Scientific Information Request on Imaging Techniques for the Surveillance, Diagnosis, and Staging of Hepatocellular Carcinoma, 49520-49523 [2013-19714]
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49520
Federal Register / Vol. 78, No. 157 / Wednesday, August 14, 2013 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents/
POCs
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Registration Form ............................................................................................
Health Plan Information Form .........................................................................
Data Use Agreement .......................................................................................
Data Files Submission .....................................................................................
80
80
60
80
7
160
3
320
a 47.34
c 37.63
$331
7,574
255
12,042
Total ..........................................................................................................
300
490
NA
20,202
a 47.34
b 85.02
* National
Compensation Survey: Occupational wages in the United States May 2012, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a Based on the mean hourly wage for Medical and Health Services Managers (11–9111).
b Based on the mean hourly wage for Chief Executives (11–1011).
c Based on the mean hourly wages for Computer Programmer (15–1131).
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: August 8, 2013.
Carolyn M. Clancy,
AHRQ Director.
[FR Doc. 2013–19712 Filed 8–13–13; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Agency for Healthcare Research and
Quality
Scientific Information Request on
Imaging Techniques for the
Surveillance, Diagnosis, and Staging
of Hepatocellular Carcinoma
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for scientific
information submissions.
AGENCY:
VerDate Mar<15>2010
16:16 Aug 13, 2013
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public on imaging techniques for the
surveillance, diagnosis, and staging of
hepatocellular carcinoma. Scientific
information is being solicited to inform
our review of Imaging Techniques for
the Surveillance, Diagnosis, and Staging
of Hepatocellular Carcinoma, 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 on
imaging techniques for the surveillance,
diagnosis, and staging of hepatocellular
carcinoma will improve the quality of
this review. AHRQ is conducting this
comparative effectiveness 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 September 13, 2013.
ADDRESSES:
Online submissions: https://
effectivehealthcare.AHRQ.gov/
index.cfm/submit-scientificinformation-packets/. 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:
Scientific Information Packet
Coordinator, 3710 SW U.S. Veterans
Hospital Road, Mail Code: R&D 71,
Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT:
Robin Paynter, Research Librarian,
SUMMARY:
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Telephone: 503–220–8262 ext. 58652 or
Email: SIPS@epc-src.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 Imaging
Techniques for the Surveillance,
Diagnosis, and Staging of
Hepatocellular Carcinoma.
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 imaging techniques for
the surveillance, diagnosis, and staging
of hepatocellular carcinoma, including
those that describe adverse events. The
entire research protocol, including the
key questions, is also available online
at: https://www.effectivehealthcare.
AHRQ.gov/search-for-guides-reviewsand-reports/?pageaction
=displayproduct&productID=1600#7839
This notice is to notify the public that
the EHC program would find the
following information on imaging
techniques for the surveillance,
diagnosis, and staging of hepatocellular
carcinoma helpful:
D A list of completed studies your
company has sponsored for this
indication. In the list, indicate whether
results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
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
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Federal Register / Vol. 78, No. 157 / Wednesday, August 14, 2013 / Notices
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies your
company 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
company for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the 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 Effective Health
Care 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.AHRQ.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://www.effective
healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/?pageaction
=displayproduct&productID=1600#7839
tkelley on DSK3SPTVN1PROD with NOTICES
Key Question 1
What is the comparative effectiveness
of available imaging-based surveillance
strategies (listed below under
interventions for KQ 1), used singly or
in sequence for detecting hepatocellular
carcinoma (HCC) among individuals
undergoing surveillance for HCC
(individuals at high risk for HCC and
individuals who have undergone liver
transplants for HCC)?
a. What is the comparative test
performance of imaging-based
surveillance strategies for detecting
HCC?
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i. How is a particular technique’s test
performance modified by use of various
reference standards (e.g., explanted liver
samples, histological diagnosis, or
clinical and imaging followup)?
ii. How is the comparative
effectiveness modified by patient-level
characteristics (e.g., body mass index,
number of lesions, tumor diameter, or
cause of liver disease) or other factors
(e.g., technical aspects of imaging
techniques, biomarker levels, test
operator or interpreter skill, setting)?
b. What is the comparative
effectiveness of imaging-based
surveillance strategies on intermediate
outcomes like diagnostic thinking?
c. What is the comparative
effectiveness of imaging-based
surveillance strategies on clinical and
patient-centered outcomes?
d. What are the adverse effects or
harms associated with imaging-based
surveillance strategies?
