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Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review
BACKGROUND: Despite recent meta-analyses of randomized controlled trials (RCTs), there remains no consensus regarding the preferred surgical treatment for humeral shaft fractures. The fragility index (FI) is an emerging tool used to evaluate the robustness of RCTs by quantifying the number of partic...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Baishideng Publishing Group Inc
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9516622/ https://www.ncbi.nlm.nih.gov/pubmed/36189338 http://dx.doi.org/10.5312/wjo.v13.i9.825 |
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author | Morris, Stephen Craig Gowd, Anirudh K Agarwalla, Avinesh Phipatanakul, Wesley P Amin, Nirav H Liu, Joseph N |
author_facet | Morris, Stephen Craig Gowd, Anirudh K Agarwalla, Avinesh Phipatanakul, Wesley P Amin, Nirav H Liu, Joseph N |
author_sort | Morris, Stephen Craig |
collection | PubMed |
description | BACKGROUND: Despite recent meta-analyses of randomized controlled trials (RCTs), there remains no consensus regarding the preferred surgical treatment for humeral shaft fractures. The fragility index (FI) is an emerging tool used to evaluate the robustness of RCTs by quantifying the number of participants in a study group that would need to switch outcomes in order to reverse the study conclusions. AIM: To investigate the fragility index of randomized control trials assessing outcomes of operative fixation in proximal humerus fractures. METHODS: We completed a systematic review of RCTs evaluating the surgical treatment of humeral shaft fractures. Inclusion criteria included: articles published in English; patients randomized and allotted in 1:1 ratio to 2 parallel arms; and dichotomous outcome variables. The FI was calculated for total complications, each complication individually, and secondary surgeries using the Fisher exact test, as previously published. RESULTS: Fifteen RCTs were included in the analysis comparing open reduction plate osteosynthesis with dynamic compression plate or locking compression plate, intramedullary nail, and minimally invasive plate osteosynthesis. The median FI was 0 for all parameters analyzed. Regarding individual outcomes, the FI was 0 for 81/91 (89%) of outcomes. The FI exceeded the number lost to follow up in only 2/91 (2%) outcomes. CONCLUSION: The FI shows that data from RCTs regarding operative treatment of humeral shaft fractures are fragile and does not demonstrate superiority of any particular surgical technique. |
format | Online Article Text |
id | pubmed-9516622 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Baishideng Publishing Group Inc |
record_format | MEDLINE/PubMed |
spelling | pubmed-95166222022-09-29 Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review Morris, Stephen Craig Gowd, Anirudh K Agarwalla, Avinesh Phipatanakul, Wesley P Amin, Nirav H Liu, Joseph N World J Orthop Systematic Reviews BACKGROUND: Despite recent meta-analyses of randomized controlled trials (RCTs), there remains no consensus regarding the preferred surgical treatment for humeral shaft fractures. The fragility index (FI) is an emerging tool used to evaluate the robustness of RCTs by quantifying the number of participants in a study group that would need to switch outcomes in order to reverse the study conclusions. AIM: To investigate the fragility index of randomized control trials assessing outcomes of operative fixation in proximal humerus fractures. METHODS: We completed a systematic review of RCTs evaluating the surgical treatment of humeral shaft fractures. Inclusion criteria included: articles published in English; patients randomized and allotted in 1:1 ratio to 2 parallel arms; and dichotomous outcome variables. The FI was calculated for total complications, each complication individually, and secondary surgeries using the Fisher exact test, as previously published. RESULTS: Fifteen RCTs were included in the analysis comparing open reduction plate osteosynthesis with dynamic compression plate or locking compression plate, intramedullary nail, and minimally invasive plate osteosynthesis. The median FI was 0 for all parameters analyzed. Regarding individual outcomes, the FI was 0 for 81/91 (89%) of outcomes. The FI exceeded the number lost to follow up in only 2/91 (2%) outcomes. CONCLUSION: The FI shows that data from RCTs regarding operative treatment of humeral shaft fractures are fragile and does not demonstrate superiority of any particular surgical technique. Baishideng Publishing Group Inc 2022-09-18 /pmc/articles/PMC9516622/ /pubmed/36189338 http://dx.doi.org/10.5312/wjo.v13.i9.825 Text en ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved. https://creativecommons.org/licenses/by-nc/4.0/This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/ |
spellingShingle | Systematic Reviews Morris, Stephen Craig Gowd, Anirudh K Agarwalla, Avinesh Phipatanakul, Wesley P Amin, Nirav H Liu, Joseph N Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review |
title | Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review |
title_full | Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review |
title_fullStr | Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review |
title_full_unstemmed | Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review |
title_short | Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review |
title_sort | fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: a systematic review |
topic | Systematic Reviews |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9516622/ https://www.ncbi.nlm.nih.gov/pubmed/36189338 http://dx.doi.org/10.5312/wjo.v13.i9.825 |
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