Supplemental Evidence and Data Request on Radiation Therapy for Brain Metastases: A Systematic Review, 5961-5963 [2020-01996]
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[FR Doc. 2020–02022 Filed 1–31–20; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Radiation Therapy for
Brain Metastases: A Systematic
Review
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Supplemental
Evidence and Data Submissions.
AGENCY:
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 Brain Metastases:
A 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unpublished pertinent scientific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 30 days after the date of
publication in the Federal Register.
SUMMARY:
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Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
Email submissions: epc@
ahrq.hhs.gov.
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: epc@ahrq.hhs.gov.
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 Radiation Therapy for
Brain Metastases: A Systematic Review.
AHRQ is conducting this systematic
review pursuant to Section 902(a) of the
Public Health Service Act, 42 U.S.C.
299b—37(a).
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
Brain Metastases: A Systematic Review,
including those that describe adverse
events. The entire research protocol is
available online at: https://
effectivehealthcare.ahrq.gov/products/
radiation-brain-metastases/protocol
This is to notify the public that the
EPC Program would find the following
information on Radiation Therapy for
Brain Metastases: A Systematic Review
helpful:
D 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.
ADDRESSES:
D 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.
D 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.
D 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 (KQ)
Key Question 1: What is the
effectiveness of whole brain radiation
therapy (WBRT), alone or in
combination with stereotactic
radiosurgery (SRS) or systemic
therapies, as initial treatment in patients
with brain metastases on patientrelevant outcomes, such as overall
survival and quality of life?
KQ1a. How does effectiveness vary by
dose fractionation schedule and
technique?
KQ1b. How does effectiveness differ
by patient prognosis and primary tumor
site?
KQ1c. How does effectiveness differ
by the addition of systemic therapies?
Key Question 2: What is the
effectiveness of SRS/fractionated
stereotactic radiation as initial treatment
in patients with brain metastases on
patient-relevant outcomes, such as
overall survival and quality of life?
KQ2a. How does effectiveness vary by
dose fractionation schedule and
technique?
KQ2b. How does effectiveness differ
by patient prognosis and primary tumor
site?
KQ2c. How does effectiveness differ
by the addition of systemic therapies?
Key Question 3: What is the
effectiveness (or comparative
effectiveness) of postoperative SRS
compared to WBRT, observation, or
preoperative SRS in patients with brain
metastases on patient-relevant
outcomes, such as overall survival and
quality of life?
KQ3a. How does effectiveness vary by
dose fractionation schedule?
Key Question 4: What are the adverse
effects (i.e., serious harms) of WBRT,
SRS, and systemic therapies for patients
with brain metastases (either alone or in
combination)?
KQ4a. Do adverse effects vary by
important patient characteristics (i.e.,
age, performance status, patient
prognosis, disease status, primary tumor
site) or dose fractionation schedule and
technique?
lotter on DSKBCFDHB2PROD with NOTICES
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)
PICOTS
Inclusion
Exclusion
Population ...........
• Primary research studies that include a majority (50% or more) of adult patients with metastases in the brain resulting from non-small cell lung cancer,
breast cancer, or melanoma.
Interventions .......
• Studies evaluating radiation therapy, including WBRT and SRS alone or in
combination, as initial or postoperative treatment, with or without systemic therapy (immunotherapy and chemotherapy).
• Study samples comprising patients
with cancer from other origins or primary
brain
tumors
(e.g.,
glioblastomas) and pediatric samples.
• Studies without WBRT or SRS treatment arms.
• Studies based exclusively on pre1990 data.
• Studies have to report on effects of radiation therapy in the 1990s or later.
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Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)—Continued
PICOTS
Inclusion
Exclusion
Comparators .......
• Studies comparing eligible interventions to other eligible interventions or other
management approaches (no intervention; waitlist; delayed intervention [radiation to be given at a later time]; placebo; observation, watchful waiting, or surveillance; supportive care, palliative care, or steroid treatment; usual care; systemic therapy, immunotherapy, or chemotherapy; WBRT; SRS; surgery; different dose fractionation schedules; different radiation therapy approaches; different intervention combinations).
• Studies reporting on patient health outcomes, such as .......................................
