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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

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

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Author(s):
Pereira, Gabriel Cambraia [1] ; Prates, Gabriela [1] ; Medina, Matheus [1] ; Ferreira, Carolina [1] ; Cruz Latorraca, Carolina de Oliveira [2] ; Pacheco, Rafael Leite [3, 4] ; Cabrera Martimbianco, Ana Luiza [5] ; Riera, Rachel [6, 7, 8]
Total Authors: 8
Affiliation:
[1] Univ Fed Sao Paulo UNIFESP, Sao Paulo, SP - Brazil
[2] Univ Fed Seto Paulo Unifesp, Hosp Sao Paulo, Oxford Brazil EBM Alliance, Sao Paulo, SP - Brazil
[3] Ctr Univ Seto Camilo CUSC, Sao Paulo, SP - Brazil
[4] Univ Fed Sao Paulo Unifesp, Hosp Strio Libanes, Oxford Brazil EBM Alliance, Sao Paulo, SP - Brazil
[5] Univ Metropolitana Santos Unimes, Hosp Strio Libanes, Oxford Brazil EBM Alliance, Santos, SP - Brazil
[6] Hosp Strio Libanes, Ctr Hlth Technol Assessment, Sao Paulo - Brazil
[7] Univ Fed Sao Paulo Unifesp, Escola Paulista Med EPM, Discipline Evidence Based Med, Sao Paulo, SP - Brazil
[8] Oxford Brazil EBM Alliance, Sao Paulo, SP - Brazil
Total Affiliations: 8
Document type: Journal article
Source: JOURNAL OF CLINICAL EPIDEMIOLOGY; v. 140, p. 3-12, DEC 2021.
Web of Science Citations: 0
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 Sao 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. (c) 2021 Elsevier Inc. All rights reserved. (AU)

FAPESP's process: 19/20691-4 - Publication bias in clinical trials on cannabinoids: a Meta-epidemiologic study
Grantee:Gabriel Cambraia Pereira
Support Opportunities: Scholarships in Brazil - Scientific Initiation