain have higher rates of ED utilization than those without?
Reference: Ray et al. Emergency Department Visit Frequency Among Adults with Chronic Abdominal Pain: Findings From the 2023 US National Health Interview Survey. AEM November 2025.
Population: Adult respondents to the National Health Interview Survey 2023 who completed the question on demographics, pain, healthcare seeking behaviours, disability, mental health, past medical history and social determinants of health.
Exclusion: The entire survey excludes people without a permanent household address, active-duty military personnel or civilians on military bases, and residents of long-term care facilities. For this study, the authors also excluded people reporting a history of cancer, Crohn’s disease and ulcerative colitis and those who were pregnant.
Exposure: Chronic abdominal pain (CAP) was defined by the authors as reporting pain “most days” or “every day” over the prior three months, and being “bothered by” abdominal, pelvic or genital pain “somewhere between a little and a lot” or “a lot” over the prior three months.
Comparison: Adults without chronic abdominal pain.
Outcomes:
Primary Outcome: ED visits in the prior 12 months.
Secondary Outcomes: Mental health status, physical comorbidities, disability, and social determinants of health.
Type of Study: Secondary analysis of a cross-sectional interview study.
Dr. Michael Ray
This is an SGEMHOP, and we are pleased to have the lead author on the episode. Dr. Michael Ray is an Assistant Research Professor, Department of Emergency Medicine at George Washington University School of Medicine & Health Sciences. Known as a pain researcher. Clinically practiced as a chiropractor in an outpatient setting, which led to an interest in chronic pain and transition to academia.
Authors’ Conclusions: This nationally representative analysis suggests that individuals with CAP have significantly higher ED utilization and face greater burdens of disability, mental health conditions, comorbidities, and SDOH-related barriers. These findings highlight the potential value of addressing BioPsychoSocial factors to reduce ED reliance and support comprehensive care for CAP patients.
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? Unsure
Was the exposure accurately measured to minimize bias? Unsure
Was the outcome accurately measured to minimize bias? Unsure
Have the authors identified all important confounding factors? Unsure
Was the follow-up of subjects complete enough? N/A
How precise are the results? The numbers are large, so they are likely to be reasonably precise, but formal measures of uncertainty, such as credible intervals, aren’t presented in the paper.
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
Funding of the Study? National Research Scientist Award via George Washington University, and the Authors declared no conflicts of interest.
Results: Just over 4.5 million (2.8%) of the nearly 163 million respondents reported Chronic Abdominal Pain. The chronic abdominal pain group had higher proportions of female sex (66% vs 50%) and age 55 to 64 (23% vs 15%), with similar race/ethnicity distribution.
Key Result: Reporting Chronic Abdominal Pain was associated with an increased frequency of ED attendance.
Primary Outcome: 1% of people with CAP reported one ED visit over the last 12 months, compared to 11.7% of people without. 16.9% had visited 2 to 4 times compared with 5.2%.
Secondary Outcomes: Chronic abdominal pain was associated with increased incidence of anxiety, depression, physical comorbidities, challenges accessing healthcare, economic instability and limitations in social and employment function.
Recall Bias: By conducting a secondary analysis of the US National Health Interview Survey, you are obviously limited by how the original survey's designers chose to collect the data. Much of the data depends on patients’ recollections, which we know can be flawed. People who go to the ED with their pain may well remember the days of pain more clearly than those who did not or could not seek healthcare. Do you have any information or a sense of how the NHIS measures up against other cohorts where the data can be triangulated
Exclusions & Missing Data: The dataset includes many potential confounding factors, such as comorbidities and some social determinants of health. However, the entire survey excludes people without a permanent household address, and there doesn’t seem to be information around alcohol or substance use, which could plausibly be associated with chronic pain and contact with healthcare. How much do you think that challenges your findings?
Outcome Measurement: The NHIS does not link ED visits to a specific presenting complaint, so some “excess” ED use among chronic abdominal pain respondents may reflect unrelated issues. In addition, modelling excluded asthma and injury. Excluding injury makes sense, but why exclude asthma?
Multiple Comparisons: You acknowledge in the paper that the multiple comparisons you have done increase your risk of Type 1 error. This is where you find something that meets the criteria for statistical significance purely by chance. However, you deliberately chose not to apply a statistical adjustment, such as a Bonferroni correction. Could you talk us through that?
Residual & Bidirectional Confounding: Although models adjusted for demographics, disability, mental health, PMH, and SDOH, unmeasured or imperfectly measured factors (access to specialty care, pain catastrophizing, prior imaging availability) could partly explain the associations. You note complex bidirectional relationships among CAP, mental health, disability, and SDOH that a cross-sectional model cannot fully resolve, which is an inherent limitation of observational designs. What do you think its implications might be for the individual patient and care provider?
Comment on Authors’ Conclusion Compared to SGEM Conclusion: We broadly agree with the authors’ conclusions, but would emphasize the need to be very cautious about inferring causation in either direction.
SGEM Bottom Line: Adults reporting chronic abdominal pain report more ED attendances than those without, and report higher levels of physical, psychological and social comorbidities.
Dr. Kirsty Challen
Case Resolution: You empathize with your resident, noting that it can be frustrating when patients present to the ED with chronic problems. However, you help her frame this in the context of the impact on multiple areas of the patient’s life of chronic pain.
Clinical Application: ED providers should recognize that people presenting with chronic abdominal pain are more likely to have physical and psychological comorbidities and be disadvantaged in terms of social determinants of health.
What Do I Tell the Patient? We know that patients with chronic abdominal pain often have challenges in other parts of their lives. Is there anything else we can help with?
Keener Kontest: The last episode’s winner was Scott Luce. He gave four examples of c-collars with geographic locations from the US (Aspen, Philly, Miami Jr and NY Ortho).
Listen to the SGEM podcast for this week’s question. If you know, then send an email to thesgem@gmail.com with “keener” in the subject line. The first correct answer will receive a shoutout on the next episode.
Now it is your turn, SGEMers. What do you think of this episode on chronic abdominal pain and ED utilization?

Nov 22, 2025 • 1h 2min
SGEM#493: You Can’t Hold Me Down with Spinal Motion Restrictions
Date: November 8, 2025
Reference: Millin M, et al., Prehospital Trauma Compendium: Prehospital Management of Spinal Cord Injuries – A NAEMSP Comprehensive Review and Analysis of the Literature, Prehospital Emergency Care, Aug 2025.
Guest Skeptic: Clay Odell, BSN, NRP, RN, is a Paramedic Firefighter with Newport (NH) Fire-EMS. He is a past Chief of the NH Bureau of Emergency Medical Services. Previous positions he held are Trauma System Coordinator for the State of NH, Executive Director of Upper Valley Ambulance in Fairlee VT, and a flight crew member at Dartmouth Hitchcock Advanced Response Team. Clay has been a paramedic since 1985 and has been a registered nurse since 1997.
Case: Your EMS unit responds to a 911 call for a hunting accident. You arrive to find the patient sitting on the tailgate of his truck. He tells you he fell out of his deer stand, approximately 20 feet, landing on his head. He walked out of the woods about a mile after the fall. His chief complaint is head and neck pain. He has a Glasgow Coma Scale (GCS) score of 15, a hematoma and laceration above his left eye, and he is quite tender over the cervical spine region.
You observe your colleagues trying to apply a rigid cervical collar without moving the patient’s neck. It goes about as well as usual, meaning the patient's head is moved a bit. Maybe more than a bit. He then decides he hates the collar and rips it off. He adamantly refuses all attempts to apply a soft collar or improvised towel roll.
On arrival at the trauma center, you give a handoff report, and the team leader demands to know why the patient is not in a collar. The patient overhears this and rather profanely informs everyone, "you ain't putting no *F-ing* collar on me".
