Scientific Information Request on the Use of Natriuretic Peptide Measurement in the Management of Heart Failure
Federal Register, Volume 77 Issue 17 (Thursday, January 26, 2012)
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 Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review.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
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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):
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What is the test performance of BNP and NT-proBNP for HF?
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What are the optimal decision cut points for BNP and NT-proBNP to diagnose and exclude HF?
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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:
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What is the test performance of BNP and NT-proBNP for HF?
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What are the optimal decision cut points for BNP and NT-proBNP to diagnose and exclude HF?
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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
