1. Diagnostic prediction models for suspected PE: systematic review and independent external validation in primary care [Wells Wins]
Hendriksen JM, et al. BMJ. 2015 Sep 8;351:h4438.
OBJECTIVE: To validate all diagnostic prediction models for ruling out pulmonary embolism that are easily applicable in primary care.
DESIGN: Systematic review followed by independent external validation study to assess transportability of retrieved models to primary care medicine.
SETTING: 300 general practices in the Netherlands.
PARTICIPANTS: Individual patient dataset of 598 patients with suspected acute pulmonary embolism in primary care.
MAIN OUTCOME MEASURES: Discriminative ability of all models retrieved by systematic literature search, assessed by calculation and comparison of C statistics. After stratification into groups with high and low probability of pulmonary embolism according to pre-specified model cut-offs combined with qualitative D-dimer test, sensitivity, specificity, efficiency (overall proportion of patients with low probability of pulmonary embolism), and failure rate (proportion of pulmonary embolism cases in group of patients with low probability) were calculated for all models.
RESULTS: Ten published prediction models for the diagnosis of pulmonary embolism were found. Five of these models could be validated in the primary care dataset: the original Wells, modified Wells, simplified Wells, revised Geneva, and simplified revised Geneva models. Discriminative ability was comparable for all models (range of C statistic 0.75-0.80). Sensitivity ranged from 88% (simplified revised Geneva) to 96% (simplified Wells) and specificity from 48% (revised Geneva) to 53% (simplified revised Geneva). Efficiency of all models was between 43% and 48%. Differences were observed between failure rates, especially between the simplified Wells and the simplified revised Geneva models (failure rates 1.2% (95% confidence interval 0.2% to 3.3%) and 3.1% (1.4% to 5.9%), respectively; absolute difference -1.98% (-3.33% to -0.74%)). Irrespective of the diagnostic prediction model used, three patients were incorrectly classified as having low probability of pulmonary embolism; pulmonary embolism was diagnosed only after referral to secondary care.
CONCLUSIONS: Five diagnostic pulmonary embolism prediction models that are easily applicable in primary care were validated in this setting. Whereas efficiency was comparable for all rules, the Wells rules gave the best performance in terms of lower failure rates.
Full-text (free): http://www.bmj.com/content/351/bmj.h4438.long
2. Derivation and validation of a clinical decision rule to identify young children with skull fracture following isolated head trauma
Gravel J, et al. CMAJ 2015 September 8 [Epub ahead of print]
Background: There is no clear consensus regarding radiologic evaluation of head trauma in young children without traumatic brain injury. We conducted a study to develop and validate a clinical decision rule to identify skull fracture in young children with head trauma and no immediate need for head tomography.
Methods: We performed a prospective cohort study in 3 tertiary care emergency departments in the province of Quebec. Participants were children less than 2 years old who had a head trauma and were not at high risk of clinically important traumatic brain injury (Glasgow Coma Scale score less than 15, altered level of consciousness or palpable skull fracture). The primary outcome was skull fracture. For each participant, the treating physician completed a standardized report form after physical examination and before radiologic evaluation. The decision to order skull radiography was at the physician's discretion. The clinical decision rule was derived using recursive partitioning.
Results: A total of 811 patients (49 with skull fracture) were recruited during the derivation phase. The 2 predictors identified through recursive partitioning were parietal or occipital swelling or hematoma and age less than 2 months. The rule had a sensitivity of 94% (95% confidence interval [CI] 83%–99%) and a specificity of 86% (95% CI 84%–89%) in the derivation phase. During the validation phase, 856 participants (44 with skull fracture) were recruited. The rule had a sensitivity of 89% and a specificity of 87% during this phase.
Interpretation: The clinical decision rule developed in this study identified about 90% of skull fractures among young children with mild head trauma who had no immediate indication for head tomography. Use of the rule would have reduced the number of radiologic evaluations by about 60%.
In an accompanying commentary, Peter Gill, MD, The Hospital for Sick Children (SickKids) and University of Toronto, Toronto, Ontario, and Terry Klassen, MD, University of Manitoba, Winnipeg, Manitoba, wrote: “The authors provide front-line clinicians with objective decision-making criteria, more helpful than 'observation versus CT. But perhaps most important, the rule is simple: in children aged less than 2 years with a minor head injury who do not meet the criteria for a CT scan, perform a skull radiograph if they are less than 2 months old or they have parietal or occipital swelling. If only all clinical decision rules could be this simple.”
Full-text (free): http://www.cmaj.ca/content/early/2015/09/09/cmaj.150540.full.pdf+html
3. Ketamine-Propofol Versus Propofol Alone for Procedural Sedation in the ED: A Systematic Review and Meta-analysis.
Yan JW, et al. Acad Emerg Med. 2015 Sep;22(9):1003-13.
OBJECTIVES: Propofol is an agent commonly used for procedural sedation and analgesia (PSA) in the emergency department (ED), but it can cause respiratory depression and hypotension. The combination of ketamine-propofol (K-P) is an alternative that theoretically provides a reduction in adverse events compared to propofol. The primary objective of this review was to determine if K-P has a lower frequency of adverse respiratory events in patients undergoing PSA in the ED than propofol alone. Secondary objectives were to compare the proportion of overall adverse events, sedation time, procedure time, and recovery time between K-P and propofol.
METHODS: Electronic searches of Medline, EMBASE, Cochrane Central Register of Controlled Trials, and CINAHL were conducted and reference lists were hand-searched. Randomized controlled trials (RCTs) published in English comparing the use of K-P to propofol alone for PSA in the ED were included.
