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[Federal Register Volume 77, Number 17 (Thursday, January 26, 2012)]
[Notices]
[Pages 4043-4044]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1403]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Scientific Information Request on the Use of Natriuretic Peptide 
Measurement in the Management of Heart Failure

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 medical device 
manufacturers of natriuretic peptide measurement assays. Scientific 
information is being solicited to inform our Comparative Effectiveness 
Review of Use of Natriuretic Peptide Measurement in the Management of 
Heart Failure, 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published and unpublished pertinent scientific information on this 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 February 27, 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 use of natriuretic peptide measurement in the management 
of heart failure.
    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 natriuretic peptide 
measurement assays, 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-and-reports/?pageaction=displayproduct&productid=899#4210.
    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

[[Page 4044]]

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

    Key Question 1: In patients presenting to the emergency department 
or urgent care facilities with signs or symptoms suggestive of heart 
failure (HF):
    1. What is the test performance of BNP and NT-proBNP for HF?
    2. What are the optimal decision cut points for BNP and NT-proBNP 
to diagnose and exclude HF?
    3. What determinants affect the test performance of BNP and 
NTproBNP (e.g., age, gender, comorbidity)?
    Key Question 2: In patients presenting to a primary care physician 
with risk factors, signs, or symptoms suggestive of HF:
    1. What is the test performance of BNP and NT-proBNP for HF?
    2. What are the optimal decision cut points for BNP and NT-proBNP 
to diagnose and exclude HF?
    3. What determinants affect the test performance of BNP and 
NTproBNP (e.g., age, gender, comorbidity)?
    Key Question 3: In HF populations, is BNP or NT-pro BNP measured at 
admission, discharge or change between admission and discharge an 
independent predictor of morbidity and mortality outcomes?
    Key Question 4: In HF populations, does BNP measured at admission, 
discharge or change between admission and discharge add predictive 
information to other prognostic methods?
    Key Question 5: Is BNP or NT-pro BNP measured in the community 
setting an independent predictor of morbidity and mortality outcomes in 
general populations?
    Key Question 6: In patients with HF, does BNP assisted therapy or 
intensified therapy compared to usual care, improve outcomes?
    Key Question 7: What is the biological variation of BNP and NT-
proBNP in patients with HF and without HF?

    Dated: January 17, 2012.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2012-1403 Filed 1-25-12; 8:45 am]
BILLING CODE 4160-90-M
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