Supplemental Evidence and Data Request on Opioid Treatments for Chronic Pain, 10080-10083 [2019-05145]
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10080
Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
date of delisting and revocation to
complete the disposition of PSWP that
is currently in the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO website
at https://www.pso.ahrq.gov.
Gopal Khanna,
Director.
[FR Doc. 2019–05150 Filed 3–18–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Opioid Treatments for
Chronic Pain
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
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
Opioid Treatments for Chronic Pain,
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published and unpublished pertinent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 April 18, 2019.
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.
SUMMARY:
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 Opioid Treatments for
Chronic Pain. AHRQ is conducting this
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Jkt 247001
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 Opioid Treatments for
Chronic Pain, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
topics/opioids-chronic-pain/protocol.
This is to notify the public that the
EPC Program would find the following
information on Opioid Treatments for
Chronic Pain 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
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov,
please provide 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 will be very
beneficial to the EPC 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
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Sfmt 4703
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.
The Key Questions:
Key Question 1. Effectiveness and
Comparative Effectiveness
a. In patients with chronic pain, what
is the effectiveness of opioid therapy
versus placebo or no opioid therapy for
outcomes related to pain, function, and
quality of life, after short-term follow-up
(up to 6 months), intermediate-term
follow-up (6 to 12 months), and longterm follow-up (at least 1 year)?
b. How does effectiveness vary
depending on:
(1) the specific type or cause of pain
(e.g., neuropathic, musculoskeletal
[including low back pain], visceral pain,
fibromyalgia, sickle cell disease,
inflammatory pain, headache disorders,
and degree of nociplasticity);
(2) patient demographics (e.g., age,
race, ethnicity, gender, socioeconomic
status);
(3) patient comorbidities (including
past or current alcohol or substance use
disorders, mental health disorders,
medical comorbidities and high risk for
opioid use disorder);
(4) the mechanism of action of opioids
used (e.g., pure opioid agonists, partial
opioid agonists such as buprenorphine
or drugs with mixed opioid and
nonopioid mechanisms of action such
as tramadol or tapentadol)?
c. In patients with chronic pain, what
is the comparative effectiveness of
opioids versus nonopioid therapies
(pharmacologic or nonpharmacologic,
including marijuana) on outcomes
related to pain, function, and quality of
life, after short-term follow-up (up to 6
months), intermediate-term follow-up (6
to 12 months), and long-term follow-up
(at least 1 year)?
d. In patients with chronic pain, what
is the comparative effectiveness of
opioids plus nonopioid interventions
(pharmacologic or nonpharmacologic,
including marijuana) versus opioids or
nonopioid interventions alone on
outcomes related to pain, function,
quality of life, and doses of opioids
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Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
used, after short-term follow-up (up to
6 months), intermediate-term follow-up
(6 to 12 months), and long-term followup (at least 1 year)?
Key Question 2. Harms and Adverse
Events
a. In patients with chronic pain, what
are the risks of opioids versus placebo
or no opioid on:
(1) substance misuse, substance use
disorder, and related outcomes;
(2) overdose (intentional and
unintentional);
(3) other harms, including
gastrointestinal-related harms, falls,
fractures, motor vehicle accidents,
endocrinological harms, infections,
cardiovascular events, cognitive harms,
and psychological harms (e.g.,
depression)?
b. How do harms vary depending on:
(1) the specific type or cause of pain
(e.g., neuropathic, musculoskeletal
[including back pain], visceral pain,
fibromyalgia, sickle cell disease,
inflammatory pain, headache disorders,
and degree of nociplasticity);
(2) patient demographics;
(3) patient comorbidities (including
past or current substance use disorder or
at high risk for opioid use disorder);
(4) the dose of opioids used and
duration of therapy;
(5) the mechanism of action of opioids
used (e.g., are there differences between
pure opioid agonists and partial opioid
agonists such as buprenorphine or drugs
with opioid and nonopioid mechanisms
of action such as tramadol and
tapentadol);
(6) use of sedative hypnotics;
(7) use of gabapentinoids;
(8) use of marijuana?
Key Question 3. Dosing Strategies
a. In patients with chronic pain, what
is the comparative effectiveness of
different methods for initiating and
titrating opioids for outcomes related to
pain, function, and quality of life; risk
of misuse, opioid use disorder, and
overdose; and doses of opioids used?