RESULTS: Six RCTs were included with a combined total of 932 patients (K-P = 520, propofol = 412). Five RCTs reported the proportion of adverse respiratory events; the pooled estimate revealed fewer adverse respiratory events with K-P compared to propofol (29.0% vs. 35.4%; risk ratio [RR] = 0.82; 95% confidence interval [CI] = 0.68 to 0.99). There was no significant difference with respect to the proportion of overall adverse events (38.8% vs. 42.5%; RR = 0.88; 95% CI = 0.75 to 1.04). Procedure time was similar when the groups were compared.
CONCLUSIONS: The premise of combining ketamine with propofol is based on the many synergies that theoretically exist between these two agents. In this study, K-P had a lower frequency of adverse respiratory events in patients undergoing PSA in the ED compared to propofol alone.
4. Common Diagnoses and Outcomes in Elderly Patients Who Present to the ED with Non-Specific Complaints.
Quinn K, et al. CJEM. 2015 Sep;17(5):516-22.
OBJECTIVE: Elderly patients often present to the emergency department (ED) with non-specific complaints. Previous studies indicate that such patients are at greater risk for life-threatening illnesses than similarly aged patients with specific complaints. We evaluated the diagnoses and outcomes of elderly patients presenting with non-specific complaints.
METHODS: Two trained data abstractors independently reviewed all records of patients over 70 years old presenting (to two academic EDs) with non-specific complaints, as defined by the Canadian Emergency Department Information System (CEDIS). Outcomes of interest were ED discharge diagnosis, hospital admission, length of stay, and ED revisit within 30 days.
RESULTS: Of the 743 patients screened for the study, 265 were excluded because they had dizziness, vertigo, or a specific complaint recorded in the triage notes. 419 patients (87.7%) presented with weakness and 59 patients (12.3%) presented with general fatigue or unwellness. The most common diagnoses were urinary tract infection (UTI) (11.3%), transient ischemic attack (TIA) (10.0%), and dehydration (5.6%). There were 11 hospital admissions with median length of stay of five days. Eighty-one (16.9%) patients revisited the ED within 30 days of discharge. Regression analysis indicated that arrival to the ED by ambulance was independently associated with hospital admission.
CONCLUSIONS: Our results suggest that elderly patients presenting to the ED with non-specific complaints are not at high risk for life-threatening illnesses. The most common diagnoses are UTI, TIA, and dehydration. Most patients can be discharged safely, although a relatively high proportion revisit the ED within 30 days.
5. The effect of targeted temperature management on coagulation parameters and bleeding events after out-of-hospital cardiac arrest of presumed cardiac cause
Jacob M, et al. Resuscitation. 2015 Sep 8 [Epub ahead of print]
AIMS: Targeted temperature management (TTM) is part of the standard treatment of comatose patients after out-of-hospital cardiac arrest (OHCA) to attenuate neurological injury. In other clinical settings, hypothermia promotes coagulopathy leading to an increase in bleeding and thrombosis tendency. Thus, concern has been raised as to whether TTM can be applied safely, as acute myocardial infarction requiring primary percutaneous coronary intervention (PCI) with the need of effective antiplatelet therapy is frequent following OHCA. This study investigated the influence of TTM at 33 or 36°C on various laboratory and coagulation parameters.
METHODS AND RESULTS: In this single-center predefined substudy of the TTM trial, 171 patients were randomized to TTM at either 33 or 36°C in the postresuscitation phase. The two subgroups were compared regarding standard laboratory coagulation parameters, thrombelastography (TEG), bleeding, and stent thrombosis events. Platelet counts were lower in the TTM33-group compared to TTM36 (p=0.009), but neither standard coagulation nor TEG-parameters showed any difference between the groups. TEG revealed a normocoagulable state in the majority of patients, while approximately 20% of the population presented as hypercoagulable. Adverse events included 38 bleeding events, one stent thrombosis, and one reinfarction, with no significant difference between the groups.
CONCLUSIONS: There was no evidence supporting the assumption that TTM at 33°C was associated with impaired hemostasis or increased the frequency of adverse bleeding and thrombotic events compared to TTM at 36°C. We found that TTM at either temperature can safely be applied in the postresuscitation phase after acute myocardial infarction and primary PCI.
6. Complications Associated With Nitrate Use in Patients Presenting With Acute Pulmonary Edema and Concomitant Moderate or Severe Aortic Stenosis
Claveau D, et al. Ann Emerg Med. 2015;66: 355–362.e1
STUDY OBJECTIVE: We evaluate the incidence of complications associated with the use of nitrates in patients presenting with acute pulmonary edema and concomitant moderate or severe aortic stenosis compared with patients without aortic stenosis. Nitrates are contraindicated in severe aortic stenosis because of the theoretical yet unproven risk of precipitating profound hypotension.
METHODS: A cohort design with retrospective chart review study was conducted at two Canadian hospitals. Patients with aortic stenosis (moderate or severe) and without aortic stenosis were included if they presented with acute cardiogenic pulmonary edema, received intravenous or sublingual nitroglycerin, and had an echocardiography report available. The primary outcome was clinically relevant hypotension, defined as hypotension leading to any of the following predefined events: nitroglycerin discontinuation, intravenous fluid bolus, vasopressor use, or cardiac arrest. The secondary outcome was sustained hypotension, defined as a systolic blood pressure less than 90 mm Hg and lasting greater than or equal to 30 minutes.
