Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice.

Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial.

Background: We aimed to examine whether using a high fraction of inspired oxygen (FIO) in the context of an individualised intra- and postoperative open-lung ventilation approach could decrease surgical site infection (SSI) in patients scheduled for abdominal surgery.

Methods: We performed a multicentre, randomised controlled clinical trial in a network of 21 university hospitals from June 6, 2017 to July 19, 2018. Patients undergoing abdominal surgery were randomly assigned to receive a high (0.

Using a videogame to facilitate nursing and medical students' first visit to the operating theatre. A randomized controlled trial.

Background: First experiences in the operating theatre with real patients are always stressful and intimidating for students. We hypothesized that a game-like simulation could improve perceptions and performance of novices.

Methods: A videogame was developed, combining pictures and short videos, by which students are interactively instructed on acting at the surgical block.

Comparative Diagnostic Utility of Low-Dose Breast-Specific Gamma Imaging to Current Clinical Standard.

To retrospectively compare low-dose (7-10 mCi) to high-dose (15-30 mCi) breast-specific gamma imaging (BSGI) in the detection of breast cancer. A retrospective review of 223 consecutive women who underwent BSGI exam between February 2011 and August 2013 with subsequent pathologic analysis was performed. Women were divided into low-dose and high-dose groups.

Educational Game Development Approach to a particular case: the donor's evaluation.

Background: Serious games are a current trend nowadays. Almost every sector has used serious games in recent years for different educational purposes. The eLearning research team of the Complutense University of Madrid main focus of research is the development of low-cost serious games.

Screening breast ultrasound: past, present, and future.

OBJECTIVE. This article discusses breast ultrasound for the detection of breast cancer in the screening environment, as well as strategies for integrating screening breast ultrasound, including automated breast ultrasound. CONCLUSION.

Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: the SomoInsight Study.

Purpose: To determine improvement in breast cancer detection by using supplemental three-dimensional (3D) automated breast (AB) ultrasonography (US) with screening mammography versus screening mammography alone in asymptomatic women with dense breasts.

Materials And Methods: Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study. The SomoInsight Study was an observational, multicenter study conducted between 2009 and 2011.

Serendipitous oxidation product of BIBN4096BS: a potent CGRP receptor antagonist.

An oxidation product (5) formed during the synthesis of BIBN-4096BS (1) was found to be a potent CGRP antagonist (IC50=0.11nM). While 5 was found to be ten-fold less potent than 1, another analog 8 with lower molecular weight containing the oxidized fragment demonstrated twenty-fold higher activity than its parent 7.

Breast-specific gamma imaging for the detection of breast cancer in dense versus nondense breasts.

Objective: The purpose of this study was to evaluate the sensitivity of breast-specific gamma imaging (BSGI) for the detection of breast cancer in dense versus nondense breasts.

Materials And Methods: This was a retrospective study of 341 women with biopsy-proven breast cancer diagnosed from January 2004 to August 2009 who underwent BSGI before surgical excision. Patients with predominantly fatty replaced (BI-RADS density 1) or scattered fibroglandular tissue (BI-RADS density 2) breasts were classified as nondense, and those with heterogeneously dense (BI-RADS density 3) or extremely dense tissue (BIRADS density 4) were classified as dense.

Application of game-like simulations in the Spanish Transplant National Organization.

Twenty years ago, the Spanish National Transplant Organization (NTO) started a management and organizational system, known as the Spanish Model, that has allowed the NTO to occupy a privileged world position regarding deceased donation rates, which have been 33-35 donors per million population in recent years. One of the key elements of this model is its instructional approach. Two years ago, the NTO started the project "educ@nt" in close collaboration with the e-UCM research group of the University Complutense of Madrid to support and maximize its successful professional training system.

Breast-specific gamma imaging influences surgical management in patients with breast cancer.

Breast-specific gamma imaging (BSGI) is a physiologic breast imaging modality that provides more sensitive detection of breast lesions than mammography or ultrasound, and appears to have greater specificity than breast MRI. The purpose of this study was to evaluate how often BSGI changed surgical management in patients with breast cancer. Charts were reviewed from 218 consecutive eligible patients who had preoperative evaluation with BSGI or MRI before surgery for breast cancer from January 2008 to May 2010.

Importance of hospital versus surgeon volume in predicting outcomes for gastric bypass procedures.

Background: A relationship between surgical volume and improved surgical outcomes has been described in gastric bypass patients but the relative importance of surgeon versus hospital volume is unknown. Our objective was to examine whether in-hospital and 30-day mortality are determined more by surgeon volume or hospital volume or whether each has an independent effect. A retrospective cohort study was performed of all hospitals in Pennsylvania providing gastric bypass surgery from 1999 to 2003.

Effect of tumor size and tumor-to-liver contrast of hypovascular liver tumors on the diagnostic performance of hepatic CT imaging.

Objective: To assess the effect of tumor size and tumor-to-liver contrast of simulated hypovascular liver tumors on the diagnostic accuracy of hepatic computed tomography (CT).

