3596 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 

(z) For improving primary clinical 

health outcomes (e.g., quality of life, 

avoiding myocardial infarction)? 

(aa) What are the adverse effects, 

consequences or harms of testing? 

(bb) How do noninvasive tests differ 

in terms of clinical management based 

on test results, including referral for 

coronary angiography or additional 

noninvasive testing? 

(cc) What harms are associated with 

additional testing following anatomic 

tests? 

(dd) Is there differential effectiveness 

or harm based on patient characteristics 

(e.g., sex, age, comorbidities) or the 

patient’s ability to exercise? 

PICOTS (Population, Intervention, 

Comparator, Outcome, Timing, Setting) 

Patient Population of Interest and PreTest Risk of CAD: 

The patient population is stable, 

symptomatic patients with suspected 

CAD who do not have previously 

diagnosed CAD and who have had a 

resting ECG. The definitions of risk 

categories are based on those described 

in the ACCF/AHA 2012 Guideline.8 In 

general, patient presentation and 

symptoms are primarily used to inform 

pre-test probability in the population of 

interest. The review will attempt to 

stratify studies based on these 

characteristics if definitions are not 

provided. 

• Include patients whose risk for CAD 

may be considered as follows: 

Æ Those considered to be at very low 

or low risk of CAD based on having 

none or only one of the following: 

• Patient age and gender (female <65 

years old, male <55 years old) 

• Negative family history for CAD 

• <2 CAD risk factors (including 

hypertension, diabetes, smoking, 

dyslipidemia, metabolic syndrome) 

• New onset angina/chest pain 

(including noncardiac or atypical chest 

pain, angina equivalents, unstable 

angina without non-ST-segment 

elevation myocardial infarction 

[NSTEMI], ST-segment elevation 

myocardial infarction [STEMI]) 

• Normal or non-diagnostic resting 

ECG 

Æ Those considered to be at 

intermediate to high risk of CAD based 

on having two or more of the following: 

• Patient age and gender (female ≥65 

years old, male ≥55 years old) 

• Positive family history for CAD 

• ≥2 CAD risk factors (including 

hypertension, diabetes, smoking, 

dyslipidemia, metabolic syndrome) 

• New onset or progressive angina/

chest pain or those with prolonged 

angina at rest (or relieved with rest or 

nitroglycerin) or nocturnal angina 

(angina including typical, atypical, 

definite, probable) 

• Possible ECG changes (e.g., T-wave, 

NSTEMI) or nondiagnostic ECG 

• Presence of other vascular disease 

(carotid disease, peripheral artery 

disease [PAD]) 

• Exclude patients with any of the 

following characteristics: 

Æ Unstable angina with elevated 

serum cardiac biomarkers, ECG changes, 

etc. 

Æ Definite acute coronary syndrome 

(ACS), Non-ST-Elevation Acute 

Coronary Syndromes (NSTE–ACS), 

NSTEMI, STEMI 

Æ Asymptomatic patients, including 

those being screened prior to surgery 

Interventions 

This systematic review will focus on 

widely available noninvasive tests used 

for diagnosis of CAD or dysfunction that 

results in symptoms attributable to 

myocardial ischemia. Coronary artery 

calcium scoring has been included since 

it has been proposed primarily for its 

ability to exclude the presence of 

obstructive disease but not necessarily 

to confirm the presence of flow-limiting 

stenosis. 

Interventions for inclusion are: 

• Functional tests (including exercise, 

vasodilator and/or dobutamine as 

stressor where appropriate) 

Æ Exercise electrocardiogram without 

imaging 

Æ Exercise/pharmacologic 

echocardiography (with or without 

myocardial echo contrast) 

Æ Exercise/pharmacologic cardiac 

nuclear imaging 

Æ SPECT 

Æ PET 

Æ Pharmacologic stress MRI 

Æ CT perfusion 

• Anatomic imaging 

Æ Coronary calcium scoring via 

electron beam CT (EBCT) or 

multidetector CT (MDCT) 

Æ CCTA 

Comparators 

Comparisons between noninvasive 

tests included in the interventions; 

comparisons with no testing or standard 

of care. (Contextual information will be 

provided in the background only for 

comparisons of noninvasive tests with 

invasive coronary angiography with or 

without FFR and for comparison 

between noninvasive tests on traditional 

diagnostic test measures such as 

sensitivity and specificity.) 

Outcomes 

• Clinical outcomes 

Æ Quality of life (QOL) 

Æ Change in angina (e.g., worsening) 

Æ MI 

Æ Heart failure 

Æ Stroke 

Æ Death 

Æ Hospitalization for cardiovascular 

events (acute coronary syndrome, heart 

failure, arrhythmias) 

Æ Dysrhythmia 

• Intermediate outcomes 

Æ Need for additional testing 

(including referral for invasive testing) 

Æ Management based on revised posttest risk stratification, including: 

• Guideline-directed medical therapy 

(GDMT), including management of 

lipids, blood pressure, and diabetes; 

counseling related to diet, physical 

activity, smoking cessation, alcohol use, 

and management of psychological 

factors; use of additional therapies to 

reduce risk of MI and death (e.g., 

antiplatelet therapy). 

