The ACR BI-RADS® Experience: Learning From History
2009; Elsevier BV; Volume: 6; Issue: 12 Linguagem: Inglês
10.1016/j.jacr.2009.07.023
ISSN1558-349X
AutoresElizabeth S. Burnside, Edward A. Sickles, Lawrence W. Bassett, Daniel L. Rubin, Cheng‐Han Lee, Debra M. Ikeda, Ellen B. Mendelson, Pamela Wilcox, Priscilla F. Butler, Carl J. D’Orsi,
Tópico(s)Radiation Dose and Imaging
ResumoThe Breast Imaging Reporting and Data System® (BI-RADS®) initiative, instituted by the ACR, was begun in the late 1980s to address a lack of standardization and uniformity in mammography practice reporting. An important component of the BI-RADS initiative is the lexicon, a dictionary of descriptors of specific imaging features. The BI-RADS lexicon has always been data driven, using descriptors that previously had been shown in the literature to be predictive of benign and malignant disease. Once established, the BI-RADS lexicon provided new opportunities for quality assurance, communication, research, and improved patient care. The history of this lexicon illustrates a series of challenges and instructive successes that provide a valuable guide for other groups that aspire to develop similar lexicons in the future. The Breast Imaging Reporting and Data System® (BI-RADS®) initiative, instituted by the ACR, was begun in the late 1980s to address a lack of standardization and uniformity in mammography practice reporting. An important component of the BI-RADS initiative is the lexicon, a dictionary of descriptors of specific imaging features. The BI-RADS lexicon has always been data driven, using descriptors that previously had been shown in the literature to be predictive of benign and malignant disease. Once established, the BI-RADS lexicon provided new opportunities for quality assurance, communication, research, and improved patient care. The history of this lexicon illustrates a series of challenges and instructive successes that provide a valuable guide for other groups that aspire to develop similar lexicons in the future. The Breast Imaging Reporting and Data System® (BI-RADS®), the first practice management system developed for imaging, is called a system because it contains several important components, including 1) a lexicon of descriptors, 2) a recommended reporting structure including final assessment categories with accompanying management recommendations, and 3) a framework for data collection and auditing. In this paper, we focus on the development of the lexicon within BI-RADS, but we also consider important aspects of the system as a whole when indicated. As mammography utilization increased in the 1980s, wide variability of practices, including disparate quality and inconsistent radiation doses, were cited as substantial problems [1McLelland R. Mammography 1984: challenge to radiology.AJR Am J Roentgenol. 1984; 143: 1-4Crossref PubMed Scopus (10) Google Scholar, 2Galkin B.M. Feig S.A. Muir H.D. The technical quality of mammography in centers participating in a regional breast cancer awareness program.Radiographics. 1988; 8: 133-145PubMed Google Scholar, 3Conway B.J. McCrohan J.L. Rueter F.G. Suleiman O.H. Mammography in the eighties.Radiology. 1990; 177: 335-339PubMed Google Scholar]. Organizations such as the American Medical Association also asserted that mammography reports too often contained unintelligible descriptions and ambiguous recommendations [4Scott W. Establishing mammographic criteria for recommending surgical biopsy. American Medical Association, Chicago, Ill1989Google Scholar]. In response, the ACR convened a committee of radiologists, medical physicists, and a US Food and Drug Administration (FDA) representative to develop a voluntary mammography accreditation program in 1986 [5McLelland R. Hendrick R.E. Zinninger M.D. Wilcox P.A. The American College of Radiology Mammography Accreditation Program.AJR Am J Roentgenol. 1991; 157: 473-479Crossref PubMed Scopus (82) Google Scholar]. The ACR recognized that meaningful descriptors of findings and the precise communication of recommendations in mammography reports were important parts of a quality assurance program. Thus, a separate ACR committee also was charged with drafting guidelines on mammography reporting and management under the title of the Breast Imaging Reporting and Data System [6D'Orsi C.J. Kopans D.B. Mammography interpretation: the BI-RADS® method.Am Fam Physician. 1997; 55 (52): 1548-1550PubMed Google Scholar]. Many well-respected groups, including the American Medical Association, the National Cancer Institute, the Centers for Disease Control and Prevention, the FDA, the American College of Surgeons, and the College of American Pathologists, participated in this development initiative to establish a broad base of support [6D'Orsi C.J. Kopans D.B. Mammography interpretation: the BI-RADS® method.Am Fam Physician. 