Nationwide Analysis of Locoregional Management for Ductal Carcinoma In Situ in Males: An NCDB Analysis of the Surgical Approach to DCIS in Males.

BACKGROUND: Limited data exist regarding the optimal locoregional approach for males with ductal carcinoma in situ (DCIS). This study examined trends in management and survival for males with DCIS. METHODS: The National Cancer Database (NCDB) was queried for males with a diagnosis of DCIS from 2006 to 2017. Patients were categorized by locoregional management. Continuous variables were evaluated by Kruskal-Wallis and categorical variables by chi-square or Fisher's exact test. Univariable and multivariable logistic regressions were performed to evaluate for predictors of patients receiving partial mastectomy (PM) with radiation. Survival was analyzed by Kaplan-Meier. RESULTS: Between 2006 and 2017, 711 males with DCIS were identified. Most received mastectomy alone (57.1%). No change was observed in management approach from 2006 to 2017. Patients who underwent mastectomy alone were mostly hormone-positive (95.9% were estrogen-positive, 90.9% were progesterone-positive), although this cohort was least likely to receive hormone therapy (17.2%). Among those who underwent PM with radiation, only 61% of those who were hormone-positive received hormone therapy. Univariable analysis demonstrated that those of black race had lower odds of receiving PM with radiation (odds ratio [OR], 0.58; 95% confidence interval [CI], 0.36-0.84), which persisted in the multivariable analysis with control for age and tumor size (OR, 0.32; 95% CI, 0.15-0.67). Overall survival did not differ significantly between the four treatment methods (p = 0.08). CONCLUSIONS: The management approach to male DCIS did not change from 2006 to 2017. Survival did not differ between treatment methods. Demographic and clinicopathologic features, including race, may influence locoregional treatments received, and further studies are needed to further understand this.

Breast infections: A review of current literature.

Breast infections are common, affect women of all ages, and are associated with significant morbidity. Despite overall prevalence, treatment varies significantly based on provider or institution and no central treatment guidelines exist to direct the management of breast infections. This article provides a summary of the current trends in management of breast infections. The etiology, epidemiology, risk factors, presentation, diagnosis, and treatment of mastitis and breast abscesses (and their relative subdivisions) are explored based on the current literature. Trends in microbiology are reviewed and an approach to antibiotic coverage is proposed. Overall, there is a lack of randomized-controlled trials focused on the treatment of breast infections. This has resulted in an absence of clinical practice guidelines for the management of breast abscesses and variable practice patterns. The development of best-care protocols or pathways could provide more uniformity in care of breast infections.

Axillary management in breast cancer after neoadjuvant chemotherapy in the modern era: A national cancer database analysis.

BACKGROUND: Axillary management for node-positive breast cancer continues to evolve. Data further supporting targeted axillary dissection after neoadjuvant chemotherapy was published in 2016 and may have induced changes in practice. METHODS: Patients included in the National Cancer Database from 2014 to 2017 with clinical T1 to T4 and node-positive disease who underwent neoadjuvant chemotherapy before surgical axillary management were evaluated. Patients were divided into the following 3 groups: selective axillary dissection, minimal axillary dissection, and maximal axillary dissection, according to surgical axillary management and pathological node status. RESULTS: Patients who underwent selective axillary dissection were younger (52.4 years ± 12.4, P < .0001) compared to maximal axillary dissection (55.1 ± 12.7) and minimal axillary dissection (54.6 ± 12.7). Patients with higher clinical stage more frequently underwent maximal axillary dissection, and those with lower tumor grade more frequently underwent minimal axillary dissection (P < .0001). Community cancer programs were more likely to perform maximal axillary dissection compared to all other types of programs and had the slowest rate of adoption of selective axillary dissection. Integrated Network Cancer Programs had the lowest proportion of maximal axillary dissection performed and the highest proportion of selective axillary dissection. Uninsured patients were more likely to receive maximal axillary dissection, and those with private insurance were more likely to undergo selective axillary dissection (P < .0001). Selective axillary dissection rates increased from 29.8% of procedures in 2016 to 41.5% in 2017, and MaxAD rates decreased from 62.4% in 2016 to 47.9% in 2017. CONCLUSION: Utilization of selective axillary dissection has increased since 2016; however, discrepancies in surgical axillary management after neoadjuvant chemotherapy still exist.