Background: Prehospital care for suspected SCI has two competing imperatives, limiting secondary cord injury while avoiding iatrogenic harm. Historically, EMS prioritized rigid immobilization (long backboard + rigid cervical collar) based on the fear that post-injury movement could precipitate delayed neurologic deterioration. In the last two decades, emergency care has shifted toward selective spinal motion restriction (SMR) and earlier collar removal when appropriate. This reflects a better understanding of risk, test performance, and harms from prolonged immobilization.
In the ED, validated decision tools (NEXUS and Canadian C‑spine Rule) help identify very‑low-risk patients who do not need imaging; when imaging is needed, modern multidetector CT outperforms plain radiography for clinically significant cervical spine injury (CSI). A large Western Trauma Association cohort (10,276 patients) found CT sensitivity of 98.5% with a negative predictive value of ~100% for clinically significant injuries. The misses were rare and occurred in patients with focal neurologic deficits, who then warranted an MRI [1].
Prehospital protocols increasingly emphasize minimizing time on a backboard and avoiding prolonged collar use because of pressure injury and other morbidities. A systematic review by the East Association for the Surgery of Trauma (EAST) supports collar removal after a negative high-quality CT in an obtunded adult. They highlight the downstream harm from extended immobilization without added benefit [2].
Pediatrics and geriatrics remain special populations. NEXUS shows high sensitivity in children, though confidence intervals are wider in the very young. Clinicians should have a low threshold for imaging in older adults, who are vulnerable to serious cervical spine injuries from low-energy mechanisms [3].
Clinical Question: In trauma patients with potential SCI, what is the evidence that post‑injury movement causes delayed neurologic deterioration, and what are the benefits and harms of prehospital spinal immobilization and SMR?
Reference: Millin M, et al., Prehospital Trauma Compendium: Prehospital Management of Spinal Cord Injuries – A NAEMSP Comprehensive Review and Analysis of the Literature, Prehospital Emergency Care, Aug 2025.
Population: Human (and some animals) with potential spinal cord injuries that addressed one of four predefined questions(pathophysiology of delayed neurologic injury, harms of immobilization, effectiveness of immobilization/SMR at limiting movement, and the relationship to delayed neurological injury).
Exclusions: Manikin/simulation‑only studies, abstracts without full publication, editorials, other reviews/meta-analyses, guidelines, book chapters, and non-English full manuscripts.
Intervention: Prehospital spinal immobilization (long backboard + cervical collar) and SMR (cervical collar ± vacuum splint/ambulance cot)
Comparison: No immobilization vs immobilization or alternative immobilization strategies.
Outcome:
Primary Outcome: Effectiveness of immobilization/SMR at limiting movement and relationship to delayed neurological injury.
Secondary Outcomes: Harms of immobilization/SMR (airway/respiratory compromise, raised ICP, pressure ulcers, delays to care, increased imaging, pain), and associations between hypoperfusion/hypoxia and worse neurologic outcomes. (See Tables 2-4 summarized in the paper.)
Type of Study: Comprehensive review with no meta-analysis
Authors’ Conclusions: There are no data in the published literature to support spinal immobilization and spinal motion restriction as standard of care. Efforts aimed to reduce the use of cervical collar should be considered, and the use of backboards and full body vacuum splint should be limited to the point in time of active patient extrication.
Quality Checklist for Therapeutic Systematic* Reviews: (Yes/No/Unsure)
* This is the list we use for SR, while the study in question was called a “Comprehensive Review.”
The main question being addressed should be clearly stated. Yes
The search for studies was detailed and exhaustive. Yes
Were the criteria used to select articles for inclusion appropriate? Yes
Were the included studies sufficiently valid for the type of question asked? Unsure
Were the results similar from study to study? No
Were there any financial conflicts of Interest? No
Results: The review synthesized 115 manuscripts spanning prehospital and hospital settings, adult and pediatric populations, and diverse geographies and time periods. The authors did not pool a single set of patient demographics due to the heterogeneity of designs and questions.
Key Results: No definitive evidence that routine immobilization/SMR prevents delayed neurologic injury, while harms are common.
Primary Outcome: Limiting movement (biomechanical surrogates) results are mixed. No randomized trials were found showing that collars/boards prevent secondary spinal cord injury. In the best-known observational comparison (immobilized vs. not), immobilization was associated with more neurologic disability. A before-and-after system study (moving from routine backboards to SMR) found no increase in delayed deficits.
Secondary Outcomes: Harms were common with negative airway/respiratory effects, increased ICP,skin breakdown, delays in care, increased imaging, and pain.
Dr. Millin is an emergency and EMS physician, retired from full-time faculty at Johns Hopkins University in Baltimore, and now runs a non-profit wilderness EMS agency in Maryland. He is also the lead author of this comprehensive review, and we asked him five nerdy questions.
Heterogeneity: The review necessarily combined diverse designs (case series, retrospective cohorts), different exposures (movement vs perfusion/hypoxia), and varied outcomes (motion metrics vs patient-important neurologic outcomes). Such heterogeneity limits inferences, and the authors appropriately did not attempt to meta-analyze the data.
Risk‑of‑Bias: While selection and abstraction processes are detailed, the report does not describe a formal risk‑of‑bias (RoB) tool. This is a common expectation in systematic reviews. They could have used the ROBINS‑I, which helps assess the risk of bias in the results of non-randomized studies that compare the potential benefit and harm of two or more interventions [4]. Without a structured RoB assessment, confidence in causal interpretations is limited.
Screening: The title/abstract was screened by a single reviewer. This may increase the chance of missed eligible studies. Best practice is for two independent reviewers to screen titles and abstracts and to review full texts independently, resolving discrepancies through discussion or a third reviewer. This process improves the validity, transparency, and reproducibility of systematic reviews [5,6,7].
Language & Publication Bias: The authors limited their search to English-language full texts. This can introduce language bias. In addition, narrative syntheses with small or observational studies are also vulnerable to publication bias, with negative studies less likely to be published.
Surrogates Outcomes. Several included papers focus on movement reduction as a surrogate for patient-important outcomes (neurologic deficits). Surrogate-oriented outcomes (SOO) do not reliably translate into patient-oriented outcomes (POOs).
Comment on Authors’ Conclusion Compared to SGEM Conclusion: I, Clay Odell, believe the results, and I think this is likely as good evidence as we’re ever going to get regarding the clinical utility (or not) of cervical collars. This may be sufficient evidence for some EMS medical directors to reduce the emphasis on c-collars, but there will remain skeptics. I wonder if the NAEMSP will adopt these conclusions into their official position statement.
We agree that routine, prolonged immobilization is not evidence-based and carries harm, and that minimizing backboard time is good practice. We would frame the conclusion more cautiously and prioritize oxygenation/perfusion, use manual stabilization/SMR selectively,

Nov 16, 2025 • 18min
SGEM#492: Give Blood – To Anemic Patients with Acute Brain Injuries
Date: November 12, 2025
Reference: Taccone et al. Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury The TRAIN Randomized Clinical Trial. JAMA 2024
Guest Skeptic: Dr. Alex Weiler is an Emergency Department staff physician in the Peterborough Regional Health Centre and is an associate professor with Queen's University Department of Family Medicine.
This podcast was recorded live at the Kawartha EM Conference in beautiful Peterborough, Ontario.
Case: A 48-year-old woman presents with a sudden, severe headache and brief loss of consciousness. CT/CTA confirms aneurysmal subarachnoid hemorrhage (SAH). She is coiled and admitted to the intensive care unit (ICU) with an external ventricular drain. On ICU day 3, Hb is 8.4 g/dL (or as we say in Canada 84 g/L), she is not actively bleeding, Glasgow Coma Scale (GCS) of 10 with fluctuating attention, and her expected ICU stay is clearly >72 hours.