Key Question 2
What is the comparative effectiveness
of imaging techniques (listed under the
interventions for KQ 2), used singly, in
combination, or in sequence in
diagnosing HCC among individuals in
whom an abnormal lesion has been
detected while undergoing surveillance
for HCC (individuals at high risk for
HCC and individuals who have
undergone liver transplants for HCC) or
through the evolution of symptoms and
abdominal imaging done for other
indications?
a. What is the comparative test
performance of imaging techniques for
diagnosing HCC?
i. How is a particular technique’s test
performance modified by use of various
reference standards (e.g., explanted liver
samples, histological diagnosis, or
clinical and imaging followup)?
ii. How is the comparative
effectiveness modified by patient-level
characteristics (e.g., body mass index,
number of lesions, tumor diameter, or
cause of liver disease) or other factors
(e.g., technical aspects of imaging
techniques, biomarker levels, test
operator or interpreter skill, setting)?
b. What is the comparative
effectiveness of the various imaging
techniques on intermediate outcomes
like diagnostic thinking and use of
additional diagnostic procedures such
as fine-needle or core biopsy?
c. What is the comparative
effectiveness of the various imaging
techniques on clinical and patientcentered outcomes?
d. What are the adverse effects or
harms (related to testing or a testassociated diagnostic workup)
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associated with the various imaging
techniques?
Key Question 3
What is the comparative effectiveness
of imaging techniques (listed under the
interventions for KQ 3), used singly, in
combination, or in sequence in staging
HCC among patients diagnosed with
HCC?
a. What is the comparative test
performance of imaging techniques to
predict HCC tumor stage?
i. How is a particular technique’s test
performance modified by use of various
reference standards (e.g., explanted liver
samples, histological diagnosis, or
clinical and imaging followup)?
ii. How is the comparative
effectiveness modified by patient-level
characteristics (e.g., body mass index,
number of lesions, tumor diameter, or
cause of liver disease) or other factors
(e.g., technical aspects of imaging
techniques, biomarker levels, test
operator or interpreter skill, setting)?
b. What is the comparative test
performance of imaging techniques on
diagnostic thinking?
c. What is the comparative
effectiveness of imaging techniques on
clinical and patient-centered outcomes?
d. What are the adverse effects or
harms associated with using imaging
techniques related to testing or testassociated diagnostic workup?
PICOTS (Population(s), Interventions,
Comparators, Outcomes, Timing,
Settings) by Key Question
Population(s)
• Key Question 1.
• Patients at high risk for HCC
undergoing surveillance. The
population of high-risk patients is
defined, as per the AASLD clinical
guidelines, as composed of the
following: Asian male HBV carriers
over age 40, Asian female HBV
carriers over age 50, HBV carriers
with a family history of HCC,
African/North American black HBV
carriers, all individuals with
cirrhosis (including alcoholic
cirrhosis), HBV or HCV carriers
with cirrhosis, and patients with
stage 4 primary biliary cirrhosis.6
Other definitions of high-risk
patients as defined by the primary
studies will be accepted.
• Patients who have undergone liver
transplants for HCC, either with or
without HCC detected in the
explanted liver.
• Both population groups will be
considered separately.
• Key Question 2.
• Patients at high risk for HCC in
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whom a suspicious lesion(s) has
been detected by surveillance or by
other means.
• Patients who have undergone liver
transplants for HCC, either with or
without HCC detected in the
explanted liver.
• Both population groups will be
considered separately.
• Key Question 3
• Patients diagnosed with HCC who
require staging before initial
treatment.
• All Key Questions
• Patients with cholangiocarcinoma
will be excluded.
tkelley on DSK3SPTVN1PROD with NOTICES
Interventions
• Key Question 1
• US, spiral CT, multidetector CT
(MDCT), dual energy CT, or MRI.
• Studies that included surveillance
strategies of any other imaging test
with or without additional
biomarkers would also be included.
The strategies could include the
techniques being used singly or in
a specific sequence.
• Key Question 2
• Imaging techniques, used singly, in
combination, or in a specific
sequence, including US, spiral CT,
MDCT, dual energy CT, MRI
(including contrast agents like GdEOB–DTPA and SPIO), or
fluorodeoxyglucose positron
emission tomography (FDG–PET)
with different tracers (including
18F, fluorothymidine [FLT], 11Ccholine, and 11C = methionine, or
others).
