A Four-Arm Randomized Clinical Trial of Topical Pain Control for Sentinel Node Radiotracer Injections in Patients with Breast Cancer.

BACKGROUND: Radioactive tracer injections for breast cancer sentinel lymph node mapping can be painful. In this randomized trial, we compared four approaches to topical pain control for radiotracer injections. METHODS: Breast cancer patients were randomized (9 April 2021-8 May 2022) to receive the institutional standard of ice prior to injection (n = 44), or one of three treatments: ice plus a vibrating distraction device (Buzzy®; n = 39), 4% lidocaine patch (n = 44), or 4% lidocaine patch plus ice plus Buzzy® (n = 40). Patients completed the Wong-Baker FACES® pain score (primary outcome) and a satisfaction with pain control received scale (secondary). Nuclear medicine technologists (n = 8) rated perceived pain control and ease of administration for each patient. At study conclusion, technologists rank-ordered treatments. Data were analyzed as intention-to-treat. Wilcoxon rank-sum tests were used to compare pain scores of control versus pooled treatment arms (primary) and then control to each treatment arm individually (secondary). RESULTS: There were no differences in pain scores between the control and treatment groups, both pooled and individually. Eighty-five percent of patients were 'satisfied/very satisfied' with treatment received, with no differences between groups. No differences in providers' perceptions of pain were observed, although providers perceived treatments involving Buzzy© more difficult to administer (p < 0.001). Providers rated lidocaine patch as the easiest, with ice being second. CONCLUSION: In this randomized trial, no differences in patient-reported pain or satisfaction with treatment was observed between ice and other topical treatments. Providers found treatments using Buzzy® more difficult to administer. Given patient satisfaction and ease of administration, ice is a reasonable standard.

Expanded Indications for Nipple-Sparing Mastectomy and Immediate Breast Reconstruction in Patients Older Than 60 Years.

INTRODUCTION: Although nipple-sparing mastectomy (NSM) and immediate breast reconstruction (IBR) have long been praised for excellent cosmetic results and the resultant psychosocial benefits, the feasibility and safety of these procedures in patients older than 60 years have yet to be demonstrated in a large population. METHODS: Patients undergoing NSM with or without IBR at the MedStar Georgetown University Hospital between 1998 and 2017 were included. Patient demographics, surgical intervention, and complication and recurrence events were retrieved from electronic medical records. Primary outcomes were recurrence and complication rates by age groups older and younger than 60 years. RESULTS: There were 673 breasts from 397 patients; 58 (8.6%) older than 60 years and 615 (91.4%) younger than 60 years with mean follow-up of 5.43 (0.12) years. The mean age for those older than 60 was 63.9 (3.3) years, whereas that for those younger than 60 was 43.1 (7.9) years (P < 0.001). The older than 60 group had significantly higher prevalence of diabetes, rates of therapeutic (vs prophylactic) and unilateral (vs bilateral) NSM, and mastectomy weight. However, there were no significant differences by age group in complication rates or increased risk of locoregional or distant recurrence with age. CONCLUSIONS: Based on similar complication profiles in both age groups, we demonstrate safety and feasibility of both NSM and IBR in the aging population. Despite increased age and comorbidity status, appropriately selected older women were able to achieve similar outcomes to younger women undergoing NSM with or without IBR.

Postoperative Outcomes After Staged Versus Coordinated Breast Surgery and Bilateral Salpingo-Oophorectomy.

