Current Status of Evidence Appraisal in Appropriateness Criteria Development AHA QCOR Conference Washington, DC May 20,2010 Ralph Brindis, MD MPH FACC.

Current Status of Evidence Appraisal in Appropriateness Criteria Development AHA QCOR Conference Washington, DC May 20,2010 Ralph Brindis, MD MPH FACC President, American College of Cardiology Senior Advisor for CV Disease, Northern California Kaiser Permanente Clinical Professor of Medicine, UCSF

Presenter Disclosure Information Ralph Brindis, MD MPH FACC FSCAIRalph Brindis, MD MPH FACC FSCAI “Current Status of Evidence Appraisal in Appropriateness Criteria Development”“Current Status of Evidence Appraisal in Appropriateness Criteria Development” FINANCIAL DISCLOSURE: NONE NONE UNLABELED/UNAPPROVED USES DISCLOSURE: NONE NONE

Institute of Medicine Priorities for America We must overhaul the system to create care to ensure it is: We must overhaul the system to create care to ensure it is: Safe, Timely, Equitable, Efficient, Evidence-based and Patient-centered Safe, Timely, Equitable, Efficient, Evidence-based and Patient-centered Care should… Care should… Be customized to patients’ needs and values Be customized to patients’ needs and values Have the patient be the source of control Have the patient be the source of control Enable knowledge to be shared freely Enable knowledge to be shared freely Adams, K & Corrigan,JM. Priority Areas for National Action: Transforming Health Care Quality, IOM 2003 Institute of Medicine, Crossing the Quality Chasm: A New Health System for the Twenty-first Century Appropriate !!!

Variation in the Use of PCI vs. CABG February 4, 2009 US average is 2.6 PCIs for each CABG http://www.dartmouthatlas.org/

Variation in PCI Higher than Other Procedures 1.0 0.3 3.0 Colectomy for CA TURPCABG Hip Replace- ment Back Surgery PCI Variation in procedures per 1000 Medicare patients in 306 hospital referral regions Source: Dartmouth Atlas

Quality assessment is a complex process that includes more than a mere tabulation of success and complication ratesQuality assessment is a complex process that includes more than a mere tabulation of success and complication rates Components of quality…include appropriateness of case selection… A quality program performs appropriately selected procedures…Components of quality…include appropriateness of case selection… A quality program performs appropriately selected procedures… If one does 1000 PCIs without a single complication, but 750 patients never needed the procedure in the first place, …. is this quality?If one does 1000 PCIs without a single complication, but 750 patients never needed the procedure in the first place, …. is this quality? 2005 ACC/AHA/SCAI PCI Guidelines Quality Assessment Process

Potential Impact of Inappropriate PCI 900,000 PCI/yr in US 6% inappropriate and 38% uncertain (NY/Rand) 0-25% of uncertain PCI are actually inappropriate 900,000 PCI/yr in US 6% inappropriate and 38% uncertain (NY/Rand) 0-25% of uncertain PCI are actually inappropriate ~700 - 1700 deaths avoidable by eliminating Inappropriate PCI Inappropriate PCI

Anderson et al. Circulation 2005; 112:2786 Indications Relationship between Procedure Relationship between Procedure Indications & Outcomes of PCI: ACC/AHA Guidelines ACC-NCDR

Anderson et al. Circulation 2005; 112:2786 Adverse Events Relationship between Procedure Indications & Outcomes of PCI by ACC/AHA Guidelines ACC-NCDR

Guidance Documents Clinical practice guidelinesClinical practice guidelines Performance measuresPerformance measures Appropriate use criteriaAppropriate use criteria Consensus statementConsensus statement Clinical competencyClinical competency Training guidelinesTraining guidelines Standards-Accreditation and certificationStandards-Accreditation and certification “White paper”“White paper”

What are Appropriateness Criteria? Define “what to do”, “when to do”, and “how often to do” in the context of local care environments combined with patient and family preferences and valuesDefine “what to do”, “when to do”, and “how often to do” in the context of local care environments combined with patient and family preferences and values Address misuse, overuse and underuseAddress misuse, overuse and underuse Connected to guideline contentConnected to guideline content Imply a level of detail and complexity that extends beyond the current recommendationsImply a level of detail and complexity that extends beyond the current recommendations

Methodology: CPGs vs. AUCs Clinical Practice Guidelines Start with a stack of literature. The task of the writing committee is to develop recommendations based on study populations.Start with a stack of literature. The task of the writing committee is to develop recommendations based on study populations. Appropriate Use Criteria Start with typical patient presentations. The task of the rating panel is combine evidence of study populations with expert opinion making recommendations that can be objectively measured.Start with typical patient presentations. The task of the rating panel is combine evidence of study populations with expert opinion making recommendations that can be objectively measured.

