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The Fragility Index in a Cohort of Pediatric Randomized Controlled Trials

Data suggest inadequacy of common statistical techniques for reporting outcomes in clinical trials. The Fragility Index can measure how many events the statistical significance hinges on, and may facilitate better interpretation of trial results. This study aimed to assess the Fragility Index in ped...

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Autores principales: Matics, Travis J., Khan, Nadia, Jani, Priti, Kane, Jason M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5575581/
https://www.ncbi.nlm.nih.gov/pubmed/28805717
http://dx.doi.org/10.3390/jcm6080079
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author Matics, Travis J.
Khan, Nadia
Jani, Priti
Kane, Jason M.
author_facet Matics, Travis J.
Khan, Nadia
Jani, Priti
Kane, Jason M.
author_sort Matics, Travis J.
collection PubMed
description Data suggest inadequacy of common statistical techniques for reporting outcomes in clinical trials. The Fragility Index can measure how many events the statistical significance hinges on, and may facilitate better interpretation of trial results. This study aimed to assess the Fragility Index in pediatric randomized controlled trials (RCTs) with statistically significant findings published in high-quality medical journals. A Fragility Index was calculated on included trials with dichotomous positive outcomes. Analysis of the relationship between trial characteristics and the Fragility Index was performed. Of the 429 abstracts screened, 17 met the inclusion criteria and underwent analysis. The median Fragility Index was 7 with an interquartile range of 2–11. In 41% of the studies, the number of patients lost to follow-up or withdrawn prior to analysis was equal to or greater than the Fragility Index. There was no correlation between the RCT sample size and the Fragility Index (r = 0.249, p = 0.335) nor the event group size and the Fragility Index (r = 0.250, p = 0.334). There was a strong negative correlation between the original p-value and the Fragility Index (r = −0.700, p = 0.002). The Fragility Index is a calculated metric that may assist in applying clinical relevance to statistically significant outcomes in pediatric randomized controlled trials with dichotomous outcomes.
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spelling pubmed-55755812017-09-01 The Fragility Index in a Cohort of Pediatric Randomized Controlled Trials Matics, Travis J. Khan, Nadia Jani, Priti Kane, Jason M. J Clin Med Article Data suggest inadequacy of common statistical techniques for reporting outcomes in clinical trials. The Fragility Index can measure how many events the statistical significance hinges on, and may facilitate better interpretation of trial results. This study aimed to assess the Fragility Index in pediatric randomized controlled trials (RCTs) with statistically significant findings published in high-quality medical journals. A Fragility Index was calculated on included trials with dichotomous positive outcomes. Analysis of the relationship between trial characteristics and the Fragility Index was performed. Of the 429 abstracts screened, 17 met the inclusion criteria and underwent analysis. The median Fragility Index was 7 with an interquartile range of 2–11. In 41% of the studies, the number of patients lost to follow-up or withdrawn prior to analysis was equal to or greater than the Fragility Index. There was no correlation between the RCT sample size and the Fragility Index (r = 0.249, p = 0.335) nor the event group size and the Fragility Index (r = 0.250, p = 0.334). There was a strong negative correlation between the original p-value and the Fragility Index (r = −0.700, p = 0.002). The Fragility Index is a calculated metric that may assist in applying clinical relevance to statistically significant outcomes in pediatric randomized controlled trials with dichotomous outcomes. MDPI 2017-08-14 /pmc/articles/PMC5575581/ /pubmed/28805717 http://dx.doi.org/10.3390/jcm6080079 Text en © 2017 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Matics, Travis J.
Khan, Nadia
Jani, Priti
Kane, Jason M.
The Fragility Index in a Cohort of Pediatric Randomized Controlled Trials
title The Fragility Index in a Cohort of Pediatric Randomized Controlled Trials
title_full The Fragility Index in a Cohort of Pediatric Randomized Controlled Trials
title_fullStr The Fragility Index in a Cohort of Pediatric Randomized Controlled Trials
title_full_unstemmed The Fragility Index in a Cohort of Pediatric Randomized Controlled Trials
title_short The Fragility Index in a Cohort of Pediatric Randomized Controlled Trials
title_sort fragility index in a cohort of pediatric randomized controlled trials
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5575581/
https://www.ncbi.nlm.nih.gov/pubmed/28805717
http://dx.doi.org/10.3390/jcm6080079
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