How the ACEP Clinical Policies Standardize How the ACEP Clinical Policies Standardize and Improve Patient Careand Improve Patient Care

Andy Jagoda, MD, FACEPAndy Jagoda, MD, FACEPProfessor of Emergency MedicineProfessor of Emergency MedicineMount Sinai School of MedicineMount Sinai School of Medicine

New York, New YorkNew York, New York

ObjectivesObjectives

• Introduce the process of how clinical policies / Introduce the process of how clinical policies / practice guidelines are developedpractice guidelines are developed

• Discuss the medical legal implications of practice Discuss the medical legal implications of practice guidelinesguidelines

• Use examples from practice guidelines on brain Use examples from practice guidelines on brain injury and headache to demonstrate applications to injury and headache to demonstrate applications to patient carepatient care

ACEP and Clinical PoliciesACEP and Clinical Policies

• Committee formed in 1987 Committee formed in 1987

• Meetings with DM EddyMeetings with DM Eddy

• Fatal flaw: decision to concentrate on Fatal flaw: decision to concentrate on symptoms or complaintssymptoms or complaints

• Topics chosen from complaints with high Topics chosen from complaints with high frequency, high risk, or high costfrequency, high risk, or high cost

• New directionsNew directions

Clinical Policies / Practice GuidelinesClinical Policies / Practice Guidelines

• Over 3000 in existenceOver 3000 in existence

• ACEP: 15ACEP: 15

• Chest Pain 1990Chest Pain 1990

• Sunsetting - no longer distributedSunsetting - no longer distributed

• Archive – reviewed and kept on websiteArchive – reviewed and kept on website

• National Guideline Clearinghouse: National Guideline Clearinghouse:

• www.guideline.govwww.guideline.gov

• Over 550 guidelines registeredOver 550 guidelines registered

Why are clinical policies being written?Why are clinical policies being written?

• Differentiate “evidence based” practice from “opinion Differentiate “evidence based” practice from “opinion based”based”• Clinical decision makingClinical decision making• EducationEducation• Reducing the risk of legal liability for negligenceReducing the risk of legal liability for negligence

• Improve quality of health careImprove quality of health care• Assist in diagnostic and therapeutic managementAssist in diagnostic and therapeutic management

• Improve resource utilizationImprove resource utilization• May decrease or increase costsMay decrease or increase costs

• Identify areas in need of researchIdentify areas in need of research

Guideline Development: Time and CostGuideline Development: Time and Cost

• Time: 1- many yearsTime: 1- many years

• Cost: Cost:

• ACEP:ACEP: $10,000$10,000

• AANS:AANS: $100,000$100,000

• AHCPR:AHCPR: $1,000,000$1,000,000

• WHO:WHO: $2,000,000$2,000,000

Interpreting the literatureInterpreting the literature

• TerminologyTerminology

• Mild traumatic brain injuryMild traumatic brain injury

• Patient populationPatient population

• Children vs adultsChildren vs adults

• CT + vs CT -CT + vs CT -

• Interventions / outcomesInterventions / outcomes

• Any brain lesionAny brain lesion

• Lesion requiring ns interventionLesion requiring ns intervention

Critically Appraising Clinical PoliciesCritically Appraising Clinical Policies

• Why was the topic chosenWhy was the topic chosen• What are the authors’ credentialsWhat are the authors’ credentials• What methodology was usedWhat methodology was used• Was it field tested Was it field tested • When was it written / updatedWhen was it written / updated

Do clinical policies change practice?Do clinical policies change practice?• ACEP Chest Pain Policy: Emergency physician ACEP Chest Pain Policy: Emergency physician

awareness. Ann Emerg Med 1996; 27:606-609Clinical awareness. Ann Emerg Med 1996; 27:606-609Clinical policy published in 1990policy published in 1990• 163 / 338 (48%) response to survey163 / 338 (48%) response to survey• 54% aware of the policy54% aware of the policy• Majority of those aware did not know contentMajority of those aware did not know content

• Wears. Headaches from practice guidelines. Ann Emerg Wears. Headaches from practice guidelines. Ann Emerg Med 2002; 39:334-337 Med 2002; 39:334-337 • 60% of practicing EPs use narcotics as first line 60% of practicing EPs use narcotics as first line

medicationsmedications• Canadian Headache Society. Guidelines for the Canadian Headache Society. Guidelines for the

diagnosis and management of Migraine in clinical diagnosis and management of Migraine in clinical practice. practice.

