1. Off-hour presentation and outcomes in patients with acute
myocardial infarction: systematic review and meta-analysis
Sorita A,
et al. BMJ 2014;348:f7393
Objective
To assess the association between off-hour (weekends and nights) presentation,
door to balloon times, and mortality in patients with acute myocardial
infarction.
Data
sources Medline in-process and other non-indexed citations, Medline, Embase,
Cochrane Database of Systematic Reviews, and Scopus through April 2013.
Study
selection Any study that evaluated the association between time of presentation
to a healthcare facility and mortality or door to balloon times among patients
with acute myocardial infarction was included.
Data
extraction Studies’ characteristics and outcomes data were extracted. Quality
of studies was assessed with the Newcastle-Ottawa scale. A random effect
meta-analysis model was applied. Heterogeneity was assessed using the Q
statistic and I2.
Results 48
studies with fair quality, enrolling 1 896 859 patients, were included in the
meta-analysis. 36 studies reported mortality outcomes for 1 892 424 patients
with acute myocardial infarction, and 30 studies reported door to balloon times
for 70 534 patients with ST elevation myocardial infarction (STEMI). Off-hour
presentation for patients with acute myocardial infarction was associated with
higher short term mortality (odds ratio 1.06, 95% confidence interval 1.04 to
1.09). Patients with STEMI presenting during off-hours were less likely to
receive percutaneous coronary intervention within 90 minutes (odds ratio 0.40,
0.35 to 0.45) and had longer door to balloon time by 14.8 (95% confidence
interval 10.7 to 19.0) minutes. A diagnosis of STEMI and countries outside
North America were associated with larger increase in mortality during
off-hours. Differences in mortality between off-hours and regular hours have
increased in recent years. Analyses were associated with statistical
heterogeneity.
Conclusion
This systematic review suggests that patients with acute myocardial infarction
presenting during off-hours have higher mortality, and patients with STEMI have
longer door to balloon times. Clinical performance measures may need to account
for differences arising from time of presentation to a healthcare facility.
2. ER Briefs: Open Season on ACEP tPA Guidelines
By Elbert
Chu. Medpage Today, Jan 29, 2014 | Updated: Jan 30, 2014
Some
medical guidelines arrive barely noticed, but others -- say, last fall's new
AHA/ACC guidelines for managing cholesterol -- lead to a ruckus. That's what
happened with a 2013 guideline from the American College of Emergency
Physicians (ACEP) that all but backed intravenous clot buster thrombolytics for
acute ischemic stroke.
And last
week, ACEP responded by declaring open season on those guidelines, launching a
60-day member comment period.
There's a
swirl of reasons why emergency physicians had concerns. WhiteCoat's Call Room
put together an excellent rundown. Here's a condensed version:
1.
Evidence inconclusive? An independent review of 12 plasminogen activator (tPA)
studies failed to reveal conclusive evidence for or against use in ischemic stroke,
even as its use rises at primary stroke centers.
2.
Author bias? The BMJ pointed out that almost all the guideline authors had
links to thrombolytic manufacturers and, perhaps more damning, noted inadequate
disclosures in some cases.
3.
Behind closed doors? The ACEP did not give its members an opportunity to review
or comment on the draft guidelines before they were published.
4.
Malpractice bait? ACEP bestowed a "Level A" ranking on the
guidelines, effectively elevating tPA to standard of care status -- and giving
plaintiffs' attorneys fodder for suits against physicians who select other
treatment for acute ischemic stroke.
So why now?
"The
crux of the issue deals with a debate of methodology and academic rigor
required for a Level A recommendation and whether these particular
meta-analyses provided sufficient evidence," Howard Mell, MD, a
spokesperson for ACEP, told MedPage Today.
Mell added
that the experience had prompted ACEP to revise its guideline review process --
which previously only included experts and other related organizations -- to
include member comment.
Regarding
conflict of interest issues, ACEP said that it reviewed all the disclosure
statements and that "perceived conflicts were managed appropriately."
Mell said, "At no point has anyone in leadership entertained the idea that
the recommendations were at the paid behest of industry."
Undecided
on the tPA/Alteplase issue? Check out the entertaining and data-packed
"tPA Cage Match" video below recorded at the EMCrit/ISMMS conference
that featured pro-tPA doc Andy Jagoda, MD, chair of the department of emergency
medicine at Mount Sinai and past chair of ACEP in one corner. The real action
starts at 5 minutes.
In the
other corner, arguing against the guidelines, Anand Swaminathan, MD, MPH,
assistant professor of emergency medicine at New York University Medical Center
and assistant residency director at Bellevue. Swaminathan (who also writes over
at EM Lyceum) posted a thorough piece, if you'd rather read than watch.
Swaminathan's slam starts around 19 minutes.
We reached
out to Swaminathan for his take on three questions about the ACEP guidelines.
See why he says the Level A recommendations are
"fraught" with problems.
Have a
comment and "supporting evidence" to add? Head over to the ACEP site
between now and March 24th. Though your comments won't be posted online, as
WhiteCoat Call Room points out, submissions will only be shared with the board.
Full-text
(free), with links to essays and videos: http://www.medpagetoday.com/EmergencyMedicine/EmergencyMedicine/44042
3. Updated ACEP Procedural Sedation Guidelines
Fesmire FM,
et al. Ann Emerg Med. 2014;63:247-258.
Abstract
This
clinical policy from the American College of Emergency Physicians is the
revision of a 2005 clinical policy evaluating critical questions related to
procedural sedation in the emergency department. A writing subcommittee
reviewed the literature to derive evidence-based recommendations to help
clinicians answer the following critical questions:
(1)
In patients undergoing procedural sedation and analgesia in the emergency
department, does preprocedural fasting demonstrate a reduction in the risk of
emesis or aspiration?