Evaluation of the SmartClip™ Nonradioactive Seed, a Novel Wireless Localization Method for the Breast: Initial Clinical Experience and Surgical Outcome.

INTRODUCTION: Wire localization has been the gold standard for breast localization of non-palpable lesions for decades. This technique remains robust but has disadvantages relative to scheduling, complications of vasovagal reactions in placement, wire migration, or transection. With more modern technologies available, several implantable markers have been developed to allow uncoupling of localization by radiology and the surgical procedure on the same day. This study summarizes our experience with the EnVisio Navigation System™ utilizing SmartClip™ as the implantable tissue localization marker. METHODS: An IRB-approved retrospective database of benign and malignant breast disease was used to perform a review of 100 consecutive patients who underwent SmartClip™ localized breast and axillary procedures in 2021. Demographic information, localization accuracy, associated surgical procedure(s) with resultant pathology findings, margin status for malignancies, and re-excision rate were collected. RESULTS: The localized breast lesion or lymph node was excised and SmartClip™ retrieved in all cases, confirmed by intraoperative specimen radiograph. The distribution of gender and race/ethnicity among the patients who underwent surgery reflects the community population and frequency of breast cancer development among men versus women. 45.1% of the cases involved malignancy, as determined pre-operatively. Positive margins requiring re-excision constituted 18.2% of cases. In twenty-six patients, two or three SmartClips™ were placed per case for either a bracketed lesion, two separate breast lesions, and/or a breast lesion and lymph node. CONCLUSION: Although this study is limited in patient number, it demonstrates safety of this technique and its reliability in guiding the surgeon directly to the lesion(s) of concern.

Clinically significant bleeding complications of percutaneous breast biopsy: 10-year analysis and a proposed management algorithm.

PURPOSE: Bleeding is a well-known risk of percutaneous breast biopsy, frequently controlled with manual pressure. However, significant bleeding complications may require further evaluation or intervention. Our objectives were to assess the rate, type, and periprocedural management of significant bleeding following percutaneous breast biopsy and to evaluate the success of any interventions. METHODS: We retrospectively reviewed percutaneous breast biopsies at our institution over a 10-year period with documented post-biopsy bleeding complications in radiology reports. Patients were included if bleeding required intervention (interventional radiology [IR], surgery, or other), imaging follow-up, or clinical evaluation for symptoms. Additional data included patient demographics, anticoagulation, history of bleeding diathesis, biopsy details, bleeding symptoms, histopathology, and intervention details, if applicable. RESULTS: Of 5820 unique patients who underwent percutaneous biopsy, 66 patients (66/5820; 1.1%) comprising 71 biopsy cases met inclusion for clinically significant bleeding with 5/71(7.0%) requiring surgery, 9/71(12.7%) requiring IR intervention, and 57/71(80.3%) requiring lower-acuity intervention including prolonged observation (5/57;7.0%), overnight admission (4/57;5.6%), aspiration (4/57;5.6%), lidocaine and suture (2/57;2.8%), primary care visit (7/57;10.0%), blood transfusion (1/57;1.4%), emergency room visit (6/57;8.5%), surgery consult (8/57;11.3%), IR consult (2/57;2.8%), and follow-up imaging (22/57;31.0%). Most patients requiring intervention by surgery or IR had acute signs of bleeding immediately after biopsy while most patients with delayed signs of bleeding required lower-acuity interventions. CONCLUSION: Clinically significant bleeding is extremely rare after percutaneous breast biopsy and is most often managed non-surgically. Developing an institutional algorithm for management of bleeding complications that consults IR before surgery may help decrease the number of patients managed surgically.

