Evidence Tables

Bruening W, Schoelles K, Treadwell J, et al. Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2009 Dec. (Comparative Effectiveness Reviews, No. 19.) Appendix E, Evidence Tables.

Table E3Previously published systematic reviews: design

Study	Search Dates	Types of Biopsy Evaluated	Types of Breast Abnormalities Evaluated	Reference Standard Required	Other Inclusion Criteria	Method of Rating the Quality	Statistical Methods
Fahrbach et al. 2006⁴⁸³	1996 to June 2004	Stereotactic vacuum-assisted core-needle biopsy and stereotactic core-needle biopsy	All-comer populations referred after screening mammography	Surgical biopsy or patient followup	English language; ten or more patients; conducted in North America, Europe, Australia, or New Zealand; reported absolute numbers of each lesion type on biopsy; studies of devices no longer on the market-SiteSelect, MIBB device, ABBI device were excluded	Narrative discussion, no overall rating given	Random-effects models in SAS and SPSS, multivariate regression models
Verkooijen et al. 2000⁴⁸⁴	1975 to May 1999	Large-core needle biopsy under stereotactic or ultrasound guidance	Non-palpable lesions detected on mammography	Surgical biopsy or a minimum of 2 years of followup in at least 90% of patients	The absolute number of benign and malignant lesions had to be derivable; a minimum of five large-core biopsy specimens per lesion had to be obtained; studies of fine-needle aspiration were excluded.	Not rated	Pooled by meta-analysis using SPSS. No further details provided.

Table E4Previously published systematic reviews: quality rating

Study	Was an ‘a priori’ design provided?	Was there duplicate study selection and data extraction?	Was a comprehensive literature search performed?	Was the status of publication (i.e., grey literature) used as an inclusion criterion?	Was a list of studies (included/excluded) provided?	Were the characteristics of the included studies provided?	Was the scientific quality of the included studies used appropriately in formulating conclusions?	Was the quality of the studies assessed and documented?	Were the methods used to combine the finding of studies appropriate?	Was the likelihood of publication bias assessed?	Was the conflict of interest stated?	Quality Rating
Fahrbach et al.2000⁴⁸⁴	Can’t tell	Yes	Yes	Yes	No	Yes	No	Yes	Yes	No	No	Moderate
Verkooijen et al.2006⁴⁸³	Can’t tell	Yes	Yes	Yes	Yes	No	No	No	Can’t tell	No	No	Moderate

Table E5Previously published systematic reviews: results

Study	N Studies	N Patients	Accuracy	Accuracy Affected by Patient Type/Breast Abnormality Types	Accuracy Affected by Procedure-related Factors	Accuracy Affected by Personnel/Facility Factors	Harms	Conclusion
Fahrbach et al. 2006⁴⁸³	12 of vacuum-assisted biopsy and 25 of core-needle biopsy	11,355 patients, 5,119 with vacuum-assisted biopsy and 6,236 patients with automated gun core-needle biopsy	Overall agreement between vacuum-assisted and reference standard was 97.3%; overall agreement between core-needle and reference standard was 93.5%. Rate of benign lesions turning out to be malignant: vacuum-assisted: 2.02% (95% CI: 0.00 to 4.35), core-needle: 2.36% (95% CI: 1.15 to 3.58). Rate of atypia lesions turning out to be malignant: vacuum-assisted: 20.38% (15.25 to 25.52), core-needle: 36.69% (26.53 to 46.84)	For atypia to malignant upgrades the type of procedure was a significant predictor, with more underestimations occurring with core-needle as compared to vacuum-assisted	Reference standard and patient position did not influence accuracy	For benign to malignant upgrades, more benign to malignant upgrades occurred in non-North American locations than in North American locations	Frequency of technical failures: 5.7% for core-needle, 1.5% for vacuum-assisted	Vacuum-assisted biopsy may provide lower miss and underestimation rates than automated gun core-needle biopsy.
Verkooijen et al. 2000⁴⁸⁴	5	865 biopsies performed	DCIS on needle biopsy upgraded to invasive cancer: 15% (95% CI: 8.0 to 26); ADH on needle biopsy upgraded to invasive cancer: 40% (95% CI: 26 to 56); sensitivity of core-needle for detecting malignancies: 97% (95% CI: 95 to 99)	Not performed	Not performed	Not performed	2 complications reported: 1 hematoma 1 infection	In a setting such as the U.S. where about 20% of cases referred for biopsy are malignant, the risk of breast cancer despite a benign diagnosis on core- needle biopsy is less than 1%. However, in a setting such as Europe where about 60% of cases referred for biopsy are malignant, the risk of breast cancer despite a benign diagnosis on core- needle biopsy is 4%.

Table E6Studies included to address Key Questions 1 and 2: design details

Study	Design of Study	Type of Study	Number of Centers	Care Setting	Country Conducted in	Funded by	Type(s) Core Biopsy	Core Biopsy Results Confirmed by	Number of Lesions Enrolled	Followup	% Attrition
Jackman et al. 2009⁴⁸⁵	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	Biopsys Medical, Inc. and Ethicon Endo-Surgery	Stereotactic guidance vacuum- assisted 11G and 14G	Combination of surgery and patient followup	1,280	2 years	10.6%
Peters et al. 2008⁴⁸⁶	Single group (cohort or case series study)	Retrospective	4	General hospital	Netherlands	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	948	2 years	5%
Schueller et al. 2008⁴⁸⁷	Single group (cohort or case series study)	Retrospective	1	General hospital	Austria	Authors stated no financial relationship to disclose	Ultrasound guidance automated gun 14G	Combination of surgery and patient followup	1438	2 years	5.7%
Sim and Kei 2008⁴⁸⁸	Single group (cohort or case series study)	Retrospective	1	General hospital	Singapore	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient folowup	105	2 years	12.4%
Tonegutti and Girardi 2008⁴⁸⁹	Single group (cohort or case series study)	Retrospective	1	General hospital	Italy	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	268	2 years	0%
Youk et al. 2008²⁴	Single group (cohort or case series study)	Retrospective	1	General hospital	South Korea	NR	US guidance automated gun 14G	Combination of surgery and patient followup	4,359	2 years	44%
Ciatto et al. 2007⁴⁹⁰	Single group (cohort or case series study)	Retrospective	1	Dedicated breast cancer center	Italy	Funded in part by a National Helath and Medical Research Council (NHMRC) grant	Multiple methods	Combination of surgery and patient followup	4,035	1 year	26%
de Lucena et al. 2007⁴⁹¹	Single group (cohort or case series study)	Prospective	1	General hospital	Brazil	NR	US guidance automated gun 14G	Open surgery or surgical biopsy only	150	Immediate surgery	0%
Uematsu et al. 2007⁴⁹²	Single group (cohort or case series study)	Prospective	1	General cancer center	Japan	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	100	Mean: 26 months Range: 5 to 44 months	0%
Vag et al. 2007⁴⁹³	Single group (cohort or case series study)	Prospective	1	General hospital	Germany	NR	US guidance vacuum-assisted 10G	Combination of surgery and patient followup	70	2 years	0%
Chapellier et al. 2006⁴⁹⁴	Single group (cohort or case series study)	Prospective	1	General cancer center	France	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	318	Range: 4 to 16 months	0%
Cipolla et al. 2006⁴⁹⁵	Single group (cohort or case series study)	NR	1	General hospital	Italy	NR	Multiple methods	Combination of surgery and patient followup	426	1 year	0%
Dhillon et al. 2006⁴⁹⁶	Single group (cohort or case series study)	Prospective	1	General hospital	UK	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	150	Median: 48 months	0%
Bolivar et al. 2005⁴⁹⁷	Single group (cohort or case series study)	Prospective	1	General hospital	Spain	NR	US guidance automated gun 14G	Combination of surgery and patient followup	214	2 years	5%
Crystal et al. 2005⁴⁹⁸	Single group (cohort or case series study)	NR	1	General hospital	Israel	NR	US guidance automated gun 14G	Combination of surgery and patient followup	715	Median: 39 months Range: 27 to 60 months	0%
Dillon et al. 2005⁴⁹⁹	Single group (cohort or case series study)	Retrospective	1	General hospital	Ireland	NR	Multiple methods	Combination of surgery and patient followup	2,427	Median: 24 months Range: 3 to 67 months	19%
Koskela et al. 2005⁵⁰⁰	Single group (cohort or case series study)	Prospective	1	General hospital	Finland	Kuopio University Hospital (the center it was conducted in)	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	213	Mean: 24 months Range: 6 to 39 months	4%
Sauer et al. 2005⁵⁰¹	Single group (cohort or case series study)	Retrospective	1	General hospital	Germany	NR	US guidance automated gun 14G	Combination of surgery and patient followup	962	Mean: 22.2 months Median: 21 months Range : 8 to 36 months	13%
Weber et al. 2005⁵⁰²	Non-randomized multiple groups study	Prospective	1	General hospital	Switzerland	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	225	Median: 2.1 years Range: 0.5 to 4.4 years	15%
Wu et al. 2005⁵⁰³	Single group (cohort or case series study)	NR	1	General hospital	Taiwan	NR	US guidance vacuum-assisted 11G	Combination of surgery and patient followup	113	1 year	0%
Alonso-Bartolome et al. 2004⁵⁰⁴	Single group (cohort or case series study)	Prospective	2	General hospital	Spain	NR	US guidance vacuum-assisted 11G	Combination of surgery and patient followup	102	6 to 12 months	0%
Delle and Terinde 2004⁵⁰⁵	Single group (cohort or case series study)	NR	1	General hospital	Germany	NR	US guidance automated gun 14G	Combination of surgery and patient followup	169	2 years	0%
Fajardo et al. 2004⁵⁰⁶	Some patients were randomized to stereotactic or US guidance but data were reported as if the study was a single-group cohort study	Prospective	22	Academic and community practice clinical sites	USA	National Cancer Institute	Multiple methods	Combination of surgery and patient followup	2,403	2 years	30%
Kettritz et al. 2004⁵⁰⁷	Single group (cohort or case series study)	Prospective	5	General hospital	Germany	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	2,893	Mean: 25 months Range: 6 to 67 months	22%
Lomoschitz et al. 2004⁵⁰⁸	Non-randomized multiple groups study	Prospective	1	General hospital	Austria	One author partially supported by both Ethicon Edonsurgery and Biopsys Medical	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	100	2 years	0%
Abdsaleh et al. 2003⁵⁰⁹	Single group (cohort or case series study)	Prospective	1	General hospital	Sweden	NR	Multiple methods	Combination of surgery and patient followup	180	1 year	21%
Ambrogetti et al. 2003⁵¹⁰	Single group (cohort or case series study)	Retrospective	1	General hospital	France	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	364	Mean: 15.8 months Range: 6 to 36 months	35%
Fishman et al. 2003⁵¹¹	Single group (cohort or case series study)	Prospective	1	General hospital	USA	NR	US guidance automated gun 14G	Combination of surgery and patient followup	73	Mammographic and US followup Median: 21 months Range: 4 to 30 months	33%
Han et al. 2003⁵¹²	Single group (cohort or case series study)	Retrospective	1	General hospital	Korea	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	271	At least 6 months	27%
Kirshenbaum et al. 2003⁵¹³	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	506	Mean: 2.1 years Range: 3 months to 5 years	23%
March et al. 2003⁵¹⁴	Single group (cohort or case series study)	Prospective	2	Dedicated breast cancer center	USA	RSNA Seed Grant and the Rays of Hope charitable fund	US guidance vacuum-assisted 11G	Combination of surgery and patient followup	34	6 months	9%
Pfleiderer et al. 2003⁵¹⁵	Single group (cohort or case series study)	Prospective	1	General hospital	Germany	NR	MRI guidance automated gun 14G	Combination of surgery and patient followup	14	2 years	0%
Philpotts et al. 2003⁵¹⁶	Non-randomized multiple groups study	Retrospective	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	281	Mean: 19 months Range: 3 to 53 months for 14G Mean: 13 months Range: 1 to 24 for 11G	24%
Wong and Hisham 2003⁵¹⁷	Single group (cohort or case series study)	Prospective	1	General hospital	Malaysia	NR	Freehand automated gun 14 or 16G	Combination of surgery and patient followup	150	Range: 6 to 13 months	0%
Apesteguia et al. 2002⁵¹⁸	Single group (cohort or case series study)	Prospective	1	General hospital	Spain	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	132	1 year	0%
Georgian-Smith et al. 2002⁵¹⁹	Single group (cohort or case series study)	Retrospective	4	General hospital	USA	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	185	Range: 6 to 12 months	21%
Jackman and Lamm 2002⁵²⁰	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	Funded in part by Biopsys Medical	Multiple methods	Combination of surgery and patient followup	31	At least 6 months	0%
Johnson et al. 2002⁵²¹	Single group (cohort or case series study)	NR	1	General hospital	USA	Fashion Footwear of NY	US guidance vacuum-assisted 11 or 8G	Combination of surgery and patient followup	101	Mean: 9.5 months	24%
Liberman et al. 2002⁵²²	Single group (cohort or case series study)	Retrospective	1	General cancer center	USA	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	800	At least 1 year	29%
Meloni et al. 2002⁵²³	Single group (cohort or case series study)	Retrospective	1	General hospital	Italy	NR	Stereotactic guidance vacuum- assisted	Combination of surgery and patient followup	129	Mean: 18.7 months Range: 14 to 26 months	0%
Morris et al. 2002⁵²⁴	Single group (cohort or case series study)	Prospective	1	Dedicated breast cancer center	USA	NR	Stereotactic guidance vacuum- assisted 14G	Combination of surgery and patient followup	21	Median: 46 months Range: 40–54 months	10%
Pfarl et al. 2002⁵²⁵	Single group (cohort or case series study)	Retrospective	1	General hospital	Austria	NR	Stereotactic guidance vacuum- assisted 11G	Open surgery or surgical biopsy only	332	Immediate surgery	4%
Verkooijen et al. COBRA 2002⁵²⁶	Single group (cohort or case series study)	Prospective	5	General hospital	Netherlands	Dutch National Health Insurance Fund Council	Stereotactic guidance automated gun 14G	Open surgery or surgical biopsy only	984	Immediate surgery	11%
Becker et al. 2001⁵²⁷	Single group (cohort or case series study)	Retrospective	1	General hospital	Canada	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	232	Range: 6 to 12 months	27%
Brenner et al. 2001⁵²⁸	Single group (cohort or case series study)	Prospective	7	Cancer centers and hospitals	USA	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	1,003	Mean: 19.3 months Range: 0 to 36 months	1%
Cangiarella et al. 2001⁵²⁹	Single group (cohort or case series study)	NR	1	General hospital	USA	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	160	Mean: 20.5 months Range: 6 to 35 months	38%
Dahlstrom and Jain 2001⁵³⁰	Single group (cohort or case series study)	NR	1	General hospital	Australia	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	301	Range: 2.4 to 7.5 years	0%
Lai et al. 2001⁵³¹	Single group (cohort or case series study)	NR	1	General hospital	Canada	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	673	Mean: 6.7 months Range: 6 to 24 months	29%
Levin et al. 2001⁵³²	Single group (cohort or case series study)	Prospective	1	General hospital	Canada	Physician’s Services Incorporated Foundation	Stereotactic guidance automated gun 14G	Open surgery or surgical biopsy only	70	Immediate surgery	0%
Margolin et al. 2001⁵³³	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	1,333	Mean: 14 months Range: 6 to 24 months; missing data were collected from SEER database; at the time of accession of SEER data followup ranged from 15 to 75 months	3%
Perez-Fuentes et al. 2001⁵³⁴	Single group (cohort or case series study)	NR	1	Dedicated breast cancer center	Venezuela	NR	US guidance vacuum-assisted 11G	Combination of surgery and patient followup	88	Median: 11.1 months Range: 4 to 24 months	33%
Smith et al. 2001⁵³⁵	Single group (cohort or case series study)	NR	1	General hospital	USA	NR	US guidance automated gun 14G	Combination of surgery and patient followup	500	Mean: 22 months Median: 14 months Range: 12 to 60 months	21%
White et al. 2001⁵³⁶	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	1,042	Median: 29 months, minimum of one year	29%
Wunderbaldinger et al. 2001⁵³⁷	Single group (cohort or case series study)	Prospective	1	General hospital	Austria	author supported by Erwin Schroedinger Auslandsstipenium of the Austrian Science Fund	US guidance automated gun 14G	Open surgery or surgical biopsy only	45	Immediate surgery	0%
Yeow et al. 2001⁵³⁸	Single group (cohort or case series study)	Prospective	1	General hospital	China	NR	US guidance automated gun 14 or 16G	Combination of surgery and patient followup	98	Mean: 4 years Range: 3 to 5 years	0%
Beck et al. 2000⁵³⁹	Single group (cohort or case series study)	NR	1	General hospital	Germany	NR	Stereotactic guidance vacuum- assisted 11G	Combination of surgery and patient followup	594	1 year	0%
Kirwan et al. 2000⁵⁴⁰	Single group (cohort or case series study)	Retrospective	1	General hospital	UK	NR	Stereotactic guidance automated gun 14G	Open surgery or surgical biopsy only	72	Immediate surgery	13%
Latosinsky et al. 2000⁵⁴¹	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NIH grant	Multiple methods	Combination of surgery and patient followup	692	Median: 17.2 months Range: 2.8 to 43 months	42%
Liberman et al. 2000⁵⁴²	Single group (cohort or case series study)	Retrospective	1	General cancer center	USA	NR	Multiple methods	Combination of surgery and patient followup	155	Median: 53 months Range: 24 to 69 months	32%
Makoske et al. 2000⁵⁴³	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	817	Mean: 1.7 years	30%
Ward et al. 2000⁵⁴⁴	Single group (cohort or case series study)	NR	1	General hospital	Canada	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	121	Mean: 16 months Range: 4 to 36 months	7%
Welle et al. 2000⁵⁴⁵	Single group (cohort or case series study)	Retrospective	3	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	225	Range: 6 to 24 months	20%
Helbich et al. 1999⁵⁴⁶	Randomized controlled trial	Prospective	1	General hospital	Austria	Ludwig-Boltzmann Institute for Radiologic Tumor Research; one author was supported by a grant from the Max Kade Foundation	Multiple methods	Open surgery or surgical biopsy only	44	Immediate surgery	0%
Jackman et al. 1999⁵⁴⁷	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	483	Median: 55 months	1%
Meyer et al. 1999⁵⁴⁸	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	1,836	At least 1 year	25%
Puglisi et al. 1999⁵⁴⁹	Single group (cohort or case series study)	Retrospective	1	General hospital	Italy	NR	Perforated compression grid automated gun 14G	Combination of surgery and patient followup	106	At least 6 months	1%
Soo et al. 1999⁵⁵⁰	Non-randomized multiple groups study	Retrospective	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	116	Mean: 16 months Range: 5 to 31 months	19%
Caruso et al. 1998⁵⁵¹	Single group (cohort or case series study)	Prospective	1	General hospital	Italy	NR	Multiple methods	Open surgery or surgical biopsy only	92	Immediate surgery	13%
Doyle et al. 1998⁵⁵²	Single group (cohort or case series study)	Retrospective	1	Dedicated breast cancer center	New Zealand	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	151	Range: 6 to 36 months	11%
Fuhrman et al. 1998⁵⁵³	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	1,440	At least 6 months	18%
Heywang- Kobrunner et al. 1998⁵⁵⁴	Single group (cohort or case series study)	NR	1	General hospital	Germany	NR	Stereotactic guidance vacuum- assisted 11 or 14G	Combination of surgery and patient followup	261	6 months	31%
Ioffe et al. 1998⁵⁵⁵	Single group (cohort or case series study)	NR	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	224	Range: 6 to 12 months	14%
Liberman et al. 1998⁵⁵⁶	Single group (cohort or case series study)	NR	1	General cancer center	USA	NR	US guidance automated gun 14G	Combination of surgery and patient followup	151	Median: 20 months Range: 6 to 48 months	23%
Schulz-Wendtland et al. 1998⁵⁵⁷	Single group (cohort or case series study)	NR	1	General hospital	Germany	NR	US guidance automated gun 14G	Combination of surgery and patient followup	307	2 years	0%
Vega-Bolivar et al. 1998⁵⁵⁸	Single group (cohort or case series study)	Retrospective	1	General hospital	Spain	NR	Stereotactic guidance Surecut 15G	Combination of surgery and patient followup	182	Mean: 27 months Range: 6 to 47 months	6%
Whitman et al. 1998⁵⁵⁹	Single group (cohort or case series study)	Retrospective	2	General hospital	USA	NR	Stereotactic guidance automated gun 16G	Open surgery or surgical biopsy only	12	Immediate surgery	0%
Zannis and Alia No 1998⁵⁶⁰	Non-randomized multiple groups study	Retrospective	1	Ambulatory surgical center	USA	NR	Multiple methods	Combination of surgery and patient followup	424	At least 6 months	31%
Bauer et al. 1997⁵⁶¹	Single group (cohort or case series study)	Retrospective	NR	NR	USA	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	799	Mean: 9 months	0%
Britton et al. 1997⁵⁶²	Single group (cohort or case series study)	NR	1	General hospital	UK	NR	Multiple methods	Combination of surgery and patient followup	202	Mean: 20.1 months Range: 5.3 to 30.8 months	2%
Helbich et al. 1997⁵⁶³	Single group (cohort or case series study)	Prospective	1	General hospital	Austria	NR	Multiple methods	Open surgery or surgical biopsy only	210	Immediate surgery	0%
Khattar et al. 1997⁵⁶⁴	Single group (cohort or case series study)	Prospective	1	General hospital	Denmark	NR	US guidance automated gun	Open surgery or surgical biopsy only	106	Immediate surgery	43%
Liberman et al. 1997⁵⁶⁵	Single group (cohort or case series study)	Retrospective	1	General cancer center	USA	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	442	Median: 18 months Range: 6 to 46 months	34%
Pitre et al. 1997⁵⁶⁶	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Stereotactic guidance automated gun	Combination of surgery and patient followup	128	1 year	8%
Stolier et al. 1997⁵⁶⁷	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	244	Mean: 12.8 months Range: 6 to 39 months	NR
Sutton, et al. 1997⁵⁶⁸	Single group (cohort or case series study)	Retrospective	1	Screening clinic	Australia	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	206	1 year	32%
Walker et al. 1997⁵⁶⁹	Single group (cohort or case series study)	NR	1	General hospital	UK	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	200	Range: 6 to 36 months	10%
Frazee et al. 1996⁵⁷⁰	Non-randomized multiple groups study	Prospective	1	General hospital	USA	NR	Stereotactic guidance automated gun	Combination of surgery and patient followup	103	At least 6 months	0%
Fuhrman et al. 1996⁵⁷¹	Single group (cohort or case series study)	NR	1	General hospital	USA	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	451	1 year	22%
Head and Haynes 1996⁵⁷²	Single group (cohort or case series study)	Prospective	1	Dedicated breast cancer center	USA	NR	Stereotactic guidance automated gun 18G	Combination of surgery and patient followup	115	2 years	8%
Mainiero et al. 1996⁵⁷³	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	138	At least 6 months	14%
Meyer et al. 1996⁵⁷⁴	Single group (cohort or case series study)	NR	1	General hospital	USA	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	388	1 year	30%
Nguyen et al. 1996⁵⁷⁵	Single group (cohort or case series study)	NR	1	General hospital	USA	American Cancer Society, UCLA Jonsson Comprehensive Cancer Center, and the Stein- Oppenheim Foundation	Multiple methods	Combination of surgery and patient followup	431	At least 6 months	10%
Pettine et al. 1996⁵⁷⁶	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Stereotactic guidance automated gun 14G	Open surgery or surgical biopsy only	25	6 month repeat mammography for benign	0%
Rosenblatt et al. 1996⁵⁷⁷	Single group (cohort or case series study)	Retrospective	1	General hospital	USA	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	25	1 year	16%
Scopa et al. 1996⁵⁷⁸	Non-randomized multiple groups study	NR	1	General hospital	Greece	NR	Freehand TruCut	Open surgery or surgical biopsy only	120	Immediate surgery	0%
Cross et al. 1995⁵⁷⁹	Single group (cohort or case series study)	NR	1	Dedicated breast cancer center	USA	NR	Stereotactic guidance automated gun 14G	Combination of surgery and patient followup	250	1 year	12%
Doyle et al. 1995⁵⁸⁰	Non-randomized multiple groups study	Prospective	1	General Hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	150	Range: 6 to 24 months	3%
Hamed et al. 1995⁵⁸¹	Randomized controlled trial	Prospective	1	General hospital	UK	NR	Freehand Biopty-cut	Open surgery or surgical biopsy only	122	Immediate surgery	0%
Burbank et al. 1994⁵⁸²	Non-randomized multiple groups study	NR	1	General hospital	USA	NR	Multiple methods	Combination of surgery and patient followup	105	At least 6 months	0%
Gisvold et al. 1994⁵⁸³	Single group (cohort or case series study)	Prospective	1	General hospital	USA	NR	Stereotactic guidance automated gun 14G	Open surgery or surgical biopsy only	160	Immediate surgery	0%
Parker et al. 1994⁵⁸⁴	Non-randomized multiple groups study	Retrospective	20	Various hospitals, breast care centers, clinics	USA	NR	Multiple methods	Combination of surgery and patient followup	6,152	At least 6 months	39%
Smyth and Cederbom 1994⁵⁸⁵	Single group (cohort or case series study)	NR	1	General hospital	USA	NR	Stereotactic guidance automated gun 14G	Open surgery or surgical biopsy only	58	Immediate surgery	0%
Elvecrog et al. 1993⁵⁸⁶	Non-randomized multiple groups study	Prospective	1	General hospital	USA	NR	Stereotactic guidance automated gun 14G	Open surgery or surgical biopsy only	100	Immediate surgery	0%
Parker et al. 1993⁵⁸⁷	Single group (cohort or case series study)	NR	1	Specialized imaging center	USA	NR	US guidance automated gun 14G	Combination of surgery and patient followup	181	Range: 12 to 36 months	0%
McMahon et al. 1992⁵⁸⁸	Randomized controlled trial	Prospective	1	General hospital	UK	NR	Multiple methods	Combination of surgery and patient followup	151	Median: 11 months Range: 1 to 24 months	0%
Barreto et al. 1991⁵⁸⁹	Single group (cohort or case series study)	NR	1	General hospital	UK	NR	Freehand automated gun 18G	Open surgery or surgical biopsy only	107	Immediate surgery	0%
Cusick et al. 1990⁵⁹⁰	Single group (cohort or case series study)	NR	1	General hospital	USA	NR	Freehand	Open surgery or surgical biopsy only	96	Immediate surgery	0%
Parker et al. 1990⁵⁹¹	Single group (cohort or case series study)	NR	1	General hospital	USA	NR	Stereotactic guidance automated gun	Open surgery or surgical biopsy only	103	Immediate surgery	0%