(2)
In patients undergoing procedural sedation and analgesia in the emergency
department, does the routine use of capnography reduce the incidence of adverse
respiratory events?
(3)
In patients undergoing procedural sedation and analgesia in the emergency
department, what is the minimum number of personnel necessary to manage
complications?
(4)
In patients undergoing procedural sedation and analgesia in the emergency
department, can ketamine, propofol, etomidate, dexmedetomidine, alfentanil and
remifentanil be safely administered?
A
literature search was performed, the evidence was graded, and recommendations
were given based on the strength of the available data in the medical
literature.
4. Pediatric Weight Estimates: Which Method Is Best?
In this
large Australian study, the Best Guess formula was the most accurate for
predicting weight in children older than 1 year.
Graves L,
et al. A comparison of actual to estimated weights in Australian children
attending a tertiary children's' hospital, using the original and updated APLS,
Luscombe and Owens, Best Guess formulae and the Broselow tape. Resuscitation.
2013 Dec 7. [Epub ahead of print]
INTRODUCTION:
During paediatric resuscitation it is essential to be able to estimate the
child's weight as it determines drug doses and equipment sizes. Age and
length-based estimations exist, with age-based estimations being especially
useful in the preparation phase and the length-based Broselow tape having
weight-based drug doses and equipment already assigned via a colour code
system. The aim of this study was to compare the actual recorded weights of
Australian children to the predicted weights using the original and updated
APLS, Luscombe and Owens and Best Guess formulae and the Broselow tape.
METHOD: A
retrospective observational study of children attending an Australian tertiary
children's hospital.
RESULTS:
From 49,565 patients extracted from the database, 37,114 children with age and
weight and 37,091 children with age and height recorded were included in the
analysis. Best Guess was the most accurate, with the smallest overall mean
difference 0.86kg. For those under 1 year old, Broselow tape was the most
accurate (mean difference -0.43kg), Best Guess was the most accurate for ages
1-5 years and 11-14 years (mean difference 0.27 and 0.20kg respectively), and
the updated APLS formula was the most accurate for 6-10 year-old (mean
difference 0.42kg). The Broselow tape was able to only classify 48.9% of
children into the correct weight colour band.
CONCLUSIONS:
For an age-based weight estimation, in infants less than one year the new APLS
formula is the most accurate and over one year the Best Guess formulae should
be used.
5. The acute management of haemorrhage, surgery and overdose in
patients receiving dabigatran
Alikhan R,
et al. Emerg Med J 2014;31:163-168
Dabigatran
is an oral direct thrombin inhibitor (DTI) licensed for stroke prevention in
atrial fibrillation and likely to be soon approved in Europe for treatment of
venous thrombosis. Predictable pharmacokinetics and a reduced risk of
intracranial haemorrhage do not negate the potential risk of haemorrhage.
Unlike warfarin, there is no reversal agent and measurement of the
anticoagulant effect is not ‘routine’.
The
prothrombin time/international normalised ratio response to dabigatran is
inconsistent and should not be measured when assessing a patient who is
bleeding or needs emergency surgery. The activated partial thromboplastin time
(APTT) provides a qualitative measurement of the anticoagulant effect of
dabigatran. Knowledge of the time of last dose is important for interpretation
of the APTT. Commercially available DTI assays provide a quantitative
measurement of active dabigatran concentration in the plasma.
If a
patient receiving dabigatran presents with bleeding: omit/delay next dose of
dabigatran; measure APTT and thrombin time (consider DTI assay if available);
administer activated charcoal, with sorbitol, if within 2 h of dabigatran
ingestion; give tranexamic acid (1 g intravenously if significant bleeding);
maintain renal perfusion and urine output to aid dabigatran excretion.
Dabigatran exhibits low protein binding and may be removed by dialysis.
Supportive care should form the mainstay of treatment.
If bleeding
is life/limb threatening, consider an additional haemostatic agent. There is
currently no evidence to support the choice of one haemostatic agent (FEIBA,
recombinant factor VIIa, prothrombin complex concentrates) over another. Choice
will depend on access to and experience with available haemostatic agent(s).
See these
related articles:
Fawole A,
et al. Practical management of bleeding due to the anticoagulants dabigatran,
rivaroxaban, and apixaban. Cleve Clin J Med. 2013;80(7):443-51.
Full-text (free): http://www.ccjm.org/content/80/7/443.long
Pollack CV
Jr. Managing bleeding in anticoagulated patients in the emergency care setting.
J Emerg Med. 2013;45(3):467-77. http://www.ncbi.nlm.nih.gov/pubmed/23786779
6. An electronic order set for AMI is associated with improved
patient outcomes through better adherence to clinical practice guidelines.
Ballesca
MA, et al. J Hosp Med. 2014 Feb 3. [Epub ahead of print]
BACKGROUND:
Adherence to evidence-based recommendations for acute myocardial infarction
(AMI) remains unsatisfactory.
OBJECTIVE:
Quantifying association between using an electronic AMI order set (AMI-OS) and
hospital processes and outcomes.
DESIGN:
Retrospective cohort study.
SETTING:
Twenty-one community hospitals.
PATIENTS: A
total of 5879 AMI patients were hospitalized between September 28, 2008 and
December 31, 2010.
MEASUREMENTS:
We ascertained whether patients were treated using the AMI-OS or individual
orders (a la carte). Dependent process variables were use of evidence-based
care; outcome variables were mortality and rehospitalization.
