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Journal of the American College of Cardiology Vol. 54, No. 14, 2009© 2009 by the the American College of Cardiology Foundation and the American Heart Association, Inc. ISSN 0735-1097/09/$36.00P

PERFORMANCE MEASURES

ACCF/AHA 2009 Performance Measures for PrimaryPrevention of Cardiovascular Disease in AdultsA Report of the American College of Cardiology Foundation/American Heart AssociationTask Force on Performance Measures (Writing Committee to Develop PerformanceMeasures for Primary Prevention of Cardiovascular Disease)Developed in Collaboration With the American Academy of Family Physicians;American Association of Cardiovascular and Pulmonary Rehabilitation; and PreventiveCardiovascular Nurses AssociationEndorsed by the American College of Preventive Medicine, American College of Sports Medicine,and Society for Women’s Health Research

WRITING COMMITTEE MEMBERSRita F. Redberg, MD, MSc, FACC, FAHA, Chair; Emelia J. Benjamin, MD, ScM, FACC, FAHA;Vera Bittner, MD, MSPH, FACC, FACP, FAHA*; Lynne T. Braun, PhD, CNP, FAHA, FAAN†;

David C. Goff, Jr, MD, PhD, FACP, FAHA; Stephen Havas, MD, MPH, MS;Darwin R. Labarthe, MD, MPH, PhD, FAHA‡; Marian C. Limacher, MD, FACC, FACP, FAHA, FSGC;

Donald M. Lloyd-Jones, MD, ScM, FACC, FAHA; Samia Mora, MD, MHS, FACC;Thomas A. Pearson, MD, MPH, PhD, FACC; Martha J. Radford, MD, FACC, FAHA§;

Gerald W. Smetana, MD, FACP�; John A. Spertus, MD, MPH, FACC; Erica W. Swegler, MD, FAAFP¶

ACCF/AHA TASK FORCE ON PERFORMANCE MEASURESFrederick A. Masoudi, MD, MSPH, FACC, Chair; Robert O. Bonow, MD, MACC, FAHA#;

Elizabeth DeLong, PhD; David C. Goff, Jr, MD, PhD, FACP, FAHA;Kathleen Grady, PhD, RN, FAHA, FAAN; Lee A. Green, MD, MPH;

Kathy J. Jenkins, MD, MPH, FACC; Ann R. Loth, RN, MS, CNS;Eric D. Peterson, MD, MPH, FACC, FAHA; Martha J. Radford, MD, FACC, FAHA;

John S. Rumsfeld, MD, PhD, FACC, FAHA; David M. Shahian, MD, FACC

*American Association of Cardiovascular and Pulmonary Rehabilitation Representative.†Preventive Cardiovascular Nurses Association Representative.‡Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion Division for Heart Disease and

troke Prevention. The findings and conclusions in this report are those of the author(s) and do not necessarily represent the official positions of theenters for Disease Control and Prevention.§ACCF/AHA Task Force on Performance Measures Liaison.�American College of Physicians Representative.¶American Academy of Family Physicians Representative.#Former Task Force Chair during this writing effort.This document was approved by the American College of Cardiology Foundation Board of Trustees in June 2009 and by the American Heart

ssociation Science Advisory and Coordinating Committee in June 2009.The American College of Cardiology Foundation requests that this document be cited as follows: Redberg RF, Benjamin EJ, Bittner V, Braun LT, Goff DC Jr., Havas

, Labarthe DR, Limacher MC, Lloyd-Jones DM, Mora S, Pearson TA, Radford MJ, Smetana GW, Spertus JA, Swegler EW. ACCF/AHA 2009 performance measuresor primary prevention of cardiovascular disease in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force onerformance Measures (Writing Committee to Develop Performance Measures for Primary Prevention of Cardiovascular Disease). J Am Coll Cardiol009;54:1364–405.

This article has been copublished in the September 29, 2009, issue of Circulation.Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org) and the American Heart Association

my.americanheart.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax 212-633-3820, e-mail [email protected].

ublished by Elsevier Inc. doi:10.1016/j.jacc.2009.08.005

Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the expressermission of the American College of Cardiology Foundation. Please contact Elsevier’s permission department at [email protected].

mailto:[email protected]

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1365JACC Vol. 54, No. 14, 2009 Redberg et al.September 29, 2009:1364–405 Performance Measures for Primary Prevention of CVD

TABLE OF CONTENTS

reamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1365

. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1366

1.1. Scope of the Problem . . . . . . . . . . . . . . . . . . . .13681.2. Structure and Membership of the

Writing Committee . . . . . . . . . . . . . . . . . . . . . . .13681.3. Disclosure of Relationships With Industry . .13681.4. Review and Endorsement. . . . . . . . . . . . . . . . .1368

. Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1368

2.1. Target Population and Care Period . . . . . . . .13682.2. Dimensions of Care . . . . . . . . . . . . . . . . . . . . . .13692.3. Literature Review . . . . . . . . . . . . . . . . . . . . . . . .13692.4. Definition of Potential Measures . . . . . . . . .13702.5. Selection of Measures for Inclusion in the

Performance Measure Set. . . . . . . . . . . . . . . .1370

. Primary Prevention of CVD PerformanceMeasures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1371

3.1. Definition of Primary Prevention . . . . . . . . . .13713.2. Brief Summary of the Measurement Set . .13713.3. Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . .13713.4. Exclusion Criteria and Challenges to

Implementation . . . . . . . . . . . . . . . . . . . . . . . . . .1372

. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1372

4.1. Sex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13724.2. Frequency of Screening . . . . . . . . . . . . . . . . .13724.3. Risk Screening . . . . . . . . . . . . . . . . . . . . . . . . .13724.4. Lifestyle Counseling . . . . . . . . . . . . . . . . . . . .13734.5. Weight Management . . . . . . . . . . . . . . . . . . . .13734.6. Hypertension . . . . . . . . . . . . . . . . . . . . . . . . . . .13734.7. Lipid Screening and Control . . . . . . . . . . . . .13744.8. Global Risk Estimation . . . . . . . . . . . . . . . . . .13744.9. Stroke Risk Assessment . . . . . . . . . . . . . . . .1375

4.10. Aspirin Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13754.11. Diabetes Mellitus . . . . . . . . . . . . . . . . . . . . . . .13754.12. Dietary Supplementation . . . . . . . . . . . . . . . .1375

. Conclusions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1375

ppendix A. Author Relationships With Industryand Other Entities—ACCF/AHA2009 Performance Measures forPrimary Prevention of CardiovascularDisease in Adults. . . . . . . . . . . . . . . . . . .1377

ppendix B. Peer Reviewer Relationships WithIndustry and Other Entities—ACCF/AHA 2009 PerformanceMeasures for Primary Prevention ofCardiovascular Disease in Adults. . . .1378

ppendix C. Sample Performance MeasureSurvey Form and ExclusionCriteria Definitions . . . . . . . . . . . . . . . . .1379

ppendix D. ACCF/AHA 2009 Primary Preventionof Cardiovascular Disease PerformanceMeasurement Set Specifications . . . .1381
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ppendix E. Sample Prospective Data CollectionFlow Sheet . . . . . . . . . . . . . . . . . . . . . . . . .1398

ppendix F. Coronary Heart Disease RiskPrediction . . . . . . . . . . . . . . . . . . . . . . . . . .1400

ppendix G. Measuring Waist Circumference. . . . .1402

ppendix H. Body Mass Index Table . . . . . . . . . . . . .1402

eferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1403

reamble

ver the past decade, there has been an increasing awarenessat the quality of medical care in the United States is highlyriable. In its seminal document dedicated to characterizingficiencies in delivering effective, timely, safe, equitable,ficient, and patient-centered medical care, the Institute ofedicine described a quality “chasm” (1). Recognition of theagnitude of the gap between the care that is delivered ande care that ought to be provided has stimulated interest in thevelopment of measures of quality of care and the use of sucheasures for the purposes of quality improvement andcountability.Consistent with this national focus on healthcare quality,e American College of Cardiology Foundation (ACCF) ande American Heart Association (AHA) have taken a leader-ip role in developing measures of the quality of care forrdiovascular disease (CVD) in several clinical areas (Table 1).he ACCF/AHA Task Force on Performance Measures wasrmed in February 2000 and was charged with identifyinge clinical topics appropriate for the development of perfor-ance measures and assembling writing committees com-sed of clinical and methodological experts. When appro-iate, these committees have included representation fromher organizations involved in the care of patients with thendition of focus. The committees are informed about theethodology of performance measure development and arestructed to construct measures for use both prospectivelyd retrospectively, rely on easily documented clinical crite-

a, and, where appropriate, incorporate administrative data. Theta elements required for the performance measures are linkedexisting ACCF/AHA clinical data standards to encourage

iform measurements of cardiovascular care. The writingmmittees are also instructed to evaluate the extent to whichisting nationally recognized performance measures conformthe attributes of performance measures described by the