Background: Acute brain injury (ABI) can occur for a variety of reasons, including aneurysmal SAH (like in this case) or trauma. Anemia is common in patients with ABI and can worsen cerebral hypoxia. For decades, ICU transfusion practice drifted toward “restrictive” triggers (Hb <7 g/dL or <70g/L) based on trials in mixed ICU populations.
However, brain-injured patients may not behave like the average ICU patient. The brain is uniquely sensitive to oxygen delivery, and secondary ischemia strongly predicts poor neurological outcomes.
Small single-center studies and physiologic work suggested higher hemoglobin could improve brain tissue oxygenation; however, prior randomized evidence has been sparse or inconclusive in discrete ABI subgroups (traumatic brain injury [TBI], SAH), leaving real uncertainty about the optimal transfusion threshold for this population.
The TRAIN trial was designed to answer a practical question that matters at the bedside: in adults with ABI who are anemic but not exsanguinating, does a liberal transfusion strategy improve downstream neurological outcomes compared with a restrictive strategy?
Clinical Question: In adults with acute brain injury (TBI, aneurysmal SAH, or ICH) who are anemic (Hb <90 g/L), does a liberal RBC transfusion threshold (transfuse when Hb <90 g/L) compared with a restrictive threshold (transfuse when Hb <70 g/L) improve 6-month neurological outcomes?
Reference: Taccone et al. Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury The TRAIN Randomized Clinical Trial. JAMA 2024
Population: Adults (18 to 80) in 72 ICUs across 22 countries with TBI, SAH, or ICH. They needed to have an Hb <90 g/L within 10 days of injury and an expected ICU stay of ≥72 hours.
Exclusions:Hb >90 g/L, GCS 3 with fixed/dilated pupils, GCS >13 at randomization, active bleeding, expected ICU stay <3 days, prior neurological disease, pregnancy, inability to receive transfusion; others are listed in the flow diagram.
Intervention: Liberal strategy (transfuse when Hb <90 g/L for 28 days).
Comparison: Restrictive strategy (transfuse when Hb <70 g/L for 28 days).
Outcome:
Primary Outcome: Unfavourable neurological outcome at 180 days, GOS‑E 1 to 5 (death to severe disability).
Secondary Outcomes: 28-day mortality; composite of death or organ failure at day 28; organ failure; ICU/hospital LOS; distribution (“shift”) of GOS‑E; prespecified serious adverse events (cerebral ischemic events, VTE, infections, TRALI, anaphylaxis).
Type of Study: A multicenter, pragmatic, parallel group, open-label, RCT
Authors’ Conclusions: “Patients with acute brain injury and anemia randomized to a liberal transfusion strategy were less likely to have an unfavorable neurological outcome than those randomized to a restrictive strategy.”
Quality Checklist for Randomized Clinical Trials:
The study population included or focused on those in the ED. 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. No
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. Yes
Financial conflicts of interest. Funded by non-profit sources, and the sponsors had no role in design/analysis/reporting. Minor author disclosures unrelated to the intervention were reported.
Results: 820 completed the trial, with 806 having the primary outcome (393 liberal; 413 restrictive). Mean age 51 and 46% women. The type of brain injury was ~59% TBI, 23% SAH, 18% ICH overall. GCS at randomization was 6 [IQR 3–8] and was Hb 85 g/L [IQR ~80 to 88]. A median of two units (IQR 1–3) were transfused in the liberal vs 0 units (IQR 0–1) in restrictive, giving an absolute mean difference 1.0 unit (95% CI 0.87–1.12).
Key result: A liberal threshold (Hb <90 g/d) reduced unfavourable neurological outcome at 180 days compared with a restrictive (Hb <70 g/L).
Primary Outcome: Unfavourable GOS E 1–5 at 180 days was 63% liberal vs 73% restrictive
ARR 10% (95% CI 3.6–16.5)
RR 0.86 (95% CI 0.79–0.94), p=0.002.
NNT 10 to prevent one additional unfavourable outcome
Secondary Outcomes:
No statistical difference in 28-day mortality: 21% liberal vs 23% restrictive; RR 0.95 (95% CI 0.74–1.22)
No statistical difference in the composite outcome of death/organ failure at day 28, organ failure, or ICU LOS
Serious adverse events were similar between groups
1. Performance Bias: Bedside teams knew the assignment (open-label), which can bias outcomes even with masked assessors. The investigators acknowledge awareness of group assignment and incomplete assessment of co-interventions as a limitation.
2. Detection Bias: Cerebral infarction was identified at clinicians’ discretion rather than by systematic imaging, risking underascertainment bias (detection bias). The authors appropriately called the serious adverse event (SAE) data exploratory.
3. Analysis Bias: The primary analysis excluded patients who withdrew consent post‑randomization (modified Intention-to-Treat analysis [mITT]). While common, exclusion after randomization can erode the protection of randomization. A pure ITT analysis better preserves unbiased comparisons. Attrition and missing data can bias estimates (the authors did perform sensitivity analyses, which were consistent).
4. Heterogeneous Acute Brain Injury Etiologies: Pooling TBI, SAH, and ICH increases generalizability but risks effect modification across pathologies. Subgroup analyses largely aligned, but power for interaction is limited. We need to be skeptical of subgroup findings because of multiplicity and low power.
5. Non‑Standardized Neuroprognostication: Prognostication practices were not standardized across centers, which can influence functional outcomes and mortality decisions. The authors correctly note this as a limitation. While mortality was similar between groups, this can mitigate but not eliminate this potential bias.
Comment on the Authors’ Conclusion Compared to the SGEM Conclusion: We generally agree with the authors’ conclusions.
SGEM Bottom Line: An anemic brain is not a happy brain. In adults with acute brain injury and Hb ≤90 g/L, targeting a 90 g/L transfusion threshold modestly improved 6-month functional outcomes vs a 70 g/L trigger, without a mortality signal and with fewer cerebral ischemic events.
Case Resolution: This patient’s Hb was 84 g/L. Therefore, we suggest giving her a transfusion of one unit of packed red blood cells to keep her Hb ≥ 90 g/L.
Dr. Alex Weiler
Clinical Application We need to remember that this applies to: Adults (18–80) with ABI (TBI, aneurysmal SAH, ICH) in the first 10 days, not actively bleeding, expected to require ICU care ≥72 h, and with Hb between 70 to 90 g/L. Outside of this group (massive hemorrhage, exsanguination, pregnancy, severe comorbidity extremes), extrapolate cautiously.
When Hb drops below 90 g/L in eligible ABI patients, it’s reasonable to transfuse RBCs to target at least this threshold, aiming to reduce unfavourable neurological outcomes by ~10%. Use shared decision-making with neurocritical care about triggers, especially if there is clinical concern for cerebral ischemia.
Don’t expect a 28-day mortality benefit or shorter ICU stays. The signal here is better functional recovery, not survival. And don’t forget to maintain standard ABI bundles (BP, oxygenation/ventilation, fever control, DVT prophylaxis).
What Do I Tell the Patient/Family? After a brain injury, the brain needs plenty of oxygen to heal. The oxygen is carried in the blood by hemoglobin. When hemoglobin levels are too low, the brain may not get enough oxygen, which can make recovery harder. Your hemoglobin is too low. We recommend a blood transfusion now to bring the hemoglobin up to a safer range. This is part of our effort to give the brain the best chance to heal.
Keener Kontest: Last week’s winner was Steven Stelts from NZ. He knew the pending legislation to address HCW violence is the Save Healthcare Workers Act (H.R. 3178 / S. 1600), which would establish federal criminal penalties for assaulting healthcare workers.
Listen to the SGEM podcast for this week’s question. If you know, then send an email to thesgem@gmail.com with “keener” in the subject line. The first correct answer will receive a shoutout on the next episode.
