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Title: Multi-Site Observational Study to Assess Biomarkers for Susceptibility or Resilience to Chronic Pain: The Acute to Chronic Pain Signatures (A2CPS) Study Protocol

Abstract

Chronic pain has become a global health problem contributing to years lived with disability and reduced quality of life. Advances in the clinical management of chronic pain have been limited due to incomplete understanding of the multiple risk factors and molecular mechanisms that contribute to the development of chronic pain. The Acute to Chronic Pain Signatures (A2CPS) Program aims to characterize the predictive nature of biomarkers (brain imaging, high-throughput molecular screening techniques, or “omics,” quantitative sensory testing, patient-reported outcome assessments and functional assessments) to identify individuals who will develop chronic pain following surgical intervention. The A2CPS is a multisite observational study investigating biomarkers and collective biosignatures (a combination of several individual biomarkers) that predict susceptibility or resilience to the development of chronic pain following knee arthroplasty and thoracic surgery. This manuscript provides an overview of data collection methods and procedures designed to standardize data collection across multiple clinical sites and institutions. Pain-related biomarkers are evaluated before surgery and up to 3 months after surgery for use as predictors of patient reported outcomes 6 months after surgery. The dataset from this prospective observational study will be available for researchers internal and external to the A2CPS Consortium to advance understanding of themore » transition from acute to chronic postsurgical pain.« less

Authors:
 [1];  [1];  [1];  [1];  [1];  [1];  [1];  [2];  [3];  [3];  [3];  [3];  [4];  [5];  [6];  [7];  [7];  [7];  [7];  [7] more »;  [7];  [7];  [7];  [8];  [8];  [8];  [9];  [9];  [9];  [10];  [11];  [11]; ORCiD logo [11];  [11];  [12];  [13];  [13];  [13];  [13];  [14];  [15];  [13];  [15];  [13];  [16] « less
+ Show Author Affiliations
  1. Univ. of Iowa, Iowa City, IA (United States)
  2. St. Ambrose Univ., Davenport, IA (United States)
  3. Rush Univ. Medical Center, Chicago, IL (United States)
  4. Univ. of Illinois, Chicago, IL (United States)
  5. NorthShore University HealthSystem, Skokie, IL (United States)
  6. Univ. of Chicago, IL (United States)
  7. Univ. of Michigan, Ann Arbor, MI (United States)
  8. Univ. of California, San Diego, CA (United States)
  9. Wake Forest Univ., Winston-Salem, NC (United States)
  10. Univ. of California, Davis, CA (United States)
  11. Pacific Northwest National Lab. (PNNL), Richland, WA (United States)
  12. Univ. of Pittsburgh, PA (United States)
  13. Johns Hopkins Univ., Baltimore, MD (United States)
  14. Univ. of Texas, Austin, TX (United States)
  15. Dartmouth College, Hanover, NH (United States)
  16. National Institutes of Health (NIH), Bethesda, MD (United States)
Publication Date:
Research Org.:
Pacific Northwest National Lab. (PNNL), Richland, WA (United States)
Sponsoring Org.:
USDOE; National Institutes of Health (NIH)
Contributing Org.:
The Acute to Chronic Pain Signatures Consortium
OSTI Identifier:
1882664
Report Number(s):
PNNL-SA-169089
Journal ID: ISSN 2296-858X
Grant/Contract Number:  
AC05-76RL01830; UO1NS077179; UO1NS077352; U54DA049116; U54DA049115; U54DA09113; UM1NS112874; UM1NS118922; U24NS112873-03S2; K08 HL159327
Resource Type:
Accepted Manuscript
Journal Name:
Frontiers in Medicine
Additional Journal Information:
Journal Volume: 9; Journal ID: ISSN 2296-858X
Publisher:
Frontiers Media S.A.
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; pain; postsurgical pain; biomarker; risk factors; protocol; total knee arthroplasty; thoracic surgery

