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The ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials

There is increasing awareness throughout biomedical science that many results do not withstand the trials of repeat investigation. The growing abundance of medical literature has only increased the urgent need for tools to gauge the robustness and trustworthiness of published science. Dichotomous ou...

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Autor principal: Grimes, David Robert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: eLife Sciences Publications, Ltd 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9586556/
https://www.ncbi.nlm.nih.gov/pubmed/36125120
http://dx.doi.org/10.7554/eLife.79573
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author Grimes, David Robert
author_facet Grimes, David Robert
author_sort Grimes, David Robert
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description There is increasing awareness throughout biomedical science that many results do not withstand the trials of repeat investigation. The growing abundance of medical literature has only increased the urgent need for tools to gauge the robustness and trustworthiness of published science. Dichotomous outcome designs are vital in randomized clinical trials, cohort studies, and observational data for ascertaining differences between experimental and control arms. It has however been shown with tools like the fragility index (FI) that many ostensibly impactful results fail to materialize when even small numbers of patients or subjects in either the control or experimental arms are recoded from event to non-event. Critics of this metric counter that there is no objective means to determine a meaningful FI. As currently used, FI is not multidimensional and is computationally expensive. In this work, a conceptually similar geometrical approach is introduced, the ellipse of insignificance. This method yields precise deterministic values for the degree of manipulation or miscoding that can be tolerated simultaneously in both control and experimental arms, allowing for the derivation of objective measures of experimental robustness. More than this, the tool is intimately connected with sensitivity and specificity of the event/non-event tests, and is readily combined with knowledge of test parameters to reject unsound results. The method is outlined here, with illustrative clinical examples.
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spelling pubmed-95865562022-10-22 The ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials Grimes, David Robert eLife Epidemiology and Global Health There is increasing awareness throughout biomedical science that many results do not withstand the trials of repeat investigation. The growing abundance of medical literature has only increased the urgent need for tools to gauge the robustness and trustworthiness of published science. Dichotomous outcome designs are vital in randomized clinical trials, cohort studies, and observational data for ascertaining differences between experimental and control arms. It has however been shown with tools like the fragility index (FI) that many ostensibly impactful results fail to materialize when even small numbers of patients or subjects in either the control or experimental arms are recoded from event to non-event. Critics of this metric counter that there is no objective means to determine a meaningful FI. As currently used, FI is not multidimensional and is computationally expensive. In this work, a conceptually similar geometrical approach is introduced, the ellipse of insignificance. This method yields precise deterministic values for the degree of manipulation or miscoding that can be tolerated simultaneously in both control and experimental arms, allowing for the derivation of objective measures of experimental robustness. More than this, the tool is intimately connected with sensitivity and specificity of the event/non-event tests, and is readily combined with knowledge of test parameters to reject unsound results. The method is outlined here, with illustrative clinical examples. eLife Sciences Publications, Ltd 2022-09-20 /pmc/articles/PMC9586556/ /pubmed/36125120 http://dx.doi.org/10.7554/eLife.79573 Text en © 2022, Grimes https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use and redistribution provided that the original author and source are credited.
spellingShingle Epidemiology and Global Health
Grimes, David Robert
The ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials
title The ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials
title_full The ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials
title_fullStr The ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials
title_full_unstemmed The ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials
title_short The ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials
title_sort ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials
topic Epidemiology and Global Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9586556/
https://www.ncbi.nlm.nih.gov/pubmed/36125120
http://dx.doi.org/10.7554/eLife.79573
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