[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

[[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published and unpublished pertinent scientific information on core 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: 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