[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11120-11121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Treatment Strategies for 
Patients With Peripheral Artery Disease (PAD)

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 
peripheral artery disease treatment medical devices. Scientific 
information is being solicited to inform our Comparative Effectiveness 
Review of Treatment Strategies for Patients with Peripheral Artery 
Disease (PAD), 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published and unpublished pertinent scientific information on this 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 March 26, 2012.

ADDRESSES:

Online Submissions

    http://effectivehealthcare.AHRQ.gov/index.cfm/submitscientific-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: <a href="/cdn-cgi/l/email-protection#bdd8d5dececfdefdd2d5cec893d8d9c8"><span class="__cf_email__" data-cfemail="d1b4b9b2a2a3b291beb9a2a4ffb4b5a4">[email protected]</span></a> (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: <a href="/cdn-cgi/l/email-protection#8beee3e8f8f9e8cbe4e3f8fea5eeeffe"><span class="__cf_email__" data-cfemail="680d000b1b1a0b2807001b1d460d0c1d">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
Public Law 108-173, the Agency

[[Page 11121]]

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 treatment 
strategies for patients with peripheral artery disease (PAD).
    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 treatment strategies for 
patients with peripheral artery disease, 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-GUIDESreviews-and-reports/?PAGEaction=displayproduct&productid=948#4546.
    This notice is a request for industry stakeholders to submit the 
following:
    <bullet> A current product label, if applicable (preferably an 
electronic PDF file).
    <bullet> 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.
    <bullet> 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.
    <bullet> 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/.

The Key Questions

    KQ 1: In adults with peripheral artery disease (PAD), including 
asymptomatic patients and symptomatic patients with atypical leg 
symptoms, intermittent claudication (IC), or critical limb ischemia 
(CLI):
    a. What is the comparative effectiveness of aspirin and other 
antiplatelet agents in reducing the risk of adverse cardiovascular 
events (e.g., all-cause mortality, myocardial infarction, stroke, 
cardiovascular death), functional capacity, and quality of life?
    b. Does the effectiveness of treatments vary according to the 
patient's PAD classification or by subgroup (age, sex, race, risk 
factors, or comorbidities)?
    c. What are the significant safety concerns associated with each 
treatment strategy (e.g., adverse drug reactions, bleeding)? Do the 
safety concerns vary by subgroup (age, sex, race, risk factors, 
comorbidities, or PAD classification)?
    KQ2: In adults with symptomatic PAD (atypical leg symptoms or IC): 
a. What is the comparative effectiveness of exercise training, 
medications (cilostazol, pentoxifylline), endovascular intervention 
(percutaneous transluminal angioplasty, atherectomy, or stents), and/or 
surgical revascularization (endarterectomy, bypass surgery) on outcomes 
including vessel patency, repeat revascularization, wound healing, 
analog pain scale score, cardiovascular events (e.g., all-cause 
mortality, myocardial infarction, stroke, cardiovascular death), 
amputation, functional capacity, and quality of life?
    b. Does the effectiveness of treatments vary by use of exercise and 
medical therapy prior to invasive management or by subgroup (age, sex, 
race, risk factors, comorbidities, or anatomic location of disease)?
    c. What are the significant safety concerns associated with each 
treatment strategy (e.g., adverse drug reactions, bleeding, contrast 
nephropathy, radiation, infection, exercise-related harms, and 
periprocedural complications causing acute limb ischemia)? Do the 
safety concerns vary by subgroup (age, sex, race, risk factors, 
comorbidities, anatomic location of disease)?
    KQ3: In adults with CLI due to PAD:
    a. What is the comparative effectiveness of endovascular 
intervention (percutaneous transluminal angioplasty, atherectomy, or 
stents) and surgical revascularization (endarterectomy, bypass surgery) 
for outcomes including vessel patency, repeat revascularization, wound 
healing, analog pain scale score, cardiovascular events (e.g., all-
cause mortality, myocardial infarction, stroke, cardiovascular death), 
amputation, functional capacity, and quality of life?
    b. Does the effectiveness of treatments vary by subgroup (age, sex, 
race, risk factors, comorbidities, or anatomic location of disease)?
    c. What are the significant safety concerns associated with each 
treatment strategy (e.g., adverse drug reactions, bleeding, contrast 
nephropathy, radiation, infection, and periprocedural complications 
causing acute limb ischemia)? Do the safety concerns vary by subgroup 
(age, sex, race, risk factors, comorbidities, or anatomic location of 
disease)?

    Dated: February 15, 2012.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2012-4261 Filed 2-23-12; 8:45 am]
BILLING CODE 4160-90-M


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