RESULTS:
Use of individual and combined therapies improved outcomes (eg, 50% lower odds
of 30-day mortality for patients with ≥3 therapies). The 3531 patients treated
using the AMI-OS were more likely to receive evidence-based therapies (eg, 50%
received 5 different therapies vs 36% a la carte). These patients had lower
30-day mortality (5.7% vs 8.5%) than the 2348 treated using a la carte orders.
Although AMI-OS patients' predicted mortality risk was lower (3.2%) than that
of a la carte patients (4.8%), the association of improved processes and
outcomes with the use of the AMI-OS persisted after risk adjustment. For
example, after inverse probability weighting, the relative risk for inpatient
mortality in the AMI-OS group was 0.67 (95% confidence interval: 0.52-0.86).
Inclusion of use of recommended therapies in risk adjustment eliminated the
benefit of the AMI-OS, highlighting its mediating effect on adherence to
evidence-based treatment.
CONCLUSIONS:
Use of an electronic order set is associated with increased adherence to
evidence-based care and better AMI outcomes.
7. New American Academy of Pediatrics Guidelines
A. Updated guidelines advise on
assessing fractures for child abuse
Certain
child fractures, such as rib and scapula fractures, are strongly linked to physical
abuse, particularly among infants, according to the American Academy of
Pediatrics' clinical report published in the journal Pediatrics. The group said
a child's age, medical history, other injuries, and the location, type and
mechanism of fracture must be evaluated to determine if injuries are caused by
physical abuse.
Abstract
Fractures
are common injuries caused by child abuse. Although the consequences of failing
to diagnose an abusive injury in a child can be grave, incorrectly diagnosing
child abuse in a child whose fractures have another etiology can be distressing
for a family. The aim of this report is to review recent advances in the
understanding of fracture specificity, the mechanism of fractures, and other
medical diseases that predispose to fractures in infants and children. This
clinical report will aid physicians in developing an evidence-based
differential diagnosis and performing the appropriate evaluation when assessing
a child with fractures.
B. Management of Dental Trauma in a
Primary Care Setting
Abstract
The
American Academy of Pediatrics and its Section on Oral Health have developed
this clinical report for pediatricians and primary care physicians regarding
the diagnosis, evaluation, and management of dental trauma in children aged 1
to 21 years. This report was developed through a comprehensive search and
analysis of the medical and dental literature and expert consensus. Guidelines
published and updated by the International Association of Dental Traumatology
(www.dentaltraumaguide.com) are an excellent resource for both dental and
nondental health care providers.
8. INR Is Not an Accurate Predictor of Coagulopathy in Trauma
Patients
Richard D.
Zane, Journal Watch Emergency Medicine.
Thromboelastography
is a better predictor and is more clinically relevant.
The
international normalized ratio (INR) is measured routinely in trauma patients
and is commonly used as a measurement of coagulopathy and a guide for the
administration of fresh frozen plasma (FFP). Thromboelastography is a
point-of-care coagulation assay that uses the time-dependent viscoelastic
properties of whole blood to provide an assessment of clotting ability; it is
considered more clinically relevant than INR.
In this
prospective observational study of 106 adult hemodynamically stable surgical
and trauma patients receiving FFP, researchers measured thromboelastography
values, clotting factor levels, and INRs before and after FFP infusion. FFP was
administered based on the attending surgeon's discretion.
Administration
of FFP significantly decreased the median INR (from 1.87 to 1.53), but did not
change thromboelastography values or clotting factor levels, all of which
remained normal.
Comment:
INR is not a clinically relevant predictor of coagulopathy in trauma patients
and should not be used to assess coagulation status or guide administration of
fresh frozen plasma. Clinical assessment of bleeding as well as transfusion
requirement should continue to guide FFP administration. As thromboelastography
becomes more available, it may have a role in guiding blood product use in the
acute management of hemorrhage.
Source: McCully
SP et al. J Trauma Acute Care Surg 2013 Dec; 75:947. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24256665
9. Serotonin Syndrome: Consider in the Older Patient with AMS
By
Christina Shenvi, MD PhD | February 3rd, 2014 | ALiEM
What’s the
first thing that pops into your head when you see an older woman presenting to
the ED from a nursing facility with atraumatic altered mental status? If you’re
like me, ‘UTI’ comes quickly to mind. I then banish the thought of a UTI and
force myself to go through a worst-first differential diagnosis to exclude,
either through the history and clinical assessment or through testing, more
dangerous causes. This is a case of a 67-year-old woman with an unusual cause
of altered mental status… and a UTI.
Full-text
(free): http://academiclifeinem.com/serotonin-syndrome-older-patient-altered-mental-status/
10. Images in Clinical Practice
Acute
Intermittent Porphyria
An Unusual
Cause of Electrocardiographic ST Elevation- Can the Japanese Fishing Industry
Help Us?
Ocular
Manifestation of Electrical Burn
11. Management of Febrile Neonates in US Pediatric EDs
Jain S, et
al. Pediatrics. 2014 Jan 27. [Epub ahead of print]
What’s
Known on This Subject
Recommended
management of febrile neonates (≤28 days) includes blood, urine, and
cerebrospinal fluid cultures with hospital admission for antibiotic therapy. No
study has reported adherence to standard recommendations in the management of febrile
neonates in US pediatric emergency departments.
What This
Study Adds
There is
wide variation in adherence to recommended management of febrile neonates. High
rates of serious infections in admitted patients but low return rates for
missed infections in discharged patients suggest additional studies needed to
understand variation from current recommendations.
