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2015 ACC/AHA Focused Updateof Secondary PreventionLipid Performance Measures

A Report of the American College of Cardiology/American Heart AssociationTask Force on Performance Measures

Endorsed by the American Academy of Family Physicians, American Association of Cardiovascular and

Pulmonary Rehabilitation, American Geriatrics Society, American Society of Health-System

Pharmacists, Association of Black Cardiologists, Inc., Preventive Cardiovascular Nurses Association,

Society for Cardiovascular Angiography and Interventions, Society for Cardiovascular Magnetic

Resonance, Society for Vascular Medicine, Society for Vascular Nursing, Society for Vascular Surgery,

Society of Cardiovascular Computed Tomography, Society of Interventional Radiology,

and Society of Thoracic Surgeons.

Writing Joseph P. Drozda, JR, MD, FACC, Chair

CommitteeMembers T. Bruce Ferguson, JR, MD, FACC, FAHA

Hani Jneid, MD, FACC, FAHA, FSCAI

This document was approved by the American College of Cardiology Board

Advisory and Coordinating Committee in October, 2014.

The American College of Cardiology requests that this document be cited as

BK, Olin JW, Ting HH. 2015 ACC/AHA focused update of secondary prevent

diology/American Heart Association Task Force on Performance Measures. J

Between July 8, 2014, and July 22, 2014, the document underwent a 15-

document underwent a 21-day public comment period.

This article has been copublished in Circulation: Cardiovascular Quality an

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permission-to-re-use-elsevier-material).

Harlan M. Krumholz, MD, SM, FACCBrahmajee K. Nallamothu, MD, FACCJeffrey W. Olin, DO, FACC, FAHA, MSVMHenry H. Ting, MD, MBA, FACC, FAHA

ACC/AHATask Force onPerformanceMeasures

Nancy M. Albert, PHD, CCNS, CCRN, CCA, FAHAPaul S. Chan, MD, MSc, FACC

Paul A. Heidenreich, MD, MS, FACC, FAHA, Chair

Lesley H. Curtis, PHDT. Bruce Ferguson, JR, MD, FACC, FAHAGregg C. Fonarow, MD, FACC, FAHA

of Trustees in

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P. MichaeSean O’BrAndrea M. Russo, MD, FACCRandal J. Thomas, MD, FACC, FAHAHenry H. Ting, MD, MBA, FACC, FAHAPaul D. Varosy, MD, FACC

November, 2014 and the American Heart Association Science

da JP Jr, Ferguson TB Jr, Jneid H, Krumholz HM, Nallamothu

ormance measures: a report of the American College of Car-

iol 2016;67:558–87.

iew period. Between July 15, 2014, and August 5, 2014, the

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J A C C V O L . 6 7 , N O . 5 , 2 0 1 6 Drozda et al.F E B R U A R Y 9 , 2 0 1 6 : 5 5 8 – 8 7 Focused Update of Secondary Prevention Lipid Performance Measures

559

TABLE OF CONTENTS

PREAMBLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 559

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 560

1.1. Rationale for Update . . . . . . . . . . . . . . . . . . . . . . . . 560

1.2. Structure and Membership of theWriting Committee . . . . . . . . . . . . . . . . . . . . . . . . . 560

1.3. Disclosure of Relationships With Industryand Other Entities . . . . . . . . . . . . . . . . . . . . . . . . . . 560

2. METHODOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 561

2.1. Target Population and Care Period . . . . . . . . . . . . 561

2.2. Literature Review . . . . . . . . . . . . . . . . . . . . . . . . . . 561

2.3. Definition and Selection of Measures . . . . . . . . . . 561

3. 2015 ACC/AHA FOCUSED UPDATE OF SECONDARY

PREVENTION LIPID PERFORMANCE MEASURES . . . . . 561

3.1. Gaps in Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 561

3.2. Broader Denominator (ASCVD)—Unique to This PM Set . . . . . . . . . . . . . . . . . . . . . . 562

4. GENERAL DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . 564

4.1. Patient-Centered PMs and SDM . . . . . . . . . . . . . . 564

4.2. “Prescribed” Versus “Offered” . . . . . . . . . . . . . . . 565

4.3. Prescription Versus Adherence . . . . . . . . . . . . . . . 565

4.4. Exceptions and Exclusions . . . . . . . . . . . . . . . . . . 567

4.5. Method of Reporting . . . . . . . . . . . . . . . . . . . . . . . 568

4.6. Limitations and Unintended Consequences . . . . . 569

5. FUTURE DIRECTIONS . . . . . . . . . . . . . . . . . . . . . . . . . 569

5.1. Improved Information Systems forCapturing Clinical Data . . . . . . . . . . . . . . . . . . . . . . 569

5.2. Measures of SDM and Shared Accountability . . . . 569

5.3. Conclusion and Summary . . . . . . . . . . . . . . . . . . . 570

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 570

APPENDIX A

2015 ACC/AHA Focused Update of SecondaryPrevention Lipid Performance Measures:Performance Measure Set . . . . . . . . . . . . . . . . . . . . . . . 572

APPENDIX B

Author Relationships With Industry and Other Entities(Relevant) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 582

APPENDIX C

Peer Reviewer Relationships With Industry andOther Entities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 583

APPENDIX D

2015 ACC/AHA Focused Update of SecondaryPrevention Lipid Performance Measures:Summary Analysis Table . . . . . . . . . . . . . . . . . . . . . . . . 587

PREAMBLE

American College of Cardiology (ACC)/American HeartAssociation (AHA) performance measures can serve asvehicles to accelerate appropriate translation of scientificevidence into clinical practice. Performance measurescover a subset of the most important recommended carepractices and are considered appropriate for publicreporting or use in pay for performance programs. Othermeasures of care that are not considered appropriate forpublic reporting or payment modification may be used asquality or test metrics for internal quality improvement.As defined by the ACC/AHA, quality metrics are thosemeasures that have been developed to support self-assessment and quality improvement at the provider,hospital, and/or healthcare system level. These metricsmay not meet all specifications of formal performancemeasures (1). In certain cases, an ACC/AHA performancemeasure writing committee may identify particular mea-sures as quality metrics for the purposes of pilot testingwith the potential of later promotion to performancemeasurement. Specific criteria for performance measureshave been published (2,3) by the ACC/AHA and include animportant gap in care and a clear path to improve care.Recently, value was added as an exclusion criterion (4),where a care practice deemed to be of poor value by anACC/AHA guideline would not be considered as a perfor-mance measure. The ACC/AHA Task Force on Perfor-mance Measures has historically focused on process ofcare measures under the control of individual providers.However, writing committees may also create structuralor outcome measures when they meet the ACC/AHAperformance measurement criteria.

A goal of the ACC/AHA Task Force on PerformanceMeasures is to rapidly create or update a performancemeasure when there are changes to a relevant ACC/AHAclinical guideline. Whenever possible, the ACC/AHAattempt to create relevant performance measures imme-diately following the publication of a guideline. However,the ACC/AHA believe that it is important to balance speedin measure development with a thorough review bystakeholders, content experts, and other interested

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parties using a public comment period. The goal is to haveup-to-date and valid measures that can be used by allinterested members of the healthcare system to evaluateand improve the quality of cardiovascular care.

Paul A. Heidenreich, MD, MS, FACC, FAHAChair, ACC/AHA Task Force on Performance Measures

1. INTRODUCTION

The “2015 ACC/AHA Focused Update of Secondary Pre-vention Lipid Performance Measures” Writing Committee(the writing committee) was charged with updating thecurrent lipid performance measures (PMs) based on thenew recommendations in the “2013 ACC/AHA Guidelineon the Treatment of Blood Cholesterol to Reduce Athero-sclerotic Cardiovascular Risk in Adults” (the CholesterolGuideline) (5). In this measure set, the writing committeepresents 5 PMs (Appendix A) 3 of which are intended forambulatory settings and 2 for hospital (inpatient) settings.Four are revisions of lipid management measuresappearing in 4 existing measure sets: “ACCF/AHA/ACR/SCAI/SIR/SVM/SVN/SVS 2010 Performance Measures forAdults With Peripheral Artery Disease” (6); “ACC/AHA2008 Performance Measures for Adults With ST-Elevationand Non-ST-Elevation Myocardial Infarction” (7); “ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 Performance Measuresfor Adults Undergoing Percutaneous Coronary Interven-tion” (8); and “ACCF/AHA/AMA-PCPI 2011 PerformanceMeasures for Adults With Coronary Artery Disease andHypertension” (9). These measure sets for percutaneouscoronary intervention (PCI), coronary artery disease(CAD), peripheral artery disease (PAD), and ST-elevationmyocardial infarction (STEMI)/non�ST-elevation myo-cardial infarction (NSTEMI) are summarized in Table 1.The fifth measure is new and applies to the populationof patients with clinical atherosclerotic cardiovasculardisease (ASCVD) as defined in the 2013 guideline (5).

1.1. Rationale for the Update

To ensure that ACC/AHA PMs for cardiovascular diseasefulfill their intended purposes, remain relevant, and are

TABLE 1 ACC/AHA Secondary Prevention Lipid PMs to Be Upda

Measure

2013 PCI Lipid Performance Measures (8) Percentage of patients $18 y omedical therapy at discharg

2011 CAD Lipid Performance Measures (9) Percentage of patients $18 y oresult <100 mg/dL OR patiecare to achieve an LDL-C <

2010 PAD Lipid Performance Measures (6) Percentage of patients $18 y o

2008 STEMI/NSTEMI Lipid PerformanceMeasures (7)

Percentage of patients with STErecord or documented LDL-

ACC/AHA indicates American College of Cardiology/American Heart Association; CADnon�ST-elevation myocardial infarction; PAD, peripheral artery disease; PCI, percutaneousinfarction.

fully aligned with current clinical practice guidelines,the ACC/AHA Task Force on Performance Measures(the Task Force) requires a transparent and consistentprocess that will allow focused updates to individualPMs when needed. This may occur when new guidelinerecommendations are released, when the Task Force re-ceives feedback from end users of the measures aboutcritical implementation problems, or when unintendedadverse consequences associated with implementationof the measure(s) are detected. The current writingeffort used the Cholesterol Guidelines’ recommendations(5), which are significantly different from those of theprior Adult Treatment Panel III guidelines and emphasizeadministration of high-intensity statin therapy insteadof achievement of low-density lipoprotein cholesterol(LDL-C) targets.

1.2. Structure and Membership of the Writing Committee

The members of the writing committee included clini-cians specializing in interventional cardiology and generalcardiology, as well as persons with expertise in develop-ment of guidelines and development, implementation,and testing of PMs. Chairs for each of the previouslypublished PMs (Table 1) were selected for the currentwriting effort.