• Can Med Assoc J 1997; 156:1273-128US Headache Can Med Assoc J 1997; 156:1273-128US Headache Consortium. Consortium. www.www.aanaan.com/public/practice.com/public/practice guidelines guidelines

Cabana et al. Why don’t physicians follow clinical Cabana et al. Why don’t physicians follow clinical practice guidelines. JAMA 1999; 282:1458-1465practice guidelines. JAMA 1999; 282:1458-1465

• Review of 76 articles dealing with adherenceReview of 76 articles dealing with adherence• Barriers to physician adherence identified:Barriers to physician adherence identified:

• Lack of familiarity (more common than lack awarenessLack of familiarity (more common than lack awareness• Lack of agreementLack of agreement• Lack of self-efficicy (lack of access to intervention, lack Lack of self-efficicy (lack of access to intervention, lack

of resources / support / social systems)of resources / support / social systems)• Thrombolytics in strokeThrombolytics in stroke

• Lack of outcome expectancy (lack of confidence that an Lack of outcome expectancy (lack of confidence that an intervention will change the outcome)intervention will change the outcome)

• Amiodarone in v-fibAmiodarone in v-fib

• Patient related barriers (inability to overcome patient Patient related barriers (inability to overcome patient expectation)expectation)

• Ottawa ankle rulesOttawa ankle rules

Medical Legal ImplicationsMedical Legal Implications

• Clinical policies can set standards for care and Clinical policies can set standards for care and

have been used in malpractice litigation have been used in malpractice litigation

• May protect against “expert” testimonyMay protect against “expert” testimony

• Regional practice vs national “standards”Regional practice vs national “standards”

• Steroids in spinal traumaSteroids in spinal trauma

• Clinical policies developed using flawed Clinical policies developed using flawed

methodology may be challenged methodology may be challenged

• Consensus / Policy statementsConsensus / Policy statements

““Do the authors seriously believe that patients Do the authors seriously believe that patients with a first seizure can be discharged from the with a first seizure can be discharged from the ED after a serum glucose and a pregnancy test ED after a serum glucose and a pregnancy test without additional lab testing? This flies in the without additional lab testing? This flies in the face of common sense and would perhaps be face of common sense and would perhaps be considered malpractice in some parts of the considered malpractice in some parts of the country.”country.”

Journal Reviewer 1995Journal Reviewer 1995

Medical Legal ImplicationsMedical Legal Implications

• 1994 Physician Payment Review Commission1994 Physician Payment Review Commission• 32 cases reviewed where guidelines were used to 32 cases reviewed where guidelines were used to

demonstrate departure from “standard of care” demonstrate departure from “standard of care” • 259 insurance claims carriers: 6.6% cited 259 insurance claims carriers: 6.6% cited

guidelines guidelines • 980 attorneys surveyed:980 attorneys surveyed:

• 75% were aware of practice guidelines 75% were aware of practice guidelines

• 36% reported cases with important role 36% reported cases with important role

• 25% reported that they had influenced a decision to 25% reported that they had influenced a decision to settle or not take a casesettle or not take a case

Deposition of Dr. X in a case of missed meningitisDeposition of Dr. X in a case of missed meningitis

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

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

Q. Yes.Q. Yes.

A. I don’t recall reading it.A. I don’t recall reading it.

Deposition of Dr. X in a case of missed meningitisDeposition of Dr. X in a case of missed meningitis

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

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

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

A. It is part of the package.A. It is part of the package.

Clinical Policy: Critical issues in the evaluation and Clinical Policy: Critical issues in the evaluation and management of patients presenting to the ED with management of patients presenting to the ED with

acute headache. Ann Emerg Med 2002; 39:108-122acute headache. Ann Emerg Med 2002; 39:108-122

• Does a response to therapy predict the etiology of an acute Does a response to therapy predict the etiology of an acute headache?headache?