Æ overall survival, progression-free survival recurrence/cancer control (local
tumor control, intracranial control/complete response, partial response, stable response of all metastases);
• Studies comparing only non-intervention features (e.g., comparing two patient subgroups).
Outcomes ............
Timing .................
Setting(s) .............
Study design .......
Æ symptom burden, health status or health-related quality of life;
Æ functional status (physical, affective or neurocognition functions);.
Æ or adverse events, including acute and late toxicity (e.g., radiation necrosis, hair loss, or nausea).
• Patient health outcomes may include patient- and caregiver-reported outcomes as well as clinical, physician assessed, and hospital record outcomes and measures may include quantitative as well as qualitative reports and no restrictions will be imposed regarding the specific measurement, metric, aggregation method (e.g., mean, proportion), or timepoint.
• Studies will not be limited by the duration of the intervention or the length of
follow up.
• Inpatient and outpatient settings ...........................................................................
• Studies may include national and international settings ......................................
All KQs ......................................................................................................................
• RCTs ..............................................................................................................
• Studies with results published in clinicaltrial.gov will be included regardless
of whether a journal publication is available.
• English-language publications .......................................................................
KQ4 ...........................................................................................................................
• Prospective experimental and observational studies (including non-randomized clinical trials and cohort studies comparing 2 or more intervention
cohorts) of 200 patients or more or those that report a statistical power
analysis for adverse events.
Dated: January 29, 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director,
AHRQ.
[FR Doc. 2020–01996 Filed 1–31–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
lotter on DSKBCFDHB2PROD with NOTICES
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
VerDate Sep<11>2014
16:47 Jan 31, 2020
Jkt 250001
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)–
SIP20–008, Validation of Self-Reported
Vaccination among Adults.
Date: May 5, 2020.
Time: 11:00 a.m.–6:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
FOR FURTHER INFORMATION CONTACT: Jaya
Raman, Ph.D., Scientific Review Officer,
CDC, 4770 Buford Highway, Mailstop
F80, Atlanta, Georgia 30341, Telephone:
(770) 488–6511, kva5@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
PO 00000
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Fmt 4703
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• Studies reporting only on therapy acceptance, provider variables (e.g.,
provider knowledge), organizational
measures (e.g., wait times), treatment
utilization, or costs.
• No exclusions apply.
• Studies in resource-limited settings
such as developing countries will be
reviewed for comparability with US
settings.
• Studies without comparator (e.g., case
studies).
• Evaluations reported only in abbreviated format (e.g., in a conference
abstract) and that are not registered in
a research registry.
• Studies exclusively reported in nonEnglish publications will be retained
as a resource but will not be eligible
for inclusion.
• Systematic reviews will be retained for
reference mining.
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–01964 Filed 1–31–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 85, Number 22 (Monday, February 3, 2020)]
[Notices]
[Pages 5961-5963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01996]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Radiation Therapy for
Brain Metastases: A Systematic Review
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Supplemental Evidence and Data Submissions.
-----------------------------------------------------------------------
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 Brain Metastases: A 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 30 days after the date of
publication in the Federal Register.
[[Page 5962]]
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 Radiation Therapy for
Brain Metastases: A Systematic Review. AHRQ is conducting this
systematic review pursuant to Section 902(a) of the Public Health
Service Act, 42 U.S.C. 299b--37(a).
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 Brain Metastases: A Systematic
Review, including those that describe adverse events. The entire
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/radiation-brain-metastases/protocol
This is to notify the public that the EPC Program would find the
following information on Radiation Therapy for Brain Metastases: A
Systematic Review 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 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)
Key Question 1: What is the effectiveness of whole brain radiation
therapy (WBRT), alone or in combination with stereotactic radiosurgery
(SRS) or systemic therapies, as initial treatment in patients with
brain metastases on patient-relevant outcomes, such as overall survival
and quality of life?
KQ1a. How does effectiveness vary by dose fractionation schedule
and technique?
KQ1b. How does effectiveness differ by patient prognosis and
primary tumor site?
KQ1c. How does effectiveness differ by the addition of systemic
therapies?
Key Question 2: What is the effectiveness of SRS/fractionated
stereotactic radiation as initial treatment in patients with brain
metastases on patient-relevant outcomes, such as overall survival and
quality of life?
KQ2a. How does effectiveness vary by dose fractionation schedule
and technique?