: NR = Not Reported

: US = Ultrasound

: UK = United Kingdom

: USA = United States of America

Table E7Quality assessment instrument

Was patient recruitment either consecutive or random?
Were more than 85% of the patients approached for recruitment enrolled in the study?
Were the patient inclusion/exclusion criteria consistently applied to all patients?
Was the study free from obvious spectrum bias? Obvious spectrum bias was defined as more than 40% or less than 10% of the breast lesions were diagnosed as malignant; and/or the mean or median age of the enrolled population was less than 50 or greater than 70.
Was the study prospective in design?
Was a complete set of data reported for at least 85% of enrolled lesions?
Were the patients assessed by the gold standard (open surgical procedure) regardless of the initial biopsy results?
Were patients assessed by a reference standard regardless of the biopsy results?
Was funding for this study provided by a source that doesn’t have an obvious financial interest in the findings of the study?
Did the study account for inter-reader/scorer differences?
Were the reader(s) of the biopsies blinded to the results of the reference standard?
Were readers of the reference standard blinded to the results of the biopsy?
Were the readers of the biopsy blinded to all other clinical information?
Were readers of the reference standard blinded to all other clinical information?

Table E8Quality of studies addressing Key Questions 1 and 2 (see Table E7 for the wording of the questions)

Study	1	2	3	4	5	6	7	8	9	10	11	12	13	14	Raw Score	Standardize
Jackman et al. 2009⁴⁸⁵	Yes	Yes	Yes	NR	No	Yes	No	Yes	No	No	Yes	NR	No	NR	1	5.4
Peters et al. 2008⁴⁸⁶	Yes	NR	Yes	No: over 40% malignant	No	Yes	No	Yes	NR	No	Yes	No	No	No	−1	4.6
Schueller et al. 2008⁴⁸⁷	Yes	Yes	Yes	No: over 40% malignant	No	Yes	No	Yes	Yes	NR	Yes	No	No	No	1	5.4
Sim and Kei 2008⁴⁸⁸	Yes	Yes	Yes	Yes	No	Yes	No	Yes	NR	NR	Yes	No	NR	No	3	6.1
Tonegutti and Girardi 2008⁴⁸⁹	Yes	Yes	Yes	No: 41.6% malignant	No	Yes	No	Yes	NR	NR	NR	NR	NR	NR	3	6.1
Youk et al. 2008²⁴	Yes	Yes	Yes	No: mean 45.3 years of age	No	No	No	Yes	NR	NR	Yes	No	No	No	−1	4.6
Ciatto et al. 2007⁴⁹⁰	Yes	Yes	Yes	NR	No	No	No	Yes	Yes	No	Yes	No	No	No	−1	4.6
de Lucena et al. 2007⁴⁹¹	NR	NR	NR	No: 67% malignant	Yes	Yes	Yes	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Uematsu et al. 2007⁴⁹²	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes	NR	No	Yes	NR	NR	NR	6	7.1
Vag et al. 2007⁴⁹³	NR	NR	NR	No: 41.4% malignant	Yes	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	3	6.1
Chapellier et al. 2006⁴⁹⁴	NR	NR	NR	Yes	Yes	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	4	6.4
Cipolla et al. 2006⁴⁹⁵	Yes	Yes	Yes	No: 43% malignant	NR	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Dhillon et al. 2006⁴⁹⁶	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	7	7.5
Bolivar et al. 2005⁴⁹⁷	Yes	Yes	Yes	No: 58% malignant	Yes	Yes	No	Yes	NR	No	Yes	NR	NR	NR	5	6.8
Crystal et al. 2005⁴⁹⁸	Yes	Yes	Yes	No: 45% malignant	NR	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Dillon et al. 2005⁴⁹⁹	Yes	Yes	Yes	No: 57% malignant	No	No	No	Yes	NR	NR	Yes	No	No	No	−1	4.6
Koskela et al. 2005⁵⁰⁰	Yes	Yes	Yes	No: 42% malignant	Yes	Yes	No	Yes	Yes	No	Yes	No	No	No	3	6.1
Sauer et al. 2005⁵⁰¹	Yes	Yes	Yes	No: 64.2% malignant	No	Yes	No	Yes	NR	No	Yes	No	No	No	0	5.0
Weber et al. 2005⁵⁰²	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes	NR	Yes	Yes	NR	NR	NR	8	7.9
Wu et al. 2005⁵⁰³	Yes	Yes	Yes	No: 0% malignant	NR	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Alonso-Bartolome et al. 2004⁵⁰⁴	NR	Yes	Yes	No: 0.9% malignant, mean age 42	Yes	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Delle and Terinde 2004⁵⁰⁵	Yes	Yes	Yes	No: 77% malignant	NR	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Fajardo et al. 2004⁵⁰⁶	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes	Yes	Yes	Yes	NR	NR	NR	9	8.2
Kettritz et al. 2004⁵⁰⁷	NR	NR	No	NR	Yes	No	No	Yes	NR	NR	Yes	NR	No	NR	−1	4.6
Lomoschitz et al. 2004⁵⁰⁸	Yes	Yes	Yes	No: 47% malignant	Yes	Yes	No	Yes	No	No	NR	NR	NR	NR	3	6.1
Abdsaleh et al. 2003⁵⁰⁹	Yes	Yes	Yes	No: 74% malignant	Yes	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	6	7.1
Ambrogetti et al. 2003⁵¹⁰	Yes	Yes	Yes	No: 43.4% malignant	No	No	No	Yes	NR	NR	Yes	No	No	No	−1	4.6
Fishman et al. 2003⁵¹¹	Yes	Yes	No	NR	Yes	No	No	Yes	NR	No	Yes	NR	Yes	NR	2	5.7
Han et al. 2003⁵¹²	Yes	Yes	Yes	No: mean age 47 years	No	No	No	Yes	NR	NR	NR	NR	NR	NR	1	5.4
Kirshenbaum et al. 2003⁵¹³	Yes	Yes	Yes	Yes	No	No	No	Yes	NR	NR	Yes	No	No	No	0	5.0
March et al. 2003⁵¹⁴	Yes	No: 67%	Yes	NR	Yes	Yes	No	Yes	Yes	No	Yes	No	No	No	2	5.7
Pfleiderer et al. 2003⁵¹⁵	No	NR	Yes	No: 42% malignant	Yes	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	4	6.4
Philpotts et al. 2003⁵¹⁶	Yes	Yes	Yes	NR	No	No	No	Yes	NR	NR	Yes	No	No	No	−1	4.6
Wong and Hisham 2003⁵¹⁷	Yes	Yes	Yes	No: 46% malignant	Yes	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	6	7.1
Apesteguia et al. 2002⁵¹⁸	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes	NR	NR	NR	NR	NR	NR	6	7.1
Georgian-Smith et al. 2002⁵¹⁹	Yes	Yes	Yes	Yes	No	Yes	No	Yes	NR	NR	Yes	No	No	No	2	5.7
Jackman and Lamm 2002⁵²⁰	Yes	Yes	Yes	Yes	No	Yes	No	Yes	No	NR	Yes	No	No	No	1	5.4
Johnson et al. 2002⁵²¹	Yes	Yes	Yes	No: 5% malignant	NR	No	No	Yes	Yes	NR	Yes	NR	NR	NR	4	6.4
Liberman et al. 2002⁵²²	Yes	Yes	Yes	No	No	No	No	Yes	NR	NR	Yes	No	No	No	−2	4.3
Meloni et al. 2002⁵²³	Yes	Yes	Yes	NR	Yes	Yes	No	Yes	NR	NR	Yes	No	No	No	3	6.1
Morris et al. 2002⁵²⁴	NR	NR	Yes	Yes	Yes	Yes	No	Yes	NR	No	Yes	NR	NR	NR	4	6.4
Pfarl et al. 2002⁵²⁵	Yes	Yes	Yes	No: 65% malignant	No	Yes	Yes	Yes	NR	NR	Yes	No	No	No	3	6.1
Verkooijen et al. COBRA 2002⁵²⁶	Yes	NR	Yes	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes	NR	NR	NR	8	7.9
Becker et al. 2001⁵²⁷	Yes	Yes	Yes	Yes	No	No	No	Yes	NR	NR	Yes	No	No	No	0	5.0
Brenner et al. 2001⁵²⁸	NR	NR	NR	NR	Yes	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	3	6.1
Cangiarella et al. 2001⁵²⁹	Yes	Yes	Yes	No: 9% malignant	NR	No	No	Yes	NR	NR	Yes	NR	NR	NR	3	6.1
Dahlstrom and Jain 2001⁵³⁰	Yes	Yes	Yes	NR	NR	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Lai et al. 2001⁵³¹	Yes	Yes	Yes	Yes	NR	No	No	Yes	NR	NR	Yes	NR	NR	NR	4	6.4
Levin et al. 2001⁵³²	NR	NR	Yes	NR	Yes	Yes	Yes	Yes	Yes	No	Yes	NR	NR	NR	6	7.1
Margolin et al. 2001⁵³³	Yes	Yes	Yes	No: mean age less than 50	No	Yes	No	Yes	NR	NR	Yes	No	No	No	1	5.4
Perez-Fuentes et al. 2001⁵³⁴	No	NR	No	No: mean age 48	NR	No	No	Yes	NR	NR	Yes	NR	NR	NR	−1	4.6
Smith et al. 2001⁵³⁵	Yes	Yes	Yes	No: mean age 47	NR	No	No	Yes	NR	NR	Yes	NR	NR	NR	3	6.1
White et al. 2001⁵³⁶	Yes	Yes	Yes	Yes	No	No	No	Yes	NR	No	Yes	No	No	No	−1	4.6
Wunderbaldinger et al. 2001⁵³⁷	No	NR	Yes	No: 49% malignant	Yes	Yes	Yes	Yes	Yes	No	No	No	NR	NR	3	6.1
Yeow et al. 2001⁵³⁸	Yes	Yes	Yes	No: mean age 46	Yes	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	6	7.1
Beck et al. 2000⁵³⁹	Yes	Yes	Yes	NR	NR	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Kirwan et al. 2000⁵⁴⁰	NR	NR	NR	NR	No	Yes	Yes	Yes	NR	NR	Yes	No	No	No	0	5.0
Latosinsky et al. 2000⁵⁴¹	Yes	Yes	Yes	NR	No	No	No	Yes	Yes	NR	NR	Yes	No	No	1	5.4
Liberman et al. 2000⁵⁴²	Yes	Yes	Yes	No: median age47 years	No	No	No	Yes	NR	NR	Yes	No	No	No	−1	4.6
Makoske et al. 2000⁵⁴³	Yes	Yes	Yes	NR	Yes	No	No	Yes	NR	NR	Yes	No	No	No	1	5.4
Ward et al. 2000⁵⁴⁴	Yes	Yes	Yes	Yes	NR	Yes	No	Yes	NR	NR	Yes	No	No	No	3	6.1
Welle et al. 2000⁵⁴⁵	NR	NR	NR	NR	No	No	No	Yes	NR	NR	Yes	No	No	No	−4	3.6
Helbich et al. 1999⁵⁴⁶	Yes	NR	Yes	No: 86% malignant	Yes	Yes	Yes	No	NR	No	Yes	NR	No	NR	3	6.1
Jackman et al. 1999⁵⁴⁷	Yes	Yes	Yes	Yes	No	Yes	No	Yes	NR	Yes	No	No	No	No	0	5.0
Meyer et al. 1999⁵⁴⁸	Yes	Yes	Yes	Yes	No	No	No	Yes	NR	No	Yes	No	No	No	−1	4.6
Puglisi et al. 1999⁵⁴⁹	Yes	Yes	Yes	Yes	No	Yes	No	Yes	NR	No	Yes	No	No	No	1	5.4
Soo et al. 1999⁵⁵⁰	Yes	Yes	Yes	NR	No	No	No	Yes	NR	Yes	Yes	No	No	No	0	5.0
Caruso et al. 1998⁵⁵¹	Yes	NR	Yes	No: 85% malignant	Yes	Yes	Yes	Yes	NR	No	Yes	NR	No	NR	5	6.8
Doyle et al. 1998⁵⁵²	Yes	Yes	Yes	NR	No	Yes	No	Yes	NR	No	Yes	No	No	No	0	5.0
Fuhrman et al. 1998⁵⁵³	Yes	Yes	Yes	Yes	No	No	No	Yes	NR	No	Yes	No	No	No	−1	4.6
Heywang-Kobrunner et al. 1998⁵⁵⁴	Yes	Yes	Yes	NR	NR	No	No	Yes	NR	NR	Yes	NR	NR	NR	3	6.1
Ioffe et al. 1998⁵⁵⁵	Yes	NR	Yes	Yes	NR	NR	No	Yes	NR	NR	NR	NR	NR	NR	3	6.1
Liberman et al. 1998⁵⁵⁶	Yes	Yes	Yes	Yes	NR	No	No	Yes	NR	NR	Yes	NR	NR	NR	4	6.4
Schulz-Wendtland et al. 1998⁵⁵⁷	Yes	Yes	Yes	No: 52% malignant	NR	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Vega-Bolivar et al. 1998⁵⁵⁸	Yes	NR	Yes	No: over 40% were malignant	No	Yes	No	Yes	NR	No	Yes	No	No	No	−1	4.6
Whitman et al. 1998⁵⁵⁹	NR	Yes	NR	No: 50% malignant	No	Yes	No	Yes	NR	NR	NR	NR	NR	NR	1	5.4
Zannis and AliaNo 1998⁵⁶⁰	Yes	Yes	Yes	Yes	No	Yes	No	Yes	NR	NR	Yes	No	No	No	2	5.7
Bauer et al. 1997⁵⁶¹	Yes	Yes	Yes	Yes	No	Yes	No	Yes	NR	Yes	Yes	No	No	No	2	5.7
Britton et al. 1997⁵⁶²	Yes	Yes	Yes	No: 50% malignant	NR	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Helbich et al. 1997⁵⁶³	Yes	Yes	Yes	No: 47% malignant	Yes	Yes	Yes	Yes	NR	No	Yes	No	NR	NR	6	7.1
Khattar et al. 1997⁵⁶⁴	NR	NR	Yes	No: 44% malignant	Yes	No	Yes	Yes	NR	NR	Yes	NR	NR	NR	4	6.4
Liberman et al. 1997⁵⁶⁵	Yes	NR	Yes	NR	No	No	No	Yes	NR	NR	Yes	No	No	No	−2	4.3
Pitre et al. 1997⁵⁶⁶	Yes	Yes	Yes	No: 8.6% malignant	No	Yes	No	Yes	NR	NR	Yes	No	No	No	1	5.4
Stolier et al. 1997⁵⁶⁷	Yes	Yes	Yes	NR	No	Yes	No	Yes	NR	NR	Yes	No	No	No	1	5.4
Sutton, et al. 1997⁵⁶⁸	NR	NR	No	Yes	No	No	No	Yes	NR	NR	Yes	No	No	No	−4	3.6
Walker et al. 1997⁵⁶⁹	Yes	Yes	Yes	No: 54% malignant	NR	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Frazee et al. 1996⁵⁷⁰	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes	NR	NR	NR	NR	NR	NR	6	7.1
Fuhrman et al. 1996⁵⁷¹	NR	Yes	Yes	NR	NR	No	No	Yes	NR	NR	NR	NR	NR	NR	1	5.4
Head and Haynes 1996⁵⁷²	NR	NR	NR	Yes	Yes	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	4	6.4
Mainiero et al. 1996⁵⁷³	NR	Yes	Yes	Yes	No	Yes	No	Yes	NR	NR	NR	NR	NR	NR	3	6.1
Meyer et al. 1996⁵⁷⁴	Yes	No: 67.7%	Yes	No: median age 49	NR	No	No	Yes	NR	NR	NR	NR	NR	NR	1	5.4
Nguyen et al. 1996⁵⁷⁵	NR	NR	Yes	No: 43% malignant	NR	Yes	No	Yes	Yes	NR	Yes	NR	NR	NR	4	6.4
Pettine et al. 1996⁵⁷⁶	NR	Yes	Yes	NR	No	Yes	Yes	NR	NR	NR	NR	NR	NR	NR	3	6.1
Rosenblatt et al. 1996⁵⁷⁷	Yes	Yes	Yes	No: 52% malignant	No	No	No	Yes	NR	NR	Yes	No	No	No	−1	4.6
Scopa et al. 1996⁵⁷⁸	NR	Yes	Yes	No: 65% malignant	NR	Yes	Yes	Yes	NR	NR	NR	NR	NR	NR	5	6.8
Cross et al. 1995⁵⁷⁹	NR	NR	NR	Yes	NR	Yes	No	Yes	NR	NR	Yes	No	No	No	0	5.0
Doyle et al. 1995⁵⁸⁰	Yes	Yes	Yes	Yes	Yes	No	No	Yes	NR	NR	NR	NR	NR	NR	4	6.4
Hamed et al. 1995⁵⁸¹	Yes	Yes	Yes	No: 88% malignant	Yes	Yes	No	No	NR	NR	NR	NR	NR	NR	3	6.1
Burbank et al. 1994⁵⁸²	NR	Yes	NR	NR	NR	Yes	No	Yes	NR	NR	NR	NR	NR	NR	2	5.7
Gisvold et al. 1994⁵⁸³	Yes	No: 33.6%	No	No: 42% malignant	Yes	Yes	Yes	Yes	NR	No	Yes	NR	NR	NR	4	6.4
Parker et al. 1994⁵⁸⁴	NR	NR	Yes	NR	No	No	No	Yes	NR	NR	No	No	NR	NR	−3	3.9
Smyth and Cederbom 1994⁵⁸⁵	NR	NR	NR	Yes	NR	Yes	Yes	No	NR	No	No	No	NR	NR	−1	4.6
Elvecrog et al. 1993⁵⁸⁶	Yes	Yes	Yes	NR	Yes	Yes	Yes	Yes	Yes	NR	NR	NR	NR	NR	8	7.9
Parker et al. 1993⁵⁸⁷	Yes	Yes	Yes	NR	NR	Yes	No	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
McMahon et al. 1992⁵⁸⁸	Yes	Yes	Yes	NR	Yes	Yes	No	Yes	NR	No	Yes	NR	NR	NR	5	6.8
Barreto et al. 1991⁵⁸⁹	NR	NR	Yes	No: 90% malignant	NR	Yes	Yes	Yes	NR	NR	Yes	NR	NR	NR	5	6.8
Cusick et al. 1990⁵⁹⁰	NR	Yes	Yes	No: 81.3% malignant	NR	Yes	Yes	No	NR	NR	NR	NR	NR	NR	3	6.1
Parker et al. 1990⁵⁹¹	Yes	No	Yes	NR	NR	Yes	Yes	No	NR	NR	NR	NR	NR	NR	2	5.7

