Impact of the Breast Cancer Index for Extended Endocrine Decision-Making: First Results of the Prospective BCI Registry Study.

BACKGROUND: The Breast Cancer Index (BCI) test assay provides an individualized risk of late distant recurrence (5-10 years) and predicts the likelihood of benefitting from extended endocrine therapy (EET) in hormone receptor-positive early-stage breast cancer. This analysis aimed to assess the impact of BCI on EET decision-making in current clinical practice. METHODS: The BCI Registry study evaluates long-term outcomes, decision impact, and medication adherence in patients receiving BCI testing as part of routine clinical care. Physicians and patients completed pre-BCI and post-BCI test questionnaires to assess a range of questions, including physician decision-making and confidence regarding EET; patient preferences and concerns about the cost, side effects, drug safety, and benefit of EET; and patient satisfaction regarding treatment recommendations. Pre-BCI and post-BCI test responses were compared using McNemar's test and Wilcoxon signed rank test. RESULTS: Pre-BCI and post-BCI questionnaires were completed for 843 physicians and 823 patients. The mean age at enrollment was 65 years, and 88.4% of patients were postmenopausal. Of the tumors, 74.7% were T1, 53.4% were grade 2, 76.0% were N0, and 13.8% were HER2-positive. Following BCI testing, physicians changed EET recommendations in 40.1% of patients (P<.0001), and 45.1% of patients changed their preferences for EET (P<.0001). In addition, 38.8% of physicians felt more confident in their recommendation (P<.0001), and 41.4% of patients felt more comfortable with their EET decision (P<.0001). Compared with baseline, significantly more patients were less concerned about the cost (20.9%; P<.0001), drug safety (25.4%; P=.0014), and benefit of EET (29.3%; P=.0002). CONCLUSIONS: This analysis in a large patient cohort of the BCI Registry confirms and extends previous findings on the significant decision-making impact of BCI on EET. Incorporating BCI into clinical practice resulted in changes in physician recommendations, increased physician confidence, improved patient satisfaction, and reduced patient concerns regarding the cost, drug safety, and benefit of EET.

Early Detection Tool of Intestinal Dysfunction: Impact on Necrotizing Enterocolitis Severity.

OBJECTIVE: The aim of this study is to determine the use of an early clinical signs and symptoms warning tool in early identification of intestinal dysfunction as a clinical strategy to decrease necrotizing enterocolitis (NEC) severity. DESIGN: Using signs and symptoms of 297 infants, of which 33 infants were diagnosed with stage II and III EC intestinal dysfunction, a five clinical category scoring tool (Neonatal Necrotizing Enterocolitis Early Detection Score [NeoNEEDS]) and strategy with abdominal X-ray alert was developed. The categories included behavior, cardiac, respiratory, gastrointestinal, and feeding tolerance. The strategy was tested in a prospective cohort of 72 infants < 1,500 g, utilizing 532 observations between 10/2012 and 9/1/2013. The statistical analysis utilized the Statistical Analysis Software (SAS). RESULTS: The earliest signs and symptoms of intestinal dysfunction (Stage I NEC) were cardiorespiratory baseline changes, p < 0.001. Abdominal distension and/or feeding intolerance were late findings associated with stage II or III NEC. Tool scores ≥ 5 predicted intestinal dysfunction (p < 0.00). Sensitivity was high (95%) with specificity of 82% and positive and negative predictive values of 76% and 95%, respectively. Use of the tool during the study period was associated with decreased NEC severity rates (Bell NEC stage II and III). CONCLUSION: Cardiorespiratory symptoms precede gastrointestinal symptoms of intestinal dysfunction. Targeting signs and symptoms in an early warning tool to identify intestinal dysfunction can impact NEC severity progression.