1.3. Disclosure of Relationships With Industry and Other Entities

The Task Force makes every effort to avoid actual, poten-tial, or perceived conflicts of interest that could arise as aresult of relationships with industry or other entities(RWI). Detailed information on the ACC/AHA policy onRWI can be found online. All members of the writing com-mittee, as well as those selected to serve as peer reviewersof this document, were required to disclose all current re-lationships and those existing within the 12 months beforeinitiation of this writing effort. ACC/AHA policy also re-quires that thewriting committee co-chairs andat least 50%of the writing committee have no relevant RWI.

Any writing committee member who develops newRWI during his or her tenure on the writing committee is

ted

Description

f age for whom PCI is performed and who are prescribed optimale

f age with a diagnosis of CAD seen within a 12-mo period who have an LDL-Cnts who have an LDL-C result $100 mg/dL and have a documented plan of100mg/dL, including at a minimum the prescription of a statin

f age with PAD who were prescribed a statin and whose LDL-C is <100 mg/dL

MI/NSTEMI who are $18 y of age with documented LDL-C level in the hospitalC testing done during the hospital stay or planned for after discharge

, coronary artery disease; LDL-C, low-density lipoprotein cholesterol; NSTEMI,coronary intervention; PM, performance measure; and STEMI, ST-elevation myocardial

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required to notify staff in writing. These statements arereviewed periodically by the Task Force and members ofthe writing committee. Author and peer reviewer RWIrelevant to the document are included in the appendixes(see Appendix B for relevant writing committee RWIand Appendix C for relevant peer reviewer RWI). Addi-tionally, to ensure complete transparency, the writingcommittee members’ comprehensive disclosure informa-tion, including RWI not relevant to the present document,is available as an online supplement. Disclosure informa-tion for the Task Force is also available online.

The work of the writing committee was supportedexclusively by the ACC and AHA without commercialsupport. Members of the writing committee volunteeredtheir time for this effort. Meetings of the writing com-mittee were confidential and attended only by committeemembers and staff from the ACC and AHA.

2. METHODOLOGY

The development of PM systems involves identification ofa set of measures targeting a specific patient populationobserved over a particular period. To achieve this goal,the Task Force has outlined a set of mandatory sequentialsteps (2). The following sections outline how these stepswere applied by the present writing committee.

2.1. Target Population and Care Period

The target population for the ASCVD PM reflects theACC/AHA Cholesterol Guidelines (5) population andconsists of patients ages 18 to 75 years. In the focusedupdate of the 4 existing lipid PMs, the target populationconsists as well of patients ages 18 to 25 years, repre-senting a change from the age range previously speci-fied in each measure set. This change was felt to benecessary in order to maintain consistency with theClass of Recommendation I, Level of Evidence A re-commendation in the guidelines for treatment of pa-tients with clinical ASCVD. Additionally, the writingcommittee developed exclusion criteria for the mea-sures where appropriate in order to further specify thetarget population.

2.2. Literature Review

The writing committee used the Cholesterol Guidelines(5) as a primary source for deriving the measures. Thewriting committee also carried out a literature review toassess contemporary gaps in care.

2.3. Definition and Selection of Measures

The writing committee focused on developing thesemeasures against the ACC/AHA attributes of PMs. Eachmeasure was constructed in a way to ensure it was evi-dence based, desirable in regard to measure selection,

feasible to implement, and consistent with accountability(Table 2). After the peer review and public commentperiod, the writing committee reviewed and discussedthe comments and made further refinements in themeasure set. The writing committee evaluated the po-tential measures against the ACC/AHA attributes of PMs(Table 2) to reach consensus on which measures shouldbe advanced for inclusion in the final measure set;the Summary Analysis Table (Appendix D) captures thisevaluation process. The majority of the writing com-mittee believed that the 5 measures in the set fulfilledthe PM attributes.

3. 2015 ACC/AHA FOCUSED UPDATE OF

SECONDARY PREVENTION LIPID

PERFORMANCE MEASURES

3.1. Gaps in Care

Each of the original writing committees that developedthe measures revised in this update identified secondaryprevention performance gaps in the patient populationsthat were the subjects of their measure sets. There isevidence that these gaps are ongoing, although thepublished studies deal primarily with prescription ofmedication.

A study from the REACH (Reduction of Athero-thrombosis for Continued Health) Registry found thatonly 83% of ambulatory patients with known ASCVDwere receiving lipid-lowering agents (11). A prospectivestudy by Rabus and colleagues of 73 patients with an-giographically diagnosed CAD found that only 44%received prescriptions for statins (12). Reports from theNational Cardiovascular Data Registry PINNACLE Reg-istry of ambulatory patients with CAD revealed thatonly 66.5% (103,830 of 156,145) were receiving optimalmedical therapy (OMT), including statins (13), that77.8% (30,160 of 38,775) were prescribed statins (14),and that uninsured patients were 6% less likely toreceive lipid-lowering therapy (15). Additionally, thestudy by Maddox and colleagues found substantialvariation in prescription patterns by practice site (13,15).Shah and colleagues reported that, among 292 patientsfrom Olmstead County, MN, with incident acute myo-cardial infarction (MI), only 44% were still taking sta-tins 3 years after their infarction (16). Interestingly, astudy by Borden and colleagues (17) involving patientsin the National Cardiovascular Data Registry CathPCIRegistry failed to show any significant improvementin the prescription of OMT after PCI following publica-tion of the results of the Clinical Outcomes UtilizingRevascularization and Aggressive Drug Evaluation(COURAGE) study, which had demonstrated no incre-mental advantage of PCI over OMT on outcomes otherthan angina-related quality of life in stable CAD. Among

TABLE 2 ACC/AHA Task Force on Performance Measures Attributes for PMs

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 carethat in turn is linked to a meaningful patient outcome.

b) For process measures, the scientific basis for the measure is well established and the processshould be closely linked to a meaningful patient outcome.

c) For outcome measures, the outcome should be clinically meaningful. If appropriate, PMs basedon outcomes should adjust for relevant clinical characteristics by using appropriatemethodology and high-quality data sources.

2. Measure Selection

Measure definition a) The patient group to whom the measure applies (denominator) and for whom conformanceis achieved is 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 assess.

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) Data required for the measure can be obtained with reasonable effort and cost.

Reasonable period b) Data required for the measure can be obtained within the period allowed for data collection.

4. Accountability

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.

Adapted with permission from Normand et al. (10).

ACC/AHA indicates American College of Cardiology/American Heart Association; and PM, performance measure.

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all 467,211 patients (173,416 before [37.1%] and 293,795after [62.9%] the COURAGE trial) who met the studycriteria, the use of OMT at discharge following PCIbefore and after the COURAGE trial was 63.5%(95% confidence interval, 63.3% to 63.7%) and 66.0%(95% confidence interval, 65.8% to 66.1%), respectively(p < 0.001).

The extent to which statin treatment is initiated as aresult of a shared decision-making (SDM) process be-tween patient and clinician has not been systematicallyassessed but is likely small. Additionally, there is min-imal information available about the statin doses beingused in practice, although there are reasons for concernthat many patients are being undertreated. It is com-mon practice among clinicians to use the smallest doseof a medication necessary to achieve a therapeutictarget and minimize the chance of adverse effects. EvenPMs such as those revised in this focused updateexclude the requirement for therapy in patients whohave achieved goals. A study of 38,775 patients inthe PINNACLE Registry by Arnold and colleaguesrevealed findings consistent with undertreatment ofpatients with CAD (14). They found that 6,573 (17.0%)patients were not receiving any lipid-lowering therapy.Cholesterol levels were available for 3,365 of these pa-tients, 1,794 (53.3%) of whom had LDL-C levels <100mg/dL, consistent with clinicians either failing to treator discontinuing lipid-lowering therapy when patient

LDL-C levels met the previously recommended thera-peutic target. In a secondary analysis of the Trans-lational Research Investigating Underlying Disparities inAcute Myocardial Infarction Patients’ Health Status(TRIUMPH) study, only 23% of 4,271 patients dischargedalive following an acute MI were on maximal statintherapy, with substantial variability across hospitals(18). Finally, a study in the Get With The GuidelinesRegistry of 65,396 patients with acute coronary syn-dromes (ACS) who were discharged with lipid-loweringagents found that only 38.3% were discharged withintensive lipid-lowering therapy (19). An editorial chal-lenged measure developers to track the use of effectivedrug therapy, including dose (20). The current measuresare designed therefore not only to promote the use ofstatins as recommended by the Cholesterol Guidelines(5) but also to emphasize the importance of high-intensity dosing.

3.2. Broader Denominator (ASCVD)—Unique to This PM Set

The target population for the ASCVD PM includes womenand men between 18 and 75 years of age who have clinicalASCVD, which includes the following: ACS, history of MI,stable or unstable angina, coronary (including PCI) orother arterial revascularization, stroke, transient ischemicattack, or PAD. Although this patient population seemsheterogeneous, it encompasses a variety of patientswho all share presumed atherosclerosis (21) as a common

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pathophysiology. Atherosclerosis is a chronic diffusedisease involving a myriad of arterial beds with inter-mittent acute clinical manifestations, predominantlyoccurring as a result of superimposed thrombosis, plaqueprogression, spasm, embolism, or a combination of theabove. Other pathophysiological processes can contributeto the creation of stenosis or aneurysms in the arterialcirculation; however, atherosclerosis remains the mostcommon pathophysiology.

Patients with clinical ASCVD represent 1 of 4 majorgroups identified by the writing committee of theCholesterol Guidelines (5). For these patients, treatmentwith a 3-hydroxy-3-methylglutaryl-coenzyme A reductaseinhibitor, commonly known as a statin, is clearly benefi-cial. According to the Cholesterol Guidelines (5), patientswith clinical ASCVD were identified by using the inclusioncriteria from randomized clinical trials (RCTs) in second-ary prevention. In addition, the potential for reductionof risk for ASCVD with statins in these patients clearlyexceeds the potential for adverse effects (22).

The Cholesterol Treatment Trialists provided acomprehensive assessment of the benefits observed withstatins (23). They undertook meta-analyses of individualparticipant data from 26 RCTs and demonstrated reduc-tion in all-cause mortality, which was largely attributableto significant reductions in deaths due to CAD and othercardiac causes (23). The majority of studies in the afore-mentioned report included patients with known ASCVD.Of the 26 RCTs included, 5 trials (39,612 subjects, all ofwhom had CAD) compared more versus less intensivestatin regimens. The trials demonstrated that moreintensive regimens produced a highly significant 15%further reduction in major vascular events, driven by re-ductions in coronary death or nonfatal MI, coronaryrevascularization, and ischemic stroke (23). The in-vestigators also found no significant effects ob-served on deaths due to cancer or other nonvascularcauses or on cancer incidence, even at low LDL-Cconcentrations (23).

