Notice2022-14735
Supplemental Evidence and Data Request on Radiation Therapy for Bone Metastases
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 12, 2022
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 87 Issue 132 (Tuesday, July 12, 2022)</title>
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[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Notices]
[Pages 41315-41317]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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published and unpublished pertinent scientific information will improve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: <a href="https://effectivehealthcare.ahrq.gov/products/radiation-therapy-bone-metastases/protocol">https://effectivehealthcare.ahrq.gov/products/radiation-therapy-bone-metastases/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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)
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Inclusion Exclusion
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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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