• Key Question 3
• Imaging techniques, used singly, in
combination, or in a specific
sequence, including US, spiral CT,
MDCT, dual energy CT, MRI with
contrast (including contrast agents
such as Gd-EOB–DTPA and SPIO),
FDG–PET with different tracers
(including 18F, FLT, 11C-choline,
and 11C-methionine, or others), or
contrast CT.
• Test performance of imaging
techniques will be stratified by the
different staging systems used.
• All Key Questions
• Outdated imaging techniques (e.g.,
conventional, nonspiral/
nonmultidetector CT, or imaging
techniques used before 1995) will
be excluded.
• Imaging techniques not available or
in use in the United States (e.g.,
hepatic portography) will be
excluded.
Comparators
• For studies of diagnostic accuracy
(comparative test performance), the
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reference standard comparators will be
histopathology (based on explanted
liver specimens or biopsy) or clinical
and imaging followup, and the imaging
comparators will be alternative imaging
tests or strategies.
• For studies of comparative
effectiveness, the comparators will be
no imaging or alternative imaging
strategies.
Outcomes for Each Key Question
Key Question 1
• Diagnostic outcomes include:
• Detection rates of HCC lesions.
• Types of HCC lesions detected.
• Test performance (e.g., sensitivity
and specificity, predictive values,
likelihood ratios, area under the
receiver operating curve, or others)
for diagnosing HCC, including
stage-specific accuracy.
• For all KQs, potential modifiers of
measures of test performance will
be evaluated, including the
reference standards used (e.g.,
explanted liver samples,
histological diagnosis, or clinical
and imaging followup), patient and
tumor-level characteristics (e.g.,
body mass index, number of
lesions, tumor diameter, or cause of
liver disease), or other factors (e.g.,
technical aspects of the imaging
techniques, biomarker levels, test
operator or interpreter skill,
setting).
• Intermediate outcomes include:
• Effects on diagnostic thinking.
• Effects on clinical decisionmaking.
• Clinical and patient-centered
outcomes include:
• Overall mortality or survival.
• Recurrence of HCC, including rates
of seeding by fine-needle aspiration.
• Quality of life as measured with
scales such as the Short-Form
Health Survey (SF–36) or EuroQol
5D (EQ–5TM) or as defined by the
primary studies.
• Psychosocial effects of diagnostic
testing on patients, patients’
caregivers, and other family
members, as measured by selfreported questionnaire instruments.
• Resource utilization and patient
burden (e.g., costs associated with
the imaging procedure, access to the
imaging facility, the number of
imaging procedures, and other
procedures conducted).
Key Question 2
• Diagnostic outcomes include:
• Type of HCC lesions detected.
• Test performance (e.g., sensitivity
and specificity, predictive values,
likelihood ratios, area under the
receiver operating curve, or others)
for diagnosing HCC. As in KQ 1,
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potential modifiers of measures of
test performance will be evaluated,
including the reference standards
used (e.g., explanted liver samples,
histological diagnosis, or clinical
and imaging followup), patient and
tumor-level characteristics (e.g.,
body mass index, number of
lesions, tumor diameter, or cause of
liver disease), or other factors (e.g.,
technical aspects of the imaging
techniques, biomarker levels, test
operator or interpreter skill,
setting).
• Intermediate outcomes include:
• Effects on diagnostic thinking.
• Effects on clinical decisionmaking.
• Clinical and patient centered
outcomes include:
• Overall mortality or survival.
• Recurrence of HCC, including rates
of seeding by fine-needle aspiration
• Quality of life as measured with
scales such as the Short-Form
Health Survey (SF–36) or EuroQol
5D (EQ–5TM) or as defined by the
primary studies.
• Psychosocial effects of diagnostic
testing on patients, patients’
caregivers, and other family
members, as measured by selfreported questionnaire instruments.
• Resource utilization and patient
burden (e.g., costs associated with
the imaging procedure, access to the
imaging facility, the number of
imaging procedures and other
procedures conducted).
Key Question 3
• Diagnostic outcomes include:
• Measures for stage-specific accuracy
of imaging (e.g., Obuchowski
method for calculating the area
under the receiver operating curve,
stage reclassification rates).
• Intermediate outcomes include:
• Effects on diagnostic thinking.
• Effects on clinical decisionmaking.
