Citations

205 Background: Central review is an important trial management and validation tool. Multisite trials require data systems to accommodate diverse image acquisition and review. Breast cancer is challenging as its imaging objects are not always easily shared across departments. Quality Assurance Review Center (QARC) has a diverse portfolio of facile data acquisition and powerful informatics support that meets these needs. We report on the role of QARC in three of the current breast cancer trials from the American College of Surgeons Oncology Group. Methods: QARC data management system includes secure network infrastructure and a validated relational operating database (MAX). QARC has data acquisition/imaging re-distribution expertise for real time response reviews, response measuring tools and corresponding data archive for secondary reviews. MAX includes query ability; records link to digital information. QARC underwent systematic information systems validation process for 21 CFR Part 11. DICOM/non-DICOM files are stored in the QARC PACS. On-site/remote reviewers use MAX to retrieve, view, annotate and save images. Data extracted is securely sent to partner statistical centers. Results: In Z1031, a neoadjuvant endocrine therapy trial, all of the mammographic exams are archived at QARC. For Z1071, a sentinel lymph node trial, pre- and post-treatment ultrasound (US) images of 321 patients were remotely reviewed. For Z1072, the cryoablation US, pre and post-cryoablation MRI for 40 of 47 cases were remotely archived, retrieved and transferred to investigator workstation for post-processing and review. The other 7 patients did not have evaluable imaging studies. In all three trials, the costs of shipping hardcopies of exams and travel to QARC for central review functions were eliminated. Conclusions: QARC data management systems provide diverse informatics supports for multi-institutional trials, ranging from archives of images, provide remote access and download of data, and central review. The vibrant informatics supports meet the growing needs of clinical trials. Future directions include radiation field review for breast cancer trials and the incorporation of pathology microarray analysis as DICOM objects.

While many hospitalized patients have orders to fast in preparation for interventions, the extent to which these orders are necessary or adhere to evidence‐based durations is unknown. In this study, we analyzed the length, indication, and associated outcomes of nil per os (NPO) orders for general medicine patients at an academic institution in the United States, and compared them to the best available evidence for recommended length of NPO. Of 924 NPO orders assessed, the indicated intervention was not performed for 183 (19.8%) orders, largely due to a change in plan (75/183, 41.0%) or scheduling barriers (43/183, 23.5%). When analyzed by indication, the median duration of NPO orders ranged from 8.3 hours for kidney ultrasound to 13.9 hours for upper endoscopy. For some indications, the literature suggested NPO orders may be unnecessary. Furthermore, in indications for which NPO was deemed necessary in the literature, the duration of most NPO orders was much longer than minimally required. These results suggest the need for establishing more robust practice guidelines or institutional protocols for NPO orders.

PurposeThe purpose of this study was to perform a pilot evaluation of an integrated molecular breast imaging/ultrasound (MBI/US) system designed to enable, in real‐time, the registration of US to MBI and diagnostic evaluation of breast lesions detected on MBI.MethodsThe MBI/US system was constructed by modifying an existing dual‐head cadmium zinc telluride (CZT)‐based MBI gamma camera. The upper MBI detector head was replaced with a mesh panel, which allowed an ultrasound probe to access the breast. An optical tracking system was used to monitor the location of the ultrasound transducer, referenced to the MBI detector. The lesion depth at which ultrasound was targeted was estimated from analysis of previously acquired dual‐head MBI datasets. A software tool was developed to project the US field of view onto the current MBI image. Correlation of lesion location between both modalities with real‐time MBI/US scanning was confirmed in a breast phantom model and assessed in 12 patients with a breast lesion detected on MBI.ResultsCombined MBI/US scanning allowed for registration of lesions detected on US and MBI as validated in phantom experiments. In patient studies, successful registration was achieved in 8 of 12 (67%) patients, with complete registration achieved in seven and partial registration achieved in one patient. In 4 of 12 (37%) patients, lesion registration was not achieved, partially attributed to uncertainty in lesion depth estimates from MBI.ConclusionThe MBI/US system enabled successful registration of US to MBI in over half of patients studied in this pilot evaluation. Future studies are needed to determine if real‐time, registered US imaging of MBI‐detected lesions may obviate the need to proceed to more expensive procedures such as contrast‐enhanced breast MRI for diagnostic workup or biopsy of MBI findings.

Background/aim To determine if Boys Bantam and Peewee and Girls U14 sustain fewer concussions, head hits, ‘other injuries’ and penalties in hockey tournaments governed by intensified fair play (IFP) than non-intensified fair play (NIFP). Methods A prospective comparison of IFP, a behaviour modification programme that promotes sportsmanship, versus control (non-intensified, NIFP) effects on numbers of diagnosed concussions, head hits without diagnosed concussion (HHWDC), ‘other injuries’, number of penalties and fair play points (FPPs). 1514 players, ages 11–14 years, in 6 IFP (N=950) and 5 NIFP (N=564) tournaments were studied. Results Two diagnosed concussions, four HHWDC, and six ‘other injuries’ occurred in IFP tournaments compared to one concussion, eight HHWDC and five ‘other injuries’ in NIFP. There were significantly fewer HHWDC in IFP than NIFP (p=0.018). However, diagnosed concussions, ‘other injuries’, penalties and FPPs did not differ significantly between conditions. In IFP, a minority of teams forfeited the majority of FPPs. Most diagnosed concussions, HHWDC, and other injuries occurred to Bantam B players and usually in penalised teams that forfeited their FPPs. Conclusions In response to significant differences in HHWDC between IFP and NIFP tournaments, the following considerations are encouraged: mandatory implementation of fair play in regular season and tournaments, empowering tournament directors to not accept heavily penalised teams, and introducing ‘no body checking’ in Bantam.

Abstract Previous preclinical studies and a phase I clinical trial suggested that myo-inositol may be a safe and effective lung cancer chemopreventive agent. We conducted a randomized, double blind, placebo-controlled phase IIb study to determine the chemopreventive effects of myo-inositol in smokers with bronchial dysplasia. Smokers with ≥1 site of dysplasia identified by autofluorescence bronchoscopy-directed biopsy were randomly assigned to receive oral placebo or myo-inositol, 9 g once a day for 2 weeks, and then twice a day for 6 months. The primary endpoint was change in dysplasia rate after 6 months of intervention on a per-participant basis. Other trial endpoints reported herein include Ki-67 labeling index, blood and bronchoalveolar lavage fluid (BAL) levels of proinflammatory, oxidant/antioxidant biomarkers, and an airway epithelial gene expression signature for PI3K activity. Seventy-four (n = 38 myo-inositol and n = 36 placebo) participants with a baseline and 6-month bronchoscopy were included in all efficacy analyses. The complete response and the progressive disease rates were 26.3% versus 13.9% and 47.4% versus 33.3%, respectively, in the myo-inositol and placebo arms (P = 0.76). Compared with placebo, myo-inositol intervention significantly reduced IL6 levels in BAL over 6 months (P = 0.03). Among those with a complete response in the myo-inositol arm, there was a significant decrease in a gene expression signature reflective of PI3K activation within the cytologically normal bronchial airway epithelium (P = 0.002). The heterogeneous response to myo-inositol suggests a targeted therapy approach based on molecular alterations is needed in future clinical trials to determine the efficacy of myo-inositol as a chemopreventive agent. Cancer Prev Res; 9(12); 906–14. ©2016 AACR.