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Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting

Appropriate outcome measures and high-quality intervention trials are critical to advancing care for children with chronic pain. Our aim was to update a core outcome set for pediatric chronic pain interventions. The first phase involved collecting providers', patients', and parents' p...

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Autores principales: Palermo, Tonya M., Walco, Gary A., Paladhi, Unmesha Roy, Birnie, Kathryn A., Crombez, Geert, de la Vega, Rocio, Eccleston, Christopher, Kashikar-Zuck, Susmita, Stone, Amanda L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8442740/
https://www.ncbi.nlm.nih.gov/pubmed/33625074
http://dx.doi.org/10.1097/j.pain.0000000000002241
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author Palermo, Tonya M.
Walco, Gary A.
Paladhi, Unmesha Roy
Birnie, Kathryn A.
Crombez, Geert
de la Vega, Rocio
Eccleston, Christopher
Kashikar-Zuck, Susmita
Stone, Amanda L.
author_facet Palermo, Tonya M.
Walco, Gary A.
Paladhi, Unmesha Roy
Birnie, Kathryn A.
Crombez, Geert
de la Vega, Rocio
Eccleston, Christopher
Kashikar-Zuck, Susmita
Stone, Amanda L.
author_sort Palermo, Tonya M.
collection PubMed
description Appropriate outcome measures and high-quality intervention trials are critical to advancing care for children with chronic pain. Our aim was to update a core outcome set for pediatric chronic pain interventions. The first phase involved collecting providers', patients', and parents' perspectives about treatment of pediatric chronic pain to understand clinically meaningful outcomes to be routinely measured. The second phase was to reach consensus of mandatory and optional outcome domains following the OMERACT framework. A modified Delphi study with 2 rounds was conducted including 3 stakeholder groups: children with chronic pain (n = 93), their parents (n = 90), and health care providers who treat youth with chronic pain (n = 52). Quantitative and qualitative data from round 1 of the Delphi study were summarized to identify important outcomes, which were condensed to a list of 10 outcome domains. Round 2 surveys were analyzed to determine the importance of the 10 domains and their relative ranking in each stakeholder group. A virtual consensus conference was held with the steering committee to reach consensus on a set of recommended outcome domains for pediatric chronic pain clinical trials. It was determined, by unanimous vote, that pain severity, pain interference with daily living, overall well-being, and adverse events, including death, would be considered mandatory domains to be assessed in all trials of any type of intervention. Emotional functioning, physical functioning, and sleep were important but optional domains. Last, the research agenda identifies several important emerging areas, including biomarkers. Future work includes selecting appropriate validated measures to assess each outcome domain.
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spelling pubmed-84427402021-09-20 Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting Palermo, Tonya M. Walco, Gary A. Paladhi, Unmesha Roy Birnie, Kathryn A. Crombez, Geert de la Vega, Rocio Eccleston, Christopher Kashikar-Zuck, Susmita Stone, Amanda L. Pain Research Paper Appropriate outcome measures and high-quality intervention trials are critical to advancing care for children with chronic pain. Our aim was to update a core outcome set for pediatric chronic pain interventions. The first phase involved collecting providers', patients', and parents' perspectives about treatment of pediatric chronic pain to understand clinically meaningful outcomes to be routinely measured. The second phase was to reach consensus of mandatory and optional outcome domains following the OMERACT framework. A modified Delphi study with 2 rounds was conducted including 3 stakeholder groups: children with chronic pain (n = 93), their parents (n = 90), and health care providers who treat youth with chronic pain (n = 52). Quantitative and qualitative data from round 1 of the Delphi study were summarized to identify important outcomes, which were condensed to a list of 10 outcome domains. Round 2 surveys were analyzed to determine the importance of the 10 domains and their relative ranking in each stakeholder group. A virtual consensus conference was held with the steering committee to reach consensus on a set of recommended outcome domains for pediatric chronic pain clinical trials. It was determined, by unanimous vote, that pain severity, pain interference with daily living, overall well-being, and adverse events, including death, would be considered mandatory domains to be assessed in all trials of any type of intervention. Emotional functioning, physical functioning, and sleep were important but optional domains. Last, the research agenda identifies several important emerging areas, including biomarkers. Future work includes selecting appropriate validated measures to assess each outcome domain. Wolters Kluwer 2021-10 2021-02-22 /pmc/articles/PMC8442740/ /pubmed/33625074 http://dx.doi.org/10.1097/j.pain.0000000000002241 Text en Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Research Paper
Palermo, Tonya M.
Walco, Gary A.
Paladhi, Unmesha Roy
Birnie, Kathryn A.
Crombez, Geert
de la Vega, Rocio
Eccleston, Christopher
Kashikar-Zuck, Susmita
Stone, Amanda L.
Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting
title Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting
title_full Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting
title_fullStr Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting
title_full_unstemmed Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting
title_short Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting
title_sort core outcome set for pediatric chronic pain clinical trials: results from a delphi poll and consensus meeting
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8442740/
https://www.ncbi.nlm.nih.gov/pubmed/33625074
http://dx.doi.org/10.1097/j.pain.0000000000002241
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