RESULTS: The cohort consisted of 195 episodes of acute pulmonary edema, representing 65 episodes with severe aortic stenosis (N=65) and an equal number of matched episodes with moderate aortic stenosis (N=65) and no aortic stenosis (N=65). Nitroglycerin was administered intravenously only in 70% of cases, intravenously and sublingually in 25%, and sublingually only in the remaining 5%. After adjustment for sex, initial systolic blood pressure, furosemide dose, and use of noninvasive ventilation, moderate and severe aortic stenosis were not associated with clinically relevant hypotension after receipt of nitroglycerin (adjusted odds ratio [OR] 0.97, 95% confidence interval [CI] 0.40 to 2.37 for moderate aortic stenosis; adjusted OR 0.99, 95% CI 0.41 to 2.41 for severe aortic stenosis). The incidence of clinically relevant hypotension was 26.2% for moderate and severe aortic stenosis and 23.1% in the no aortic stenosis reference group. The secondary outcome of sustained hypotension occurred in 29.2% of patients with severe aortic stenosis, 16.9% with moderate aortic stenosis, and 13.8% in the no aortic stenosis group (adjusted OR for severe aortic stenosis 2.34; 95% CI 0.91 to 6.01).
CONCLUSION: In this retrospective study, neither moderate nor severe aortic stenosis was associated with a greater risk of clinically relevant hypotension requiring intervention when nitroglycerin was used for acute pulmonary edema. Future studies should investigate safety and efficacy of nitroglycerin for patients with aortic stenosis because this study was limited by a small sample size and design limitations. Cautious use of nitroglycerin in patients with moderate or severe aortic stenosis and presenting with acute pulmonary edema may be a safer strategy than traditionally thought.
Full-text (free): http://www.annemergmed.com/article/S0196-0644(15)00234-6/fulltext
7. Accuracy of WBC Count and CRP Levels Related to Duration of Sxs in Pts Suspected of Acute Appendicitis.
Atema JJ, et al. Acad Emerg Med. 2015 Sep;22(9):1015-24.
OBJECTIVES: Low levels of white blood cell (WBC) count and C-reactive protein (CRP) have been suggested to sufficiently rule out acute appendicitis. The diagnostic value of these tests is likely to depend on the duration of complaints. The aim of this study was to evaluate the accuracy of these inflammatory markers in relation to duration of symptoms in patients suspected of acute appendicitis.
METHODS: Patients suspected of having acute appendicitis were retrospectively selected from five prospective cohorts of patients with acute abdominal pain presenting at the emergency department (ED) in two European countries. Only adult patients with clinical suspicion of acute appendicitis based on medical history, physical examination, and laboratory studies at the time of registration in the original cohorts were included in this analysis. WBC count and CRP level were determined in all patients and a final diagnosis was assigned to every patient by an expert panel based on all available clinical data and follow-up. For categories based on symptom duration, the diagnostic accuracy of single and combined cutoff values was determined, and negative predictive values (NPV) and positive predictive values (PPV) were calculated. Subgroup analyses for age (less than 40 years or ≥40 years) and sex were performed.
RESULTS: A total of 1,024 patients with clinically suspected acute appendicitis were included, of whom 580 (57%) were assigned a final diagnosis of appendicitis. No value of WBC count, CRP level, or their combination resulted in a NPV of more than 90%, regardless of the duration of symptoms. A WBC count of over 20 × 10(9) /L in combination with symptoms for more than 48 hours was associated with a PPV of 100%. However, only eight of the 1,024 patients (1%) fulfilled these criteria, limiting the clinical applicability. No other cutoff level of WBC count, CRP level, or their combination resulted in a PPV of more than 80%, regardless of the duration of symptoms. In female patients, normal levels of CRP and WBC count more accurately excluded the diagnosis of appendicitis than normal levels did in male patients.
CONCLUSIONS: No WBC count or CRP level can safely and sufficiently confirm or exclude the suspected diagnosis of acute appendicitis in patients who present with abdominal pain of 5 days or less in duration.
8. ‘Landmark’ Study Supports New, More Aggressive BP Targets
Gina Kolata. New York Times. September 11, 2015
Declaring they had “potentially lifesaving information,” federal health officials said on Friday that they were ending a major study early because it has already conclusively answered a question cardiologists have puzzled over for decades: how low should blood pressure go?
The answer: way lower than the current guidelines.
For years doctors have been uncertain what the optimal goal should be for patients with high blood pressure. The aim of course is to bring it down, but how far and how aggressively remained a mystery. There are trade-offs — risks and side effects from drugs — and there were lingering questions about whether older patients needed somewhat higher blood pressure to push blood to the brain.
The study found that patients who were assigned to reach a systolic blood pressure goal below 120 — far lower than current guidelines of 140, or 150 for people over 60 — had their risk of heart attacks, heart failure and strokes reduced by a third and their risk of death reduced by nearly a quarter.
The study, called Sprint, randomly assigned more than 9,300 men and women ages 50 and over who were at high risk of heart disease or had kidney disease to of two systolic blood pressure targets: less than 120 millimeters of mercury, which is lower than any guideline ever suggested, or less than 140. (Systolic pressure is the higher of the two blood pressure numbers and represents pressure on blood vessels when the heart contracts.)
The study was expected to conclude in 2017, but considering the results of great importance to public health, the National Heart, Lung and Blood Institute announced them Friday morning, saying a paper with the data would be published within a few months.
9. ED Corticosteroid Use for Allergy or Anaphylaxis Is Not Associated With Decreased Relapses
Grunau BE, et al. Ann Emerg Med 2015;66:381–389
STUDY OBJECTIVE: Corticosteroids (steroids) are often used to mitigate symptoms and prevent subsequent reactions in emergency department (ED) patients with allergic reactions, despite a lack of evidence to support their use. We sought to determine the association of steroid administration with improved clinical outcomes.
