JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
VOL. 67, NO. 5, 2016
ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION AND
THE AMERICAN HEART ASSOCIATION, INC.
ISSN 0735-1097/$36.00
http://dx.doi.org/10.1016/j.jacc.2015.02.003
PUBLISHED BY ELSEVIER
FOCUSED UPDATE
2015 ACC/AHA Focused Update
of Secondary Prevention
Lipid Performance Measures
A Report of the American College of Cardiology/American Heart Association
Task Force on Performance Measures
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
Members
ACC/AHA
Harlan M. Krumholz, MD, SM, FACC
Brahmajee K. Nallamothu, MD, FACC
Committee
T. Bruce Ferguson, JR, MD, FACC, FAHA
Jeffrey W. Olin, DO, FACC, FAHA, MSVM
Hani Jneid, MD, FACC, FAHA, FSCAI
Henry H. Ting, MD, MBA, FACC, FAHA
Paul A. Heidenreich, MD, MS, FACC, FAHA, Chair
P. Michael Ho, MD, PHD, FACC, FAHA
Sean O’Brien, PHD
Task Force on
Performance
Nancy M. Albert, PHD, CCNS, CCRN, CCA, FAHA
Andrea M. Russo, MD, FACC
Measures
Paul S. Chan, MD, MSc, FACC
Randal J. Thomas, MD, FACC, FAHA
Lesley H. Curtis, PHD
Henry H. Ting, MD, MBA, FACC, FAHA
T. Bruce Ferguson, JR, MD, FACC, FAHA
Paul D. Varosy, MD, FACC
Gregg C. Fonarow, MD, FACC, FAHA
This document was approved by the American College of Cardiology Board of Trustees in November, 2014 and the American Heart Association Science
Advisory and Coordinating Committee in October, 2014.
The American College of Cardiology requests that this document be cited as follows: Drozda JP Jr, Ferguson TB Jr, Jneid H, Krumholz HM, Nallamothu
BK, Olin JW, Ting HH. 2015 ACC/AHA focused update of secondary prevention lipid performance measures: a report of the American College of CarListen to this manuscript’s
audio summary by
JACC Editor-in-Chief
Dr. Valentin Fuster.
diology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol 2016;67:558–87.
Between July 8, 2014, and July 22, 2014, the document underwent a 15-day peer review period. Between July 15, 2014, and August 5, 2014, the
document underwent a 21-day public comment period.
This article has been copublished in Circulation: Cardiovascular Quality and Outcomes.
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Drozda et al.
JACC VOL. 67, NO. 5, 2016
FEBRUARY 9, 2016:558–87
Focused Update of Secondary Prevention Lipid Performance Measures
TABLE OF CONTENTS
PREAMBLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 559
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 560
1.1. Rationale for Update . . . . . . . . . . . . . . . . . . . . . . . . 560
1.2. Structure and Membership of the
Writing Committee . . . . . . . . . . . . . . . . . . . . . . . . . 560
1.3. Disclosure of Relationships With Industry
and Other Entities . . . . . . . . . . . . . . . . . . . . . . . . . . 560
APPENDIX C
Peer Reviewer Relationships With Industry and
Other Entities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 583
APPENDIX D
2015 ACC/AHA Focused Update of Secondary
Prevention Lipid Performance Measures:
Summary Analysis Table . . . . . . . . . . . . . . . . . . . . . . . . 587
PREAMBLE
2. METHODOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 561
2.1. Target Population and Care Period . . . . . . . . . . . . 561
American College of Cardiology (ACC)/American Heart
Association (AHA) performance measures can serve as
2.2. Literature Review . . . . . . . . . . . . . . . . . . . . . . . . . . 561
vehicles to accelerate appropriate translation of scientific
2.3. Definition and Selection of Measures . . . . . . . . . . 561
evidence into clinical practice. Performance measures
cover a subset of the most important recommended care
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
practices and are considered appropriate for public
reporting or use in pay for performance programs. Other
measures of care that are not considered appropriate for
public reporting or payment modification may be used as
quality or test metrics for internal quality improvement.
As defined by the ACC/AHA, quality metrics are those
measures that have been developed to support selfassessment and quality improvement at the provider,
4. GENERAL DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . 564
hospital, and/or healthcare system level. These metrics
4.1. Patient-Centered PMs and SDM . . . . . . . . . . . . . . 564
may not meet all specifications of formal performance
4.2. “Prescribed” Versus “Offered” . . . . . . . . . . . . . . . 565
measures (1). In certain cases, an ACC/AHA performance
measure writing committee may identify particular mea-
4.3. Prescription Versus Adherence . . . . . . . . . . . . . . . 565
sures as quality metrics for the purposes of pilot testing
4.4. Exceptions and Exclusions . . . . . . . . . . . . . . . . . . 567
with the potential of later promotion to performance
4.5. Method of Reporting . . . . . . . . . . . . . . . . . . . . . . . 568
have been published (2,3) by the ACC/AHA and include an
4.6. Limitations and Unintended Consequences . . . . . 569
important gap in care and a clear path to improve care.
measurement. Specific criteria for performance measures
Recently, value was added as an exclusion criterion (4),
5. FUTURE DIRECTIONS . . . . . . . . . . . . . . . . . . . . . . . . . 569
where a care practice deemed to be of poor value by an
ACC/AHA guideline would not be considered as a perfor-
5.1. Improved Information Systems for
Capturing Clinical Data . . . . . . . . . . . . . . . . . . . . . . 569
mance measure. The ACC/AHA Task Force on Perfor-
5.2. Measures of SDM and Shared Accountability . . . . 569
care measures under the control of individual providers.
5.3. Conclusion and Summary . . . . . . . . . . . . . . . . . . . 570
However, writing committees may also create structural
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 570
APPENDIX A
2015 ACC/AHA Focused Update of Secondary
Prevention Lipid Performance Measures:
Performance Measure Set . . . . . . . . . . . . . . . . . . . . . . . 572
mance Measures has historically focused on process of
or outcome measures when they meet the ACC/AHA
performance measurement criteria.
A goal of the ACC/AHA Task Force on Performance
Measures is to rapidly create or update a performance
measure when there are changes to a relevant ACC/AHA
clinical guideline. Whenever possible, the ACC/AHA
attempt to create relevant performance measures immediately following the publication of a guideline. However,
APPENDIX B
Author Relationships With Industry and Other Entities
(Relevant) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 582
the ACC/AHA believe that it is important to balance speed
in measure development with a thorough review by
stakeholders, content experts, and other interested
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Focused Update of Secondary Prevention Lipid Performance Measures
parties using a public comment period. The goal is to have
fully aligned with current clinical practice guidelines,
up-to-date and valid measures that can be used by all
the ACC/AHA Task Force on Performance Measures
interested members of the healthcare system to evaluate
(the Task Force) requires a transparent and consistent
and improve the quality of cardiovascular care.
process that will allow focused updates to individual
Paul A. Heidenreich, MD, MS, FACC, FAHA
PMs when needed. This may occur when new guideline
Chair, ACC/AHA Task Force on Performance Measures
recommendations are released, when the Task Force receives feedback from end users of the measures about
1. INTRODUCTION
critical implementation problems, or when unintended
The “2015 ACC/AHA Focused Update of Secondary Prevention Lipid Performance Measures” Writing Committee
(the writing committee) was charged with updating the
current lipid performance measures (PMs) based on the
new recommendations in the “2013 ACC/AHA Guideline
on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults” (the Cholesterol
Guideline) (5). In this measure set, the writing committee
presents 5 PMs (Appendix A) 3 of which are intended for
ambulatory settings and 2 for hospital (inpatient) settings.