Guidelines and AUC Clinical Practice Guidelines (State of Science) Exhaustive review of literature Virtually all-inclusive Best practice “Should do, should not do” Class I, Class III, Class IIa, IIb Appropriate Use Criteria - AUC Selective indications Largely guideline based Clinical scenarios/frequency “Reasonable to do ” Used to evaluate practice patterns Clinical Practice Guidelines (State of Science) Exhaustive review of literature Virtually all-inclusive Best practice “Should do, should not do” Class I, Class III, Class IIa, IIb Appropriate Use Criteria - AUC Selective indications Largely guideline based Clinical scenarios/frequency “Reasonable to do ” Used to evaluate practice patterns

Development of CPG’s, Performance Measures, and Appropriate Use Documents Antman, Circulation 2009:119:1180-1185. Antman & Peterson, Circulation 2009:119:1180-1185.

APPROPRIATE USE CRITERIA The ACC Queue √Nuclear cardiology (SPECT) October, 2005 √Cardiac CT/CMR September, 2006 √Echocardiography (TTE, TEE) July, 2007 √Echocardiography (Stress) December, 2007 Coronary revascularization December, 2008 Revised radionuclide imaging May, 2009 Multi-modality criteria (with ACR) –Heart failure –Acute chest pain Revised CT criteria (completed) Revised echocardiography criteria Peripheral vascular disease Diagnostic catheterization COMPLETED IN PROGRESS

Appropriateness Use Criteria Developed Using a Modified Rand/Delphi Methodology The Writing Committee Define “Appropriateness” for Coronary Revascularization “Coronary revascularization is appropriate when the expected benefits, in terms of survival or health outcomes (symptoms, functional status, and/or quality of life) exceed the expected negative consequences of the procedure” “Coronary revascularization is appropriate when the expected benefits, in terms of survival or health outcomes (symptoms, functional status, and/or quality of life) exceed the expected negative consequences of the procedure”

Appropriateness Use Criteria Developed Using a Modified Rand/Delphi Methodology The Writing Committee Define “Appropriateness” for Coronary Revascularization Extensive CPG & literature review and synthesis of the evidence (usually after clinical scenarios created) What are the known indications for coronary revascularization? - Major randomized trials - Major randomized trials - Guidelines - Guidelines - Other sources - Other sources

Developing the Appropriateness Use Criteria The Writing Committee Define “Appropriateness” for Coronary Revascularization CPG and literature review and synthesis of the evidence (pre and/or post clinical scenario creation) Assumptions and Definitions What are the known indications for coronary revascularization? - Major randomized trials - Major randomized trials - Guidelines - Guidelines - Other sources - Other sources  70% stenosis significant (>50% for LM) Maximum medical therapy (use of  2 drug classes) (use of  2 drug classes) High, Intermediate, low-risk stress tests High-risk clinical features (ECG, biomarkers, exam findings)

Developing the Appropriateness Use Criteria The Writing Committee Define “appropriateness” Preliminary CPG & literature search Assumptions & definitions Develop clinical scenarios How are we going to do this? Sobering realization as to how complex our daily decisions really areSobering realization as to how complex our daily decisions really are –~ 4000 possible combinations Needed an understandable framework built upon known data and clinical practiceNeeded an understandable framework built upon known data and clinical practice

SYMPTOMS STABILITY ISCHEMIA TESTING MEDICAL Rx ANATOMY Stableangina STEMI Class I ASx Class IV None Low risk High risk None Max No sig. CAD LM + 3v CAD 180 Clinical Scenarios Domains for Clinical Decision Making Five Core Variables Over 4000 Possible Clinical Scenarios