1997; 55 (52): 1548-1550PubMed Google Scholar]. The inclusion of diverse stakeholders in the development process helped promote consensus and facilitated acceptance. The first version of BI-RADS included recommendations for the conduct of mammographic imaging, an overall structure for mammography reports, final assessment categories with management recommendations, and a mammography lexicon. The introduction of the document outlined the recommended method to provide efficient and cost-effective mammography: screening mammography, which can be performed without an interpreting physician in attendance (batch reading) to optimize efficiency; and diagnostic mammography, which should be performed with “direct supervision” so that examinations can be tailored to individual patients. Direct supervision is defined as a physician's being present and immediately available to furnish assistance and direction throughout the performance of the procedure. Direct supervision may also be accomplished “via telemammography as long as the interpreting physician is immediately available” [7American College of RadiologyACR practice guideline for the performance of screening and diagnostic mammography.in: Practice guidelines and technical standards. American College of Radiology, Reston, Va2008: 525-534Google Scholar]. These guidelines clarified the optimal practice of mammography services for radiologists, referring physicians, and patients. The original BI-RADS document also described the overall structure of the breast imaging report, which included a summary of breast density, a description of significant findings (using appropriate descriptors as well as size and location), and a final assessment and management section. The inclusion of a statement describing the general breast tissue type arose from evidence in the literature establishing that increased breast density is accompanied by decreased sensitivity [8Fajardo L.L. Hillman B.J. Frey C. Correlation between breast parenchymal patterns and mammographers' certainty of diagnosis.Invest Radiol. 1988; 23: 505-508Crossref PubMed Scopus (40) Google Scholar, 9van Gils C.H. Otten J.D. Verbeek A.L. Hendriks J.H. Holland R. Effect of mammographic breast density on breast cancer screening performance: a study in Nijmegen, the Netherlands.J Epidemiol Community Health. 1998; 52: 267-271Crossref PubMed Scopus (101) Google Scholar, 10Mandelson M.T. Oestreicher N. Porter P.L. et al.Breast density as a predictor of mammographic detection: comparison of interval- and screen-detected cancers.J Natl Cancer Inst. 2000; 92: 1081-1087Crossref PubMed Scopus (857) Google Scholar, 11Mann B.D. Giuliano A.E. Bassett L.W. Barber M.S. Hallauer W. Morton D.L. Delayed diagnosis of breast cancer as a result of normal mammograms.Arch Surg. 1983; 118: 23-24Crossref PubMed Scopus (81) Google Scholar]. Subsequently, evidence has mounted that increased breast density also is associated with increased breast cancer risk [12Hainline S. Myers L. McLelland R. Newell J. Grufferman S. Shingleton W. Mammographic patterns and risk of breast cancer.AJR Am J Roentgenol. 1978; 130: 1157-1158Crossref PubMed Scopus (41) Google Scholar, 13Carlile T. Kopecky K.J. Thompson D.J. et al.Breast cancer prediction and the Wolfe classification of mammograms.JAMA. 1985; 254: 1050-1053Crossref PubMed Scopus (51) Google Scholar, 14Whitehead J. Carlile T. Kopecky K.J. et al.Wolfe mammographic parenchymal patterns A study of the masking hypothesis of Egan and Mosteller.Cancer. 1985; 56: 1280-1286Crossref PubMed Scopus (64) Google Scholar]. Although these hypotheses are still active areas of research, the inclusion of 4 categories describing breast density (ranging from the almost entirely fatty breast to the extremely dense breast) in the standard mammography report is designed to improve the communication of predicted mammographic performance and breast cancer risk. The descriptors in the BI-RADS lexicon were selected on the basis of their ability to discriminate between benign and malignant findings as determined by well-designed reader studies. These studies suggested that feature lists containing predictive descriptors could improve diagnostic accuracy. In the first study, investigators developed a decision aid consisting of predictive terms and scales used to assess xeroradiography and reported increased decision-making accuracy in a small reader study [15Getty D.J. Pickett R.M. D'Orsi C.J. Swets J.A. Enhanced interpretation of diagnostic images.Invest Radiol. 1988; 23: 240-252Crossref PubMed Scopus (143) Google Scholar]. These early features were then adapted to screen-film mammography and studied in a larger reader study of 150 cases and 6 radiologists [16Swets J.A. Getty D.J. Pickett R.M. D'Orsi C.J. Seltzer S.E. McNeil B.J. Enhancing and evaluating diagnostic accuracy.Med Decis Making. 1991; 11: 9-18Crossref PubMed Scopus (102) Google Scholar, 17D'Orsi C.J. Getty D.J. Swets J.A. Pickett R.M. Seltzer S.E. McNeil B.J. Reading and decision aids for improved accuracy and standardization of mammographic diagnosis.Radiology. 