: NR = Not Reported

Table E9Details of the core-needle biopsies performed in the studies addressing Key Questions 1 and 2

Study	Number of Different People Performing Biopsies	Training of Persons Performing Biopsies	Experience of Persons Performing Biopsies	Method of Imaging Guidance	Patient Position	Biopsy Device	Number of Cores
Jackman et al. 2009⁴⁸⁵	4	Radiologists	0.25 to 3.75 years of experience performing stereotactic biopsies but no experience with vacuum-assisted biopsies before the study began	Stereotactic	Prone	Mammotome 11G or 14G	12 or more
Peters et al. 2008⁴⁸⁶	NR	NR	NR	Stereotactic	Prone	Biopty automated gun 14G	Range: 5 to 8
Schueller et al. 2008⁴⁸⁷	2	Radiologists	Performed 100 or more biopsies before the study period began	US	Supine or decubitus	Bard automated gun 14G	Mean: 5.9 Range: 5 to 10
Sim and Kei 2008⁴⁸⁸	1	Radiologist	NR	Stereotactic	Seated	Mammotome 11G	Mean: 13.5 Range: 2 to 36
Tonegutti and Girardi 2008⁴⁸⁹	1	Radiologists	Short training period with 30 patients	Stereotactic	Prone	Mammotome 11G	20
Youk et al. 2008²⁴	9	Radiologists	7 had fellowship training, 2 had extensive clinical experience in breast imaging and biopsy	US	Supine	Pro-Mag automated gun, 14G	Mean: 5.4 cores Range: 3 to 8
Ciatto et al. 2007⁴⁹⁰	13	Radiologists	NR	US or stereotactic guidance	NR	Automated gun 14G or Mammotome 11G	2 to 4
de Lucena et al. 2007⁴⁹¹	1	NR	NR	US	NR	Pro-Mag automated gun 14G	6
Uematsu et al. 2007⁴⁹²	1	Radiologists	1 year of prior experience with the procedure	Stereotactic	Prone	Mammotome 11G	NR
Vag et al. 2007⁴⁹³	NR	Radiologists	reports the device is new and they are trying it out, but the radiologist was highly experienced in breast interventions	US	NR	VACORA 10G	NR
Chapellier et al. 2006⁴⁹⁴	NR	Radiologists	Device was newly acquired at start of the study	Stereotactic	NR	Mammotome	NR
Cipolla et al. 2006⁴⁹⁵	NR	NR	NR	Stereotactic or US	NR	14G needle	Mean: 3 Range: 2 to 5
Dhillon et al. 2006⁴⁹⁶	NR	NR	NR	Stereotactic	Prone	Mammotome 11G	Mean: 12 Range: 6 to 18
Bolivar et al. 2005⁴⁹⁷	NR	NR	NR	US	Supine	Automated gun 14G	Mean: 3.5 cores Range: 1 to 7
Crystal et al. 2005⁴⁹⁸	NR	NR	NR	US	NR	Biopty automated gun 14G	Median: 4 cores Range: 1 to 8
Dillon et al. 2005⁴⁹⁹	NR	NR	NR	US or stereotactic guidance or freehand	Supine or seated	Automated 14G or 16G needles	NR
Koskela et al. 2005⁵⁰⁰	5	Radiologists	4 to 6 years of experience	Stereotactic	Seated	Biopty automated gun 14G	Mean: 7 cores Range: 4 to 15
Sauer et al. 2005⁵⁰¹	3	NR	Undergone dedicated training in the biopsy method	US	NR	Biopty automated gun 14G	Mean: 2
Weber et al. 2005⁵⁰²	NR	Surgeons	5 month training period with the device before the study commenced	Stereotactic	Prone	Mammotome 11G	NR
Wu et al. 2005⁵⁰³	1	Surgeons	Reported to be “skilled”	US	NR	Mammotome 11G	NR
Alonso-Bartolome et al. 2004⁵⁰⁴	NR	NR	NR	US	Supine	NR	NR
Delle and Terinde 2004⁵⁰⁵	NR	NR	NR	US	NR	Automated gun	Median: 2 Range: 1 to 4
Fajardo et al. 2004⁵⁰⁶	NR	Radiologists	Radiologists at each participating site performed at least 50 procedures before enrolling patients into the trial	Stereotactic	NR	14G needle	Minimum: 5
Kettritz et al. 2004⁵⁰⁷	NR	Radiologists	NR	Stereotactic	Prone	Mammotome 11G	At least 20 or remove entire lesion
Lomoschitz et al. 2004⁵⁰⁸	4	Radiologists	Two were highly experienced with the procedure, two were not	Stereotactic	Prone	Mammotome 11G	20
Abdsaleh et al. 2003⁵⁰⁹	1	Radiologists	NR	Stereotactic or US	NR	Semi-automated 14G	NR
Ambrogetti et al. 2003⁵¹⁰	1	NR	NR	Stereotactic	Prone	NR	Mean: 10.2 Range: 4 to 25
Fishman et al. 2003⁵¹¹	1	Radiologists	Person performing procedure was a resident supervised by an attending radiologist	US	NR	Bard automated gun 14G	5
Han et al. 2003⁵¹²	2	Radiologists	NR	Stereotactic	Prone	Biopty automated gun 14G	Mean: 7 Range: 5 to 20
Kirshenbaum et al. 2003⁵¹³	3	Radiologists	NR	Stereotactic	72% seated	Bard automated gun 14G or Mammotome 11G	Bard gun Mean: 5.9 Range: 1 to 11 Mammotome Mean: 5.1 Range: 4 to 8
March et al. 2003⁵¹⁴	3	Radiologists	Reports the procedure is not their usual practice	US	NR	Mammotome 11G	Mean: 29 Range: 10 to 70
Pfleiderer et al. 2003⁵¹⁵	NR	NR	NR	MRI	Prone	Magnum automated gun 14G	Range: 3 to 6
Philpotts et al. 2003⁵¹⁶	More than 5	Radiologists	Majority of the procedures appear to have been performed by fellows and residents under the supervision of 5 experienced breast radiologists	US	Supine	US Biopty automated gun 14G or Mammotome 11G	Biopty Mean: 4.7 Range: 1 to 17 Mammotome Mean: 5.8 Range: 1 to 12
Wong and Hisham 2003⁵¹⁷	NR	NR	NR	Freehand	NR	Bard automated gun 14 or 16G	NR
Apesteguia et al. 2002⁵¹⁸	NR	Radiologists	NR	Stereotactic	Prone	Mammotome 11G	Mean: 10.7 Range: 1 to 26
Georgian-Smith et al. 2002⁵¹⁹	NR	Radiologists	NR	Stereotactic	Most seated	Mammotome 11G	Mean: 9.5 Range: 5 to 26
Jackman and Lamm 2002⁵²⁰	NR	Radiologists	NR	Stereotactic	Prone	Biopty automated gun 14G or Mammotome 11G or 14G	Median 14 Range: 5 to 30
Johnson et al. 2002⁵²¹	NR	NR	No experience at the beginning of the study	US	Supine	Mammotome 11G or 8G	Attempt to completely remove lesion
Liberman et al. 2002⁵²²	NR	NR	NR	Stereotactic	Prone	Mammotome 11G	Median: 15 Range: 4 to 47
Meloni et al. 2002⁵²³	NR	NR	NR	Stereotactic	Seated	Vacuum-assisted	Mean: 12 Range: 3 to 14
Morris et al. 2002⁵²⁴	NR	NR	NR	Stereotactic	Prone	Mammotome 14G	NR
Pfarl et al. 2002⁵²⁵	More than 7	Radiologists	7 had an average of 2.6 (Range: 0 to 18) procedures before the study commenced; non specified number of residents in training had no experience before the study commenced	Stereotactic	Prone	Mammotome 11G	15 to 20
Verkooijen et al. COBRA 2002⁵²⁶	More than 5	Radiologists	radiologists first attended 10 biopsy procedures and subsequently they performed another 10 under the supervision of a radiologist with considerable experience	Stereotactic	Prone	Bard automated gun 14G	NR
Becker et al. 2001⁵²⁷	4	Radiologists	NR	Stereotactic	Seated	14G needle	NR
Brenner et al. 2001⁵²⁸	NR	NR	All took a two-day course	Stereotactic	Prone	Automated gun 14G	5 or more
Cangiarella et al. 2001⁵²⁹	NR	Radiologists	NR	Stereotactic	Prone	Mammotome 11G	Mean: 11 Range: 7 to 15
Dahlstrom and Jain 2001⁵³⁰	NR	NR	NR	Stereotactic	NR	Biopty automated gun 14G	5
Lai et al. 2001⁵³¹	NR	NR	NR	Stereotactic	Prone	Mammotome 11G	Mean: 17.2
Levin et al. 2001⁵³²	3	Radiologists	2 of 3 radiologists had prior training in stereotactic core biopsy and attended a two-day course on use of the add-on unit; these two taught the third radiologist	Stereotactic	Seated	BIP automated gun 14G	5
Margolin et al. 2001⁵³³	3	Radiologists	NR	Stereotactic or US	Prone	Automated 14G, 16G, or 18G gun or Mammotome 11G or 14G	NR
Perez-Fuentes et al. 2001⁵³⁴	NR	NR	NR	US	Supine	Mammotome 11G	Median: 17 Range: 8 to 40
Smith et al. 2001⁵³⁵	NR	NR	NR	US	NR	Automated 14G gun	NR
White et al. 2001⁵³⁶	NR	Radiologists	NR	Stereotactic or US	Prone or supine	Automated 14G gun or Mammotome 11G or 14G	NR
Wunderbaldinger et al. 2001⁵³⁷	1	Radiologists	Performed 30 procedures on phantoms prior to the study	US	Seated	Magnum automated gun 14G	Mean: 6 Range: 3 to 10
Yeow et al. 2001⁵³⁸	1	Radiologists	NR	US	NR	Automated gun 14G or 16G	Mean: 3.4 Range: 1 to 7
Beck et al. 2000⁵³⁹	NR	NR	NR	Stereotactic	Prone	Mammotome 11G	NR
Kirwan et al. 2000⁵⁴⁰	NR	NR	NR	Stereotactic	Prone	Automated gun 14G	NR
Latosinsky et al. 2000⁵⁴¹	NR	NR	NR	Stereotactic or US	Prone for stereotactic	Automated gun or vacuum-assisted 14G	NR
Liberman et al. 2000⁵⁴²	NR	NR	NR	US or stereotactic	NR	Automated 14G gun	Median: 4 Range: 1 to 7
Makoske et al. 2000⁵⁴³	More than 1	Radiologists and surgeons	No experience in the procedure at the beginning of study; they were, however, trained and credentialed.	Stereotactic	NR	Automated gun or Mammotome	Minimum: 5
Ward et al. 2000⁵⁴⁴	2	Radiologists	Radiologists described as “specialize in breast imaging and diagnosis”	Stereotactic	NR	Bard automated gun 14G or 16G	Mean: 11 Range: 4 to 18
Welle et al. 2000⁵⁴⁵	NR	NR	NR	Stereotactic	Most decubitus	Bard automated gun 14G or Mammotome 11G	3 to 16
Helbich et al. 1999⁵⁴⁶	1	Radiologists	NR	Stereotactic	Seated	Patients randomized to various automated biopsy guns with different needle G	NR
Jackman et al. 1999⁵⁴⁷	NR	NR	NR	Stereotactic	Prone	Biopty automated gun 14G	Mean: 8.1 Range: 2 to 20
Meyer et al. 1999⁵⁴⁸	NR	NR	NR	Stereotactic	Prone	Automated gun 14G or Mammotome 11G or 14G	Mean: 5 to 8
Puglisi et al. 1999⁵⁴⁹	NR	NR	NR	Perforated compression grid	NR	Automated gun 14G	Median: 5
Soo et al. 1999⁵⁵⁰	4	Radiologists	NR	Stereotactic	Prone	Magnum automated gun 14G or Mammotome 14G	Automated gun Mean: 5.8 Mammotome Mean: 15.8
Caruso et al. 1998⁵⁵¹	1	Surgeons	Reports “experienced surgeon”	Freehand	NR	Trucut 18G	NR
Doyle et al. 1998⁵⁵²	NR	NR	No experience with the procedure at the beginning of the study	Stereotactic	Decubitus	Pro-Mag automated gun 14G	NR
Fuhrman et al. 1998⁵⁵³	3	Radiologists	Reports “radiologists with expertise in breast imaging”	Stereotactic or US	Stereotactic prone, US supine	Automated gun 14G	At least 5
Heywang-Kobrunner et al. 1998⁵⁵⁴	NR	NR	NR	Stereotactic	Prone	Mammotome 11G or 14G	NR
Ioffe et al. 1998⁵⁵⁵	NR	NR	NR	Stereotactic or US	NR	Bard automated gun 14G	At least 5
Liberman et al. 1998⁵⁵⁶	NR	NR	NR	US	Supine	Pro-Mag automated gun 14G	Median: 4 Range: 2 to 7
Schulz-Wendtland et al. 1998⁵⁵⁷	NR	NR	NR	US	NR	14G needle	1 to 3
Vega-Bolivar et al. 1998⁵⁵⁸	1	Radiologists	NR	Stereotactic	NR	Surecut 15G	At least 2
Whitman et al. 1998⁵⁵⁹	NR	NR	NR	Stereotactic	NR	Monopty 16G	NR
Zannis and AliaNo 1998⁵⁶⁰	1	Surgeons	NR	Stereotactic	Prone	Trucut 14G or Mammotome 14G or 11G	Trucut Mean: 4.8 cores Range: 1 to 7 Mammotome at least 16
Bauer et al. 1997⁵⁶¹	NR	NR	NR	Stereotactic	Prone or seated	BIP automated gun 14G	Mean: 9 Range: 1 to 13
Britton et al. 1997⁵⁶²	4	Radiologists	NR	Stereotactic or US	Supine for US	Automated gun 14, 16, or 18G	Mean: 5
Helbich et al. 1997⁵⁶³	1	Radiologists	Described as an “expert”	Stereotactic or US	Prone or supine or seated	Automated gun 14G	NR
Khattar et al. 1997⁵⁶⁴	NR	Surgeons	NR	US	Supine	Pro-Mag automated gun	2 or 3
Liberman et al. 1997⁵⁶⁵	NR	NR	NR	Stereotactic	Prone	Biopty-cut 14G	Mean: 6 Range: 1 to 22
Pitre et al. 1997⁵⁶⁶	NR	NR	NR	Stereotactic	Prone	Pro-Mag automated gun	Mean: 5
Stolier et al. 1997⁵⁶⁷	1	Surgeons	No experience in the procedure at the beginning of study	Stereotactic	Prone	Automated gun 14G or Mammotome	Minimum: 5
Sutton, et al. 1997⁵⁶⁸	5	Radiologists	All involved radiologists have experience in mammography and interventional techniques in breast disease diagnosis	Stereotactic	Prone	Biopty automated gun 14G	NR
Walker et al. 1997⁵⁶⁹	NR	NR	NR	Stereotactic	NR	Automated gun 14G	Minimum: 5
Frazee et al. 1996⁵⁷⁰	NR	Radiologists	NR	Stereotactic	Prone	NR	Minimum: 5
Fuhrman et al. 1996⁵⁷¹	NR	NR	NR	Stereotactic	Prone	Automated gun 14G	Minimum: 5
Head and Haynes 1996⁵⁷²	NR	NR	NR	Stereotactic	Prone	Biopty automated gun 18G	NR
Mainiero et al. 1996⁵⁷³	NR	NR	NR	Stereotactic	Prone	Biopty automated gun 14G	NR
Meyer et al. 1996⁵⁷⁴	NR	Radiologists	NR	Stereotactic	Prone	Biopty automated gun 14G	NR
Nguyen et al. 1996⁵⁷⁵	NR	NR	NR	Stereotactic or US	Prone	Automated gun 14G	5 to 10
Pettine et al. 1996⁵⁷⁶	NR	NR	NR	Stereotactic	Prone	Biopty automated 14G gun	5 to 9
Rosenblatt et al. 1996⁵⁷⁷	NR	NR	NR	Stereotactic	Prone	Biopty automated gun 14G	NR
Scopa et al. 1996⁵⁷⁸	NR	NR	NR	Freehand	NR	TruCut	NR
Cross et al. 1995⁵⁷⁹	NR	NR	NR	Stereotactic	Prone	Bard automated gun 14G	Mean: 3.4 Range: 1 to 8
Doyle et al. 1995⁵⁸⁰	NR	NR	NR	Stereotactic or US	Prone	Automated gun 14G or 15G	NR
Hamed et al. 1995⁵⁸¹	NR	NR	NR	Freehand	NR	Biopty automated gun 14G or 18G	Mean: 3
Burbank et al. 1994⁵⁸²	NR	NR	NR	Stereotactic or US	NR	NR	NR
Gisvold et al. 1994⁵⁸³	7	Radiologists	All attended a training session before performing any procedures	Stereotactic	Prone	Biopty automated gun 14G	Minimum: 5
Parker et al. 1994⁵⁸⁴	NR	Radiologists	The radiologists participated in a two-day training session before the study commenced	Freehand	NR	Biopty automated gun 14G	NR
Smyth and Cederbom 1994⁵⁸⁵	NR	NR	NR	Stereotactic	Prone	Automated gun	NR
Elvecrog et al. 1993⁵⁸⁶	2	Radiologists	NR	Stereotactic	Prone	Biopty automated gun 14G	Minimum: 5
Parker et al. 1993⁵⁸⁷	NR	Radiologists	NR	US	Supine	Biopty automated gun 14G	4 to 5
McMahon et al. 1992⁵⁸⁸	More than 8	Surgeons	NR	Freehand	NR	Various 14 to 18G devices	1
Barreto et al. 1991⁵⁸⁹	NR	NR	No experience at the beginning of the study	Freehand	NR	Biopty automated gun 18G	1
Cusick et al. 1990⁵⁹⁰	NR	NR	NR	Freehand	NR	NR	NR
Parker et al. 1990⁵⁹¹	4	Radiologists	NR	Stereotactic	NR	Biopty automated gun 14, 16, or 18G	NR

