Scientific Information Request on Emerging Approaches To Diagnosis and Treatment of Non-Muscle-Invasive Bladder Cancer, 52339-52341 [2014-20690]
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Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices
• For adverse events: immediate
Settings
• Primary care (outpatient) or acute care
setting, preferentially
• Outpatient rheumatology practices/
academic medical centers
Dated: August 26, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–20689 Filed 9–2–14; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Scientific Information Request on
Emerging Approaches To Diagnosis
and Treatment of Non-Muscle-Invasive
Bladder Cancer
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Scientific
Information 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 of
Emerging Approaches to Diagnosis and
Treatment of Non-Muscle-Invasive
Bladder Cancer, which is currently
being conducted by the Evidence-based
Practice Centers for the AHRQ Effective
Health Care Program. Access to
published and unpublished pertinent
scientific information will improve the
quality of this review. AHRQ is
conducting this systematic review
pursuant to Section 1013 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173, and Section
902(a) of the Public Health Service Act,
42 U.S.C. 299a(a).
DATES: Submission Deadline on or
before October 3, 2014.
ADDRESSES: Online submissions: https://
effectivehealthcare.AHRQ.gov/
index.cfm/submitscientific-informationpackets/. Please select the study for
which you are submitting information
from the list to upload your documents.
Email submissions: SIPS@epc-src.org.
Print submissions:
Mailing Address: Portland VA
Research Foundation, Scientific
Resource Center, ATTN: Scientific
Information Packet Coordinator, PO Box
69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.):
Portland VA Research Foundation,
Scientific Resource Center, ATTN:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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18:17 Sep 02, 2014
Jkt 232001
Scientific Information Packet
Coordinator, 3710 SW U.S. Veterans
Hospital Road, Mail Code: R&D 71,
Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT:
Ryan McKenna, Telephone: 503–220–
8262 ext. 58653 or Email: SIPS@epcsrc.org.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the Effective
Health Care (EHC) Program Evidencebased Practice Centers to complete a
review of the evidence for Emerging
Approaches to Diagnosis and Treatment
of Non-Muscle-Invasive Bladder Cancer.
The EHC 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 Emerging Approaches to
Diagnosis and Treatment of NonMuscle-Invasive Bladder Cancer,
including those that describe adverse
events. The entire research protocol,
including the key questions, is also
available online at: https://
effectivehealthcare.AHRQ.gov/searchfor-guides-reviews-and-reports/
?pageaction=displayproduct&product
ID=1941.
This notice is to notify the public that
the EHC Program would find the
following information on Emerging
Approaches to Diagnosis and Treatment
of Non-Muscle-Invasive Bladder Cancer
helpful:
• A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicafTrials.gov along with the
ClinicalTrials.gov trial number.
• For completed studies that do not
have results on ClinicalTrials.gov,
please provide 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.
• 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,
PO 00000
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Fmt 4703
Sfmt 4703
52339
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
• 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 will be very
beneficial to the EHC Program. The
contents of all submissions will be made
available to the public upon request.
Materials submitted must be publicly
available or can 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 EHC
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 EHC Program Web site 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://effectivehealthcare.AHRO.gov/
index.cfm/join-the-email-list1/.
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. The entire
research protocol, is also available
online at: https://effectivehealth
care.AHRO.gov/search-for-guidesreviews-and-reports/
?pageaction=displayproduct&productID
=1941.
The Key Questions
Key Question 1
What is the diagnostic accuracy of
various urinary biomarkers compared
with other urinary biomarkers or
standard diagnostic methods
(cystoscopy, cytology, and imaging) in
(1) persons with signs or symptoms
warranting evaluation for possible
bladder cancer or (2) persons
undergoing surveillance for previously
treated bladder cancer?
• Does the diagnostic accuracy differ
according to patient characteristics (e.g.,
age, sex, ethnicity), or according to the
nature of the presenting signs or
symptoms?
