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2014;20:51 7. S6-16. Zimolzak AJ, Spettell CM, Fernandes J, et al. Early detection of poor adherers to statins: applying individualized surveillance to pay for performance. PLoS One 2013:8;e79611. S6-17. Bitton A, Choudhry NK, Matlin OS, et al. The impact of medica- tion adherence on coronary artery disease costs and outcomes: a systematic review. Am J Med. 2013;126:357. e7 .e27. S6-18. Korhonen MJ, Robinson JG, Annis IE, et al. Adherence tradeoff to multiple preventive therapies and all-cause mortality after acute myocardial infarction. J Am Coll Cardiol. 2017;70:1543 54. S6-19. Dragomir A, Cote R, White M, et al. Relationship between adher- ence level to statins, clinical issues and health-care costs in real-life clinical setting. Value Health. 2010;13:87 94. S6-20. Zhao Y, Zabriski S, Bertram C. Associations between statin adher- ence level, health care costs, and utilization. J Manag Care Spec Pharm. 2014;20:703 13. S6-21. Happe LE, Clark D, Holliday E, et al. A systematic literature review assessing the directional impact of managed care formulary restric- tions on medication adherence, clinical outcomes, economic CLINICAL STATEMENTS AND GUIDELINES outcomes, and health care resource utilization. J Manag Care Spec Pharm. 2014;20:677 84. S6-22. Drozda JP Jr, Ferguson TB Jr, Jneid H, et al. 2015 ACC/AHA focused update of secondary prevention lipid performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. Circ Cardiovasc Qual Outcomes. 2016;9:68 95. S6-23. Krones T, Keller H, Sonnichsen A, et al. Absolute cardiovascular dis- ease risk and shared decision making in primary care: a randomized controlled trial. Ann Fam Med. 2008;6:218 27. S6-24. ASCVD Risk Estimator Plus. Available at: http://tools.acc.org/ASCVD- Risk-Estimator-Plus/#!/calculate/estimate/. Accessed September 1, 2018. S6-25. Statin Choice Decision Aid. Available at: https://statindecisionaid. mayoclinic.org/. Accessed October 13, 2018. S6-26. Barry MJ, Edgman-Levitan S. Shared decision making pinnacle of patient-centered care.


Barry MJ, Edgman-Levitan S. Shared decision making pinnacle of patient-centered care. N Engl J Med. 2012;366:780 1. S6-27. Shay LA, Lafata JE. Where is the evidence? A systematic review of shared decision making and patient outcomes. Med Decis Making. 2015;35:114 31. S6-28. Using Motivational Interviewing to Create Change. Available at: http:// tCookieSupport=1. Accessed March 27, 2018. 7. COST AND VALUE CONSIDERATIONS 7.1. Economic Value Considerations: S7.1-1. Anderson JL, Heidenreich PA, Barnett PG, et al. ACC/AHA state- ment on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines. Circulation. 2014;129:2329 45. S7.1-2. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clini- cal outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713 22. S7.1-3. Hlatky MA, Kazi DS. PCSK9 Inhibitors: economics and policy. J Am Coll Cardiol. 2017;70:2677 87. S7.1-4. Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267 78. S7.1-5. Fonarow GC, Keech AC, Pedersen TR, et al. Cost-effectiveness of evo- locumab therapy for reducing cardiovascular events in patients with ath- erosclerotic cardiovascular disease. JAMA Cardiol. 2017;2:1069 78. S7.1-6. Robinson JG, Huijgen R, Ray K, et al. Determining when to add nonstatin therapy: a quantitative approach. J Am Coll Cardiol. 2016;68:2412 21. S7.1-7. Kazi DS, Moran AE, Coxson PG, et al. Cost-effectiveness of PCSK9 inhibitor therapy in patients with heterozygous familial hypercho- lesaaaaaaaaterolemia or atherosclerotic cardiovascular disease. JAMA. 2016;316:743 53. S7.1-8. Gandra SR, Villa G, Fonarow GC, et al. Cost-effectiveness of LDL-C lowering with evolocumab in patients with high cardiovascular risk in the United States. Clin Cardiol. 2016;39:313 20. S7.1-9.


Cost-effectiveness of LDL-C lowering with evolocumab in patients with high cardiovascular risk in the United States. Clin Cardiol. 2016;39:313 20. S7.1-9. Choosing interventions that are cost effective (WHO-CHOICE): cost-effectiveness thresholds. Geneva, Switzerland: World Health Organization, 2009. 8. LIMITATIONS AND KNOWLEDGE GAPS 8.2. Risk Assessment S8.2-1. Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce ath- erosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129:S1 45. CLINICAL STATEMENTS AND GUIDELINES Appendix 1. Author Relationships With Industry and Other Entities (Relevant) 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/ NLA/PCNA Guideline on the Management of Blood Cholesterol* (August 2018) Committee Member Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Scott M. Grundy Chair VA North Texas Health Care System and University of Texas Southwestern Medical Center at Dallas Professor of Internal Medicine None None None None None None Neil J.


Author Relationships With Industry and Other Entities (Relevant) 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/ NLA/PCNA Guideline on the Management of Blood Cholesterol* (August 2018) Committee Member Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Scott M. Grundy Chair VA North Texas Health Care System and University of Texas Southwestern Medical Center at Dallas Professor of Internal Medicine None None None None None None Neil J. Stone Vice Chair Northwestern Medicine/Northwestern University Bonow Professor of Medicine, Cardiology None None None None None None Alison L. Bailey Erlanger Health System/University of Tennessee College of Medicine Program Director, Cardiovascular Diseases Fellowship; Director, Preventive cardiology and Cardiac Rehabilitation None None None None None None Craig Beam CBRE Managing Director; National Cultivation/Strategic Investments Leader None None None None None None Kim K. Birtcher University of Houston College of Pharmacy Clinical Professor None None None None None None Roger S. Blumenthal Johns Hopkins University, Ciccarone Center for the Prevention of Heart Disease Professor of Medicine None None None None None None Lynne T. Braun Rush University Medical Center Professor of Nursing and Medicine None None None None None None Sarah De Ferranti Boston Children s Hospital Assistant Professor of Pediatrics None None None None None None Joseph Faiella- Tommasino Touro College, School of Health Sciences Chairman and Assistant Dean of Physician Assistant Programs None None None None None None Daniel E. Forman University of Pittsburgh Chair, Geriatric Cardiology None None None None None None Ronald Goldberg University of Miami, Diabetes Research Institute Professor of Medicine, Division of Endocrinology, Metabolism and Diabetes None None None None None None Paul A. Heidenreich Stanford University, Department of Medicine Professor, Vice Chair for Quality None None None None None None Mark A. Hlatky Stanford University, School of Medicine Professor of Health Research Policy, Professor of Cardiovascular Medicine None None None None None None Daniel W. Jones University of Mississippi Medical Center Professor of Medicine and Physiology; Director, Clinical and Population Science None None None None None None Donald Lloyd-Jones Northwestern University Eileen M. Foell Professor; Chair, Department of Preventive Medicine None None None None None None Nuria Lopez-Pajares Temple University Physician None None None None None None Chiadi Ndumele Johns Hopkins University School of Medicine Robert E. Meyerhoff Assistant Professor of Medicine None None None None None None Carl E. Orringer University of Miami, Soffer Clinical Research Center Associate Professor None None None None None None Carmen Peralta University of California, San Francisco Associate Professor of Medicine; Kidney Health Research Collaborative Executive Director None None None None None None (Continued) CLINICAL STATEMENTS AND GUIDELINES Joseph Saseen University of Colorado, Anschutz Medical Campus Professor and Vice Chair, Department of Clinical Pharmacy; Professor, Department of Family Medicine None None None None None None Sidney C. Smith, Jr University of North Carolina, Chapel Hill Professor of Medicine None None None None None None Laurence S. Sperling Emory University, Rollins School of Public Health Professor of Medicine, Cardiology; Professor of Global Health None None None None None None Salim S. Virani Baylor College of Medicine Professor, Section of Cardiovascular Research and Director, Cardiology Fellowship Training Program; Michael E. DeBakey VA Medical Center Staff Cardiologist and Investigator, Health Policy, Quality & Informatics Program, Center for Innovations in Quality, Effectiveness and Safety None None None None None None Joseph Yeboah Wake Forest Baptist Health Assistant Professor, Internal Medicine, Cardiovascular None None None None None None This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document.


