Comparative Study of Radial and Median Nerve Blocks with Hematoma Block under Ultrasound Guide in Distal Radius Fracture Reduction: A Randomized Clinical Trial.

Background: Distal radius fractures are one of the most common upper extremity fractures, and their incidence continues to increase due to an aging population and an increase in osteoporosis. Various methods of analgesia for distal radius fractures have been described-including hematoma blocks and nerve blocks. Hematoma blocks are a simple and effective method of providing analgesia; nonetheless, their efficacy may be limited in some cases. On the other hand, nerve blocks provide more targeted analgesia and may be more effective in reducing pain during fracture reduction. This study aimed to compare the analgesic effectiveness of radial and median nerve blocks with hematoma blocks under ultrasound guidance in treating distal radius fractures. Also, this study aimed to compare the analgesia of radial and median nerve blocks with hematoma blocks under ultrasound guidance to reduce distal radius fractures. Methods: In this prospective trial, patients with distal radius fractures referring to 2 academic centers were placed into 2 randomized groups, including hematoma block, and radial median block, both of which were ultrasound-guided. The patient's pain levels were measured and recorded based on the visual analog scale before the block, 5, 10, and 15 minutes after the block, at the start of reduction, during reduction, and 5, 10, and 15 minutes after reduction. Patient satisfaction and physician satisfaction rates were assessed, and side effects were also observed for 1 week. Quantitative variables were reported as mean ± standard deviation, and number and frequency percentages were reported for qualitative variables. The Student t test and the chi-square test were used on a case-by-case basis. The significance level was set at P ˂ 0.05. Results: In this study, 120 patients were included. The groups had no significant differences in pain reduction during the procedure. Analgesic medication was needed during the procedure for 17 patients; nerve blocks were applied for 6 patients, and hematoma blocks for 11 patients, which was statistically significant (P = 0.041). Satisfaction rates for patients and physicians performing the procedure were significantly higher in the nerve block group than in the hematoma block group ( P = 0.001; P ˂ 0.001, respectively). Conclusion: The results of this study suggest that ultrasound-guided radial and median nerve blocks can be used as alternative methods of analgesia with other techniques in the reduction of distal radius fractures in emergency departments.

MUC1 (CA27.29) before and after Chemotherapy and Prognosis in High-Risk Early Breast Cancer Patients.

Soluble MUC1 has been discussed as a biomarker for predicting prognosis, treatment efficacy, and monitoring disease activity in breast cancer (BC) patients. Most studies in adjuvant settings have used preoperative assessment. This study, part of the SUCCESS-A trial (NCT02181101), assessed the prognostic value of soluble MUC1 before and after standard adjuvant chemotherapy. Patients with high-risk BC were treated within the SUCCESS-A trial with either three cycles of 5-fluorouracil, epirubicin, and cyclophosphamide followed by three cycles of docetaxel or three cycles of FEC followed by three cycles of docetaxel and gemcitabine. Cox regression analyses were performed to investigate the prognostic value of CA27.29 before and after chemotherapy relative to disease-free survival (DFS), along with established BC prognostic factors such as age, body mass index, tumor size, nodal status, estrogen receptor, progesterone receptor, HER2 status, and grading. Pre-chemotherapy and post-chemotherapy CA27.29 assessments were available for 2687 patients of 3754 randomized patients. Pre-chemotherapy CA27.29 assessment was associated with DFS in addition to established prognostic factors. It had no prognostic value in node-negative patients, but there was a clear association in node-positive patients. Post-chemotherapy CA27.29 assessment did not add any prognostic value, either on its own or in addition to pre-chemotherapy CA27.29 assessment.

Skin manifestations as potential symptoms of diffuse vascular injury in critical COVID-19 patients.

As a respiratory viral infection caused by a novel coronavirus, COVID-19 became rapidly pandemic within a few months. Despite the wide range of manifestations and organ involvement in COVID-19 patients, the exact pathogenesis of severe and fatal types of COVID-19 and causes involved with the individual base of the disease is not yet understood. Several studies have reported clinical, laboratory, and histopathological data in favor of vascular injury in multiple organs of critically ill patients with COVID-19 as a result of hyperactive immune response, inflammation, and cytokine storm. Also, both clinical and histopathological evidence points to such vascular involvements in the skin. Given the ease of clinical examinations and skin biopsy and the lower risks of transmission of COVID-19 to healthcare workers, the present review article was conducted to investigate the vascular skin manifestations of COVID-19 patients clinically and/or histopathologically as helpful clues for better understanding the pathogenesis and predicting the prognosis of the disease, especially in severe cases.

