[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]


=======================================================================
-----------------------------------------------------------------------

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Access to published and unpublished pertinent scientific information 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