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Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials
PURPOSE: To our knowledge, no study has quantified the rate of discontinuation and nonpublication of randomized controlled trials (RCTs) regarding upper and lower extremity fractures. METHODS: We searched ClinicalTrials.gov on September 9th, 2020, for phase 3 and 4 RCTs pertaining to upper and lower...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10053675/ https://www.ncbi.nlm.nih.gov/pubmed/36991514 http://dx.doi.org/10.1186/s13018-023-03698-5 |
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author | Shepard, Samuel Anderson, J. Michael Heigle, Benjamin Thompson, Jay C. Detweiler, Byron Hartwell, Micah Vassar, Matt |
author_facet | Shepard, Samuel Anderson, J. Michael Heigle, Benjamin Thompson, Jay C. Detweiler, Byron Hartwell, Micah Vassar, Matt |
author_sort | Shepard, Samuel |
collection | PubMed |
description | PURPOSE: To our knowledge, no study has quantified the rate of discontinuation and nonpublication of randomized controlled trials (RCTs) regarding upper and lower extremity fractures. METHODS: We searched ClinicalTrials.gov on September 9th, 2020, for phase 3 and 4 RCTs pertaining to upper and lower extremity fractures. Trial completion status was determined using records available on ClinicalTrials.gov. Publication status was determined using records on ClinicalTrials.gov and by searching PubMed (MEDLINE), Embase, and Google Scholar. We queried corresponding authors on trial status if a peer-reviewed publication was not identified. RESULTS: Our final analysis included 142 RCTs, of which 57 (40.1%) were discontinued and 71 (50%) were unpublished. Thirty-six (of 57, 63.2%) discontinued trials failed to provide a reason for discontinuation, the most commonly identified reason for discontinuation was due to inadequate recruitment (13/21, 61.9%). Completed trials were more likely to reach publication (59/85; 69.4%; X(2) = 32.92; P ≤ 0.001) than discontinued trials. Trials with more than 80 participants were less likely not to reach publication (AOR: 0.12; 95% CI 0.15–0.66). CONCLUSION: Our analysis of 142 upper and lower extremity fracture RCTs demonstrated one-half failed to reach publication and two-fifths were discontinued prior to trial completion. These findings indicate the need for increased guidance in developing, completing, and publishing RCTs in upper and lower extremity fractures. Discontinuation and nonpublication of orthopaedic RCTs hinder the public’s access to collected data and negate the valued contribution from study participants. Discontinuation and non-publication of clinical trials may subject participants to potentially harmful interventions, limit the advancement of clinical research, and contribute to research waste. Level of Evidence: III. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13018-023-03698-5. |
format | Online Article Text |
id | pubmed-10053675 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-100536752023-03-30 Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials Shepard, Samuel Anderson, J. Michael Heigle, Benjamin Thompson, Jay C. Detweiler, Byron Hartwell, Micah Vassar, Matt J Orthop Surg Res Research Article PURPOSE: To our knowledge, no study has quantified the rate of discontinuation and nonpublication of randomized controlled trials (RCTs) regarding upper and lower extremity fractures. METHODS: We searched ClinicalTrials.gov on September 9th, 2020, for phase 3 and 4 RCTs pertaining to upper and lower extremity fractures. Trial completion status was determined using records available on ClinicalTrials.gov. Publication status was determined using records on ClinicalTrials.gov and by searching PubMed (MEDLINE), Embase, and Google Scholar. We queried corresponding authors on trial status if a peer-reviewed publication was not identified. RESULTS: Our final analysis included 142 RCTs, of which 57 (40.1%) were discontinued and 71 (50%) were unpublished. Thirty-six (of 57, 63.2%) discontinued trials failed to provide a reason for discontinuation, the most commonly identified reason for discontinuation was due to inadequate recruitment (13/21, 61.9%). Completed trials were more likely to reach publication (59/85; 69.4%; X(2) = 32.92; P ≤ 0.001) than discontinued trials. Trials with more than 80 participants were less likely not to reach publication (AOR: 0.12; 95% CI 0.15–0.66). CONCLUSION: Our analysis of 142 upper and lower extremity fracture RCTs demonstrated one-half failed to reach publication and two-fifths were discontinued prior to trial completion. These findings indicate the need for increased guidance in developing, completing, and publishing RCTs in upper and lower extremity fractures. Discontinuation and nonpublication of orthopaedic RCTs hinder the public’s access to collected data and negate the valued contribution from study participants. Discontinuation and non-publication of clinical trials may subject participants to potentially harmful interventions, limit the advancement of clinical research, and contribute to research waste. Level of Evidence: III. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13018-023-03698-5. BioMed Central 2023-03-29 /pmc/articles/PMC10053675/ /pubmed/36991514 http://dx.doi.org/10.1186/s13018-023-03698-5 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Shepard, Samuel Anderson, J. Michael Heigle, Benjamin Thompson, Jay C. Detweiler, Byron Hartwell, Micah Vassar, Matt Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials |
title | Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials |
title_full | Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials |
title_fullStr | Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials |
title_full_unstemmed | Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials |
title_short | Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials |
title_sort | rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10053675/ https://www.ncbi.nlm.nih.gov/pubmed/36991514 http://dx.doi.org/10.1186/s13018-023-03698-5 |
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