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

StudyDesign of StudyType of StudyNumber of CentersCare SettingCountry Conducted inFunded byType(s) Core BiopsyCore Biopsy Results Confirmed byNumber of Lesions EnrolledFollowup% Attrition
Jackman et al. 2009485Single group (cohort or case series study)Retrospective1General hospitalUSABiopsys Medical, Inc. and Ethicon Endo-SurgeryStereotactic guidance vacuum- assisted 11G and 14GCombination of surgery and patient followup1,2802 years10.6%
Peters et al. 2008486Single group (cohort or case series study)Retrospective4General hospitalNetherlandsNRStereotactic guidance automated gun 14GCombination of surgery and patient followup9482 years5%
Schueller et al. 2008487Single group (cohort or case series study)Retrospective1General hospitalAustriaAuthors stated no financial relationship to discloseUltrasound guidance automated gun 14GCombination of surgery and patient followup14382 years5.7%
Sim and Kei 2008488Single group (cohort or case series study)Retrospective1General hospitalSingaporeNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient folowup1052 years12.4%
Tonegutti and Girardi 2008489Single group (cohort or case series study)Retrospective1General hospitalItalyNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup2682 years0%
Youk et al. 200824Single group (cohort or case series study)Retrospective1General hospitalSouth KoreaNRUS guidance automated gun 14GCombination of surgery and patient followup4,3592 years44%
Ciatto et al. 2007490Single group (cohort or case series study)Retrospective1Dedicated breast cancer centerItalyFunded in part by a National Helath and Medical Research Council (NHMRC) grantMultiple methodsCombination of surgery and patient followup4,0351 year26%
de Lucena et al. 2007491Single group (cohort or case series study)Prospective1General hospitalBrazilNRUS guidance automated gun 14GOpen surgery or surgical biopsy only150Immediate surgery0%
Uematsu et al. 2007492Single group (cohort or case series study)Prospective1General cancer centerJapanNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup100Mean: 26 months

Range: 5 to 44 months
0%
Vag et al. 2007493Single group (cohort or case series study)Prospective1General hospitalGermanyNRUS guidance vacuum-assisted 10GCombination of surgery and patient followup702 years0%
Chapellier et al. 2006494Single group (cohort or case series study)Prospective1General cancer centerFranceNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup318Range: 4 to 16 months0%
Cipolla et al. 2006495Single group (cohort or case series study)NR1General hospitalItalyNRMultiple methodsCombination of surgery and patient followup4261 year0%
Dhillon et al. 2006496Single group (cohort or case series study)Prospective1General hospitalUKNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup150Median: 48 months0%
Bolivar et al. 2005497Single group (cohort or case series study)Prospective1General hospitalSpainNRUS guidance automated gun 14GCombination of surgery and patient followup2142 years5%
Crystal et al. 2005498Single group (cohort or case series study)NR1General hospitalIsraelNRUS guidance automated gun 14GCombination of surgery and patient followup715Median: 39 months

Range: 27 to 60 months
0%
Dillon et al. 2005499Single group (cohort or case series study)Retrospective1General hospitalIrelandNRMultiple methodsCombination of surgery and patient followup2,427Median: 24 months

Range: 3 to 67 months
19%
Koskela et al. 2005500Single group (cohort or case series study)Prospective1General hospitalFinlandKuopio University Hospital (the center it was conducted in)Stereotactic guidance automated gun 14GCombination of surgery and patient followup213Mean: 24 months

Range: 6 to 39 months
4%
Sauer et al. 2005501Single group (cohort or case series study)Retrospective1General hospitalGermanyNRUS guidance automated gun 14GCombination of surgery and patient followup962Mean: 22.2 months

Median: 21 months Range : 8 to 36 months
13%
Weber et al. 2005502Non-randomized multiple groups studyProspective1General hospitalSwitzerlandNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup225Median: 2.1 years

Range: 0.5 to 4.4 years
15%
Wu et al. 2005503Single group (cohort or case series study)NR1General hospitalTaiwanNRUS guidance vacuum-assisted 11GCombination of surgery and patient followup1131 year0%
Alonso-Bartolome et al. 2004504Single group (cohort or case series study)Prospective2General hospitalSpainNRUS guidance vacuum-assisted 11GCombination of surgery and patient followup1026 to 12 months0%
Delle and Terinde 2004505Single group (cohort or case series study)NR1General hospitalGermanyNRUS guidance automated gun 14GCombination of surgery and patient followup1692 years0%
Fajardo et al. 2004506Some patients were randomized to stereotactic or US guidance but data were reported as if the study was a single-group cohort studyProspective22Academic and community practice clinical sitesUSANational Cancer InstituteMultiple methodsCombination of surgery and patient followup2,4032 years30%
Kettritz et al. 2004507Single group (cohort or case series study)Prospective5General hospitalGermanyNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup2,893Mean: 25 months

