[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3594-3596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00763]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Scientific Information Request on Noninvasive Testing for
Coronary Artery Disease
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Scientific Information Submissions.
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review of ``Noninvasive
Testing for Coronary Artery Disease'', which is currently being
conducted by the AHRQ's Evidence-based Practice Centers (EPC) Programs.
Access to published and unpublished pertinent scientific information
will improve the quality of this review. AHRQ is conducting this
systematic review pursuant to Section 902(a) of the Public Health
Service Act, 42 U.S.C. 299a(a).
DATES: Submission Deadline on or before February 23, 2015.
ADDRESSES: Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the
study for which you are submitting information from the list to upload
your documents.
Email submissions: src.org">SIPS@epc-src.org.
Print submissions:
Mailing Address: Portland VA Research Foundation,Scientific
Resource Center, ATTN: Scientific Information Packet Coordinator, PO
Box 69539, Portland, OR 97239. Shipping Address (FedEx, UPS, etc.):
Portland VA Research Foundation, Scientific Resource Center, ATTN:
Scientific Information Packet Coordinator, 3710 SW U.S. Veterans
Hospital Road, Mail Code: R&D 71, Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262
ext. 58653 or Email: src.org">SIPS@epc-src.org.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Programs to complete a review of the evidence for ``Noninvasive Testing
for Coronary Artery Disease''.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on ``Noninvasive Testing for Coronary Artery Disease'',
including those that describe adverse events. The entire research
protocol, including the key questions, is also available online at:
http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2017.
[[Page 3595]]
This notice is to notify the public that the EPC Program would find
the following information on ``Noninvasive Testing for Coronary Artery
Disease'' helpful:
A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
For completed studies that do not have results on
ClinicalTrials.gov, please provide a summary, including the following
elements: Study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
Description of whether the above studies constitute all
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution will be very beneficial to the EPC Program. The
contents of all submissions will be made available to the public upon
request. Materials submitted must be publicly available or can be made
public. Materials that are considered confidential; marketing
materials; study types not included in the review; or information on
indications not included in the review cannot be used by the EPC
Program. This is a voluntary request for information, and all costs for
complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC program Web
site and available for public comment for a period of 4 weeks. If you
would like to be notified when the draft is posted, please sign up for
the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions. The entire research
protocol, is available online at: http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=isplayproduct&productID=2017.
The Key Questions
In stable, symptomatic patients with suspected coronary artery
disease (CAD) who do not have previously diagnosed CAD and who have had
a resting electrocardiogram (ECG):
1. For patients considered to be at very low or low risk for CAD,
what is the comparative effectiveness of anatomic tests (compared with
each other, standard of care, or no testing):
(a) For improving primary clinical health outcomes (e.g., quality
of life, avoiding myocardial infarction)? In the absence of comparative
studies linking testing with outcomes, do the tests predict future
clinical events (predictive accuracy)?
(b) What are the adverse effects, consequences, or harms of
testing?
(c) How do noninvasive tests differ in terms of clinical management
based on test results, including referral for coronary angiography or
additional noninvasive testing?
(d) What harms are associated with additional testing following
anatomic tests?
(e) Is there differential effectiveness or harm based on patient
characteristics (e.g., sex, age, comorbidities)?
2. For patients considered to be at very low or low risk for CAD,
what is the comparative effectiveness of functional tests (compared
with each other, standard of care, or no testing):
(f) For improving primary clinical health outcomes (e.g., quality
of life, avoiding myocardial infarction)? In the absence of comparative
studies linking testing with outcomes, do the tests predict future
clinical events (predictive accuracy)?
(g) What are the adverse effects, consequences or harms of testing?
(h) How do noninvasive tests differ in terms of clinical management
based on test results, including referral for coronary angiography or
additional noninvasive testing?
(i) What harms are associated with additional testing following
anatomic tests?
(j) Is there differential effectiveness or harm based on patient
characteristics (e.g., sex, age, comorbidities) or the patient's
ability to exercise?
3. For patients considered to be at intermediate to high risk for
CAD, what is the comparative effectiveness of anatomic tests (compared
with each other standard of care, or no testing):
(k) For improving primary clinical health outcomes (e.g., quality
of life, avoiding myocardial infarction)? In the absence of comparative
studies linking testing with outcomes, do the tests predict future
clinical events (predictive accuracy)?
(l) What are the adverse effects, consequences, or harms of
testing?
(m) How do noninvasive tests differ in terms of clinical management
based on test results, including referral for coronary angiography or
additional noninvasive testing?
(n) What harms are associated with additional testing following
anatomic tests?
(o) Is there differential effectiveness or harm based on patient
characteristics (e.g., sex, age, comorbidities)?
4. For patients considered to be at intermediate to high risk for
CAD, what is the comparative effectiveness of functional tests
(compared with each other, standard of care, or no testing):
(p) For improving primary clinical health outcomes (e.g., quality
of life, avoiding myocardial infarction)? In the absence of comparative
studies linking testing with outcomes, do the tests predict future
clinical events (predictive accuracy)?
(q) What are the adverse effects, consequences, or harms of
testing?
(r) How do noninvasive tests differ in terms of clinical management
based on test results, including referral for coronary angiography or
additional noninvasive testing?
(s) What harms are associated with additional testing following
anatomic tests?
(t) Is there differential effectiveness or harm based on patient
characteristics (e.g., sex, age, comorbidities) or the patient's
ability to exercise?
5. What is the comparative effectiveness of anatomic tests versus
functional tests in those who are at very low or low risk for CAD?
(u) For improving primary clinical health outcomes (e.g., quality
of life, avoiding myocardial infarction)?
(v) What are the adverse effects, consequences or harms of testing?
(w) How do noninvasive tests differ in terms of clinical management
based on test results, including referral for coronary angiography or
additional noninvasive testing?
