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Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation

BACKGROUND: Safety is important in the assessment of health interventions, while the results of adverse events are often susceptive to potential effect modifiers since the event risk tends to be rare. In this study, we investigated whether the potential impact of the important effect modifiers on ha...

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Autores principales: Zhou, Xiaoqin, Yang, Xi, Cai, Fei, Wang, Li, Xu, Chang, Jia, Pengli
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10142201/
https://www.ncbi.nlm.nih.gov/pubmed/37118664
http://dx.doi.org/10.1186/s12874-023-01928-2
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author Zhou, Xiaoqin
Yang, Xi
Cai, Fei
Wang, Li
Xu, Chang
Jia, Pengli
author_facet Zhou, Xiaoqin
Yang, Xi
Cai, Fei
Wang, Li
Xu, Chang
Jia, Pengli
author_sort Zhou, Xiaoqin
collection PubMed
description BACKGROUND: Safety is important in the assessment of health interventions, while the results of adverse events are often susceptive to potential effect modifiers since the event risk tends to be rare. In this study, we investigated whether the potential impact of the important effect modifiers on harmful effects was analyzed in meta-analyses of adverse events. METHODS: Systematic reviews of healthcare interventions, had adverse events as the exclusive outcomes, had at least one meta-analysis, and published between 1(st) January 2015, and 1(st) January 2020 were collected. An adverse event was defined as any untoward medical occurrence in a patient or subject in healthcare practice. Six effect modifiers that are the most important for harmful effects were identified by a group discussion. The proportions of eligible systematic reviews that investigated the potential impact of the six effect modifiers on harmful effects were summarized. RESULTS: We identified 279 systematic reviews eligible for this study. Except for the modifier of interventions/controls (70.61%, 197/279), most of the systematic reviews failed to investigate the potential impact of treatment duration (21.15%, 59/279), dosage (24.73%, 69/279), age (11.47%, 32/279), risk of bias (6.45%, 18/279), and source of funding (1.08%, 3/279) on harmful effects. Systematic reviews with meta-analyses containing more studies were more likely to investigate the potential impacts of these modifiers on the effects, but the proportion was still low (2.3% to 33.3%). Systematic reviews that developed a protocol were significantly more likely to investigate the potential impact of all these effect modifiers (e.g. treatment duration: odds ratio = 5.08, 95% CI: 2.76 to 9.35) on the results. CONCLUSIONS: Current systematic reviews rarely investigated the potential impact of the important effect modifiers on harmful effects. Methodological guidelines for meta-analysis of adverse events should consider “effect modifier” as one of the domains to help systematic review authors better investigate harmful effects. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-023-01928-2.
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spelling pubmed-101422012023-04-29 Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation Zhou, Xiaoqin Yang, Xi Cai, Fei Wang, Li Xu, Chang Jia, Pengli BMC Med Res Methodol Research BACKGROUND: Safety is important in the assessment of health interventions, while the results of adverse events are often susceptive to potential effect modifiers since the event risk tends to be rare. In this study, we investigated whether the potential impact of the important effect modifiers on harmful effects was analyzed in meta-analyses of adverse events. METHODS: Systematic reviews of healthcare interventions, had adverse events as the exclusive outcomes, had at least one meta-analysis, and published between 1(st) January 2015, and 1(st) January 2020 were collected. An adverse event was defined as any untoward medical occurrence in a patient or subject in healthcare practice. Six effect modifiers that are the most important for harmful effects were identified by a group discussion. The proportions of eligible systematic reviews that investigated the potential impact of the six effect modifiers on harmful effects were summarized. RESULTS: We identified 279 systematic reviews eligible for this study. Except for the modifier of interventions/controls (70.61%, 197/279), most of the systematic reviews failed to investigate the potential impact of treatment duration (21.15%, 59/279), dosage (24.73%, 69/279), age (11.47%, 32/279), risk of bias (6.45%, 18/279), and source of funding (1.08%, 3/279) on harmful effects. Systematic reviews with meta-analyses containing more studies were more likely to investigate the potential impacts of these modifiers on the effects, but the proportion was still low (2.3% to 33.3%). Systematic reviews that developed a protocol were significantly more likely to investigate the potential impact of all these effect modifiers (e.g. treatment duration: odds ratio = 5.08, 95% CI: 2.76 to 9.35) on the results. CONCLUSIONS: Current systematic reviews rarely investigated the potential impact of the important effect modifiers on harmful effects. Methodological guidelines for meta-analysis of adverse events should consider “effect modifier” as one of the domains to help systematic review authors better investigate harmful effects. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-023-01928-2. BioMed Central 2023-04-28 /pmc/articles/PMC10142201/ /pubmed/37118664 http://dx.doi.org/10.1186/s12874-023-01928-2 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
Zhou, Xiaoqin
Yang, Xi
Cai, Fei
Wang, Li
Xu, Chang
Jia, Pengli
Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation
title Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation
title_full Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation
title_fullStr Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation
title_full_unstemmed Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation
title_short Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation
title_sort effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10142201/
https://www.ncbi.nlm.nih.gov/pubmed/37118664
http://dx.doi.org/10.1186/s12874-023-01928-2
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