Developing the Appropriateness Use Criteria The Writing Committee Define “appropriateness” Preliminary CPG & literature search Assumptions & definitions Developed 180 clinical scenarios The Technical PanelThe Technical Panel –Nominated by professional societies –Selected for balance by the writing committee and Task Force 4 interventional cardiologists4 interventional cardiologists 4 CT surgeons4 CT surgeons 8 cardiologists8 cardiologists 1 Health plan officer1 Health plan officer Scenarios critiqued by all organizations Scenarios modified and improved & In-depth literature, CPG search & In-depth literature, CPG search Most examine the “appropriateness” of revascularization

Appropriateness Score (7-9) Appropriate (4-6) Possibly Appropriate/Uncertain (1-3) Inappropriate Scored by a Technical Panel 4 interventional cardiologists; 4 CT surgeons; 8 cardiologists; 1 Health plan officer The Technical Panel MODIFIED RAND DELPHI METHODOLOGY Independent 1 st round ratings Ratings tabulated – agreement determined Face-to-face meeting – ratings discussed Independent 2 nd and final round ratings CCS Angina Class ASx I or II III or IV Number 17 Stable patients without prior CABG

Framework for Decision Making Five Core Variables SYMPTOMS STABILITY ISCHEMIA MEDICAL Rx ANATOMY Stableangina STEMI Class I ASx Class IV None Low risk High risk None Max No sig. CAD LM + 3v CAD A U I

Low-Risk Findings on Non-invasive Imaging Study Low-Risk Findings on Non-invasive Imaging Study And Asymptomatic (Patients Without Prior Bypass Surgery) Non-invasive testing Symptoms/Rx Burden of disease

AUC Methods are Robust, Thoughtful & Evidence Based Unprecedented Transparency: Appendices Unprecedented Transparency: Appendices AUC Scores; Evidence tables & Maps to CPGs AUC Scores; Evidence tables & Maps to CPGs AUC Coronary Revascularization: AUC Coronary Revascularization: 100% Congruence for CPG’s Class I & III Recs 100% Congruence for CPG’s Class I & III Recs Cost is implicitly considered Cost is implicitly considered Successfully Identifies new areas for research Successfully Identifies new areas for research

Mapping of AUC with CPGs 6. A(8)  STEMI with presumed successful treatment with fibrinolysis  Asymptomatic; no HF, no recurrent ischemic symptoms, or no unstable ventricular arrhythmias at time of presentation  Depressed LVEF  Three vessel coronary artery disease  Elective/semi-elective revascularization STEMI (p. e65) Percutaneous Coronary Intervention After Fibrinolysis Class IIa It is reasonable to perform routine PCI in patients with LVEF less than or equal to 0.40, CHF, or serious ventricular arrhythmias. (Level of Evidence: C) PCI (p. e53) PCI After Successful Fibrinolysis or for Patients Not Undergoing Primary Reperfusion Class IIa It is reasonable to perform routine PCI in patients with LV ejection fraction less than or equal to 0.40, HF, or serious ventricular arrhythmias. (Level of Evidence: C) CABG (p. e281 ) ST-Segment Elevation MI (STEMI) Class IIa In patients who have had an STEMI or NSTEMI, CABG mortality is elevated for the first 3 to 7 days after infarction, and the benefit of revascularization must be balanced against this increased risk. Beyond 7 days after infarction, the criteria for revascularization described in previous sections are applicable. (Level of Evidence: B)

Mapping of AUC with CPGs 13. Asymptomatic: I2 I or II: U5 III or IV: A7  One or two vessel coronary artery disease without involvement of proximal LAD  Low-risk findings on non-invasive testing  Receiving a course of maximal anti-ischemic medical Rx Chronic Stable Angina (p. 77-78 ) Recommendations for Revascularization With PCI (or Other Catheter-Based Techniques) and CABG in Patients With Stable Angina Class I Coronary artery bypass grafting for patients with one- or two-vessel CAD without significant proximal LAD CAD who have survived sudden cardiac death or sustained ventricular tachycardia. (Level of Evidence: C) Class III Use of PCI or CABG for patients with one- or two vessel CAD without significant proximal LAD CAD, who have mild symptoms that are unlikely due to myocardial ischemia, or who have not received an adequate trial of medical therapy and a.have only a small area of viable myocardium or b.have no demonstrable ischemia on noninvasive testing. (Level of Evidence: C) Chronic Stable Angina (p. 90-91) Recommendations for Revascularization with PCI and CABG in Asymptomatic Patients Class III  Use of PCI or CABG for patients with one- or two-vessel CAD without significant proximal LAD CAD and a.only a small area of viable myocardium or b.no demonstrable ischemia on noninvasive testing. (Level of Evidence: C)  Use of PCI or CABG for patients with borderline coronary stenoses (50% to 60% diameter in locations other than the left main coronary artery) and no demonstrable ischemia on noninvasive testing. (Level of Evidence: C)

