Scientific Information Request on Core Needle and Open Surgical Biopsy for Diagnosis of Breast Lesions, 66932-66934 [2013-26617]
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Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
As required by OMB regulations, 5
CFR Part 1320, the FTC is providing this
second opportunity for public comment.
Likely Respondents: Real estate agents
and brokers, advertising agencies, home
builders, lead generators, rate
aggregators, and others that may provide
commercial communications regarding
mortgage credit product terms.9
Estimated Annual Hours Burden:
1,800,000 hours.
• Derived from 1.2 million likely
respondents 10 × approximately 3 hours
each respondent per year to do these
tasks = 3.6 million hours.
• Since the FTC shares enforcement
authority with the CFPB for Regulation
N, the FTC’s allotted PRA burden is
1,800,000 annual hours.11
Estimated Annual Cost Burden:
$24,264,000, which is derived from 1.8
million hours × $13.48 per hour.12
9 The Commission does not know what
percentage of these persons are, in fact, engaged in
covered conduct under the Rule, i.e., providing
commercial communications about mortgage credit
product terms. For purposes of these estimates, the
Commission has assumed all of them are covered
by the recordkeeping provisions and are not
retaining these records in the ordinary course of
business.
10 No general source provides precise numbers of
the various categories of covered persons.
Commission staff, therefore, has used the following
sources and inputs to arrive at this estimated total:
(1) 1 million real estate brokers and agents—from
the National Association of Realtors, see https://
www.realtor.org (last visited June 24, 2013) ; (2)
140,000 home builders—from the National
Association of Home Builders, see https://
www.NAHB.org (last visited June 24, 2013); (3) 350
finance companies—from the American Financial
Services Association, see https://www.afsaonline.org
(last visited June 24, 2013); (4) 29,770 advertising
agencies—from the North American Industry
Classification System Association’s database of U.S.
businesses, see https://www.naics.com (last visited
June 24, 2013); (5) 1,000 lead generators and rate
aggregators—based on staff’s administrative
experience. These inputs add to 1,171,120; for
rounding, and to account further for potentially
unspecified other covered persons, however, staff
has increased the resulting total to 1.2 million.
11 This burden estimate includes recordkeeping
requirements of the FTC’s Mortgage Acts and
Practices Rule for the period from December 1,
2013—December 29, 2013. The Commission
retained its authority to enforce the Mortgage Acts
and Practices—Advertising Rule from the Rule’s
issuance in July 2011 until the CFPB’s republished
rule, Regulation N, became effective on December
30, 2011. Thus, the Commission’s Rule had a
correlative two-year recordkeeping for the above
period concluding on December 29, 2013. Burden
imposed on covered entities after that time are
covered by the same recordkeeping requirements
under Regulation N, which commenced December
30, 2011.
12 This estimate is based on mean hourly wages
for office support file clerks provided by the Bureau
of Labor Statistics. See U.S. Bureau of Labor
Statistics, Occupational Employment and Wages—
May 2012, table 1 (‘‘National employment and wage
data from the Occupational Employment Statistics
survey by occupation,’’ released Mar. 29, 2013),
available at https://www.bls.gov/news.release/pdf/
ocwage.pdf.
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Request for Comment
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before December 9, 2013. Write
‘‘Regulation N: FTC File No. P134811;
K05’’ on your comment. Your
comment—including your name and
your state—will be placed on the public
record of this proceeding, including, to
the extent practicable, on the public
Commission Web site, at https://
www.ftc.gov/os/publiccomments.shtm.
As a matter of discretion, the
Commission tries to remove individuals’
home contact information from
comments before placing them on the
Commission Web site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, such as anyone’s Social
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any ‘‘[t]rade secret or any commercial or
financial information which is * * *
privileged or confidential,’’ as discussed
in Section 6(f) of the FTC Act, 15 U.S.C.
46(f), and FTC Rule 4.10(a)(2), 16 CFR
4.10(a)(2). In particular, do not include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you are required to follow the procedure
explained in FTC Rule 4.9(c), 16 CFR
4.9(c). Your comment will be kept
confidential only if the FTC General
Counsel, in his or her sole discretion,
grants your request in accordance with
the law and the public interest.