• Level A recommendation: NoneLevel A recommendation: None

• Level B recommendation: NoneLevel B recommendation: None

• Level C recommendation: Pain response to therapy Level C recommendation: Pain response to therapy should not be used as the sole indicator of the should not be used as the sole indicator of the underlying etiology of an acute headacheunderlying etiology of an acute headache

Guideline DevelopmentGuideline Development

• Informal Consensus Informal Consensus

• Formal consensusFormal consensus

• Evidence basedEvidence based

Informal ConsensusInformal Consensus

• Group of experts assembleGroup of experts assemble

• ““Global subjective judgement”Global subjective judgement”

• Recommendations not necessarily Recommendations not necessarily

supported by scientific evidencesupported by scientific evidence

• Limited by biasLimited by bias

Informal Consensus: ExamplesInformal Consensus: Examples

• MAST trousers in traumatic shockMAST trousers in traumatic shock• Hyperventilation in severe TBIHyperventilation in severe TBI• Oxygen for patient with chest painOxygen for patient with chest pain• Magnesium level for patients who have Magnesium level for patients who have

had a seizurehad a seizure

Formal ConsensusFormal Consensus

• Group of experts assembleGroup of experts assemble• Appropriate literature reviewedAppropriate literature reviewed• Recommendations not necessarily Recommendations not necessarily

supported by scientific evidence supported by scientific evidence • Limited by bias and lack of defined Limited by bias and lack of defined

analytic proceduresanalytic procedures

Formal Consensus: LimitationsFormal Consensus: Limitations

• Plain film radiographs after head traumaPlain film radiographs after head trauma• Phenytoin to prevent development of Phenytoin to prevent development of

epilepsy after head traumaepilepsy after head trauma

Evidence Based GuidelinesEvidence Based Guidelines

• Define the clinical questionDefine the clinical question• Focused question better than global Focused question better than global

questionquestion• Outcome measure must be determinedOutcome measure must be determined

• Grade the strength of evidenceGrade the strength of evidence• Incorporate practice patterns, available Incorporate practice patterns, available

expertise, resources and risk benefit expertise, resources and risk benefit ratiosratios• External validityExternal validity

Description of the ProcessDescription of the Process

• Medical literature searchMedical literature search

• Secondary search of referencesSecondary search of references

• Articles graded Articles graded

• Recommendations based on strength Recommendations based on strength

of evidenceof evidence

• Multi-specialty and peer reviewMulti-specialty and peer review

Description of the ProcessDescription of the Process

Strength of evidence (Class of evidence)Strength of evidence (Class of evidence)

• I:I: Randomized, double blind interventional studies Randomized, double blind interventional studies for therapeutic effectiveness; prospective cohort for for therapeutic effectiveness; prospective cohort for diagnostic testing or prognosisdiagnostic testing or prognosis

• II:II: Retrospective cohorts, case control studies, cross- Retrospective cohorts, case control studies, cross-sectional studiessectional studies

• III:III: Observational reports; consensus reports Observational reports; consensus reports

Strength of evidence can be downgraded based on Strength of evidence can be downgraded based on methodologic flawsmethodologic flaws

Description of the process:Description of the process:

Strength of recommendations:Strength of recommendations:

• A / Standard:A / Standard: Reflects a high degree of Reflects a high degree of

certainty based on Class I studiescertainty based on Class I studies

• B / Guideline:B / Guideline: Moderate clinical certainty Moderate clinical certainty

based on Class II studiesbased on Class II studies

• C / Option:C / Option: Inconclusive certainty based Inconclusive certainty based

on Class III evidenceon Class III evidence

Evidence Based Guidelines: LimitationsEvidence Based Guidelines: Limitations

• Different groups can read the same Different groups can read the same evidence and come up with different evidence and come up with different recommendationsrecommendations• MTBIMTBI• t-PA in stroket-PA in stroke• Steroids in spinal traumaSteroids in spinal trauma

Concussion in SportsConcussion in Sports

• American Academy of NeurologyAmerican Academy of Neurology• Evidence based methodologyEvidence based methodology• Concussion: a trauma induced alteration in Concussion: a trauma induced alteration in

mental status, with or without LOCmental status, with or without LOC• Confusion and amnesia are the hallmarksConfusion and amnesia are the hallmarks