Continued: Asymptomatic: I2; I or II: U5; III or IV: A7 One or two vessel coronary artery disease without involvement of proximal LAD Low-risk findings on non-invasive testing Receiving a course of maximal anti-ischemic medical Rx CABG (p. e 279) Asymptomatic or Mild Angina Class IIb CABG may be considered for patients with asymptomatic or mild angina who have 1- or 2- vessel disease not involving the proximal LAD (If a large area of viable myocardium and high- risk criteria are met on noninvasive testing, this recommendation becomes (Class I)Evidence:B CABG (p. e280) Stable Angina Class I CABG is beneficial for patients with stable angina who have developed disabling angina despite maximal noninvasive therapy, when surgery can be performed with acceptable risk. If angina is not typical, objective evidence of ischemia should be obtained. (Level of Evidence: B) Class III CABG is not recommended for patients with stable angina who have 1- or 2-vessel disease not involving significant proximal LAD stenosis, patients who have mild symptoms that are unlikely due to myocardial ischemia, or patients who have not received an adequate trial of medical therapy and a. a. have only a small area of viable myocardium or (Level of Evidence: B) b. b. have no demonstrable ischemia on noninvasive testing. (Level of Evidence: B)

Continued: Asymptomatic: I2; I or II: U5; III or IV: A7 One or two vessel coronary artery disease without involvement of proximal LAD Low-risk findings on non-invasive testing Receiving a course of maximal anti-ischemic medical Rx PCI (p. e40) Patients With Asymptomatic Ischemia or CCS Class I or II Angina Class III PCI is not recommended in patients with asymptomatic ischemia or CCS class I or II angina who do not meet the criteria as listed under the class II recommendations or who have 1 or more of the following: a. Only a small area of viable myocardium at risk b. No objective evidence of ischemia. c. Lesions that have a low likelihood of successful dilatation. d. Mild symptoms that are unlikely to be due to myocardial ischemia. e. Factors associated with increased risk of morbidity or mortality. f. Left main disease and eligibility for CABG. g. Insignificant disease (less than 50% coronary stenosis). (Level of Evidence: C) Stable Ischemic Heart Disease Recommendations for Revascularization with CABG to Improve Survival in Patients with Stable Ischemic Heart Disease Class IIa Embargoed Class III Embargoed

Continued: Asymptomatic: I2; I or II: U5; III or IV: A7 One or two vessel coronary artery disease without involvement of proximal LAD Low-risk findings on non-invasive testing Receiving a course of maximal anti-ischemic medical Rx Recommendations for Revascularization with PCI to Improve Survival in Patients with Stable Ischemic Heart Disease Class IIa Embargoed Class III Embargoed Recommendations for Revascularization with CABG or PCI to Improve Symptoms in Patients with Stable Ischemic Heart Disease Class IIa Embargoed Class Ib Embargoed

Lessons with AUC-CPG Mapping Identification of “Holes” in Evidence Base possibly not acknowledged in CPGs WGs Identification of “Holes” in Evidence Base possibly not acknowledged in CPGs WGs Highlights opportunities of potential focus for Highlights opportunities of potential focus for future studies or clinical trials to fill Evidence Gaps future studies or clinical trials to fill Evidence Gaps Opportunities for “cross-talk” with WGs of AUCs, CPGs, Consensus Documents, Scientific Advisories, Performance Measures, and NCDR already occurring! Opportunities for “cross-talk” with WGs of AUCs, CPGs, Consensus Documents, Scientific Advisories, Performance Measures, and NCDR already occurring!