The aforementioned report was a meta-analysis ofRCTs (23). Concerns about the quality and quantity ofsafety reporting in RCTs have been raised previously,and many researchers find the reporting of risks inRCTs to be largely inadequate (24–26). Data fromRCTs should generally be supplemented by evidencefrom effectiveness studies to inform best clinicalpractice (27).

On extensive examination of clinical studies from theliterature, the current clinical evidence does not supportthe notion that titrating lipid therapy to achieve pro-posed low LDL-C levels is beneficial or safe. Conversely,compelling evidence supports near-universal empiricalstatin therapy for patients at high cardiovascular riskregardless of their LDL-C levels (28). Thus, many argued

to abandon the paradigm of treating patients to LDL-Ctargets and instead replace it with a more tailored treat-ment approach (i.e., personalized care), which aims notonly to improve patient outcomes but also reduce harmsand costs caused by overtreating patients at low risk(29,30).

For patients with ACS, which includes unstableangina, NSTEMI, and STEMI, the general period ofassessment is the inpatient hospitalization or relatedemergency department visit. For other patients (non-ACS patients), the PM is intended to assess the care forpatients at the practitioner level in an ambulatory caresetting for the primary purpose of quality improvement.For these non-ACS patients, the outpatient care periodis defined as the care provided in an outpatient settingwithin the time under evaluation, which is usually12 months.

There are important potential exceptions for routineinitiation of statin treatment. For primary prevention,the Cholesterol Guidelines expert panel determined that,despite the high level of risk for cardiovascular diseasein patients with a higher New York Heart Associationclass of heart failure or receiving hemodialysis, theavailable evidence suggests that initiation of statintherapy might not achieve a significant risk reduction(31–33). In recognizing this, the expert panel made norecommendations about the initiation or discontinuationof statins in these populations, allowing for physicianjudgment in individual patients (5). Additional excep-tions and exclusions related to secondary preventionmeasures are discussed in a separate section of thisreport.

Historically, the Task Force has developed separatesets of PMs in discrete patient populations, includingpatients with STEMI and NSTEMI (7), PAD (6), CAD (9),and those undergoing PCI (8). These separate seminaldocuments, each inclusive of a PM pertaining to statintherapy in its corresponding population, may generallybe more useful in specialty care quality improvementprograms. Although the writing committee is adheringto this philosophy in revising the lipid PMs for each ofthese 4 specific populations, it is taking a novelapproach in creating a new PM that applies to themuch broader population of patients with ASCVD. ThisPM is concordant with the Cholesterol Guidelines (5),which was based on evidence from RCTs and theirmeta-analyses showing risk reduction among the vari-ety of patients with clinical ASCVD, including thosewith ischemic cerebrovascular events. The writingcommittee believes that primary care clinicians andspecialists concerned with secondary prevention ofASCVD will find these new PMs easy to use in theclinical setting. The 5 updated measure sets are sum-marized in Table 3.

TABLE 3 2015 ACC/AHA Focused Update of Secondary Prevention Lipid PMs

PM Description

PAD Percentage of patients 18-75 y of age with PAD who were offered moderate- to high-intensity statin

STEMI/NSTEMI Percentage of patients 18-75 y of age with AMI who were offered moderate- to high-intensity statin at hospital discharge

PCI Percentage of patients 18-75 y of age for whom PCI was performed who were offered optimal medical therapy at discharge

CAD Percentage of patients 18-75 y of age with CAD who were offered moderate- to high-intensity statin

ASCVD Percentage of patients 18-75 y of age with clinical ASCVD who were offered moderate- to high-intensity statin

ACC/AHA indicates American College of Cardiology/American Heart Association; AMI, acute myocardial infarction; ASCVD, atherosclerotic cardiovascular disease; CAD, coronary arterydisease; NSTEMI, non-ST elevation myocardial infarction; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; PM, performance measure; and STEMI, ST elevationmyocardial infarction.

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4. GENERAL DISCUSSION

4.1. Patient-Centered PMs and SDM

The recommendation to initiate statins for secondaryprevention is based on strong evidence in which benefitfar exceeds risk (34). However, better patient outcomesare realized only if patients agree with, act on, and adhereto the recommendation for 5 to 10 years. The importanceof clinician-patient discussions about statin therapy isspecifically emphasized in the Cholesterol Guidelines(5). Among patients who are prescribed statins for sec-ondary prevention, most initiate treatment, but up to halfdiscontinue statins at 1 to 2 years’ follow-up (16,35).Therefore, a PM that represents only the number of pa-tients prescribed statins in the numerator divided by thenumber of patients eligible to receive statins for second-ary prevention in the denominator is inadequate anddoes not reflect quality of care. Rather, a measure thatreflects the proportion of patients who participated inSDM would promote patient participation in the treat-ment plan, potentially increasing adherence to guideline-recommended care and improving patient-centeredoutcomes.

SDM: What Is It?

The SDM approach aims to promote a process wherebypatients and clinicians together make a choice abouttreatments that incorporates 2 perspectives: 1) cliniciansrecommending treatments based on strong evidence inwhich benefit exceeds risk, and 2) patients deliberating onhow treatments fit with their preferences, values, andpersonal context (36). In this framing, the clinician is theexpert on evidence-based medicine and guidelines, andthe patient is the expert on his or her preferences, values,and personal context. SDM mitigates the power differen-tial between these 2 experts and acknowledges that bothperspectives contribute equal weight to decision making.By incorporating patient preferences, values, and per-sonal context to decision making, clinicians strengthentheir implementation of evidence-based medicine andguidelines in a patient-centered manner to improve

outcomes that matter to patients. A PM that integratespatient values, preferences, and personal context withevidence-based medicine and guidelines is novel andchanges the focus from recommending and prescribingstatins based on strong evidence to promoting choiceby an informed patient whether or not to initiate statins.

SDM: Why Do It?

SDM has often been framed as an approach to curb over-use of expensive or unnecessary treatments. However,clinicians and healthcare organizations should bearthe responsibility for curbing overuse, that is, recom-mending treatments where benefit does not exceed risk.The rationale for SDM includes patient safety, patientengagement, patient experience, and ethical principles.The patient safety reasoning arises from the notion that amisdiagnosis of a patient’s medical condition leads tounnecessary and unwanted tests and treatments associ-ated with harm and cost. Similarly, misdiagnosis of a pa-tient’s preferences, values, and personal context can leadto unnecessary and unwanted treatments. The patientengagement principle poses the question “What wouldthe patient choose if the patient knew what the clinicianknows?” When patients are offered the opportunity toparticipate in SDM, the majority prefer this approach, andpatient satisfaction and experience with care improve(37). The ethical justification for SDM is based on theprinciple of autonomy that patients should be empoweredto make informed decisions about their health.

SDM: How to Do It?

The path forward includes advancing how cliniciansengage patients in decision making, developing tools topromote and facilitate SDM, and measuring that SDMoccurred (38,39). Clinicians need to embrace the conceptthat evidence-based medicine and guidelines alone arenot sufficient to make a recommendation or decision;rather, the evidence has to be considered from the view-point of what matters to individual patients. Hence,the clinical encounter transforms from one wherethe clinician strives to convince the patient of the

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“right answer” to one where the clinician and patientcollaborate, deliberate, and arrive at the “best answer”that fits patient preferences, values, and context. Decisionaids are one type of tool used during clinical encountersand have been shown to increase knowledge transfer topatients about personalized benefit and risk, improvepatient involvement in decision making, and reducedecisional conflict (40). Decision aids can be implementedat the point of care to promote SDM, including the choiceof whether or not to initiate a statin for the next5 to 10 years to lower cardiovascular risk (http://statindecisionaid.mayoclinic.org). Measuring the occur-rence of SDM is a developing science, and in the scenarioof clinicians recommending statins for secondary pre-vention, potential measures to assess if SDM occurredinclude: 1) Does the patient know his or her personalizedcardiovascular risk? 2) Was a statin offered to reduce risk?3) What decision did the patient make about whether ornot to initiate statins?

4.2. “Prescribed” Versus “Offered”

A true measure of SDM would assess the process ofimparting information on statin therapy, including ben-efits, harms, and alternative approaches, along withthe patient “outcomes” of that discussion. The possibleoutcomes of SDM on statin therapy would be that the

1. Patient agrees to initiate statin therapy and gets aprescription

2. Patient declines to initiate statin therapy3. Patient is undecided and will continue deliberations

Given the short time frame available for completingthis focused update, it was determined that developing ameasure of SDM that could be implemented inclusive ofits key components was not possible, and the decisionwas made to defer this task to the writing committees ofeach of the individual PM sets at the times of the next fullrevisions. At the same time, the writing committeedetermined that it would be important to put forwardmeasures that more closely approximated SDM than domeasures of prescription only.

Prescription-only measures have the disadvantage thatthey assess an action (prescribing medication) that iscompletely under a provider’s control but one that can beperformed without any participation by the patient. Inother words, prescription-only measures reflect none ofthe patient outcomes of SDM.

The writing committee thought that, at the least, someindication of the outcome of a patient declining a statinprescription should be included in the numerator. Anexample of reporting such a PM is presented in Figure 1.The ACC/AHA PM methodology states that if the providerdocuments the patient’s refusal of medication, the pa-tient should be removed from the denominator of the

measure as an exception for patient reasons (2). In theseinstances, the patient is removed from both numeratorand denominator. This approach does accommodate SDM.However, the writing committee decided to constructmeasures whereby patients with exceptions for patientreasons would be retained in both numerators and de-nominators in order to “give credit” for SDM rather thanhave these efforts simply disappear from measuresshould the patient decline medication. The combinationof “prescribed” and “exception for patient reasons” wastermed “offered” and was considered to be a surrogatefor the patient outcomes of agreement and decline andto represent an initial step away from the current stateof measuring prescribing toward more comprehensiveand direct measures of SDM. The methodology ofcapturing patients with exceptions in the numerator wasactually used in the construction of the prior PAD statinmeasure so that patients with LDL-C levels <100 mg/dLwho had medical or personal reasons for not being pre-scribed a statin were retained in the numerator (6).Additionally, a strength of using patient exceptions inthis manner is that it does not require capturing any newdata elements for the measures but is simply an alter-ation of measure construction using the same measurecomponents.

