Friday, June 19, 2015

Lit Bits: June 19, 2015

From the recent medical literature...

1. The Safety and Effectiveness of Droperidol for Sedation of Acute Behavioral Disturbance in the ED.

Calver L, et al. Ann Emerg Med. 2015 Apr 11 [Epub ahead of print]

STUDY OBJECTIVE: We investigate the safety and effectiveness of droperidol for sedation of acute behavioral disturbance in the emergency department (ED).

METHODS: This was a prospective observational study in 6 EDs (August 2009 to April 2013). Adult patients requiring parenteral sedation for acute behavioral disturbance received droperidol 10 mg. If this did not sedate the patient within 15 minutes, further sedation was allowed but droperidol 10 mg was recommended as part of a sedation protocol. The primary outcome was the proportion of patients with an abnormal QT interval, defined by the at-risk line on the QT nomogram. Secondary outcomes were effectiveness determined by the time to sedation measured on the Sedation Assessment Tool, use of additional sedation, adverse events, and injury to staff or patients.

RESULTS: There were 1,009 patients with an ECG performed within 2 hours of droperidol administration, with a median dose of 10 mg (interquartile range [IQR]10 to 17.5 mg). Thirteen of the 1,009 patients had an abnormal QT (1.3%; 95% confidence interval 0.7% to 2.3%), but 7 of these had another cause attributed for prolonged QT (methadone, escitalopram, amiodarone, or preexisting). In 1,403 patients sedated with a median total dose of droperidol of 10 mg (IQR 10 to 20 mg), the median time to sedation was 20 minutes (IQR 10 to 30 minutes) and 97% were sedated within 120 minutes. Additional sedation was required for 435 patients (31.0%; 95% confidence interval 28.6% to 33.5%). Adverse events occurred in 70 patients (5%) and oversedation without complications in 109 (8%), the latter more common for patients receiving benzodiazepines as additional sedation (16/109 [15%]). There were no cases of torsades de pointes. Injuries occurred in 34 staff members and 4 patients.

CONCLUSION: The study supports the use of high-dose droperidol as a safe sedating agent for patients with acute behavioral disturbance in the ED. There is no evidence of increased risk for QT prolongation with the doses used in this study.

2. The Circus Comes to the ED

Baer N. JAMA Intern Med. 2015;175(6):883-884.

This Viewpoint discusses why the presence of reality television cameras in the ED inevitably conflicts with good patient care.

Television cameras have been in the emergency department (ED) ever since ABC News began airing a series of documentaries, such as Boston Med and NY Med, depicting the high-pitched life-and-death drama of saving lives in the ED. Renowned hospitals such as Johns Hopkins, New York–Presbyterian, Brigham and Women’s, Massachusetts General, and Boston Medical Center have welcomed camera crews into their EDs to present the wrenching decisions that physicians and their patients and families must make at the most critical times in their lives.1,2

That makes for great television.

I know. I was a writer and producer on the hit television series ER for its first 7 seasons. We strove to tell emotional stories that we hoped would captivate the audience and, as an added bonus, educate them about disease processes and prevention. But at the end of a shooting day, it was still only make-believe. No one was really hit by a car or a bullet; no life-or-death decisions had to be made in an instant; and no one’s personal tragedy was hung out for all to see.

But the stories on ABC News are not make-believe. They are real. And that is their selling point. But are they truly as “real” as the producers tout them to be?

I am also a documentary filmmaker. I know that the times when I decide to turn on the camera, what I choose to edit in or out, and my very presence filming the subjects all affect the outcome of the film. I look for dramatic moments, and I have found that I encourage them in the questions I ask or in the people I choose to film. Those subjects need to be charismatic to hold the audience’s attention. So it is no surprise, then, that NY Med, a reality medical show produced by ABC, promotes one of the young trauma surgeons as “Dr McDreamy–like” as a nod to its dramatic series, Grey’s Anatomy.

Therein lies the rub. Of course ABC would choose a Dr McDreamy–like surgeon from among all the surgeons at New York–Presbyterian, just as we cast George Clooney on ER to be a pediatrician the viewers would swoon over. It makes for good television. What else makes for good reality television? Dramatic moments. The executive producer of the ABC series echoed this view when he told Capital New York that his goal is to give the viewer “the ‘goodbye’ moment… where a family says goodbye to their loved one going into surgery[. I]f you don’t capture that moment, because a nurse shut the door on your camera’s face, you kill that piece.”3

The point here is that these reality medical series are much like the dramas that I wrote on ER. They are constructed—in their case from thousands of hours of footage, with telegenic physicians taking the viewer through the minefield of the decisions, elations, and tragedies only the ED can provide. I cannot say whether the presence of the camera crew had any impact on the decisions that these physicians made, but I do know that it does affect the participants’ behavior in terms of wanting to look competent and caring. We are human beings. We care about how we are being seen. And we may question our decisions, hesitate or refrain from being who we really are as physicians when the camera is recording our every move.

This raises a broader question. Can filming be done in a manner that does not impinge on a physician’s duty to the patient? Reality television producers will argue affirmatively that as long as informed consent is in place everything is fine.

But can a patient and family truly give consent when they are likely at their most vulnerable? Might they consent only because they do not want to alienate the physicians who are caring for them? Finally, does the benefit to the patient outweigh any possible harm that might come from filming? It is hard to see what benefit comes to a patient when his or her most personal problems are displayed on the television screen.

Reality television producers also argue, and their sentiments are echoed by the chief executive officers of these hospitals, that these shows are educational and therefore that makes them above criticism. Indeed they are educational—no doubt viewers learn a great deal about critical care—but does that make them ethical? Even though the ABC News programs are produced under the news division, they must emotionally resonate with the audience. News shows, too, must deliver ratings; otherwise advertisers will withhold their dollars—which is why the producers look for those “goodbye moments,” which arguably may be in conflict with what is best for the patient.

Am I saying, then, that reality television crews should never be allowed into the ED? Yes. The bottom line is that television journalists and physicians have different agendas. The agenda of television journalists is to tell compelling and dramatic stories; to find the most telegenic physicians; to capture all the messy conflict in the life-and-death decisions being made around the clock. Their agenda conflicts baldly with our duty to our patients. Despite what the executive producer of NY Med claimed, that “[i]n no way will your care be affected one way or another”4 by the presence of camera crews, it cannot possibly be true because the goal of the television journalist is in direct conflict with the duty of the physician to the patient.…

The remainder of the essay (subscription required): http://archinte.jamanetwork.com/article.aspx?articleid=2276927

3. Absence of clinical findings reliably excludes unstable cervical spine injuries in children 5 years or younger.

Hale DF, et al. J Trauma Acute Care Surg. 2015 May;78(5):943-8.

BACKGROUND: Increased accessibility and rapidity of computed tomography (CT) have led to increased use and radiation exposure to pediatric trauma patients. The thyroid is radiosensitive and therefore at risk for developing malignancy from radiation exposure during cervical spine CT. This analysis aimed to determine which preelementary trauma patients warrant cervical spine CT by defining incidence and clinical characteristics of preelementary cervical spine injury.