Citation Formats

Berardi, Giovanni, Frey-Law, Laura, Sluka, Kathleen A., Bayman, Emine O., Coffey, Christopher S., Ecklund, Dixie, Vance, Carol G. T., Dailey, Dana L., Burns, John, Buvanendran, Asokumar, McCarthy, Robert J., Jacobs, Joshua, Zhou, Xiaohong Joe, Wixson, Richard, Balach, Tessa, Brummett, Chad M., Clauw, Daniel, Colquhoun, Douglas, Harte, Steven E., Harris, Richard E., Williams, David A., Chang, Andrew C., Waljee, Jennifer, Fisch, Kathleen M., Jepsen, Kristen, Laurent, Louise C., Olivier, Michael, Langefeld, Carl D., Howard, Timothy D., Fiehn, Oliver, Jacobs, Jon M., Dakup, Panshak P., Qian, Wei-Jun, Swensen, Adam C., Lokshin, Anna, Lindquist, Martin, Caffo, Brian S., Crainiceanu, Ciprian, Zeger, Scott, Kahn, Ari, Wager, Tor, Taub, Margaret, Ford, James, Sutherland, Stephani P., and Wandner, Laura D. Multi-Site Observational Study to Assess Biomarkers for Susceptibility or Resilience to Chronic Pain: The Acute to Chronic Pain Signatures (A2CPS) Study Protocol. United States: N. p., 2022. Web. doi:10.3389/fmed.2022.849214.
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Berardi, Giovanni, Frey-Law, Laura, Sluka, Kathleen A., Bayman, Emine O., Coffey, Christopher S., Ecklund, Dixie, Vance, Carol G. T., Dailey, Dana L., Burns, John, Buvanendran, Asokumar, McCarthy, Robert J., Jacobs, Joshua, Zhou, Xiaohong Joe, Wixson, Richard, Balach, Tessa, Brummett, Chad M., Clauw, Daniel, Colquhoun, Douglas, Harte, Steven E., Harris, Richard E., Williams, David A., Chang, Andrew C., Waljee, Jennifer, Fisch, Kathleen M., Jepsen, Kristen, Laurent, Louise C., Olivier, Michael, Langefeld, Carl D., Howard, Timothy D., Fiehn, Oliver, Jacobs, Jon M., Dakup, Panshak P., Qian, Wei-Jun, Swensen, Adam C., Lokshin, Anna, Lindquist, Martin, Caffo, Brian S., Crainiceanu, Ciprian, Zeger, Scott, Kahn, Ari, Wager, Tor, Taub, Margaret, Ford, James, Sutherland, Stephani P., & Wandner, Laura D. Multi-Site Observational Study to Assess Biomarkers for Susceptibility or Resilience to Chronic Pain: The Acute to Chronic Pain Signatures (A2CPS) Study Protocol. United States. https://doi.org/10.3389/fmed.2022.849214
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Berardi, Giovanni, Frey-Law, Laura, Sluka, Kathleen A., Bayman, Emine O., Coffey, Christopher S., Ecklund, Dixie, Vance, Carol G. T., Dailey, Dana L., Burns, John, Buvanendran, Asokumar, McCarthy, Robert J., Jacobs, Joshua, Zhou, Xiaohong Joe, Wixson, Richard, Balach, Tessa, Brummett, Chad M., Clauw, Daniel, Colquhoun, Douglas, Harte, Steven E., Harris, Richard E., Williams, David A., Chang, Andrew C., Waljee, Jennifer, Fisch, Kathleen M., Jepsen, Kristen, Laurent, Louise C., Olivier, Michael, Langefeld, Carl D., Howard, Timothy D., Fiehn, Oliver, Jacobs, Jon M., Dakup, Panshak P., Qian, Wei-Jun, Swensen, Adam C., Lokshin, Anna, Lindquist, Martin, Caffo, Brian S., Crainiceanu, Ciprian, Zeger, Scott, Kahn, Ari, Wager, Tor, Taub, Margaret, Ford, James, Sutherland, Stephani P., and Wandner, Laura D. Mon . "Multi-Site Observational Study to Assess Biomarkers for Susceptibility or Resilience to Chronic Pain: The Acute to Chronic Pain Signatures (A2CPS) Study Protocol". United States. https://doi.org/10.3389/fmed.2022.849214. https://www.osti.gov/servlets/purl/1882664.