Remember to be skeptical of anything you learn,

Nov 8, 2025 • 32min
SGEM Xtra: Talkin’ Bout a Revolution…Training Health Communicators
Date: October 17, 2025
Dr. Kristen Panthagani
Guest Skeptic: Dr. Kristen Panthagani is an emergency medicine resident and Yale Emergency Scholar at Yale New Haven Hospital. She’s a physician-scientist, having completed her MD/PhD at Baylor College of Medicine. She’s also well known as a science communicator, creator of You Can Know Things which helps explain science in a way everybody can understand, with an emphasis on addressing health rumors and explaining evidence-based medicine.
This SGEM Xtra is inspired by piece in the New England Journal of Medicine titled, Training Health Communicators-The Need for a New Approach. It covers the shifting landscape of how and where people are getting health information, specifically social media. It also provides some key competencies to keep in mind as we train healthcare professionals and scientists to communicate in these spaces.
The idea of "social media" has existed for a long time. Check out the book Writing on the Wall by Tom Standage to learn more.
We last covered the topic of science communication on a SGEM Xtra with Sarah Mojarad where she gave us five tips for science communication. Today we have five themes from your article to discuss.
Listen to the SGEM Xtra podcast to hear Dr. Panthagani discuss these themes in detail.
Shifting Information Sources
People’s habits are changing. They are going to different sources to get health information, and we have to adapt and evolve to stay relevant.
The idea of "talk with your doctor if you have questions" is often impractical if people cannot get timely appointments in clinic.
Websites for universities and organizations can be reputable sources, but health information is not always presented at the recommended health literacy level.
People are not fans of the top-down, “I am the high and mighty institution or organization. Let me tell you what to do” approach anymore. So where are people turning for health information?
People are increasingly getting their information from social media.
Over half of adults in the US report getting health information from social media.
It is unlikely that we can simply tell people to stop using social media for this purpose.
Putting a Face to the Message
How can we harness social media? The typical dry and stiff presentation with text-heavy slides at a scientific conference is unlikely to grab people’s attention.
People gravitate toward authenticity.
A more raw, informal style may be resonate more compared to a polished, rehearsed message
"Be a real person."
These were tips about style of communication. What tips do you have for creating content?
If it's boring to you, it's probably boring for your audience.
Don't do stuff you hate. If you like writing, don't create reels. Find ways to write articles, commentary, Substack, etc.
You don't have to do it all.
Bidirectional Communication
Traditional health communication has been top-down from institutions/organizations to the consumer. There is a difference between information dissemination versus communication.
Information dissemination is one direction.
Communication is bi-directional
Listen to the audience
Be careful that the scientific understanding of a term (ex. "immunity") may not be the colloquial understanding.
Data is not enough. Unite over shared values.
Bidirectional communication requires time and effort.
Don't feel obligated to respond to every comment.
Read the comments to gauge understanding and identify points of confusion.
Acknowledging Uncertainty
This is a sore spot when it comes to the communication that came during the Covid-19 pandemic. We have to acknowledge that this was a really tough time. We confronted a novel disease and pathogen. The language around topics like vaccines, social distancing, masking, did not really acknowledge that these interventions are not perfect. Guidance changed based on new and emerging data.
This is difficult and requires balancing the simplicity of the message with the nuance.
We did not do a good job communicating nuance and uncertainty in the early data.
How will the public receive scientists acknowledging uncertainty when there are other voices (who may lack knowledge or expertise) proclaiming their message loudly and confidently?
People may appreciate nuance more than we give them credit for.
Sometimes saying, "I don't know" can actually built trust.
Be Nice
Dr. Panthagani has a Substack article about why criticizing “anti-vaxxers” backfires. In it she brings up a distinction between shame and guilt from research Brene Brown.
Guilt focuses on the behavior and the decision.
Shame attacks the character of the person.
Not surprisingly, making people feel stupid, calling them stupid, or being quick to label them doesn’t really work when it comes to effective science communication.
Using shame-based methods makes things worse
Find ways to connect over shared values.
Keep in mind Graham’s hierarchy of disagreement. We want to be refuting the central point that is being made and do so respectfully. We can disagree without being disagreeable.
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.
References:
Rooney MK, Santiago G, Perni S, et al. Readability of patient education materials from high-impact medical journals: a 20-year analysis. Journal of Patient Experience. 2021;8:2374373521998847. doi:10.1177/2374373521998847
Mishra V, Dexter JP. Comparison of readability of official public health information about covid-19 on websites of international agencies and the governments of 15 countries. JAMA Network Open. 2020;3(8):e2018033. doi:10.1001/jamanetworkopen.2020.18033
https://www.kff.org/public-opinion/kff-health-information-and-trust-tracking-poll-health-information-and-advice-on-social-media/

Nov 1, 2025 • 43min
SGEM#491: Prevalence of violence against health care workers among agitated patients in an urban emergency department
Date: October 30, 2025
Reference: Boes et al. Prevalence of violence against health care workers among agitated patients in an urban emergency department. October 2025 AEM
Guest Skeptic: Dr. Suchismita Datta. She is an Assistant Professor and Director of Research in the Department of Emergency Medicine at the NYU Grossman Long Island Hospital Campus.
Case: It's 7:34 pm. You just took a sip of your portable espresso machine coffee from your favourite Batman cup. It's been 34 minutes into your Tuesday overnight shift. Things are a little crazy, but you are proud of yourself for getting your day colleague out on time.
Just then, your second-year resident walks briskly towards you and sits down next to you, an air of fluster about her. She is trying to keep her cool, but you can see her hands are trembling as she is putting in orders for the patient she just saw. You ask her what's up, and she responds, "The intoxicated patient in bed 12 just threatened to punch me when I told him I couldn't give him more pain medications. He said pretty awful things about me, called me names, and cursed at me... they called over security... but I still feel a little shook up about it... " She looks down and shakes her head, and then looks back at you and asks, "How often does this actually happen? Violence against us?"
Background: Violence toward clinicians is not a rare event in the ED but rather a predictable occupational hazard. The Canadian Association of Emergency Physicians (CAEP) has called ED violence “unacceptable,” urging a system-wide, zero-tolerance culture and coordinated mitigation efforts across hospitals, EMS, and law enforcement. Their formal CAEP Position Statement on violence in the ED summarizes scope, risk factors, and policy recommendations for prevention and reporting [1].
In the US, the American College of Emergency Physicians (ACEP) maintains a consolidated resource hub on ED workplace violence, including policy statements and advocacy for federal legislation (OSHA standards and the SAVE Act) to mandate prevention programs and establish penalties for assaults on healthcare workers. ACEP’s 2022-member poll found 85% of respondents reported violence had increased in their ED over the prior five years, with 45% saying it had greatly increased. The 2024 follow-up highlighted that >90% feared threats or attacks in the prior year. These data align with the day-to-day experience of emergency physicians and underscore persistent underreporting and inadequate institutional responses [2].
Both CAEP and ACEP emphasize practical approaches such as environmental design, staffing and security policies, de-escalation training, standardized reporting, and partnerships with law enforcement. At the same time, they reject the idea that violence is “part of the job.”
Clinical Question: Among ED patients with, what is the prevalence of violent events against health care workers, and how does that compare with events formally reported to the hospital?
Reference: Boes et al. Prevalence of violence against health care workers among agitated patients in an urban emergency department. October 2025 AEM
Population: ED patients from a locked observation unit at Hennepin County Medical Center (Minneapolis, MN).
Exclusions: Patients known to be in custody at the time of the encounter were excluded from data collection.
Exposure: Agitation, defined as an Altered Mental Status Score (AMSS) ≥ +1 (range from −4 to +4). Observers then recorded whether the encounter included verbal abuse, a threat of violence, or a violent act against a health care worker.