The writing committee also thought that it wasimportant for the measures to reflect the CholesterolGuidelines’ recommendation that patients with clinicalASCVD be offered high-intensity statin therapy andreceive moderate-intensity statin when high-intensitystatin therapy is contraindicated according to eachmanufacturer’s prescribing information or when charac-teristics predisposing the patient to statin-associatedadverse effects are present (5). Again, it was determinedthat the statin dose should also be subjected to SDM.As such, patients “offered” high-intensity statin therapyare included in the numerators and denominators ofthe revised measures, as are patients who have docu-mented medical exceptions (2) for not being offered ahigh-intensity statin and who are “offered” a moderate-intensity statin instead. Patients with medical excep-tions to moderate-intensity statin therapy are excludedboth from the numerators and denominators. High-intensity and moderate-intensity statins are definedaccording to the dosing tables included in the CholesterolGuidelines (5).

4.3. Prescription Versus Adherence

Rethinking Adherence

The writing committee also considered measures ofpatient adherence to statin medications but ultimatelyconcluded that, as with prescription-only measures, suchmeasures would not be optimal for assessing providerperformance and improving quality of care. Measures of

FIGURE 1 Method for Reporting Secondary Prevention Lipid PMs: Example Using PM for the Treatment of Blood Cholesterol to Reduce

Atherosclerotic Cardiovascular Risk in Adults With ST-Elevation and Non–ST-Elevation Myocardial Infarction

Patients with STEMI and NSTEMI (hypothetical sample meeting denominator criteria) 105

Exceptions: Patients not prescribed statins for medical reasons (excluded from numerator and denominator)

Exclusions (excluded from numerator and denominator)

3

2 Patients not prescribed statins for patient reasons (included in numerator and denominator) 10

Patients prescribed statins

Patients not offered statins (not prescribed and with no documented exceptions)

80

10

Measure calculation (percentage of patients with STEMI and NSTEMI statins): 09)01+08(rotaremuN

Denominator (105–5) 100 %09ecnamrofreP

Numerator analysis: Proportion of patients prescribed statins calculation:Numerator 80 Denominator 100

Proportion prescribed statins 80%

Proportion of patients not prescribed statins for patient reasons:Numerator 10 Denominator 100

Proportion not prescribed statins for patient reasons 10%

NSTEMI indicates non–ST-elevation myocardial infarction; PM, performance measure; and STEMI, ST-elevation myocardial infarction.

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adherence suffer from the same inadequacy as measuresof prescription in that they ignore patient preferences.Furthermore, adherence is a different process, occurringafter the patient has agreed to a treatment plan as a resultof SDM. Measures of adherence oversimplify complexhuman behaviors, and when used in provider incentiveand public reporting programs, put the onus for adher-ence entirely on the clinician. Additionally, measuringadherence is quite difficult, particularly when usingclinical data from the electronic health record (EHR).

Several components ultimately determine whether apatient derives maximum benefit from medications thatdecrease cardiovascular event rates. Clinicians must pre-scribe the medication at an optimal dose and the patientmust take the medication as instructed on a long-termbasis. There is still an opportunity to improve persis-tence in taking statins among patients with known car-diovascular disease. This is especially true for patientswith PAD: only 33% were using statins within 3 months ofincident diagnosis, whereas 37% were using statins 18months after incident diagnosis (41).

Ensuring adherence is not simply a matter of writing aprescription and advising the patient to take the medi-cation (42). It has been estimated that at 2 years’ follow-up, one-half of patients are no longer taking statins (42).The discontinuation rate is highest in patients withasymptomatic chronic diseases such as hypertension andhypercholesterolemia (42). In those who do not discon-tinue the medication completely, studies have demon-strated that patients take fewer than 50% of the dosesprescribed (42). Nonadherence to taking medication is animportant public health consideration, affecting healthoutcomes and overall healthcare costs (43). The conceptof shared accountability as related to long-term adher-ence and PMs is important to achieve the ultimate goalof improved patient outcomes and quality of life. Sharedaccountability must include the healthcare team, thehealthcare system, and the patient (44). At the sametime, it remains important that the clinician and patienthave ongoing discussions about statin therapy and thereasons for less than optimal adherence if such is foundto be the case.

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Intentional and Unintentional Nonadherence

The reasons for the high discontinuation rate and misseddoses are complex and multifactorial and may includeboth intentional (45) and unintentional nonadherence(46):

1. Cost of medication2. Patient cannot afford the co-pay3. Unclear label instructions4. Patient forgetfulness5. Adverse effects from medication that patient is too

embarrassed to discuss with doctor6. Patient does not like the idea of having to take

medication7. Patient does not understand the importance of a given

medication for a condition for which he or she has nosymptoms

8. Patient–practitioner relationship is suboptimal9. Polypharmacy and complexity of regimen

It is important to understand the concept of “unin-tentional nonadherence,” which is defined in the Instituteof Medicine report Health Literacy: A Prescription to EndConfusion as “the degree to which individuals have thecapacity to obtain, process, and understand basic healthinformation and services needed to make appropriatehealth decisions (47).” Unintentional nonadherence isthought to be a passive process on the part of the patientand may involve a lack of understanding of physicalproblems, resulting in an inability to follow treatmentinstructions, impaired manual dexterity, poor eyesight, orforgetfulness. In a recent systematic review and meta-analysis, it was noted that there is a statistically signifi-cant relationship between health literacy and medicationadherence; however, the magnitude of effect was smallwhen compared with other causes of nonadherence, suchas medication beliefs and cost (48). One of the mostimportant aspects of long-term medication adherence isto review the medication list; ask about adverse effects,cost, and adherence; and discuss barriers to adherence atevery office visit (44). Finally, the shared accountabilityof all of those involved in the prescription process,including the patient, is critical to the success or failure oflong-term medication adherence (44).

Medication adherence is dependent on a complexinterrelationship between the disease and demographicand socioeconomic factors; beliefs of the patient and thepatient’s family and friends; the medication itself; andthe healthcare system (patient�care provider interaction,access to care and care organizations) (49). It is readilyapparent that an individual clinician should not be solelyaccountable for a patient’s adherence to medication,because many factors related to nonadherence are out ofthe healthcare provider’s control, although there aremeasures the clinician can take to increase the likelihood

of adherence. These include the quality of the patient�care provider relationship, SDM, and avoidance ofoverly complex and expensive medication regimens.

A Cochrane Database systematic review concludedthat some interventions were nominally effective in theshort term. However, it was found that current methods ofimproving adherence for chronic health problems aremostly complex and not very effective (43). These complexsolutions to adherence included combinations of moreconvenient care, information, counseling, reminders, self-monitoring, reinforcement, family therapy, psychologicaltherapy, mailed communications, crisis intervention,manual telephone follow-up, and other forms of addi-tional supervision or attention (43). Even with the mosteffective methods to increase adherence, the magnitude ofeffect was quite small. Clearly, much more research isneeded to determine the causes of nonadherence and todevelop patient- and systemwide strategies to reduce thelikelihood that the patient will stop taking medicationshown to have beneficial effects on overall health.

4.4. Exceptions and Exclusions

The detailed description of exceptions is central to thecharacterization of the PM for the treatment of bloodcholesterol to reduce the risks of ASCVD in adults withestablished disease. In developing exceptions and exclu-sions for these measures, the writing committee fol-lowed the ACC/AHA PM development methodology (2,3),which is concordant with that of the American MedicalAssociation�Physician Consortium for Performance Im-provement (now PCPI) (50). Notably, measure exceptionsare based predominantly on clinical judgment, individualpatient characteristics, or patient preferences. On theother hand, exclusions are used in circumstances notrequiring clinical judgment to factor into the decisionmaking (e.g., patients who died, left against medicaladvice, or were discharged to hospice). In accordancewith the ACC/AHA PM development methodology (3),the writing committee maintains that if a patient has apotential contraindication but does in fact receive treat-ment, then that patient should be included in both thenumerator and denominator of the PM. This approachrecognizes that contraindications may be relative and re-wards clinicians for exerting clinical judgment and suc-cessfully fulfilling the PM (by offering a medication whenthe clinician believes the benefits outweigh the risks).

The writing committee recognizes that there are justifi-able reasons for patients not receiving a service thatis the subject of a process PM. According to the ACC/AHAreport “New Insights Into theMethodology of PerformanceMeasurement” (3), exceptions are used in these instancesbecause the data from these patients should still becaptured for the purposes of internal quality improvementanalyses. Exceptions can be related to medical reasons

*Apply specifically to STEMI/NSTEMI and PCI measure sets.

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(e.g., the patient’s allergic history, concern for potentialadverse drug interaction, and intolerance to therapy), pa-tient reasons (e.g., patient preference, social or religiousreasons, economic reasons), or system reasons (e.g., lackof available resources, insurance coverage/payer-relatedlimitation). The writing committee has provided for ex-ceptions from the denominator for medical reasons onlyand does not allow exceptions for system reasons. Thewriting committee concluded that the frequency of eventsthat could be interpreted as system reasons for not offeringa statin would be very low and would not likely have amaterial impact onmeasure results, making it unnecessaryto make provisions for them in measure construction.(As noted previously, patients with exceptions for pa-tient reasons are retained in the denominator.) Addition-ally, the writing committee has chosen to use onlyexceptions for most patients with ASCVD but has alsomade exclusions for patients with STEMI and NSTEMIand those undergoing PCI in concordance with the meth-odology previously used in the PM documents for thesepatients (7,8).

The ACC/AHA PM methodology (2,3) advocates that allpatients who receive the treatment (e.g., statin) should beincluded in the numerator and denominator of the mea-sure and that the assessment of the documented contra-indications to therapy will be undertaken only among theremaining patients who did not receive it. As previouslynoted (7), some contraindications are relative or tempo-rary or both and may resolve between the time of docu-mentation and provision of therapy. This approach willlikely help eliminate false exclusions of patients who areultimately appropriately treated and further decrease theburden of data abstraction.

The writing committee endorses the recommendationsin the ACC/AHA PM methodology report (3) that cliniciansdocument the specific reasons for exclusions and excep-tions in the patient’s health records for purposes ofoptimal patient management, future research, and audit-readiness; to identify practice patterns and opportunitiesfor quality improvement; and for accountability purposes.The sources of data where exclusions and exceptions canbe sought include all administrative data and claims,prospective flow sheets, and patient health records (bothelectronic and hard copy [paper]). The writing committeemaintains that the abstractor may wish to pay closeattention to the clinician’s documentation. In the patienthealth record, any of the above care providers must stilllink the specific reason reported for the nonuse of statinsfor the documentation to count as a reason for not offeringmoderate- to high-intensity statin (as an example:“Patient receiving hemodialysis; no statins needed”).

