[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Pages 24716-24717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Medical Devices To Treat Otitis 
Media With Effusion

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 manufacturers of otitis 
media with effusion medical devices, such as tympanostomy tubes and 
autoinflation devices. Scientific information is being solicited to 
inform our Comparative Effectiveness Review of Otitis Media with 
Effusion (OME) Treatments, 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 Access to published and unpublished pertinent scientific 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 May 25, 2012.

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 of current studies 
and complete the form to upload your documents.
    Email submissions: <a href="/cdn-cgi/l/email-protection#6f0a070c1c1d0c2f00071c1a410a0b1a"><span class="__cf_email__" data-cfemail="74111c17070617341b1c07015a111001">[email protected]</span></a> (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: <a href="/cdn-cgi/l/email-protection#52373a31212031123d3a21277c373627"><span class="__cf_email__" data-cfemail="c6a3aea5b5b4a586a9aeb5b3e8a3a2b3">[email protected]</span></a>.

[[Page 24717]]


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 otitis media with effusion treatments.
    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 treatments for otitis media 
with effusion, 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-guides-reviews-and-reports/?pageaction=displayproduct&productid=1013#5070.
    This notice is a request for industry stakeholders to submit the 
following:
    <bullet> A current product label, if applicable (preferably an 
electronic PDF file).
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 (KQs)

    KQ 1: What is the comparative effectiveness of the following 
treatment options (active treatments and watchful waiting) in affecting 
clinical outcomes or health care utilization in patients with OME? 
Clinical outcomes include changes in: OME signs (middle ear fluid) and 
symptoms (fullness in ear, difficulty in hearing), objective hearing 
thresholds, episodes of Acute Otitis Media (AOM), and vestibular 
function such as balance and coordination. Treatment options include:

a. Tympanostomy tubes
b. Adenoidectomy with or without myringotomy
c. Myringotomy
d. Oral or topical nasal steroids
e. Autoinflation
f. Complementary and alternative medical procedures
g. Watchful waiting
h. Variations in surgical technique or procedure
    KQ 2: What is the comparative effectiveness of the different 
treatment options listed in KQ 1 (active treatments and watchful 
waiting) in improving functional and health-related quality-of-life 
outcomes in patients with OME? Outcomes include: Hearing, speech and 
language development, auditory processing, academic achievement, 
attention and behavioral outcomes, health-related quality of life, and 
patient and parent satisfaction with care.
    KQ 3: What are the differences in harms or tolerability among the 
different treatment options?
    KQ 4: What are the comparative benefits and harms of treatment 
options in subgroups of patients with OME? Subgroups include:

a. Patients of different age groups
b. Patients of different racial/ethnic backgrounds
c. Patients in different socioeconomic status groups
d. Patients with comorbidities such as craniofacial abnormalities 
(e.g., cleft palate), Down syndrome, and existing speech, language, and 
hearing problems
e. Patients with a medical history of AOM or OME (with and without 
clinical hearing loss)
    KQ 5: Is the comparative effectiveness of treatment options 
affected by the following: Health insurance coverage, physician 
specialty, type of facility of the treatment provider, geographic 
location, continuity of care, or prior inoculation with the 
pneumococcal vaccine?

    Dated: April 12, 2012.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2012-9818 Filed 4-24-12; 8:45 am]
BILLING CODE 4160-90-M


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