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Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results

BACKGROUND: Trial sequential analysis (TSA) may establish when firm evidence about the efficacy of interventions is reached in a cumulative meta-analysis, combining a required information size with adjusted thresholds for conservative statistical significance. Our aim was to demonstrate TSA results...

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Autores principales: Castellini, Greta, Gianola, Silvia, Banzi, Rita, Corbetta, Davide, Gatti, Roberto, Sirtori, Valeria, Gluud, Christian, Moja, Lorenzo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4307139/
https://www.ncbi.nlm.nih.gov/pubmed/25542215
http://dx.doi.org/10.1186/1745-6215-15-512
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author Castellini, Greta
Gianola, Silvia
Banzi, Rita
Corbetta, Davide
Gatti, Roberto
Sirtori, Valeria
Gluud, Christian
Moja, Lorenzo
author_facet Castellini, Greta
Gianola, Silvia
Banzi, Rita
Corbetta, Davide
Gatti, Roberto
Sirtori, Valeria
Gluud, Christian
Moja, Lorenzo
author_sort Castellini, Greta
collection PubMed
description BACKGROUND: Trial sequential analysis (TSA) may establish when firm evidence about the efficacy of interventions is reached in a cumulative meta-analysis, combining a required information size with adjusted thresholds for conservative statistical significance. Our aim was to demonstrate TSA results on randomized controlled trials (RCTs) included in a Cochrane systematic review on the effectiveness of constraint-induced movement therapy (CIMT) for stroke patients. METHODS: We extracted data on the functional independence measure (FIM) and the action research arm test (ARAT) from RCTs that compared CIMT versus other rehabilitative techniques. Mean differences (MD) were analyzed using a random-effects model. We calculated the information size and the cumulative Z-statistic, applying the O’Brien-Fleming monitoring boundaries. RESULTS: We included data from 14 RCTs. In the conventional meta-analysis (seven trials, 233 patients), the effect of CIMT on FIM was reported as significant (MD 2.88, 95% CI 0.08 to 5.68; P = 0.04). The diversity-adjusted required information size was 142 patients, and the cumulative Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.02 to 5.78). The effect of CIMT on ARAT (nine trials, 199 patients) was reported as significant (MD 7.78, 95% CI 1.19 to 14.37; P = 0.02). However, the diversity-adjusted required information size was 252 patients, and the Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.06 to 15.62). CONCLUSIONS: Although conventional meta-analyses of CIMT reached statistical significance, their overall results remain inconclusive and might be spurious. Researchers should not be overconfident on CIMT efficacy based on the results of meta-analyses and derived recommendations.
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spelling pubmed-43071392015-01-28 Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results Castellini, Greta Gianola, Silvia Banzi, Rita Corbetta, Davide Gatti, Roberto Sirtori, Valeria Gluud, Christian Moja, Lorenzo Trials Research BACKGROUND: Trial sequential analysis (TSA) may establish when firm evidence about the efficacy of interventions is reached in a cumulative meta-analysis, combining a required information size with adjusted thresholds for conservative statistical significance. Our aim was to demonstrate TSA results on randomized controlled trials (RCTs) included in a Cochrane systematic review on the effectiveness of constraint-induced movement therapy (CIMT) for stroke patients. METHODS: We extracted data on the functional independence measure (FIM) and the action research arm test (ARAT) from RCTs that compared CIMT versus other rehabilitative techniques. Mean differences (MD) were analyzed using a random-effects model. We calculated the information size and the cumulative Z-statistic, applying the O’Brien-Fleming monitoring boundaries. RESULTS: We included data from 14 RCTs. In the conventional meta-analysis (seven trials, 233 patients), the effect of CIMT on FIM was reported as significant (MD 2.88, 95% CI 0.08 to 5.68; P = 0.04). The diversity-adjusted required information size was 142 patients, and the cumulative Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.02 to 5.78). The effect of CIMT on ARAT (nine trials, 199 patients) was reported as significant (MD 7.78, 95% CI 1.19 to 14.37; P = 0.02). However, the diversity-adjusted required information size was 252 patients, and the Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.06 to 15.62). CONCLUSIONS: Although conventional meta-analyses of CIMT reached statistical significance, their overall results remain inconclusive and might be spurious. Researchers should not be overconfident on CIMT efficacy based on the results of meta-analyses and derived recommendations. BioMed Central 2014-12-26 /pmc/articles/PMC4307139/ /pubmed/25542215 http://dx.doi.org/10.1186/1745-6215-15-512 Text en © Castellini et al.; licensee BioMed Central. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), 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 Research
Castellini, Greta
Gianola, Silvia
Banzi, Rita
Corbetta, Davide
Gatti, Roberto
Sirtori, Valeria
Gluud, Christian
Moja, Lorenzo
Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results
title Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results
title_full Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results
title_fullStr Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results
title_full_unstemmed Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results
title_short Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results
title_sort constraint-induced movement therapy: trial sequential analysis applied to cochrane collaboration systematic review results
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4307139/
https://www.ncbi.nlm.nih.gov/pubmed/25542215
http://dx.doi.org/10.1186/1745-6215-15-512
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