Abstract
BACKGROUND:
Blood, urine, and cerebrospinal fluid cultures and admission for antibiotics
are considered standard management of febrile neonates (0–28 days). We examined
variation in adherence to these recommendations across US pediatric emergency
departments (PEDs) and incidence of serious infections (SIs) in febrile
neonates.
METHODS:
Cross-sectional study of neonates with a diagnosis of fever evaluated in 36
PEDs in the 2010 Pediatric Health Information System database. We analyzed
performance of recommended management (laboratory testing, antibiotic use,
admission to hospital), 48-hour return visits to PED, and diagnoses of SI.
RESULTS: Of
2253 neonates meeting study criteria, 369 (16.4%) were evaluated and discharged
from the PED; 1884 (83.6%) were admitted. Recommended management occurred in
1497 of 2253 (66.4%; 95% confidence interval, 64.5–68.4) febrile neonates.
There was more than twofold variation across the 36 PEDs in adherence to
recommended management, recommended testing, and recommended treatment of
febrile neonates. There was significant variation in testing and treatment
between admitted and discharged neonates (P less than .001). A total of 269 in
2253 (11.9%) neonates had SI, of whom 223 (82.9%; 95% confidence interval,
77.9–86.9) received recommended management.
CONCLUSIONS:
There was wide variation across US PEDs in adherence to recommended management
of febrile neonates. One in 6 febrile neonates was discharged from the PED;
discharged patients were less likely to receive testing or antibiotic therapy
than admitted patients. A majority of neonates with SI received recommended
evaluation and management. High rates of SI in admitted patients but low return
rates for missed infections in discharged patients suggest a need for
additional studies to understand variation from the current recommendations.
12. Two ACS Rules for Safe Expedited ED Discharge of Low Risk Pts
A. Development and validation of the
Emergency Department Assessment of Chest pain Score and 2 h accelerated
diagnostic protocol.
Than M, et
al. Emerg Med Australas. 2014 Jan 15. [Epub ahead of print]
OBJECTIVE:
Risk scores and accelerated diagnostic protocols can identify chest pain
patients with low risk of major adverse cardiac event who could be discharged
early from the ED, saving time and costs. We aimed to derive and validate a
chest pain score and accelerated diagnostic protocol (ADP) that could safely
increase the proportion of patients suitable for early discharge.
METHODS:
Logistic regression identified statistical predictors for major adverse cardiac
events in a derivation cohort. Statistical coefficients were converted to whole
numbers to create a score. Clinician feedback was used to improve the clinical
plausibility and the usability of the final score (Emergency Department
Assessment of Chest pain Score [EDACS]). EDACS was combined with
electrocardiogram results and troponin results at 0 and 2 h to develop an ADP
(EDACS-ADP). The score and EDACS-ADP were validated and tested for reproducibility
in separate cohorts of patients.
RESULTS: In
the derivation (n = 1974) and validation (n = 608) cohorts, the EDACS-ADP
classified 42.2% (sensitivity 99.0%, specificity 49.9%) and 51.3% (sensitivity
100.0%, specificity 59.0%) as low risk of major adverse cardiac events,
respectively. The intra-class correlation coefficient for categorisation of
patients as low risk was 0.87.
CONCLUSION:
The EDACS-ADP identified approximately half of the patients presenting to the
ED with possible cardiac chest pain as having low risk of short-term major
adverse cardiac events, with high sensitivity. This is a significant
improvement on similar, previously reported protocols. The EDACS-ADP is
reproducible and has the potential to make considerable cost reductions to
health systems.
What’s this
fancy new risk stratification tool? Full-text (free): http://onlinelibrary.wiley.com/doi/10.1111/1742-6723.12164/full
B. The new Vancouver Chest Pain Rule
using troponin as the only biomarker: an external validation study
Cullen L,
et al. Amer J Emerg Med. 2014;2:129-134.
Objectives
To
externally evaluate the accuracy of the new Vancouver Chest Pain Rule and to
assess the diagnostic accuracy using either sensitive or highly sensitive
troponin assays.
Methods
Prospectively
collected data from 2 emergency departments (EDs) in Australia and New Zealand
were analysed. Based on the new Vancouver Chest Pain Rule, low-risk patients
were identified using electrocardiogram results, cardiac history, nitrate use,
age, pain characteristics and troponin results at 2 hours after presentation.
The primary outcome was 30-day diagnosis of acute coronary syndrome (ACS),
including acute myocardial infarction, and unstable angina. Sensitivity,
specificity, positive predictive values and negative predictive values were
calculated to assess the accuracy of the new Vancouver Chest Pain Rule using
either sensitive or highly sensitive troponin assay results.
Results
Of the 1635
patients, 20.4% had an ACS diagnosis at 30 days. Using the highly sensitive
troponin assay, 212 (13.0%) patients were eligible for early discharge with 3
patients (1.4%) diagnosed with ACS. Sensitivity was 99.1% (95% CI 97.4-99.7),
specificity was 16.1 (95% CI 14.2-18.2), positive predictive values was 23.3
(95% CI 21.1-25.5) and negative predictive values was 98.6 (95% CI 95.9-99.5).
The diagnostic accuracy of the rule was similar using the sensitive troponin
assay.
Conclusions
The new
Vancouver Chest Pain Rule should be used for the identification of low risk
patients presenting to EDs with symptoms of possible ACS, and will reduce the
proportion of patients requiring lengthy assessment; however we recommend
further outpatient investigation for coronary artery disease in patients
identified as low risk.
