PORTRAIT Registry:
*Patient-centered Outcomes Related to Treatment practices in peripheral Arterial disease: an International Trajectory*

Despite continuing efforts worldwide directed towards secondary prevention and
optimization of treatment in cardiovascular disease, peripheral arterial
disease (PAD) is still an under-recognized condition. PAD is a chronic
atherosclerotic condition in which the blood flow of the arteries in the lower
limbs is affected and prevalence increases up to 15-20% in the elderly. PAD
patients have a disproportionate high disease burden compared with other
atherosclerotic conditions. Approximately 1 in 3 patients experience a
cardiovascular event 5 year following diagnosis, and survivors continue to have
a compromised health status. Under-treatment of risk factors may partially
explain this disproportionate high disease burden. How treatment variation is
associated with patient-centered outcomes (health status, quality-of-life), and
which vulnerable patient groups are most affected is unknown.

Through the development of a high-quality international PAD registry, we aim to
evaluate the following priorities: (1) to further study the shortcomings in the
way care for PAD is organized, (2) to identify high-risk subpopulations in
terms of their PAD care and outcomes, (3) to study the impact of identified
differences in PAD care on health status, and (4) to relate differences in PAD
care practices with outcomes.


These aims will be addressed in an observational prospective, multi-center
registry enrolling patients from 15 international vascular outpatient clinics
with new-onset PAD or exacerbation of previous PAD symptoms. Data collection
will consist of 4 assessments: baseline, 3-, 6-, and 12 months.

Specific Aim 1: Documentation of Treatment Practices in PAD

Research focusing specifically on the compliance with PAD-specific guidelines
across different outpatient clinics treating these patients, has not been
prospectively evaluated. We will therefore collect components needed to assess
compliance with guideline-recommended care for PAD in an observational,
multi-center, international PAD registry. The major advantage of information
obtained from a registry refers to the fact that no large proportion of
patients are excluded due to clinical considerations, and will more closely
represent those patients seen in daily clinical practice, rather than the more
*healthy* participants included in clinical trials.15 Guideline-recommended
care (diagnostic methods, cardiovascular risk reduction, and revascularization
treatments) will be documented from vascular outpatient settings.

Successfully accomplishing this aim would provide us with (1) detailed
information on the availability and the extent to which guideline-recommended
care in PAD is provided to patients, (2) insights into variations across
international institutions, and (3) would identify significant gaps in the
administration of PAD care to be targeted in future interventions.

Specific Aim 2: Identify Important PAD Subpopulations at Risk

Along with the data on PAD treatment patterns, relevant patient data that might
influence both treatment and outcomes (e.g. socio-demographic, clinical,
psychological, health habits) will be collected. These data will be necessary
to document disparities in care in vulnerable subgroups of patients.
Cardiovascular risk factors are disproportionately represented in minorities,
and in patients who are vulnerable in terms of their socio-economic and
psychological background. It is known from other patient populations that
access and delivery of care is considerably compromised in these vulnerable
groups. Research on disparities in PAD care and outcomes (including its
socio-economic and psychological determinants) in vulnerable populations has
not been well developed. Examples of under-documented areas include gender and
racial disparities. For example, despite epidemiological findings indicating
that women are at least equally afflicted with PAD as men, preliminary evidence
indicates that women are more likely to present with atypical symptoms, which
could impact their chances on being diagnosed with PAD, and subsequently
receiving appropriate treatment Furthermore, PAD prevalence rates are twice as
high in non-Hispanic Blacks as compared with Caucasians, and Blacks and
Hispanics have markedly higher amputation rates that Caucasians.

Given the scarcity of research on disparities in PAD care and outcomes,
accomplishing this aim would further the field and would give us information as
to how to prioritize future awareness, prevention, and treatment programs to
eliminate these disparities.

Specific Aim 3: Quantify Outcomes, with a Focus on Health Status

Current PAD guidelines stress that treatment should be primarily aimed at
improving patients* functioning and quality-of-life, and that patients* health
status should be preferentially assessed with a disease-specific health status
measure. Research on the impact of treatment variations in PAD on outcomes has
thus far primarily focused on mortality and patency rates (i.e., the likelihood
that a vessel remains free of occlusion). The association between treatment
differences in PAD health status outcomes, however, has rarely been
prospectively evaluated in real-world practice. Measuring PAD-specific health
status in a prospective way with a disease-specific instrument would allow us
to rigorously map the effects of differences in care practices on PAD patients*
health status and to identify patients* at risk for having worse health status
based on their demographic, socio-economic, or psychological characteristics.
For this purpose, we will use the Peripheral Artery Questionnaire (PAQ), a
validated, disease-specific measure that evaluates PAD patients* symptoms,
physical function, social limitations, treatment satisfaction, and
quality-of-life.

