Protocol for the development of a core outcome set and reporting guidelines for locoregional treatment in neoadjuvant systemic breast cancer treatment trials: the PRECEDENT project.

INTRODUCTION: Neoadjuvant systemic anticancer therapy (neoSACT) is increasingly used in the treatment of early breast cancer. Response to therapy is prognostic and allows locoregional and adjuvant systemic treatments to be tailored to minimise morbidity and optimise oncological outcomes and quality of life. Accurate information about locoregional treatments following neoSACT is vital to allow the translation of downstaging benefits into practice and facilitate meaningful interpretation of oncological outcomes, particularly locoregional recurrence. Reporting of locoregional treatments in neoSACT studies, however, is currently poor. The development of a core outcome set (COS) and reporting guidelines is one strategy by which this may be improved. METHODS AND ANALYSIS: A COS for reporting locoregional treatment (surgery and radiotherapy) in neoSACT trials will be developed in accordance with Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development guidelines. Reporting guidance will be developed concurrently.The project will have three phases: (1) generation of a long list of relevant outcome domains and reporting items from a systematic review of published neoSACT studies and interviews with key stakeholders. Identified items and domains will be categorised and formatted into Delphi consensus questionnaire items. (2) At least two rounds of an international online Delphi survey in which at least 250 key stakeholders (surgeons/oncologists/radiologists/pathologists/trialists/methodologists) will score the importance of reporting each outcome. (3) A consensus meeting with key stakeholders to discuss and agree the final COS and reporting guidance. ETHICS AND DISSEMINATION: Ethical approval for the consensus process will be obtained from the Queen's University Belfast Faculty Ethics Committee. The COS/reporting guidelines will be presented at international meetings and published in peer-reviewed journals. Dissemination materials will be produced in collaboration with our steering group and patient advocates so the results can be shared widely. REGISTRATION: The study has been prospectively registered on the COMET website (https://www.comet-initiative.org/Studies/Details/2854).

Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP.

PURPOSE: The Standardized Definitions for Efficacy End Points (STEEP) criteria, established in 2007 and updated in 2021 (STEEP 2.0), provide standardized definitions of adjuvant breast cancer (BC) end points. STEEP 2.0 identified a need to separately address end points for neoadjuvant clinical trials. The multidisciplinary NeoSTEEP working group of experts was convened to critically evaluate and align neoadjuvant BC trial end points. METHODS: The NeoSTEEP working group concentrated on neoadjuvant systemic therapy end points in clinical trials with efficacy outcomes-both pathologic and time-to-event survival end points-particularly for registrational intent. Special considerations for subtypes and therapeutic approaches, imaging, nodal staging at surgery, bilateral and multifocal diseases, correlative tissue collection, and US Food and Drug Administration regulatory considerations were contemplated. RESULTS: The working group recommends a preferred definition of pathologic complete response (pCR) as the absence of residual invasive cancer in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0 per AJCC staging). Residual cancer burden should be a secondary end point to facilitate future assessment of its utility. Alternative end points are needed for hormone receptor-positive disease. Time-to-event survival end point definitions should pay particular attention to the measurement starting point. Trials should include end points originating at random assignment (event-free survival and overall survival) to capture presurgery progression and deaths as events. Secondary end points adapted from STEEP 2.0, which are defined from starting at curative-intent surgery, may also be appropriate. Specification and standardization of biopsy protocols, imaging, and pathologic nodal evaluation are also crucial. CONCLUSION: End points in addition to pCR should be selected on the basis of clinical and biologic aspects of the tumor and the therapeutic agent investigated. Consistent prespecified definitions and interventions are paramount for clinically meaningful trial results and cross-trial comparison.

An Upstream Reparative Justice Framework for Improving Diversity in Radiology.

Health care workforce diversity is vital in combating health disparities. Despite much recent attention to downstream strategies to improve diversity in radiology, such as increased recruitment efforts and holistic application review, workforce diversity has not tangibly improved in recent decades. Yet, little discussion has been devoted to defining the obstacles that might delay, complicate, or altogether prevent persons from groups that have been traditionally marginalized and minoritized from a career in radiology. Refocusing attention to upstream barriers to medical education is vital to develop sustainable workforce diversity efforts in radiology. The purpose of this article is to highlight the varied obstacles students and trainees from historically underrepresented communities may face along the radiology career pathway and to provide concrete corollary programmatic solutions. Using a reparative justice framework, which encourages race- and gender-conscious repair of historical injustices, and the socioecological model, which recognizes an individual's choices are informed by historical and ongoing systems of power, this article advocates for tailored programs to improve justice, equity, diversity, and inclusion in radiology.