These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $5000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. According to the ACC/ AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document or makes a competing drug or device addressed in the document; or c) the person or a member of the person s household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document. *The Cholesterol Guideline began in September 2016. Over the initial years of the CMS Open Payment System, understandably, there have been many issues related to the accurate reporting of food and beverage payments. For this reason, the ACC and AHA have not considered these minor charges relevant relationships with industry.


For this reason, the ACC and AHA have not considered these minor charges relevant relationships with industry. AACVPR indicates American Association of Cardiovascular and Pulmonary Rehabilitation; AAPA, American Academy of Physician Assistants; ABC, Association of Black Cardiologists; ACC, American College of Cardiology; ACPM, American College of Preventive Medicine; ADA, American Diabetes Association; AGS, American Geriatrics Society; AHA, American Heart Association; APhA, American Pharmacists Association; ASPC, American Society for Preventive Cardiology; PCNA, Preventive Cardiovascular Nurses Association; and VA, Veterans Affairs. Appendix 1. Continued Committee Member Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness CLINICAL STATEMENTS AND GUIDELINES Appendix 2.


Continued Committee Member Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness CLINICAL STATEMENTS AND GUIDELINES Appendix 2. Reviewer Relationships With Industry and Other Entities (Comprehensive) 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol (August 2018) Peer Reviewer Representation Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Salary Philip A. Ades Official Reviewer AACVPR University of Vermont Medical Center Professor of Medicine None None None None None None None Karen P. Alexander Official Reviewer ACC Science and Quality Committee Duke University Medical Center Professor of Medicine/Cardiology None None None GSK NIH None None None Theresa M. Beckie Official Reviewer AACVPR University of South Florida Professor and Associate Dean of the PhD Program None None None None None None None Kathy Berra Official Reviewer PCNA Stanford University Omada Health None None None Council on Aspirin for Health and Prevention - a committee of the Altarum Institute Preventive Cardiovascular Nurses Association None None William T. Cefalu Official Reviewer ADA American Diabetes Association Chief Scientific, Medical and Mission Officer None None None None None None None Mary Ann Champagne Official Peer Reviewer PCNA Stanford Hospital and Clinics Clinical Nurse Specialist and Coordinator None None None None None None None Joaquin Cigarroa Official Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Oregon Health and Science University Clinical Professor of Medicine None None None None None None None Stephen R. Daniels Official Reviewer AAP University of Colorado School of Medicine Professor and Chair, Department of Pediatrics; Children s Hospital Colorado Pediatrician- in-Chief and L. Joseph Butterfield Chair in Pediatrics Sanofi-Aventis None None None Novo Nordisk Inc. None None Dave Dixon Official Reviewer NLA Virginia Commonwealth University School of Pharmacy Associate Professor and Vice-Chair for Clinical Services None None None None None None None Earl W. Ferguson Official Reviewer ACPM Ridgecrest Regional Hospital Independent Consultant None None Bakersfield Heart Hospital None Growth Creators Inc./Radekal/ Pertexa California Health Information Partnership and Services Organization None None Edward A. Gill, Jr Official Reviewer NLA University of Colorado Cardiology Division Professor of Clinic Practice, Medicine- Cardiology None None None None None None Acute Coronary Syndrome Tyler J. Gluckman Official Reviewer ACC Board of Governors Providence St. Vincent Heart Clinic Medical Director Boehringer Ingelheim Pharmaceuticals None None None None None None Rita Kalyani Official Reviewer ADA Johns Hopkins School of Medicine Associate Professor of Medicine None None None None None None None Norma M. Keller Official Reviewer ACC Board of Governors New York University Medical Center Chief of Cardiology None None None None None None None Amit Khera Official Reviewer ASPC University of Texas Southwestern Medical Center Assistant Professor of Medicine None None None None None None None (Continued) CLINICAL STATEMENTS AND GUIDELINES Carol Kirkpatrick Official Reviewer NLA Idaho State University Wellness Center Director/ Clinical Associate Professor Kasiska Division of Health Sciences National Lipid Association None None None None None None G. B. John Mancini Official Reviewer ACC Board of Governors Vancouver Hospital Research Pavilion Professor of Medicine Amgen Bayer Boehringer Ingelheim Pharmaceuticals, Inc Eli Lilly and Company Esperion Merck Pfizer Regeneron Sanofi-aventis/ Regeneron Servier None None None None None None Laxmi S. Mehta Official Reviewer ACC Science and Quality Committee Ohio State University Professor of Medicine; Section Director of Preventative Cardiology and Women s Cardiovascular Health None None None None AHA None None David Montgomery Official Reviewer ABC Piedmont Heart Institute Cardiologist None None None None None None None Michelle Odden Official Reviewer AGS Oregon State University Associate Professor None None None None None None None Daniel J. Rader Official Reviewer AHA Cooper-McClure Professor of Medicine; University of Pennsylvania School of Medicine Director, Preventive Cardiovascular Medicine Alnylam* Novartis* Pfizer* DalCor MedImmune, Inc None Staten Bio* VascularStrategies* None None None None Michael W. Rich Official Reviewer AGS Washington University School of Medicine Professor of Medicine None None None None None None None Mirvat A. Alasnag Content Reviewer ACC Early Career Member Section King Fahd Armed Forces Hospital, Jeddah- KSA Interventional Cardiologist None None None None None None None Kim K. Birtcher Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines University of Houston College of Pharmacy Clinical Professor Jones & Bartlett Learning None None None Accreditation Council for Clinical Lipidology None Conrad B. Blum Content Reviewer ACC/AHA Medicine at Columbia University Medical Center Professor None None None None ACC-AHA None None Bernard Dennis Content Reviewer ACC/AHA Lay Reviewer Dennis Associates, LLC None None None None None None None Henry Ginsberg Content Reviewer AHA Columbia University, Irving Professor of Medicine Merck Resverlogix Sanofi- Regeneron Amgen Akcea Kowa Janssen Esperion None None None None None None Ira Goldberg Content Reviewer AHA NYU Division of Endocrinology, Diabetes, and Metabolism Director Akcea* Amgen Arrowhead Intarcia Merck Regeneron None None None None None None Jos A. Joglar Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines UT Southwestern Medical Center University Professor of Medicine None None None None None None None Appendix 2.


