How the ACEP Clinical Policies Standardize
        and Improve Patient Care

           Andy Jagoda, MD, FACEP
        Professor of Emergency Medicine
         Mount Sinai School of Medicine
              New York, New York

• Introduce the process of how clinical policies /
  practice guidelines are developed
• Discuss the medical legal implications of practice
• Use examples from practice guidelines on brain
  injury and headache to demonstrate applications to
  patient care
    ACEP and Clinical Policies
• Committee formed in 1987
• Meetings with DM Eddy
• Fatal flaw: decision to concentrate on
  symptoms or complaints
• Topics chosen from complaints with high
  frequency, high risk, or high cost
• New directions
Clinical Policies / Practice Guidelines

  • Over 3000 in existence
  • ACEP: 15
     • Chest Pain 1990
     • Sunsetting - no longer distributed
     • Archive – reviewed and kept on website
  • National Guideline Clearinghouse:
     • Over 550 guidelines registered
 Why are clinical policies being written?

• Differentiate “evidence based” practice from “opinion
   • Clinical decision making
   • Education
   • Reducing the risk of legal liability for negligence
• Improve quality of health care
   • Assist in diagnostic and therapeutic management
• Improve resource utilization
   • May decrease or increase costs
• Identify areas in need of research
Guideline Development: Time and Cost

   • Time: 1- many years
   • Cost:
     • ACEP:       $10,000
     • AANS:       $100,000
     • AHCPR:      $1,000,000
     • WHO:        $2,000,000
Interpreting the literature

• Terminology
   • Mild traumatic brain injury
• Patient population
   • Children vs adults
   • CT + vs CT -
• Interventions / outcomes
   • Any brain lesion
   • Lesion requiring ns intervention
Critically Appraising Clinical Policies

  •   Why was the topic chosen
  •   What are the authors’ credentials
  •   What methodology was used
  •   Was it field tested
  •   When was it written / updated
   Do clinical policies change practice?
• ACEP Chest Pain Policy: Emergency physician
  awareness. Ann Emerg Med 1996; 27:606-609Clinical
  policy published in 1990
   • 163 / 338 (48%) response to survey
   • 54% aware of the policy
   • Majority of those aware did not know content
• Wears. Headaches from practice guidelines. Ann Emerg
  Med 2002; 39:334-337
   • 60% of practicing EPs use narcotics as first line
   • Canadian Headache Society. Guidelines for the
     diagnosis and management of Migraine in clinical
   • Can Med Assoc J 1997; 156:1273-128US Headache
     Consortium. guidelines
Cabana et al. Why don’t physicians follow clinical
practice guidelines. JAMA 1999; 282:1458-1465
 • Review of 76 articles dealing with adherence
 • Barriers to physician adherence identified:
    • Lack of familiarity (more common than lack awareness
    • Lack of agreement
    • Lack of self-efficicy (lack of access to intervention, lack
      of resources / support / social systems)
        • Thrombolytics in stroke
    • Lack of outcome expectancy (lack of confidence that an
      intervention will change the outcome)
        • Amiodarone in v-fib
    • Patient related barriers (inability to overcome patient
        • Ottawa ankle rules
        Medical Legal Implications

• Clinical policies can set standards for care and
  have been used in malpractice litigation
• May protect against “expert” testimony
   • Regional practice vs national “standards”
   • Steroids in spinal trauma
• Clinical policies developed using flawed
  methodology may be challenged
   • Consensus / Policy statements
“Do the authors seriously believe that patients
with a first seizure can be discharged from the
ED after a serum glucose and a pregnancy test
without additional lab testing? This flies in the
face of common sense and would perhaps be
considered malpractice in some parts of the

                                 Journal Reviewer 1995
            Medical Legal Implications

• 1994 Physician Payment Review Commission
• 32 cases reviewed where guidelines were used to
  demonstrate departure from “standard of care”
• 259 insurance claims carriers: 6.6% cited
• 980 attorneys surveyed:
  • 75% were aware of practice guidelines
  • 36% reported cases with important role
  • 25% reported that they had influenced a decision to
    settle or not take a case
 Deposition of Dr. X in a case of missed meningitis

Q. Do you read the policies of the American College of ER

A. I don’t recall reading that policy. Is it something
   published by ACEP?

Q. Yes.

A. I don’t recall reading it.
  Deposition of Dr. X in a case of missed meningitis

Q. So if torodol releives a headache, does that cause you to
   believe the patient does not have meningitis in a patient in
   whom you are suspecting meningitis a a possible cause of
   their headache

