1. Andy Jagoda, MD, FACEP Clinical Policies: What are they? How are they developed? How do they improve patient care?

2. Andy Jagoda, MD, FACEP FERNE/EMRA Session Chicago, IL May 18, 2007

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

4. Andy Jagoda, MD, FACEP Disclosures FERNE Executive Board, Treasurer FERNE grants by industry Participation on industry-sponsored advisory boards and as lecturer in programs supported by industry ACEP Clinical Policy Committee

5. Andy Jagoda, MD, FACEP Why are clinical policies written? Differentiate “evidence based” practice from “opinion based” practice Differentiate “evidence based” practice from “opinion based” practice Clinical decision making Clinical decision making Education Education Reducing the risk of legal liability for negligence Reducing the risk of legal liability for negligence

6. Andy Jagoda, MD, FACEP Why are clinical policies written? Improve quality of health care Improve quality of health care Assist in diagnostic and therapeutic management Assist in diagnostic and therapeutic management Improve resource utilization Improve resource utilization May decrease or increase costs May decrease or increase costs Identify areas in need of research Identify areas in need of research

7. Andy Jagoda, MD, FACEP Clinical Policies & Practice Guidelines Thousands in existence Thousands in existence ACEP: 16 ACEP: 16 Chest Pain 1990Chest Pain 1990 Sunsetting - no longer distributedSunsetting - no longer distributed National Guideline Clearinghouse: National Guideline Clearinghouse: www.guideline.gov www.guideline.gov www.guideline.gov Over 1700 registered Over 1700 registered

8. Andy Jagoda, MD, FACEP 2006 / 2007 Objectives Continue developing / updating clinical policies Continue developing / updating clinical policies Review and comment on other organizations’ guidelines Review and comment on other organizations’ guidelines Continue to promote interdisciplinary clinical policy development Continue to promote interdisciplinary clinical policy development Develop clinical quality measures for emergency medicine Develop clinical quality measures for emergency medicine Develop a strategy to integrate clinical policies into informatic technology (IT) systems Develop a strategy to integrate clinical policies into informatic technology (IT) systems

9. Andy Jagoda, MD, FACEP Clinical Policies in Review or Preparation Toxic ingestion Toxic ingestion Acetaminophen / hyperbaric oxygen Acetaminophen / hyperbaric oxygen Abdominal pain Abdominal pain Syncope Syncope Community acquired pneumonia Community acquired pneumonia Headache Headache Early pregnancy Early pregnancy Pulmonary embolism Pulmonary embolism Deep vein thrombosis Deep vein thrombosis Pediatric fever Pediatric fever Acute stroke Acute stroke

10. Andy Jagoda, MD, FACEP Guideline Development: Time and Cost Time: 1 - 5 YEARS Time: 1 - 5 YEARS Cost: Cost: ACEP:$10,000 ACEP:$10,000 AANS:$100,000 AANS:$100,000 AHCPR:$1,000,000 AHCPR:$1,000,000 WHO:$2,000,000 WHO:$2,000,000

11. Andy Jagoda, MD, FACEP Multi-disciplinary Clinical Policies Neuroimaging in new onset seizures Neuroimaging in new onset seizures Diagnosis and management of MTBI Diagnosis and management of MTBI Pediatric fever Pediatric fever Pediatric sedation and analgesia Pediatric sedation and analgesia Management of ED patients with acute psychiatric complaints Management of ED patients with acute psychiatric complaints Management of acute stroke Management of acute stroke

12. Andy Jagoda, MD, FACEP Critically Appraising Clinical Policies Why was the topic chosen? Why was the topic chosen? t-PA in stroke t-PA in stroke Sedation and analgesia Sedation and analgesia What are the authors’ credentials? What are the authors’ credentials? Were emergency physicians included? Were emergency physicians included? What methodology was used? What methodology was used? Consensus vs evidence based Consensus vs evidence based How as it reviewed? How as it reviewed? When was it written / updated? When was it written / updated?

13. Andy Jagoda, MD, FACEP Do clinical policies change practice? ACEP Chest Pain Policy: Emergency physician awareness. Ann Emer Med 1996; 27:606-609 ACEP Chest Pain Policy: Emergency physician awareness. Ann Emer Med 1996; 27:606-609 Clinical policy published in 1990 Clinical policy 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