Therapy response and prognosis of patients with early breast cancer with low positivity for hormone receptors - An analysis of 2765 patients from neoadjuvant clinical trials.

AIM: To evaluate HER2-negative breast cancer (BC) with a low hormone receptor (HR) expression, with regard to pathological complete response (pCR) and survival, in comparison to triple-negative BC (TNBC) and strong HR-positive BC. METHODS: We compared negative [oestrogen (ER) and progesterone receptor (PR) <1%], low-positive (ER and/or PR 1-9%) and strong-positive (ER or PR 10-100%) HR-expression in neoadjuvant clinical trial cohorts (n = 2765) of BC patients. End-points were disease-free survival (DFS), distant-disease free survival (DDFS) and overall survival (OS). We performed RNA sequencing on available tumour tissue samples from patients with low-HR expression (n = 38). RESULTS: Ninety-four (3.4%) patients had low HR-positive tumours, 1769 (64.0%) had strong HR-positive tumours, and 902 (32.6%) had TNBC. There were no significant differences in pCR rates between women with low HR-positive tumours (27.7%) and women with TNBC (35.5%). DFS and DDFS were also not different [for DFS, hazard ratio 1.26, 95%-CI (confidence interval) : 0.87-1.83, log-rank test p = 0.951; for DDFS, hazard ratio 1.17, 95%-CI: 0.78-1.76, log-rank test p = 0.774]. Patients with strong HR-positive tumours had a significantly lower pCR rate (pCR 9.4%; odds ratio 0.38, 95%-CI: 0.23-0.63), but better DFS (hazard ratio 0.48, 95%-CI: 0.33-0.70) and DDFS (hazard ratio 0.49, 95%-CI: 0.33-0.74) than patients with low HR-positive tumours. Molecular subtyping (RNA sequencing) of low HR-positive tumours classified these predominantly into a basal subtype (86.8%). CONCLUSION: Low HR-positive, HER2-negative tumours have a similar clinical behaviour to TNBC showing high pCR rates and poor survival and also a basal-like gene expression signature. Patients with low HR-positive tumours should be regarded as candidates for therapy strategies targeting TNBC.

The effect of interprofessional education on healthcare providers' intentions to engage in interprofessional shared decision-making: Perspectives from the theory of planned behaviour.

AIMS AND OBJECTIVES: The present study aimed to investigate the effects of interprofessional education on healthcare providers' intentions to engage in an interprofessional shared decision-making (IP-SDM) process at emergency department and exploring the affecting factors on their intentions. METHODS: We conducted the study through a sequential explanatory mixed method (quantitative-qualitative) design. All ED residents and nurses from two university hospitals were invited and assigned to the intervention and control groups. The intervention group was exposed to case-based learning sessions conducted by applying interprofessional strategies. The intentions of the participants engaged in IP-SDM were assessed before and 2 weeks after the intervention by a questionnaire designed based on the theory of planned behaviour. The questionnaire scores were compared between the intervention and control groups using analysis of covariance (ANCOVA). Partial eta-squared (η2 ) was used for effect size calculations in ANCOVA. Subsequently, to explore the affecting factors in engagement in IP-SDM, qualitative data were collected through semi-structured individual interviews. The inductive content analysis approach by Elo and Kyngas was employed to analyze the qualitative data. RESULTS: Out of 117 potentially eligible healthcare professionals, 113 completed the study in the intervention (n = 55) and control (n = 58) groups. The results showed that the difference between the mean scores of the learners in the intervention (1.41 ± 0.27) and control (0.80 ± 0.52) groups was statistically significant (P-value = .00001). The main effect of the intervention and a large educational effect size for the intervention were found to be statistically significant F (1, 11) = 180.54, P-value = .00001, η2 = 0.62. The qualitative data analysis showed two main categories of "team-based facilitators" and "contextual challenges" as the main affecting factors in the engagement of participant in IP-SDM. CONCLUSION: Our findings suggested that applying interprofessional education strategies could improve the learners' intention to engage in IP-SDM. Moreover, the results showed that the interprofessional collaboration among team members, adherence to the team-based care principles, and administrative support at different levels could be the influential factors the intentions of the participants to engage in IP-SDM.