Four are revisions of lipid management measures
appearing in 4 existing measure sets: “ACCF/AHA/ACR/
SCAI/SIR/SVM/SVN/SVS 2010 Performance Measures for
Adults With Peripheral Artery Disease” (6); “ACC/AHA
2008 Performance Measures for Adults With ST-Elevation
and Non-ST-Elevation Myocardial Infarction” (7); “ACC/
AHA/SCAI/AMA-PCPI/NCQA 2013 Performance Measures
for Adults Undergoing Percutaneous Coronary Interven-
adverse consequences associated with implementation
of the measure(s) are detected. The current writing
effort used the Cholesterol Guidelines’ recommendations
(5), which are significantly different from those of the
prior Adult Treatment Panel III guidelines and emphasize
administration of high-intensity statin therapy instead
of 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 clinicians specializing in interventional cardiology and general
cardiology, as well as persons with expertise in development of guidelines and development, implementation,
and testing of PMs. Chairs for each of the previously
published PMs (Table 1) were selected for the current
writing effort.
tion” (8); and “ACCF/AHA/AMA-PCPI 2011 Performance
1.3. Disclosure of Relationships With Industry and Other Entities
Measures for Adults With Coronary Artery Disease and
The Task Force makes every effort to avoid actual, poten-
Hypertension” (9). These measure sets for percutaneous
tial, or perceived conflicts of interest that could arise as a
coronary intervention (PCI), coronary artery disease
result of relationships with industry or other entities
(CAD), peripheral artery disease (PAD), and ST-elevation
(RWI). Detailed information on the ACC/AHA policy on
myocardial infarction (STEMI)/non ST-elevation myo-
RWI can be found online. All members of the writing com-
cardial infarction (NSTEMI) are summarized in Table 1.
mittee, as well as those selected to serve as peer reviewers
The fifth measure is new and applies to the population
of this document, were required to disclose all current re-
of patients with clinical atherosclerotic cardiovascular
lationships and those existing within the 12 months before
disease (ASCVD) as defined in the 2013 guideline (5).
initiation of this writing effort. ACC/AHA policy also requires that the writing committee co-chairs and at least 50%
1.1. Rationale for the Update
of the writing committee have no relevant RWI.
To ensure that ACC/AHA PMs for cardiovascular disease
Any writing committee member who develops new
fulfill their intended purposes, remain relevant, and are
RWI during his or her tenure on the writing committee is
TABLE 1
ACC/AHA Secondary Prevention Lipid PMs to Be Updated
Measure
Description
2013 PCI Lipid Performance Measures (8)
Percentage of patients $18 y of age for whom PCI is performed and who are prescribed optimal
medical therapy at discharge
2011 CAD Lipid Performance Measures (9)
Percentage of patients $18 y of age with a diagnosis of CAD seen within a 12-mo period who have an LDL-C
result <100 mg/dL OR patients who have an LDL-C result $100 mg/dL and have a documented plan of
care to achieve an LDL-C <100mg/dL, including at a minimum the prescription of a statin
2010 PAD Lipid Performance Measures (6)
Percentage of patients $18 y of age with PAD who were prescribed a statin and whose LDL-C is <100 mg/dL
2008 STEMI/NSTEMI Lipid Performance
Measures (7)
Percentage of patients with STEMI/NSTEMI who are $18 y of age with documented LDL-C level in the hospital
record or documented LDL-C testing done during the hospital stay or planned for after discharge
ACC/AHA indicates American College of Cardiology/American Heart Association; CAD, coronary artery disease; LDL-C, low-density lipoprotein cholesterol; NSTEMI,
non ST-elevation myocardial infarction; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; PM, performance measure; and STEMI, ST-elevation myocardial
infarction.
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Focused Update of Secondary Prevention Lipid Performance Measures
required to notify staff in writing. These statements are
feasible to implement, and consistent with accountability
reviewed periodically by the Task Force and members of
(Table 2). After the peer review and public comment
the writing committee. Author and peer reviewer RWI
period, the writing committee reviewed and discussed
relevant to the document are included in the appendixes
the comments and made further refinements in the
(see Appendix B for relevant writing committee RWI
measure set. The writing committee evaluated the po-
and Appendix C for relevant peer reviewer RWI). Addi-
tential measures against the ACC/AHA attributes of PMs
tionally, to ensure complete transparency, the writing
(Table 2) to reach consensus on which measures should
committee members’ comprehensive disclosure informa-
be advanced for inclusion in the final measure set;
tion, including RWI not relevant to the present document,
the Summary Analysis Table (Appendix D) captures this
is available as an online supplement. Disclosure informa-
evaluation process. The majority of the writing com-
tion for the Task Force is also available online.
mittee believed that the 5 measures in the set fulfilled
The work of the writing committee was supported
the PM attributes.
exclusively by the ACC and AHA without commercial
support. Members of the writing committee volunteered
3. 2015 ACC/AHA FOCUSED UPDATE OF
their time for this effort. Meetings of the writing com-
SECONDARY PREVENTION LIPID
mittee were confidential and attended only by committee
PERFORMANCE MEASURES
members and staff from the ACC and AHA.
3.1. Gaps in Care
2. METHODOLOGY
Each of the original writing committees that developed
The development of PM systems involves identification of
prevention performance gaps in the patient populations
the measures revised in this update identified secondary
a set of measures targeting a specific patient population
that were the subjects of their measure sets. There is
observed over a particular period. To achieve this goal,
evidence that these gaps are ongoing, although the
the Task Force has outlined a set of mandatory sequential
published studies deal primarily with prescription of
steps (2). The following sections outline how these steps
medication.
were applied by the present writing committee.
A study from the REACH (Reduction of Atherothrombosis for Continued Health) Registry found that
2.1. Target Population and Care Period
only 83% of ambulatory patients with known ASCVD
The target population for the ASCVD PM reflects the
were receiving lipid-lowering agents (11). A prospective
ACC/AHA Cholesterol Guidelines (5) population and
study by Rabus and colleagues of 73 patients with an-
consists of patients ages 18 to 75 years. In the focused
giographically diagnosed CAD found that only 44%
update of the 4 existing lipid PMs, the target population
received prescriptions for statins (12). Reports from the
consists as well of patients ages 18 to 25 years, repre-
National Cardiovascular Data Registry PINNACLE Reg-
senting a change from the age range previously speci-
istry of ambulatory patients with CAD revealed that
fied in each measure set. This change was felt to be
only 66.5% (103,830 of 156,145) were receiving optimal
necessary in order to maintain consistency with the
medical therapy (OMT), including statins (13), that
Class of Recommendation I, Level of Evidence A re-
77.8% (30,160 of 38,775) were prescribed statins (14),
commendation in the guidelines for treatment of pa-
and that uninsured patients were 6% less likely to
tients with clinical ASCVD. Additionally, the writing
receive lipid-lowering therapy (15). Additionally, the
committee developed exclusion criteria for the mea-
study by Maddox and colleagues found substantial
sures where appropriate in order to further specify the
variation in prescription patterns by practice site (13,15).
target population.
Shah and colleagues reported that, among 292 patients
from Olmstead County, MN, with incident acute myo-
2.2. Literature Review
cardial infarction (MI), only 44% were still taking sta-
The writing committee used the Cholesterol Guidelines
tins 3 years after their infarction (16). Interestingly, a
(5) as a primary source for deriving the measures. The
study by Borden and colleagues (17) involving patients
writing committee also carried out a literature review to
in the National Cardiovascular Data Registry CathPCI
assess contemporary gaps in care.
Registry failed to show any significant improvement
in the prescription of OMT after PCI following publica-
2.3. Definition and Selection of Measures
tion of the results of the Clinical Outcomes Utilizing
The writing committee focused on developing these
Revascularization
measures against the ACC/AHA attributes of PMs. Each
(COURAGE) study, which had demonstrated no incre-
measure was constructed in a way to ensure it was evi-
mental advantage of PCI over OMT on outcomes other
dence based, desirable in regard to measure selection,
than angina-related quality of life in stable CAD. Among
and
Aggressive
Drug
Evaluation
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Focused Update of Secondary Prevention Lipid Performance Measures
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 care
that in turn is linked to a meaningful patient outcome.
b) For process measures, the scientific basis for the measure is well established and the process
should be closely linked to a meaningful patient outcome.
c) For outcome measures, the outcome should be clinically meaningful. If appropriate, PMs based
on outcomes should adjust for relevant clinical characteristics by using appropriate
methodology and high-quality data sources.
