[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 Access to published and unpublished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