14. Andy Jagoda, MD, FACEP Do clinical policies change practice? Wears. Headaches from practice guidelines. Ann Emer Med 2002; 39:334-337 Wears. Headaches from practice guidelines. Ann Emer Med 2002; 39:334-337 Canadian Headache Society. Guidelines for the diagnosis and management of Migraine in clinical practice.Canadian Headache Society. Guidelines for the diagnosis and management of Migraine in clinical practice. Can Med Assoc J 1997; 156:1273-128US Headache Consortium. www.aan.com/public/practice guidelinesCan Med Assoc J 1997; 156:1273-128US Headache Consortium. www.aan.com/public/practice guidelines www.aan.com/public/practice 60% of practicing EPs use narcotics as first line medications60% of practicing EPs use narcotics as first line medications

15. Andy Jagoda, MD, FACEP Why don’t physicians follow clinical practice guidelines? JAMA 1999; 282:1458-1465 Cabana et al. JAMA 1999; 282:1458-1465 Cabana et al. Review of 76 articles dealing with adherence Review of 76 articles dealing with adherence Barriers to physician adherence identified: Barriers to physician adherence identified: Lack of familiarity (more common than lack of awareness)Lack of familiarity (more common than lack of awareness) Lack of agreementLack of agreement Lack of self-efficacy (lack of access to intervention, lack of resources / support / social systems)Lack of self-efficacy (lack of access to intervention, lack of resources / support / social systems) Lack of outcome expectancy (lack of confidence that an intervention will change the outcome)Lack of outcome expectancy (lack of confidence that an intervention will change the outcome) Patient related barriers (inability to overcome patient expectation)Patient related barriers (inability to overcome patient expectation)

16. Andy Jagoda, MD, FACEP Guideline Development Consensus Consensus Evidence based Evidence based

17. Andy Jagoda, MD, FACEP Consensus Group of experts assemble Group of experts assemble “Global subjective judgement” “Global subjective judgement” Recommendations not necessarily supported by scientific evidence Recommendations not necessarily supported by scientific evidence Limited by bias Limited by bias

18. Andy Jagoda, MD, FACEP Consensus: Examples MAST trousers in traumatic shock MAST trousers in traumatic shock Hyperventilation in severe TBI Hyperventilation in severe TBI Narcotics in migraine headache therapy Narcotics in migraine headache therapy Blood cultures in CAP / 4 hour time antibiotic rule of CAP Blood cultures in CAP / 4 hour time antibiotic rule of CAP “Keep the brain dry” in severe TBI “Keep the brain dry” in severe TBI

19. Andy Jagoda, MD, FACEP Consensus: Examples Gastric freezing for ulcers Gastric freezing for ulcers Case series, historical controls in 1960s Case series, historical controls in 1960s ~15,000 pts treated ~15,000 pts treated RCT showed ineffective in 1969 RCT showed ineffective in 1969 Lidocaine prophylaxis in AMI Lidocaine prophylaxis in AMI Intermediate outcome: suppress PVCs, VT Intermediate outcome: suppress PVCs, VT Pt centered outcome: increased mortality Pt centered outcome: increased mortality

20. Andy Jagoda, MD, FACEP Evidence Based Guidelines Define the clinical question Define the clinical question Focused question better than global question Focused question better than global question Outcome measure must be determined Outcome measure must be determined Grade the strength of evidence Grade the strength of evidence Incorporate practice patterns, available expertise, resources and risk benefit ratios Incorporate practice patterns, available expertise, resources and risk benefit ratios

21. Andy Jagoda, MD, FACEP Two Separate Questions How strong is the evidence from one study? How strong is the evidence from one study? Critical appraisal Critical appraisal How strong is the combined evidence from multiple studies? How strong is the combined evidence from multiple studies? Synthesis Synthesis Consistency in magnitude, direction Consistency in magnitude, direction Sufficiency Sufficiency Greater risk, cost, implausibility require greater evidence Greater risk, cost, implausibility require greater evidence

22. Andy Jagoda, MD, FACEP Interpreting the literature Terminology Terminology MTBI: GCS of 15 or GCS 13-15? MTBI: GCS of 15 or GCS 13-15? Patient population Patient population Adult vs children Adult vs children ED patients vs hospitalized patients ED patients vs hospitalized patients AHA / ACC recommendations AHA / ACC recommendations

23. Andy Jagoda, MD, FACEP Interpreting the literature Interventions / outcomes Interventions / outcomes Head trauma: abnormal CT or neurosurgical lesion? Head trauma: abnormal CT or neurosurgical lesion? Status epilepticus: end of motor activity or end of abnormal neuronal firing? Status epilepticus: end of motor activity or end of abnormal neuronal firing?

