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What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry

BACKGROUND: There is an increasing number of interventions aimed at reducing the incidence and improving the identification and management of intimate partner violence (IPV), which are being tested in randomized clinical trials. Publication bias, improper reporting, and selective reporting in clinic...

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Autores principales: Madden, Kim, Tai, Kerry, Schneider, Patricia, Evaniew, Nathan, Ghert, Michelle A., Bhandari, Mohit
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6537377/
https://www.ncbi.nlm.nih.gov/pubmed/31133073
http://dx.doi.org/10.1186/s13063-019-3412-6
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author Madden, Kim
Tai, Kerry
Schneider, Patricia
Evaniew, Nathan
Ghert, Michelle A.
Bhandari, Mohit
author_facet Madden, Kim
Tai, Kerry
Schneider, Patricia
Evaniew, Nathan
Ghert, Michelle A.
Bhandari, Mohit
author_sort Madden, Kim
collection PubMed
description BACKGROUND: There is an increasing number of interventions aimed at reducing the incidence and improving the identification and management of intimate partner violence (IPV), which are being tested in randomized clinical trials. Publication bias, improper reporting, and selective reporting in clinical trials have led to widespread adoption of pre-registration of clinical trials. Non-publication of study results leads to inefficiency, ethical issues, and scientific issues with the IPV literature. When study results and methodology are not made available through publication or other public means, the results cannot be used to their full potential. The objective of this study was to determine the publication rates of IPV trials registered in a large clinical trial registry. METHODS: We conducted a systematic review of all IPV-related clinicaltrials.gov records and determined whether the studies that had been completed for ≥ 18 months have been published in a peer-reviewed journal or in the clinicaltrials.gov registry. Two authors extensively searched the literature and contacted study investigators to locate full-text publications for each included study. RESULTS: Of 83 completed IPV-related trials registered on clinicaltrials.gov, 64 (77.1%, 95% CI: 66.6–85.6) were subsequently published in full-text form. Of the 19 unpublished studies, authors confirmed that there was no publication for 11 studies; we were unable to contact the investigator or locate a publication for the remaining eight studies. Only four studies (all published) posted their results on clinicaltrials.gov upon completion. CONCLUSION: Approximately one in four IPV trials are not published 18 months after completion, indicating that clinicians, researchers, and other evidence users should consider whether publication bias might affect their interpretation of the IPV literature. Further research is warranted to understand reasons for non-publication of IPV research and methods to improve publication rates.
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spelling pubmed-65373772019-05-30 What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry Madden, Kim Tai, Kerry Schneider, Patricia Evaniew, Nathan Ghert, Michelle A. Bhandari, Mohit Trials Review BACKGROUND: There is an increasing number of interventions aimed at reducing the incidence and improving the identification and management of intimate partner violence (IPV), which are being tested in randomized clinical trials. Publication bias, improper reporting, and selective reporting in clinical trials have led to widespread adoption of pre-registration of clinical trials. Non-publication of study results leads to inefficiency, ethical issues, and scientific issues with the IPV literature. When study results and methodology are not made available through publication or other public means, the results cannot be used to their full potential. The objective of this study was to determine the publication rates of IPV trials registered in a large clinical trial registry. METHODS: We conducted a systematic review of all IPV-related clinicaltrials.gov records and determined whether the studies that had been completed for ≥ 18 months have been published in a peer-reviewed journal or in the clinicaltrials.gov registry. Two authors extensively searched the literature and contacted study investigators to locate full-text publications for each included study. RESULTS: Of 83 completed IPV-related trials registered on clinicaltrials.gov, 64 (77.1%, 95% CI: 66.6–85.6) were subsequently published in full-text form. Of the 19 unpublished studies, authors confirmed that there was no publication for 11 studies; we were unable to contact the investigator or locate a publication for the remaining eight studies. Only four studies (all published) posted their results on clinicaltrials.gov upon completion. CONCLUSION: Approximately one in four IPV trials are not published 18 months after completion, indicating that clinicians, researchers, and other evidence users should consider whether publication bias might affect their interpretation of the IPV literature. Further research is warranted to understand reasons for non-publication of IPV research and methods to improve publication rates. BioMed Central 2019-05-27 /pmc/articles/PMC6537377/ /pubmed/31133073 http://dx.doi.org/10.1186/s13063-019-3412-6 Text en © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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 Review
Madden, Kim
Tai, Kerry
Schneider, Patricia
Evaniew, Nathan
Ghert, Michelle A.
Bhandari, Mohit
What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry
title What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry
title_full What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry
title_fullStr What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry
title_full_unstemmed What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry
title_short What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry
title_sort what happens to intimate partner violence studies registered on clinicaltrials.gov? a systematic review of a clinical trials registry
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6537377/
https://www.ncbi.nlm.nih.gov/pubmed/31133073
http://dx.doi.org/10.1186/s13063-019-3412-6
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