: NR = Not Reported

Table E10Patient inclusion/exclusion criteria for studies addressing Key Questions 1 and 2

Study	Patient Inclusion Criteria	Patient Exclusion Criteria
Jackman et al. 2009⁴⁸⁵	Consecutive patients referred for core-needle biopsy between March 1995 through December 2001	Weighed more than 300 lbs; had bleeding diathesis; use of anti-coagulants that could not be discontinued (but no patients had these conditions during the study period).
Peters et al. 2008⁴⁸⁶	All patients with nonpalpable lesions referred for core-needle biopsy between February 2000 and June 2002	Coagulopathies or the use of anti-coagulants that could not be discontinued and an inability to stay in the prone position for one hour
Schueller et al. 2008⁴⁸⁷	All patients referred to the center for core-needle biopsy between January 1995 and February 2004	Patients unable to cooperate with the procedure or had a bleeding diathesis
Sim and Kei et al. 2008⁴⁸⁸	All patients with microcalcifications referred for core-needle biopsy between November 2002 and August 2005	NR
Tonegutti and Girardi 2008⁴⁸⁹	Women with suspicious nonpalpable mammographic lesions (microcalcifications, mass with or without microcalcifications, architectural distortion) not recognisable by ultrasound	NR
Youk et al. 2008²⁴	All patients undergoing US-guided core-needle biopsy between February 2000 and June 2005	NR
Ciatto et al. 2007⁴⁹⁰	All consecutive core-needle biopsies performed at the study center between January 1996 and March 2005	NR
de Lucena et al. 2007⁴⁹¹	NR	NR
Uematsu et al. 2007⁴⁹²	Consecutive patients with mammographically-detected microcalcifications BIRADS 3, 4, or 5 whose lesions were not visible on US	Unable to provide consent or undergo MRI imaging due to pacemaker, claustrophobia, or metallic clip; blood coagulation disorder; currently being treated with anti- coagulants; unable to cooperate with the biopsy procedure
Vag et al. 2007⁴⁹³	NR	NR
Chapellier et al. 2006⁴⁹⁴	Core-needle biopsies performed between January 2001 to November 2002	NR
Cipolla et al. 2006⁴⁹⁵	Consecutive patients undergoing core-needle biopsy at the center between September 1999 to February 2004	NR
Dhillon et al. 2006⁴⁹⁶	The first 150 consecutive patients who met these criteria: all indeterminate calcifications; distortions or masses not seen on US; a non-diagnostic biopsy on US; problem cases referred from other units	NR
Bolivar et al. 2005⁴⁹⁷	All patients with suspicious non-palpable breast lumps who underwent US-guided biopsy between August 1997 to April 2001	NR
Crystal et al. 2005⁴⁹⁸	Patients with US visible solid breast lesions referred for biopsy between October 1, 1998 and September 1, 2001	Lesions that appeared to be radial scars were excluded
Dillon et al. 2005⁴⁹⁹	All women who underwent biopsy at the center between January 1999 to September 2003	NR
Koskela et al. 2005⁵⁰⁰	Between June 1998 and January 2001, all patients with lesions not visible on US who were scheduled for core-needle stereotactic biopsy	Lesions located too high or too close to the chest wall such that it could not be reached by the stereotactic equipment
Sauer et al. 2005⁵⁰¹	All patients undergoing US biopsy of lesions detected on routine screening over a 28 month period	NR
Weber et al. 2005⁵⁰²	All patients between October 1999 to August 2003 with mammographically suspicious but nonpalpable lesions	Breast too small, lesion too close to the chest wall, lesion not evident on image
Wu et al. 2005⁵⁰³	Patients suspected of having benign lesions who underwent vacuum-assisted biopsy between July 2000 and July 2003	NR
Alonso-Bartolome et al. 2004⁵⁰⁴	Patients with “probably benign” lesions	NR
Delle and Terinde 2004⁵⁰⁵	Patients referred to the clinic because of palpable or non-palpable lesions or because of suspicion of cancer on mammography between September 2000 and September 2001	NR
Fajardo et al. 2004⁵⁰⁶	NR	Lesions located in prior lumpectomy or radiation therapy site, known bleeding disorder or anticoagulant therapy, pregnancy, allergy to local anesthesia, breast implants, psychiatric or neurologic conditions limiting patient’s ability to cooperate during biopsy and/or provide informed consent
Kettritz et al. 2004⁵⁰⁷	NR	NR
Lomoschitz et al. 2004⁵⁰⁸	Consecutive women with solitary non-palpable lesions referred for 11G mammotome between February 1999 and July 2000, consecutive until 50 women with mammographic masses and 50 women with microcalcifications were enrolled	NR
Abdsaleh et al. 2003⁵⁰⁹	Consecutive patients between August 2000 and December 2001	NR
Ambrogetti et al. 2003⁵¹⁰	Consecutive nonpalpable isolated microcalcifications detected in routine screening considered suspicious enough to warrant investigation between February 1999 and June 2002	NR
Fishman et al. 2003⁵¹¹	Consecutive patients referred for an US-guided biopsy over a 7-month period	Lesion turned out to be a cyst, pathological material was lost in one case, and in two cases ad hoc exclusion because the pathologist involved in the study had come to a different diagnosis than the “routine” pathology reading
Han et al. 2003⁵¹²	Nonpalpable calcifications referred between April 1997- March 2002	NR
Kirshenbaum et al. 2003⁵¹³	All patients undergoing stereotactic core-needle biopsy between October 1994 and February 2001 with nonpalpable lesions.	NR
March et al. 2003⁵¹⁴	Patients referred to two outpatient centers between August 2000 and October 2001 for US-guided biopsy of a single breast lesion well- visualized on US and located at least 0.5 cm from the skin and pectoralis margin and at least 2 cm from the nipple with the lesion measuring 1.2 cm or less in diameter	Lesion turned out to be a cyst
Pfleiderer et al. 2003⁵¹⁵	Women were invited after an MRI exam that found lesions with suspicious contrast enhancement, reasons why they had the MRI exam not reported	Pregnancy or lactation, coagulation abnormalities, allergies to local anesthetics or MRI contrast agents, compressed breast thickness less than 25 mm
Philpotts et al. 2003⁵¹⁶	All patients who underwent US-guided biopsy between January 1997 and August 2001	NR
Wong and Hisham 2003⁵¹⁷	Consecutive biopsies of palpable breast lesions from May 2000 to May 2001	Nonpalpable lesion, less than 6 months followup
Apesteguia et al. 2002⁵¹⁸	All cases detected between April and December 1999 with suspicious non-palpable lesion which could not be reliably detected by US	NR
Georgian-Smith et al. 2002⁵¹⁹	Consecutive patients between June 1999 and August 2000	NR
Jackman and Lamm 2002⁵²⁰	All patients who underwent core-needle biopsy between July 1991 and December 1999 who had breast implants	NR
Johnson et al. 2002⁵²¹	All patients with probably benign lesions scheduled for US-guided mammotome excisional attempt between April 2000 to January 2002	NR
Liberman et al. 2002⁵²²	Consecutive lesions undergoing stereotactic biopsy between October 31, 1996 to March 8, 2001. Indications for biopsy were nonpalpable lesions suspicious of malignancy, calcifications or masses 0.5 cm or less or masses that could not be viewed on US	Bleeding diathesis, patient unable to cooperate, lesion could not be targeted
Meloni et al. 2002⁵²³	All cases of non-palpable mammographically detected lesions undergoing vacuum-assisted core-needle biopsy at the center between December 1999 and November 2000	NR
Morris et al. 2002⁵²⁴	Twenty-one nonpalpable masses seen on mammography in 19 women who gave informed consent. The masses on mammography had no associated calcifications and were classified as either BI-RADS 4 (n = 17) or 5 (n = 4) lesions.	NR
Pfarl et al. 2002⁵²⁵	All patients undergoing 11G Mammotome biopsy from September 1997 to December 2001	Unable to cooperate with the procedure, had a bleeding diathesis
Verkooijen et al. COBRA 2002⁵²⁶	Nonpalpable breast lesions requiring histologic exam enrolled in 19 Dutch hospitals	Coagulotherapies or use of anticoagulants that could not be discontinued, inability to maintain prone position for one hour, inability to comprehend study protocol
Becker et al. 2001⁵²⁷	Biopsies performed for microcalcifications at the center between November 1993 and January 1997	NR
Brenner et al. 2001⁵²⁸	NR	NR
Cangiarella et al. 2001⁵²⁹	Patients with indeterminate microcalcifications that had been detected by routine screening and had no evidence of a mammographic density or mass biopsied between January 1997 and December 1997	NR
Dahlstrom and Jain 2001⁵³⁰	Women with suspicious calcifications detected on routine screening between July 1993 and August 1998	NR
Lai et al. 2001⁵³¹	Consecutive patients who underwent biopsy between	NR
Levin et al. 2001⁵³²	September 1997 and March 2000 Women with a single non-palpable lesion detected during a routine mammography and scheduled for a lumpectomy. Spiculated lesions, indeterminate nodules, indeterminate calcifications, and localized asymmetric density were eligible.	Palpable lesion, radial scar, bleeding diathesis, lesion not well visualized, in a difficult location
Margolin et al. 2001⁵³³	All patients who underwent core biopsy between January 1994 and December 1998	NR
Perez-Fuentes et al. 2001⁵³⁴	All patients who underwent US-guided vacuum-assisted core needle biopsies at the center between August 1998 to December 2000. Criteria for deciding who got this type of core biopsy rather than another type seemed vague and inconsistently applied. Listed below: palpable or nonpalpable masses that could be seen with US and that were suspicious or highly suggestive of malignancy. Also used for occasional lesions that appeared to probably be benign. Selectively used for solid lesions that were suspicious and measured 2 cm or less. Solid lesions that were suggestive of malignancy and measured 1 cm or less. Complex lesions, intraductal lesions, subtle lesions, cysts with mural thickening, intramural nodules, or thick septations regardless of size; lesions suspected of being radial scars or papillomas; other lesions; occasional probably benign lesions 2 cm or less.	Bleeding diathesis or unable to cooperate with the procedure.
Smith et al. 2001⁵³⁵	Betweeen August 1991 and February 1998, women referred for US-guided biopsy because of non-calcificied US visible masses	NR
White et al. 2001⁵³⁶	All patients who had image-guided core-needle biopsy at the center between August 1992 and February 1999	NR
Wunderbaldinger et al. 2001⁵³⁷	Patients scheduled to undergo open biopsy for non-palpable breast lesions	NR
Yeow et al. 2001⁵³⁸	Consecutive patients referred for needle biopsy January 1995 to October 1997 with palpable breast masses	Lesion was identified as a cyst
Beck et al. 2000⁵³⁹	Until April 1999 patients with indeterminate lesions who were sent for biopsy	NR
Kirwan et al. 2000⁵⁴⁰	Women with mammographically-detected stellate lesions with or without microcalcifications	NR
Latosinsky et al. 2000⁵⁴¹	Between November 1994 to May 1998, all patients who underwent core biopsy	NR
Liberman et al. 2000⁵⁴²	Patients with palpable lesions who underwent core-needle biopsy betweeen August 1992 and May 1998	NR
Makoske et al. 2000⁵⁴³	All eligible patients from 1993 through 1998, those with nonpalpable lesions found on mammography who were sent for biopsy	NR
Ward et al. 2000⁵⁴⁴	Patients with indeterminate microcalcifications sent for core biopsy between November 1993 and January 1997	Cases with associated mass, distortion, or palpable lesion were excluded
Welle et al. 2000⁵⁴⁵	Patients with stereotactic core-needle biopies performed between September 1995 trhough March 1999	NR
Helbich et al. 1999⁵⁴⁶	NR	NR
Jackman et al. 1999⁵⁴⁷	Consecutive patients with nonpalpable lesions who had stereotactic core-needle biopsy between July 1991 and December 1993	NR
Meyer et al. 1999⁵⁴⁸	Patients seen between August 1991 and December 31, 1997 for suspicious nonpalpable breast abnormalities	NR
Puglisi et al. 1999⁵⁴⁹	Consecutive patients seen from July 1992-December 1997	US-guided procedures
Soo et al. 1999⁵⁵⁰	Patients with noncalcified, nonpalpable, mammographically-detected lesions referred for biopsy between October 1995 and August 1997	NR
Caruso et al. 1998⁵⁵¹	From 1990 to 1995, a consecutive series of 91 patients	NR
Doyle et al. 1998⁵⁵²	Patients who underwent stereotactic core-needle biopsy between September 1994 and March 1998	NR
Fuhrman et al. 1998⁵⁵³	All nonpalpable breast lesions from July 1993-February 1997 that underwent image-guided core needle breast biopsy.	Palpable masses, lesions not clearly visualized in the stereotactic unit (usually lesions deep in the breast along the chest wall), lesions found in small breasts which compress to <2 cm in the stereotactic unit, asymmetric dense breast tissue, unable to tolerate the prone position for 30 minutes.
Heywang-Kobrunner et al. 1998⁵⁵⁴	Patients referred for biopsy up to March 1997	NR
Ioffe et al. 1998⁵⁵⁵	Consecutive core-needle biopsies between July 1995 and January 1997	NR
Liberman et al. 1998⁵⁵⁶	Patients with a solitary, nonpalpable mass who underwent US-guided biopsy between May 1993 and June 1997	The parenchyma was too thin to support the excursion of the needle, a hemorrhagic diathesis, unable to cooperate, or the lesion was less than 5 mm
Schulz-Wendtland et al. 1998⁵⁵⁷	Patients who underwent US-guided biopsies between May 1992 and April 1993	NR
Vega-Bolivar et al. 1998⁵⁵⁸	Patients seen between October 1993-October 1996 for nonpalpable breast lesions	NR
Whitman et al. 1998⁵⁵⁹	Mammographically-guided coaxial core-needle biopsy procedures performed with a fenestrated alphanumeric compression device between 1995-1997	NR
Zannis and AliaNo 1998⁵⁶⁰	Consecutive records of patients undergoing a stereotactic procedure and biopsy by the same surgeon for a non-palpable, mammographically-detected lesion between January 1993 and August 1997	NR
Bauer et al. 1997⁵⁶¹	Mammographically-detected breast lesions considered worrisome enough to require biopsy, such as clustered microcalcifications, a spiculated mass, or an area of architectural distortion during the 30 months from July 1, 1993 to January 1, 1996.	NR
Britton et al. 1997⁵⁶²	All patients after April 1994 who were recalled for core-needle biopsy after routine mammographic screening	NR
Helbich et al. 1997⁵⁶³	Consecutive patients with solid breast lesions over 20 months	NR
Khattar et al. 1997⁵⁶⁴	Between February 1993 and March 1995, patients over 18 years of age with a palpable mass scheduled for surgical excision	Lesion was revealed to be a simple cyst on US
Liberman et al. 1997⁵⁶⁵	Patients who underwent stereotactic core biopsy between August 7, 1992 and December 14, 1995	Thickness of compressed breast was inadequate to accommodate the needle; the lesion measured less than 5 mm in diameter; the lesion could not be targeted accurately; the patient had a bleeding diathesis; the patient was on anticoagulants; the patient was unable to cooperate with the procedure.
Pitre et al. 1997⁵⁶⁶	Patients who had stereotactic core-needle biopsy for a nonpalpable unicentric mammographically-detected breast lesion between January 1994 and February 1995	NR
Stolier et al. 1997⁵⁶⁷	All patients who underwent core-needle biopsy at the center by the study author from August 1993 through May 1996	NR
Sutton, et al. 1997⁵⁶⁸	Women who elected to have stereotactic-guided large-gauge core biopsy between July 1993 and June 1995 after detection of suspicious non-palpable abnormalities at a mammographic screening clinic	Initially, women with abnormalities considered to be obviously malignant were excluded from the series (from July to December 1993) but after the first 70 patients, these highly suspicious lesions were offered core biopsy
Walker et al. 1997⁵⁶⁹	All patients who had stereotactic core-needle for a nonpalpable lesion since 1993	NR
Frazee et al. 1996⁵⁷⁰	Patients with nonpalpable mammographic abnormality between July 1994 to June 1995	NR
Fuhrman et al. 1996⁵⁷¹	All non-palpable suspicious masses and calcifications noted on mammography from July 1993 - January 1995	Lesions not clearly visualized in the stereotactic unit, usually lesions deep within the breast along the chest wall, lesions found in small breasts which compress to less than 2cm in the stereotactic unit, asymmetric dense breast tissue, and patients unable to tolerate the prone position for 30 minutes
Head and Haynes 1996⁵⁷²	Patients with nonpalpable breast lesions discovered during routine mammography	NR
Mainiero et al. 1996⁵⁷³	Patients with microcalcifications were considered indeterminate or suspicious for malignancy	Lesions in which calcifications were within a mass or an area of architectural distortion
Meyer et al. 1996⁵⁷⁴	Clinically occult suspicious mammographic abnormalities. The mass must be at least 6mm in diameter and be clearly visible on mammography	NR
Nguyen et al. 1996⁵⁷⁵	All core-needle biopsies performed between December 1992 and June 1995	NR
Pettine et al. 1996⁵⁷⁶	Patients with nonpalable lesions discovered on mammogram followed immediately by wire localized biopsy	NR
Rosenblatt et al. 1996⁵⁷⁷	All patients who underwent biopsy of multiple unilateral lesions between January 1994 and September 1995	NR
Scopa et al. 1996⁵⁷⁸	Patients undergoing Tru-Cut biopsies who had not been previously investigated with fine-needle aspiration	NR
Cross et al. 1995⁵⁷⁹	Patients who were referred to the center for stereotactic biopsy of a nonpalpable mammographic abnormality	NR.
Doyle et al. 1995⁵⁸⁰	Mammographically-detected impalpable breast lesions, completely well-circumscribed masses less than 8mm in diameter with smooth borders. Opacities containing fat or with concave margins, clusters or uniform tiny rounded calcifications, scattered calcifications, and scattered nodules. Lesions considered strongly suggestive of cancer included new spiculated masses, new clustered pleomorphic calcifications, or both.	Inability to provide informed consent and irreversible bleeding diathesis
Hamed et al. 1995⁵⁸¹	Female patients with clinically suspected breast carcinoma	Patients with locally advanced breast carcinoma
Burbank et al. 1994⁵⁸²	NR	Patients who underwent bone biopsies
Gisvold et al. 1994⁵⁸³	All patients referred for wire-localized open surgery between October 19, 1991 and January 15, 1993 were considered for the study. The inclusion criteria are: If it appeared the lesion and patient were suitable (patient could lie prone for an hour, no bleeding problems, and no allergy to local anesthesia; lesions thought to be visualizable and were not too superficial or close to the nipple).	Equipment or radiologist not available, lesion visualizable only on US
Parker et al. 1994⁵⁸⁴	Core-needle biopsies performed at sites at which the radiologists and assisting technologists had undergone dedicated training in larger core breast biopsy and had followed a standard protocol	NR
Smyth and Cederbom 1994⁵⁸⁵	Patients with mammographically suspicious non palpable lesions	NR
Elvecrog et al. 1993⁵⁸⁶	Patients with single non-palpable mammographic lesion; study restricted to patients who would have undergone open biopsy if core biopsy wasn’t available	Lesions less than 5 mm in diameter
Parker et al. 1993⁵⁸⁷	Consecutive patients with solid or indeterminate breast lesions visualized by US between August 1989 and July 1991	NR
McMahon et al. 1992⁵⁸⁸	Consecutive patients with palpable breast lumps between September 1989 and August 1991	NR
Barreto et al. 1991⁵⁸⁹	Symptomatic patients with palpable breast lumps suspected of having early breast cancer who were scheduled for open surgical excision	NR
Cusick et al. 1990⁵⁹⁰	Patients with suggestive mammary lumps seen at the surgery clinic of San Bernardino County Medical Center	NR
Parker et al. 1990⁵⁹¹	During a 13-month period, consecutive patients who underwent stereotactic-needle core breast biopsies	NR

: NR = Not Reported

Table E11Characteristics of patients enrolled in studies addressing Key Questions 1 and 2

