[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 Access to published and unpublished pertinent scientific 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