A. It’s an indicator that would decrease the likelihood.

Q. If torodol relieved their headache, would you rely on that
   as a factor in ruling out meningitis?

A. It is part of the package.
Clinical Policy: Critical issues in the evaluation and
 management of patients presenting to the ED with
acute headache. Ann Emerg Med 2002; 39:108-122

• Does a response to therapy predict the etiology of an acute
   • Level A recommendation: None
   • Level B recommendation: None
   • Level C recommendation: Pain response to therapy
     should not be used as the sole indicator of the
     underlying etiology of an acute headache
Guideline Development

• Informal Consensus

• Formal consensus

• Evidence based
      Informal Consensus

• Group of experts assemble
• “Global subjective judgement”
• Recommendations not necessarily
 supported by scientific evidence
• Limited by bias
    Informal Consensus: Examples

•   MAST trousers in traumatic shock
•   Hyperventilation in severe TBI
•   Oxygen for patient with chest pain
•   Magnesium level for patients who have
    had a seizure
        Formal Consensus

• Group of experts assemble
• Appropriate literature reviewed
• Recommendations not necessarily
  supported by scientific evidence
• Limited by bias and lack of defined
  analytic procedures
    Formal Consensus: Limitations

• Plain film radiographs after head trauma
• Phenytoin to prevent development of
  epilepsy after head trauma
  Evidence Based Guidelines

• Define the clinical question
   • Focused question better than global
   • Outcome measure must be determined
• Grade the strength of evidence
• Incorporate practice patterns, available
  expertise, resources and risk benefit
   • External validity
  Description of the Process

• Medical literature search
• Secondary search of references
• Articles graded
• Recommendations based on strength
 of evidence
• Multi-specialty and peer review
       Description of the Process

Strength of evidence (Class of evidence)
   • I: Randomized, double blind interventional studies
     for therapeutic effectiveness; prospective cohort for
     diagnostic testing or prognosis
   • II: Retrospective cohorts, case control studies, cross-
     sectional studies
   • III: Observational reports; consensus reports
Strength of evidence can be downgraded based on
  methodologic flaws
        Description of the process:

Strength of recommendations:

  • A / Standard: Reflects a high degree of
  certainty based on Class I studies

  • B / Guideline: Moderate clinical certainty
  based on Class II studies

  • C / Option: Inconclusive certainty based
  on Class III evidence
Evidence Based Guidelines: Limitations

   • Different groups can read the same
     evidence and come up with different
      • MTBI
      • t-PA in stroke
      • Steroids in spinal trauma
            Concussion in Sports

• American Academy of Neurology
• Evidence based methodology
• Concussion: a trauma induced alteration in
  mental status, with or without LOC
      • Confusion and amnesia are the hallmarks
• Justifications:
   • Repeated concussions can cause cumulative
     brain injury
   • Provide physicians with guidelines to help
     overcome the bias in management from
     athletes, coaches, media, spectators
Guidelines for the management of concussion
 in sports. American Academy of Neurology
     • Grade 1: Confusion: No LOC or amnesia
        • remove from event for 20 minutes
        • 2 grade 1 concussions; no play for one day
        • 3 grade 1 concussions; no play for 3 months
     • Grade 2: No amnesia; + amnesia
        • remove from event
        • no play for 1 week
        • 2 grade 2 concussions; no play for 1 month
        • 3 grade 2 concussions; no play for the season
     • Grade 3: LOC
        • hospital evaluation
        • no play for 1 month
        • 2 grade 3 concussions: no play for the season
Guidelines for Prehospital Management of TBI

     • Multidisciplinary: Brain Trauma
       Foundation / Grant from NHTSA
     • Evidence Based
     • Prehospital care is the “first link”
       in appropriate care in TBI
     • Prehospital providers play a key
       role in determining the need for
       trauma center access
   Guidelines for Prehospital Management
                   of TBI

• Identifies the need for focused prehospital
• Establishes need to perform a field assessment
  including vital signs, GCS, pupils
• Guidelines: Hypotension and hypoxia must be
   • Option: Secure the airway with intubation
• Option: Herniation should be treated with
     ED Management of MTBI in Adults

• Multidisciplinary group funded by a grant
  from the IBIA: ACEP, ASNR, AANS
• Evidence based: Three Questions:
   • Is there a role for plain film radiographs in
     the assessment of MTBI in the ED
   • Which patients with acute MTBI should
     have a noncontrast head CT in the ED
   • Can a patient with MTBI be safely
     discharged from the ED if a noncontrast
     CT shows no evidence of acute injury
ED Management of MTBI in Adults

• Blunt trauma to the head within 24
  hours of presentation to the ED
• Any period of post-traumatic LOC or
• A GCS score at initial evaluation in
  the ED of 15
• A nonfocal neurologic exam
• Age greater than 15 years
  ED Management of MTBI in Adults

