Supplemental Evidence and Data Request on Behavioral Interventions for Migraine Prevention, 10331-10335 [2023-03406]
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10331
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[FR Doc. 2023–03465 Filed 2–16–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Behavioral Interventions
for Migraine Prevention
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
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Behavioral Interventions for Migraine
Prevention, which is currently being
conducted by the AHRQ’s Evidencebased Practice Centers (EPC) Program.
Access to published and unpublished
pertinent scientific information will
improve the quality of this review.
SUMMARY:
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Submission Deadline on or
before March 20, 2023.
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.
FOR FURTHER INFORMATION CONTACT:
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 Behavioral Interventions
for Migraine Prevention. 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 Behavioral Interventions
for Migraine Prevention, including those
that describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/behavioral-interventionsmigraine-prevention/protocol.
This is to notify the public that the
EPC Program would find the following
information on Behavioral Interventions
for Migraine Prevention helpful:
D A list of completed studies that
your organization has sponsored for this
DATES:
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Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
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
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.effectivehealth
care.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 Questions (KQ)
KQ 1: What are the benefits and harms
of behavioral interventions, either alone
or in combination with other preventive
strategies (including pharmacologic
therapy), for migraine prevention
compared to inactive control for
children and adults?
KQ 1a: What are the benefits and
harms of behavioral interventions
delivered via telehealth and digital
health (e/mHealth) technology
compared to inactive control?
KQ 2: What is the comparative
effectiveness and harms of a behavioral
intervention for migraine prevention
compared to either (a) a pharmacologic
preventive agent or (b) another
behavioral intervention for children and
adults?
KQ 2a: What is the comparative
effectiveness and harms of behavioral
interventions delivered via telehealth
and digital health (e/mHealth)
technology compared to (a)
pharmacologic prevention or (b) other
behavioral interventions?
KQ 3: For multicomponent or
combined behavioral interventions,
what are the effects of individual
behavioral intervention components?
KQ 4: What are the benefits and harms
of non-headache focused behavioral
interventions (e.g., CBT for insomnia,
CBT for depression/anxiety, parent
training) for migraine prevention in
children and adults with migraine?
KQ 5: For key questions 1–4, how do
the findings vary by baseline
biopsychosocial factors (e.g., sex,
socioeconomic status, co-occurring
mental health conditions)?
Contextual Questions
CQ 1: What evidence is available on
the benefits of behavioral preventive
treatments for children and adults with
migraine that include intervention
components targeting caregivers (e.g.,
parents, spouses, and other key support
people)?
CQ 2: What are patient and provider
perceptions of the benefits, harms, and
barriers to engaging with behavioral
treatments for migraine prevention in
children and adults?
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
PICOTS
Inclusion
Patients ................................
All KQs:
• Children (age 6 to 11), adolescents (12 to 17),
and adults (18 or older) with migraine headache
(episodic or chronic).
We will not require studies to only include individuals
with an International Classification of Headache Disorders diagnosis of migraine headache.
• ≥80% of study participants had migraine headache, or the study reports a subgroup analysis
comprised of at least 80% migraine patients.
• We will include studies with participants with
other headache types (e.g., medication overuse
headache, tension type headache, cluster headache, etc.) in addition to migraine, as long as
≥80% of participants have migraine.
KQs 1–3.
Migraine-focused behavioral interventions used for prevention, administered either alone or with
pharmacotherapy, delivered in-person, via telehealth,
or with e- or mHealth.
1. CBT.
• Cognitive behavioral therapy.
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Interventions .........................
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Exclusion
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All KQs:
Studies conducted exclusively
• Among individuals in institutions (e.g., psychiatric
inpatients, long-term care facilities, incarcerated
populations).
• Parents, for studies with interventions targeting
children and adolescents.
• Individuals with psychotic disorders.
We will exclude studies focused solely on the following
interventions:
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PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
PICOTS
Inclusion
Exclusion
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•
•
•
•
•
•
Comparisons ........................
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Cognitive therapy .................................................
Behavioral therapy ...............................................
Stress management training (SMT) .....................
Coping skills training ............................................
‘‘Learning to cope with triggers’’ (LCT) ................
Parent/caregiver operant training (parent or caregiver reinforces coping behaviors).
• Problem-solving training.
2. Biofeedback.
• Thermal/temperature biofeedback (Hand warming/Thermal biofeedback) (often feedback of skin
temperature from finger).