METHODS: This was a retrospective review of pre-elementary trauma patients from 1998 to 2010 with cervical spine injury admitted to a Level I trauma center. Patients were identified from the trauma registry using DRG International Classification of Diseases-9th Rev. codes and reviewed for demographics, mechanism of injury, clinical presentation, injury location, injury type, treatment, and outcome.

RESULTS: A total of 2,972 preelementary trauma patients were identified. Twenty-two (0.74%) had confirmed cervical spine injuries. Eleven (50%) were boys, and the mean (SD) age was 3 (1.7) years. The most common mechanism of injury was motor vehicle collision (n = 16, 73%). The majority (59%) were in extremis, and 12 (55%) arrived intubated. The median Glasgow Coma Scale (GCS) score was 3 (interquartile range, 3-10); the median Injury Severity Score (ISS) was 33 (interquartile range, 17-56). Nineteen injuries (76%) were at the level of C4 level and higher. The mortality rate was 50%. All patients had clinical findings suggestive of or diagnostic for cervical spine injury; 18 (82%) had abnormal neurologic examination result, 2 (9%) had torticollis, and 2 (9%) had neck pain.

CONCLUSION: The incidence of cervical spine injury in preelementary patients was consistent with previous reports. Missing a cervical spine injury in asymptomatic preelementary patients is extremely low. Reserving cervical spine CT to symptomatic preelementary patients would decrease unnecessary radiation exposure to the thyroid.

Ryan Radecki comments
The Very Young Pediatric C-Spine Rarely Needs Radiologic Clearance

It is usually reasonable to exercise an abundance of caution with trauma patients suspected of having cervical spine injuries.  However, an abundance of caution sometimes means an abundance of radiation – and the costs and harms associated with such testing can be immense, regardless of technical difficulty in a young pediatric population.

This is a retrospective evaluation of 2,972 trauma patients aged less than 5 years, reviewing specifically the overall incidence of diagnosed cervical spine injury.  In this 12 year cohort, a grand total of 22 had confirmed CSI.  Most importantly, however, nearly all cases of CSI were associated with other serious injuries – a cohort with a median ISS of 33.  Twelve of 22 arrived intubated, 13 were in extremis, and overall mortality was 50%.  All evaluable patients had either neurologic deficits, severe neck pain, or were unable to range their neck.

These authors do not further describe their cohort for evaluation with regard to developing a predictive instrument for cervical spine injury, but these data do support a very reasonable conclusion regarding the rarity of pediatric injuries – and the near impossibility of isolated cervical spine injuries.  I tend to agree with the authors’ stated management strategy for such patients:

"Pediatric patients with abnormal neurologic examination result, decreased mental status, neck pain, or torticollis are evaluated with cervical spine CT; however if the child is asymptomatic defined by a normal neurologic examination result, appropriate mental status, with absence of neck pain or torticollis, our first step is to remove the cervical collar. We examine the patient for cervical tenderness if they are able to communicate and observe the child for normal range of motion of the neck. In preverbal patients, we simply observe neck range of motion with the collar removed. If the child seems to move his or her neck without discomfort and full range of motion, then we do not pursue any further radiologic evaluation."

4. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis

Salminen P, et al. JAMA. 2015 Jun 16;313(23):2340-8.

IMPORTANCE: An increasing amount of evidence supports the use of antibiotics instead of surgery for treating patients with uncomplicated acute appendicitis.

OBJECTIVE: To compare antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis confirmed by computed tomography (CT).

DESIGN, SETTING, AND PARTICIPANTS: The Appendicitis Acuta (APPAC) multicenter, open-label, noninferiority randomized clinical trial was conducted from November 2009 until June 2012 in Finland. The trial enrolled 530 patients aged 18 to 60 years with uncomplicated acute appendicitis confirmed by a CT scan. Patients were randomly assigned to early appendectomy or antibiotic treatment with a 1-year follow-up period.

INTERVENTIONS: Patients randomized to antibiotic therapy received intravenous ertapenem (1 g/d) for 3 days followed by 7 days of oral levofloxacin (500 mg once daily) and metronidazole (500 mg 3 times per day). Patients randomized to the surgical treatment group were assigned to undergo standard open appendectomy.

MAIN OUTCOMES AND MEASURES: The primary end point for the surgical intervention was the successful completion of an appendectomy. The primary end point for antibiotic-treated patients was discharge from the hospital without the need for surgery and no recurrent appendicitis during a 1-year follow-up period.

RESULTS: There were 273 patients in the surgical group and 257 in the antibiotic group. Of 273 patients in the surgical group, all but 1 underwent successful appendectomy, resulting in a success rate of 99.6% (95% CI, 98.0% to 100.0%). In the antibiotic group, 70 patients (27.3%; 95% CI, 22.0% to 33.2%) underwent appendectomy within 1 year of initial presentation for appendicitis. Of the 256 patients available for follow-up in the antibiotic group, 186 (72.7%; 95% CI, 66.8% to 78.0%) did not require surgery. The intention-to-treat analysis yielded a difference in treatment efficacy between groups of -27.0% (95% CI, -31.6% to ∞) (P = .89). Given the prespecified noninferiority margin of 24%, we were unable to demonstrate noninferiority of antibiotic treatment relative to surgery. Of the 70 patients randomized to antibiotic treatment who subsequently underwent appendectomy, 58 (82.9%; 95% CI, 72.0% to 90.8%) had uncomplicated appendicitis, 7 (10.0%; 95% CI, 4.1% to 19.5%) had complicated acute appendicitis, and 5 (7.1%; 95% CI, 2.4% to 15.9%) did not have appendicitis but received appendectomy for suspected recurrence. There were no intra-abdominal abscesses or other major complications associated with delayed appendectomy in patients randomized to antibiotic treatment.

CONCLUSIONS AND RELEVANCE: Among patients with CT-proven, uncomplicated appendicitis, antibiotic treatment did not meet the prespecified criterion for noninferiority compared with appendectomy. Most patients randomized to antibiotic treatment for uncomplicated appendicitis did not require appendectomy during the 1-year follow-up period, and those who required appendectomy did not experience significant complications.

Editorial (excerpt)
The majority (73%) of the 257 patients initially treated with antibiotics did not require surgery during the 1-year follow-up period. Of those who did undergo surgery, none had major complications attributable to receiving antibiotics before surgery—dispelling the notion that appendectomy is necessarily an emergency. These findings suggest that for CT-diagnosed uncomplicated appendicitis, an initial trial of antibiotics is reasonable followed by elective appendectomy for patients who do not improve with antibiotics or present with recurrent appendicitis.

As with any study, it is important to understand the patients for whom these findings do not apply. Patients with complicated appendicitis, children, and pregnant women were excluded from this study so the results do not apply to these groups. Because appendicoliths are associated with treatment failure when appendicitis is managed with antibiotics,5 Salminen et al4 excluded patients whose CT scans showed an appendicolith to be present. Thus, the report by Salminen et al4 does provide good evidence that antibiotics may be a reasonable alternative to appendectomy for patients with acute, CT-verified uncomplicated appendicitis.