Combination of liver enzymes, amylase and abdominal ultrasound tests have acceptable diagnostic values as an alternative test for abdominopelvic CT scan in blunt abdominal trauma.

INTRODUCTION: Abdominal trauma accounts for 15-20% of all-cause mortality of trauma. Abdominopelvic CT scan with intravenous contrast is considered the most accurate non-invasive diagnostic tool in detecting intra-abdominal injuries. In previous studies, rise in liver enzymes and amylase was associated with intra-abdominal injuries but the studies were not sufficient. Our aim was to assess the diagnostic values of liver enzymes and amylase for intra-abdominal injuries in blunt trauma patients. METHODS: We included blunt abdominal trauma patients who referred to three teaching hospitals in 2018. The patients who had 14 years old or more and Glasgow Coma Scale above 8 were enrolled the study if the treating physician had high index of suspicion for intra-abdominal injuries and sent the patients for abdominopelvic CT scan with intravenous contrast. Sensitivity, specificity, positive and negative predictive values are calculated for results of liver enzymes, amylase and abdominal ultrasound. RESULTS: Eventually, 300 patients with blunt abdominal trauma entered the study. Sensitivity, specificity, positive and negative predictive values of concurrent positive results of abdominal ultrasound, amylase and liver enzymes were 81.73 (95% CI, 73.2-88.1), 63.78 (95% CI, 65.36-70.61), 58.38 (95% CI, 56.36-70.61) and 84.89 (95% CI, 77.6-90.19), respectively. CONCLUSION: Considering findings of the present study, the combination of liver enzymes, amylase and abdominal ultrasound results can be an alternative method for detecting intra-abdominal injuries in patients in whom treating physicians have limitations such as overweight, instability of hemodynamic and lack of CT scan facility.

Intravenous Acetaminophen vs. Ketorolac in Terms of Pain Management in Prehospital Emergency Services: A Randomized Clinical Trial.

INTRODUCTION: Although pain management in EDs has been fully addressed in clinical trials, prehospital settings have rarely been investigated. OBJECTIVE: The present study was conducted to compare the effectiveness of intravenous acetaminophen with that of ketorolac in pre-hospital pain control. METHOD: This randomized clinical trial (RCT) was performed at a prehospital setting during EMS missions in Tehran, Iran. The eligible candidates comprised all patients over the age of 7 years with a complaint of moderate to severe pain. The patients were randomly assigned to two groups, one receiving 30 mg of intravenous (IV) ketorolac and the other 1 g of IV acetaminophen. The pain intensity was measured using a visual analog scale (VAS) before administering the analgesic and upon admission to the ED. RESULTS: The present study was conducted on 150 patients aged 8-81 years with a mean age of 40.4 ± 17.7, including 84 (56%) males. The mean reduction in the pain score was 14.9±8.6 in the acetaminophen group and 16.0±8.8 in the ketorolac group. Univariate analyses suggested no statistically significant differences between the two groups in terms of delta pain score (pain reduction) (P=0.429). CONCLUSION: Based on the obtained findings, both ketorolac and acetaminophen could be administered for pain management in prehospital settings in both traumatic and non-traumatic patients in case their contraindications are considered.

Daylight saving time and incidence ratio of acute myocardial infarction among Iranian people.

Iran is among the countries which change official time, every year according to their constitutions. Studies have shown an increase of incidence ratio (IR) of acute myocardial infarction by these time transitions. Despite annual time changes in Iran, there is no published data to prove this among the Iranian. This retrospective study examined the IR of patients with AMI, who were admitted to the Emergency Department (ED) of 5 teaching hospitals during the week just after the time transitions (observed period), with two weeks before and after the time transitions (expected period), both in spring and fall. In total, 11051 patients were admitted during the ten weeks (observed and expected), in both spring and fall time transitions. The IR of AMI during both observed and expected period did not show any significant difference (p > 0.05); however, the incidence of AMI was increased during the first week after the transition in spring (p > 0.05). Although the results of the present study did not prove the relation between time transitions and incidence of AMI, a slight increase existed for IR of AMI during three days after spring shift. This increase in IR of AMI can be due to Nowrooz, the national holidays which lasts four days after turning clocks forward in Iran.