• Justifications:Justifications:• Repeated concussions can cause cumulative Repeated concussions can cause cumulative

brain injurybrain injury• Provide physicians with guidelines to help Provide physicians with guidelines to help

overcome the bias in management from overcome the bias in management from athletes, coaches, media, spectatorsathletes, coaches, media, spectators

Guidelines for the management of concussion Guidelines for the management of concussion in sports. American Academy of Neurologyin sports. American Academy of Neurology

• Grade 1: Grade 1: Confusion: No LOC or amnesiaConfusion: No LOC or amnesia• remove from event for 20 minutesremove from event for 20 minutes• 2 grade 1 concussions; no play for one day2 grade 1 concussions; no play for one day• 3 grade 1 concussions; no play for 3 months3 grade 1 concussions; no play for 3 months

• Grade 2: Grade 2: No amnesia; + amnesiaNo amnesia; + amnesia• remove from eventremove from event• no play for 1 weekno play for 1 week• 2 grade 2 concussions; no play for 1 month2 grade 2 concussions; no play for 1 month• 3 grade 2 concussions; no play for the season3 grade 2 concussions; no play for the season

• Grade 3: Grade 3: LOCLOC• hospital evaluationhospital evaluation• no play for 1 monthno play for 1 month• 2 grade 3 concussions: no play for the season 2 grade 3 concussions: no play for the season

Guidelines for Prehospital Management of TBIGuidelines for Prehospital Management of TBI

• Multidisciplinary: Brain Trauma Multidisciplinary: Brain Trauma Foundation / Grant from NHTSA Foundation / Grant from NHTSA

• Evidence BasedEvidence Based• Prehospital care is the “first link” Prehospital care is the “first link”

in appropriate care in TBIin appropriate care in TBI• Prehospital providers play a key Prehospital providers play a key

role in determining the need for role in determining the need for trauma center accesstrauma center access

Guidelines for Prehospital Management Guidelines for Prehospital Management of TBIof TBI

• Identifies the need for focused prehospital Identifies the need for focused prehospital researchresearch

• Establishes need to perform a field assessment Establishes need to perform a field assessment including vital signs, GCS, pupilsincluding vital signs, GCS, pupils

• Guidelines: Hypotension and hypoxia must be Guidelines: Hypotension and hypoxia must be preventedprevented• Option: Secure the airway with intubationOption: Secure the airway with intubation

• Option: Herniation should be treated with Option: Herniation should be treated with hyperventilationhyperventilation

ED Management of MTBI in AdultsED Management of MTBI in Adults

• Multidisciplinary group funded by a grant Multidisciplinary group funded by a grant from the IBIA: ACEP, ASNR, AANSfrom the IBIA: ACEP, ASNR, AANS

• Evidence based: Three Questions:Evidence based: Three Questions:• Is there a role for plain film radiographs in Is there a role for plain film radiographs in

the assessment of MTBI in the EDthe assessment of MTBI in the ED• Which patients with acute MTBI should Which patients with acute MTBI should

have a noncontrast head CT in the EDhave a noncontrast head CT in the ED• Can a patient with MTBI be safely Can a patient with MTBI be safely

discharged from the ED if a noncontrast discharged from the ED if a noncontrast CT shows no evidence of acute injuryCT shows no evidence of acute injury

ED Management of MTBI in AdultsED Management of MTBI in Adults

• Blunt trauma to the head within 24 Blunt trauma to the head within 24 hours of presentation to the EDhours of presentation to the ED

• Any period of post-traumatic LOC or Any period of post-traumatic LOC or PTAPTA

• A GCS score at initial evaluation in A GCS score at initial evaluation in the ED of 15the ED of 15

• A nonfocal neurologic examA nonfocal neurologic exam• Age greater than 15 yearsAge greater than 15 years