Range: 6 to 67 months
22%
Lomoschitz et al. 2004508Non-randomized multiple groups studyProspective1General hospitalAustriaOne author partially supported by both Ethicon Edonsurgery and Biopsys MedicalStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup1002 years0%
Abdsaleh et al. 2003509Single group (cohort or case series study)Prospective1General hospitalSwedenNRMultiple methodsCombination of surgery and patient followup1801 year21%
Ambrogetti et al. 2003510Single group (cohort or case series study)Retrospective1General hospitalFranceNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup364Mean: 15.8 months

Range: 6 to 36 months
35%
Fishman et al. 2003511Single group (cohort or case series study)Prospective1General hospitalUSANRUS guidance automated gun 14GCombination of surgery and patient followup73Mammographic and US followup

Median: 21 months

Range: 4 to 30 months
33%
Han et al. 2003512Single group (cohort or case series study)Retrospective1General hospitalKoreaNRStereotactic guidance automated gun 14GCombination of surgery and patient followup271At least 6 months27%
Kirshenbaum et al. 2003513Single group (cohort or case series study)Retrospective1General hospitalUSANRMultiple methodsCombination of surgery and patient followup506Mean: 2.1 years

Range: 3 months to 5 years
23%
March et al. 2003514Single group (cohort or case series study)Prospective2Dedicated breast cancer centerUSARSNA Seed Grant and the Rays of Hope charitable fundUS guidance vacuum-assisted 11GCombination of surgery and patient followup346 months9%
Pfleiderer et al. 2003515Single group (cohort or case series study)Prospective1General hospitalGermanyNRMRI guidance automated gun 14GCombination of surgery and patient followup142 years0%
Philpotts et al. 2003516Non-randomized multiple groups studyRetrospective1General hospitalUSANRMultiple methodsCombination of surgery and patient followup281Mean: 19 months

Range: 3 to 53 months for 14G

Mean: 13 months

Range: 1 to 24 for 11G
24%
Wong and Hisham 2003517Single group (cohort or case series study)Prospective1General hospitalMalaysiaNRFreehand automated gun 14 or 16GCombination of surgery and patient followup150Range: 6 to 13 months0%
Apesteguia et al. 2002518Single group (cohort or case series study)Prospective1General hospitalSpainNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup1321 year0%
Georgian-Smith et al. 2002519Single group (cohort or case series study)Retrospective4General hospitalUSANRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup185Range: 6 to 12 months21%
Jackman and Lamm 2002520Single group (cohort or case series study)Retrospective1General hospitalUSAFunded in part by Biopsys MedicalMultiple methodsCombination of surgery and patient followup31At least 6 months0%
Johnson et al. 2002521Single group (cohort or case series study)NR1General hospitalUSAFashion Footwear of NYUS guidance vacuum-assisted 11 or 8GCombination of surgery and patient followup101Mean: 9.5 months24%
Liberman et al. 2002522Single group (cohort or case series study)Retrospective1General cancer centerUSANRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup800At least 1 year29%
Meloni et al. 2002523Single group (cohort or case series study)Retrospective1General hospitalItalyNRStereotactic guidance vacuum- assistedCombination of surgery and patient followup129Mean: 18.7 months

Range: 14 to 26 months
0%
Morris et al. 2002524Single group (cohort or case series study)Prospective1Dedicated breast cancer centerUSANRStereotactic guidance vacuum- assisted 14GCombination of surgery and patient followup21Median: 46 months

Range: 40–54 months
10%
Pfarl et al. 2002525Single group (cohort or case series study)Retrospective1General hospitalAustriaNRStereotactic guidance vacuum- assisted 11GOpen surgery or surgical biopsy only332Immediate surgery4%
Verkooijen et al. COBRA 2002526Single group (cohort or case series study)Prospective5General hospitalNetherlandsDutch National Health Insurance Fund CouncilStereotactic guidance automated gun 14GOpen surgery or surgical biopsy only984Immediate surgery11%
Becker et al. 2001527Single group (cohort or case series study)Retrospective1General hospitalCanadaNRStereotactic guidance automated gun 14GCombination of surgery and patient followup232Range: 6 to 12 months27%
Brenner et al. 2001528Single group (cohort or case series study)Prospective7Cancer centers and hospitalsUSANRStereotactic guidance automated gun 14GCombination of surgery and patient followup1,003Mean: 19.3 months

