1. Interpreting RBCs in LP: Distinguishing True SAH From Traumatic Tap
Czuczman AD, et al. Acad Emerg Med. 2013;20:247-256.
Objectives: The study purpose was to determine the optimal
use of lumbar puncture (LP) red blood cell (RBC) counts to identify
subarachnoid hemorrhage (SAH) when some blood remains in the final tube.
Methods: A case series was performed at a tertiary emergency
department (ED). Records of 4,496 consecutive adult patients billed for LPs
between 2001 and 2009 were reviewed. Inclusion criteria were headache (HA),
final tube RBCs ≥ 5, and neurovascular imaging within 2 weeks of the visit.
Demographics, relevant history and physical examination components, LP results,
and neuroimaging findings were recorded for 280 patients. True-positive (TP)
and true-negative (TN) SAH were strictly defined. Primary outcomes were the
areas under the receiver operating characteristic curves (AUC) for final tube
RBC count, differential RBC count between the final and initial tubes, and
absolute differential RBC count between the final and initial tubes divided by
the mean RBC count of the two tubes (also called the percent change in RBC
count).
Results: There were 26 TP and 196 TN results; 58 patients
were neither. The TP group consisted of 19 patients with visible or possible
SAH on imaging (17 on noncontrast head computed tomography [CT; 12 definite and
five possible] and two on magnetic resonance imaging), six with xanthochromia
and a vascular lesion (aneurysm or arteriovenous malformation [AVM] greater
than 2 mm), and one with xanthochromia and polymerase chain reaction
(PCR)-positive meningitis. As a test for SAH, final tube RBC AUC was 0.85 (95%
confidence interval [CI] = 0.80 to 0.91). Interval likelihood ratios (LRs) for
final tube RBC count were LR 0 (95% CI = 0 to 0.3) for RBCs below 100, LR 1.6
(95% CI = 1.1 to 2.3) for RBCs between 100 and 10,000, and LR 6.3 (95% CI = 4.8
to 23.4) for RBCs above 10,000. Differential RBC count was not associated with
SAH, with AUC 0.45 (95% CI = 0.31 to 0.60). However, the percent change in RBC
count between the final and initial tubes had an AUC 0.84 (95% CI = 0.78 to
0.90), and the optimal test threshold for SAH was 0.63, with positive LR 3.6
(95% CI = 2.7 to 4.7) and negative LR 0.10 (95% CI = 0.03 to 0.4) for percent
change less than 63% and greater than 63%,
respectively. This test added additional independent information to the final
tube RBC count based on improved logistic regression model fit and
discriminatory ability as measured by the LR test and c statistic,
respectively.
Conclusions: Final LP tube RBC count and the percent change
in RBC count, but not the simple differential count between the final and
initial tubes, were associated with SAH. In this sample, there were no patients
with SAH who had RBCs below 100 in the final tube, and RBCs above 10,000
increased the odds of SAH by a factor of 6.
2. Stress Testing Has Low Yield in Young Adults with
Chest Pain
Observation and further testing yielded few abnormal test
results, and most were false-positive.
Ely S, et al. J Emerg Med. 2013;44:306-312.
Background: Determining which patients presenting to the
Emergency Department (ED) require further work-up for acute coronary syndrome
(ACS) can be difficult. The utility of routine observation for cardiac testing
in low-risk young adult patients has been questioned.
Study Objectives: We investigated the rate of positive
findings yielded by routine cardiac observation unit work-up in patients aged
40 years or younger.
Methods: This was a retrospective observational cohort study
of patients aged 18–40 years who were evaluated for ACS in an ED-based
observation unit. Data were collected by trained abstractors from electronic
medical records.
Results: A total of 362 patients met inclusion criteria. Of
those, 239 received stress testing, yielding five positive and nine indeterminate
results. One other patient had acute troponin elevation while under
observation. The positive stress test patients and troponin-elevated patient
underwent cardiac angiography. Only one positive stress test patient showed
significant coronary stenosis and received coronary interventions. In follow-up
data, one patient had an adverse cardiac outcome within 1 year of index visit,
but no coronary interventions. Thus, only 3 patients had adverse cardiac
events, with only one patient warranting intervention discovered by observation
unit stress testing and a second via serial cardiac markers.
Conclusion: Routine observation of symptomatic young adults
for ACS had low yield. Observation identified one patient with acute cardiac
marker elevation and further stress testing identified only one patient with
intervenable ACS, despite a high false-positive rate. This suggests that
observation and stress testing should not be routinely performed in this
demographic absent other high-risk features.
J. Stephen Bohan, MD, MS, FACP, FACEP, Journal Watch, wrote:
"It's unlikely that anyone would find it reasonable to stress test 250
individuals to find 1 who had cardiac disease, especially considering the cost
and risk associated with testing."
3. Single-operator Ultrasound-guided IV Placement by
Emergency Nurses Reduces the Need for Physician Intervention in Patients with
Difficult-to-establish IV Access
Weiner SG, et al. J Emerg Med. 2013; 653-660.
Background: Emergency physicians (EPs) have become facile
with ultrasound-guided intravenous line (USIV) placement in patients for whom
access is difficult to achieve, though the procedure can distract the EP from
other patient care activities.
Objectives: We hypothesize that adequately trained Emergency
Nurses (ENs) can effectively perform single-operator USIV placement with less
physician intervention than is required with blind techniques.
Methods: This was a prospective multicenter pilot study.
Interested ENs received a 2-h tutorial from an experienced EP. Patients were
eligible for inclusion if they had either two failed blind peripheral
intravenous (i.v.) attempts, or if they reported or had a known history of
difficult i.v. placement. Consenting patients were assigned to have either EN
USIV placement or standard of care (SOC).