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b. In patients with chronic pain, what
is the comparative effectiveness of
short-acting versus long-acting opioids
on outcomes related to pain, function,
and quality of life; risk of misuse, opioid
use disorder, and overdose; and doses of
opioids used?
c. In patients with chronic pain, what
is the comparative effectiveness of
different long-acting opioids on
outcomes related to pain, function, and
quality of life; and risk of misuse, opioid
use disorder, and overdose?
d. In patients with chronic pain, what
is the comparative effectiveness of
short- plus long-acting opioids versus
long-acting opioids alone on outcomes
related to pain, function, and quality of
life; risk of misuse, opioid use disorder,
and overdose; and doses of opioids
used?
e. In patients with chronic pain, what
is the comparative effectiveness of
scheduled, continuous versus as-needed
dosing of opioids on outcomes related to
pain, function, and quality of life; risk
of misuse, opioid use disorder, and
overdose; and doses of opioids used?
f. In patients with chronic pain, what
is the comparative effectiveness of
opioid dose escalation versus dose
maintenance or use of dose thresholds
on outcomes related to pain, function,
and quality of life?
g. In patients with chronic pain, what
is the comparative effectiveness of
opioid rotation versus maintenance of
current opioid therapy on outcomes
related to pain, function, and quality of
life; and doses of opioids used?
h. In patients with chronic pain, what
is the comparative effectiveness of
different strategies for treating acute
exacerbations of chronic pain on
outcomes related to pain, function, and
quality of life?
i. In patients with chronic pain, what
are the effects of decreasing opioid
doses or of tapering off opioids versus
continuation of opioids on outcomes
related to pain, function, quality of life,
and withdrawal?
j. In patients with chronic pain, what
is the comparative effectiveness of
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different tapering protocols and
strategies on measures related to pain,
function, quality of life, withdrawal
symptoms, and likelihood of opioid
cessation?
k. In patients with chronic pain, what
is the comparative effectiveness of
different opioid dosages and durations
of therapy for outcomes related to pain,
function, and quality of life; risk of
misuse, opioid use disorder, and
overdose?
Key Question 4. Risk Assessment and
Risk Mitigation Strategies
a. In patients with chronic pain being
considered for opioid therapy, what is
the accuracy of instruments and tests
(including metabolic and/or genetic
testing) for predicting risk of misuse,
opioid use disorder, and overdose?
b. In patients with chronic pain, what
is the effectiveness of use of risk
prediction instruments and tests
(including metabolic and/or genetic
testing) on outcomes related to misuse,
opioid use disorder, and overdose?
c. In patients with chronic pain who
are prescribed opioid therapy, what is
the effectiveness of risk mitigation
strategies, including (1) opioid
management plans, (2) patient
education, (3) urine drug screening, (4)
use of prescription drug monitoring
program data, (5) use of monitoring
instruments, (6) more frequent
monitoring intervals, (7) pill counts, (8)
use of abuse-deterrent formulations, (9)
consultation with mental health
providers when mental health
conditions are present, (10) avoidance of
co-prescribing of sedative hypnotics,
and (11) co-prescribing of naloxone on
outcomes related to misuse, opioid use
disorder, and overdose?
d. In patients with chronic pain, what
is the comparative effectiveness of
treatment strategies for managing
patients with opioid use disorder
related to prescription opioids on
outcomes related to misuse, opioid use
disorder, overdose, pain, function, and
quality of life?
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PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)
Key question
Population
Intervention
Comparator
1a, b ..................
Adults (age ≥18 years) with various types of chronic pain including pregnant/breast-feeding
women and patients treated with
opioids for opioid use disorder.
Key Question 1b: Subgroups: (1)
The specific type or cause of
pain (e.g., neuropathic, musculoskeletal [including low back
pain], fibromyalgia, sickle cell
disease, inflammatory pain, and
headache disorders); (2) patient
demographics (e.g., age, race,
ethnicity, gender); (3) patient
comorbidities (including past or
current alcohol or substance
use disorders, mental health
disorders, medical comorbidities
and high risk for opioid use disorder).
Adults (age ≥18 years) with various types of chronic pain.
Long- or short-acting opioids (including partial agonists and dual
mechanism agents).
Exclude: Intravenous or
intramuscular administration of
opioids.
Placebo or no opioid therapy ........
Pain, function, and quality of life).
Long- or short-acting opioids (including partial agonists and dual
action medications).
Exclude: Intravenous or
intramuscular administration of
opioids.
Pain, function, and quality of life;
doses of opioids used.
