Supplemental Evidence and Data Request on Therapies for Clinically Localized Prostate Cancer, 49304-49305 [2019-20303]
Download as PDF
<![CDATA[
49304
Federal Register / Vol. 84, No. 182 / Thursday, September 19, 2019 / Notices
access, utilization, cost, safety, and
quality of hospital, physician, and other
services. Disseminates data, tools, and
statistics to facilitate and inform public
and private health policy analysis,
clinical studies, and socioeconomic
research to inform public and private
healthcare policy.
Division of Survey Operations (DSO):
Responsible for the MEPS data
collection, processing and distribution
activities. These responsibilities include
directing data collection for the three
major MEPS surveys, preparing data
files for public use, conducting
workshops on the appropriate use of
MEPS data and the development of a
website for disseminating MEPS
products. Publishes statistical briefs,
research findings and a series of
methodological reports. Administers a
data center at which researchers can,
with approved projects and under
specific technical controls and privacy
protocols, access data that cannot be
released to the public for use in specific
research activities. Maintains liaisons
with individuals and organizations
engaged in health services research both
within and outside the federal
government.
All delegations and redelegations of
authority to officers and employees of
the Agency for Healthcare Research and
Quality that were in effect immediately
prior to the effective date of this
reorganization shall continue in effect
pending further redelegation provided
they are consistent with this
reorganization.
These changes are effective upon date
of signature.
Dated: September 18, 2019.
Gopal Khanna,
Director.
[FR Doc. 2019–20218 Filed 9–18–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Therapies for Clinically
Localized Prostate Cancer
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
jbell on DSK3GLQ082PROD with NOTICES
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
SUMMARY:
VerDate Sep<11>2014
17:30 Sep 18, 2019
Jkt 247001
Therapies for Clinically Localized
Prostate Cancer, 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: Comments
must be received on or before 30 days
after date of publication of this notice.
ADDRESSES:
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 Therapies for Clinically
Localized Prostate Cancer. AHRQ is
conducting this systematic review
pursuant to Section 902(a) of the Public
Health Service Act, 42 U.S.C. 299a(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 Therapies for Clinically
Localized Prostate Cancer, including
those that describe adverse events. The
entire research protocol is available
online at: https://
effectivehealthcare.ahrq.gov/products/
prostate-cancer-therapies/protocol.
This is to notify the public that the
EPC Program would find the following
information on Therapies for Clinically
Localized Prostate Cancer 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.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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 1: What are the comparative
effectiveness and harms of CLPC
therapies?
(1) Watchful waiting
(2) Active surveillance
(3) Androgen deprivation therapy (ADT)
(4) Focal therapies
(a) Brachytherapy
(b) Cryotherapy
(c) High-intensity focused ultrasound
(HIFU)
(d) Laser ablation
E:\FR\FM\19SEN1.SGM
19SEN1
Federal Register / Vol. 84, No. 182 / Thursday, September 19, 2019 / Notices
(e) Photodynamic therapy
(f) Irreversible electroporation
(5) Whole gland therapies
(a) Brachytherapy
(b) Cryotherapy
(c) External beam radiation therapy
(i) three-dimensional conformal
radiotherapy
(ii) intensity-modulated radiation
therapy
(iii) proton beam therapy
(iv) stereotactic body radiation
therapy
(d) Radical prostatectomy
(i) open
(ii) laparoscopic
(1) without robotic assistance
(2) with robotic assistance
(6) Combination of above
KQ 2: How do patient characteristics
modify comparative effectiveness and
harms of CLPC therapies?
(1) Age
(2) Race/ethnicity
(3) Comorbidities
(4) Health status
KQ 3: How do tumor characteristics
modify comparative effectiveness and
harms of CLPC therapies?
(1) Baseline PSA
(2) Gleason score
(3) Tumor index scores (e.g., Cancer of
the Prostate Risk Assessment Score
[CAPRA], D’Amico Risk
Classification for Prostate Cancer,
etc.)
(4) Biomarker Status
(a) Decipher (Genomic Classifier)
(b) Oncotype Dx (Genomic Prostate
Score)
(c) Prolaris (Cell Cycle Progression)
KQ 4: How do provider/hospital
characteristics modify comparative
effectiveness of RP compared to other
therapies?