The writing committee has revised the exceptions andexclusions for the lipid measures from the prior PM doc-uments (6–9). Most importantly, it has decided not to

exclude patients with a known LDL-C level <100 mg/dL,as was done specifically in the “ACC/AHA 2008 Per-formance Measures for Adults with ST-Elevation andNon-ST-Elevation Myocardial Infarction” (7). This is inalignment with the Cholesterol Guidelines (5), which donot recommend an approach of treat-to-cholesterol targetbut rather the use of fixed doses of cholesterol-loweringdrugs (specifically statins) to reduce the risk of ASCVD.This is also concordant with the evidence from RCTsshowing that ASCVD events are reduced by using maxi-mally tolerated statins in those patients shown to benefit(23). Notably, statin dosage increases occurred in only afew RCTs with the intent of maximizing therapy, butthese were not true tests of defining optimal goals forLDL-C, because not all persons in the statin treatmentgroups received drug therapy titrated to achieve a specificLDL-C, nor were specific treatment targets compared (5).

Denominator Exclusions (Not Included in Numerator or

Denominator)*:

� Patient died� Patient left against medical advice� Patient discharged to hospice or for whom a comfort

measures�only order is documented� Patient transferred to another hospital for inpatient care

Denominator Exceptions (Not Included in Numerator or

Denominator):

� Documentation of medical reason(s) for not prescribinga statin (e.g., allergy, intolerance to statin[s], hepaticfailure, hemodialysis, heart failure, other medicalreasons)

4.5. Method of Reporting

In selecting a methodology for measures that calls forinclusion of patients in the numerator for 1 of 2 reasons,that is, patients for whom statins were prescribed andpatients for whom statins were not prescribed for patientreasons, the writing committee recognizes the need formore visibility for both components of the numerator.The writing committee therefore recommends thatreporting of these measures include the proportion ofpatients for whom statins were prescribed and the pro-portion for whom statins were not prescribed due to ex-ceptions for patient reasons. In this construct, thepercentage of patients offered statins remains the PM foraccountability purposes, whereas reporting the additionaldata provides full transparency for the components ofthe measure along with information useful to the careteam in understanding their performance (Figure 1).

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4.6. Limitations and Unintended Consequences

The writing committee recognizes that a differentapproach to medication PMs from that used with mostprior such measures is presented in this paper. As such, atthis time conclusions cannot be drawn about the effec-tiveness of these measures in helping to close the per-formance gaps described above. Furthermore, as with allPMs, the potential for unintended consequences existsfor these measures and may be greater because of thedifferent methodology being used. For instance, whenPMs are used in accountability programs, the risk of“gaming” by clinicians is always present. Clinicians could,for example, convince patients not to take high-intensitystatins for fear of adverse effects and still receive “credit”under the methodology described herein. The method forreporting these measures described in this paper shouldmitigate the potential for gaming, but it remains to beseen whether or not that will be the case. Although thewriting committee is convinced that these measures willassist clinicians in improving patient care, careful evalu-ations of benefits and unintended consequences shouldbe carried out, particularly when they are used in pay-for-performance and public reporting programs.

5. FUTURE DIRECTIONS

5.1. Improved Information Systems for Capturing Clinical Data

Measures of provider-patient interaction, including SDM,require data from clinical sources such as EHRs and clin-ical registries and cannot be derived from insuranceclaims. Unfortunately, challenges remain for imple-mentation of such measures in clinical data sets. EHRshave a relatively constrained number of discrete datafields related to provider-patient encounters that can beused for calculating measures. In addition, significantvariation in data definitions exists among registries andEHRs and among instances of ostensibly the same EHR,making comparisons among providers difficult. Finally,and of particular importance to measures of SDM, patient-reported data are rarely captured in EHRs or registries.

Registries have typically obtained discrete datathrough the use of case report forms, but completion ofsuch forms is labor intensive and not a feasible solution inthe nonresearch clinical setting. Checklists and “smartforms” are often used in EHRs to collect key data ele-ments for PMs, particularly measures of patient educationand counseling. These techniques have proved to beless than satisfactory, because checking a box that SDMhas occurred communicates little of what that processincluded. Additionally, smart forms require additionalwork by the provider during the patient encounter andare therefore used only sporadically.

As was the case with the original measures on whichthey are based, the revised lipid measures were designed

with the current reality of clinical information systems inmind. For truly robust measures of SDM to be feasible,significant improvements in collecting clinical data willbe required. Efforts to capture data in the course of care,as opposed to requiring providers to enter data, are beingmade by a variety of health information technologycompanies and by registries such as the National Cardio-vascular Data Registry PINNACLE Registry, which em-ploys a system integration software utility (51) to extractelements from the EHR that are necessary for measurescalculation. Structured data capture whereby data fromthe EHR would be collected as discrete elements hasbeen recognized by the Office of the National Coordinatorfor Health Information Technology as a priority and isthe subject of a major initiative (52). An example of a“structured format” is a standardized provider office notethat contains discrete fields for key data elementspotentially including those necessary for assessing SDM.

Methods for capturing patient-reported data for com-parative effectiveness research are also being inves-tigated, with significant interest in the use of EHRpatient portals for that purpose (53). Patient-reporteddata collected in this way would be useful as well inassessing SDM from the patient’s point of view. Addi-tionally, integration of EHR-derived data with nationalregistries would provide a mechanism for implementationof standard data definitions, enabling valid comparisonsand analyses employing common data models.

5.2. Measures of SDM and Shared Accountability

SDM has been a core concept that the writing committeehas considered in the construction of these PMs for statintherapy in ASCVD. It is the writing committee’s rationalefor the numerator to include the number of patientsoffered a statin as defined. This outcome reflects bothpatients who declined a statin as well as those for whom aprescription was provided. However, measuring whetheror not SDM has occurred during a clinical encounter is adeveloping science and pushes the boundaries of the newfield of shared accountability measures. In particular,determining whether high-quality SDM has been provideddepends on understanding the process. Ideally, this in-volves the extent to which a patient 1) has obtainedknowledge of the risks and benefits of a decision, and 2)has demonstrated engagement in the decision-makingprocess through deliberations that consider the patient’spreferences, values, and capacity for action and agree-ment for long-term adherence. Future approaches toaddress PMs in this area will require a better under-standing of both of these issues, perhaps allowing foraddressing situations where patients remain undecidedand continue deliberations with their providers.

In addition to measuring whether a statin was offeredto reduce risk for patients with ASCVD, potential measures

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to assess the quality of SDM may include: 1) measuring ifthe patient knows his or her personalized cardiovascularrisk; 2) assessing whether the patient understands theavailable options and their risks and benefits; 3) askingpatients about interactions with their provider; and4) determining if high-quality decision tools were incor-porated into the clinical encounter. Future studies inthese areas will need to determine that reliable andvalid PMs may be constructed under this framework ofshared accountability measures that potentially requiresurveying the patient about these domains. The exam-ples listed above also must be broadened to addressadditional challenges in measurement of longitudinaladherence and across multiple care settings (hospital,outpatient clinic, home), as well as development of PMsand incentives that also target patients directly ratherthan providers alone, because having participated inSDM and having agreed to take a statin, the patientassumes responsibility for following through on thiscommitment or bringing any concerns back to the pro-vider. PMs should also measure the performance of otherstakeholders who share accountability for adherence,including insurance companies, policy makers (benefitdesign and care coordination programs), and accountablecare organizations.

5.3. Conclusion and Summary

The writing committee believes that these new PMsclosely support the new ACC/AHA Cholesterol Guidelines,will assist providers in providing better care to theirpatients with improved outcomes, and represent anadvance in medication measures because they promoteSDM and appropriate dosing. At the same time, the

writing committee recognizes that much remains to bedone to develop truly robust measures of SDM as wellas measures of shared accountability for medicationadherence.

STAFF

American College of Cardiology

Patrick T. O’Gara, MD, FACC, PresidentShalom Jacobovitz, Chief Executive OfficerWilliam J. Oetgen, MD, MBA, FACC, Executive Vice

President, Science, Education, and QualityLara Slattery, MHS, Senior Director, ACC Scientific

ReportingJensen S. Chiu, MHA, Team Lead, Quality MeasurementLaura L. Ritzenthaler, PA, MBA, Associate, PINNACLE

RegistryAmelia Scholtz, PhD, Publications Manager, Clinical

Policy and PathwaysPenelope Solis, JD, Associate, Clinical MeasurementAmerican College of Cardiology/American Heart Association

Naira Tahir, MPH, Associate, Clinical MeasurementAmerican Heart Association

Elliott Antman, MD, FAHA, PresidentNancy Brown, Chief Executive OfficerRose Marie Robertson, MD, FACC, FAHA, Chief Science

and Medical OfficerGayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice

President, Office of Science OperationsMelanie B. Turner, MPH, Science and Medicine Advisor,

Office of Science OperationsJody Hundley, Production Manager, Scientific Publications,

Office of Science Operations

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12. Rabus SA, Izzettin FV, Sancar M, et al. Five-yearfollow-up of drug utilization for secondary preventionin coronary artery disease. Pharm World Sci. 2008;30:753–8.

13. Maddox TM, Chan PS, Spertus JA, et al. Variationsin coronary artery disease secondary prevention pre-scriptions among outpatient cardiology practices: in-sights from the NCDR (National Cardiovascular DataRegistry). J Am Coll Cardiol. 2014;63:539–46.

14. Arnold SV, Spertus JA, Tang F, et al. Statin use inoutpatients with obstructive coronary artery disease.Circulation. 2011;124:2405–10.

15. Smolderen KG, Spertus JA, Tang F, et al. Treatmentdifferences by health insurance among outpatientswith coronary artery disease: insights from the Na-tional Cardiovascular Data Registry. J Am Coll Cardiol.2013;61:1069–75.

16. Shah ND, Dunlay SM, Ting HH, et al. Long-termmedication adherence after myocardial infarction: expe-rience of a community. Am J Med. 2009;122. 961–13.

17. Borden WB, Redberg RF, Mushlin AI, et al. Patternsand intensity of medical therapy in patients undergoingpercutaneous coronary intervention. JAMA. 2011;305:1882–9.

18. Arnold SV, Kosiborod M, Tang F, et al. Patterns ofstatin initiation, intensification, and maximizationamong patients hospitalized with an acute myocardialinfarction. Circulation. 2014;129:1303–9.

19. Javed U, Deedwania PC, Bhatt DL, et al. Use ofintensive lipid-lowering therapy in patients hospital-ized with acute coronary syndrome: an analysis of65,396 hospitalizations from 344 hospita participatingin Get With The Guidelines (GWTG). Am Heart J. 2011;161:418–24.