The study by Salminen et al has several limitations and more research is needed. When future trials are designed of surgery compared with antibiotic treatment of appendicitis, careful consideration of the study design and definition of what represents a clinically important difference needs to be carefully considered. Salminen et al designed their trial as a noninferiority study. Because appendectomy is the commonly accepted treatment for appendicitis, the investigators needed to show that an alternative treatment not involving surgery would not be worse than the currently accepted treatments by some margin. This margin, the minimal clinically important difference, was established somewhat arbitrarily by Salminen et al because little clinical information was available to provide a better estimate for it.

Future studies should be carefully designed with a strong justification for the minimal clinically important difference. Antibiotics with broad enough coverage to treat appendicitis may cause the development of resistant organisms or Clostridium difficile infections. Given the balance between potential complications of antibiotic treatment or appendectomy for appendicitis, is 10% of patients with appendicitis not experiencing successful treatment with antibiotics clinically important? 30%? 50%? Investigators will need to determine and fully justify how much worse than appendectomy antibiotic treatment of appendicitis must be before the notion of replacing appendectomy with antibiotic treatment is rejected.

Because appendectomy is performed to prevent major pelvic infection, the strongest design would be one showing that antibiotics could prevent pelvic abscesses as effectively as surgery. However, because pelvic abscess is infrequent, a trial using this outcome would need to enroll a very large number of patients.

The time has come to consider abandoning routine appendectomy for patients with uncomplicated appendicitis. The operation served patients well for more than 100 years. With development of more precise diagnostic capabilities like CT and effective broad-spectrum antibiotics, appendectomy may be unnecessary for uncomplicated appendicitis, which now occurs in the majority of acute appendicitis cases.

5. Assessing Current Practices in the Evaluation and Treatment of Acute Sinusitis: A Comparison of Primary Care, Urgent Care and ED Care.

Sharp AL, et al. J Patient-Centered Res Rev. 2015;2:136..

Background/Aims: Acute sinusitis (AS) affects 1 in 7 adults and costs over $5.8 billion annually. As part of the American Board of Internal Medicine’s Choosing Wisely campaign, three organizations make recommendations regarding appropriate sinus imaging and antibiotics for uncomplicated AS. The extent to which AS recommendations are followed is unknown; our aim is to measure adherence with recommendations for AS and to compare AS encounters in primary care (PC), urgent care (UC) and emergency (ED) departments.

Methods: A retrospective, observational study of AS care using structured data from electronic health records, complemented by more extensive chart review in a smaller subsample of encounters. All immunocompetent adults with an initial AS encounter (ICD-9 code 461.x) from 2010 to 2012 were included. Primary outcomes (structured data) were filled antibiotic prescriptions and the performance of a face, head or sinus computerized tomography (CT) scan, and secondary outcomes (chart review) were length of symptoms and adherence to AS recommendations.

Results: The median age of patients was 46 (interquartile range: 34–58), 67.5% were female and the mean Elixhauser comorbidity score was 1.5 (±1.6 standard deviation). Of 152,774 AS encounters (77% PC, 22% UC and 1% ED), 89.2% resulted in a filled antibiotic prescription and 1.1% in a CT scan. Compared with the PC setting, UC encounters were more likely to result in antibiotics (adjusted odds ratio [OR]: 1.12, 95% confidence interval [CI]: 1.08–1.17) or obtaining a CT scan (adjusted OR: 2.4, 95% CI: 2.1–2.7, and ED encounters were less likely to result in antibiotics (adjusted OR: 0.57, 95% CI: 0.50–0.65) but more likely to result in a CT scan (adjusted OR: 59.4, 95% CI: 51.3–68.7). Chart review of 300 encounters resulting in antibiotics determined that 50% were for symptoms ≤ 7 days (95% CI: 41–58%) and 35% for symptoms ≥ 14 days (95% CI: 27–44%). Only 29% (95% CI: 22–36%) of encounters resulted in guideline adherent care (30% PC, 26% UC, 16% ED).

Discussion: Among adults with AS in a large, integrated health care system, CT imaging is infrequent but antibiotic treatment is common, even for uncomplicated cases with a short duration of symptoms.

6. More Evidence Supporting Endovascular Therapy for Eligible Pts with Acute Stroke

A. Editorial: Endovascular Therapy for Stroke — It's about Time

Furlan AJ, et al. N Engl J Med 2015; 372:2347-2349

Although many stroke centers worldwide have performed endovascular stroke therapy since the results of the Prolyse in Acute Cerebral Thromboembolism (PROACT) II trial were published in 1999,1 lingering uncertainties about efficacy and the selection of patients created an uneasy equipoise. Especially nettlesome was the uncertain benefit of endovascular therapy as compared with intravenous tissue plasminogen activator (t-PA). The controversy over endovascular therapy was heightened in 2013 when the results of the Interventional Management of Stroke (IMS) III,2 Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE),3 and Local versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS Expansion)4 clinical trials suggested that endovascular therapy was no more effective than intravenous t-PA alone.

Now, in resounding fashion, five randomized clinical trials — the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN),5 the Extending the Time for Thrombolysis in Emergency Deficits — Intra-Arterial (EXTEND-IA) trial,6 the Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial,7 the Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment (SWIFT PRIME) trial,8 and the Randomized Trial of Revascularization with Solitaire FR Device versus Best Medical Therapy in the Treatment of Acute Stroke Due to an Anterior Circulation Large Vessel Occlusion Presenting within Eight Hours of Symptom Onset (REVASCAT),9 the results of the latter two now being published in the Journal — have shown that endovascular therapy is highly beneficial, as compared with intravenous t-PA alone, in patients with occlusions of the intracranial internal carotid artery or middle cerebral artery up to 6 hours after stroke onset. The absolute benefit of endovascular therapy, as compared with intravenous t-PA alone, with regard to an outcome of functional independence at 90 days (defined as a modified Rankin scale score of ≤2, on a scale from 0 [no symptoms] to 6 [death]) ranged from 13.5 to 31 percentage points. This translates into a number needed to treat for benefit as low as three patients and no more than seven patients. There was no significant increase in the rate of symptomatic brain hemorrhage with endovascular therapy in any of the trials…

The rest of the editorial (subscription required): http://www.nejm.org/doi/full/10.1056/NEJMe1503217

B. Stent-Retriever Thrombectomy after Intravenous t-PA vs. t-PA Alone in Stroke

Saver JL, et al; SWIFT PRIME Investigators. N Engl J Med. 2015 Jun 11;372(24):2285-95.

BACKGROUND: Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, less than 40% regain functional independence when treated with intravenous tissue plasminogen activator (t-PA) alone. Thrombectomy with the use of a stent retriever, in addition to intravenous t-PA, increases reperfusion rates and may improve long-term functional outcome.

METHODS: We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone (control group) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset (intervention group). Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions. The primary outcome was the severity of global disability at 90 days, as assessed by means of the modified Rankin scale (with scores ranging from 0 [no symptoms] to 6 [death]).