• Clinical and patient-centered
outcomes include:
• Overall mortality or survival.
• Recurrence of HCC, including rates
of seeding by fine-needle aspiration
• Quality of life as measured with
scales such as the Short-Form
Health Survey (SF–36) or EuroQol
5D (EQ–5TM) or as defined in the
primary studies.
• Psychosocial effects of diagnostic
testing on patients, patients’
caregivers, and other family
members as measured by selfreported questionnaire instruments.
• Resource utilization and patient
burden (e.g., costs associated with
the imaging procedure, access to the
imaging facility, the number of
imaging procedures and additional
procedures conducted).
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Key Questions 1d, 2d, and 3d (Adverse
Events or Harms)
• Adverse effects or harms associated
with the imaging techniques (e.g.,
test-related anxiety, adverse events
secondary to venipuncture, contrast
allergy, exposure to radiation).
• Adverse effects or harms associated
with test-associated diagnostic
workup (e.g., harms of biopsy or
harms associated with workup of
other incidental tumors discovered
on imaging).
Proposed Project
Timing
• No restrictions will be placed on
timing.
• For studies of comparative
effectiveness, duration of followup,
timing of interventions, and frequency
of interventions will be recorded.
Health professionals recommend at
least 12 months of breastfeeding, and
Healthy People 2020 establishes specific
national breastfeeding goals. In addition
to increasing overall rates, a significant
public health priority in the United
States (U.S.) is to reduce variation in
breastfeeding rates across population
subgroups. Because hospital practices
strongly influence infant feeding
outcomes, the health care system is one
of the most important and effective
settings for improving breastfeeding
initiation rates.
In 2007, CDC conducted the first
national survey of Maternity Practices in
Infant Nutrition and Care, known as the
mPINC Survey. The survey inquired
about care practices and support for
breastfeeding throughout the maternity
stay as well as staff training and
maternity care practices. Following the
collection of baseline information in
2007, the mPINC survey was conducted
again in 2009 and 2011.
CDC proposes to repeat the mPINC in
2013 and 2015, with changes. In
previous cycles of data collection, two
versions of the mPINC survey
instrument were used: one for hospitals
and one for birth centers. In 2013 and
2015, one instrument will be used for
both hospitals and birth centers. There
are no changes to survey content, other
than the minor changes needed to
produce a single streamlined instrument
for all facilities. There is no change to
the estimated burden per response (30
minutes). Similarly, in 2013 and 2015
screening for eligible facilities will be
conducted with a single screening
instrument.
Settings
• All relevant care settings (e.g.,
primary and secondary care).
Dated: August 6, 2013.
Carolyn M. Clancy,
AHRQ Director.
[FR Doc. 2013–19714 Filed 8–13–13; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day-13–0743]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Assessment and Monitoring of
Breastfeeding-Related Maternity Care
Practices in Intra-partum Care Facilities
in the United States and Territories
(OMB No. 0920–0743, exp. 12/31/
2011)—Reinstatement with Changes—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Facilities will identified by using
information obtained through the
American Association of Birth Centers
(AABC) and the American Hospital
Association (AHA) Annual Survey of
Hospitals. Facilities that will be invited
to participate in the survey include
those that participated in previous
iterations and those that were invited
but did not participate in the previous
iterations, as well as those that have
become eligible since the most recent
mPINC survey. All birth centers and
hospitals with ≥1 registered maternity
bed will be screened for eligibility via
a brief phone call to assess their
eligibility, identify additional locations,
and identify the appropriate point of
contact.
As with the initial surveys, a major
goal of the 2013 and 2015 follow-up
surveys is to be fully responsive to
facilities’ needs for information and
technical assistance. CDC will provide
direct feedback to respondents in a
customized benchmark report of their
results and identify and document
progress since 2007 on their quality
improvement efforts. CDC will use
information from the mPINC surveys to
identify, document, and share
information related to incremental
changes in practices and care processes
over time at the hospital, state, and
national levels. Data will be also used
by researchers to better understand the
relationships between hospital
characteristics, maternity-care practices,
state level factors, and breastfeeding
initiation and continuation rates.
OMB approval is requested for three
years. On an annualized basis, CDC
estimates initial contact with 2,570
facilities that will complete Part A of the
Screening Telephone Call, and 2,200
respondents that will also complete Part
B of the Screening Telephone Call. CDC
estimates receipt of completed surveys
from 1,825 facilities.