(1) Geographic region
(2) Hospital type
(3) Provider volume
(4) Institutional volume
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
Interventions
KQ1 to 3
jbell on DSK3GLQ082PROD with NOTICES
(1) Radical prostatectomy (RP)
Comparators
KQ1 to KQ4
• Any other intervention of listed above
except certain within category
comparisons (e.g., nerve-sparing vs
non-nerve sparing prostatectomy;
different dosage/frequency/timing/
duration of same therapy)
(1) Watchful waiting (WW)
(2) Active surveillance (AS)
(3) Androgen deprivation therapy (ADT)
(4) Focal therapies
(a) Brachytherapy
(b) Cryotherapy
(c) High-intensity focused ultrasound
Jkt 247001
KQ1 to KQ3
• Overall survival/mortality
• Prostate cancer specific survival/
mortality
• Metastatic-progression free survival
• Metastases (lymph nodes/distant)
• Health status
• Quality of life (measured with
validated instruments)
• Prostate-cancer related quality of life
(measured with validated
instruments)
KQ4
• Overall survival/mortality
• Prostate cancer specific survival/
mortality
• Metastatic free survival/metastases
(lymph nodes/distant)
Common and serious treatment side
effects:
• Bowel, bladder, and sexual/erectile
dysfunction
• Serious adverse effects associated
with ADT such as cognitive
impairment, MACE, fractures
Timing
KQ1 to KQ3
Follow up from treatment initiation:
PO 00000
Frm 00061
• Mortality/survival outcomes/
metastases: 5 years or more
• Health status, quality of life and
harms: 1 year or more
KQ4
Follow up from treatment initiation:
• Mortality/survival outcomes/
metastases: 5 years or more
Setting
KQ1 to KQ4
• All settings
Study Design
KQ1 to KQ4
(1) RCTs
(2) Non-RCT if:
(a) Comparative
(b) Concurrent
(c) Multicenter (enrolling patients
treated at multiple locations)
(d) ≥500 patients
(e) Some method to control for
selection bias (propensity scores,
instrumental variables, multivariate
regression)
(f) Prospective data collection
Dated: September 16, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–20303 Filed 9–18–19; 8:45 am]
BILLING CODE 4160–90–P
Outcomes
KQ1 to KQ3
• Treatment naı¨ve men with CLPC
(stages T1 to T3)
17:30 Sep 18, 2019
KQ4
Harms
Population(s)
VerDate Sep<11>2014
(HIFU)
(d) Laser ablation
(e) Photodynamic therapy
(f) Irreversible electroporation
(5) Whole gland therapies
(a) Brachytherapy
(b) Cryotherapy
(c) External beam radiation therapy
(i) Three-dimensional conformal
radiotherapy
(ii) Intensity-modulated radiation
therapy
(iii) Proton beam therapy
(iv) Stereotactic body radiation
therapy
(d) Radical prostatectomy
(i) Open
(ii) Laparoscopic
(1) Without robotic assistance
(2) With robotic assistance
(6) Combination of above
49305
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review:
Assessing Models of Coordinated
Services for Low-Income Children and
Their Families (AMCS) (New
Collection)
Office of Planning, Research,
and Evaluation; ACF; HHS
ACTION: Request for public comment.
AGENCY:
The Office of Planning,
Research, and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
proposing to collect data for a new
study, Assessing Models of Coordinated
Services for Low-Income Children and
Their Families (AMCS).
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
SUMMARY:
E:\FR\FM\19SEN1.SGM
19SEN1
]]>Agencies
[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49304-49305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20303]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Therapies for
Clinically Localized Prostate Cancer
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 Therapies for
Clinically Localized Prostate Cancer, 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: Comments must be received on or before 30 days
after date of publication of this notice.
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 Therapies for
Clinically Localized Prostate Cancer. AHRQ is conducting this
systematic review pursuant to Section 902(a) of the Public Health
Service Act, 42 U.S.C. 299a(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 Therapies for Clinically Localized Prostate Cancer,
including those that describe adverse events. The entire research
protocol is available online at: https://effectivehealthcare.ahrq.gov/products/prostate-cancer-therapies/protocol.
This is to notify the public that the EPC Program would find the
following information on Therapies for Clinically Localized Prostate
Cancer 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 1: What are the comparative effectiveness and harms of CLPC
therapies?