KQ2b. How does effectiveness differ by patient prognosis and
primary tumor site?
KQ2c. How does effectiveness differ by the addition of systemic
therapies?
Key Question 3: What is the effectiveness (or comparative
effectiveness) of postoperative SRS compared to WBRT, observation, or
preoperative SRS in patients with brain metastases on patient-relevant
outcomes, such as overall survival and quality of life?
KQ3a. How does effectiveness vary by dose fractionation schedule?
Key Question 4: What are the adverse effects (i.e., serious harms)
of WBRT, SRS, and systemic therapies for patients with brain metastases
(either alone or in combination)?
KQ4a. Do adverse effects vary by important patient characteristics
(i.e., age, performance status, patient prognosis, disease status,
primary tumor site) or dose fractionation schedule and technique?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings)
----------------------------------------------------------------------------------------------------------------
PICOTS Inclusion Exclusion
----------------------------------------------------------------------------------------------------------------
Population.................... Primary research studies that include a Study samples
majority (50% or more) of adult patients with comprising patients with
metastases in the brain resulting from non-small cancer from other origins or
cell lung cancer, breast cancer, or melanoma. primary brain tumors (e.g.,
glioblastomas) and pediatric
samples.
Interventions................. Studies evaluating radiation therapy, Studies without WBRT
including WBRT and SRS alone or in combination, or SRS treatment arms.
as initial or postoperative treatment, with or Studies based
without systemic therapy (immunotherapy and exclusively on pre-1990
chemotherapy). data.
Studies have to report on effects of
radiation therapy in the 1990s or later.
[[Page 5963]]
Comparators................... Studies comparing eligible interventions Studies comparing
to other eligible interventions or other only non-intervention
management approaches (no intervention; features (e.g., comparing
waitlist; delayed intervention [radiation to be two patient subgroups).
given at a later time]; placebo; observation,
watchful waiting, or surveillance; supportive
care, palliative care, or steroid treatment;
usual care; systemic therapy, immunotherapy, or
chemotherapy; WBRT; SRS; surgery; different dose
fractionation schedules; different radiation
therapy approaches; different intervention
combinations).
Outcomes...................... Studies reporting on patient health Studies reporting
outcomes, such as. only on therapy acceptance,
[cir] overall survival, progression-free survival provider variables (e.g.,
recurrence/cancer control (local tumor control, provider knowledge),
intracranial control/complete response, partial organizational measures
response, stable response of all metastases);. (e.g., wait times),
treatment utilization, or
costs.
[cir] symptom burden, health status or health-
related quality of life;
[cir] functional status (physical, affective
or neurocognition functions);.
[cir] or adverse events, including acute and
late toxicity (e.g., radiation necrosis,
hair loss, or nausea).
Patient health outcomes may include
patient- and caregiver-reported outcomes as
well as clinical, physician assessed, and
hospital record outcomes and measures may
include quantitative as well as qualitative
reports and no restrictions will be imposed
regarding the specific measurement, metric,
aggregation method (e.g., mean, proportion),
or timepoint.
Timing........................ Studies will not be limited by the No exclusions apply.
duration of the intervention or the length of
follow up.
Setting(s).................... Inpatient and outpatient settings....... Studies in resource-
Studies may include national and limited settings such as
international settings. developing countries will be
reviewed for comparability
with US settings.
Study design.................. All KQs.......................................... Studies without
RCTs.................................... comparator (e.g., case
Studies with results published in studies).
clinicaltrial.gov will be included regardless of Evaluations reported
whether a journal publication is available. only in abbreviated format
English-language publications........... (e.g., in a conference
KQ4.............................................. abstract) and that are not
Prospective experimental and registered in a research
observational studies (including non-randomized registry.
clinical trials and cohort studies comparing 2 Studies exclusively
or more intervention cohorts) of 200 patients or reported in non-English
more or those that report a statistical power publications will be
analysis for adverse events. retained as a resource but
will not be eligible for
inclusion.
Systematic reviews
will be retained for
reference mining.
----------------------------------------------------------------------------------------------------------------
Dated: January 29, 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director, AHRQ.
[FR Doc. 2020-01996 Filed 1-31-20; 8:45 am]
BILLING CODE 4160-90-P