BACKGROUND: The objective of this study was to compare postoperative complication rates and healthcare charges between patients who underwent coordinated versus staged breast surgery and bilateral salpingo-oophorectomy (BSO). PATIENTS AND METHODS: The MarketScan administrative database was used to identify adult female patients with invasive breast cancer or BRCA1/BRCA2 mutations who underwent BSO and breast surgery (lumpectomy or mastectomy with or without reconstruction) between 2010 and 2015. Patients were assigned to the coordinated group if a breast operation and BSO were performed simultaneously or assigned to the staged group if BSO was performed separately. Primary outcomes were (1) incidence of 90-day postoperative complications and (2) 2-year aggregate perioperative healthcare charges. Fisher's exact tests, Wilcoxon rank-sum tests, and multivariable regression analyses were performed. RESULTS: Of the 4228 patients who underwent breast surgery and BSO, 412 (9.7%) were in the coordinated group and 3816 (90.3%) were in the staged group. The coordinated group had a higher incidence of postoperative complications (24.0% vs. 17.7%, p < 0.01), higher risk-adjusted odds of postoperative complications [odds ratio (OR) 1.37, 95% confidence interval (CI) 1.06-1.76, p = 0.02], and similar aggregate healthcare charges before (median charges: $106,500 vs. $101,555, p = 0.96) and after risk-adjustment [incidence rate ratio (IRR) 1.00, 95% CI 0.93-1.07; p = 0.95]. In a subgroup analysis, incidence of postoperative complications (12.9% for coordinated operations vs. 11.7% for staged operation, p = 0.73) was similar in patients whose breast operation was a lumpectomy. CONCLUSIONS: While costs were similar, coordinating breast surgery with BSO was associated with more complications in patients who underwent mastectomy, but not in patients who underwent lumpectomy. These data should inform shared decision-making in high-risk patients.

Opioid-free anesthesia for patients undergoing mastectomy: A matched comparison.

Opioid-free anesthesia (OFA) is being implemented in breast surgery due to increased awareness of adverse effects and the national opioid crisis. The objective of this study was to examine the effect of OFA on postoperative pain and postoperative nausea and vomiting (PONV) in mastectomy patients. A single-institution matched-cohort study was conducted from 2014 to 2017 on 48 women undergoing mastectomy, with the majority also undergoing immediate prosthetic-based reconstruction. Patients received either conventional anesthesia (CA) or a novel OFA regimen. Primary outcomes included postoperative pain scores, opioid use, and need for antiemetics that were evaluated both in the PACU and on the hospital floors. No significant differences were found in PACU opioid or antiemetic use between OFA and CA. Pain scores in PACU and on POD0 were not significantly different. There was a significant but modest decrease on POD1 in OFA patients (3.9 vs. 5.1, P = .046). Additionally, patients with higher intraoperative opioid regimens experienced significantly increased PONV (P = .023). This study demonstrated the efficacy of OFA in controlling postoperative pain and nausea compared to a traditional opioid-based regimen. Regardless of intraoperative opioids, patients experienced similar postoperative opioid requirements and PONV with decreased pain scores. Thus, OFA is feasible in mastectomy patients and should be further evaluated in select patients.

A Systematic Review of Utility Score Assessments in the Breast Surgery Cost-Analysis Literature.

BACKGROUND: Surgery for breast cancer can have significant impact on patient quality-of-life. Cost-utility analysis provides a way to analyze the economic impact of a surgical procedure with the change in a patient's quality of life. Utility scores are used in these analyses to quantify the impact on quality of life. We undertook a systematic review of the literature on breast cancer surgical procedures to compile a repository of utility scores and to assess gaps in the current literature. METHODS: Following PRISMA guidelines, a systematic review was performed for studies reporting utility scores for breast surgery and breast reconstruction. The health states and utility scores were extracted and grouped into seven procedural categories based on oncologic and reconstructive methods. Mean utility score and ranges were calculated and reported for each procedural category. RESULTS: Nineteen articles met the inclusion criteria assessing 118 health states. Most utility scores were obtained from healthcare professionals. Breast-conserving therapy yielded the highest mean utility score at 0.79, whereas mastectomy yielded a mean utility score of 0.75. Among reconstruction health states, implant reconstruction had a lower score than autologous reconstruction (0.64 implant vs. latissimus dorsi 0.69 and TRAM/DIEP 0.71). No utility scores were found associated with oncoplasty or nipple-sparing mastectomy procedures. CONCLUSIONS: A reliable body of utility scores is important in enabling future cost-utility and value-based analysis comparisons for breast surgical oncology. Additional work is needed to obtain health state assessments from the patient perspective, as well as assessment of more modern surgical and reconstructive approaches.

Physician Perspectives on Fertility Preservation Discussions with Premenopausal Breast Cancer Patients: Results from a Multihospital Health Care System.