(x) What harms are associated with additional testing following
anatomic tests?
(y) Is there differential effectiveness or harm based on patient
characteristics (e.g., sex, age, comorbidities) or the patient's
ability to exercise?
6. What is the comparative effectiveness of anatomic tests versus
functional tests in those who are at intermediate to high risk for CAD?
[[Page 3596]]
(z) For improving primary clinical health outcomes (e.g., quality
of life, avoiding myocardial infarction)?
(aa) What are the adverse effects, consequences or harms of
testing?
(bb) How do noninvasive tests differ in terms of clinical
management based on test results, including referral for coronary
angiography or additional noninvasive testing?
(cc) What harms are associated with additional testing following
anatomic tests?
(dd) Is there differential effectiveness or harm based on patient
characteristics (e.g., sex, age, comorbidities) or the patient's
ability to exercise?
PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)
Patient Population of Interest and Pre-Test Risk of CAD:
The patient population is stable, symptomatic patients with
suspected CAD who do not have previously diagnosed CAD and who have had
a resting ECG. The definitions of risk categories are based on those
described in the ACCF/AHA 2012 Guideline.\8\ In general, patient
presentation and symptoms are primarily used to inform pre-test
probability in the population of interest. The review will attempt to
stratify studies based on these characteristics if definitions are not
provided.
Include patients whose risk for CAD may be considered as
follows:
[cir] Those considered to be at very low or low risk of CAD based
on having none or only one of the following:
Patient age and gender (female <65 years old, male <55
years old)
Negative family history for CAD
<2 CAD risk factors (including hypertension, diabetes,
smoking, dyslipidemia, metabolic syndrome)
New onset angina/chest pain (including noncardiac or
atypical chest pain, angina equivalents, unstable angina without non-
ST-segment elevation myocardial infarction [NSTEMI], ST-segment
elevation myocardial infarction [STEMI])
Normal or non-diagnostic resting ECG
[cir] Those considered to be at intermediate to high risk of CAD
based on having two or more of the following:
Patient age and gender (female >=65 years old, male >=55
years old)
Positive family history for CAD
>=2 CAD risk factors (including hypertension, diabetes,
smoking, dyslipidemia, metabolic syndrome)
New onset or progressive angina/chest pain or those with
prolonged angina at rest (or relieved with rest or nitroglycerin) or
nocturnal angina (angina including typical, atypical, definite,
probable)
Possible ECG changes (e.g., T-wave, NSTEMI) or
nondiagnostic ECG
Presence of other vascular disease (carotid disease,
peripheral artery disease [PAD])
Exclude patients with any of the following
characteristics:
[cir] Unstable angina with elevated serum cardiac biomarkers, ECG
changes, etc.
[cir] Definite acute coronary syndrome (ACS), Non-ST-Elevation
Acute Coronary Syndromes (NSTE-ACS), NSTEMI, STEMI
[cir] Asymptomatic patients, including those being screened prior
to surgery
Interventions
This systematic review will focus on widely available noninvasive
tests used for diagnosis of CAD or dysfunction that results in symptoms
attributable to myocardial ischemia. Coronary artery calcium scoring
has been included since it has been proposed primarily for its ability
to exclude the presence of obstructive disease but not necessarily to
confirm the presence of flow-limiting stenosis.
Interventions for inclusion are:
Functional tests (including exercise, vasodilator and/or
dobutamine as stressor where appropriate)
[cir] Exercise electrocardiogram without imaging
[cir] Exercise/pharmacologic echocardiography (with or without
myocardial echo contrast)
[cir] Exercise/pharmacologic cardiac nuclear imaging
[cir] SPECT
[cir] PET
[cir] Pharmacologic stress MRI
[cir] CT perfusion
Anatomic imaging
[cir] Coronary calcium scoring via electron beam CT (EBCT) or
multidetector CT (MDCT)
[cir] CCTA
Comparators
Comparisons between noninvasive tests included in the
interventions; comparisons with no testing or standard of care.
(Contextual information will be provided in the background only for
comparisons of noninvasive tests with invasive coronary angiography
with or without FFR and for comparison between noninvasive tests on
traditional diagnostic test measures such as sensitivity and
specificity.)
Outcomes
Clinical outcomes
[cir] Quality of life (QOL)
[cir] Change in angina (e.g., worsening)
[cir] MI
[cir] Heart failure
[cir] Stroke
[cir] Death
[cir] Hospitalization for cardiovascular events (acute coronary
syndrome, heart failure, arrhythmias)
[cir] Dysrhythmia
Intermediate outcomes
[cir] Need for additional testing (including referral for invasive
testing)
[cir] Management based on revised post-test risk stratification,
including:
Guideline-directed medical therapy (GDMT), including
management of lipids, blood pressure, and diabetes; counseling related
to diet, physical activity, smoking cessation, alcohol use, and
management of psychological factors; use of additional therapies to
reduce risk of MI and death (e.g., antiplatelet therapy).
Any need for subsequent revascularization (percutaneous
coronary intervention [PCI] or coronary artery bypass grafting [CABG])
Harms, risks and consequences of testing
[cir] Procedural harms, adverse events of testing (e.g., renal
failure, allergy, nephrogenic systemic fibrosis, contrast-related
harms, adverse reactions to drugs for stress tests), vascular
complications
[cir] Consequences of testing (e.g., radiation exposure,
psychological consequences, consequences of additional testing or
incidental findings)
Setting
Nonemergent inpatient settings or ambulatory/outpatient settings,
including emergency department.
Timing
At time of first test for evaluation using a noninvasive test other
than resting ECG.
Dated: December 29, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2015-00763 Filed 1-22-15; 8:45 am]
BILLING CODE 4160-90-M