Supplemental Evidence and Data Request on Treatments for Acute Episodic Migraine, 2426-2429 [2020-00488]
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jbell on DSKJLSW7X2PROD with NOTICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Treatments for Acute
Episodic Migraine
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
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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published and unpublished pertinent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: 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 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:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
SUMMARY:
GOVERNMENT ACCOUNTABILITY
OFFICE
PO 00000
Frm 00044
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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.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 antiinflammatory drugs [NSAIDs], triptans,
ergots alkaloids, combination
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Federal Register / Vol. 85, No. 10 / Wednesday, January 15, 2020 / Notices
analgesics, muscle relaxants, antinausea 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 antiinflammatory drugs [NSAIDs], triptans,
ergots alkaloids, combination
analgesics, muscle relaxants, antinausea 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, kidneyrelated 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?
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PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)
PICOTS elements
Inclusion criteria
Population ...........
• Patients with acute episodic migraine seeking abortive
treatment.
• Adults 18 years and older ....................................................
* Special populations:
Æ General adult.
Æ Older populations >65 years.
Æ Patients with history of substance use disorder.
Æ Patients currently under treatment for opioid use
disorder with opioid agonist therapy or naltrexone.
Æ Patients with a history of mental illness.
Æ Patients with history of overdose.
Æ Pregnant/breastfeeding women.
Æ Patients with comorbidities (e.g., kidney disease,
sleep disordered breathing).
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Exclusion criteria
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• Animals.
• Children (age <18 years).
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PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)—Continued
PICOTS elements
Inclusion criteria
Exclusion criteria
Interventions .......
KQ 1 a–e: Any systemic opioid abortive therapy, include:
• Codeine.
• Fentanyl (Actiq, Duragesic, Fentora, Abstral, Onsolis).
For all KQs, exclude Invasive treatments, and preventive
(prophylactic) treatment.
For KQ2, exclude NSAIDs vs placebo and triptans vs placebo.
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• 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 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.
None.
Outcomes ............
KQ 1. Opioid Therapy:
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.
None.
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PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)—Continued
PICOTS elements
Inclusion criteria
Exclusion criteria
Timing .................
At the following intervals: <1 Day; 1 day to <1 week; 1 week
to <2 weeks; 2 weeks to 4 weeks.
None.
Settings ...............
ER, physician’s office, hospital ................................................
None.
Study design .......
• Original studies:
Æ RCTs.
Æ Comparative observational studies.
• Any sample size.
• Relevant systematic reviews, or meta-analyses (used
for identifying additional studies)
In vitro studies, non-original data (e.g., narrative reviews,
editorials, letters, or erratum), single-arm observational
studies, case series, qualitative studies, cost-benefit analysis, cross-sectional (i.e., non-longitudinal) studies, beforeafter 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]
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[Docket No. HHS–OS–2019–0015]
Solicitation for Public Comments on
Questions From the National Clinical
Care Commission
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Request for public comment.
AGENCY:
The National Clinical Care
Commission (the Commission) solicits
public comments on a set of questions
concerning the context, policies,
effectiveness, promising practices, and
limitations and gaps related to
prevention and treatment of diabetes
and its complications. The Commission
is charged to evaluate and make
recommendations to the Secretary of
Health and Human Services (HHS) and
Congress regarding improvements to the
coordination and leveraging of federal
programs related to awareness and
clinical care for diabetes and its
complications. The set of questions is
available in the SUPPLEMENTARY
INFORMATION section, below.
DATES: Electronic or written/paper
comments will be accepted through
midnight Eastern Standard Time (EST)
February 3, 2020.
ADDRESSES: Public comments can be
submitted in the following ways:
• Electronic submissions can be filed
on the online docket at https://
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SUMMARY:
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• If you prefer to comment on paper,
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MD 20852. For mailed submissions, the
Office of Disease Prevention and Health
Promotion will post your comments, as
well as any attachments, to https://
www.regulations.gov.
Instructions for Public Comments: All
electronic submissions must be
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For access to the docket to provide and/
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Comments are encouraged from the
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into https://www.regulations.gov and
are under the same limitations as for
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into https://www.regulations.gov: 5,000character limit for text box, and
maximum number (10) of attached files
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and maximum size (10 MB) of each
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FOR FURTHER INFORMATION CONTACT:
Linda Harris, Designated Federal
Officer, National Clinical Care
Commission, U.S. Department of Health
and Human Services, Office of the
Assistant Secretary for Health, Office of
Disease Prevention and Health
Promotion, 1101 Wootton Parkway,
Suite 420, Rockville, MD 20852. Email:
linda.harris@hhs.gov.
SUPPLEMENTARY INFORMATION: The
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(Pub. L. 115–80) requires the HHS
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of specific federal agencies and nonfederal individuals and entities who
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Specifically, the Commission requests
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]]>Agencies
[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