2. Measure Selection
Measure definition
a) The patient group to whom the measure applies (denominator) and for whom conformance
is 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.
all 467,211 patients (173,416 before [37.1%] and 293,795
LDL-C levels met the previously recommended thera-
after [62.9%] the COURAGE trial) who met the study
peutic target. In a secondary analysis of the Trans-
criteria, the use of OMT at discharge following PCI
lational Research Investigating Underlying Disparities in
before
63.5%
Acute Myocardial Infarction Patients’ Health Status
(95% confidence interval, 63.3% to 63.7%) and 66.0%
(TRIUMPH) study, only 23% of 4,271 patients discharged
(95% confidence interval, 65.8% to 66.1%), respectively
alive following an acute MI were on maximal statin
(p < 0.001).
therapy, with substantial variability across hospitals
and
after
the
COURAGE
trial
was
The extent to which statin treatment is initiated as a
(18). Finally, a study in the Get With The Guidelines
result of a shared decision-making (SDM) process be-
Registry of 65,396 patients with acute coronary syn-
tween patient and clinician has not been systematically
dromes (ACS) who were discharged with lipid-lowering
assessed but is likely small. Additionally, there is min-
agents found that only 38.3% were discharged with
imal information available about the statin doses being
intensive lipid-lowering therapy (19). An editorial chal-
used in practice, although there are reasons for concern
lenged measure developers to track the use of effective
that many patients are being undertreated. It is com-
drug therapy, including dose (20). The current measures
mon practice among clinicians to use the smallest dose
are designed therefore not only to promote the use of
of a medication necessary to achieve a therapeutic
statins as recommended by the Cholesterol Guidelines
target and minimize the chance of adverse effects. Even
(5) but also to emphasize the importance of high-
PMs such as those revised in this focused update
intensity dosing.
exclude the requirement for therapy in patients who
have achieved goals. A study of 38,775 patients in
3.2. Broader Denominator (ASCVD)—Unique to This PM Set
the
colleagues
The target population for the ASCVD PM includes women
revealed findings consistent with undertreatment of
and men between 18 and 75 years of age who have clinical
patients with CAD (14). They found that 6,573 (17.0%)
ASCVD, which includes the following: ACS, history of MI,
patients were not receiving any lipid-lowering therapy.
stable or unstable angina, coronary (including PCI) or
Cholesterol levels were available for 3,365 of these pa-
other arterial revascularization, stroke, transient ischemic
tients, 1,794 (53.3%) of whom had LDL-C levels <100
attack, or PAD. Although this patient population seems
mg/dL, consistent with clinicians either failing to treat
heterogeneous, it encompasses a variety of patients
or discontinuing lipid-lowering therapy when patient
who all share presumed atherosclerosis (21) as a common
PINNACLE
Registry
by
Arnold
and
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Focused Update of Secondary Prevention Lipid Performance Measures
pathophysiology. Atherosclerosis is a chronic diffuse
to abandon the paradigm of treating patients to LDL-C
disease involving a myriad of arterial beds with inter-
targets and instead replace it with a more tailored treat-
mittent acute clinical manifestations, predominantly
ment approach (i.e., personalized care), which aims not
occurring as a result of superimposed thrombosis, plaque
only to improve patient outcomes but also reduce harms
progression, spasm, embolism, or a combination of the
and costs caused by overtreating patients at low risk
above. Other pathophysiological processes can contribute
(29,30).
to the creation of stenosis or aneurysms in the arterial
For patients with ACS, which includes unstable
circulation; however, atherosclerosis remains the most
angina, NSTEMI, and STEMI, the general period of
common pathophysiology.
assessment is the inpatient hospitalization or related
Patients with clinical ASCVD represent 1 of 4 major
emergency department visit. For other patients (non-
groups identified by the writing committee of the
ACS patients), the PM is intended to assess the care for
Cholesterol Guidelines (5). For these patients, treatment
patients at the practitioner level in an ambulatory care
with a 3-hydroxy-3-methylglutaryl-coenzyme A reductase
setting for the primary purpose of quality improvement.
inhibitor, commonly known as a statin, is clearly benefi-
For these non-ACS patients, the outpatient care period
cial. According to the Cholesterol Guidelines (5), patients
is defined as the care provided in an outpatient setting
with clinical ASCVD were identified by using the inclusion
within the time under evaluation, which is usually
criteria from randomized clinical trials (RCTs) in second-
12 months.
ary prevention. In addition, the potential for reduction
There are important potential exceptions for routine
of risk for ASCVD with statins in these patients clearly
initiation of statin treatment. For primary prevention,
exceeds the potential for adverse effects (22).
the Cholesterol Guidelines expert panel determined that,
The
Cholesterol
Treatment
Trialists
provided
a
despite the high level of risk for cardiovascular disease
comprehensive assessment of the benefits observed with
in patients with a higher New York Heart Association
statins (23). They undertook meta-analyses of individual
class of heart failure or receiving hemodialysis, the
participant data from 26 RCTs and demonstrated reduc-
available evidence suggests that initiation of statin
tion in all-cause mortality, which was largely attributable
therapy might not achieve a significant risk reduction
to significant reductions in deaths due to CAD and other
(31–33). In recognizing this, the expert panel made no
cardiac causes (23). The majority of studies in the afore-
recommendations about the initiation or discontinuation
mentioned report included patients with known ASCVD.
of statins in these populations, allowing for physician
Of the 26 RCTs included, 5 trials (39,612 subjects, all of
judgment in individual patients (5). Additional excep-
whom had CAD) compared more versus less intensive
tions and exclusions related to secondary prevention
statin regimens. The trials demonstrated that more
measures are discussed in a separate section of this
intensive regimens produced a highly significant 15%
report.
further reduction in major vascular events, driven by re-
Historically, the Task Force has developed separate
ductions in coronary death or nonfatal MI, coronary
sets of PMs in discrete patient populations, including
revascularization, and ischemic stroke (23). The in-
patients with STEMI and NSTEMI (7), PAD (6), CAD (9),
vestigators
also
found
no
significant
effects
ob-
and those undergoing PCI (8). These separate seminal
served on deaths due to cancer or other nonvascular
documents, each inclusive of a PM pertaining to statin
causes or on cancer incidence, even at low LDL-C
therapy in its corresponding population, may generally
concentrations (23).
be more useful in specialty care quality improvement
The aforementioned report was a meta-analysis of
programs. Although the writing committee is adhering
RCTs (23). Concerns about the quality and quantity of
to this philosophy in revising the lipid PMs for each of
safety reporting in RCTs have been raised previously,
these 4 specific populations, it is taking a novel
and many researchers find the reporting of risks in
approach in creating a new PM that applies to the
RCTs to be largely inadequate (24–26). Data from
much broader population of patients with ASCVD. This
RCTs should generally be supplemented by evidence
PM is concordant with the Cholesterol Guidelines (5),
from
which was based on evidence from RCTs and their
effectiveness
studies
to
inform
best
clinical
practice (27).
On extensive examination of clinical studies from the
meta-analyses showing risk reduction among the variety of patients with clinical ASCVD, including those
literature, the current clinical evidence does not support
with
the notion that titrating lipid therapy to achieve pro-
committee believes that primary care clinicians and
posed low LDL-C levels is beneficial or safe. Conversely,
specialists concerned with secondary prevention of
compelling evidence supports near-universal empirical
ASCVD will find these new PMs easy to use in the
statin therapy for patients at high cardiovascular risk
clinical setting. The 5 updated measure sets are sum-
regardless of their LDL-C levels (28). Thus, many argued
marized in Table 3.
ischemic
cerebrovascular
events.
The
writing
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Focused Update of Secondary Prevention Lipid Performance Measures
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 artery
disease; NSTEMI, non-ST elevation myocardial infarction; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; PM, performance measure; and STEMI, ST elevation
myocardial infarction.
4. GENERAL DISCUSSION
outcomes that matter to patients. A PM that integrates
patient values, preferences, and personal context with
4.1. Patient-Centered PMs and SDM
evidence-based medicine and guidelines is novel and
The recommendation to initiate statins for secondary
changes the focus from recommending and prescribing
prevention is based on strong evidence in which benefit
statins based on strong evidence to promoting choice
far exceeds risk (34). However, better patient outcomes
by an informed patient whether or not to initiate statins.
are realized only if patients agree with, act on, and adhere
to the recommendation for 5 to 10 years. The importance
SDM: Why Do It?
of clinician-patient discussions about statin therapy is
SDM has often been framed as an approach to curb over-
specifically emphasized in the Cholesterol Guidelines
use of expensive or unnecessary treatments. However,
(5). Among patients who are prescribed statins for sec-
clinicians and healthcare organizations should bear
ondary prevention, most initiate treatment, but up to half
the responsibility for curbing overuse, that is, recom-
discontinue statins at 1 to 2 years’ follow-up (16,35).
mending treatments where benefit does not exceed risk.
