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Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions

The overarching goals of treatments for orthopedic conditions are generally to improve or restore function and alleviate pain. Results of clinical trials are generally used to determine whether a treatment is efficacious; however, a statistically significant improvement may not actually be clinicall...

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Autores principales: Katz, Nathaniel P, Paillard, Florence C, Ekman, Evan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4327973/
https://www.ncbi.nlm.nih.gov/pubmed/25645576
http://dx.doi.org/10.1186/s13018-014-0144-x
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author Katz, Nathaniel P
Paillard, Florence C
Ekman, Evan
author_facet Katz, Nathaniel P
Paillard, Florence C
Ekman, Evan
author_sort Katz, Nathaniel P
collection PubMed
description The overarching goals of treatments for orthopedic conditions are generally to improve or restore function and alleviate pain. Results of clinical trials are generally used to determine whether a treatment is efficacious; however, a statistically significant improvement may not actually be clinically important, i.e., meaningful to the patient. To determine whether an intervention has produced clinically important benefits requires a two-step process: first, determining the magnitude of change considered clinically important for a particular measure in the relevant population and, second, applying this yardstick to a patient’s data to determine whether s/he has benefited from treatment. Several metrics have been devised to quantify clinically important differences, including the minimum clinically important difference (MCID) and clinically important difference (CID). Herein, we review the methods to generate the MCID and other metrics and their use and interpretation in clinical trials and practice. We particularly highlight the many pitfalls associated with the generation and utilization of these metrics that can impair their correct use. These pitfalls include the fact that different pain measures yield different MCIDs, that efficacy in clinical trials is impacted by various factors (population characteristics, trial design), that the MCID value is impacted by the method used to calculate it (anchor, distribution), by the type of anchor chosen and by the definition (threshold) of improvement. The MCID is also dependent on the population characteristics such as disease type and severity, sex, age, etc. For appropriate use, the MCID should be applied to changes in individual subjects, not to group changes. The MCID and CID are useful tools to define general guidelines to determine whether a treatment produces clinically meaningful effects. However, the many pitfalls associated with these metrics require a detailed understanding of the methods to calculate them and their context of use. Orthopedic surgeons that will use these metrics need to carefully understand them and be aware of their pitfalls.
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spelling pubmed-43279732015-02-15 Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions Katz, Nathaniel P Paillard, Florence C Ekman, Evan J Orthop Surg Res Review The overarching goals of treatments for orthopedic conditions are generally to improve or restore function and alleviate pain. Results of clinical trials are generally used to determine whether a treatment is efficacious; however, a statistically significant improvement may not actually be clinically important, i.e., meaningful to the patient. To determine whether an intervention has produced clinically important benefits requires a two-step process: first, determining the magnitude of change considered clinically important for a particular measure in the relevant population and, second, applying this yardstick to a patient’s data to determine whether s/he has benefited from treatment. Several metrics have been devised to quantify clinically important differences, including the minimum clinically important difference (MCID) and clinically important difference (CID). Herein, we review the methods to generate the MCID and other metrics and their use and interpretation in clinical trials and practice. We particularly highlight the many pitfalls associated with the generation and utilization of these metrics that can impair their correct use. These pitfalls include the fact that different pain measures yield different MCIDs, that efficacy in clinical trials is impacted by various factors (population characteristics, trial design), that the MCID value is impacted by the method used to calculate it (anchor, distribution), by the type of anchor chosen and by the definition (threshold) of improvement. The MCID is also dependent on the population characteristics such as disease type and severity, sex, age, etc. For appropriate use, the MCID should be applied to changes in individual subjects, not to group changes. The MCID and CID are useful tools to define general guidelines to determine whether a treatment produces clinically meaningful effects. However, the many pitfalls associated with these metrics require a detailed understanding of the methods to calculate them and their context of use. Orthopedic surgeons that will use these metrics need to carefully understand them and be aware of their pitfalls. BioMed Central 2015-02-03 /pmc/articles/PMC4327973/ /pubmed/25645576 http://dx.doi.org/10.1186/s13018-014-0144-x Text en © Katz et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Review
Katz, Nathaniel P
Paillard, Florence C
Ekman, Evan
Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions
title Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions
title_full Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions
title_fullStr Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions
title_full_unstemmed Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions
title_short Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions
title_sort determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4327973/
https://www.ncbi.nlm.nih.gov/pubmed/25645576
http://dx.doi.org/10.1186/s13018-014-0144-x
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