1d ......................
Adults (age ≥18 years) with various types of chronic pain.
2a ......................
Adults (age ≥18 years) with various types of chronic pain.
Key Question 2b: Subgroups (1)
the specific type or cause of
pain (e.g., neuropathic, musculoskeletal [including back
pain], fibromyalgia, sickle cell
disease, inflammatory pain,
headache disorders); (2) patient
demographics; (3) patient
comorbidities (including past or
current substance use disorder
or at high risk for opioid use disorder); (4) the dose of opioids
used; (5) the mechanisms of actions of the opioids; and (6) use
of sedative hypnotics.
Adults (age ≥18 years) with various types of chronic pain.
Opioids plus nonopioid interventions (pharmacologic or nonpharmacologic).
Exclude: Intravenous or
intramuscular administration of
opioids.
Long- or short-acting opioids (including tapentadol,
buprenorphine, and tramadol)
opioids.
Exclude: Intravenous or
intramuscular administration of
opioids.
Nonopioid therapies (pharmacologic [antiepileptic drugs,
benzodiazepines, nonsteroidal
antiinflammatory drugs, skeletal
muscle relaxants, serotonin
norepinephrine reuptake inhibitors, topical lidocaine, topical
capsaicin, topical diclofenac,
tricyclica antidepressants, acetaminophen, memantine, and
marijuana/cannabis] or nonpharmacologic [noninvasive]).
Opioids or nonopioid interventions
alone, including marijuana.
Placebo or no opioid .....................
Substance misuse, substance use
disorder and related outcomes,
overdose, and other harms.
1c .......................
3a ......................
Outcome
Long- or short-acting opioids (including tapentadol,
buprenorphine, and tramadol).
Short-acting opioid ........................
Other opioids with different dose
initiation and titration strategies.
Pain, function, and quality of life;
doses of opioids used.
Long-acting opioid .........................
Pain, function, and quality of life;
risk of misuse, opioid use disorder, overdose and other
harms; doses of opioids used.
Pain, function, and quality of life;
risk of misuse, opioid use disorder, and overdose and other
harms; doses of opioids used.
Pain, function, and quality of life;
risk of misuse, opioid use disorder, overdose and other
harms; doses of opioids used.
Pain, function, and quality of life;
risk of misuse, opioid use disorder, overdose, and other
harms; doses of opioids used.
Pain, function, and quality of life.
3b ......................
Adults (age ≥18 years) with various types of chronic pain.
3c .......................
Adults (age ≥18 years) with various types of chronic pain.
Long-acting opioid .........................
Other long-acting opioid ................
3d ......................
Adults (age ≥18 years) with various types of chronic pain.
Short and long acting opioid .........
Long-acting opioid .........................
3e ......................
Adults (age ≥18 years) with various types of chronic pain.
Scheduled, continuous dosing ......
As-needed dosing .........................
3f .......................
Adults (age ≥18 years) with various types of chronic pain.
Adults (age ≥18 years) with various types of chronic pain.
Adults (age ≥18 years) with various types of chronic pain and
an acute exacerbation.
Opioid dose escalation ..................
Dose maintenance or use of dose
thresholds.
Maintenance of current opioid
therapy.
Other treatments for acute exacerbations of chronic pain.
3g ......................
3h ......................
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Pain, function, and quality of life,
doses of opioids used.
Opioid rotation ...............................
Treatments for acute exacerbations of chronic pain.
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Pain, function, and quality of life;
doses of opioids used.
Pain, function, and quality of life.
10083
Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)—Continued
Comparator
Outcome
3i ........................
Key question
Adults (age ≥18 years) with various types of chronic pain.
Population
Decreasing opioid doses or of tapering off opioids.
Continuation of opioids ..................
3j ........................
Adults (age ≥18 years) with various types of chronic pain.
Tapering protocols and strategies
Other tapering protocols or strategies.
3k .......................
Adults (age ≥18 years) with various types of chronic pain.
Dosage of opioid ...........................
Other dose of same opioid ............
4a ......................
Adults (age ≥18 years) with various types of chronic pain.
Reference standard for misuse,
opioid use disorder, or overdose; or other benchmarks.
4b ......................
Adults (age ≥18 years) with various types of chronic pain.
Adults (age ≥18 years) with various types of chronic pain.
Instruments, genetic/metabolic
tests for predicting risk of misuse, opioid use disorder, and
overdose.
