Utilization of the evidence from studies with no events in meta-analyses of adverse events: an empirical investigation

<h2>Backgrounds</h2> <p>Zero-events studies frequently occur in systematic reviews of adverse events, which consist of an important source of evidence. We aimed to examine how evidence of zero-events studies was utilized in the meta-analyses of systematic reviews of adverse events....

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Main Author: Chang Xu (102022) (author)
Other Authors: Xiaoqin Zhou (3368027) (author), Liliane Zorzela (10970928) (author), Ke Ju (8976416) (author), Luis Furuya-Kanamori (477124) (author), Lifeng Lin (2034385) (author), Cuncun Lu (6535076) (author), Omran A. H. Musa (10970931) (author), Sunita Vohra (130014) (author)
Published: 2022
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author Chang Xu (102022)
author2 Xiaoqin Zhou (3368027)
Liliane Zorzela (10970928)
Ke Ju (8976416)
Luis Furuya-Kanamori (477124)
Lifeng Lin (2034385)
Cuncun Lu (6535076)
Omran A. H. Musa (10970931)
Sunita Vohra (130014)
author2_role author
author
author
author
author
author
author
author
author_facet Chang Xu (102022)
Xiaoqin Zhou (3368027)
Liliane Zorzela (10970928)
Ke Ju (8976416)
Luis Furuya-Kanamori (477124)
Lifeng Lin (2034385)
Cuncun Lu (6535076)
Omran A. H. Musa (10970931)
Sunita Vohra (130014)
author_role author
dc.creator.none.fl_str_mv Chang Xu (102022)
Xiaoqin Zhou (3368027)
Liliane Zorzela (10970928)
Ke Ju (8976416)
Luis Furuya-Kanamori (477124)
Lifeng Lin (2034385)
Cuncun Lu (6535076)
Omran A. H. Musa (10970931)
Sunita Vohra (130014)
dc.date.none.fl_str_mv 2022-11-22T21:17:59Z
dc.identifier.none.fl_str_mv 10.1186/s12916-021-02008-2
dc.relation.none.fl_str_mv https://figshare.com/articles/journal_contribution/Utilization_of_the_evidence_from_studies_with_no_events_in_meta-analyses_of_adverse_events_an_empirical_investigation/21598395
dc.rights.none.fl_str_mv CC BY 4.0
info:eu-repo/semantics/openAccess
dc.subject.none.fl_str_mv Clinical sciences
General Medicine
dc.title.none.fl_str_mv Utilization of the evidence from studies with no events in meta-analyses of adverse events: an empirical investigation
dc.type.none.fl_str_mv Text
Journal contribution
info:eu-repo/semantics/publishedVersion
text
contribution to journal
description <h2>Backgrounds</h2> <p>Zero-events studies frequently occur in systematic reviews of adverse events, which consist of an important source of evidence. We aimed to examine how evidence of zero-events studies was utilized in the meta-analyses of systematic reviews of adverse events.</p> <h2>Methods</h2> <p>We conducted a survey of systematic reviews published in two periods: January 1, 2015, to January 1, 2020, and January 1, 2008, to April 25, 2011. Databases were searched for systematic reviews that conducted at least one meta-analysis of any healthcare intervention and used adverse events as the exclusive outcome. An adverse event was defined as any untoward medical occurrence in a patient or subject in healthcare practice. We summarized the frequency of occurrence of zero-events studies in eligible systematic reviews and how these studies were dealt with in the meta-analyses of these systematic reviews.</p> <h2>Results</h2> <p>We included 640 eligible systematic reviews. There were 406 (63.45%) systematic reviews involving zero-events studies in their meta-analyses, among which 389 (95.11%) involved single-arm-zero-events studies and 223 (54.93%) involved double-arm-zero-events studies. The majority (98.71%) of these systematic reviews incorporated single-arm-zero-events studies into the meta-analyses. On the other hand, the majority (76.23%) of them excluded double-arm-zero-events studies from the meta-analyses, of which the majority (87.06%) did not discuss the potential impact of excluding such studies. Systematic reviews published at present (2015-2020) tended to incorporate zero-events studies in meta-analyses than those published in the past (2008-2011), but the difference was not significant (proportion difference=−0.09, 95% CI −0.21 to 0.03, p = 0.12).</p> <h2>Conclusion</h2> <p>Systematic review authors routinely treated studies with zero-events in both arms as “non-informative” carriers and excluded them from their reviews. Whether studies with no events are “informative” or not largely depends on the methods and assumptions applied, thus sensitivity analyses using different methods should be considered in future meta-analyses.</p><h2>Other Information</h2> <p> Published in: BMC Medicine<br> License: <a href="https://creativecommons.org/licenses/by/4.0" target="_blank">https://creativecommons.org/licenses/by/4.0</a><br>See article on publisher's website: <a href="http://dx.doi.org/10.1186/s12916-021-02008-2" target="_blank">http://dx.doi.org/10.1186/s12916-021-02008-2</a></p>