1992; 184: 619-622Crossref PubMed Scopus (61) Google Scholar]. These initial studies helped refine the feature lists and led to the development of computer programs to improve both sensitivity and specificity. Furthermore, careful cataloging of descriptors significantly improved performance as case difficulty increased and brought generalist performance to the level of the mammography specialist [16Swets J.A. Getty D.J. Pickett R.M. D'Orsi C.J. Seltzer S.E. McNeil B.J. Enhancing and evaluating diagnostic accuracy.Med Decis Making. 1991; 11: 9-18Crossref PubMed Scopus (102) Google Scholar, 17D'Orsi C.J. Getty D.J. Swets J.A. Pickett R.M. Seltzer S.E. McNeil B.J. Reading and decision aids for improved accuracy and standardization of mammographic diagnosis.Radiology. 1992; 184: 619-622Crossref PubMed Scopus (61) Google Scholar]. The studies also guided the development of descriptors in the original BI-RADS lexicon. Once the terms were chosen, they were precisely defined to eliminate ambiguity. The final list of terms was intended to be evidence based and predictive and to foster the clear and accurate communication of mammographic findings. The BI-RADS Committee went beyond advocating the use of clear and standardized terms and recommended that mammography be “decision oriented.” During the early days of mammography, the American Medical Association specifically complained that mammography interpretation was often indecisive and confusing [4Scott W. Establishing mammographic criteria for recommending surgical biopsy. American Medical Association, Chicago, Ill1989Google Scholar]. In response, the BI-RADS Committee recommended that final impressions be summarized by choosing only one among several standardized final assessment categories at the end of a report, each of which included a matched, also standardized management recommendation. These categories currently are as follows: category 1: negative; category 2: benign finding(s); category 3: probably benign finding—initial short-interval follow-up suggested; category 4: suspicious abnormality—biopsy should be considered; category 5: highly suggestive of malignancy—appropriate action should be taken; and category 6: known biopsy-proven malignancy—appropriate action should be taken. An incomplete category was also provided, category 0: need additional imaging evaluation and/or prior mammograms for comparison. These categories also took an evidence-based approach. The “probably benign” category was based on literature demonstrating that follow-up rather than biopsy is safe and effective management for a clearly defined subset of findings that are very likely benign [18Sickles E.A. Periodic mammographic follow-up of probably benign lesions: results in 3,184 consecutive cases.Radiology. 1991; 179: 463-468PubMed Google Scholar]. The final assessment of “highly suggestive for malignancy” was included at the request of representatives of the American College of Surgeons. Thus, the “highly suggestive” category implied a “classic” finding for malignancy, which enabled women living in underserved areas (without expertise in image-guided diagnosis) to be scheduled for operative diagnosis, using frozen section, and immediate surgical management. Concurrent with the development of the BI-RADS lexicon, the mammography community was recognizing the importance of automating clinical practice for a variety of mission critical reasons. First, as a population-based initiative, screening mammography involves the management of a substantial amount of data. Second, the conduct of medical audits to ensure optimal performance and fulfill compliance requirements is onerous if performed manually. Third, optimal tracking for the accurate communication of results requires reliable and reproducible data storage and retrieval. Automated, computer-based management and tracking of mammography results addressed these challenges more efficiently than conventional manual methods [19Sickles E.A. The usefulness of computers in managing the operation of a mammography screening practice.AJR Am J Roentgenol. 1990; 155: 755-761Crossref PubMed Scopus (19) Google Scholar, 20Monticciolo D.L. Sickles E.A. Computerized follow-up of abnormalities detected at mammography screening.AJR Am J Roentgenol. 1990; 155: 751-753Crossref PubMed Scopus (29) Google Scholar]. The explosive increase in data was not unique to breast imaging practices during the late 1980s. The entire biomedical infrastructure was straining under the increases in data inherent in clinical care and research. There were other, more general efforts to standardize biomedical terminology that paralleled the construction of the BI-RADS mammography lexicon. For example, the Unified Medical Language System (UMLS) was designed and constructed by the National Library of Medicine in 1986 to enhance access to medical data and the scientific literature. The UMLS provides the infrastructure to collect and link controlled vocabularies to facilitate the development of computer systems that understand, retrieve, and classify biomedical literature. The National Library of Medicine itself uses components of UMLS for its PubMed system. The UMLS, a powerful tool to enable computers to communicate about biomedical data generally, parallels BI-RADS, which provides the same capabilities in the domain of breast imaging. BI-RADS in general and the lexicon specifically were not intended to be static [6D'Orsi C.J. Kopans D.B. Mammography interpretation: the BI-RADS® method.Am Fam Physician. 