Continued Peer Reviewer Representation Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Salary (Continued) CLINICAL STATEMENTS AND GUIDELINES Glenn N. Levine Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Baylor College of Medicine Professor of Medicine; Michael E. DeBakey Medical Center Director, Cardiac Care Unit None None None None None Defendant, Out-of-hospital cardiopulmonary None Daniel Levy Content Reviewer ACC/AHA Center for Population Studies Director; Journal of the American Society of Hypertension Editor- in-Chief None None None None None None None Theodore Mazzone Content Reviewer ACC/AHA NorthShore University Health System Chairman, Department of Medicine None None None None None None None Patrick E. McBride Content Reviewer ACC/AHA University of Wisconsin School of Medicine and Public Health Professor Emeritus, Departments of Medicine (Cardiovascular Medicine) and Family Medicine None None Health Decisions, Inc None None None None Karen J. McConnell Content Reviewer APhA Catholic Health Initiatives System Director of Clinical Pharmacy Services None None None None None None None Pamela B. Morris Content Reviewer ACC Prevention of Cardiovascular Disease Member Section The Medical University of South Carolina Professor of Medicine, Director of Preventative Cardiology Amgen Esperion Sanofi Regeneron None None None None None None Nathalie Pamir Content Reviewer AHA Scientific Council Oregon Health and Science University Assistant Professor None None None None None None None Janelle F. Ruisinger Content Reviewer APhA The University of Kansas School of Pharmacy, Department of Pharmacy Practice Clinical Pharmacist; KUMC Atherosclerosis and LDL-Apheresis Center Clinical Associate Professor None None None Amgen Regeneron Sanofi- Aventis American Society of Health System Pharmacists None None Joshua Schulman- Marcus Content Reviewer ACC Early Career Member Section Albany Medical Center Assistant Professor of Medicine None None None None None None None Michael D. Shapiro Content Reviewer ACC Prevention of Cardiovascular Disease Member Section Oregon Health & Science University Associate Professor of Medicine and Radiology Akcea Amgen Kastle* Novartis Corporation Regeneron None None Akcea Amarin Amgen None None None Susan Shero Content Reviewer ACC/AHA NIHNHLBI Public Health Advisor None None None None None None None James L. Young II Content Reviewer AHA Beaumont Health Patient/Family Liaison None None None None None None None This table represents all relationships of reviewers with industry and other entities that were reported at the time of peer review, including those not deemed to be relevant to this document, at the time this document was under review.


The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $5000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Please refer to http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/relationships-with-industry-policy for definitions of disclosure categories or additional information about the ACC/AHA Disclosure Policy for Writing Committees. *Significant relationship. No financial benefit. AACVPR indicates American Association of Cardiovascular and Pulmonary Rehabilitation; AAPA, American Academy of Physician Assistants; ABC, Association of Black Cardiologists; ACC, American College of Cardiology; ACPM, American College of Preventive Medicine; ADA, American Diabetes Association; AGS, American Geriatrics Society; AHA, American Heart Association; APhA, American Pharmacists Association; ASPC, American Society for Preventive Cardiology; GSK, GlaskoSmithKline; KSA, Kingdom of Saudi Arabia; KUMC, University of Kansas Medical Center; LDL, low-density lipoprotein; NHLBI, National Heart, Lung, and Blood Institute; NIH, National Institutes of Health; NLA, National Lipid Association; NYU, New York University; PCNA, Preventive Cardiovascular Nurses Association; and UT, University of Texas. Appendix 2. Continued Peer Reviewer Representation Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Salary


PERFORMANCE MEASURES ACC/AHA/SCAI/AMA Convened PCPI/NCQA 2013 Performance Measures for Adults Undergoing Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures, the Society for Cardiovascular Angiography and Interventions, the American Medical Association Convened Physician Consortium for Performance Improvement, and the National Committee for Quality Assurance Developed in Collaboration With the American Association of Cardiovascular and Pulmonary Rehabilitation and Mended Hearts Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and Mended Hearts WRITING COMMITTEE MEMBERS Brahmajee K. Nallamothu, MD, MPH, FACC, FAHA, Co-Chair*; CarlL.Tommaso,MD,FACC,FAHA,FSCAI,Co-Chairy;H.VernonAnderson,MD,FACC,FAHA,FSCAI*; Jeffrey L. Anderson, MD, FACC, FAHA, MACP*; Joseph C. Cleveland, JR, MDz; R. Adams Dudley, MD, MBA; Peter Louis Duffy, MD, MMM, FACC, FSCAIy; David P. Faxon, MD, FACC, FAHA*; Hitinder S. Gurm, MD, FACC; Lawrence A. Hamilton, Neil C. Jensen, MHA, MBA; Richard A. Josephson, MD, MS, FACC, FAHA, FAACVPRx; David J. Malenka, MD, FACC, FAHA*; Calin V. Maniu, MD, FACC, FAHA, FSCAIy; Kevin W. McCabe, MD; James D. Mortimer, Manesh R. Patel, MD, FACC*; Stephen D. Persell, MD, MPH; John S. Rumsfeld, MD, PhD, FACC, FAHAjj; Kendrick A. Shunk, MD, PhD, FACC, FAHA, FSCAI*; Sidney C. Smith, JR, MD, FACC, FAHA, FACP{; Stephen J. Stanko, MBA, BA, AA#; Brook Watts, MD, MS *ACC/AHA Representative. ySociety of Cardiovascular Angiography and Interventions Representative. zSociety of Thoracic Surgeons Representative. xAmerican Association of Cardiovascular and Pulmonary Rehabilitation Representative. kACC/AHA Task Force on Performance Measures Liaison. {National Heart Lung and Blood Institute Representative. #Mended Hearts Representative. The measure speci cations were approved by the American College of Cardiology Board of Trustees, American Heart Association Science Advisory and Coordinating Committee, in January 2013 and the American Medical Association Physician Consortium for Performance Improvement in February 2013.


The measure speci cations were approved by the American College of Cardiology Board of Trustees, American Heart Association Science Advisory and Coordinating Committee, in January 2013 and the American Medical Association Physician Consortium for Performance Improvement in February 2013. This document was approved by the American College of Cardiology Board of Trustees and the American Heart Association Science Advisory and Coordinating Committee in October 2013, and the Society of Cardiovascular Angiography and Interventions in December 2013. The American College of Cardiology requests that this document be cited as follows: Nallamothu BK, Tommaso CL, Anderson HV, Anderson JL, Cleveland JC, Dudley RA, Duffy PL, Faxon DP, Gurm HS, Hamilton LA, Jensen NC, Josephson RA, Malenka DJ, Maniu CV, McCabe KW, Mortimer JD, Patel MR, Persell SD, Rumsfeld JS, Shunk KA, Smith SC, Stanko SJ, Watts B. ACC/AHA/SCAI/AMA Convened PCPI/NCQA 2013 perfor- mance measures for adults undergoing percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures, the Society for Cardiovascular Angiography and Interventions, the American Medical Association Convened Physician Consortium for Performance Improvement, and the National Committee for Quality Assurance. J Am Coll Cardiol 2014;63:722 45. This article has been copublished in Circulation. Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.cardiosource.org) and the American Heart Asso- ciation (http://my.americanheart.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax (212) 633-3820, e-mail reprints@elsevier.com. Permissions: Multiple copies, modi cation, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology. Requests may be completed online via the Elsevier site (http://www.elsevier.com/authors/obtaining- permission-to-re-use-elsevier-material).