Therefore, a PM that represents only the number of pa-
The rationale for SDM includes patient safety, patient
tients prescribed statins in the numerator divided by the
engagement, patient experience, and ethical principles.
number of patients eligible to receive statins for second-
The patient safety reasoning arises from the notion that a
ary prevention in the denominator is inadequate and
misdiagnosis of a patient’s medical condition leads to
does not reflect quality of care. Rather, a measure that
unnecessary and unwanted tests and treatments associ-
reflects the proportion of patients who participated in
ated with harm and cost. Similarly, misdiagnosis of a pa-
SDM would promote patient participation in the treat-
tient’s preferences, values, and personal context can lead
ment plan, potentially increasing adherence to guideline-
to unnecessary and unwanted treatments. The patient
recommended
care
and
improving
patient-centered
outcomes.
engagement principle poses the question “What would
the patient choose if the patient knew what the clinician
knows?” When patients are offered the opportunity to
SDM: What Is It?
participate in SDM, the majority prefer this approach, and
The SDM approach aims to promote a process whereby
patient satisfaction and experience with care improve
patients and clinicians together make a choice about
(37). The ethical justification for SDM is based on the
treatments that incorporates 2 perspectives: 1) clinicians
principle of autonomy that patients should be empowered
recommending treatments based on strong evidence in
to make informed decisions about their health.
which benefit exceeds risk, and 2) patients deliberating on
how treatments fit with their preferences, values, and
SDM: How to Do It?
personal context (36). In this framing, the clinician is the
The path forward includes advancing how clinicians
expert on evidence-based medicine and guidelines, and
engage patients in decision making, developing tools to
the patient is the expert on his or her preferences, values,
promote and facilitate SDM, and measuring that SDM
and personal context. SDM mitigates the power differen-
occurred (38,39). Clinicians need to embrace the concept
tial between these 2 experts and acknowledges that both
that evidence-based medicine and guidelines alone are
perspectives contribute equal weight to decision making.
not sufficient to make a recommendation or decision;
By incorporating patient preferences, values, and per-
rather, the evidence has to be considered from the view-
sonal context to decision making, clinicians strengthen
point of what matters to individual patients. Hence,
their implementation of evidence-based medicine and
the clinical encounter transforms from one where
guidelines in a patient-centered manner to improve
the clinician strives to convince the patient of the
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“right answer” to one where the clinician and patient
measure as an exception for patient reasons (2). In these
collaborate, deliberate, and arrive at the “best answer”
instances, the patient is removed from both numerator
that fits patient preferences, values, and context. Decision
and denominator. This approach does accommodate SDM.
aids are one type of tool used during clinical encounters
However, the writing committee decided to construct
and have been shown to increase knowledge transfer to
measures whereby patients with exceptions for patient
patients about personalized benefit and risk, improve
reasons would be retained in both numerators and de-
patient involvement in decision making, and reduce
nominators in order to “give credit” for SDM rather than
decisional conflict (40). Decision aids can be implemented
have these efforts simply disappear from measures
at the point of care to promote SDM, including the choice
should the patient decline medication. The combination
of whether or not to initiate a statin for the next
of “prescribed” and “exception for patient reasons” was
5 to 10 years to lower cardiovascular risk (http://
termed “offered” and was considered to be a surrogate
statindecisionaid.mayoclinic.org). Measuring the occur-
for the patient outcomes of agreement and decline and
rence of SDM is a developing science, and in the scenario
to represent an initial step away from the current state
of clinicians recommending statins for secondary pre-
of measuring prescribing toward more comprehensive
vention, potential measures to assess if SDM occurred
and direct measures of SDM. The methodology of
include: 1) Does the patient know his or her personalized
capturing patients with exceptions in the numerator was
cardiovascular risk? 2) Was a statin offered to reduce risk?
actually used in the construction of the prior PAD statin
3) What decision did the patient make about whether or
measure so that patients with LDL-C levels <100 mg/dL
not to initiate statins?
who had medical or personal reasons for not being pre-
4.2. “Prescribed” Versus “Offered”
Additionally, a strength of using patient exceptions in
A true measure of SDM would assess the process of
this manner is that it does not require capturing any new
imparting information on statin therapy, including ben-
data elements for the measures but is simply an alter-
efits, harms, and alternative approaches, along with
ation of measure construction using the same measure
the patient “outcomes” of that discussion. The possible
components.
scribed a statin were retained in the numerator (6).
outcomes of SDM on statin therapy would be that the
1. Patient agrees to initiate statin therapy and gets a
prescription
2. Patient declines to initiate statin therapy
3. Patient is undecided and will continue deliberations
The writing committee also thought that it was
important for the measures to reflect the Cholesterol
Guidelines’ recommendation that patients with clinical
ASCVD be offered high-intensity statin therapy and
receive moderate-intensity statin when high-intensity
statin therapy is contraindicated according to each
Given the short time frame available for completing
manufacturer’s prescribing information or when charac-
this focused update, it was determined that developing a
teristics predisposing the patient to statin-associated
measure of SDM that could be implemented inclusive of
adverse effects are present (5). Again, it was determined
its key components was not possible, and the decision
that the statin dose should also be subjected to SDM.
was made to defer this task to the writing committees of
As such, patients “offered” high-intensity statin therapy
each of the individual PM sets at the times of the next full
are included in the numerators and denominators of
revisions. At the same time, the writing committee
the revised measures, as are patients who have docu-
determined that it would be important to put forward
mented medical exceptions (2) for not being offered a
measures that more closely approximated SDM than do
high-intensity statin and who are “offered” a moderate-
measures of prescription only.
intensity statin instead. Patients with medical excep-
Prescription-only measures have the disadvantage that
tions to moderate-intensity statin therapy are excluded
they assess an action (prescribing medication) that is
both from the numerators and denominators. High-
completely under a provider’s control but one that can be
intensity and moderate-intensity statins are defined
performed without any participation by the patient. In
according to the dosing tables included in the Cholesterol
other words, prescription-only measures reflect none of
Guidelines (5).
the patient outcomes of SDM.
The writing committee thought that, at the least, some
4.3. Prescription Versus Adherence
indication of the outcome of a patient declining a statin
Rethinking Adherence
prescription should be included in the numerator. An
The writing committee also considered measures of
example of reporting such a PM is presented in Figure 1.
patient adherence to statin medications but ultimately
The ACC/AHA PM methodology states that if the provider
concluded that, as with prescription-only measures, such
documents the patient’s refusal of medication, the pa-
measures would not be optimal for assessing provider
tient should be removed from the denominator of the
performance and improving quality of care. Measures of
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F I G U R E 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)
3
Exclusions (excluded from numerator and denominator)
Patients not prescribed statins for patient reasons (included in numerator and
denominator)
2
10
Patients prescribed statins
80
Patients not offered statins (not prescribed and with no documented exceptions)
10
Measure calculation (percentage of patients with STEMI and NSTEMI statins):
Numerator (80+10)
Denominator (105–5)
Performance
90
100
90%
Numerator analysis:
Proportion of patients prescribed statins calculation:
Numerator
Denominator
Proportion prescribed statins
80
100
80%
Proportion of patients not prescribed statins for patient reasons:
Numerator
Denominator
Proportion not prescribed statins for patient reasons
10
100
10%
NSTEMI indicates non–ST-elevation myocardial infarction; PM, performance measure; and STEMI, ST-elevation myocardial infarction.
adherence suffer from the same inadequacy as measures
Ensuring adherence is not simply a matter of writing a
of prescription in that they ignore patient preferences.
prescription and advising the patient to take the medi-
Furthermore, adherence is a different process, occurring
cation (42). It has been estimated that at 2 years’ follow-
after the patient has agreed to a treatment plan as a result
up, one-half of patients are no longer taking statins (42).
of SDM. Measures of adherence oversimplify complex
The discontinuation rate is highest in patients with
human behaviors, and when used in provider incentive
asymptomatic chronic diseases such as hypertension and
and public reporting programs, put the onus for adher-
hypercholesterolemia (42). In those who do not discon-
ence entirely on the clinician. Additionally, measuring
tinue the medication completely, studies have demon-
adherence is quite difficult, particularly when using
strated that patients take fewer than 50% of the doses
clinical data from the electronic health record (EHR).
prescribed (42). Nonadherence to taking medication is an
Several components ultimately determine whether a
important public health consideration, affecting health
patient derives maximum benefit from medications that
outcomes and overall healthcare costs (43). The concept
decrease cardiovascular event rates. Clinicians must pre-
of shared accountability as related to long-term adher-
scribe the medication at an optimal dose and the patient
ence and PMs is important to achieve the ultimate goal
must take the medication as instructed on a long-term
of improved patient outcomes and quality of life. Shared
basis. There is still an opportunity to improve persis-
accountability must include the healthcare team, the
tence in taking statins among patients with known car-
healthcare system, and the patient (44). At the same
diovascular disease. This is especially true for patients
time, it remains important that the clinician and patient
with PAD: only 33% were using statins within 3 months of
have ongoing discussions about statin therapy and the
incident diagnosis, whereas 37% were using statins 18
reasons for less than optimal adherence if such is found
months after incident diagnosis (41).
to be the case.
