Supplemental Evidence and Data Request on Management of Infantile Epilepsy, 12946-12948 [2021-04538]
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12946
Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Average
hourly wage
rate *
Total burden
hours
Total cost
burden
Qualitative semi-structured interviews with AIM Team Leads ........................
Qualitative semi-structured interviews with frontline staff ...............................
Focus group discussions with AIM Team Leads and frontline staff ...............
8
32
40
8
16
40
$49.83
49.83
49.83
$398.64
797.28
1,993.20
Total ..........................................................................................................
80
64
........................
$3,189.12
* National Compensation Survey: Occupational wages in the United States May 2017 ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
Weighted mean hourly wage for obstetrician-gynecologists ($113.10; occupation code 29–1064; 30%); nurse-midwives ($49.83; occupation code
29–1161; 30%); registered nurses ($35.36; occupation code 29–1161; 20%); and nurse practitioners ($51.86; occupation code 29–1171; 20%).
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
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: epc@
ahrq.hhs.gov.
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.
Dated: March 1, 2021.
Marquita Cullom,
Associate Director.
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
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
[FR Doc. 2021–04502 Filed 3–4–21; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
jbell on DSKJLSW7X2PROD with NOTICES
Supplemental Evidence and Data
Request on Management of Infantile
Epilepsy
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Supplemental
Evidence and Data Submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
SUMMARY:
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20:30 Mar 04, 2021
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FOR FURTHER INFORMATION CONTACT:
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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:
D 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.
D 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.
D 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.
D 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
E:\FR\FM\05MRN1.SGM
05MRN1
12947
Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices
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 nonpharmacologic 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
Population ............................
• Infants (1 month to <3 years) diagnosed with epilepsy ...........................................
• Subpopulations based on baseline seizure severity/frequency, history of previous
treatment, length of gestation.
Intervention ..........................
• KQ 1, 3: Pharmacologic interventions ......................................................................
• KQ 2, 3: Non-pharmacologic intervention: dietary therapies, surgery, brain stimulation, and gene therapy.
Comparator ..........................
•
•
•
•
•
•
•
•
•
Outcomes .............................
Timing ..................................
jbell on DSKJLSW7X2PROD with NOTICES
Exclusion
Setting ..................................
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20:30 Mar 04, 2021
KQ1: Other pharmacologic interventions or usual care.
KQ2: Other pharmacologic or non-pharmacologic interventions or usual care.
KQ3: Inclusive of comparators for KQ1&2.
All-cause mortality.
SUDEP.
Hospitalization.
Seizure freedom.
Seizure frequency.
Seizure severity (including seizure duration, seizure burden, and status
epilepticus).
• Engel classification.
• Progression to other seizure types or syndromes (e.g., infantile spasms, LennoxGastaut Syndrome).
• Time to seizure remission.
• Neurodevelopment.
• Quality of life (including eating).
• Sleep outcomes (e.g., total time spent asleep at night).
• Behavioral function.
• Cognitive function.
• Functional performance (including school).
• Social function.
• Caregiver anxiety.
• Caregiver quality of life.
• General health status.
• Cost of treatment.
• Adverse events (infection, new neurological deficits, surgical complications, irritability, somnolence, dizziness, drug toxicity, etc.).
Effectiveness: 12 week minimum follow-up.
Harms: No minimum follow-up.
Setting not limited.
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E:\FR\FM\05MRN1.SGM
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• West syndrome/infantile
spasms.
• Non-epileptic seizures.
• Provoked seizures, including febrile seizures.
• Metabolic epilepsies.
• Status epilepticus.
• Acute symptomatic seizures.
• Diagnostic research.
• Provider/organization
level interventions such
as awareness campaigns.
• Metabolic therapies.
• Vitamin therapies.
• Social and community
services.
12948
Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices
Dated: March 1, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–04538 Filed 3–4–21; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Request for Information on the Use of
Clinical Algorithms That Have the
Potential To Introduce Racial/Ethnic
Bias Into Healthcare Delivery
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of Request for
Information.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
information from the public on clinical
algorithms that are used or
recommended in medical practice and
any evidence on clinical algorithms that
may introduce bias into clinical
decision- making and/or influence
access to care, quality of care, or health
outcomes for racial and ethnic
minorities and those who are
socioeconomically disadvantaged.
DATES: Comments must be submitted on
or before May 4, 2021. The EPC Program
will not respond individually to
responders but will consider all
comments submitted by the deadline.
ADDRESSES: Submissions should follow
the Submission Instructions below. We
prefer that comments be submitted
electronically on the submission
website. Email submissions may also be
sent to: epc@ahrq.gov
FOR FURTHER INFORMATION CONTACT:
Anjali Jain, Email: Anjali.Jain@
ahrq.hhs.gov.
SUMMARY:
The
Agency for Healthcare Research and
Quality (AHRQ) is seeking information
from the public on clinical algorithms
that are used or recommended in
medical practice and any evidence on
clinical algorithms that may introduce
bias into clinical decision-making and/
or influence access to care, quality of
care, or health outcomes for racial and
ethnic minorities and those who are
socioeconomically disadvantaged.
Information received in response to
this request will be used to inform an
AHRQ Evidence-Based Practice Center
Program (EPC) evidence review and may
inform other activities commissioned by
or in collaboration with AHRQ.
Established in 1997, the mission of the
jbell on DSKJLSW7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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Jkt 253001
EPC Program (https://
effectivehealthcare.ahrq.gov/about/epc)
is to create evidence reviews that
improve healthcare by supporting
evidence-based decision-making by
patients, providers, and policymakers.