Non-sentinel axillary tumor burden applying the ACOSOG Z0011 eligibility criteria to a large routine cohort.

PURPOSE: In the ACOSOG Z0011 trial, patients with primary breast cancer (BC) and 1-2 tumor-involved sentinel lymph nodes (SLN) undergoing breast-conserving surgery gained no benefit from completing axillary lymph node dissection (cALND). This paper reports cALND rates performed in clinical routine on patients who would meet the Z0011 criteria. Further, patients still received cALND were analyzed concerning the number of non-sentinel metastases (NSM) to estimate occult axillary tumor burden. METHODS: Data were retrospectively analyzed from patients treated in 179 German breast centers between 2008 and 2015. Time-trend rates were determined for cALND regarding the presence of axillary macrometastases or micrometastases. Descriptive statistics were used to report the number of NSM depending on the number of SLN removed, tumor-involved SLN, tumor stage (pT1-2), and immunohistochemical subtype. Factors associated with NSM were identified using multivariable logistic regression. RESULTS: Altogether, data for 188,909 patients were available, of whom 13,741 (7.3%) were identified eligible for the Z0011 criteria. For these patients, the cALND rate for macrometastases declined from 96.4% in 2008 to 49.7% in 2015, for micrometastases from 86.7 to 5.9%. In total 9773 patients still received cALND, 33.4% of whom had NSM. The NSM rates were: 38.8% for pN(1/1sn), 28.6% for pN(1/2sn), and 50.9% for pN(2/2sn). Hormone receptor (HR) positive/HER2+ showed the highest NSM rate (41.6%), HR-/HER2- the lowest rate (29.4%). CONCLUSIONS: The rate of cALND for ACOSOG Z0011 eligible patients has decreased substantially in routine care in our nationwide cohort. Our data reveal a relatively high prevalence of additional axillary NSM tumor burden.

Influence of patient and tumor characteristics on therapy persistence with letrozole in postmenopausal women with advanced breast cancer: results of the prospective observational EvAluate-TM study.

BACKGROUND: Treatment of postmenopausal, hormone receptor-positive metastatic breast cancer (MBC) patients varies despite clear therapy guidelines, favoring endocrine treatment (ET). Aim of this study was to analyze persistence of palliative aromatase inhibitor (AI) monotherapy in MBC patients. METHODS: EvAluate-TM is a prospective, multicenter, noninterventional study to evaluate treatment with letrozole in postmenopausal women with hormone receptor-positive breast cancer. To assess therapy persistence, defined as the time from therapy start to the end of the therapy (TTEOT), two pre-specified study visits took place after 6 and 12 months. Competing risk survival analyses were performed to identify patient and tumor characteristics that predict TTEOT. RESULTS: Out of 200 patients, 66 patients terminated treatment prematurely, 26 (13%) of them due to causes other than disease progression. Persistence rate for reasons other than progression at 12 months was 77.7%. Persistence was lower in patients who reported any adverse event (AE) in the first 30 days of ET (89.5% with no AE and 56% with AE). Furthermore, patients had a lower persistence if they reported compliance problems in the past before letrozole treatment. CONCLUSIONS: Despite suffering from a life-threatening disease, AEs of an AI will result in a relevant number of treatment terminations that are not related to progression. Some subgroups of patients have very low persistence rates. Especially with regard to novel endocrine combination therapies, these data imply that some groups of patients will need special attention to guide them through the therapy process. TRIAL REGISTRATION: Clinical Trials Number: CFEM345DDE19.

Prospective, Multicenter, Randomized Phase III Trial Evaluating the Impact of Lymphoscintigraphy as Part of Sentinel Node Biopsy in Early Breast Cancer: SenSzi (GBG80) Trial.

