Weekly cisplatin, epirubicin, and paclitaxel with granulocyte colony-stimulating factor support vs triweekly epirubicin and paclitaxel in locally advanced breast cancer: final analysis of a sicog phase III study

The present study aimed at evaluating whether a weekly cisplatin, epirubicin, and paclitaxel (PET) regimen could increase the pathological complete response (pCR) rate in comparison with a tri-weekly epirubicin and paclitaxel administration in locally advanced breast cancer (LABC) patients. Patients with stage IIIB disease were randomised to receive either 12 weekly cycles of cisplatin 30 mg m−2, epirubicin 50 mg m−2, and paclitaxel 120 mg m−2 (PET) plus granulocyte-colony stimulating factor support, or four cycles of epirubicin 90 mg m−2+paclitaxel 175 mg m−2 (ET) every 3 weeks. Overall, 200 patients (PET/ET=100/100) were included in this study. A pCR in both breast and axilla occurred in 16 (16%) PET patients and in six (6%) ET patients (P=0.02). The higher activity of PET was evident only in ER negative (27.5 vs 5.4%; P=0.026), and in HER/neu positive (31 vs 5%; P=0.037) tumours. The two arms yielded similar pCR rate in ER positive (PET/ET=7.5/7.1%) and HER/neu negative (PET/ET=10/6%) patients. At a 39 months median follow-up, 70 patients showed a progression or relapses (PET, 32 vs ET, 38). Anaemia, mucositis, peripheral neuropathy, and gastrointestinal toxicity were substantially more frequent in the PET arm. The PET weekly regimen is superior to ET in terms of pCR rate in LABC patients with ER negative and/or HER2 positive tumours Mature data in terms of disease-free and overall survival are needed to ascertain whether this approach could improve the prognosis of these subsets of LABC patients

Quality of Reporting on the Vegetative State in Italian Newspapers. The Case of Eluana Englaro

Background: Media coverage of the vegetative state (VS) includes refutations of the VS diagnosis and describes behaviors inconsistent with VS. We used a quality score to assess the reporting in articles describing the medical characteristics of VS in Italian newspapers. Methodology/Principal Findings: Our search covered a 7-month period from July 1, 2008, to February 28, 2009, using the online searchable databases of four major Italian newspapers: Corriere della Sera, La Repubblica, La Stampa, and Avvenire. Medical reporting was judged as complete if three core VS characteristics were described: patient unawareness of self and the environment, preserved wakefulness (eyes open), and spontaneous respiration (artificial ventilator not needed). We retrieved 2,099 articles, and 967 were dedicated to VS. Of these, 853 (88.2%) were non-medical and mainly focused on describing the political, legal, and ethical aspects of VS. Of the 114 (11.8%) medical articles, 53 (5.5%) discussed other medical problems such as death by dehydration, artificial nutrition, neuroimaging, brain death, or uterine hemorrhage, and 61 (6.3%) described VS. Of these 61, only 18 (1.9%) reported all three CORE characteristics and were judged complete. We found no differences among the four investigated newspapers (Fisher’s exact = 0.798), and incomplete articles were equally distributed between journalistic pieces and expert opinions (x 2 = 1.8854, P = 0.170). Incorrect descriptions of VS were significantly more common among incomplete articles (13 of 43 vs. 1 of 18; Fisher’s exact P = 0.047)

Is prolonged infusion of piperacillin/tazobactam and meropenem in critically ill patients associated with improved pharmacokinetic/pharmacodynamic and patient outcomes? An observation from the Defining Antibiotic Levels in Intensive care unit patients (DALI) cohort

Objectives:We utilized the database of the Defining Antibiotic Levels in Intensive care unit patients (DALI) study to statistically compare the pharmacokinetic/pharmacodynamic and clinical outcomes between prolonged-infusion and intermittent-bolus dosing of piperacillin/tazobactam and meropenem in critically ill patients using inclusion criteria similar to those used in previous prospective studies.Methods: This was a post hoc analysis of a prospective, multicentre pharmacokinetic point-prevalence study (DALI), which recruited a large cohort of critically ill patients from 68 ICUs across 10 countries.Results: Of the 211 patients receiving piperacillin/tazobactam and meropenem in the DALI study, 182 met inclusion criteria. Overall, 89.0% (162/182) of patients achieved the most conservative target of 50% fT(> MIC) (time over which unbound or free drug concentration remains above the MIC). Decreasing creatinine clearance and the use of prolonged infusion significantly increased the PTA for most pharmacokinetic/pharmacodynamic targets. In the subgroup of patients who had respiratory infection, patients receiving beta-lactams via prolonged infusion demonstrated significantly better 30 day survival when compared with intermittent-bolus patients [86.2% (25/29) versus 56.7% (17/30); P=0.012]. Additionally, in patients with a SOFA score of >= 9, administration by prolonged infusion compared with intermittent-bolus dosing demonstrated significantly better clinical cure [73.3% (11/15) versus 35.0% (7/20); P=0.035] and survival rates [73.3% (11/15) versus 25.0% (5/20); P=0.025].Conclusions: Analysis of this large dataset has provided additional data on the niche benefits of administration of piperacillin/tazobactam and meropenem by prolonged infusion in critically ill patients, particularly for patients with respiratory infections

Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

Background: Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients. Methods/design The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH2O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH2O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint. Discussion To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs. Trial registration ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1929-0) contains supplementary material, which is available to authorized users

An international survey: Public awareness and perception of sepsis

BACKGROUND: Sepsis is a common cause of death throughout the world. Early treatment improves outcome; however, treatment may be delayed if the patient does not present himself/herself for medical care until late in the disease process. Lack of knowledge about the syndrome may contribute to delay in presenting for medical care. However, we need to acknowledge the complexity of sepsis. General awareness of sepsis by the public may increase political pressure for research funding. Increased public awareness of acute myocardial infarction has contributed to reduced mortality over the last 50 yrs. This example provides a rationale for future efforts to increase the public awareness of sepsis. OBJECTIVE: The survey was designed to gain insight into public perceptions and attitudes regarding sepsis. DESIGN: Prospective, international survey performed using structured telephone interviews. SUBJECTS: A total of 6021 interviewees, 5021 in Europe and 1000 in the United States. MEASUREMENTS AND MAIN RESULTS: In Italy, Spain, the United Kingdom, France and the United States, a mean of 88% of interviewees had never heard of the term "sepsis". In Germany 53% of people knew the word sepsis. In Italy, Spain, United Kingdom, France, and United States, of people who recognized the term sepsis, 58% did not recognize that sepsis is a leading cause of death. CONCLUSIONS: There is poor public awareness about the existence of a syndrome known as sepsis. Results of this questionnaire underscore the challenges in early management and treatment of infected patients at risk for developing sepsis syndrome

The Competency-Based Training in Intensive Care Medicine in Europe (CoBaTrICE) Italian collaborative : national results from the Picker survey

Background. The aim of the Competency-Based Training in Intensive Care medicine in Europe (CoBaTrICE) project is to create an internationally acceptable competency-based training program for specialists in intensive care medicine. The CoBaTrICE project has performed a survey, in collaboration with the Picket institute, United Kingdom, to identify desirable characteristics of Intensive Care Unit (ICU) specialists, as expressed by patients and their relatives. Methods. A questionnaire was developed to assess 21 elements of professional competence. Each element was assigned to one of four categories of a Likert scale: 1=essential; 2=very important; 3=not too important; 4=does not matter. The results were dichotomized into essential (score: 1) and not essential (scores: 2-4) categories. Further, the elements were related to three key concepts: "medical skills and competencies", "communication with patients", and "communication with relatives". Questionnaire statements grouped by theme were also ranked for each item using a number: 1=highest rank; 21=lowest rank. Free text responses were also invited. Results. Ten Italian ICUs were enrolled in the study. There were 249 questionnaires completed (18% total return rate). Conclusion. Priority in Italy was given to medical skills and competence. Involvement of patients and relatives in decision-making processes were among the items considered least important. Italian families preferred a paternalist approach to the end of life decision-making process

X-ray tomography of termite nests from Senegal and Guinea

In this study, two different African <i>Trinervitermes geminatus</i> termite nests were excavated, one from Nguekokh, Senegal (during early October 2010) and the other from Kankan, Guinea (during early July 2007), which are about 1100 km apart. Both nests were in Savanna type vegetation, with higher tree density in Guinea. Both nests were exposed to the sun. The excavated nests were first imaged with a medical X-ray CT scanner at a pixel-resolution of 0.3-0.6 mm, which allowed us to investigate the complete structure of the nests in three dimensions non-destructively.<br><br>We then drilled multiple samples from different parts of the inner and outer walls of the nests, and scanned them non-destructively with a high-resolution X-ray micro-tomography scanner at a voxel size of 5 µm. All the X-ray micro-tomographic images in these datasets are from the outer walls, except the sample 'Senegal_termite_nest_Xray_micro_CT_sample_3' which was taken from the internal walls of the Senegal nest.<br><br>The details of the image properties and the usage notes are provided in the 'Read_me_files_Termite_nest' file.<br><br>The display pic shows the Guinea nest imaged with a medical X-ray CT scanner (left). The outer solid wall of the nest was imaged with a high-resolution X-ray micro-tomography scanner (right).<br><br><br