Results: Fifty patients were enrolled, of which 29 were
assigned to USIV and 21 to SOC. There were no significant differences in age,
race, gender, or reason for inclusion. Physicians were called to assist in
11/21 (52.4%) of SOC cases and 7/29 (24.1%) of USIV cases (p = 0.04). Mean time
to i.v. placement (USIV 27.6 vs. SOC 26.4 minutes, p = 0.88) and the number of
skin punctures (USIV 2.0 vs. SOC 2.1, p = 0.70) were not significantly
different. Patient satisfaction was higher in the USIV group, though the difference
did not reach statistical significance (USIV 86.2% vs. SOC 63.2%, p = 0.06).
Patient perception of pain on a 10-point scale was also similar (USIV 4.9 vs.
SOC 5.5, p = 0.50).
Conclusions; ENs performing single-operator USIV placement
in patients with difficult-to-establish i.v. access reduces the need for EP
intervention.
4. Patients Not Always Told About CT Risks
By Cole Petrochko, Staff Writer, MedPage Today. March 05,
2013
Physicians often don't communicate the risks of CT studies
to patients undergoing the scans and usually leave patients out of the
decision-making process, researchers found. A survey of patients receiving
outpatient CT scans showed that only 35% said they had discussed risks
associated with the test with a healthcare professional, according to Tanner
Caverly, MD, of the University of Colorado in Aurora, and colleagues. In
addition, 62% said they thought the final decision to undergo the procedure was
up to their doctors, the authors wrote online in the March 4 issue of JAMA
Internal Medicine.
They noted that "up to one in three imaging tests in
the U.S. are ordered in situations when the expected benefits do not
sufficiently exceed the risks," adding that "clinicians are not well
informed about the risks of medical imaging." They also wrote that prior
research has shown that fully informed patients tend to ask for fewer tests and
less aggressive care.
Caverly and colleagues studied the frequency of risk
communication among patients undergoing CT studies through a survey issued to a
sample of 271 patients at the Denver Veterans Affairs Medical Center.
Participants were mostly older than 50 (86%), male (92%), and had undergone a
prior CT scan (92%). More than one-third had received more than five CT scans
(38%).
The survey included questions on patient demographics,
presence of risk communication, preference for more information, and knowledge
of potential harms. The response rate was 94.8%.
Respondents were grouped as having basic knowledge about the
hazards of the procedure -- that CT scan was associated with higher radiation
exposure than a chest x-ray -- and those without that basic knowledge, as well
as into groups who did and did not have a discussion with a healthcare
professional about the risks and benefits of CT scan. The rate of patients who
said they knew the radiation exposure in CT scan was higher than chest x-ray
was 63%. The rate of patients who said they did not have a risk-benefit
discussion was 65%.
Only 17% reported all of the following before having the CT
scan:
·
Having a shared final decision
·
Discussing the potential benefits with the
healthcare provider
·
Talking about the potential risks with the
healthcare provider
Finally, less than 1% of patients could correctly identify
the relative amount of radiation exposure the scan exposed them to (0.4%).
"Those who reported discussing both risks and benefits with their
healthcare provider were no more likely to know that CT was associated with
more radiation than chest x-ray than were respondents not reporting a
risk-benefit discussion," the authors wrote.
In an accompanying editorial, Patrick O'Malley, MD, MPH, of
Walter Reed Army Medical Center in Washington, D.C., noted that if healthcare
professionals likely do not understand the risks associated with a test, it
cannot be expected that patients will understand those risks either.
He suggested that "much work needs to be done" to
educate physicians on the magnitude of radiation exposure and associated risks
involved in "commonly used CT scans" so that patients can fully
understand the risks of a procedure they may undertake through a discussion
that "assures patient understanding of the risks" and "should be
part of every discussion surrounding the decision to image."
The researchers noted that their study was limited by use of
a single center and a population of mostly older patients, meaning results may
not be generalizable.
5. Watching CPR Helps Ease Family's Grief
By Nancy Walsh, Staff Writer, MedPage Today. March 13, 2013
The proportion of family members with PTSD 3 months after
the resuscitative attempt was lower among those in an intervention group
routinely offered the opportunity to be present than for controls who were not
directly invited (27% versus 37%), according to Frederic Adnet, MD, PhD, of
Hôpital Avicenne in Bobigny, France, and colleagues.
The odds ratio for PTSD after not witnessing the CPR process
was 1.7 (95% CI 1.2 to 2.5, P=0.004), the researchers reported in the March 14
issue of the New England Journal of Medicine.
Whether or not witnessing CPR on a family member who
experienced cardiac arrest at home is beneficial or harmful has been
controversial ever since the topic was first addressed 25 years ago.
Some have argued that being present would be associated with
an increased emotional burden and other difficulties, not only for the family
but also for the emergency medical services team, yet the sole randomized trial
looking at this was stopped prematurely because of apparent benefits for
families. Despite the lack of evidence, international guidelines today favor
family presence during CPR.
To address the ongoing controversy, Adnet and colleagues
conducted a prospective study in which eight EMS units routinely asked family
members if they wanted to witness their attempts to resuscitate the patient,
explaining the process in a structured fashion. In seven control units, the medical
team did not systematically invite family members to witness the resuscitation
attempt.
Three months later, the researchers contacted the 570 family
members, interviewing them about PTSD symptoms on the Impact of Event Scale,
and about other symptoms on the Hospital Anxiety and Depression Scale.
A single family member was used for each patient in the
analysis, with 266 in the intervention group and 304 in the control group.
A total of 79% of family members in the intervention group
chose to be present, compared with 43% of controls.
At the 3-month interview, a total of 17% of family members
declined to participate further because of emotional distress. This included
five in the intervention group and 20 controls (P=0.007). Only 4% of patients survived
for a month or longer following CPR. In an analysis that excluded these
patients, whose family members might be experiencing less grief, the greater
likelihood of PTSD at 3 months was still higher in the control group (P=0.009).
Symptoms of anxiety were more common in the control group
than in the intervention group overall (23% versus 15%, P less than 0.001), and
also as reported by individual family members (24% versus 16%, P less than 0.001).
There was no significant difference between the intervention and control groups
in the proportion of family members who reported symptoms of depression,
although more individual members who did not witness the CPR reported symptoms
of depression (26% versus 15%, P=0.009).
