[Federal Register Volume 85, Number 232 (Wednesday, December 2, 2020)]
[Notices]
[Pages 77466-77467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26570]



[[Page 77466]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Living Systematic 
Review on Plant-Based Treatment for Chronic Pain

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Supplemental Evidence and Data Submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our Living Systematic Review 
on Plant-Based Treatment 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Access to published and unpublished pertinent scientific information 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 January 4, 2021.

ADDRESSES: 
    Email submissions: <a href="/cdn-cgi/l/email-protection#86e3f6e5c6e7eef4f7a8eeeef5a8e1e9f0"><span class="__cf_email__" data-cfemail="4421342704252c36356a2c2c376a232b32">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#5336233013323b21227d3b3b207d343c25"><span class="__cf_email__" data-cfemail="6e0b1e0d2e0f061c1f4006061d40090118">[email protected]</span></a>.

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 a Living Systematic 
Review on Plant-Based Treatment for Chronic Pain. AHRQ is conducting 
this systematic review pursuant to Section 902 of the Public Health 
Service Act, 42 U.S.C. 299a.
    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 Plant-Based Treatment for Chronic Pain, including those 
that describe adverse events. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/plant-based-chronic-pain-treatment/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Plant-Based Treatment for Chronic Pain 
helpful:
    [squf] 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.
    [squf] 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.
    [squf] 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.
    [squf] 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 (KQs)

    1. In adults with chronic pain, what are the benefits of 
cannabinoids?
    2. In adults with chronic pain, what are the harms of cannabinoids?
    3. In adults with chronic pain, what are the benefits of kratom or 
other plant-based substances for treatment of chronic pain?
    4. In adults with chronic pain, what are the harms of kratom or 
other plant-based substances for treatment of chronic pain?

   PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
                                Settings)
------------------------------------------------------------------------
      PICOTS element          Inclusion criteria     Exclusion criteria
------------------------------------------------------------------------
Population................  All KQs: Adults        All KQs: Children and
                             (including pregnant    adolescents <18
                             or breastfeeding       years old; adults
                             women) 18 years and    with acute or
                             older with chronic     subacute pain;
                             pain (>12 weeks or     patients at end of
                             pain persisting past   life or in
                             the time for normal    palliative care
                             tissue healing). See   (e.g., with late
                             categorization of      stage cancer-related
                             specifically           pain).
                             included pain
                             populations below.
Interventions.............  KQs 1 and 2:           All KQs: Non-plant-
                             Cannabinoids           based interventions,
                             (including             capsaicin, herbal
                             synthetics) using      supplements.
                             different delivery
                             mechanisms such as
                             oral, buccal,
                             inhalational,
                             topical, or other
                             administration
                             routes.
                            KQs 3 and 4: Kratom
                             or other plant-based
                             substances; co-use
                             of kratom or other
                             plant-based
                             substances and
                             opioids.
                            All KQs: Co-use of
                             other drugs for
                             pain.
Comparators...............  All KQs: Any           All KQs: No
                             comparator, or usual   comparison.
                             care.

[[Page 77467]]

 
Outcomes..................  All KQs: Primary       All KQs: Other
                             efficacy outcomes      outcomes.
                             (i.e., pain,
                             function,
                             disability, pain
                             interference); harms
                             and adverse effects
                             (e.g., dizziness,
                             nausea, sedation,
                             development of
                             cannabis use
                             disorder); secondary
                             outcomes (i.e.,
                             psychological
                             distress including
                             depression and
                             anxiety, quality of
                             life, opioid use,
                             sleep quality, sleep
                             disturbance, health
                             care utilization).
Time of follow-up.........  All KQs: short term    All KQs: studies with
                             (1 to <6 months),      <1-month of
                             intermediate term (6   treatment or
                             to <12 months), long   followup after
                             term (>=1 year).       treatment.
Setting...................  All KQs: Any           All KQs: Hospital
                             nonhospital setting    care, hospice care,
                             or setting of self-    emergency department
                             directed care.         care.
Study design..............  All KQs: RCTs;         All KQs: Other study
                             observational          designs.
                             studies with a
                             concurrent control
                             group for harms, and
                             to fill gaps in the
                             evidence for
                             benefits.
------------------------------------------------------------------------
Abbreviations: RCT = randomized controlled trial.


    Dated: November 27, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020-26570 Filed 12-1-20; 8:45 am]
BILLING CODE 4160-90-P


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