{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T20:53:51Z","timestamp":1771275231563,"version":"3.50.1"},"reference-count":11,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2023,3,7]],"date-time":"2023-03-07T00:00:00Z","timestamp":1678147200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Sensors"],"abstract":"<jats:p>Accurate clinical sensors and devices are essential to support optimal medical decision-making, and accuracy can be demonstrated through the conduct of clinical validation studies using validated reference sensors and\/or devices for comparison. Typically unmeasurable, the true reference value can be substituted with an accepted physiological measurement with an associated uncertainty. We describe a basic model of measurement uncertainty that specifies the factors that may degrade the accuracy of an observed measurement value from a sensor, and we detail validation study design strategies that may be used to quantify and minimize these uncertainties. In addition, we describe a model that extends the observed measurement uncertainty to the resultant clinical decision and the factors that may impact the uncertainty of this decision. Clinical validation studies should be designed to estimate and minimize uncertainty that is unrelated to the sensor accuracy. The contribution of measurement observation uncertainty to clinical decision-making should be minimized but also acknowledged and incorporated into the clinical decision-making process.<\/jats:p>","DOI":"10.3390\/s23062900","type":"journal-article","created":{"date-parts":[[2023,3,8]],"date-time":"2023-03-08T02:08:14Z","timestamp":1678241294000},"page":"2900","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Measurement Uncertainty in Clinical Validation Studies of Sensors"],"prefix":"10.3390","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8427-2035","authenticated-orcid":false,"given":"John Mark","family":"Ansermino","sequence":"first","affiliation":[{"name":"British Columbia Children\u2019s Hospital Research Institute, The University of British Columbia, Vancouver, BC V6T 1Z6, Canada"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2048-4391","authenticated-orcid":false,"given":"Guy Albert","family":"Dumont","sequence":"additional","affiliation":[{"name":"British Columbia Children\u2019s Hospital Research Institute, The University of British Columbia, Vancouver, BC V6T 1Z6, Canada"},{"name":"Department of Electrical and Computer Engineering, British Columbia Children\u2019s Hospital Research Institute, The University of British Columbia, Vancouver, BC V6T 1Z8, Canada"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2291-2276","authenticated-orcid":false,"given":"Amy Sarah","family":"Ginsburg","sequence":"additional","affiliation":[{"name":"Clinical Trials Center, University of Washington, Seattle, WA 98105, USA"}]}],"member":"1968","published-online":{"date-parts":[[2023,3,7]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2477","DOI":"10.1056\/NEJMc2029240","article-title":"Racial Bias in Pulse Oximetry Measurement","volume":"383","author":"Sjoding","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"252","DOI":"10.4187\/respcare.09795","article-title":"Pulse Oximeter Performance, Racial Inequity, and the Work Ahead","volume":"67","author":"Okunlola","year":"2021","journal-title":"Respir. Care"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"699","DOI":"10.1001\/jamainternmed.2022.1903","article-title":"Racial and Ethnic Bias in Pulse Oximetry and Clinical Outcomes","volume":"182","author":"Valbuena","year":"2022","journal-title":"JAMA Intern. Med."},{"key":"ref_4","unstructured":"(2020). Accuracy (Trueness and Precision) of Measurement Methods and Results\u2014Part 4: Basic Methods for the Determination of the Trueness of a Standard Measurement Method (Standard No. ISO 5725-4:2020). Available online: https:\/\/www.iso.org\/standard\/69421.html."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"451","DOI":"10.1093\/bja\/aev356","article-title":"Disagreement between cardiac output measurement devices: Which device is the gold standard?","volume":"116","author":"Collins","year":"2016","journal-title":"Br. J. Anaesth."},{"key":"ref_6","unstructured":"(2023, January 03). Joint Committee for Guides of Metrology (JCGM). Available online: https:\/\/www.bipm.org\/en\/committees\/jc\/jcgm."},{"key":"ref_7","unstructured":"(2023, January 03). Bureau International des Poids et Mesures (BIPM). Available online: https:\/\/www.bipm.org\/en\/home."},{"key":"ref_8","unstructured":"Joint Committee for Guides in Metrology (JCGM) (2023, January 03). Guide to the Expression of Uncertainty in Measurement (GUM). Available online: https:\/\/www.bipm.org\/en\/committees\/jc\/jcgm."},{"key":"ref_9","unstructured":"Joint Committee for Guides in Metrology (JCGM) (2023, January 03). International Vocabulary of Metrology\u2013Basic and General Concepts and Associated Terms (VIM). JCGM 200. Available online: https:\/\/www.bipm.org\/en\/committees\/jc\/jcgm."},{"key":"ref_10","unstructured":"Carlson, L., Hoelscher, C., and Shipley, T. (2011, January 20\u201332). Number preference, precision and implicit confidence. Proceedings of the 33rd Annual Meeting of the Cognitive Science Society (CogSci 2011), Boston, MA, USA."},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Vityazeva, T., Vityazev, S., and Mikheev, A. (2018, January 10\u201314). Synchronization of heart rate and respiratory signals for HRV analysis. Proceedings of the 2018 7th Mediterranean Conference on Embedded Computing (MECO), Budva, Montenegro.","DOI":"10.1109\/MECO.2018.8405989"}],"container-title":["Sensors"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1424-8220\/23\/6\/2900\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T18:50:04Z","timestamp":1760122204000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1424-8220\/23\/6\/2900"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3,7]]},"references-count":11,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2023,3]]}},"alternative-id":["s23062900"],"URL":"https:\/\/doi.org\/10.3390\/s23062900","relation":{},"ISSN":["1424-8220"],"issn-type":[{"value":"1424-8220","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,7]]}}}