Requests may be completed online via the Elsevier site (http://www.elsevier.com/authors/obtaining- permission-to-re-use-elsevier-material). This Physician Performance Measurement Set (PPMS) and related data speci cations were developed by the Physician Consortium for Performance Improvement (the Consortium), including the American College of Cardiology (ACC), the American Heart Association (AHA), and the American Medical Association (AMA),to facilitatequality-improvementactivitiesby physicians.Theperformancemeasurescontained inthisPPMS are notclinical guidelines,do not establish a standard of medical care, and have not been tested for all potential applications. Although copyrighted, they can be reproduced and distributed, without modi cation, for noncommercial purposesdfor example, use by health care providers in connection with their practices. Commercial use is de ned as the sale, license, or distribution of the performance measures for commercial gain, or incorporation of the performance measures into a product or service that is sold, licensed, or distributed for commercial gain. Commercial uses of the PPMS require a license agreement between the user and the AMA (on behalf of the Consortium) or the ACC or the AHA. Neither the AMA, ACC, AHA, the Consortium, nor its members shall be responsible for any use of this PPMS. THE MEASURES AND SPECIFICATIONS ARE PROVIDED AS IS WITHOUT WARRANTY OF ANY KIND. Limited proprietary coding is contained in the measures speci cations for convenience. Users of the proprietary code sets should obtain all necessary licenses from the owners of the code sets. The AMA, the ACC, the AHA, the NCQA, and the PCPI and its members disclaim all liability for use or accuracy of any Current Procedural Terminology (CPT ) or other coding contained in the speci cations. CPT contained in the measures speci cations is copyright 2004-2012 American Medical Association. LOINC copyright 2004-2012 Regenstrief Institute, Inc. This material contains SNOMED CLINICAL TERMS (SNOMED CT ) copyright 2004-2012 International Health Terminology Standards Development Organization. All Rights Reserved.


This material contains SNOMED CLINICAL TERMS (SNOMED CT ) copyright 2004-2012 International Health Terminology Standards Development Organization. All Rights Reserved. Journal of the American College of Cardiology 2014 by the American College of Cardiology Foundation, American Heart Association, Inc., American Medical Association, and National Committee for Quality Assurance Published by Elsevier Inc. ACC/AHA TASK FORCE ON PERFORMANCE MEASURES Eric D. Peterson, MD, MPH, FACC, FAHA, Chair; Paul A. Heidenreich, MD, MS, FACC, FAHA, Chair-Elect; Nancy M. Albert, PhD, CCNS, CCRN, FAHA; Paul S. Chan, MD, MSc, FACC; Lesley H. Curtis, PhD; T. Bruce Ferguson, JR, MD, FACC; Gregg C. Fonarow, MD, FACC, FAHA; Marjorie Funk, RN, PhD, FAHA, FAAN; P. Michael Ho, MD, PhD, FACC, FAHA; Kathy J. Jenkins, MD, MPH, FACC; Sean O Brien, PhD; Paul D. Varosy, MD, FACC; Henry H. Ting, MD, MBA, FACC, FAHA TABLE OF CONTENTS Preamble 723 1. Introduction 724 1.1. Scope of the Problem 724 1.2. Structure and Membership of the Writing Committee 724 1.3. Disclosure of Relationships With Industry and Other Entities 725 2. Methodology 726 2.1. Identifying Clinically Important Outcomes 726 2.2. Dimensions of Care 726 2.3. Literature Review 727 2.4. De nition and Selection of Measures 727 Percutaneous Coronary Intervention Measures . 727 3.1. Target Population and Care Period 727 3.2. Avoiding Overlap and Ensuring Alignment With Existing Measure Sets and Guidelines 727 4. General Discussion 728 4.1. Process Measures 728 4.1.1. Patient Selection Measures 728 4.1.2. Patient Education/Shared Decision-Making Measures 729 4.2. Outcome Measures 729 4.2.1. Level of Attribution/Aggregation 730 4.2.2. Infrequently Occurring Complications 730 4.2.3. Death/Readmission 730 4.2.4. Patient Surveys 730 4.3. Structural Measures 730 5. Measures Included in This Set 731 5.1. Comprehensive Documentation of Indications for PCI 731 5.2. Appropriate Indication for Elective PCI 731 5.3.


Comprehensive Documentation of Indications for PCI 731 5.2. Appropriate Indication for Elective PCI 731 5.3. Assessment of Candidacy for Dual-Antiplatelet Therapy 732 of Saphenous Vein Bypass Graft Disease 732 5.5. Documentation of Preprocedural Glomerular Filtration Rate and Contrast Dose Used During the Procedure 732 5.6. Radiation Dose Documentation 733 5.7. Postprocedural Optimal Medical Therapy Composite 733 5.8. Cardiac Rehabilitation Patient Referral 733 5.9. Regional or National PCI Registry Participation 733 5.10. Annual Operator and Hospital PCI Volume 734 6. Potential Measures Considered But Not Included in This Set 734 6.1. Process Measures 734 6.2. Outcome Measures 734 6.3. Structural Measures 735 7. Areas for Further Research 736 7.1. Documentation of Prescription of Drugs Versus Filling of Drug Prescriptions and Optimal Dosing of Drugs 736 7.2. Limitations of Current Data Systems for PCI 736 7.3. Shared Accountability 736 7.4. Patient Surveys 736 Staff 736 References 737 Key Words 738 Appendix A. Relevant Author Relationships With Industry and Other Entities 739 Appendix B. Relevant Reviewer Relationships With Industry and Other Entities 741 Appendix C. ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 Percutaneous Coronary Interventions Performance Measures: Summary Analysis Table 744 Preamble American College of Cardiology (ACC)/American Heart Association (AHA) performance measure sets can serve as vehicles to accelerate appropriate translation of scienti c evidence into clinical practice. These documents are intended to provide practitioners and institutions that deliver cardiovascular services with tools to measure the JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA quality of their care and identify opportunities for improvement. The present set of measures breaks important ground for performance measurement. Here, the writing committee was charged with developing measures to benchmark and improve the quality of one of cardiology s most common and important procedures: percutaneous coronary inter- vention (PCI).


Here, the writing committee was charged with developing measures to benchmark and improve the quality of one of cardiology s most common and important procedures: percutaneous coronary inter- vention (PCI). In this task, the ACC/AHA Task Force on Performance Measures partnered with representatives from several other organizations, including the Society for Cardiovascular Angiography and Interventions (SCAI), the American Medical Association (AMA) Convened Physician Consortium for Performance Improvement (PCPI), and the National Committee for Quality Assur- ance (NCQA). These bodies provided invaluable input in the development and review of these measures. The writing committee was instructed to follow the methodology of performance measure development (1,2) and to assure that the measures developed were aligned with national standards so as to promote harmony across measures. The writing committee was also charged with constructing measures that maximally capture multiple important aspects of quality (timeliness, safety, effec- tiveness, ef ciency, equity, and patient-centeredness) while minimizing the reporting burden imposed on participants. As in other cases, all selected measures pose potential challenges to implementation that could result in unin- tended consequences. The manner in which these issues are addressed is dependent on several factors, including the measure design, data collection method, performance attribution, baseline performance rates, reporting methods, and incentives linked to these reports. These imple- mentation challenges are appropriately discussed in indi- vidual sections dedicated to each of the measures. These new performance measures for PCI are notable for several reasons. First, the writing committee considered the key initial question of whether performing the proce- dure was appropriate, in line with a growing body of evidence in this area.


