Federal Register, Volume 78 Issue 216 (Thursday, November 7, 2013)

[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66932-66934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26617]

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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.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from

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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published and unpublished pertinent scientific information on core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: http://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: http://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: http://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: http://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