Participation in the survey is
voluntary, and responses may be
submitted by mail or through a Webbased system. There are no costs to
respondents other than their time. The
total estimated annualized burden hours
are 1,103.
ESTIMATED ANNUALIZED BURDEN HOURS
tkelley on DSK3SPTVN1PROD with NOTICES
Type of respondent
Form name
Maternity facility .................................
Number of
respondents
Screening telephone call script .........
Part A ..........
Part B ..........
19:09 Aug 13, 2013
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Average
burden per
response
(in hours)
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2,570
2,200
1
1
1/60
4/60
1,825
mPINC Facility Survey
VerDate Mar<15>2010
Number of
responses per
respondent
1
30/60
14AUN1
]]>Agencies
[Federal Register Volume 78, Number 157 (Wednesday, August 14, 2013)]
[Notices]
[Pages 49520-49523]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19714]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Scientific Information Request on Imaging Techniques for the
Surveillance, Diagnosis, and Staging of Hepatocellular Carcinoma
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 on imaging
techniques for the surveillance, diagnosis, and staging of
hepatocellular carcinoma. Scientific information is being solicited to
inform our review of Imaging Techniques for the Surveillance,
Diagnosis, and Staging of Hepatocellular Carcinoma, 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 on imaging techniques for the
surveillance, diagnosis, and staging of hepatocellular carcinoma will
improve the quality of this review. AHRQ is conducting this comparative
effectiveness 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 September 13, 2013.
ADDRESSES:
Online submissions: https://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-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: Robin Paynter, Research Librarian,
Telephone: 503-220-8262 ext. 58652 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 Imaging Techniques for the Surveillance, Diagnosis, and Staging of
Hepatocellular Carcinoma.
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 imaging techniques for the surveillance, diagnosis, and
staging of hepatocellular carcinoma, including those that describe
adverse events. The entire research protocol, including the key
questions, is also available online at: https://www.effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1600#7839
This notice is to notify the public that the EHC program would find
the following information on imaging techniques for the surveillance,
diagnosis, and staging of hepatocellular carcinoma helpful:
[ssquf] A list of completed studies your company has sponsored for
this indication. In the list, 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
[[Page 49521]]
to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety
results.
[ssquf] A list of ongoing studies your company 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 company for this
indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the 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 Effective Health Care
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.AHRQ.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://www.effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1600#7839
Key Question 1
What is the comparative effectiveness of available imaging-based
surveillance strategies (listed below under interventions for KQ 1),
used singly or in sequence for detecting hepatocellular carcinoma (HCC)
among individuals undergoing surveillance for HCC (individuals at high
risk for HCC and individuals who have undergone liver transplants for
HCC)?
a. What is the comparative test performance of imaging-based
surveillance strategies for detecting HCC?
i. How is a particular technique's test performance modified by use
of various reference standards (e.g., explanted liver samples,
histological diagnosis, or clinical and imaging followup)?
ii. How is the comparative effectiveness modified by patient-level
characteristics (e.g., body mass index, number of lesions, tumor
diameter, or cause of liver disease) or other factors (e.g., technical
aspects of imaging techniques, biomarker levels, test operator or
interpreter skill, setting)?
b. What is the comparative effectiveness of imaging-based
surveillance strategies on intermediate outcomes like diagnostic
thinking?
c. What is the comparative effectiveness of imaging-based
surveillance strategies on clinical and patient-centered outcomes?
d. What are the adverse effects or harms associated with imaging-
based surveillance strategies?
Key Question 2
What is the comparative effectiveness of imaging techniques (listed
under the interventions for KQ 2), used singly, in combination, or in
sequence in diagnosing HCC among individuals in whom an abnormal lesion
has been detected while undergoing surveillance for HCC (individuals at
high risk for HCC and individuals who have undergone liver transplants
for HCC) or through the evolution of symptoms and abdominal imaging
done for other indications?
a. What is the comparative test performance of imaging techniques
for diagnosing HCC?
i. How is a particular technique's test performance modified by use
of various reference standards (e.g., explanted liver samples,
histological diagnosis, or clinical and imaging followup)?
ii. How is the comparative effectiveness modified by patient-level
characteristics (e.g., body mass index, number of lesions, tumor
diameter, or cause of liver disease) or other factors (e.g., technical
aspects of imaging techniques, biomarker levels, test operator or
interpreter skill, setting)?
b. What is the comparative effectiveness of the various imaging
techniques on intermediate outcomes like diagnostic thinking and use of
additional diagnostic procedures such as fine-needle or core biopsy?
c. What is the comparative effectiveness of the various imaging
techniques on clinical and patient-centered outcomes?
d. What are the adverse effects or harms (related to testing or a
test-associated diagnostic workup) associated with the various imaging
techniques?
