[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Pages 24718-24719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Chronic Venous Ulcers 
Treatments

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 
chronic venous ulcer treatment medical devices. Scientific information 
is being solicited to inform our Chronic Venous Ulcers: A Comparative 
Effectiveness Review of Treatment Modalities report, which is currently 
being conducted by the Evidence-based Practice Centers for the AHRQ 
Effective Health Care Program. Access to published and unpublished

[[Page 24719]]

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 May 25, 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: [email protected] (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: [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 chronic venous ulcer treatment modalities.
    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 chronic venous ulcer 
treatments, 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/?productid=995&pageaction=displayproduct#4886
    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

    For patients with chronic venous leg ulcers, what are the benefits 
and harms of using dressings that regulate wound moisture with or 
without active chemical, enzymatic, biologic, or antimicrobial 
components in conjunction with compression systems when compared with 
using solely compression systems?

Question 2

    a. For patients with chronic venous leg ulcers that do not have 
clinical signs of cellulitis that are being treated with compression 
systems, what are the benefits and harms of using systemic antibiotics 
when compared with using solely compression systems?
    b. For patients with chronic venous leg ulcers that do not have 
clinical signs of cellulitis that are being treated with dressings that 
regulate wound moisture with or without active chemical, enzymatic, 
biologic, or antimicrobial components, what are the benefits and harms 
of using systemic antibiotics when compared with using dressings alone?
Question 3
    a. For patients with chronic venous leg ulcers, what are the 
benefits and harms of surgical procedures aimed at the underlying 
venous abnormalities when compared with using solely compression 
systems?
    b. For patients with chronic venous leg ulcers, what are the 
comparative benefits and harms of different surgical procedures for a 
given type of venous reflux and obstruction?

    Dated: April 12, 2012.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2012-9820 Filed 4-24-12; 8:45 am]
BILLING CODE 4160-90-M