Psychometric Testing of the Oncology Nurses Health Behaviors Determinants Scale: A Cross-Sectional Study.

OBJECTIVES: Adherence by oncology nurses to chemotherapy safe handling guidelines is essential to prevent hazards of chemotherapy exposure. A review of the literature revealed the need for an instrument with evidence of reliability and validity to measure factors influencing adherence to safe chemotherapy-handling guidelines among oncology nurses. The purpose of this study was to psychometrically test the Oncology Nurses' Health Behaviors Determinants Scale (HBDS-ON) that measures the mentioned factors. DATA SOURCES: Methodological research of a quantitative cross-sectional survey design was used. The study surveys were administered by email to a sample of 108 oncology nurses. Cronbach alpha, item analysis, exploratory factor analysis using principal axis factoring, and convergence validity testing were used to test reliability and validity. CONCLUSION: Factor analysis yielded six subscales, each having acceptable internal consistency reliability (Cronbach alpha between 0.70 and 0.88). The subscales included four oncology nurse health beliefs (perceived threat, benefits, barriers, and self-efficacy), cues to action, and personal protective equipment availability and accessibility. Convergence validity testing results support the Oncology Nurses Health Behaviors Determinant Scale (HBDS-ON) construct validity. Oncology nurses' self-efficacy to adherence to chemotherapy-handling guidelines, the perceived barriers to adhere to chemotherapy-handling guidelines, and cues to action are associated with adherence to chemotherapy-handling guidelines. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses' health beliefs, the cues to action, and personal protection equipment availability and accessibility are important determinants of nurses' adherence to chemotherapy-handling guidelines. The HBDS-ON is an instrument that has evidence of reliability and validity and could be used in practice to measure these determinants.

An Electronic Algorithm to Identify Vancomycin-Associated Acute Kidney Injury.

Background: The burden of vancomycin-associated acute kidney injury (V-AKI) is unclear because it is not systematically monitored. The objective of this study was to develop and validate an electronic algorithm to identify cases of V-AKI and to determine its incidence. Methods: Adults and children admitted to 1 of 5 health system hospitals from January 2018 to December 2019 who received at least 1 dose of intravenous (IV) vancomycin were included. A subset of charts was reviewed using a V-AKI assessment framework to classify cases as unlikely, possible, or probable events. Based on review, an electronic algorithm was developed and then validated using another subset of charts. Percentage agreement and kappa coefficients were calculated. Sensitivity and specificity were determined at various cutoffs, using chart review as the reference standard. For courses ≥48 hours, the incidence of possible or probable V-AKI events was assessed. Results: The algorithm was developed using 494 cases and validated using 200 cases. The percentage agreement between the electronic algorithm and chart review was 92.5% and the weighted kappa was 0.95. The electronic algorithm was 89.7% sensitive and 98.2% specific in detecting possible or probable V-AKI events. For the 11 073 courses of ≥48 hours of vancomycin among 8963 patients, the incidence of possible or probable V-AKI events was 14.0%; the V-AKI incidence rate was 22.8 per 1000 days of IV vancomycin therapy. Conclusions: An electronic algorithm demonstrated substantial agreement with chart review and had excellent sensitivity and specificity in detecting possible or probable V-AKI events. The electronic algorithm may be useful for informing future interventions to reduce V-AKI.

Food and Drug Administration Public Workshop Summary-Development Considerations of Antifungal Drugs to Address Unmet Medical Need.

