[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3596-3598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00766]


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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.

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[[Page 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 Evidence-based 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Access to published and unpublished pertinent scientific information 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-scientific-information-packets/. Please select the study for 
which you are submitting information from the list to upload your 
documents.
    Email submissions: <a href="/cdn-cgi/l/email-protection#0d5e445d5e4d687d6e20316c2d657f686b30" http: src.org">src.org</a>">SIPS@epc-src.org</a>.
    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: <a href="/cdn-cgi/l/email-protection#2a79637a796a4f5a4907164b0a42584f4c17" http: src.org">src.org</a>">SIPS@epc-src.org</a>.

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/search-for-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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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?
    <bullet> 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 beta-
blockers 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

[[Page 3598]]

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:
<bullet> Magnetic resonance imaging
<bullet> Computed tomography
<bullet> Magnetic resonance angiography
<bullet> Echocardiography
<bullet> Ultrasonography
<bullet> Endoscopy
Comparator
<bullet> Other workup evaluation approaches for treatment planning
<bullet> Other imaging modalities
Outcomes
<bullet> Ability to identify presence, number, and extent of 
hemangiomas and associated structural anomalies (sensitivity and 
specificity)
<bullet> Harms including, but not limited to, effects of sedation or 
imaging dye
Timing
<bullet> Immediate and short-term (<=3 months)
<bullet> 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
<bullet> Systemic (e.g., propranolol) or topical (e.g., timolol) beta-
blockers
<bullet> Corticosteroids (topical, intralesional, or systemic)
KQ3 Pharmacologic interventions
<bullet> Immunosuppressants (e.g., sirolimus)
<bullet> Immunomodulators (e.g., imiquimod, interferon)
<bullet> Antineoplastics (e.g., intralesional bleomycin, intravenous 
vincristine)
<bullet> Angiotensin-converting enzyme inhibitors
<bullet> Antiangiogenic agents
KQ4 Surgical interventions
Laser treatment
<bullet> Pulsed dye
<bullet> Fractionated laser
<bullet> Argon
<bullet> Carbon dioxide
<bullet> Neodymium (Nd): Yttrium Aluminium Garnet YAG
<bullet> Erbium
Surgical treatment
<bullet> Cryotherapy
<bullet> Resection
<bullet> Embolization
<bullet> Radiofrequency ablation therapy
Comparator
KQ2, 3
<bullet> No treatment
<bullet> Other pharmacologic interventions
<bullet> Observation
<bullet> Complementary and alternative medicine (CAM) (e.g., massage, 
compression therapy, essential oils)
KQ4
<bullet> No treatment
<bullet> Other laser or surgical interventions
<bullet> Observation
<bullet> CAM (e.g., massage, compression therapy, essential oils)
Outcomes
Intermediate outcomes (KQ2, 3, 4)
<bullet> Size/volume of hemangioma
<bullet> Impact on vision
<bullet> Aesthetic appearance as assessed by clinician or parent
<bullet> Degree of ulceration
<bullet> Harms
<bullet> Quality of life
Final outcomes (KQ2, 3, 4)
<bullet> Marked improvement of hemangiomas
<bullet> Prevention of disfigurement
<bullet> Resolution of airway obstruction
<bullet> Preservation of vision
<bullet> Preservation of organ function (e.g., thyroid function, 
cardiac function)
<bullet> Resolution of ulceration
<bullet> Psychological impact on the patient
<bullet> Harms including: pain, bleeding, sequelae of scarring, skin 
atrophy, venous prominence, disfigurement, distortion of anatomic 
landmarks, ulceration, infection, hypopigmentation
Timing
KQ2, 3
    <bullet> Immediate and short-term (<=2 years of age)
    <bullet> Long-term (>2 years of age)
KQ4
<bullet> Immediate and short-term (<=3 months)
<bullet> 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


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