[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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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Access to published and unpublished pertinent scientific information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: src.org">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: src.org">SIPS@epc-src.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/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:
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 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
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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