Pressing challenges in the treatment of invasive fungal infections (IFIs) include emerging and rare pathogens, resistant/refractory infections, and antifungal armamentarium limited by toxicity, drug-drug interactions, and lack of oral formulations. Development of new antifungal drugs is hampered by the limitations of the available diagnostics, clinical trial endpoints, prolonged trial duration, difficulties in patient recruitment, including subpopulations (eg, pediatrics), and heterogeneity of the IFIs. On 4 August 2020, the US Food and Drug Administration convened a workshop that included IFI experts from academia, industry, and other government agencies to discuss the IFI landscape, unmet need, and potential strategies to facilitate the development of antifungal drugs for treatment and prophylaxis. This article summarizes the key topics presented and discussed during the workshop, such as incentives and research support for drug developers, nonclinical development, clinical trial design challenges, lessons learned from industry, and potential collaborations to facilitate antifungal drug development.

30th Annual GP2A Medicinal Chemistry Conference.

The Group for the Promotion of Pharmaceutical Chemistry in Academia (GP2A) held their 30th annual conference in August 2022 in Trinity College Dublin, Ireland. There were 9 keynote presentations, 10 early career researcher presentations and 41 poster presentations.

Lessons from other fields of medicine, Part 1: Breast cancer.

Through the understanding of multiple etiologies, pathologies, and disease progression trajectories, breast cancer shifted historically from a singular malignancy of the breast to a complex of molecular/biological entities, translating into individualized disease-modifying treatments. As a result, this led to various de-escalations of treatment compared with the gold standard in the era preceding systems biology: radical mastectomy. Targeted therapies have minimized morbidity from the treatments and mortality from the disease. Biomarkers further individualized tumor genetics and molecular biology to optimize treatments targeting specific cancer cells. Landmark discoveries in breast cancer management have evolved through histology, hormone receptors, human epidermal growth factor, single-gene prognostic markers, and multigene prognostic markers. Relevant to the reliance on histopathology in neurodegenerative disorders, histopathology evaluation in breast cancer can serve as a marker of overall prognosis rather than predict response to therapies. This chapter reviews the successes and failures of breast cancer research through history, with focus on the transition from a universal approach for all patients to divergent biomarker development and individualized targeted therapies, discussing future areas of growth in the field that may apply to neurodegenerative disorders.

The Factors That Influence Chemotherapy Exposure Among Nurses: An Integrative Review.

BACKGROUND: Exposure to chemotherapy is an occupational hazard predisposing nurses to severe health effects. The purpose of this integrative review was to identify the recent literature describing the risk factors for occupational exposure to chemotherapy among nurses. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology was employed to conduct the review. The databases searched were Scopus, PubMed, and CINAHL using the search terms "chemotherapy," "drugs," "exposure," and "nurses." Included articles were published between January 2010 and February 2022, published in peer-reviewed journals for research conducted in the United States, and written in English language. Excluded articles were studies that did not involve nurses in their samples. Review articles, books, theses, and dissertations were excluded as well. The Johns Hopkins Nursing Evidence-Based Practice Model was used to assess the level of evidence from the reviewed studies. FINDINGS: Fourteen studies were included in this review. Ten studies were rated on Evidence Level III, two on Evidence Level II, one on Evidence Level I, and one on Evidence Level V. The main risk factors for occupational exposure were nurses' knowledge of chemotherapy handling guidelines, nurses' adherence to using the personal protective equipment, nurses' health beliefs regarding chemotherapy exposure, and workplace-related factors such as workload and managerial support. CONCLUSION: Addressing the identified risk factors would protect nurses from chemotherapy exposure. More research on nurses' health beliefs regarding chemotherapy exposure and the cues to adhere to chemotherapy handling guidelines in the work environment is needed.

Outcomes of a pilot virtual mentorship program for medical students interested in surgery.

