Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in Cuba.

PURPOSE: Dual HER2 blockade chemotherapy is the standard of care for localized HER2+ breast cancer (BC). However, despite the efficacy of neoadjuvant therapy, relapses occurring in around 10% of patients highlight the need to improve its clinical approach. Therefore, this study aimed to evaluate the effectiveness/safety of neoadjuvant therapy with subcutaneous (SC) trastuzumab- pertuzumab chemotherapy (real world) to extend the evidence, which comes mainly from clinical trials (selected population; intravenous [IV] trastuzumab). MATERIALS AND METHODS: A prospective, longitudinal, observational study in a Cuban hospital. POPULATION: women aged ≥18 years with histologically confirmed HER2+ early-stage BC (2017-2021) eligible for neoadjuvant treatment (IV pertuzumab, SC trastuzumab, taxane-based chemotherapy). The aim was to determine the pathological complete response (pCR) rate to this scheme, its safety, and the impact of patient's characteristics on the outcomes. RESULTS: Eighty-seven women were included: n=29 (DPT [docetaxel-IV pertuzumab- SC trastuzumab 600 mg; 4 cycles]); n=58 (ddAC-DPT [dose-dense anthracycline-based scheme+DPT]; 8 cycles). The median age was 57 years (range 30-83), ECOG 0: 97%. Time from diagnosis to treatment (median) was 28 days. The overall pCR rate was 62.1% (55.2%, DPT; 66.5%, ddAC-DPT; p =0.351); HR+, 47.7% vs. HR-, 76.7% (p=0.006). There were no statistically significant differences based on nodal status, stage, or Ki-67 levels. Overall, 94.2% of patients experienced ≥1 adverse event related to treatment, all of them grade 1-3 and more common with ddAC-DPT. The main cause of treatment delays (n=19; ddAC-DPT, 16; DPT, 3) was treatment-related toxicities. CONCLUSION: Neoadjuvant trastuzumab (SC) and pertuzumab plus chemotherapy for HER2+ early-stage BC showed benefits in a real-life setting, with an acceptable safety profile.

Pressure Injury Development, Mitigation, and Outcomes of Patients Proned for Acute Respiratory Distress Syndrome.

OBJECTIVE: To describe trends and risk factors for pressure injuries (PIs) in adult critical care patients proned to alleviate acute respiratory distress syndrome secondary to COVID-19 and examine the effectiveness of products and strategies used to mitigate PIs. METHODS: The authors conducted a retrospective chart review between April 9 and June 8, 2020. Demographic data were analyzed using descriptive statistics. Differences between groups with and without PIs were analyzed. RESULTS: Among 147 patients, significant PI risk factors included male sex (P = .019), high body mass index (>40 kg/m2; P = .020), low Braden Scale score (<12; P = .018), and low-dose vasopressor therapy (P = .020). Taping endotracheal tubes (ETTs) caused significantly fewer facial PIs than commercial ETT holders (P < .0001). Maximum prone duration/session was a significant risk factor for anterior PIs (P = .016), which dropped 71% with newer pressure redistribution products. d-Dimer greater than 3,200 µg/mL (P = .042) was a significant risk factor for sacrococcygeal PIs while supine. Mortality was 30%; significant risk factors included age older than 60 years (P = .005), Sequential Organ Failure Assessment score greater than 11 (P = .003), and comorbid congestive heart failure (P = .016). CONCLUSIONS: Taping the ETT, limiting the maximum duration of prone positioning to less than 32 hours, and frequent repositioning while supine may reduce the number of modifiable risk factors for PIs. Standardized methods for testing products for PI prevention will inform individualized patient care.

Development of a Prone Team and Exploration of Staff Perceptions During COVID-19.

OBJECTIVE: As intensive care unit bed capacity doubled because of COVID-19 cases, nursing leaders created a prone team to support labor-intensive prone positioning of patients with COVID-related acute respiratory distress syndrome. The goal of the prone team was to reduce workload on intensive care teams, standardize the proning process, mitigate pressure injuries and turning-related adverse events, and ensure prone team safety. METHODS: Staff were trained using a hybrid learning model focused on prone-positioning techniques, pressure injury prevention, and turning-related adverse events. RESULTS: No adverse events occurred to patients or members of the prone team. The prone team mitigated pressure injuries using prevention strategies. The prone team and intensive care unit staff were highly satisfied with their experience. CONCLUSION: The prone team provided support for critically ill patients, and team members reported feeling supported and empowered. Intensive care unit staff were highly satisfied with the prone team.