What Do We Do When There is No Evidence? Research!! SPECT AUC: New Onset Atrial Fibrillation SPECT AUC: New Onset Atrial Fibrillation Low CAD risk: U Low CAD risk: U High CAD: A High CAD: A SPECT CPG: No comment !! SPECT CPG: No comment !! JACC 2007 50:1080 Percentage of High-Risk SSS by Clinical Risk Groups Summed Stress Score Results in Patients W and Wo Atrial Fibrillation

What Does Evidence-Based Mean? Methodology Manual for ACCF/AHA Guideline Writing Methodology Manual for ACCF/AHA Guideline Writing Level of Evidence C: Consensus opinion of experts, case studies, or standard of care. Level of Evidence C: Consensus opinion of experts, case studies, or standard of care. ‘Despite all the evidence that may be available for writing the guideline, expert interpretation is always necessary. Unfortunately, much of the evidence falls into the “gray zone” of uncertainty.’ ‘Despite all the evidence that may be available for writing the guideline, expert interpretation is always necessary. Unfortunately, much of the evidence falls into the “gray zone” of uncertainty.’ IOM 2001: Evidence based practice is the integration of best research evidence with clinical expertise and patient values IOM 2001: Evidence based practice is the integration of best research evidence with clinical expertise and patient values Even so, must guard against over-reaching: Even so, must guard against over-reaching: Echo GL Class III: Routine screening echo for participation in competitive sports in pts with a normal cardiovascular exam Echo GL Class III: Routine screening echo for participation in competitive sports in pts with a normal cardiovascular exam Echo AUC: No comment Echo AUC: No comment

AMA Physician Consortium for Performance Improvement (PCPI) Evidence Required for Measures Development PCPI considers all types of evidence reviewed in guidelines, including expert opinion. PCPI considers all types of evidence reviewed in guidelines, including expert opinion. Additional conditions must be met for acceptance of guidelines with recommendations based on expert opinion (e.g., use of a formal consensus development process). Additional conditions must be met for acceptance of guidelines with recommendations based on expert opinion (e.g., use of a formal consensus development process).

PCPI Evidence & Consensus Development Process

PCPI Conditions for Acceptance of Recommendations Based on Consensus Opinion Recommendation Statements Strength of Recommendation rated – HIGH PRIORITY (H.P.) Strength of Recommendation rated – HIGH PRIORITY (H.P.) Methods used for grading strength of Rec. described - H.P. Methods used for grading strength of Rec. described - H.P. Consensus Development Process Consensus Development Process Described- REQUIRED Consensus Development Process Described- REQUIRED Formal Consensus Method Used – REQUIRED Formal Consensus Method Used – REQUIRED Informal Consensus Method Used – NOT ACCEPTABLE Informal Consensus Method Used – NOT ACCEPTABLE Potential Benefits and Harms Anticipated benefits and potential risks associated with recommendations described. Benefits must > risk – H.P. Anticipated benefits and potential risks associated with recommendations described. Benefits must > risk – H.P.

Reproducibility of Appropriateness Ratings in Cardiovascular Imaging 2 Independent Panels (15 multi-speciality physicians) 2 Independent Panels (15 multi-speciality physicians) Stress Echo Panel and TTE/TEE panel Stress Echo Panel and TTE/TEE panel Rated the same 19 clinical indications Rated the same 19 clinical indications (Mixture of Stress and TTE/TEE) (Mixture of Stress and TTE/TEE) 8 (42%) Inappropriate, 9 (47%) Appropriate, 8 (42%) Inappropriate, 9 (47%) Appropriate, 2 (11%) Uncertain 2 (11%) Uncertain Agreement between panels for overall appropriateness group (A,I,U) was 100% Agreement between panels for overall appropriateness group (A,I,U) was 100% Patel QCOR 2008 Patel QCOR 2008

GL and AUC Have Limitations Shared by GL and AUC (Antman Circ 2009 119:1180) Shared by GL and AUC (Antman Circ 2009 119:1180) Insufficient evidence base; Not yet ‘living’ documents Insufficient evidence base; Not yet ‘living’ documents Incomplete translation to practice Incomplete translation to practice Untapped potential to improve care Untapped potential to improve care Weak methods to measure consistent use Weak methods to measure consistent use Neither can cover all clinical scenarios Neither can cover all clinical scenarios Practice Guidelines have additional limitations Practice Guidelines have additional limitations Explicitly exclude costs, cost effectiveness Explicitly exclude costs, cost effectiveness Real risk of ‘academic vacuum’- Unrealistic, unmanageable in our current health care environment Real risk of ‘academic vacuum’- Unrealistic, unmanageable in our current health care environment

