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Bruening W, Launders J, Pinkney N, et al. Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb. (Comparative Effectiveness Reviews, No. 2.)

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  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities [Internet].

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Appendix CList of Studies Excluded from Questions 1 and 2

Table 22Studies of PET that Did Not Meet the Inclusion Criteria

StudyReason
Adler et al. 1993210 Report of the same study published in greater detail in Crowe et al.53
Avril et al. 1997211 Did not report any of the outcomes of interest.
Avril et al. 1996212 Patients enrolled were of a mixed population, and data from the population of interest were not reported separately.
Avril et al. 2000213 Update, with additional patients, of Avril et al.213, which reports that it studied a mixed population of patients (some patients had a history of breast cancer).
Buck et al. 2002214 Did not report any of the outcomes of interest.
Danforth et al. 2002215 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Fujiwara et al. 1999216 Did not study the population of interest. Enrolled patients with various types of cancer to look for metastatic lesions. Less than 10 patients.
Inoue et al. 2004217 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Levine et al. 200361 Did not study the technology of interest-- experimental methods.
Murthy et al. 2000218 Did not study the technology of interest-- experimental methods.
Nieweg et al. 1993219 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Noh et al. 1998220 Fewer than 85% were evaluated by biopsy.
Pietrzyk et al. 1995221 Did not report any of the outcomes of interest.
Scheidhauer et al. 1996222 Confounded. Results of the PET exam were used to change or direct the surgical procedure for some of the patients, increasing the chances that the biopsy results matched the PET results.
Smyczek-Gargya et al. 2004223 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Yutani et al. 199967 Did not report any of the outcomes of interest.

Table 23Studies of Scintimammography that Did Not Meet the Inclusion Criteria

StudyReason
Arslan et al. 1999224 Fewer than 85% were evaluated by biopsy.
Aziz et al. 1999225 Case-control design
Becherer et al. 1997226 Fewer than 85% were evaluated by biopsy.
Buscombe et al. 2001227 Retrospective review of patient data.
Buscombe et al. 1997228 Reports that not all patients were evaluated by biopsy, but does not report how many were.
Clifford et al. 1996229 Fewer than 85% were evaluated by biopsy.
Cwikla et al. 1998230 Reports that not all patients were evaluated by biopsy, but does not report how many were.
Danielsson et al. 2003231 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Dunnwald et al. 1997232 Fewer than 85% were evaluated by biopsy.
Farias-Jimenez et al. 2002233 Retrospective review of patient data.
Fleming 2002234 Did not study the technology of interest-- experimental methods.
Fleming 2002235 Did not study the technology of interest-- experimental methods.
Horne et al. 1999236 Fewer than 85% were evaluated by biopsy.
Horne et al. 2001237 Reports that not all patients were evaluated by biopsy, but does not report how many were.
Howarth et al. 1999238 Fatally confounded. Results of the SC exam were used to change or direct the surgical procedure for some of the patients, increasing the chances that the biopsy results matched the SC results.
Howarth et al. 1999239 Patients enrolled were of a mixed population, and data from the population of interest were not reported separately.
Iraniha et al. 1999240 Reports that not all patients were evaluated by biopsy, but does not report how many were.
Khalkhali et al. 1995241 Fewer than 85% were evaluated by biopsy.
Khalkhali et al. 1995242 Fewer than 85% were evaluated by biopsy.
Khalkhali et al. 1994243 Fewer than 85% were evaluated by biopsy.
Khalkhali et al. 1997244 This is a summary of data published in full in Iraniha et al.240
Kim et al. 2004245 Fewer than 85% were evaluated by biopsy.
Lumachi et al. 1999246 Retrospective review of patient data.
Lumachi et al. 2001247 Retrospective review of patient data. Appears to be reporting a subgroup analysis of data already reported in Lumachi et al.248
Lumachi et al. 2002249 Retrospective review of patient data. Appears to be reporting a subgroup analysis of data already reported in Lumachi et al.250
Massardo et al. 2002251 This is part of a study published in full in Alonso et al.103
Maurer et al. 1995252 Did not study the technology of interest-- experimental methods.
Myslivecek et al. 2004253 Fewer than 85% were evaluated by biopsy.
Nishiyama et al. 2001254 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Palmedo et al. 1998255 Patients enrolled were of a mixed population, and data from the population of interest were not reported separately.
Papantoniou et al. 2002256 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Polan et al. 2001257 Only patients positive by SC were biopsied.
Prats et al. 1999258 Retrospective review of patient data.
Ren et al. 2002259 Case-control design
Sampalis et al. 2001260 This is an interim report of a study that was published in full in Sampalis260
Scopinaro et al. 1999261 Fewer than 85% were evaluated by biopsy.
Sillar et al. 1997262 Fatally confounded. Results of the SC exam were used to change or direct the surgical procedure for some of the patients, increasing the chances that the biopsy results matched the SC results.
Taillefer et al. 1995263 Patients enrolled were of a mixed population, and data from the population of interest were not reported separately.
Tiling et al. 1998264 Fewer than 85% were evaluated by biopsy.
Tiling et al. 2005265 Fewer than 85% were evaluated by biopsy.
Tolmos et al. 1998266 Retrospective review of patient data.
Tolmos et al. 1998266 Retrospective review of patient data.
Vargas et al. 2001267 Retrospective review of patient data.
Yildiz et al. 2001118 Fewer than 85% were evaluated by biopsy.