• Electromyographic (EMG) biofeedback (feedback
of electrical activity from muscles of scalp, neck,
or upper body).
• Heart rate variability biofeedback.
• Electrocardio biofeedback.
• Pulse.
• Blood Volume Pulse.
• Respiratory.
• Electroencephalography (EEG)/Neurofeedback.
3. Relaxation.
• Diaphragmatic Breathing.
• Progressive muscle relaxation (alternatively tensing/relaxing selected muscles).
• Autogenic feedback (use of calm, self-soothing
statements to promote a state of deep relaxation).
• Autogenic training.
4. Mindfulness based stress reduction.
• Meditation (use of silently repeated word or
sound to promote mental calm and relaxation).
• Transcendental meditation.
• Guided imagery/Guided visual imagery.
5. Third wave CBT.
• Acceptance and commitment therapy.
6. Education.
• Education (skills, lifestyle, exercise, nutrition, hydration, stress management, sleep hygiene).
• Neuroscience education therapy.
• Healthy lifestyle counseling.
• Sleep counseling.
• Trigger avoidance.
• Weight management (informational).
• Diary/tracking.
7. Hypnotherapy.
8. Trauma-informed therapy.
• Eye movement desensitization and reprocessing
(EMDR).
• Trauma-focused therapy.
9. Dialectical behavioral therapy (DBT).
10. Motivational interviewing and stages of change.
11. Professionally led support groups/peer support.
12. Combination therapies.
KQ1a and KQ2a: The above interventions delivered via
telehealth or with e- or mHealth.
KQ 4.
Non-headache focused behavioral interventions, e.g.,
• CBT for insomnia or depression/anxiety.
• Sleep hygiene counseling.
• Parent/caregiver operant training (parent or caregiver reinforces adaptive sleep behaviors).
• Healthy lifestyle counseling.
KQ5 Interventions included for KQs 1–4.
KQs 1 ..............................................................................
• No intervention (e.g., waitlist, usual care) ............
• Minimal intervention (e.g., educational materials
without skills training).
• Most active: Attention control, sham, or placebo
KQs 2–4.
A different eligible behavioral intervention.
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• Physical therapy.
• Exercise.
• Catharsis therapy (e.g., written emotional disclosure).
• Occupational therapy.
• Creative arts therapy (art therapy, music therapy, dance therapy).
Comparators not listed as included.
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PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
PICOTS
Outcomes .............................
Study Design Criteria ...........
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Setting ..................................
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Inclusion
Exclusion
KQ 2–4.
Medications from the following drug classes (see Table
2):
• Alpha agonists.
• Angiotensin-converting
enzyme
inhibitors/
Angiotensin receptor blockers.
• Antiepileptics.
• Antihistamines (for child and adolescents only).
• Beta-blockers.
• Botulinum toxin type A.
• Calcitonin gene–related peptide antagonists.
• Calcium channel blockers.
• Other antidepressants.
• Serotonin norepinephrine reuptake inhibitors
(SNRIs).
• Tricyclic antidepressants.
KQ5 Comparators in KQs 1–4.
All KQs.
Migraine/Headache frequency:
• Migraine/headache count: Migraine days per
month, migraine attacks per month, headache
days per month, or headaches per month..
• Responder rate: 50% or more reduction in one
of the above quantities.
Functional Status/Disability.
• MIDAS, PedMIDAS, HANA, MIBS, FIS, FDI
(Parent form), FDI-(child and adolescent),
IMPAC).
Quality of Life (QOL).
• Migraine Specific: HIT–6, MSQoL v2.1, MSQ .....
• General: SF–36, EQ–5, SF–12, PedsQL.
Adverse effects such as dropout and any reported.
Emotional Status.
• Anxiety symptoms (e.g., GAD–7, PROMIS Pediatric—Anxiety, HADS).
• Depression symptoms (e.g., PHQ4, PHQ 9, CDI,
PROMIS Pediatric-Depression, HADS).
Other:
• Most bothersome symptoms.
• Headache pain intensity (VAS, NRS).
• Acute headache medication use.
• Discontinuation of preventive medication.
KQ 4. Additional outcomes:
• Anxiety (e.g., GAD–7, PROMIS Pediatric—Anxiety).
• Depression (e.g., PHQ 4, PHQ 9, CDI, PROMIS
Pediatric-Depression).