Study	Number of Patients Recruited for Enrollment	Number of Patients Enrolled	Number of Lesions Enrolled	Age	Age Dispersion	Ethnicity
Jackman et al. 2009⁴⁸⁵	1,152	1,152	1,280	NR	NR	NR
Peters et al. 2008⁴⁸⁶	955	948	948	NR	NR	NR
Schueller et al. 2008⁴⁸⁷	1390	1390	1438	Median: 51	Range: 15 to 93	NR
Sim and Kei et al. 2008⁴⁸⁸	106	97	105	Mean: 53.2	Range: 36 to 81	Asian: 100%
Tonegutti and Girardi 2008⁴⁸⁹	268	268	268	Mean: 52	Range: 22–79	NR
Youk et al. 2008²⁴	4,359	4,359	4,359	Median: 45 Mean: 45.3	Range: 12 to 88	NR
Ciatto et al. 2007⁴⁹⁰	4,035	4,035	4,035	NR	NR	NR
de Lucena et al. 2007⁴⁹¹	NR	144	150	Mean: 50	Range: 15 to 89 Standard deviation: 16	NR
Uematsu et al. 2007⁴⁹²	NR	96	100	Mean: 49.4	Range: 28 to 85	NR
Vag et al. 2007⁴⁹³	NR	65	70	Median: 57	Range: 31 to 82	NR
Chapellier et al. 2006⁴⁹⁴	NR	301	318	Mean: 56	Range: 35 to 78, 64% postmenopausal	NR
Cipolla et al. 2006⁴⁹⁵	426	426	426	64% post-menopausal	NR	NR
Dhillon et al. 2006⁴⁹⁶	150	150	150	Median: 56	Range: 37 to 77	NR
Bolivar et al. 2005⁴⁹⁷	208	208	214	Mean: 55	Range: 32 to 87	NR
Crystal et al. 2005⁴⁹⁸	652	652	715	NR	NR	NR
Dillon et al. 2005⁴⁹⁹	2,427 (lesions)	NR	2,427	NR	NR	NR
Koskela et al. 2005⁵⁰⁰	212	205	213	Mean: 56	Range: 32 to 88	NR
Sauer et al. 2005⁵⁰¹	906	906	962	NR	NR	NR
Weber et al. 2005⁵⁰²	239	225	225	Median: 56.1	Range: 30 to 84	NR
Wu et al. 2005⁵⁰³	113	113	113	Median: 31	Range: 18 to 35	NR
Alonso-Bartolome et al. 2004⁵⁰⁴	97	97	102	Mean: 42	Range: 18 to 77	NR
Delle and Terinde 2004⁵⁰⁵	146	146	169	NR	NR	NR
Fajardo et al. 2004⁵⁰⁶	2,403	2,403	2,403	Mean: 54.6	Range: 25 to 89	% White European descent: 1,313 (78.1%) % Black African descent: 265 (15.8%) % Asian descent: 27 (1.6%) % Hispanic descent: 62 (3.7%) % other, please specify: 6 Native American (0.4%), 8 another race (0.5%)
Kettritz et al. 2004⁵⁰⁷	2,939	NR	2,893	NR	NR	NR
Lomoschitz et al. 2004⁵⁰⁸	100	100	100	Median: 55	Range: 31 to 81	NR
Abdsaleh et al. 2003⁵⁰⁹	180	180	180	NR	Range: 35 to 93	NR
Ambrogetti et al. 2003⁵¹⁰	364	364	364	Mean: 54.9	Range: 33 to 81	NR
Fishman et al. 2003⁵¹¹	75	70	73	NR	NR	NR
Han et al. 2003⁵¹²	284 (lesions)	267	271	Mean: 47 yrs	Range: 23 to 72	NR
Kirshenbaum et al. 2003⁵¹³	492	492	506	Mean: 59.1	Range: 27 to 78	NR
March et al. 2003⁵¹⁴	57	34	34	NR	NR	NR
Pfleiderer et al. 2003⁵¹⁵	NR	14	14	Mean: 47.9	Standard deviation: 13.1	NR
Philpotts et al. 2003⁵¹⁶	271	271	281	NR	NR	NR
Wong and Hisham 2003⁵¹⁷	NR	145	150	NR	Range: 20 to 80	% Asian descent: 80% % other, please specify: 18% Indian 2% “other”
Apesteguia et al. 2002⁵¹⁸	126	126	132	Mean: 50.5	Range: 29 to 81 Standard deviation: 10.2	NR
Georgian-Smith et al. 2002⁵¹⁹	179	179	185	Mean: 54.6	Range: 35 to 85	NR
Jackman and Lamm 2002⁵²⁰	25	25	31	Median: 58	Range: 35 to 75	NR
Johnson et al. 2002⁵²¹	81	81	101	Mean: 46.8	Range: 21 to 72	NR
Liberman et al. 2002⁵²²	797	797	800	Median: 57	Range: 28 to 88	NR
Meloni et al. 2002⁵²³	138	129	129	NR	NR	NR
Morris et al. 2002⁵²⁴	NR	19	21	Mean: 57	Range: 36 to 75	NR
Pfarl et al. 2002⁵²⁵	332 (lesions)	325	332	Median: 56	Range: 28 to 83	NR
Verkooijen et al. COBRA 2002⁵²⁶	973	928	984	Mean: 58	Range: 29 to 85	NR
Becker et al. 2001⁵²⁷	218	218	232	Mean: 57.3	Range: 33 to 84	NR
Brenner et al. 2001⁵²⁸	NR	1003	1003	NR	NR	NR
Cangiarella et al. 2001⁵²⁹	142	142	160	Mean: 53.5	Range: 34 to 79	NR
Dahlstrom and Jain 2001⁵³⁰	266	discrepancy: study reports data for 301 core biopsies but states in methods that 266 women with 274 lesions were enrolled	310	NR	NR	NR
Lai et al. 2001⁵³¹	650	650	673	Mean: 54.7	Range: 22 to 89 Standard deviation: 11.6	NR
Levin et al. 2001⁵³²	NR	70	70	NR	Range: 39 to 80	NR
Margolin et al. 2001⁵³³	1,183	1,183	1,333	Mean: split into three groups 55, 52, 40	Range: 17 to 93	NR
Perez-Fuentes et al. 2001⁵³⁴	88 (lesions)	83	88	Median: 48	Range: 25 to 78	NR
Smith et al. 2001⁵³⁵	446	446	500	Median: 46 Mean: 47	Range: 18 to 89	NR
White et al. 2001⁵³⁶	939	939	1042	Median: 60	Range: 32 to 85	NR
Wunderbaldinger et al. 2001⁵³⁷	NR	45	45	Mean: 50	Range: 20 to 77	NR
Yeow et al. 2001⁵³⁸	104	98	98	Mean: 46.5	Range: 23 to 85 Standard deviation: 12.3	NR
Beck et al. 2000⁵³⁹	560	560	594	NR	NR	NR
Kirwan et al. 2000⁵⁴⁰	NR	72	72	NR	NR	NR
Latosinsky et al. 2000⁵⁴¹	607	607	692	NR	NR	NR
Liberman et al. 2000⁵⁴²	155 (lesions)	NR	155	Median: 47	Range: 19 to 88	NR
Makoske et al. 2000⁵⁴³	817	817	887	NR	NR	NR
Ward et al. 2000⁵⁴⁴	161	NR	121	Mean: 58	Range: 33 to 83	NR
Welle et al. 2000⁵⁴⁵	NR	225	225	NR	NR	NR
Helbich et al. 1999⁵⁴⁶	NR	44	44	NR	Range: 20 to 77	NR
Jackman et al. 1999⁵⁴⁷	410	410	483	Median: 55	Range: 29 to 89	NR
Meyer et al. 1999⁵⁴⁸	NR	1,643	1,836	Mean: 50	Range: 20 to 85	NR
Puglisi et al. 1999⁵⁴⁹	NR	99	106	Median: 57	Range: 33 to 84	NR
Soo et al. 1999⁵⁵⁰	110	110	116	NR	NR	NR
Caruso et al. 1998⁵⁵¹	NR	91	92	Median: 65	Range: 29 to 81	NR
Doyle et al. 1998⁵⁵²	151 (lesions)	NR	151	NR	NR	NR
Fuhrman et al. 1998⁵⁵³	1,440	1,440	1,440	NR	NR	NR
Heywang-Kobrunner et al. 1998⁵⁵⁴	238	238	261	NR	NR	NR
Ioffe et al. 1998⁵⁵⁵	NR	198	224	Mean: 51	Range: 14 to 87	NR
Liberman et al. 1998⁵⁵⁶	179	151	151	Median: 50	Range: 23 to 80	NR
Schulz-Wendtland et al. 1998⁵⁵⁷	307	307	2,307	NR	NR	NR
Vega-Bolivar et al. 1998⁵⁵⁸	180	180	182	Mean: 55	Range: 30 to 79	NR
Whitman et al. 1998⁵⁵⁹	11	11	12	Mean: 55	Range: 31 to 75, 8.3% older than age 65	NR
Zannis and AliaNo 1998⁵⁶⁰	372	372	424	Mean: 57.7	Range: 25 to 90	NR
Bauer et al. 1997⁵⁶¹	799 (lesions)	NR	799	Mean: 61	Range: 38 to 87	NR
Britton et al. 1997⁵⁶²	202	202	202	NR	NR	NR
Helbich et al. 1997⁵⁶³	205	205	210	Mean: 52.2	Range: 23 to 88	NR
Khattar et al. 1997⁵⁶⁴	117	106	106	Median: 52	Range: 19 to 85	NR
Liberman et al. 1997⁵⁶⁵	NR	NR	442	NR	NR	NR
Pitre et al. 1997⁵⁶⁶	128	128	128	Mean: 56.4	NR	NR
Stolier et al. 1997⁵⁶⁷	242	242	244	NR	NR	NR
Sutton, et al. 1997⁵⁶⁸	200	200	206	Mean: 59	Range: 41 to 85	NR
Walker et al. 1997⁵⁶⁹	200	200	200	NR	Range: 35 to 86	NR
Frazee et al. 1996⁵⁷⁰	103	103	103	Mean: 60	NR	NR
Fuhrman et al. 1996⁵⁷¹	451 (lesions)	NR	451	NR	NR	NR
Head and Haynes 1996⁵⁷²	115	115	115	NR	NR	NR
Mainiero et al. 1996⁵⁷³	128	124	138	Mean: 56.2	Range: 30 to 87	NR
Meyer et al. 1996⁵⁷⁴	545 (lesions)	369	388	Median: 49 yrs Mean: 51 yrs	Range: 24 to 81	NR
Nguyen et al. 1996⁵⁷⁵	NR	408	431	NR	NR	NR
Pettine et al. 1996⁵⁷⁶	25	25	25	NR	NR	NR
Rosenblatt et al. 1996⁵⁷⁷	156	25	58	NR	NR	NR
Scopa et al. 1996⁵⁷⁸	109	109	120	Mean: 51.2	Range: 21 to 85	NR
Cross et al. 1995⁵⁷⁹	NR	225	250	Mean: 54	Range: 26 to 89	NR
Doyle et al. 1995⁵⁸⁰	366	365	365	Mean: 57 years	NR	NR
Hamed et al. 1995⁵⁸¹	122	122	122	NR	NR	NR
Burbank et al. 1994⁵⁸²	105 (lesions)	NR	105	NR	NR	NR
Gisvold et al. 1994⁵⁸³	471	158	160	NR	NR	NR
Parker et al. 1994⁵⁸⁴	6,152 (lesions)	NR	6,152	NR	NR	NR
Smyth and Cederbom 1994⁵⁸⁵	52	52	58	Mean: 57	NR	NR
Elvecrog et al. 1993⁵⁸⁶	107	100	100	NR	NR	NR
Parker et al. 1993⁵⁸⁷	164	164	181	NR	NR	NR
McMahon et al. 1992⁵⁸⁸	151	152	151	Median: 57 Trucut 50 Bipopty 14G 56 Biopty 18G	Range: 24 to 87	NR
Barreto et al. 1991⁵⁸⁹	NR	107	107	Mean: 60.5 one group, 57.9 other group	SE 1.3 one group, 2.4 other group	NR
Cusick et al. 1990⁵⁹⁰	95	95	96	Mean: 52 years	Range: 24 to 78	NR
Parker et al. 1990⁵⁹¹	103	103	103	NR	NR	NR
	Sum		55,936

: NR = Not Reported

Table E12Characteristics of the breast lesions in the studies addressing Key Questions 1 and 2

Study	Number of Lesions Enrolled	% Non- palpable Lesions	Number of Non- palpable Lesions	Number of Microcalcifications	Number with Mammographic Masses	Number with Mammographic Distortions	Lesion Size	BIRADS 5	BIRADS 4	BIRADS 3
Jackman et al. 2009⁴⁸⁵	1,280	NR	NR	NR	NR	NR	NR	NR	NR	NR
Peters et al. 2008⁴⁸⁶	948	100%	948	NR	NR	NR	NR	NR	NR	NR
Schueller et al. 2008⁴⁸⁷	1438	100%	0	NR	NR	NR	Median: 17 mm Range: 5 to 55 mm	36.0%	50.6%	13.4%
Sim and Kei et al. 2008⁴⁸⁸	105	NR	NR	105	NR	NR	NR	0%	89%	1.9%
Tonegutti and Girardi 2008⁴⁸⁹	268	100%	268	186	36	18	67% were 10 mm or less	7%	40%	19%
Youk et al. 2008²⁴	4,359	NR	NR	NR	NR	NR	NR	NR	NR	NR
Ciatto et al. 2007⁴⁹⁰	4,035	67%	2,714	1,887	NR	NR	NR	NR	NR	NR
de Lucena et al. 2007⁴⁹¹	150	NR	NR	NR	NR	NR	44% were 2 cm or less 52% were 2 to 5 cm	NR	NR	NR
Uematsu et al. 2007⁴⁹²	100	NR	NR	100	NR	NR	NR	18%	27%	55%
Vag et al. 2007⁴⁹³	70	63%	44	NR	NR	NR	Median: 12 mm Range: 5 to 35 mm	15.70%	33%	51.40%
Chapellier et al. 2006⁴⁹⁴	318	NR	NR	288	30	NR	NR	11%	53.50%	34.90%
Cipolla et al. 2006⁴⁹⁵	426	71%	302	NR	NR	NR	NR	10.10%	10.60%	50.20%
Dhillon et al. 2006⁴⁹⁶	150	NR	NR	130	12	8	NR	NR	NR	NR
Bolivar et al. 2005⁴⁹⁷	214	95%	204	9	152	34	53 lesions 1 to 10 mm 119 lesions 11 to 20 mm 32 lesions larger than 20 mm	NR	NR	NR
Crystal et al. 2005⁴⁹⁸	715	NR	NR	NR	NR	NR	NR	NR	NR	NR
Dillon et al. 2005⁴⁹⁹	2,427	NR	NR	NR	NR	NR	NR	NR	NR	NR
Koskela et al. 2005⁵⁰⁰	213	NR	NR	108	NR	NR	NR	22.10%	56.80%	16.40%
Sauer et al. 2005⁵⁰¹	962	75%	726	NR	NR	NR	Mean: 2.5 cm Range: 0.2 to 11 cm	NR	NR	NR
Weber et al. 2005⁵⁰²	225	100%	225	NR	NR	NR	NR	NR	NR	NR
Wu et al. 2005⁵⁰³	113	27%	30	NR	NR	NR	Median size: 1.4 cm Range: 0.5 to 2.0 cm	NR	NR	NR
Alonso-Bartolome et al. 2004⁵⁰⁴	102	61%	62	NR	NR	NR	Mean: 14.7 mm Range: 6–30 mm	NR	NR	100%
Delle and Terinde 2004⁵⁰⁵	169	NR	NR	NR	NR	NR	Mean 1.5 cm	NR	NR	NR
Fajardo et al. 2004⁵⁰⁶	2,403	70%	1,681	NR	NR	NR	NR	NR	NR	NR
Kettritz et al. 2004⁵⁰⁷	2,893	NR	NR	2,013	NR	61	1,677 were less than 10 mm, 809 were 11 to 20 mm, and 388 were larger	5.90%	84.30%	9.80%
Lomoschitz et al. 2004⁵⁰⁸	100	100%	100	50	50	NR	NR	NR	NR	NR
Abdsaleh et al. 2003⁵⁰⁹	180	NR	NR	15	130	NR	6 to 80 mm	NR	NR	NR
Ambrogetti et al. 2003⁵¹⁰	364	100%	364	326	NR	NR	NR	NR	NR	NR
Fishman et al. 2003⁵¹¹	73	78%	57	NR	NR	NR	Mean: 1.7 cm Range: 0.6 to 6 cm	NR	NR	NR
Han et al. 2003⁵¹²	271	100%	271	228	NR	NR	NR	NR	NR	NR
Kirshenbaum et al. 2003⁵¹³	506	100%	506	228	212	75	Mean: 0.8 cm Range: 0.3 to 2.3 cm	NR	NR	NR
March et al. 2003⁵¹⁴	34	71%	24	3	NR	NR	Mean: 0.7 cm Range: 0.4 to 1.2 cm	NR	NR	NR
Pfleiderer et al. 2003⁵¹⁵	14	NR	NR	NR	NR	NR	NR	28.60%	64.30%	NR
Philpotts et al. 2003⁵¹⁶	281	NR	NR	NR	NR	NR	NR	NR	NR	NR
Wong and Hisham 2003⁵¹⁷	150	0%	0	NR	NR	NR	NR	NR	NR	NR
Apesteguia et al. 2002⁵¹⁸	132	100%	132	82	NR	24	NR	NR	NR	NR
Georgian- Smith et al. 2002⁵¹⁹	185	NR	NR	159	16	5	NR	NR	NR	NR
Jackman and Lamm 2002⁵²⁰	31	97%	30	21	10	NR	NR	9.70%	90.30%	0%
Johnson et al. 2002⁵²¹	101	27%	27	NR	NR	NR	Mean: 1.15 cm	NR	NR	NR
Liberman et al. 2002⁵²²	800	100%	800	606	194	NR	Median: 0.8 cm Range: 0.2 to 10 cm	NR	NR	NR
Meloni et al. 2002⁵²³	129	100%	129	NR	NR	NR	NR	NR	NR	NR
Morris et al. 2002⁵²⁴	21	100%	21	NR	21	NR	Mean: 1.8 cm Range: 0.8 to 5.5 cm	NR	NR	NR
Pfarl et al. 2002⁵²⁵	332	NR	NR	166	152	NR	NR	NR	NR	NR
Verkooijen et al. COBRA 2002⁵²⁶	984	100%	984	533	310	26	NR	NR	NR	NR
Becker et al. 2001⁵²⁷	232	NR	NR	232	NR	NR	NR	NR	NR	NR
Brenner et al. 2001⁵²⁸	1,003	100%	1003	355	630	92	NR	11.10%	39.10%	35.70%
Cangiarella et al. 2001⁵²⁹	160	NR	NR	160	NR	NR	NR	NR	NR	NR
Dahlstrom and Jain 2001⁵³⁰	310	NR	NR	301	NR	NR	NR	NR	NR	NR
Lai et al. 2001⁵³¹	673	NR	NR	NR	NR	NR	NR	NR	NR	NR
Levin et al. 2001⁵³²	70	100%	70	27	NR	NR	NR	NR	NR	NR
Margolin et al. 2001⁵³³	1,333	NR	NR	NR	NR	NR	NR	NR	94%	NR
Perez-Fuentes et al. 2001⁵³⁴	88	73%	64	NR	NR	NR	NR	9.10%	81.80%	8.00%
Smith et al. 2001⁵³⁵	500	95%	475	0	NR	NR	Mean: 15 mm Range: 4 to 60 mm	NR	NR	NR
White et al. 2001⁵³⁶	1,042	NR	NR	NR	NR	NR	NR	NR	NR	NR
Wunderbaldinger et al. 2001⁵³⁷	45	100%	45	4	41	NR	Mean: 18 mm Range: 8 to 41 mm	NR	NR	NR
Yeow et al. 2001⁵³⁸	98	0%	0	NR	NR	NR	Mean: 2.6 cm Range: 0.9 to 10 cm	NR	NR	NR
Beck et al. 2000⁵³⁹	594	NR	NR	NR	NR	NR	NR	16.50%	83.50%	NR
Kirwan et al. 2000⁵⁴⁰	72	NR	NR	NR	NR	NR	NR	NR	NR	NR
Latosinsky et al. 2000⁵⁴¹	692	NR	NR	313	426	4	NR	NR	NR	NR
Liberman et al. 2000⁵⁴²	155	0%	0	NR	NR	NR	Median: 1.7 cm Range: 0.5 to 15 cm	NR	NR	NR
Makoske et al. 2000⁵⁴³	887	100%	887	NR	NR	NR	NR	NR	NR	NR
Ward et al. 2000⁵⁴⁴	121	100%	121	121	NR	NR	NR	NR	NR	NR
Welle et al. 2000⁵⁴⁵	225	NR	NR	90	135	NR	NR	NR	NR	NR
Helbich et al. 1999⁵⁴⁶	44	NR	NR	24	5	5	Mean 12.9 mm Range: 8 to 27 mm	NR	NR	NR
Jackman et al. 1999⁵⁴⁷	483	100%	483	234	249	NR	NR	NR	NR	NR
Meyer et al. 1999⁵⁴⁸	1,836	100%	1,836	643	1,194	NR	NR	NR	NR	NR
Puglisi et al. 1999⁵⁴⁹	106	75%	79	66	59	NR	NR	NR	NR	NR
Soo et al. 1999⁵⁵⁰	116	100%	116	0	NR	NR	NR	NR	NR	NR
Caruso et al. 1998⁵⁵¹	92	0%	0	11	92	NR	NR	NR	NR	NR
Doyle et al. 1998⁵⁵²	151	100%	151	88	71	5	NR	NR	NR	NR
Fuhrman et al. 1998⁵⁵³	1,440	100%	1,440	749	691	NR	NR	NR	NR	NR
Heywang- Kobrunner et al. 1998⁵⁵⁴	261	NR	NR	134	127	NR	NR	1.90%	10.00%	88.10%
Ioffe et al. 1998⁵⁵⁵	224	NR	NR	51	173	NR	NR	NR	NR	NR
Liberman et al. 1998⁵⁵⁶	151	100%	151	NR	NR	NR	NR	NR	NR	NR
Schulz- Wendtland et al. 1998⁵⁵⁷	2,307	NR	NR	NR	NR	NR	NR	NR	NR	NR
Vega-Bolivar et al. 1998⁵⁵⁸	182	100%	182	75	33	24	NR	NR	NR	NR
Whitman et al. 1998⁵⁵⁹	12	NR	NR	NR	NR	NR	NR	NR	NR	NR
Zannis and AliaNo 1998⁵⁶⁰	424	100%	424	NR	424	NR	NR	NR	NR	NR
Bauer et al. 1997⁵⁶¹	799	NR	NR	NR	NR	NR	NR	NR	NR	NR
Britton et al. 1997⁵⁶²	202	NR	NR	NR	NR	NR	NR	NR	NR	NR
Helbich et al. 1997⁵⁶³	210	NR	NR	NR	NR	NR	Mean: 14 mm Range: 7 to 30 mm	NR	NR	NR
Khattar et al. 1997⁵⁶⁴	106	0%	0	NR	NR	NR	NR	NR	NR	NR
Liberman et al. 1997⁵⁶⁵	442	NR	NR	196	246	NR	NR	NR	NR	NR
Pitre et al. 1997⁵⁶⁶	128	100%	128	NR	NR	NR	NR	3.90%	NR	NR
Stolier et al. 1997⁵⁶⁷	244	NR	NR	65	173	4	NR	NR	NR	44.70%
Sutton, et al. 1997⁵⁶⁸	206	100%	206	81	125	NR	Mean: 14 mm Range: 2 mm to 30 mm	NR	NR	NR
Walker et al. 1997⁵⁶⁹	200	100%	200	136	28	36	NR	NR	NR	NR
Frazee et al. 1996⁵⁷⁰	103	100%	103	NR	NR	NR	NR	NR	NR	NR
Fuhrman et al. 1996⁵⁷¹	451	NR	NR	NR	NR	NR	NR	NR	NR	NR
Head and Haynes 1996⁵⁷²	115	100%	115	22	85	NR	NR	NR	NR	NR
Mainiero et al. 1996⁵⁷³	138	NR	NR	138	NR	NR	NR	NR	NR	NR
Meyer et al. 1996⁵⁷⁴	388	100%	388	NR	NR	NR	NR	NR	NR	NR
Nguyen et al. 1996⁵⁷⁵	431	NR	NR	NR	NR	NR	NR	NR	NR	NR
Pettine et al. 1996⁵⁷⁶	25	100%	25	NR	NR	NR	NR	NR	NR	NR
Rosenblatt et al. 1996⁵⁷⁷	58	NR	NR	22	14	NR	Median: 1.5 cm Range: 0.8 to 3.0 cm	NR	NR	NR
Scopa et al. 1996⁵⁷⁸	120	NR	NR	NR	NR	NR	Range: 0.7 to 5 cm	NR	NR	NR
Cross et al. 1995⁵⁷⁹	250	100%	250	NR	NR	NR	NR	NR	NR	NR
Doyle et al. 1995⁵⁸⁰	365	62%	225	59	225		Larger than 5 mm	NR	NR	NR
Hamed et al. 1995⁵⁸¹	122	NR	NR	NR	NR	NR	NR	NR	NR	NR
Burbank et al. 1994⁵⁸²	105	NR	NR	NR	NR	NR	NR	NR	NR	NR
Gisvold et al. 1994⁵⁸³	160	NR	NR	NR	NR	NR	Range: 3 to 70 mm	NR	NR	NR
Parker et al. 1994⁵⁸⁴	6,152	93%	5,702	1,637	4,515		NR	NR	NR	NR
Smyth and Cederbom 1994⁵⁸⁵	58	100%	58	NR	NR	NR	NR	NR	NR	NR
Elvecrog et al. 1993⁵⁸⁶	100	100%	100	26	100		NR	NR	NR	NR
Parker et al. 1993⁵⁸⁷	181	46%	84	NR	NR	NR	NR	NR	NR	NR
McMahon et al. 1992⁵⁸⁸	151	0%	0	NR	NR	NR	NR	NR	NR	NR
Barreto et al. 1991⁵⁸⁹	107	0%	0	NR	NR	NR	NR	NR	NR	NR
Cusick et al. 1990⁵⁹⁰	96	NR	NR	NR	NR	NR	NR	NR	NR	NR
Parker et al. 1990⁵⁹¹	103	NR	NR	NR	NR	NR	NR	NR	NR	NR
Sum	55,936		25,760	13,303	11,186	421

