Scientific Information Request on Treatment Strategies for Patients With Peripheral Artery Disease (PAD), 11120-11121 [2012-4261]

Download as PDF 11120 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices In order to assist AHRQ and CMS to assess the importance, validity, and feasibility of submitted measures, a Subcommittee on Children’s Healthcare Quality Measures of the AHRQ National Advisory Council on Healthcare Research and Quality (SNAC) has been established (http://www.ahrq.gov/ chipra/panellist11.htm). The Subcommittee will consider measures submitted through this public call, and measures submitted by the 7 AHRQ– CMS Centers of Excellence. CHIPRA asks that measures in the improved core sets be: evidence-based; able to identify disparities by race, ethnicity, socioeconomic status, and special health care need; risk-adjusted as appropriate; and designed to ensure that data are collected and reported in a standard format that permits comparison of quality and data at a State, plan, and provider level. Dated: February 15, 2012. Carolyn M. Clancy, AHRQ Director. BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From UAB Health System Patient Safety Organization Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of Delisting. AGENCY: AHRQ has accepted a notification of voluntary relinquishment from the UAB Health System Patient Safety Organization of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109–41, 42 U.S.C. 299b–21—b–26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: 18:34 Feb 23, 2012 DEPARTMENT OF HEALTH AND HUMAN SERVICES The directories for both listed and delisted PSOs are ongoing and reviewed weekly by AHRQ. The delisting was effective at 12:00 Midnight ET (2400) on January 13, 2012. Agency for Healthcare Research and Quality DATES: Both directories can be accessed electronically at the following HHS Web site: http:// www.pso.AHRQ.gov/index.html. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Susan Grinder, Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither. Road, Rockville, MD 20850; Telephone (toll free): (866) 403–3697; Telephone (local): (301) 427–1111; TTY (toll free): (866) 438–7231; TTY (local): (301) 427–1130; Email: pso@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: Background [FR Doc. 2012–4267 Filed 2–23–12; 8:45 am] VerDate Mar<15>2010 voluntarily relinquish its status as a PSO for any reason. Jkt 226001 The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule (PDF file, 450 KB. PDF Help) relating to the listing and operation of PSOs. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved PSOs. AHRQ has accepted a notification from the UAB Health System Patient Safety Organization, PSO number P0042, which is a component entity of the UAB Health System to voluntarily relinquish its status as a PSO. Accordingly, the UAB Health System Patient Safety Organization was delisted effective at 12:00 Midnight ET (2400) on January 13, 2012. More information on PSOs can be obtained through AHRQ’s PSO Web site at http://www.pso.AHRQ.gov/ index.html. Dated: February 15, 2012. Carolyn M. Clancy, Director. [FR Doc. 2012–4265 Filed 2–23–12; 8:45 am] BILLING CODE 4160–90–M PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Scientific Information Request on Treatment Strategies for Patients With Peripheral Artery Disease (PAD) 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 peripheral artery disease treatment medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of Treatment Strategies for Patients with Peripheral Artery Disease (PAD), 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 March 26, 2012. ADDRESSES: SUMMARY: 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. SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173, the Agency E:\FR\FM\24FEN1.SGM 24FEN1 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

Agencies

[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11120-11121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Treatment Strategies for 
Patients With Peripheral Artery Disease (PAD)

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 
peripheral artery disease treatment medical devices. Scientific 
information is being solicited to inform our Comparative Effectiveness 
Review of Treatment Strategies for Patients with Peripheral Artery 
Disease (PAD), 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 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

[[Page 11121]]

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-for-GUIDESreviews-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 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 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