20. Roger VL. The quality of quality: is it time for newtools? Circulation. 2014;129:1270–2.

21. Libby P, Ridker PM, Hansson GK. Progress andchallenges in translating the biology of atherosclerosis.Nature. 2011;473:317–25.

22. Kashani A, Phillips CO, Foody JM, et al. Risks associ-ated with statin therapy: a systematic overview of ran-domized clinical trials. Circulation. 2006;114:2788–97.

23. Baigent C, Blackwell L, Emberson J, et al. Efficacyand safety of more intensive lowering of LDL

cholesterol: a meta-analysis of data from 170,000participants in 26 randomised trials. Lancet. 2010;376:1670–81.

24. Ioannidis JP, Lau J. Completeness of safetyreporting in randomized trials: an evaluation of 7medical areas. JAMA. 2001;285:437–43.

25. Ethgen M, Boutron I, Steg PG, et al. Reporting ofharm in randomized controlled trials evaluating stentsfor percutaneous coronary intervention. Trials. 2009;10:29.

26. Ioannidis JP, Evans SJ, Gotzsche PC, et al. Betterreporting of harms in randomized trials: an extensionof the CONSORT statement. Ann Intern Med. 2004;141:781–8.

27. Nallamothu BK, Hayward RA, Bates ER. Beyond therandomized clinical trial: the role of effectivenessstudies in evaluating cardiovascular therapies. Circu-lation. 2008;118:1294–303.

28. Hayward RA, Hofer TP, Vijan S. Narrative review:lack of evidence for recommended low-density lipo-protein treatment targets: a solvable problem. AnnIntern Med. 2006;145:520–30.

29. Krumholz HM, Hayward RA. Shifting views on lipidlowering therapy. BMJ. 2010;341:c3531.

30. Hayward RA, Krumholz HM. Three reasons toabandon low-density lipoprotein targets: an open let-ter to the Adult Treatment Panel IV of the NationalInstitutes of Health. Circ Cardiovasc Qual Outcomes.2012;5:2–5.

31. Tavazzi L, Maggioni AP, Marchioli R, et al. Effect ofrosuvastatin in patients with chronic heart failure (theGISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:1231–9.

32. Kjekshus J, Apetrei E, Barrios V, et al. Rosuvastatinin older patients with systolic heart failure. N Engl JMed. 2007;357:2248–61.

33. Fellstrom BC, Jardine AG, Schmieder RE, et al.Rosuvastatin and cardiovascular events in patientsundergoing hemodialysis. N Engl J Med. 2009;360:1395–407.

34. Elwyn G, Dehlendorf C, Epstein RM, et al. Shareddecision making and motivational interviewing:achieving patient-centered care across the spectrumof health care problems. Ann Fam Med. 2014;12:270–5.

35. Jackevicius CA, Mamdani M, Tu JV. Adherencewith statin therapy in elderly patients with andwithout acute coronary syndromes. JAMA. 2002;288:462–7.

36. Ting HH, Brito JP, Montori VM. Shared decisionmaking: science and action. Circ Cardiovasc Qual Out-comes. 2014;7:323–7.

37. Weymiller AJ, Montori VM, Jones LA, et al. Helpingpatients with type 2 diabetes mellitus make treatmentdecisions: statin choice randomized trial. Arch InternMed. 2007;167:1076–82.

38. Krumholz HM. The new cholesterol and bloodpressure guidelines: perspective on the path forward.JAMA. 2014;311:1403–5.

39. Montori VM, Brito JP, Ting HH. Patient-centeredand practical application of new high cholesterolguidelines to prevent cardiovascular disease. JAMA.2014;311:465–6.

40. Coylewright M, Branda M, Inselman JW, et al.Impact of sociodemographic patient characteristics onthe efficacy of decision aids: a patient-level meta-analysis of 7 randomized trials. Circ Cardiovasc QualOutcomes. 2014;7:360–7.

41. Subherwal S, Patel MR, Kober L, et al. Missedopportunities: despite improvement in use of car-dioprotective medications among patients with lower-extremity peripheral artery disease, underuse remains.Circulation. 2012;126:1345–54.

42. Haynes RB, Ackloo E, Sahota N, et al. Interventionsfor enhancing medication adherence. Cochrane Data-base Syst Rev. 2008; CD000011.

43. Iuga AO, McGuire MJ. Adherence and health carecosts. Risk Manag Healthc Policy. 2014;7:35–44.

44. Peterson ED, Ho PM, Barton M, et al. ACC/AHA/AACVPR/AAFP/ANA concepts for clinician patientshared accountability in performance measures: areport of the American College of Cardiology/AmericanHeart Association Task Force on Performance Mea-sures. J Am Coll Cardiol. 2014;64:2133–45.

45. Mukhtar O, Weinman J, Jackson SH. Intentionalnon-adherence to medications by older adults. DrugsAging. 2014;31:149–57.

46. Bailey SC, Oramasionwu CU, Wolf MS. Rethinkingadherence: a health literacy-informed model of medi-cation self-management. J Health Commun. 2013;18Suppl 1:20–30.

47. Nielsen-Bohlman L, Panzer AM, Kindig DA. HealthLiteracy: A Prescription to End Confusion. Washington,DC: National Academies Press, 2004.

48. Zhang NJ, Terry A, McHorney CA. Impact of healthliteracy on medication adherence: a systematicreview and meta-analysis. Ann Pharmacother. 2014;48:741–51.

49. Lehmann A, Aslani P, Ahmed R, et al. Assessingmedication adherence: options to consider. Int J ClinPharm. 2014;36:55–69.

50. Physician Consortium for Performance Improve-ment. PCPI position statement: specification and cate-gorization of measure exclusions: recommendations toPCPI work groups: Available at: http://www.ama-assn.org/ama/pub/physician-resources/physician-consortium-performance-improvement/about-pcpi.page?. AccessedJanuary 6, 2015.

51. American College of Cardiology. NCDR PINNACLERegistry. Available at: https://www.ncdr.com/WebNCDR/pinnacle/PINNACLErequestinfo. AccessedJanuary 6, 2015.

52. Office of the National Coordinator for Health In-formation Technology. Standards and interoperabilityframework: Available at: Available at http://www.siframework.org/. Accessed April 17, 2014.

53. WuAW,Kharrazi H,Boulware LE, et al.Measure once,cut twice–adding patient-reported outcomemeasures tothe electronic health record for comparative effective-ness research. J Clin Epidemiol. 2013;66:S12–20.

KEY WORDS ACC/AHA Performance Measures,coronary artery disease, health policy andoutcome research, myocardial infarction,percutaneous coronary intervention, peripheralarterial disease, shared decision making, statins

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MEASURES: PERFORMANCE MEASURE SET

1. Updated Performance Measure for the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults With Peripheral

Artery Disease 3-hydroxy-3-methylglutaryl-coenzyme A Reductase Inhibitor (Statin) Therapy in Patients With PAD

Measure Description: Percentage of patients 18-75 y of age with PAD who were offered moderate- to high-intensity statin.Numerator: Patients in the denominator who

Have been offered* high-intensity statin† or •

•••••

•Have been offered* moderate-intensity statin† and have documentation of a medical reason for not prescribing high-intensity statin

Definitions: *A statin is “offered” if it is prescribed or if a patient reason exception is documented. †Moderate-intensity and high-intensity statin doses are defined in Table 5 of the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (5).

Denominator: Patients 18-75 y of age with PAD* seen in a 12-mo period

Definition: *PAD is defined as the presence of ≥1 of the following:

Claudication Critical limb ischemia (ischemic rest pain, nonhealing ischemic ulcers, gangrene) History of vascular reconstruction, bypass surgery, or percutaneous intervention to the extremities Amputation for critical limb ischemia Abnormal noninvasive test (e.g., ankle brachial index, ultrasound, magnetic resonance, or computed tomography imaging demonstrating stenosis in any peripheral artery, i.e., aorta, iliac, femoral, popliteal, tibial, peroneal)

Denominator Exclusions:

None

Denominator Exceptions:

Documentation of medical reason(s) for not prescribing a statin (e.g., allergy, intolerance to statin[s], other medical reasons)

Period of Assessment:

12 mo

Attribution: Clinician practices caring for patients with PAD Rationale

This measure was revised based on the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (5) and is consistent with the ACC/AHA 3-hydroxy-3-methylglutaryl-coenzyme A Reductase Inhibitor (Statin) Therapy in Patients with Atherosclerotic Cardiovascular Disease (ASCVD) Performance Measure.

Clinical Recommendation(s)The following evidence statements are quoted verbatim from the referenced 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults:

“High-intensity statin therapy should be initiated or continued as first-line therapy in women and men ≤75 years of age who have clinical ASCVD*, unless contraindicated.” (Class I; Level of Evidence: A)

“In individuals with clinical ASCVD * in whom high-intensity statin therapy would otherwise be used, when high-intensity statin therapy is contraindicated† or when characteristics predisposing to statin-associated adverse effects are present, moderate-intensity statin should be used as the second option if tolerated.” (Class I; Level of Evidence: A)

“In individuals with clinical ASCVD* >75 years of age, it is reasonable to evaluate the potential for ASCVD risk-reduction benefits and for adverse effects, drug-drug interactions and to consider patient preferences, when initiating a moderate- or high-intensity statin. It is reasonable to continue statin therapy in those who are tolerating it.” (Class IIb; Level of Evidence: A)

Definition: *Clinical ASCVD includes acute coronary syndromes, a history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, and peripheral arterial disease presumed to be of atherosclerotic origin.

Table 5. High-, Moderate-, and Low-Intensity Statin Therapy (Used in the RCTs Reviewed by the Expert Panel)* (5)

High-Intensity Statin Therapy Moderate-Intensity Statin Therapy Low-Intensity Statin Therapy

Daily dose lowers LDL-C, on average, by approximately ≥50%

Daily dose lowers LDL-C, on average, by approximately 30% to <50%

Daily dose lowers LDL-C, on average, by <30%

Continued on the next page

Atorvastatin (40†)–80 mg Rosuvastatin 20 (40) mg

Atorvastatin 10 (20) mgRosuvastatin (5) 10 mg Simvastatin 20–40 mg‡Pravastatin 40 (80) mg Lovastatin 40 mg Fluvastatin XL 80 mg Fluvastatin 40 mg BIDPitavastatin 2–4 mg

Simvastatin 10 mg Pravastatin 10–20 mg Lovastatin 20 mg Fluvastatin 20–40 mg Pitavastatin 1 mg

CQ1: What is the evidence for LDL–C and non-HDL–C goals for the secondary prevention of ASCVD?; CQ2: What is the evidence for LDL–C and non-HDL–Cgoals for the primary prevention of ASCVD?; and CQ3: For primary and secondary prevention, what is the impact on lipid levels, effectiveness, and safety of specific cholesterol-modifying drugs used for lipid management in general and in selected subgroups?

