Supplemental Evidence and Data Request on Treatments for Acute Episodic Migraine
| Published date | 15 January 2020 |
| Citation | 85 FR 2426 |
| Record Number | 2020-00488 |
| Section | Notices |
| Court | Agency For Healthcare Research And Quality |
Federal Register, Volume 85 Issue 10 (Wednesday, January 15, 2020)
[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]
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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.
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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 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published and unpublished pertinent scientific information will improve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: Patients with acute episodic Animals.
migraine seeking abortive treatment.
Adults 18 years and older..... Children (age 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).
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[[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.................
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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.
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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.
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[[Page 2429]]
Timing........................ At the following intervals: 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.
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Publications.................. Studies published in English only...... Foreign language studies.
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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