RESULTS: The study was stopped early because of efficacy. At 39 centers, 196 patients underwent randomization (98 patients in each group). In the intervention group, the median time from qualifying imaging to groin puncture was 57 minutes, and the rate of substantial reperfusion at the end of the procedure was 88%. Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale (P less than 0.001). The rate of functional independence (modified Rankin scale score, 0 to 2) was higher in the intervention group than in the control group (60% vs. 35%, P less than 0.001). There were no significant between-group differences in 90-day mortality (9% vs. 12%, P=0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P=0.12).

CONCLUSIONS: In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days. (Funded by Covidien; SWIFT PRIME ClinicalTrials.gov number, NCT01657461.).

C. Thrombectomy within 8 Hours after Symptom Onset in Ischemic Stroke

Jovin TG, et al. for the REVASCAT Trial Investigators. N Engl J Med 2015; 372:2296-2306

Background
We aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population-based stroke reperfusion registry.

Methods
During a 2-year period at four centers in Catalonia, Spain, we randomly assigned 206 patients who could be treated within 8 hours after the onset of symptoms of acute ischemic stroke to receive either medical therapy (including intravenous alteplase when eligible) and endovascular therapy with the Solitaire stent retriever (thrombectomy group) or medical therapy alone (control group). All patients had confirmed proximal anterior circulation occlusion and the absence of a large infarct on neuroimaging. In all study patients, the use of alteplase either did not achieve revascularization or was contraindicated. The primary outcome was the severity of global disability at 90 days, as measured on the modified Rankin scale (ranging from 0 [no symptoms] to 6 [death]). Although the maximum planned sample size was 690, enrollment was halted early because of loss of equipoise after positive results for thrombectomy were reported from other similar trials.

Results
Thrombectomy reduced the severity of disability over the range of the modified Rankin scale (adjusted odds ratio for improvement of 1 point, 1.7; 95% confidence interval [CI], 1.05 to 2.8) and led to higher rates of functional independence (a score of 0 to 2) at 90 days (43.7% vs. 28.2%; adjusted odds ratio, 2.1; 95% CI, 1.1 to 4.0). At 90 days, the rates of symptomatic intracranial hemorrhage were 1.9% in both the thrombectomy group and the control group (P=1.00), and rates of death were 18.4% and 15.5%, respectively (P=0.60). Registry data indicated that only eight patients who met the eligibility criteria were treated outside the trial at participating hospitals.

Conclusions
Among patients with anterior circulation stroke who could be treated within 8 hours after symptom onset, stent retriever thrombectomy reduced the severity of post-stroke disability and increased the rate of functional independence.

7. ED management of AF/flutter and patient quality of life at one-month post-visit.

Ballard DW, et al. Ann Emerg Med. 2015 May 29 [Epub ahead of print].

Study objective: We identify characteristics of patients with atrial fibrillation or flutter associated with favorable assessments of emergency department (ED) effectiveness and 30-day quality of life.

Methods: As part of a prospective observational study of ED management and short-term outcomes of patients with nonvalvular atrial fibrillation or flutter, we adapted a disease-specific quality-of-life instrument. By telephone, we administered the Atrial Fibrillation Effect on Quality-of-life survey to patients 30 days after an ED visit in which they were treated for newly diagnosed or recent-onset atrial fibrillation or flutter and discharged home. We also asked respondents to rate the effectiveness of ED treatment. Using data prospectively collected in the ED and extracted from electronic health records, we recorded rhythm management (cardioversion attempts and type) and patient and ED treatment characteristics. Using multivariable regression, we examined the association between these characteristics and patient-reported effectiveness of ED treatment (“very effective” or not) and any atrial fibrillation or flutter quality-of-life effect.

Results: Six hundred fifty-two eligible ED patients (response rate 89%) treated between May 2011 and November 2012 completed follow-up. Of these patients, 454 (69.6%) reported that their ED treatment was “very effective” and 113 (17.3%) reported no quality-of-life influence. In multivariable analyses, there was an association between ED electrocardioversion and perceived ED effectiveness (P less than .05) but none between treatment strategy and 30-day atrial fibrillation or flutter quality-of-life score. Respondents who were younger, women, and had worse pre-ED self-reported health (P less than .05) were more likely to report a quality-of-life effect.

Conclusion: In this observational study, ED rhythm management strategy was associated with greater perceived effectiveness of the ED visit but not with a difference in 30-day quality-of-life score.

8. No Place to Call Home — Policies to Reduce ED Use in Medicaid

Friedman AB, et al. N Engl J Med 2015; 372:2382-2385

One goal of Medicaid expansion under the Affordable Care Act (ACA) is to provide low-income, medically vulnerable adults with a source of care outside the emergency department (ED) and the means to pay for that care. Yet Medicaid expansion alone may not reduce ED use among new enrollees. Although some research suggests that Medicaid coverage is associated with reduced ED use, a lottery-based, controlled study from Oregon found that newly enrolled beneficiaries actually increased their ED use, at least temporarily.1 This finding is not surprising, since health insurance reduces financial barriers to being seen promptly, and the newly enrolled Medicaid population has pent-up demand for care and a high burden of chronic disease. Although the contribution of ED use to cost growth is sometimes exaggerated, it remains a substantial source of health care costs, representing at least 5 to 6% of U.S. health expenditures.2 Medicaid alone spends $23 billion to $47 billion annually on ED care,2 and some of the sickest Medicaid enrollees are seen in the ED.

Broadly speaking, two approaches have been proposed for reducing use of the ED in this population. One focuses on making the ED more costly for patients to use; the other, on creating more robust alternatives to the ED. Although not incompatible, these approaches reflect different beliefs about why Medicaid beneficiaries use the ED for medical issues that could potentially be addressed elsewhere.

By imposing steep copayments for certain ED visits, the first approach aims to place responsibility on beneficiaries to make vigilant choices about when medical issues require emergency attention. For instance, as part of its ACA Medicaid expansion, Indiana was granted permission by the Centers for Medicare and Medicaid Services (CMS) to undertake a demonstration project involving charging Medicaid recipients — many of whom have family incomes below the federal poverty level — $8 for their first visit to the ED and $25 for subsequent visits during the same year. The copayment applies when the visit is determined to be for “nonemergency” care, the patient did not receive prior authorization from his or her managed-care organization, or the emergency provider informed the patient that the problem could be managed in another setting.

The logic behind increasing cost sharing for “nonemergency” ED visits is that it will motivate patients to use lower-cost care sites for most conditions, reserving the ED for times when they truly need immediate attention. This simple narrative, however, is challenged by research. States have had the option since 2005 of imposing copayments for Medicaid beneficiaries of up to $15 for nonemergency ED use, yet the eight states that implemented these programs saw no reduction in ED visits by Medicaid recipients relative to other states.3 Case studies of Medicaid cost sharing in other contexts similarly found that copayments alone do not reduce ED visits for diseases that can safely be treated in primary care settings. Analyses that have shown associations between copayments and reductions in “unnecessary” ED use are limited by their use of diagnosis or triage codes to determine retrospectively whether a visit qualifies as “nonurgent.”