SC = scintimammography

Table 24Studies of MRI that Did Not Meet the Inclusion Criteria

StudyReason
Barbacioru et al. 2003268 Meeting abstract. Not a full-length peer-reviewed publication.
Baum et al. 2002269 Fewer than 85% of patients were evaluated with biopsy.
Baum et al. 2002270 Patients enrolled were of a mixed population, and data from the population of interest were not reported separately.
Boetes et al. 2004271 Retrospective review of patient data.
Bone et al. 2003272 Retrospective review of patient data. Does not report any of the outcomes of interest. Did not study the population of interest. Only patients with confirmed breast cancer were enrolled.
Carriero et al. 2002273 Did not study the technology of interest-- experimental methods.
Choi et al. 2002274 Fewer than 85% of patients were evaluated with biopsy.
Fenlon et al. 1997275 Patients enrolled were of a mixed population, and data from the population of interest were not reported separately.
Furman et al. 2003276 Retrospective review of patient data.
Gibbs et al. 2004277 Retrospective review of patient data.
Gibis et al. 1999278 Not published in English.
Guo et al. 2002279 Did not study the population of interest. Only patients with confirmed breast lesions were enrolled.
Heywang-Kobrunner et al. 2001167 Confounded. For some patients, results of the histology were used to direct and change the readings of the MRI images.
Jacobs et al. 2003280 Does not report any of the outcomes of interest.
Jacobs et al. 2003281 Retrospective review of patient data.
Kaiser 1985282 Does not report any of the outcomes of interest. Did not use a contrast agent.
Kelcz et al. 2002165 Fatally confounded. Results of the MRI exam were used to change, direct, or repeat the biopsy procedure for some of the patients, increasing the chances that the biopsy results matched the MRI results.
Khatri et al. 2001283 Does not report any of the outcomes of interest.
Kim et al. 2001284 Retrospective review of patient data. Did not study the population of interest. Only patients with confirmed invasive breast cancer were enrolled.
Kramer et al. 1998285 Fatally confounded. Results of the MRI exam were used to change, direct, or repeat the biopsy procedure for some of the patients, increasing the chances that the biopsy results matched the MRI results.
Lee et al. 2003286 Did not study the population of interest. Only patients with confirmed breast cancer were enrolled.
Lucht et al. 2001287 Did not study the technology of interest-- experimental methods.
Nagashima et al. 2002288 Did not study the population of interest. Only patients with confirmed breast cancer were enrolled.
Nakahara et al. 2002289 Did not study the population of interest. Only patients with confirmed breast cancer were enrolled.
Obenauer et al. 2002290 Did not study the population of interest. Patients were enrolled only after a breast lesion was detected by MRI.
Reinikainen et al. 2002291 Does not report any of the results of interest.
Rigauts et al. 1993292 Study enrolled only five patients from the population of interest.
Schelfout et al. 2004293 Fatally confounded. Results of the MRI exam were used to change, direct, or repeat the biopsy procedure for some of the patients, increasing the chances that the biopsy results matched the MRI results.
Schelfout et al. 2004294 Retrospective review of patient data.
Shahar et al. 2002295 Did not study the technology of interest-- experimental methods.
Siegmann et al. 2002208 Does not report any of the results of interest. A quarter of the enrolled patients had previously had cancer, and their data were not reported separately.
Slanetz et al. 2002296 Did not study the population of interest. Only patients with confirmed breast cancer were enrolled.
Szabo et al. 2003297 Did not study the population of interest. Only patients with confirmed invasive breast cancer were reported on.
Szabo et al. 2004164 Did not study the technology of interest-- experimental methods.
Teifke et al. 2002298 Only data from patients referred for surgery or biopsy were reported. Results of the MRI exam may have influenced the decision to refer for surgery/biopsy.
Trecate et al. 2002299 Patients enrolled were of a mixed population, and data from the population of interest were not reported separately.
Tuncbilek 2003300 Does not report any of the results of interest.
Van Goethem et al. 2004301 Fatally confounded. Results of the MRI exam were used to change, direct, or repeat the biopsy procedure for some of the patients, increasing the chances that the biopsy results matched the MRI results.
Wedegartner et al. 2001302 Does not report any of the results of interest.
White et al. 2002303 Does not report any of the results of interest.
Wiberg et al. 2003304 Does not report any of the results of interest.
Yeh et al. 2003305 Retrospective review of patient data.
Zuiani et al. 2002306 Retrospective review of patient data.

