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Practice
Guidelines: Development and Applications
to Clinical Decision Making
A
Focus on Seizures and Status Epilepticus:
Key Learning Points
Overview
of Practice Guidelines
William Dalsey,
MD, MBA
How do you
create a Clinical Guideline?
1. The best review of the
general principles for clinical guideline development may be the series
of articles in JAMA written by David Eddy. He has also written a book
on the subject called Clinical Decision Making: From Theory to Practice,
Jones and Bartlett 1996. In the writings he emphasizes the need for
open communication of the members creating the guidelines, their process
and criteria for evaluating and using literature, establishing criteria
for the strength of recommendations and honest communication of when
cons ensus is used.
2. ACEP's Clinical Policy
Committee has published their process for creating Clinical Policies
and our grading system for evaluating the literature in the Annals of
Emergency Medicine, but it is also available on our website. We have
begun using critical clinical questions to focus our clinical policies
on key areas. This allows for easier literature searches and the creation
of better evidence tables.
3. The topics selected for
clinical guidelines may be generated from interested physicians, attempts
by other physician groups to dictate care in the ED without using an
appropriate evidence-based approach, frequency or severity of clinical
problems, and development of new diagnostic or therapeutic interventions.
4. We use a subcommittee
process that allows us to have members from the main clinical policy
committee that are familiar with our process and format, as well as
seeking experts to participate from outside the committee.
5. One of the most important
aspects to successfully creating a useful clinical guideline is to make
sure that the key clinical questions are appropriately designed to facilitate
a literature search and determining as answer. The existence of Clinical
Guidelines in the area you have chosen can be identified by using the
databases of clinical policies available on the web.(ie. www.guideline.gov
and Cochrane Library) Experts can identify key articles on the topic
area, and their bibliographies may be valuable. Almost everyone performs
a computerized search of the medical literature. This can be more difficult
than it might appear. Broad searches frequently identify more articles
than can be reviewed and narrow searches can miss key articles that
need to be included.
6. When possible the best
scientific evidence comes from prospective randomized controlled clinical
trials. Meta-analysis and other statistical techniques can be used to
combine the results of several small trials to answer some questions.
However, many clinical questions can't be adequately answered by the
existing literature. In these cases it is necessary to clearly state
that the literature does not provide an answer or to clearly indicate
when expert consensus is used to provide an answer.
Types
of Guidelines
Andy Jagoda,
MD
1. All guidelines are not
the same; methodology used to develop the guideline must be assessed.
2. Consensus guidelines are
the easiest to write but are of limited value due to bias which may
impact the guidelines development.
3. Evidence based guidelines
are theoretically the most valid type of guideline.
4. Evidence based guidelines
must utilize well-defined outcome measures in answering the questions
asked and the evidence must be systematically reviewed and graded.
Clinical
Guidelines: Do they make a difference in practice?
J. Stephen
Huff, MD
1. What are the goals
in creating clinical guidelines and in what scenarios are they likely
to be of use?
The goals of clinical guidelines
are admirable with improved efficiency, decreased variation, safe practice
environments, patient safety, and monetary savings all targets. Clinical
scenarios where guidelines are likely to be useful include infrequent
clinical events with poor outcomes and clinical problems where there
is diagnostic or therapeutic uncertainty.
2. What factors deter
clinicians from not using guidelines?
Many clinicians voice concerns
that guidelines may not apply to an individual patient. Other reasons
cited for lack of guideline use include physician unawareness, specialty-specific
formulation ("turf"), and lack of need for a guideline with
a specific problem.
3. What are some examples
of guidelines for common clinical guidelines?
ACLS and the Ottawa ankle
rules are cited as examples of guidelines that are often followed likely
because they fulfill clinical needs. Traumatic brain injury guidelines
and migraine guidelines have been found not to be followed by emergency
physicians for a variety of reasons.
4. How can physician behavior
be changed?
Each clinical scenario should
be examined to identify likely reasons for noncompliance. Didactic presentations
have been shown to be ineffective in changing physician behavior. Performance
feedback with both positive and negative rewards is advocated to effect
change.
The Use
of Clinical Guidelines for Educational Efforts in the Academic Setting
Edward P. Sloan,
MD, MPH
1. All lectures regarding
clinical care that are given to Emergency Medicine residents and faculty
should utilize evidence-based clinical guidelines.
2. The search of the medical literature and internet should include
the following steps:
a. Search the medical
literature using MEDLINE/PubMed.
b. Perform an internet search using www.google.com or another search
engine.
c. Look at the websites for foundations relevant to your clinical
topic.
d. Look at the websites for physician organizations that are relevant
to your topic.
e. Determine if guidelines are available at www.guidelines.gov.
f. Search for Cochrane library reviews using www.update-software.com.
g. Find cases and radiographs using radiology teaching files.
3. The educational experience can be maximized by providing content
in the following way:
a. Utilize journal club
articles to direct individual learning off-line.
b. Make the lecture available via the internet using videostreaming
technology.
c. Provide the content via CD-ROM or the internet using PDF files.
4. Inform the learners as to how you conducted your search and what
publications and websites were utilized so that they can do similar
work when they present a lecture.
5. Please examine the FERNE website at www.FERNE.org for relevant examples.
Evaluation
of the ED Patient with a First Time Seizure
Andy Jagoda,
MD
1. Patients with a first
time seizure with no co-morbidities should have a serum glucose, electrolytes;
women of child bearing age should have a pregnancy test. Patients with
co-morbidities should be considered for more extensive metabolic profiling.
(Class II and Class III evidence)
2. Patients with a first
time seizure should have a noncontrast head CT in the emergency department.