1997; 55 (52): 1548-1550PubMed Google Scholar]. After the initial creation of BI-RADS in 1993 [21American College of RadiologyBreast Imaging Reporting and Data System® (BI-RADS®). American College of Radiology, Reston, Va1992Google Scholar], 3 more editions were created in 1995 [22American College of RadiologyBreast Imaging Reporting and Data System® (BI-RADS®).2nd ed. American College of Radiology, Reston, Va1995Google Scholar], 1998 [23American College of RadiologyBreast Imaging Reporting and Data System® (BI-RADS®).3rd ed. American College of Radiology, Reston, Va1998Google Scholar], and 2003 [24American College of RadiologyBreast Imaging Reporting and Data System® (BI-RADS®).4th ed. American College of Radiology, Reston, Va2003Google Scholar]. However, the path to a successfully adopted breast imaging lexicon was not always smooth. Controversy involving the BI-RADS lexicon arose in 1994 with the publication of an editorial in which the author contested that “expertise is the heart of the problem, not terminology. BI-RADS, with its emphasis on words and definitions, is barking up the wrong tree” [25Heilbrunn K.S. The American College of Radiology's mammography lexicon: barking up the wrong tree?.AJR Am J Roentgenol. 1994; 162: 593-594Crossref PubMed Scopus (18) Google Scholar]. The authors of the BI-RADS lexicon responded in a follow-up editorial that addressed many concerns that were being voiced by the community. In particular, the response clarified that the BI-RADS lexicon was intended to be a tool that radiologists would use to communicate with clinicians to convey concise and orderly descriptions of findings in understandable, standardized language, which in turn contributes to an orderly thought process and logical assessments and recommendations. Furthermore, BI-RADS was designed to encourage improvements in expertise because it provided standardized recommendations that could be used for performance tracking: “Without standardized terms to describe important features…there is no means of obtaining objective data to improve. Indeed, this format is important for all reports we generate, not only mammography” [26D'Orsi C.J. Kopans D.B. The American College of Radiology's mammography lexicon: barking up the only tree.AJR Am J Roentgenol. 1994; 162: 595Crossref PubMed Scopus (18) Google Scholar]. This thoughtful and productive debate strengthened support for the lexicon. Each BI-RADS revision added components that were important for clarification, management, or quality assurance. The third edition of BI-RADS incorporated an atlas that provided an artist's renderings of examples of each descriptor. The fourth edition made several changes in lexicon terminology [27D'Orsi C.J. Newell M.S. BI-RADS® decoded: detailed guidance on potentially confusing issues.Radiol Clin North Am. 2007; 45: 751-763Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar]. To decrease confusion between terminology for overall breast density and the descriptor density (referring to a noncalcified finding seen on only one of the two standard mammographic views), the authors adopted the descriptor term asymmetry in place of density. To parallel this change in terminology, asymmetric breast tissue was renamed global asymmetry (a nonmass finding seen on at least two views that occupies at least a quadrant), and focal asymmetric density was renamed focal asymmetry (a nonmass finding seen on at least two views that occupies less than a quadrant). Furthermore, a study demonstrating that amorphous microcalcifications carried a 20% risk for malignancy [28Berg W.A. Arnoldus C.L. Teferra E. Bhargavan M. Biopsy of amorphous breast calcifications: pathologic outcome and yield at stereotactic biopsy.Radiology. 2001; 221: 495-503Crossref PubMed Scopus (126) Google Scholar] prompted the BI-RADS Committee to subcategorize suspicious microcalcification descriptors into “intermediate risk” (including the amorphous descriptor) and “higher probability of malignancy.” Additional published data related to microcalcification descriptors demonstrated that the pleomorphic descriptor was not stratifying risk beyond the overall risk for suspicious microcalcifications [29Liberman L. Abramson A.F. Squires F.B. Glassman J.R. Morris E.A. Dershaw D.D. The Breast Imaging Reporting and Data System: positive predictive value of mammographic features and final assessment categories.AJR Am J Roentgenol. 1998; 171: 35-40Crossref PubMed Scopus (380) Google Scholar]. In response, the BI-RADS Committee divided “pleomorphic” microcalcifications into two more specific categories: “coarse heterogeneous” and “fine pleomorphic.” This distinction was subsequently shown to effectively stratify the probability of malignancy among these types of calcifications [30Burnside E.S. Ochsner J.E. Fowler K.J. et al.Use of microcalcification descriptors in BI-RADS® 4th edition to stratify risk of malignancy.Radiology. 