PURPOSE: The aim of the current work was to clarify whether a preoperative lymphoscintigraphy (LSG) enhances staging accuracy of sentinel lymph node biopsy (SLNB). PATIENTS AND METHODS: In a prospective, multicenter, randomized phase III trial, patients with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid LSG with subsequent SLNB were randomly assigned 1:1 to receive SLNB either with knowledge of the LSG findings or without. As the false-negative rate of SLNB correlates with the number of resected sentinel lymph nodes (SLNs), our primary end point was the mean number of histologically detected SLNs per patient. One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG. Stratified one-sided 95% CI for the difference (without LSG - with LSG) in the mean number of histologically detected SLNs had to be greater than -0.27 (10% noninferiority margin). Stratification was performed according to tumor focality and trial site. Additional predefined secondary end points (rates of node-positive patients and of completion axillary lymph node dissection) were analyzed to rule out differences in the reliable detection of nodal metastases. RESULTS: Between May 2014 and October 2015, 1,198 patients were randomly assigned in 23 German and Swiss breast centers. Modified intention-to-treat analysis (n = 1,163) showed a mean number of histologically detected SLNs of 2.21 with LSG and 2.26 without LSG (difference 0.05; stratified 95% CI, -0.18 to infinity), thus establishing noninferiority of omitting preoperative LSG. Secondary end points displayed no statistically significant differences. CONCLUSION: We show that SLNB is equally effective irrespective of the surgeon's knowledge of preoperative LSG results. SLNB without LSG will speed up the preoperative workflow and reduce cost.

Evolution of the Use of Completion Axillary Lymph Node Dissection in Patients with T1/2N0M0 Breast Cancer and Tumour-Involved Sentinel Lymph Nodes Undergoing Mastectomy: A Cohort Study.

BACKGROUND: In breast cancer, completion axillary lymph node dissection (cALND) was previously recommended for patients with at least one tumour-affected sentinel lymph node (SLN). Several prospective trials predominantly in patients undergoing breast-conserving surgery showed no benefit and increased arm morbidity with this procedure. We report the influence of these trials on clinical practice of patients undergoing mastectomy. METHODS: We analysed prospectively collected data from patients with primary invasive breast cancer treated at German breast cancer units between January 2008 and December 2015. Time trends of cALND rates were analysed in patients undergoing mastectomy for T1/2N0M0 breast cancer with one or two tumour-involved SLNs. Multivariable logistic regression was used to determine factors influencing the decision not to perform cALND. RESULTS: Among the entire study cohort of 166,074 patients treated at 179 breast cancer units, 4093 patients (2%) had T1/2N0M0 breast cancer with one or two tumour-involved SLNs and underwent mastectomy. cALND rates decreased from 89.9% in 2010 to 55.5% in 2015 (p < 0.001). Rates decreased from 82% to 8% in patients with micrometastatic SLN disease and from 93% to 63% in those with macrometastasis (p < 0.001). In multivariable analysis, factors associated with omission of cALND were treatment at a general, nonacademic hospital, pT1 status, older age, higher number of removed SLNs, fewer tumour-affected SLNs, and SLN micrometastasis (all p < 0.001). CONCLUSIONS: Despite limited evidence from prospective trials relating to the omission of cALND specifically in patients undergoing mastectomy, our nationwide data show that use of cALND decreased in these patients in routine clinical practice.

Development of central nervous system metastases as a first site of metastatic disease in breast cancer patients treated in the neoadjuvant trials GeparQuinto and GeparSixto.

BACKGROUND: The incidence of central nervous system (CNS) metastases in breast cancer patients is rising and has become a major clinical challenge. Only few data are published concerning risk factors for the development of CNS metastases as a first site of metastatic disease in breast cancer patients. Moreover, the incidence of CNS metastases after modern neoadjuvant treatment is not clear. METHODS: We analyzed clinical factors associated with the occurrence of CNS metastases as the first site of metastatic disease in breast cancer patients after neoadjuvant treatment in the trials GeparQuinto and GeparSixto (n = 3160) where patients received targeted treatment in addition to taxane and anthracycline-based chemotherapy. RESULTS: After a median follow-up of 61 months, 108 (3%) of a total of 3160 patients developed CNS metastases as the first site of recurrence and 411 (13%) patients had metastatic disease outside the CNS. Thirty-six patients (1%) developed both CNS metastases and other distant metastases as the first site of metastatic disease. Regarding subtypes of the primary tumor, 1% of luminal A-like (11/954), 2% of luminal B-like (7/381), 4% of HER2-positive (34/809), and 6% of triple-negative patients (56/1008) developed CNS metastases as the first site of metastatic disease. In multivariate analysis, risk factors for the development of CNS metastases were larger tumor size (cT3-4; HR 1.63, 95% CI 1.08-2.46, p = 0.021), node-positive disease (HR 2.57, 95% CI 1.64-4.04, p < 0.001), no pCR after neoadjuvant chemotherapy (HR 2.29, 95% CI 1.32-3.97, p = 0.003), and HER2-positive (HR 3.80, 95% CI 1.89-7.64, p < 0.001) or triple-negative subtype (HR 6.38, 95% CI 3.28-12.44, p < 0.001). CONCLUSIONS: Especially patients with HER2-positive and triple-negative tumors are at risk of developing CNS metastases despite effective systemic treatment. A better understanding of the underlying mechanisms is required in order to develop potential preventive strategies.

