[Federal Register Volume 85, Number 10 (Wednesday, January 15, 2020)]
[Notices]
[Pages 2426-2429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00488]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Treatments for Acute 
Episodic Migraine

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 Treatments for 
Acute Episodic Migraine, 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published and unpublished pertinent scientific information will improve 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 30 days after date of 
publication in Federal Register.

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 Treatments for Acute 
Episodic Migraine. AHRQ is conducting this systematic review pursuant 
to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
    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 Treatments for Acute Episodic Migraine, including those 
that describe adverse events. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/migraine-treatments/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Treatments for Acute Episodic Migraine 
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 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)

    For patients with acute episodic migraine.

KQ 1. Opioid Therapy

    KQ1a. What is the comparative effectiveness of opioid therapy 
versus: (1) Nonopioid pharmacologic therapy (e.g., acetaminophen, 
nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergots 
alkaloids, combination

[[Page 2427]]

analgesics, muscle relaxants, anti-nausea medications, and marijuana/
cannabis) or (2) nonpharmacologic therapy (e.g., exercise, cognitive 
behavioral therapy, acupuncture, biofeedback, neuromodulatory devices) 
for outcomes related to pain, function, pain relief satisfaction, and 
quality of life and after follow-up at the following intervals: <1 Day; 
1 day to <1 week; 1 week to <2 weeks; 2 weeks to 4 weeks?
    KQ1b. How does effectiveness of opioid therapy vary depending on: 
(1) Patient demographics (e.g. age, race, ethnicity, gender, 
socioeconomic status (SES)); (2) patient medical comorbidities 
(previous opioid use, body mass index (BMI)); (3) dose of opioids; (4) 
duration of opioid therapy, including number of opioid prescription 
refills and quantity of pills used?
    KQ1c. What are the harms of opioid therapy versus nonopioid 
pharmacologic therapy, or nonpharmacologic therapy with respect to: (1) 
Misuse, opioid use disorder, and related outcomes; (2) overdose; (3) 
medication overuse headache (MOH), (4) other harms including 
gastrointestinal-related harms, falls, fractures, motor vehicle 
accidents, endocrinological harms, infections, cardiovascular events, 
cognitive harms, and psychological harms (e.g., depression)?
    KQ1d. How do harms vary depending on: (1) Patient demographics 
(e.g., age, gender); (2) patient medical comorbidities; (3) the dose of 
opioid used; (4) the duration of opioid therapy?
    KQ1e. What are the effects of prescribing opioid therapy versus not 
prescribing opioid therapy for acute episodic migraine pain on (1) 
short-term (<3 months) continued need for prescription pain relief, 
such as need for opioid refills, and (2) long-term opioid use (3 months 
or greater)?
    KQ1f. For patients with acute episodic migraine being considered 
for opioid therapy, what is the accuracy of instruments for predicting 
risk of opioid misuse, opioid use disorder, or overdose?
    KQ1g. For patients with acute episodic migraine being considered 
for opioid therapy, what is the effectiveness of instruments for 
predicting risk of opioid misuse, opioid use disorder, or overdose?
    KQ1h. For patients with acute episodic migraine being considered 
for opioid therapy, what is the effect of the following risk mitigation 
strategies on the decision to prescribe opioids: (1) Existing opioid 
management plans; (2) patient education; (3) clinician and patient 
values and preferences related to opioids; (4) urine drug screening; 
(5) use of prescription drug monitoring program data; (6) availability 
of close follow-up?