CCF/AHA and to strive to create measures aligned withceptable existing measures when this is feasible.The initial measure sets published by the ACCF/AHAcused primarily on processes of medical care or actionsken by healthcare providers, such as the prescription of aedication for a condition. These process measures areunded on the strongest recommendations contained in theCCF/AHA clinical practice guidelines, delineating actionsken by clinicians in the care of patients, such as the prescrip-n of a particular drug for a specific condition. Specifically, the

riting committees consider as candidates for measures those
ocesses of care that are recommended by the guidelines either

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1366 Redberg et al. JACC Vol. 54, No. 14, 2009Performance Measures for Primary Prevention of CVD September 29, 2009:1364–405

Class I, which identifies procedures/treatments that shouldadministered, or Class III, which identifies procedures/

eatments that should not be administered (Table 2). Class IIcommendations are not considered as candidates for per-rmance measures. The methodology guiding the translation

guideline recommendations into process measures hasen explicitly delineated by the ACCF/AHA, providingidance to the writing committees (8).Although they possess several strengths, processes of caree limited as the sole measures of quality. Thus, currentCCF/AHA Performance Measures Writing Committees arestructed to consider structures of care, outcomes, andficiency as complements to process measures. In develop-g such measures, the committees are guided by methodol-y established by the ACC/AHA (9). Although implemen-

tion of measures of outcomes and efficiency is currently notwell established as that of process measures, it is expected

at such measures will become more pervasive over time.Although the focus of the performance measures writingmmittees is on measures intended for quality improvementforts, other organizations may use these measures forternal review or public reporting of provider performance.

herefore, it is within the scope of the writing committee’ssk to comment, when appropriate, on the strengths and

itations of such external reporting for a particular CVDate or patient population. Thus, the metrics contained withinis document are categorized as either performance mea-res or test measures. Performance measures are thoseetrics that the committee designates as appropriate for user both quality improvement and external reporting. In contrast,st measures are those that have been deemed appropriate fore purposes of quality improvement but not for externalporting until further validation and testing are performed.All measures have limitations and pose challenges toplementation that could result in unintended consequences

hen used for accountability. The implementation of mea-res for purposes other than quality improvement requires

eld testing to address issues related but not limited to sampleze, frequency of use of an intervention, comparability, and

ble 1. ACCF/AHA Performance Measurement Sets

pic Original Publication Date

ronic heart failure (2) 2005

ronic stable coronary artery disease (3) 2005

pertension (4) 2005

-elevation and non–ST-elevation myocardialfarction (5)

2006

rdiac rehabilitation (6) 2007

rial fibrillation (7) 2008

imary prevention of cardiovascular disease 2009

ripheral arterial disease 2010*

ACC indicates American College of Cardiology; ACCF, American College ofsociation–Physician Consortium for Performance Improvement; AACVPR, Amllege of Radiology; SCAI, Society for Cardiac Angiography and Interventions;ciety for Vascular Nursing; and SVS, Society for Vascular Surgery.*Planned publication date.

dit requirements. The manner in which these issues is th

dressed is dependent on several factors, including theethod of data collection, performance attribution, baselinerformance rates, incentives, and public reporting methods.

he ACCF/AHA encourages those interested in implementingese measures for purposes beyond quality improvement toork with the ACCF/AHA to consider these complex issues inlot implementation projects, to assess limitations and con-unding factors, and to guide refinements of the measures tohance their utility for these additional purposes.By facilitating measurements of cardiovascular healthcareality, ACCF/AHA performance measurement sets mayrve as vehicles to accelerate appropriate translation ofientific evidence into clinical practice. These documents aretended to provide practitioners and institutions that deliverre with tools to measure the quality of their care andentify opportunities for improvement. It is our hope thatplication of these performance measures will provide aechanism through which the quality of medical care can beeasured and improved.

Frederick A. Masoudi, MD, MSPH, FACCChair, ACCF/AHA Task Force on Performance Measures

. Introduction

he ACCF/AHA Primary Prevention of Cardiovascular Dis-se Performance Measures Writing Committee (the Writingommittee) was charged to develop performance measuresr the prevention of CVD. These performance measures dot specifically address prevention of stroke, although be-use risk factors for heart disease and stroke overlap, theire should contribute to the prevention of stroke as well.

hese measures are intended for adults (18 years of age andder) evaluated in the outpatient setting. The Writing Com-ittee designed most of the measures, including all of theestyle measures, to begin at age 18 because we recognizeat risk for atherosclerosis accumulates over a lifetime and,though it is never too late to make changes to prevent heartsease, the greatest benefit accrues with early lifestyleanges. The relation between cardiovascular risk factors and

Partnering Organizations Status

ACC/AHA—inpatient measuresACC/AHA/PCPI—outpatient measures

Currently undergoing updateCurrently undergoing update

ACC/AHA/PCPI Currently undergoing update

ACC/AHA/PCPI Currently undergoing update

ACC/AHA Updated 2008

AACVPR/ACC/AHA

ACC/AHA/PCPI

ACCF/AHA

ACCF/AHA/ACR/SCAI/SIR/SVM/SVN/SVS

gy Foundation; AHA, American Heart Association; PCPI, American Medicalssociation of Cardiovascular and Pulmonary Rehabilitation; ACR, Americaniety for Interventional Radiology; SVM, Society for Vascular Medicine; SVN,

Cardioloerican ASIR, Soc

e extent and severity of coronary atherosclerosis in the

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enage years and earlier is well established on the basis oftopsy studies (10,11). Evidence from long-term follow-up

udies demonstrates that a favorable risk factor profilering the working years is associated with a longer, healthiere and reduced medical care expenses after age 65 (12–17).

hese observations indicate the value of prevention of riskctors in the first place, beginning in childhood and youth, aslled for by the AHA’s “Guidelines for Primary Prevention

Atherosclerotic Cardiovascular Disease Beginning inhildhood” (18). Although the greatest long-term benefitcurs with changes early in life, changes in adults are alsocouraged because they have been demonstrated to reduce

sk and prevent heart disease in both middle-aged and olderults. The Writing Committee also acknowledges that the

eld of primary prevention is rapidly evolving because of the

ble 2. Applying Classification of Recommendations and Level

*Data available from clinical trials or registries about the usefulness/efficacy iyocardial infarction, history of heart failure, and prior aspirin use. A recommendany important clinical questions addressed in the guidelines do not lend them

a very clear clinical consensus that a particular test or therapy is useful or†In 2003, the ACCF/AHA Task Force on Practice Guidelines developed a

commendations have been written in full sentences that express a completee rest of the document (including headings above sets of recommendations),rease readers’ comprehension of the guidelines and will allow queries at the

ntributions of observational research, registries, and clini- ol

l trials. Hence, modifications to these performance measuresr primary prevention will be necessary as the field advances.The Writing Committee designed the performance mea-res to be applicable to the broadest possible population. Aalthy lifestyle is believed to be beneficial across the entireectrum of age, race, and sex. With respect to age, however,e recognize that there comes a time when the benefits ofreening and treatment to avert future events may be of

ited value because life expectancy is limited. Moreover, amber of the investigations establishing the benefits ofimary prevention have not included elderly patients. In anfort to balance the competing interests of applying primaryevention as broadly as possible and being consistent withher organizations’ age criteria, the Writing Committeecommends the use of the proposed measures for patients

ence

nt subpopulations, such as gender, age, history of diabetes, history of priorth Level of Evidence B or C does not imply that the recommendation is weak.o clinical trials. Even though randomized trials are not available, there may.suggested phrases to use when writing recommendations. All guideline, such that a recommendation, even if separated and presented apart fromstill convey the full intent of the recommendation. It is hoped that this willual recommendation level.