Another concern the researchers addressed was whether family
members would become disruptive while witnessing the resuscitation, but this
occurred in fewer than 1% of cases. A total of 12% of those who were not
present said they wished they had been, while only 3% of those who were present
regretted it (P less than 0.001).
The median level of stress reported by the medical team
during CPR was 5 on a visual analog scale of 100 points. No family members
claimed damages or pursued lawsuits during a mean follow-up period of almost 2
years.
"Many medical team members are reluctant to permit the
presence of family members during resuscitation because of fear of medicolegal
conflicts," Adnet and colleagues noted. "Although our sample size is
small and the medicolegal culture may be different in France than elsewhere,
our findings should help allay physicians' medicolegal concerns," they
wrote.
A possible limitation of the study was its exclusion of
resuscitative attempts taking place in the hospital, and further work will be
needed to establish the generalizability of these findings to other settings.
"This study provides useful data that will advance
debate surrounding family-witnessed resuscitation," observed Daniel B.
Kramer, MD, and Susan L. Mitchell, MD, of Harvard University in an accompanying
editorial. "Most notably, when offered the choice to witness resuscitative
efforts, most relatives opted to do so, and having that choice improved mental
health outcomes, with no evidence of harm to any stakeholders," Kramer and
Mitchell wrote. "Future studies should aim to improve our understanding of
why this choice may reduce the suffering of family members and whether such an
approach could be implemented in practice in a safe and cost-effective
manner," they advised.
See also (Pros and
Cons of) Family Presence during Cardiac Resuscitation. N Engl J Med 2013;
368:1060-1062
Full-text (free): http://www.nejm.org/doi/full/10.1056/NEJMclde1301020
6. Head CT Not Useful for Evaluating Acute Dizziness
in the ED
Magnetic resonance imaging has a higher diagnostic yield.
In a retrospective chart review, investigators determined
the diagnostic yield (acute and subacute findings) of head computed tomography
(CT) in 448 adult patients who presented to a single urban academic emergency
department (ED) with acute dizziness (vertigo, lightheadedness, disequilibrium,
presyncope).
The overall diagnostic yield of head CT was 2.2%, with
emergent findings detected on only 1.6% of the scans. Of the 448 patients, 104
underwent follow-up imaging, most often with magnetic resonance imaging or angiography
(MRI/A; 78.7%). Seventeen patients (13%) had findings on follow-up imaging that
changed or confirmed the diagnosis; most of the changes in diagnosis were
ischemic stroke that was not identified on initial CT. MRI was the follow-up
modality that most often led to a change in diagnosis (16% of the time).
Comment: These findings are consistent with the
recommendation from the American College of Radiology and American College of
Emergency Physicians that head CT be used in the evaluation of acute dizziness
only when hemorrhage is the suspected cause. When an intracranial cause of
dizziness is suspected (unless the patient presents with trauma or severe
headache suspicious for hemorrhage), MRI is the test of choice.
— Richard D. Zane, MD, FAAEM. Published in Journal Watch
Emergency Medicine March 15, 2013. Citation: Lawhn-Heath C et al. Utility of
head CT in the evaluation of vertigo/dizziness in the emergency department.
Emerg Radiol 2013 Jan; 20:45. (http://dx.doi.org/10.1007/s10140-012-1071-y)
7. Incremental Value of Objective Cardiac Testing in
Addition to Physician Impression and Serial Contemporary Troponin Measurements
in Women
Diercks DB, et al. Acad Emerg Med. 2013;265-270.
Objectives: Guidelines recommend that patients presenting to
the emergency department (ED) with chest pain who are at low risk for acute
coronary syndrome (ACS) receive an objective cardiac evaluation with a stress
test or coronary imaging. It is uncertain whether all women derive benefit from
this process. The study aim was to determine the incremental value of objective
cardiac testing after serial cardiac markers and physician risk assessment.
Methods: Women enrolled in the 18-site Myeloperoxidase in
the Diagnosis of Acute Coronary Syndrome (MIDAS) study had serial troponin I
measured at time 0 and 90 minutes and physician risk assessment for the
presence of ACS. Risk estimates obtained at the time of ED evaluation were
dichotomized as high or non–high risk. The primary outcome was the composite of
acute myocardial infarction (AMI) or revascularization at 30 days. Logistic
regression with receiver operator characteristic (ROC) curves and net
reclassification index were used to determine the diagnostic accuracy for the
composite outcome of 30-day MI or revascularization for two models: 1) troponin
I results and physician risk assessment alone and 2) troponin I results,
physician risk assessment, and objective cardiac testing.
Results: A total of 460 women with a median age 58 years
(interquartile range [IQR] = 48.5 to 68 years) were included, and 32 (6.9%)
experienced AMI or revascularization by 30 days. Comparison of the area under
the ROC curves (AUC) showed that the addition of objective cardiac testing to
the combination of troponin I results and physician risk assessment did not
significantly improve prediction of 30-day AMI or revascularization (AUC = 0.85
vs. 0.89; p = 0.053). Using a threshold of 1%, net reclassification index
showed that the addition of objective cardiac testing to troponin I results and
physician risk assessment worsened the prediction for 30-day AMI and
revascularization. All of the reclassified patients were false positives, with
nine (2.1%) patients incorrectly reclassified from less than 1% risk to ≥1%
risk of 30-day AMI or revascularization.
Conclusions: In the era of contemporary troponin assays,
objective cardiac testing after an ED clinician risk assessment of non–high
risk and negative troponin I results at 0 and 90 minutes does not improve the
prediction of 30-day AMI or revascularization in women presenting with chest
pain or other symptoms of cardiac ischemia.
8. Prehospital ECG Provides Important Information
In this Canadian study, some cases of STEMI, ST-segment
depression, and arrhythmia were seen on prehospital ECGs but not on initial emergency
department ECGs.
Boothroyd LJ et al. Prehosp Emerg Care. Epub 2013 Feb 15
Background. The prehospital electrocardiogram (ECG) allows
earlier identification of acute ST-segment elevation myocardial infarction
(STEMI). Its utility for detection of other acute cardiac events, as well as
for transient ST-segment abnormalities no longer present when the first
hospital ECG is performed, is not well characterized.
