[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Notices]
[Pages 10748-10749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3937]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Mechanical Prophylaxis of 
Venous Thromboembolism (VTE)

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 
antithrombotic medical devices. Scientific information is being 
solicited to inform our Comparative Effectiveness of Pharmacologic and 
Mechanical Prophylaxis of Venous Thromboembolism Among Special 
Populations Review, 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Access to published and unpublished pertinent scientific information on 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: [email protected] (please do not send zipped 
files--they

[[Page 10749]]

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: [email protected].

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 pharmacologic and mechanical prophylaxis of venous 
thromboembolism (VTE) among special populations.
    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 mechanical prophylaxis of 
venous thromboembolism among special populations, 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://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-andreports/?pageaction=displayproduct&productid=928#4370.
    This notice is a request for industry stakeholders to submit the 
following:
     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/.

The Key Questions

Question 1

    What is the comparative effectiveness and safety of Inferior Vena 
Cava filters to prevent Pulmonary Emboli in hospitalized patients with 
trauma?

Question 2

    1. What is the comparative effectiveness and safety of 
pharmacologic and mechanical strategies to prevent VTE in hospitalized 
patients with traumatic brain injury?
    2. What is the optimal timing of initiation and duration of 
pharmacologic prophylaxis to prevent VTE in hospitalized patients with 
traumatic brain injury?

Question 3

    What is the comparative effectiveness and safety of pharmacologic 
and mechanical strategies to prevent VTE in hospitalized patients with 
burns?

Question 4

    What is the comparative effectiveness and safety of pharmacologic 
and mechanical strategies to prevent VTE in hospitalized patients with 
liver disease?

Question 5

    What is the comparative effectiveness and safety of pharmacologic 
and mechanical strategies to prevent VIE in hospitalized patients 
receiving antiplatelet therapy?

Question 6

    What is the comparative effectiveness and safety of pharmacologic 
and mechanical strategies to prevent VTE in patients having bariatric 
surgery?

Question 7

    What is the comparative effectiveness and safety of pharmacologic 
prophylaxis for prevention of VTE during hospitalization of obese and 
underweight patients?

Question 8

    What is the comparative effectiveness and safety of pharmacologic 
prophylaxis for prevention of VTE during hospitalization of patients 
with acute kidney injury, moderate renal impairment, or severe renal 
impairment not undergoing dialysis and patients receiving dialysis?

    Dated: February 7, 2012.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2012-3937 Filed 2-21-12; 8:45 am]
BILLING CODE 4160-90-M