[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77834-77835]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32048]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Scientific Information Request on Intravascular Diagnostic and
Imaging Medical Devices
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 manufacturers of
intravascular diagnostic and imaging medical devices, including:
Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR),
Intravascular Ultrasound (IVUS), Intravascular Ultrasound (VH-IVUS)
with Virtual Histology, Optical Coherent Tomography (OCT), Near-
Infrared Spectroscopy (NIR), Angioscopy, Intravascular Magnetic
Resonance Imaging (MRI), Elastrography, and Thermography. Scientific
information is being solicited to inform our Comparative Effectiveness
Review of Intravascular Diagnostic Procedures and Imaging Techniques
versus Angiography Alone, which is currently being conducted by the
Evidence-based Practice Centers for the AHRQ Effective Health Care
Program. Access to published and unpublished pertinent scientific
information on this device will improve the quality of this comparative
effectiveness review. AHRQ is requesting this scientific information
and conducting this comparative effectiveness review pursuant to
Section 1013 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Public Law 108-173.
DATES: Submission Deadline on or before January 13, 2012.
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 of current studies
and complete the form to upload your documents.
Email submissions: ehcsrc@ohsu.edu (please do not send zipped
files--they are automatically deleted for security reasons).
Print submissions: Robin Paynter, Oregon Health and Science
University, Oregon Evidence-based Practice Center, 3181 SW Sam Jackson
Park Road, Mail Code: BICC, Portland, OR 97239-3098.
FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian,
Telephone: (503) 494-0147 or Email: ehcsrc@ohsu.edu.
SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003,
Public Law 108-173, the Agency for Healthcare Research and Quality has
commissioned the Effective Health Care (EHC) Program Evidence-based
Practice Centers to complete a comparative effectiveness review of the
evidence for intravascular diagnostic procedures and imaging techniques
versus angiography alone.
The EHC 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 systematically requesting
information (e.g., details of studies conducted) from medical device
industry stakeholders through public information requests, including
via the Federal Register and direct postal and/or online solicitations.
We are looking for studies that report on intravascular diagnostic and
imaging medical devices, including those that describe adverse events,
as specified in the key questions detailed below. The entire research
protocol, including the key questions, is also available online at:
http://www.effectivehealthcare.AHRQ.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=766#3456.
This notice is a request for industry stakeholders to submit the
following:
[[Page 77835]]
A current product label, if applicable (preferably an
electronic PDF file).
Information identifying published randomized controlled
trials and observational studies relevant to the clinical outcomes.
Please provide both a list of citations and reprints if possible.
Information identifying unpublished randomized controlled
trials and observational studies relevant to the clinical outcomes. If
possible, please provide a summary that includes 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 withdrawn/follow-
up/analyzed, and effectiveness/efficacy and safety results.
Registered ClinicalTrials.gov studies. Please provide a
list including the ClinicalTrials.gov identifier, condition, and
intervention.
Your contribution is very beneficial to this program. AHRQ is not
requesting and will not consider marketing material, health economics
information, or information on other indications. This is a voluntary
request for information, and all costs for complying with this request
must be borne by the submitter. In addition to your scientific
information please submit an index document outlining the relevant
information in each file along with a statement regarding whether or
not the submission comprises all of the complete information available.
Please Note: The contents of all submissions, regardless of
format, will be available to the public upon request unless
prohibited by law. The draft of this review will be posted on AHRQ's
EHC 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/.
Key Questions
Key Question 1: For patients undergoing diagnostic
coronary angiography to evaluate the presence/extent of Coronary Artery
Disease (CAD) in order to decide on the necessity for coronary
intervention, what is the impact of using an IVDx technique--when
compared to angiography alone--on the diagnostic thinking and
therapeutic decision making, short-term outcomes, and long-term
outcomes?
Key Question 2: For patients undergoing Percutaneous
Coronary Intervention (PCI), what is the impact of using an
Intravascular Diagnostic Device (IVDx) technique to guide the PCI
procedure (either immediately prior to or during the procedure)--when
compared to angiography-guided PCI--on the diagnostic thinking and
therapeutic decision making, short-term outcomes, and long-term
outcomes?
Key Question 3: For patients having just undergone a PCI,
what is the impact of using an IVDx technique to evaluate the success
of PCI immediately after the procedure--when compared to angiography
alone--on the diagnostic thinking and therapeutic decision making,
short-term outcomes, and long-term outcomes?
Key Question 4: How do different IVDx techniques compare
to each other in their effects on the diagnostic thinking and
therapeutic decision making, short-term outcomes, and long-term
outcomes?
During diagnostic coronary angiography for the evaluation
of the presence/extent of CAD and the potential necessity of coronary
intervention?
During PCI to guide the procedure?
Immediately after PCI to evaluate the success of PCI?
Key Question 5: What factors (e.g., patient/physician
characteristics, availability of prior noninvasive testing, type of PCI
performed) influence the effect of IVDx techniques--when compared to
angiography (or among different IVDx techniques)--on the diagnostic
thinking and therapeutic decision making, short-term outcomes, and
long-term outcomes?
During diagnostic coronary angiography for the evaluation
of the presence/extent of CAD and the potential need for coronary
intervention?
During PCI to guide the procedure?
Immediately after PCI to evaluate the success of PCI?
Dated: November 23, 2011.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2011-32048 Filed 12-13-11; 8:45 am]
BILLING CODE 4160-90-M