Comparison: N/A
Outcome:
Primary Outcome: Assault against any health care worker, defined by Minnesota state statute as an act with intent to cause fear of immediate bodily harm or death, or intentional infliction/attempt to inflict bodily harm.
Secondary Outcomes: Verbal abuse of health care workers by agitated patients (distinct from threats), defined as harsh/insulting/derogatory language or gestures intended to frighten, humiliate, or belittle.
Type of Study: A secondary analysis of two prospective, observational studies conducted in the ED setting.
This is an SGEMHOP, and we are pleased to have the lead author on the episode, Dr. Brian Driver. He is a faculty emergency physician and Director of Clinical Research in the Department of Emergency Medicine at Hennepin County Medical Center.
Authors’ Conclusions: “Verbal abuse, threats of assault, and violent acts occurred frequently in ED patients with agitation and were underreported.”
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? Unsure
Do you believe the results? Yes
Can the results be applied to the local population? Unsure
Do the results of this study fit with other available evidence? Yes
Funding of the Study. None is stated in the manuscript, while the authors declare no conflicts of interest.
Results: Across 17,873 screened encounters, 4,609 (26%) involved agitation (AMSS ≥ +1). Alcohol or drug intoxication was present in 4,108 (89%) encounters. Among agitated patients, the median age was ~36 to 39 years, about 50% were male, and the cohort included a substantial proportion of Black, non-Hispanic patients (40–46% across violence strata). The study took place in a locked ED observation unit within an urban safety‑net hospital with ~100,000 annual visits.
Key Result: Among agitated ED encounters, assaults were common, formal reports of verbal abuse were rarely reported, while most violent acts were reported.
Only 0.5% (9/1,786) of verbal-abuse events and 61.9% (224/362) of violent acts were formally reported to the hospital.
Listen to the SGEM podcast to hear Brian answer our five nerdy questions.
External Validity: This was a single-center analysis in a locked ED observation unit that preferentially rooms patients with suspected intoxication. While you suggest similar patients would otherwise be mixed in general ED beds, concentrating intoxicated, agitated patients may change the observed prevalence and risk environment.
Measurement Bias and Lack of Inter-Rater Reliability. Trained observers used standardized definitions, but inter-rater reliability was not reported, and observers were embedded in the clinical setting (not blinded), which can introduce observation/expectation bias. This is particularly important for subjective constructs like “verbal abuse.”
Comparator Misalignment & Underreporting Bias: The “formal report” comparator aggregated events from anywhere in the ED, not just the studied unit or only agitated patients. Using the same denominator (n=4,609) overestimates reporting percentages and biases toward the null in observed–reported differences. Institutional reporting is also known to be incomplete. Don't these differences limit the interpretation of the magnitude of underreporting?
Ascertainment Constraints: The authors note constraints such as language limitations (inability to capture some non-English events), areas not observed (triage), and binary counting at the encounter level (not tallying multiple events per visit). Each can attenuate or distort true prevalence. Could this not systematically shift some of the point estimates?
Descriptive Design: As a prevalence study, it does not adjust for potential drivers of violence (staffing, throughput, intoxication level, and de-escalation availability), limiting inference about determinants or modifiable factors. These confounders make it challenging to know how best to address the problem of violence based on this data set.
Comment on the Authors’ Conclusion Compared to the SGEM Conclusion: We generally agree with the author that the rate of violence in agitated patients against health care workers is high and under-reported.
SGEM Bottom Line: Violence against ED staff is common and substantially underreported, especially for verbal abuse.
Dr. Suchi Datta
Case Resolution: You tell your resident that, sadly, her experience is not singular and that violence against healthcare workers is a problem, especially amongst agitated patients. You encourage her to report the incident, as there needs to be more documented encounters to help facility advocacy on a systemic level. You also provide her with some resources to help process her trauma. She is very thankful and goes on to talk to you about how the encounter made her feel. You take a walk outside to the trauma bay and, after some breathing exercises, feel strong enough to come back and continue running the ED the rest of the night.
Clinical Application: Be careful around agitated patients. Make sure you accurately report incidents of violence. We need to advocate for systemic changes to protect healthcare workers as per ACEP and CAEP. This includes more robust prevention, reporting, and accountability. Violence should not be part of our job.
What Do I Tell My Patient? N/A
Keener Kontest: Last week’s winner was Dr. Steven Stelts from New Zealand. He knew Magnesium got its name from Magnesia, a region in Thessaly, Greece. This is an area known in ancient times for its deposits of minerals and stones containing magnesium.
Listen to the SGEM podcast for this week’s question. If you know, then send an email to thesgem@gmail.com with “keener” in the subject line. The first correct answer will receive a shoutout on the next episode.
Now it is your turn, SGEMers.

Oct 25, 2025 • 23min
SGEM#490: These (Removable) Boots are Made for Walking
Reference: Boutin A, et al. Removable Boot vs Casting of Toddler’s Fractures: A Randomized Clinical Trial. JAMA Pediatr. Published April 2025.
Date: July 23, 2025
Dr. Andrew Tagg
Guest Skeptic: Dr. Andrew (Andy) Tagg is an Emergency Physician with a special interest in education and lifelong learning. He is the co-founder and website lead of Don’t Forget the Bubbles (DFTB).
Case: A two-year-old boy presents to your pediatric emergency department (ED) with a limp and refusal to bear weight. His parents aren’t exactly sure what happened. They were at the park and suspected that he might have twisted his leg coming down a slide. On your exam, he does not have a fever. He does not have any swelling or deformity of his bilateral lower extremities. You order X-rays, which confirm a nondisplaced spiral fracture of the distal tibia, a classic toddler’s fracture. After you disclose his diagnosis, his worried parents ask you, “A fracture? Does that mean it’s broken? Will he need to get a cast? He’s such an active little guy, typically.”
Background: Toddler’s fractures are subtle, nondisplaced spiral fractures of the tibia. They typically occur in children between the ages of 9 months and 4 years. They often present in children who are just beginning to walk, hence the term “toddler’s fracture.” These kids can come in with inability to bear weight, a limp, or nonspecific pain. Another challenge is that the history you get may or may not help guide you. These injuries usually result from low-energy trauma, such as a twisting injury during a fall. That can happen multiple times a day when you’re learning to walk! The mechanism of injury is so subtle sometimes that parents or caretakers may not recall any inciting event.
The findings on X-ray can be quite subtle as well. AP and lateral views may reveal a very small hairline fracture that’s easily missed. In some situations, X-rays will be negative despite clinical exam findings suggestive of a toddler’s fracture. In those situations, repeated X-rays in a week or so can show some evidence of periosteal reaction.
The traditional management has included immobilization with a long leg or short leg cast, based on the belief that toddlers are unlikely to limit activity independently and require rigid immobilization to promote healing and pain relief. However, growing concerns about the discomfort, skin breakdown, need for follow-up visits, and potential complications from casting have led to interest in less restrictive treatments. such as removable walking boots.
Clinical Question: In children with radiographically confirmed toddler’s fractures, is treatment with a removable walking boot noninferior to a circumferential cast?
Reference: Boutin A, et al. Removable Boot vs Casting of Toddler’s Fractures: A Randomized Clinical Trial. JAMA Pediatr. Published April 2025.
Population: Children aged 9 months to 4 years with radiograph-visible tibial toddler’s fractures seen in 4 Canadian pediatric emergency departments.
Exclusion: Presented more than 5 days after injury or had an increased risk for pathological fracture or delayed healing
Intervention: Removable prefabricated walking boot. Parents were told to use the boot for one week, then use it as needed for symptoms for up to three weeks. This was based on caregiver discretion, with no scheduled follow-up.
