[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Pages 52339-52341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20690]
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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.
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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 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published and unpublished pertinent scientific information will improve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: http://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: http://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: http://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: http://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
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Dated: August 26, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-20690 Filed 9-2-14; 8:45 am]
BILLING CODE 4160-90-M