Key Question 3
What is the comparative effectiveness of imaging techniques (listed
under the interventions for KQ 3), used singly, in combination, or in
sequence in staging HCC among patients diagnosed with HCC?
a. What is the comparative test performance of imaging techniques
to predict HCC tumor stage?
i. How is a particular technique's test performance modified by use
of various reference standards (e.g., explanted liver samples,
histological diagnosis, or clinical and imaging followup)?
ii. How is the comparative effectiveness modified by patient-level
characteristics (e.g., body mass index, number of lesions, tumor
diameter, or cause of liver disease) or other factors (e.g., technical
aspects of imaging techniques, biomarker levels, test operator or
interpreter skill, setting)?
b. What is the comparative test performance of imaging techniques
on diagnostic thinking?
c. What is the comparative effectiveness of imaging techniques on
clinical and patient-centered outcomes?
d. What are the adverse effects or harms associated with using
imaging techniques related to testing or test-associated diagnostic
workup?
PICOTS (Population(s), Interventions, Comparators, Outcomes, Timing,
Settings) by Key Question
Population(s)
Key Question 1.
Patients at high risk for HCC undergoing surveillance. The
population of high-risk patients is defined, as per the AASLD clinical
guidelines, as composed of the following: Asian male HBV carriers over
age 40, Asian female HBV carriers over age 50, HBV carriers with a
family history of HCC, African/North American black HBV carriers, all
individuals with cirrhosis (including alcoholic cirrhosis), HBV or HCV
carriers with cirrhosis, and patients with stage 4 primary biliary
cirrhosis.6 Other definitions of high-risk patients as defined by the
primary studies will be accepted.
Patients who have undergone liver transplants for HCC,
either with or without HCC detected in the explanted liver.
Both population groups will be considered separately.
Key Question 2.
Patients at high risk for HCC in
[[Page 49522]]
whom a suspicious lesion(s) has been detected by surveillance or by
other means.
Patients who have undergone liver transplants for HCC,
either with or without HCC detected in the explanted liver.
Both population groups will be considered separately.
Key Question 3
Patients diagnosed with HCC who require staging before
initial treatment.
All Key Questions
Patients with cholangiocarcinoma will be excluded.
Interventions
Key Question 1
US, spiral CT, multidetector CT (MDCT), dual energy CT, or
MRI.
Studies that included surveillance strategies of any other
imaging test with or without additional biomarkers would also be
included. The strategies could include the techniques being used singly
or in a specific sequence.
Key Question 2
Imaging techniques, used singly, in combination, or in a
specific sequence, including US, spiral CT, MDCT, dual energy CT, MRI
(including contrast agents like Gd-EOB-DTPA and SPIO), or
fluorodeoxyglucose positron emission tomography (FDG-PET) with
different tracers (including 18F, fluorothymidine [FLT], 11C-choline,
and 11C = methionine, or others).
Key Question 3
Imaging techniques, used singly, in combination, or in a
specific sequence, including US, spiral CT, MDCT, dual energy CT, MRI
with contrast (including contrast agents such as Gd-EOB-DTPA and SPIO),
FDG-PET with different tracers (including 18F, FLT, 11C-choline, and
11C-methionine, or others), or contrast CT.
Test performance of imaging techniques will be stratified
by the different staging systems used.
All Key Questions
Outdated imaging techniques (e.g., conventional,
nonspiral/nonmultidetector CT, or imaging techniques used before 1995)
will be excluded.
Imaging techniques not available or in use in the United
States (e.g., hepatic portography) will be excluded.
Comparators
For studies of diagnostic accuracy (comparative test
performance), the reference standard comparators will be histopathology
(based on explanted liver specimens or biopsy) or clinical and imaging
followup, and the imaging comparators will be alternative imaging tests
or strategies.
For studies of comparative effectiveness, the comparators
will be no imaging or alternative imaging strategies.
Outcomes for Each Key Question
Key Question 1
Diagnostic outcomes include:
Detection rates of HCC lesions.
