Statistical techniques to assess publication integrity in groups of randomized trials: a narrative review

• Published in: Journal of clinical epidemiology 2024-06, Vol.170, p.111365, Article 111365
• Main Authors: Bolland, Mark J., Avenell, Alison, Grey, Andrew
• Format: Article
• Language: English
• Subjects: Clinical trials; Cohort analysis; Data integrity; Datasets; Fabricated data; Integrity; Narratives; P values; Randomization; Research integrity; Statistical analysis; Statistical methods; Variables
• ISSN: 0895-4356; 1878-5921; 1878-5921
• DOI: 10.1016/j.jclinepi.2024.111365

To describe statistical tools available for assessing publication integrity of groups of randomized controlled trials (RCTs). Narrative review. Freely available statistical tools have been developed that compare the observed distributions of baseline variables with the expected distributions that would occur if successful randomization occurred. For continuous variables, the tools assess baseline means, baseline P values, and the occurrence of identical means and/or standard deviation. For categorical variables, they assess baseline P values, frequency counts for individual or all variables, numbers of trial participants randomized or withdrawing, and compare reported with independently calculated P values. The tools have been used to identify publication integrity concerns in RCTs from individual groups, and performed at an acceptable level in discriminating intentionally fabricated baseline summary data from genuine RCTs. The tools can be used when concerns have been raised about RCT(s) from an individual/group and when the whole body of their work is being examined, when conducting systematic reviews, and could be adapted to aid screening of RCTs at journal submission. Statistical tools are useful for the assessment of publication integrity of groups of RCTs.