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Intentional and Unintentional Nonadherence
of adherence. These include the quality of the patient
The reasons for the high discontinuation rate and missed
care provider relationship, SDM, and avoidance of
doses are complex and multifactorial and may include
overly complex and expensive medication regimens.
both intentional (45) and unintentional nonadherence
(46):
A Cochrane Database systematic review concluded
that some interventions were nominally effective in the
short term. However, it was found that current methods of
1. Cost of medication
improving adherence for chronic health problems are
2. Patient cannot afford the co-pay
mostly complex and not very effective (43). These complex
3. Unclear label instructions
solutions to adherence included combinations of more
4. Patient forgetfulness
convenient care, information, counseling, reminders, self-
5. Adverse effects from medication that patient is too
monitoring, reinforcement, family therapy, psychological
embarrassed to discuss with doctor
6. Patient does not like the idea of having to take
medication
therapy, mailed communications, crisis intervention,
manual telephone follow-up, and other forms of additional supervision or attention (43). Even with the most
7. Patient does not understand the importance of a given
effective methods to increase adherence, the magnitude of
medication for a condition for which he or she has no
effect was quite small. Clearly, much more research is
symptoms
needed to determine the causes of nonadherence and to
8. Patient–practitioner relationship is suboptimal
develop patient- and systemwide strategies to reduce the
9. Polypharmacy and complexity of regimen
likelihood that the patient will stop taking medication
It is important to understand the concept of “unin-
shown to have beneficial effects on overall health.
tentional nonadherence,” which is defined in the Institute
of Medicine report Health Literacy: A Prescription to End
4.4. Exceptions and Exclusions
Confusion as “the degree to which individuals have the
The detailed description of exceptions is central to the
capacity to obtain, process, and understand basic health
characterization of the PM for the treatment of blood
information and services needed to make appropriate
cholesterol to reduce the risks of ASCVD in adults with
health decisions (47).” Unintentional nonadherence is
established disease. In developing exceptions and exclu-
thought to be a passive process on the part of the patient
sions for these measures, the writing committee fol-
and may involve a lack of understanding of physical
lowed the ACC/AHA PM development methodology (2,3),
problems, resulting in an inability to follow treatment
which is concordant with that of the American Medical
instructions, impaired manual dexterity, poor eyesight, or
Association Physician Consortium for Performance Im-
forgetfulness. In a recent systematic review and meta-
provement (now PCPI) (50). Notably, measure exceptions
analysis, it was noted that there is a statistically signifi-
are based predominantly on clinical judgment, individual
cant relationship between health literacy and medication
patient characteristics, or patient preferences. On the
adherence; however, the magnitude of effect was small
other hand, exclusions are used in circumstances not
when compared with other causes of nonadherence, such
requiring clinical judgment to factor into the decision
as medication beliefs and cost (48). One of the most
making (e.g., patients who died, left against medical
important aspects of long-term medication adherence is
advice, or were discharged to hospice). In accordance
to review the medication list; ask about adverse effects,
with the ACC/AHA PM development methodology (3),
cost, and adherence; and discuss barriers to adherence at
the writing committee maintains that if a patient has a
every office visit (44). Finally, the shared accountability
potential contraindication but does in fact receive treat-
of all of those involved in the prescription process,
ment, then that patient should be included in both the
including the patient, is critical to the success or failure of
numerator and denominator of the PM. This approach
long-term medication adherence (44).
recognizes that contraindications may be relative and re-
Medication adherence is dependent on a complex
wards clinicians for exerting clinical judgment and suc-
interrelationship between the disease and demographic
cessfully fulfilling the PM (by offering a medication when
and socioeconomic factors; beliefs of the patient and the
the clinician believes the benefits outweigh the risks).
patient’s family and friends; the medication itself; and
The writing committee recognizes that there are justifi-
the healthcare system (patient care provider interaction,
able reasons for patients not receiving a service that
access to care and care organizations) (49). It is readily
is the subject of a process PM. According to the ACC/AHA
apparent that an individual clinician should not be solely
report “New Insights Into the Methodology of Performance
accountable for a patient’s adherence to medication,
Measurement” (3), exceptions are used in these instances
because many factors related to nonadherence are out of
because the data from these patients should still be
the healthcare provider’s control, although there are
captured for the purposes of internal quality improvement
measures the clinician can take to increase the likelihood
analyses. Exceptions can be related to medical reasons
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(e.g., the patient’s allergic history, concern for potential
exclude patients with a known LDL-C level <100 mg/dL,
adverse drug interaction, and intolerance to therapy), pa-
as was done specifically in the “ACC/AHA 2008 Per-
tient reasons (e.g., patient preference, social or religious
formance Measures for Adults with ST-Elevation and
reasons, economic reasons), or system reasons (e.g., lack
Non-ST-Elevation Myocardial Infarction” (7). This is in
of available resources, insurance coverage/payer-related
alignment with the Cholesterol Guidelines (5), which do
limitation). The writing committee has provided for ex-
not recommend an approach of treat-to-cholesterol target
ceptions from the denominator for medical reasons only
but rather the use of fixed doses of cholesterol-lowering
and does not allow exceptions for system reasons. The
drugs (specifically statins) to reduce the risk of ASCVD.
writing committee concluded that the frequency of events
This is also concordant with the evidence from RCTs
that could be interpreted as system reasons for not offering
showing that ASCVD events are reduced by using maxi-
a statin would be very low and would not likely have a
mally tolerated statins in those patients shown to benefit
material impact on measure results, making it unnecessary
(23). Notably, statin dosage increases occurred in only a
to make provisions for them in measure construction.
few RCTs with the intent of maximizing therapy, but
(As noted previously, patients with exceptions for pa-
these were not true tests of defining optimal goals for
tient reasons are retained in the denominator.) Addition-
LDL-C, because not all persons in the statin treatment
ally, the writing committee has chosen to use only
groups received drug therapy titrated to achieve a specific
exceptions for most patients with ASCVD but has also
LDL-C, nor were specific treatment targets compared (5).
made exclusions for patients with STEMI and NSTEMI
and those undergoing PCI in concordance with the meth-
Denominator Exclusions (Not Included in Numerator or
odology previously used in the PM documents for these
Denominator)*:
patients (7,8).
Patient died
The ACC/AHA PM methodology (2,3) advocates that all
patients who receive the treatment (e.g., statin) should be
included in the numerator and denominator of the measure and that the assessment of the documented contra-
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
indications to therapy will be undertaken only among the
remaining patients who did not receive it. As previously
Denominator Exceptions (Not Included in Numerator or
noted (7), some contraindications are relative or tempo-
Denominator):
rary or both and may resolve between the time of docu-
Documentation of medical reason(s) for not prescribing
mentation and provision of therapy. This approach will
likely help eliminate false exclusions of patients who are
ultimately appropriately treated and further decrease the
burden of data abstraction.
