Selective outcome reporting across psychopharmacotherapy randomized controlled trials

M. Lancee, M. Schuring, J.K. Tijdink, A.W. Chan, C.H. Vinkers, J.J. Luykx*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Objective Selective reporting impairs the valid interpretation of trials and leads to bias with regards to the clinical evidence. We aimed to examine factors associated with selective reporting in psychopharmacotherapy trials and thus enable solutions to prevent such selective reporting in the future. Methods We retrieved all registry records of trials investigating medication for depressive, bipolar and psychotic disorders. Multivariate logistic regression was performed with selective reporting as outcome, and funding source, psychiatric disorder, year of study start date, participating centers, and anticipated sample size as explanatory variables, after testing for multicollinearity. Adjusted odds ratios (AOR) were calculated. Two-sided Fisher exact test was used to compare the proportions of newly added positive primary outcomes with the proportions of positive results in the overall group of primary outcomes. Results Of 151 included trials (N = 94,303 participants), 21 (14%) showed irregularities between registered and published primary outcomes. Higher odds of such irregularities were associated with non-industry-funded RCTs (AOR 5.3; p = 0.014) and trials investigating major depressive disorder (AOR 12.7; p = 0.024) or schizophrenia (AOR 14.5; p = 0.016; Table 1). Conclusion We demonstrate discrepancies between trial registrations and publications across RCTs investigating debilitating psychiatric disorders, especially in non-industry funded RCTs.
Original languageEnglish
Article numbere1900
Number of pages4
JournalInternational Journal of Methods in Psychiatric Research
Volume31
Issue number1
Early online date11 Nov 2021
DOIs
Publication statusPublished - Mar 2022

Keywords

  • outcome reporting bias
  • psychiatry
  • research ethics
  • selective outcome reporting
  • BIAS

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