First, the writing committee considered the key initial question of whether performing the proce- dure was appropriate, in line with a growing body of evidence in this area. Determining procedural appropri- ateness of PCI is complex and requires comprehensive documentation of the procedure s priority, the presence and severity of angina symptoms, the use of antianginal medical therapies, and the presence and severity of stenosis (as documented by angiography or other metrics of lesion severity, e.g., intravascular ultrasound or fractional ow reserve). The present PCI performance measure set rep- resents the rst time in the cardiology literature that a speci c performance measure has been constructed to address procedural appropriateness. Next, the writing committee listed important tasks to be done by the care team before the procedure, including determining whether the patient can and would be likely to take dual-antiplatelet therapy on an ongoing basis (an important requirement if drug-eluting stents are to be used), as well as documenting the patient s renal function (which can in uence both the patient s candidacy for the procedure and procedural strategiesde.g., amount of iodinated contrast). Many procedural and postprocedural factors that can affect patient outcomes are considered in this measure set, such as the use of embolic protection devices and the documentation of ionized radiation and iodinated contrast dosage. The writing committee also put the procedure in the context of patients longitudinal disease process. Specif- ically, they considered that procedural quality must extend beyond the laboratory and should involve implementation of appropriate secondary prevention cardiac rehabilitation and medications to modify long-term risk. Finally, the writing committee considered other indicators of quality related to the interventionalist and the institution.


Finally, the writing committee considered other indicators of quality related to the interventionalist and the institution. These measures include such factors as procedural volume and whether the institution routinely tracks and benchmarks their care relative to others in clinical registries. Combined, these PCI metrics break important new ground. As noted by the authors, the eld of quality assessment and performance measurement in PCI is maturing, and many advances are still needed. Neverthe- less, this initial metric set provides a solid foundation for quality improvement in the eld and sets the stage for future advancement. Eric D. Peterson, MD, MPH, FACC, FAHA Chair, ACC/AHA Task Force on Performance Measures The ACC/AHA/SCAI/AMA-PCPI/NCQA Percuta- neous Coronary Interventions Performance Measures Writing Committee (the writing committee) was charged with creating the rst performance measure set in this area. In this measure set, the writing committee presents 11 mea- sures, which are intended for ambulatory and hospital (inpatient) settings. The measure set is summarized in Table 1. 1.1. Scope of the Problem The ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI performance measurement set, which is available on the PCPI Web site at http://www.ama-assn.org/apps/listserv/ x-check/qmeasure.cgi?submit PCPI, discusses in detail the scope of the problem and opportunities for improving the quality of care provided to patients undergoing PCI. 1.2. Structure and Membership of the Writing Committee The members of the writing committee included clinicians specializing in interventional cardiology, general cardiol- ogy, internal medicine, cardiac surgery, and cardiac reha- bilitation, as well as individuals with expertise in guideline development and performance measure development, implementation, and testing. The writing committee also included patient/consumer representatives and a payer Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 representative.


63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 representative. The writing committee had representation from the American Association of Cardiovascular and Pulmonary Rehabilitation, Mended Hearts, SCAI, and the Society for Thoracic Surgeons (STS). 1.3. Disclosure of Relationships With Industry and Other Entities The ACC/AHA Task Force on Performance Measures makes every effort to avoid actual, potential, or perceived con icts of interest that could arise as a result of re- lationships with industry or other entities (RWI). Detailed information on the ACC/AHA policy on RWI can be found at http://www.cardiosource.org/Science-And-Quality/ Practice-Guidelines-and-Quality-Standards/Relationships- With-Industry-Policy.aspx. All members of the writing committee, as well as those selected to serve as peer re- viewers of this document, were required to disclose all current relationships and those existing within the 12 months before the initiation of this writing effort. ACC/ AHA policy also requires that the writing committee co- chairs and at least 50% of the writing committee have no relevant RWI. Table 1. 2013 ACC/AHA/SCAI/AMA-PCPI/NCQA Percutaneous Coronary Intervention Measurement Set Measure Description* 1. Comprehensive Documentation of Indications for PCIy Percentage of patients aged 18 years for whom PCI is performed with comprehensive documentation of the procedure. This documentation includes, at a minimum, the following elements: 1. Priority (acute coronary syndrome, elective, urgent, emergency/salvage); 2. Presence and severity of angina symptoms (e.g., Canadian Cardiovascular Society classification system); 3. Use of antianginal medical therapies within 2 weeks before the procedure, if any; 4. Presence, results, and timing of noninvasive stress test, fractional flow reserve, or intravascular ultrasound, if performed; and 5. Significance of angiographic stenosis (may be quantitative or qualitative) on coronary angiography for treated lesion. 2.


Significance of angiographic stenosis (may be quantitative or qualitative) on coronary angiography for treated lesion. 2. Appropriate Indication for Elective PCIz Percentage of patients aged 18 years for whom elective PCI is performed in a native coronary artery who have an appropriate indication for the procedure that suggests its overall benefits outweigh its risks. 3. Assessment of Candidacy for Dual-Antiplatelet Therapyy Percentage of patients aged 18 years for whom PCI is performed who have documentation in the medical record that an assessment of candidacy for initiation and duration of dual-antiplatelet therapy was performed prior to the procedure. 4. Use of Embolic Protection Devices in the Treatment of Saphenous Vein Bypass Graft Diseasez Percentage of patients aged 18 years for whom saphenous vein graft PCI is performed who received an embolic protection device during the procedure. 5. Documentation of Preprocedural Glomerular Filtration Rate and Contrast Dose Used During the Procedurez Percentage of patients aged 18 years for whom PCI is performed who have both preprocedural estimated glomerular filtration rate or an indication that the patient is on dialysis AND the administered contrast dose documented in the catheterization report or procedure notes. 6. Radiation Dose Documentationz Percentage of patients aged 18 years for whom PCI is performed who have the administered radiation dose documented in the catheterization report or procedure notes. 7. Postprocedural Optimal Medical Therapy Compositey Percentage of patients aged 18 years for whom PCI is performed who are prescribed optimal medical therapy at discharge. 8. Cardiac Rehabilitation Patient Referraly Percentage of patients aged 18 years for whom PCI is performed who have been referred to an outpatient cardiac rehabilitation / secondary prevention program. 9. Regional or National PCI Registry Participationy Participation in a national or multisystem geographic regional PCI registry that provides regular performance reports based on benchmarked data. 10.