METHODS: Adult allergy-related encounters to 2 urban EDs during a 5-year period were identified and classified as "anaphylaxis" or "allergic reaction." Regional and provincial databases identified subsequent ED visits or deaths within a 7-day period. The primary outcome was allergy-related ED revisits in the steroid- and nonsteroid-exposed groups, adjusting for potential confounders with a propensity score analysis; secondary outcomes included the number of clinically important biphasic reactions and deaths.
RESULTS: Two thousand seven hundred one encounters (473 anaphylactic) were included; 48% were treated with steroids. Allergy-related ED revisits occurred in 5.8% and 6.7% of patients treated with and without steroids, respectively (adjusted odds ratio [OR] 0.91; 95% confidence interval [CI] 0.64 to 1.28), with a number needed to treat (NNT) to benefit of 176 (95% CI NNT to benefit 39 to ∞ to NNT to harm 65). The adjusted OR in the anaphylaxis subgroup was 1.12 (95% CI 0.41 to 3.27). In the allergic reaction group, the adjusted OR was 0.91 (95% CI 0.63 to 1.31), with an NNT to benefit of 173 (95% CI NNT to benefit 38 to ∞ to NNT to harm 58). In the steroid and nonsteroid groups, there were 4 and 1 clinically important biphasic reactions, respectively. There were no deaths.
CONCLUSION: Among ED patients with allergic reactions or anaphylaxis, corticosteroid use was not associated with decreased relapses to additional care within 7 days.
10. Images in Clinical Practice
A Viper Bite
Ptosis after Swimming in the Red Sea
Young Girl with Nasal Congestion and Pain
Elderly Man with Dark Urine
Discussion: Catheter-Associated Urinary Tract Infections: If You Hear Hoofbeats…
11. A Systematic Review and Meta-analysis of D-dimer as a Rule-out Test for Suspected Acute Aortic Dissection.
Asha SE, et al. Ann Emerg Med. 2015;66:368-78.
STUDY OBJECTIVE: The aim of this systematic review and meta-analysis is to determine the diagnostic accuracy of D-dimer as a rule-out test for acute aortic dissection. Previous meta-analyses have had methodological problems with conflicting conclusions, and new diagnostic accuracy studies have been published since.
METHODS: All prospective cross-sectional analytic studies of D-dimer as a diagnostic test for acute aortic dissection were included where diagnosis was confirmed by an accepted reference standard. Studies were identified with MEDLINE, EMBASE, Medion, Google Scholar, Web of Science, and bibliographies of relevant articles and previous systematic reviews. Two reviewers independently screened articles for inclusion, assessed study quality, and extracted data.
RESULTS: Abstracts from 800 articles were reviewed, yielding 30 potentially relevant studies that were reviewed in full text. Five studies met all eligibility criteria. Data from 4 studies (1,557 participants) that used a D-dimer cutoff of 0.50 μg/mL were pooled to estimate sensitivity, specificity, and positive and negative likelihood ratios. Overall, sensitivity and negative likelihood ratio were 98.0% (95% confidence interval [CI] 96.3% to 99.1%) and 0.05 (95% CI 0.03 to 0.09), respectively. These measurements had little statistical heterogeneity. Specificity (41.9%; 95% CI 39.0% to 44.9%) and positive likelihood ratio (2.11; 95% CI 1.46 to 3.05) showed significant statistical heterogeneity. When applied to a low-risk population as defined by the American Heart Association (prevalence 6%), the posttest probability for acute aortic dissection was 0.3%.
CONCLUSION: This meta-analysis suggests that a negative D-dimer result may be useful to help rule out acute aortic dissection in low-risk patients.
Full-text (free): http://www.annemergmed.com/article/S0196-0644(15)00118-3/fulltext
12. Burnout in ED healthcare professionals is associated with coping style: a cross-sectional survey.
Howlett M, et al. Emerg Med J. 2015 Sep;32(9):722-7.
INTRODUCTION: Ineffective coping may lead to impaired job performance and burnout, with adverse consequences to staff well-being and patient outcomes. We examined the relationship between coping styles and burnout in emergency physicians, nurses and support staff at seven small, medium and large emergency departments (ED) in a Canadian health region (population 500 000).
METHODS: Linear regression with the Coping Inventory for Stressful Situations (CISS) and Maslach Burnout Inventory (MBI) was used to evaluate the effect of coping style on levels of burnout in a cross-sectional survey of 616 ED staff members. CISS measures coping style in three categories: task-oriented, emotion-oriented and avoidance-oriented coping; MBI, in use for 30 years, assesses the level of burnout in healthcare workers.
RESULTS: Task-oriented coping was associated with decreased risk of burnout, while emotion-oriented coping was associated with increased risk of burnout.
DISCUSSION: Specific coping styles are associated with varied risk of burnout in ED staff across several different types of hospitals in a regional network. Coping style intervention may reduce burnout, while leading to improvement in staff well-being and patient outcomes. Further studies should focus on building and sustaining task-oriented coping, along with alternatives to emotion-oriented coping.
What are these different coping styles?
Task-oriented coping: a primary control style that is adaptive when situations are appraised as changeable. Focus is maintained and emotions are controlled. This can be maladaptive for complex changing social problems.
Emotion-oriented coping: a secondary control style adaptive when situations are appraised as unchangeable. The aim is to reduce stress, but over the long term it can increase stress and produce negative outcomes like anxiety and depression.
Avoidant-distracted coping: This is adaptive in the short-term for uncontrollable problems. You just don’t let the problem bother you and focus on something more interesting. If problems are controllable, this strategy will be maladaptive over the long run.