Key Question 2
For patients with non-muscleinvasive bladder cancer, does the use of
a formal risk-adapted assessment
approach to treatment decisions (e.g.,
E:\FR\FM\03SEN1.SGM
03SEN1
52340
Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices
Guidelines of the European Association
of Urology or based on urinary
biomarker tests) decrease mortality or
improve other outcomes (e.g.,
recurrence, progression, need for
cystectomy, quality of life) compared
with treatment not guided by an
assessed risk-adapted approach?
Key Question 3
For patients with non-muscleinvasive bladder cancer treated with
transurethral resection of bladder tumor
(TURBT), what is the effectiveness of
various intravesical chemotherapeutic
or immunotherapeutic agents for
decreasing mortality or improving other
outcomes (e.g., recurrence, progression,
need for cystectomy, quality of life)
compared with other agents, TURBT
alone, or cystectomy?
• What is the comparative
effectiveness of various
chemotherapeutic or
imnnunotherapeutic agents, as
monotherapy or in combination?
• Does the comparative effectiveness
differ according to tumor characteristics,
such as histology, stage, grade, size, or
molecular/genetic markers?
• Does the comparative effectiveness
of various chemotherapeutic or
immunotherapeutic agents differ
according to dosing frequency, duration
of treatment, and/or the timing of
administration relative to TURBT?
• Does the comparative effectiveness
differ according to patient
characteristics, such as age, sex,
ethnicity, performance status, or
medical comorbidities?
mstockstill on DSK4VPTVN1PROD with NOTICES
Key Question 4
For patients with high risk nonmuscle-invasive bladder cancer treated
with TURBT, what is the effectiveness
of external beam radiation therapy
(either alone or with systemic
chernotherapy/immunotherapy) for
decreasing mortality or improving other
outcomes compared with intravesical
chemotherapy/immunotherapy alone or
cystectomy?
Key Question 5
In surveillance of patients treated for
non-muscle-invasive bladder cancer,
what is the effectiveness of various
urinary biomarkers to decrease mortality
or improve other outcomes compared
with other urinary biomarkers or
standard diagnostic methods
(cystoscopy, cytology, and imaging)?
• Does the comparative effectiveness
differ according to tumor characteristics,
such as histology, stage, grade, size, or
molecular/genetic markers?
• Does the comparative effectiveness
differ according to the treatment used
VerDate Mar<15>2010
17:40 Sep 02, 2014
Jkt 232001
(i.e., specific chemotherapeutic or
immunotherapeutic agents and/or
TURBT)?
• Does the comparative effectiveness
differ according to the length of
surveillance intervals?
• Does the comparative effectiveness
differ according to patient
characteristics, such as age, sex, or
ethnicity?
• For KQ 2: Risk-adapted treatment
approaches
• For KQ 3a, 3b, 3c, 3d, and 8:
Intravesical chemotherapeutic or
immunotherapeutic agents b
• For KQ 4: External beam radiation
therapy, with or without systemic
chemotherapy or immunotherapy
• For KQ 6: Blue light or other methods
of augmented cystoscopy
Key Question 6
Comparators
For initial diagnosis or surveillance of
patients treated for non-muscle-invasive
bladder cancer, what is the effectiveness
of blue light or other methods of
augmented cystoscopy compared with
standard cystoscopy for recurrence
rates, progression of bladder cancer,
mortality, or other clinical outcomes?
• For KQ 1, 5, and 7: Other urinary
biomarkers or standard diagnostic
methods (cystoscopy, cytology, and
imaging)
• For KQ 2: Treatment not guided by
risk-adapted approach
• For KQ 3a, 3b, 3c, 3d, and 8: Other
intravesical chemotherapeutic or
innmunotherapeutic agent, different
dose or duration of intravesical
chemotherapy or immunotherapy, or
transurethral resection of bladder
tumor (TURBT) alone
• For KQ 4: Intravesical
chemotherapeutic or
immunotherapeutic agents or
cystectomy
Key Question 7
What are the comparative adverse
effects of various tests for diagnosis and
post-treatment surveillance of bladder
cancer, including urinary biomarkers,
cytology, and cystoscopy?