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blic reporting. Certain measures have an upper age limit ofyears because of a paucity of evidence to support the

easure in an older age group. In addition, there may beeasurement circumstances in which a narrower target agenge is appropriate, and those who implement measures mayoose to specify an age range that is less broad.Certain measures, such as blood pressure control, may not behievable in all patients. Good blood pressure control is aallenge for providers in selected patient subsets, includingose with multiple comorbidities and some older patients witholated systolic hypertension. In addition, patient adherence toedical regimens varies for many reasons. The Writing Com-ittee recognizes that providers may care for patients withmplex medical and socioeconomic conditions for whomtainment of target levels for risk factors is difficult. Thus, targetvels for attainment of performance measure goals will vary bytient population and by practice setting; for internal qualityprovement initiatives, they are set by the providers.

.1. Scope of the Problemr more than a century, CVD has been the number 1 killerthe United States for all but 1 year (1918, in which there

as an influenza pandemic). CVD is the underlying cause of.3% of all deaths, or 1 of every 2.8 deaths, in the Unitedates, according to data from 2004. In 2008, an estimated0 000 Americans suffered a first coronary attack (thiscludes myocardial infarction and unstable angina). Another5 000 had a silent, or unrecognized, myocardial infarction.

he total cost of CVD and stroke in the United States for07 is estimated at $448.5 billion (19).Given the magnitude of the problem and the financialrden of CVD, improvements in the quality of primaryevention of cardiovascular disease will lead to substantialprovement in healthcare outcomes. Despite advances and

ide publication and dissemination of prevention guidelinesthe cardiovascular literature, the inconsistent application ofst practices does a disservice to patients and leaves manyportunities for improvement in care and systems. Account-ility at the practice level is 1 step toward more consistentplication of best practice guidelines and improved clinicaltcomes. The size of the performance measure set may placeburden on the practitioner but reflects the complexity ofVD prevention due to its multifactorial pathogenesis. Manyactitioners are assuming this burden to ensure the quality ofeir practice (20,21). In addition, external groups are en-ged in quality performance measurement and reporting.here logical, the Writing Committee has attempted tostinguish between measures that are appropriate for ac-untability or public reporting and those that should be usedly for internal quality improvement.

.2. Structure and Membership of theriting Committee

he members of the Writing Committee included seniorinicians (physicians and an advanced practice nurse) andecialists in internal and family medicine, cardiology, pre-ntive medicine, and epidemiology. The Writing Committeeso included representatives from the American Academy of
mily Physicians; American Association of Cardiovascular sc
d Pulmonary Rehabilitation; American College of Physi-ans; Preventive Cardiovascular Nurses Association; andenters for Disease Control and Prevention, National Centerr Chronic Disease Prevention and Health Promotion, Divi-on for Heart Disease and Stroke Prevention.

.3. Disclosure of Relationships With Industryhe work of the Writing Committee was supported exclusively

the ACCF and AHA. Committee members volunteered theire, and there was no commercial support for the developmentthese performance measures. Meetings of the Writing Com-

ittee were confidential and attended only by Writing Commit-e members and staff. Writing Committee members werequired to disclose in writing all financial relationships withdustry relevant to this topic according to standard ACCF andHA reporting policies, and they verbally acknowledged theselationships to the other members (Appendix A).

.4. Review and Endorsementetween January 22 and February 22, 2008, the performanceeasures document underwent a 30-day public commentriod, during which ACCF and AHA members and otheralth professionals had an opportunity to review and com-ent on the text in advance of its final approval andblication. The official peer and content review of thecument was conducted simultaneously with the 30-dayblic comment period, with 2 peer reviewers nominated bye ACCF and 2 nominated by the AHA. We sought addi-nal comments from clinical content experts and perfor-

ance measurement experts. See Appendix B for relation-ips with industry and other entities of the peer reviewers.The ACCF/AHA 2009 Clinical Performance Measures forimary Prevention of Cardiovascular Disease in Adults wasopted by the respective boards of directors of the ACCFd AHA in June 2009. These measures will be reviewed forrrency once annually and updated as needed. They shouldconsidered valid until either updated or rescinded by the

CCF/AHA Task Force on Performance Measures.

. Methodology

he development of performance systems involves identifica-n of a set of measures that target a specific patient populationserved over a particular time period. To achieve this goal, the

CCF/AHA Task Force on Performance Measures has outlinedmandatory sequential steps. Sections 2.1 through 2.5 outlinew the Writing Committee addressed these elements.

.1. Target Population and Care Periodhe target population consists of patients 18 years of age order. We developed exclusion criteria and upper age limitsr certain measures to further specify the target population.hese performance measures are intended for primary pre-ntion in the adult population and do not address preventionecific to children and adolescents. More information onimary prevention for children and adolescents can be foundthe AHA “Guidelines for Primary Prevention of Athero-

lerotic Cardiovascular Disease Beginning in Childhood” (18).

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The Writing Committee recognizes that there are manyportunities and healthcare settings for primary prevention of

VD. Thus, these performance measures are aimed at anyysician or healthcare professional who sees adult patients (ageyears and older) at risk for CVD. For this document, the

tpatient care period is defined as the period of care providedan outpatient setting. An ongoing relationship with the

althcare professional is critical to both the initiation andentual success of preventive measures. In addition, any singlesit may not provide the opportunity to address the full range ofeventive care required, and in general, the Writing Committeecommends that evidence of at least 2 encounters over a period1 year be established before the physician is expected to have

sponsibility for primary CVD prevention. However, certaineasures, such as smoking cessation, are so important forevention that the Writing Committee believed they shouldcur even in 1 acute visit over a 2-year period.

.2. Dimensions of Careiven the multiple potential domains of treatment that can beeasured, the Writing Committee identified the relevant dimen-ons of care that should be evaluated. We placed each potentialrformance measure into the relevant dimension-of-care cate-ries. Performance measures selected for inclusion in the finalt and their dimensions of care are summarized in Table 3.Although the Writing Committee considered a number ofditional measures that focus on equally important aspects ofre, length and complexity considerations did not allow theirclusion in the present set. Final selection of performanceeasures was based on 1) the evidence base for a given measure,ease/complexity of measurement, and 3) coverage in other

easurement sets. The Writing Committee focused on outcome

Table 3. ACCF/AHA Primary PreventionMeasurement Set: Dimension of Care Mea

easures rather than process measures whenever possible. The Pa

riting Committee recognized that for some patients, there areany obstacles to attaining the desired outcome. For example, itdifficult for some patients to attain blood pressures less than0/90 mm Hg because of medication noncompliance, costs,

de effects, or other reasons. To avoid penalizing clinicians whore for such patients, the Writing Committee designed perfor-ance measures that give credit for good faith attempts to attaine treatment goal (e.g., documentation of the use of at least 2tihypertensive medications in patients with blood pressureseater than 140/90 mm Hg), as well for attainment of thesired outcome. Such a strategy fulfills the goals of perfor-ance measurement by balancing attainment of targets for bloodessure or lipids with recognition of obstacles despite attentiongoals. For internal quality improvement purposes, the Writing

ommittee believed that the standards could be more rigorous.he final set includes both process measures (risk assessmentd risk factor counseling) and intermediate outcome measureslood pressure, cholesterol values).