Multisite Implementation of Radiology-TEACHES (Technology-Enhanced Appropriateness Criteria Home for Education Simulation).

PURPOSE: After encouraging results from a single-institution pilot, a novel case-based education portal using integrated clinical decision support at the simulated point of order entry was implemented at multiple institutions to evaluate whether the program is scalable and results transferable. The program was designed to fill key health systems' science gaps in traditional medical education curricula, ultimately aiding the transition from volume to value in health care. The module described uses commonly encountered medical vignettes to provide learners with a low-stakes educational environment to improve their awareness and apply curricular content regarding appropriate resource utilization, patient safety, and cost. METHODS: In 2016 and 2017, the team implemented the modules at eight US medical schools. A total of 199 learners participated in this institutional review board-approved study; 108 completed the module, and 91 were in the control group. RESULTS: The module group had higher posttest scores than their control group peers, after controlling for pretest scores (ß = 4.05, P < .001). The greatest knowledge gains were on questions related to chest radiography (22% improvement) and adnexal cysts (20.33% improvement) and the least on items related to pulmonary embolism (0.33% improvement). The majority of learners expressed satisfaction with the educational content provided (70.4%) and an increased perception to appropriately select imaging studies (65.2%). CONCLUSIONS: This program is promising as a standardized educational resource for widespread implementation in developing health systems science curricula. Learners at multiple institutions judged this educational resource as valuable and, through this initiative, synthesized practice behaviors by applying evidence-based guidelines in a cost-effective, safe, and prudent manner.

Identifying Barriers to Building a Diverse Physician Workforce: A National Survey of the ACR Membership.

PURPOSE: The aim of this study was to identify potential barriers to building a diverse workforce in radiology and radiation oncology by conducting a national survey of physicians in these fields and studying their reported career experiences. METHODS: An electronic survey of ACR members (February 27, 2018, to April 26, 2018) was conducted in which physicians' attitudes about their work environment, relationships, and culture were queried. The aim was to determine if responses differed by gender or race/ethnicity. In total, 900 invitations were issued; women were oversampled with the goal of equal representation. Descriptive summaries (proportions of yes or no responses) were calculated per item, per subgroup of interest. Logistic regression analysis was used to identify significant associations between gender- and item-specific responses; it was not used in the race/ethnicity analysis because of the small sizes of many subgroups. RESULTS: The response rate was 51.2% (461 of 900). In total, 51.0% of respondents identified as women (235 of 461); the 9.5% (44 of 461) who identified as black or African American, Hispanic, or American Indian or Alaska Native were considered underrepresented minorities. Respondents' mean age was 40.2 ± 10.4 years. Subgroups varied most in their reporting of unfair or disrespectful treatment. Women were significantly more likely than men to report such treatment attributable to gender (50.6% versus 5.4%; odds ratio, 18.00; 95% confidence interval, 9.29-34.86; P < .001), and 27.9% of underrepresented minorities compared with 2.6% of white non-Hispanic respondents reported such treatment attributable to race/ethnicity. CONCLUSIONS: Women and underrepresented minorities disproportionately experience unfair or disrespectful treatment in the workplace. Addressing this problem is likely to be critically important for improving workforce diversity.

Gender Diversity in Academic Radiology Departments: Barriers and Best Practices to Optimizing Inclusion and Developing Women Leaders.

Gender diversity remains a challenge for radiology. As we aspire to embrace Diversity 3.0 and the goal of making diversity core to our organizations' mission, there must be increasing awareness of the barriers to achieving inclusion and to best practices for making diversity integral to achieving excellence. This article reviews the literature on gender diversity in radiology and in academic radiology leadership and discusses lessons learned from non-health-care industry and from academic radiology departments that have been successful in developing and supporting female employees.

Impact of Simulation-Based Training on Radiology Trainee Education in Ultrasound-Guided Breast Biopsies.