Postal mail addressed to the
Commission is subject to delay due to
heightened security screening. As a
result, we encourage you to submit your
comment online, or to send it to the
Commission by courier or overnight
service. To make sure that the
Commission considers your online
comment, you must file it at https://
ftcpublic.commentworks.com/ftc/
regulationnpra2, by following the
instructions on the web-based form. If
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this Notice appears at https://
www.regulations.gov, you also may file
a comment through that Web site.
If you file your comment on paper,
write ‘‘Regulation N: FTC File No.
P134811; K05’’ on your comment and
on the envelope, and mail or deliver it
to the following address: Federal Trade
Commission, Office of the Secretary,
Room H–113 (Annex J), 600
Pennsylvania Avenue NW., Washington,
DC 20580. If possible, submit your
paper comment to the Commission by
courier or overnight service.
Visit the Commission Web site at
https://www.ftc.gov to read this Notice.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before December 9, 2013. You can find
more information, including routine
uses permitted by the Privacy Act, in
the Commission’s privacy policy, at
https://www.ftc.gov/ftc/privacy.shtm.
Comments on the information
collection requirements subject to
review under the PRA should also be
submitted to OMB. If sent by U.S. mail,
address comments to: Office of
Information and Regulatory Affairs,
Office of Management and Budget,
Attention: Desk Officer for the Federal
Trade Commission, New Executive
Office Building, Docket Library, Room
10102, 725 17th Street NW.,
Washington, DC 20503. Comments sent
to OMB by U.S. postal mail, however,
are subject to delays due to heightened
security precautions. Thus, comments
instead should be sent by facsimile to
(202) 395–5167.
David C. Shonka,
Principal Deputy General Counsel.
[FR Doc. 2013–26697 Filed 11–6–13; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Scientific Information Request on Core
Needle and Open Surgical Biopsy for
Diagnosis of Breast Lesions
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
SUMMARY:
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices
the public on core needle and open
surgical biopsy for diagnosis of breast
lesions. Scientific information is being
solicited to inform our review of Core
Needle and Open Surgical Biopsy for
Diagnosis of Breast Lesions, 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 core
needle and open surgical biopsy 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 December 9, 2013.
ADDRESSES:
Online submissions: https://effective
healthcare.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: 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: 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 Core Needle
and Open Surgical Biopsy for Diagnosis
of Breast Lesions—An Update to the
2009 Report.
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 core needle and open
surgical biopsy, including those that
describe adverse events. The entire
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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=1723.
This notice is to notify the public that
the EHC program would find the
following information on core needle
and open surgical biopsy 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
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/.
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66933
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.effectivehealth
care.AHRQ.gov/search-for-guidesreviews-and-reports/
?pageaction=display
Product&productID=1723.
The Key Questions
The Key Questions (KQs) and study
selection criteria (population,
intervention, comparator, outcome,
timing, and setting; PICOTS) for this
update began with those specified in the
original report. On the basis of input
from clinical experts during the
development of this protocol, we have
made selected revisions to the KQs and
study eligibility criteria to clarify the
focus of the updated systematic review.
The following three KQs will be
addressed in the review:
Question 1
In women with a palpable or
nonpalpable breast abnormality, what is
the test performance of different types of
core-needle breast biopsy when
compared with open biopsy for
diagnosis?
I. What factors associated with the
patient and her breast abnormality
influence the test performance of
different types of core-needle breast
biopsy when compared with open
biopsy for diagnosis of a breast
abnormality?
II. What factors associated with the
procedure itself influence the test
performance of different types of coreneedle breast biopsy when compared
with open biopsy for diagnosis of a
breast abnormality?
III. What clinician and facility factors
influence the test performance of coreneedle breast biopsy when compared
with open biopsy for diagnosis of a
breast abnormality?
Question 2
In women with a palpable or
nonpalpable breast abnormality, what
are the harms associated with different
types of core-needle breast biopsy when
compared with open biopsy for
diagnosis?
I. What factors associated with the
patient and her breast abnormality
influence the harms of core-needle
breast biopsy when compared with the
open biopsy technique in the diagnosis
of a breast abnormality?
