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Core patient-reported outcome measures for chronic pain patients treated with spinal cord stimulation or dorsal root ganglia stimulation

BACKGROUND: Neurostimulation is a highly effective therapy for the treatment of chronic Intractable pain, however, due to the complexity of pain, measuring a subject’s long-term response to the therapy remains difficult. Frequent measurement of patient-reported outcomes (PROs) to reflect multiple as...

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Autores principales: Huygen, Frank, Hagedorn, Jonathan M., Falowski, Steven, Schultz, David, Vesper, Jan, Heros, Robert D., Patterson, Denis G., Dehghan, Soroush, Ross, Erika, Kyani, Anahita, Mansouri, Misagh B., Kallewaard, Jan Willem
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10357671/
https://www.ncbi.nlm.nih.gov/pubmed/37474950
http://dx.doi.org/10.1186/s12955-023-02158-2
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author Huygen, Frank
Hagedorn, Jonathan M.
Falowski, Steven
Schultz, David
Vesper, Jan
Heros, Robert D.
Patterson, Denis G.
Dehghan, Soroush
Ross, Erika
Kyani, Anahita
Mansouri, Misagh B.
Kallewaard, Jan Willem
author_facet Huygen, Frank
Hagedorn, Jonathan M.
Falowski, Steven
Schultz, David
Vesper, Jan
Heros, Robert D.
Patterson, Denis G.
Dehghan, Soroush
Ross, Erika
Kyani, Anahita
Mansouri, Misagh B.
Kallewaard, Jan Willem
author_sort Huygen, Frank
collection PubMed
description BACKGROUND: Neurostimulation is a highly effective therapy for the treatment of chronic Intractable pain, however, due to the complexity of pain, measuring a subject’s long-term response to the therapy remains difficult. Frequent measurement of patient-reported outcomes (PROs) to reflect multiple aspects of subjects’ pain is a crucial step in determining therapy outcomes. However, collecting full-length PROs is burdensome for both patients and clinicians. The objective of this work is to identify the reduced set of questions from multiple validated PROs that can accurately characterize chronic pain patients’ responses to neurostimulation therapies. METHODS: Validated PROs were used to capture pain, physical function and disability, as well as psychometric, satisfaction, and global health metrics. PROs were collected from 509 patients implanted with Spinal Cord Stimulation (SCS) or Dorsal Root Ganglia (DRG) neurostimulators enrolled in the prospective, international, post-market REALITY study (NCT03876054, Registration Date: March 15, 2019). A combination of linear regression, Pearson’s correlation, and factor analysis were used to eliminate highly correlated questions and find the minimal meaningful set of questions within the predefined domains of each scale. RESULTS: The shortened versions of the questionnaires presented almost identical accuracy for classifying the therapy outcomes as compared to the validated full-length versions. In addition, principal component analysis was performed on all the PROs and showed a robust clustering of pain intensity, psychological factors, physical function, and sleep across multiple PROs. A selected set of questions captured from multiple PROs can provide adequate information for measuring neurostimulation therapy outcomes. CONCLUSIONS: PROs are important subjective measures to evaluate the physiological and psychological aspects of pain. However, these measures are cumbersome to collect. These shorter and more targeted PROs could result in better patient engagement, and enhanced and more frequent data collection processes for digital health platforms that minimize patient burden while increasing therapeutic benefits for chronic pain patients. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12955-023-02158-2.
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spelling pubmed-103576712023-07-21 Core patient-reported outcome measures for chronic pain patients treated with spinal cord stimulation or dorsal root ganglia stimulation Huygen, Frank Hagedorn, Jonathan M. Falowski, Steven Schultz, David Vesper, Jan Heros, Robert D. Patterson, Denis G. Dehghan, Soroush Ross, Erika Kyani, Anahita Mansouri, Misagh B. Kallewaard, Jan Willem Health Qual Life Outcomes Research BACKGROUND: Neurostimulation is a highly effective therapy for the treatment of chronic Intractable pain, however, due to the complexity of pain, measuring a subject’s long-term response to the therapy remains difficult. Frequent measurement of patient-reported outcomes (PROs) to reflect multiple aspects of subjects’ pain is a crucial step in determining therapy outcomes. However, collecting full-length PROs is burdensome for both patients and clinicians. The objective of this work is to identify the reduced set of questions from multiple validated PROs that can accurately characterize chronic pain patients’ responses to neurostimulation therapies. METHODS: Validated PROs were used to capture pain, physical function and disability, as well as psychometric, satisfaction, and global health metrics. PROs were collected from 509 patients implanted with Spinal Cord Stimulation (SCS) or Dorsal Root Ganglia (DRG) neurostimulators enrolled in the prospective, international, post-market REALITY study (NCT03876054, Registration Date: March 15, 2019). A combination of linear regression, Pearson’s correlation, and factor analysis were used to eliminate highly correlated questions and find the minimal meaningful set of questions within the predefined domains of each scale. RESULTS: The shortened versions of the questionnaires presented almost identical accuracy for classifying the therapy outcomes as compared to the validated full-length versions. In addition, principal component analysis was performed on all the PROs and showed a robust clustering of pain intensity, psychological factors, physical function, and sleep across multiple PROs. A selected set of questions captured from multiple PROs can provide adequate information for measuring neurostimulation therapy outcomes. CONCLUSIONS: PROs are important subjective measures to evaluate the physiological and psychological aspects of pain. However, these measures are cumbersome to collect. These shorter and more targeted PROs could result in better patient engagement, and enhanced and more frequent data collection processes for digital health platforms that minimize patient burden while increasing therapeutic benefits for chronic pain patients. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12955-023-02158-2. BioMed Central 2023-07-20 /pmc/articles/PMC10357671/ /pubmed/37474950 http://dx.doi.org/10.1186/s12955-023-02158-2 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits 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/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Huygen, Frank
Hagedorn, Jonathan M.
Falowski, Steven
Schultz, David
Vesper, Jan
Heros, Robert D.
Patterson, Denis G.
Dehghan, Soroush
Ross, Erika
Kyani, Anahita
Mansouri, Misagh B.
Kallewaard, Jan Willem
Core patient-reported outcome measures for chronic pain patients treated with spinal cord stimulation or dorsal root ganglia stimulation
title Core patient-reported outcome measures for chronic pain patients treated with spinal cord stimulation or dorsal root ganglia stimulation
title_full Core patient-reported outcome measures for chronic pain patients treated with spinal cord stimulation or dorsal root ganglia stimulation
title_fullStr Core patient-reported outcome measures for chronic pain patients treated with spinal cord stimulation or dorsal root ganglia stimulation
title_full_unstemmed Core patient-reported outcome measures for chronic pain patients treated with spinal cord stimulation or dorsal root ganglia stimulation
title_short Core patient-reported outcome measures for chronic pain patients treated with spinal cord stimulation or dorsal root ganglia stimulation
title_sort core patient-reported outcome measures for chronic pain patients treated with spinal cord stimulation or dorsal root ganglia stimulation
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10357671/
https://www.ncbi.nlm.nih.gov/pubmed/37474950
http://dx.doi.org/10.1186/s12955-023-02158-2
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