Comparison: Standard circumferential casting. This varied across sites: Two sites did a long-leg splint in the ED, followed by a fiberglass cast. Another site did a short or long leg splint/cast in the ED, followed by a long leg fiberglass cast. The final site placed a short-leg splint in the ED, followed by a short-leg fiberglass cast. The casts were applied within seven days of the ED visit. Two sites had casts that were peelable, meaning they could be removed by caregivers at home. The other two sites had patients return to the clinic for cast removal.
Outcome:
Primary: Evaluation Enfant Douleur (EVENDOL) pain score at 4 weeks
Secondary: Return to activity, complications, caregiver satisfaction, care burden, healthcare utilization.
Trial: Pragmatic, multicenter, assessor-masked, noninferiority randomized clinical trial
Authors’ Conclusions : In this multicenter randomized clinical trial examining the management of children with TF, a removable boot without physician follow-up was noninferior to circumferential casting with respect to pain recovery. While there was a clinically relevant but not statistically significant trend toward more skin complications in the boot group, there was no difference in caregiver satisfaction, and the boot strategy demonstrated reduced childcare-related challenges
Quality Checklist for Randomized Clinical Trials:
The study population included or focused on those in the emergency department. Yes
The patients were adequately randomized. Yes
The randomization process was concealed. Yes
The patients were analyzed in the groups to which they were randomized. Yes
The study patients were recruited consecutively (i.e. no selection bias). Unsure.
The patients in both groups were similar with respect to prognostic factors. Yes
All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No
All groups were treated equally except for the intervention. 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
Financial conflicts of interest. Some authors reported grant funding from healthcare institutions or relevant foundations, but no direct industry sponsorship from Big Boot
Results: They enrolled 129 children in the study, with 65 children randomized to the boot group and 64 children randomized to the cast group. The mean age was 2.2 years.
Key Results: Removable boot was non-inferior compared to circumferential casting in the management of children with Toddler Fractures.
Primary Outcome:
This was pain at 4 Weeks on the EVENDOL scale. The non-inferiority margin was defined as 2 points on the EVENDOL scale.
The boot group had a EVENDOL mean score of 1.2 (SD 1.5) while the cast group had a mean score of 1.8 (SD 2.1). We mentioned before that they did both an intention-to-treat and per-protocol analysis. The upper bound of the confidence interval was well below the threshold of 2, supporting non-inferiority.
Secondary Outcomes:
Children treated with a boot were more likely to return to their usual activities by four weeks, with over three-quarters back to normal compared to just 41% in the cast group.
This was a difference of 36% (95% CI 9-63%). By 12 weeks, everyone had returned to normal weight bearing and baseline activities. Any other positives for the boot group?
They also reported fewer day-to-day challenges. Bathing was easier. Only 41% in the boot group moderately/strongly agreed that bathing the child was a challenge compared to 72% of the cast group (Difference -32%, 95% CI -47 to -18%). There was less need to carry their child around (44% vs 68%; Difference -22%, 95% CI -27 to -15%).
Skin complications like mild redness or pressure sores were slightly more common in the boot group, but these were not statistically significant (difference of 22%, 95% CI -6 to 50%). These were generally minor and picked up early.
Overall satisfaction was high in both groups; 80% satisfied in the boot group compared to 70% in the cast group (difference 9%, 95% CI -20 to 39%). Though caregivers in the boot group were more likely to say they'd choose the same treatment again mainly because of the care burden and inconvenience of getting the cast placed and removed.
There was no difference in unplanned doctor visits or repeat X-rays between the two groups.
Radiograph-Visible Fractures Only
This study only included radiograph-visible toddler fractures, the clear, obvious ones. But a large chunk of toddler’s fractures don’t show up on the initial X-ray. Those occult injuries may have different trajectories and pain profiles, and we often treat them similarly in practice. So, while the findings are robust for visible fractures, we can’t automatically apply them to every limping toddler with a presumed injury and a normal X-ray.
The fracture morphologies included were also interesting. Toddlers' fractures are classically nondisplaced spiral fractures. This study included buckle fracture and transverse fractures too. They even included a few fractures with very minimal displacement, albeit those types of fractures only represented a smaller portion of the population. This feature may add a bit to the generalizability and makes us wonder…could we adopt the less is more approach for even more fracture types?
Masking and Bias: The Pragmatic Trade-Off
This was a pragmatic trial, which is great for real-world relevance, but only the outcome assessors were blinded. Parents and clinicians knew exactly which treatment was given, which might influence how they reported things like activity levels or skin problems. That’s a potential source of reporting bias, especially when dealing with subjective outcomes. Still, the fact that the EVENDOL scores, assessed blindly via video, aligned with parental reports adds some weight to the findings.
Harms vs Benefits: What Matters Most?
The boot came out ahead in terms of day-to-day practicality. It’s easier to bathe. There’s less carrying. The kids also returned to their activities quicker. That’s huge for families.
Skin complications in the boot group were more common. Most of these (92%) were mild erythema but there were a few minor pressure sores. What’s more meaningful to parents? A slightly higher risk of a rash or being able to get through a week without plastic-wrapping their child’s leg for every bath?

Oct 18, 2025 • 46min
SGEM#489: Smooth Muscle Relaxator – But does Magnesium Work for Renal Colic?
Date: October 10, 2025
Guest Skeptic: Dr. Sergey Motov is an Emergency Physician in the Department of Emergency Medicine, Maimonides Medical Center in New York City. He is also one of the world’s leading researchers on pain management in the emergency department.
Case: A 37-year-old man presents to the emergency department (ED) with severe right-sided flank pain. The pain started about eight hours ago as a vague discomfort in his right flank, but it has gotten progressively worse and now is radiating to his groin. Patient reports nausea, an increased urge to urinate and noticing blood in his urine on one occasion. The patient denies prior medical or surgical history.
Upon ED arrival, his vital signs are normal. Physical examination revealed a stated age patient in distress due to severe right flank pain, prominent right-sided costovertebral angle tenderness, and absence of abdominal tenderness or guarding. While strongly considering renal colic in differential diagnosis and reaching for the bedside ultrasound, you are wondering if a single dose of a non-steroidal anti-inflammatory (NSAID) will be enough to relieve this patient’s pain, or should you add Magnesium or Lidocaine?
Background: Renal colic is a common and extremely painful emergency department (ED) complaint encountered in the ED that frequently recurs. The nonsteroidal anti-inflammatory drugs (NSAIDs) given intravenously or intramuscularly (IM) are frequently used as first-line therapy. However, about 30% of ED patients receiving NSAIDS require rescue analgesia in the form of opioids. Opioid use, though effective, is limited at times due to the potentially dangerous adverse effects. Thus, there might be a role for other non-opioid classes of drugs to be co-administered with NSAIDs for relief of renal colic.
Magnesium sulfate (MgSO₄) has been suggested as a possible treatment option. It may blunt ureteral smooth muscle spasm by antagonizing calcium influx in smooth muscle and by N‑methyl‑D‑aspartate (NMDA) receptor antagonism. These are mechanisms that can reduce visceral pain and augment other analgesics. Small ED trials and meta‑analyses suggest MgSO₄ can reduce pain scores and opioid use in renal colic, though the evidence base has been limited and heterogeneous [1].
Another suggested treatment modality for renal colic is intravenous lidocaine. We looked at this treatment on SGEM#202 and were unimpressed with the efficacy. Systemic lidocaine blocks voltage‑gated sodium channels and appears to modulate central sensitization and visceral pain pathways. In ED populations, systematic reviews indicate IV lidocaine offers variable analgesia with a mixed signal for benefit, and renal colic–specific RCTs suggest it may be inferior to ketorolac and best considered (if at all) as part of a multimodal strategy rather than as monotherapy [2].