II. What factors associated with the
procedure itself influence the harms of
core-needle breast biopsy when
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Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices
compared with the open biopsy
technique in the diagnosis of a breast
abnormality?
III. What clinician and facility factors
influence the harms of core-needle
breast biopsy when compared with the
open biopsy technique in the diagnosis
of a breast abnormality?
Question 3
How do open biopsy and various
core-needle techniques differ in terms of
patient preference, availability, costs,
availability of qualified pathologist
interpretations, and other factors that
may influence choice of a particular
technique?
Study Eligibility Criteria (PICOTS:
Population, Intervention, Comparators,
Outcomes, Timing, and Setting)
Population
The population for all KQs is women
who have been referred for biopsy for
the diagnosis of primary breast cancer
(including multifocal and bilateral
disease) following self-examination,
physical examination, or screening
mammography. Studies carried out in
women at high baseline risk of breast
cancer (e.g., due to BRCA mutations)
will therefore be included; however
studies carried out in women who have
been previously diagnosed with breast
cancer and are being examined for
recurrence will be excluded a.
tkelley on DSK3SPTVN1PROD with NOTICES
Interventions
For all KQs, the intervention is a coreneedle biopsy done to evaluate whether
a breast lesion is malignant. Other uses
of biopsy techniques (e.g., use of biopsy
to examine the sentinel lymph nodes in
women with an established diagnosis of
breast cancer) are excluded.
Comparators (Reference Standard and
Comparator Index Tests)
For test performance outcomes (KQ 1)
the reference standard is either open
surgical biopsy or follow-up by clinical
examination and/or mammography for
at least 6 months. The diagnostic
performance of each core biopsy
technique (each index test) will be
quantified versus the reference
standard b. The comparative diagnostic
performance of alternative core-needle
biopsy techniques is also of interest c.
For harms and patient-relevant
outcomes (outcomes other than
diagnostic performance; KQs 2 and 3)
the comparators are:
I. Open surgical biopsy
II. Follow-up by clinical examination
and/or mammography for at least 6
months
III. Alternative core-needle biopsy
methods (e.g., stereotactic
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Jkt 232001
mammography vs. ultrasound to
locate the breast lesion; use vs.
nonuse of vacuum assistance to
extract tissue samples)
Outcomes
I. For KQ 1, test performance
outcomes, as assessed by the following
measures:
A. Sensitivity (proportion of cancerous
tumors detected by the reference
standard that are also detected by
core-needle biopsy)
B. False-negative rate (proportion of
negative findings according to coreneedle biopsy that are classified as
positive by the reference standard)
C. The underestimation rate for atypical
ductal hyperplasia (ADH;
proportion of core needle biopsy
findings of ADH that are found to
be malignant according to the
reference standard)
D. The underestimation rate for DCIS
(proportion of core-needle biopsy
findings of DCIS that are found to
be invasive according to the
reference standard)
II. For KQ 2:
A. Rate of inconclusive biopsy findings
(e.g., inadequate sampling of the
lesion)
B. Repeat biopsy rate
C. Subsequent false-positive and falsenegative rates on mammography
D. Dissemination (seeding) of cancerous
cells along the needle track
E. Patient-centered outcomes (including
bruising, bleeding or hematomas,
pain, use of pain medication,
infections, fainting or near fainting,
and time to recover)
III. For KQ 3:
A. Patient-relevant outcomes
1. Patient preferences for specific
procedures
2. Cosmetic results
3. Quality of life
4. Anxiety and other psychological
outcomes
5. Time to complete tumor removal
(for women with cancer)
6. Recurrence rate (for women with
cancer, including local, regional,
and distant recurrence)
7. Cancer-free survival and overall
survival
B. Resource use and logistics
1. Costs
2. Resource utilization other than cost
(number of additional surgical
procedures [e.g., re-excisions,
procedural time])
3. Subsequent surgical procedures
4. Wait time for test results
C. Availability of technology and
relevant expertise
1. Physician experience
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2. Availability of equipment
3. Availability of (qualified)
pathologists to evaluate biopsy
samples
Timing
Duration of clinical and/or
mammographic follow-up must be at
least 6 months in studies where open
surgical biopsy was not performed.
Setting
Studies in all geographic locations
and care settings will be evaluated,
including general hospitals, academic
medical centers, and ambulatory
surgical centers, among others.