BACKGROUND: Lack of mentorship may deter medical students who identify as underrepresented minorities (URM) from entering academic surgery. METHODS: 30 mentor-medical student pairs from the AWS 2020 virtual mentorship pilot-program were surveyed pre-and post-program to explore 1) feasibility of meetings, and, 2) program's perceived efficacy in fostering professional development skills. Participants responded using a 5-point Likert scale (1 = not at all; 5 = completely). Proportions of participants in each category were compared. RESULTS: Proportion of participants perceiving monthly meetings to be completely feasible did not differ from pre-to post-program surveys for mentees (75%(21/28) vs. 71%(12/17); p = 0.743) or mentors (71%(17/24) vs 71%(13/18); p = 1.00). Compared to pre-program responses, mentees endorsed "completely" (Likert scale 5) improving with regard to their elevator speech (p = 0.001), developing their curriculum vitae (p = 0.003), ability to network (p = 0.021), and acquiring skills for career advancement (p = 0.003). CONCLUSION: Virtual mentorship may be a feasible and effective means of increasing access to mentors for URM medical students.

Exploiting the advantages of a wireless seed localization system that differentiates between the seeds: Breast cancer resection following neoadjuvant chemotherapy.

BACKGROUND: Most wireless localization methods utilize only one means of detection for the surgeon, sufficient to localize a single small breast lesion for excision. Complex cases requiring bracketing of a larger lesion or localization of two or more close lesions can superimpose the signal from separate "seeds" with such methods. The lack of discernment between the localization "seeds" can disorient the surgeon, risking a missed lesion on excision and longer operative times. with the use of neoadjuvant chemotherapy prior to breast surgery, the necessity of localizing both a breast lesion and an axillary lymph node previously biopsied is becoming frequent. CASE: A 44 year-old woman underwent neoadjuvant chmotherapy for a breast cancer the did not express estrogen receptor, progesterone receptor, or HER2 receptor. In establishing the extent of disease, a suspicious ipsilateral lymph node was biopsied and found to contain metastatic disease. She had an excellent response to the chemotherapy, with decreased size of the primary tumor and the previously biopsied lymph node. The patient desired breast conservation. The primary tumor and associated calcifications were bracketed using two different Smartclips™, with a third localizing the lymph node biopsied. CONCLUSION: This report illustrates how the use of three SmartClips™, within the EnVisioTM system, allowed for separate tracking of each "seed" throughout a complex surgery in a patient following neoadjuvant chemotherapy. This resulted in successful resection of both the tumor and the tagged lymph node.

Comparison of Male and Female Surgeons' Experiences With Gender Across 5 Qualitative/Quantitative Domains.

Importance: A growing body of literature has been developed with the goal of attempting to understand the experiences of female surgeons. While it has helped to address inequities and promote important programmatic improvements, work remains to be done. Objective: To explore how practicing male and female surgeons' experiences with gender compare across 5 qualitative/quantitative domains: career aspirations, gender-based discrimination, mentor-mentee relationships, perceived barriers, and recommendations for change. Design, Setting, and Participants: This national concurrent mixed-methods survey of Fellows of the American College of Surgeons (FACS) compared differences between male and female FACS. Differences between female FACS and female members of the Association of Women Surgeons (AWS) were also explored. A randomly selected 3:1 sample of US-based male and female FACS was surveyed between January and June 2020. Female AWS members were surveyed in May 2020. Exposure: Self-reported gender. Main Outcomes and Measures: Self-reported experiences with career aspirations (quantitative), gender-based discrimination (quantitative), mentor-mentee relationships (quantitative), perceived barriers (qualitative), and recommendations for change (qualitative). Results: A total of 2860 male FACS (response rate: 38.1% [2860 of 7500]) and 1070 female FACS (response rate: 42.8% [1070 of 2500]) were included, in addition to 536 female AWS members. Demographic characteristics were similar between randomly selected male and female FACS, with the notable exception that female FACS were less likely to be married (720 [67.3%] vs 2561 [89.5%]; nonresponse-weighted P < .001) and have children (660 [61.7%] vs 2600 [90.9%]; P < .001). Compared with female FACS, female AWS members were more likely to be younger and hold additional graduate degrees (320 [59.7%] were married; 238 [44.4%] had children). FACS of both genders acknowledged positive and negative aspects of dealing with gender in a professional setting, including shared experiences of gender-based harassment, discrimination, and blame. Female FACS were less likely to have had gender-concordant mentors. They were more likely to emphasize the importance of gender when determining career aspirations and prioritizing future mentor-mentee relationships. Moving forward, female FACS emphasized the importance of avoiding competition among female surgeons. They encouraged male surgeons to acknowledge gender bias and admit their potential role. Male FACS encouraged male and female surgeons to treat everyone the same. Conclusions and Relevance: Experiences with gender are not limited to supportive female surgeons. The results of this study emphasize the importance of recognizing the voices of all stakeholders involved when striving to promote workforce diversity and the related need to develop quality improvement/surgical education initiatives that enhance inclusion through open, honest discourse.

