[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73710-73712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25451]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Integrated Pain 
Management Programs

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 Integrated Pain 
Management Programs, 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unpublished pertinent scientific information will improve the quality 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 December 21, 2020.

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 Integrated Pain 
Management Programs. 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 Integrated Pain Management Programs, including those 
that describe adverse events. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/integrated-pain-management/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Integrated Pain Management Programs 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

[[Page 73711]]

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 (KQs)

    KQ1: What are the effectiveness and harms of integrated or 
comprehensive pain management programs for Medicare beneficiaries with 
complex acute/subacute pain or chronic, non-active cancer pain? 
Population subgroups of interest include those with disabilities 
(including ESRD), prior substance use disorder, psychological co-
morbidities (including suicidal behaviors), and degree of 
nociplasticity.
    KQ2: Have any of the following factors been evaluated and/or shown 
to impact outcomes in studies of comprehensive or integrated pain 
management models?
    a. Treatment delivery including session formats (group, one-on-
one), duration, intensity and frequency of sessions, number of 
sessions; general structure and scope of sessions.
    b. Treatment components (e.g., medication review and/or management, 
including transition from opioid to nonopioid medications; 
psychological support or mental health services; physical 
reconditioning, such as physical therapy and occupational therapy; use 
of complementary and integrative medicine treatments; patient 
education; use of medical procedures or devices).
    c. Care provision.

i. Care coordination methods or decision support
ii. Provider types involved
iii. Personalization, care pathways
    d. Program characteristics.

i. Program emphasis/goals
ii. Target population
iii. Referral sources
iv. Staffing characteristics (e.g., turn over)

                  PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings)
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                PICOTS                                  Inclusion                            Exclusion
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Population...........................  Medicare beneficiaries (i.e., adults >=65    Patients undergoing
                                        years old and those under 65 years old      end-of-life care, terminally
                                        who qualify for Medicare due to             ill (e.g., hospice)
                                        disability including ESRD) with complex     patients; those under
                                        acute/subacute pain \a\ or chronic non-     supervised palliative care.
                                        active cancer pain.\b\ In the absence of    Young, non-disabled
                                        publications in Medicare populations,       populations.
                                        studies of adults with these types of
                                        pain will be considered.
                                       Population subgroups of interest include
                                        those with disabilities (including ESRD),
                                        prior substance use disorder,
                                        psychological co-morbidities (including
                                        suicidal behaviors), degree of
                                        nociplasticity.\c\
Intervention.........................  Pain management programs that address the    Unimodal pain
                                        biopsychosocial model of pain and           management.
                                        include:                                    Pain management
                                        Multidisciplinary                   confined to a single
                                        (interdisciplinary) teams that at a         provider type, practice, or
                                        minimum have the following components       isolated method of
                                        available: Pharmacotherapy review and/or    management.
                                        management, psychological care (mental      Programs focused on
                                        health services), and physical              functional restoration and/
                                        reconditioning (e.g., PT, OT); studies      or occupational health
                                        may also include other components in        focused on return to work
                                        addition to these; and                      such as work hardening
                                        Description of care coordination,   programs, unless they are
                                        case management or mechanisms of            specifically done in a
                                        multidisciplinary, interdisciplinary        Medicare eligible population
                                        collaboration and communication.            or are clearly applicable to
                                       Integrated pain management programs          the Medicare population.
                                        (IPMPs) will be defined as those that       Programs in very
                                        include the above and are based in          young and non-disabled
                                        primary care. Comprehensive pain            populations (e.g., military
                                        management programs (CPMPs) will be         populations).
                                        defined as those including the above but    Studies evaluating
                                        are not based in primary care.              incremental value of adding
                                                                                    a single treatment modality
                                                                                    to another single treatment
                                                                                    modality (e.g., addition of
                                                                                    CBT to PT).
                                                                                    Post-operative or
                                                                                    post-trauma rehabilitation
                                                                                    programs.
Comparator...........................  Any.                                        None.
Outcome..............................  Patient oriented outcomes:                  Patient-oriented outcomes:
                                           Primary: Pain, function (focus      Non-validated
                                           on ``success'' if reported), opioid         instruments for outcomes
                                           use.                                        (e.g., pain, function,
                                        Secondary: HRQOL, emotional            HRQOL, depression, etc.)
                                        function (e.g., depression, anxiety),       Intermediate
                                        patient satisfaction, global improvement.   outcomes (e.g., range of
                                                                                    motion, physical strength,
                                                                                    etc.).
                                       Harms, adverse events, unintended
                                        consequences Program-related outcomes:
                                           Utilization (e.g., pain-
                                           related hospital/ED visits or short-
                                           term skilled nursing facility use,
                                           long term care facility or
                                           institutional care transfer, Medicaid
                                           enrollment).

[[Page 73712]]

 
Timing...............................  Duration of follow up: Focus on
                                        persistence of effects evaluated short
                                        term (1 to <6 months), intermediate term
                                        (>=6 to <12 months) and long term (>=12
                                        months) following intervention.
Setting..............................  Outpatient, inpatient, institutional         Inpatient or
                                        residence.                                  outpatient settings
                                                                                    exclusively providing
                                                                                    treatment for SUD/OUD or
                                                                                    tertiary care, hospice, or
                                                                                    similar settings.
Study design, publication type.......  Inclusion will focus on RCTs. Prospective    Case reports.
                                        cohort studies that control for             Case series (unless
                                        confounding will be considered if RCTs      no comparative studies).
                                        are not available. Comparative cohorts      Case-control
                                        that do not control for confounding will    studies, cross-sectional
                                        be considered if cohorts controlling for    studies.
                                        confounding are not available. In the       Conference
                                        absence of comparative studies, single      proceedings, editorials,
                                        arm (e.g., case series, pre-post studies)   letters, white papers,
                                        will be considered if they are clearly      citations that have not been
                                        relevant to the Medicare population.        peer-reviewed.
----------------------------------------------------------------------------------------------------------------
CBT = Cognitive Behavioral Therapy; ED = emergency department; ESDR = end stage renal disease; HRQOL = Health-
  related quality of life; OT = occupational therapy; OUD = opioid use disorder; PICOTS = population,
  intervention, comparator, outcomes, timing, study design; PT = physical therapy; RCT = randomized control
  trial; SUD = substance use disorder.
\a\ Complex acute or subacute pain: Patients with acute pain (<6 weeks duration) or subacute pain (6 weeks to 12
  weeks duration) who are at risk of developing chronic pain).
\b\ Chronic, nonactive cancer pain (based on Mersky 1994): Pain that persists for at least three months and is
  not associated with [active] malignant disease''; pain could, however, be resultant from a previous malignancy
  that is no longer active.
\c\ The term nociplasticity has been used to describe pain resulting from altered nociception without underlying
  tissue damage resulting in hypersensitivity (e.g., fibromyalgia). Many pain conditions may have a nociplastic
  component. Some additional terms used in the literature include centralized pain and amplified pain.


    Dated: November 13, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020-25451 Filed 11-18-20; 8:45 am]
BILLING CODE 4160-90-P