Tracking of Systemic Lupus Erythematosus (SLE) Longitudinally Using Biosensor and Patient-Reported Data: A Report on the Fully Decentralized Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals—The OASIS Study

(1) Objective: Systemic lupus erythematosus (SLE) is a complex disease involving immune dysregulation, episodic flares, and poor quality of life (QOL). For a decentralized digital study of SLE patients, machine learning was used to assess patient-reported outcomes (PROs), QOL, and biometric data for...

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Main Authors: Eldon R. Jupe, Gerald H. Lushington, Mohan Purushothaman, Fabricio Pautasso, Georg Armstrong, Arif Sorathia, Jessica Crawley, Vijay R. Nadipelli, Bernard Rubin, Ryan Newhardt, Melissa E. Munroe, Brett Adelman
Format: Article
Language:English
Published: MDPI AG 2023-11-01
Series:BioTech
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Online Access:https://www.mdpi.com/2673-6284/12/4/62
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author Eldon R. Jupe
Gerald H. Lushington
Mohan Purushothaman
Fabricio Pautasso
Georg Armstrong
Arif Sorathia
Jessica Crawley
Vijay R. Nadipelli
Bernard Rubin
Ryan Newhardt
Melissa E. Munroe
Brett Adelman
author_facet Eldon R. Jupe
Gerald H. Lushington
Mohan Purushothaman
Fabricio Pautasso
Georg Armstrong
Arif Sorathia
Jessica Crawley
Vijay R. Nadipelli
Bernard Rubin
Ryan Newhardt
Melissa E. Munroe
Brett Adelman
author_sort Eldon R. Jupe
collection DOAJ
description (1) Objective: Systemic lupus erythematosus (SLE) is a complex disease involving immune dysregulation, episodic flares, and poor quality of life (QOL). For a decentralized digital study of SLE patients, machine learning was used to assess patient-reported outcomes (PROs), QOL, and biometric data for predicting possible disease flares. (2) Methods: Participants were recruited from the LupusCorner online community. Adults self-reporting an SLE diagnosis were consented and given a mobile application to record patient profile (PP), PRO, and QOL metrics, and enlisted participants received smartwatches for digital biometric monitoring. The resulting data were profiled using feature selection and classification algorithms. (3) Results: 550 participants completed digital surveys, 144 (26%) agreed to wear smartwatches, and medical records (MRs) were obtained for 68. Mining of PP, PRO, QOL, and biometric data yielded a 26-feature model for classifying participants according to MR-identified disease flare risk. ROC curves significantly distinguished true from false positives (ten-fold cross-validation: <i>p</i> < 0.00023; five-fold: <i>p</i> < 0.00022). A 25-feature Bayesian model enabled time-variant prediction of participant-reported possible flares (P(true) > 0.85, <i>p</i> < 0.001; P(nonflare) > 0.83, <i>p</i> < 0.0001). (4) Conclusions: Regular profiling of patient well-being and biometric activity may support proactive screening for circumstances warranting clinical assessment.