Regional or National PCI Registry Participationy Participation in a national or multisystem geographic regional PCI registry that provides regular performance reports based on benchmarked data. 10. Annual Operator PCI Volumez Average annual volume of PCIs performed by an operator over the previous 2 calendar years. 11. Annual Hospital PCI Volumey Annual volume of PCIs performed by a hospital over the previous calendar year. *For comprehensive information on these measures, including measure exceptions, please refer to the complete ACC/AHA/AMA-PCPI/NCQA/SCAI performance measurement specifications through the PCPI Web site (http://www.ama-assn.org/apps/listserv/x-check/qmeasure.cgi?submit PCPI). yThese measures have been designated performance measures. Performance measures are process, structure, efficiency, or outcome measures that have been developed with ACCF/AHA methodology, including the process of public comment and peer review, and have been specifically designated as performance measures by the ACC/AHA Task Force on Performance Measures. These measures not only are intended for internal quality improvement but also may be considered for purposes of public reporting or other forms of accountability. zIndicated in shading, these measures have been designated quality metrics. Quality metrics are measures that have been developed to support self-assessment and quality improvement at the provider, hospital, or healthcare system level. These metrics are valuable tools to aid clinicians and hospitals in improving quality of care and enhancing patient outcomes but might not meet all specifications of formal performance measures and are, therefore, not appropriate for any use other than internal quality improvement. ACC indicates American College of Cardiology; AHA, American Heart Association; AMA-PCPI, American Medical Association Physician Consortium for Performance Improvement;NCQA,NationalCommitteeforQualityAssurance;PCI,percutaneouscoronaryintervention;andSCAI,SocietyforCardiovascularAngiographyandInterventions. JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA Any writing committee member who develops new RWI during his or her tenure on the writing committee is required to notify staff in writing.


February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA Any writing committee member who develops new RWI during his or her tenure on the writing committee is required to notify staff in writing. These statements are reviewed periodically by the Task Force and by members of the writing committee. Author and peer reviewer RWI relevant to the document are included in the appendices: Please see Appendix A for relevant writing committee RWI and Appendix B for relevant peer reviewer RWI. Additionally, to ensure complete transparency, the writing committee members comprehensive disclosure information, including RWI not relevant to the present document, is available on- line at http://jaccjacc.cardiosource.com/DataSupp/ACCF/ 2013_Comprehensive_RWI_WC.pdf. Disclosure infor- mation for the Task Force is also available online at http:// www.cardiosource.org/ACC/About-ACC/Who-We-Are/ Leadership/Guidelines-and-Documents-Task-Forces.aspx. The work of the writing committee was supported exclusively by the ACC, the AHA, and the AMA, without commercial support. Members of the writing committee volunteered their time for this effort. Meetings of the writing committee were con dential and attended only by committee members and staff from the ACC, AHA, SCAI, AMA-PCPI, and NCQA. The development of performance measurement systems involves identi cation of a set of measures targeting a speci c patient population observed over a particular time period. To achieve this goal, the ACC/AHA Task Force on Performance Measures has outlined a set of mandatory sequential steps (1). The following sections outline how these steps were applied by the present writing committee. 2.1. Identifying Clinically Important Outcomes To guide the selection of measures for inclusion in the measure set, the writing committee sought to identify structures, processes, and outcomes that are most mean- ingful to patients undergoing PCI, as recommended by recent guidelines and appropriate use criteria (AUC). A key aspect was to determine outcomes that are most rele- vant for patients.


A key aspect was to determine outcomes that are most rele- vant for patients. A complete list of the desirable outcomes identi ed by the writing committee and how they relate to the proposed process measures is included in the measure speci cations that can be found at http://www.ama-assn. org/apps/listserv/x-check/qmeasure.cgi?submit PCPI. 2.2. Dimensions of Care Given the multiple measurable domains of providing care, the writing committee identi ed and explicitly articulated the relevant dimensions of care that should be evaluated. As part of the methodology, each potential performance measure was categorized into its relevant dimension of care (Table 2). Classi cation into dimensions of care facilitated identi cation of areas in which evidence was lacking and prevented duplication of measures within the set. Diagnostics, patient education (including on the topics of prognosis and etiology), treatment, self-management, and Table 2. 2013 ACC/AHA/SCAI/AMA-PCPI/NCQA Percutaneous Coronary Intervention Performance Measure Set: Dimensions of Care Measures Matrix* Measure Name Diagnostics Patient Education Treatment Self-Management Monitoring of Disease Status 1. Comprehensive Documentation of Indications for PCIy U 2. Appropriate Indication for Elective PCIz U U 3. Assessment of Candidacy for Dual-Antiplatelet Therapyy U U U 4. Use of Embolic Protection Devices in the Treatment of Saphenous Vein Bypass Graft Diseasez U 5. Documentation of Preprocedural Glomerular Filtration Rate and Contrast Dose Used During the Procedurez U U 6. Radiation Dose Documentationz U 7. Postprocedural Optimal Medical Therapy Compositey U 8. Cardiac Rehabilitation Patient Referraly U U U U 9. Regional or National PCI Registry Participationy U 10. Annual Operator PCI Volumez U 11. Annual Hospital PCI Volumey U *For comprehensive information on these measures, including measure exceptions, please refer to the complete ACC/AHA/AMA-PCPI/NCQA/SCAI performance measurement set through the PCPI Web site (http://www.ama-assn.org/apps/listserv/x-check/qmeasure.cgi?submit PCPI). yThese measures are performance measures.


Annual Hospital PCI Volumey U *For comprehensive information on these measures, including measure exceptions, please refer to the complete ACC/AHA/AMA-PCPI/NCQA/SCAI performance measurement set through the PCPI Web site (http://www.ama-assn.org/apps/listserv/x-check/qmeasure.cgi?submit PCPI). yThese measures are performance measures. zIndicated in shading, these measures have been designated quality metrics and are for use in internal quality-improvement programs only. They are not appropriate for any other use (e.g., pay-for-performance, physician ranking, public reporting programs). ACC indicates American College of Cardiology; AHA, American Heart Association; AMA-PCPI, American Medical Association Physician Consortium for Performance Improvement; NCQA, National Committee for Quality Assurance; PCI Percutaneous Coronary Intervention; and SCAI, Society for Cardiovascular Angiography and Interventions. Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 monitoring of disease status were selected as the relevant dimensions of care for PCI performance measures. In addition, to ensure the measure set would be as comprehensive as possible, the writing committee evaluated the potential measures against the Institute of Medicine domains of healthcare quality (safety, effectiveness, patient- centeredness, timeliness, ef ciency, and equity) (3). The writing committee focused primarily on processes of care, but they also considered structural and outcome measures for PCI. Although the writing committee cannot endorse speci c measures developed by others and believes that many measures are needed to quantify the full spectrum of relevant healthcare dimensions of quality, the measures proposed in the present set are intended to complement existing National Quality Forum endorsed PCI measures. 2.3. Literature Review The practice guidelines and other clinical guidance docu- ments that provided the basis for these measures can be seen in Table 3. 2.4. De nition and Selection of Measures The writing committee reviewed both recent guidelines and other clinical guidance documents, such as the ACCF/ Appropriate Use Criteria for Coronary Revascularization (11).


De nition and Selection of Measures The writing committee reviewed both recent guidelines and other clinical guidance documents, such as the ACCF/ Appropriate Use Criteria for Coronary Revascularization (11). The writing committee also examined available information on gaps in care and the clinical epidemiology of PCI. All measures were designed to assess quality of care in pa- tients undergoing PCI across a variety of ambulatory and hos- pital settings to support achievement of the desirable outcomes identi ed. The measures also were designed to allow for the exclusion of patients with contraindications or other valid rea- sons for exclusion from the measure. In de ning the measure exceptions, the writing committee was guided by the AMA- PCPI Recommendations for Speci cation and Categoriza- tion of Measure Exclusions (13), as discussed further below. The writing committee evaluated the potential measures against the ACC/AHA attributes of performance measures (Table 4) to reach consensus on which measures should be advanced for inclusion in the nal measure set; the Summary Analysis Table (Appendix C) captures this evaluation process. After the peer review and public comment period, the writing committee reviewed and discussed the comments received, and further re nements were made in the measure set. 2013 Percutaneous Coronary Intervention Measures 3.1. Target Population and Care Period The target population for the measures consists of all patients undergoing PCI for coronary artery disease. That said, a large focus of the writing committee was on measures aimed at patients coming to the cardiac cath- eterization laboratory for elective proceduresdthat is, those originating as outpatients. Patients arriving from the inpatient setting or emergency department and those with acute coronary syndromes were considered second- arily. The writing committee decided on this approach for 2 reasons.


