Credibility Evidence for Computational Patient Models Used in the Development of Physiological Closed-Loop Controlled Devices for Critical Care Medicine
Open accessAbstract
Physiological closed-loop controlled medical devices automatically adjust therapy delivered to a patient to adjust a measured physiological variable. In critical care scenarios, these types of devices could automate, for example, fluid resuscitation, drug delivery, mechanical ventilation, and/or anesthesia and sedation. Evidence from simulations using computational models of physiological systems can play a crucial role in the development of physiological closed-loop controlled devices; but the utility of this evidence will depend on the credibility of the computational model used. Computational models of physiological systems can be complex with numerous non-linearities, time-varying properties, and unknown parameters, which leads to challenges in model assessment. Given the wide range of potential uses of computational patient models in the design and evaluation of physiological closed-loop controlled systems, and the varying risks associated with the diverse uses, the specific model as well as the necessary evidence to make a model credible for a use case may vary. In this review, we examine the various uses of computational patient models in the design and evaluation of critical care physiological closed-loop controlled systems (e.g., hemodynamic stability, mechanical ventilation, anesthetic delivery) as well as the types of evidence (e.g., verification, validation, and uncertainty quantification activities) presented to support the model for that use. We then examine and discuss how a credibility assessment framework (American Society of Mechanical Engineers Verification and Validation Subcommittee, V&V 40 Verification and Validation in Computational Modeling of Medical Devices) for medical devices can be applied to computational patient models used to test physiological closed-loop controlled systems.
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Some examples of how to map model risk to credibility goals for a specific COU have been provided in medical device applications.
“Some examples of how to map model risk to credibility goals for a specific COU has been provided in medical device applications.13, 14, 15”
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Self-citationController design for neuromuscular blockade level tracking based on optimal control
Almeida, J., Mendonça, T., Rocha, P., & Rodrigues, L. (2016) · Control Engineering Practice · doi:10.1016/j.conengprac.2016.08.019 · Cited by 4 · see citing works
Fernando, T. L., Packer, J. S., & Cade, J. F. (1995) · Control Engineering Practice · doi:10.1016/0967-0661(95)00146-l · Cited by 2 · see citing works
Nonlinear controller for bispectral index tracking: Robustness and on-line retuning
Nogueira, F. N., Mendonça, T., & Rocha, P. (2016) · Control Engineering Practice · doi:10.1016/j.conengprac.2016.03.021 · Cited by 2 · see citing works
Urzúa, J., Sauma, E. E., Cipriano, A. Z., Guarini, M. W., & Zapata, P. (1999) · PubMed · Cited by 1 · see citing works
Flagged first, then by citations
Research works printed but not linked: 1
- Kharisov E. Beck C. L. Bloom M. (2012). “ Control of patient response to anesthesia using L1 adaptive methods,” in Proceedings of the 8th Annual IFAC Symposium on Biological and Medical Systems, Budapest.
Cited by
Sorted by citations
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Peri‐operative considerations for sedation‐analgesia during cataract surgery: a narrative review
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Toward Good Simulation Practice
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Arnal, J.-M., Katayama, S., & Howard, C. (2022) · Current Opinion in Critical Care · doi:10.1097/mcc.0000000000001012 · Cited by 19 · see citing works
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Perspectives on Hybrid Control of the Anesthesia-Hemodynamic System in the Pandemic Context
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Biophysical Model: A Promising Method in the Study of the Mechanism of Propofol: A Narrative Review
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Mulpuru, V., & Mishra, N. (2023) · BENTHAM SCIENCE PUBLISHERS eBooks · doi:10.2174/9789815196986123010005
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Self-citation
- Authors
- Parvinian, B., Pathmanathan, P., Daluwatte, C., Yaghouby, F., Gray, R. A., Weininger, S., Morrison, T. M., & Scully, C. G.
- Affiliations
- United States Food and Drug Administration (US)
- Corresponding author
- Parvinian, Bahram
- ORCID
- Venue
- Frontiers in Physiology
- Publisher
- Frontiers Media SA
- Published
- 2019-03-26
- Volume
- 10
- Pages
- 220-220
- ISSN
- 1664-042X (ISSN-L)
- PMC
- PMC6445134
- OpenAlex
- W2922820107
- Cited by
- 44
- References
- 106
- Citations by year
- 2025: 3 · 2024: 7 · 2023: 4 · 2022: 8 · 2021: 9 · 2020: 8 · 2019: 5
- FWCI
- 1.55
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Frontiers in Physiology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- U.S. Department of Energy
- U.S. Food and Drug Administration
- Oak Ridge Institute for Science and Education
- Topics
- Health Sciences › Medicine › Surgery › Healthcare Technology and Patient Monitoring
- Health Sciences › Medicine › Physiology › Simulation-Based Education in Healthcare
- Physical Sciences › Computer Science › Computational Theory and Mathematics › Modeling and Simulation Systems
- Keywords
- intensive care, model credibility, verification and validation, uncertainty quantification, hemodynamic stability, mechanical ventilation, anesthetic delivery, fluid resuscitation, medical device development
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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