Table 25Studies of Ultrasound that Did Not Meet the Inclusion Criteria

StudyReason
Allen et al. 2001307 Did not report any of the outcomes of interest.
Arger et al. 2001308 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Baker and Soo 2002309 Retrospective review of patient data. Does not report any of the outcomes of interest.
Baker et al. 1999200 Retrospective review of patient data.
Beeckman et al. 1991310 Did not report any of the outcomes of interest.
Bhatti et al. 2001311 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Bosch et al. 2003312 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Brittenden et al. 1995313 Did not study the technology of interest-- experimental methods.
Britton and Coulden 1990314 Fewer than 85% were evaluated by biopsy.
Buadu et al. 1997315 Did not study the technology of interest-- experimental methods.
Carson et al. 1997316 Did not study the technology of interest-- experimental methods.
Caruso et al. 2002317 Did not study the technology of interest-- experimental methods.
Chandawarkar and Shinde 1997318 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Chao et al. 1999319 Did not study the technology of interest-- experimental methods.
Chen et al. 2003320 Did not study the population of interest-- screening study of women with dense breasts.
Chen et al. 2002321 Did not study the technology of interest-- experimental methods.
Chen et al. 2003322 Retrospective review of patient data.
Choi et al. 2000323 Retrospective review of patient data.
Ciatto et al. 1994324 Fewer than 85% were evaluated by biopsy.
Cilotti et al. 1997325 Fewer than 85% were evaluated by biopsy, and results of the ultrasound exam influenced the decision to perform biopsy.
Cimitan et al. 1995326 Did not study the population of interest. An unspecified number of patients were only enrolled because of prior positive findings by ultrasound.
Cosgrove et al. 1993327 Fewer than 85% were evaluated by biopsy.
Cosmacini 1990328 Fewer than 85% were evaluated by biopsy.
Debniak et al. 2004329 Did not study the technology of interest-- experimental methods.
Delorme et al. 1998330 Retrospective review of patient data.
Dixon et al. 1992331 Case-control design.
Dock 1993332 Did not study the technology of interest-- experimental methods.
Drukker et al. 2003333 Did not study the technology of interest-- experimental methods.
Edde 1994334 Fewer than 85% were evaluated by biopsy.
Edgar 1995335 Retrospective review of patient data.
Eltahir et al. 1999336 Retrospective review of patient data.
Finlay et al. 1994337 Retrospective review of patient data.
Flobbe et al. 2003188 Fewer than 85% were evaluated by biopsy, and results of the ultrasound exam influenced the decision to perform biopsy.
Forsberg et al. 2004338 Did not study the technology of interest-- experimental methods.
Foxcroft et al. 2004339 Retrospective case-control design.
Fung and Jackson 1990340 Did not study the population of interest-- screening study of women with dense breasts.
Garra et al. 1993341 Retrospective review of patient data.
Gefan et al. 2003342 Did not report any of the outcomes of interest.
Germer et al. 2002343 Did not report any of the outcomes of interest.
Giuseppetti et al. 1998344 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Golshan et al. 2003345 Retrospective review of patient data.
Golub et al. 1993346 Did not study the technology of interest-- experimental methods.
Graf et al. 2004347 Retrospective review of patient data.
Hieken et al. 2001348 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Hieken et al. 1998349 Fewer than 85% were evaluated by biopsy.
Hollerweger et al. 1997350 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Houssami et al. 2003351 Case-control design.
Huang et al. 1999352 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Huber et al. 1998353 Did not study the technology of interest-- experimental methods.
Huber et al. 1994354 Did not study the technology of interest-- experimental methods.
Jackson et al. 1986355 Fewer than 85% were evaluated by biopsy.
Joo et al. 2004356 Did not study the technology of interest-- experimental methods.
Kaiser et al. 2002357 Retrospective review of patient data.
Kaplan et al. 2001358 Did not study the population of interest-- screening study of women with dense breasts.
Kedar et al. 1995359 Did not study the technology of interest-- experimental methods.
Kimme-Smith et al. 1988360 Fewer than 85% were evaluated by biopsy.
Kolb et al. 2002361 Did not study the population of interest-- screening study of women with dense breasts.
Kolb et al. 1998362 Did not study the population of interest-- screening study of women with dense breasts.
Kolb et al. 1997363 Meeting abstract. Not a full-length peer-reviewed publication.
Kook et al. 2003364 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Kook et al. 1999365 Retrospective review of patient data.
Krestan et al. 2002366 Case-control design.
Kuupers et al. 1994367 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Lam et al. 2004368 Retrospective review of patient data.
Leconte et al. 2003369 Retrospective review of patient data.
Lee et al. 1995370 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Lee et al. 1996371 Only data from patients referred for surgery or biopsy were reported. Number of patients initially enrolled in the study is not reported. Results of the ultrasound exam may have influenced the decision to refer for surgery/biopsy.
Leung et al. 2002372 Retrospective review of patient data.
Lister et al. 1998373 Did not study the population of interest. Only enrolled patients with confirmed benign lesions.
Louie et al. 2003374 Did not report any of the outcomes of interest.
Madjar et al. 1995375 Did not report any of the outcomes of interest.
Madjar et al. 1997376 Did not report any of the outcomes of interest.
Madjar et al. 1994377 Did not study the technology of interest-- experimental methods.
Madjar et al. 1991378 Did not study the technology of interest-- experimental methods.
Madjar et al. 2000379 Did not study the technology of interest-- experimental methods.
Marini et al. 2003380 Fewer than 85% were evaluated by biopsy.
Martinez et al. 2003381 Did not study the technology of interest-- experimental methods.