13. Effects of Immediate BP Reduction on Death and Major Disability in Patients with Acute Ischemic Stroke: The CATIS RCT
He J, et
al. JAMA. 2014;311(5):479-489.
Importance Although the benefit of reducing blood
pressure for primary and secondary prevention of stroke has been established,
the effect of antihypertensive treatment in patients with acute ischemic stroke
is uncertain.
Objective To evaluate whether immediate blood pressure
reduction in patients with acute ischemic stroke would reduce death and major
disability at 14 days or hospital discharge.
Design,
Setting, and Participants The China
Antihypertensive Trial in Acute Ischemic Stroke, a single-blind, blinded
end-points randomized clinical trial, conducted among 4071 patients with
nonthrombolysed ischemic stroke within 48 hours of onset and elevated systolic
blood pressure. Patients were recruited from 26 hospitals across China between
August 2009 and May 2013.
Interventions Patients (n = 2038) were randomly assigned to
receive antihypertensive treatment (aimed at lowering systolic blood pressure
by 10% to 25% within the first 24 hours after randomization, achieving blood
pressure less than 140/90 mm Hg within 7 days, and maintaining this level
during hospitalization) or to discontinue all antihypertensive medications
(control) during hospitalization (n = 2033).
Main
Outcomes and Measures Primary outcome
was a combination of death and major disability (modified Rankin Scale score
≥3) at 14 days or hospital discharge.
Results Mean systolic blood pressure was reduced from 166.7 mm Hg to 144.7 mm Hg (−12.7%) within 24 hours in the antihypertensive treatment group and from 165.6 mm Hg to 152.9 mm Hg (−7.2%) in the control group within 24 hours after randomization (difference, −5.5% [95% CI, −4.9 to −6.1%]; absolute difference, −9.1 mm Hg [95% CI, −10.2 to −8.1]; P less than .001). Mean systolic blood pressure was 137.3 mm Hg in the antihypertensive treatment group and 146.5 mm Hg in the control group at day 7 after randomization (difference, −9.3 mm Hg [95% CI, −10.1 to −8.4]; P less than .001). The primary outcome did not differ between treatment groups (683 events [antihypertensive treatment] vs 681 events [control]; odds ratio, 1.00 [95% CI, 0.88 to 1.14]; P = .98) at 14 days or hospital discharge. The secondary composite outcome of death and major disability at 3-month posttreatment follow-up did not differ between treatment groups (500 events [antihypertensive treatment] vs 502 events [control]; odds ratio, 0.99 [95% CI, 0.86 to 1.15]; P = .93).
Conclusion
and Relevance Among patients with acute
ischemic stroke, blood pressure reduction with antihypertensive medications,
compared with the absence of hypertensive medication, did not reduce the
likelihood of death and major disability at 14 days or hospital discharge.
14. Intussusception Risk Slightly Increases after Rotavirus Immunization
A. Risk of Intussusception after
Monovalent Rotavirus Vaccination
Weintraub
ES, et al. N Engl J Med 2014; 370:513-519
Background
Although
current rotavirus vaccines were not associated with an increased risk of
intussusception in large trials before licensure, recent postlicensure data
from international settings suggest the possibility of a small increase in risk
of intussusception after monovalent rotavirus vaccination. We examined this
risk in a population in the United States.
Methods
Participants
were infants between the ages of 4 and 34 weeks who were enrolled in six
integrated health care organizations in the Vaccine Safety Datalink (VSD)
project. We reviewed medical records and visits for intussusception within 7
days after monovalent rotavirus vaccination from April 2008 through March 2013.
Using sequential analyses, we then compared the risk of intussusception among
children receiving monovalent rotavirus vaccine with historical background
rates. We further compared the risk after monovalent rotavirus vaccination with
the risk in a concurrent cohort of infants who received the pentavalent
rotavirus vaccine.
Results
During the
study period, 207,955 doses of monovalent rotavirus vaccine (including 115,908
first doses and 92,047 second doses) were administered in the VSD population.
We identified 6 cases of intussusception within 7 days after the administration
of either dose of vaccine. For the two doses combined, the expected number of
intussusception cases was 0.72, resulting in a significant relative risk of
8.4. For the pentavalent rotavirus vaccine, 1,301,810 doses were administered
during the study period, with 8 observed intussusception cases (7.11 expected),
for a nonsignificant relative risk of 1.1. The relative risk of chart-confirmed
intussusception within 7 days after monovalent rotavirus vaccination, as
compared with the risk after pentavalent rotavirus vaccination, was 9.4 (95%
confidence interval, 1.4 to 103.8). The attributable risk of intussusception
after the administration of two doses of monovalent rotavirus vaccine was
estimated to be 5.3 per 100,000 infants vaccinated.
Conclusions
In this
prospective postlicensure study of more than 200,000 doses of monovalent
rotavirus vaccine, we observed a significant increase in the rate of
intussusception after vaccination, a risk that must be weighed against the
benefits of preventing rotavirus-associated illness. (Funded by the Centers for
Disease Control and Prevention.)
B. Intussusception Risk after
Rotavirus Vaccination in U.S. Infants
Yih WK, et
al. N Engl J Med 2014; 370:503-512
Background
International
postlicensure studies have identified an increased risk of intussusception
after vaccination with the second-generation rotavirus vaccines RotaTeq (RV5, a
pentavalent vaccine) and Rotarix (RV1, a monovalent vaccine). We studied this
association among infants in the United States.