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spelling doaj.art-8ba90c05cea54456b978d5cd7bb61a1a2023-12-22T13:56:28ZengMDPI AGBioTech2673-62842023-11-011246210.3390/biotech12040062Tracking of Systemic Lupus Erythematosus (SLE) Longitudinally Using Biosensor and Patient-Reported Data: A Report on the Fully Decentralized Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals—The OASIS StudyEldon R. Jupe0Gerald H. Lushington1Mohan Purushothaman2Fabricio Pautasso3Georg Armstrong4Arif Sorathia5Jessica Crawley6Vijay R. Nadipelli7Bernard Rubin8Ryan Newhardt9Melissa E. Munroe10Brett Adelman11Progentec Diagnostics, Inc., Oklahoma City, OK 73104, USAProgentec Diagnostics, Inc., Oklahoma City, OK 73104, USAProgentec Diagnostics, Inc., Oklahoma City, OK 73104, USAProgentec Diagnostics, Inc., Oklahoma City, OK 73104, USAProgentec Diagnostics, Inc., Oklahoma City, OK 73104, USAProgentec Diagnostics, Inc., Oklahoma City, OK 73104, USAProgentec Diagnostics, Inc., Oklahoma City, OK 73104, USAGSK, Philadelphia, PA 19104, USAGSK, Raleigh, NC 27709, USAProgentec Diagnostics, Inc., Oklahoma City, OK 73104, USAProgentec Diagnostics, Inc., Oklahoma City, OK 73104, USAProgentec Diagnostics, Inc., Oklahoma City, OK 73104, USA(1) Objective: Systemic lupus erythematosus (SLE) is a complex disease involving immune dysregulation, episodic flares, and poor quality of life (QOL). For a decentralized digital study of SLE patients, machine learning was used to assess patient-reported outcomes (PROs), QOL, and biometric data for predicting possible disease flares. (2) Methods: Participants were recruited from the LupusCorner online community. Adults self-reporting an SLE diagnosis were consented and given a mobile application to record patient profile (PP), PRO, and QOL metrics, and enlisted participants received smartwatches for digital biometric monitoring. The resulting data were profiled using feature selection and classification algorithms. (3) Results: 550 participants completed digital surveys, 144 (26%) agreed to wear smartwatches, and medical records (MRs) were obtained for 68. Mining of PP, PRO, QOL, and biometric data yielded a 26-feature model for classifying participants according to MR-identified disease flare risk. ROC curves significantly distinguished true from false positives (ten-fold cross-validation: <i>p</i> < 0.00023; five-fold: <i>p</i> < 0.00022). A 25-feature Bayesian model enabled time-variant prediction of participant-reported possible flares (P(true) > 0.85, <i>p</i> < 0.001; P(nonflare) > 0.83, <i>p</i> < 0.0001). (4) Conclusions: Regular profiling of patient well-being and biometric activity may support proactive screening for circumstances warranting clinical assessment.https://www.mdpi.com/2673-6284/12/4/62SLEdigitalbiosensorpatient-reported outcomessigns and symptoms of flarereal-world evidence
spellingShingle Eldon R. Jupe
Gerald H. Lushington
Mohan Purushothaman
Fabricio Pautasso
Georg Armstrong
Arif Sorathia
Jessica Crawley
Vijay R. Nadipelli
Bernard Rubin
Ryan Newhardt
Melissa E. Munroe
Brett Adelman
Tracking of Systemic Lupus Erythematosus (SLE) Longitudinally Using Biosensor and Patient-Reported Data: A Report on the Fully Decentralized Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals—The OASIS Study
BioTech
SLE
digital
biosensor
patient-reported outcomes
signs and symptoms of flare
real-world evidence
title Tracking of Systemic Lupus Erythematosus (SLE) Longitudinally Using Biosensor and Patient-Reported Data: A Report on the Fully Decentralized Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals—The OASIS Study
title_full Tracking of Systemic Lupus Erythematosus (SLE) Longitudinally Using Biosensor and Patient-Reported Data: A Report on the Fully Decentralized Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals—The OASIS Study
title_fullStr Tracking of Systemic Lupus Erythematosus (SLE) Longitudinally Using Biosensor and Patient-Reported Data: A Report on the Fully Decentralized Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals—The OASIS Study
title_full_unstemmed Tracking of Systemic Lupus Erythematosus (SLE) Longitudinally Using Biosensor and Patient-Reported Data: A Report on the Fully Decentralized Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals—The OASIS Study
title_short Tracking of Systemic Lupus Erythematosus (SLE) Longitudinally Using Biosensor and Patient-Reported Data: A Report on the Fully Decentralized Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals—The OASIS Study
title_sort tracking of systemic lupus erythematosus sle longitudinally using biosensor and patient reported data a report on the fully decentralized mobile study to measure and predict lupus disease activity using digital signals the oasis study
topic SLE
digital
biosensor
patient-reported outcomes
signs and symptoms of flare
real-world evidence
url https://www.mdpi.com/2673-6284/12/4/62
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