Major mistakes or errors in the use of trial sequential analysis in systematic reviews or meta-analyses – the METSA systematic review

  1. Riberholt, Christian ORCID logo
  2. Olsen, Markus Harboe ORCID logo
  3. Milan, Joachim Birch ORCID logo
  4. Hafliðadóttir, Sigurlaug Hanna ORCID logo
  5. Svanholm, Jeppe Houmann ORCID logo
  6. Buck Pedersen, Elisabeth ORCID logo
  7. Lew, Charles Chin Han ORCID logo
  8. Asante, Mark Aninakwah ORCID logo
  9. Pereira Ribeiro, Johanne ORCID logo
  10. Wagner, Vibeke ORCID logo
  11. Kumburegama, Wijesinghe Mudiyansele Buddheera Bandara ORCID logo
  12. Lee, Zheng Yii ORCID logo
  13. Schaug, Julie Perrine ORCID logo
  14. Madsen, Christina ORCID logo
  15. Gluud, Christian ORCID logo

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1000 Titel
  • Major mistakes or errors in the use of trial sequential analysis in systematic reviews or meta-analyses – the METSA systematic review
1000 Autor/in
  1. Riberholt, Christian |
  2. Olsen, Markus Harboe |
  3. Milan, Joachim Birch |
  4. Hafliðadóttir, Sigurlaug Hanna |
  5. Svanholm, Jeppe Houmann |
  6. Buck Pedersen, Elisabeth |
  7. Lew, Charles Chin Han |
  8. Asante, Mark Aninakwah |
  9. Pereira Ribeiro, Johanne |
  10. Wagner, Vibeke |
  11. Kumburegama, Wijesinghe Mudiyansele Buddheera Bandara |
  12. Lee, Zheng Yii |
  13. Schaug, Julie Perrine |
  14. Madsen, Christina |
  15. Gluud, Christian |
1000 Verlag
  • BioMed Central
1000 Erscheinungsjahr 2024
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2024-09-09
1000 Erschienen in
1000 Quellenangabe
  • 24(1):196
1000 Copyrightjahr
  • 2024
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s12874-024-02318-y |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11382479/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>Systematic reviews and data synthesis of randomised clinical trials play a crucial role in clinical practice, research, and health policy. Trial sequential analysis can be used in systematic reviews to control type I and type II errors, but methodological errors including lack of protocols and transparency are cause for concern. We assessed the reporting of trial sequential analysis.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>We searched Medline and the Cochrane Database of Systematic Reviews from 1 January 2018 to 31 December 2021 for systematic reviews and meta-analysis reports that include a trial sequential analysis. Only studies with at least two randomised clinical trials analysed in a forest plot and a trial sequential analysis were included. Two independent investigators assessed the studies. We evaluated protocolisation, reporting, and interpretation of the analyses, including their effect on any GRADE evaluation of imprecision.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>We included 270 systematic reviews and 274 meta-analysis reports and extracted data from 624 trial sequential analyses. Only 134/270 (50%) systematic reviews planned the trial sequential analysis in the protocol. For analyses on dichotomous outcomes, the proportion of events in the control group was missing in 181/439 (41%), relative risk reduction in 105/439 (24%), alpha in 30/439 (7%), beta in 128/439 (29%), and heterogeneity in 232/439 (53%). For analyses on continuous outcomes, the minimally relevant difference was missing in 125/185 (68%), variance (or standard deviation) in 144/185 (78%), alpha in 23/185 (12%), beta in 63/185 (34%), and heterogeneity in 105/185 (57%). Graphical illustration of the trial sequential analysis was present in 93% of the analyses, however, the Z-curve was wrongly displayed in 135/624 (22%) and 227/624 (36%) did not include futility boundaries. The overall transparency of all 624 analyses was very poor in 236 (38%) and poor in 173 (28%).</jats:p> </jats:sec><jats:sec> <jats:title>Conclusions</jats:title> <jats:p>The majority of trial sequential analyses are not transparent when preparing or presenting the required parameters, partly due to missing or poorly conducted protocols. This hampers interpretation, reproducibility, and validity.</jats:p> </jats:sec><jats:sec> <jats:title>Study registration</jats:title> <jats:p>PROSPERO CRD42021273811</jats:p> </jats:sec>
1000 Sacherschließung
lokal Research Design/standards [MeSH]
lokal Trial sequential analysis
lokal Randomized Controlled Trials as Topic/standards [MeSH]
lokal Humans [MeSH]
lokal Systematic review
lokal Meta-analysis
lokal Randomized Controlled Trials as Topic/methods [MeSH]
lokal Research-on-research
lokal Methodology
lokal Research
lokal Randomized Controlled Trials as Topic/statistics
lokal Meta-Analysis as Topic [MeSH]
lokal Systematic Reviews as Topic/methods [MeSH]
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0002-6170-1869|https://orcid.org/0000-0003-0981-0723|https://orcid.org/0000-0001-7093-5432|https://orcid.org/0000-0002-7570-565X|https://orcid.org/0000-0002-1131-2216|https://orcid.org/0009-0000-2333-7405|https://orcid.org/0000-0001-6410-3859|https://orcid.org/0009-0002-8034-4139|https://orcid.org/0000-0001-6019-022X|https://orcid.org/0000-0002-1712-1648|https://orcid.org/0009-0003-0698-0775|https://orcid.org/0000-0003-4505-7476|https://orcid.org/0000-0002-1283-4024|https://orcid.org/0009-0002-9764-7144|https://orcid.org/0000-0002-8861-0799
1000 Hinweis
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  1. Københavns Universitet |
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    1000 Förderer Københavns Universitet |
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