The writing committee endorses the recommendations
in the ACC/AHA PM methodology report (3) that clinicians
a statin (e.g., allergy, intolerance to statin[s], hepatic
failure, hemodialysis, heart failure, other medical
reasons)
4.5. Method of Reporting
document the specific reasons for exclusions and excep-
In selecting a methodology for measures that calls for
tions in the patient’s health records for purposes of
inclusion of patients in the numerator for 1 of 2 reasons,
optimal patient management, future research, and audit-
that is, patients for whom statins were prescribed and
readiness; to identify practice patterns and opportunities
patients for whom statins were not prescribed for patient
for quality improvement; and for accountability purposes.
reasons, the writing committee recognizes the need for
The sources of data where exclusions and exceptions can
more visibility for both components of the numerator.
be sought include all administrative data and claims,
The writing committee therefore recommends that
prospective flow sheets, and patient health records (both
reporting of these measures include the proportion of
electronic and hard copy [paper]). The writing committee
patients for whom statins were prescribed and the pro-
maintains that the abstractor may wish to pay close
portion for whom statins were not prescribed due to ex-
attention to the clinician’s documentation. In the patient
ceptions for patient reasons. In this construct, the
health record, any of the above care providers must still
percentage of patients offered statins remains the PM for
link the specific reason reported for the nonuse of statins
accountability purposes, whereas reporting the additional
for the documentation to count as a reason for not offering
data provides full transparency for the components of
moderate- to high-intensity statin (as an example:
the measure along with information useful to the care
“Patient receiving hemodialysis; no statins needed”).
team in understanding their performance (Figure 1).
The writing committee has revised the exceptions and
exclusions for the lipid measures from the prior PM documents (6–9). Most importantly, it has decided not to
*Apply specifically to STEMI/NSTEMI and PCI measure sets.
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4.6. Limitations and Unintended Consequences
with the current reality of clinical information systems in
The writing committee recognizes that a different
mind. For truly robust measures of SDM to be feasible,
approach to medication PMs from that used with most
significant improvements in collecting clinical data will
prior such measures is presented in this paper. As such, at
be required. Efforts to capture data in the course of care,
this time conclusions cannot be drawn about the effec-
as opposed to requiring providers to enter data, are being
tiveness of these measures in helping to close the per-
made by a variety of health information technology
formance gaps described above. Furthermore, as with all
companies and by registries such as the National Cardio-
PMs, the potential for unintended consequences exists
vascular Data Registry PINNACLE Registry, which em-
for these measures and may be greater because of the
ploys a system integration software utility (51) to extract
different methodology being used. For instance, when
elements from the EHR that are necessary for measures
PMs are used in accountability programs, the risk of
calculation. Structured data capture whereby data from
“gaming” by clinicians is always present. Clinicians could,
the EHR would be collected as discrete elements has
for example, convince patients not to take high-intensity
been recognized by the Office of the National Coordinator
statins for fear of adverse effects and still receive “credit”
for Health Information Technology as a priority and is
under the methodology described herein. The method for
the subject of a major initiative (52). An example of a
reporting these measures described in this paper should
“structured format” is a standardized provider office note
mitigate the potential for gaming, but it remains to be
that contains discrete fields for key data elements
seen whether or not that will be the case. Although the
potentially including those necessary for assessing SDM.
writing committee is convinced that these measures will
Methods for capturing patient-reported data for com-
assist clinicians in improving patient care, careful evalu-
parative effectiveness research are also being inves-
ations of benefits and unintended consequences should
tigated, with significant interest in the use of EHR
be carried out, particularly when they are used in pay-
patient portals for that purpose (53). Patient-reported
for-performance and public reporting programs.
data collected in this way would be useful as well in
assessing SDM from the patient’s point of view. Addi-
5. FUTURE DIRECTIONS
tionally, integration of EHR-derived data with national
registries would provide a mechanism for implementation
5.1. Improved Information Systems for Capturing Clinical Data
of standard data definitions, enabling valid comparisons
Measures of provider-patient interaction, including SDM,
and analyses employing common data models.
require data from clinical sources such as EHRs and clinical registries and cannot be derived from insurance
5.2. Measures of SDM and Shared Accountability
claims. Unfortunately, challenges remain for imple-
SDM has been a core concept that the writing committee
mentation of such measures in clinical data sets. EHRs
has considered in the construction of these PMs for statin
have a relatively constrained number of discrete data
therapy in ASCVD. It is the writing committee’s rationale
fields related to provider-patient encounters that can be
for the numerator to include the number of patients
used for calculating measures. In addition, significant
offered a statin as defined. This outcome reflects both
variation in data definitions exists among registries and
patients who declined a statin as well as those for whom a
EHRs and among instances of ostensibly the same EHR,
prescription was provided. However, measuring whether
making comparisons among providers difficult. Finally,
or not SDM has occurred during a clinical encounter is a
and of particular importance to measures of SDM, patient-
developing science and pushes the boundaries of the new
reported data are rarely captured in EHRs or registries.
field of shared accountability measures. In particular,
data
determining whether high-quality SDM has been provided
through the use of case report forms, but completion of
depends on understanding the process. Ideally, this in-
such forms is labor intensive and not a feasible solution in
volves the extent to which a patient 1) has obtained
the nonresearch clinical setting. Checklists and “smart
knowledge of the risks and benefits of a decision, and 2)
forms” are often used in EHRs to collect key data ele-
has demonstrated engagement in the decision-making
Registries
have
typically
obtained
discrete
ments for PMs, particularly measures of patient education
process through deliberations that consider the patient’s
and counseling. These techniques have proved to be
preferences, values, and capacity for action and agree-
less than satisfactory, because checking a box that SDM
ment for long-term adherence. Future approaches to
has occurred communicates little of what that process
address PMs in this area will require a better under-
included. Additionally, smart forms require additional
standing of both of these issues, perhaps allowing for
work by the provider during the patient encounter and
addressing situations where patients remain undecided
are therefore used only sporadically.
and continue deliberations with their providers.
As was the case with the original measures on which
In addition to measuring whether a statin was offered
they are based, the revised lipid measures were designed
to reduce risk for patients with ASCVD, potential measures
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to assess the quality of SDM may include: 1) measuring if
writing committee recognizes that much remains to be
the patient knows his or her personalized cardiovascular
done to develop truly robust measures of SDM as well
risk; 2) assessing whether the patient understands the
as measures of shared accountability for medication
available options and their risks and benefits; 3) asking
adherence.
patients about interactions with their provider; and
4) determining if high-quality decision tools were incor-
STAFF
porated into the clinical encounter. Future studies in
these areas will need to determine that reliable and
American College of Cardiology
valid PMs may be constructed under this framework of
Patrick T. O’Gara, MD, FACC, President
shared accountability measures that potentially require
Shalom Jacobovitz, Chief Executive Officer
surveying the patient about these domains. The exam-
William J. Oetgen, MD, MBA, FACC, Executive Vice
ples listed above also must be broadened to address
additional challenges in measurement of longitudinal
adherence and across multiple care settings (hospital,
President, Science, Education, and Quality
Lara Slattery, MHS, Senior Director, ACC Scientific
Reporting
outpatient clinic, home), as well as development of PMs
Jensen S. Chiu, MHA, Team Lead, Quality Measurement
and incentives that also target patients directly rather
Laura L. Ritzenthaler, PA, MBA, Associate, PINNACLE
than providers alone, because having participated in
SDM and having agreed to take a statin, the patient
assumes responsibility for following through on this
Registry
Amelia Scholtz, PhD, Publications Manager, Clinical
Policy and Pathways
commitment or bringing any concerns back to the pro-
Penelope Solis, JD, Associate, Clinical Measurement
vider. PMs should also measure the performance of other
American College of Cardiology/American Heart Association
stakeholders who share accountability for adherence,
Naira Tahir, MPH, Associate, Clinical Measurement
including insurance companies, policy makers (benefit
American Heart Association
design and care coordination programs), and accountable
Elliott Antman, MD, FAHA, President
Nancy Brown, Chief Executive Officer
care organizations.
Rose Marie Robertson, MD, FACC, FAHA, Chief Science
5.3. Conclusion and Summary
and Medical Officer
The writing committee believes that these new PMs
closely support the new ACC/AHA Cholesterol Guidelines,
will assist providers in providing better care to their
patients with improved outcomes, and represent an
advance in medication measures because they promote
SDM and appropriate dosing. At the same time, the
Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice
President, Office of Science Operations
Melanie B. Turner, MPH, Science and Medicine Advisor,
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18. Arnold SV, Kosiborod M, Tang F, et al. Patterns of
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19. Javed U, Deedwania PC, Bhatt DL, et al. Use of
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23. Baigent C, Blackwell L, Emberson J, et al. Efficacy
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24. Ioannidis JP, Lau J. Completeness of safety
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27. Nallamothu BK, Hayward RA, Bates ER. Beyond the
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28. Hayward RA, Hofer TP, Vijan S. Narrative review:
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29. Krumholz HM, Hayward RA. Shifting views on lipid
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31. Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of
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45. Mukhtar O, Weinman J, Jackson SH. Intentional
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cut twice–adding patient-reported outcome measures to
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38. Krumholz HM. The new cholesterol and blood
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2014;311:465–6.
