Supplemental Evidence and Data Request on Radiation Therapy for Brain Metastases: A Systematic Review
| Published date | 03 February 2020 |
| Record Number | 2020-01996 |
| Section | Notices |
| Court | Agency For Healthcare Research And Quality |
Federal Register, Volume 85 Issue 22 (Monday, February 3, 2020)
[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]
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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
Brain Metastases: A 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 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 Access to published and unpublished pertinent scientific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)
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PICOTS Inclusion Exclusion
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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.
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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