Objective. We sought to examine whether the prehospital ECG
adds supplemental information to the first ECG obtained in hospital, by
comparing data on possible cardiac ischemia and arrhythmias provided by the two
ECGs, in ambulance patients later diagnosed as having cardiac disorders,
including STEMI.
Methods. Ambulance personnel acquired 12-lead ECGs for
patients suspected of having an acute ischemic event, prior to transport to
hospital. The first emergency department 12-lead ECG was provided by medical
records at the receiving hospital, and the principal hospital diagnosis for the
event was extracted from chart data. Two cardiologists, blinded to the hospital
diagnosis, provided their consensus interpretation of 1,209 pairs of ECGs,
noting the presence or absence of specific abnormalities on each tracing.
Results. Among the 82 patients who had an eventual hospital
diagnosis of STEMI, the study cardiologists identified 71 with ST-segment
elevations on the ECGs they examined. The vast majority of these (97%) were
observed on both ECGs, but the prehospital ECG showed ST-segment elevation for
two additional patients (3%). No additional instances were seen only on the
hospital ECG. Among the 116 patients with a hospital diagnosis of
non–ST-segment elevation myocardial infarction (NSTEMI), the cardiologists
identified 36 with ST-segment depressions: 28 (78%) of these were present on
both ECGs, seven (19%) only on the prehospital ECG, and one (3%) only on the
hospital ECG. Among the 567 patients with any cardiac hospital diagnosis, the
cardiologists identified 87 with arrhythmias: 73 (84%) on both ECGs, 12 (14%)
only on the prehospital ECG, and two (2%) only on the hospital ECG.
Conclusions. Beyond identifying ST-segment elevation
earlier, prehospital ECGs detect important transient abnormalities, information
not otherwise available from the first emergency department ECG. These data can
expedite diagnosis and clinical management decisions among patients suspected
of having an acute cardiac event. The prehospital ECG should be fully
integrated into emergency medicine practice.
9. ACEP Focus On
Each "Focus On" article has been planned and
implemented in accordance with the Essential Areas and Policies of the
Accreditation Council for Continuing Medical Education (ACCME). The American
College of Emergency Physicians is accredited by the ACCME to provide
continuing medical education for physicians. The American College of Emergency
Physicians designates this enduring material for a maximum of 1 AMA PRA
Category 1 CreditTM and 1 ACEP Category I credit.
Focus On: Chemical Restraint in the ED
December, 2012
Focus On: Ultrasound-Guided Paracentesis
November, 2012
Focus On: Bedside Ultrasound Assessment of Left Ventricular
Function
October, 2012
Focus On: Hypertensive Emergency
September, 2012
Focus On: Focused Renal Ultrasonography
August, 2012
Focus On: Pediatric Hip Ultrasound
July, 2012
Link to each of these reviews: http://www.acep.org/focuson/
10. Steroids Trim
Pneumonia Hospital Stays, Mortality Unchanged
Diedtra Henderson. Medscape Medical News. Mar 07, 2013
Giving steroids to adults who were hospitalized for
community-acquired pneumonia (CAP) shortened their hospital stays but had no
effect on mortality or on how much time patients spent in the intensive care
unit, according to a meta-analysis.
Majid Shafiq, MD, formerly from the Mayo Clinic College of
Medicine in Rochester, Minnesota, and now at Johns Hopkins University,
Baltimore, Maryland, and colleagues report their findings in the February issue
of the Journal of Hospital Medicine.
CAP is the most common lower respiratory tract infection
among adults in the United States. In addition, pneumonia is the most common
reason for patients to be admitted to hospitals from the emergency department,
with hospital mortality rates ranging from 5% to 18%, yet consensus guidelines
are neutral about using steroids in CAP because of unconvincing clinical trial
efficacy data.
Therefore, Dr. Shafiq and colleagues examined how steroids
affected the health of adult patients with CAP by conducting a meta-analysis of
8 randomized controlled trials published before July 2011. The trials included
a total of 1119 patients. The mean ages in 7 of the trials ranged from 60 to 80
years; the mean age in the intervention group of the eighth study was 31.7 years.
The patients taking steroids used low doses: less than 2 mg/kg/day of
methylprednisolone or an equivalent.
"Although adjunctive steroid therapy had no effect on
hospital mortality or [intensive care unit] length of stay, it was associated
with reduced hospital length of stay," Dr. Shafiq and colleagues report
(relative risk [RR], −1.21 days; 95% confidence interval [CI], −2.12 to −0.29
days). In addition, the authors found that "steroid use was associated
with lower incidence of delayed shock (ie, shock occurring after enrollment
(RR: 0.12 [95% CI: 0.03 to 0.41]) and lower incidence of persistent chest x-ray
abnormalities at 1 week (RR: 0.13 [95% CI: 0.06 to 0.27])."
Study limitations included the moderate quality of the
evidence; variations in the patients' baseline illness severity and
comorbidities and the length of follow-up; and considerable variation in
steroid therapy regimes. The authors recommend that more robust clinical trials
be conducted with tighter controls, such as standardized steroid doses,
concurrent measurement of inflammatory markers, and accurate measurement of
secondary outcomes of interest.
"In conclusion, although evidence suggests that
adjunctive steroid therapy is associated with reduced hospital length of stay,
the data are not strong enough to recommend routine use of steroids among all
adults hospitalized with CAP," the authors write. "However,
considering that there was no increase in mortality or hospital length of stay
with steroid use, it is reasonable to continue steroids if warranted for
treatment of underlying comorbid conditions."
J Hosp Med. 2013;8:68-75. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23184813
11. The NNT: Quick
summaries of evidence-based medicine.
From their webpage: “We are a group of physicians that have
developed a framework and rating system to evaluate therapies based on their
patient-important benefits and harms as well as a system to evaluate
diagnostics by patient sign, symptom, lab test or study.
“We only use the highest quality, evidence-based studies
(frequently, but not always Cochrane Reviews), and we accept no outside funding
or advertisements.”