Evidence reviews summarize and
synthesize existing literature and
evidence using rigorous methods.
AHRQ is conducting this review
pursuant to sections 902 and 901(c) of
the Public Health Service Act, 42 U.S.C.
299a and 42 U.S.C. 299(c).
AHRQ intends to commission an
evidence review that will critically
appraise the evidence on commonly
used algorithms, including whether
race/ethnicity is included as an explicit
variable, and how algorithms have been
developed and validated. The review
would examine how race/ethnicity and
related variables included in clinical
algorithms impact healthcare use,
patient outcomes and healthcare
disparities. In addition, the review will
identify and assess other variables with
the potential to introduce bias such as
prior utilization. The review will
identify and review approaches to
clinical algorithm development that
avoid the introduction of racial and
ethnic bias into clinical decision making
and resulting outcomes.
For the purposes of this evidence
review, clinical algorithms are defined
as a set of steps that clinicians use to
guide decision-making in preventive
services (such as screening), in
diagnosis, clinical management, or
otherwise assessing or improving a
patient’s health. Algorithms are
informed by data and research evidence
and may include patient-specific factors
or characteristics which may be
sociodemographic factors such as race/
ethnicity, physiologic factors such as,
for example, blood sugar level, or others
such as patterns of healthcare
utilization.
When used appropriately, algorithms
can improve disease management and
patient health by creating efficiencies in
place of individuals having to weigh
multiple and complex factors when
making a clinical judgement. As a
result, the use of clinical algorithms has
become widespread in healthcare and
includes a heterogeneous set of tools
including clinical pathways/guidelines,
the establishment of norms and
standards that may vary according to
patient-specific factors, clinical decision
support embedded in electronic health
records (EHRs) or within medical
devices, pattern recognition software
used for diagnosis, and apps and
calculators that predict patient risk and
prognosis. Some clinical algorithms
include information about a patient’s
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race or ethnicity among its inputs and
thus lead clinicians to decision-making
that varies by race/ethnicity, including
decisions about how best to diagnose
and manage individual patients.
The purpose of this evidence review
is to understand which algorithms are
currently used in different clinical
settings; the type and extent of their
validation; their potential for bias with
impact on access, quality, and outcomes
of care; awareness among clinicians of
these issues; and strategies for
developing and testing clinical
algorithms to assure that they are free of
bias in order to inform the scope of a
future evidence review. We are
interested in understanding which
algorithms are currently in use in
clinical practice including those related
to the use of clinical preventive
services. How many include race/
ethnicity and other factors that could
lead to bias within the algorithm? We
are interested in all algorithms
including clinical pathways/guidelines,
norms and standards (including
laboratory values) that vary according to
patient-specific factors such as race/
ethnicity and related variables, clinical
decision support embedded in EHRs,
pattern recognition software, and apps
and calculators for patient risk and
prognosis. We are interested both in
algorithms developed through
traditional methods and through new
and ongoing methods including
machine learning and artificial
intelligence. AHRQ seeks information
• From healthcare providers who use
clinical algorithms to screen, diagnose,
triage, treat or otherwise care for
patients
• From laboratorians or technicians
who use algorithms to interpret lab or
radiology data
• From researchers and clinical
decision support developers who
develop algorithms used in healthcare
for patients
• From clinical professional societies
or other groups who develop clinical
algorithms for healthcare
• From payers who use clinical
algorithms to guide payment decisions
for care for patients
• From healthcare delivery
organizations who use clinical
algorithms to determine healthcare
practices and policies for patients
• From device developers who
incorporate algorithms into device
software to interpret data and set
standards
• From patients whose healthcare and
healthcare decisions may be informed
by clinical algorithms
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]]>Agencies
[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: [email protected].
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: [email protected].
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.............................. Infants (1 month to <3 years) West syndrome/
diagnosed with epilepsy. infantile spasms.
Subpopulations based on baseline Non-epileptic
seizure severity/frequency, history of seizures.
previous treatment, length of gestation. Provoked
seizures, including
febrile seizures.
Metabolic
epilepsies.
Status
epilepticus.
Acute symptomatic
seizures.
Intervention............................ KQ 1, 3: Pharmacologic Diagnostic
interventions. research.
KQ 2, 3: Non-pharmacologic Provider/
intervention: dietary therapies, surgery, organization level
brain stimulation, and gene therapy. interventions such as
awareness campaigns.
Metabolic
therapies.
Vitamin
therapies.
Social and
community services.
Comparator.............................. KQ1: Other pharmacologic
interventions or usual care.
KQ2: Other pharmacologic or non-
pharmacologic interventions or usual care.
KQ3: Inclusive of comparators for
KQ1&2.
Outcomes................................ All-cause mortality..............
SUDEP............................
Hospitalization..................
Seizure freedom..................
Seizure frequency................
Seizure severity (including
seizure duration, seizure burden, and
status epilepticus).
Engel classification.............
Progression to other seizure
types or syndromes (e.g., infantile
spasms, Lennox-Gastaut Syndrome).
Time to seizure remission........
Neurodevelopment.................
Quality of life (including
eating).
Sleep outcomes (e.g., total time
spent asleep at night).
Behavioral function..............
Cognitive function...............
Functional performance (including
school).
Social function..................
Caregiver anxiety................
Caregiver quality of life........
General health status............
Cost of treatment................
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