(Class II evidence; no outcome data to support recommendation)
3. Patients with a first
time seizure with HIV should have a lumbar puncture either in the ED
or after admission to the hospital. (Class II data)
4. Patients with a first
time seizure who have a normal head CT, glucose and electrolytes, and
normal neurologic examination can be safely discharged from the ED on
no AED therapy. (Class III data)
5. AED therapy has potential
complications and risk of recurrence is multifactorial; initiation of
AED therapy is best reserved for the physician who will assume primary
care of the patient. (Class III data)
Oral
Versus Intravenous Loading of Anticonvulsants
Edwin Kuffner,
MD
1. No well designed study
has addressed the short term rate of seizure recurrence and the short
term rate and severity of adverse events by directly comparing any of
the common contemporary dosing strategies used to treat a patient with
who presents to the emergency department after having had a seizure
with a "subtherapeutic" phenytoin level. A serum phenytoin
level > 10 mg/L can be achieved by all of the common contemporary
dosing strategies including intravenous loading, oral loading and starting/restarting
oral maintenance dosing.
2. Fewer adverse local effects
(phlebitis, purple glove syndrome and tissue necrosis) and fewer adverse
systemic effects (impairment of myocardial contractility, dysrhythmias,
hypotension and cardiac arrest) are associated with intravenous fosphenytoin
administration when compared to intravenous phenytoin administration.
3. This difference in adverse
effects between parenteral phenytoin and fosphenytoin is believed to
be in part related to the fact that parenteral phenytoin preparations
contain propylene glycol (40%) and ethanol (10%) and are adjusted to
a pH of 12. Fosphenytoin which is more water soluble does not contain
these same diluents and has a more physiologic pH of 8.6 to 9.
4. Fosphenytoin is significantly
more expensive than intravenous phenytoin.
First
Line Therapy in Acute Seizure Management
William Dalsey,
MD, MBA
1. Use a benzodiazepine as
the first-line therapy.
2. If there is no IV access
consider IM versed or posphenytoin, or rectal valium.
3. Lorazepam is the preferred
first line agent for seizure control due to its long lasting anticonvulsant
properties.
4. Diazepam is equally effective
but requires that a concomitant, long acting AED be administered (ie
Dilantin).
5. When the IV access is
unavailable, alternate routes such as IM injections of midazolam, rectal
solutions of diazepam, and IM fosphenytoin should be considered; of
the three, IM midazolam is probably the fastest and easiest to use.
Emergency
Department Management of Patients with Seizures and SE: The Role of Therapies
Utilizes After Initial Benzodizepine Therapy
Edward P. Sloan,
MD, MPH
1. There is good data to
support the initial use of benzodizepines in ED paitents with seizures
and SE. Both lorazepam and diazepam are useful IV agents, with slightly
different characteristics that guide ED use.
2. The phenytoins are a useful
second agent for use in ED SE patients. Factors such as the need for
a rapid infusion, safety, the need for IM use, and cost will guide the
ED physician in selecting fosphenytoin over phenytoin. Both may be useful
in doses up to 30 mg/kg in SE patients.
3. Phenobarbital and valproate
may be useful for the treatment of ED SE patients who are refractory
to the benzodiazepines and phenytoins, as well as in pediatric patients.
4. Propofol can be utilized
to achieve burst suppression in refractory SE patients, as can an IV
midazolam infusion.
Status
Epilepticus Classification and Emergent EEG Use in The Emergency Department
J. Stephen
Huff, MD
1. What is status epilepticus?
Typically status epilepticus is defined as 30 minutes of continuous
seizure activity or a series of seizures without return to full consciousness
between the seizures. Many feel that pathophysiologic studies suggest
that a shorter period of seizure activity causes neuronal injury and
suggest 20 minutes or briefer times define status epilepticus. A consensus
panel states that aggressive treatment for generalized convulsive status
epilepticus should be initiated when a seizure has persisted 10 minutes
and further states that patients still seizing on arrival to the emergency
department should be aggressively treated. There is controversy in the
term "nonconvulsive status epilepticus" (NCSE). Currently,
nonconvulsive status epilepticus is best reserved for absence status
epilepticus and partial complex status epilepticus. The term "subtle
status epilepticus" is more correctly used to indicate patients
that have evolved from generalized convulsive status epilepticus or
are in a comatose state with epileptiform activity.
2. Why is status epilepticus
a medical emergency?
Generalized tonic-clonic (GTC) status epilepticus injures the brain
even if acidosis, ventilation, and hemodynamic factors are controlled.
Studies indicate that the longer GTC status continues, the less likely
it is to terminate spontaneously. Secondary complications may further
injure the brain.
3. When is an EEG indicated
in the emergency department?
Recommendations have been made to obtain emergency EEG for persistent
altered consciousness, refractory status epilepticus, pharmacologically
managed sedation and coma, and for the diagnosis of viral encephalitis
as well as for a variety of other clinical conditions including coma
and brain death. The most compelling argument for emergent EEG is for
the detection of generalized convulsive status epilepticus that may
have evolved into subtle status epilepticus with continuing abnormal
electroencephalograhic discharges. In spite of recommendations,
a recently published multicenter survey of management of patients with
seizures revealed that EEG was uncommonly performed in ED's and only
rarely in the ED for the indication of status epilepticus. A survey
of medical directors of accredited North American clinical EEG laboratories
and directors of facilities offering accredited EEG fellowships revealed
that the majority of facilities required neurologic consultation or
other specialized consultation before emergent EEG could be obtained.
In spite of recommendations,
no clear guidelines mandate EEG use by emergency physicians. Neurologic
consultation is the pathway for assistance in problematic cases.
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