Here are the latest blog entries:
·
Heart Diets, Heart Numbers, and Truth That Lasts
·
Delusions of Benefit in the International Stroke
Trial
·
Drugs, Data, and Deception: A True Story (on
Statins)
·
Introducing: The Modern H&P
12. Dabigatran and
Postmarketing Reports of Bleeding
Southworth MR, et al. N Engl J Med. March 13, 2013; online
first DOI: 10.1056/NEJMp1302834
In the months following the approval of the oral
anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in October 2010, the
Food and Drug Administration (FDA) received through the FDA Adverse Event
Reporting System (FAERS) many reports of serious and fatal bleeding events
associated with use of the drug. Because dabigatran is an anticoagulant,
reports of bleeding were anticipated, but the rate of reported incidents was
unusually high and was greater than the concurrent rate of reported bleeding
incidents with warfarin, which had been the anticoagulant of choice for nearly
60 years before dabigatran was approved. In contrast, the controlled trial that
supported the approval of dabigatran (Randomized Evaluation of Long-Term
Anticoagulation Therapy [RE-LY]), which compared warfarin with dabigatran in
patients with nonvalvular atrial fibrillation,1 showed that the two drugs
conferred a similar risk of bleeding.
The postmarketing reports of bleeding with dabigatran led to
discussions in medical publications as well as the mainstream media about the
agency's approval of the drug. Many of these discussions cited the large
numbers of reports of bleeding events in FAERS as a reason to question the
benefit–risk profile of dabigatran as described in its labeling. But important
factors that could have affected reporting rates, such as the novelty of
dabigatran (relative to the well-established warfarin) and the coverage of
novel drugs in the media, which can greatly influence how and when adverse
events are reported, were not generally considered.
The RE-LY trial enrolled patients with nonvalvular atrial
fibrillation and at least one risk factor for stroke. Dabigatran at a dose of
150 mg twice daily was shown to be superior to warfarin for reducing the
combined rate of stroke and systemic embolism (1.1 vs. 1.7 per 100
patient-years) among these patients. Dabigatran resulted in a lower rate of
both thrombotic and hemorrhagic strokes than warfarin, and the mortality rate
was lower in the dabigatran group than in the warfarin group (3.6 vs. 4.1 per
100 patient-years). The level of the primary risk, bleeding, was similar among
the patients who received dabigatran at a dose of 150 mg and those who received
warfarin (for major bleeding, the rates were 3.3 and 3.6 per 100 patient-years,
respectively). (Major bleeding in the RE-LY study was defined as a reduction in
hemoglobin concentration of at least 2 g per deciliter, the need to transfuse
at least 2 units of blood or packed cells, or symptomatic bleeding in a
critical area or organ.) Although major gastrointestinal bleeding events were
more frequent in the dabigatran group than in the warfarin group (1.6 vs. 1.1
per 100 patient-years), the rate of intracranial bleeding events was lower for
dabigatran than for warfarin (0.3 vs. 0.8 per 100 patient-years). The
superiority of dabigatran (at the 150-mg dose) over warfarin for reducing the
rates of stroke and systemic embolism with a similar rate of clinically
significant bleeding led to FDA approval of dabigatran.
Because the RE-LY trial had clearly shown that bleeding was
a serious side effect of dabigatran, it was expected that bleeding events would
be reported after the product was approved, but the number of reports was
sufficiently high to prompt the FDA to initiate a review of the spontaneous
reports received by FAERS. We were concerned that postmarketing use of
dabigatran might be different from its use in the RE-LY trial (e.g., different
patient populations, dosing, concomitant medications, and degree of renal
impairment) or that adjustments for renal function had not been made correctly.
As is often the case with spontaneous reports, the reports
of bleeding generally did not include information on patients' risk factors,
age, renal function, or cause of death. In a small number of cases, the
dabigatran dose had not been reduced for a patient who had impaired renal
function. Overall, however, the case review did not identify any unrecognized
risk factors for bleeding, and there was generally no indication that
dabigatran was not being used in accordance with its labeled directions….
…We believe that the large number of reported cases of
bleeding associated with dabigatran provides a salient example of stimulated
reporting. In this case, such reporting provided a distorted estimate of the
comparative bleeding rates associated with dabigatran and warfarin in clinical
practice. The Mini-Sentinel assessment suggests that bleeding rates associated
with dabigatran are not higher than those with warfarin, a finding that is
consistent with the results of RE-LY.
Although some have noted the lack of an available reversal
agent for the anticoagulant effects of dabigatran as an important limitation of
its use, data from RE-LY are reassuring with respect to bleeding. We believe
that dabigatran provides an important health benefit when used as directed.
Further analysis of the Mini-Sentinel and other claims databases is ongoing, as
is routine postmarketing surveillance through FAERS.
The remainder of the essay (free for now): http://www.nejm.org/doi/full/10.1056/NEJMp1302834
13. How Quickly Do
Germs Spread in the Office?
Betty Ann Bowser. PBS News. HEALTH. March 7, 2013
We've all done it. Come to work when we're sick.
We know we're not doing our fellow workers any favors by exposing
them to whatever we've got, but pressure to get our jobs done almost always
trumps common sense.
Well, now there is research to back up what common sense has
been telling us all along: It's a bad idea. Environmental microbiologist Kelly
Reynolds at the University of Arizona in Tucson noticed the trend in her own
office. As winter wore on, more and more of her colleagues started feeling ill.
"So we asked the obvious question: how well do germs spread if one person
comes to work sick?" she said.
So Reynolds and her team launched a study in one of the
University of Arizona offices involving a typical cast of winter characters:
several dozen coworkers in good health and one "sick" colleague
carrying a virus mimicking the flu.
Within four hours, more than 50 percent of surfaces and
employees were contaminated with the virus. Pretty startling stuff.
We spoke with Reynolds recently to learn more about her
experiment...