Are serial hematocrit measurements sensitive enough to predict intra-abdominal injuries in blunt abdominal trama?

OBJECTIVE: Routine serial hematocrit measurements are a component of the trauma evaluation for patients without serious injury identified on initial evaluation. We sought to determine whether serial hematocrit testing was useful in predicting the probable injuries in blunt abdominal trauma. MATERIALS AND METHOD: We performed a prospective study of trauma patients admitted in our observation unit over a 12-month period. Patients routinely underwent serial hematocrit testing in 6-hour intervals (two hematocrit levels). We compared trauma patients with a hematocrit drop of 5 and 10 points or more to those without a significant hematocrit drop. RESULTS: Five hundred forty-two isolated blunt abdominal trauma patients were admitted to observation unit, and 468 patients (86.35%) had serial hematocrit during their 6-hour stay. Of these patients, 36.11% had a hematocrit drop of 5 or more and 12.61% a drop of 10 or more. Of patients with the hematocrit drop >10, 50.8% have had diagnostic manifestations of intra-abdominal injury in both ultrasonographic and computed tomography scanning (P<0.001). There was no significant correlation between hematocrit drop >5 and positive imaging. CONCLUSION: Although serial hematocrit testing may be useful in specific situations, routine use of serial hematocrit testing in trauma patients at a level I trauma center's observation unit did not significantly aid in the prediction of occult injuries.

Evaluation of soluble carbonic anhydrase IX as predictive marker for efficacy of bevacizumab: A biomarker analysis from the geparquinto phase III neoadjuvant breast cancer trial.

We analyzed the predictive potential of pretreatment soluble carbonic anhydrase IX levels (sCAIX) for the efficacy of bevacizumab in the phase III neoadjuvant GeparQuinto trial. sCAIX was determined by enzyme-linked immunosorbent assay (ELISA). Correlations between sCAIX and pathological complete response (pCR), disease-free and overall survival (DFS, OS) were assessed with logistic and Cox proportional hazard regression models using bootstrapping for robust estimates and internal validation. 1,160 HER2-negative patient sera were analyzed, of whom 577 received bevacizumab. Patients with low pretreatment sCAIX had decreased pCR rates (12.1 vs. 20.1%, p = 0.012) and poorer DFS (adjusted 5-year DFS 71.4 vs. 80.5 months, p = 0.010) compared to patients with high sCAIX when treated with neoadjuvant chemotherapy (NCT). For patients with low sCAIX, pCR rates significantly improved upon addition of bevacizumab to NCT (12.1 vs. 20.4%; p = 0.017), which was not the case in patients with high sCAIX (20.1% for NCT vs. 17.0% for NCT-B, p = 0.913). When analyzing DFS we found that bevacizumab improved 5-year DFS for patients with low sCAIX numerically but not significantly (71.4 vs. 78.5 months; log rank 0.234). In contrast, addition of bevacizumab worsened 5-year DFS for patients with high sCAIX (81 vs. 73.6 months, log-rank 0.025). By assessing sCAIX levels we identified a patient cohort in breast cancer that is potentially undertreated with NCT alone. Bevacizumab improved pCR rates in this group, suggesting sCAIX is a predictive biomarker for bevacizumab with regards to treatment response. Our data also show that bevacizumab is not beneficial in patients with high sCAIX.

Which patients with sentinel node-positive breast cancer after breast conservation still receive completion axillary lymph node dissection in routine clinical practice?

