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

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 reported the effects of the using balanced solutions compared with saline in critically ill adults. 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, as described in the original protocol. We herein present the search strategies for the BEST-Living Study and provide details for future analysis and presentation. 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. We will use the latest PRISMA flowchart for clarity. This statistical analysis plan reflects the plan for the first iteration of this living meta-analysis and may be subject to changes for future iterations.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study is not externally funded but received institutional support by HCor-Hospital do Coracao, Brazil and The George Institute for Global Health, Australia.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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