Methods
The study
included data from infants 5.0 to 36.9 weeks of age who were enrolled in three
U.S. health plans that participate in the Mini-Sentinel program sponsored by
the Food and Drug Administration. Potential cases of intussusception and
vaccine exposures from 2004 through mid-2011 were identified through procedural
and diagnostic codes. Medical records were reviewed to confirm the occurrence
of intussusception and the status with respect to rotavirus vaccination. The
primary analysis used a self-controlled risk-interval design that included only
vaccinated children. The secondary analysis used a cohort design that included
exposed and unexposed person-time.
Results
The
analyses included 507,874 first doses and 1,277,556 total doses of RV5 and
53,638 first doses and 103,098 total doses of RV1. The statistical power for
the analysis of RV1 was lower than that for the analysis of RV5. The number of
excess cases of intussusception per 100,000 recipients of the first dose of RV5
was significantly elevated, both in the primary analysis (attributable risk,
1.1 [95% confidence interval, 0.3 to 2.7] for the 7-day risk window and 1.5
[95% CI, 0.2 to 3.2] for the 21-day risk window) and in the secondary analysis
(attributable risk, 1.2 [95% CI, 0.2 to 3.2] for the 21-day risk window). No
significant increase in risk was seen after dose 2 or 3. The results with
respect to the primary analysis of RV1 were not significant, but the secondary
analysis showed a significant risk after dose 2.
Conclusions
RV5 was
associated with approximately 1.5 (95% CI, 0.2 to 3.2) excess cases of
intussusception per 100,000 recipients of the first dose. The secondary
analysis of RV1 suggested a potential risk, although the study of RV1 was
underpowered. These risks must be considered in light of the demonstrated
benefits of rotavirus vaccination. (Funded by the Food and Drug
Administration.)
15. Treatment of Calcium Channel Blocker Poisoning: Should We Reprioritize Our Potpourri of Treatment Options?
Pfeffer AN,
et al. Ann Emerg Med. 2014;63:259-265.
16. Traumatic lacerations: what are the risks for infection and has the ‘golden period’ of laceration care disappeared?
Quinn JV,
et al. Emerg Med J 2014;31:96-100
Objective
To determine risk factors associated with infection and traumatic lacerations
and to see if a relationship exists between infection and time to wound closure
after injury.
Methods
Consecutive patients presenting with traumatic lacerations at three diverse
emergency departments were prospectively enrolled and 27 variables were
collected at the time of treatment. Patients were followed for 30 days to
determine the development of a wound infection and desire for scar revision.
Results
2663 patients completed follow-up and 69 (2.6%, 95% CI 2.0% to 3.3%) developed
infection. Infected wounds were more likely to receive a worse cosmetic rating
and more likely to be considered for scar revision (RR 2.6, 95% CI 1.7 to 3.9).
People with diabetes (RR 2.70, 95% CI 1.1 to 6.5), lower extremity lacerations
(RR 4.1, 95% CI 2.5 to 6.8), contaminated lacerations (RR 2.0, 95% CI 1.2 to 3.4) and lacerations greater than 5 cm (RR
2.9, 95% CI 1.6 to 5.2) were more likely to develop an infection. There were no
differences in the infection rates for lacerations closed before 3% (95% CI
2.3% to 3.8%) or after 1.2% (95% CI 0.03% to 6.4%) 12 h.
Conclusions
Diabetes, wound contamination, length greater than 5 cm and location on the
lower extremity are important risk factors for wound infection. Time from
injury to wound closure is not as important as previously thought. Improvements
in irrigation and decontamination over the past 30 years may have led to this
change in outcome.
17. Ultrasound: Undifferentiated Hypotension
Marcucci J,
et al, Emergency Physicians Monthly, January 15, 2014
An
84-year-old woman is brought to the emergency department by ambulance for
evaluation of altered mental status and syncope. Per family, the patient had
complaints of abdominal pain for two days, tactile fevers, decreased PO intake
and one episode of non-bloody, non-bilious vomiting. The patient also fell from
her bed to the carpet with loss of consciousness for 10 seconds. Her review of
systems is negative for: focal weakness, aphasia, seizures, chest pain,
shortness of breath, cough, jaundice, icterus, change in stool color, dysuria,
hematuria, urinary odor, diarrhea, hematemesis, hematochezia and melena.
At
baseline, the patient lives with her son, but is independent in all activities
of daily living, and has no physical or mental deficits. Her past medical history is significant for
hypertension and hyperlipidemia, and her only medication is hydrochlorothiazide
daily.
Her
physical exam reveals an elderly female in no acute respiratory distress. Vital
signs are significant for tachycardia to 130 bpm and a low grade fever to
38.3C. Initial blood pressure was normotensive at 114/90 mmHg. Abdominal exam
was notable for mild periumbilical tenderness. There were no significant
neurological deficits and the patient was alert and oriented x 2. She was noted
to have waxing and waning confusion during her ED evaluation. The remainder of
the physical exam was unremarkable.
A stat head
CT and cervical spine CT without contrast revealed no acute intracranial
hemorrhage or relevant findings. Upon returning to the emergency department,
the patient was noted to be hypotensive with a blood pressure of 80/40 mmHg
which responded to a 1L normal saline bolus. Initial I-STAT laboratory studies
demonstrated an elevated Troponin I (0.93), a leukocytosis with a left shift
(15.7 with 95% neutrophils) and an EKG with sinus tachycardia and no other
acute abnormalities.
Given the
patient’s hemodynamic instability and altered mental status, an emergency
bedside ultrasound was performed. Her cardiac exam showed a hyperdynamic left
ventricle without wall motion abnormalities or pericardial effusion. The IVC
was collapsible. There was no abdominal aortic aneurysm or abdominal/pelvic
free fluid. These findings were consistent with a high output, low volume
state, which with no evidence of bleeding, was consistent with distributive shock.