PURPOSE: In the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial, patients with 1 or 2 tumour-involved sentinel lymph nodes (SLNs) gained no benefit from completion axillary lymph dissection (cALND). We examined implementation of evidence from this trial into routine clinical management. METHODS: Data were included from patients diagnosed with primary breast cancer in German breast cancer units between 2008 and 2015 and analysed retrospectively from a prospective maintained database. Descriptive analyses assessed time-trend changes in axillary surgery. Factors associated with cALND in patients with 1 or 2 positive SLNs were identified using multivariable logistic regression analysis. RESULTS: Overall, 179 breast cancer units provided data for 188,909 patients, of whom 13,741 (7.3%) had pT1/2cN0M0 invasive breast cancer with 1 or 2 tumour-involved SLNs and underwent breast-conserving surgery and adjuvant radiotherapy. cALND use decreased from 94.6% in 2008 to 46.9% in 2015 (p < 0.001). In multivariable analyses, the following factors were associated with cALND: fewer removed SLNs; two tumour-affected SLNs; younger age; lower annual case volume per hospital; higher tumour grade and lymphovascular invasion. No statistically significant influence was detected for hormone receptor or HER2 status. CONCLUSION: In our cohort, 7.3% of patients with primary breast cancer met the ACOSOG Z0011 inclusion criteria and could potentially have been spared the morbidity of cALND. cALND tended to be performed in patients with a higher axillary tumour burden. This study shows a shift towards less extensive axillary surgery through rapid implementation of new clinical trial evidence into routine clinical practice.

Intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for neoadjuvant treatment of high-risk early breast cancer (GeparOcto-GBG 84): A randomised phase III trial.

BACKGROUND: GeparOcto compared efficacy and safety of two chemotherapy regimens in high-risk early breast cancer (BC): sequential treatment with intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) and weekly treatment with paclitaxel plus non-pegylated liposomal doxorubicin (M, Myocet®) with additional carboplatin (PM(Cb)) in triple-negative BC (TNBC). PATIENTS AND METHODS: Patients with cT1c-cT4a-d and centrally assessed human epidermal growth factor receptor (HER)2-positive BC or TNBC were eligible, irrespective of nodal status, luminal B-like tumours only if pN+. Patients were randomised (stratified by BC subtype, Ki67, lymphocyte-predominant BC) to receive 18 weeks of E (150 mg/m2) followed by P (225 mg/m2) followed by C (2000 mg/m2), each q2w for 3 cycles or weekly P (80 mg/m2) plus M (20 mg/m2) plus, in TNBC, Cb (area under curve (AUC) 1.5). HER2-positive BC patients additionally received trastuzumab (6 [loading dose 8]mg/kg q3w) and pertuzumab (420 [840]mg q3w) with all P and C cycles. Primary end-point was pathological complete response (pCR, ypT0/is ypN0), secondary end-points included other pCR definitions, pCR in stratified subpopulations, tolerability and compliance. This trial is registered with ClinicalTrials.gov number NCT02125344. RESULTS: 945/961 randomised patients started treatment. The median age was 48 years; 7.6% had cT3-4, 46% cN+, 66% G3, 40% HER2-positive, 43% TNBC. pCR rate with iddEPC was 48.3%, with PM(Cb) 48.0%, respectively (PM(Cb) versus iddEPC odds ratio 0.99; 95% confidence interval 0.77-1.28, P = 0.979) with no significant differences observed in TNBC, HER2-positive, luminal B-like subtypes. 16.4% with iddEPC and 34.1% with PM(Cb) discontinued treatment (P < 0.001), mainly due to adverse events; two patients on PM(Cb) died. CONCLUSIONS: In high-risk early BC there is no difference in pCR rates following neoadjuvant treatment with iddEPC or weekly PM(Cb), respectively. iddEPC is one of the effective dose-dense regimens feasible in daily practice.

Validity, reliability and acceptability of Professionalism Mini-Evaluation Exercise (P-MEX) for emergency medicine residency training.

Professionalism is a core competency in the medical profession. In this paper, we aimed to confirm the validity, reliability and acceptability of the Professionalism Mini-Evaluation Exercise (P-MEX) instrument for the emergency medicine (EM) residency program. Twenty-two EM attending physicians completed 383 P-MEX forms (the Persian version) for 90 EM residents. Construct validity was assessed via structural equation modeling (SEM). The reliability coefficient was estimated by the generalizability theory, and acceptability was assessed using two researcher-made questionnaires to evaluate the perspectives of residents and assessors. There was a consensus among the participants regarding the content of P-MEX. According to the results of SEM, the first implementation of the original model was associated with a moderate fit and high item loadings. The model modified with correlated error variances for two pairs of items showed an appropriate fit. The reliability of P-MEX was 0.81 for 14 occasions. The perception survey indicated high acceptability for P-MEX from the viewpoint of the residents and increasing satisfaction with P-MEX among the assessors over time. According to the results of the research, P-MEX is a reliable, valid, and acceptable instrument for assessing professionalism in EM residents.

