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Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study

INTRODUCTION: Chronic pain assessment and post-treatment evaluation continues to be challenging due to a lack of validated, objective tools to measure patient outcomes. Validation of mechanistic pain biomarkers would allow clinicians to objectively identify abnormal biochemistry contributing to pain...

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Autores principales: Amirdelfan, Kasra, Pope, Jason E., Gunn, Joshua, Hill, Melissa M., Cotten, Bradley M., Beresh, John E., Dobecki, Douglas, Miller, Nathan, Mehta, Pankaj, Girardi, George, Deer, Timothy R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7648807/
https://www.ncbi.nlm.nih.gov/pubmed/32495188
http://dx.doi.org/10.1007/s40122-020-00175-3
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author Amirdelfan, Kasra
Pope, Jason E.
Gunn, Joshua
Hill, Melissa M.
Cotten, Bradley M.
Beresh, John E.
Dobecki, Douglas
Miller, Nathan
Mehta, Pankaj
Girardi, George
Deer, Timothy R.
author_facet Amirdelfan, Kasra
Pope, Jason E.
Gunn, Joshua
Hill, Melissa M.
Cotten, Bradley M.
Beresh, John E.
Dobecki, Douglas
Miller, Nathan
Mehta, Pankaj
Girardi, George
Deer, Timothy R.
author_sort Amirdelfan, Kasra
collection PubMed
description INTRODUCTION: Chronic pain assessment and post-treatment evaluation continues to be challenging due to a lack of validated, objective tools to measure patient outcomes. Validation of mechanistic pain biomarkers would allow clinicians to objectively identify abnormal biochemistry contributing to painful symptoms. METHODS: We describe the clinical validation of a multi-biomarker assay with algorithmic analysis known as the Foundation Pain Index (FPI) in diverse cohorts of chronic pain patients in a prospective, cross-sectional, observational validation study. Levels of 11 urinary pain biomarkers were measured and tabulated using a proprietary algorithm to generate FPI scores for chronic pain subjects (N = 153) and age- and sex-matched pain-free controls (N = 334). RESULTS: FPI scores were significantly correlated with the 36-Item Short Form Health Survey (SF-36) scores among chronic pain subjects (P value < 0.015) and specific components of SF-36, including emotional well-being, limitations due to emotional problems, and general health (P value < 0.05). Area under ROC analysis (AUROC) revealed FPI to accurately distinguish biomarker profiles between pain-free and chronic pain cohorts (AUROC: 0.7490, P value < 0.0001) as well as the SF-36 scores between chronic pain subjects with low vs. high FPI scores (AUROC: 0.7715, P value < 0.01). CONCLUSIONS: Our findings establish the validity and discriminatory power of a novel multi-biomarker test that evaluates the role of biochemistry in chronic pain and correlates with clinical assessments of patients. This test provides novel, reproducible, objective data which may pave the way for non-opioid therapeutic strategies to treat chronic pain.
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spelling pubmed-76488072020-11-10 Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study Amirdelfan, Kasra Pope, Jason E. Gunn, Joshua Hill, Melissa M. Cotten, Bradley M. Beresh, John E. Dobecki, Douglas Miller, Nathan Mehta, Pankaj Girardi, George Deer, Timothy R. Pain Ther Original Research INTRODUCTION: Chronic pain assessment and post-treatment evaluation continues to be challenging due to a lack of validated, objective tools to measure patient outcomes. Validation of mechanistic pain biomarkers would allow clinicians to objectively identify abnormal biochemistry contributing to painful symptoms. METHODS: We describe the clinical validation of a multi-biomarker assay with algorithmic analysis known as the Foundation Pain Index (FPI) in diverse cohorts of chronic pain patients in a prospective, cross-sectional, observational validation study. Levels of 11 urinary pain biomarkers were measured and tabulated using a proprietary algorithm to generate FPI scores for chronic pain subjects (N = 153) and age- and sex-matched pain-free controls (N = 334). RESULTS: FPI scores were significantly correlated with the 36-Item Short Form Health Survey (SF-36) scores among chronic pain subjects (P value < 0.015) and specific components of SF-36, including emotional well-being, limitations due to emotional problems, and general health (P value < 0.05). Area under ROC analysis (AUROC) revealed FPI to accurately distinguish biomarker profiles between pain-free and chronic pain cohorts (AUROC: 0.7490, P value < 0.0001) as well as the SF-36 scores between chronic pain subjects with low vs. high FPI scores (AUROC: 0.7715, P value < 0.01). CONCLUSIONS: Our findings establish the validity and discriminatory power of a novel multi-biomarker test that evaluates the role of biochemistry in chronic pain and correlates with clinical assessments of patients. This test provides novel, reproducible, objective data which may pave the way for non-opioid therapeutic strategies to treat chronic pain. Springer Healthcare 2020-06-03 2020-12 /pmc/articles/PMC7648807/ /pubmed/32495188 http://dx.doi.org/10.1007/s40122-020-00175-3 Text en © The Author(s) 2020 https://creativecommons.org/licenses/by-nc/4.0/This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Amirdelfan, Kasra
Pope, Jason E.
Gunn, Joshua
Hill, Melissa M.
Cotten, Bradley M.
Beresh, John E.
Dobecki, Douglas
Miller, Nathan
Mehta, Pankaj
Girardi, George
Deer, Timothy R.
Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study
title Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study
title_full Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study
title_fullStr Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study
title_full_unstemmed Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study
title_short Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study
title_sort clinical validation of a multi-biomarker assay for the evaluation of chronic pain patients in a cross-sectional, observational study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7648807/
https://www.ncbi.nlm.nih.gov/pubmed/32495188
http://dx.doi.org/10.1007/s40122-020-00175-3
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