.3. Literature Reviewhe Writing Committee used the 2002 AHA “Guidelines forimary Prevention of Cardiovascular Disease and Stroke” ase primary source for deriving these measures (22). In addition,e Writing Committee reviewed other more recent guidelines tonsider the most current available evidence. These included theS Preventive Services Task Force’s “Guide to Clinical Preven-e Services” (23), the European guidelines on CVD preventionclinical practice (24), the AHA’s “Evidence-Based Guidelinesr Cardiovascular Disease Prevention in Women: 2007 Up-te” (25), the Joint British Societies’ “Guidelines on PreventionCardiovascular Disease in Clinical Practice” (26), the Third

eport of the National Cholesterol Education Program Expert

iovascular Disease PerformanceMatrix

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holesterol in Adults (Adult Treatment Panel III) (27), and theventh report of the Joint National Committee on Prevention,etection, Evaluation, and Treatment of High Blood Pressure (28).

.4. Definition of Potential Measuresxplicit criteria exist for the development of performanceeasures that accurately reflect quality of care, includingfining the numerators and denominators of potential mea-res and evaluating their applicability, interpretability, andasibility. To select measures for inclusion in the perfor-ance measurement set, the Writing Committee prioritizede recommendations from the 2002 AHA guidelines forimary prevention of CVD and stroke (22).The AHA primary prevention guidelines (22) were draftedfore the AHA’s adoption of a formal rating system regard-g the strength of the recommendation and the level ofidence. That system, adopted by the AHA and the ACCF,ables guideline writing groups to specify the degree tohich the benefit of the care is likely to outweigh anytential risk, as well as the level of evidence supporting thatnclusion. In general, ACCF/AHA Class I (benefit ��

sk) and Class III (risk greater than or equal to benefit)dications for therapy identify potential dimensions of cared processes for performance measurement; however, not allrformance measures must be based on grade A level ofidence (general consistency of direction and magnitude offect from multiple [3 to 5] randomized trials or meta-analysesith population risk strata evaluated). In particular, whennsidering interventions to remove harmful exposures (e.g.,oking cessation counseling), or to restore norms thatisted during earlier phases of human evolution (e.g.,creased consumption of fruits, vegetables, and whole grainsd decreased consumption of animal products), the need totain evidence from clinical trials is less obligatory than forcommendations to add a pharmaceutical agent to a patient’sgimen. The Writing Committee recognizes that random-ed, controlled trials of lifestyle interventions are morefficult to perform than pharmaceutical trials; however,estyle behavior change remains the cornerstone of a suc-ssful prevention strategy. The recommended performanceeasures in this document are based on processes of care thate expected to lead to benefit that far outweighs any potentialsk based on evidence sufficiently strong to support broadpulation-wide applicability. For some measures, we neededmake recommendations despite the absence of evidence

om randomized, controlled trials that used clinical eventsd deaths as outcomes.The Writing Committee recognizes that performance mea-res imply performance standards, and there are those whoay find these implicit standards lower than their ownactice standards, particularly with respect to assessmentequency and target intermediate outcomes, such as choles-rol and blood pressure. Physicians using these measures tosess their practice quality are invited to choose moregressive measure specifications. The measures outlinedrein are geared towards the minimum level of acceptablerformance rather than optimal care, particularly when used
compare providers or for public reporting. In
.5. Selection of Measures for Inclusion ine Performance Measure Setom analysis of these recommendations, the Writing Com-ittee identified potential measures relevant to the primaryevention of CVD and then independently evaluated theirtential for use as performance measures using 8 exclusioniteria adapted from the “ACCF/AHA Attributes of Perfor-ance Measures” (Table 4) and the Sample Performanceeasure Survey Form and Exclusion Criteria Definitionsppendix C). As part of this process, the Writing Committee

so evaluated the optimal use of each measure for account-ility/public reporting (A/PR) versus internal quality im-ovement (IQI) only. Member ratings of all the potentialeasures were collated and discussed by the full Writingommittee to reach consensus about which measures shouldvance for inclusion in the final measure set and whethery should be designated as IQI measures. Nineteen potentialeasures were advanced initially for full specification tosess their suitability as performance measures. These wereentually reduced to 13 final measures through an iterativeocess of repeated surveys within the Writing Committee,ditional literature review, and detailed group discussions.

he 13 performance measures generally support practicespected to reduce long-term risk of cardiovascular events.owever, most patient encounters offer opportunities toaintain low risk among persons not yet exhibiting increasedsk. Reinforcement of favorable health behavior patterns issirable as part of every patient encounter, including thoseat do not require specific risk-reducing interventions.The Writing Committee has designated 2 measures (Global

isk Estimation and Aspirin Use) as appropriate for IQI only.

ble 4. Summary of ACCF/AHA Attributes ofrformance Measures

nsideration Attribute

eful in improvingtient outcomes

Evidence-based

Interpretable

Actionable

easure design Denominator precisely defined

Numerator precisely defined

Validity type

● Face*

● Content†

● Construct‡

Reliability

easureplementation

Feasibility

● Reasonable effort

● Reasonable cost

● Reasonable time period for collection

erall assessment Overall assessment of measure forinclusion in measurement set

*The measure intuitively appears to capture what it is intended to capture.†The extent to which the items comprehensively capture the domain they

e intended to measure.‡The extent to which the measures correlate with other methods ofantifying the underlying construct.

addition, for some measures, separate numerators and/or

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nominators that may be used in IQI programs have beenecified in addition to numerators/denominators that arepropriate for use in A/PR programs. In making thesesignations, the Writing Committee weighed a number ofctors, including the strength of evidence for the intervention

the primary prevention population; the availability (orck) of evidence in specific subgroups, such as women orderly patients; the potential for unintended consequences ifed for A/PR (e.g., incentives to avoid treating sicker orrder to control patients or to overtreat) and the lack ofsted risk models to adjust for variations across providertient populations (especially for measures of intermediatetcomes, e.g., Blood Pressure Control and Blood Lipid

herapy and Control), which could lead to misleading resultsused for A/PR. Although these IQI measures representluable tools to aid clinicians in improving quality of cared enhancing outcomes for patients, they are not ready fore in A/PR programs until there is further testing andlidation.

. Primary Prevention of CVDerformance Measures

.1. Definition of Primary Preventionr purposes of this document, primary prevention is defined asevention of the first occurrence of CVD. These measures areerefore appropriate for all patients without clinical CVD,cluding those with diabetes mellitus. This measure set istended to include asymptomatic individuals with disease iden-ied only by imaging studies. It does not apply to patients whoould be included in the existing ACCF/AHA/Physician Con-rtium coronary artery disease performance measures (3).

.2. Brief Summary of the Measurement Setable 5 summarizes the ACCF/AHA Primary Prevention ofardiovascular Disease Performance Measurement Set—ose measures with the highest level of evidence and supportong the Writing Committee members. Appendix D pro-

des the detailed specifications for each performance mea-re, including the numerator, denominator, period of assess-ent, method of reporting, sources of data, rationale, clinicalcommendations, and challenges to implementation.