ED Management of MTBI in AdultsED Management of MTBI in Adults

• Outcome measures in the TBI literature:Outcome measures in the TBI literature:• Acute traumatic abnormality on CTAcute traumatic abnormality on CT• Clinical deteriorationClinical deterioration• Need for neurosurgical interventionNeed for neurosurgical intervention• Development of post-concussive Development of post-concussive

syndromesyndrome• Outcome measure for this policy:Outcome measure for this policy:

• Presence of an acute intracranial Presence of an acute intracranial abnormality on noncontrast head CTabnormality on noncontrast head CT

Is there a role for plain film radiographs in Is there a role for plain film radiographs in the assessment of MTBI in the EDthe assessment of MTBI in the ED

• Masters 1987 NEJM: Prospective study 7035 pts.Masters 1987 NEJM: Prospective study 7035 pts.• Flawed methodology. 63% with + xray had - CT; 50% with Flawed methodology. 63% with + xray had - CT; 50% with

+CT had negative xray+CT had negative xray• Skull films have low sensitivity for intracranial lesionsSkull films have low sensitivity for intracranial lesions

• Hoffman 2000 Lancet: Meta-analysisHoffman 2000 Lancet: Meta-analysis• 20 articles reviewed out of 200 identified20 articles reviewed out of 200 identified• Sensitivity .13-.75; PPV of skull fracture in predicting +CT .4Sensitivity .13-.75; PPV of skull fracture in predicting +CT .4• Specificity .9-.99; NPVof skull fracture in predicting +CT .94 Specificity .9-.99; NPVof skull fracture in predicting +CT .94

• Recommendation Level B:Recommendation Level B: Skull films are not recommended in Skull films are not recommended in the evaluation of MTBI; although the presence of a skull film the evaluation of MTBI; although the presence of a skull film increases the likelihood of an intracranial lesion, its sensitivity is increases the likelihood of an intracranial lesion, its sensitivity is not high enough to allow it to be a useful screennot high enough to allow it to be a useful screen

• Various studies in patients with a GCS of 15 report a 5% - Various studies in patients with a GCS of 15 report a 5% - 15% incidence of an intracranial lesion15% incidence of an intracranial lesion

• .3-.5 incidence of lesions needing neurosurgical intervention.3-.5 incidence of lesions needing neurosurgical intervention• Stiell 2001 Lancet. Prospective 3021 patientsStiell 2001 Lancet. Prospective 3021 patients

• Outcome: Neurosurgical interventionOutcome: Neurosurgical intervention• 67% had CT; only 33% of the remainder had telephone 67% had CT; only 33% of the remainder had telephone

follow-upfollow-up• Survey used to determine “insignificant” lesions: patients Survey used to determine “insignificant” lesions: patients

with those lesions were not followed upwith those lesions were not followed up• 5 high risk predictors: failure to reach GCS 15 within 2 5 high risk predictors: failure to reach GCS 15 within 2

hours; suspected open skull fracture; sign of basal skull hours; suspected open skull fracture; sign of basal skull fracture; vomiting more than once; age over 64fracture; vomiting more than once; age over 64

• High risk factors were 100% sensitive identifying need for High risk factors were 100% sensitive identifying need for neurosurgery and would decrease CT by 68%neurosurgery and would decrease CT by 68%

Which patients with acute MTBI should Which patients with acute MTBI should have a noncontrast head CT in the EDhave a noncontrast head CT in the ED

Which patients with acute MTBI should Which patients with acute MTBI should have a noncontrast head CT in the EDhave a noncontrast head CT in the ED

• Haydel 2000 NEJM; Class I study; 2 phasesHaydel 2000 NEJM; Class I study; 2 phases

• Phase I 520 patients to establish predictive criteriaPhase I 520 patients to establish predictive criteria

• Phase II 909 patients to validate criteriaPhase II 909 patients to validate criteria

• 7 predictors identified with 100% sensitivity for 7 predictors identified with 100% sensitivity for predicting intracranial lesion. predicting intracranial lesion.

• Use of criteria would decrease head CT by 22%Use of criteria would decrease head CT by 22%

• No follow-up provided after dischargeNo follow-up provided after discharge• Recommendation Level A:Recommendation Level A: A head CT is not recommended A head CT is not recommended

in those patients with MTBI who do not have HA, vomiting, in those patients with MTBI who do not have HA, vomiting, age > 60, drug or ETOH intoxication, deficits in short term age > 60, drug or ETOH intoxication, deficits in short term memory, physical evidence of trauma above the clavicle, or memory, physical evidence of trauma above the clavicle, or seizure.seizure.