KQ 2. Nonopioid Pharmacologic Therapy

    KQ2a. What is the comparative effectiveness of nonopioid 
pharmacologic therapy (e.g., acetaminophen, nonsteroidal anti-
inflammatory drugs [NSAIDs], triptans, ergots alkaloids, combination 
analgesics, muscle relaxants, anti-nausea medications, and marijuana/
cannabis) versus: (1) Other nonopioid pharmacologic treatments, such as 
those in a different medication class; or (2) nonpharmacologic therapy 
for outcomes related to pain, function, pain relief satisfaction, and 
quality of life after follow-up at the following intervals: <1 Day; 1 
day to <1 week; 1 week to <2 weeks; 2 weeks to 4 weeks?
    KQ2b. How does effectiveness of nonopioid pharmacologic therapy 
vary depending on: (1) Patient demographics (e.g. age, race, ethnicity, 
gender); (2) patient medical comorbidities; (3) the type of nonopioid 
medication; (4) dose of medication; (5) duration of treatment?
    KQ2c. What are the harms of nonopioid pharmacologic therapy versus 
other nonopioid pharmacologic therapy, or nonpharmacologic therapy with 
respect to: (1) Misuse, (2) overdose; (3) medication overuse headache 
(MOH), (4) other harms including gastrointestinal-related harms, 
cardiovascular-related harms, kidney-related harms, falls, fractures, 
motor vehicle accidents, endocrinological harms, infections, cognitive 
harms, and psychological harms (e.g., depression)?
    KQ2d. How do harms vary depending on: (1) Patient demographics 
(e.g. age, gender); (2) patient medical comorbidities; (3) the type of 
nonopioid medication; (4) dose of medication; (5) the duration of 
therapy?

KQ 3. Nonpharmacologic Therapy

    KQ3a. What is the comparative effectiveness of nonpharmacologic 
therapy versus sham treatment, waitlist, usual care, attention control, 
and no treatment after follow-up at the following intervals: <1 Day; 1 
day to <1 week; 1 week to <2 weeks; 2 weeks to 4 weeks?
    KQ3b. What is the comparative effectiveness of nonpharmacologic 
treatments (e.g. exercise, cognitive behavioral therapy, acupuncture, 
biofeedback, neuromodulatory devices) for outcomes related to pain, 
function, pain relief satisfaction, and quality of life?
    KQ3c. How does effectiveness of nonpharmacologic therapy vary 
depending on: (1) Patient demographics (e.g. age, gender); (2) patient 
medical comorbidities?
    KQ3d. How do harms vary depending on: (1) Patient demographics 
(e.g., age, gender); (2) patient medical comorbidities; (3) the type of 
treatment used; (4) the frequency of therapy; (5) the duration of 
therapy?

                  PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings)
----------------------------------------------------------------------------------------------------------------
        PICOTS elements                    Inclusion criteria                       Exclusion criteria
----------------------------------------------------------------------------------------------------------------
Population....................   Patients with acute episodic     Animals.
                                 migraine seeking abortive treatment.
                                 Adults 18 years and older.....   Children (age <18 years).
                                * Special populations:
                                     [cir] General adult...............
                                     [cir] Older populations >65 years.
                                     [cir] Patients with history of
                                      substance use disorder.
                                     [cir] Patients currently under
                                      treatment for opioid use disorder
                                      with opioid agonist therapy or
                                      naltrexone.
                                     [cir] Patients with a history of
                                      mental illness.
                                     [cir] Patients with history of
                                      overdose.
                                     [cir] Pregnant/breastfeeding women
                                     [cir] Patients with comorbidities
                                      (e.g., kidney disease, sleep
                                      disordered breathing).
----------------------------------------------------------------------------------------------------------------

[[Page 2428]]