.3. Data Collectionhese performance measures for primary prevention of CVDe ideally intended for prospective use to enhance the qualityprovement process but may also be applied retrospectively.e recommend use of a data collection instrument to aidmpliance and measurement (Appendix E). Individual insti-tions may modify the sample instrument or develop afferent tool based on local practice and standards.The burden of collection of accurate data may be greaterr certain performance measures because of the inconsistentd potentially incomplete recording of lifestyle screeningd counseling. This reporting could be facilitated by inclu-

on of specific entry fields for history, physical examination,d nonpharmacological interventions (such as counseling,
et, or physical activity prescriptions) in electronic health tio
cords. Otherwise, electronic health records or retrospectiveedical record reviews will miss much of the lifestyleunseling that occurs during routine clinical practice. Theseould then require prospective data collection as a relativelyrdensome means to collect the lifestyle variables. Indition, the Writing Committee recognized that there arefferent levels of counseling but chose to allow any mention

counseling for lifestyle changes to satisfy these perfor-ance measures, to be consistent with the philosophy thatese performance measures represent a minimum expecta-

ble 5. ACCF/AHA Primary Prevention of Cardiovascularsease Performance Measurement Set

rformanceeasure Name Measure Description Designation

. Lifestyle/riskfactorscreening

Assessment of lifestyles and riskfactors for development of CVD

A/PRIQI

. Dietaryintakecounseling

Counseling to eat a healthy diet A/PR

. Physicalactivitycounseling

Counseling to engage in regularphysical activity

A/PR

. Smoking/tobacco use

Risk assessment for smoking andtobacco use behaviors

A/PRIQI

. Smoking/tobaccocessation

Cessation intervention for activesmoking (tobacco use)

A/PR

. Weight/adiposityassessment

Measurement of weight and bodymass index and/or waistcircumference

A/PR

. Weightmanagement

Counseling to achieve and maintainideal body weight

A/PRIQI

. Bloodpressuremeasurement

Measurement of blood pressure in allpatients

A/PR

. Bloodpressurecontrol

Effective blood pressure control orcombination therapy for patientswith hypertension

A/PRIQI

. Blood lipidmeasurement

Fasting lipid profile performed A/PRIQI

. Blood lipidtherapy andcontrol

Proportion of patients who meetcurrent LDL-C treatment targets ORwho are prescribed �1 lipidlowering medications at maximumtolerated dose

A/PR

. Global riskestimation

Use of a multivariable risk score toestimate a patient’s absolute riskfor development of coronary heartdisease

IQI

. Aspirin use Aspirin in patients without clinicalevidence of atherosclerotic diseasewho are at higher CVD risk

IQI

A/PR indicates accountability/public reporting measures (appropriate for all uses,luding internal quality improvement, pay for performance, physician ranking, andblic reporting); CVD, Cardiovascular disease; IQI, internal quality improvementeasures (recommended for use in internal quality improvement programs only;t appropriate for any other use, e.g., pay for performance, physician ranking, orblic reporting); and LDL-C, low-density lipoprotein cholesterol.

n for good quality care. Other performance measures

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lated to end points that are usually recorded in an electronicalth record include physical measurements (body weight,ood pressure), laboratory values (blood lipids), and pre-ription pharmaceuticals; these would confer relatively lowrdens of data collection. Calculation and recording ofobal risk scores may be enhanced by an electronic healthcord, which can be designed to automatically calculate theamingham Risk Score or other global risk scores withailability of the required risk factor data.

.4. Exclusion Criteria and ChallengesImplementation

he Writing Committee added exclusion criteria, recognizingat there are justifiable reasons for not meeting the perfor-ance measures. These reasons, which may be due to patient,edical, or system factors, should be recorded on the datallection form. Documentation of such factors should becouraged to provide data for future research and facilitate-depth quality improvement in situations in which there areparent outliers with respect to the number of patients withedical or patient-centered reasons for exclusion.Challenges to implementation of the measures are dis-ssed where applicable. In general, the initial challengecing any measurement effort is inadequate documentation.iscussion of these challenges is not an argument against anydividual measure. Rather, these discussions are cautionarytes that draw attention to areas in which additional researchay enhance the value of the measures.

. Discussion

.1. Sexhe Writing Committee recommends identical screening andvice for men and women for most cardiovascular riskctors, including lifestyle, diet, physical activity, smoking,d blood pressure. Sex-specific age of onset of cardiac riskllows from the varying epidemiology of heart disease inen and women (22,25,27). For men 35 years of age andder and for women 45 years of age and older, global risksessment takes into account the sex-specific levels of riskthat interventions are not sex-specific but rather tailored to

sk. We have recommended sex-specific assessment ofiposity to target patients with waist circumference of 35ches or more for women and 40 inches or more for men forditional intervention. For assessment of lipid therapy andntrol, the risk from a family history of CVD is relegated toale first-degree relatives younger than 55 years of age andmale first-degree relatives younger than 65 years of age,hereas the risk associated with low levels of high-densityoprotein cholesterol is defined as less than 40 mg/dL in

en and less than 50 mg/dL in women. We recommendobal risk screening for all men 35 years of age or older andr all women 45 years of age or older. Finally, we recom-end administration of aspirin as preventive therapy for menith a 10-year coronary heart disease (CHD) risk of 10% orore and for women with 10-year CHD risk of 20% or more,
ven different thresholds of risk and benefit (25,27). an
.2. Frequency of Screeninggeneral, a comprehensive assessment of risk factors shouldperformed at least every 5 years starting at 18 years of age,d a global risk score should be calculated at least every 5ars starting at the age of 35 years for men and 45 years foromen. Those with increased cardiovascular risk, for exam-e, those with diabetes, cigarette smokers, or those withesity, should have their risk factors and cardiovascular risksessed more frequently.

.3. Risk Screeningumerous observational studies have documented the powerfulsociations of healthy lifestyle choices, such as healthier diet,eater physical activity, avoidance of smoking, and maintaininglean body mass, with marked reductions in CVD events5,29,30). Although limited data indicate that assessmentlone) of diet and physical activity improves outcomes, andere are concerns regarding the reliability of patient self-report,sessment and documentation of these factors are importanteans to help the patient and provider understand the patient’ssk for CVD, to begin a dialogue regarding healthy lifestyleoices, and to provide specific counseling regarding risk factorduction to lower overall risk. Although the addition ofngitudinal, multicomponent behavioral interventions increases thefectiveness of clinical recommendations alone regarding healthyet and physical activity, advice alone has been shown to reducek factor levels and overall CHD risk (31,32).There is no consensus on what constitutes adequate docu-entation of diet, physical activity, and alcohol use. Theriting Committee believes that physicians and other prac-ioners should strive to capture the healthy and unhealthypects of the patient’s habits to provide counseling andserve change over time. Although the Writing Committeed not think that any specific tools should be required forsessment of diet and physical activity, the Committee notede existence of numerous validated measures that couldsist patients and providers in assessing the quality andantity of diet and physical activity. The numerous dietarystruments range from the extensive Diet History Question-ire (available at http://riskfactor.cancer.gov/DHQ/) to a

mple nutrition history form that a patient can fill out (33) orsimple question regarding how many servings of fruits andgetables a patient eats on average every day. Likewise,ere are a variety of validated instruments to help measureysical activity frequency and intensity, such as the Inter-tional Physical Activity Questionnaire (available at http://ww.ipaq.ki.se/ipaq.htm). Some of these instruments are exten-ve and are designed for research purposes, but portions of themay be useful to clinicians, and many can be self-administeredd are available in a wide variety of languages.There was not a clear consensus among the Writing

ommittee members regarding assessment and counseling oncohol in CVD risk. Likewise, although premature CVD in atient’s first-degree relative is clearly a risk factor for CVD4,35), there were concerns regarding the ability of provid-s to adequately assess and document a family history ofVD given reliance on patient self-report and varying defi-tions of a positive family history. Therefore, alcohol use
d family history were included for use in internal quality
http://www.ipaq.ki.se/ipaq.htm

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provement only, not for accountability or public reporting.onetheless, providers are strongly encouraged to ascertainlevant family history and history of alcohol use as reliablypossible, including verifying diagnoses of premature CVD

ith review of medical records of first-degree relatives if thetient can obtain them. One widely available tool that cansist patients and providers in ascertaining and updatingmily history information is the US Surgeon General’smily History Initiative (available at http://www.hhs.gov/milyhistory/). The “My Family Health Portrait” tool on thiseb site is intended to make the process of gathering and

oring family history information easier and more efficientr both patients and healthcare professionals.