AUC and CPG Interplay Imaging AUC Writing Groups has led to increased interest in the role & value of Framingham Risk Score and also the new CV Risk Guidelines publication for AUC ratings of imaging testing. Imaging AUC Writing Groups has led to increased interest in the role & value of Framingham Risk Score and also the new CV Risk Guidelines publication for AUC ratings of imaging testing. Leape describes Guideline adherence poorer when changing practice patterns “ahead” of the CPG revisions. True also with AUC. Leape describes Guideline adherence poorer when changing practice patterns “ahead” of the CPG revisions. True also with AUC. To remain useful and credible, Guidelines and AUC documents need frequent revision when practice is advancing. Annual revisions may be needed. To remain useful and credible, Guidelines and AUC documents need frequent revision when practice is advancing. Annual revisions may be needed.

AUC Implementation and Evaluation : What Have We Learned So Far Retrospective and prospective reviews Retrospective and prospective reviews >20 abstracts published; 2 peer-reviewed publications >20 abstracts published; 2 peer-reviewed publications Average inappropriate rates prior to intervention 10% - 20% Average inappropriate rates prior to intervention 10% - 20% Preliminary studies of tools and education reduce by 50% or more inappropriate use Preliminary studies of tools and education reduce by 50% or more inappropriate use Refinement of process; validation of ratings Refinement of process; validation of ratings

Challenges with Appropriateness Use Ratings Rely on collection of currently unavailable clinical data to map patients to appropriateness ratings Rely on collection of currently unavailable clinical data to map patients to appropriateness ratings Can the data always be collected? Can the data always be collected? Can patients be mapped to the prototypical scenarios? Can patients be mapped to the prototypical scenarios? SPECT MPI pilot project suggests yes with ideas to make data collection easier and quicker!! SPECT MPI pilot project suggests yes with ideas to make data collection easier and quicker!! Still being validated - AUC implementation will provide pragmatic, observational research opportunities to study outcomes in specific populations Still being validated - AUC implementation will provide pragmatic, observational research opportunities to study outcomes in specific populations No data yet demonstrating equal, improved, or worse outcomes with AUC implementation No data yet demonstrating equal, improved, or worse outcomes with AUC implementation Potential of CER (PCORI) for increasing evidence base Potential of CER (PCORI) for increasing evidence base

Stress or Imaging Studies Performed 5100 : O No O Yes → If Yes, Specify Test Performed: Test Performed NoYes Result Risk/Extent Of Ischemia Standard Exercise Stress Test: (w/o imaging ) OO → If Yes, O Negative O Positive O Indeterminant O Unavailable → If Positive, O Low O Intermediate O High O Unavailable Stress Echocardiogram OO → If Yes, O Negative O Positive O Indeterminant O Unavailable → If Positive, O Low O Intermediate O High O Unavailable Stress Testing w/SPECT MPI OO → If Yes, O Negative O Positive O Indeterminant O Unavailable → If Positive, O Low O Intermediate O High O Unavailable Stress Testing w/CMR OO → If Yes, O Negative O Positive O Indeterminant O Unavailable → If Positive, O Low O Intermediate O High O Unavailable Cardiac CTA OO → If Yes, O No disease O 1VD O 2VD O 3VD O Indeterminant O Unavailable Coronary Calcium Score OO → If Yes,Calcium Score: 5251 ____________ Noninvasive Testing

AUC: Implementation & Evaluation New Technology AUC: Implementation & Evaluation New Technology ACC Cardiovascular Imaging Solution Migration towards point-of-order Migration towards point-of-order Embedded clinical decision support Embedded clinical decision support Tracking/data registry Tracking/data registry Reporting/feedback Reporting/feedback

“The right objective for health care is to increase value for patients, which is the quality of patient outcomes relative to the dollars expended.” - Michael Porter “The right objective for health care is to increase value for patients, which is the quality of patient outcomes relative to the dollars expended.” - Michael Porter

Current Status of Evidence Appraisal in Appropriateness Criteria Development AHA QCOR Conference Washington, DC May 20,2010 Ralph Brindis, MD MPH FACC.

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Current Status of Evidence Appraisal in Appropriateness Criteria Development AHA QCOR Conference Washington, DC May 20,2010 Ralph Brindis, MD MPH FACC.

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