• Any need for subsequent 

revascularization (percutaneous 

coronary intervention [PCI] or coronary 

artery bypass grafting [CABG]) 

• Harms, risks and consequences of 

testing 

Æ Procedural harms, adverse events of 

testing (e.g., renal failure, allergy, 

nephrogenic systemic fibrosis, contrastrelated harms, adverse reactions to 

drugs for stress tests), vascular 

complications 

Æ Consequences of testing (e.g., 

radiation exposure, psychological 

consequences, consequences of 

additional testing or incidental findings) 

Setting 

Nonemergent inpatient settings or 

ambulatory/outpatient settings, 

including emergency department. 

Timing 

At time of first test for evaluation 

using a noninvasive test other than 

resting ECG. 

Dated: December 29, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2015–00763 Filed 1–22–15; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Strategies to Treat and Manage 

Infantile Hemangioma 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for Scientific 

Information Submissions. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 3597 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review of 

Strategies to Treat and Manage Infantile 

Hemangioma, which is currently being 

conducted by the AHRQ’s Evidencebased Practice Centers (EPC) Programs. 

Access to published and unpublished 

pertinent scientific information will 

improve the quality of this review. 

AHRQ is conducting this systematic 

review pursuant to Section 902(a) of the 

Public Health Service Act, 42 U.S.C. 

299a(a). 

DATES: Submission Deadline on or 

before February 23, 2015. 

ADDRESSES: 

Online submissions: http://

effectivehealthcare.AHRQ.gov/

index.cfm/submit-scientificinformation-packets/. Please select the 

study for which you are submitting 

information from the list to upload your 

documents. 

Email submissions: SIPS@epc-src.org. 

Print submissions: Mailing Address: 

Portland VA Research Foundation, 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, P.O. Box 69539, Portland, 

OR 97239. Shipping Address (FedEx, 

UPS, etc.): Portland VA Research 

Foundation, Scientific Resource Center, 

ATTN: Scientific Information Packet 

Coordinator, 3710 SW U.S. Veterans 

Hospital Road, Mail Code: R&D 71m 

Portland, OR 97239 

FOR FURTHER INFORMATION CONTACT: 

Ryan McKenna, Telephone: 503–220– 

8262 ext. 58653 or Email: SIPS@epcsrc.org. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the 

Evidence-based Practice Centers (EPC) 

Programs to complete a review of the 

evidence for Strategies to Treat and 

Manage Infantile Hemangioma. 

The EPC 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 requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Strategies to Treat and 

Manage Infantile Hemangioma, 

including those that describe adverse 

events. The entire research protocol, 

including the key questions, is also 

available online at: http://

effectivehealthcare.AHRQ.gov/searchfor-guides-reviews-and-reports/

?pageaction=displayproduct&

productID=2016. 

This notice is to notify the public that 

the EPC Program would find the 

following information on Strategies to 

Treat and Manage Infantile 

Hemangioma helpful: 

• A list of completed studies that 

your organization has sponsored for this 

indication. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

• For completed studies that do not 

have results on ClinicalTrials.gov, 

please provide a summary, including 

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 follow-up/withdrawn/

analyzed, effectiveness/efficacy, and 

safety results. 

• A list of ongoing studies that your 

organization has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, and primary and secondary 

outcomes. 

• Description of whether the above 

studies constitute all ALL Phase II and 

above clinical trials sponsored by your 

organization for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution will be very 

beneficial to the EPC Program. The 

contents of all submissions will be made 

available to the public upon request. 

Materials submitted must be publicly 

available or can be made public. 

Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the EPC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EPC 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 systematic review will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. The entire 

research protocol, is available online at: 

http://effectivehealthcare.AHRQ.gov/

search-for-guides-reviews-and-reports/

?pageaction=displayproduct&

productID=2016. 

The Key Questions 

Our Contextual Questions (CQs) are as 

follows: 

CQ1 

What is known about the natural 

history of infantile hemangiomas, by 

hemangioma site and subtype? What are 

the adverse outcomes of untreated 

infantile hemangiomas? What 

characteristics of the hemangioma (e.g., 

subtype, size, location, number of 

lesions) indicate risk of significant 

medical complications that would 

prompt immediate medical or surgical 

intervention? 

CQ2 

What is the evidence that five or more 

cutaneous hemangiomas are associated 

with an increased risk of occult 

hemangiomas? 

Our Key Questions (KQs) are as 

follows: 

KQ1 

Among newborns, infants, and 

children up to 18 years of age with 

known or suspected infantile 

hemangiomas, what is the comparative 

effectiveness (benefits/harms) of various 

imaging modalities for identifying and 

characterizing hemangiomas? 

• Does the comparative effectiveness 

differ by location and subtype of the 

hemangioma? 

KQ2 

Among newborns, infants, and 

children up to 18 years of age with 

infantile hemangiomas who have been 

referred for pharmacologic intervention, 

what is the comparative effectiveness 

(benefits/harms) of corticosteroids or 

beta-blockers? 