Key Question 8
What are the comparative adverse
effects of various treatments for nonmuscle-invasive bladder cancer,
including intravesical chemotherapeutic
or immunotherapeutic agents and
TURBT?
• How do adverse effects of treatment
vary by patient characteristics, such as
age, sex, ethnicity, performance status,
or medical connorbidities such as
chronic kidney disease?
PICOTS (Population, Intervention,
Comparator, Outcome, Timing, Setting)
Population(s)
• For KQ 1, 6, and 7: Adults with signs
or symptoms of possible bladder
cancer (e.g., gross or microscopic
hematurla, irritative voiding
symptoms)
• For KQ 2: Adults with non-muscleinvasive bladder cancer (stages Ta,
Tis, or Ti)
• For KQ 3 and 8: Adults with nonmuscle invasive bladder cancer
treated with TURBT
• For KQ 4 and 8: Adults with high-risk
non-muscle invasive bladder cancer
treated with TURBT
• For KQs 1 and 5 through 7: Adults
undergoing surveillance following
treatment for non-muscle invasive
bladder cancer
Interventions
• For KQ 1, 5, and 7: Urinary
biomarkers a
a Restricted to tests that are approved for
diagnosis of bladder cancer by the U.S. Food and
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Fmt 4703
Sfmt 4703
Outcomes
• For KQ 1 and 5: Diagnostic accuracy,
using cystoscopy with biopsy as the
reference standard
• For KQ 2, KQ 3, KQ 4, KQ 5:
Mortality, disease-specific and allcause
• For KQ 2, KQ 3, KQ 4, KQ 5: Need
for cystectomy
• For KQ 2, KQ 3, KQ 4, KQ 5, KQ 6:
Recurrence of cancer
• For KQ 2, KQ 3, KQ 4, KQ 5:
Progression of cancer
• For KQ 2, KQ 3, KQ 4, KQ 5: Quality
of life
• For KQ 7: Adverse effects of
diagnostic testing (e.g., false-positives,
labeling, anxiety, complications of
cystoscopy)
• For KQ 8: Adverse effects of treatment
(e.g., cystitis, urinary urgency, urinary
frequency, incontinence, hematuria,
pain, urosepsis, myelosuppression
Timing
Any duration of follow-up
Settings
• Inpatient settings
• Outpatient settings
Drug Administration (BTAstat® [BTA], Alere
NMP228, BladderChek® [NMP22], UroVysion®
[FISH] and ImmunoCytrm [immunocytology]) or
available in the U.S. and classified as a Laboratory
Developed Test by the FDA (CxBladderrm).
b Chemotherapeutic and immunotherapeutic
agents of interest include: mitomycin; apaziquone;
paclitaxel; gemcitabine; thiotepa; valrubicin;
doxorubicin; bacillus Calnnette-Guerin (BCG); and
interferon.
E:\FR\FM\03SEN1.SGM
03SEN1
52341
Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices
Dated: August 26, 2014.
Richard Kronick,
AHRQ Director.
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395-5806. Written
comments should be received within 30
days of this notice.
[FR Doc. 2014–20690 Filed 9–2–14; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–14–14AAO]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
Proposed Project
Testing Act Early Messages and
Materials for ‘‘Learn the Signs. Act
Early.’’—Phase II,—New—National
Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The CDC initiated the ‘‘Learn the
Signs. Act Early.’’ (LTSAE) campaign in
2004 in an effort to improve the
likelihood that children with
developmental disabilities are identified
and connected with appropriate services
at the earliest age possible. To this end,
the campaign’s overall goal has been to
empower parents to ‘‘Act Early’’ if they
have concerns about their child’s
development. Children from families
insured by Medicaid and those from
families with low incomes are at higher
risk for developmental delays and
disabilities, and thus are the target
audience for the campaign.
The study described in this
information collection request seeks to
assess the impact of ‘‘Act Early’’
messages embedded within LTSAE
campaign materials. To achieve this
goal, we will work with our contractor,
Westat, to test revised draft messages
and materials with low-income parents
through focus groups and intercept
interviews administered via the web on
a tablet device. Parents/guardians who
are age 18–55 and who have children
age 5 or younger will recruited from six
primary care practices (3 in the
Baltimore, Maryland metropolitan area
and 3 in the Atlanta, Georgia
metropolitan area) to participate in
focus groups followed by an intercept
interview.