The rich information obtained by this aim would allow us to identify
opportunities to improve patients* health status, and to prospectively quantify
the health status benefits associated with guideline-recommended treatment.

Specific Aim 4: Study Treatment Practices and Association with Outcomes

Since guideline-based treatment practices will be specifically documented in
specialized PAD outpatient settings, the current registry will give us the
opportunity to provide much more detailed information on PAD-specific
treatments than previously available in large cardiovascular registries.
Information on the availability and access to supervised exercise programs, on
opportunities to organize effective risk factor management, and on applied
revascularization strategies would allow us to document treatment variation
throughout practices and within PAD patients, and to evaluate the degree to
which this variation compromises the ability to achieve guideline-based risk
factor control targets and could explain variations in long-term outcomes
(mortality and hospitalizations).

Due to the rich and detailed information on patients* clinical, demographic,
socio-economic and psychological characteristics obtained by this registry, we
would be able to study the impact of these characteristics on health outcomes.
This is particularly important since prior studies on health outcomes in PAD
were unable to adjust for these factors or to assess the extent to which these
factors were associated with outcomes.

Methods

Population and Study Design
Consecutive patients consulting a vascular outpatient clinic with newly
diagnosed symptomatic PAD or exacerbation of PAD symptoms will form the study
population. Patients aged >=18 years, with a confirmed PAD diagnosis; supported
by an abnormal resting or post-exercise ankle-brachial index (ABI<=0.90) will be
included. Exclusion criteria include patients with a non-compressible ABI,
critical leg ischemia, peripheral intervention procedure within the prior 12
months, patients that do not speak English patients who are hard of hearing,
or are unable to provide informed consent (e.g. too ill). Inclusion will take
place over a period of 2 year. The design is a prospective design with 4
assessments (baseline, 3 months, 6 months, 12 months), with the total study
period being 12 months. Long-term follow-up (i.e., up to 5 years) will be
included, but will be based on data retrieved from the patients* medical
records only.

The novel character of this sampling refers to the fact that only patients with
new-onset PAD will be included, whereas most registries used mixed populations
of patients with prior PAD, with a history of revascularizations, or with
different disease stages. This rigorous approach allows us to study a more
homogeneous population providing results that are more easily interpretable and
implementable in clinical practice.

Enrolling Centers and Patient Numbers
We will select 17 vascular outpatient clinics:(12 US and 5 non-US centers):
Mid America Heart Institute Kansas City, MO; Minneapolis Heart Institute,
Minneapolis, MN; Denver Veterans Affairs Medical Center, Denver, CO,
Massachusetts General Hospital, Boston, MA, Duke University Medical Center,
Durham, NC, Ochsner Health System, New Orleans, LA, CO, St. Joseph Mercy Health
System - St. Joseph Mercy, Ann Arbor, Michigan, RI Hospital, Providence, RI,
Miriam Hospital, Providence, RI, Prairie Heart Institute, Springfield, IL, and
, Greenville Health System, Greenville, SC, Yale University, Connecticut, NY;
4 Dutch centers [St. Elisabeth Hospital/Tilburg University, Tilburg; Albert
Schweitzer Hospital, Dordrecht]) and The Queen Elizabeth Hospital in Adelaide,
Australia that have the infrastructure to collect the study data. Estimating
that 75% of new patients will agree to participate in the registry, we expect
to annually enroll 120 patients per center (note that RI Hospital and Miriam
Hospital will work together to enroll 120 patients), with a total of 1800
patients being enrolled. The Mid America Heart Institute and Tilburg University
will serve as coordinating centers. Details of the research group and
mentorship team are provided in Section 2c.

Data Elements and Data Collection Process
Data from each patient with new-onset PAD will be collected at baseline
(on-site during the 1st visit for a diagnostic work-up or via telephone by a
dedicated study coordinator). Follow-up information will be obtained by patient
telephone interviews and by medical chart abstraction Interviews will use
standardized and validated self-report instruments. Data entry will occur
through a web-based data template accessible to all participating centers.

No risks are involved. Patients will only be asked to invest their time (20
minutes per interview at baseline, 3, 6, and 12 months follow-up)