Use of risk prediction instruments,
genetic/metabolic tests.
Risk mitigation strategies, including (1) opioid management
plans, (2) patient education, (3)
urine drug screening, (4) use of
prescription drug monitoring program data, (5) use of monitoring
instruments, (6) more frequent
monitoring intervals, (7) pill
counts, (8) use of abuse-deterrent formulations, (9) consultation with mental health providers
when mental health conditions
are present, (10) avoidance of
benzodiazepine co-prescribing
and (11) co-prescribing of
naloxone.
Treatment strategies .....................
Pain, function, and quality of life;
withdrawal and other harms (including overdose, use of illicit
opioids, suicidality, and anger/violence).
Pain, function, quality of life, likelihood of opioid cessation, withdrawal symptoms and other
harms (including overdose, use
of illicit opioids, suicidality, and
anger/violence).
Pain, function, and quality of life;
risk of misuse, opioid use disorder, overdose and other
harms.
Measures of diagnostic accuracy.
4c .......................
Intervention
Adults (age ≥18 years) with various types of chronic pain and
opioid use disorder.
4d ......................
Additional Inclusion Criteria
Usual care .....................................
Other treatment strategies ............
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Timing
• For all questions, studies with at
least 1 month of followup will be
included. Results will be stratified
according to short-term (1 to 6 months),
intermediate term (6 to 12 months), and
long-term (≥1 year) followup.
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
Setting
• Include: Outpatient settings (e.g.,
primary care, pain clinics, other
specialty clinics, emergency rooms,
urgent care clinics).
• Exclude: Addiction treatment
settings, inpatient settings.
Gopal Khanna,
Director.
[FR Doc. 2019–05145 Filed 3–18–19; 8:45 am]
BILLING CODE 4160–90–P
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Usual care or other control ...........
17:54 Mar 18, 2019
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This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project: ‘‘Child
Hospital Consumer Assessment of
Healthcare Providers and Systems
(Child HCAHPS) Survey Database.’’
This proposed information collection
was previously published in the Federal
Register on November 7th, 2018, and
allowed 60 days for public comments.
AHRQ received and responded to one
substantive comment from a member of
the public. The purpose of this notice is
SUMMARY:
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Misuse, opioid use disorder, overdose and other harms.
Pain, function, quality of life, misuse, opioid use disorder, overdose and other harms (including
use of illicit opioids, suicidality,
and anger/violence).
Pain, function, quality of life, misuse, opioid use disorder, overdose, other harms, pain, function, and quality of life.
to allow an additional 30 days for public
comment.
DATES: Comments on this notice must be
received by April 18, 2019.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer).
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Child Hospital Consumer Assessment of
Healthcare Providers and Systems
(Child HCAHPS) Survey Database
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
The Child Hospital CAHPS Survey
(Child HCAHPS) assesses the
experiences of pediatric patients (less
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]]>Agencies
[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Notices]
[Pages 10080-10083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05145]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Opioid Treatments for
Chronic Pain
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 Opioid
Treatments for Chronic Pain, 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 April 18, 2019.
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 Opioid Treatments for
Chronic Pain. 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 Opioid Treatments for Chronic Pain, including those that
describe adverse events. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/topics/opioids-chronic-pain/protocol.
This is to notify the public that the EPC Program would find the
following information on Opioid Treatments for Chronic Pain 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, please provide 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 will be very beneficial to the EPC 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.
The Key Questions:
Key Question 1. Effectiveness and Comparative Effectiveness
a. In patients with chronic pain, what is the effectiveness of
opioid therapy versus placebo or no opioid therapy for outcomes related
to pain, function, and quality of life, after short-term follow-up (up
to 6 months), intermediate-term follow-up (6 to 12 months), and long-
term follow-up (at least 1 year)?
b. How does effectiveness vary depending on:
(1) the specific type or cause of pain (e.g., neuropathic,
musculoskeletal [including low back pain], visceral pain, fibromyalgia,
sickle cell disease, inflammatory pain, headache disorders, and degree
of nociplasticity);
(2) patient demographics (e.g., age, race, ethnicity, gender,
socioeconomic status);
(3) patient comorbidities (including past or current alcohol or
substance use disorders, mental health disorders, medical comorbidities
and high risk for opioid use disorder);
(4) the mechanism of action of opioids used (e.g., pure opioid
agonists, partial opioid agonists such as buprenorphine or drugs with
mixed opioid and nonopioid mechanisms of action such as tramadol or
tapentadol)?
