[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Notices]
[Pages 12946-12948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04538]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Management of Infantile 
Epilepsy

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Supplemental Evidence and Data Submissions.

-----------------------------------------------------------------------

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 on Management of 
Infantile Epilepsy, which is currently being conducted by the AHRQ's 
Evidence-based Practice Centers (EPC) Program. Access to published and 
unpublished pertinent scientific information will improve the quality 
of this review.

DATES: Submission Deadline on or before April 5, 2021.

ADDRESSES: 
    Email submissions: <a href="/cdn-cgi/l/email-protection#2247524162434a50530c4a4a510c454d54"><span class="__cf_email__" data-cfemail="c1a4b1a281a0a9b3b0efa9a9b2efa6aeb7">[email protected]</span></a>.
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: <a href="/cdn-cgi/l/email-protection#1f7a6f7c5f7e776d6e3177776c31787069"><span class="__cf_email__" data-cfemail="0366736043626b71722d6b6b702d646c75">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Management of 
Infantile Epilepsy. AHRQ is conducting this systematic review pursuant 
to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
    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 Management of Infantile Epilepsy, including those that 
describe adverse events. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/management-infantile-epilepsy/research-protocol.
    This is to notify the public that the EPC Program would find the 
following information on Management of Infantile Epilepsy helpful:
    [ssquf] 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.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, 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.
    [ssquf] 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.
    [ssquf] Description of whether the above studies constitute 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 is very beneficial to the Program. Materials 
submitted must be publicly available or able to 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

[[Page 12947]]

with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website 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: https://www.effectivehealthcare.ahrq.gov/email-updates.
    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.

Key and Contextual Questions

    Key Question 1. What is the effectiveness and comparative 
effectiveness of pharmacologic treatments for infantile epilepsy 
(infants age 1 month to <3 years)?
    Key Question 2. What is the effectiveness and comparative 
effectiveness of non-pharmacologic treatments for infantile epilepsy 
(e.g., dietary therapies, surgery, and brain stimulation therapies), 
including comparisons to other non-pharmacologic and/or pharmacologic 
therapies?
    Key Question 3. What are the harms or comparative harms of 
treatments for infantile epilepsy?
    Contextual Question 1. What are the parental preferences for 
treatment options for infantile epilepsy?
    Contextual Question 2. What are the harms or comparative harms of 
not treating infantile epilepsy?

                                                     PICOTS
                        [Population, intervention, comparator, outcome, timing, setting]
----------------------------------------------------------------------------------------------------------------
                                                           Inclusion                           Exclusion
----------------------------------------------------------------------------------------------------------------
Population..............................  <bullet> Infants (1 month to <3 years)      <bullet> West syndrome/
                                           diagnosed with epilepsy.                    infantile spasms.
                                          <bullet> Subpopulations based on baseline   <bullet> Non-epileptic
                                           seizure severity/frequency, history of      seizures.
                                           previous treatment, length of gestation.   <bullet> Provoked
                                                                                       seizures, including
                                                                                       febrile seizures.
                                                                                      <bullet> Metabolic
                                                                                       epilepsies.
                                                                                      <bullet> Status
                                                                                       epilepticus.
                                                                                      <bullet> Acute symptomatic
                                                                                       seizures.
Intervention............................  <bullet> KQ 1, 3: Pharmacologic             <bullet> Diagnostic
                                           interventions.                              research.
                                          <bullet> KQ 2, 3: Non-pharmacologic         <bullet> Provider/
                                           intervention: dietary therapies, surgery,   organization level
                                           brain stimulation, and gene therapy.        interventions such as
                                                                                       awareness campaigns.
                                                                                      <bullet> Metabolic
                                                                                       therapies.
                                                                                      <bullet> Vitamin
                                                                                       therapies.
                                                                                      <bullet> Social and
                                                                                       community services.
Comparator..............................  <bullet> KQ1: Other pharmacologic
                                           interventions or usual care.
                                          <bullet> KQ2: Other pharmacologic or non-
                                           pharmacologic interventions or usual care.
                                          <bullet> KQ3: Inclusive of comparators for
                                           KQ1&2.
Outcomes................................  <bullet> All-cause mortality..............
                                          <bullet> SUDEP............................
                                          <bullet> Hospitalization..................
                                          <bullet> Seizure freedom..................
                                          <bullet> Seizure frequency................
                                          <bullet> Seizure severity (including
                                           seizure duration, seizure burden, and
                                           status epilepticus).
                                          <bullet> Engel classification.............
                                          <bullet> Progression to other seizure
                                           types or syndromes (e.g., infantile
                                           spasms, Lennox-Gastaut Syndrome).
                                          <bullet> Time to seizure remission........
                                          <bullet> Neurodevelopment.................
                                          <bullet> Quality of life (including
                                           eating).
                                          <bullet> Sleep outcomes (e.g., total time
                                           spent asleep at night).
                                          <bullet> Behavioral function..............
                                          <bullet> Cognitive function...............
                                          <bullet> Functional performance (including
                                           school).
                                          <bullet> Social function..................
                                          <bullet> Caregiver anxiety................
                                          <bullet> Caregiver quality of life........
                                          <bullet> General health status............
                                          <bullet> Cost of treatment................
                                          <bullet> Adverse events (infection, new
                                           neurological deficits, surgical
                                           complications, irritability, somnolence,
                                           dizziness, drug toxicity, etc.).
Timing..................................  Effectiveness: 12 week minimum follow-up.
                                          Harms: No minimum follow-up...............
Setting.................................  Setting not limited.......................
----------------------------------------------------------------------------------------------------------------



[[Page 12948]]

    Dated: March 1, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-04538 Filed 3-4-21; 8:45 am]
BILLING CODE 4160-90-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>