Explanation to References in
Population and Interventions Sections
Above
a The original review excluded studies
carried out in women at high risk of breast
cancer; however, magnetic resonance
imaging (MRI)-guided biopsy, which has
been identified as a topic of interest for the
updated review, is used mainly in this subset
of patients. For this reason, following
extensive discussions with the TEP
(Technical Expert Panel), we decided to
broaden the scope of the review to cover
women at high risk for cancer. In effect, this
will be a de novo review with respect to this
population subset.
b Most assessments of diagnostic
performance quantify the sensitivity and the
specificity of each index test—here each
core-needle biopsy technique. Sensitivity and
specificity are probabilities conditional on
true disease status and are noncomparative in
nature. The reference standard is used in
their definition and is not a ‘‘comparator
test.’’
c That is, differences or ratios of
sensitivities and of specificities between
alternative core-needle biopsy techniques.
Dated: October 31, 2013.
Richard Kronick,
AHRQ Director.
[FR Doc. 2013–26617 Filed 11–6–13; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–14–0026]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
E:\FR\FM\07NON1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66932-66934]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26617]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Scientific Information Request on Core Needle and Open Surgical
Biopsy for Diagnosis of Breast Lesions
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
[[Page 66933]]
the public on core needle and open surgical biopsy for diagnosis of
breast lesions. Scientific information is being solicited to inform our
review of Core Needle and Open Surgical Biopsy for Diagnosis of Breast
Lesions, 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 core
needle and open surgical biopsy 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 December 9, 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 Core Needle and Open Surgical Biopsy for Diagnosis of Breast
Lesions--An Update to the 2009 Report.
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 core needle and open surgical biopsy, 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=1723.
This notice is to notify the public that the EHC program would find
the following information on core needle and open surgical biopsy
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 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=1723.
The Key Questions
The Key Questions (KQs) and study selection criteria (population,
intervention, comparator, outcome, timing, and setting; PICOTS) for
this update began with those specified in the original report. On the
basis of input from clinical experts during the development of this
protocol, we have made selected revisions to the KQs and study
eligibility criteria to clarify the focus of the updated systematic
review.
The following three KQs will be addressed in the review:
Question 1
In women with a palpable or nonpalpable breast abnormality, what is
the test performance of different types of core-needle breast biopsy
when compared with open biopsy for diagnosis?
I. What factors associated with the patient and her breast
abnormality influence the test performance of different types of core-
needle breast biopsy when compared with open biopsy for diagnosis of a
breast abnormality?
II. What factors associated with the procedure itself influence the
test performance of different types of core-needle breast biopsy when
compared with open biopsy for diagnosis of a breast abnormality?
III. What clinician and facility factors influence the test
performance of core-needle breast biopsy when compared with open biopsy
for diagnosis of a breast abnormality?
Question 2
In women with a palpable or nonpalpable breast abnormality, what
are the harms associated with different types of core-needle breast
biopsy when compared with open biopsy for diagnosis?
I. What factors associated with the patient and her breast
abnormality influence the harms of core-needle breast biopsy when
compared with the open biopsy technique in the diagnosis of a breast
abnormality?
II. What factors associated with the procedure itself influence the
harms of core-needle breast biopsy when
[[Page 66934]]
compared with the open biopsy technique in the diagnosis of a breast
abnormality?
III. What clinician and facility factors influence the harms of
core-needle breast biopsy when compared with the open biopsy technique
in the diagnosis of a breast abnormality?
Question 3
How do open biopsy and various core-needle techniques differ in
terms of patient preference, availability, costs, availability of
qualified pathologist interpretations, and other factors that may
influence choice of a particular technique?
Study Eligibility Criteria (PICOTS: Population, Intervention,
Comparators, Outcomes, Timing, and Setting)
Population
The population for all KQs is women who have been referred for
biopsy for the diagnosis of primary breast cancer (including multifocal
and bilateral disease) following self-examination, physical
examination, or screening mammography. Studies carried out in women at
high baseline risk of breast cancer (e.g., due to BRCA mutations) will
therefore be included; however studies carried out in women who have
been previously diagnosed with breast cancer and are being examined for
recurrence will be excluded \a\.