Screening performance of Ultrasonographic B-lines in Detection of Lung Contusion following Blunt Trauma; a Diagnostic Accuracy Study.

INTRODUCTION: Chest ultrasonography is routinely used in evaluation of chest trauma for diagnosis of pulmonary injury. This study aimed to evaluate the accuracy of B-Lines for diagnosing lung contusion in patients with blunt trauma of the chest. METHODS: Trauma patients who met the inclusion criteria were enrolled in the study and underwent ultrasonography by trained emergency medicine residents. Ultrasound results were recorded in terms of number of B-lines and the existence of peripheral parenchymal lesion (PPL). After ultrasound, the patient underwent chest x-ray and chest CT scan (as reference test) and screening performance of B-lines and PPL were evaluated. RESULTS: 147 patients underwent chest ultrasound. The mean age of the patients was 40.74 ± 18.6 (78.9% male). B-lines˃3 had 94.0% (95% CI: 83.45-98.75) sensitivity and 57.7% (95% CI: 47.3-67.7) specificity, B-lines˃6 had 90.0% (95% CI: 78.2-96.7) sensitivity and 93.81% (95% CI: 87.0-97.7) specificity, and PPL had 34.0% (95% CI: 21.2-48.8) sensitivity and 100% (95% CI: 96.3-100.0) specificity. Composite findings of B-lines˃6 + PPL had 92.0% (95% CI: 80.8-97. 8) sensitivity and 93.8% (95% CI: 87.0-97.7) specificity in the diagnosis of lung contusion. CONCLUSION: PPL and B-Lines˃6 had the highest accuracy in detecting lung contusion. B-Line˃6 had high sensitivity and specificity and was easy to perform; thus, it seems that B-Line˃6 could be considered as an alternative screening tool in detection of lung contusion.

BRCA1/2 Mutations and Bevacizumab in the Neoadjuvant Treatment of Breast Cancer: Response and Prognosis Results in Patients With Triple-Negative Breast Cancer From the GeparQuinto Study.

Purpose BRCA1/2 mutations are frequent in patients with triple-negative breast cancer (TNBC). These patients are often treated with primary systemic chemotherapy. The aim of this study was to analyze the effects of BRCA1/2 mutations on pathologic complete response (pCR) and disease-free survival (DFS) in a cohort of patients with TNBC treated with anthracycline and taxane-containing chemotherapy, with or without bevacizumab. Patients and Methods Germline DNA was sequenced to identify mutations in BRCA1 and BRCA2 in 493 patients with TNBC from the GeparQuinto study. The pCR rates were compared in patients with and without mutation, as well as in patients treated with and without bevacizumab. In addition, the influence of BRCA1/2 mutation status and pCR status on DFS was evaluated relative to treatment. Results BRCA1/2 mutations were detected in 18.3% of patients with TNBC. Overall, patients with mutations had a pCR rate of 50%, compared with 31.5% in patients without a mutation (odds ratio [OR], 2.17; 95% CI, 1.37 to 3.46; P = .001). The pCR rate among patients treated with bevacizumab was 61.5% for BRCA1/2 mutation carriers and 35.6% for those without mutations (OR, 2.90; 95% CI, 1.43 to 5.89; P = .004). pCR was a strong predictor of DFS for patients without BRCA1/2 mutations (hazard ratio, 0.18; 95% CI, 0.11 to 0.31) but not for patients with BRCA1/2 mutations (hazard ratio, 0.74; 95% CI, 0.32 to 1.69). Conclusion The addition of bevacizumab may increase the pCR after standard neoadjuvant chemotherapy for patients with TNBC with BRCA1/2 mutations. In patients treated with anthracycline and taxane-based chemotherapy (with or without bevacizumab), pCR was a weaker predictor of DFS for BRCA1/2 mutation carriers than for patients without mutations.