c. In patients with chronic pain, what is the comparative
effectiveness of opioids versus nonopioid therapies (pharmacologic or
nonpharmacologic, including marijuana) on outcomes related to pain,
function, and quality of life, after short-term follow-up (up to 6
months), intermediate-term follow-up (6 to 12 months), and long-term
follow-up (at least 1 year)?
d. In patients with chronic pain, what is the comparative
effectiveness of opioids plus nonopioid interventions (pharmacologic or
nonpharmacologic, including marijuana) versus opioids or nonopioid
interventions alone on outcomes related to pain, function, quality of
life, and doses of opioids
[[Page 10081]]
used, after short-term follow-up (up to 6 months), intermediate-term
follow-up (6 to 12 months), and long-term follow-up (at least 1 year)?
Key Question 2. Harms and Adverse Events
a. In patients with chronic pain, what are the risks of opioids
versus placebo or no opioid on:
(1) substance misuse, substance use disorder, and related outcomes;
(2) overdose (intentional and unintentional);
(3) other harms, including gastrointestinal-related harms, falls,
fractures, motor vehicle accidents, endocrinological harms, infections,
cardiovascular events, cognitive harms, and psychological harms (e.g.,
depression)?
b. How do harms vary depending on:
(1) the specific type or cause of pain (e.g., neuropathic,
musculoskeletal [including back pain], visceral pain, fibromyalgia,
sickle cell disease, inflammatory pain, headache disorders, and degree
of nociplasticity);
(2) patient demographics;
(3) patient comorbidities (including past or current substance use
disorder or at high risk for opioid use disorder);
(4) the dose of opioids used and duration of therapy;
(5) the mechanism of action of opioids used (e.g., are there
differences between pure opioid agonists and partial opioid agonists
such as buprenorphine or drugs with opioid and nonopioid mechanisms of
action such as tramadol and tapentadol);
(6) use of sedative hypnotics;
(7) use of gabapentinoids;
(8) use of marijuana?
Key Question 3. Dosing Strategies
a. In patients with chronic pain, what is the comparative
effectiveness of different methods for initiating and titrating opioids
for outcomes related to pain, function, and quality of life; risk of
misuse, opioid use disorder, and overdose; and doses of opioids used?
b. In patients with chronic pain, what is the comparative
effectiveness of short-acting versus long-acting opioids on outcomes
related to pain, function, and quality of life; risk of misuse, opioid
use disorder, and overdose; and doses of opioids used?
c. In patients with chronic pain, what is the comparative
effectiveness of different long-acting opioids on outcomes related to
pain, function, and quality of life; and risk of misuse, opioid use
disorder, and overdose?
d. In patients with chronic pain, what is the comparative
effectiveness of short- plus long-acting opioids versus long-acting
opioids alone on outcomes related to pain, function, and quality of
life; risk of misuse, opioid use disorder, and overdose; and doses of
opioids used?
e. In patients with chronic pain, what is the comparative
effectiveness of scheduled, continuous versus as-needed dosing of
opioids on outcomes related to pain, function, and quality of life;
risk of misuse, opioid use disorder, and overdose; and doses of opioids
used?
f. In patients with chronic pain, what is the comparative
effectiveness of opioid dose escalation versus dose maintenance or use
of dose thresholds on outcomes related to pain, function, and quality
of life?
g. In patients with chronic pain, what is the comparative
effectiveness of opioid rotation versus maintenance of current opioid
therapy on outcomes related to pain, function, and quality of life; and
doses of opioids used?
h. In patients with chronic pain, what is the comparative
effectiveness of different strategies for treating acute exacerbations
of chronic pain on outcomes related to pain, function, and quality of
life?
i. In patients with chronic pain, what are the effects of
decreasing opioid doses or of tapering off opioids versus continuation
of opioids on outcomes related to pain, function, quality of life, and
withdrawal?
j. In patients with chronic pain, what is the comparative
effectiveness of different tapering protocols and strategies on
measures related to pain, function, quality of life, withdrawal
symptoms, and likelihood of opioid cessation?
k. In patients with chronic pain, what is the comparative
effectiveness of different opioid dosages and durations of therapy for
outcomes related to pain, function, and quality of life; risk of
misuse, opioid use disorder, and overdose?
