ArticleBMC medical research methodology2020
Statistical methods for the analysis of adverse event data in randomised controlled trials: a scoping review and taxonomy.
Article in BMC medical research methodology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis 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
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Reporting of adverse events associated with spinal manipulation in randomised clinical trials: an updated systematic review.BMJ open · 2023Pooled it
- Exploring the strategies used by managers to support midwives experiencing adverse events in a selected district of Gauteng province.Health SA = SA Gesondheid · 2026Article
- The hidden dangers in routine medical complaints: uncovering patient harm.BMC health services research · 2025Article
- Modernizing the assessment and reporting of adverse events in oncology clinical trials using complementary statistical approaches: a case study of the MOTIVATE trial.Investigational new drugs · 2024Article
- Measurement of Adverse Events in Studies of Digital Health Interventions for Psychosis: Guidance and Recommendations Based on a Literature Search and Framework Analysis of Standard Operating Procedures.Schizophrenia bulletin · 2024Article
- Statistical methods leveraging the hierarchical structure of adverse events for signal detection in clinical trials: a scoping review of the methodological literature.BMC medical research methodology · 2024Article
- Article
- Accelerating evidence synthesis for safety assessment through ClinicalTrials.gov platform: a feasibility study.BMC medical research methodology · 2024Article
- An Overview of Regression Models for Adverse Events Analysis.Drug safety · 2024Review
- Advancing Precision Medicine: A Review of Innovative In Silico Approaches for Drug Development, Clinical Pharmacology and Personalized Healthcare.Pharmaceutics · 2024Review
- A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels.Advances in therapy · 2024Article
- Potential implicit bias in attribution of adverse events in randomized controlled trials in cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2023Article
- Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials.Epidemiologic reviews · 2022Article
- BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRADrug safety · 2022Article
- A Narrative Review of Adverse Event Detection, Monitoring, and Prevention in Indian Hospitals.Cureus · 2022Review
- Advancing drug safety science by integrating molecular knowledge with post-marketing adverse event reports.CPT: pharmacometrics & systems pharmacology · 2022Review
- Advantages of visualisations to evaluate and communicate adverse event information in randomised controlled trials.Trials · 2020Article
- Article
- Tree-temporal scan statistics for safety signal detection in vaccine clinical trials.Pharmaceutical statisticsArticle
- Interpreting Safety Analyses in Psoriasis Clinical Trials.The Journal of clinical and aesthetic dermatologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundStatistical methods for the analysis of harm outcomes in randomised controlled trials (RCTs) are rarely used, and there is a reliance on simple approaches to display information such as in frequency tables. We aimed to identify whether any statistical methods had been specifically developed to analyse prespecified secondary harm outcomes and non-specific emerging adverse events (AEs).
methodsA scoping review was undertaken to identify articles that proposed original methods or the original application of existing methods for the analysis of AEs that aimed to detect potential adverse drug reactions (ADRs) in phase II-IV parallel controlled group trials. Methods where harm outcomes were the (co)-primary outcome were excluded. Information was extracted on methodological characteristics such as: whether the method required the event to be prespecified or could be used to screen emerging events; and whether it was applied to individual events or the overall AE profile. Each statistical method was appraised and a taxonomy was developed for classification.
resultsForty-four eligible articles proposing 73 individual methods were included. A taxonomy was developed and articles were categorised as: visual summary methods (8 articles proposing 20 methods); hypothesis testing methods (11 articles proposing 16 methods); estimation methods (15 articles proposing 24 methods); or methods that provide decision-making probabilities (10 articles proposing 13 methods). Methods were further classified according to whether they required a prespecified event (9 articles proposing 12 methods), or could be applied to emerging events (35 articles proposing 61 methods); and if they were (group) sequential methods (10 articles proposing 12 methods) or methods to perform final/one analyses (34 articles proposing 61 methods).
conclusionsThis review highlighted that a broad range of methods exist for AE analysis. Immediate implementation of some of these could lead to improved inference for AE data in RCTs. For example, a well-designed graphic can be an effective means to communicate complex AE data and methods appropriate for counts, time-to-event data and that avoid dichotomising continuous outcomes can improve efficiencies in analysis. Previous research has shown that adoption of such methods in the scientific press is limited and that strategies to support change are needed.
trial registrationPROSPERO registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=97442.
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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.