2007; 242: 388-395Crossref PubMed Scopus (150) Google Scholar]. To further help with risk stratification, the fourth edition provided the option to subdivide BI-RADS assessment category 4 into 4A (low suspicion for malignancy), 4B (intermediate suspicion for malignancy), and 4C (moderate concern but not classic for malignancy). These subdivisions provide assessment and reporting options designed to help both physicians and patients understand likely biopsy findings and probable follow-up recommendations [27D'Orsi C.J. Newell M.S. BI-RADS® decoded: detailed guidance on potentially confusing issues.Radiol Clin North Am. 2007; 45: 751-763Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar, 31Lazarus E. Mainiero M.B. Schepps B. Koelliker S.L. Livingston L.S. BI-RADS lexicon for US and mammography: interobserver variability and positive predictive value.Radiology. 2006; 239: 385-391Crossref PubMed Scopus (394) Google Scholar]. The development of a breast ultrasound lexicon, BI-RADS–Ultrasound, first published as part of the fourth edition of BI-RADS, demonstrated similar themes. In 1998, the ACR received a grant from the Office on Women's Health of the US Department of Health and Human Services to support protocol development for research in breast ultrasound (contract 282-97-0076, Federal Technology Transfer Program to Advance Novel Breast Imaging Technologies, US Public Health Service, Office on Women's Health, Department of Health and Human Services). An ACR expert working group of national and international breast imagers with special interest in breast ultrasound met in Maine to design research projects that might advance use of ultrasound in conjunction with mammography and other imaging modalities. These potential studies included 1) the identification of criteria to differentiate benign from malignant solid masses, 2) ultrasound for breast cancer screening, and 3) using ultrasound to guide diagnostic interventions and as a therapeutic agent (high-frequency ultrasound). Until that time, ultrasound was used primarily for cyst-solid differentiation, despite FDA premarket approval of Advanced Technology Laboratories' (Bothell, Washington; now Philips Medical Systems, Andover, Massachusetts) “high-definition imaging” in 1996. This approval was based on an international, multicenter study involving ultrasound evaluation of nearly 1,000 breast lesions (published as a monograph by Advanced Technology Laboratories rather than in the peer-reviewed literature), which indicated that ultrasound improved specificity for masses found to be indeterminate on mammography and physical examination. This study asserted the need for additional research in defining diagnostic criteria for classifying solid breast masses on ultrasound. The ACR expert working group proposed a standardized lexicon, similar to BI-RADS for mammography, to provide a foundation for research characterizing solid masses for risk stratification and evidence-based management. For example, this strictly defined lexicon could be used to determine benign and probably benign masses. Soon after the Maine meeting, a subcommittee of the ACR's BI-RADS Committee was formed to officially develop BI-RADS–Ultrasound. After several iterations, the consensus document was presented and tested at select subspecialty meetings, including the Society of Breast Imaging's biennial meeting in San Diego in 2001. The descriptors and assessment categories were validated by statistical analysis of interobserver consistency (κ), showing good agreement for most terms among the experienced and novice breast imaging participants [31Lazarus E. Mainiero M.B. Schepps B. Koelliker S.L. Livingston L.S. BI-RADS lexicon for US and mammography: interobserver variability and positive predictive value.Radiology. 2006; 239: 385-391Crossref PubMed Scopus (394) Google Scholar]. BI-RADS–Ultrasound was predicated on high-quality images and real-time ultrasound observations and encourages the assessment of combined features. Using descriptors from several feature categories can balance the risk associated with all relevant features, but usually, the most suspicious feature will dominate the final assessment and recommendation [32Mendelson E.B. Berg W.A. Merritt C.R. Toward a standardized breast ultrasound lexicon, BI-RADS: ultrasound.Semin Roentgenol. 2001; 36: 217-225Abstract Full Text PDF PubMed Scopus (117) Google Scholar]. Validation of the grouping of features is derived from univariate, bivariate, and multivariate analyses of features characterizing the lesions submitted as evidence for FDA premarket approval by Advanced Technology Laboratories for its high-definition imaging system. Groups of features were also used in the development of the mass classification algorithm proposed by Stavros et al [33Stavros A.T. Thickman D. Rapp C.L. Dennis M.A. Parker S.H. Sisney G.A. Solid breast nodules: use of sonography to distinguish between benign and malignant lesions.Radiology. 