One explanation for these findings is that even informed patients cannot necessarily translate their symptoms and history into a diagnosis, much less a prognosis. Patients present to the ED with symptoms that may signal an emergency, such as chest pain, and clinicians are able to rule out an emergency only after performing an evaluation and diagnostic tests. Indeed, 88% of all visits that are retrospectively determined to be for “nonemergency” (primary care treatable) diagnoses cannot be distinguished from true emergencies at the time of admission on the basis of the patient's chief complaint.4 It is neither ethical nor prudent for clinicians to withhold care until they can determine whether a case is an emergency — and at that point opportunities for cost savings through diversion from the ED would probably be minimal.

Instead of requiring Medicaid patients to pay for a portion of their ED care, some states are trying to provide them with better alternatives to the ED. This strategy requires that beneficiaries have access to a primary care provider who can help prevent exacerbations of chronic illnesses such as asthma that might otherwise lead to acute crises. Well-managed systems can also provide prompt appointments to patients with time-sensitive health concerns that are not necessarily emergencies — such as a persistent, moderate headache that does not get better with over-the-counter medications.

At the core of this alternative approach to reducing ED visits are key components of the patient-centered medical home model, including care coordination, case management, extended hours, and walk-in visits. Medical-home initiatives emphasize prevention and post-acute care, and preliminary studies have shown these models to be effective in reducing ED use among Medicaid beneficiaries.5 The ACA includes an optional program that gives states additional funding to support providers that develop “health homes” for Medicaid beneficiaries with multiple chronic physical conditions or severe mental illness. The program has been adopted by 16 states to date…

The remainder of the essay (subscription required): http://www.nejm.org/doi/full/10.1056/NEJMp1502627

9. Ondansetron in pregnancy is not associated with any risk of adverse fetal outcomes.

Pasternak B, et al. N Engl J Med. 2013;368(9):814-23.

[The results of this well-done study contradict those of the lower quality piece by Danielsson B, et al. in Repro Tox 2014: http://www.ncbi.nlm.nih.gov/pubmed/25450422]

BACKGROUND: Ondansetron is frequently used to treat nausea and vomiting during pregnancy, but the safety of this drug for the fetus has not been well studied.

METHODS: We investigated the risk of adverse fetal outcomes associated with ondansetron administered during pregnancy. From a historical cohort of 608,385 pregnancies in Denmark, women who were exposed to ondansetron and those who were not exposed were included, in a 1:4 ratio, in propensity-score-matched analyses of spontaneous abortion (1849 exposed women vs. 7396 unexposed women), stillbirth (1915 vs. 7660), any major birth defect (1233 vs. 4932), preterm delivery (1792 vs. 7168), and birth of infants at low birth weight and small for gestational age (1784 vs. 7136). In addition, estimates were adjusted for hospitalization for nausea and vomiting during pregnancy (as a proxy for severity) and the use of other antiemetics.

RESULTS: Receipt of ondansetron was not associated with a significantly increased risk of spontaneous abortion, which occurred in 1.1% of exposed women and 3.7% of unexposed women during gestational weeks 7 to 12 (hazard ratio, 0.49; 95% confidence interval [CI], 0.27 to 0.91) and in 1.0% and 2.1%, respectively, during weeks 13 to 22 (hazard ratio, 0.60; 95% CI, 0.29 to 1.21). Ondansetron also conferred no significantly increased risk of stillbirth (0.3% for exposed women and 0.4% for unexposed women; hazard ratio, 0.42; 95% CI, 0.10 to 1.73), any major birth defect (2.9% and 2.9%, respectively; prevalence odds ratio, 1.12; 95% CI, 0.69 to 1.82), preterm delivery (6.2% and 5.2%; prevalence odds ratio, 0.90; 95% CI, 0.66 to 1.25), delivery of a low-birth-weight infant (4.1% and 3.7%; prevalence odds ratio, 0.76; 95% CI, 0.51 to 1.13), or delivery of a small-for-gestational-age infant (10.4% and 9.2%; prevalence odds ratio, 1.13; 95% CI, 0.89 to 1.44).

CONCLUSIONS: Ondansetron taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes.


10. ED Bounce Backs: A Multistate Analysis and a Single-center Patient Survey

A. Revisit rates and associated costs after an ED encounter: a multistate analysis.

Duseja R, et al. Ann Intern Med. 2015 Jun 2;162(11):750-6.

BACKGROUND: Return visits to the emergency department (ED) or hospital after an index ED visit strain the health system, but information about rates and determinants of revisits is limited.

OBJECTIVE: To describe revisit rates, variation in revisit rates by diagnosis and state, and associated costs.

DESIGN: Observational study using the Healthcare Cost and Utilization Project databases.

SETTING: 6 U.S. states.

PATIENTS: Adults with ED visits between 2006 and 2010.

MEASUREMENTS: Revisit rates and costs.

RESULTS: Within 3 days of an index ED visit, 8.2% of patients had a revisit; 32% of those revisits occurred at a different institution. Revisit rates varied by diagnosis, with skin infections having the highest rate (23.1% [95% CI, 22.3% to 23.9%]). Revisit rates also varied by state. For skin infections, Florida had higher risk-adjusted revisit rates (24.8% [CI, 23.5% to 26.2%]) than Nebraska (10.6% [CI, 9.2% to 12.1%]). In Florida, the only state with complete cost data, total revisit costs for the 19.8% of patients with a revisit within 30 days were 118% of total index ED visit costs for all patients (including those with and without a revisit).

LIMITATION: Whether a revisit reflects inadequate access to primary care, a planned revisit, the patient's nonadherence to ED recommendations, or poor-quality care at the initial ED visit remains unknown.

CONCLUSION: Revisits after an index ED encounter are more frequent than previously reported, in part because many occur outside the index institution. Among ED patients in Florida, more resources are spent on revisits than on index ED visits.

B. Emergency Department Bouncebacks: Is Lack of Primary Care Access the Primary Cause?

Moskovitz JB, et al. J Emerg Med. 2015;49:70-77.  

BACKGROUND: National emergency department (ED) bounceback rates within 30 days of previous ED discharge have been found to be as high as 26%. We hypothesize that having a primary care physician (PCP) would prevent bouncebacks to the ED because a patient would have a medical resource for follow-up and continued care.

METHODS: We performed a prospective, consecutive, anonymous survey study of adult ED patients at a suburban teaching hospital with 88,000 visits annually, from July 5, 2011 through August 8, 2011. Using chi-squared and Fisher's exact tests, we compared patients with an initial visit to those returning within 30 days of a previous visit to our ED.

RESULTS: We collected 1084 surveys. Those in the bounceback group were more likely to have no insurance (10.2% vs. 4.4%) or Medicaid (17.7% vs. 10.8%) and less likely to have a PCP (79% vs. 86%). Of those with a PCP, 9% in both groups had seen their PCP that day, 58% (initial visit) and 49% (bouncebacks) could have been seen that day, and 35% & 36%, respectively, within 1 week. Of those with a PCP, 38% of initial visits and 32% of bouncebacks stated they had already seen their physician at least once.

CONCLUSION: Our results suggest that patients who bounce back to the ED might have already contacted their PCP. Although insurance status and the lack thereof predict a higher likelihood to bounce back to the ED, many bouncebacks are insured patients with PCPs able to be seen the same day.