• Sleep outcomes (sleep onset latency, wake after
sleep onset, total sleep time, sleep efficiency).
All KQs: ...........................................................................
• Randomized controlled trials reporting outcomes
for ≥10 participants per treatment arm.
• Period 1 data from crossover RCTs ....................
• Published in English-language .............................
• Published 1975 or after ........................................
For KQ1–4, we will require studies to report at least
one of four primary outcomes: Migraine/Headache
frequency, migraine-related disability, migraine-specific quality of life, and/or adverse events.
• Any non-inpatient setting ......................................
• Trials conducted in countries rated as ‘‘very
high’’ on the 2022 Human Development Index
(as defined by the United Nations Development
Programme).
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All KQs:
• Exclude crossover trials not reporting period 1
data separately.
• Exclude reviews, letters, guidelines, position
statements and commentaries.
• Exclude single arm or non-randomized controlled
studies.
SRs will only be used to identify potential RCTs for inclusion.
Hospitalized patients.
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10335
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
PICOTS
Inclusion
Exclusion
Timing ..................................
Studies must report a primary outcome at 4 weeks or
longer after treatment initiation.
CDI = Children’s Depression Inventory, EQ–5D = EuroQol-5D, FDI-Child Form = Functional Disability Inventory—Child and Adolescent Form,
FDI-Parent Form = Functional Disability Inventory—Parent Form, FIS = Fatigue Impact Scale, GAD–7 = General Anxiety Disorder-7, HADS =
Hospital Anxiety and Depression Scale, HANA = Headache Needs Assessment, HIT–6TM = Headache Impact Test, IMPAC = Impact of Migraine
on Partners and Adolescent Children, MIBS = Migraine Interictal Burden Scale, MIDAS = Migraine Disability Assessment, MSQ = Migraine Specific Quality of Life Questionnaire v. 2.1, NRS = Numeric Rating Scale, PedMIDAS = Pediatric Migraine-Specific Disability Assessment, PedsQL
= Pediatric Quality of Life Inventory, PHQ = Patient Health Questionnaire–Depression, PQ–LES–Q = Pediatric quality of life enjoyment and satisfaction, SF–12 = 12-Item Short Form Survey, SF–36 = 36-Item Short Form Survey, VAS = Visual Analogue Scale.
Dated: February 14, 2023.
Marquita Cullom,
Associate Director.
The meeting will be held from
2:00 to 2:45 p.m. Eastern on Thursday,
March 16, 2023.
ADDRESSES: The meeting will be held
virtually.
DATES:
[FR Doc. 2023–03406 Filed 2–16–23; 8:45 am]
BILLING CODE 4160–90–P
Dr.
Hamid Jalal, Medical Officer, Center for
Quality Improvement and Patient
Safety, AHRQ, 5600 Fishers Lane,
Rockville, MD 20857; Telephone (toll
free): (866) 403–3697; Telephone (local):
(301) 427–1111; TTY (toll free): (866)
438–7231; TTY (local): (301) 427–1130;
Email: pso@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting for Software Developers on
the Common Formats for Patient
Safety Data Collection
AGENCY:
Background
AHRQ coordinates the
development of sets of standardized
definitions and formats (Common
Formats) that make it possible to collect,
aggregate, and analyze uniformly
structured information about health care
quality and patient safety for local,
regional, and national learning. The
Common Formats include technical
specifications to facilitate the collection
of electronically comparable data by
Patient Safety Organizations (PSOs) and
other entities. Additional information
about the Common Formats can be
obtained through AHRQ’s PSO website
at https://pso.ahrq.gov/common-formats
and the PSO Privacy Protection Center’s
website at https://www.psoppc.org/
psoppc_web/publicpages/
commonFormatsOverview. The purpose
of this notice is to announce a meeting
to discuss implementation of the
Common Formats with software
developers and other interested parties.
This meeting is designed as an
interactive forum where software
developers can provide input on use of
the formats. AHRQ especially requests
participation by and input from those
entities which have used AHRQ’s
technical specifications and
implemented, or plan to implement, the
Common Formats electronically.
The Patient Safety and Quality
Improvement Act of 2005, 42 U.S.C.
