ArticlePloS one2010
Standardizing clinical trials workflow representation in UML for international site comparison.
Article in PloS one, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
- Transforming evidence-based clinical guidelines into implementable clinical decision support services: the CAREPATH study for multimorbidity management.Frontiers in medicine · 2024Article
- A virtual experimenter to increase standardization for the investigation of placebo effects.BMC medical research methodology · 2016Article
- A Design Methodology for Medical Processes.Applied clinical informatics · 2016Article
- Analysis and classification of oncology activities on the way to workflow based single source documentation in clinical information systems.BMC medical informatics and decision making · 2015Article
- Extension of the primary care research object model (PCROM) as clinical research information model (CRIM) for the "learning healthcare system".BMC medical informatics and decision making · 2014Article
- Knowledge translation: a case study on pneumonia research and clinical guidelines in a low- income country.Implementation science : IS · 2014Article
- Time motion studies in healthcare: what are we talking about?Journal of biomedical informatics · 2014Review
- Modeling of outpatient prescribing process in iran: a gateway toward electronic prescribing system.Iranian journal of pharmaceutical research : IJPR · 2014Article
- Inter-observer reliability assessments in time motion studies: the foundation for meaningful clinical workflow analysis.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2013Review
- Detecting dissonance in clinical and research workflow for translational psychiatric registries.PloS one · 2013Article
- Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.PloS one · 2013Article
- A formal representation for numerical data presented in published clinical trial reports.Studies in health technology and informatics · 2013Article
- Workflow in clinical trial sites & its association with near miss events for data quality: ethnographic, workflow & systems simulation.PloS one · 2012Article
- Improving the accuracy of therapy descriptions in clinical trials using a bottom-up approach.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2012Article
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Authors and funding
10 authors.
Funding
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Abstract
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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