11. Syncope in the Pediatric ED – Can We Predict Cardiac Disease Based on History Alone?

Hurst D, et el. J Emerg Med 2015;49:1–7

Background
The American Heart Association recommends a “meticulous history” when evaluating patients with an initial episode of syncope. However, little is known about which historical features are most helpful in identifying children with undiagnosed cardiac syncope.

Objectives
Our objectives were 1) to describe the cardiac disease burden in Emergency Department (ED) syncope presentations, and 2) to identify which historical features are associated with a cardiac diagnosis.

Methods
Using syncope presentations in our ED between May 1, 2009 and February 28, 2013, we 1) performed a cross-sectional study describing the burden of cardiac syncope, and 2) determined the sensitivity and specificity of four historical features identifying cardiac syncope.

Results
Of 3445 patients, 44.5% were male presenting at 11.5 ± 4.5 years of age. Of patients with a cardiac diagnosis (68, 2%), only 3 (0.09%) were noted to have a previously undiagnosed cardiac cause of syncope: 2 with supraventricular tachycardia and 1 with myocarditis. Among the three cases and 100 randomly selected controls, the respective sensitivity and specificity of the historical features were 67% and 100% for syncope with exercise, 100% and 98% for syncope preceded by palpitations, and 67% and 70% for syncope without prodrome. The presence of at least two features yielded a sensitivity of 100% and specificity of 100%.

Conclusions
Our study, which represents the largest published series of pediatric syncope presenting to the ED, confirms that newly diagnosed cardiac causes of syncope are rare. Using a few specific historical features on initial interview can help guide further work-up more precisely.

12. Early Bystander CPR in Out-of-Hospital Cardiac Arrest Saves Lives

Hasselqvist-Ax I, et al. N Engl J Med 2015; 372:2307-2315

Background
Three million people in Sweden are trained in cardiopulmonary resuscitation (CPR). Whether this training increases the frequency of bystander CPR or the survival rate among persons who have out-of-hospital cardiac arrests has been questioned.

Methods
We analyzed a total of 30,381 out-of-hospital cardiac arrests witnessed in Sweden from January 1, 1990, through December 31, 2011, to determine whether CPR was performed before the arrival of emergency medical services (EMS) and whether early CPR was correlated with survival.

Results
CPR was performed before the arrival of EMS in 15,512 cases (51.1%) and was not performed before the arrival of EMS in 14,869 cases (48.9%). The 30-day survival rate was 10.5% when CPR was performed before EMS arrival versus 4.0% when CPR was not performed before EMS arrival (P less than 0.001). When adjustment was made for a propensity score (which included the variables of age, sex, location of cardiac arrest, cause of cardiac arrest, initial cardiac rhythm, EMS response time, time from collapse to call for EMS, and year of event), CPR before the arrival of EMS was associated with an increased 30-day survival rate (odds ratio, 2.15; 95% confidence interval, 1.88 to 2.45). When the time to defibrillation in patients who were found to be in ventricular fibrillation was included in the propensity score, the results were similar. The positive correlation between early CPR and survival rate remained stable over the course of the study period. An association was also observed between the time from collapse to the start of CPR and the 30-day survival rate.

Conclusions
CPR performed before EMS arrival was associated with a 30-day survival rate after an out-of-hospital cardiac arrest that was more than twice as high as that associated with no CPR before EMS arrival.

13. Vancomycin Use in Patients Discharged From the ED: A Retrospective Observational Cohort Study

Mueller K, et al. J Emerg Med. 2015;49:50-57.

Background
Infections due to methicillin-resistant Staphylococcus aureus (MRSA) are associated with significant morbidity and mortality and are typically treated with intravenous vancomycin. Given vancomycin's time-dependent mechanism of action, it is unlikely that vancomycin administration in the emergency department (ED) prior to disposition home could be beneficial.

Study Objectives
To characterize the indications, dosing, and appropriateness of vancomycin use in patients discharged from the ED.

Methods
This is a single-center retrospective observational cohort study of patients who received vancomycin in an urban, academic, tertiary care ED. The subjects were consecutive adult patients administered intravenous vancomycin in the ED and then discharged home over an 18-month period. Outcomes were measured 1) to characterize patients receiving vancomycin prior to discharge home from the ED; and 2) to identify patients that did not meet indications for appropriate use based on the 2011 Infectious Diseases Society of America guidelines for treating MRSA infections.

Results
There were 526 patients that received vancomycin in the ED prior to discharge during the study period. In this cohort, 368 (70%) patients were diagnosed with skin and soft tissue infections. A MRSA risk factor was present in 396 (75%) patients. Prior to discharge, one dose of vancomycin was administered to 357 (68%) patients. Underdosing of vancomycin occurred in 239 (73%) patients.

Conclusions
Vancomycin was given frequently to patients discharged home from the ED, most commonly for conditions where vancomycin was not indicated, such as skin and soft tissue infections. The majority of these patients received a vancomycin dosing strategy that is not only unlikely to lead to clinical improvement, but also has the potential to contribute adversely to the development of antibiotic resistance. Further investigation is needed into the impact of vancomycin use, the emergence of vancomycin resistance, and the role of ED-based antibiotic stewardship.

14. Tendon Rupture Associated With Excessive Smartphone Gaming 

Gilman L, et al. JAMA Intern Med. 2015;175(6):1048-1049.

Importance:  Excessive use of smartphones has been associated with injuries.

Observations:  A 29-year-old, right hand–dominant man presented with chronic left thumb pain and loss of active motion from playing a Match-3 puzzle video game on his smartphone all day for 6 to 8 weeks. On physical examination, the left extensor pollicis longus tendon was not palpable, and no tendon motion was noted with wrist tenodesis. The thumb metacarpophalangeal range of motion was 10° to 80°, and thumb interphalangeal range of motion was 30° to 70°. The clinical diagnosis was rupture of the left extensor pollicis longus tendon. The patient subsequently underwent an extensor indicis proprius (1 of 2 tendons that extend the index finger) to extensor pollicis longus tendon transfer. During surgery, rupture of the extensor pollicis longus tendon was seen between the metacarpophalangeal and wrist joints.

Conclusions and Relevance:  The potential for video games to reduce pain perception raises clinical and social considerations about excessive use, abuse, and addiction. Future research should consider whether pain reduction is a reason some individuals play video games excessively, manifest addiction, or sustain injuries associated with video gaming.

15. Comparative risk of GI bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study.

Abraham NS, et al. BMJ. 2015;350:h1857.

OBJECTIVE: To determine the real world risk of gastrointestinal bleeding associated with the use of the novel oral anticoagulants dabigatran and rivaroxaban compared with warfarin.

DESIGN: Retrospective, propensity matched cohort study.

SETTING: Optum Labs Data Warehouse, a large database including administrative claims data on privately insured and Medicare Advantage enrollees.

PARTICIPANTS: New users of dabigatran, rivaroxaban, and warfarin from 1 November 2010 to 30 September 2013.