Range: 0 to 36 months
1%
Cangiarella et al. 2001529Single group (cohort or case series study)NR1General hospitalUSANRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup160Mean: 20.5 months

Range: 6 to 35 months
38%
Dahlstrom and Jain 2001530Single group (cohort or case series study)NR1General hospitalAustraliaNRStereotactic guidance automated gun 14GCombination of surgery and patient followup301Range: 2.4 to 7.5 years0%
Lai et al. 2001531Single group (cohort or case series study)NR1General hospitalCanadaNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup673Mean: 6.7 months

Range: 6 to 24 months
29%
Levin et al. 2001532Single group (cohort or case series study)Prospective1General hospitalCanadaPhysician’s Services Incorporated FoundationStereotactic guidance automated gun 14GOpen surgery or surgical biopsy only70Immediate surgery0%
Margolin et al. 2001533Single group (cohort or case series study)Retrospective1General hospitalUSANRMultiple methodsCombination of surgery and patient followup1,333Mean: 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. 2001534Single group (cohort or case series study)NR1Dedicated breast cancer centerVenezuelaNRUS guidance vacuum-assisted 11GCombination of surgery and patient followup88Median: 11.1 months

Range: 4 to 24 months
33%
Smith et al. 2001535Single group (cohort or case series study)NR1General hospitalUSANRUS guidance automated gun 14GCombination of surgery and patient followup500Mean: 22 months

Median: 14 months

Range: 12 to 60 months
21%
White et al. 2001536Single group (cohort or case series study)Retrospective1General hospitalUSANRMultiple methodsCombination of surgery and patient followup1,042Median: 29 months, minimum of one year29%
Wunderbaldinger et al. 2001537Single group (cohort or case series study)Prospective1General hospitalAustriaauthor supported by Erwin Schroedinger Auslandsstipenium of the Austrian Science FundUS guidance automated gun 14GOpen surgery or surgical biopsy only45Immediate surgery0%
Yeow et al. 2001538Single group (cohort or case series study)Prospective1General hospitalChinaNRUS guidance automated gun 14 or 16GCombination of surgery and patient followup98Mean: 4 years

Range: 3 to 5 years
0%
Beck et al. 2000539Single group (cohort or case series study)NR1General hospitalGermanyNRStereotactic guidance vacuum- assisted 11GCombination of surgery and patient followup5941 year0%
Kirwan et al. 2000540Single group (cohort or case series study)Retrospective1General hospitalUKNRStereotactic guidance automated gun 14GOpen surgery or surgical biopsy only72Immediate surgery13%
Latosinsky et al. 2000541Single group (cohort or case series study)Retrospective1General hospitalUSANIH grantMultiple methodsCombination of surgery and patient followup692Median: 17.2 months

Range: 2.8 to 43 months
42%
Liberman et al. 2000542Single group (cohort or case series study)Retrospective1General cancer centerUSANRMultiple methodsCombination of surgery and patient followup155Median: 53 months

Range: 24 to 69 months
32%
Makoske et al. 2000543Single group (cohort or case series study)Retrospective1General hospitalUSANRMultiple methodsCombination of surgery and patient followup817Mean: 1.7 years30%
Ward et al. 2000544Single group (cohort or case series study)NR1General hospitalCanadaNRStereotactic guidance automated gun 14GCombination of surgery and patient followup121Mean: 16 months

Range: 4 to 36 months
7%
Welle et al. 2000545Single group (cohort or case series study)Retrospective3General hospitalUSANRMultiple methodsCombination of surgery and patient followup225Range: 6 to 24 months20%
Helbich et al. 1999546Randomized controlled trialProspective1General hospitalAustriaLudwig-Boltzmann Institute for Radiologic Tumor Research; one author was supported by a grant from the Max Kade FoundationMultiple methodsOpen surgery or surgical biopsy only44Immediate surgery0%
Jackman et al. 1999547Single group (cohort or case series study)Retrospective1General hospitalUSANRStereotactic guidance automated gun 14GCombination of surgery and patient followup483Median: 55 months1%
Meyer et al. 1999548Single group (cohort or case series study)Retrospective1General hospitalUSANRMultiple methodsCombination of surgery and patient followup1,836At least 1 year25%
Puglisi et al. 1999549Single group (cohort or case series study)Retrospective1General hospitalItalyNRPerforated compression grid automated gun 14GCombination of surgery and patient followup106At least 6 months1%
Soo et al. 1999550Non-randomized multiple groups studyRetrospective1General hospitalUSANRMultiple methodsCombination of surgery and patient followup116Mean: 16 months

