CLINICAL PRACTICE GUIDELINES AND APPROPRIATE USE CRITERIA Robert Hendel, MD, FACC, FAHA, FASNC Professor of Medicine and Radiology Director of Cardiac Imaging and Outpatient Services University of Miami Miller School of Medicine Miami, Florida Director, Cardiovascular Intensive Care Unit University of Miami Hospital Miami, Florida
Presenter Disclosure Information Robert C. Hendel, MD The following relationships exist related to this presentation: Consulting Forest Laboratories Modest Astellas Pharma Modest GE Healthcare Modest Research support Forest Laboratories Modest Organizational ACC (Appropriate Use Criteria Task Force) ASNC (Past President, Founding Member
WHY ARE CLINICAL PRACTIC GUIDELINES AND APPROPRIATE USE CRITERIA NEEDED? Unprecedented focus on assessment and improving quality Explosive growth of CV imaging Substantial regional variation True nature of utilization unknown Overuse/ Under-use/Appropriate Clinicians, patients, and especially payers seeking guidance
GUIDELINES, MEASURES, AND APPROPRIATENESS CRITERIA Clinical Guidelines 1 Exhaustive review of literature Virtually all-inclusive Best practice Should do, should not do Performance Measures 2 Selective, focused, measurable Based on guidelines Must do Tools for quality measurement Appropriateness Criteria 3 Selective indications Largely guideline based Clinical scenarios Reasonable to do 1. Klocke FJ, Baird MG, Lorell BH, et al. ACC/AHA/ASNC guidelines for the clinical use of cardiacradionuclide imaging. Circulation 2003; 106: 1883-92 2. Krumholtz HM, Anderson JL, Brooks, et al. ACC/AHA clinical performance measures for adults with STelevation and non-st-elevation myocardial infarction. J Am Coll Cardiol 2006; 47: 236-65. 3. Hendel RC, Berman DS, Di Carli M Fet al. ACCF/ASNC appropriateness use criteria for cardiac radionuclide imaging. J Am Coll Cardiol 2009; 53: 2201-29. Approriate use measures (proposed) Technology based
ACC/AHA CLINICAL PRACTICE GUIDELINES Firmly routed in medical literature and clinical evidence Comprehensive evaluation of disease and/or technology Radionuclide imaging Chronic stable angina Exhaustive publication Hundreds of references Frequent limited updates
ACC/AHA GUIDELINES FOR CHRONIC STABLE ANGINA (2002) I II a I II a II b II b EXERCISE TESTING II I II I Class I, Level B: Intermediate pre-test probability Class IIa, Level B: High or low pre-test probability I II a I II a II b II b STRESS IMAGING II I II I Class I, level B: Intermediate pre-test probability with rest ECG abnormalities or prior revascularization; Exercise preferred if possible. Class IIb, Level B: Low or High pre-test probability with abnormal ECG
DEVELOPMENT OF CLINICAL PRACTICE GUIDELINES, PERFORMANCE MEASURES, AND APPROPRIATE USE DOCUMENTS Antman, Circulation 2009:119:1180-1185.
ACCF APPROPRIATENESS USE CRITERIA Literature-based (when possible) approach to improve utilization of resource-intensive tests and procedures Developed by physicians/providers Initial focus on cardiac imaging Expansion to revascularization, potential for other procedures Serves as a method for focused reduction of procedures based on clinical value, not indiscriminant volume reduction Keeps money within the system and permits continuous quality improvement though education Preserves patient/provider relationship Provides for continued patient access
APPROPRIATE USE CRITERIA COMPLETED Nuclear cardiology (SPECT)-2005 Cardiac CT/CMR-2006 Echocardiography (TTE, TEE)-2007 Echocardiography (Stress)-2007 Coronary revascularization-2008 Revised radionuclide imaging-2009 IN PROGRESS Multi-modality criteria (with ACR) Heart failure (under review) Acute chest pain (in preparation) Peripheral vascular disease Diagnostic catheterization ICD/BiVentricular pacemakers Revised CT criteria-2010 Revised echocardiography criteria -2010
APPROPRIATE USE CRITERIA Guidance for Technology Utilization Shaw et al, 2011 JNC 18: 385
VOLUME OF SPECT MYOCARDIAL PERFUSION IMAGING STUDIES Potential Impact by Appropriate Use Criteria Appropriateness Criteria AMR
HIERARCHY OF POTENTIAL TEST ORDERING FOR AUC DETERMINATION Pre-op? NO w/i 3 mo ACS? NO Prior Revasc? NO Prior Imaging? NO Ischemic equivalent? NO Asymptomatic? YES YES YES YES YES YES Table 4 Figure 5 Table 5 Table 6 Figure 6 Table 3 Figure 4 Table 1 Figure 2 Table 3 Figure 3
