[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Notices]
[Pages 41315-41317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14735]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Radiation Therapy for 
Bone Metastases

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 Radiation 
Therapy for Bone Metastases, 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published and unpublished pertinent scientific information will improve 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 August 11, 2022.

ADDRESSES: 
    Email submissions: <a href="/cdn-cgi/l/email-protection#6d081d0e2d0c051f1c4305051e430a021b"><span class="__cf_email__" data-cfemail="b1d4c1d2f1d0d9c3c09fd9d9c29fd6dec7">[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#1b7e6b785b7a73696a35737368357c746d"><span class="__cf_email__" data-cfemail="f1948192b190998380df999982df969e87">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Center (EPC) 
Program to complete a review of the evidence for Radiation Therapy for 
Bone Metastases. 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 Radiation Therapy for Bone Metastases, including those 
that describe adverse events. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/radiation-therapy-bone-metastases/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Radiation Therapy for Bone Metastases 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 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

[[Page 41316]]

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 (KQ)

    KQ 1: What is the effectiveness and what are the harms of external 
beam radiation therapy (EBRT) in the palliative treatment of bone 
metastases in symptomatic adults when combined with additional 
therapies (e.g., surgery, radionuclide therapy, bisphosphonate therapy, 
ablation kyphoplasty/vertebroplasty) compared with EBRT alone?
    KQ 2: For symptomatic adults with bone metastases who will receive 
initial radiation for palliation, what is the comparative effectiveness 
and what are the comparative harms of dose-fractionation schemes and 
techniques for delivery (e.g., three-dimensional conformal radiation 
therapy, stereotactic body radiation)?
    KQ 3: For symptomatic adults with bone metastases who will receive 
re-irradiation for palliation, what is the comparative effectiveness 
and what are the comparative harms of dose-fractionation schemes and 
techniques for delivery (e.g., three-dimensional conformal radiation 
therapy, stereotactic body radiation)?

Contextual Questions (CQ)

    CQ 1: What are common barriers and facilitators to implementing 
guidance in radiation oncology, specifically related to palliative 
radiation for metastatic bone disease (MBD)?
    CQ 2: What strategies could be used to promote the use and 
implementation of guidance in radiation oncology, specifically related 
to palliative radiation for MBD?
    CQ 3: In symptomatic patients considered for palliative radiation 
therapy for MBD, to what extent does patient financial distress/
hardship differ between EBRT dose/fraction schemes or technique?

 PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
                                Setting)
------------------------------------------------------------------------
                                       Inclusion            Exclusion
------------------------------------------------------------------------
Population.....................  KQ 1: Symptomatic      <bullet>
                                  adults with cancer     Patients <18
                                  that has               years old.
                                  metastasized to the   <bullet>
                                  bone.                  Asymptomatic
                                 KQ 2: Symptomatic       patients.
                                  adults with bone      <bullet>
                                  metastases who will    Patients with
                                  receive initial        primary bone
                                  palliative radiation.  tumors.
                                 KQ 3: Symptomatic
                                  adults with bone
                                  metastases who will
                                  receive re-radiation
                                  for palliation.
                                 For all KQ: Consider
                                  patient and clinical
                                  characteristics
                                  (e.g., age, sex,
                                  social determinants
                                  of health, primary
                                  tumor histology,
                                  site of metastases).
Interventions..................  KQ 1: External beam    KQ 1, 2, 3:
                                  radiation therapy      Proton beam
                                  for the palliative     therapy.
                                  management of bone    KQ1:
                                  metastasis with co-    Brachytherapy.
                                  interventions,
                                  additional therapies
                                  (e.g., surgery,
                                  radionuclide
                                  therapy,
                                  bisphosphonate
                                  therapy, ablation,
                                  kyphoplasty/
                                  vertebroplasty).
                                 KQ 2 and KQ 3:
                                  Comparisons of dose-
                                  fractionation
                                  schemes for EBRT,
                                  comparisons of EBRT
                                  techniques (e.g.,
                                  conventional RT vs.
                                  SBRT, SBRT vs. IMRT).
Comparators....................  KQ 1: No
                                  cointervention
                                  (i.e., EBRT alone).
                                 KQ 2 and KQ 3:
                                  Comparisons of dose-
                                  fractionation
                                  schemes, comparisons
                                  of EBRT modalities/
                                  techniques.
Outcomes.......................  Effectiveness:.......  <bullet> Non-
                                 Primary outcomes:....   validated
                                 <bullet> Pain (level    measurement
                                  and duration).         instruments for
                                 <bullet> Skeletal       clinician or
                                  function.              patient rated
                                 <bullet> Relief of      outcomes (e.g.,
                                  spinal cord            pain, function,
                                  compression.           HRQOL).
                                 <bullet> Quality of
                                  life.
                                 Additional
                                  (secondary)
                                  outcomes:
                                 <bullet> Local
                                  recurrence.
                                 <bullet> Fracture
                                  prevention.
                                 <bullet> Overall
                                  survival.
                                 <bullet> Need for re-
                                  radiation.
                                 <bullet> Use of pain
                                  medication, need for
                                  other interventions
                                  for pain relief.
                                 Harms and adverse
                                  events: Harms (e.g.,
                                  rate of radiation/
                                  treatment toxicity,
                                  radiation-induced
                                  fracture rates,
                                  reduced mobility,
                                  reduced
                                  independence),
                                  adverse events (pain
                                  flare, radiation
                                  recall, fatigue,
                                  skin changes, etc.).
Timing.........................  Any (timing may        None.
                                  depend on treatments
                                  provided and
                                  outcomes assessed).
Setting........................  Any..................  None.

[[Page 41317]]

 
Study design and publication     All KQ: Focus will be  General:
 dates.                           on the best evidence  <bullet>
                                  available that         Dosimetry
                                  permits direct         modeling
                                  comparisons to         studies.
                                  answer key questions. <bullet> Non-
                                 RCTs will be            human studies.
                                  initially sought; in  <bullet> NRSI
                                  the absence of RCTs,   for
                                  prospective            effectiveness
                                  comparative studies    if RCTs are
                                  that control for       available.
                                  confounding will be   <bullet> Studies
                                  considered; if no      with <10
                                  comparative            patients per
                                  prospective studies    arm.
                                  are available,        <bullet> Single
                                  retrospective          arm studies
                                  comparative studies    (unless no
                                  that control for       comparative
                                  confounding will be    studies); if
                                  considered.            used, exclude
                                 In the absence of       studies of <10
                                  comparative studies,   patients.
                                  single arm (e.g.,     <bullet> Case
                                  case series, pre-      reports.
                                  post studies) may be  Publication
                                  considered.            dates: Prior to
                                 For evaluation of       1985.
                                  harms, comparative    Publication
                                  cohort and case-       types:
                                  control studies will   Conference
                                  be included; we will   abstracts or
                                  focus on studies       proceedings,
                                  specifically           editorials,
                                  designed to evaluate   letters, white
                                  harms.                 papers,
                                 Studies of at least     citations that
                                  10 patients per        have not been
                                  treatment arm..        peer-reviewed,
                                                         single site
                                                         reports of
                                                         multi-site
                                                         studies.
------------------------------------------------------------------------
EBRT = external beam radiation therapy; HRQOL = health-related quality
  of life; IMRT = intensity modulated radiation therapy; KQ = key
  question; NRSI = nonrandomized studies of intervention; RCT =
  randomized controlled trial; RT = radiation therapy; SBRT =
  stereotactic radiation therapy.


    Dated: July 6, 2022.
Mamatha Pancholi,
Acting Chief of Staff, Chief Data Officer.
[FR Doc. 2022-14735 Filed 7-11-22; 8:45 am]
BILLING CODE 4160-90-P


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