Interview here: http://www.pbs.org/newshour/rundown/2013/03/how-quickly-do-germs-spread-in-the-office.html
14. A randomized
open-label study of sodium valproate vs sumatriptan and metoclopramide for
prolonged migraine headache
Bakhshayesh B, et al. Amer J Emerg Med.
2013;31:540-544.
Objective: The objective of this study is to compare the
efficacy and tolerability of intravenous valproic acid (iVPA) with
intramuscular metoclopramide + subcutaneous (SQ) sumatriptan for prolonged
acute migraine.
Background: Intravenous valproic acid has been explored as a
possible treatment of acute migraine. Sumatriptan and newer generation triptans
are also effective for migraine. However, iVPA has not yet been compared with
triptans in head-to-head studies.
Methods: Patients presenting with moderate to severe
intensity migraine without aura were randomized to receive either 400 mg of
iVPA or 10 mg intramuscular metoclopramide + 6 mg SQ sumatriptan (30 patients
in each study arm). The severity of headache and other associated symptoms such
as photophobia and phonophobia were assessed at baseline and after 20 minutes
and 1, 2, 4, and 24 hours. The primary end point was to compare the efficacy of
the 2 study treatments in relieving headache from moderate-severe to none-mild
and of other associated symptoms within a period of 24 hours.
Results: Pain relief from severe or moderate to mild or none
was obtained in 53.3% of subjects in the iVPA arm and 23.3% in the
metoclopramide + sumatriptan arm at 1 hour following treatment (P = .033),
whereas 60% and 30% reported pain relief at 2 hour (P = .037). There was no
other significant difference in alleviation of associated migraine symptoms
between the 2 arms. No serious adverse effects were noted.
Conclusion: Treatment with iVPA was more effective than
metoclopramide + SQ sumatriptan during the first 2 hours in patients with a
prolonged migraine.
15. Decreasing
Hospital LOS for Bronchiolitis by Using an Observation Unit and Home Oxygen
Therapy
Sandweiss DR, et al. JAMA Pediatr. 2013;():1-7.
doi:10.1001/jamapediatrics.2013.1435.
Published online March 11, 2013.
Importance Pediatric
observation units (OUs) offer the opportunity to safely and efficiently care
for common illnesses previously cared for in an inpatient setting. Home oxygen
therapy (HOT) has been used to facilitate hospital discharge in patients with
hypoxic bronchiolitis. It is unknown how implementation of a hospitalwide
bronchiolitis treatment protocol promoting OU-HOT would affect hospital length
of stay (LOS).
Objective To test the
hypothesis that using OU-HOT for bronchiolitis would decrease LOS.
Design and Setting
Retrospective cohort study at Primary Children's Medical Center, Salt
Lake City, Utah.
Participants
Uncomplicated bronchiolitis patients younger than 2 years admitted
during the winter seasons of 2005 through 2011.
Interventions
Implementation of a new bronchiolitis care process encouraging use of an
OU-HOT protocol.
Main Outcome Measures
Mean hospital LOS, discharge within 24 hours, emergency department (ED)
bronchiolitis admission rates and ED revisit/readmission rates, and
inflation-adjusted cost.
Results A total of
692 patients with bronchiolitis from the 2010-2011 bronchiolitis season were
compared with 725 patients from the 2009-2010 season. Implementation of an
OU-HOT protocol was associated with a 22.1% decrease in mean LOS (63.3 hours vs
49.3 hours, P less than .001). Although LOS decreased during all 6 winter
seasons, linear regression and linear quantile regression analyses for the
2005-2011 LOS data demonstrated a significant acceleration in the LOS decrease
for the 2010-2011 season after implementation of the OU-HOT protocol.
Discharges within 24 hours increased from 20.0% to 38.4% (P less than .001),
with no difference in ED bronchiolitis admission or ED revisit/readmission
rates. After implementation of the OU-HOT protocol, the total cost per admitted
case decreased by 25.4% ($4800 vs $3582, P less than .001).
Conclusions and Relevance
Implementation of an OU-HOT protocol for patients with bronchiolitis
safely reduces hospital LOS with significant cost savings. Although widespread
implementation has the potential for dramatic cost savings nationally, further
studies assessing overall health care use and cost, including the impact on
families and outpatient practices, are needed.
Full-text (free for now): http://archpedi.jamanetwork.com/article.aspx?articleID=1663078&utm
16. Viewpoint: Myths
about ‘Inappropriate’ ED Visits
Smulowitz PB et al. EM News. 2013;35:3,18.
The recent Washington State Medicaid proposal to deny
payment for patients' use of EDs for a “non-emergency” reminds us of the first
“ER abuser” one of us saw as a resident. He had the characteristics typically
described in “inappropriate” users of the ED: It was his second visit in three
days for a vague complaint of trouble breathing. He seemed anxious, demanding
immediate attention despite his stable appearance. He was impoverished,
presumably uninsured or on Medicaid. And he was not cooperative, refusing to
hold still for a blood draw.
And then he died, sustaining a cardiac arrest from which he
could not be resuscitated. Absent an autopsy, the presumed diagnosis was
pulmonary embolism, missed on his previous visit.
All experienced emergency physicians have similar stories of
patients who on first assessment did not seem to have an emergency condition
but who turned out to have a life-threatening problem. Every shift we work, we
treat many patients with seemingly minor complaints, each of whom might have a
life-threatening emergency that can only be ruled out through a thorough
evaluation. How do we reconcile the inconsistency between our daily experience
and the common wisdom of policy-makers that widespread “ER abuse” for
non-emergency conditions threatens the financial viability of our medical care
system, compromises continuity of care, and causes ED crowding? And, for those
of us whose EDs serve many patients who end up not requiring high-acuity care,
how do we deal with our own burnout?
Five common misunderstandings about ED use require
understanding of the literature.
Is there a lot of
“inappropriate,” “non-emergency,” or “avoidable” ED use? Different studies
have reported the proportion of ED visits that are “inappropriate” as anywhere
from 11 percent to 82 percent. These inconsistencies largely reflect the lack
of any validated measure of “appropriateness.” (Ann Emerg Med 2001;37[6]:629.)
