Supplemental Evidence and Data Request on Nonopioid Pharmacologic Treatments for Chronic Pain, 10076-10077 [2019-05142]

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Scientific information is being solicited to inform our review on Nonopioid Pharmacologic 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 SUMMARY: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 Nonopioid Pharmacologic 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 Nonopioid Pharmacologic Treatments for Chronic Pain, including those that describe adverse events. The entire research protocol is available online at: https:// effectivehealthcare.ahrq.gov/topics/ nonopioid-chronic-pain/protocol. This is to notify the public that the EPC Program would find the following information on Nonopioid Pharmacologic 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. E:\FR\FM\19MRN1.SGM 19MRN1 Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices 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 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 nonopioid pharmacologic agents versus placebo for outcomes related to pain, function, and quality of life, after short-term treatment duration (3 to 6 months), intermediateterm treatment duration (6 to 12 months), and long-term treatment duration (≥12 months)? b. In patients with chronic pain, what is the comparative effectiveness of nonopioid pharmacologic agents compared to other nonopioid pharmacologic agents for outcomes related to pain, function, and quality of life, after short-term treatment duration (3 to 6 months), intermediate-term treatment duration (6 to 12 months), and long-term treatment duration (≥12 months)? c. How does effectiveness or comparative effectiveness vary depending on: (1) The specific type or cause of pain, (2) patient demographics, (3) patient comorbidities, (4) the dose of medication used, (5) the duration of treatment, and (6) dose titration, including tapering. VerDate Sep<11>2014 17:54 Mar 18, 2019 Jkt 247001 Key Question 2. Harms and Adverse Events a. In patients with chronic pain, what are the risks of nonopioid pharmacologic agents for harms including overdose, misuse, dependence, withdrawals due to adverse events, and serious adverse events (including falls, fractures, motor vehicle accidents), and specific adverse events, according to drug class? b. How do harms vary depending on: (1) The specific type or cause of pain, (2) patient demographics, (3) patient comorbidities, (4) the dose of medication used, (5) the duration of treatment, and (6) dose titration, including tapering. PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) Population(s): • For all Key Questions (KQs): Adults (age ≥18 years) with various types of chronic pain (defined as pain lasting >3 months), including patients with acute exacerbations of chronic pain, pregnant/ breastfeeding women, and patients with opioid use disorder • For KQs 1c, 2b: Subgroups of the above patient populations as defined by specific pain condition (neuropathic pain, musculoskeletal pain, fibromyalgia, inflammatory arthritis, and chronic headache), patient demographics (e.g., age, race, ethnicity, and sex), comorbidities and degree of nociplasticity/central sensitization. Interventions: • Oral pharmacologic agents: Nonsteroidal anti-inflammatory drugs, acetaminophen, muscle relaxants (including benzodiazepines), antidepressants, and anticonvulsants • Topical pharmacologic agents: diclofenac, capsaicin, and lidocaine • Medical cannabis (any formulation) Comparators: • For KQ 1a/c and KQ2: Placebo (effectiveness) • For KQ 1b/c and KQ2: Another included nonopioid pharmacologic agent, different doses, or treatment durations (comparative effectiveness) Outcomes: • KQ 1: Pain (intensity, severity, bothersomeness), function (physical disability, activity limitations, activity interference, work function), and quality of life (including depression) o Only validated scales for assessments of pain, function, and quality of life • KQ 2: For all drug classes: Overdose, misuse, dependence, withdrawals due to adverse events, and serious adverse events. Specific adverse events for each drug class, such as PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 10077 gastrointestinal events, cardiovascular events, and liver or kidney-related harms for non-steroidal antiinflammatory drugs; weight gain, sedation, and cognitive effects for gabapentin and pregabalin, etc. Timing: • Short-term treatment duration (3 to 6 months), intermediate-term treatment duration (6 to 12 months), and longterm treatment duration (≥12 months) • We will assess available literature to ensure that adequate evidence exists from studies of ≥3 months’ treatment duration. If adequate evidence is not available for this shorter-duration, we will consider adding shorter-duration studies. If high-quality systematic reviews are available covering the scope of the review for shorter duration studies, we will summarize these in this case Settings: • Outpatient settings (e.g., primary care, pain clinics, other specialty clinics) Gopal Khanna, Director. [FR Doc. 2019–05142 Filed 3–18–19; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: 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: ‘‘Hospital Survey on Patient Safety Culture Comparative Database.’’ DATES: Comments on this notice must be received by May 20, 2019. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov. Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by SUMMARY: E:\FR\FM\19MRN1.SGM 19MRN1

Agencies

[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Notices]
[Pages 10076-10077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Nonopioid Pharmacologic 
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 Nonopioid 
Pharmacologic 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 Nonopioid 
Pharmacologic 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 Nonopioid Pharmacologic Treatments for Chronic Pain, 
including those that describe adverse events. The entire research 
protocol is available online at: https://effectivehealthcare.ahrq.gov/topics/nonopioid-chronic-pain/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Nonopioid Pharmacologic 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.

