Scientific Information Request on Treatment of Atrial Fibrillation, 11121-11122 [2012-4260]

Download as PDF srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 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 treatment strategies for patients with peripheral artery disease (PAD). 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 treatment strategies for patients with peripheral artery disease, 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-forGUIDESreviews-and-reports/ ?PAGEaction=displayproduct& productid=948#4546. 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 • Information identifying unpublished randomized controlled trials and observational studies relevant to the clinical outcomes.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primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/ enrolled/lost to withdrawn/follow-up/ analyzed, and effectiveness/efficacy and safety results.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 VerDate Mar<15>2010 18:34 Feb 23, 2012 Jkt 226001 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 KQ 1: In adults with peripheral artery disease (PAD), including asymptomatic patients and symptomatic patients with atypical leg symptoms, intermittent claudication (IC), or critical limb ischemia (CLI): a. What is the comparative effectiveness of aspirin and other antiplatelet agents in reducing the risk of adverse cardiovascular events (e.g., all-cause mortality, myocardial infarction, stroke, cardiovascular death), functional capacity, and quality of life? b. Does the effectiveness of treatments vary according to the patient’s PAD classification or by subgroup (age, sex, race, risk factors, or comorbidities)? c. What are the significant safety concerns associated with each treatment strategy (e.g., adverse drug reactions, bleeding)? Do the safety concerns vary by subgroup (age, sex, race, risk factors, comorbidities, or PAD classification)? KQ2: In adults with symptomatic PAD (atypical leg symptoms or IC): a. What is the comparative effectiveness of exercise training, medications (cilostazol, pentoxifylline), endovascular intervention (percutaneous transluminal angioplasty, atherectomy, or stents), and/or surgical revascularization (endarterectomy, bypass surgery) on outcomes including vessel patency, repeat revascularization, wound healing, analog pain scale score, cardiovascular events (e.g., all-cause mortality, myocardial infarction, stroke, cardiovascular death), amputation, functional capacity, and quality of life? b. Does the effectiveness of treatments vary by use of exercise and medical therapy prior to invasive management or by subgroup (age, sex, race, risk factors, comorbidities, or anatomic location of disease)? c. What are the significant safety concerns associated with each treatment PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 11121 strategy (e.g., adverse drug reactions, bleeding, contrast nephropathy, radiation, infection, exercise-related harms, and periprocedural complications causing acute limb ischemia)? Do the safety concerns vary by subgroup (age, sex, race, risk factors, comorbidities, anatomic location of disease)? KQ3: In adults with CLI due to PAD: a. What is the comparative effectiveness of endovascular intervention (percutaneous transluminal angioplasty, atherectomy, or stents) and surgical revascularization (endarterectomy, bypass surgery) for outcomes including vessel patency, repeat revascularization, wound healing, analog pain scale score, cardiovascular events (e.g., all-cause mortality, myocardial infarction, stroke, cardiovascular death), amputation, functional capacity, and quality of life? b. Does the effectiveness of treatments vary by subgroup (age, sex, race, risk factors, comorbidities, or anatomic location of disease)? c. What are the significant safety concerns associated with each treatment strategy (e.g., adverse drug reactions, bleeding, contrast nephropathy, radiation, infection, and periprocedural complications causing acute limb ischemia)? Do the safety concerns vary by subgroup (age, sex, race, risk factors, comorbidities, or anatomic location of disease)? Dated: February 15, 2012. Carolyn M. Clancy, AHRQ, Director. [FR Doc. 2012–4261 Filed 2–23–12; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Treatment of Atrial Fibrillation Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Scientific Information Submissions. AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of atrial fibrillation medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of the Treatment of Atrial Fibrillation, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. SUMMARY: E:\FR\FM\24FEN1.SGM 24FEN1 11122 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 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-informationpackets/. 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. 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 the treatment of atrial fibrillation. 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 atrial fibrillation treatment, 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-reviewsand- srobinson on DSK4SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 18:34 Feb 23, 2012 Jkt 226001 reports/?PAGEaction=displayproduct& productid=946. 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.AHRO.gov/ index.cfm/join-the-email-list1/. The Key Questions Our first three KQs focus on ratecontrol therapies. Specifically: KQ 1: What are the comparative safety and effectiveness of pharmacological agents used for ventricular rate control in patients with AF? Do the comparative safety and effectiveness of these therapies differ among specific patient subgroups of interest? PO 00000 Frm 00060 Fmt 4703 Sfmt 9990 KQ 2: What are the comparative safety and effectiveness of a strict rate-control strategy versus a more lenient ratecontrol strategy in patients with AF? Do the comparative safety and effectiveness of these therapies differ among specific patient subgroups of interest? KQ 3: What are the comparative safety and effectiveness of newer procedural and other nonpharmacological ratecontrol therapies compared with pharmacological agents in patients with AF who have failed initial pharmacotherapy? Do the comparative safety and effectiveness of these therapies differ among specific patient subgroups of interest? Our next three KQs focus specifically on rhythm-control therapies: KQ 4: What are the comparative safety and effectiveness of available antiarrhythmic agents and electrical cardioversion for conversion of AF to sinus rhythm? Do the comparative safety and effectiveness of these therapies differ among specific patient subgroups of interest? KQ 5: What are the comparative safety and effectiveness of newer procedural rhythm-control therapies, other nonpharmacological rhythm-control therapies, and pharmacological agents (either separately or in combination with each other) for maintenance of sinus rhythm in patients with AF? Do the comparative safety and effectiveness of these therapies differ among specific patient subgroups of interest? KQ 6: What are the comparative diagnostic accuracy, diagnostic thinking, therapeutic, and patient outcome efficacy of echocardiographic studies and other clinical parameters for predicting successful conversion, successful ablation, successful maintenance of sinus rhythm, and improved outcomes in patients with AF? Our final KQ seeks to evaluate the comparison of the available rate- and rhythm-control therapies. KQ 7: What are the comparative safety and effectiveness of rhythm-control therapies compared to rate-control therapies in patients with AF? Does the comparative safety and effectiveness of these therapies differ among specific patient subgroups of interest? Dated: February 15, 2012. Carolyn M. Clancy, Director, AHRQ. [FR Doc. 2012–4260 Filed 2–23–12; 8:45 am] BILLING CODE 4160–90–M E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11121-11122]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Treatment of Atrial 
Fibrillation