Interventions
For all KQs, the intervention is a core-needle biopsy done to
evaluate whether a breast lesion is malignant. Other uses of biopsy
techniques (e.g., use of biopsy to examine the sentinel lymph nodes in
women with an established diagnosis of breast cancer) are excluded.
Comparators (Reference Standard and Comparator Index Tests)
For test performance outcomes (KQ 1) the reference standard is
either open surgical biopsy or follow-up by clinical examination and/or
mammography for at least 6 months. The diagnostic performance of each
core biopsy technique (each index test) will be quantified versus the
reference standard \b\. The comparative diagnostic performance of
alternative core-needle biopsy techniques is also of interest \c\.
For harms and patient-relevant outcomes (outcomes other than
diagnostic performance; KQs 2 and 3) the comparators are:
I. Open surgical biopsy
II. Follow-up by clinical examination and/or mammography for at least 6
months
III. Alternative core-needle biopsy methods (e.g., stereotactic
mammography vs. ultrasound to locate the breast lesion; use vs. nonuse
of vacuum assistance to extract tissue samples)
Outcomes
I. For KQ 1, test performance outcomes, as assessed by the
following measures:
A. Sensitivity (proportion of cancerous tumors detected by the
reference standard that are also detected by core-needle biopsy)
B. False-negative rate (proportion of negative findings according to
core-needle biopsy that are classified as positive by the reference
standard)
C. The underestimation rate for atypical ductal hyperplasia (ADH;
proportion of core needle biopsy findings of ADH that are found to be
malignant according to the reference standard)
D. The underestimation rate for DCIS (proportion of core-needle biopsy
findings of DCIS that are found to be invasive according to the
reference standard)
II. For KQ 2:
A. Rate of inconclusive biopsy findings (e.g., inadequate sampling of
the lesion)
B. Repeat biopsy rate
C. Subsequent false-positive and false-negative rates on mammography
D. Dissemination (seeding) of cancerous cells along the needle track
E. Patient-centered outcomes (including bruising, bleeding or
hematomas, pain, use of pain medication, infections, fainting or near
fainting, and time to recover)
III. For KQ 3:
A. Patient-relevant outcomes
1. Patient preferences for specific procedures
2. Cosmetic results
3. Quality of life
4. Anxiety and other psychological outcomes
5. Time to complete tumor removal (for women with cancer)
6. Recurrence rate (for women with cancer, including local,
regional, and distant recurrence)
7. Cancer-free survival and overall survival
B. Resource use and logistics
1. Costs
2. Resource utilization other than cost (number of additional
surgical procedures [e.g., re-excisions, procedural time])
3. Subsequent surgical procedures
4. Wait time for test results
C. Availability of technology and relevant expertise
1. Physician experience
2. Availability of equipment
3. Availability of (qualified) pathologists to evaluate biopsy
samples
Timing
Duration of clinical and/or mammographic follow-up must be at least
6 months in studies where open surgical biopsy was not performed.
Setting
Studies in all geographic locations and care settings will be
evaluated, including general hospitals, academic medical centers, and
ambulatory surgical centers, among others.
Explanation to References in Population and Interventions Sections
Above
\a\ The original review excluded studies carried out in women at
high risk of breast cancer; however, magnetic resonance imaging
(MRI)-guided biopsy, which has been identified as a topic of
interest for the updated review, is used mainly in this subset of
patients. For this reason, following extensive discussions with the
TEP (Technical Expert Panel), we decided to broaden the scope of the
review to cover women at high risk for cancer. In effect, this will
be a de novo review with respect to this population subset.
\b\ Most assessments of diagnostic performance quantify the
sensitivity and the specificity of each index test--here each core-
needle biopsy technique. Sensitivity and specificity are
probabilities conditional on true disease status and are
noncomparative in nature. The reference standard is used in their
definition and is not a ``comparator test.''
\c\ That is, differences or ratios of sensitivities and of
specificities between alternative core-needle biopsy techniques.
Dated: October 31, 2013.
Richard Kronick,
AHRQ Director.
[FR Doc. 2013-26617 Filed 11-6-13; 8:45 am]
BILLING CODE 4160-90-P
