Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial.

OBJECTIVES: To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. METHODS: In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. RESULTS: Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. CONCLUSIONS: With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. KEY POINTS: • Iodine concentration is an important parameter for image quality in coronary CTA. • Contrast enhancement must be balanced against the amount of iodine injected. • Iobitridol 350 is non-inferior compared to CM with higher iodine concentrations. • Higher attenuation with higher iodine concentrations, but no SNR or CNR differences.

Level of distress, somatisation and beliefs on health-disease in newly arrived immigrant patients attended in primary care centres in Catalonia and definition of professional competences for their most effective management: PROMISE Project.

BACKGROUND: Newly arrived immigrant patients who frequently use primary health care resources have difficulties in verbal communication. Also, they have a system of beliefs related to health and disease that makes difficult for health care professionals to comprehend their reasons for consultation, especially when consulting for somatic manifestations. Consequently, this is an important barrier to achieve optimum care to these groups. The current project has two main objectives: 1. To define the different stressors, the level of distress perceived, and its impact in terms of discomfort and somatisation affecting the main communities of immigrants in our area, and 2. To identify the characteristics of cross-cultural competence of primary health care professionals to best approach these reasons for consultation. METHODS/DESIGN: It will be a transversal, observational, multicentre, qualitative-quantitative study in a sample of 980 people from the five main non-European Union immigrant communities residing in Catalonia: Maghrebis, Sub-Saharans, Andean South Americans, Hindustanis, and Chinese. Sociodemographic data, level of distress, information on the different stressors and their somatic manifestations will be collected in specific questionnaires. Through a semi-structured interview and qualitative methodology, it will be studied the relation between somatic manifestations and particular beliefs of each group and how these are associated with the processes of disease and seeking for care. A qualitative methodology based on individual interviews centred on critical incidents, focal groups and in situ questionnaires will be used to study the cross-cultural competences of the professionals. DISCUSSION: It is expected a high level of chronic stress associated with the level of somatisations in the different non-European Union immigrant communities. The results will provide better knowledge of these populations and will improve the comprehension and the efficacy of the health care providers in prevention, communication, care management and management of resources.

Phase I assessment of new mechanism-based pharmacodynamic biomarkers for MLN8054, a small-molecule inhibitor of Aurora A kinase.

The mitotic kinase Aurora A is an important therapeutic target for cancer therapy. This study evaluated new mechanism-based pharmacodynamic biomarkers in cancer patients in two phase I studies of MLN8054, a small-molecule inhibitor of Aurora A kinase. Patients with advanced solid tumors received MLN8054 orally for 7 consecutive days in escalating dose cohorts, with skin and tumor biopsies obtained before and after dosing. Skin biopsies were evaluated for increased mitotic cells within the basal epithelium. Tumor biopsies were assessed for accumulation of mitotic cells within proliferative tumor regions. Several patients in the highest dose cohorts showed marked increases in the skin mitotic index after dosing. Although some tumors exhibited increases in mitotic cells after dosing, others displayed decreases, a variable outcome consistent with dual mechanisms of mitotic arrest and mitotic slippage induced by antimitotics in tumors. To provide a clearer picture, mitotic cell chromosome alignment and spindle bipolarity, new biomarkers of Aurora A inhibition that act independently of mitotic arrest or slippage, were assessed in the tumor biopsies. Several patients, primarily in the highest dose cohorts, had marked decreases in the percentage of mitotic cells with aligned chromosomes and bipolar spindles after dosing. Evidence existed for an exposure-effect relationship for mitotic cells with defects in chromosome alignment and spindle bipolarity that indicated a biologically active dose range. Outcomes of pharmacodynamic assays from skin and tumor biopsies were concordant in several patients. Together, these new pharmacodynamic assays provide evidence for Aurora A inhibition by MLN8054 in patient skin and tumor tissues.

Accuracy of chest sonography and polymorphonuclear elastase in the assessment of bacterial pleural effusion.

Background: The relationship between chest sonography findings and inflammatory markers for assessing bacterial pleural effusion is not well established. We decided to study the accuracy of chest sonography in determining the nature of bacterial pleural effusion and its relationship with polymorphonuclear elastase (PMN-E) results. Methods: Pleural sonography and PMN-E were evaluated in a prospective study of 144 consecutive patients with pleural effusion of various etiologies: 25 complicated parapneumonic, 18 uncomplicated parapneumonic, 33 tuberculous, 17 malignant, 12 transudates, and 39 of unknown etiology. The sonographer distinguished between anechoic and septated pattern. The relationship between sonographic appearance and inflammatory markers was evaluated. Results: All of the complicated parapneumonic, 11 uncomplicated parapneumonic, and 28 tuberculous effusions were septated. Septated pattern and PMN-E value were independent predictors of infectious pleural disease (p <0.05). The simultaneous presence of a septated pattern and a PMN-E higher than 100 microg/l had a sensitivity of 79.1% and a specificity of 91.1% for the diagnosis of bacterial effusions. Conclusions: PMN-E level and the sonographic pattern of pleural fluid may be useful in the diagnosis of bacterial pleural effusions.