Clinical Question: In adult ED patients with suspected renal colic receiving IM diclofenac, does adding IV magnesium sulfate or IV lidocaine increase the proportion achieving ≥50% reduction in pain at 30 minutes compared to a saline placebo?
Reference: Toumia M, Sassi S, Dhaoui R, et al. Magnesium Sulfate Versus Lidocaine as an Adjunct for Renal Colic in the Emergency Department: A Randomized, Double-Blind Controlled Trial. Ann Emerg Med 2024
Population: The study enrolled adults aged 18 to 65 years with suspected acute renal colic and a pain score of 5 or more on a 10-point numerical rating scale (NRS).
Exclusions: Pregnancy/breastfeeding; NSAID, MgSO₄, or lidocaine contraindication or allergy; renal/hepatic dysfunction; analgesic use in prior 6 h; bleeding diathesis or GI hemorrhage; significant CAD/arrhythmia; seizures; peritoneal signs; altered mental status; anticoagulation; hemodynamic instability; morphine allergy.
Intervention: All patients received 75 mg IM diclofenac. The intervention groups then received either 1g IV MgSO₄ (10 mL) over 2-4 minutes or 1.5 mg/kg IV lidocaine (10 mL) over 2-4 minutes.
Comparison: Placebo(10 mL normal saline) after 75 mg IM diclofenac.
Outcome:
Primary Outcome: The proportion of participants achieving at least a 50% reduction in the NRS score at 30 minutes after drug administration.
Secondary Outcomes: Need for rescue analgesia, time required for 50% pain reduction, proportion of participants with persistent pain (NRS>2) at 90 minutes, frequency of adverse events, and frequency of return visits to the ED for renal colic recurrence.
Type of Study: Prospective, multicenter, randomized, double‑blind, placebo‑controlled, 3-arm trial conducted from November 2022 to August 2023 in three academic hospital EDs and one regional hospital ED in Tunisia.
Authors’ Conclusions: “Adding intravenous MgSO4, but not lidocaine, to IM diclofenac offered superior pain relief but at levels below accepted thresholds for clinical importance.”
Quality Checklist for Randomized Clinical Trials:
The study population included or focused on those in the emergency department. Yes
The patients were adequately randomized. Yes
The randomization process was concealed. Yes
The patients were analyzed in the groups to which they were randomized. Yes
The study patients were recruited consecutively (i.e. no selection bias). Unsure
The patients in both groups were similar with respect to prognostic factors. Yes
All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Yes
All groups were treated equally except for the intervention. Yes
Follow-up was complete (i.e. at least 80% for both groups). Yes
All patient-important outcomes were considered. Yes
The treatment effect was large enough and precise enough to be clinically significant. No
Financial conflicts of interest. This study was conducted without financial support. The authors have no conflict of interest relevant to this article to disclose.
Results: They screened 1,321 patients and included 840 who were randomized (280 per arm). The mean age is in the mid 40s with a fairly even male/female split. The mean baseline NRS ~8.5–8.7. Ultrasound showed stones in ~20% and pyelocaliceal dilation in over one-third of patients.
Key Result: Adding IV MgSO₄ to IM diclofenac increased the proportion of patients achieving ≥50% pain reduction at 30 min and reduced rescue analgesia use, but pain score differences never reached the 1.3‑point MCID, while IV lidocaine was not superior to diclofenac alone.
Primary Outcome: ≥50% NRS reduction at 30 minutes
MgSO₄ + diclofenac: 227/280 (81.7%)
Lidocaine + diclofenac: 204/280 (72.9%)
Placebo + diclofenac: 201/280 (71.8%)
MgSO₄ vs lidocaine +8.8% (95% CI 1.89–15.7, p=0.013)
MgSO₄ vs control +9.9% (95% CI 2.95–16.84, p=0.004).
Secondary Outcomes:
Rescue analgesia: Lower need in MgSO₄ group (17.1%) versus lidocaine (22.5%) and control (28.9%).
Time to 50% pain reduction: No significant differences between groups (approximately 21 minutes for all groups).
Persistent pain at 90 minutes: Similar across groups (20-22.1% with NRS>2).
Return ED visits: No differences (22-26%)
Adverse events: Significantly more in MgSO₄ group (57.1%) versus control (22.5%), primarily facial flushing (48% MgSO₄ vs 10% Lido vs 14% placebo)
Statistical vs. Clinical Significance: This study exemplifies a critical issue in clinical research: achieving statistical significance without clinical importance. While the primary outcome showed statistical significance for MgSO₄ lidocaine and even more so for control, the actual NRS differences were all below 0.5 points at every time point. In addition, no between-group differences reached the generally accepted reduction of 1.3 for being clinically important [3,4]. There are concerns in the literature about what is considered a minimally important difference (MID) or minimally clinically important difference (MCID) [5, 6].
Choice of Primary Outcome Metric: The primary outcome was the proportion of patients achieving ≥50% pain reduction rather than the actual change in pain scores. This dichotomization of a continuous variable has several problems:
Loss of Information: Converting continuous NRS data to a binary outcome discards valuable information about the magnitude of pain relief. For example, a patient going from NRS 10 to 5 (50% reduction) is counted the same as a patient going from 10 to 2 (80% reduction), yet these represent vastly different clinical scenarios.
Arbitrary Threshold: The 50% reduction threshold, while commonly used, may not represent meaningful relief for all patients. For example, some patients with NRS 10→5 may still require rescue analgesia, while others with NRS 10→6 (40% reduction) might be satisfied.
Diagnostic Verification of Kidney Stone: The diagnosis of renal colic was based on emergency physician clinical judgment or imaging with ultrasound showing direct or indirect signs of urinary tract stones in only 58% of participants when performed. This is consistent with current radiology, emergency medicine and urology guidelines not to get imaging on all patients [7]. We cover this on the SGEM Xtra: Come Together, Right Now...Over Renal Colic. While this approach may increase real-world applicability (generalizability), the “suspected renal colic” inclusion without universal confirmatory imaging may reduce internal validity and introduce misclassification bias. A confirmed stone sensitivity analysis would have helped strengthen the findings.
Adjunct to IM Rather Than IV NSAID: While acknowledging and respecting the authors’ standard of care practice of using IM Diclofenac, there are several important implications:
Delayed NSAID Absorption: IM administration results in slower and more variable absorption compared to IV administration.

Oct 11, 2025 • 0sec
SGEM#488: It’s Just a Minor Stroke – Should We Still Lyse?
Date: October 3, 2025
Reference: Doheim et al. Meta-Analysis of Randomized Controlled Trials on IV Thrombolysis in Patients With Minor Acute Ischemic Stroke. Neurology 2025
Guest Skeptic: Dr. Casey Parker is a Rural Generalist, Evidence-based medicine enthusiast and Ultrasound Nerd.
This episode was recorded live, in beautiful Broome, Australia, at the Spring Seminar on Emergency Medicine (SSEM 2025). You can get copies of the slides used in the presentation at this LINK. You can also watch the episode on YouTube.
Case: Dani is a recently retired emergency department (ED) doc who has spent the last year travelling the world, playing banjo & sharing time with family and friends. This morning, whilst eating a breakfast of eggs and ham, Dani had a sudden onset of right-hand weakness and difficulty speaking. Dani’s family called 000 (911 in North America), and she was taken to the ED within one hour. On arrival at your medium-sized rural ED, Dani is assessed by the “Stroke Team aka, you” as having mild motor weakness in the right hand and mild dysarthria. Dani is given an NIHSS score of 4. A rapid CT and CTA is quickly reported as “no acute large vessel occlusion” and “No intracranial bleed and no established cortical infarction”. You know that many centers in the city are offering intravenous tPA for patients with acute ischemic stroke. You wonder if Dani should get a dose?