MAIN OUTCOME MEASURES: Incidence rates (events/100 patient years) and propensity score matched Cox proportional hazards models were used to estimate rates of total gastrointestinal bleeds, upper gastrointestinal bleeds, and lower gastrointestinal bleeds for the novel oral anticoagulants compared with warfarin in patients with and without atrial fibrillation. Heterogeneity of treatment effect related to age was examined using a marginal effects model.

RESULTS: The incidence of gastrointestinal bleeding associated with dabigatran was 2.29 (95% confidence interval 1.88 to 2.79) per 100 patient years and that associated with warfarin was 2.87 (2.41 to 3.41) per 100 patient years in patients with atrial fibrillation. In non-atrial fibrillation patients, the incidence of gastrointestinal bleeding was 4.10 (2.47 to 6.80) per 100 patient years with dabigatran and 3.71 (2.16 to 6.40) per 100 patient years with warfarin. With rivaroxaban, 2.84 (2.30 to 3.52) gastrointestinal bleeding events per 100 patient years occurred in atrial fibrillation patients (warfarin 3.06 (2.49 to 3.77)/100 patient years) and 1.66 (1.23 to 2.24) per 100 patient years in non-atrial fibrillation patients (warfarin 1.57 (1.25 to 1.99)/100 patient years). In propensity score matched models, the risk of gastrointestinal bleeding with novel oral anticoagulants was similar to that with warfarin in atrial fibrillation patients (dabigatran v warfarin, hazard ratio 0.79 (0.61 to 1.03); rivaroxaban v warfarin, 0.93 (0.69 to 1.25)) and in non-AF patients (dabigatran v warfarin, hazard ratio 1.14 (0.54 to 2.39); rivaroxaban v warfarin, 0.89 (0.60 to 1.32)). The risk of gastrointestinal bleeding increased after age 65, such that by age 76 the risk exceeded that with warfarin among atrial fibrillation patients taking dabigatran (hazard ratio 2.49 (1.61 to 3.83)) and patients with and without atrial fibrillation taking rivaroxaban (2.91 (1.65 to 4.81) and 4.58 (2.40 to 8.72), respectively).

CONCLUSIONS: The risk of gastrointestinal bleeding related to novel oral anticoagulants was similar to that for warfarin. Caution should be used when prescribing novel oral anticoagulants to older people, particularly those over 75 years of age.

16. Efficacy of an Acute Pain Titration Protocol Driven by Patient Response to a Simple Query: “Do You Want More Pain Medication?”

Chang AK, et al. Ann Emerg Med. 2015 June 11 [Epub ahead of print]

Study objective
We assess the efficacy of a simple pain titration protocol of 1-mg increments of intravenous hydromorphone, given at fixed intervals, driven solely by patient response to a yes/no question.

Methods
This was a prospective interventional cohort study of nonelderly adults with acute severe pain defined as requiring intravenous opioids in the judgment of the attending emergency physician. All patients received 1 mg intravenous hydromorphone and 30 minutes later were asked, “Do you want more pain medication?” Patients responding yes received an additional 1 mg of intravenous hydromorphone and were asked the same question 30 minutes after receiving it. Those responding no did not receive additional opioid and were asked the question again 30 minutes later. Each patient was queried 4 times. The primary endpoint was the proportion of patients achieving satisfactory pain control, defined as declining additional pain medication on 1 or more occasions.

Results
Of 215 patients enrolled, there were 8 protocol violations, leaving 207 patients with analyzable data; 205 of 207 patients (99%; 95% confidence interval 97% to 100%) achieved satisfactory analgesia at 1 or more points during the study. Nine patients desaturated below 95% on room air, 2 had respiratory rates less than 10 breaths/min, and 2 had pulse rates less than 50 beats/min. No adverse events were associated with amount of hydromorphone received.

Conclusion
A pain protocol, based on titration of 1 mg intravenous hydromorphone, driven solely by patient response to a simple standardized question repeated at intervals, resulted in achievement of satisfactory analgesia on at least 1 occasion in 99% of patients.

17. Common Diagnoses and Outcomes in Elderly Patients Who Present to the ED with Non-Specific Complaints

Quinna K, et al. CJEM. 11 June 2015 [Epub ahead of print]

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.

18. Medical expulsive therapy in adults with ureteric colic [is bunk!]: a multicentre, randomised, placebo-controlled trial.

Pickard R, et al. Lancet. 2015 May 18. [Epub ahead of print]

BACKGROUND: Meta-analyses of previous randomised controlled trials concluded that the smooth muscle relaxant drugs tamsulosin and nifedipine assisted stone passage for people managed expectantly for ureteric colic, but emphasised the need for high-quality trials with wide inclusion criteria. We aimed to fulfil this need by testing effectiveness of these drugs in a standard clinical care setting.

METHODS: For this multicentre, randomised, placebo-controlled trial, we recruited adults (aged 18-65 years) undergoing expectant management for a single ureteric stone identified by CT at 24 UK hospitals. Participants were randomly assigned by a remote randomisation system to tamsulosin 400 μg, nifedipine 30 mg, or placebo taken daily for up to 4 weeks, using an algorithm with centre, stone size (≤5 mm or over 5 mm), and stone location (upper, mid, or lower ureter) as minimisation covariates. Participants, clinicians, and trial personnel were masked to treatment assignment. The primary outcome was the proportion of participants who did not need further intervention for stone clearance within 4 weeks of randomisation, analysed in a modified intention-to-treat population defined as all eligible patients for whom we had primary outcome data. This trial is registered with the European Clinical Trials Database, EudraCT number 2010-019469-26, and as an International Standard Randomised Controlled Trial, number 69423238.

FINDINGS: Between Jan 11, 2011, and Dec 20, 2013, we randomly assigned 1167 participants, 1136 (97%) of whom were included in the primary analysis (17 were excluded because of ineligibility and 14 participants were lost to follow-up). 303 (80%) of 379 participants in the placebo group did not need further intervention by 4 weeks, compared with 307 (81%) of 378 in the tamsulosin group (adjusted risk difference 1·3% [95% CI -5·7 to 8·3]; p=0·73) and 304 (80%) of 379 in the nifedipine group (0·5% [-5·6 to 6·5]; p=0·88). No difference was noted between active treatment and placebo (p=0·78), or between tamsulosin and nifedipine (p=0·77). Serious adverse events were reported in three participants in the nifedipine group (one had right loin pain, diarrhoea, and vomiting; one had malaise, headache, and chest pain; and one had severe chest pain, difficulty breathing, and left arm pain) and in one participant in the placebo group (headache, dizziness, lightheadedness, and chronic abdominal pain).

INTERPRETATION: Tamsulosin 400 μg and nifedipine 30 mg are not effective at decreasing the need for further treatment to achieve stone clearance in 4 weeks for patients with expectantly managed ureteric colic.

19. A Review of Lawsuits Related to Point-of-care Emergency US Applications

Stolz L, et al. Western J Emerg Med. 2015;16(1):1-4.

Introduction New medical technology brings the potential of lawsuits related to the usage of that new technology. In recent years the use of point-of-care (POC) ultrasound has increased rapidly in the emergency department (ED). POC ultrasound creates potential legal risk to an emergency physician (EP) either using or not using this tool. The aim of this study was to quantify and characterize reported decisions in lawsuits related to EPs performing POC ultrasound.