[[Page 10077]]

    [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 
nonopioid pharmacologic agents versus placebo for outcomes related to 
pain, function, and quality of life, after short-term treatment 
duration (3 to 6 months), intermediate-term treatment duration (6 to 12 
months), and long-term treatment duration (>=12 months)?
    b. In patients with chronic pain, what is the comparative 
effectiveness of nonopioid pharmacologic agents compared to other 
nonopioid pharmacologic agents for outcomes related to pain, function, 
and quality of life, after short-term treatment duration (3 to 6 
months), intermediate-term treatment duration (6 to 12 months), and 
long-term treatment duration (>=12 months)?
    c. How does effectiveness or comparative effectiveness vary 
depending on: (1) The specific type or cause of pain, (2) patient 
demographics, (3) patient comorbidities, (4) the dose of medication 
used, (5) the duration of treatment, and (6) dose titration, including 
tapering.

Key Question 2. Harms and Adverse Events

    a. In patients with chronic pain, what are the risks of nonopioid 
pharmacologic agents for harms including overdose, misuse, dependence, 
withdrawals due to adverse events, and serious adverse events 
(including falls, fractures, motor vehicle accidents), and specific 
adverse events, according to drug class?
    b. How do harms vary depending on: (1) The specific type or cause 
of pain, (2) patient demographics, (3) patient comorbidities, (4) the 
dose of medication used, (5) the duration of treatment, and (6) dose 
titration, including tapering.
    PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings) Population(s):
     For all Key Questions (KQs): Adults (age >=18 years) with 
various types of chronic pain (defined as pain lasting >3 months), 
including patients with acute exacerbations of chronic pain, pregnant/
breastfeeding women, and patients with opioid use disorder
     For KQs 1c, 2b: Subgroups of the above patient populations 
as defined by specific pain condition (neuropathic pain, 
musculoskeletal pain, fibromyalgia, inflammatory arthritis, and chronic 
headache), patient demographics (e.g., age, race, ethnicity, and sex), 
comorbidities and degree of nociplasticity/central sensitization.

    Interventions:
 Oral pharmacologic agents: Nonsteroidal anti-inflammatory 
drugs, acetaminophen, muscle relaxants (including benzodiazepines), 
antidepressants, and anticonvulsants
 Topical pharmacologic agents: diclofenac, capsaicin, and 
lidocaine
 Medical cannabis (any formulation)

    Comparators:
 For KQ 1a/c and KQ2: Placebo (effectiveness)
 For KQ 1b/c and KQ2: Another included nonopioid pharmacologic 
agent, different doses, or treatment durations (comparative 
effectiveness)

    Outcomes:
 KQ 1: Pain (intensity, severity, bothersomeness), function 
(physical disability, activity limitations, activity interference, work 
function), and quality of life (including depression)
    o Only validated scales for assessments of pain, function, and 
quality of life
 KQ 2: For all drug classes: Overdose, misuse, dependence, 
withdrawals due to adverse events, and serious adverse events. Specific 
adverse events for each drug class, such as gastrointestinal events, 
cardiovascular events, and liver or kidney-related harms for non-
steroidal anti-inflammatory drugs; weight gain, sedation, and cognitive 
effects for gabapentin and pregabalin, etc.

    Timing:
 Short-term treatment duration (3 to 6 months), intermediate-
term treatment duration (6 to 12 months), and long-term treatment 
duration (>=12 months)
 We will assess available literature to ensure that adequate 
evidence exists from studies of >=3 months' treatment duration. If 
adequate evidence is not available for this shorter-duration, we will 
consider adding shorter-duration studies. If high-quality systematic 
reviews are available covering the scope of the review for shorter 
duration studies, we will summarize these in this case

    Settings:
 Outpatient settings (e.g., primary care, pain clinics, other 
specialty clinics)

Gopal Khanna,
Director.
[FR Doc. 2019-05142 Filed 3-18-19; 8:45 am]
BILLING CODE 4160-90-P