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Scientific Information Submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from manufacturers of atrial 
fibrillation medical devices. Scientific information is being solicited 
to inform our Comparative Effectiveness Review of the Treatment of 
Atrial Fibrillation, which is currently being conducted by the 
Evidence-based Practice Centers for the AHRQ Effective Health Care 
Program.

[[Page 11122]]

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: 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 the treatment of atrial fibrillation.
    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 atrial fibrillation 
treatment, 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-reviewsand-reports/?PAGEaction=displayproduct&productid=946.
    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.AHRO.gov/index.cfm/join-the-email-list1/.

The Key Questions

    Our first three KQs focus on rate-control therapies. Specifically:
    KQ 1: What are the comparative safety and effectiveness of 
pharmacological agents used for ventricular rate control in patients 
with AF? Do the comparative safety and effectiveness of these therapies 
differ among specific patient subgroups of interest?
    KQ 2: What are the comparative safety and effectiveness of a strict 
rate-control strategy versus a more lenient rate-control strategy in 
patients with AF? Do the comparative safety and effectiveness of these 
therapies differ among specific patient subgroups of interest?
    KQ 3: What are the comparative safety and effectiveness of newer 
procedural and other nonpharmacological rate-control therapies compared 
with pharmacological agents in patients with AF who have failed initial 
pharmacotherapy? Do the comparative safety and effectiveness of these 
therapies differ among specific patient subgroups of interest?
    Our next three KQs focus specifically on rhythm-control therapies:
    KQ 4: What are the comparative safety and effectiveness of 
available antiarrhythmic agents and electrical cardioversion for 
conversion of AF to sinus rhythm? Do the comparative safety and 
effectiveness of these therapies differ among specific patient 
subgroups of interest?
    KQ 5: What are the comparative safety and effectiveness of newer 
procedural rhythm-control therapies, other nonpharmacological rhythm-
control therapies, and pharmacological agents (either separately or in 
combination with each other) for maintenance of sinus rhythm in 
patients with AF? Do the comparative safety and effectiveness of these 
therapies differ among specific patient subgroups of interest?
    KQ 6: What are the comparative diagnostic accuracy, diagnostic 
thinking, therapeutic, and patient outcome efficacy of 
echocardiographic studies and other clinical parameters for predicting 
successful conversion, successful ablation, successful maintenance of 
sinus rhythm, and improved outcomes in patients with AF?
    Our final KQ seeks to evaluate the comparison of the available 
rate- and rhythm-control therapies.
    KQ 7: What are the comparative safety and effectiveness of rhythm-
control therapies compared to rate-control therapies in patients with 
AF? Does the comparative safety and effectiveness of these therapies 
differ among specific patient subgroups of interest?

    Dated: February 15, 2012.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2012-4260 Filed 2-23-12; 8:45 am]
BILLING CODE 4160-90-M