Range: 5 to 31 months
19%
Caruso et al. 1998551Single group (cohort or case series study)Prospective1General hospitalItalyNRMultiple methodsOpen surgery or surgical biopsy only92Immediate surgery13%
Doyle et al. 1998552Single group (cohort or case series study)Retrospective1Dedicated breast cancer centerNew ZealandNRStereotactic guidance automated gun 14GCombination of surgery and patient followup151Range: 6 to 36 months11%
Fuhrman et al. 1998553Single group (cohort or case series study)Retrospective1General hospitalUSANRMultiple methodsCombination of surgery and patient followup1,440At least 6 months18%
Heywang- Kobrunner et al. 1998554Single group (cohort or case series study)NR1General hospitalGermanyNRStereotactic guidance vacuum- assisted 11 or 14GCombination of surgery and patient followup2616 months31%
Ioffe et al. 1998555Single group (cohort or case series study)NR1General hospitalUSANRMultiple methodsCombination of surgery and patient followup224Range: 6 to 12 months14%
Liberman et al. 1998556Single group (cohort or case series study)NR1General cancer centerUSANRUS guidance automated gun 14GCombination of surgery and patient followup151Median: 20 months

Range: 6 to 48 months
23%
Schulz-Wendtland et al. 1998557Single group (cohort or case series study)NR1General hospitalGermanyNRUS guidance automated gun 14GCombination of surgery and patient followup3072 years0%
Vega-Bolivar et al. 1998558Single group (cohort or case series study)Retrospective1General hospitalSpainNRStereotactic guidance Surecut 15GCombination of surgery and patient followup182Mean: 27 months

Range: 6 to 47 months
6%
Whitman et al. 1998559Single group (cohort or case series study)Retrospective2General hospitalUSANRStereotactic guidance automated gun 16GOpen surgery or surgical biopsy only12Immediate surgery0%
Zannis and Alia No 1998560Non-randomized multiple groups studyRetrospective1Ambulatory surgical centerUSANRMultiple methodsCombination of surgery and patient followup424At least 6 months31%
Bauer et al. 1997561Single group (cohort or case series study)RetrospectiveNRNRUSANRStereotactic guidance automated gun 14GCombination of surgery and patient followup799Mean: 9 months0%
Britton et al. 1997562Single group (cohort or case series study)NR1General hospitalUKNRMultiple methodsCombination of surgery and patient followup202Mean: 20.1 months

Range: 5.3 to 30.8 months
2%
Helbich et al. 1997563Single group (cohort or case series study)Prospective1General hospitalAustriaNRMultiple methodsOpen surgery or surgical biopsy only210Immediate surgery0%
Khattar et al. 1997564Single group (cohort or case series study)Prospective1General hospitalDenmarkNRUS guidance automated gunOpen surgery or surgical biopsy only106Immediate surgery43%
Liberman et al. 1997565Single group (cohort or case series study)Retrospective1General cancer centerUSANRStereotactic guidance automated gun 14GCombination of surgery and patient followup442Median: 18 months

Range: 6 to 46 months
34%
Pitre et al. 1997566Single group (cohort or case series study)Retrospective1General hospitalUSANRStereotactic guidance automated gunCombination of surgery and patient followup1281 year8%
Stolier et al. 1997567Single group (cohort or case series study)Retrospective1General hospitalUSANRMultiple methodsCombination of surgery and patient followup244Mean: 12.8 months