299b–21 to 299b–26 (Patient Safety Act),
and the related Patient Safety and
Quality Improvement Final Rule, 42
CFR part 3 (Patient Safety Rule),
published in the Federal Register on
November 21, 2008, 73 FR 70731–
70814, provide for the Federal listing of
Patient Safety Organizations (PSOs),
which collect, aggregate, and analyze
confidential information (patient safety
work product) regarding the quality and
safety of health care delivery.
The Patient Safety Act requires PSOs,
to the extent practical and appropriate,
to collect patient safety work product
from providers in a standardized
manner that permits valid comparisons
of similar cases among similar
providers. (42 U.S.C. 299b–24(b)(1)(F)).
The Patient Safety Act also authorizes
the development of data standards,
known as the Common Formats, to
facilitate the aggregation and analysis of
non-identifiable patient safety data
collected by PSOs and reported to the
network of patient safety databases
(NPSD). (42 U.S.C. 299b–23(b)). The
Patient Safety Act and Patient Safety
Rule can be accessed at: https://
www.pso.ahrq.gov/legislation/.
AHRQ has issued Common Formats
for Event Reporting (CFER) for three
settings of care—hospitals, nursing
homes, and community pharmacies.
AHRQ has also issued Common Formats
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of public meeting.
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for Event Reporting—Diagnostic Safety
(CFER–DS) designed for use in all
healthcare settings.
Federally listed PSOs can meet the
requirement to collect patient safety
work product in a standardized manner
to the extent practical and appropriate
by using AHRQ’s Common Formats. The
Common Formats are also available in
the public domain to encourage their
widespread adoption. An entity does
not need to be listed as a PSO or
working with one to use the Common
Formats. However, the Federal privilege
and confidentiality protections only
apply to information developed as
patient safety work product by
providers and PSOs working under the
Patient Safety Act.
Agenda, Registration, and Other
Information About the Meeting
The Agency for Healthcare Research
and Quality (AHRQ) will be hosting this
fully virtual meeting to discuss
implementation of the Common Formats
with members of the public, including
software developers and other interested
parties. Agenda topics will include
discussion of the Network of Patient
Safety Databases, including the Falls
2022 Supplemental Dashboard. Active
participation and discussion by meeting
participants is encouraged.
AHRQ requests that interested
persons send an email to SDMeetings@
infinityconferences.com for registration
information. Before the meeting, an
agenda and logistical information will
be provided to registrants.
Dated: February 13, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–03328 Filed 2–16–23; 8:45 am]
BILLING CODE 4160–90–P
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]]>Agencies
[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10331-10335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03406]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Behavioral
Interventions for Migraine Prevention
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 Behavioral
Interventions for Migraine Prevention, 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 March 20, 2023.
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 Behavioral
Interventions for Migraine Prevention. 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 Behavioral Interventions for Migraine Prevention,
including those that describe adverse events. The entire research
protocol is available online at: https://effectivehealthcare.ahrq.gov/products/behavioral-interventions-migraine-prevention/protocol.
This is to notify the public that the EPC Program would find the
following information on Behavioral Interventions for Migraine
Prevention helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this
[[Page 10332]]
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 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 Questions (KQ)
KQ 1: What are the benefits and harms of behavioral interventions,
either alone or in combination with other preventive strategies
(including pharmacologic therapy), for migraine prevention compared to
inactive control for children and adults?
KQ 1a: What are the benefits and harms of behavioral interventions
delivered via telehealth and digital health (e/mHealth) technology
compared to inactive control?
KQ 2: What is the comparative effectiveness and harms of a
behavioral intervention for migraine prevention compared to either (a)
a pharmacologic preventive agent or (b) another behavioral intervention
for children and adults?
KQ 2a: What is the comparative effectiveness and harms of
behavioral interventions delivered via telehealth and digital health
(e/mHealth) technology compared to (a) pharmacologic prevention or (b)
other behavioral interventions?
KQ 3: For multicomponent or combined behavioral interventions, what
are the effects of individual behavioral intervention components?
KQ 4: What are the benefits and harms of non-headache focused
behavioral interventions (e.g., CBT for insomnia, CBT for depression/
anxiety, parent training) for migraine prevention in children and
adults with migraine?
KQ 5: For key questions 1-4, how do the findings vary by baseline
biopsychosocial factors (e.g., sex, socioeconomic status, co-occurring
mental health conditions)?