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@article{osti_1882664,
title = {Multi-Site Observational Study to Assess Biomarkers for Susceptibility or Resilience to Chronic Pain: The Acute to Chronic Pain Signatures (A2CPS) Study Protocol},
author = {Berardi, Giovanni and Frey-Law, Laura and Sluka, Kathleen A. and Bayman, Emine O. and Coffey, Christopher S. and Ecklund, Dixie and Vance, Carol G. T. and Dailey, Dana L. and Burns, John and Buvanendran, Asokumar and McCarthy, Robert J. and Jacobs, Joshua and Zhou, Xiaohong Joe and Wixson, Richard and Balach, Tessa and Brummett, Chad M. and Clauw, Daniel and Colquhoun, Douglas and Harte, Steven E. and Harris, Richard E. and Williams, David A. and Chang, Andrew C. and Waljee, Jennifer and Fisch, Kathleen M. and Jepsen, Kristen and Laurent, Louise C. and Olivier, Michael and Langefeld, Carl D. and Howard, Timothy D. and Fiehn, Oliver and Jacobs, Jon M. and Dakup, Panshak P. and Qian, Wei-Jun and Swensen, Adam C. and Lokshin, Anna and Lindquist, Martin and Caffo, Brian S. and Crainiceanu, Ciprian and Zeger, Scott and Kahn, Ari and Wager, Tor and Taub, Margaret and Ford, James and Sutherland, Stephani P. and Wandner, Laura D.},
abstractNote = {Chronic pain has become a global health problem contributing to years lived with disability and reduced quality of life. Advances in the clinical management of chronic pain have been limited due to incomplete understanding of the multiple risk factors and molecular mechanisms that contribute to the development of chronic pain. The Acute to Chronic Pain Signatures (A2CPS) Program aims to characterize the predictive nature of biomarkers (brain imaging, high-throughput molecular screening techniques, or “omics,” quantitative sensory testing, patient-reported outcome assessments and functional assessments) to identify individuals who will develop chronic pain following surgical intervention. The A2CPS is a multisite observational study investigating biomarkers and collective biosignatures (a combination of several individual biomarkers) that predict susceptibility or resilience to the development of chronic pain following knee arthroplasty and thoracic surgery. This manuscript provides an overview of data collection methods and procedures designed to standardize data collection across multiple clinical sites and institutions. Pain-related biomarkers are evaluated before surgery and up to 3 months after surgery for use as predictors of patient reported outcomes 6 months after surgery. The dataset from this prospective observational study will be available for researchers internal and external to the A2CPS Consortium to advance understanding of the transition from acute to chronic postsurgical pain.},
doi = {10.3389/fmed.2022.849214},
journal = {Frontiers in Medicine},
number = ,
volume = 9,
place = {United States},
year = {Mon Apr 25 00:00:00 EDT 2022},
month = {Mon Apr 25 00:00:00 EDT 2022}
}
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journal, September 2011

