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297 The Acute to Chronic Pain Signatures Program (A2CPS): Conceptual Design and Protocol Implementation of a Multi-site Observational Study Assessing Risk and Resilience Biomarkers
OBJECTIVES/GOALS: The A2CPS was funded by the National Institutes of Health (NIH) Common Fund to identify biomarkers and their collective biosignatures (combination of several biomarkers) that predict susceptibility or resilience to the development of chronic pain. METHODS/STUDY POPULATION: The A2CP...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cambridge University Press
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9209278/ http://dx.doi.org/10.1017/cts.2022.162 |
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author | Berardi, Giovanni Vance, Carol GT Dailey, Dana L Ecklund, Dixie Coffey, Christopher Bayman, Emine Sluka, Kathleen A. |
author_facet | Berardi, Giovanni Vance, Carol GT Dailey, Dana L Ecklund, Dixie Coffey, Christopher Bayman, Emine Sluka, Kathleen A. |
author_sort | Berardi, Giovanni |
collection | PubMed |
description | OBJECTIVES/GOALS: The A2CPS was funded by the National Institutes of Health (NIH) Common Fund to identify biomarkers and their collective biosignatures (combination of several biomarkers) that predict susceptibility or resilience to the development of chronic pain. METHODS/STUDY POPULATION: The A2CPS includes 2-Multisite Clinical Centers (10 recruitment sites and 6 data collection sites), 1-Clinical Coordinating Center, 1-Data Integration and Resource Center, 3-Omics Data Generation Centers, and representation from the NIH. The A2CPS will recruit a large cohort from 2 different surgical interventions, total knee arthroplasty (n?1800) and thoracotomy (n?1800). This observational study will collect candidate and exploratory biomarkers across the following domains: clinical pain, fatigue, function, sleep, psychosocial, genomics, proteomics, metabolomics, lipidomics, pain sensitivity, and brain imaging. Data will be collected before and up to 3 months after surgery to determine factors that predict chronic pain at 6 months. RESULTS/ANTICIPATED RESULTS: Recruitment started in 2021 following standard operating procedures and is ongoing at both Multisite Clinical Centers. The A2CPS will provide an example of collaborative, multidisciplinary efforts in establishing a data repository consisting of biopsychosocial markers that will be available to the research community to test novel hypotheses. This presentation will describe the conceptual design, study aims, biomarker selection, protocol standardization and study implementation for the A2CPS. An update on study progress and data completeness will be presented. Final results will be reported after study completion which is anticipated by 2024. DISCUSSION/SIGNIFICANCE: Identifying biomarkers and biosignatures that predict high- versus low-risk for the transition to chronic pain will inform future clinical trials, identify novel therapeutic targets, and advance personalized pain treatment strategies; ultimately transforming the prevention and treatment of chronic postsurgical pain. |
format | Online Article Text |
id | pubmed-9209278 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Cambridge University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-92092782022-07-01 297 The Acute to Chronic Pain Signatures Program (A2CPS): Conceptual Design and Protocol Implementation of a Multi-site Observational Study Assessing Risk and Resilience Biomarkers Berardi, Giovanni Vance, Carol GT Dailey, Dana L Ecklund, Dixie Coffey, Christopher Bayman, Emine Sluka, Kathleen A. J Clin Transl Sci Valued Approaches OBJECTIVES/GOALS: The A2CPS was funded by the National Institutes of Health (NIH) Common Fund to identify biomarkers and their collective biosignatures (combination of several biomarkers) that predict susceptibility or resilience to the development of chronic pain. METHODS/STUDY POPULATION: The A2CPS includes 2-Multisite Clinical Centers (10 recruitment sites and 6 data collection sites), 1-Clinical Coordinating Center, 1-Data Integration and Resource Center, 3-Omics Data Generation Centers, and representation from the NIH. The A2CPS will recruit a large cohort from 2 different surgical interventions, total knee arthroplasty (n?1800) and thoracotomy (n?1800). This observational study will collect candidate and exploratory biomarkers across the following domains: clinical pain, fatigue, function, sleep, psychosocial, genomics, proteomics, metabolomics, lipidomics, pain sensitivity, and brain imaging. Data will be collected before and up to 3 months after surgery to determine factors that predict chronic pain at 6 months. RESULTS/ANTICIPATED RESULTS: Recruitment started in 2021 following standard operating procedures and is ongoing at both Multisite Clinical Centers. The A2CPS will provide an example of collaborative, multidisciplinary efforts in establishing a data repository consisting of biopsychosocial markers that will be available to the research community to test novel hypotheses. This presentation will describe the conceptual design, study aims, biomarker selection, protocol standardization and study implementation for the A2CPS. An update on study progress and data completeness will be presented. Final results will be reported after study completion which is anticipated by 2024. DISCUSSION/SIGNIFICANCE: Identifying biomarkers and biosignatures that predict high- versus low-risk for the transition to chronic pain will inform future clinical trials, identify novel therapeutic targets, and advance personalized pain treatment strategies; ultimately transforming the prevention and treatment of chronic postsurgical pain. Cambridge University Press 2022-04-19 /pmc/articles/PMC9209278/ http://dx.doi.org/10.1017/cts.2022.162 Text en © The Association for Clinical and Translational Science 2022 https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work. |
spellingShingle | Valued Approaches Berardi, Giovanni Vance, Carol GT Dailey, Dana L Ecklund, Dixie Coffey, Christopher Bayman, Emine Sluka, Kathleen A. 297 The Acute to Chronic Pain Signatures Program (A2CPS): Conceptual Design and Protocol Implementation of a Multi-site Observational Study Assessing Risk and Resilience Biomarkers |
title | 297 The Acute to Chronic Pain Signatures Program (A2CPS): Conceptual Design and Protocol Implementation of a Multi-site Observational Study Assessing Risk and Resilience Biomarkers |
title_full | 297 The Acute to Chronic Pain Signatures Program (A2CPS): Conceptual Design and Protocol Implementation of a Multi-site Observational Study Assessing Risk and Resilience Biomarkers |
title_fullStr | 297 The Acute to Chronic Pain Signatures Program (A2CPS): Conceptual Design and Protocol Implementation of a Multi-site Observational Study Assessing Risk and Resilience Biomarkers |
title_full_unstemmed | 297 The Acute to Chronic Pain Signatures Program (A2CPS): Conceptual Design and Protocol Implementation of a Multi-site Observational Study Assessing Risk and Resilience Biomarkers |
title_short | 297 The Acute to Chronic Pain Signatures Program (A2CPS): Conceptual Design and Protocol Implementation of a Multi-site Observational Study Assessing Risk and Resilience Biomarkers |
title_sort | 297 the acute to chronic pain signatures program (a2cps): conceptual design and protocol implementation of a multi-site observational study assessing risk and resilience biomarkers |
topic | Valued Approaches |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9209278/ http://dx.doi.org/10.1017/cts.2022.162 |
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