 
Interventions.................  KQ 1 a-e: Any systemic opioid abortive   For all KQs, exclude Invasive
                                 therapy, include:                        treatments, and preventive
                                 Codeine.......................   (prophylactic) treatment.
                                 Fentanyl (Actiq, Duragesic,     For KQ2, exclude NSAIDs vs placebo and
                                 Fentora, Abstral, Onsolis)..             triptans vs placebo.
                                    Hydrocodone (Hysingla,
                                    Zohydro ER).
                                    Hydrocodone/acetaminophen
                                    (Lorcet, Lortab, Norco, Vicodin).
                                    Hydromorphone (Dilaudid,
                                    Exalgo).
                                    Meperidine (Demerol).......
                                    Methadone (Dolophine,
                                    Methadose).
                                    Morphine (Kadian, MS
                                    Contin, Morphabond).
                                    Oxycodone (OxyContin,
                                    Oxaydo).
                                    Oxycodone and acetaminophen
                                    (Percocet, Roxicet).
                                    Oxycodone and naloxone.....
                                    And other agonists, partial
                                    agonists and mixed mechanism
                                    opioids.
                                KQ 1 f-g: Instruments and genetic/
                                 metabolic tests for predicting risk of
                                 misuse, opioid use disorder, and
                                 overdose.
                                KQ 1 h: Risk mitigation strategies,
                                 including:
                                    Existing opioid management
                                    plans.
                                    Patient education..........
                                    Clinician and patient
                                    values and preferences related to
                                    opioids.
                                    Urine drug screening.......
                                    Use of prescription drug
                                    monitoring program data.
                                    Availability of close
                                    follow-up.
                                    And others.................
                                KQ 2: Any oral, injection, infusion,
                                 topical nonopioid abortive drug,
                                 including:
                                    Acetaminophen..............
                                    Nonsteroidal anti-
                                    inflammatory drugs [NSAIDs] (if
                                    compared against active treatment).
                                    Triptans (if compared
                                    against active treatment).
                                    Ergots alkaloids...........
                                    Combination analgesics.....
                                    Muscle relaxants...........
                                    Anti-nausea medications....
                                    Marijuana/cannabis.........
                                    And others.................
                                KQ 3: Any non-invasive nonpharmacologic
                                 abortive therapy, including:
                                    Exercise...................
                                    Cognitive behavioral
                                    therapy.
                                    Acupuncture................
                                    And others.................
----------------------------------------------------------------------------------------------------------------
Comparators...................  KQ 1: a-e. Usual care, another opioid    None.
                                 therapy, nonopioid pharmacologic
                                 therapy, nonpharmacologic therapy.
                                KQ 1 f. Reference standard for misuse,
                                 opioid use disorder, or overdose; or
                                 other benchmarks.
                                KQ g-h. Usual care.....................
                                KQ 2: Another nonopioid pharmacologic
                                 therapy, nonpharmacologic therapy.
                                KQ3: Sham treatment, waitlist, usual
                                 care, attention control, and no
                                 treatment, another non-invasive
                                 nonpharmacologic therapy.
----------------------------------------------------------------------------------------------------------------
Outcomes......................  KQ 1. Opioid Therapy:                    None.
                                KQ 1a-e. Pain, function, pain relief
                                 satisfaction and quality of life,
                                 harms/adverse events (including
                                 withdrawal, risk of misuse, opioid,
                                 OUD, overdose, MOH).
                                KQ 1f. Measures of diagnostic accuracy.
                                KQ 1g-h. Misuse, opioid use disorder,
                                 overdose and other harms.
                                KQ 2. Non-Opioid Therapy: Pain,
                                 function, pain relief satisfaction,
                                 quality of life, and quality of life,
                                 harms/adverse events.
                                KQ 3: Non-invasive non-pharm Therapy:
                                 Pain, function, pain relief
                                 satisfaction, quality of life and
                                 quality of life, harms, adverse events.
----------------------------------------------------------------------------------------------------------------

[[Page 2429]]

 
Timing........................  At the following intervals: <1 Day; 1    None.
                                 day to <1 week; 1 week to <2 weeks; 2
                                 weeks to 4 weeks.
----------------------------------------------------------------------------------------------------------------
Settings......................  ER, physician's office, hospital.......  None.
----------------------------------------------------------------------------------------------------------------
Study design..................   Original studies:               In vitro studies, non-original data
                                [cir] RCTs.............................   (e.g., narrative reviews, editorials,
                                [cir] Comparative observational           letters, or erratum), single-arm
                                 studies..                                observational studies, case series,
                                 Any sample size...............   qualitative studies, cost-benefit
                                 Relevant systematic reviews,     analysis, cross-sectional (i.e., non-
                                 or meta-analyses (used for identifying   longitudinal) studies, before-after
                                 additional studies).                     studies, survey.
----------------------------------------------------------------------------------------------------------------
Publications..................  Studies published in English only......  Foreign language studies.
----------------------------------------------------------------------------------------------------------------
Abbreviations: RCT = randomized controlled trial.


    Dated: January 9, 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director, AHRQ.
[FR Doc. 2020-00488 Filed 1-14-20; 8:45 am]
 BILLING CODE 4160-90-P