Identification of quality improvement areas in pediatric MRI from analysis of patient safety reports.

BACKGROUND: Analysis of safety reports has been utilized to guide practice improvement efforts in adult magnetic resonance imaging (MRI). Data specific to pediatric MRI could help target areas of improvement in this population. OBJECTIVE: To estimate the incidence of safety reports in pediatric MRI and to determine associated risk factors. MATERIALS AND METHODS: In a retrospective HIPAA-compliant, institutional review board-approved study, a single-institution Radiology Information System was queried to identify MRI studies performed in pediatric patients (0-18 years old) from 1/1/2010 to 12/31/2015. The safety report database was queried for events matching the same demographic and dates. Data on patient age, gender, location (inpatient, outpatient, emergency room [ER]), and the use of sedation/general anesthesia were recorded. Safety reports were grouped into categories based on the cause and their severity. Descriptive statistics were used to summarize continuous variables. Chi-square analyses were performed for univariate determination of statistical significance of variables associated with safety report rates. A multivariate logistic regression was used to control for possible confounding effects. RESULTS: A total of 16,749 pediatric MRI studies and 88 safety reports were analyzed, yielding a rate of 0.52%. There were significant differences in the rate of safety reports between patients younger than 6 years (0.89%) and those older (0.41%) (P<0.01), sedated (0.8%) and awake children (0.45%) (P<0.01), and inpatients (1.1%) and outpatients (0.4%) (P<0.01). The use of sedation/general anesthesia is an independent risk factor for a safety report (P=0.02). The most common causes for safety reports were service coordination (34%), drug reactions (19%), and diagnostic test and ordering errors (11%). CONCLUSION: The overall rate of safety reports in pediatric MRI is 0.52%. Interventions should focus on vulnerable populations, such as younger patients, those requiring sedation, and those in need of acute medical attention.

Outpatient falls prevention program outcome: an increase, a plateau, and a decrease in incident reports.

OBJECTIVE: We implemented an outpatient falls guideline in 2008 in the department of radiology. Here, we describe our multiyear experience. MATERIALS AND METHODS: This was a retrospective study conducted between April 2006 and September 2013 to investigate outpatient falls. The span of the study was divided into eight periods. The incident reporting system was searched for the falls and the fall-related variables. RESULTS: A total of 327 falls occurred during 5,080,512 radiology examinations (rate, 0.64/10,000 total examinations). The highest rate was in period 6 (0.83/10,000 examinations). The average for periods 1 and 2 is 0.39/10,000 examinations (37 falls/945,427 examinations), and the average for periods 3-6 is 0.77/10,000 examinations (204 falls/2,656,805 examinations). The average rate for periods 7 and 8 is 0.58/10,000 examinations (86 falls/1,478,280 examinations). There was a statistically significant increase in the total number of falls reported between period 2 and period 3 (p = 0.02). There was a statistically significant decrease in outpatient falls between period 6 and period 7 (p = 0.01). The number of falls among patients 60 years old or older was 177 falls/2,180,093 examinations (rate, 0.81/10,000 examinations), and that among patients younger than 60 years was 150 falls/2,900,419 examinations (rate, 0.52/10,000 examinations), with a statistically significant difference (p = 0.007). Although the rate of falls was higher among female patients, there was no statistically significant difference between the sexes (p = 0.18). CONCLUSION: The outcome of the outpatient falls guideline was characterized by an increase, a plateau, and a decrease in incident reports. The initial increase may be due to the Hawthorne effect. The plateau may represent the value closest to the true incidence. The decrease may represent the effect of the program.

Team training: a safer future for neurointerventional practice.

As medical errors and patient harm mount in today's healthcare arena, healthcare administrators have turned to high efficiency, high reliability, and high risk industries for strategies and guidance. By adopting elements of Crew Resource Management (CRM), healthcare teams have been shown to work more effectively together, allowing for earlier recognition of medical errors and catching them before they cause serious patient harm.