Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta-analyses – protocol for a systematic review

Abstract Background Adequately conducted systematic reviews with meta-analyses are considered the highest level of evidence and thus directly defines many clinical guidelines. However, the risks of type I and II errors in meta-analyses are substantial. Trial Sequential Analysis is a method for contr...

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Main Authors: Christian Gunge Riberholt, Markus Harboe Olsen, Joachim Birch Milan, Christian Gluud
Format: Article
Language:English
Published: BMC 2022-06-01
Series:Systematic Reviews
Subjects:
Online Access:https://doi.org/10.1186/s13643-022-01987-4
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author Christian Gunge Riberholt
Markus Harboe Olsen
Joachim Birch Milan
Christian Gluud
author_facet Christian Gunge Riberholt
Markus Harboe Olsen
Joachim Birch Milan
Christian Gluud
author_sort Christian Gunge Riberholt
collection DOAJ
description Abstract Background Adequately conducted systematic reviews with meta-analyses are considered the highest level of evidence and thus directly defines many clinical guidelines. However, the risks of type I and II errors in meta-analyses are substantial. Trial Sequential Analysis is a method for controlling these risks. Erroneous use of the method might lead to research waste or misleading conclusions. Methods The current protocol describes a systematic review aimed to identify common and major mistakes and errors in the use of Trial Sequential Analysis by evaluating published systematic reviews and meta-analyses that include this method. We plan to include all studies using Trial Sequential Analysis published from January 2018 to January 2022, an estimated 400 to 600 publications. We will search Medical Literature Analysis and Retrieval System Online and the Cochrane Database of Systematic Reviews, including studies with all types of participants, interventions, and outcomes. Two independent reviewers will screen titles and abstracts, include relevant full text articles, extract data from the studies into a predefined checklist, and evaluate the methodological quality of the study using the AMSTAR 2, assessing the methodological quality of the systematic reviews. Discussion This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P). The identified mistakes and errors will be published in peer reviewed articles and form the basis of a reviewed guideline for the use of Trial Sequential Analysis. Appropriately controlling for type I and II errors might reduce research waste and improve quality and precision of the evidence that clinical guidelines are based upon.
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spelling doaj.art-d7ee99f03c7742e4a11f62f033712fa02022-12-22T03:22:21ZengBMCSystematic Reviews2046-40532022-06-011111610.1186/s13643-022-01987-4Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta-analyses – protocol for a systematic reviewChristian Gunge Riberholt0Markus Harboe Olsen1Joachim Birch Milan2Christian Gluud3Department of Neurorehabilitation, Traumatic Brain Injury, Copenhagen University Hospital − RigshospitaletDepartment of Neuroanaesthesiology, Neuroscience Centre, Copenhagen University Hospital − RigshospitaletCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital − RigshospitaletCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital − RigshospitaletAbstract Background Adequately conducted systematic reviews with meta-analyses are considered the highest level of evidence and thus directly defines many clinical guidelines. However, the risks of type I and II errors in meta-analyses are substantial. Trial Sequential Analysis is a method for controlling these risks. Erroneous use of the method might lead to research waste or misleading conclusions. Methods The current protocol describes a systematic review aimed to identify common and major mistakes and errors in the use of Trial Sequential Analysis by evaluating published systematic reviews and meta-analyses that include this method. We plan to include all studies using Trial Sequential Analysis published from January 2018 to January 2022, an estimated 400 to 600 publications. We will search Medical Literature Analysis and Retrieval System Online and the Cochrane Database of Systematic Reviews, including studies with all types of participants, interventions, and outcomes. Two independent reviewers will screen titles and abstracts, include relevant full text articles, extract data from the studies into a predefined checklist, and evaluate the methodological quality of the study using the AMSTAR 2, assessing the methodological quality of the systematic reviews. Discussion This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P). The identified mistakes and errors will be published in peer reviewed articles and form the basis of a reviewed guideline for the use of Trial Sequential Analysis. Appropriately controlling for type I and II errors might reduce research waste and improve quality and precision of the evidence that clinical guidelines are based upon.https://doi.org/10.1186/s13643-022-01987-4Meta analysisMethodologySystematic reviewTrial Sequential Analysis
spellingShingle Christian Gunge Riberholt
Markus Harboe Olsen
Joachim Birch Milan
Christian Gluud
Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta-analyses – protocol for a systematic review
Systematic Reviews
Meta analysis
Methodology
Systematic review
Trial Sequential Analysis
title Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta-analyses – protocol for a systematic review
title_full Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta-analyses – protocol for a systematic review
title_fullStr Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta-analyses – protocol for a systematic review
title_full_unstemmed Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta-analyses – protocol for a systematic review
title_short Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta-analyses – protocol for a systematic review
title_sort major mistakes and errors in the use of trial sequential analysis in systematic reviews or meta analyses protocol for a systematic review
topic Meta analysis
Methodology
Systematic review
Trial Sequential Analysis
url https://doi.org/10.1186/s13643-022-01987-4
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