Given her abdominal tenderness on exam, a RUQ ultrasound was performed to
evaluate the hepatobiliary system. This showed a dilated common bile duct with
several prominent stones (Figures 1 and 2).
For the
remainder of the essay (with images): http://www.epmonthly.com/departments/clinical-skills/ultrasound/undifferentiated-hypotension/
18. Acute Appendicitis: Investigating an Optimal Outer Appendiceal Diameter Cut-Point in a Pediatric Population
Prendergast
PM, et al. J Emerg Med. 2014;46:157-164.
Background
Acute
appendicitis is the most common cause of abdominal pain in children requiring
operative intervention. Among a number of sonographic criteria to aid in the
diagnosis of appendicitis, an outer diameter above 6 mm is the most objective
and widely accepted. However, there is a lack of evidence-based standards
governing this consensus.
Study
Objectives
The aim of
this study was to determine the outer appendiceal diameter that maximizes
sensitivity and specificity in a pediatric population.
Methods
A
retrospective review of all urgent diagnostic ultrasounds (US) was performed
over 2 years in children aged less than 18 years. The diagnostic accuracy of
various cut-points was assessed by calculating the sensitivity and specificity
and plotting a receiver operating characteristic (ROC) curve.
Results
The study
sample consisted of 398 patients in whom the appendix was visualized on US. The
median outer appendiceal diameter was significantly higher in the surgical
group compared to the nonsurgical group (9.4 mm; range = 8.1–12.0 vs. 5.5 mm;
range = 4.4–6.5, p less than 0.01). The optimal cut-point with the greatest
area under the ROC curve was determined to be an outer appendiceal diameter of
7.0 mm.
Conclusions
In our
patients, adopting a 7-mm rather than a 6-mm appendiceal diameter threshold
would balance a greater number of missed cases of acute appendicitis for a
reduction in the number of unnecessary surgeries.
19. URIs, Antibiotics Affect Warfarin
Having an
acute upper respiratory tract infection -- with or without treatment with an
antibiotic -- may be associated with excessive anti-coagulation in patients
taking warfarin, a retrospective study showed.
Clark NP,
et al. JAMA Intern Med. Published online January 20, 2014.
Importance The effect of antibiotic coadministration on
the international normalized ratio (INR) in a relatively stable, real-world
warfarin population has not been adequately described. Case reports and studies
of healthy volunteers do not account for the potential contribution of acute
illness to INR variability.
Objective To compare the risk of excessive
anticoagulation among patients with stable warfarin therapy purchasing an
antibiotic (antibiotic group) with the risk in patients purchasing a warfarin
refill (stable controls) and patients with upper respiratory tract infection
but not receiving an antibiotic (sick controls).
Design,
Setting, and Participants A
retrospective, longitudinal cohort study evaluated patients receiving warfarin
between January 1, 2005, and March 31, 2011, at Kaiser Permanente Colorado, an
integrated health care delivery system. Continuous data were expressed as mean
(SD) or median (interquartile range). Multivariable logistic regression
analysis was used to identify factors independently associated with a follow-up
INR of 5.0 or more. A total of 5857 (48.8%), 5579 (46.5%), and 570 (4.7%)
patients were included in the antibiotic, stable control, and sick control
groups, respectively. Mean age was 68.3 years, and atrial fibrillation was the
most common (44.4%) indication for anticoagulation.
Exposures Warfarin therapy with a medical visit for
upper respiratory tract infection or coadministration of antibiotics.
Main
Outcomes and Measures Primary outcomes
were the proportion of patients experiencing a follow-up INR of 5.0 or more and
change between the last INR measured before the index date and the follow-up
INR.
Results The proportion of patients experiencing an INR
of 5.0 or more was 3.2%, 2.6%, and 1.2% for the antibiotic, sick, and stable
groups, respectively (P less than .001, antibiotic vs stable control group;
P less than .017, sick vs stable control group; P = .44, antibiotic vs sick
control group). Cancer diagnosis, elevated baseline INR, and female sex
predicted a follow-up INR of 5.0 or more. Among antibiotics, those interfering
with warfarin metabolism posed the greatest risk for an INR of 5.0 or more.
Conclusions
and Relevance Acute upper respiratory
tract infection increases the risk of excessive anticoagulation independent of
antibiotic use. Antibiotics also increase the risk; however, most patients with
previously stable warfarin therapy will not experience clinically relevant
increases in INR following antibiotic exposure or acute upper respiratory tract
infection.
20. What an ED Report Card Tells Us
By Elbert
Chu, Associate Producer, MedPage Today, Jan 16, 2014
The press
release promised that a new report would answer the question: "Are your
state's emergency rooms making the grade?"
But while
an American College of Emergency Physicians (ACEP) report card out today said
the nation's emergency care environment has worsened since their effort in 2009,
it doesn't really answer that specific question.
ACEP
analyzed the condition of emergency care based on state and national policies,
which they captured through 136 metrics. These include measures such as numbers
of trauma centers and emergency physicians. More relevant for physicians, the
2014 report card includes medical liability measures like average premium
levels and average malpractice award payments. Authors divided the indicators
into five areas: access, liability, quality and patient safety environment,
public health, and disaster preparedness.
The authors
downgraded the U.S. emergency care environment from a "C-" in 2009 to
a "D+" this year. The District of Columbia, Massachusetts, and Maine
topped the list, while New Mexico, Arkansas, and Wyoming rounded out the
bottom.