Boldface type indicates specific statins and doses that were evaluated in RCTs (16-18,46-48,64-77) included in CQ1, CQ2, and the Cholesterol Treatment Trialists 2010 meta-analysis included in CQ3 (20). All of these RCTs demonstrated a reduction in major cardiovascular events. Italic type indicates statins and doses that have been approved by the FDA but were not tested in the RCTs reviewed. *Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice. There might be a biological basis for a less-than-average response. †Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in the IDEAL (Incremental Decrease through Aggressive Lipid Lowering) study (47). ‡Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA because of the increased risk of myopathy, including rhabdomyolysis. BID indicates twice daily; CQ, critical question; FDA, U.S. Food and Drug Administration; LDL-C, low-density lipoprotein cholesterol; and RCTs, randomized controlled trials.

Method of Reporting Proportion or percentage of patients meeting the measure during the measurement period

Secondary Measures to Consider for Quality Improvement A potential measure to consider is the proportion of patients with PAD on statin therapy who have had 1 or more lipid panels during the 12-mo observation period. This is based on the following recommendation from the ACC/AHA Cholesterol Guideline:

“Adherence to medication and lifestyle, therapeutic response to statin therapy, and safety should be regularly assessed. This should also include a fasting lipid panel performed within 4 to 12 weeks after initiation or dose adjustment, and every 3 to 12 months thereafter. Other safety measurements should be measured as clinically indicated.” (Class I; Level of Evidence: A)

ACC/AHA indicates American College of Cardiology/American Heart Association; ASCVD, atherosclerotic cardiovascular disease; HDL-C, high-density lipoprotein cholesterol; MI, myocardial infarction; PAD, peripheral artery disease; and TIA, transient ischemic attack.

APPENDIX A. CONTINUED

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ASCVD

ASCVD

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ASCVD

ASCVD

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APPENDIX A. CONTINUED

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APPENDIX A. CONTINUED

Physician performance measures and related data specifications were developed by the American Medical Association (AMA) convened Physician Consortium for Performance Improvement® (PCPI®), the American College of Cardiology (ACC), the American Heart Association (AHA) and the National Committee for Quality Assurance (NCQA) to facilitate quality improvement activities by physicians. These performance measures are not clinical guidelines and do not establish a standard of medical care, and have not been tested for all potential applications. While copyrighted, they can be reproduced and distributed, without modification, for noncommercial purposes, e.g., use by health care providers in connection with their practices. Commercial use is defined 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 measures require a license agreement between the user and the AMA (on behalf of the PCPI), or the ACC, or the AHA or the NCQA. Neither the AMA, ACC, AHA, NCQA, the PCPI nor its members shall be responsible for any use of these measures.

THE MEASURES AND SPECIFICATIONS ARE PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND.

© 2015 American College of Cardiology Foundation, American Heart Association, Inc.,American Medical Association and National Committee for Quality Assurance. All Rights Reserved.

Limited proprietary coding is contained in the measures specifications for convenience. Users of the proprietary code sets should obtain all necessary licenses from the owners of these code sets. The AMA, the ACC, the AHA, the NCQA, the PCPI and its members disclaim all liability for use or accuracy of any Current Procedural Terminology (CPT®) or other coding contained in the specifications.

CPT® contained in the measures specifications is copyright 2015 American Medical Association.LOINC® copyright 2004-2015 Regenstrief Institute, Inc. This material contains SNOMED CLINICAL TERMS (SNOMED CT®) copyright 2004-2015 International Health Terminology Standards Development Organisation. All Rights Reserved. Use of SNOMED CT® is only authorized within the United States.

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ASCVD

ASCVD

ASCVD

*

Continued on the next page

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APPENDIX A. CONTINUED

Physician performance measures and related data specifications were developed by the American Medical Association (AMA) convened Physician Consortium for Performance Improvement® (PCPI®), the American College of Cardiology (ACC), and the American Heart Association (AHA) to facilitate quality improvement activities by physicians. These performance measures are not clinical guidelines and do not establish a standard of medical care, and have not been tested for all potential applications. While copyrighted, they can be reproduced and distributed, without modification, for noncommercial purposes, e.g., use by health care providers in connection with their practices. Commercial use is defined 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 measures require a license agreement between the user and the AMA (on behalf of the PCPI) or the ACC or the AHA. Neither the AMA, ACC, AHA, the PCPI nor its members shall be responsible for any use of these measures.

THE MEASURES AND SPECIFICATIONS ARE PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND.

© 2015 American College of Cardiology Foundation, American Heart Association, Inc., and American Medical Association. All Rights Reserved.

Limited proprietary coding is contained in the measure specifications for convenience. Users of the proprietary code sets should obtain all necessary licenses from the owners of these code sets. The AMA, the ACC, the AHA, the PCPI and its members disclaim all liability for use or accuracy of any Current Procedural Terminology (CPT®) or other coding contained in the specifications.

CPT® contained in the measures specifications is copyright 2015 American Medical Association. LOINC® copyright 2004-2015 Regenstrief Institute, Inc. This material contains SNOMED CLINICAL TERMS (SNOMED CT®) copyright 2004-2015 International Health Terminology Standards Development Organisation. All Rights Reserved. Use of SNOMED CT® is only authorized within the United States.

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APPENDIX B. AUTHOR RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES (RELEVANT)—

2015 ACC/AHA FOCUSED UPDATE OF SECONDARY PREVENTION LIPID PERFORMANCE MEASURES

Committee Member Employment ConsultantSpeakersBureau

Ownership/Partnership/Principal

PersonalResearch

Institutional,Organizational, or

Other Financial BenefitExpertWitness

Joseph P. Drozda, Jr(Chair)

Mercy Health Director ofOutcomes Research

None None None None None None

T. Bruce Ferguson, Jr Brody School of Medicineat ECU, Department ofCardiovascular Sciences

None None None None None None

Hani Jneid Baylor College ofMedicine—MEDVAMC

None None None None None None

Harlan M. Krumholz Yale University Schoolof Medicine

None None None � Johnson &Johnson*

� UnitedHealth* None

Brahmajee K.Nallamothu

University of Michigan—Assistant Professor,Internal Medicine,

Division of Cardiology

� Abbott� United Health

None None None None None

Jeffrey W. Olin Mt. Sinai School ofMedicine

� Merck� Novartis

None None � AstraZeneca* � AstraZeneca None

Henry H. Ting New York-PresbyterianHospital/Columbia

University Medical Center

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 werereviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarilyreflect 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 votingstock or share of the business entity, or ownership of$$10,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% ofthe 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 tableare 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, orissue 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 competingdrug 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 asa result of the issues/content addressed in the document.*No financial benefit.

ACC/AHA indicates American College of Cardiology/American Heart Association; ECU, East Carolina University; and MEDVAMC, Michael E. DeBakey Veterans Affairs Medical Center.

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APPENDIX C. PEER REVIEWER RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES—

2015 ACC/AHA FOCUSED UPDATE OF SECONDARY PREVENTION LIPID PERFORMANCE MEASURES

Peer Reviewer Representation ConsultantSpeakersBureau

Ownership/Partnership/Principal

PersonalResearch

Institutional,Organizational, orOther Financial

BenefitExpertWitness

Lynne Braun Official Reviewer—AHA None None None None None None

Blair D. Erb, Jr Official Reviewer—ACCBoard of Trustees

None None � Abbott†� Amgen†� Merck

None None None

Gregg C. Fonarow Official Reviewer—ACC/AHA Task Force for

Performance Measures

Content Reviewer—ACC/AHA Task Force

on Clinical DataStandards

� Amgen� Johnson &

Johnson� Novartis†� Takeda

Pharmaceutical

None None � Novartis† None None

G.B. John Mancini Official Reviewer—ACCBoard of Governors

� Amgen� Merck� Pfizer� Regeneron/

Sanofi-aventis

None None � Amgen† None None

Robert Shor Official Reviewer(Alternate)—ACC

Board of Governors

None None None None None None

Laith G. Alsayegh OrganizationalReviewer—SVM

None � Amarin-Vascepa

None None None None

Christie M.Ballantyne

OrganizationalReviewer—NLA

� Aegerion� Amarin� Amgen� Cerenis� Esperion

Therapeutics� Genentech� Genzyme� Merck†� Novartis� Omthera� Pfizer†� Regeneron� Resverlogix� Sanofi-aventis/

Synthelabo

None None � Amarin†� Amgen†� Eli Lilly†� Merck†� Novartis†� Pfizer†� Regeneron†� Sanofi-aventis/

Synthelabo†

None None

Mary Barton OrganizationalReviewer—NCQA

None None None None None None

Vera Bittner OrganizationalReviewer—AACVPR

� Amarin None None � Amgen� AstraZeneca*� Eli Lilly*� GlaxoSmithKline†� Hoffman-La

