Trial sequential analysis in anesthesiology and intensive care: a systematic review

Abstract

Introduction: The reliability of statistical analysis and its results is becoming a focal point in scientific discourse, overshadowing concerns about statistical significance. Systematic reviews and meta-analyses are characterized by a range of serious statistical and methodological limitations, including insufficient statistical power, clinical and statistical heterogeneity, systematic errors, potential low quality of included examinations, limited data availability, and publication bias. In this context, “Trial Sequential Analysis” (TSA) emerges as a promising methodological tool used in combination with meta-analyses to enhance the precision and robustness of scientific conclusions. Objective: The study is aimed to demonstrating potential scenarios for the using TSA and its role in improving the reliability of scientific conclusions through meta-analyses published in Russian journals on anesthesiology-resuscitation, as well as the authors’ own meta-analyses.Methods: This study is a systematic review without a detailed description of the case studies. The search for meta-analyses was conducted using the keywords “meta-analysis”, “mortality”, “delirium”, “sedation”. Two researchers independently reviewed the titles and abstracts of the selected meta-analyses and extracted data. TSA was conducted for all meta-analyses using “TSA software” (Copenhagen, Denmark). Results: 6 studies were considered, and 7 TSA evaluations were performed. Six out of the seven TSA evaluations confirmed the conclusions of the pertinent meta-analyses. In one TSA, the cumulative Z-line did not reach the required sample size, highlighting the need for additional studies to definitively confirm the result. In two TSAs, the sample size in the meta-analysis was insufficient to draw definitive conclusions. The application of TSA in these cases could provide more substantiated and cautious conclusions.Conclusion: This study explores various scenarios for the application of TSA in meta-analyses published in both Russian and international journals in the fields of anesthesiology and resuscitation. The significance of TSA for enhancing the validity and clinical relevance of research findings was substantiated. Received 3 February 2024. Revised 18 March 2024. Accepted 20 March 2024. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: M.Ya. YadgarovData collection and analysis: M.Ya. Yadgarov, L.B. Berikashvili, P.A. PolyakovStatistical analysis: M.Ya. Yadgarov, P.A. PolyakovDrafting the article: M.Ya. Yadgarov, L.B. Berikashvili, K.K. Kadantseva, A.V. Smirnova, I.V. Kuznetsov, A.A. YakovlevCritical revision of the article: V.V. LikhvantsevFinal approval of the version to be published: M.Ya. Yadgarov, L.B. Berikashvili, P.A. Polyakov, K.K. Kadantseva, A.V. Smirnova, I.V. Kuznetsov, A.A. Yakovlev, V.V. Likhvantsev