Selected primary care practices will
see children as part of their patient
population and consist of a substantial
number of low income families. Each of
the six selected practices will receive
study promotional materials, including
a poster to hang in the office and
waiting room as well as handouts to
leave at the front desk. These materials
will advertise the focus groups and
outline eligibility criteria.
Parents interested in participating
will be advised to call an 800 number
to be screened and scheduled for a
group discussion (if eligible). The 800
number will be staffed by the Westat
study team who will be responsible for
screening and scheduling.
Representatives from each of the
practices will be provided with brief
‘‘talking points’’ and study FAQs to
refer to if interested parents have any
basic questions about the study. It is
estimated that 80 respondents will have
to be screened in order to recruit 40
participants for the focus groups.
The focus groups will have 10
participants each. Four focus groups
will be conducted in two locations (the
metropolitan areas of Atlanta, Georgia
and Baltimore, Maryland) with a total of
40 participants. Parents/guardians will
be asked to complete an informed
consent, which will take approximately
15 minutes to review and the focus
group discussion using the moderator’s
guide will take 60 minutes to complete.
Both of these focus group activities will
have a total burden of 50 hours.
We plan to conduct a total of 40
intercept interviews. The intercept
interviews will take place in the waiting
rooms or right outside the waiting
rooms. Parents will be recruited as they
are waiting for their appointment. It is
estimated that 80 respondents will have
to be screened in order to recruit 40
participants. Twenty interviews will be
conducted in each of two locations
(Atlanta, Georgia and Baltimore,
Maryland). The intercept interview will
be conducted as a computer-assisted
personal interviewing (CAPI) and will
take each respondent approximately 15
minutes to complete, for an estimated
total burden of 10 hours.
The total estimated burden for this
data collection is 74 hours. There is no
cost to respondents other than their
time.
mstockstill on DSK4VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Parents/Guardians
Parents/Guardians
Parents/Guardians
Parents/Guardians
VerDate Mar<15>2010
...........................
...........................
...........................
...........................
17:40 Sep 02, 2014
Number of
respondents
Form name
Focus Group Screener .................................................
Focus Group Informed Consent ...................................
Focus Group Moderator’s Guide ..................................
Intercept Interview Screener .........................................
Jkt 232001
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80
40
40
80
03SEN1
Number of
responses per
respondent
1
1
1
1
Average
burden per
response
in hours)
5/60
15/60
1
5/60
]]>Agencies
[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Pages 52339-52341]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20690]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Scientific Information Request on Emerging Approaches To
Diagnosis and Treatment of Non-Muscle-Invasive Bladder Cancer
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Scientific Information 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 of Emerging
Approaches to Diagnosis and Treatment of Non-Muscle-Invasive Bladder
Cancer, which is currently being conducted by the Evidence-based
Practice Centers for the AHRQ Effective Health Care Program. Access to
published and unpublished pertinent scientific information will improve
the quality of this review. AHRQ is conducting this systematic review
pursuant to Section 1013 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, Public Law 108-173, and
Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
DATES: Submission Deadline on or before October 3, 2014.
ADDRESSES: Online submissions: https://effectivehealthcare.AHRQ.gov/index.cfm/submitscientific-information-packets/. Please select the
study for which you are submitting information from the list to upload
your documents.
Email submissions: src.org">SIPS@epc-src.org.
Print submissions:
Mailing Address: Portland VA Research Foundation, Scientific
Resource Center, ATTN: Scientific Information Packet Coordinator, PO
Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): Portland VA Research
Foundation, Scientific Resource Center, ATTN: Scientific Information
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D
71, Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262
ext. 58653 or Email: src.org">SIPS@epc-src.org.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Effective Health Care (EHC) Program
Evidence-based Practice Centers to complete a review of the evidence
for Emerging Approaches to Diagnosis and Treatment of Non-Muscle-
Invasive Bladder Cancer.
