Statistical Analysis Plan for Balanced versus Saline trialists living systematic review individual patient and aggregated data meta-analysis of randomized controlled trials (BEST-Living Study)
Abstract Purpose The Balanced versus Saline Trialists (BEST) -Living Study is an ongoing living systematic review with aggregated and individual patient data meta-analysis (IPDMA) from eligible trials that assessed the effects of using balanced solutions compared with saline in critically ill adults. We herein present the search strategies for the BEST-Living Study and provide details for future analysis and presentation.Methods The report will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses of Individual Participant Data (PRISMA-IPD) recommendations. Search was performed in Pubmed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL). The primary endpoint will be hospital mortality, which will be analyzed using a Bayesian hierarchical model. Secondary endpoints include nurvival until longest follow-up available, use of kidney replacement therapy, and intensive care unit and hospital length-of-stay. Details on the analysis plan are provided in this statistical analysis plan.Conclusion The study will provide the most up-to-date and comprehensive assessment using the best evidence available for the use of balanced solutions in critically ill patients.Approvals The undersigned and all authors have reviewed this plan and approve it as final. They find it to be consistent with the requirements of the protocol as it applies to their respective areas. They also find it to be compliant with ICH-E9 principles and, in particular, confirm that this analysis plan was final prior to any analysis of the aggregated data.<jats:table-wrap id="utbl1" orientation="portrait" position="float"><jats:graphic xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="22279363v1_utbl1" position="float" orientation="portrait" /></jats:table-wrap>.
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Preprint| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
bioRxiv.org - (2022) vom: 12. Sept. Zur Gesamtaufnahme - year:2022 |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zampieri, Fernando G [VerfasserIn] |
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| Links: |
Volltext [kostenfrei] |
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| doi: |
10.1101/2022.09.06.22279363 |
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| PPN (Katalog-ID): |
XBI037243764 |
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| 520 | |a Abstract Purpose The Balanced versus Saline Trialists (BEST) -Living Study is an ongoing living systematic review with aggregated and individual patient data meta-analysis (IPDMA) from eligible trials that assessed the effects of using balanced solutions compared with saline in critically ill adults. We herein present the search strategies for the BEST-Living Study and provide details for future analysis and presentation.Methods The report will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses of Individual Participant Data (PRISMA-IPD) recommendations. Search was performed in Pubmed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL). The primary endpoint will be hospital mortality, which will be analyzed using a Bayesian hierarchical model. Secondary endpoints include nurvival until longest follow-up available, use of kidney replacement therapy, and intensive care unit and hospital length-of-stay. Details on the analysis plan are provided in this statistical analysis plan.Conclusion The study will provide the most up-to-date and comprehensive assessment using the best evidence available for the use of balanced solutions in critically ill patients.Approvals The undersigned and all authors have reviewed this plan and approve it as final. They find it to be consistent with the requirements of the protocol as it applies to their respective areas. They also find it to be compliant with ICH-E9 principles and, in particular, confirm that this analysis plan was final prior to any analysis of the aggregated data.<jats:table-wrap id="utbl1" orientation="portrait" position="float"><jats:graphic xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="22279363v1_utbl1" position="float" orientation="portrait" /></jats:table-wrap> | ||
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| 700 | 1 | |a Cavalcanti, Alexandre B |e verfasserin |4 aut | |
| 700 | 1 | |a Tanna, Gian Luca Di |e verfasserin |4 aut | |
| 700 | 1 | |a Damiani, Lucas P |e verfasserin |4 aut | |
| 700 | 1 | |a Hammond, Naomi E |e verfasserin |4 aut | |
| 700 | 1 | |a Machado, Flavia R |e verfasserin |4 aut | |
| 700 | 1 | |a Micallef, Sharon |e verfasserin |4 aut | |
| 700 | 1 | |a Myburgh, John |e verfasserin |4 aut | |
| 700 | 1 | |a Ramanan, Mahesh |e verfasserin |4 aut | |
| 700 | 1 | |a Rice, Todd W |e verfasserin |4 aut | |
| 700 | 1 | |a Semler, Matthew W |e verfasserin |4 aut | |
| 700 | 1 | |a Young, Paul J |e verfasserin |4 aut | |
| 700 | 1 | |a Finfer, Simon |e verfasserin |4 aut | |
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