A FRAMEWORK FOR CREDIBILITY ASSESSMENT OF SUBJECT-SPECIFIC PHYSIOLOGICAL MODELS

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dc.contributor.advisorHahn, Jin-Ohen_US
dc.contributor.authorParvinian, Bahramen_US
dc.contributor.departmentMechanical Engineeringen_US
dc.contributor.publisherDigital Repository at the University of Marylanden_US
dc.contributor.publisherUniversity of Maryland (College Park, Md.)en_US
dc.date.accessioned2022-09-27T05:40:41Z
dc.date.available2022-09-27T05:40:41Z
dc.date.issued2022en_US
dc.description.abstractPhysiological closed-loop controllers and decision support systems are medical devices that enable some degree of automation to meet the needs of patients in resource-limited environments such as critical care and surgical units. Traditional methods of safety and effectiveness evidence generation such as pre-clinical animal and human clinical studies are cost prohibitive and may not fully capture different performance attributes of such complex safety-criticalsystems primarily due to subject variability. In silico studies using subject-specific physiological models (SSPMs) may provide a versatile platform to generate pre-clinical and clinical safety evidence for medical devices and help reduce the size and scope of animal studies and/or clinical trials. To achieve such a goal, the credibility of the SSPMs must be established for the purpose it is intended to serve. While in the past decades significant research has been dedicated towards development oftools and methods for development and evaluation of SSPMs, adoption of such models remains limited, partly due to lack of trust in SSPMs for safety-critical applications. This may be due to a lack of a cohesive and disciplined credibility assessment framework for SSPMs. In this dissertation a novel framework is proposed for credibility assessment of SSPMs. The framework combines various credibility activities in a unified manner to avoid or reduce resource intensive steps, effectively identify model or data limitations, provide direction as to how to address potential model weaknesses, and provide much needed transparency in the model evaluation process to the decision-makers. To identify various credibility activities, the framework is informed by an extensive literature review of more mature modeling spaces focusing on non- SSPMs as well as a literature review identifying gaps in the published work related to SSPMs. The utility of the proposed framework is successfully demonstrated by its application towards credibility assessment of a CO2 ventilatory gas exchange model intended to predict physiological parameters, and a blood volume kinetic model intended to predict changes in blood volume inresponse to fluid resuscitation and hemorrhage. The proposed framework facilitates development of more reliable SSPMs and will result in increased adoption of such models to be used for evaluation of safety-critical medical devices such as Clinical Decision Support (CDS) and Physiological Closed-Loop Controlled (PCLC) systems.en_US
dc.identifierhttps://doi.org/10.13016/wkfj-d5t3
dc.identifier.urihttp://hdl.handle.net/1903/29350
dc.language.isoenen_US
dc.subject.pqcontrolledBiomedical engineeringen_US
dc.subject.pqcontrolledMechanical engineeringen_US
dc.subject.pqcontrolledMathematicsen_US
dc.subject.pquncontrolledidentifiabilityen_US
dc.subject.pquncontrolledMathematical modelen_US
dc.subject.pquncontrolledModel validationen_US
dc.subject.pquncontrolledPhysiological modelen_US
dc.subject.pquncontrolledsubject specificen_US
dc.titleA FRAMEWORK FOR CREDIBILITY ASSESSMENT OF SUBJECT-SPECIFIC PHYSIOLOGICAL MODELSen_US
dc.typeDissertationen_US

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