We cannot study its frequency without a measure of inappropriateness.
What about “appropriateness” from the patient perspective?
Patients who use the ED usually go there for two reasons: lack of access to
other providers (80%) and perception of the seriousness of the medical problem
(66%). (National Center for Health Statistics, May 2012.) It is difficult to
argue that these are “inappropriate” reasons for ED use.
Does ED use disrupt
continuity of care? Many frequent ED users also have frequent visits to
their primary care physicians. These high utilizers of overall health care
services suffer from poor physical or mental health. (Ann Emerg Med
2006;48[1]:1.) Their chronic illnesses — not their ED use — are what make it
challenging to coordinate their care. That said, many of the care coordination
challenges need to be dealt with better. Improving the coordination of care for
patients seen in the ED calls for new models of team-based care. It will be one
of our biggest challenges, yet it may also provide one of the greatest sources
of satisfaction in the years to come.
Is the ED costly?
It is the charge for ED care that is so substantial, not the cost. Like many
parts of the medical care delivery system, EDs cost-shift, charging more for
lower intensity visits to be able to afford the resources needed for the most
seriously ill and injured patients. But ED care accounts for only two to four
percent of total U.S. medical expenditures. The major cost drivers of medical
spending are in-patient care (29%), office-based care (24%), and prescription
drugs (20%). Put simply, policy changes that led to a three percent drop in
these costs would save more money than eliminating half the charges for ED
care.
Does “inappropriate
ED use” cause ED crowding? The “input” side of ED use has little to do with
ED crowding. Rather, the major contributor is “output,” the time it takes to
move admitted patients out of the ED into an inpatient bed. (Ann Emerg Med
2003;42[2]:173.) Many EDs' biggest challenge is the loss of beds because they
are boarding psychiatric patients. Even if we could figure out ahead of time
which discharged patients didn't need to be in the ED, we wouldn't make a dent
in the problem of crowding.
Is ED “overuse” easy
to fix? Health care organizations have tried a variety of strategies to
reduce ED utilization, with mixed results. Creating barriers to emergen cy
medical care through triage or preauthorization requirements carries risks. The
most effective strategies have been higher copayments and the extension of
primary care availability.
We still don't know, however, what level of copayments is
safe, and evidence suggests that lower-income patients may be placed at higher
risk by such copayments. (Health Serv Res 2008;43[2]:515.) Moreover, the
reasons people use EDs for care are complex and not likely to be “fixed” by any
single organizational strategy. One possibility for the long term is that the
move toward Accountable Care Organizations will redirect our focus on improving
overall health for populations. The consequence of this is that better health
(and improved value) will be the main outcome measure, not a single data point
like “inappropriate” use of the ED.
I know what to say to policy-makers, but what do I tell my
colleagues and myself when we are being hammered by Medicaid patients with
toothaches? Difficult as it may be during a busy shift, try not to blame the
victim. Instead, think about how current patterns of ED use present opportunity
for solutions. Three percent of Medicaid and five percent of uninsured ED
visits in Oregon are primarily for dental conditions. Let's advocate for
safety-net dental clinics!
A tenfold variation exists between the different communities
in Oregon Health Plan enrollees' ED utilization rates. (Med Care
2009;47[1]:15.) What can we learn from the low-use communities? Philadelphia
Medicaid enrollees whose primary care providers have 12 or more evening hours a
week use EDs 20 percent less than enrollees whose primary care physicians lack
evening hours. (Med Care Aug 2005;43[8]:792.) How can we incentivize providers
to expand hours?
We emergency physicians see the successes — and failures —
of the entire health care system, and we — like no others — are in a position
to advocate for our patients and to fix the system.
17. Unusual Headache
Syndromes
Queiroz LP. Headache. 2013;53(1):12-22.
Objective/Background.—Some headache syndromes have few cases
reported in the literature. Their clinical characteristics, pathogenesis, and
treatment may have not been completely defined. They may not actually be
uncommon but rather under-recognized and/or underreported.
Methods.—A literature review of unusual headache syndromes,
searching PubMed and ISI Web of Knowledge, was performed. After deciding which
disorders to study, relevant publications in scientific journals, including
original articles, reviews, meeting abstracts, and letters or correspondences
to the editors were searched.
Findings.—This paper reviewed the clinical characteristics,
the pathogenesis, the diagnosis, and the treatment of five interesting and
unusual headache syndromes: exploding head syndrome, red ear syndrome,
neck-tongue syndrome, nummular headache, and cardiac cephalgia.
Conclusions.—Recognizing some unusual headaches, either
primary or secondary, may be a challenge for many non-headache specialist
physicians. It is important to study them because the correct diagnosis may
result in specific treatments that may improve the quality of life of these
patients, and this can even be life saving.
Full-text: http://www.medscape.com/viewarticle/779107
18. Treating
Cirrhotics: What's the NNT?
David H. Newman, MD. EP Monthly. February 18, 2013
Q: Does it help to use prophylactic antibiotics during
management of gastrointestinal bleeding in cirrhotic patients?
A: Yes! (by Daniel P.
Runde, MD)
Take Home Message: Antibiotics for cirrhotics with upper GI
bleeding appear to save lives by reducing infections.
Q: Do somatostatin analogues drugs improve survival or
reduce morbidity during acute variceal bleeding?
A: NO! (by Lucy
Willis, MD)
Take Home Message: Somatostatin analogues like octreotide
did not reduce morbidity or mortality in randomized trials of patients with
variceal bleeding.
Further elaboration here: http://www.epmonthly.com/features/current-features/treating-cirrhotics-whats-the-nnt-/
19. Recognition of
Psychogenic Non-epileptic Seizures: A Curable Neurophobia?
O'Sullivan SS, et al. J Neurol Neurosurg Psychiatry. 2013;84(2):228-231.
Background Diagnosing psychogenic non-epileptic seizures
(PNES) remains challenging. The majority of 'PNES status' cases are likely to
be seen in the emergency department or similar non-specialised units, where
patients are initially assessed and managed by physicians of varying expertise
in neurology.