Types of HCC lesions detected.
Test performance (e.g., sensitivity and specificity,
predictive values, likelihood ratios, area under the receiver operating
curve, or others) for diagnosing HCC, including stage-specific
accuracy.
For all KQs, potential modifiers of measures of test
performance will be evaluated, including the reference standards used
(e.g., explanted liver samples, histological diagnosis, or clinical and
imaging followup), patient and tumor-level characteristics (e.g., body
mass index, number of lesions, tumor diameter, or cause of liver
disease), or other factors (e.g., technical aspects of the imaging
techniques, biomarker levels, test operator or interpreter skill,
setting).
Intermediate outcomes include:
Effects on diagnostic thinking.
Effects on clinical decisionmaking.
Clinical and patient-centered outcomes include:
Overall mortality or survival.
Recurrence of HCC, including rates of seeding by fine-
needle aspiration.
Quality of life as measured with scales such as the Short-
Form Health Survey (SF-36) or EuroQol 5D (EQ-5TM) or as
defined by the primary studies.
Psychosocial effects of diagnostic testing on patients,
patients' caregivers, and other family members, as measured by self-
reported questionnaire instruments.
Resource utilization and patient burden (e.g., costs
associated with the imaging procedure, access to the imaging facility,
the number of imaging procedures, and other procedures conducted).
Key Question 2
Diagnostic outcomes include:
Type of HCC lesions detected.
Test performance (e.g., sensitivity and specificity,
predictive values, likelihood ratios, area under the receiver operating
curve, or others) for diagnosing HCC. As in KQ 1, potential modifiers
of measures of test performance will be evaluated, including the
reference standards used (e.g., explanted liver samples, histological
diagnosis, or clinical and imaging followup), patient and tumor-level
characteristics (e.g., body mass index, number of lesions, tumor
diameter, or cause of liver disease), or other factors (e.g., technical
aspects of the imaging techniques, biomarker levels, test operator or
interpreter skill, setting).
Intermediate outcomes include:
Effects on diagnostic thinking.
Effects on clinical decisionmaking.
Clinical and patient centered outcomes include:
Overall mortality or survival.
Recurrence of HCC, including rates of seeding by fine-
needle aspiration
Quality of life as measured with scales such as the Short-
Form Health Survey (SF-36) or EuroQol 5D (EQ-5TM) or as
defined by the primary studies.
Psychosocial effects of diagnostic testing on patients,
patients' caregivers, and other family members, as measured by self-
reported questionnaire instruments.
Resource utilization and patient burden (e.g., costs
associated with the imaging procedure, access to the imaging facility,
the number of imaging procedures and other procedures conducted).
Key Question 3
Diagnostic outcomes include:
Measures for stage-specific accuracy of imaging (e.g.,
Obuchowski method for calculating the area under the receiver operating
curve, stage reclassification rates).
Intermediate outcomes include:
Effects on diagnostic thinking.
Effects on clinical decisionmaking.
Clinical and patient-centered outcomes include:
Overall mortality or survival.
Recurrence of HCC, including rates of seeding by fine-
needle aspiration
Quality of life as measured with scales such as the Short-
Form Health Survey (SF-36) or EuroQol 5D (EQ-5TM) or as
defined in the primary studies.
Psychosocial effects of diagnostic testing on patients,
patients' caregivers, and other family members as measured by self-
reported questionnaire instruments.
Resource utilization and patient burden (e.g., costs
associated with the imaging procedure, access to the imaging facility,
the number of imaging procedures and additional procedures conducted).
[[Page 49523]]
Key Questions 1d, 2d, and 3d (Adverse Events or Harms)
Adverse effects or harms associated with the imaging
techniques (e.g., test-related anxiety, adverse events secondary to
venipuncture, contrast allergy, exposure to radiation).
Adverse effects or harms associated with test-associated
diagnostic workup (e.g., harms of biopsy or harms associated with
workup of other incidental tumors discovered on imaging).
Timing
No restrictions will be placed on timing.
For studies of comparative effectiveness, duration of
followup, timing of interventions, and frequency of interventions will
be recorded.
Settings
All relevant care settings (e.g., primary and secondary
care).
Dated: August 6, 2013.
Carolyn M. Clancy,
AHRQ Director.
[FR Doc. 2013-19714 Filed 8-13-13; 8:45 am]
BILLING CODE 4160-90-P