24. Andy Jagoda, MD, FACEP Description of the Process Medical literature search Medical literature search Secondary search of references Secondary search of references Articles graded Articles graded Recommendations based on evidence strength Recommendations based on evidence strength Multi-specialty and peer review Multi-specialty and peer review

25. Andy Jagoda, MD, FACEP 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 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 II: Retrospective cohorts, case control studies, cross-sectional studies III: Observational reports; consensus reports III: Observational reports; consensus reports Strength of evidence can be downgraded based on methodological flaws

26. Andy Jagoda, MD, FACEP Description of the Process Strength of recommendations: Strength of recommendations: A / Standard: Reflects a high degree of certainty based on Class I studies A / Standard: Reflects a high degree of certainty based on Class I studies B / Guideline: Moderate clinical certainty based on Class II studies B / Guideline: Moderate clinical certainty based on Class II studies C / Option: Inconclusive certainty based on Class III evidence C / Option: Inconclusive certainty based on Class III evidence

27. Andy Jagoda, MD, FACEP Description of the Process Different societies use different classification schemes which may impact applications of the recommendation Different societies use different classification schemes which may impact applications of the recommendation ACEP Class I evidence must have high quality support; AHA allows Class I evidence to include “general agreement that a given procedure or treatment is useful and effective” ACEP Class I evidence must have high quality support; AHA allows Class I evidence to include “general agreement that a given procedure or treatment is useful and effective” AHA Class Ic recommendation is based on consensus of experts AHA Class Ic recommendation is based on consensus of experts

28. Andy Jagoda, MD, FACEP Evidence Based Guidelines: Limitations Different groups can read the same evidence and come up with different recommendations Different groups can read the same evidence and come up with different recommendations Outcome measure can be major factor Outcome measure can be major factor MTBI MTBI t-PA in stroke t-PA in stroke

29. Andy Jagoda, MD, FACEP Medico-Legal Implications Clinical policies can set standards for care and have been used in malpractice litigation Clinical policies can set standards for care and have been used in malpractice litigation May protect against “expert” testimony May protect against “expert” testimony Regional practice vs national “standards” Regional practice vs national “standards”  Steroids in spinal trauma

30. Andy Jagoda, MD, FACEP Medico-Legal Implications Clinical policies developed using flawed methodology may be challenged Clinical policies developed using flawed methodology may be challenged Consensus / Policy statements Consensus / Policy statements

31. Andy Jagoda, MD, FACEP Deposition of Dr. X in a case of missed meningitis Q. Do you read the policies of the American College of ER physicians? A. I don’t recall reading that policy. Is it something published by ACEP? Q. Yes. A. I don’t recall reading it.

32. Andy Jagoda, MD, FACEP Deposition of Dr. X in a case of missed meningitis Q. So if toradol relieves 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.

33. Andy Jagoda, MD, FACEP Deposition of Dr. X in a case of missed meningitis Q. If toradol relieved their headache, would you rely on that as a factor in ruling out meningitis? A. It is part of the package.

34. Andy Jagoda, MD, FACEP Clinical Policy: Critical issues in the evaluation and management of patients presenting to the ED with acute headache. Ann Emer Med 2002; 39:108-122 Ann Emer Med 2002; 39:108-122 Does a response to therapy predict the etiology of an acute headache? Does a response to therapy predict the etiology of an acute headache? Level A recommendation: None Level A recommendation: None Level B 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 Level C recommendation: Pain response to therapy should not be used as the sole indicator of the underlying etiology of an acute headache

35. Andy Jagoda, MD, FACEP How Will Clinical Guidelines Change Your Practice? Conclusions Guideline development lends itself to a multi-disciplinary approach and helps to identify best practice patterns Guideline development lends itself to a multi-disciplinary approach and helps to identify best practice patterns Evidence based clinical policies are useful tools in clinical decision making Evidence based clinical policies are useful tools in clinical decision making

36. Andy Jagoda, MD, FACEP How Will Clinical Guidelines Change Your Practice? Conclusions Clinical policy development must be rigorous Clinical policy development must be rigorous Clinical policies do not create a “standard of care” and do not necessarily override “expert witness” Clinical policies do not create a “standard of care” and do not necessarily override “expert witness” Clinical policy dissemination continues to be a challenge Clinical policy dissemination continues to be a challenge

37. Andy Jagoda, MD, FACEP Clinical Guidelines Questions Are guidelines just an academic exercise? Are guidelines just an academic exercise? Is it cookbook medicine? Is it cookbook medicine? Do guidelines help or hurt the practitioner? Do guidelines help or hurt the practitioner? Lawyers know them more that doctors…what to do about this? Lawyers know them more that doctors…what to do about this? How should we learn from guidelines? How should we learn from guidelines?

38. Andy Jagoda, MD, FACEP Questions? www.FERNE.org Andy.Jagoda@msnyuhealth.org ferne_emra_2007_sz_jagoda_clinpolicies_051707 8/23/2015 8:13 PM