Medl et al. 1994382 Did not study the technology of interest-- experimental methods.
Mesaki et al. 2003383 Fewer than 85% were evaluated by biopsy.
Milz et al. 2001384 Did not study the technology of interest-- experimental methods.
Moss et al. 1999385 Retrospective review of patient data.
Murad and Bari 2004203 Retrospective review of patient data.
Obwegeser et al. 1999386 Not a full-length peer-reviewed publication.
Ohlinger et al. 2004387 Did not report any of the outcomes of interest.
Ozdemir et al. 2004388 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Ozdemir et al. 2004389 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Ozdemir et al. 2001390 Did not study the technology of interest-- experimental methods.
Ozdemir et al. 1997391 Only data from patients referred for surgery or biopsy were reported. Number of patients initially enrolled in the study is not reported. Results of the ultrasound exam may have influenced the decision to refer for surgery/biopsy.
Pamilo et al. 1991392 Does not describe what reference standard was used.
Park et al. 2003393 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Peters-Engl et al. 1998394 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Peters-Engl et al. 1994395 Did not study the technology of interest-- experimental methods.
Pillsbury et al. 2005396 Retrospective review of patient data.
Pinero et al. 2003397 Did not study the technology of interest-- experimental methods.
Pritt et al. 2004398 Retrospective review of patient data.
Puglisi et al. 2003399 Pooled the results of US and mammography into a single diagnosis.
Rahbar et al. 1999202 Retrospective review of patient data.
Ramlau and Sledzikowski 1993400 Did not study the technology of interest-- experimental methods.
Ranieri et al. 1997401 Fewer than 85% were evaluated by biopsy.
Raza and Baum 1997402 Only data from patients referred for surgery or biopsy were reported. Number of patients initially enrolled in the study is not reported. Results of the ultrasound exam may have influenced the decision to refer for surgery/biopsy.
Reinikainen et al. 2001403 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Richter 1995404 Did not study the technology of interest-- experimental methods.
Richter 1996405 Did not study the technology of interest-- experimental methods.
Richter and Heywang-Kobrunner 1995406 Did not study the technology of interest-- experimental methods.
Richter and Kobrunner 1995407 Did not study the technology of interest-- experimental methods.
Richter et al. 1997408 Did not study the technology of interest-- experimental methods.
Rosen and Soo 2001409 Fewer than 85% were evaluated by biopsy.
Rubin et al. 2001410 Retrospective review of patient data.
Saarenmaa et al. 2001411 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Sahin-Akyar and Sumer 1996412 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Saitoh et al. 1994413 Only data from patients referred for surgery or biopsy were reported. Number of patients initially enrolled in the study is not reported. Results of the ultrasound exam may have influenced the decision to refer for surgery/biopsy.
Schelling et al. 1997414 Did not report any of the outcomes of interest.
Schroeder et al. 1999415 Fewer than 85% were evaluated by biopsy.
Schutze et al. 1998416 Fewer than 85% were evaluated by biopsy, and results of the ultrasound exam influenced the decision to perform biopsy.
Sehgal et al. 2004417 Retrospective review of patient data.
Selinko et al. 2004418 Retrospective review of patient data.
Seo et al. 2002419 Fewer than 85% were evaluated by biopsy.
Shetty et al. 2003420 Fewer than 85% were evaluated by biopsy.
Shimamoto et al. 1998206 Retrospective review of patient data.
Skaane 1999421 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Skaane 1999186 Retrospective review of patient data.
Skaane and Sauer 1999422 Retrospective review of patient data.
Skaane et al. 1997204 Retrospective review of patient data.
Skanne and Skjorten 1999423 Retrospective review of patient data.
Skanne et al. 1999424 Retrospective review of patient data.
Snelling et al. 2004425 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Spreafico et al. 1994426 Did not study the population of interest. Only enrolled patients with a palpable mass that was not visible on ultrasound.
Stavros et al. 1995427 Did not study the population of interest. Some patients were only enrolled because of prior positive findings by ultrasound. Only reported data for patients with solid, visible lesions on ultrasound. Unknown how many patients were originally examined.
Steinberg et al. 2001428 Did not study the technology of interest-- experimental methods.
Szopinski et al. 2003429 Did not study the technology of interest-- experimental methods.
Tavassoli et al. 1997430 Does not describe what reference standard was used.
Taylor et al. 2002431 Pooled the results of US and mammography into a single diagnosis.
Tohnosu et al. 1993432 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Vetto et al. 1996433 Fewer than 85% were evaluated by biopsy.
Wang et al. 2002434 Did not study the population of interest-- screening study of women with dense breasts.
Whitehouse et al. 2001435 Fewer than 85% were evaluated by biopsy.
Whitehouse et al. 2001436 Meeting abstract. Not a full-length peer-reviewed publication.
Wilkens et al. 1998437 Did not study the population of interest. An unspecified number of patients were only enrolled because of prior positive findings by ultrasound.
Wright et al. 1998438 Does not describe what reference standard was used.
Yang and Metreweli 1996439 Did not report any of the outcomes of interest.
Yang and Tse 2004440 Retrospective review of patient data.
Yang et al. 1997441 Did not report any of the outcomes of interest.
Yang et al. 2001442 Did not study the technology of interest-- experimental methods.
Yang et al. 1996443 Fewer than 85% were evaluated by biopsy.
Youssefzadeh et al. 1996444 Did not study the technology of interest-- experimental methods.
Zonderland et al. 1999445 Fewer than 85% were evaluated by biopsy, and results of the ultrasound exam influenced the decision to perform biopsy.