  • Simon, Corey; Stryker, Sandra; George, Steven
  • Journal of Pain Research
  • DOI: 10.2147/JPR.S22457

The PHQ-8 as a measure of current depression in the general population
journal, April 2009

  • Kroenke, Kurt; Strine, Tara W.; Spitzer, Robert L.
  • Journal of Affective Disorders, Vol. 114, Issue 1-3
  • DOI: 10.1016/j.jad.2008.06.026

Transition from acute to chronic pain and disability: A model including cognitive, affective, and trauma factors
journal, January 2008

Acute postoperative pain is an independent predictor of chronic postsurgical pain following total knee arthroplasty at 6 months: a prospective cohort study
journal, February 2019

  • Buvanendran, Asokumar; Della Valle, Craig J.; Kroin, Jeffrey S.
  • Regional Anesthesia & Pain Medicine, Vol. 44, Issue 3
  • DOI: 10.1136/rapm-2018-100036

Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations
journal, February 2008

Recommendations for the Generation, Quantification, Storage, and Handling of Peptides Used for Mass Spectrometry–Based Assays
journal, January 2016

Preoperative Predictors of Pain Following Total Knee Arthroplasty
journal, July 2014

  • Noiseux, Nicolas O.; Callaghan, John J.; Clark, Charles R.
  • The Journal of Arthroplasty, Vol. 29, Issue 7
  • DOI: 10.1016/j.arth.2014.01.034

MS-DIAL: data-independent MS/MS deconvolution for comprehensive metabolome analysis
journal, May 2015

  • Tsugawa, Hiroshi; Cajka, Tomas; Kind, Tobias
  • Nature Methods, Vol. 12, Issue 6
  • DOI: 10.1038/nmeth.3393

Preliminary validation of the Michigan Body Map
journal, June 2016

Quantitative sensory testing: a comprehensive protocol for clinical trials
journal, January 2006

Central sensitization: Implications for the diagnosis and treatment of pain
journal, January 2011

High Resolution GC-Orbitrap-MS Metabolomics Using Both Electron Ionization and Chemical Ionization for Analysis of Human Plasma
journal, January 2020

Preoperative Anxiety and Catastrophizing: A Systematic Review and Meta-analysis of the Association With Chronic Postsurgical Pain
journal, January 2012

Reference Values for the Five-Repetition Sit-to-Stand Test: A Descriptive Meta-Analysis of Data from Elders
journal, August 2006

Chronic pain: an update on burden, best practices, and new advances
journal, May 2021

The REDCap consortium: Building an international community of software platform partners
journal, July 2019

  • Harris, Paul A.; Taylor, Robert; Minor, Brenda L.
  • Journal of Biomedical Informatics, Vol. 95
  • DOI: 10.1016/j.jbi.2019.103208

Systematic Error Removal Using Random Forest for Normalizing Large-Scale Untargeted Lipidomics Data
journal, February 2019

Normal walking speed: a descriptive meta-analysis
journal, September 2011

The Role of Psychosocial Processes in the Development and Maintenance of Chronic Pain
journal, September 2016

Conditioned pain modulation
journal, June 2015

High Dynamic Range Characterization of the Trauma Patient Plasma Proteome
journal, October 2006

Pain, perceived injustice and the persistence of post-traumatic stress symptoms during the course of rehabilitation for whiplash injuries
journal, October 2009

Persistent postoperative pain after total knee arthroplasty: a prospective cohort study of potential risk factors
journal, October 2018

Preventing Post-Thoracotomy Pain Syndrome
journal, January 2012

  • Khelemsky, Yury; Noto, Christopher J.
  • Mount Sinai Journal of Medicine: A Journal of Translational and Personalized Medicine, Vol. 79, Issue 1
  • DOI: 10.1002/msj.21286

The self-administered comorbidity questionnaire: A new method to assess comorbidity for clinical and health services research
journal, April 2003

  • Sangha, Oliver; Stucki, Gerold; Liang, Matthew H.
  • Arthritis & Rheumatism, Vol. 49, Issue 2
  • DOI: 10.1002/art.10993

Corticostriatal functional connectivity predicts transition to chronic back pain
journal, July 2012

  • Baliki, Marwan N.; Petre, Bogdan; Torbey, Souraya
  • Nature Neuroscience, Vol. 15, Issue 8
  • DOI: 10.1038/nn.3153

Validation of the Pain Resilience Scale in a Chronic Pain Sample
journal, August 2017

Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients
journal, September 2016

  • McNeely, Jennifer; Wu, Li-Tzy; Subramaniam, Geetha
  • Annals of Internal Medicine, Vol. 165, Issue 10
  • DOI: 10.7326/M16-0317

Relationships among pain intensity, pain-related distress, and psychological distress in pre-surgical total knee arthroplasty patients: a secondary analysis
journal, May 2016

Experimental knee pain impairs submaximal force steadiness in isometric, eccentric, and concentric muscle actions
journal, September 2015

  • Rice, David A.; McNair, Peter J.; Lewis, Gwyn N.
  • Arthritis Research & Therapy, Vol. 17, Issue 1
  • DOI: 10.1186/s13075-015-0768-1
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