BACKGROUND: Ten percent of new breast cancer diagnoses occur in premenopausal women, and oncologic therapies may compromise fertility. Thus, fertility preservation discussions (FPDs) and referral to fertility specialists are imperative prior to initiation of therapy. A previous retrospective chart review showed 45% FPD rates at our institution. The aim of this study is to investigate physician perspectives and limitations regarding FPD. METHODS: An electronic survey was distributed to 30 surgical, medical, and radiation oncologists across ten regional hospitals. Questions addressed provider demographics, and barriers to and facilitators of FPD. RESULTS: The survey response rate was 63.3%. Only 31.6% of physicians reported "always" documenting FPD. Respondents opined that the physician prescribing systemic therapy was the most appropriate person to provide FPD. Patient age, treatment with chemotherapy, and patient desire for FPD were more likely to increase FPD (p < 0.0001, p < 0.05, and p < 0.0001, respectively). The majority of physicians (84.2%) expressed intent to increase FPD rates. CONCLUSIONS: Fertility preservation is an integral aspect of breast cancer care, requiring thorough discussion and clear documentation. This study identified that physicians believe the medical oncologist is the most appropriate person to have FPDs with patients and that empowering patients to bring up fertility concerns may improve rates of FPDs. Education of physicians and patients about fertility preservation techniques is likely to improve FPDs.

Breast cancer risk reduction: who, why, and what?

Women at increased risk of breast cancer have options to mitigate that risk. Understanding factors that increase risk and utilizing tools for quantitative estimates are important to be able to adequately counsel and target strategies for patients. On the basis of these estimates, patients may be able to engage in risk reduction interventions and increased screening, including chemoprevention or surgical risk reduction. Multiple organizations have published guidelines supporting risk assessment, genetic assessment, increased screening, and prevention measures for these women.

ACR Appropriateness Criteria® Evaluation of Nipple Discharge: 2022 Update.

The type of nipple discharge dictates the appropriate imaging study. Physiologic nipple discharge is common and does not require diagnostic imaging. Pathologic nipple discharge in women, men, and transgender patients necessitates breast imaging. Evidence-based guidelines were used to evaluate breast imaging modalities for appropriateness based on patient age and gender. For an adult female or male 40 years of age or greater, mammography or digital breast tomosynthesis (DBT) is performed initially. Breast ultrasound is usually performed at the same time with rare exception. For males or females 30 to 39 years of age, mammography/DBT or breast ultrasound is performed based on institutional preference and individual patient considerations. For young women less than 30 years of age, ultrasound is performed first with mammography/DBT added if there are suspicious findings or if the patient is at elevated lifetime risk for developing breast cancer. There is a high incidence of breast cancer in males with pathologic discharge. Men 25 years and older should be evaluated using mammography/DBT and ultrasound added when indicted. In transfeminine (male-to-female) patients, mammography/DBT and ultrasound are useful due to the increased incidence of breast cancer. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer-reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances in which peer-reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

Interprofessional education about shared decision making for patients in primary care settings.

With an increasingly complex array of interventions facing healthcare professionals and patients, coupled with a potentially diverse number of professionals operating within the primary care team, the adoption of shared decision making (SDM) - with or without patients' decision aids - in an interprofessional manner is essential to ensure the highest quality of care for patients. In this article, we propose a framework for interprofessional education about SDM targeted to primary care settings. Five areas of knowledge and skills were agreed to be essential for all relevant stakeholders for interprofessional education in SDM to be successful: understanding the concept of SDM; acquiring relevant communication skills to facilitate SDM; understanding interprofessional sensitivities; understanding the roles of different professions within the relevant primary care group; and acquiring relevant skills to implement SDM. We suggest a series of teaching methods for the aforementioned areas, using principles from adult learning.

Decreased postoperative pain and opioid use following prepectoral versus subpectoral breast reconstruction after mastectomy: A retrospective cohort study: Pain after pre- versus subpectoral reconstruction.