(1) Watchful waiting
(2) Active surveillance
(3) Androgen deprivation therapy (ADT)
(4) Focal therapies
(a) Brachytherapy
(b) Cryotherapy
(c) High-intensity focused ultrasound (HIFU)
(d) Laser ablation
[[Page 49305]]
(e) Photodynamic therapy
(f) Irreversible electroporation
(5) Whole gland therapies
(a) Brachytherapy
(b) Cryotherapy
(c) External beam radiation therapy
(i) three-dimensional conformal radiotherapy
(ii) intensity-modulated radiation therapy
(iii) proton beam therapy
(iv) stereotactic body radiation therapy
(d) Radical prostatectomy
(i) open
(ii) laparoscopic
(1) without robotic assistance
(2) with robotic assistance
(6) Combination of above
KQ 2: How do patient characteristics modify comparative
effectiveness and harms of CLPC therapies?
(1) Age
(2) Race/ethnicity
(3) Comorbidities
(4) Health status
KQ 3: How do tumor characteristics modify comparative effectiveness
and harms of CLPC therapies?
(1) Baseline PSA
(2) Gleason score
(3) Tumor index scores (e.g., Cancer of the Prostate Risk Assessment
Score [CAPRA], D'Amico Risk Classification for Prostate Cancer, etc.)
(4) Biomarker Status
(a) Decipher (Genomic Classifier)
(b) Oncotype Dx (Genomic Prostate Score)
(c) Prolaris (Cell Cycle Progression)
KQ 4: How do provider/hospital characteristics modify comparative
effectiveness of RP compared to other therapies?
(1) Geographic region
(2) Hospital type
(3) Provider volume
(4) Institutional volume
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
Population(s)
Treatment na[iuml]ve men with CLPC (stages T1 to T3)
Interventions
KQ1 to 3
(1) Watchful waiting (WW)
(2) Active surveillance (AS)
(3) Androgen deprivation therapy (ADT)
(4) Focal therapies
(a) Brachytherapy
(b) Cryotherapy
(c) High-intensity focused ultrasound (HIFU)
(d) Laser ablation
(e) Photodynamic therapy
(f) Irreversible electroporation
(5) Whole gland therapies
(a) Brachytherapy
(b) Cryotherapy
(c) External beam radiation therapy
(i) Three-dimensional conformal radiotherapy
(ii) Intensity-modulated radiation therapy
(iii) Proton beam therapy
(iv) Stereotactic body radiation therapy
(d) Radical prostatectomy
(i) Open
(ii) Laparoscopic
(1) Without robotic assistance
(2) With robotic assistance
(6) Combination of above
KQ4
(1) Radical prostatectomy (RP)
Comparators
KQ1 to KQ4
Any other intervention of listed above except certain within
category comparisons (e.g., nerve-sparing vs non-nerve sparing
prostatectomy; different dosage/frequency/timing/duration of same
therapy)
Outcomes
KQ1 to KQ3
Overall survival/mortality
Prostate cancer specific survival/mortality
Metastatic-progression free survival
Metastases (lymph nodes/distant)
Health status
Quality of life (measured with validated instruments)
Prostate-cancer related quality of life (measured with
validated instruments)
KQ4
Overall survival/mortality
Prostate cancer specific survival/mortality
Metastatic free survival/metastases (lymph nodes/distant)
Harms
KQ1 to KQ3
Common and serious treatment side effects:
Bowel, bladder, and sexual/erectile dysfunction
Serious adverse effects associated with ADT such as cognitive
impairment, MACE, fractures
Timing
KQ1 to KQ3
Follow up from treatment initiation:
Mortality/survival outcomes/metastases: 5 years or more
Health status, quality of life and harms: 1 year or more
KQ4
Follow up from treatment initiation:
Mortality/survival outcomes/metastases: 5 years or more
Setting
KQ1 to KQ4
All settings
Study Design
KQ1 to KQ4
(1) RCTs
(2) Non-RCT if:
(a) Comparative
(b) Concurrent
(c) Multicenter (enrolling patients treated at multiple locations)
(d) >=500 patients
(e) Some method to control for selection bias (propensity scores,
instrumental variables, multivariate regression)
(f) Prospective data collection
Dated: September 16, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-20303 Filed 9-18-19; 8:45 am]
BILLING CODE 4160-90-P