eu_rights_str_mv openAccess
id Manara2_8bfd6fc92f74d7094f0fe5b4668dd873
identifier_str_mv 10.1186/s12916-021-02008-2
network_acronym_str Manara2
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oai_identifier_str oai:figshare.com:article/21598395
publishDate 2022
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rights_invalid_str_mv CC BY 4.0
spelling Utilization of the evidence from studies with no events in meta-analyses of adverse events: an empirical investigationChang Xu (102022)Xiaoqin Zhou (3368027)Liliane Zorzela (10970928)Ke Ju (8976416)Luis Furuya-Kanamori (477124)Lifeng Lin (2034385)Cuncun Lu (6535076)Omran A. H. Musa (10970931)Sunita Vohra (130014)Clinical sciencesGeneral Medicine<h2>Backgrounds</h2> <p>Zero-events studies frequently occur in systematic reviews of adverse events, which consist of an important source of evidence. We aimed to examine how evidence of zero-events studies was utilized in the meta-analyses of systematic reviews of adverse events.</p> <h2>Methods</h2> <p>We conducted a survey of systematic reviews published in two periods: January 1, 2015, to January 1, 2020, and January 1, 2008, to April 25, 2011. Databases were searched for systematic reviews that conducted at least one meta-analysis of any healthcare intervention and used adverse events as the exclusive outcome. An adverse event was defined as any untoward medical occurrence in a patient or subject in healthcare practice. We summarized the frequency of occurrence of zero-events studies in eligible systematic reviews and how these studies were dealt with in the meta-analyses of these systematic reviews.</p> <h2>Results</h2> <p>We included 640 eligible systematic reviews. There were 406 (63.45%) systematic reviews involving zero-events studies in their meta-analyses, among which 389 (95.11%) involved single-arm-zero-events studies and 223 (54.93%) involved double-arm-zero-events studies. The majority (98.71%) of these systematic reviews incorporated single-arm-zero-events studies into the meta-analyses. On the other hand, the majority (76.23%) of them excluded double-arm-zero-events studies from the meta-analyses, of which the majority (87.06%) did not discuss the potential impact of excluding such studies. Systematic reviews published at present (2015-2020) tended to incorporate zero-events studies in meta-analyses than those published in the past (2008-2011), but the difference was not significant (proportion difference=−0.09, 95% CI −0.21 to 0.03, p = 0.12).</p> <h2>Conclusion</h2> <p>Systematic review authors routinely treated studies with zero-events in both arms as “non-informative” carriers and excluded them from their reviews. Whether studies with no events are “informative” or not largely depends on the methods and assumptions applied, thus sensitivity analyses using different methods should be considered in future meta-analyses.</p><h2>Other Information</h2> <p> Published in: BMC Medicine<br> License: <a href="https://creativecommons.org/licenses/by/4.0" target="_blank">https://creativecommons.org/licenses/by/4.0</a><br>See article on publisher's website: <a href="http://dx.doi.org/10.1186/s12916-021-02008-2" target="_blank">http://dx.doi.org/10.1186/s12916-021-02008-2</a></p>2022-11-22T21:17:59ZTextJournal contributioninfo:eu-repo/semantics/publishedVersiontextcontribution to journal10.1186/s12916-021-02008-2https://figshare.com/articles/journal_contribution/Utilization_of_the_evidence_from_studies_with_no_events_in_meta-analyses_of_adverse_events_an_empirical_investigation/21598395CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/215983952022-11-22T21:17:59Z
spellingShingle Utilization of the evidence from studies with no events in meta-analyses of adverse events: an empirical investigation
Chang Xu (102022)
Clinical sciences
General Medicine
status_str publishedVersion
title Utilization of the evidence from studies with no events in meta-analyses of adverse events: an empirical investigation
title_full Utilization of the evidence from studies with no events in meta-analyses of adverse events: an empirical investigation
title_fullStr Utilization of the evidence from studies with no events in meta-analyses of adverse events: an empirical investigation
title_full_unstemmed Utilization of the evidence from studies with no events in meta-analyses of adverse events: an empirical investigation
title_short Utilization of the evidence from studies with no events in meta-analyses of adverse events: an empirical investigation
title_sort Utilization of the evidence from studies with no events in meta-analyses of adverse events: an empirical investigation
topic Clinical sciences
General Medicine