Can a patient with MTBI be safely discharged from the Can a patient with MTBI be safely discharged from the ED if a noncontrast CT shows no evidence of acute injuryED if a noncontrast CT shows no evidence of acute injury

• Stein 1992 J Trauma. Retrospective Stein 1992 J Trauma. Retrospective

• 1339 patients with negative CT, none deteriorated1339 patients with negative CT, none deteriorated

• Dunham 1996 J Trauma Infect Crit Care. Retrospective review of a Dunham 1996 J Trauma Infect Crit Care. Retrospective review of a prospectively collected data baseprospectively collected data base

• 2587 patients, no patient with a negative CT deteriorated; those patients 2587 patients, no patient with a negative CT deteriorated; those patients who did deteriorate (without initial CT), did so within 4 hourswho did deteriorate (without initial CT), did so within 4 hours

• Nagy 1999 J Trauma Infect Crit Care. Retrospective Nagy 1999 J Trauma Infect Crit Care. Retrospective

• 1190 patients with CT and admission1190 patients with CT and admission

• No patient with a negative CT deteriorated (spectrum bias towards No patient with a negative CT deteriorated (spectrum bias towards sicker patients)sicker patients)

• Recommendation Level C:Recommendation Level C: Patients with MTBI who are 6 hours out from Patients with MTBI who are 6 hours out from their injury and who have a head CT that does not demonstrate acute injury their injury and who have a head CT that does not demonstrate acute injury can be safely discharged from the ED can be safely discharged from the ED

Severe TBI GuidelinesSevere TBI Guidelines

• AANS / Grant from the BTFAANS / Grant from the BTF• StandardsStandards

• prophylactic hyperventilation should be avoidedprophylactic hyperventilation should be avoided• use of glucocosteriods is not recommended use of glucocosteriods is not recommended • prophylactic phenytoin is not recommended for late szprophylactic phenytoin is not recommended for late sz

• Guidelines:Guidelines:• hypotension and hypoxia must be avoidedhypotension and hypoxia must be avoided• ICP monitoring is appropriateICP monitoring is appropriate• mannitol is effective for controlling raised ICPmannitol is effective for controlling raised ICP

• OptionsOptions• Hyperventilation may be necessary for brief periods Hyperventilation may be necessary for brief periods

when there is acute neurologic deteriorationwhen there is acute neurologic deterioration• AEDs may be used to prevent early posttraumatic szAEDs may be used to prevent early posttraumatic sz

Huizenga et al. Guidelines for the management of severe Huizenga et al. Guidelines for the management of severe head injury: Are emergency physicians following them? head injury: Are emergency physicians following them? Acad Emerg Med 2002; 9:806-812Acad Emerg Med 2002; 9:806-812

• 319 / 566 survey responses (56%) to 3 cases319 / 566 survey responses (56%) to 3 cases• 78% corrected hypotension78% corrected hypotension• 46% used prophylactic hyperventilation46% used prophylactic hyperventilation• 14% used glucocorticoids14% used glucocorticoids• 8% used prophylactic mannitol8% used prophylactic mannitol

• Authors conclusion: A majority of emergency Authors conclusion: A majority of emergency physicians are managing TBI according to the physicians are managing TBI according to the guidelinesguidelines

• My conclusion: 7 years post publication, a My conclusion: 7 years post publication, a significant number of emergency physicians are significant number of emergency physicians are not correctly managing severe TBInot correctly managing severe TBI

ConclusionsConclusions

• Evidence based clinical policies are useful Evidence based clinical policies are useful tools in clinical decision makingtools in clinical decision making

• Clinical policy development must be rigorousClinical policy development must be rigorous• Clinical policies do not create a “standard of Clinical policies do not create a “standard of

care” and do not necessarily override “expert care” and do not necessarily override “expert witness”witness”

• Clinical policy dissemination continues to be Clinical policy dissemination continues to be a challengea challenge