ArticleBMC medical research methodology2025
Trial Sequential Analysis for dichotomous outcomes - a practical guide for systematic review protocols.
Article in BMC medical research methodology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Microneedling with Topical Insulin Versus Microneedling with Platelet-rich Plasma for Post-Acne Scars: A Systematic Review and Meta-Analysis with Trial Sequential Analysis.Aesthetic plastic surgery · 2026Pooled it
- Multidimensional clinical evaluation of remimazolam versus propofol and dexmedetomidine: two systematic reviews and meta-analyses based on differentiated endpoints.BMC anesthesiology · 2026Pooled it
- Pretreatment creatinine-to-cystatin c ratio as a prognostic marker in digestive tract cancers: a meta-analysis with reconstructed individual patient data and trial sequential analysis.Frontiers in nutrition · 2026Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTrial Sequential Analysis (TSA) is a statistical method to control random errors in systematic reviews with meta-analyses of randomised clinical trials. In our results from the Major Mistakes and Errors in Trial Sequential Analysis (METSA) project, we systematically assessed the use of TSA across all medical fields and found significant mistakes in the preplanning and reporting of most TSAs. This article provides a practical guide for authors of systematic review protocols on what to consider when planning Trial Sequential Analysis for dichotomous outcomes.
methodsThis practical guide has been developed based on the TSA manual, the recommendations published previously by Jakobsen and colleagues and Wetterslev and colleagues along with the findings from our recently published results from the METSA project.
resultsThe following five parameters should be clearly defined in a publicly available protocol before the review is undertaken: 1) the proportion of participants with an event in the control group; 2) the relative risk reduction or increase in the experimental group; 3) the risk of type I errors (alpha); 4) the risk of type II errors (beta); and 5) the diversity of the meta-analysis. Improving the planning and reporting of these parameters will improve the interpretation, reproducibility, and validity of Trial Sequential Analysis results used in systematic reviews.
conclusionsWe hope this practical guide will aid in improving pre-registration and reporting of TSAs of dichotomous outcomes within systematic review protocols with meta-analysis of randomised clinical trials in the future.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.