While several studies have assessed the efficacy of adrenal fine-needle aspiration, there are few data regarding adrenal tissue core biopsies. We performed a retrospective study, for a 12-year period, of 204 percutaneous adrenal core biopsy specimens. A core was the only specimen obtained, and on-site evaluation was not used. About half of the cases (104/204) were diagnosed as metastatic carcinoma, with lung as the most common origin (78/204). A specificity and sensitivity of 100% for benign vs malignant was calculated, with a specificity of 88% and sensitivity of 86% for specific diagnoses. Diagnostic and sampling errors were identified. False-negatives were limited to biopsies using 20-gauge needles. Cases with a clinical history provided had specific diagnoses made at a slightly higher frequency compared with cases without an available history. Immunohistochemical workup was performed in more than half of the cases; specific diagnoses were made more frequently than in cases without immunostains.
BackgroundWith the globalization of clinical trials, a growing emphasis has been placed on the standardization of the workflow in order to ensure the reproducibility and reliability of the overall trial. Despite the importance of workflow evaluation, to our knowledge no previous studies have attempted to adapt existing modeling languages to standardize the representation of clinical trials. Unified Modeling Language (UML) is a computational language that can be used to model operational workflow, and a UML profile can be developed to standardize UML models within a given domain. This paper's objective is to develop a UML profile to extend the UML Activity Diagram schema into the clinical trials domain, defining a standard representation for clinical trial workflow diagrams in UML.MethodsTwo Brazilian clinical trial sites in rheumatology and oncology were examined to model their workflow and collect time-motion data. UML modeling was conducted in Eclipse, and a UML profile was developed to incorporate information used in discrete event simulation software.ResultsEthnographic observation revealed bottlenecks in workflow: these included tasks requiring full commitment of CRCs, transferring notes from paper to computers, deviations from standard operating procedures, and conflicts between different IT systems. Time-motion analysis revealed that nurses' activities took up the most time in the workflow and contained a high frequency of shorter duration activities. Administrative assistants performed more activities near the beginning and end of the workflow. Overall, clinical trial tasks had a greater frequency than clinic routines or other general activities.ConclusionsThis paper describes a method for modeling clinical trial workflow in UML and standardizing these workflow diagrams through a UML profile. In the increasingly global environment of clinical trials, the standardization of workflow modeling is a necessary precursor to conducting a comparative analysis of international clinical trials workflows.
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