But since
the grades are based on indicators such as percent of obese children, bicyclist
fatalities, and percentage of adults with Medicaid, it's unclear how they would
help judge a given state's emergency departments, let alone a specific one.
It's also
unclear how any of these indicators measure what really counts: Patient
outcomes.
What's
really unfortunate is that already other media outlets have picked up the
report and tied them to emergency departments' quality with headlines like:
"N.J. Emergency Rooms get D+ on National Report Card." (That headline
seems to have been changed to "N.J.'s Emergency Room Policies get D+ on
National Report Card.")
Still, the
report card could be helpful on the state and policy level. On a conference
call about the report, ACEP president Alex Rosenau, MD, DO, said that some
states had responded to the 2009 report with new policies to improve emergency
care.
Jon Mark
Hirshon, MD, MPH, PhD, associate professor of emergency medicine at the University
of Maryland School of Medicine, who headed the ACEP report task force, said
that they'd seen evidence that doctors have migrated to states depending on the
liability environment.
21. Two Good Reads on How our Brains Work
Matthew D.
Lieberman, Social: Why Our Brains Are Wired to Connect (New York: Crown,
2013). http://www.amazon.com/dp/0307889092/
Bruce Hood,
The Self Illusion: How the Social Brain
Creates Identity (Oxford: Oxford University Press, 2013). http://www.amazon.com/dp/0199988781/
22. Tid Bits
A. Surrogates often make decisions
for older patients, study finds
Indiana
University researchers who studied 1,083 hospital patients over age 65 found
570 made all of their own medical decisions, 264 got help from a surrogate and
249 had all of their medical decisions made by someone else. The study in JAMA
Internal Medicine found that in the first two days of hospitalization,
surrogates made about 60% of decisions regarding life-sustaining treatments and
about half of decisions about surgery or discharge destinations. Only about 25%
of patients had a living will or advance directive.
B. Uninsured rate in U.S. is down to
16.1%
The
percentage of Americans without health insurance fell to 16.1% in January, 1.2
percentage points lower than in December, according to a Gallup-Healthways
poll. The uninsured rate for unemployed people dropped 6.7 percentage points,
the rate for nonwhites fell 2.6 percentage points and the rate for women was
down 1.9 points. There was no substantial change in the 18- to 34-year-old
demographic.
Associated
Press: http://www.washingtonpost.com/politics/apnewsbreak-poll-finds-drop-in-uninsured-rate/2014/01/23/7f1c6612-8405-11e3-a273-6ffd9cf9f4ba_story.html
C. Topol interviews Gawande
Atul
Gawande, MD, MPH, wears many hats, including that of a surgeon, researcher,
journalist, and author. In this segment of Medscape One-on-One, Dr. Gawande
talks with Eric J. Topol, MD, about what inspires him, his plans for the
future, and why he's secretly a frustrated rock singer.
D. FDA review finds naproxen safer
for heart than other NSAIDs
FDA
reviewers said study data appear to show naproxen does not carry the
cardiovascular risks that other nonsteroidal anti-inflammatory drugs do, and
the FDA may consider revising the label warning for the drug. All NSAID drugs
got boxed warnings in 2005 indicating cardiovascular risks
Reference
Lancet meta-analysis from 2013 (full-text free): http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3778977/
E. Is communication a casualty of
computers in the exam room?
Research
published in the journal Medical Informatics found physicians spend about a
third of their time with patients looking at the computer screen, potentially
missing nonverbal cues and other subtle forms of communication. "It's
likely that the ability to listen, problem-solve and think creatively is not
optimal when physicians' eyes are glued to the screen," said researcher
Enid Montague. In addition, patients tend to look at the computer screens,
although they may not understand the content.
F. Help patients use OTC medications
safely
Each year,
thousands of children younger than age 12 end up in emergency rooms as a result
of misuse of over-the-counter medications. Help educate your patients about
safe, effective use of OTC cold and cough medications. FamilyDoctor.org has
developed patient education handouts available for free download.
G. Study: Posters help reduce
inappropriate antibiotic scripts
A RAND
Corp. study found that when primary care clinics displayed poster-size letters
of clinician commitment to appropriately use antibiotics, it led to reductions
in inappropriate prescriptions for the drugs for acute respiratory infections.
The report in JAMA Internal Medicine found prescribing rates increased slightly
among clinicians in the study who were assigned to follow standard prescribing
practices.
H. Spouse's diabetes tied to
increased risk of developing the condition
People
whose spouses had type 2 diabetes had 26% increased odds of developing the
disease, according to an analysis in BMC Medicine. "The results of our
review suggest that diabetes diagnosis in one spouse may warrant increased
surveillance in the other," said senior author Dr. Kaberi Dasgupta.
Full-text (free): http://www.ncbi.nlm.nih.gov/pubmed/24460622
I. Early vs. Delayed Cholecystectomy
for Acute Cholecystitis
Early
surgery is the better choice for patients who aren't critically ill.
J. Fewer Kids Dying in Car Accidents
Motor
vehicle crashes are a leading cause of death for children in the US. Buckling
up is the best way to save lives and reduce injuries.
Child
passenger restraint laws result in more children being buckled up. Only 2 out
of every 100 children live in states that require car seat or booster seat use
for children age 8 and under.
A third of
children who died in crashes in 2011 were not buckled up. We—especially parents
and caregivers—can do more to protect children on the road.
K. Insulin
Pill Passes Safety Test
A pill formulation
of insulin has met safety and pharmacokinetic endpoints in a phase IIa trial,
developer Oramed announced.