KEY WORDS ACC/AHA Performance Measures,
coronary artery disease, health policy and
outcome research, myocardial infarction,
percutaneous coronary intervention, peripheral
arterial disease, shared decision making, statins
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APPENDIX A. 2015 ACC/AHA FOCUSED UPDATE OF SECONDARY PREVENTION LIPID PERFORMANCE
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.
Patients in the denominator who
Numerator:
• 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).
Patients 18-75 y of age with PAD* seen in a 12-mo period
*
Denominator:
Denominator
Exclusions:
Denominator
Exceptions:
Period of
Assessment:
Attribution:
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)
None
Documentation of medical reason(s) for not prescribing a statin (e.g., allergy, intolerance to statin[s], other medical reasons)
12 mo
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, drugdrug 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
Daily dose lowers LDL-C, on average, by
approximately ≥50%
Daily dose lowers LDL-C, on average, by
approximately 30% to <50%
Low-Intensity Statin Therapy
Daily dose lowers LDL-C, on average,
by <30%
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APPENDIX A. CONTINUED
Atorvastatin (40†)–80 mg
Rosuvastatin 20 (40) mg
Atorvastatin 10 (20) mg
Rosuvastatin (5) 10 mg
Simvastatin 20–40 mg‡
Pravastatin 40 (80) mg
Lovastatin 40 mg
Fluvastatin XL 80 mg
Fluvastatin 40 mg BID
Pitavastatin 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–C
goals 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-thanaverage 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.
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ASCVD
ASCVD
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ASCVD
ASCVD
ASCVD
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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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APPENDIX A. CONTINUED
*
ASCVD
ASCVD
ASCVD
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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
Ownership/
Partnership/
Principal
Personal
Research
Institutional,
Organizational, or
Other Financial Benefit
Expert
Witness
Committee Member
Employment
Consultant
Speakers
Bureau
Joseph P. Drozda, Jr
(Chair)
Mercy Health Director of
Outcomes Research
None
None
None
None
None
None
T. Bruce Ferguson, Jr
Brody School of Medicine
at ECU, Department of
Cardiovascular Sciences
None
None
None
None
None
None
Hani Jneid
Baylor College of
Medicine—MEDVAMC
None
None
None
None
None
None
Harlan M. Krumholz
Yale University School
of Medicine
None
None
None
None
None
None
None
None
AstraZeneca*
None
None
None
Brahmajee K.
Nallamothu
University of Michigan— Abbott
Assistant Professor,
United Health
Internal Medicine,
Division of Cardiology
Jeffrey W. Olin
Mt. Sinai School of
Medicine
Henry H. Ting
New York-Presbyterian
Hospital/Columbia
University Medical Center
Merck
Novartis
None
Johnson &
Johnson*
UnitedHealth*
None
None
None
AstraZeneca
None
None
None
This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were
reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily
reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of $5% of the voting
stock or share of the business entity, or ownership of $$10,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of
the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table
are modest unless otherwise noted.
According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or
issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing
drug or device addressed in the document; or c) the person or a member of the person’s household, has a reasonable potential for financial, professional or other personal gain or loss as
a result of the issues/content addressed in the document.
*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
Representation
Consultant
Speakers
Bureau
Lynne Braun
Official Reviewer—AHA
None
None
Blair D. Erb, Jr
Official Reviewer—ACC
Board of Trustees
None
None
Gregg C. Fonarow
Official Reviewer—ACC/ Amgen
AHA Task Force for
Johnson &
Performance Measures
Johnson
Novartis†
Takeda
Content Reviewer—
ACC/AHA Task Force
Pharmaceutical
on Clinical Data
Standards
None
G.B. John Mancini
Official Reviewer—ACC Amgen
Board of Governors Merck
Pfizer
Regeneron/
Sanofi-aventis
Peer Reviewer
Robert Shor
Official Reviewer
(Alternate)—ACC
Board of Governors
None
Laith G. Alsayegh
Organizational
Reviewer—SVM
None
Christie M.
Ballantyne
Organizational
Reviewer—NLA
Mary Barton
Organizational
Reviewer—NCQA
Vera Bittner
Organizational
Reviewer—AACVPR
Ownership/
Partnership/
Principal
Expert
Witness
None
None
None
None
None
None
None
Novartis†
None
None
None
None
Amgen†
None
None
None
None
None
None
None
None
None
None
None
Amarin†
Amgen†
Eli Lilly†
Merck†
Novartis†
Pfizer†
Regeneron†
Sanofi-aventis/
Synthelabo†
None
None
None
None
None
AmarinVascepa
None
Abbott†
Amgen†
Merck
Aegerion
Amarin
Amgen
Cerenis
Esperion
Therapeutics
Genentech
Genzyme
Merck†
Novartis
Omthera
Pfizer†
Regeneron
Resverlogix
Sanofi-aventis/
Synthelabo
None
None
None
None
None
None
None
Amarin
Personal
Research
Institutional,
Organizational, or
Other Financial
Benefit
Foundation of
Amgen
the National
AstraZeneca*
Lipid
Eli Lilly*
Association*
GlaxoSmithKline†
Hoffman-La
National Lipid
Roche
Association
Janssen
American Board
Pharmaceuticals†
of Clinical
Lipidology*
Pfizer
Sanofi-aventis*
Schering Plough*
University of
Oxford*
None
Michael Blaha
Organizational
Reviewer—SCCT
None
None
None
None
None
None
Konstantinos
Boudoulas
Organizational
Reviewer—SCAI
None
None
None
None
None
None
Continued on the next page
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Focused Update of Secondary Prevention Lipid Performance Measures
APPENDIX C. CONTINUED
Consultant
Speakers
Bureau
Ownership/
Partnership/
Principal
Personal
Research
None
None
Institutional,
Organizational, or
Other Financial
Benefit
Expert
Witness
Peer Reviewer
Representation
W. Virgil Brown
Organizational
Reviewer—NLA
J. Thomas Cross,
Jr
Organizational
Reviewer—ACP
None
None
None
None
None
None
Michael Crouch
Organizational
Reviewer—AAFP
None
None
None
None
None
None
Andrew Dunn
Organizational
Reviewer—ACP
None
None
None
Desai
Pharmaceuticals*
None
None
Daniel
Edmundowicz
Organizational
Reviewer—SAIP
None
None
None
None
None
None
Mary Ann
Forciea
Organizational
Reviewer—ACP
None
None
None
None
None
None
Robert A.
Gluckman
Organizational
Reviewer—ACP
None
None
Abbvie†
Abbott†
BristolMyers
Squibb*
Walgreens†
None
None
None
Richard Hellman
Organizational
Reviewer—
AMA-PCPI
None
None
None
None
None
None
Robert H. Hopkins,
Jr
Organizational
Reviewer—ACP
None
None
None
None
None
None
Matthew K. Ito
Organizational
Reviewer—NLA
Regeneron
None
None
Kowa
Pharmaceuticals*
None
None
Terry A. Jacobson
Organizational
Reviewer—NLA
None
None
REDUCE IT Trial
Peter Jones
Organizational
Reviewer—NLA
Atherotech†
Merck
Regeneron/
Sanofi-aventis
Parag Joshi
Organizational
Reviewer—SCCT
None
Eve Askanas Kerr
Organizational
Reviewer—ACP
Debra KohlmanTrigoboff
Amgen†
Merck†
AstraZeneca
Eli Lilly
Genzyme†
GlaxoSmithKline†
LipoScience
Merck
Amarin
AstraZeneca
LipoScience
Merck
Regeneron/
Sanofi-aventis
Defendant,
expert in
lipid metabolism,
2014
Plaintiff,
ezetimibe
patent
challenge,
2015-
National Lipid
Association
None
None
None
Amarin*
Amgen*
Regeneron/
Sanofi-aventis*
None
None
None
None
None
None
None
None
None
None
None
None
Organizational
Reviewer—SVN
None
None
None
None
None
None
Kesavan Kutty
Organizational
Reviewer—ACP
None
None
None
None
None
None
Ngoc-Anh Le
Organizational
Reviewer —AHA
None
None
Sei Lee
Organizational
Reviewer—AGS
None
None
None
None
None
None
Ana Maria Lopez
Organizational
Reviewer—ACP
None
None
None
None
None
None
Catherine MacLean
Organizational
Reviewer—ACP
None
None
None
None
WellPoint, Inc.†
None
LipoScience
Merck
National Lipid
Association*
AstraZeneca†
Abbott†
Merck†
None
Continued on the next page
Drozda et al.