PURPOSE: The aim of this study is to determine the impact of a simulation-based ultrasound-guided (USG) breast biopsy training session on radiology trainee procedural knowledge, comfort levels, and overall procedural confidence and anxiety. METHODS: Twenty-one diagnostic radiology residents from a single academic institution were recruited to participate in an USG breast biopsy training session. The residents filled out a questionnaire before and after the training session. Ten multiple-choice questions tested general knowledge in diagnostic breast ultrasound and USG breast biopsy concepts. Subjective comfort levels with ultrasound machine and biopsy device functionality, patient positioning, proper biopsy technique, image documentation, needle safety and overall procedural confidence and anxiety levels were reported on a 5-point Likert scale before and after training. RESULTS: Participants demonstrated significant improvement in number of correctly answered general knowledge questions after training (P < .0001). Significant improvement was seen in resident comfort level in ultrasound machine functionality, patient positioning, biopsy device functionality, biopsy technique, image documentation, as well as overall confidence level (all P < .05). Participants indicated a slight but not significant reduction in anxiety levels (P = .27). CONCLUSIONS: A simulation-based USG breast biopsy training session may improve radiology trainee procedural knowledge, comfort levels, and overall procedural confidence.

Spindle cell lesions of the breast: Multimodality imaging and clinical differentiation of pathologically similar neoplasms.

Spindle cell lesions of the breast comprise a wide-range of entities including reactive, benign and malignant proliferations. They can be pathologically challenging to differentiate as there is often immunohistochemical and morphologic similarities with characteristic spindle shaped cellular patterns. Radiological and pathological correlation is essential. Radiology detects, defines the size and extent, and assists in localizing the lesions. Pathology confirms the diagnosis and provides prognostic parameters. Familiarity with the clinicoradiological features of these diagnostically challenging lesions helps to establish an accurate pathological diagnosis and subsequent clinical decision making.

ACR Appropriateness Criteria® Palpable Breast Masses.

Breast cancer is the most common female malignancy and the second leading cause of female cancer death in the United States. Although the majority of palpable breast lumps are benign, a new palpable breast mass is a common presenting sign of breast cancer. Any woman presenting with a palpable lesion should have a thorough clinical breast examination, but because many breast masses may not exhibit distinctive physical findings, imaging evaluation is necessary in almost all cases to characterize the palpable lesion. Recommended imaging options in the context of a palpable mass include diagnostic mammography and targeted-breast ultrasound and are dependent on patient age and degree of radiologic suspicion as detailed in the document Variants. There is little role for advanced technologies such as MRI, positron emission mammography, or molecular breast imaging in the evaluation of a palpable mass. When a suspicious finding is identified, biopsy is indicated. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

ACR Appropriateness Criteria® Breast Pain.

Breast pain (or tenderness) is a common symptom, experienced by up to 80% of women at some point in their lives. Fortunately, it is rarely associated with breast cancer. However, breast pain remains a common cause of referral for diagnostic breast imaging evaluation. Appropriate workup depends on the nature and focality of the pain, as well as the age of the patient. Imaging evaluation is usually not indicated if the pain is cyclic or nonfocal. For focal, noncyclic pain, imaging may be appropriate, mainly for reassurance and to identify treatable causes. Ultrasound can be the initial examination used to evaluate women under 30 with focal, noncyclic breast pain; for women 30 and older, diagnostic mammography, digital breast tomosynthesis, and ultrasound may all serve as appropriate initial examinations. However, even in the setting of focal, noncyclic pain, cancer as an etiology is rare. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer-reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

ACR Appropriateness Criteria® Stage I Breast Cancer: Initial Workup and Surveillance for Local Recurrence and Distant Metastases in Asymptomatic Women.

Women and health care professionals generally prefer intensive follow-up after a diagnosis of breast cancer. However, there are no survival differences between women who obtain intensive surveillance with imaging and laboratory studies compared with women who only undergo testing because of the development of symptoms or findings on clinical examinations. American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines state that annual mammography is the only imaging examination that should be performed to detect a localized breast recurrence in asymptomatic patients; more imaging may be needed if the patient has locoregional symptoms (eg, palpable abnormality). Women with other risk factors that increase their lifetime risk for breast cancer may warrant evaluation with breast MRI. Furthermore, the quality of life is similar for women who undergo intensive surveillance compared with those who do not. There is little justification for imaging to detect or rule out metastasis in asymptomatic women with newly diagnosed stage I breast cancer. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Role of Imaging in the Era of Precision Medicine.

Precision medicine is an emerging approach for treating medical disorders, which takes into account individual variability in genetic and environmental factors. Preventive or therapeutic interventions can then be directed to those who will benefit most from targeted interventions, thereby maximizing benefits and minimizing costs and complications. Precision medicine is gaining increasing recognition by clinicians, healthcare systems, pharmaceutical companies, patients, and the government. Imaging plays a critical role in precision medicine including screening, early diagnosis, guiding treatment, evaluating response to therapy, and assessing likelihood of disease recurrence. The Association of University Radiologists Radiology Research Alliance Precision Imaging Task Force convened to explore the current and future role of imaging in the era of precision medicine and summarized its finding in this article. We review the increasingly important role of imaging in various oncological and non-oncological disorders. We also highlight the challenges for radiology in the era of precision medicine.