Background: Minor ischemic strokes (MIS), often defined by NIHSS ≤5, are very common, with roughly half of all ischemic strokes presenting with mild deficits. Despite the mild presentation, these strokes are not always benign. About 30% of patients with initially minor stroke symptoms end up significantly disabled (unable to walk independently) at 90 days [1]. In short, a small stroke can still have a big impact on a patient’s life if it isn’t effectively treated or if it progresses.
Dr. Daniel Fatovich
There have been gallons of ink spilled in the discussion of the stroke literature, with much debate on previous SGEM episodes about the relative risks and benefits of IV thrombolytic therapy for acute strokes. Drs. Ken Milne and Danny Fatovich have earned themselves the title of “non-expert EM contrarians” when discussing the literature around acute ischemic stroke management with Neurologists all over the world.
IV thrombolysis (tissue plasminogen activator [tPA], or newer Tenecteplase [TNK]) is a well-established therapy for acute ischemic stroke based on some questionable evidence [2-6]. However, its role in mild strokes has been hotly debated. On one hand, treating early might prevent a minor stroke from evolving or causing hidden disability. On the other hand, tPA carries a risk of intracerebral hemorrhage, and many minor stroke patients recover well without aggressive intervention. Guidelines have wrestled with this nuance: current recommendations endorse tPA for mild strokes that have clearly disabling deficits, but advise against tPA for mild non-disabling strokes [7]. The core controversy is whether the potential functional benefit in MIS is worth the bleeding risk if the patient is already doing okay.
Things changed 10 years ago after Mr. CLEAN was published. It showed that endovascular interventions (EVT) for acute large vessel occlusions (LVOs) could have impressive results (NNT of 7). However, the role of IV thrombolytics for minor stroke syndromes remains unclear and controversial. Legendary (now-retired) ED Dr. Joe Lex once stated, “If I can kick the syringe outta’ your hand – then don’t give me the tPA!” Was Joe right?
Before 2019, practice varied widely. Some neurologists treated almost any stroke within the window, reasoning that “time is brain” even for mild deficits, while others were more conservative. Observational studies yielded mixed signals. Several studies suggested that thrombolysis in mild strokes improves the chance of an excellent outcome at discharge or 90 days, while others showed minimal benefit.
The PRISMS trial (2018) was a key randomized study in this area. It compared alteplase vs. aspirin in patients with minor non-disabling strokes (NIHSS ≤5). PRISMS found no difference in 90-day functional outcomes (mRS score 0-1) between the tPA and aspirin groups, but did find an increase in symptomatic intracerebral hemorrhage with tPA [8].
However, that trial was stopped early after only ~1/3 of the planned enrolment (313/948). This was reported due to a lack of funding. There are issues with stopping trials early, which we have discussed on previous SGEM episodes. Stopping PRISMS early meant it lacked the power to definitively settle the question of lysis minor, non-disabling strokes. Consequently, equipoise remained, and actual practice often followed guideline nuance, treating “minor-but-disabling” strokes (for example, isolated aphasia or hemiparesis that significantly limits function) while generally avoiding tPA in trivial or rapidly improving strokes. Viele et al JAMA 2016, Guyatt et al BMJ 2012, Tyson et al Trials 2016
Clinical Question: In adults with minor acute ischemic stroke (generally NIHSS ≤5), does IV thrombolysis (IVT) improve functional outcomes compared with non‑thrombolytic standard care?
Reference: Doheim et al. Meta-Analysis of Randomized Controlled Trials on IV Thrombolysis in Patients With Minor Acute Ischemic Stroke. Neurology 2025
Population: Adults (≥18 y) with minor ischemic stroke (NIHSS <6) eligible to receive IVT within 12 hours of onset from RCTs.
Excluded: Nonrandomized studies or those without a control arm. Trials included patients with nondisabling and, in some RCTs, mildly disabling symptoms.
Intervention: A variety of IV thrombolytic drugs (Alteplase, Tenecteplase, pro-urokinase) given within varying time windows, but most within 3 to 4.5 hours, followed by standard care.
Comparison: Non-thrombolytic standard care (NT‑SC), which could include dual or single antiplatelet therapy, anticoagulants, statins, antihypertensives, glucose control, and other risk‑factor–directed treatments.
Outcome:
Primary Outcome: Excellent functional outcome at ~90 days, defined as mRS 0-1. (For IST‑3 subgroup data, OHS was converted to mRS; where only 6-month data existed, it was used.)
Secondary Outcomes: Favourable outcome mRS 0-2, 90-day mortality, recurrent ischemic or hemorrhagic stroke and safety (symptomatic ICH [sICH]and any ICH).
Type of Study: Systematic review and meta-analysis or RCTs
Authors’ Conclusions: “IVT does not confer improved functional outcomes among patients with minor strokes and can be associated with higher odds of sICH and mortality.”
Quality Checklist for Therapeutic Systematic Reviews: (yes/no/unsure)
Was the clinical question sensible and answerable? Yes
Was the search detailed and exhaustive? Yes
Were primary studies of high methodological quality? Yes
Were the assessments of studies reproducible? Yes
Were the outcomes clinically relevant? Yes
Was there low statistical heterogeneity for the primary outcomes? Unsure
Was the treatment effect large and precise enough to be clinically significant? No
Who funded the review? No targeted funding reported.
Conflicts of interest declared? Authors report no relevant disclosures. (though not true for the primary trials - most had conflicts/funding by drug companies)
Results: A total of 3,364 patients from four RCTs were included in the primary analysis. The age ranged from ~56 to 80 years across trials. Most had non-disabling deficits. Some RCTs included a minority with disabling symptoms. Trials varied in time windows (≤3 h, ≤4.5 h, ≤12 h) and imaging criteria (TEMPO‑2 required evidence of intracranial occlusion). The typical baseline NIHSS medians ~2 to 4 in the RCT.
Key Results: Compared with non-thrombolytic standard care, IV thrombolysis did not improve excellent 90‑day functional outcome (mRS 0-1) and was associated with higher odds of symptomatic ICH and mortality in patients with minor stroke.
Primary Outcome: mRS 0-1 at ~90 days: OR 85 (95% CI 0.70–1.03). No significant benefit of IVT vs NT‑SC. Similar null results across Alteplase, Tenecteplase, and prourokinase subgroups. Null also across disabling and nondisabling presentations.
Secondary Outcomes:
mRS 0–2 at ~90 days: OR 71 (95% CI 0.55–0.91). Lower odds of independence with IVT. It became non-significant when post hoc IST‑3 data were added (OR 0.85, 95% CI 0.58–1.24).
Symptomatic ICH: OR 10 (95% CI 2.01–12.96). Increased with IVT.
Any ICH: OR 21 (95% CI 1.63–3.01). Increased with IVT.
90‑day Mortality: OR 84 (95% CI 1.18–2.89). Increased with IVT.
Recurrent Stroke: OR 01 (95% CI 0.79–1.29). No statistical difference.
What Goes Into the Sausage Machine: This meta-analysis includes a range of trials with different inclusion, exclusion criteria, differing baselines, geographic/demographic and “standard care” comparators, so it is a bit of an evidentiary fruit salad. It can be hard to know how this data applies to the patient and the drugs/system of care that you are working with in your hospital. To make this decision, we may need to look back at individual cohorts and see if they represent our patients and system of care.
Rural Stroke Application: In large tertiary hospitals where access to immediate imaging, stroke teams, and endovascular “clot retrieval” interventions has become the standard of care, all of the options are available. However, in rural or remote hospitals where we often do not have as much information or access to interventional neuro-radiology, we run the risk of delivering “second-class” care to our patients with acute ischemic strokes. This trial gives us some clarification around the role of tPA in our smaller community. Is it best to transfer patients with large, disabling strokes to a bigger centre,