.4. Lifestyle Counselingonsuming a heart-healthy diet (lower in animal products andch in fruits and vegetables, whole grains, low-fat or nonfatiry products, fish, legumes, poultry, and lean meats; calorientrolled; and moderate in sodium intake), as well as engagingregular physical activity, lowers an individual’s risk for CVD.

herefore, the Writing Committee strongly believes that diet andysical activity counseling is the foundation of primary pre-ntion. Such counseling has the potential to either reduce orevent the development of risk factors, for example, hyperten-on, hyperlipidemia, obesity, and diabetes. The Writing Com-ittee recognizes that clinical trial evidence related to morbidityd mortality outcomes for lifestyle counseling provided inedical practice settings is not as robust as the evidence forher medical therapies; however, strong evidence supports theportance of diet and activity in the risk of CVD, andcumulated evidence supports the impact of practice-basedunseling on behaviors (36). The Writing Committee believesat a performance measure for lifestyle counseling should beopted despite the lack of definitive evidence for morbidity andortality benefits, because such trials are unlikely to be con-cted, and efforts to restore biological and evolutionary normse less likely to introduce harm than are pharmacologicalterventions. Given that the adoption of lifestyle changes canevent and treat CVD risk factors, the need for other medicalerapies may be reduced or averted entirely. The Writingommittee agreed that unless diet counseling and physicaltivity counseling are put forward as performance measures,ere is no incentive for clinicians to provide such interventionspatients. Yet, the literature provides evidence that patients

spond favorably when counseling is provided. In a recentudy (37), physicians who gave brief advice on physical activityd educational materials showed that patients increased phys-al activity by 18 minutes per week more than control patients6 months, and a 4% higher proportion of patients achieved theinimum recommended physical activity level. Furthermore,bgroup analyses showed that individuals 50 years of age andder and those who were given an individual physical activityescription had even greater success, for example, doublingeir minutes per week of moderate or vigorous physical activity.A problem identified by the Writing Committee is that the

inician’s cognitive interactions with patients, for example,unseling, are undervalued and therefore are not reimbursedthird-party payers. However, the creation of an incentive by

ming these interactions as performance measures will help re

entify barriers to effective counseling and improve the valueaced on these interventions by the reimbursement system.The Writing Committee acknowledges the challenges as-ciated with mandating diet and physical activity counsel-g. First, counseling takes time during an already briefinician office visit. We encourage clinicians to provide arect message to patients and to use available resources tolp deliver lifestyle information, for example, by givingem printed educational materials, referring patients toww.mypyramid.gov, and handing patients an activity pre-ription (goal equals 30 minutes of brisk walking 5 days pereek). Second, as performance measures, diet and physicaltivity counseling must be documented. We encourageactices to integrate counseling interventions into electronicedical records or paper form so that such documentationn be expedited. One obvious concern is that complianceith a counseling measure does not provide an understandingthe intensity or quality of the counseling.

.5. Weight Managementody mass index and waist circumference are the designatedeasures for assessment of obesity and abdominal obesity,spectively. Body mass index has been linked with manyalth outcomes and is the measure most commonly reportedtreatment trials. However, studies have also demonstrated

e independent contribution of abdominal obesity to cardio-scular risk, particularly in blacks (38–40). Therefore, theriting Committee encourages the assessment of both ofese simple measurements, but only 1 is necessary to meete performance standard. At present, there is no evidenceat defining and managing patients on the basis of thencept of metabolic syndrome results in reduced morbidityd mortality; hence, we focused on the individual riskctors and not on the concept of the metabolic syndrome.

.6. Hypertensionypertension is a major risk factor for the development ofVD. The evidence linking untreated hypertension to in-eased cardiovascular morbidity is undisputed. However,erature surveys continue to report suboptimal population-sed management of hypertension. For example, in the99–2002 National Health and Nutrition Examination Surveynon-Hispanic whites, 62.9% of patients with hypertension

ere aware of their diagnosis, 48.6% were receiving treatment,d only 29.8% had their hypertension controlled (41). Theriting Committee elected to develop separate performanceeasures that evaluate measurement and control.Published guidelines differ regarding the age at whichood pressure assessment should commence. We elected toe the recommendations of the seventh report of the Jointational Committee on Prevention, Detection, Evaluation,d Treatment of High Blood Pressure (28), which recom-ends screening beginning at 18 years of age. We chose0/90 mm Hg as the threshold for satisfactory blood pres-re control because it is the target blood pressure suggested

the seventh report of the Joint National Committee onevention, Detection, Evaluation, and Treatment of Highlood Pressure for the general hypertensive population. We
cognize that target blood pressure should be lower for
http://www.hhs.gov/familyhistory/

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ecial high-risk populations (such as patients with diabeteschronic kidney disease). Our selected target represents the

inimum degree of control, or floor, that is acceptable as arformance measure. We do not mean to imply that lowerrgets are not desirable for special populations.Controversy remains as to the optimal role of specific classesantihypertensive medication in the treatment of hypertension.r example, the seventh report of the Joint National CommitteePrevention, Detection, Evaluation, and Treatment of High

lood Pressure and the European Society of Hypertension differith regard to preferred agents for initial monotherapy. This area

inquiry continues to evolve. Recognizing that individualysicians may reasonably choose 1 initial strategy over anotherd still comply with published guidelines, we have chosen notmandate the use of particular antihypertensive drug classes totisfy the blood pressure control performance measure. Rather,e require that blood pressure be below the target or that at leastmedications have been prescribed. This allows for differentarmacological strategies and also recognizes that blood pres-re for a subset of patients will remain uncontrolled despite

eatment that includes at least 2 medications. We included thetter criterion because we did not wish to penalize physicianshose practices may include more challenging patients or moretients with refractory hypertension due to case-mix issues. Ifood pressure is not controlled despite antihypertensive medi-tion, clinicians should assess possible reasons for poor control.g., patient adherence to recommended treatments) beforeanging the choice or dose of medication. Both of our bloodessure measures will require electronic or paper medicalcord reviews. With the exception of patients with hypertensionho have filled prescriptions for at least 2 antihypertensiveedications, claims data will not adequately capture the infor-ation necessary to evaluate these performance measures.

.7. Lipid Screening and Controlhe Writing Committee had an extensive discussion aboute appropriate age at which lipid screening should beitiated. The Adult Treatment Panel III guidelines recom-end lipid screening from age 20 years onward. The USeventive Services Task Force recommends lipid screeningage 35 years for all men and at age 45 years for women

ho are at increased risk for CHD and does not make acommendation for or against screening in younger individ-ls who are not at increased risk for CHD. Some Writing

ommittee members advocated the younger age cutoff,ting that atherosclerosis originates in youth and progressesyoung adults; however, many Writing Committee membersvocated older age thresholds for lipid screening because ofe lack of an evidence base of randomized, controlled trials

younger cohorts documenting that lipid screening atunger ages results in reduction of cardiovascular events ine long term. The Writing Committee adopted the older ageresholds as the minimum standard for accountability/publicporting, whereas the internal quality improvement standardlls for screening at younger ages.Decisions about lipid-lowering therapy should be based onindividual’s risk for CVD rather than solely on sex or age

7,42). The Writing Committee acknowledges that evidence
limited for women and the elderly (43,44). Such risk po
sessment requires comprehensive ascertainment and docu-entation of lipid and nonlipid risk factors. Data on individ-l risk factors are best synthesized by validated risk scores,d global risk estimation is thus recommended by currentid-lowering guidelines and included in the present docu-

ent as an internal quality improvement measure (see Sec-n 4.9). Given the lack of consensus regarding which global

sk assessment instrument most correctly captures risk andhich time frame for risk estimation is most appropriate, andcause there are no studies to date that directly demonstrateperior patient outcomes with formal risk scoring as op-sed to comprehensive risk factor assessment alone, theriting Committee has chosen not to designate global risktimation as a performance measure. Ascertainment of theta elements for global risk estimation, however, meetsrformance measure criteria.Considerations similar to those discussed in detail in thection on hypertension treatment and control apply to theeatment and control of dyslipidemia. Statins are the main-ay of pharmacological lipid-lowering therapy, but the Writingommittee has chosen not to prescribe certain lipid-loweringgimens in favor of others given the variability of lipoproteinenotypes and the heterogeneity of patients’ tolerance torious medication classes and agents within classes.