Contextual Questions
CQ 1: What evidence is available on the benefits of behavioral
preventive treatments for children and adults with migraine that
include intervention components targeting caregivers (e.g., parents,
spouses, and other key support people)?
CQ 2: What are patient and provider perceptions of the benefits,
harms, and barriers to engaging with behavioral treatments for migraine
prevention in children and adults?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
----------------------------------------------------------------------------------------------------------------
PICOTS Inclusion Exclusion
----------------------------------------------------------------------------------------------------------------
Patients..................................... All KQs: All KQs:
Children (age 6 to Studies conducted exclusively
11), adolescents (12 to 17),
and adults (18 or older)
with migraine headache
(episodic or chronic).
We will not require studies to Among individuals
only include individuals with in institutions (e.g.,
an International Classification psychiatric inpatients,
of Headache Disorders diagnosis long-term care facilities,
of migraine headache. incarcerated populations).
>=80% of study Parents, for
participants had migraine studies with interventions
headache, or the study targeting children and
reports a subgroup analysis adolescents.
comprised of at least 80%
migraine patients.
We will include Individuals with
studies with participants psychotic disorders.
with other headache types
(e.g., medication overuse
headache, tension type
headache, cluster headache,
etc.) in addition to
migraine, as long as >=80%
of participants have
migraine.
Interventions................................ KQs 1-3.........................
Migraine-focused behavioral We will exclude studies focused
interventions used for solely on the following
prevention, administered either interventions:
alone or with pharmacotherapy,
delivered in-person, via
telehealth, or with e- or
mHealth.
1. CBT..........................
Cognitive behavioral
therapy.
[[Page 10333]]
Cognitive therapy... Physical therapy.
Behavioral therapy..... Exercise.
Stress management Catharsis therapy
training (SMT). (e.g., written emotional
Coping skills training. disclosure).
``Learning to cope with Occupational therapy.
triggers'' (LCT). Creative arts therapy
Parent/caregiver (art therapy, music therapy,
operant training (parent or dance therapy).
caregiver reinforces coping
behaviors).
Problem-solving
training..
2. Biofeedback..................
Thermal/temperature
biofeedback (Hand warming/
Thermal biofeedback) (often
feedback of skin temperature
from finger).
Electromyographic
(EMG) biofeedback (feedback
of electrical activity from
muscles of scalp, neck, or
upper body).
Heart rate variability
biofeedback..
Electrocardio
biofeedback..
Pulse..................
Blood Volume Pulse.....
Respiratory............
Electroencephalography
(EEG)/Neurofeedback..
3. Relaxation.
Diaphragmatic
Breathing..
Progressive muscle
relaxation (alternatively
tensing/relaxing selected
muscles)..
Autogenic feedback (use
of calm, self-soothing
statements to promote a state
of deep relaxation)..
Autogenic training.....
4. Mindfulness based stress
reduction.
Meditation (use of
silently repeated word or sound
to promote mental calm and
relaxation)..
Transcendental
meditation..
Guided imagery/Guided
visual imagery..
5. Third wave CBT.
Acceptance and
commitment therapy..
6. Education.
Education (skills,
lifestyle, exercise,
nutrition, hydration, stress
management, sleep hygiene).
Neuroscience education
therapy..
Healthy lifestyle
counseling..
Sleep counseling.......
Trigger avoidance......
Weight management
(informational)..
Diary/tracking.........
7. Hypnotherapy.................
8. Trauma-informed therapy.
Eye movement
desensitization and
reprocessing (EMDR).
Trauma-focused therapy.
9. Dialectical behavioral
therapy (DBT).
10. Motivational interviewing
and stages of change.
11. Professionally led support
groups/peer support.
12. Combination therapies.......
KQ1a and KQ2a: The above
interventions delivered via
telehealth or with e- or
mHealth.
KQ 4.
Non-headache focused behavioral
interventions, e.g.,.
CBT for insomnia or
depression/anxiety..
Sleep hygiene
counseling..
Parent/caregiver
operant training (parent or
caregiver reinforces adaptive
sleep behaviors)..
Healthy lifestyle
counseling..
KQ5 Interventions included for
KQs 1-4.
Comparisons.................................. KQs 1........................... Comparators not listed as
No intervention (e.g., included.
waitlist, usual care).
Minimal intervention
(e.g., educational materials
without skills training).
Most active: Attention
control, sham, or placebo.
KQs 2-4.
