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Pragmatic trials of pain therapies: a systematic review of methods

Pragmatic randomised clinical trials aim to directly inform clinical or health policy decision making. Here, we systematically review methods and design of pragmatic trials of pain therapies to examine methods, identify common challenges, and areas for improvement. Seven databases were searched for...

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Autores principales: Hohenschurz-Schmidt, David, Kleykamp, Bethea A., Draper-Rodi, Jerry, Vollert, Jan, Chan, Jessica, Ferguson, McKenzie, McNicol, Ewan, Phalip, Jules, Evans, Scott R., Turk, Dennis C., Dworkin, Robert H., Rice, Andrew S.C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8675058/
https://www.ncbi.nlm.nih.gov/pubmed/34490854
http://dx.doi.org/10.1097/j.pain.0000000000002317
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author Hohenschurz-Schmidt, David
Kleykamp, Bethea A.
Draper-Rodi, Jerry
Vollert, Jan
Chan, Jessica
Ferguson, McKenzie
McNicol, Ewan
Phalip, Jules
Evans, Scott R.
Turk, Dennis C.
Dworkin, Robert H.
Rice, Andrew S.C.
author_facet Hohenschurz-Schmidt, David
Kleykamp, Bethea A.
Draper-Rodi, Jerry
Vollert, Jan
Chan, Jessica
Ferguson, McKenzie
McNicol, Ewan
Phalip, Jules
Evans, Scott R.
Turk, Dennis C.
Dworkin, Robert H.
Rice, Andrew S.C.
author_sort Hohenschurz-Schmidt, David
collection PubMed
description Pragmatic randomised clinical trials aim to directly inform clinical or health policy decision making. Here, we systematically review methods and design of pragmatic trials of pain therapies to examine methods, identify common challenges, and areas for improvement. Seven databases were searched for pragmatic randomised controlled clinical trials that assessed pain treatment in a clinical population of adults reporting pain. All screening steps and data extractions were performed twice. Data were synthesised descriptively, and correlation analyses between prespecified trial features and PRECIS-2 (PRagmatic–Explanatory Continuum Indicator Summary 2) ratings and attrition were performed. Protocol registration: PROSPERO-ID CRD42020178954. Of 57 included trials, only 21% assessed pharmacological interventions, the remainder physical, surgical, psychological, or self-management pain therapies. Three-quarters of the trials were comparative effectiveness designs, often conducted in multiple centres (median: 5; Q1/3: 1, 9.25) and with a median sample size of 234 patients at randomization (Q1/3: 135.5; 363.5). Although most trials recruited patients with chronic pain, reporting of pain duration was poor and not well described. Reporting was comprehensive for most general items, while often deficient for specific pragmatic aspects. Average ratings for pragmatism were highest for treatment adherence flexibility and clinical relevance of outcome measures. They were lowest for patient recruitment methods and extent of follow-up measurements and appointments. Current practice in pragmatic trials of pain treatments can be improved in areas such as patient recruitment and reporting of methods, analysis, and interpretation of data. These improvements will facilitate translatability to other real-world settings—the purpose of pragmatic trials.
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spelling pubmed-86750582021-12-23 Pragmatic trials of pain therapies: a systematic review of methods Hohenschurz-Schmidt, David Kleykamp, Bethea A. Draper-Rodi, Jerry Vollert, Jan Chan, Jessica Ferguson, McKenzie McNicol, Ewan Phalip, Jules Evans, Scott R. Turk, Dennis C. Dworkin, Robert H. Rice, Andrew S.C. Pain Systematic Review and Meta-Analysis Pragmatic randomised clinical trials aim to directly inform clinical or health policy decision making. Here, we systematically review methods and design of pragmatic trials of pain therapies to examine methods, identify common challenges, and areas for improvement. Seven databases were searched for pragmatic randomised controlled clinical trials that assessed pain treatment in a clinical population of adults reporting pain. All screening steps and data extractions were performed twice. Data were synthesised descriptively, and correlation analyses between prespecified trial features and PRECIS-2 (PRagmatic–Explanatory Continuum Indicator Summary 2) ratings and attrition were performed. Protocol registration: PROSPERO-ID CRD42020178954. Of 57 included trials, only 21% assessed pharmacological interventions, the remainder physical, surgical, psychological, or self-management pain therapies. Three-quarters of the trials were comparative effectiveness designs, often conducted in multiple centres (median: 5; Q1/3: 1, 9.25) and with a median sample size of 234 patients at randomization (Q1/3: 135.5; 363.5). Although most trials recruited patients with chronic pain, reporting of pain duration was poor and not well described. Reporting was comprehensive for most general items, while often deficient for specific pragmatic aspects. Average ratings for pragmatism were highest for treatment adherence flexibility and clinical relevance of outcome measures. They were lowest for patient recruitment methods and extent of follow-up measurements and appointments. Current practice in pragmatic trials of pain treatments can be improved in areas such as patient recruitment and reporting of methods, analysis, and interpretation of data. These improvements will facilitate translatability to other real-world settings—the purpose of pragmatic trials. Wolters Kluwer 2022-01 2021-04-21 /pmc/articles/PMC8675058/ /pubmed/34490854 http://dx.doi.org/10.1097/j.pain.0000000000002317 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 Systematic Review and Meta-Analysis
Hohenschurz-Schmidt, David
Kleykamp, Bethea A.
Draper-Rodi, Jerry
Vollert, Jan
Chan, Jessica
Ferguson, McKenzie
McNicol, Ewan
Phalip, Jules
Evans, Scott R.
Turk, Dennis C.
Dworkin, Robert H.
Rice, Andrew S.C.
Pragmatic trials of pain therapies: a systematic review of methods
title Pragmatic trials of pain therapies: a systematic review of methods
title_full Pragmatic trials of pain therapies: a systematic review of methods
title_fullStr Pragmatic trials of pain therapies: a systematic review of methods
title_full_unstemmed Pragmatic trials of pain therapies: a systematic review of methods
title_short Pragmatic trials of pain therapies: a systematic review of methods
title_sort pragmatic trials of pain therapies: a systematic review of methods
topic Systematic Review and Meta-Analysis
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8675058/
https://www.ncbi.nlm.nih.gov/pubmed/34490854
http://dx.doi.org/10.1097/j.pain.0000000000002317
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