Materials And Methods: This retrospective study was approved by the institutional review board, and informed consent was waived. A total of 153 simulated hypovascular liver tumors were embedded in 70 hepatic CT data sets that were acquired during the portal venous phase.

Diagnostic accuracy of pulmonary CT angiography at low tube voltage: intraindividual comparison of a normal-dose protocol at 120 kVp and a low-dose protocol at 80 kVp using reduced amount of contrast medium in a simulation study.

Objective: The purpose of this study was to simulate pulmonary emboli (PE) and image quality at low tube energy and reduced contrast material volume in normal-dose pulmonary CT angiography (CTA) images and to analyze the diagnostic accuracy with normal- and low-dose pulmonary CTA.

Materials And Methods: Normal-dose pulmonary CTA examinations using 120 kVp and 100 mL of contrast material in 10 patients with no PE were retrospectively selected. The image characteristics of an 80-kVp low-dose pulmonary CTA protocol (patient exposure reduction, 57%) with 75 mL of contrast material were simulated.

CT screening and follow-up of lung nodules: effects of tube current-time setting and nodule size and density on detectability and of tube current-time setting on apparent size.

Objective: The purpose of the study was to quantify and compare the effect of CT dose and of size and density of nodules on the detectability of lung nodules and to quantify the influence of CT dose on the size of the nodules.

Materials And Methods: From 50 patients a total of 125 cuboidal regions of interest (3 × 3 × 1.5 cm volumes) showing a single nodule (≤ 8 mm) and 27 normal cuboids were selected.

Breast-specific gamma imaging as an adjunct modality for the diagnosis of invasive breast cancer with correlation to tumour size and grade.

Objectives: The purpose of this study was to determine the sensitivity of breast-specific gamma imaging (BSGI) in the detection of invasive breast cancers and to characterise the sensitivity of BSGI based on tumour size and pathological grade.

Methods: 139 females with invasive carcinoma who underwent BSGI were retrospectively reviewed. Patients were injected in the antecubital vein with 20-30 mCi (925-1110 MBq) of (99m)Tc-sestamibi.

Full-field digital mammographic interpretation with prior analog versus prior digitized analog mammography: time for interpretation.

Objective: The purpose of our study was to quantitatively compare the time for interpretation of screening full-field digital mammography (FFDM) images using prior analog film mammograms for comparison versus digitized prior analog mammograms.

Materials And Methods: Images from 100 FFDM studies were interpreted by four radiologists. All FFDM images had comparison analog mammograms obtained a minimum of 1 year earlier that were digitized using a 43-μm film digitizer.

Decreased detection of hypovascular liver tumors with MDCT in obese patients: a phantom study.

Objective: The purpose of this article is to assess the impact of large patient size on the detection of hypovascular liver tumors with MDCT and the effect of a noise filter on image quality and lesion detection in obese patients.

Materials And Methods: A liver phantom with 45 hypovascular tumors (diameters of 5, 10, and 15 mm) was placed into two water containers mimicking intermediate and large patients. The containers were scanned with a 64-MDCT scanner.

Nonlinear three-dimensional noise filter with low-dose CT angiography: effect on the detection of small high-contrast objects in a phantom model.

Purpose: To study the effect of a nonlinear noise filter on the detection of simulated endoleaks in a phantom with 80- and 100-kVp multidetector computed tomographic (CT) angiography.

Materials And Methods: An aortic aneurysm phantom, including iodinated endoleaks, was constructed. Multidetector CT angiography with use of 80-, 100-, and 120-kVp tube voltages was performed for simulated intermediate-sized and large patients (estimated body weights, 72-85 kg and 118-142 kg, respectively).

Detection of occult foci of breast cancer using breast-specific gamma imaging in women with one mammographic or clinically suspicious breast lesion.

Rationale And Objectives: The aim of this study was to determine how often breast-specific gamma imaging (BSGI) identifies occult cancerous lesions in women with one suspicious lesion detected on mammography or physical exam.

Materials And Methods: A retrospective review was performed of the records of all patients who underwent BSGI between January 1, 2004, and June 4, 2007. Included in the study were 159 women who had one suspicious breast lesion on physical exam and/or mammography and who underwent BSGI to evaluate for occult lesions in the breast.

Factors associated with re-excision in patients with early-stage breast cancer treated with breast conservation therapy.

One of the risks of breast conservation surgery is local recurrence, which predominantly occurs as a result of inadequate surgical margins. The purpose of this study was to identify factors associated with close or positive surgical margins leading to reexcision (RE). The charts of 532 consecutive breast cancer patients treated at our center between September 2001 and June 2007 were reviewed to evaluate patients who opted for breast conservation surgery and needed reexcision.

Application of a low-cost web-based simulation to improve students' practical skills in medical education.

Background: Practical sessions in undergraduate medical education are often costly and have to face constraints in terms of available laboratory time and practice materials (e.g. blood samples from animals).

[Choosing the dialysis method for kidney transplant patients with advanced kidney disease].

The choice of the most of dialysis modality after renal graft loss is an unanswered question. Most patients start hemodialysis (HD) in this situation, because of several reasons: 1. In most dialysis programs HD predominates clearly over Peritoneal Dialysis (PD).