Avoidant-social coping: Recourse to others is sought in the face of threat, for diversion or for assistance. This strategy is also adaptive for short-term, but over time it is more effective to develop the skills needed to address the threat as an instrumental problem.
13. The Frequency of Postreduction Interventions After Successful Enema Reduction of Intussusception.
Lessenich EM, et al. Acad Emerg Med. 2015 Sep;22(9):1042-7.
OBJECTIVES: The objective was to determine the frequency of postreduction, hospital-level interventions among children with successful reduction of ileocolic intussusception and identify factors that predict the need for such interventions.
METHODS: This was a retrospective cross-sectional study of children who underwent successful enema reduction for ileocolic intussusception at a single emergency department. Hospital-level interventions were included if they occurred within 24 hours of reduction and were further classified as either major (recurrence or possible perforation) or minor (imaging for suspected recurrence or administration of parenteral narcotics or antiemetics). Binary logistic regression was used to identify predictors for hospital-level interventions.
RESULTS: A total of 464 children underwent enema reduction. The median age was 1.7 years (interquartile range [IQR] = 0.8 to 2.5 years), and 66% were male. A total of 435 (94%) were hospitalized with a median hospital stay of 25 hours (IQR = 19 to 34 hours). Nineteen percent (95% confidence interval [CI] = 15% to 22%) needed postreduction interventions, including 6% (95% CI = 4% to 9%) who required major interventions. The median time to any hospital intervention was 9.9 hours (IQR = 6.3 to 16.4 hours). We identified two independent predictors for hospital-level interventions: duration of symptoms over 24 hours (adjusted odds ratio [OR] = 2.1, 95% CI = 1.3 to 3.4) and location of the intussusception tip at (or proximal to) the hepatic flexure (adjusted OR = 1.9, 95% CI = 1.1 to 3.3); the latter factor was also a predictor of a major intervention. None of the children (95% CI = 0 to 1.0%) had an acute decompensation after an initially successful enema reduction.
CONCLUSIONS: Clinical decompensation is rare and recurrence is relatively low after an uncomplicated reduction of ileocolic intussusception. However, one in five children required hospital-level interventions after reduction. Children with the intussusception tip at (or proximal to) the hepatic flexure, and those with symptoms for longer than 24 hours, are more likely to require subsequent interventions. Although outpatient management appears safe after a period of observation, caregivers should be counseled about the risk of ongoing symptoms and recurrence.
14. Marketers should at least be required to try to communicate risk information as effectively as they do their promotional messages.
The Vernacular of Risk — Rethinking Direct-to-Consumer Advertising of Pharmaceuticals
The Vernacular of Risk — Rethinking Direct-to-Consumer Advertising of Pharmaceuticals
Greene JA , et al. N Engl J Med 2015; 373:1087-1089.
Aside from New Zealand, the United States is the only country with a strong pharmaceutical regulatory infrastructure that allows direct-to-consumer advertising (DTCA) of prescription drugs in print, broadcast, and electronic media. U.S. consumers are accustomed to full-page ads in newspapers and magazines detailing a drug's benefits — followed by another page of fine print in which its contraindications, risks, and side effects are spelled out in minute detail and equally minute print.
That may soon change, however, as the Food and Drug Administration (FDA) moves to enact new regulations regarding risk communication in DTCA. Earlier this year, the FDA sought public comments on new guidance for pharmaceutical marketers on communicating risks to consumers in print advertisements. This proposal, which the FDA has kicked around in one form or another since 2004, responds to mounting research showing that reprinting highly technical package inserts in print ads does very little to communicate risks to consumers. The goal is to communicate those risks in a new vernacular.
Instead of reproducing the fine print meant for physicians and pharmacists, the FDA proposes that drug marketers use a new “consumer brief summary” focused “on the most important risk information . . . in a way most likely to be understood by consumers.” A summary written in everyday language might take the form of a Q&A list, for example, or a Drug Facts box like those on packaging for over-the-counter medicines. Drug marketers are being asked to use popular idiom to communicate with people with a wide range of literacy levels; to use larger fonts and more readable formats; and to use visual elements such as white space, logos, and color schemes to highlight the most relevant risks.1…
The remainder of the essay: http://www.nejm.org/doi/full/10.1056/NEJMp1507924
15. If It's in the News, It Won't Happen to You
Cook T. Emergency Medicine News. 2015;37(8):23
A few years back, the news was all about flesh-eating bacteria. Stories surfaced about a small number of people who died from necrotizing fasciitis, and one happened to be a young guy living in my hometown of Columbia, SC. Soon after, everyone with a rash came to the ED to make sure it wasn't that flesh-eating stuff. Parents lined up to ignore our opinion that it was not serious and to demand antibiotics (not realizing antibiotics caused these rare flesh-eaters in the first place).
Recently on an evening shift, we were taking care of a teenage girl with pleuritic chest pain. It was her second visit that week, and her mother was demanding and anxious. We eventually did x-rays, blood and urine tests, an ECG, and even an echocardiogram and chest CT. All normal.
This still did not make the mother comfortable. “The previous doctor we saw here told us that if she did not get better, we should come back so she could be admitted.” Of course, the previous doctor was one of my interns. Even though she had come for our opinion and received an extensive workup, she clung to the idea that we were overlooking something. She wagged her finger in our faces. “What if something terrible happens to her tonight? Are you sure you know what you are doing?”
How do you talk someone off this cliff of anxiety? Despite our best efforts to inject reality into the discussion, she clung to her fear and the interaction ended tensely. Situations such as these are common in our job, and learning how to manage and deal with the frustration they cause is a part of becoming an emergency physician.