: NR = Not Reported

Table E13Studies of the dissemination of cancerous cells during biopsy procedures

Reference	Design of Study	Number of Patients	Biopsy Methods	Conclusion
Michalopoulos et al. 2008³³	Prospective study. Patients underwent core-needle biopsy followed by open surgery 6–8 days later. The needle track was excised and examined by a pathologist.	21 with DCIS and 10 with invasive ductal carcinoma	Vacuum-assisted 11G Mammotome device	No cases of dissemination of cancerous cells were observed. In two cases benign epithelial displacement was observed. The duration of the core-needle procedure was significantly longer in these two cases than for cases with no displacement observed.
Uematsu and Kasami 2007⁹⁶	The exterior of the core needles was washed immediately following withdrawl and the washings were examined for cells.	207	US-guided 18G automated Bard Magnum gun	65% of the washings were positive for cells. Lesions diagnosed as invasive lobular carcinoma were significantly less likely to have had cells in the washings than lesions diagnosed as DCIS or invasive ductal carcinoma. Biopsies that had been performed using multiple passes were slightly but not significantly more likely to yield cells in the washings than biopsies performed with a single pass.
Fitzal et al. 2006¹¹⁰	Retrospective case-control study of patients treated with breast-conserving surgery and radiotherapy, with or without chemotherapy/hormonal therapy.	189 with preoperative core-needle biopsy, 530 without preoperative core-needle biopsy	14G or 11G; stereotactic or US guidance; vacuum-assisted or not.	In patients with preoperative core-needle biopsy, the local recurrence rate was 1.1% with a median followup of 78 months (range 46 to 108 months); the mortality rate was 0%. In patients without preoperative core-needle biopsy, the local recurrence rate was 2.1% with a median followup of 71 months (range 8 to 128 months); the mortality rate was 4.7%.
Newman et al. 2006¹³⁰	Retrospective chart review of women who underwent sentinel lymph node biopsy	279 with core-needle biopsy, 41 with fine-needle biopsy, and 217 with open excisional biopsy	Not described	The method of biopsy did not correlate with metastasis to the sentinel lymph node; however, patients who underwent excisional biopsy were more likely to have micrometastases to the sentinel lymph node than patients who underwent needle biopsies.
Uriburu et al. 2006¹³⁹	Case report	3	14G under stereotactic guidance	Three women treated with skin-sparing mastectomy are reported on. All three developed recurrences of their breast tumors at the core-needle biopsy scar. Two of the three had invasive ductal carcinomas and one had a mucinous carcinoma.
Hansen et al. 2004¹⁸⁸	Retrospective chart review of women who underwent sentinel lymph node biopsy	126 with fine-needle biopsy, 227 with core-needle biopsy and 323 with open excisional biopsy	11 or 14G, under stereotactic or US guidance	The incidence of metastases to the sentinel lymph node was significantly higher in women who underwent needle biopsies compared to women who had excisional biopsy.
Hoorntje et al. 2004¹⁹⁰	Prospective study. Patients underwent core-needle biopsy followed by open surgery a mean of 21 days later. The needle track was excised and examined by a pathologist.	13	14G automated device Bard under stereotactic guidance	Needle tracks were visible in 11 cases, and of these, 7 had displaced cells in the needle track.
Peters-Engl et al. 2004¹⁹⁵	Retrospective review of women who underwent sentinel lymph node biopsy	1,048 with fine-needle or core-needle biopsy, 842 with open excisional biopsy	Not described	Patients who had undergone a needle biopsy had a 1.37 times increased risk of metastases to the lymph nodes, but after adjusting for known risk factors of axillary node metastases this result was overturned, 1.09 times increased risk (95% CI: 0.85% to 1.40%).
Chen et al. 2002²⁴⁴	Retrospective review of women treated with breast-conserving surgery and radiation therapy	86 with core-needle biopsy, 465 with open excisional biopsy	14G Bard device or 11G vacuum-assisted device Mammotome, all under stereotactic guidance	At a mean followup of 4.9 years (range 2.0 to 8.9 years), tumor recurrence rate was 2.3% in the core-needle group and 7.7% in the open biopsy group.
Knight et al. 2002²⁵⁶	Retrospective review of women treated with breast-conserving surgery; 78.6% had radiation therapy as well	297 with core-needle biopsy, 101 with open excisional biopsy	14G Bard device under stereotactic or ultrasound guidance	At a mean followup of 29.7 months (range: 2 to 90 months), 3.7% of the patients with core-needle biopsy had a tumor recurrence compared to 3.96% of patients with open biopsy who had a tumor recurrence.
Chao et al. 2001²⁸²	Case report	3	14G under stereotactic guidance	Two of the patients developed tumor recurrences at the site of the core-needle biopsy; the third patient had the needle track excised 1 month after biopsy and cancer cells were detected in the needle track. None of the patients received radiation therapy for the primary tumor.
King et al. 2001²⁹⁵	Retrospective review of women diagnosed with breast cancer by either core-needle biopsy or wire-localized open excisional biopsy and then treated with breast-conserving surgery; 91% had radiation therapy as well	132 with core-needle biopsy, 79 with open excisional biopsy	14G under US or stereotactic guidance	At a median followup of 44.4 months, 3.0% of patients with core-needle biopsy had tumor recurrences; at a median followup of 50.1 months, 2.5% of patients with open biopsy had tumor recurrences.
Stoller et al. 2000³⁴²	Prospective study. Patients underwent core-needle biopsy followed by open surgery a mean of 10.5 days later. The needle track was excised and examined by a pathologist.	89	14 or 11G, stereotactic or US guidance, multiple puncture or vacuum-assisted	2 patients had tumor cells in the needle tract. One of these patients had a local tumor recurrence 34 months after surgery at the biopsy site. Both of these patients had multiple puncture core-needle biopsies and no radiation treatment.

: US = Ultrasound

Table E14Surgical procedures avoided

Reference	Design of Study	Number of Patients	Biopsy Methods	Conclusion
Friese et al. 2009⁵⁹²	Analysis of data from the SEER data of women diagnosed with DCIS or stage I/II breast cancer between 1991 and 1999	45,542	Needle or surgical	Needle biopsy use was associated with a reduced likelihood of multiple breast surgeries (odds ratio 0.35, 95% CI: 0.34 to 0.37)
Altomare et al. 2005¹⁴⁵	Retrospective chart review of patients with nonpalpable breast lesions who underwent core-needle biopsy between January 2001-January 2004.	591	US- or stereotactic-guided vacuum-assisted biopsy (Mammotome) 11-gauge needle or ABBI	Core-needle biopsy spared a surgical procedure for 128 cancer patients and 134 non-cancer patients, but did not spare a procedure in 17 women
Bolivar et al. 2005⁴⁹⁷	Prospective case series of patients with non-palpable suspicious breast lesions who underwent core-needle biopsy from August 1997–August 2001.	198	US-guided (7.5 MHz linear array transducer) using a freehand technique with patient in supine or supine oblique position.	Core-needle biopsy spared 155/198 (or 78%) women a surgical procedure.
Chapellier et al. 2005⁴⁹⁴	Prospective case series of the first 318 aspiration-guided macrobiopsy procedures performed at one institution. The majority of patients had microcalcifications; approximately 50% were BIRADS 4 while 35% were BIRADS 3 but had risk factors.	301	Fischer stereotactic imaging table, vacuum-assisted biopsy (AND).	128 BIRADS 4 patients and six BIRADS 5 patients were spared an additional operation by use of core-needle biopsy.
Carmon et al. 2004¹⁷⁶	Retrospective chart review of patients with nonpalpable breast lesions who were ultimately operated on for primary breast carcinoma between 1997-mid-2001.	167	Percutaneous image-guided core biopsy	From 1997 to 2001, the percent of patients requiring a second operation decreased from 56.2% to 11.1%, with increased availability of a preoperative diagnosis. 79.2% of subjects with a preoperative diagnosis of invasive duct carcinoma had axillary lymph node dissection vs. 37.7% of those without a preoperative CNB diagnosis.
Apesteguia et al. 2002⁵¹⁸	Prospective consecutive case series of patients with nonpalpable breast lesions non-visible or non-accessible by US.	126	Vacuum-assisted core biopsy on a digital stereotaxic table with an 11-gauge needle.	Second surgical procedures due to involved margins were required in 17.4% of cases and 5 additional lymphadenectomy procedures were needed based on core-needle biopsy’s inability to predict invasion.
Liberman et al. 2002⁵²²	Retrospective study. Rate of spared surgical procedures was compared for those whose lesion was completely excised compared to those whose lesion was only sampled.	800 (565 calcifications, 194 mass, 41 both)	Vacuum-assisted core biopsy (Mammotome) with 11-gauge needle	466 lesions were totally removed by the core-needle procedure. Surgery was spared in 80.6% of lesions. There was not a significant difference between the excised versus sampled lesion groups in spared surgery rates (81.5% vs. 82%, p = 0.95).
Becker et al. 2001⁵²⁷	Retrospective chart review of lesions with indeterminate microcalcifications	218	DMR regular mammography machine plus either a Stereotix 2 conventional add-on unit or a SenoVision digital add-on unit. Core-needle biopsy was performed with a 14-gauge needle in all but 5 cases (in which a 16-gauge needle was used)	Open biopsy was avoided in 78 (69.6%) of patients in the conventional treatment group and in 78 (73.6%) of the digital treatment group.
Liberman et al. 2001²⁹⁸	Retrospective review of women with calcifications highly suggestive of malignancy who underwent a diagnostic biopsy procedure from 1993–2000.	139	Stereotactic vacuum-assisted biopsy with 11 or 14-gauge needle	The mean number of surgical procedures was 1.2 and 1.6 for core-needle biopsy vs. surgical biopsy. 62% of surgical biopsy patients overall and 83.8% of diagnostic surgical biopsy with cancer needed two procedures. The likelihood of requiring a single operation was greater for women who had core-needle biopsy. A surgical procedure was spared in 58.4% of this group.
Perez-Fuentes et al. 2001⁵³⁴	Prospective case series of patients seen between August 1998-December 2000 with palpable or nonpalpable breast masses	83	US-guided vacuum-assisted biopsy (Mammotome) with 11-gauge needle	Of the 83 patients studied, 79 were spared a surgical procedure (95.2%).
Verkooijen et al. 2001⁵⁹³	Prospective comparison of patients with nonpalpable breast lesions	164	Patient prone, 14-gauge needle	In 75% of core-needle cases, only a single surgical procedure was needed, while this was true in only 16% of open biopsy cases (p <0.001). Mean number of surgical procedures was 1.31 vs. 1.91 (p <0.001) in the core-needle and open biopsy groups, respectively.
Liberman et al. 2000⁵⁴²	Retrospective chart review of patients with breast masses that were palpable on physical examination from 1992 to 1998.	107	Stereotactic- or US-guided core biopsy with a 14-gauge needle.	Core-needle biopsy spared 74% of subjects in this study an additional diagnostic tissue sampling
Morrow et al. 2000³⁰⁵	Prospective nonrandomized comparative study of patients with nonpalpable mammographically-detected abnormalities	1,550	Core-needle or open biopsy	Among those with cancer, a single procedure was performed in 33% of the excisional biopsy subjects versus 84% of the core-needle group (p <0.001). The core-needle group consistently had a larger proportion of subjects treated with a single procedure, regardless of lesion type: for architectural distortions 71% vs. 46% and for highly suspicious lesions 83% vs. 45%.
Al-Sobhi et al. 1999³⁴⁶	Retrospective review of patients found to have cancer	67	Vacuum-assisted with an 11 or 14-gauge needle	The number of surgical procedures performed in an operating room differed significantly for the two groups overall (CNB mean 1.1 ±0.3 and wire localization mean 1.8 ±0.4). For the subset who underwent breast-conserving treatment a significant difference between groups was also evident, mean surgical procedures were 1.2 ±0.4 and 2.1 ±0.2, respectively.
Williams et al. 1999³⁸⁴	Prospective case series of patients with impalpable breast lesions diagnosed by stereotactic CNB on a prone table vs. a historical cohort of patients with similar lesions diagnosed prior to the use of prone stereotactic CNB.	222	Stereotactic prone core-needle with Mammotest and 14-gauge needle.	More patients in the prone group required only a single operation (p <0.03). The average number of operations was 1.33 (SE 0.053) vs.1.47 (SE 0.054) in the prone and control groups, respectively.
Johnson et al. 1998³⁹⁵	Retrospective review of patients with malignant-appearing microcalcifications without an associated parenchymal abnormality on mammography.	167	Stereotactic biopsy was performed using Lorad Stereotactic prone biopsy table with 14-gauge needle. Digital mammography was used to localize the lesions. US biopsies were performed using a 7.5 MHz probe with real-time imaging using the same CNB device.	The mean number of procedures required until definitive treatment was 2.4 and 1.7 for the initial IGBB and initial NLOB, respectively (p = 0.0002)
Kaufman et al. 1998³⁹⁶	Retrospective review of consecutive mammographically-detected nonpalpable breast lesions ultimately diagnosed as in situ or invasive carcinoma.	113	Core-needle or open biopsy	Negative margins were achieved twice as often in the core-needle group as in the open biopsy group after the first surgical procedure (77% vs. 38%, p <0.001). A one-stage surgical procedure was possible in many more of the core-needle patients than in the open biopsy group (79% vs. 21%, p <0.001). On average, 2.2 procedures (surgery and biopsy) were needed in the core-needle group vs. 1.8 among the open biopsy patients. However, the average number of surgeries was 50% higher in the open biopsy group (1.8 vs. 1.2).
Liberman et al. 1998⁵⁵⁶	Retrospective review of patients with nonpalpable breast masses.	151	US-guided biopsy was performed in the supine or supine oblique position using high resolution (7.5 MHz linear array transducer) equipment with a 14-gauge cutting needle.	85% of patients in this study were spared a surgical procedure by use of core-needle biopsy.
Lind et al. 1998⁴⁰²	Retrospective review of patients with mammographically-detected breast cancer that underwent breast-conserving surgery	117	Biopsies were performed on a dedicated prone table with 14-gauge needle	Only 6% of patients in the core-needle group had positive margins vs. 55% of the open biopsy patients (p <0.01). One patient with positive margins in the core-needle group was re-excised vs. 34/38 of those with positive margins in the open group (p <0.01).
Fenoglio et al. 1997⁴¹⁹	Retrospective chart review of patients with mammographically-detected breast cancer	40	14-gauge long throw Biopty gun plus Mammotest Stereotactic System	All 20 patients diagnosed with core-needle biopsy required one surgical procedure only whereas among the 20 initially diagnosed with open biopsy a total of 41 procedures were required to diagnose and treat their cancers
Liberman et al. 1997⁴²⁸	Retrospective chart review of nonpalpable breast cancers	197	Stereotactic CNB were done with patient in prone position using StereoGuide; sonographically-guided CNB were done with patients in supine or supine oblique using a 7.5 MHz linear array transducer and high resolution sonographic equipment; all CNB used a 14-gauge needle or an ultra-core biopsy needle.	84% of patients in the CNB group underwent a single surgical procedure vs. 29% of those diagnosed by surgical biopsy (p <0.00001). 16% of the CNB patients required two surgical procedures while 66% of the open-biopsy patients needed two surgeries and 5% underwent three surgical procedures.
Smith et al. 1997⁴³³	Retrospective review.	677	US-guided Mammotest (67) or wire localized excisional biopsy (610)	On average, 1.25 surgical procedures were required by the core-needle group versus 2.01 in the surgical biopsy group (p <0.001).
Sutton et al. 1997⁵⁶⁸	Retrospective review of patients with nonpalpable mammographic abnormalities detected at routine screening in a community-based clinic.	200	Biopsies were performed on a dedicated prone stereotactic table (Mammotest) with an autoguide attachment and 14-gauge 22 mm-throw Bard Biopty-cut needles held in a Bard Biopty gun.	The authors estimated that open biopsy was avoided in 82% of cases by using core-needle biopsy for diagnosis.
Whitten et al. 1997⁴³⁵	Retrospective review	171	Stereotactic- or US-guided biopsy with a 14-gauge needle	Among the 86 subjects diagnosed by image-guided core-needle biopsy, 98 surgical procedures were completed (1.1 surgeries per patient) compared with 1.9 operations on average for the 85 patients undergoing a diagnostic needle localized biopsy (157 surgeries total in 85 subjects).
Yim et al. 1996⁴⁵⁴	Retrospective review	52	Stereotactic biopsy with a 14-gauge needle was performed on a dedicated prone table	At the time of excision, surgical margins were more frequently positive in the open biopsy group (55%) vs. the CNB group (0%); the distance of the tumor from the surgical margin was greater for the CNB vs. open biopsy patients among the negative margins; and, among those having breast conservation surgery, the rate of re-excision was higher for the open biopsy group (74%) vs. no patients in the CNB treatment group.
Liberman et al. 1995⁴⁵⁸	Retrospective chart review of patients with impalpable speculated masses.	43	Biopsies were performed with patients prone on a dedicated table using either a 14-gauge Bard Biopty needle or a 14-gauge Manan needle and either a Bard Biopty gun with 23 mm throw or Manan ProMag 2.2 gun with a 22 mm throw.	The use of core-needle biopsy in the diagnosis of breast cancer reduced the number of procedures required in 33 (77%) patients.
Strong et al. 1995⁴⁶³	Prospective study of patients with mammographically-detected, asymptomatic, nonpalpable breast lesions	97	Mammotest stereotactic device using 14-gauge Manan needle.	In eight benign cases, open biopsy was performed, adding an extra procedure to the diagnostic protocol for these patients. However, 74 women (76%) were spared an open biopsy by core-needle biopsy. As the 15 women with carcinoma went directly to mastectomy without an open biopsy, core- needle biopsy did not add a diagnostic procedure in these cases.
Elliott et al. 1992⁴⁷⁹	Retrospective review of 12-month period of patients with nonpalpable breast lesions.	115	Mammotest II with 18-gauge Bard biopsy needle using Bard Biopty gun	Core-needle biopsy spared 97 patients an open surgical biopsy.