.8. Global Risk Estimationhe current framework for assessment of risk for CHD ande selection of potential patients for drug therapy includessessment of absolute risk for CHD in the next 10 yearssed on multivariable equations that include a number oftablished risk factors. These risk equations have facelidity and provide excellent discrimination of high-risk0% or greater), intermediate-risk (10% to 20%), and low-sk (less than 10%) individuals. Their calibration may varypending on differences in event rates and prevalence of riskctors between the population from which the equationsere derived and the population in which they are beingilized. Limited data indicate that the use of these riskuations improves outcomes (45,46); this area of researchquires further study. Furthermore, most risk equations focus10-year risk, whereas it is increasingly recognized that risk

r CHD occurs over one’s lifespan, and low 10-year pre-cted risk in a young person may not indicate low lifetimesk (14). Indeed, 10-year risk estimates are universally low,en in the face of significant risk factor burden (47–49), inunger men (younger than 35 years of age) and womenounger than 45 years of age). Therefore, several panels (25,27)ve recommended consideration of long-term or lifetime risktimates for younger individuals to help emphasize the impor-nce of early positive lifestyle changes. Lifetime risks may betimated for individuals 50 years of age or younger with ablished simple risk factor stratification scheme (14).A number of 10-year risk scores are currently available. Of

ese, the 1998 Framingham Risk Score (50) has been assessedd validated in the broadest range of populations and has theost years of follow-up. A modification of this risk score wasopted by the third Adult Treatment Panel of the National

holesterol Education Program for risk assessment for the end
int of nonfatal myocardial infarction or coronary death. A

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wer version of Framingham 10-year risk scores was publishedcently (51) with the added utility of prediction of 10-yearobal CVD risk and specific CVD end points (CHD, stroke,art failure, and peripheral arterial disease). Although theriting Committee recommends that documentation of theamingham 10-year risk estimate be the preferred method ofsessing compliance with this measure (Appendix F), the use ofother risk score is also acceptable if it is relevant to thetient/population. The Adult Treatment Panel III global risktimates are for hard CHD (fatal CHD or nonfatal myocardialfarction, but excluding angina pectoris), whereas the 1998amingham scores that are provided in Appendix F are for totalHD (including angina pectoris), although hard CHD risks canso be derived. The European SCORE (Systematic Coronaryisk Evaluation) (52) estimates fatal CVD risk, whereas theeynolds Risk Score (53) estimates women’s risk for CVDcluding stroke and revascularization.

.9. Stroke Risk Assessmentlobal risk assessment tools such as the Framingham Strokeofile for first stroke are also available. Although they havet been validated as widely as the Framingham CHD risksessment tool, external validity has been demonstrated inuropean cohorts (54–59). On the other hand, the global risksessment for CHD is widely used and has been adopted ine Adult Treatment Panel III guideline. Although the calcu-tions differ, patients at higher CHD risk will also be atgher risk for stroke. At this time, we recommend use of aobal risk assessment tool for CHD or CVD. Considerationay also be given to use of the recent Framingham globalVD risk scores and the stroke-specific score (51,54,60,61).

.10. Aspirin Uselthough the benefits of aspirin therapy to prevent myocar-al infarction, stroke, and vascular disease death in men andomen with established CVD are well known, the use ofpirin in primary prevention is less clear. Among men andomen without CVD, there has been little or no benefit forpirin in reducing CVD death or all-cause death (62). In acent meta-analysis of primary prevention studies, there wassignificant 12% relative risk reduction in CVD events withpirin, which was similar across CHD risk categories (62).nother meta-analysis of individuals without establishedsease reported a sex-specific reduction in cardiovascularents (63). Aspirin reduced the risk of myocardial infarctionmen and the risk of stroke in women; however, aspirin

gnificantly increased the risk of bleeding in both men andomen (64). Aspirin did not reduce the risk of cardiovascularsease in Japanese patients with diabetes in the primaryevention setting unless they were 65 years of age or older5). The use of aspirin for prevention of CVD in patientsith diabetes mellitus or peripheral arterial disease remainsclear (63,65). Thus, in patients without cardiovascularsease, the benefit-risk ratio for aspirin should be carefullyeighed since these patients are at lower baseline CVD thantients with known atherosclerotic disease and aspirin in-eases the risk of bleeding (gastrointestinal bleeding andmorrhagic stroke). The updated US Preventive Services

ask Force statement provides an algorithm that clinicians va

ay sue to assess the potential benefits and risks of aspirinerapy (23).The Writing Committee discussed using an age cut pointwever, because the clinical trial data that examined the useaspirin for primary prevention according to age cut points

ere based on subgroup analysis, with fewer events occurringyounger individuals, rather than an effect modification by age,e committee preferred to tailor the use of aspirin according tovel of CHD risk, consistent with current guideline recommen-tions. Recent data suggests that those at highest risk (e.g.,

HD risk of 20% or greater) may benefit most in terms ofsolute risk reduction with aspirin as their absolute risk is high,though they are also at higher risk of bleeding (62).Available evidence, primarily from secondary prevention

udies, shows that low-dose aspirin (75 to 81 mg/d) is adequatefully inhibit platelet aggregation, although doses of 81 to 325g/d are typically prescribed (66). Higher doses of aspirin aresociated with an increased risk of bleeding. Guidelines differaspirin dose recommendations for primary prevention (81 to5 mg/d); however, all 3 guidelines (22,23,25) agree that aspirin iscommended for patients at high risk for CHD. Healthcare provid-s should consider documenting adverse effects, for example,eeding complications, with respect to aspirin dose.

.11. Diabetes Mellitushere is increased risk of developing CHD and stroke in bothpe 1 and type 2 diabetes mellitus. However, opinions are dividedto whether they should be considered as CHD risk equivalents.e believed the available evidence favored classifying diabetesa risk factor rather than as a CHD equivalent (67,68).The literature on the effects of blood glucose control on

sk of developing CHD is mixed. There is strong evidenceat tight control of glucose in type 1 diabetes mellitusduces the risk of developing nonfatal myocardial infarction,roke, and CVD by up to 57% (69). The evidence for thefectiveness of tight glucose control with regard to primaryVD prevention is negative for type 2 diabetes mellitus anday even be associated with increased risk (70–73). Weerefore elected not to develop performance measures forabetes, particularly in light of the fact that the Nationaliabetes Quality Improvement Alliance has already devel-ed such measures (74). There is very compelling evidencestudies of patients with type 2 diabetes mellitus that tightntrol of blood pressure and of blood cholesterol signifi-ntly reduces the risk of developing CHD.

.12. Dietary Supplementationecause of the lack of an established evidence base support-g a primary prevention benefit for antioxidant vitamins,lic acid, coenzyme Q, fish oil capsules, and so on, theseere not included in these performance measures.