Every day, the media tell us about incredibly rare ways people have been maimed or killed. Last year it was Ebola. The United States has seen four cases with one death. Preventing the spread of the disease is necessary, but you would think thousands of Americans were going to die if you watched the news at that time. My hospital spent millions to provide quarantine areas in the ED, buy special equipment and protective gear, and train personnel on proper decontamination techniques. None of it has been used.
But what choice did anyone have? If you were the unlucky hospital (or emergency physician) taking care of the first Ebola patient, you were skewered by the press for missing the diagnosis of a disease that had never been seen on the continent. I'm surprised they did not hang the emergency physician, but you can be sure he will be in court. (Seriously, I would have missed the diagnosis, too.)
All of this overlooks the most common causes of unexpected death in the United States, however. Every day, 110 people die in car accidents, 57 from self-inflicted gunshot wounds, and a whopping 44 from prescription drug overdose. But you can be sure you will not see anyone stop driving their cars (while texting, no less) or asking for pain meds. If I could tell the mother of the young girl with chest pain what to worry about, it would be to teach her to drive safely, secure their firearms, and lock up their pain meds. These are way more likely to cause the tragedy she intensely fears.
The bottom line is human beings are irrational and natural worriers, and our unique gift of communication fans the flames of panic. If the story involves sharks, large snakes, lightning, terrorist attacks, tornados, child abductions, or any other number of incredible events that are almost entirely viewed in movie theaters, we cannot wait to worry about it. But if we are advised to alter the activities in our day-to-day lives of convenience so that we may safeguard our future existence, it will be a hard sell to get us to change.
16. Commonly Dispensed Medications During Pregnancy: Think Twice Before You Prescribe
Antibiotics topped the list of prescription medications among pregnant women on Medicaid, and 42% received category D or X medications
Palmsten K, et al. The Most Commonly Dispensed Prescription Medications Among Pregnant Women Enrolled in the U.S. Medicaid Program. Obstet Gynecol. 2015 Sep;126(3):465-73.
OBJECTIVE: To characterize the 20 most common prescription medications and the 10 most common prescription medications classified in the former U.S. Food and Drug Administration categories D or X dispensed to pregnant women enrolled in the U.S. Medicaid program.
METHODS: We conducted a cohort study of 1,106,757 pregnant women with live births using 2000-2007 Medicaid Analytic eXtract data. We used outpatient pharmacy records to identify medication dispensings and reported the proportion of pregnancies that were dispensed at least one prescription medication. Maternal age and race and ethnicity-stratified estimates were compared using prevalence ratios and 95% confidence intervals (CIs).
RESULTS: During pregnancy, 82.5% of the cohort had a dispensing for one or more prescription medication. The most commonly dispensed medications during pregnancy included nitrofurantoin (21.6%), metronidazole (19.4%), amoxicillin (18.0%), azithromycin (16.9%), and promethazine (13.5%). Proportions were highest among younger women for several medications; eg, nitrofurantoin (23.9% compared with 15.4%; prevalence ratio 1.55, CI 1.52-1.58), metronidazole (20.7% compared with 12.0%; prevalence ratio 1.73, CI 1.69-1.77), and azithromycin (21.1% compared with 11.0%; prevalence ratio 1.93, CI 1.89-1.97) were more common among women younger than 20 years than among women aged 35 years or older. Proportions were highest among white women with some exceptions; eg, compared with white women, metronidazole was more common among black women (29.8% compared with 14.4%; prevalence ratio 2.07, CI 2.05-2.09). Excluding fertility treatments, 42.0% had at least one dispensing for a D or X medication during pregnancy. Codeine (11.9%) and hydrocodone (10.2%) were the most common D medications.
CONCLUSION: Medications used to treat infections were the most commonly dispensed prescription medications. Dispensing of commonly used prescription medications during pregnancy varied by maternal age and race-ethnicity.
17. Brief Lit Reviews
A. Can Transtracheal Ultrasonography Be Used to Verify Endotracheal Tube Placement?
Full-text (free): http://www.annemergmed.com/article/S0196-0644(15)00182-1/fulltext
B. Do patients with a clinically suspected subsegmental PE need anticoagulation therapy?
Answer: Who knows?
Choi H, et al. Emerg Med J 2015;32:744-747
A short cut review was carried out to establish whether the incidence of recurrent venous thromboembolism and mortality is lower among patients with isolated subsegmental pulmonary embolism who are treated with anticoagulant therapy compared with those who are not treated with anticoagulant therapy.
We identified six studies that were directly relevant to the question. All of these studies were observational in nature and included only a small number of patients with isolated subsegmental pulmonary embolism who were not treated with anticoagulants. Of those studies, only two included patients with confirmed isolated subsegmental pulmonary embolism that were not treated with anticoagulation. Among the 47 patients meeting those criteria, no recurrent venous thromboembolism was noted within 3 months. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of these papers are tabulated.
The clinical bottom line is that the limited available evidence suggests that the incident of recurrent venous thromboembolism is very low in patients with isolated subsegmental pulmonary embolism. However, this is based on limited data from small observational studies. Further evidence from larger trials is necessary before a recommendation can be made to withhold anticoagulation in this situation.