Range: 6 to 39 months
NR
Sutton, et al. 1997568Single group (cohort or case series study)Retrospective1Screening clinicAustraliaNRStereotactic guidance automated gun 14GCombination of surgery and patient followup2061 year32%
Walker et al. 1997569Single group (cohort or case series study)NR1General hospitalUKNRStereotactic guidance automated gun 14GCombination of surgery and patient followup200Range: 6 to 36 months10%
Frazee et al. 1996570Non-randomized multiple groups studyProspective1General hospitalUSANRStereotactic guidance automated gunCombination of surgery and patient followup103At least 6 months0%
Fuhrman et al. 1996571Single group (cohort or case series study)NR1General hospitalUSANRStereotactic guidance automated gun 14GCombination of surgery and patient followup4511 year22%
Head and Haynes 1996572Single group (cohort or case series study)Prospective1Dedicated breast cancer centerUSANRStereotactic guidance automated gun 18GCombination of surgery and patient followup1152 years8%
Mainiero et al. 1996573Single group (cohort or case series study)Retrospective1General hospitalUSANRStereotactic guidance automated gun 14GCombination of surgery and patient followup138At least 6 months14%
Meyer et al. 1996574Single group (cohort or case series study)NR1General hospitalUSANRStereotactic guidance automated gun 14GCombination of surgery and patient followup3881 year30%
Nguyen et al. 1996575Single group (cohort or case series study)NR1General hospitalUSAAmerican Cancer Society, UCLA Jonsson Comprehensive Cancer Center, and the Stein- Oppenheim FoundationMultiple methodsCombination of surgery and patient followup431At least 6 months10%
Pettine et al. 1996576Single group (cohort or case series study)Retrospective1General hospitalUSANRStereotactic guidance automated gun 14GOpen surgery or surgical biopsy only256 month repeat mammography for benign0%
Rosenblatt et al. 1996577Single group (cohort or case series study)Retrospective1General hospitalUSANRStereotactic guidance automated gun 14GCombination of surgery and patient followup251 year16%
Scopa et al. 1996578Non-randomized multiple groups studyNR1General hospitalGreeceNRFreehand TruCutOpen surgery or surgical biopsy only120Immediate surgery0%
Cross et al. 1995579Single group (cohort or case series study)NR1Dedicated breast cancer centerUSANRStereotactic guidance automated gun 14GCombination of surgery and patient followup2501 year12%
Doyle et al. 1995580Non-randomized multiple groups studyProspective1General HospitalUSANRMultiple methodsCombination of surgery and patient followup150Range: 6 to 24 months3%
Hamed et al. 1995581Randomized controlled trialProspective1General hospitalUKNRFreehand Biopty-cutOpen surgery or surgical biopsy only122Immediate surgery0%
Burbank et al. 1994582Non-randomized multiple groups studyNR1General hospitalUSANRMultiple methodsCombination of surgery and patient followup105At least 6 months0%
Gisvold et al. 1994583Single group (cohort or case series study)Prospective1General hospitalUSANRStereotactic guidance automated gun 14GOpen surgery or surgical biopsy only160Immediate surgery0%
Parker et al. 1994584Non-randomized multiple groups studyRetrospective20Various hospitals, breast care centers, clinicsUSANRMultiple methodsCombination of surgery and patient followup6,152At least 6 months39%
Smyth and Cederbom 1994585Single group (cohort or case series study)NR1General hospitalUSANRStereotactic guidance automated gun 14GOpen surgery or surgical biopsy only58Immediate surgery0%
Elvecrog et al. 1993586Non-randomized multiple groups studyProspective1General hospitalUSANRStereotactic guidance automated gun 14GOpen surgery or surgical biopsy only100Immediate surgery0%
Parker et al. 1993587Single group (cohort or case series study)NR1Specialized imaging centerUSANRUS guidance automated gun 14GCombination of surgery and patient followup181Range: 12 to 36 months0%
McMahon et al. 1992588Randomized controlled trialProspective1General hospitalUKNRMultiple methodsCombination of surgery and patient followup151Median: 11 months Range: 1 to 24 months0%
Barreto et al. 1991589Single group (cohort or case series study)NR1General hospitalUKNRFreehand automated gun 18GOpen surgery or surgical biopsy only107Immediate surgery0%
Cusick et al. 1990590Single group (cohort or case series study)NR1General hospitalUSANRFreehandOpen surgery or surgical biopsy only96Immediate surgery0%
Parker et al. 1990591Single group (cohort or case series study)NR1General hospitalUSANRStereotactic guidance automated gunOpen surgery or surgical biopsy only103Immediate surgery0%

NR = Not Reported

US = Ultrasound

UK = United Kingdom

USA = United States of America

From: Appendix E, Evidence Tables

Cover of Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions
Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions [Internet].
Comparative Effectiveness Reviews, No. 19.
Bruening W, Schoelles K, Treadwell J, et al.

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