BACKGROUND: Prepectoral (PP) breast reconstruction is now commonly performed and minimizes dissection of the pectoralis major muscle. Data are lacking comparing the immediate postoperative recovery of these patients as compared with traditional subpectoral (SP) breast reconstruction. METHODS: From December 2015 to February 2017, 73 patients underwent PP prosthetic-based reconstruction at a single academic institution. PP cases were matched 1:1, by age and stage, to patients undergoing traditional SP reconstruction. Analysis of postoperative pain (visual analog scale) and opioid use (oral morphine equivalents, OME), was performed with both bi- and multivariate analyses. Additional outcomes explored included length of stay (LOS) and reconstructive intervention by plane of prosthetic reconstruction. RESULTS: A total of 146 patients were included in the final cohort. PP reconstruction was associated with higher rates of direct-to-implant reconstruction (84.9% vs. 34.3%, p <0.001) and higher rates of initial prosthetic fill (401.53 mL vs. 280.88 mL, p<0.001). Patients undergoing PP reconstruction had significantly reduced postoperative pain (4.29 vs. 5.44, p<0.001) and in-hospital opioid use (62.63 mg OME vs. 98.84 mg OME, p = 0.03) compared with SP patients. This result remained in multivariate analysis for both pain (3.94 vs. 5.25, p<0.001) and opioid use (17.14 mg OME vs. 63.03 mg OME, p = 0.03). Additionally, patients undergoing PP reconstruction had significantly reduced overall LOS on multivariate analysis (21.36 vs. 26.28 h, p = 0.02). CONCLUSION: Following mastectomy, PP breast reconstruction results in significantly reduced pain, opioid use, and hospital LOS compared with SP reconstruction.

Executive Summary of the Early-Onset Breast Cancer Evidence Review Conference.

The Centers for Disease Control and Prevention launched the Bring Your Brave campaign to increase knowledge about early-onset breast cancer, defined as breast cancer in women aged 18-45 years. The American College of Obstetricians and Gynecologists convened a panel of experts in breast disease from the Society for Academic Specialists in General Obstetrics and Gynecology to review relevant literature, validated tools, best practices, and practice guidelines as a first step toward developing educational materials for women's health care providers about early-onset breast cancer. Panel members conducted structured literature reviews, which were then reviewed by other panel members and discussed at an in-person meeting of stakeholder professional and patient advocacy organizations in April 2019. This article summarizes the relevant literature, existing guidance, and validated tools to guide health care providers in the prevention, early detection, and special considerations of early-onset breast cancer. Substantive knowledge gaps were noted and summarized to provide guidance for future research.

Effects of Delivery Volume and High-Risk Condition Volume on Maternal Morbidity Among High-Risk Obstetric Patients.

OBJECTIVE: To evaluate the effect of obstetric delivery volume, high-risk condition volume, and their combined effect on maternal outcomes. METHODS: This retrospective cohort study examined more than 10 million deliveries in three states from 1995 to 2009 using linked birth-hospital discharge records. Surgical high-risk patients had one of three prenatally identifiable conditions; the high-risk medical cohort had 1 or more of 14 complicating diagnoses. Hospitals were divided into quartiles of total obstetric delivery volume and tertiles of high-risk patient volume. The primary outcome was a composite outcome of severe maternal morbidity identified by International Classification of Diseases, 9th Revision, Clinical Modification, codes. Data were controlled for nonindependence using clustering by hospital and results were adjusted for patient and hospital level factors. RESULTS: We identified 142,194 high-risk surgical deliveries and 1,322,276 high-risk medical deliveries for evaluation. Among surgical high-risk patients, higher hospital total obstetric delivery volume was associated with 22% decreased risk for maternal morbidity (4th quartile adjusted odds ratio [AOR] 0.78; 95% CI 0.64-0.94); likewise for medical high-risk patients, higher total delivery volume was associated with a 28% decreased risk (4th quartile AOR 0.72; 95% CI 0.59-0.86). Conversely, as the volume of medical high-risk patients at hospitals increased, the AOR for severe morbidity increased (AOR=1.27, 95% CI 1.10-1.48). There was a significant interaction effect of both types of volume on maternal complications for both surgical (likelihood ratio [LR] χ=18.2, P=.006) and medical high-risk patients (LR χ=99.4, P<.001). CONCLUSION: Patients with high-risk medical and surgical conditions had decreasing adverse maternal outcomes as total obstetric delivery volume increased. There were increased odds of adverse maternal outcomes in centers with high volumes of high-risk patients. These two types of volume had significant combined effect on maternal risk. Both types of volume should be considered in assessing hospital obstetric performance.