18. Using baby oil to remove asphalt from burn.
Nawrocki PS, Thompson H. CJEM. 2015 Aug 3 [Epub ahead of print]
Hot mix asphalt concrete is a composite material composed of asphalt mixed with sand, gravel, or stone aggregate. Informally known as blacktop, tarmac, or just asphalt, it is most commonly used in the construction of road surfaces and roofing after being mixed and heated to between 150°C (302°F) and 190°C (374°F). The hot mix asphalt concrete is either heated at a plant away from the construction site or by a mobile mixer on-site, transported to the desired location, offloaded onto the road surface, compacted with a roller, and allowed to dry. Each step in this process represents a risk to workers as the asphalt remains at a high temperature during the entire process. Not surprisingly, hot asphalt burns affect primarily those in the road construction and roofing industries. A review of the Occupational Safety and Health Administration (OSHA) Accident Investigation Summaries yielded 43 reported “hot asphalt” burns and 41 reported “hot tar” burns since 2003, including several fatalities, although injuries are likely underreported…
A 39-year-old male presented to the emergency department with asphalt burns to both upper extremities following a construction site accident. He had been carrying a bucket of hot asphalt when he tripped and dropped the bucket, splashing the asphalt over him. He presented within 30 minutes of the accident and reported that he could still feel the tar burning him. Both upper extremities were immediately immersed in cold water to cool the asphalt and prevent further thermal injury. Upon surveying the extent of the burn, it was noted that both anterior forearms were affected, and several areas of his face, neck, and shoulders were spattered with asphalt. The burns encompassed approximately 6% of the total body surface area.
Baby oil was directly applied to both upper extremities and the areas of his face, neck, and shoulders that had been splashed. Gauze was then soaked in baby oil and applied to the affected areas. After gently pressing the gauze into the skin and allowing the asphalt to emulsify for several minutes, the gauze was peeled off. This process was then repeated every 5 to 10 minutes, and, at 1 hour, nearly all of the asphalt had been removed. Rubbing of the gauze on skin was avoided to prevent mechanical injury to the damaged skin. Partial thickness (second degree) burns were noted over the anterior right forearm and wrist (Figure 1), where the majority of asphalt was spilled. The areas that had been spattered showed signs of superficial (first degree) burns. Following the removal of all asphalt, the affected areas were covered with a nonadherent dressing. The patient was then referred to a designated burn care facility for further management…
Full-text, link to journal from here (subscription required): http://www.ncbi.nlm.nih.gov/pubmed/26235727
19. Endotracheal intubation versus supraglottic airway placement in out-of-hospital cardiac arrest: A meta-analysis.
Benoit JL, et al. Resuscitation. 2015 Aug;93:20-6.
Objective: Overall survival from out-of-hospital cardiac arrest (OHCA) is less than 10%. After initial bag-valve mask ventilation, 80% of patients receive an advanced airway, either by endotracheal intubation (ETI) or placement of a supraglottic airway (SGA). The objective of this meta-analysis was to compare patient outcomes for these two advanced airway methods in OHCA patients treated by Emergency Medical Services (EMS).
Methods: A dual-reviewer search was conducted in PubMed, Scopus, and the Cochrane Database to identify all relevant peer-reviewed articles for inclusion in the meta-analysis. Exclusion criteria were traumatic arrests, pediatric patients, physician/nurse intubators, rapid sequence intubation, video devices, and older airway devices. Outcomes were (1) return of spontaneous circulation (ROSC), (2) survival to hospital admission, (3) survival to hospital discharge, and (4) neurologically intact survival to hospital discharge. Results were adjusted for covariates when available and combined using the random effects model.
Results: From 3,454 titles, 10 observational studies fulfilled all criteria, representing 34,533 ETI patients and 41,116 SGA patients. Important covariates were similar between groups. Patients who received ETI had statistically significant higher odds of ROSC (odds ratio [OR] 1.28, 95% confidence interval [CI] 1.05–1.55), survival to hospital admission (OR 1.34, CI 1.03–1.75), and neurologically intact survival (OR 1.33, CI 1.09–1.61) compared to SGA. Survival to hospital discharge was not statistically different (OR 1.15, CI 0.97–1.37).
Conclusions: Patients with OHCA who receive ETI by EMS are more likely to obtain ROSC, survive to hospital admission, and survive neurologically intact when compared to SGA.
20. Improving Care for Lesbian, Gay, Bisexual, and Transgender Patients in the ED
Jalali S, et al. Ann Emerg Med. 2015;66: 417–423
Providing quality care in the emergency department (ED) has become more challenging as the patient census becomes increasingly diverse.1 Studies have shown that marginalized populations face greater social inequalities and health disparities, placing them at higher risk for disease burden and death.2 The lesbian, gay, bisexual, and transgender (LGBT) community is no exception.
An estimated 9 million people in the United States identify themselves as LGBT.3 Although the abbreviation “LGBT” serves as a commonly accepted inclusive term, there is significant diversity of sexuality and gender identity within this community. Figure 1 outlines the commonly used LGBT terms, but these are not meant to define a person’s sexual practices or orientation.4, 5 Despite what popular stereotypes tell us, one’s sexual orientation or gender identity is not always evident, and patients often hide this information from providers for fear of discrimination.5, 6
Medical education has proven to be effective in improving providers’ comfort level, attitude, and communication for the care of LGBT patients.7, 8, 9 However, without standards for LGBT health education, providers are often poorly prepared to care for this at-risk population, resulting in patients’ distrust and avoidance in seeking prompt medical care.5 Until recently, there have been no educational guidelines that teach providers how to effectively care for LGBT patients. The ED is a place where all people should feel safe seeking medical care, so having a better understanding of the disparities and health care risks the LGBT patients face may help emergency providers communicate more effectively with these at-risk patients…
Full-text (free): http://www.annemergmed.com/article/S0196-0644(15)00092-X/fulltext
21. Have you heard this one?
A doctor walks into the room and says to his patient, “I’m sorry Mrs Smith, but your test results are back. I have some bad news and some more bad news.”