Key Question 4. Risk Assessment and Risk Mitigation Strategies
a. In patients with chronic pain being considered for opioid
therapy, what is the accuracy of instruments and tests (including
metabolic and/or genetic testing) for predicting risk of misuse, opioid
use disorder, and overdose?
b. In patients with chronic pain, what is the effectiveness of use
of risk prediction instruments and tests (including metabolic and/or
genetic testing) on outcomes related to misuse, opioid use disorder,
and overdose?
c. In patients with chronic pain who are prescribed opioid therapy,
what is the effectiveness of risk mitigation strategies, including (1)
opioid management plans, (2) patient education, (3) urine drug
screening, (4) use of prescription drug monitoring program data, (5)
use of monitoring instruments, (6) more frequent monitoring intervals,
(7) pill counts, (8) use of abuse-deterrent formulations, (9)
consultation with mental health providers when mental health conditions
are present, (10) avoidance of co-prescribing of sedative hypnotics,
and (11) co-prescribing of naloxone on outcomes related to misuse,
opioid use disorder, and overdose?
d. In patients with chronic pain, what is the comparative
effectiveness of treatment strategies for managing patients with opioid
use disorder related to prescription opioids on outcomes related to
misuse, opioid use disorder, overdose, pain, function, and quality of
life?
[[Page 10082]]
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings)
----------------------------------------------------------------------------------------------------------------
Key question Population Intervention Comparator Outcome
----------------------------------------------------------------------------------------------------------------
1a, b................... Adults (age >=18 Long- or short- Placebo or no opioid Pain, function, and
years) with various acting opioids therapy. quality of life).
types of chronic (including partial
pain including agonists and dual
pregnant/breast- mechanism agents).
feeding women and Exclude: Intravenous
patients treated or intramuscular
with opioids for administration of
opioid use disorder. opioids..
Key Question 1b:
Subgroups: (1) The
specific type or
cause of pain
(e.g., neuropathic,
musculoskeletal
[including low back
pain],
fibromyalgia,
sickle cell
disease,
inflammatory pain,
and headache
disorders); (2)
patient
demographics (e.g.,
age, race,
ethnicity, gender);
(3) patient
comorbidities
(including past or
current alcohol or
substance use
disorders, mental
health disorders,
medical
comorbidities and
high risk for
opioid use
disorder)..
1c...................... Adults (age >=18 Long- or short- Nonopioid therapies Pain, function, and
years) with various acting opioids (pharmacologic quality of life;
types of chronic (including partial [antiepileptic doses of opioids
pain. agonists and dual drugs, used.
action medications). benzodiazepines,
Exclude: Intravenous nonsteroidal
or intramuscular antiinflammatory
administration of drugs, skeletal
opioids.. muscle relaxants,
serotonin
norepinephrine
reuptake
inhibitors, topical
lidocaine, topical
capsaicin, topical
diclofenac,
tricyclica
antidepressants,
acetaminophen,
memantine, and
marijuana/cannabis]
or nonpharmacologic
[noninvasive]).
1d...................... Adults (age >=18 Opioids plus Opioids or nonopioid Pain, function, and
years) with various nonopioid interventions quality of life,
types of chronic interventions alone, including doses of opioids
pain. (pharmacologic or marijuana. used.
nonpharmacologic).
Exclude: Intravenous
or intramuscular
administration of
opioids..
2a...................... Adults (age >=18 Long- or short- Placebo or no opioid Substance misuse,
years) with various acting opioids substance use
types of chronic (including disorder and
pain. tapentadol, related outcomes,
Key Question 2b: buprenorphine, and overdose, and other
Subgroups (1) the tramadol) opioids. harms.
specific type or Exclude: Intravenous
cause of pain or intramuscular
(e.g., neuropathic, administration of
musculoskeletal opioids..
[including back
pain],
fibromyalgia,
sickle cell
disease,
inflammatory pain,
headache
disorders); (2)
patient
demographics; (3)
patient
comorbidities
(including past or
current substance
use disorder or at
high risk for
opioid use
disorder); (4) the
dose of opioids
used; (5) the
mechanisms of
actions of the
opioids; and (6)
use of sedative
hypnotics..
3a...................... Adults (age >=18 Long- or short- Other opioids with Pain, function, and
years) with various acting opioids different dose quality of life;
types of chronic (including initiation and doses of opioids
pain. tapentadol, titration used.
buprenorphine, and strategies.
tramadol).