• Outcome measures in the TBI literature:
  • Acute traumatic abnormality on CT
  • Clinical deterioration
  • Need for neurosurgical intervention
  • Development of post-concussive
• Outcome measure for this policy:
  • Presence of an acute intracranial
    abnormality on noncontrast head CT
          Is there a role for plain film radiographs in
               the assessment of MTBI in the ED
• Masters 1987 NEJM: Prospective study 7035 pts.
   • Flawed methodology. 63% with + xray had - CT; 50% with
     +CT had negative xray
   • Skull films have low sensitivity for intracranial lesions
• Hoffman 2000 Lancet: Meta-analysis
   • 20 articles reviewed out of 200 identified
   • Sensitivity .13-.75; PPV of skull fracture in predicting +CT .4
   • Specificity .9-.99; NPVof skull fracture in predicting +CT .94
• Recommendation Level B: Skull films are not recommended in
  the evaluation of MTBI; although the presence of a skull film
  increases the likelihood of an intracranial lesion, its sensitivity is
  not high enough to allow it to be a useful screen
      Which patients with acute MTBI should
      have a noncontrast head CT in the ED
• Various studies in patients with a GCS of 15 report a 5% -
  15% incidence of an intracranial lesion
• .3-.5 incidence of lesions needing neurosurgical intervention
• Stiell 2001 Lancet. Prospective 3021 patients
    • Outcome: Neurosurgical intervention
    • 67% had CT; only 33% of the remainder had telephone
    • Survey used to determine “insignificant” lesions: patients
      with those lesions were not followed up
    • 5 high risk predictors: failure to reach GCS 15 within 2
      hours; suspected open skull fracture; sign of basal skull
      fracture; vomiting more than once; age over 64
    • High risk factors were 100% sensitive identifying need for
      neurosurgery and would decrease CT by 68%
      Which patients with acute MTBI should
      have a noncontrast head CT in the ED
• Haydel 2000 NEJM; Class I study; 2 phases
   • Phase I 520 patients to establish predictive criteria
   • Phase II 909 patients to validate criteria
   • 7 predictors identified with 100% sensitivity for
      predicting intracranial lesion.
   • Use of criteria would decrease head CT by 22%
   • No follow-up provided after discharge
• Recommendation Level A: A head CT is not recommended
  in those patients with MTBI who do not have HA, vomiting,
  age > 60, drug or ETOH intoxication, deficits in short term
  memory, physical evidence of trauma above the clavicle, or
Can a patient with MTBI be safely discharged from the
ED if a noncontrast CT shows no evidence of acute injury
 • Stein 1992 J Trauma. Retrospective
     • 1339 patients with negative CT, none deteriorated
 • Dunham 1996 J Trauma Infect Crit Care. Retrospective review of a
   prospectively collected data base
     • 2587 patients, no patient with a negative CT deteriorated; those patients
       who did deteriorate (without initial CT), did so within 4 hours
 • Nagy 1999 J Trauma Infect Crit Care. Retrospective
     • 1190 patients with CT and admission
     • No patient with a negative CT deteriorated (spectrum bias towards
       sicker patients)
 • Recommendation Level C: Patients with MTBI who are 6 hours out from
   their injury and who have a head CT that does not demonstrate acute injury
   can be safely discharged from the ED
               Severe TBI Guidelines
• AANS / Grant from the BTF
• Standards
   • prophylactic hyperventilation should be avoided
   • use of glucocosteriods is not recommended
   • prophylactic phenytoin is not recommended for late sz
• Guidelines:
   • hypotension and hypoxia must be avoided
   • ICP monitoring is appropriate
   • mannitol is effective for controlling raised ICP
• Options
   • Hyperventilation may be necessary for brief periods
     when there is acute neurologic deterioration
   • AEDs may be used to prevent early posttraumatic sz
Huizenga et al. Guidelines for the management of severe
head injury: Are emergency physicians following them?
Acad Emerg Med 2002; 9:806-812
     • 319 / 566 survey responses (56%) to 3 cases
        • 78% corrected hypotension
        • 46% used prophylactic hyperventilation
        • 14% used glucocorticoids
        • 8% used prophylactic mannitol
     • Authors conclusion: A majority of emergency
       physicians are managing TBI according to the
     • My conclusion: 7 years post publication, a
       significant number of emergency physicians are
       not correctly managing severe TBI

• Evidence based clinical policies are useful
  tools in clinical decision making
• Clinical policy development must be rigorous
• Clinical policies do not create a “standard of
  care” and do not necessarily override “expert
• Clinical policy dissemination continues to be
  a challenge

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