KQ3 

Among newborns, infants, and 

children up to 18 years of age with 

infantile hemangiomas for whom 

treatment with corticosteroids or betablockers is unsuccessful what is the 

comparative effectiveness of second line 

therapies including immunomodulators 

and angiotensin-converting enzyme 

inhibitors? 

KQ4 

Among newborns, infants, and 

children up to 18 years of age with 

infantile hemangiomas who have been 


tkelley on DSK3SPTVN1PROD with NOTICES
3598 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 

referred for surgical intervention, what 

is the comparative effectiveness 

(benefits/harms) of various types of 

surgical interventions (including laser 

and resection)? 

PICOTS (Population, Intervention, 

Comparator, Outcomes, Timing, 

Setting) 

KQ 1 

Population 

Newborns, infants, and children up to 

18 years of age with known or suspected 

infantile hemangiomas. 

Intervention(s) 

Diagnostic imaging: 

• Magnetic resonance imaging 

• Computed tomography 

• Magnetic resonance angiography 

• Echocardiography 

• Ultrasonography 

• Endoscopy 

Comparator 

• Other workup evaluation approaches 

for treatment planning 

• Other imaging modalities 

Outcomes 

• Ability to identify presence, number, 

and extent of hemangiomas and 

associated structural anomalies 

(sensitivity and specificity) 

• Harms including, but not limited to, 

effects of sedation or imaging dye 

Timing 

• Immediate and short-term (≤3 

months) 

• Long-term (>3 months) 

Setting 

Inpatient and outpatient settings (e.g., 

pediatric radiology clinic, 

otolaryngology clinics, dermatology 

clinics, pediatric surgical unit) 

KQs 2, 3, and 4 

Population 

Newborns, infants, and children up to 

18 years of age with infantile 

hemangiomas. 

Intervention(s) 

KQ2 Pharmacologic interventions 

• Systemic (e.g., propranolol) or topical 

(e.g., timolol) beta-blockers 

• Corticosteroids (topical, intralesional, 

or systemic) 

KQ3 Pharmacologic interventions 

• Immunosuppressants (e.g., sirolimus) 

• Immunomodulators (e.g., imiquimod, 

interferon) 

• Antineoplastics (e.g., intralesional 

bleomycin, intravenous vincristine) 

• Angiotensin-converting enzyme 

inhibitors 

• Antiangiogenic agents 

KQ4 Surgical interventions 

Laser treatment 

• Pulsed dye 

• Fractionated laser 

• Argon 

• Carbon dioxide 

• Neodymium (Nd): Yttrium 

Aluminium Garnet YAG 

• Erbium 

Surgical treatment 

• Cryotherapy 

• Resection 

• Embolization 

• Radiofrequency ablation therapy 

Comparator 

KQ2, 3 

• No treatment 

• Other pharmacologic interventions 

• Observation 

• Complementary and alternative 

medicine (CAM) (e.g., massage, 

compression therapy, essential oils) 

KQ4 

• No treatment 

• Other laser or surgical interventions 

• Observation 

• CAM (e.g., massage, compression 

therapy, essential oils) 

Outcomes 

Intermediate outcomes (KQ2, 3, 4) 

• Size/volume of hemangioma 

• Impact on vision 

• Aesthetic appearance as assessed by 

clinician or parent 

• Degree of ulceration 

• Harms 

• Quality of life 

Final outcomes (KQ2, 3, 4) 

• Marked improvement of 

hemangiomas 

• Prevention of disfigurement 

• Resolution of airway obstruction 

• Preservation of vision 

• Preservation of organ function (e.g., 

thyroid function, cardiac function) 

• Resolution of ulceration 

• Psychological impact on the patient 

• Harms including: pain, bleeding, 

sequelae of scarring, skin atrophy, 

venous prominence, disfigurement, 

distortion of anatomic landmarks, 

ulceration, infection, 

hypopigmentation 

Timing 

KQ2, 3 

• Immediate and short-term (≤2 years 

of age) 

• Long-term (>2 years of age) 

KQ4 

• Immediate and short-term (≤3 

months) 

• Long-term (>3 months) 

Setting 

Inpatient and outpatient settings (e.g., 

pediatric radiology clinic, 

otolaryngology clinics, dermatology 

clinics, pediatric surgical unit) 

Dated: December 30, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2015–00766 Filed 1–22–15; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–15–15LB] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

The Centers for Disease Control and 

Prevention (CDC), as part of its 

continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on proposed and/or 

continuing information collections, as 

required by the Paperwork Reduction 

Act of 1995. To request more 

information on the below proposed 

project or to obtain a copy of the 

information collection plan and 

instruments, call 404–639–7570 or send 

comments to Leroy A. Richardson, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an email to omb@cdc.gov. 

Comments submitted in response to 

this notice will be summarized and/or 

included in the request for Office of 

Management and Budget (OMB) 

approval. Comments are invited on: 

(a) Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; (d) ways to 

minimize the burden of the collection of 

information on respondents, including 

through the use of automated collection 

techniques or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 


tkelley on DSK3SPTVN1PROD with NOTICES