Clinical Decision Support at the Point-of-Order Entry: An Education Simulation Pilot with Medical Students.

RATIONALE AND OBJECTIVES: We have been called to reform radiology undergraduate medical education (UME) curricula. Clinically available clinical decision support provides an opportunity to improve education regarding appropriate imaging utilization, patient safety, and cost-effective care. MATERIAL AND METHODS: We created an education simulation portal utilizing integrated clinical decision support. The portal was then piloted with 34 volunteer medical students at our institution in a blended learning environment. A program assessment was performed utilizing the results from a qualitative survey, pre-test, and post-test. RESULTS: The large majority of medical students felt this supplemental education resource should be included in our UME curriculum (85.29%). All students perceived value in the education simulation portal. The students performed significantly better on the post-test in multiple categories (overall P <.0001), including Choosing Wisely topics (P = .0207). CONCLUSIONS: Based on our program assessment from this pilot program, we believe this innovative educational resource has significant potential to fill curricular gaps in radiology UME curricula. This platform is scalable and can be further customized to fill needs across the continuum of medical education.

Stereotactic Biopsy of Segmental Breast Calcifications: Is Sampling of Anterior and Posterior Components Necessary?

RATIONALE AND OBJECTIVES: Core needle biopsy results of segmental calcifications on mammography can have direct impact on surgical management. Although dependent on breast size, cancer spanning greater than 5 cm is usually treated with mastectomy, and cancer less than 5 cm is managed with lumpectomy. Approach to stereotactic biopsy of morphologically similar segmental calcifications that span more than 5 cm on mammography varies geographically and is currently largely based on preference of the surgical or medical oncology colleagues. Some clinicians prefer biopsy of the anterior and posterior aspects of the abnormality, whereas others believe a single biopsy within the abnormality is adequate. There is insufficient data to support whether a single biopsy of calcifications is adequate to establish the need for mastectomy, or if pathology-proven cancer in the anterior and posterior components to define the extent of disease is required. This study aims to evaluate concordance rates of paired biopsies of suspicious segmental mammographic calcifications. MATERIALS AND METHODS: From a 5-year review of our imaging database, 32 subjects were identified with breast imaging reporting and data system (BI-RADS) 4 or 5 segmental calcifications on mammography who underwent anterior and posterior stereotactic biopsies. The paired biopsy results were independently analyzed for concordance on benign, high-risk, or malignant pathology. RESULTS: Of the 32 cases, there was perfect agreement (32/32 cases = 100% concordance, 95% confidence interval = 89.3-100%) in anterior and posterior pairs in benign, high-risk, or malignant findings (kappa = 1, P < 0.001). CONCLUSIONS: The absence of data on pathological concordance in anterior and posterior aspects of suspicious, morphologically similar, segmental calcifications spanning 5 cm or more has led to a varied clinical approach to stereotactic biopsy. The 100% rate of pathological concordance in our study suggests that a single biopsy is adequate for diagnosis and representative of the whole mammographic abnormality. Implementation of this approach will potentially reduce unnecessary biopsies and surgeries, minimize healthcare costs, and decrease patient morbidity.

BI-RADS update for breast cancer caregivers.

This review will discuss changes relevant to breast cancer caregivers in the fifth edition of the Breast Imaging Reporting and Data System.

Dedifferentiated liposarcoma of the adult male breast.

A 66-year-old male presented with a right breast mass, enlarging insidiously over a one-year period after trauma to the site. After the findings were attributed to glandular injury and hematoma, the patient eventually underwent mammographic and ultrasonographic evaluation that demonstrated masses in the breast and the axilla. A subsequent ultrasound-guided biopsy of the breast mass yielded a diagnosis of fibromatosis. However, the imaging features were suggestive of malignancy. Surgical resection was performed and revealed dedifferentiated liposarcoma-a neoplasm with components of well- and poorly differentiated liposarcoma as well as nonlipomatous sarcoma. This tumor type is primarily described in the retroperitoneum and limbs and is especially rare in the breast. We report an unusual case of multifocal primary dedifferentiated liposarcoma involving the breast in a man.