The EHC 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 Emerging Approaches to Diagnosis and Treatment of Non-
Muscle-Invasive Bladder Cancer, including those that describe adverse
events. The entire research protocol, including the key questions, is
also available online at: https://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1941.
This notice is to notify the public that the EHC Program would find
the following information on Emerging Approaches to Diagnosis and
Treatment of Non-Muscle-Invasive Bladder Cancer helpful:
A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicafTrials.gov along with the
ClinicalTrials.gov trial number.
For completed studies that do not have results on
ClinicalTrials.gov, please provide 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.
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.
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 will be very beneficial to the EHC Program. The
contents of all submissions will be made available to the public upon
request. Materials submitted must be publicly available or can 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 EHC
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 EHC Program Web
site 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://effectivehealthcare.AHRO.gov/index.cfm/join-the-email-list1/.
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. The entire research
protocol, is also available online at: https://effectivehealthcare.AHRO.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1941.
The Key Questions
Key Question 1
What is the diagnostic accuracy of various urinary biomarkers
compared with other urinary biomarkers or standard diagnostic methods
(cystoscopy, cytology, and imaging) in (1) persons with signs or
symptoms warranting evaluation for possible bladder cancer or (2)
persons undergoing surveillance for previously treated bladder cancer?
Does the diagnostic accuracy differ according to patient
characteristics (e.g., age, sex, ethnicity), or according to the nature
of the presenting signs or symptoms?
Key Question 2
For patients with non-muscle-invasive bladder cancer, does the use
of a formal risk-adapted assessment approach to treatment decisions
(e.g.,
[[Page 52340]]
Guidelines of the European Association of Urology or based on urinary
biomarker tests) decrease mortality or improve other outcomes (e.g.,
recurrence, progression, need for cystectomy, quality of life) compared
with treatment not guided by an assessed risk-adapted approach?
Key Question 3
For patients with non-muscle-invasive bladder cancer treated with
transurethral resection of bladder tumor (TURBT), what is the
effectiveness of various intravesical chemotherapeutic or
immunotherapeutic agents for decreasing mortality or improving other
outcomes (e.g., recurrence, progression, need for cystectomy, quality
of life) compared with other agents, TURBT alone, or cystectomy?
What is the comparative effectiveness of various
chemotherapeutic or imnnunotherapeutic agents, as monotherapy or in
combination?
Does the comparative effectiveness differ according to
tumor characteristics, such as histology, stage, grade, size, or
molecular/genetic markers?
Does the comparative effectiveness of various
chemotherapeutic or immunotherapeutic agents differ according to dosing
frequency, duration of treatment, and/or the timing of administration
relative to TURBT?
Does the comparative effectiveness differ according to
patient characteristics, such as age, sex, ethnicity, performance
status, or medical comorbidities?
Key Question 4
For patients with high risk non-muscle-invasive bladder cancer
treated with TURBT, what is the effectiveness of external beam
radiation therapy (either alone or with systemic chernotherapy/
immunotherapy) for decreasing mortality or improving other outcomes
compared with intravesical chemotherapy/immunotherapy alone or
cystectomy?
Key Question 5
In surveillance of patients treated for non-muscle-invasive bladder
cancer, what is the effectiveness of various urinary biomarkers to
decrease mortality or improve other outcomes compared with other
urinary biomarkers or standard diagnostic methods (cystoscopy,
cytology, and imaging)?
Does the comparative effectiveness differ according to
tumor characteristics, such as histology, stage, grade, size, or
molecular/genetic markers?
Does the comparative effectiveness differ according to the
treatment used (i.e., specific chemotherapeutic or immunotherapeutic
agents and/or TURBT)?
Does the comparative effectiveness differ according to the
length of surveillance intervals?
Does the comparative effectiveness differ according to
patient characteristics, such as age, sex, or ethnicity?
Key Question 6
For initial diagnosis or surveillance of patients treated for non-
muscle-invasive bladder cancer, what is the effectiveness of blue light
or other methods of augmented cystoscopy compared with standard
cystoscopy for recurrence rates, progression of bladder cancer,
mortality, or other clinical outcomes?