The writing committee decided on this approach for 2 reasons. First, in patients with acute coronary syndromes, abundant data indicate that revascularization with PCI is bene cial, and prior measure sets focused on this disease condition have included measures targeting these patients (e.g., door-to-balloon time in ST-elevation myocardial infarction). Second, in selected patients un- dergoing elective procedures, such as those with chronic stable angina, there is greater controversy as to the best therapy that should be used. Patients referred to the cardiac catheterization laboratory in these settings usually have stable angina that is no longer controlled with medications or have high-risk ndings on a noninvasive stress test. The bene t of PCI in these patients is pri- marily symptom reduction, and data on a mortality rate bene t for this group are limited (14 16). 3.2. Avoiding Overlap and Ensuring Alignment With Existing Measure Sets and Guidelines The writing committee made every effort to avoid overlap with existing measure sets and to harmonize these Table 3.


Avoiding Overlap and Ensuring Alignment With Existing Measure Sets and Guidelines The writing committee made every effort to avoid overlap with existing measure sets and to harmonize these Table 3. Associated Guidelines and Other Clinical Guidance Documents ACCF/AHA/SCAI 2011 Guideline for Percutaneous Coronary Intervention (4) ACCF/AHA 2013 Guideline for the Management of ST-Elevation Myocardial ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non ST-Elevation Myocardial Infarction (6) ACCF/AHA 2011 Focused Update of the Guidelines for the Management of Patients with Unstable Angina/Non ST-Elevation Myocardial Infarction (updating the 2007 guideline) (7) ACCF/AHA 2012 Focused Update of the Guideline for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction (updating the 2007 guideline and replacing the 2011 focused update) (8) AHA/ACCF 2011 Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and other Atherosclerotic Vascular Disease: 2011 Update (9) ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 Appropriate Use Criteria for Coronary Revascularization Focused Update (11) Appropriate Use Criteria for Diagnostic Catheterization (12) AATS indicates American Association for Thoracic Surgery; ACC, American College of Cardiology; ACCF, American College of Cardiology Foundation; AHA, American Heart Association; ASE, American Society of Echocardiography; ASNC, American Society of Nuclear Cardiology; HFSA, Heart Failure Society of America; HRS, Heart Rhythm Society; PCI, percutaneous coronary intervention; SCAI, Society for Cardiovascular Angiography and Interventions; SCCM, Society of Critical Care Medicine; SCCT, Society of Cardiovascular Computed To- mography; SCMR, Society for Cardiovascular Magnetic Resonance; STEMI, ST- elevation myocardial infarction; and STS, Society of Thoracic Surgeons. JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA performance measures with other ACC/AHA/AMA- PCPI performance measure sets when possible.


February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA performance measures with other ACC/AHA/AMA- PCPI performance measure sets when possible. For example, the writing committee did not explore door-to- balloon time as a performance measure, given that this would overlap with performance measures for acute myocardial infarction already constructed and endorsed by numerous organizations. An example of harmonization within the measure set is the postprocedural optimal medical therapy composite measure in the present docu- ment, which is aligned with the similar National Quality Forum endorsed ACCF facility-level measure. 4. General Discussion 4.1. Process Measures Process measures have several advantages. They are more readily under the control of clinicians than are structural or outcome measures and also are actionable targets for quality improvement. Performance measures of processes are most useful when 1) they are directly linked to improved clinical outcomes through robust evidence, and 2) true gaps in care exist. Expending resources to measure processes that are already conducted at uniformly high rates is not justi ed, particularly when burdensome chart abstraction is required. An acknowledged limitation of process measures is that they might not always indicate how well the process was done. For example, measure 4 (use of embolic protection devices in the treatment of saphenous vein bypass graft disease) measures use of the embolic protection device during PCI but does not capture the technical skill with which it was deployed. We considered including measures assessing technical care processes performed in the cardiac catheterization labora- tory but did not include any such measures because of the lack of feasible, nonsubjective measurement criteria. This should be an area of future investigation. Two areas in which the writing committee tried to advance process measures were in patient selection measures and patient education/shared decision-making measures.


Two areas in which the writing committee tried to advance process measures were in patient selection measures and patient education/shared decision-making measures. Given the novelty of these topics, these are discussed in greater detail in the subsequent sections. 4.1.1. Patient Selection Measures As with many procedures, evaluating patient selection and determining appropriateness is a crucial rst step in ensuring high-quality clinical care. Nevertheless, this has not been done previously in performance measures for procedures. Ideally, this evaluation would revolve around both patients undergoing PCI and patients who are de- ferred from the procedure, to ensure that underutilization of potentially bene cial treatments is not occurring (17). Moreover, the indication (or reason) for the revasculariza- tion is attributable to several providers, including the referring physician and interventional cardiologist, as well as their discussions with the consenting patient. To date, the ACCF/SCAI/STS/AATS/AHA/ASNC/ HFSA/SCCT 2012 Appropriate Use Criteria for Coronary Table 4. ACC/AHA Task Force on Performance Measures: Attributes for Performance Measures 1. Evidence Based High-impact area that is useful in improving patient outcomes a) For structural measures, the structure should be closely linked to a meaningful process of care that in turn is linked to a meaningful patient outcome. b) For process measures, the scientific basis for the measure should be well established, and the process should be closely linked to a meaningful patient outcome. c) For outcome measures, the outcome should be clinically meaningful. If appropriate, performance measures based on outcomes should adjust for relevant clinical characteristics through the use of appropriate meth- odology and high-quality data sources. 2. Measure Selection Measure de nition a) The patient group to whom the measure applies (denominator) and the patient group for whom conformance is achieved (numerator) are clearly defined and clinically meaningful.


Measure Selection Measure de nition a) The patient group to whom the measure applies (denominator) and the patient group for whom conformance is achieved (numerator) are clearly defined and clinically meaningful. Measure exceptions and exclusions b) Exceptions and exclusions are supported by evidence. Reliability c) The measure is reproducible across organizations and delivery settings. Face validity d) The measure appears to assess what it is intended to. Content validity e) The measure captures most meaningful aspects of care. Construct validity f) The measure correlates well with other measures of the same aspect of care. 3. Measure Feasibility Reasonable effort and cost* a) The data required for the measure can be obtained with reasonable effort and cost. Reasonable time period b) The data required for the measure can be obtained within the period allowed for data collection. Actionable* a) Those held accountable can affect the care process or outcome. Unintended consequences avoided b) The likelihood of negative unintended consequences with the measure is low. ACC indicates American College of Cardiology; AHA, American Heart Association. Adapted from: Normand SL, McNeil BJ, Peterson LE, et al. Eliciting expert opinion using the Delphi technique: identifying performance indicators for cardiovascular disease. Int J Qual Health Care. 1998;10:247 60. Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 Revascularization (11) and the ACCF/SCAI/AATS/ AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/ STS 2012 Appropriate Use Criteria for Diagnostic Catheter- ization (12) represent the professional societies attempt at providing a framework for evaluating the appropriateness of procedures in the cardiac catheterization laboratory (18). Prior research demonstrated that the indication for revascularization can be captured and evaluated for appropriateness, although high rates of incomplete data collection were noted (19). These criteria propose that emergency or urgent revascularization for patients with acute coronary syndromes is generally considered appropriate.


