Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 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-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unpublished randomized controlled 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enrolled/lost to withdrawn/follow-up/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 

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 

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. 


srobinson on DSK4SPTVN1PROD with NOTICES
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. 

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-reviewsandreports/?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? 

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 


srobinson on DSK4SPTVN1PROD with NOTICES