Key Question 7
What are the comparative adverse effects of various tests for
diagnosis and post-treatment surveillance of bladder cancer, including
urinary biomarkers, cytology, and cystoscopy?
Key Question 8
What are the comparative adverse effects of various treatments for
non-muscle-invasive bladder cancer, including intravesical
chemotherapeutic or immunotherapeutic agents and TURBT?
How do adverse effects of treatment vary by patient
characteristics, such as age, sex, ethnicity, performance status, or
medical connorbidities such as chronic kidney disease?
PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)
Population(s)
For KQ 1, 6, and 7: Adults with signs or symptoms of possible
bladder cancer (e.g., gross or microscopic hematurla, irritative
voiding symptoms)
For KQ 2: Adults with non-muscle-invasive bladder cancer
(stages Ta, Tis, or Ti)
For KQ 3 and 8: Adults with non-muscle invasive bladder cancer
treated with TURBT
For KQ 4 and 8: Adults with high-risk non-muscle invasive
bladder cancer treated with TURBT
For KQs 1 and 5 through 7: Adults undergoing surveillance
following treatment for non-muscle invasive bladder cancer
Interventions
For KQ 1, 5, and 7: Urinary biomarkers \a\
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\a\ Restricted to tests that are approved for diagnosis of
bladder cancer by the U.S. Food and Drug Administration
(BTAstat[supreg] [BTA], Alere NMP228, BladderChek[supreg] [NMP22],
UroVysion[supreg] [FISH] and ImmunoCytrm [immunocytology]) or
available in the U.S. and classified as a Laboratory Developed Test
by the FDA (CxBladderrm).
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For KQ 2: Risk-adapted treatment approaches
For KQ 3a, 3b, 3c, 3d, and 8: Intravesical chemotherapeutic or
immunotherapeutic agents \b\
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\b\ Chemotherapeutic and immunotherapeutic agents of interest
include: mitomycin; apaziquone; paclitaxel; gemcitabine; thiotepa;
valrubicin; doxorubicin; bacillus Calnnette-Guerin (BCG); and
interferon.
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For KQ 4: External beam radiation therapy, with or without
systemic chemotherapy or immunotherapy
For KQ 6: Blue light or other methods of augmented cystoscopy
Comparators
For KQ 1, 5, and 7: Other urinary biomarkers or standard
diagnostic methods (cystoscopy, cytology, and imaging)
For KQ 2: Treatment not guided by risk-adapted approach
For KQ 3a, 3b, 3c, 3d, and 8: Other intravesical
chemotherapeutic or innmunotherapeutic agent, different dose or
duration of intravesical chemotherapy or immunotherapy, or
transurethral resection of bladder tumor (TURBT) alone
For KQ 4: Intravesical chemotherapeutic or immunotherapeutic
agents or cystectomy
Outcomes
For KQ 1 and 5: Diagnostic accuracy, using cystoscopy with
biopsy as the reference standard
For KQ 2, KQ 3, KQ 4, KQ 5: Mortality, disease-specific and
all-cause
For KQ 2, KQ 3, KQ 4, KQ 5: Need for cystectomy
For KQ 2, KQ 3, KQ 4, KQ 5, KQ 6: Recurrence of cancer
For KQ 2, KQ 3, KQ 4, KQ 5: Progression of cancer
For KQ 2, KQ 3, KQ 4, KQ 5: Quality of life
For KQ 7: Adverse effects of diagnostic testing (e.g., false-
positives, labeling, anxiety, complications of cystoscopy)
For KQ 8: Adverse effects of treatment (e.g., cystitis,
urinary urgency, urinary frequency, incontinence, hematuria, pain,
urosepsis, myelosuppression
Timing
Any duration of follow-up
Settings
Inpatient settings
Outpatient settings
[[Page 52341]]
Dated: August 26, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-20690 Filed 9-2-14; 8:45 am]
BILLING CODE 4160-90-M