Table E15Patient procedure preference

Reference	Design of study	Number of patients	Biopsy methods	Conclusion
Duschesne et al. 2007⁶¹	Prospective trial of new device	113	US-guided radiofrequency tipped vacuum-assisted with 9-gauge needle (SenoCor 360 Biopsy System).	They rated patient comfort as equivalent with other types of biopsies.
Krainick-Strobel et al. 2007⁷³	Prospective case series of patients with benign lesions undergoing biopsy for the purpose of complete extirpation.	45	Hand-held US-guided vacuum-assisted biopsy (Mammotome) using either an 8- or 11-gauge needle.	Ninety-five percent of respondents said they would prefer core-needle to open excisional biopsy if they needed a future procedure. A minimum of 7 days post- procedure, patients were given a questionnaire about their experience. The mean level of satisifaction with the procedure, on a scale of 0–10, was 9.2 (range 3–10).
Killebrew et al. 2006¹²⁰	Retrospective comparison study of patients with BIRADS 4 or 5 and mammographic lesions presenting as microcalcifications.	1600	Vacuum-assisted procedure (Mammotome) with 11-gauge needle vs. vacuum-assisted intact specimen biopsy with 10 or 15 mm probe.	Self-reports by patients showed that those undergoing both treatments tolerated their respective procedures equally. Patients were asked to rate the biopsy procedure for comfort and to rate comfort of lying on stereotactic table, as a comparison. In the vacuum- assisted arm, ratings of 5.8 and 2.0 (with 10 = extreme pain) were given for lying on table and actual biopsy procedure, respectively. In the other group, the ratings were 4.1 and 1.9, respectively.
Chapellier et al. 2005⁴⁹⁴	Prospective case series of the first 318 aspiration-guided macrobiopsy procedures performed at one institution. The majority of patients had microcalcifications; approximately 50% were BIRADS 4 while 35% were BIRADS 3 but had risk factors.	301	Fischer stereotactic imaging table, vacuum-assisted	Patient tolerance of procedure was excellent, as measured by a self-administered patient questionnaire. The authors also found that the post- procedure psychological state was associated with the procedure outcome, the information given to patients and the attitudes of medical staff members.
Weber et al. 2005⁵⁰²	Retrospective comparison study of patients with nonpalpable breast lesions	387	Stereotactically-guided vacuum-assisted (Mammotome) technique with 11-gauge needle or ABBI	Three patients in this series underwent both procedures but they did not indicate a preference for one over the other.
Wong et al. 2005¹⁷¹	Prospective trial of Asian patients with nonpalpable mammographic abnormalities	114	Vacuum-assisted (Mammotome) on a prone biopsy table with 8- to 11-gauge needle	Bruising (one week post- procedure) occurred in 79 patients (46 minimal, 25 mild, 5 moderate and 3 severe). All patients were able to be discharged after 2–3 hours following the procedure and all reported the procedure was acceptable without undo discomfort.
Alonso-Bartolome et al. 2004⁵⁰⁴	Prospective study of women with probably benign breast lesions who refused radiologic followup and, instead, insisted on removal. Complete lesion removal was the intended goal for all lesions.	97	US-guided vacuum-assisted biopsy (Mammotome) with 11-gauge needle	Patients estimated that the time lost to core-needle biopsy is less than 20% of the time required for a surgical biopsy.
Geller et al. 2004¹⁸³	Survey of women with nonpalpable breast lesions	315	US-guided core-needle biopsy or open excisional biopsy	Survey results 1–3 months post procedure measured convenience of the procedure (distance travelled, procedure time, and number of days of work missed post procedure). No difference was found between two groups in terms of miles travelled for procedure, but the excisional biopsy group missed more work.
March et al. 2003⁵¹⁴	Prospective study of women with breast masses who underwent biopsy in which complete removal of the lesion was attempted.	34	US-guided vacuum-assisted biopsy with an 11-gauge biopsy device	Radiologists examined the biopsy site 2–5 days post- procedure and found 24 subjects (71%) had ecchymosis, nine (26%) had no visible abnormality aside from the skin incision and one (3%) had slight skin convexity without ecchymosis at the biopsy site. Twenty-one subjects who did not undergo an open procedure were examined at 6 months post core-needle biopsy. All 21 said they would recommend the procedure to others.
Mariotti et al. 2003²²⁸	Retrospective study of patients with suspicious non palpable mammographic lesions not confirmed by ultrasonography.	360	Vacuum-assisted (Mammotome) with an 11-gauge needle or ABBI	Patient acceptance of the biopsy procedure was high.
Fine et al. 2003²¹⁷	Women with low risk palpable masses were assessed prospectively.	216	Vacuum-assisted (Mammotome) with US guidance with either an 8- or 11-gauge probe	A majority of patients stated that they would recommend the procedure to others in a survey conducted 10 days post-procedure (82% and 92%, respectively). By the 6-month follow-up visit, 100% stated they would recommend the procedure to others, while 97% stated they themselves would have the procedure again, if needed.
Chun et al. 2002²⁴⁵	Retrospective review and survey of patients who had undergone a Mammotome, ABBI or wire localized biopsy more than 2 years ago for benign disease.	59	Stereotactic vacuum-assisted 11-gauge (Mammotome) or stereotactic excisional biopsy with ABBI (15 or 20 mm cannula) or wire localized open biopsy	The biopsy experience was rated as satisfactory by 90%, 75% and 80% of patients in the open, ABBI, and Mammotome groups, respectively. Complaints about the procedures included uncomfortable (2 Mammotome, 4 ABBI), pain (2 each open and Mammotome), painful breast compression (3 ABBI), delay in getting results (1 each Mammotome and ABBI), rude doctors (2 Mammotome) and length of procedure (1 open).
Hui et al. 2002²⁵²	Prospective case series of patients with nonpalpable breast lesions requiring a biopsy procedure.	79	Stereotactic-guided breast biopsy (StereoGuide with Digital Spot Mammography): Trucut with a 14-gauge needle, vacuum-assisted (Mammotome) with 11-gauge probe	31.6% of patients were very satisfied with the procedure; 73.7% felt the level of pain associated with the biopsy was less severe than erect mammography; 34.2% felt the pain experienced was less severe than needle pricking; and 14.5% felt it was less severe than previous free- hand or ultrasound-guided breast biopsy.
Beck et al. 2000⁵³⁹	Retrospective review of first experience using vacuum- assisted core-needle biopsy.	560	Digital stereotaxic biopsy table, vacuum-assisted (Mammotome) with 11-gauge needle.	A majority of patients tolerated the procedure well.
Gukas et al. 2000³²⁶	Prospective study of 112 consecutive patients with palpable breast lesions	108	Tru-Cut and excisional biopsies.	A majority of patients, 90.7%, accepted the procedure. The authors note that patients experienced more apprehension about the procedure than actual discomfort.
Welle et al. 2000⁵⁴⁵	Retrospective review of patients who underwent a stereotactic CNB in a decubitus or recumbent position from September 1995-March 1999.	225	Stereotactic-guided core- needle biopsy in a decubitus or recumbent position.	Two patients out of the 225 had experienced a traditional prone position CNB and both stated they preferred the decubitus position, preferring to lie on their sides. Overall, 29% of patients reported mild discomfort or numbness in the dependent arm with the decubitis or recumbent position.
Doyle et al. 1999⁵⁵²	Retrospective study of patients with mammographically-detected lesions	151	Senographe 600T was used for 136 biopsies; 15 using Mammomat 3000; all in decubitus position unless the patient couldn’t tolerate that positioning and with a 14-gauge needle.	90% of subjects were able to tolerate the decubitus position although some developed discomfort in the dependent arm and required supporting the arm away from the body on a chair or small trolley.
Helbich et al. 1998³⁹³	Prospective randomized study of consecutive patients with indeterminate or suggestive lesions on mammography	64	Mammotest stereotactic system with 13-gauge coaxial needle.	Author reports that all patients tolerated the procedure well.
Handy et al. 1996⁴⁴⁵	Prospective survey of patients. Patients completed a pre-procedure survey, one immediately after the procedure, one 24 hours post-procedure and 5 days later.	58	StereoGuide SM Breast Biopsy System with 14-gauge needle. The majority of patients were in a prone position.	67% of patients reported that they understood the procedure they were about to undergo. Immediately after the procedure, 78% said they understood the procedure but the remainder still felt they did not understand it. Five of those who initially thought they understood decided they really had not after experiencing it. 38% said the clinic nurse/technologist was the best source of information about the procedure, 26% said it was the physician, 15% said there was no good source of information available to them and 21 said other (books, friends, popular media). Pre-procedure, 79% were most concerned about the results of the biopsy while 10% were most concerned about the procedure itself. 31% reported none or slight anxiety about the impending procedure, 60% said they were mild to moderately anxious and 9% were extremely anxious. Five days post procedure, 97% said they would have the procedure again in the future, if needed.
Elliott et al. 1992⁴⁷⁹	Retrospective review of 12 month period	115	Mammotest II with 18-gauge Bard biopsy needle using Bard Biopty gun	The authors explain that patients are very accepting of the CNB procedure and found the test easy to perform in the office.

: US = Ultrasound

Table E16Cosmetic outcome

Reference	Design of Study	Number of Patients	Biopsy Methods	Conclusion
Krainick-Strobel et al. 2007⁷³	Prospective case series of patients with benign lesions undergoing vacuum-assisted biopsy for the purpose of complete lesion removal	45	Hand-held ultrasound-guided vacuum-assisted CNB biopsy (Mammotome) using either an 8- or 11-gauge needle.	Ninety-five percent of respondents said they would prefer CNB to open excisional biopsy if they needed a future procedure. A minimum of seven days post-procedure, patients were given a questionnaire about their experience. All patients said that the scar from the needle was cosmetically unimportant to them and, on a scale of 0–10, their mean level of satisfaction with CNB was 9.2 (range 3–10).
Weber et al. 2005⁵⁰²	Retrospective comparison study of patients with impalpable breast lesions undergoing either Mammotome or ABBI	387	Stereotactically-guided vacuum-assisted CNB biopsy (Mammotome ) technique with 11-gauge needle or ABBI	Incomplete satisfaction with the cosmetic result occurred at a higher rate in the ABBI group (6.7% vs. 1.3%, p = 0.03).
Wong et al. 2005¹⁷¹	Prospective trial of Asian patients with nonpalpable mammographic abnormalities underwent either ABBI (N = 7) or Mammotome (N = 107).	114	CNB was performed on a prone biopsy table with vacuum-assisted CNB (Mammotome) with 8- to 11-gauge needle or ABBI.	Bruising (one week post- procedure) occurred in 79 patients (46 minimal, 25 mild, 5 moderate and 3 severe) and at one-month followup a scar was visible in 79 patients (40 minimal, 32 mild, 7 moderate, 0 severe).
Mariotti et al. 2003²²⁸	Retrospective study of patients undergoing either ABBI or Mammotome from June 1999-December 2001 for suspicious non palpable mammographic lesions not confirmed by ultrasonography	360	Vacuum-assisted CNB (Mammotome) with 11-gauge needle or ABBI	Both surgeons and patients were pleased with the cosmetic outcome.
March et al. 2003⁵¹⁴	Prospective study of women with breast masses who underwent CNB in which complete removal of the lesion was attempted.	34	Ultrasound-guided vacuum- assisted CNB with an 11-gauge biopsy device	The twenty-one subjects who did not undergo an open procedure following CNB were examined at 6 months post-CNB. Nineteen (90%) were very satisfied with appearance of biopsy area, 2 were satisfied and none were dissatisfied. Sixteen were very satisfied with how the biopsy area felt, 5 satisfied, none dissatisfied. At 6-month follow-up examination, four (19%) had no visible scar, 17 (81%) minimal scarring = 2–9 mm, none had skin retraction concavity, convexity, or other changes in breast contour.
Fine et al. 2003²¹⁷	Women who underwent CNB for low risk palpable masses were assessed prospectively.	216	Ultrasound-guided vacuum-assisted handheld biopsy device (Mammotome) with either an 8- or 11-gauge needle	A majority of patients were both satisfied with the appearance of their incisions and stated that they would recommend the procedure to others in a survey conducted 10 days post-procedure (82% and 92%, respectively). By the 6-month follow-up visit, 100% were happy with the incision’s appearance and would recommend the procedure to others, while 97% stated they themselves would have the procedure again, if needed.
Kettritz et al. 2003⁵⁹⁴	Retrospective analysis of patients who underwent a CNB between January 1996- June 2000 for indeterminate lesions and microcalcifications.	2874	Vacuum-assisted CNB on a digital prone table (Mammotest) with an 11-gauge needle.	Scarring at the latest postbiopsy visit was graded as not relevant (86%), slight (14%) or relevant (0.3%).
Chun et al. 2002²⁴⁵	Retrospective review and survey of patients who had undergone a Mammotome, ABBI or wire localized biopsy more than 2 years ago for benign disease, 20 patients per group.	59	Stereotactic vacuum-assisted CNB biopsy (Mammotome) with 11-gauge needle or stereotactic excisional biopsy with ABBI (15 or 20 mm cannula) or wire localized open biopsy	Patients were asked to rate the appearance of their scar, if they were satisfied with the biopsy procedure, and which mattered most to them, complete lesion removal or scar appearance. Ninety-five percent of the core-needle biopsy group and only 25% of the open biopsy group were very satisfied with the appearance of their breast. None of the core-needle biopsy group said the cosmetic results were unacceptable compared to 20% of the open biopsy group who found the results unacceptable. Overall, eighty percent of subjects were more concerned with complete lesion removal than scar appearance.
Perez-Fuentes et al. 2001⁵³⁴	Prospective case series of patients seen between August 1998-December 2000 with palpable or nonpalpable breast masses diagnosed with CNB.	83	Ultrasound-guided vacuum-assisted CNB (Mammotome) with 11-gauge needle	No scarring was evident at followup.
Beck et al. 2000⁵³⁹	Retrospective review of first experience using vacuum- assisted CNB	560	Digital stereotaxic biopsy table and vacuum-assisted CNB (Mammotome) 11-gauge needle.	In 90% no scar was visible at final followup.

: CNB = Core-needle Biopsy

Table E17Physician experience

Reference	Design of Study	Number of Patients	Biopsy Methods	Conclusion
Duschesne et al. 2007⁶¹	Prospective trial of new device used on patients already scheduled for CNB between December 2002–April 2003.	113	US-guided radiofrequency tipped vacuum-assisted CNB with 9-gauge needle (SenoCor 360 Biopsy System).	Operators of the new device rated it in terms of ease of penetration, positioning and holding the device, acquiring a satisfactory specimen, positioning accuracy, safety, and patient comfort and compared it to existing spring and vacuum devices based on their past experiences with these. All operators of the study device were experienced in US breast biopsy techniques. Operators found the new device to be equivalent to 14-gauge biopsy devices but superior to other vacuum-assisted devices in terms of penetration of the lesion and positioning of the device at the desired location. They rated patient comfort as equivalent with other types of biopsies.
Holloway et al. 2007⁶⁷	Retrospective review of patients with breast abnormality seen between April 2002–December 31, 2002 who were diagnosed by CNB or fine-needle aspiration and/or surgery as the initial procedure in Ontario Canada.	17,068	Fine-needle aspiration or CNB or mastectomy	Differences in the availability of the CNB (specialized expertise) may account for some of the geographic variation in how often women received a needle-biopsy procedure rather than proceeding immediately to open surgery.
Liberman et al. 2007⁸⁰	Retrospective chart review of patients who had lesions detected with MRI and then had an MRI-guided CNB	237 lesions	MRI-guided vacuum-assisted CNB with a 9-gauge needle	The median number of previous MRI-guided CNB performed by the radiologists was 21 (Range: 1–55).
Hoffman 2005¹¹⁵	To compare the quality of service at a clinic only partially staffed with breast specialists in 1998 to the same clinic in 2003 after it had become fully specialized. Technologically, the only change in diagnostic equipment in that time period was more sophisticated US scanners, which were used in a majority of 2003 procedures but only a small percent of 1998 procedures.	5,451	CNB vs. excisional biopsy	Over time, excisional biopsy was used less, more women had breast-conserving surgery and complication rates decreased. It is the author’s conclusion that a dedicated, specialized breast care center improved the quality of care.
Lehman et al. 2004¹⁶⁰	Retrospective review of consecutive patients with nonpalpable lesions not clearly visible on mammography or targeted sonography, many of whom had recently been diagnosed with breast cancer.	28	MRI-guided vacuum-assisted CNB with the ETEC Breast Biopsy and Excision System.	The experience level of those performing the procedures was low, with half having no prior experience and the other half having one month of experience performing the procedure only (although they had one year of experience with MRI-guided CNB).
Popiela et al. 2002²⁶³	Retrospective review of asymptomatic women without pathological resistance on physical examination but with breast pathologies below 0.5 cm confirmed by complementary examination.	122	Vacuum-assisted CNB (Mammotome) biopsy with either ultrasonography or digital mammography guidance	The authors contend that a lack of experience, rather than a problem with the equipment, explains problems encountered early on in precise targeting and complete removal of the lesion.
Schneider et al. 2001³¹²	Prospective case series of patients undergoing a new unilateral MR-guided breast lesion localization and core biopsy system.	14	MR image guidance CNB using a mechanical needle guide and trajectory planning software with 14-gauge needle.	The authors report that the new device is intuitive and easy to use as well.
Wunderbaldinger et al. 2001⁵³⁷	Prospective nonconsecutive first-experience case series of patients with nonpalpable breast lesions diagnosed by CNB followed by surgical excision.	45	New dedicated US system for computer-guided CNB (Sonopsy) with a 14-gauge needle.	The authors also comment that this new device may hold promise for non-skilled physicians.
McMahon et al. 1992⁵⁸⁸	Prospective randomized trial of consecutive patients with palpable breast lumps. Patients were randomized to percutaneous biopsy using Tru-Cut 14-gauge needle, Biopty-cut 14-gauge needle or a Biopty-cut 18-gauge needle.	151	Biopty-cut needles were used with the Biopty gun. A standard technique was used for the Tru Cut.	Tru Cut’s poor performance (sensitivity 68%) may be related to the fact that eight different surgeons performed the 49 Tru Cut biopsies included in this study whereas the Biopty gun, with an absolute diagnostic sensitivity of 92%, may be less dependent on operator experience.
Parker et al. 1990⁵⁹¹	Prospective case series of consecutive patients referred for biopsy of nonpalpable mammographically-suggestive lesions. Subjects underwent CNB followed by wire localization and excisional surgery.	103	14-, 16-, or 18-gauge Biopty-cut needles were used in conjunction with a Biopty gun. The first 30 patients were treated with Senographe Mammographic System 600T coupled with Stereotix computerized stereotactic needle localization device. Logistical problems caused investigators to switch to the Mammotest Stereotactic System for remaining patients.	Increased operator experience brought about a reduction in procedure time.