A different eligible behavioral
intervention.
[[Page 10334]]
KQ 2-4.
Medications from the following
drug classes (see Table 2):.
Alpha agonists.
Angiotensin-converting
enzyme inhibitors/Angiotensin
receptor blockers..
Antiepileptics.........
Antihistamines (for
child and adolescents only)..
Beta-blockers..........
Botulinum toxin type A.
Calcitonin gene-related
peptide antagonists..
Calcium channel
blockers.
Other antidepressants..
Serotonin
norepinephrine reuptake
inhibitors (SNRIs)..
Tricyclic
antidepressants..
KQ5 Comparators in KQs 1-4...
Outcomes..................................... All KQs.
Migraine/Headache frequency:....
Migraine/headache
count: Migraine days per month,
migraine attacks per month,
headache days per month, or
headaches per month..
Responder rate: 50% or
more reduction in one of the
above quantities.
Functional Status/Disability.
MIDAS, PedMIDAS, HANA,
MIBS, FIS, FDI (Parent form),
FDI-(child and adolescent),
IMPAC).
Quality of Life (QOL).
Migraine Specific: HIT-
6, MSQoL v2.1, MSQ.
General: SF-36, EQ-5,
SF-12, PedsQL.
Adverse effects such as dropout
and any reported.
Emotional Status.
Anxiety symptoms (e.g.,
GAD-7, PROMIS Pediatric--
Anxiety, HADS).
Depression symptoms
(e.g., PHQ4, PHQ 9, CDI, PROMIS
Pediatric-Depression, HADS).
Other:
Most bothersome
symptoms..
Headache pain intensity
(VAS, NRS)..
Acute headache
medication use..
Discontinuation of
preventive medication..
KQ 4. Additional outcomes:
Anxiety (e.g., GAD-7,
PROMIS Pediatric--Anxiety).
Depression (e.g., PHQ
4, PHQ 9, CDI, PROMIS Pediatric-
Depression).
Sleep outcomes (sleep
onset latency, wake after sleep
onset, total sleep time, sleep
efficiency).
Study Design Criteria........................ All KQs:........................ All KQs:
Randomized controlled Exclude crossover
trials reporting outcomes for trials not reporting period 1
>=10 participants per treatment data separately.
arm. Exclude reviews,
Period 1 data from letters, guidelines, position
crossover RCTs. statements and commentaries.
Published in English- Exclude single arm or
language. non-randomized controlled
Published 1975 or after studies.
For KQ1-4, we will require SRs will only be used to
studies to report at least one identify potential RCTs for
of four primary outcomes: inclusion.
Migraine/Headache frequency,
migraine-related disability,
migraine-specific quality of
life, and/or adverse events.
Setting...................................... Any non-inpatient Hospitalized patients.
setting.
Trials conducted in
countries rated as ``very
high'' on the 2022 Human
Development Index (as defined
by the United Nations
Development Programme).
[[Page 10335]]
Timing....................................... Studies must report a primary ...............................
outcome at 4 weeks or longer
after treatment initiation.
----------------------------------------------------------------------------------------------------------------
CDI = Children's Depression Inventory, EQ-5D = EuroQol-5D, FDI-Child Form = Functional Disability Inventory--
Child and Adolescent Form, FDI-Parent Form = Functional Disability Inventory--Parent Form, FIS = Fatigue
Impact Scale, GAD-7 = General Anxiety Disorder-7, HADS = Hospital Anxiety and Depression Scale, HANA =
Headache Needs Assessment, HIT-6TM = Headache Impact Test, IMPAC = Impact of Migraine on Partners and
Adolescent Children, MIBS = Migraine Interictal Burden Scale, MIDAS = Migraine Disability Assessment, MSQ =
Migraine Specific Quality of Life Questionnaire v. 2.1, NRS = Numeric Rating Scale, PedMIDAS = Pediatric
Migraine-Specific Disability Assessment, PedsQL = Pediatric Quality of Life Inventory, PHQ = Patient Health
Questionnaire-Depression, PQ-LES-Q = Pediatric quality of life enjoyment and satisfaction, SF-12 = 12-Item
Short Form Survey, SF-36 = 36-Item Short Form Survey, VAS = Visual Analogue Scale.
Dated: February 14, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-03406 Filed 2-16-23; 8:45 am]
BILLING CODE 4160-90-P