Roche� Janssen

Pharmaceuticals†� Pfizer� Sanofi-aventis*� Schering Plough*� University of

Oxford*

� Foundation ofthe NationalLipidAssociation*

� National LipidAssociation

� American Boardof ClinicalLipidology*

None

Michael Blaha OrganizationalReviewer—SCCT

None None None None None None

KonstantinosBoudoulas

OrganizationalReviewer—SCAI

None None None None None None

Continued on the next page

Peer Reviewer Representation ConsultantSpeakersBureau

Ownership/Partnership/Principal

PersonalResearch

Institutional,Organizational, orOther Financial

BenefitExpertWitness

W. Virgil Brown OrganizationalReviewer—NLA

� Amgen†� AstraZeneca� Eli Lilly� Genzyme†� GlaxoSmithKline†� LipoScience� Merck

� Merck† None None � National LipidAssociation*

� Defendant,expert inlipid meta-bolism,2014

� Plaintiff,ezetimibepatentchallenge,2015-

J. Thomas Cross,Jr

OrganizationalReviewer—ACP

None None None None None None

Michael Crouch OrganizationalReviewer—AAFP

None None None None None None

Andrew Dunn OrganizationalReviewer—ACP

None None None � DesaiPharmaceuticals*

None None

DanielEdmundowicz

OrganizationalReviewer—SAIP

None None None None None None

Mary AnnForciea

OrganizationalReviewer—ACP

None None None None None None

Robert A.Gluckman

OrganizationalReviewer—ACP

None None � Abbvie†� Abbott†� Bristol-

MyersSquibb*

� Walgreens†

None None None

Richard Hellman OrganizationalReviewer—AMA-PCPI

None None None None None None

Robert H. Hopkins,Jr

OrganizationalReviewer—ACP

None None None None None None

Matthew K. Ito OrganizationalReviewer—NLA

� Regeneron None None � KowaPharmaceuticals*

None None

Terry A. Jacobson OrganizationalReviewer—NLA

� Amarin� AstraZeneca� LipoScience� Merck� Regeneron/

Sanofi-aventis

None None � REDUCE IT Trial � National LipidAssociation

None

Peter Jones OrganizationalReviewer—NLA

� Atherotech†� Merck� Regeneron/

Sanofi-aventis

� Merck None None � Amarin*� Amgen*� Regeneron/

Sanofi-aventis*

None

Parag Joshi OrganizationalReviewer—SCCT

None None None None None None

Eve Askanas Kerr OrganizationalReviewer—ACP

None None None None None None

Debra Kohlman-Trigoboff

OrganizationalReviewer—SVN

None None None None None None

Kesavan Kutty OrganizationalReviewer—ACP

None None None None None None

Ngoc-Anh Le OrganizationalReviewer —AHA

� LipoScience None None � AstraZeneca† � Abbott†� Merck†

None

Sei Lee OrganizationalReviewer—AGS

None None None None None None

Ana Maria Lopez OrganizationalReviewer—ACP

None None None None None None

Catherine MacLean OrganizationalReviewer—ACP

None None None None � WellPoint, Inc.† None

Continued on the next page

APPENDIX C. CONTINUED

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Peer Reviewer Representation ConsultantSpeakersBureau

Ownership/Partnership/Principal

PersonalResearch

Institutional,Organizational, orOther Financial

BenefitExpertWitness

Charles E. Mahan OrganizationalReviewer—ASHP

� JanssenPharmaceuticals

� Bristol-MyersSquibb

� JanssenPharmaceuticals†

� Pfizer

None None None None

Michael McConnell OrganizationalReviewer—SCMR

None None None � GE Healthcare†� Tiara

Pharmaceuticals†

None None

James McKenney OrganizationalReviewer—NLA

None None None None None None

Pamela B. Morris OrganizationalReviewer—NLA

� Aegerion� AstraZeneca� Genzyme� LipoScience

� Merck None None None None

Carol E. Orringer OrganizationalReviewer—NLA

� Merck None None None � National LipidAssociation*

None

Stephen D. Persell OrganizationalReviewer—ACP

None None None None None None

Amir Qaseem OrganizationalReviewer—ACP

None None None None None None

Robert Ratner OrganizationalReviewer—ADA

None None None None None None

Russell Samson OrganizationalReviewer—SVS

None None None None None None

Howell Sasser OrganizationalReviewer—ACP

None None None None None None

TerrenceShaneyfelt

OrganizationalReviewer—ACP

None None None None None None

Elaine Tseng OrganizationalReviewer—STS

None None None None None None

GeogyVatakencherry

OrganizationalReviewer—SIR

None None None None None None

Kaye-Eileen Willard OrganizationalReviewer—NLA

� Merck None None None None None

John Doherty Content Reviewer—ACC/AHA Appropriate

Use Criteria TaskForce

None None None None None None

Eric Peterson Content Reviewer—ACC/AHA/AACVPR/AAFP/AMA-PCPI/ANA/ASHP/NCQAThe Concepts forClinician-Patient

Shared Accountabilityin PerformanceMeasures Writing

Committee

� Genentech� Janssen

Pharmaceuticals� Sanofi-aventis

None None � Eli Lilly†� Janssen

Pharmaceuticals†

None None

Binh An P. Phan Content Reviewer—ACCPrevention Council

None None None None � National LipidAssociation*

None

Paul Poirier Content Reviewer—AHA � AstraZeneca� Bristol-Myers

Squibb� Janssen

Pharmaceuticals� Merck

None None None None None

Continued on the next page

APPENDIX C. CONTINUED

J A C C V O L . 6 7 , N O . 5 , 2 0 1 6 Drozda et al.F E B R U A R Y 9 , 2 0 1 6 : 5 5 8 – 8 7 Focused Update of Secondary Prevention Lipid Performance Measures

585

Peer Reviewer Representation ConsultantSpeakersBureau

Ownership/Partnership/Principal

PersonalResearch

Institutional,Organizational, orOther Financial

BenefitExpertWitness

John Spertus Content Reviewer—ACC/AHA 2008 AMI

Performance MeasuresWriting Committee;ACC Clinical QualitySteering Committee;ACCF/AHA/AMA-PCPI2011 PerformanceMeasures for Adults

With CAD andHypertension

� Amgen� Genentech� Janssen

Pharmaceuticals� Novartis� Regeneron*� United Healthcare—

Scientific AdvisoryBoard

None None � Eli Lilly† None None

Neil Stone Content Reviewer—2013ACC/AHA Guideline on

the Treatment ofBlood Cholesterol

to ReduceAtherosclerotic

Cardiovascular Riskin Adults Writing

Committee

None None None None None None

Carl Tommaso Content Reviewer—ACC/AHA/SCAI/AMA-PCPI/NCQA

Percutaneous CoronaryInterventionPerformance

Measurement WritingCommittee

None None None None None None

Diane Treat-Jacobson

Content Reviewer—ACC/AHA/ACR/SCAI/SIR/SVM/SVN/SVS2010 PerformanceMeasures for Adults

With PeripheralArtery Disease

None None None None None None

This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document. Itdoes 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 ownershipof $5% of the voting stock or share of the business entity, or ownership of $$10,000 of the fair market value of the business entity; or if funds received by the person from thebusiness entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceding definition.Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Names are listed inalphabetical order within each category of review.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, orissue 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 competingdrug 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 asa result of the issues/content addressed in the document.*No financial benefit.†Significant relationship.

AACVPR indicates American Association of Cardiovascular and Pulmonary Rehabilitation; AAFP, American Academy of Family Physicians; ACC/AHA, American College of Cardiology/American Heart Association; ACCF, American College of Cardiology Foundation; ACP, American College of Physicians; ACR, American College of Radiology; ADA, for American DiabetesAssociation; AGS, American Geriatrics Society; AMA-PCPI, American Medical Association�Physician Consortium for Performance Improvement; AMI, acute myocardial infarction; ANA,American Nurses Association; ASHP, American Society of Health-System Pharmacists; NCQA, National Committee for Quality Assurance; NLA, National Lipid Association; SAIP, Societyof Atherosclerosis Imaging and Prevention; SCAI, Society for Cardiovascular Angiography and Interventions; SCCT, Society of Cardiovascular Computed Tomography; SCMR; Society forCardiovascular Magnetic Resonance; SIR, Society of Interventional Radiology; STS, Society of Thoracic Surgeons; SVM, Society for Vascular Medicine; SVN, Society for Vascular Nursing;and SVS, Society for Vascular Surgery.

APPENDIX C. CONTINUED

Drozda et al. J A C C V O L . 6 7 , N O . 5 , 2 0 1 6

Focused Update of Secondary Prevention Lipid Performance Measures F E B R U A R Y 9 , 2 0 1 6 : 5 5 8 – 8 7

586

J A C C V O L . 6 7 , N O . 5 , 2 0 1 6 Drozda et al.F E B R U A R Y 9 , 2 0 1 6 : 5 5 8 – 8 7 Focused Update of Secondary Prevention Lipid Performance Measures

587

APPENDIX D. 2015 ACC/AHA FOCUSED UPDATE OF SECONDARY PREVENTION LIPID PERFORMANCE

MEASURES: SUMMARY ANALYSIS TABLE

Measures Included in thePerformance Measure Set

CompletelyFulfills

Attribute*

Partially Fulfills orDoes Not Fulfill

Attribute* Summary Comments†

3-hydroxy-3-methylglutaryl-coenzyme AReductase Inhibitor (Statin) Therapyin Patients With PAD

1,2,3,4 Fulfills all attributes The measure was included in the measure set as a replacementfor the Cholesterol Lowering Medications (Statins) measure

in the ACCF/AHA/ACR/SCAI/SIR/SVM/SVN/SVS 2010Performance Measures for Adults With Peripheral Artery

Disease (6).

Statin Therapy for Patients With AcuteMyocardial Infarction

1,2,3,4 Fulfills all attributes The measure was included in the measure set as a replacementfor the Statin Prescribed at Discharge measure in the ACC/AHA

2008 Performance Measures for Adults With ST-Elevationand Non-ST-Elevation Myocardial Infarction (7).

Postprocedural Optimal Medical TherapyComposite

1,2,3,4 Fulfills all attributes The measure was included in the measure set as a replacementfor the Post-Procedural Optimal Medical Therapy Compositemeasure in the ACC/AHA/SCAI/AMA–Convened PCPI/NCQA

2013 Performance Measures for Adults Undergoing PercutaneousCoronary Intervention (8).

3-hydroxy-3-methylglutaryl-coenzyme AReductase Inhibitor (Statin) Therapyin Patients With CAD

1,2,3,4 Fulfills all attributes The measure was included in the measure set as a replacementfor the Lipid Control measure in the ACCF/AHA/AMA-PCPI

2011 Performance Measures for Adults With CoronaryArtery Disease and Hypertension (9).

3-hydroxy-3-methylglutaryl-coenzyme AReductase Inhibitor (Statin) Therapy inPatients With Clinical AtheroscleroticCardiovascular Disease

1,2,3,4 Fulfills all attributes The measure was included as a stand-alone measure becauseof the strong recommendation made for the use of high-intensity

statins in patients with ASCVD found in the 2013 ACC/AHAGuideline on the Treatment of Blood Cholesterol to Reduce

Atherosclerotic Cardiovascular Risk in Adults (5).

*Corresponding numbers are linked to the ACC/AHA Task Force on Performance Measures Attributes for Performance Measures. Numbers indicate the entire attribute.†Where applicable, the writing committee provided summary comments about why certain measures were or were not included in the final measure set.

ACC indicates American College of Cardiology/American Heart Association; ACCF, American College of Cardiology Foundation; ACR, American College of Radiology; AMA-PCPI,American Medical Association�Physician Consortium for Performance Improvement; ASCVD, atherosclerotic cardiovascular disease; CAD, coronary artery disease; NCQA, NationalCommittee for Quality Assurance; PAD, peripheral artery disease; SCAI, Society for Cardiovascular Angiography and Interventions; SIR, Society for Interventional Radiology; SVM,Society for Vascular Medicine; SVN, Society for Vascular Nursing; and SVS, Society for Vascular Surgery.