The Development and the Content Validation of the Oncology Nurses Health Behaviors Determinants Scale.

OBJECTIVE: Chemotherapy exposure is an occupational hazard affecting oncology nurses. The adherence to chemotherapy-handling guidelines is essential to prevent exposure to these drugs. Oncology nurses' health beliefs and the cues in the environment are factors influencing the adherence to these guidelines. There is a lack of instruments with evidence of reliability and validity in the literature that address these factors. The purpose of this article is to describe the development and the content validation of the Oncology Nurses' Health Behaviors' Determinants Scale relative to adherence to chemotherapy-handling guidelines. DATA SOURCES: This study was conducted in two phases: item development, then, content validation using a quantitative cross-sectional design with an exploratory part. A convenience sample of seven experts reviewed the items for relevance, wording, and comprehensiveness. The initial version of the scale that was sent to experts contained 65 items. CONCLUSION: The Oncology Nurses' Health Behaviors Determinants' Scale has evidence of content validity. Twenty-eight items in the final instrument met the required level of content validity (item content validity index = 0.83). Four additional items were retained due to conceptual significance. Two items were added. The final scale contains 34 items with a total scale content validity index = 0.90. IMPLICATIONS FOR NURSING PRACTICE: This newly developed instrument could be used to assess the factors that influence chemotherapy exposure among oncology nurses in the light of the Health Belief Model. Following that, interventions can be developed and implemented to foster greater adherence to safe chemotherapy handling guidelines.

Oncology alternative payment models: lessons from commercial insurance.

Many payers and clinicians are committed to advancing value-based care through the establishment of alternative payment models (APMs) that incentivize practices and clinicians to improve quality and reduce cost. A multistakeholder working group has observed that in specialty fields such as oncology, despite many attempts to design and implement APM pilots for commercial and Medicare Advantage populations, practical challenges and small numbers of episodes and patients present headwinds to viability and scalability. Despite this, some payers report emerging good practices and are optimistic about APMs. Careful and realistic consideration of the specific goals of a proposed model is warranted, as is close examination of the feasibility of transferring risk.

If You Can See It, You Can Be It: Perceptions of Diversity in Surgery Among Under-Represented Minority High School Students.

PURPOSE: Increasing racial and ethnic diversity in the surgical workforce is essential to improving outcomes for marginalized communities. To address the persistent shortage of under-represented minority (URM) surgeons, this study assessed the impact of providing early exposure to the field of surgery on URM high school students' perceptions of pursuing surgical careers. METHODS: The Association of Women Surgeons organized a pilot 3-hour "Day in the Life" virtual event geared toward URM high school students involving suturing/knot-tying, case conferences, and mentoring activities. RESULTS: Pre- and post-event survey results from 65 participants showed that students became more familiar with surgery (p < 0.001) and perceived the field as more diverse (p = 0.017). Over 70% felt capable of becoming surgeons themselves and over 80% were interested in learning more and gaining mentorship. CONCLUSIONS: Our programming provides a model for future initiatives aimed at strengthening the pipeline of URM surgeons.