“Oh, ok. So what’s the bad news?”
“Well, the bad news is that you have cancer.”
“And the more bad news?”
“You also have Alzheimer’s disease.”
Long pause . . .
Then Mrs Smith says, “Well, at least I don’t have cancer.”
I know, I know. It’s …
Source: Mukadam N. BMJ 2015;351:h4592
22. Micro Bits
0. Cave divers uncover new humanlike species in South Africa
Full-text (free): http://elifesciences.org/content/4/e09560
New York Times: http://www.nytimes.com/2015/09/11/science/south-africa-fossils-new-species-human-ancestor-homo-naledi.html
PBS NatGeo Special: http://www.pbs.org/wgbh/nova/evolution/dawn-of-humanity.html
A. More research needed on when to deprescribe heart drugs
Few, if any, clinical studies have focused on when aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors -- and many other drugs -- should be discontinued, according to a review in the Journal of the American College of Cardiology. Long-term prescribing is based on the assumption that benefits persist, but the theory has not been tested and interactions are more likely as patients age and receive more drugs, the authors wrote.
B. Sleep quality, duration tied to cardiovascular risk, study finds
Adults who sleep for five hours or less a night have 50% more coronary artery calcification than those who sleep for seven hours, and those who sleep nine hours or more have 70% more coronary calcium than intermediate sleepers, according to new research. The authors, whose work was published in the journal Arteriosclerosis, Thrombosis and Vascular Biology, found the lowest levels of cardiovascular disease in people who slept seven hours a night and said their sleep quality was good.
C. Surgeon general seeks to make walking a national campaign
The federal government, under a call to action by US Surgeon General Vivek Murthy, is expected to work with schools, nonprofits and the private sector to promote walking. "We've really lost touch with physical activity. It has slowly vanished from the workplace. More and more kids in school don't have time to exercise," Murthy said.
Washington Post: https://www.washingtonpost.com/national/health-science/surgeon-general-to-call-for-national-walking-campaign/2015/09/08/eaac79f6-5665-11e5-b8c9-944725fcd3b9_story.html
D. Acceptability of Uncoated Mini-Tablets in Neonates-A Randomized Controlled Trial.
The administration of uncoated mini-tablets proved to be a valuable alternative to syrup for term neonates. Our data on neonates close the age gap of prior findings in toddlers and infants: uncoated mini-tablets offer the potential of a single formulation for all age groups. These findings further shift the paradigm from liquid toward small-sized solid drug formulations for children of all age groups, as the World Health Organization proposes.
E. CDC Commits $20 Million to Combat Prescription Drug Overdose
F. Medicine's Wild West — Unlicensed Stem-Cell Clinics in the United States
… Stem-cell clinics in the United States and abroad have capitalized on this confusion by selling treatments that are not approved by the Food and Drug Administration (FDA), supported by clinical studies, or covered by insurers.
The FDA has approved few treatments involving stem cells. The approved therapies use hematopoietic stem cells to treat diseases of the blood and immune system. But the majority of therapies offered by stem-cell clinics use adipose-derived stem cells packaged as a product called stromal vascular fraction (SVF). Procedures using SVF have become increasingly popular because of the relative ease of acquiring the cells. To produce SVF, clinics collect liposuction aspirate from a patient, separate the cells from the surrounding fat tissue, and administer the isolated cells back to the patient intravenously or by injection into the tissue to be treated. The stem cells found in SVF are multipotent, and proponents postulate that they may regenerate injured tissue or alter the immune system's inflammatory response. Although the FDA has not determined that SVF is safe or effective in treating any disease, U.S. clinics sell SVF-based procedures to patients with myriad conditions — from benign conditions such as hair loss to chronic and life-threatening diseases such as heart failure, muscular dystrophy, and Parkinson's disease.
These clinics neither claim their treatments are effective nor explicitly state that they're unfounded. Their websites frame their work as experimental — although none of the clinics are conducting FDA-approved clinical trials — and emphasize the potential regenerative capabilities of stem cells. Their language is intentionally imprecise and exploits the vulnerability of patients with debilitating diseases…
Full-text (free) at NEJM: http://www.nejm.org/doi/full/10.1056/NEJMp1504560
G. Survey shows physician concerns over increased use of quality metrics
A survey found about half of primary care physicians said increased emphasis on quality metrics has had a negative impact on quality of care. The report from the Commonwealth Fund and the Kaiser Family Foundation found half of physicians said health IT has a positive effect on patient care, and 47% said new trends in health care have made them consider an earlier retirement.
H. Voluntary Stopping of Eating and Drinking (VSED), Physician-Assisted Death (PAD), or Neither in the Last Stage of Life? Both Should be Available as a Last Resort
Physician experience with the practice: http://www.annfammed.org/content/13/5/421.full
I. Efficacy of common hypertension treatment varies among racial groups
Angiotensin-converting-enzyme inhibitors, widely used in treating hypertension, are less effective in black patients than white patients, according to a study in the Journal of the American College of Cardiology. Black patients treated with ACE inhibitors experienced an 8.7% rate of poor cardiovascular outcomes, compared with 6.4% of white patients. The study follows Joint National Committee recommendations that clinicians choose an alternative to ACE inhibitors for black patients with hypertension.
J. Socioeconomic factors may affect readmission risk, study shows
Patients who have limited incomes, are covered by Medicaid or who did not graduate from high school may be at higher risk for hospital readmission within 30 days, researchers reported in JAMA Internal Medicine. Researchers said the data suggest Medicare readmission penalties may punish hospitals for patient outcomes that are beyond a physician's ability to control.