These criteria propose that emergency or urgent revascularization for patients with acute coronary syndromes is generally considered appropriate. However, for elective revascularization, several important features should be considered in determining appropriateness of cases, including symptom status, degree of ischemia, anatomy, and current medical therapy. These ele- ments are central to the data that should be captured as the indicationformostrevascularizationprocedures.Therefore,the initial goal of measure 1 (comprehensive documentation of indications for PCI) and measure 2 (appropriate indication for elective PCI) is to ensure that adequate information for assessing the indication for revascularization procedures is captured and reported, so that continued evaluation and feed- back to improve both the AUC ratings and clinical care can occur. 4.1.2. Patient Education/Shared Decision-Making Measures Although the aforementioned factors highlight the dif- culty of determining when PCI is clinically indicated, reaching a high-quality decision goes beyond meeting the AUC. In an area in which decision making is so com- plex, performance measurement ideally also would address how the decision was made. This is necessary because patient preferences can play an important role in many cases, especially with regard to elective PCI. For example, some patients whose medical history and diagnostic testing results suggest PCI is indicated might still want to consider other options. Conversely, there will be patients for whom it is equivocal whether PCI is indicated, but the patient nonetheless expresses a strong preference to undergo PCI. The ideal approach to decision making is to involve the patient to the extent he or she wishes to be involved. Performance measurement should re ect this process as much as possible.


Performance measurement should re ect this process as much as possible. Many patients will want to be involved in these crucial decisions, and physicians performance with these patients ideally would be assessed in part by surveying patients about whether their input was solicited and their preferences drove or at least in uenced the decision. Alternatively, some patients will prefer that their physician make their decisions for them, and physicians who do so in such instances should be regarded as giving patient-centered care. In addition, all patients should be educated about their options. This education can be very brief in urgent settings, such as when a patient is having an ST-elevation myocardial infarction with cardiogenic shock. However, if any uncertainty exists about the superiority of PCI versus optimal medical therapy or surgical revascularization (as is usually the case with elective PCI), then the patient should be provided an opportunity to learn about the relative risks and bene ts of therapies under consideration. The writing committee struggled with whether to include process measures that focused on decision making and education through patient surveys. Surveys might be able to address general quality of decisions and ask patients about whether they were involved as much or as little as they desired. Survey results could then be shared at the physician and hospital levels, so both individual clinicians and institutions could understand and improve their decision-making processes. However, there are as yet no validated instruments addressing these domains, nor have other critical details been worked out. These limitations left the writing committee less enthusiastic about sup- porting a measure at the present time, but this should be a priority area for future investigation. 4.2.


These limitations left the writing committee less enthusiastic about sup- porting a measure at the present time, but this should be a priority area for future investigation. 4.2. Outcome Measures If the focus of process measures re ects the journey, outcome measures shed light on the destinationdthe end, rather than the means. Outcome measures offer the potential advantage of providing readouts on entire populations, rather than smaller population subsets, and they focus on the end results of care that are most important to clinicians and patients. The challenges with outcome measures are primarily in the risk-adjustment modeling methods, which, though never perfect, can substantially enhance the ability to compare outcomes across different delivery teams, settings, locations, and systems (20). Krumholz et al. (20) have described 7 preferred attributes of models used for outcomes that are publicly reported (Table 5), which this the writing com- mittee strongly believes should remain at the core of any performance measure that includes outcomes. Table 5. Preferred Attributes of Models Used for Publicly Reported Outcomes 1. Clear and explicit definition of an appropriate patient sample 2. Clinical coherence of model variables 3. Sufficient high-quality and timely data 4. Designation of an appropriate reference time before which covariates are derived and after which outcomes are derived 5. Use of an appropriate outcome and a standardized period of outcome assessment 6. Application of an analytical approach that takes into account the multilevel organization of data 7. Disclosure of the methods used to compare outcomes, including disclosure of performance or risk-adjustment methodology in derivation and validation samples Reprinted with permission from Krumholz et al. (20). JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA 4.2.1.


7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA 4.2.1. Level of Attribution/Aggregation Contributions of multiple healthcare providers across mul- tiple settings are re ected in outcomes associated with any particular episode of care, and this can be especially true in the case of PCI. In addition, various data sources and data systems are the window into that episode, such that the ability to aggregate data at the level of an individual clinician versus a broader grouping (e.g., practice or hospital) will depend on the types of data available and the outcomes being evaluated. Although data are increasingly available, most sources of information, like administrative claims data, generally lack adequate granularity to be of meaningful use for attribution of outcomes performance at the level of the individual provider, which makes aggregation of PCI out- comes more appropriate for the health system or hospital. 4.2.2. Infrequently Occurring Complications Certain outcomes could be of inarguable importance in PCI but occur rarely. Such outcomes are dif cult to interpret at the individual-provider level simply because of the fact that low-frequency events in a small sample size will produce unreliable estimates of provider performance. For this reason, certain measures are appropriately applied only to larger aggregated provider groupings where sample sizes are larger. These principles have substantial implications for PCI outcomes because the rates of major complications, such as death and the need for emergency coronary artery bypass surgery, have decreased signi cantly in recent years. Death is perhaps the most important and least ambiguous outcome measure. Proper risk adjustment isdand will remainda mandatory cornerstone of mortality monitoring for PCI. However, the writing committee also recognized that even the best risk-adjustment model cannot correct for potentially unmeasured confounders, and most risk- adjustment models perform less well at the extremes of risk.


However, the writing committee also recognized that even the best risk-adjustment model cannot correct for potentially unmeasured confounders, and most risk- adjustment models perform less well at the extremes of risk. This requires a careful design of outcome measures to avoid the unintended consequence of either penalizing facilities or clinicians who take on more dif cult cases or rewarding those who avoid certain high-risk patients requiring treatment. In this context, the writing committee did not believe it was necessary to reproduce existing National Quality Forum endorsed measures that are already available in the public realm on in-hospital and 30-day mortality rate after PCI. The writing committee also considered a potential measure of 30-day readmission after PCI, given reportedly high rates of readmission and recent interest in this outcome by payers and policymakers. As in the case of mortality rate, risk- adjusted measures of 30-day readmission after PCI have been developed, and we point interested readers toward those measures (21 23). 4.2.4. Patient Surveys Patient survey data have been used to compare the care provided across health systems and providers. For example, the Mended Hearts pilot program conducted surveys of patients 6 months after PCI, asking a range of questions: What type of procedure did you have?, Are you following your medication regimen?, and What can be done to improve knowledge of medications? Medicare Health Outcome Surveys also have been administered, as have a NCQA-HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) and system-level survey. In addition, many individual hospital systems have devel- oped and implemented diagnosis-related group-based postdischarge surveys. Such surveys might be appropriate for measuring certain outcomes, including subjective func- tional status, symptoms, knowledge, and overall satisfaction with the care process.