Table 26Studies of Multiple Imaging Technologies that Did Not Meet the Inclusion Criteria

StudyReason
Bagni et al. 2003446 Fewer than 85% evaluated by biopsy.
Berg et al. 2004447 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Boetes et al. 1995448 Patients enrolled were of a mixed population, and data from the population of interest were not reported separately.
Hardy et al. 1990449 Fewer than 85% evaluated by biopsy.
Hata et al. 2004450 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.
Hlawatsch et al. 2002451 Patients enrolled were of a mixed population, and data from the population of interest were not reported separately.
Klaus et al. 2000127 Did not study the population of interest. Only enrolled patients with prior positive findings by ultrasound.
Leinsinger et al. 2001452 Patients enrolled were of a mixed population, and data from the population of interest were not reported separately.
Liang et al. 2003453 Did not report any of the outcomes of interest.
Malur et al. 2001454 Retrospective review of patient data.
Muller-Schimpfle et al. 1997455 Retrospective review of patient data.
Rieber et al. 2002456 Fatally confounded. Results of the imaging exams were used to change or direct the surgical procedure for some of the patients, increasing the chances that the biopsy results matched the PET results.
Sommer et al. 1997457 Duplicate publication of data reported in Tiling et al.95
Tiling et al. 1998458 Retrospective review of patient data.
Wang et al. 2002459 Did not study the population of interest-- screening study of women with dense breasts.
Yang et al. 1997460 Did not study the population of interest. Enrolled only patients with confirmed breast cancer.

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