. Conclusions

e believe that these measures will provide a useful tool for theared goal of improving care in the critical arena of primaryevention of CVD. Cardiac risk factor reduction has the addednefit of promoting overall good health, in addition to cardio-
scular health. Current federal mandates have made prevention

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priority area in health care, recognizing the pivotal role ofevention in good health. We hope that these ACCF/AHAetrics and discussion will help the nation achieve our goal ofproving health and health care for all Americans.

taff

merican College of Cardiology Foundationhn C. Lewin, MD, Chief Executive Officerharlene May, Senior Director, Science and Clinical Policyelanie Shahriary, RN, BSN, Associate Director, Perfor-
mance Measures and Data Standards K
ay Conley, RN, MSN, BC, Senior Specialist, PerformanceMeasures

rin A. Barrett, Senior Specialist, Science and Clinical Policy

merican Heart Associationancy Brown, Chief Executive Officerose Marie Robertson, MD, FAHA, FACC, FESC, ChiefScience Officerayle R. Whitman, PhD, RN, FAHA, FAAN, Senior VicePresident, Office of Science Operations
athryn A. Taubert, PhD, FAHA, Senior Scientist

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ppendix A

thor Relationships With Industry and Other Entities—ACCF/AHA 2009 Performance Measures for Primary Prevention ofrdiovascular Disease in Adults

me Research Grant

Speakers’ Bureau/Honoraria/

Expert WitnessStock Ownership/Equity Interests

Consultant/Advisory Board/

SteeringCommittee

Institutional,Organizational or Other

Financial Benefit

Rita F. Redberg None None None None None

Emelia J. Benjamin None None None None None

Vera Bittner ● Atherogenics*● CV Therapeutics*

● Merck*● NIH/Abbott joint

effort*● Pfizer*● Roche*

None None ● CV Therapeutics● Novartis● Pfizer● Reliant

Pharmaceuticals

None

Lynne T. Braun None ● AstraZeneca● diaDexus

None None None

David C. Goff, Jr ● Merck* ● Scientific Evidence, Inc* None None ● Pfizer● St Jude Medical

Stephen Havas None None None None None

Darwin R. Labarthe None None None None None

Marian C. Limacher ● Orexigen Therapeutics* None None None None

Donald M. Lloyd-Jones None ● Abbott● Merck● Pfizer

None None None

Samia Mora ● AstraZeneca*● Merck*

● Pfizer None None None

Thomas A. Pearson ● Sanofi-aventis ● Bayer*● Johnson & Johnson/Merck

● Kos Pharmaceuticals● Merck/Schering-Plough

● Pfizer● Sanofi-aventis

None None None

Martha J. Radford None None None None None

Gerald W. Smetana None None ● SafeMed ● Harvard MedicalInternational/Novartis● Pharma SchweizCME course director

None

John A. Spertus ● Amgen*● BMS/Sanofi-

aventisPartnership*● Lilly*

None ● CV Outcomes, Inc● Health Outcomes

Sciences, LLC● KCCQ (copyright)*

● OutcomesInstruments, LLC*

● PAQ (copyright)*● PRISM Technology● SAQ (copyright)*

None None

Erica W. Swegler None ● Abbott None None None

CME indicates continuing medical education; KCCQ, Kansas City Cardiomyopathy Questionnaire; NIH, National Institutes of Health; PAQ, personal assessmentestionnaire; and SAQ, Seattle Angina Questionnaire.This table represents the relationships of committee members with industry and other entities that were reported by the authors as relevant to this topic during

e document development process. It does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significanterest in a business if the interest represents ownership of 5% or more of the voting stock or share of the business entity, or ownership of $10 000 or more ofe fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previousar. A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships in this table are modest unless otherwiseted.
*Significant (greater than $10 000) relationship.

A

PeCa

Na

Dr

Dr

Dr

Dr

Dr

Dr

Dr

Dr

Dr

dePareorif


ppendix B

er Reviewer Relationships With Industry and Other Entities—ACCF/AHA 2009 Performance Measures for Primary Prevention ofrdiovascular Disease in Adults

me Representation Research Grant

Speakers’ Bureau/Honoraria/

Expert WitnessStock Ownership/Equity Interests

Consultant/Advisory Board/

SteeringCommittee

Institutional,Organizational, or Other

Financial Benefit

Gerald Fletcher Official reviewer—AHA None None None None None

Lee Green Official reviewer—ACCF/AHA

Task Force onPerformance

Measures: Leadreviewer

None None None None None

Laura Hayman Official reviewer—AHA None None None None None

Chittur A. Sivaram Official reviewer—ACCFBoard of Governors

None ● ATS* None None None

Janet Wright Official reviewer—ACCFBoard of Trustees


Roger Blumenthal Content reviewer—ACCF Prevention of

CardiovascularDisease Committee

● General Electric(fellowship support)

None None None None

C. Annette DuBard Content reviewer—individual


JoAnne M. Foody Content reviewer—individual

None ● Johnson & Johnson● Merck

● Novartis● Pfizer

None None None

Patrick McBride Content reviewer—ACCFPrevention of

CardiovascularDisease Committee

None ● Reliant● Sanofi-aventis

None None None

ACC indicates American College of Cardiology; ACCF, American College of Cardiology Foundation; and AHA, American Heart Association.This table represents the relationships of peer reviewers with industry and other entities that were reported as relevant to this topic during the documentvelopment process. It does not necessarily reflect relationships at the time of publication. Names are listed in alphabetical order within each category of review.rticipation in the peer review process does not imply endorsement of this document. A person is deemed to have a significant interest in a business if the interestpresents ownership of 5% or more of the voting stock or share of the business entity, ownership of $10 000 or more of the fair market value of the business entity,if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modestit is less than significant under the preceding definition. Relationships in this table are modest unless otherwise noted.
*Significant (greater than $10 000) relationship.

pr30izmarla

lo

16


CHD score sheet for men using total cholesterol or LDL-C categories. Uses age, total cholesterol (or LDL-C), HDL-C, bloodessure, diabetes, and smoking. Estimates risk for CHD over a period of 10 years based on Framingham experience in mento 74 years of age at baseline. Average risk estimates are based on typical Framingham subjects, and estimates of ideal-

ed risk are based on optimal blood pressure, total cholesterol 160 to 199 mg/dL (or LDL-C 100 to 129 mg/dL), HDL-C of 45g/dL in men, no diabetes, and no smoking. Use of the LDL-C categories is appropriate when fasting LDL-C measurementse available. Risk estimates were derived from the experience of the Framingham Heart Study, a predominantly white popu-tion in Massachusetts.CHD indicates cardiovascular heart diease; chol, cholesterol; HDL-C, high-density lipoprotein cholesterol; LDL-C,w-density lipoprotein cholesterol; and Pts, patients.Adapted from Wilson et al (50), with permission from Lippincott Williams & Wilkins. Copyright 1998, American Heart Association.*Hard CHD events exclude angina pectoris.**Low risk was calculated for a person the same age, optimal blood pressure, LDL-C 100 –129 mg/dL or cholesterol
0 –199 mg/dL. HDL-C 45 mg/dL for men or 55 mg/dL for women, nonsmoker, no diabetes.

Adapted from: NIH Publ


Reprinted from NIH Publication No. 00-4084 (103).

BMI indicates body mass index.
ication No. 00-4084 (103).

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ease.
http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf

http://www.icsi.org/guidelines_and_more/preventive_services_for_adults_4.html

http://www.icsi.org/guidelines_and_more/preventive_services_for_adults_4.html

http://www.ahrq.gov/clinic/uspstf08/lipid/lipidrs.htm

http://www.ahrq.gov/clinic/uspstf08/lipid/lipidrs.htm

http://www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf

preventie primara, jacc, 2009

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