Notice2023-03406
Supplemental Evidence and Data Request on Behavioral Interventions for Migraine Prevention
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 17, 2023
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 88 Issue 33 (Friday, February 17, 2023)</title>
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[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10331-10335]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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 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Access to published and unpublished pertinent scientific information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: <a href="/cdn-cgi/l/email-protection#4e2b3e2d0e2f263c3f6026263d60292138"><span class="__cf_email__" data-cfemail="d5b0a5b695b4bda7a4fbbdbda6fbb2baa3">[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#9efbeefddefff6ecefb0f6f6edb0f9f1e8"><span class="__cf_email__" data-cfemail="d6b3a6b596b7bea4a7f8bebea5f8b1b9a0">[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 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: <a href="https://effectivehealthcare.ahrq.gov/products/behavioral-interventions-migraine-prevention/protocol">https://effectivehealthcare.ahrq.gov/products/behavioral-interventions-migraine-prevention/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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)
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PICOTS Inclusion Exclusion
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Patients..................................... All KQs: All KQs:
<bullet> 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 <bullet> 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).
<bullet> >=80% of study <bullet> 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.
<bullet> We will include <bullet> 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..........................
<bullet> Cognitive behavioral
therapy.
[[Page 10333]]
<bullet> Cognitive therapy... <bullet> Physical therapy.
<bullet> Behavioral therapy..... <bullet> Exercise.
<bullet> Stress management <bullet> Catharsis therapy
training (SMT). (e.g., written emotional
<bullet> Coping skills training. disclosure).
<bullet> ``Learning to cope with <bullet> Occupational therapy.
triggers'' (LCT). <bullet> Creative arts therapy
<bullet> Parent/caregiver (art therapy, music therapy,
operant training (parent or dance therapy).
caregiver reinforces coping
behaviors).
<bullet> Problem-solving
training..
2. Biofeedback..................
<bullet> Thermal/temperature
biofeedback (Hand warming/
Thermal biofeedback) (often
feedback of skin temperature
from finger).
<bullet> Electromyographic
(EMG) biofeedback (feedback
of electrical activity from
muscles of scalp, neck, or
upper body).
<bullet> Heart rate variability
biofeedback..
<bullet> Electrocardio
biofeedback..
<bullet> Pulse..................
<bullet> Blood Volume Pulse.....
<bullet> Respiratory............
<bullet> Electroencephalography
(EEG)/Neurofeedback..
3. Relaxation.
<bullet> Diaphragmatic
Breathing..
<bullet> Progressive muscle
relaxation (alternatively
tensing/relaxing selected
muscles)..
<bullet> Autogenic feedback (use
of calm, self-soothing
statements to promote a state
of deep relaxation)..
<bullet> Autogenic training.....
4. Mindfulness based stress
reduction.
<bullet> Meditation (use of
silently repeated word or sound
to promote mental calm and
relaxation)..
<bullet> Transcendental
meditation..
<bullet> Guided imagery/Guided
visual imagery..
5. Third wave CBT.
<bullet> Acceptance and
commitment therapy..
6. Education.
<bullet> Education (skills,
lifestyle, exercise,
nutrition, hydration, stress
management, sleep hygiene).
<bullet> Neuroscience education
therapy..
<bullet> Healthy lifestyle
counseling..
<bullet> Sleep counseling.......
<bullet> Trigger avoidance......
<bullet> Weight management
(informational)..
<bullet> Diary/tracking.........
7. Hypnotherapy.................
8. Trauma-informed therapy.
<bullet> Eye movement
desensitization and
reprocessing (EMDR).
<bullet> 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.,.
<bullet> CBT for insomnia or
depression/anxiety..
<bullet> Sleep hygiene
counseling..
<bullet> Parent/caregiver
operant training (parent or
caregiver reinforces adaptive
sleep behaviors)..
<bullet> Healthy lifestyle
counseling..
KQ5 Interventions included for
KQs 1-4.
Comparisons.................................. KQs 1........................... Comparators not listed as
<bullet> No intervention (e.g., included.
waitlist, usual care).
<bullet> Minimal intervention
(e.g., educational materials
without skills training).
<bullet> 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):.
<bullet> Alpha agonists.
<bullet> Angiotensin-converting
enzyme inhibitors/Angiotensin
receptor blockers..
<bullet> Antiepileptics.........
<bullet> Antihistamines (for
child and adolescents only)..
<bullet> Beta-blockers..........
<bullet> Botulinum toxin type A.
<bullet> Calcitonin gene-related
peptide antagonists..
<bullet> Calcium channel
blockers.
<bullet> Other antidepressants..
<bullet> Serotonin
norepinephrine reuptake
inhibitors (SNRIs)..
<bullet> Tricyclic
antidepressants..
KQ5 Comparators in KQs 1-4...
Outcomes..................................... All KQs.
Migraine/Headache frequency:....
<bullet> Migraine/headache
count: Migraine days per month,
migraine attacks per month,
headache days per month, or
headaches per month..
<bullet> Responder rate: 50% or
more reduction in one of the
above quantities.
Functional Status/Disability.
<bullet> MIDAS, PedMIDAS, HANA,
MIBS, FIS, FDI (Parent form),
FDI-(child and adolescent),
IMPAC).
Quality of Life (QOL).
<bullet> Migraine Specific: HIT-
6, MSQoL v2.1, MSQ.
<bullet> General: SF-36, EQ-5,
SF-12, PedsQL.
Adverse effects such as dropout
and any reported.
Emotional Status.
<bullet> Anxiety symptoms (e.g.,
GAD-7, PROMIS Pediatric--
Anxiety, HADS).
<bullet> Depression symptoms
(e.g., PHQ4, PHQ 9, CDI, PROMIS
Pediatric-Depression, HADS).
Other:
<bullet> Most bothersome
symptoms..
<bullet> Headache pain intensity
(VAS, NRS)..
<bullet> Acute headache
medication use..
<bullet> Discontinuation of
preventive medication..
KQ 4. Additional outcomes:
<bullet> Anxiety (e.g., GAD-7,
PROMIS Pediatric--Anxiety).
<bullet> Depression (e.g., PHQ
4, PHQ 9, CDI, PROMIS Pediatric-
Depression).
<bullet> Sleep outcomes (sleep
onset latency, wake after sleep
onset, total sleep time, sleep
efficiency).
Study Design Criteria........................ All KQs:........................ All KQs:
<bullet> Randomized controlled <bullet> Exclude crossover
trials reporting outcomes for trials not reporting period 1
>=10 participants per treatment data separately.
arm. <bullet> Exclude reviews,
<bullet> Period 1 data from letters, guidelines, position
crossover RCTs. statements and commentaries.
<bullet> Published in English- <bullet> Exclude single arm or
language. non-randomized controlled
<bullet> 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...................................... <bullet> Any non-inpatient Hospitalized patients.
setting.
<bullet> 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.
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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
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