1995; 196: 123-134PubMed Google Scholar]. For BI-RADS–Ultrasound, the three most important feature categories, taken together are shape, margin, and orientation, the last a feature unique to ultrasound. BI-RADS–Ultrasound can also contribute to the investigation of emerging technologies. Computer-assisted diagnosis programs use segmentation and feature extraction to classify breast masses on the basis of features similar to BI-RADS–Ultrasound. Structured reporting, rapidly evolving and currently available in breast imaging reporting software packages initially designed for mammography, uses BI-RADS-Ultrasound to construct standardized reports and encourage consistent communication. The development of BI-RADS–Ultrasound that began more than a decade ago will continue. New feature categories (eg, elasticity) will require standardization, evidence, and validation. The continuing goals for BI-RADS of providing useful, comprehensive guides to breast imagers for analyzing, assessing, reporting, and managing breast lesions is especially critical for breast ultrasound, which has long been considered an operator-dependent modality. The fourth edition of BI-RADS also incorporated breast MRI descriptors. Between the early 1970s and the late 1990s, contrast-enhanced breast MRI had shown great promise. Studies demonstrated near 100% sensitivity for detecting early invasive breast cancer, though these results were tempered by more modest specificity [34Stomper P.C. Herman S. Klippenstein D.L. et al.Suspect breast lesions: findings at dynamic gadolinium-enhanced MR imaging correlated with mammographic and pathologic features.Radiology. 1995; 197: 387-395PubMed Google Scholar]. However, attempts to systematically evaluate the literature were stymied by nonuniform approaches to image acquisition and reporting. Variable magnet field strength, hardware, pulse sequences, and lesion characterization (including both morphologic and kinetic data) led to freedom of innovation but also impeded consensus development. A Web-based survey of the members of the Society of Breast Imaging conducted from September 2006 to January 2007 showed that poorly standardized breast MRI protocols were a serious problem [35Bassett L.W. Dhaliwal S.G. Eradat J. et al.National trends and practices in breast MRI.AJR Am J Roentgenol. 2008; 191: 332-339Crossref PubMed Scopus (94) Google Scholar]. Of 551 responding facilities, 84% indicated they never or rarely would interpret contrast-enhanced breast MRI examinations performed at other facilities because of protocol variability. Recognizing a clear need to achieve consensus on MRI acquisition techniques and lesion terminology, the Public Health Service's Office on Women's Health funded the International Working Group for Breast MRI in 1997. This group's goal was to disseminate evidence-based consensus on the performance and interpretation of breast MRI. A subset of the international working group, the Lesion Diagnosis Working Group, composed of internationally recognized breast MRI investigators, was charged with developing a standardized breast MRI lexicon and reporting system [36Ikeda D.M. Progress report from the American College of Radiology Breast MR Imaging Lexicon Committee.Magn Reson Imaging Clin North Am. 2001; 9: 295-302PubMed Google Scholar]. This group later became the Subcommittee on MRI Lexicon Breast Cancer. In 1998, the Lesion Diagnosis Working Group developed minimum reporting standards on MRI scanning techniques, region-of-interest kinetic curve acquisition, lesion architecture, and kinetic curve interpretation. These experts used the breast MRI literature to compile the most important descriptors for lesion diagnosis that would prompt specific patient management recommendations, such as biopsy. The morphologic descriptors were based on terms used in the BI-RADS mammography lexicon, when appropriate, to facilitate use and adoption in clinical practice. After the development of the preliminary breast MRI lexicon, this group performed several reader studies (funded by the National Cancer Institute, the Susan G. Komen Breast Cancer Foundation, and the ACR) to evaluate the reproducibility of these descriptors for the characterization of biopsy-proven MRI abnormalities [37Ikeda D.M. Hylton N.M. Kinkel K. et al.Development, standardization, and testing of a lexicon for reporting contrast-enhanced breast magnetic resonance imaging studies.J Magn Reson Imaging. 2001; 13: 889-895Crossref PubMed Scopus (225) Google Scholar]. Using the results of each study, portions of the lexicon were expanded and others eliminated in a stepwise, progressive manner. Optimization and testing of the lexicon continued for a period of 6 years, resulting in BI-RADS–MRI, first published in the fourth edition of BI-RADS in 2003 [24American College of RadiologyBreast Imaging Reporting and Data System® (BI-RA
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