Methods We conducted a retrospective review of all United States reported state and federal cases in the Westlaw database. We assessed the full text of reported cases between January 2008 and December 2012. EPs with emergency ultrasound fellowship training reviewed the full text of each case. Cases were included if an EP was named, the patient encounter was in the emergency department, the interpretation or failure to perform an ultrasound was a central issue and the application was within the American College of Emergency Physician (ACEP) ultrasound core applications. In order to assess deferred risk, cases that involved ultrasound examinations that could have been performed by an EP but were deferred to radiology were included.

Results We identified five cases. All reported decisions alleged a failure to perform an ultrasound study or a failure to perform it in a timely manner. All studies were within the scope of emergency medicine and were ACEP emergency ultrasound core applications. A majority of cases (n=4) resulted in a patient death. There were no reported cases of failure to interpret or misdiagnoses.

Conclusion In a five-year period from January 2008 through December 2012, five malpractice cases involving EPs and ultrasound examinations that are ACEP core emergency ultrasound applications were documented in the Westlaw database. All cases were related to failure to perform an ultrasound study or failure to perform a study in a timely manner and none involved failure to interpret or misdiagnosis when using of POC ultrasound.


20. Some benefits of reading good fiction

Here’s a little 5-minute British video by practical philosopher and educator Alain de Botton that articulates a number of reasons why so many of us find good novels not just entertaining but also enlightening and in some small way transforming:  http://youtu.be/4RCFLobfqcw
  • Good fiction saves time by serving as a reality simulator, helping us accrue wisdom from others’ experiences
  • It makes us nicer by cultivating empathy (especially for outgroups that we might not otherwise engage with)
  • It cures a sense of isolation by helping us reframe our sense of ‘normal’ by discovering that others share our doubts and dreams, fears and fantasies
  • It prepares us for failure by understanding the complex contradictions of human nature and our all-too-common moral shortcomings (in contrast to the harsh monochromatic criticism characteristic of the media)

De Botton is a brilliant polymath whose insights I have enjoyed over the years—mostly from his non-fiction work, though he started his writing career with a fictional piece undertaken on the side (!) during his doctoral studies (of French philosophy). The first book sold over 2 million copies, so he dropped out of Harvard to pursue a writing career. Good career move.  

21. Micro Bits

A. Podcast Review of Thyroid Storm

Via EM CRIT via EM RAP


B. Supplemental Temporary IVC Filters No Help in Anticoagulated PE Patients

No reduction in recurrence or mortality in randomized study.


C. Eleanor Roosevelt's last days: A bioethical case study

When Eleanor Roosevelt died in 1962, she was widely regarded as "the greatest woman in the world." Despite her celebrity, or more likely because of it, she had to endure a prolonged period of intense suffering and humiliation before dying, which was due in large part to her medical care. Her case reveals a great deal about the evolution of the bioethics of dying and concepts of end-of-life care in America.


D. Metabolic syndrome affects 35% of U.S. adults, study finds

Metabolic syndrome, a combination of health conditions including hypertension, waist measurements, high blood sugar and irregular cholesterol, is a key sign of heart disease and diabetes risk, according to a study in the Journal of the American Medical Association. Researchers found that in 2011 to 2012, 35% of adult Americans had metabolic syndrome. Among people 60 years old and older, 47% of people had metabolic syndrome, while 18% between ages 20 to 39 had the condition.


E. Report estimates 10% of children are diagnosed with ADHD

A report from the CDC says that 1 in 10 children and teenagers has been diagnosed with attention-deficit/hyperactivity disorder. Boys are diagnosed at about double the rate of girls. Hispanic children and teens are the least likely to be diagnosed with ADHD, and children from more affluent families are less likely to have an ADHD diagnosis than children from lower-income families.


F. Conditioned analgesia from known placebo

Belief in effective placebo treatment is widely thought to be critical for placebo analgesia. Many placebo responses appear to be mediated by expectations that are strengthened as treatment cues are reinforced with positive outcomes. Yet placebo effects may occur even when participants know they are receiving placebo. Can conditioned placebo analgesia persist in the absence of expectations? This report studied long (four days) vs. short (one day) conditioning to placebo treatment. After an initial placebo test, a "reveal" manipulation convincingly showed participants they had never received an active drug. Placebo analgesia persisted after the reveal in the long conditioning group only.


G. Concussion may affect children's academic performance

Researchers followed 349 students, ages 5 to 18, who had a concussion and found that 77% of those still recovering had difficulty taking notes and took longer to complete homework, while 88% experienced fatigue, headaches, had problems concentrating or found it difficult to understand lessons. The findings, published in Pediatrics, also showed students with severe head injuries were more likely to have the most academic problems.


H. Searching for Joy in Residency by Listening to Our Patients

Charlton B, et al. JAMA Intern Med 2015 June 08 [Epub ahead of print].

As medical trainees, we have come to appreciate that today’s health care systems can be chaotic, fragmented, and filled with menial administrative tasks—in short, often joyless. Recently, Sinsky et al1 argued that such joylessness is one reason why fewer trainees choose primary care and why seasoned primary care physicians are leaving the field in droves. To re-instill joy, those authors proposed practice transformation—team-based care, pre-visit planning, scribes—to return “healing relationships with patients” to the center of outpatient medicine. These ideas inspired us to ask a similar question: how can we find joy in residency training? Some aspects of residency are joyless: sleep deprivation, difficulty seeing our loved ones, anxiety about knowing enough medicine, and doubts about clinical decisions made in the middle of the night. However, like Sinsky et al1 suggest, we have found healing relationships with patients to be often joyful and always reinvigorating. Cultivating such relationships means developing practical strategies that allow us to listen generously and communicate compassionately despite the many demands on our time…


I. Outcomes of ED thoracotomy in a tertiary care Canadian trauma centre

Survival following an EDT in our small, regional trauma centre is consistent with survival rates from larger published datasets. An EDT should continue to be performed under accepted clinical indications.


J. Kidney function and the use of nitrofurantoin to treat UTI in older women

Background: The antibiotic nitrofurantoin is commonly used to treat uncomplicated urinary tract infections. However, when this drug is used by patients with reduced kidney function, its urine concentration may be subtherapeutic.

Conclusion: In this study, the presence of mild or moderate reductions in estimated glomerular filtration rate did not justify avoidance of nitrofurantoin.


K. Methicillin-resistant Staphylococcus Aureus Lip Infection Mimicking Angioedema


L. Faculty Prediction of In-Training Examination Scores of EM Residents: A Multicenter Study


M. Fecal transplants effective in 85% of patients with recurrent C. diff infection

A review study funded by the Department of Veterans Affairs found fecal transplantation successfully treated recurrent Clostridium difficile infection in 85% of cases and helped 55% of patients who did not respond to drugs. Researchers said, however, the available data is "low strength" and is inadequate to draft guidelines for determining ideal donors, identifying fecal preparation methods or recommending the best way to deliver the stool to patients.