: CNB = Core-needle Biopsy

Table E18Procedure duration time

Reference	Design of Study	Number of Patients	Biopsy Methods	Conclusion
Duschesne et al. 2007⁶¹	Prospective trial of new device used on patients already scheduled for CNB between December 2002–April 2003.	113	US-guided radiofrequency tipped vacuum-assisted (SenoCor 360 Biopsy System) with 9-gauge needle	Procedure time is decreased for this device as the breast tissue offers no resistance to penetration, but the authors do not report a time estimate.
Liberman et al. 2007⁸⁰	Retrospective chart review of patients who had lesions detected with MRI and then had a MRI-guided CNB	237 lesions	MRI-guided vacuum-assisted (Mammotome) with 9-gauge needle	Median procedure time was 31 minutes, with procedures ranging from 17–57 minutes in total
Michalopoulos et al. 2007³³	Prospective review of nonpalpable mammographic lesions diagnosed by CNB as either DCIS or IDC then surgically excised.	31	Vacuum-assisted CNB (Mammotome) with 11-gauge needle	Two cases of benign epithelial cell displacement occurred. The duration of the procedure was significantly longer in the two cases with displacement (52.5 ±3.5 minutes) vs. in cases without any displacement (42.0 ±4.4 min., p = 0.018).
Uematsu et al. 2007⁹⁷	Retrospective study of all patients who had had an 18-gauge CNB performed from July 2003–June 2004 followed by a surgical excision.	235 lesions	US-guided 18-gauge CNB	Average procedure time was 10 minutes.
Viehweg et al. 2006¹⁴²	Retrospective review of consecutive patients with a family history, but no personal history, of breast cancer.	63	Either MR-guided preoperative wire localization or vacuum-assisted CNB.	Examination time was approximately 40 minutes per wire localization and 20–30 minutes for the vacuum-assisted CNB procedure, including pre- and post-interventional imaging.
Bolivar et al. 2005⁴⁹⁷	Prospective case series of patients with non-palpable suspicious breast lesions who underwent 14-gauge US-guided CNB from August 1997–August 2001.	198	US-guided (7.5 MHz linear array transducer) CNB using a freehand technique with patient in supine or supine oblique position.	Examination time did not exceed 20 minutes in any cases.
Chapellier et al. 2005⁴⁹⁴	Prospective case series of the first 318 aspiration-guided macrobiopsies procedures performed at one institution.	301	Fischer stereotactic imaging table system, AND vacuum-assisted CNB	The procedure, including manual pressure application, took less than one hour in 79% of cases, 90 minutes in 16% of cases, and two hours in about 5% of cases.
Diebold et al. 2005¹⁵²	Prospective consecutive case series of patients with mammographic BI-RADS IV microcalcifications who underwent stereostatic vacuum-assisted CNB.	58	Vacuum-assisted CNB (Mammotome) with 8-gauge needle with the ST driver (Holster) on a Mammotest plus S biopsy table.	Mean biopsy time was 28.2 minutes (Range: 10–120 minutes). Removing 5 highly complicated cases from this analysis reduced the average procedure time to 16.1 minutes.
Orel et al. 2005¹³¹	Retrospective review of patients with suspicious lesions identified at MR imaging who either underwent surgery or had six month follow-up imaging.	75	MR-guided vacuum-assisted CNB with a 9-gauge needle	Total MRI-guided procedure time (including pre-biopsy imaging examination, biopsy and postbiopsy care) ranged from 30–60 minutes.
Perlet et al. 2005¹³²	Prospective study of MR-guided vacuum-assisted CNB visible by CE- MRI alone or localized in 3 dimensions by MRI alone	538	Impact, Expert or Vision MR scanner guidance, vacuum-assisted CNB (Mammotome) with an 11-gauge needle	On average, MR-guided CNB lasted 70 minutes if the patient was having one lesion biopsied and 90 minutes for patients with two lesions.
Weber et al. 2005⁵⁰²	Retrospective comparison study of patients with impalpable breast lesions undergoing either Mammotome or ABBI.	387	Stereotactically-guided vacuum-assisted CNB (Mammotome) with 11-gauge needle or ABBI	Median duration of the Mammotome procedure was shorter than the ABBI procedure (p <0.0001).
Wong et al. 2005¹⁷¹	Prospective trial of Asian patients with nonpalpable mammographic abnormalities underwent either ABBI (N = 7) or vacuum-assisted CNB (N = 107).	114	Vacuum-assisted CNB (Mammotome) with an 8- to 11-gauge needle prone or ABBI.	Procedures lasted from 30–128 minutes (Median: 68.5).
Alonso-Bartolome et al. 2004⁵⁰⁴	Prospective study of women with probably benign breast lesions who refused radiologic followup and, instead, insisted on removal. Complete lesion removal was the intended goal for all lesions.	97	US-guided vacuum-assisted CNB (Mammotome) with 11-gauge needle	Mean procedure time was one hour (Range: 40–75 minutes). Based on a cost to patient estimate in terms of hours lost, investigators report that the time lost to CNB is less than 20% of the time required for a surgical biopsy.
Geller et al. 2004¹⁸³	Survey of women with nonpalpable breast lesions who had an US-guided CNB or excisional biopsy between 1997–1999.	315	US-guided CNB vs. excisional biopsy.	Survey results 1–3 months post procedure measured convenience of the procedure (distance travelled, procedure time, and number of days of work missed post procedure). No difference was found between two groups in terms of miles travelled for procedure, but the excisional biopsy group missed more work.
Lehman et al. 2004¹⁶⁰	Retrospective review of consecutive patients with nonpalpable lesions not clearly visible on mammography or targeted sonography, many of whom had recently been diagnosed with breast cancer.	28	MRI-guided vacuum- assisted CNB with the ETEC Breast Biopsy and Excision System.	Time to perform procedure was defined as the start of the first MRI sequence (localizing) to the last scan sequence (clip deployment). The average time for single biopsy procedures was 38 minutes (range: 23–57 minutes). Average time for multiple biopsy procedures in a single breast was 59 minutes (51–68 minutes) and for bilateral procedures 64 (46–80 minutes).
Rotenberg et al. 2004²⁰⁰	Prospective case series of patients with palpable tumors and patients with tumors which were visible on ultrasound imaging or radiology.	30	Spirotome System with 8- to 10-gauge needle. No stereotactic tables were used in the study.	Biopsies took a maximum of 20 minutes to complete, with 80% of the biopsies being completed in only 10 minutes.
Chen et al. 2003²¹⁰	Retrospective study of patients with nonpalpable breast lesions from January 1998–2001 undergoing either a CNB or open biopsy.	232	Comparison of vacuum-assisted CNB (Mammotome) with 11-gauge needle vs. ultrasound-guided excisional biopsy	Procedure times were measured from initial skin incision to wound closure or needle withdrawal. Procedure times were as follows: for benign tumor cases 44.3 and 21.5 minutes (p <0.001); for malignant cases 44.0 and 27.0 (P = 0.036); for tumors <1 cm in diameter, 43.5 and 20.6 (p <0.001) and for tumors 1–2 cm, 44.2 and 23.6 minutes (p <0.001) for open and CNB, respectively. Procedure time for the older model Mammotome device (used in first year of study) vs. newer handheld variant, which was used in the second year, was 24 and 18 minutes on average, respectively (p <0.001).
Liberman et al. 2003²²⁷	Prospective case series of women with one of the following: a nonpalpable mammographically-occult lesion at high risk for breast cancer or for extent of disease assessment.	20	MRI-guided 9-gauge vacuum-assisted breast biopsy.	Imaging time was 20 minutes, on average, including three contrast enhanced acquisitions. Median MRI-guided CNB time, from localizing image to imaging after clip deployment was 35 minutes (Mean: 35, Range: 24–48 for a single lesion and 65 minutes (Mean: 69, Range: 62–86) for patients with two lesions. Median tissue acquisition time was 38 seconds (Mean: 41, Range: 29–87).
Mariotti et al. 2003²²⁸	Retrospective study of patients undergoing either ABBI or CNB from June 1999–December 2001 for suspicious non palpable mammographic lesions not confirmed by ultrasonography.	360	Vacuum-assisted CNB (Mammotome) with 11-gauge needle vs. ABBI	ABBI and Mammotome procedure times were 20 and 10 minutes, on average, respectively, for the operative portion of the procedure only.
Pleiderer et al. 2003⁵¹⁵	Prospective nonconsecutive case series of patients with suspicious breast lesions who had a diagnostic CNB with a new device.	14	Remote controlled MRI compatible prototype manipulator system (ROBITOM) using 14-gauge large core breast biopsy.	Total procedure time was between 50–70 minutes.
Apesteguia et al. 2002⁵¹⁸	Prospective consecutive case series of patients with nonpalpable breast lesions non-visible or non-accessible by US.	126	Vacuum-assisted CNB on a digital stereotaxic table with an 11-gauge needle.	Mean procedure time was 29.6 ±14 minutes (Range: 15–90 minutes).
Hui et al. 2002²⁵²	Prospective case series of patients with nonpapable breast lesions requiring a biopsy procedure.	79	Stereotactic-guided breast biopsy (StereoGuide with Digital Spot Mammography): Trucut with a 14-gauge needle, Mammotome with 11-gauge probe, or FNA with a 22-gauge needle, depending on the characteristics of the lesion.	Mean duration of the biopsy procedure was 49 minutes (range: 30–90).
Mainiero et al. 2002²⁵⁹	Prospective nonrandomized comparison study of patients with suspicious breast lesions undergoing a CNB between 1997–1999.	193	Either freehand high resolution sonographically- guided large core biopsy with 14-gauge needle vs. stereotactic vacuum-assisted CNB (Mammotest with 11-gauge needle).	The authors examined how much room time and physician time was expended for each type of procedure. They found stereotactic VABB took more room and physician time when all biopsies were examined together. When only room and physician time for patients with masses was examined, only room time significantly differed in the same direction by procedure type. The authors conclude that sonographically-guided breast biopsies reduce procedure time compared with stereotactic biopsy.
Becker et al. 2001⁵²⁷	Retrospective chart review of 232 lesions with indeterminate microcalcifications in 218 women.	218	DMR regular mammography machine plus either a Stereotix 2 conventional add-on unit or a SenoVision digital add-on unit. CNB was performed with a 14-gauge needle in all but 5 cases (in which a 16-gauge needle was used)	Changing from a conventional to a digital add-on unit cut the procedure time by half (from 50 to 20 minutes). Most of this time savings is related to the speed of displaying digital images, 15 seconds per image, versus 3 minutes to develop radiographs.
Perez-Fuentes et al. 2001⁵³⁴	Prospective case series of patients seen between August 1998–December 2000 with palpable or nonpalpable breast masses diagnosed with CNB.	83	Sonographically-guided vacuum-assisted CNB (Mammotome) with 11-gauge needle	Median procedure time (acquisition of prebiopsy sonogram to positioning of sterile bandage on skin) was 17 minutes (Range: 10–40)
Schneider et al. 2001³¹²	Prospective case series of patients undergoing a new unilateral MR-guided breast lesion localization and core biopsy system.	14	MR image guidance AND CNB using a mechanical needle guide and trajectory planning software with 14-gauge needle.	Mean procedure time was 15 ±5 minutes (Range: 5–24), including 3D acquisition scan, completion of the verification scan, placement of single and multiple stylettes for multiple localization wire placements, and multiple tissue sampling by CNB.
Wunderbaldinger et al. 2001⁵³⁷	Prospective nonconsecutive first-experience case series of patients with nonpalpable breast lesions diagnosed by CNB followed by surgical excision.	45	New dedicated US system for computer-guided CNB (Sonopsy) with a 14-gauge needle.	Average procedure time (including patient positioning, biopsy, localization but not post procedural handling) was 30 ±2.7 minutes.
Beck et al. 2000⁵³⁹	Retrospective review of first experience using vacuum-assisted CNB	560	Digital stereotaxic biopsy table and vacuum-assisted CNB (Mammotom) with 11-gauge needle.	The authors report that patient positioning took approximately 15 minutes; 30 minutes for the actual procedure; 15 minutes for compression; 10 minutes for a final mammogram; and another 30–45 for observation.
Welle et al. 2000⁵⁴⁵	Retrospective review of patients who underwent a stereotactic CNB in a decubitus or recumbent position from September 1995–March 1999.	225	Stereotactic CNB in a decubitus or recumbent position.	Procedure time was recorded as minutes in compression (mean 25, range: 20–50). Procedures done with digital mammographic equipment and the Mammotome were approximately 10 minutes shorter
Bloomston et al. 1999³⁴⁸	Prospective consecutive case series of women with nonpalpable breast abnormalities who had an ABBI.	100	Stereotactic ABBI.	Average procedure time was 20 ±8 minutes.
Doyle et al. 1999⁵⁵²	Retrospective study of patients with mammographically-detected lesions on CNB from 1994–1998.	151	Senographe 600T was used for 136 biopsies; 15 using Mammomat 3000; all in decubitus position unless the patient couldn’t tolerate that positioning and with a 14-gauge needle.	Mean procedure time was 20 minutes
Bolivar et al. 1998⁵⁵⁸	Patients seen between October 1993–October 1996 having a CNB for nonpalpable breast lesions.	180	Stereotactic CNB (Stereotix localization stereotaxic device attached to Senix 500T screen film mammographic unit) with the Menghini nonautomatic 15-gauge needle with multiple pass technique (Surecut).	THE CNB procedure averaged between 45–55 minutes.
Whitman et al. 1998⁵⁵⁹	Retrospective chart review of 12 CNB in 11 women.	11	Mammographically- guided coaxial CNB procedure performed with a fenestrated alphanumeric compression device with a 15-gauge Tru Guide outer cannula and a 16-gauge Monopty biopsy instrument	The CNB procedure ranged in time from 30–80 minutes.
Burbank 1997⁴¹³	Retrospective study comparing the accuracy of directional, vacuum-assisted stereotactic CNB with stereotactic automated gun CNB	101	Prone position under stereotactic guidance on the Mammotest with 14-gauge needles	Directional, vacuum-assisted biopsy tissue harvest time was 18.6 ±15.8 minutes per lesion, on average, meaning 26.5 specimens can be obtained in that amount of time, at a tissue harvest rate of 1.4 specimens per minute. No information is given for automated procedure.
Florentine et al. 1997⁴²¹	Retrospective review of patients with palpable breast lesions who underwent a combined FNA/CNB procedure.	12	CNB using an 18-gauge Temno needle	The CNB procedure took approximately 20 minutes, on average.
Helbich et al. 1997⁵⁶³	Prospective randomized trial of patients with mammographically- suspicious solid lesions. Patients were randomized to stereotactic CNB in a sitting position; stereotactic CNB in the prone position; or CNB with US guidance. CNB was followed by surgical excision.	210	CNB with either stereotactic or US guidance using a 14-gauge needle.	Acquisition of the CNB specimen took an average of 19±3 minutes with stereotactic guidance vs. 13±4 minutes with US guidance.
Howisey et al. 1997⁴²⁴	Retrospective review of Medicare patients with mammographic abnormalities who went on to have ultrasound-guided CNB, stereotactic-guided CNB or wire localization with surgical excision between July 1994–December 1995.	139	Ultrasound or stereotactic-guided CNB	US-guided CNB had a shorter procedure time (<20 minutes per case) than stereotactic- guided CNB. No time given for stereotactic procedure.
Yim et al. 1996⁴⁵⁴	Retrospective chart review of subjects with invasive breast cancer diagnosed by either CNB or needle localization surgical biopsy.	52	Stereotactic CNB with a 14-gauge needle was performed on a dedicated prone table (Lorad, Danbury, CT) vs. needle localized open biopsy	Average total procedure time for the CNB was 40–50 minutes, but the biopsy time itself was shorter than for open biopsy.
Janes et al. 1994⁴⁶⁹	Prospective case series of initial 300 CNBs performed by a group of five surgeons.	288	CNB using Fischer Imaging Mammotest with Auto-Guide and the Mammoscan System, 14-gauge needle Biopty-Cut Biopsy Needle.	By the 100^th procedure, total procedure time, from initial image taking to completion of the acquisition, rarely exceeded 30 minutes. Acquisition times for lesions centered on the initial image were 15–20 minutes.
Elvecrog et al. 1993⁵⁸⁶	Prospective study of women with a single nonpalpable breast lesion imaged by mammography who underwent CNB followed by hook-wire localization and open surgical biopsy.	100	Mammotest stereotaxic system and 14-gauge needle.	Average per case procedure time, including obtaining preliminary views, was 50–60 minutes. The CNB alone took between 30–40 minutes, on average. No data on average time for the open biopsy procedure was presented.
Parker et al. 1990⁵⁹¹	Prospective case series of consecutive patients referred for biopsy of nonpalpable mammographically- suggestive lesions. Subjects underwent CNB followed by wire localization and excisional surgery.	103	14-, 16-, or 18-gauge Biopty-cut needles were used in conjunction with a Biopty gun. The first 30 patients were treated with Senographe Mammographic System 600T coupled with Stereotix computerized stereotactic needle localization device. Logistical problems caused investigators to switch to the Mammotest Stereotactic System for remaining patients.	Average procedure time by end of the study was 20–30 minutes without localization wire placement. No data on procedure time for early cases was provided.

: CNB = Core-needle Biopsy

Table E19Wait time for test results

Reference	Design of Study	Number of Patients	Biopsy Methods	Conclusion
Verkooijen et al. 2001⁵⁹³	Prospective comparison of patients with nonpalpable breast lesions	164	Stereotactic guidance on a prone table with a 14-gauge needle.	Median wait time was 9 days for core-needle biopsies and 19 days for wire-localized open biopsies.
Gukas et al. 2000³²⁶	Prospective study of patients with palpable lesions	108	Tru-Cut	Reduced wait time to get back a test result was, on average, 7.3 days less for Tru-Cut than excisional biopsy.

Table E20Availability of a qualified pathologist

Reference	Design of study	Number of patients	Biopsy methods	Conclusion
Collins et al. 2004¹⁷⁹	Retrospective chart review of patients with nonpalpable lesions	2,004	CNB using either stereotactic mammography or ultrasound. In some cases a 14-gauge needle was used, in others a vacuum-assisted procedure was done with either a 14- or 11-gauge needle.	Local pathology diagnoses were compared to those made by a central pathologist. In 96% of CNB cases the two pathologists were in agreement. Agreement rates were as follows for the subcategories of benign lesions, invasive cancers, DCIS cases, ADH, and lobular neoplasia: 99%, 97%, 83%, 63%, and 53%, respectively. Agreement rates remained stable regardless of biopsy guidance system and biopsy device used.
Gukas et al. 2000³²⁶	Prospective study of 112 consecutive patients with palpable breast lesions.	108	Tru-Cut and excisional biopsies.	The pathologist in this study was not highly experienced with Tru-Cut, which the authors believe explains its poor diagnosis rate in this study.

Table E21Availability of equipment

Reference	Design of Study	Number of Patients	Biopsy Methods	Conclusion
Deurloo et al. 2001²⁸⁵	Retrospective review of patients with nonpalpable breast lesions.	84	StereoGuide with 14-gauge needle	Vacuum-assisted biopsy is increasingly being used in the United States. But, in Europe, acceptance of vacuum-assisted biopsy is considerably less whereas core biopsy devices are used much more.
Verkooijen et al. 2001⁵⁹³	Prospective comparison of patients with nonpalpable breast lesions	164	Stereotactic guidance, on a prone table with a 14-gauge needle.	Median wait times for access to core-needle biopsy equipment were only 4 days while access to open surgical biopsy had a median wait time of 13 days.
Williams et al. 1999³⁸⁴	Prospective case series of patients with impalpable breast lesions diagnosed by stereotactic core- needle biopsy on a prone table vs. a historical cohort of patients with similar lesions diagnosed prior to the availability of a prone table.	222	Stereotactic prone CNB with Mammotest and 14-gauge needle.	There was no significant difference in lag time between screening and definitive diagnosis for the two groups. However, there was a delay in having the prone procedure due to the longer waiting list.

Table E22Resource usage

Reference	Design of Study	Number of Patients	Biopsy Methods	Conclusion
Mainiero et al. 2002²⁵⁹	Prospective nonrandomized comparison study of patients with suspicious breast lesions	193	Either freehand high resolution US-guided large core biopsy with 14-gauge needle or a stereotactic-guided vacuum- assisted biopsy (Mammotest) with 11-gauge needle	The authors examined how much room time and physician time was expended for each type of procedure. They found vacuum-assisted procedures took more room and physician time when all biopsies were examined together. When only room and physician time for patients with masses was examined, only room time significantly differed in the same direction by procedure type.
Wunderbaldinger et al. 2002²⁷⁷	Prospective randomized study	200	Stereotactic-guided biopsies in either sitting or prone position with a 14-gauge needle.	In the conclusion the authors report that prone systems require four times the amount of space as a regular unit and are often underused as their only function is breast biopsy. In addition, there is a weight limit to prone machines.