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Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant

BACKGROUND: An observed statistically significant difference between two interventions does not necessarily imply that this difference is clinically important for patients and clinicians. We aimed to assess if treatment effects of randomized controlled trials (RCTs) for low back pain (LBP) are stati...

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Autores principales: Gianola, Silvia, Castellini, Greta, Corbetta, Davide, Moja, Lorenzo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647152/
https://www.ncbi.nlm.nih.gov/pubmed/31331343
http://dx.doi.org/10.1186/s12955-019-1196-8
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author Gianola, Silvia
Castellini, Greta
Corbetta, Davide
Moja, Lorenzo
author_facet Gianola, Silvia
Castellini, Greta
Corbetta, Davide
Moja, Lorenzo
author_sort Gianola, Silvia
collection PubMed
description BACKGROUND: An observed statistically significant difference between two interventions does not necessarily imply that this difference is clinically important for patients and clinicians. We aimed to assess if treatment effects of randomized controlled trials (RCTs) for low back pain (LBP) are statistically significant and clinically relevant, and if RCTs were powered to achieve clinically relevant differences on continuous outcomes. METHODS: We searched for all RCTs included in Cochrane Systematic Reviews focusing on the efficacy of rehabilitation interventions for LBP and published until April 2017. RCTs having sample size calculation and a planned minimal important difference were considered. In the primary analysis, we calculated the proportion of RCTs classified as “statistically significant and clinically relevant”, “statistically significant but not clinically relevant”, “not statistically significant but clinically relevant”, and “not statistically significant and not clinically relevant”. Then, we investigated how many times the mismatch between statistical significance and clinical relevance was due to inadequate power. RESULTS: From 20 eligible SRs including 101 RCTs, we identified 42 RCTs encompassing 81 intervention comparisons. Overall, 60% (25 RCTs) were statistically significant while only 36% (15 RCTs) were both statistically and clinically significant. Most trials (38%) did not discuss the clinical relevance of treatment effects when results did not reached statistical significance. Among trials with non-statistically significant findings, 60% did not reach the planned sample size, therefore being at risk to not detect an effect that is actually there (type II error). CONCLUSION: Only a minority of positive RCT findings was both statistically significant and clinically relevant. Scarce diligence or frank omissions of important tactic elements of RCTs, such as clinical relevance, and power, decrease the reliability of study findings to current practice. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12955-019-1196-8) contains supplementary material, which is available to authorized users.
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spelling pubmed-66471522019-07-31 Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant Gianola, Silvia Castellini, Greta Corbetta, Davide Moja, Lorenzo Health Qual Life Outcomes Research BACKGROUND: An observed statistically significant difference between two interventions does not necessarily imply that this difference is clinically important for patients and clinicians. We aimed to assess if treatment effects of randomized controlled trials (RCTs) for low back pain (LBP) are statistically significant and clinically relevant, and if RCTs were powered to achieve clinically relevant differences on continuous outcomes. METHODS: We searched for all RCTs included in Cochrane Systematic Reviews focusing on the efficacy of rehabilitation interventions for LBP and published until April 2017. RCTs having sample size calculation and a planned minimal important difference were considered. In the primary analysis, we calculated the proportion of RCTs classified as “statistically significant and clinically relevant”, “statistically significant but not clinically relevant”, “not statistically significant but clinically relevant”, and “not statistically significant and not clinically relevant”. Then, we investigated how many times the mismatch between statistical significance and clinical relevance was due to inadequate power. RESULTS: From 20 eligible SRs including 101 RCTs, we identified 42 RCTs encompassing 81 intervention comparisons. Overall, 60% (25 RCTs) were statistically significant while only 36% (15 RCTs) were both statistically and clinically significant. Most trials (38%) did not discuss the clinical relevance of treatment effects when results did not reached statistical significance. Among trials with non-statistically significant findings, 60% did not reach the planned sample size, therefore being at risk to not detect an effect that is actually there (type II error). CONCLUSION: Only a minority of positive RCT findings was both statistically significant and clinically relevant. Scarce diligence or frank omissions of important tactic elements of RCTs, such as clinical relevance, and power, decrease the reliability of study findings to current practice. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12955-019-1196-8) contains supplementary material, which is available to authorized users. BioMed Central 2019-07-22 /pmc/articles/PMC6647152/ /pubmed/31331343 http://dx.doi.org/10.1186/s12955-019-1196-8 Text en © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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 Research
Gianola, Silvia
Castellini, Greta
Corbetta, Davide
Moja, Lorenzo
Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant
title Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant
title_full Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant
title_fullStr Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant
title_full_unstemmed Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant
title_short Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant
title_sort rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647152/
https://www.ncbi.nlm.nih.gov/pubmed/31331343
http://dx.doi.org/10.1186/s12955-019-1196-8
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