3b...................... Adults (age >=18 Short-acting opioid. Long-acting opioid.. Pain, function, and
years) with various quality of life;
types of chronic risk of misuse,
pain. opioid use
disorder, overdose
and other harms;
doses of opioids
used.
3c...................... Adults (age >=18 Long-acting opioid.. Other long-acting Pain, function, and
years) with various opioid. quality of life;
types of chronic risk of misuse,
pain. opioid use
disorder, and
overdose and other
harms; doses of
opioids used.
3d...................... Adults (age >=18 Short and long Long-acting opioid.. Pain, function, and
years) with various acting opioid. quality of life;
types of chronic risk of misuse,
pain. opioid use
disorder, overdose
and other harms;
doses of opioids
used.
3e...................... Adults (age >=18 Scheduled, As-needed dosing.... Pain, function, and
years) with various continuous dosing. quality of life;
types of chronic risk of misuse,
pain. opioid use
disorder, overdose,
and other harms;
doses of opioids
used.
3f...................... Adults (age >=18 Opioid dose Dose maintenance or Pain, function, and
years) with various escalation. use of dose quality of life.
types of chronic thresholds.
pain.
3g...................... Adults (age >=18 Opioid rotation..... Maintenance of Pain, function, and
years) with various current opioid quality of life;
types of chronic therapy. doses of opioids
pain. used.
3h...................... Adults (age >=18 Treatments for acute Other treatments for Pain, function, and
years) with various exacerbations of acute exacerbations quality of life.
types of chronic chronic pain. of chronic pain.
pain and an acute
exacerbation.
[[Page 10083]]
3i...................... Adults (age >=18 Decreasing opioid Continuation of Pain, function, and
years) with various doses or of opioids. quality of life;
types of chronic tapering off withdrawal and
pain. opioids. other harms
(including
overdose, use of
illicit opioids,
suicidality, and
anger/violence).
3j...................... Adults (age >=18 Tapering protocols Other tapering Pain, function,
years) with various and strategies. protocols or quality of life,
types of chronic strategies. likelihood of
pain. opioid cessation,
withdrawal symptoms
and other harms
(including
overdose, use of
illicit opioids,
suicidality, and
anger/violence).
3k...................... Adults (age >=18 Dosage of opioid.... Other dose of same Pain, function, and
years) with various opioid. quality of life;
types of chronic risk of misuse,
pain. opioid use
disorder, overdose
and other harms.
4a...................... Adults (age >=18 Instruments, genetic/ Reference standard Measures of
years) with various metabolic tests for for misuse, opioid diagnostic
types of chronic predicting risk of use disorder, or accuracy.
pain. misuse, opioid use overdose; or other
disorder, and benchmarks.
overdose.
4b...................... Adults (age >=18 Use of risk Usual care or other Misuse, opioid use
years) with various prediction control. disorder, overdose
types of chronic instruments, and other harms.
pain. genetic/metabolic
tests.
4c...................... Adults (age >=18 Risk mitigation Usual care.......... Pain, function,
years) with various strategies, quality of life,
types of chronic including (1) misuse, opioid use
pain. opioid management disorder, overdose
plans, (2) patient and other harms
education, (3) (including use of
urine drug illicit opioids,
screening, (4) use suicidality, and
of prescription anger/violence).
drug monitoring
program data, (5)
use of monitoring
instruments, (6)
more frequent
monitoring
intervals, (7) pill
counts, (8) use of
abuse-deterrent
formulations, (9)
consultation with
mental health
providers when
mental health
conditions are
present, (10)
avoidance of
benzodiazepine co-
prescribing and
(11) co-prescribing
of naloxone.
4d...................... Adults (age >=18 Treatment strategies Other treatment Pain, function,
years) with various strategies. quality of life,
types of chronic misuse, opioid use
pain and opioid use disorder, overdose,
disorder. other harms, pain,
function, and
quality of life.
----------------------------------------------------------------------------------------------------------------
Additional Inclusion Criteria
Timing
For all questions, studies with at least 1 month of
followup will be included. Results will be stratified according to
short-term (1 to 6 months), intermediate term (6 to 12 months), and
long-term (>=1 year) followup.
Setting
Include: Outpatient settings (e.g., primary care, pain
clinics, other specialty clinics, emergency rooms, urgent care
clinics).
Exclude: Addiction treatment settings, inpatient settings.
Gopal Khanna,
Director.
[FR Doc. 2019-05145 Filed 3-18-19; 8:45 am]
BILLING CODE 4160-90-P
