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ObjectiveProject 1 of the Preclinical Multicenter Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx) consortium aims to identify preclinical biomarkers for antiepileptogenic therapies following traumatic brain injury (TBI). The international participating centers in Finland, Australia, and the United States have made a concerted effort to ensure protocol harmonization. Here, we evaluate the success of harmonization process by assessing the timing, coverage, and performance between the study sites.MethodWe collected data on animal housing conditions, lateral fluid-percussion injury model production, postoperative care, mortality, post-TBI physiological monitoring, timing of blood sampling and quality, MR imaging timing and protocols, and duration of video-electroencephalography (EEG) follow-up using common data elements. Learning effect in harmonization was assessed by comparing procedural accuracy between the early and late stages of the project.ResultsThe animal housing conditions were comparable between the study sites but the postoperative care procedures varied. Impact pressure, duration of apnea, righting reflex, and acute mortality differed between the study sites (p  0.05). Plasma quality was poor in 4% of the samples in UEF, 1% in Monash and 14% in UCLA. More than 97% of the final cohort were MR imaged at all timepoints in all study sites. The timing of imaging did not differ on D2 and D9 (p > 0.05), but varied at D30, 5 months, and ex vivo timepoints (p  0.05). A decrease in acute mortality and increase in plasma quality across time reflected a learning effect in the TBI production and blood sampling protocols.SignificanceOur study is the first demonstration of the feasibility of protocol harmonization for performing powered preclinical multi-center trials for biomarker and therapy discovery of post-traumatic epilepsy.

PurposeTo determine if PSAD, PSADtz, and ADC values improve the accuracy of PI-RADS v2 and identify men whose concurrent systematic biopsy detects clinically significant cancer on areas without mpMRI visible lesions.Materials and methodsSingle reference-center, cross-sectional, retrospective study of consecutive men with suspected or known low to intermediate-risk prostate cancer who underwent 3T mpMRI and TRUS-MRI fusion biopsy from 07/15/2014 to 02/17/2018. Cluster-corrected logistic regression analyses were utilized to predict clinically significant prostate cancer (Gleason score ≥3+4) at targeted mpMRI lesions and on systematic biopsy.Results538 men (median age=66 years, median PSA=7.0ng/mL) with 780mpMRI lesions were included. Clinically significant disease was diagnosed in 371 men. PI-RADS v2 scores of 3, 4, and 5 were clinically significant cancer in 8.0% (16/201), 22.8% (90/395), and 59.2% (109/184). ADC values, PSAD, and PI-RADS v2 scores were independent predictors of clinically significant cancer in targeted lesions (OR 2.25-8.78; P values

PurposeTo determine if PSAD, PSADtz, and ADC values improve the accuracy of PI-RADS v2 and identify men whose concurrent systematic biopsy detects clinically significant cancer on areas without mpMRI visible lesions.Materials and methodsSingle reference-center, cross-sectional, retrospective study of consecutive men with suspected or known low to intermediate-risk prostate cancer who underwent 3T mpMRI and TRUS-MRI fusion biopsy from 07/15/2014 to 02/17/2018. Cluster-corrected logistic regression analyses were utilized to predict clinically significant prostate cancer (Gleason score ≥3+4) at targeted mpMRI lesions and on systematic biopsy.Results538 men (median age=66 years, median PSA=7.0ng/mL) with 780mpMRI lesions were included. Clinically significant disease was diagnosed in 371 men. PI-RADS v2 scores of 3, 4, and 5 were clinically significant cancer in 8.0% (16/201), 22.8% (90/395), and 59.2% (109/184). ADC values, PSAD, and PI-RADS v2 scores were independent predictors of clinically significant cancer in targeted lesions (OR 2.25-8.78; P values