[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4077-4079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Interventional 
Treatments for Acute and Chronic Pain: Systematic Review

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

ACTION: Request for Supplemental Evidence and Data Submissions

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Interventional 
Treatments for Acute and Chronic Pain: Systematic Review, 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 Access to published and unpublished pertinent scientific 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 February 16, 2021.

ADDRESSES: 

    Email submissions: <a href="/cdn-cgi/l/email-protection#95f0e5f6d5f4fde7e4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="690c190a2908011b184701011a470e061f">[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#7d180d1e3d1c150f0c5315150e531a120b"><span class="__cf_email__" data-cfemail="ee8b9e8dae8f869c9fc086869dc0898198">[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 Interventional 
Treatments for Acute and Chronic Pain: Systematic Review. 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 Interventional Treatments for Acute and Chronic Pain, 
including those that describe adverse events. The entire research 
protocol is available online at: https://effectivehealthcare.ahrq.gov/products/interventional-treatments-pain/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Interventional Treatments for Acute and 
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

[[Page 4078]]

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)

    KQ1: What are the effectiveness and harms of selected 
interventional procedures (vertebral augmentation procedures, 
piriformis injection, sphenopalatine block, occipital nerve 
stimulation, cooled or pulsed radiofrequency ablation, intradiscal and 
facet joint platelet rich plasma, intradiscal methylene blue, 
intradiscal ozone, and peripheral nerve stimulation) versus placebo, a 
sham procedure, or no interventional procedure for Medicare 
beneficiaries with pain?
    a. How do the effectiveness and harms vary according to demographic 
(age, sex, race/ethnicity), clinical (type of pain, severity of pain, 
prior treatments, medical and psychiatric co-morbidities), and 
technical factors (variations in techniques, intensity, frequency, 
dose, and number of treatments)?
    PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings)

------------------------------------------------------------------------
              PICOTS                    Inclusion          Exclusion
------------------------------------------------------------------------
Population.......................  Adults with pain    <bullet> Patients
                                    of any duration     undergoing end-
                                    (pain conditions    of-life care,
                                    for each            terminally ill
                                    interventional      (e.g., hospice)
                                    procedure           patients; those
                                    specified below);   under supervised
                                    will highlight      palliative care;
                                    studies of          those with pain
                                    populations         due to
                                    applicable to       metastatic or
                                    Medicare, defined   advanced cancer.
                                    as persons         <bullet>
                                    enrolled in         Children.
                                    Medicare, age >55
                                    years, or persons
                                    with disability
                                    (including end-
                                    stage renal
                                    disease [ESRD]),
                                    if available.
                                   Population
                                    subgroups of
                                    interest include
                                    those based on
                                    demographics
                                    (age, sex, race/
                                    ethnicity) and
                                    clinical factors
                                    (type of pain,
                                    severity of pain,
                                    prior treatments,
                                    medical and
                                    psychiatric co-
                                    morbidities,
                                    including
                                    presence of
                                    disability
                                    [including ESRD],
                                    prior substance
                                    use disorder, and
                                    psychological co-
                                    morbidities).
Intervention.....................  (1) Vertebral       <bullet>
                                    augmentation        Minimally
                                    procedures          invasive
                                    (vertebroplasty     surgical
                                    and kyphoplasty)    procedures
                                    for pain due to    <bullet>
                                    vertebral           Orthopedic intra-
                                    compression         articular and
                                    fracture.           soft tissue
                                   (2) Piriformis       injections
                                    injection (local   <bullet> Local
                                    anesthetic,         soft tissue
                                    corticosteroid,     injections
                                    and/or botulinum   <bullet> Other
                                    toxin) for          interventional
                                    piriformis          procedures and
                                    syndrome.           conditions not
                                   (3) Sphenopalatine   listed as
                                    block for           included
                                    trigeminal
                                    neuralgia or
                                    headache.
                                   (4) Occipital
                                    stimulation for
                                    headache.
                                   (5) Cooled
                                    radiofrequency
                                    denervation for
                                    degenerative back
                                    or hip pain and
                                    pulsed
                                    radiofrequency
                                    denervation for
                                    degenerative back
                                    pain.
                                   (6) Intradiscal
                                    and facet joint
                                    platelet rich
                                    plasma for
                                    presumed
                                    discogenic back
                                    pain.
                                   (7) Intradiscal
                                    stem cells for
                                    presumed
                                    discogenic back
                                    pain.
                                   (8) Intradiscal
                                    methylene blue
                                    for presumed
                                    discogenic back
                                    pain.
                                   (9) Intradiscal
                                    ozone for
                                    radicular low
                                    back pain or non-
                                    radicular,
                                    presumed
                                    discogenic back
                                    pain.
                                   (10) Peripheral
                                    nerve stimulation
                                    for ulnar,
                                    median, or radial
                                    neuropathy.
                                   Technical factors
                                    of interest as
                                    potential
                                    modifiers of
                                    treatment effect
                                    include
                                    variations in
                                    techniques,
                                    intensity,
                                    frequency, dose,
                                    or number of
                                    treatments.
Comparator.......................  Placebo, sham       Active
                                    interventional      treatments,
                                    procedure, or no    other than
                                    interventional      standard
                                    procedure.          radiofrequency
                                   For cooled and       denervation as a
                                    pulsed              comparison for
                                    radiofrequency      cooled
                                    denervation:        radiofrequency
                                    standard            denervation.
                                    (thermal,
                                    continuous)
                                    radiofrequency
                                    denervation.
Outcome..........................  <bullet> Primary:   Patient-oriented
                                    Pain, function.     outcomes:
                                   <bullet>            <bullet> Non-
                                    Secondary: HRQOL,   validated
                                    emotional           instruments for
                                    function (e.g.,     outcomes (e.g.,
                                    depression,         pain, function,
                                    anxiety), opioid    HRQOL,
                                    use, surgery        depression,
                                    rates.              etc.).
                                   <bullet> Global     <bullet>
                                    improvement.        Intermediate
                                   <bullet> Harms       outcomes (e.g.,
                                    (e.g., bleeding,    range of motion,
                                    infection, other    physical
                                    complications),     strength, etc.).
                                    adverse events,
                                    unintended
                                    consequences.

[[Page 4079]]

 
Timing...........................  Duration of         <1 month.
                                    followup: >=1
                                    month;
                                    categorized as
                                    short term (1 to
                                    <6 months),
                                    intermediate term
                                    (>=6 to <12
                                    months) and long
                                    term (>=12
                                    months) following
                                    intervention.
Setting..........................  Any...............  None.
Study design, publication type...  Randomized          <bullet> Case
                                    clinical trials     reports.
                                    and cohort         <bullet> Case
                                    studies if RCTs     series (other
                                    are not             than large case
                                    available..         series for
                                   Large (n > 500)      serious, rare
                                    case series for     harms).
                                    serious, rare      <bullet> Case-
                                    harms.              control studies,
                                                        cross-sectional
                                                        studies.
                                                       <bullet>
                                                        Conference
                                                        proceedings,
                                                        editorials,
                                                        letters, white
                                                        papers,
                                                        citations that
                                                        have not been
                                                        peer-reviewed.
------------------------------------------------------------------------


Marquita Cullom,
Associate Director.
[FR Doc. 2021-00800 Filed 1-14-21; 8:45 am]
BILLING CODE 4160-90-P


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