Standardizing clinical trials workflow representation in UML for international site comparison.

<h4>Background</h4>With 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...

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Autores principales:	Elias Cesar Araujo de Carvalho, Madhav Kishore Jayanti, Adelia Portero Batilana, Andreia M O Kozan, Maria J Rodrigues, Jatin Shah, Marco R Loures, Sunita Patil, Philip Payne, Ricardo Pietrobon
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2010
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/d783b61f164842b58faae00e36252017
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spelling	oai:doaj.org-article:d783b61f164842b58faae00e362520172021-11-18T07:37:03ZStandardizing clinical trials workflow representation in UML for international site comparison.1932-620310.1371/journal.pone.0013893https://doaj.org/article/d783b61f164842b58faae00e362520172010-11-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21085484/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>With 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.<h4>Methods</h4>Two 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.<h4>Results</h4>Ethnographic 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.<h4>Conclusions</h4>This 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.Elias Cesar Araujo de CarvalhoMadhav Kishore JayantiAdelia Portero BatilanaAndreia M O KozanMaria J RodriguesJatin ShahMarco R LouresSunita PatilPhilip PayneRicardo PietrobonPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 5, Iss 11, p e13893 (2010)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Elias Cesar Araujo de Carvalho Madhav Kishore Jayanti Adelia Portero Batilana Andreia M O Kozan Maria J Rodrigues Jatin Shah Marco R Loures Sunita Patil Philip Payne Ricardo Pietrobon Standardizing clinical trials workflow representation in UML for international site comparison.
description	<h4>Background</h4>With 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.<h4>Methods</h4>Two 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.<h4>Results</h4>Ethnographic 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.<h4>Conclusions</h4>This 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.
format	article
author	Elias Cesar Araujo de Carvalho Madhav Kishore Jayanti Adelia Portero Batilana Andreia M O Kozan Maria J Rodrigues Jatin Shah Marco R Loures Sunita Patil Philip Payne Ricardo Pietrobon
author_facet	Elias Cesar Araujo de Carvalho Madhav Kishore Jayanti Adelia Portero Batilana Andreia M O Kozan Maria J Rodrigues Jatin Shah Marco R Loures Sunita Patil Philip Payne Ricardo Pietrobon
author_sort	Elias Cesar Araujo de Carvalho
title	Standardizing clinical trials workflow representation in UML for international site comparison.
title_short	Standardizing clinical trials workflow representation in UML for international site comparison.
title_full	Standardizing clinical trials workflow representation in UML for international site comparison.
title_fullStr	Standardizing clinical trials workflow representation in UML for international site comparison.
title_full_unstemmed	Standardizing clinical trials workflow representation in UML for international site comparison.
title_sort	standardizing clinical trials workflow representation in uml for international site comparison.
publisher	Public Library of Science (PLoS)
publishDate	2010
url	https://doaj.org/article/d783b61f164842b58faae00e36252017
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Standardizing clinical trials workflow representation in UML for international site comparison.

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