Recommendation Indication text RNI Echo CT MR Risk Assessment: Preoperative Evaluation for Noncardiac Surgery Without Active Cardiac Conditions Low-Risk Surgery - - - - Preoperative evaluation for noncardiac surgery risk assessment I(1) I (1) I (1) I (2) Intermediate-Risk Surgery - - - - Moderate to good functional capacity (greater than or equal to 4 METs) I(3) I (3) I (2) N/A No clinical risk factors I(2) I (2) I (2) N/A Greater than or equal to 1 clinical risk factor Poor or unknown functional capacity (less than 4 METs) A(7) U (6) U (5) U (6) Asymptomatic up to 1 year postnormal catheterization, noninvasive test, or previous revascularization I(2) I (1) I (1) N/A Vascular Surgery - - - - Moderate to good functional capacity (greater than or equal to 4 METs) I(3) I (3) I (2) N/A No clinical risk factors I(2) I (2) I (2) N/A Greater than or equal to 1 clinical risk factor Poor or unknown functional capacity (less than 4 METS) A(8) A (7) U (6) U (6) Asymptomatic up to 1 year postnormal catheterization, noninvasive test, or previous revascularization I(2) I (2) I (2) N/A Preoperative Non-coronary Cardiac Surgery - - - - Preoperative Coronary Assessment Prior to Noncoronary Cardiac Surgery Coronary evaluation before noncoronary cardiac surgery Low pre-test probability Preoperative Coronary Assessment Prior to Noncoronary Cardiac Surgery Coronary evaluation before noncoronary cardiac surgery Intermediate pre-test probability Preoperative Coronary Assessment Prior to Noncoronary Cardiac Surgery Coronary evaluation before noncoronary cardiac surgery High pre-test probability N/A N/A U( 6) N/A N/A N/A A (7) N/A N/A N/A I (3) N/A
APPROPRIATENESS OF CARDIOVASCULAR IMAGING Potential Impact of Appropriateness Criteria Establishment of partnership among clinicians, educators, and payers regarding rational practices in cardiovascular imaging and fair reimbursement Education of clinicians regarding their practice habits Emphasis of clinical indications to drive testing Facilitate reimbursement for appropriate and uncertain indications Support for requirement of preauthorization or denial of reimbursement for inappropriate indications Improve cost-effectiveness of cardiovascular imaging
APPROPRIATENESS USE CRITERIA Concerns and Limitations Appropriateness criteria are NOT substitutes for sound clinical judgment and practice experience Should NOT be used to provide information regarding the technical aspects of imaging nor delineate training/performance requirements Imperfect product Indications not inclusive but also too specific May differ from guidelines Difficult to use, but logistics improving
APPROPRIATE USE CRITERIA Implementation and Evaluation Integration within practice workflow Point-of-service Point-of-order Logistics Requisitions Web tools POE/EMR Must preserve physician autonomy and flexibility
EVALUATION OF APPROPRIATENESS FOR RADIONUCLIDE IMAGING Appropriate Uncertain Inappropriate Hendel, 2006 83% 6% 11% Williams, 2006 78% 5% 8% Ayyad, 2007 85% 5% 10% Druz, 2007 57% 33% 10% Gaztanega, 2007 55% 28% 17% Al-Mallah, 2007 75% 12% 13% Gibbons, 2008 64% 11% 14% Hendel, 2009 71% 15% 14% Gibbons, 2010 66% 15% 7% Koh, 2010 82% 5% 10% Carryer, 2010 60% 16% 24% Gupta, 2011 84% 5% 11%
ACCF/ UNITED HEALTHCARE Appropriateness Classification (n=5,928) INDICATION % INAPPRO INDICATIONS % TOTAL STUDIES Detection of CAD Asymptomatic, low CHD risk 44.5% 6.0% Asymptomatic, post-revascularization < 2 years after PCI, symptoms before PCI 23.8% 3.2% Evaluation of chest pain, low probability pt Interpretable ECG and able to exercise 16.1% 2.2% Asymptomatic/stable symptoms, known CAD,< 1 year after cath/abnormal SPECT 3.9% 0.5% Pre-operative assessment Low risk surgery 3.8% 0.5 % Hendel RC et al, 2010 JACC 55: 156-62 TOTAL 92.1% 12.4 %
APPROPRIATENESS CATEGORY Based on Referral p < 0.0001 13.2% 16.1% 19.5% 9.9% 70.7% 70.7% Based on: Hendel RC et al, 2010 JACC 55: 156-62 n = 4,792 n = 1,136
GENDER DIFFERENCES IN APPROPRIATENESS 100% Gender reversal analysis 80% Difference in classification OR= 2.36 Similar findings: Mehta, 2008 Hendel, 2010 60% 40% 20% 0% Male Female Inappropriate Uncertain Appropriate Based on: Gupta et al, 2011 JNC : Apr 23. [Epub ahead of print]
EVALUATION OF APPROPRIATENESS IN SINGAPORE 2009 Appropriate Use Criteria INAPPROPRIATE INDICATIONS Pre-operative, low risk surgery Low probability w interp. ECG and able to exercise Asymptomatic, low risk patient First use of AUC internationally First use of revised RNI AUC (2009) Koh et al, 2011 JNC 18: 324
