High frequency of spin bias in controlled trials of cannabis derivatives and their synthetic analogues: A meta-epidemiologic study.

J Clin Epidemiol

Centre of Health Technology Assessment, Hospital Sírio-Libanês, São Paulo, Brazil. Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp), São Paulo - SP, Brazil. Oxford-Brazil EBM Alliance.

Published: December 2021

AI Article Synopsis

  • - The study aimed to analyze the occurrence and quality of spin bias in publications of controlled trials related to cannabis derivatives and their synthetic analogues at the Universidade Federal de São Paulo, Brazil.
  • - Out of 65 publications analyzed, 44.6% reported statistically significant positive outcomes, while 44.4% of those with nonsignificant results still presented favorable conclusions, indicating spin bias.
  • - The presence of spin bias can mislead readers and potentially lead to the promotion of ineffective treatments in clinical practice, underlining the importance of recognizing and addressing such biases in research.

Article Abstract

Objective: To investigate the frequency and perform a qualitative analysis of spin bias in publications of controlled trials assessing the therapeutic use of cannabis derivatives and their synthetic analogues.

Study Design And Setting: Meta-epidemiologic study carried out at the Universidade Federal de São Paulo, Brazil.

Results: A total of 65 publications with at least one efficacy primary outcome were considered. The results analysis for the primary outcome indicated statistically significant effects in 44.6% (29/65) of the publications, and 70.7% (45/65) of the conclusions were considered favorable to the intervention. Among the 36 publications that found statistically nonsignificant results for the primary outcome, 44.4% (16/36) presented conclusions favorable to or recommending the intervention, which represents spin bias according to the definition adopted in this study. Qualitative analysis of the 16 studies with spin bias showed selective outcomes reporting (elevating secondary outcomes that had positive results or reporting only subgroup results), deviations from the planned statistical analysis, and failure to consider or report uncertainty in the estimates of treatment effects.

Conclusion: The frequency of spin bias among publications of controlled trials with statistically nonsignificant results assessing the therapeutic use of cannabis derivatives and their synthetic analogues reached 44.4%. When not observed by readers, such deviation can lead to misconduct in clinical practice through the adoption of interventions that are not effective or whose effectiveness is uncertain.

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http://dx.doi.org/10.1016/j.jclinepi.2021.08.024DOI Listing

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