JACC VOL. 67, NO. 5, 2016
FEBRUARY 9, 2016:558–87
Focused Update of Secondary Prevention Lipid Performance Measures
APPENDIX C. CONTINUED
Personal
Research
Institutional,
Organizational, or
Other Financial
Benefit
Expert
Witness
None
None
None
None
Ownership/
Partnership/
Principal
Bristol-Myers
Squibb
Janssen
Pharmaceuticals†
Pfizer
Speakers
Bureau
Peer Reviewer
Representation
Consultant
Charles E. Mahan
Organizational
Reviewer—ASHP
Janssen
Pharmaceuticals
Michael McConnell
Organizational
Reviewer—SCMR
None
None
None
GE Healthcare†
Tiara
Pharmaceuticals†
None
None
James McKenney
Organizational
Reviewer—NLA
None
None
None
None
None
None
Pamela B. Morris
Organizational
Reviewer—NLA
None
None
None
None
Carol E. Orringer
Organizational
Reviewer—NLA
Merck
None
None
None
Stephen D. Persell
Organizational
Reviewer—ACP
None
None
None
None
None
None
Amir Qaseem
Organizational
Reviewer—ACP
None
None
None
None
None
None
Robert Ratner
Organizational
Reviewer—ADA
None
None
None
None
None
None
Russell Samson
Organizational
Reviewer—SVS
None
None
None
None
None
None
Howell Sasser
Organizational
Reviewer—ACP
None
None
None
None
None
None
Terrence
Shaneyfelt
Organizational
Reviewer—ACP
None
None
None
None
None
None
Elaine Tseng
Organizational
Reviewer—STS
None
None
None
None
None
None
Geogy
Vatakencherry
Organizational
Reviewer—SIR
None
None
None
None
None
None
Kaye-Eileen Willard
Organizational
Reviewer—NLA
None
None
None
None
None
None
None
None
None
None
None
None
Eli Lilly†
Janssen
Pharmaceuticals†
None
None
None
None
None
None
None
None
Aegerion
AstraZeneca
Genzyme
LipoScience
Merck
John Doherty
Content Reviewer—
ACC/AHA Appropriate
Use Criteria Task
Force
None
Eric Peterson
Content Reviewer—
Genentech
ACC/AHA/AACVPR/
Janssen
AAFP/AMA-PCPI/
Pharmaceuticals
ANA/ASHP/NCQA
Sanofi-aventis
The Concepts for
Clinician-Patient
Shared Accountability
in Performance
Measures Writing
Committee
Binh An P. Phan
Content Reviewer—ACC
Prevention Council
None
Paul Poirier
Content Reviewer—AHA AstraZeneca
Bristol-Myers
Squibb
Janssen
Pharmaceuticals
Merck
Merck
National Lipid
Association*
National Lipid
Association*
None
None
None
None
Continued on the next page
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FEBRUARY 9, 2016:558–87
Focused Update of Secondary Prevention Lipid Performance Measures
APPENDIX C. CONTINUED
Peer Reviewer
None
None
Amgen
Genentech
Janssen
Pharmaceuticals
Novartis
Regeneron*
United Healthcare—
Scientific Advisory
Board
None
None
Content Reviewer—2013
ACC/AHA Guideline on
the Treatment of
Blood Cholesterol
to Reduce
Atherosclerotic
Cardiovascular Risk
in Adults Writing
Committee
None
None
None
None
None
None
Content Reviewer—
ACC/AHA/SCAI/
AMA-PCPI/NCQA
Percutaneous Coronary
Intervention
Performance
Measurement Writing
Committee
None
None
None
None
None
None
Content Reviewer—
ACC/AHA/ACR/SCAI/
SIR/SVM/SVN/SVS
2010 Performance
Measures for Adults
With Peripheral
Artery Disease
None
None
None
None
None
None
Consultant
Content Reviewer—
ACC/AHA 2008 AMI
Performance Measures
Writing Committee;
ACC Clinical Quality
Steering Committee;
ACCF/AHA/AMA-PCPI
2011 Performance
Measures for Adults
With CAD and
Hypertension
Neil Stone
Carl Tommaso
Diane TreatJacobson
Expert
Witness
Speakers
Bureau
Representation
John Spertus
Institutional,
Organizational, or
Other Financial
Benefit
Ownership/
Partnership/
Principal
Personal
Research
Eli Lilly†
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. It
does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership
of $5% of the voting stock or share of the business entity, or ownership of $$10,000 of the fair market value of the business entity; or if funds received by the person from the
business entity exceed 5% of the person’s gross income for the previous year. 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 in
alphabetical 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, or
issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing
drug or device addressed in the document; or c) the person or a member of the person’s household, has a reasonable potential for financial, professional or other personal gain or loss as
a result of the issues/content addressed in the document.
*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 Diabetes
Association; 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, Society
of Atherosclerosis Imaging and Prevention; SCAI, Society for Cardiovascular Angiography and Interventions; SCCT, Society of Cardiovascular Computed Tomography; SCMR; Society for
Cardiovascular 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.
Drozda et al.
JACC VOL. 67, NO. 5, 2016
FEBRUARY 9, 2016:558–87
Focused Update of Secondary Prevention Lipid Performance Measures
APPENDIX D. 2015 ACC/AHA FOCUSED UPDATE OF SECONDARY PREVENTION LIPID PERFORMANCE
MEASURES: SUMMARY ANALYSIS TABLE
Measures Included in the
Performance Measure Set
Completely
Fulfills
Attribute*
Partially Fulfills or
Does Not Fulfill
Attribute*
Summary Comments†
3-hydroxy-3-methylglutaryl-coenzyme A
Reductase Inhibitor (Statin) Therapy
in Patients With PAD
1,2,3,4
Fulfills all attributes
The measure was included in the measure set as a replacement
for the Cholesterol Lowering Medications (Statins) measure
in the ACCF/AHA/ACR/SCAI/SIR/SVM/SVN/SVS 2010
Performance Measures for Adults With Peripheral Artery
Disease (6).
Statin Therapy for Patients With Acute
Myocardial Infarction
1,2,3,4
Fulfills all attributes
The measure was included in the measure set as a replacement
for the Statin Prescribed at Discharge measure in the ACC/AHA
2008 Performance Measures for Adults With ST-Elevation
and Non-ST-Elevation Myocardial Infarction (7).
Postprocedural Optimal Medical Therapy
Composite
1,2,3,4
Fulfills all attributes
The measure was included in the measure set as a replacement
for the Post-Procedural Optimal Medical Therapy Composite
measure in the ACC/AHA/SCAI/AMA–Convened PCPI/NCQA
2013 Performance Measures for Adults Undergoing Percutaneous
Coronary Intervention (8).
3-hydroxy-3-methylglutaryl-coenzyme A
Reductase Inhibitor (Statin) Therapy
in Patients With CAD
1,2,3,4
Fulfills all attributes
The measure was included in the measure set as a replacement
for the Lipid Control measure in the ACCF/AHA/AMA-PCPI
2011 Performance Measures for Adults With Coronary
Artery Disease and Hypertension (9).
3-hydroxy-3-methylglutaryl-coenzyme A
Reductase Inhibitor (Statin) Therapy in
Patients With Clinical Atherosclerotic
Cardiovascular Disease
1,2,3,4
Fulfills all attributes
The measure was included as a stand-alone measure because
of the strong recommendation made for the use of high-intensity
statins in patients with ASCVD found in the 2013 ACC/AHA
Guideline 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, National
Committee 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.
587