CHANGES IN APPROPRIATENESS BASED ON 2005 OR 2009 CRITERIA (n=281) 2005 Elimination of unclassified Reduced appropriate studies Increased uncertain and inappropriate categories 2009 Carryer et al, 2010 AHJ 160; 244
EVALUATION OF APPROPRIATE USE OF CARDIAC CT IN 267 CONSECUTIVE PATIENTS 2006 ACC/ASNC/SCCT Appropriate Use Criteria Non CAD indications more appropriate MOST FREQUENT INDICATION Equivocal stress test results Murphy MK et al JNC 2010; 17: 881 MOST FREQUENT INAPPROPRIATE Asymptomatic low risk patient
STRESS TESTING AND SPECT MPI AFTER REVASCULARIZATION Medicare database review in 28,172 patients High frequency of post-procedural stress testing 39% @ 1 year 59% @ 2 year Clustering at 6 and 12 months ( routine ) SPECT is most common Geographic variation noted Rate exceeds historical recurrence rate of angina (18%) Post-test: 11% cath, 5% revascularization Shah et al, 2010 JACC 56: 1328
STRESS TESTING AND SPECT MPI AFTER REVASCULARIZATION Too much, too soon George Beller (JACC 2010; 56: 1335) More diligence advised for adherence to AUC Willingness to alter utilization patterns, reduce use
TEMPORAL CHANGES IN COMPLIANCE WITH APPROPRIATE USE CRITERIA FOR SPECT (n=284 for each group) 5/2005 10/2006 Decrease in specific inappropriate indications Low risk, asymptomatic patients Asymptomatic patients <2 years after PCI Reason? Greater knowledge of AUC NOT due to internal intervention Gibbons et al, 2010 AHJ 159: 484-9
Gibbons et al, 2011 Circulation 123:499 CHANGES IN APPROPRIATENESS Impact of AUC Awareness and/or Education
EFFORTS TO ALTER SPECT UTILIZATION An Internal Quality Improvement Project at Mayo Clinic Multiple education efforts Newsletter Medical grand rounds Practice administrators Focused meetings with PCP Education focused on 4 indications (88%) Asymptomatic, low-risk (48%) Symptomatic, low risk, able to exercise with interp. ECG (27%) Pre-op: low and intermediate risk (13%) NO IMPACT ON INAPPROPRIATE RATE Gibbons et al, 2011 Circulation 123: 499
IMPROVING APPROPRIATENESS Does education work? Inconsistent results Limited impact on sites with low inappropriate use What methods? Multifaceted approach (cases, peer discussions) Interactive Longitudinal Behavior reinforcement (feedback) Integrated into workflow (clinical decision support)
Goals Reduce geographic variation in cardiovascular imaging use by addressing underuse, overuse, and preference/supply sensitive use while recognizing patient centered appropriate variation Reduce unnecessary/inappropriate imaging by 15% during the first year and 50% within 3 years in aggregate while identifying best practice rates and understanding the goal for an absolute inappropriate rate will not be zero
Formation of Optimal Cardiovascular Utilization Strategies: IMAGING A National Campaign A collaborative learning community Share knowledge, experience, and best practices Develop educational materials Non-confrontational Blogs, listservs, webinars Advantage for participation Competitive advantage Laboratory accreditation QI through PIM CME credit opportunities
50% reduction in the inappropriate rate (10% to 5%) (p<0.0001)
AUC: IMPLEMENTATION AND EVALUATION New Technology Migration towards point-of-order Embedded clinical decision support Tracking/data registry Reporting/feedback
IMPLEMENTATION AND EVALUATION WHAT HAVE WE LEARNED SO FAR Retrospective and prospective reviews >30 abstracts published; 5 peer-reviewed publications Average inappropriate rates prior to intervention 10% - 15% Preliminary studies of tools and education may reduce by 50% or more inappropriate use Refinement of process; validation of ratings
CLINICAL PRACTICE GUIDELINES AND APPROPRIATE USE CRITERIA Conclusions Utilization management of cardiac imaging will continue Physicians must take responsibility for all aspects of cardiac imaging, including utilization Emphasis must be on QUALITY Joint effort by physicians, policymakers and patients Most physicians are not knowingly ordering inappropriate tests Inappropriate rate should not be zero Guidance documents helpful Must strive for AUC/GL/PM consistence AUC likely most applicable to clinical scenarios Clinical judgment and practice variation must be considered AUC and other quality metrics: Foundation for utilization strategies AUC, CPG, PM have been developed to provide guidance, but their implementation and evaluation are key to improving performance These provide alternatives to more onerous utilization management strategies, including prior authorization