Methods 216 participants including medical students and
doctors of all grades from a wide range of medical disciplines were shown video
recordings of six patients with PNES and six other patients with convulsive
epileptic seizures (ES). Participants were asked to choose between PNES and ES
as a diagnosis and to rate their confidence in each diagnosis, both before and
after a 15-minute teaching presentation on PNES and ES.
Results Pre-teaching sensitivity for diagnosing PNES was
0.77, specificity 0.55. The positive predictive value (PPV) of diagnosing PNES
was 0.63, and was 0.7 for ES. Diagnostic accuracy increased with increasing
clinical grades (p=0.022), as did clinical confidence (p less than 0.0005).
Clinical accuracy and clinical confidence increased post-teaching (p less than 0.0005).
Sensitivity for diagnosing PNES post-teaching improved to 0.88, specificity to
0.67. The PPV of diagnosing PNES increased to 0.72, and to 0.84 for ES.
Conclusions Diagnosing PNES can be improved by clinical
experience in neurology and focussed teaching interventions.
Full-text: http://www.medscape.com/viewarticle/778435
20. Study Criticizes
Policy Penalizing Nonemergency ED Visits
Robert Lowes, Medscape Medical News. Mar 19, 2013
In an effort to control Medicaid costs, some state
legislators have wanted to deny or limit payment for emergency department (ED)
visits if a later discharge diagnosis indicated the problem was a nonemergency
that could have been handled in a physician's office.
Good luck making that work, says a new study published in
the Journal of the American Medical Association (JAMA). Lead author Maria
Raven, MD, MPH, and colleagues write that in ED visits later deemed to be
primary care treatable based on the discharge diagnosis, patients presented the
same chief complaints given by the vast majority of all ED patients.
In other words, clinicians can't accurately predict an ED
discharge diagnosis based on the chief complaint at the time of the visit.
Initially, true emergencies and nonemergencies look an awful lot alike.
Remainder of the essay: http://www.medscape.com/viewarticle/781081
Full-text (free): http://jama.jamanetwork.com/article.aspx?articleid=1669818
21. Phenobarbital for
Acute Alcohol Withdrawal: A Prospective Randomized Double-blind Placebo-controlled
Study
Rosenson J, et al. J Emerg Med. 2013;44: 592-598.e2
Background: Acute alcohol withdrawal syndrome (AAWS) is
encountered in patients presenting acutely to the Emergency Department (ED) and
often requires pharmacologic management.
Objective: We investigated whether a single dose of
intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based
alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED
patients with acute alcohol withdrawal.
Methods: This was a prospective, randomized, double-blind,
placebo-controlled study. Patients were randomized to receive either a single
dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100
mL normal saline). All patients were placed on the institutional symptom-guided
lorazepam-based alcohol withdrawal protocol. The primary outcome was initial
level of hospital admission (ICU vs. telemetry vs. floor ward).
Results: There were 198 patients enrolled in the study, and
102 met inclusion criteria for analysis. Fifty-one patients received
phenobarbital and 51 received placebo. Baseline characteristics and severity
were similar in both groups. Patients that received phenobarbital had fewer ICU
admissions (8% vs. 25%, 95% confidence interval 4–32). There were no
differences in adverse events.
Conclusions: A single dose of i.v. phenobarbital combined
with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in
decreased ICU admission and did not cause increased adverse outcomes.
22. FYIs
A.
Azithromycin Poses Fatal Cardiac Risk, FDA Warns
Robert Lowes. Medscape Medical News. Mar 12, 2013
The popular antibiotic azithromycin (Zithromax and Zmax,
Pfizer) poses the risk for a potentially fatal irregular heart rhythm, which
therefore warrants careful screening of patients for this drug, the US Food and
Drug Administration (FDA) announced today.
The macrolide-class antibiotic can cause abnormal changes in
the electrical activity of the heart that may prolong the QT interval and
trigger a rare, associated arrhythmia called torsades de pointes.
The FDA stated that patients at risk for this
azithromycin-induced arrhythmia include those who already have a prolonged QT
interval, low blood levels of potassium or magnesium, and an abnormally slow
heart rate, or who take drugs to treat arrhythmias. Elderly patients and
patients with cardiac disease also may be more susceptible to the
arrhythmogenic effects of the antibiotic.
The agency advised clinicians to put the cardiac risk for
azithromycin in an "appropriate context," because other antibiotics
in the macrolide class as well as nonmacrolides such as fluoroquinolones can
prolong the heart's QT interval.
The FDA safety announcement about azithromycin follows a
review of a study conducted by Pfizer on the antibiotic's effect on cardiac
electrical activity and another study published in the New England Journal of
Medicine in May 2012. The study reported that patients receiving a 5-day course
of azithromycin had a small, increased risk for sudden cardiac death compared
with those who received amoxicillin or no antibiotics. The FDA said at the time
that it would review these findings.
The agency has updated the label of azithromycin to warn of
the risk for QT interval prolongation and torsades de pointes.
More information about today's drug safety communication is
available on the FDA Web site: http://www.fda.gov/Drugs/DrugSafety/ucm341822.htm
B.
Hardening of the arteries an ancient disease
Atherosclerosis was common in four preindustrial populations
including preagricultural hunter-gatherers. Although commonly assumed to be a
modern disease, the presence of atherosclerosis in premodern humans raises the
possibility of a more basic predisposition to the disease.
C. CDC: Norovirus is
top cause of acute gastroenteritis in young children
An estimated 1 million medical visits by U.S. children
younger than age 5 every year are attributed to norovirus infection, exceeding
for the first time visits linked to rotovirus, CDC researchers said. They
reported that the annual cost of norovirus-related acute gastroenteritis was
$273 million.
D. Surgery is not
routinely needed for presumed symptomatic meniscal tears in patients with knee
osteoarthritis
E. Drug for Severe
Sepsis Not a Life Saver
Eritoran, a novel agent that blocks inflammatory reactions
to the major endotoxin from gram-negative bacteria, doesn’t help save lives in
severe sepsis, the ACCESS trial showed.
