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Selective outcome reporting across psychopharmacotherapy randomized controlled trials

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 futu...

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Autores principales: Lancee, Michelle, Schuring, Marleen, Tijdink, Joeri K., Chan, An‐Wen, Vinkers, Christiaan H., Luykx, Jurjen J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8886282/
https://www.ncbi.nlm.nih.gov/pubmed/34766419
http://dx.doi.org/10.1002/mpr.1900
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author Lancee, Michelle
Schuring, Marleen
Tijdink, Joeri K.
Chan, An‐Wen
Vinkers, Christiaan H.
Luykx, Jurjen J.
author_facet Lancee, Michelle
Schuring, Marleen
Tijdink, Joeri K.
Chan, An‐Wen
Vinkers, Christiaan H.
Luykx, Jurjen J.
author_sort Lancee, Michelle
collection PubMed
description 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.
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spelling pubmed-88862822022-03-04 Selective outcome reporting across psychopharmacotherapy randomized controlled trials Lancee, Michelle Schuring, Marleen Tijdink, Joeri K. Chan, An‐Wen Vinkers, Christiaan H. Luykx, Jurjen J. Int J Methods Psychiatr Res Original Articles 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. John Wiley and Sons Inc. 2021-11-11 /pmc/articles/PMC8886282/ /pubmed/34766419 http://dx.doi.org/10.1002/mpr.1900 Text en © 2021 The Authors. International Journal of Methods in Psychiatric Research published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Lancee, Michelle
Schuring, Marleen
Tijdink, Joeri K.
Chan, An‐Wen
Vinkers, Christiaan H.
Luykx, Jurjen J.
Selective outcome reporting across psychopharmacotherapy randomized controlled trials
title Selective outcome reporting across psychopharmacotherapy randomized controlled trials
title_full Selective outcome reporting across psychopharmacotherapy randomized controlled trials
title_fullStr Selective outcome reporting across psychopharmacotherapy randomized controlled trials
title_full_unstemmed Selective outcome reporting across psychopharmacotherapy randomized controlled trials
title_short Selective outcome reporting across psychopharmacotherapy randomized controlled trials
title_sort selective outcome reporting across psychopharmacotherapy randomized controlled trials
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8886282/
https://www.ncbi.nlm.nih.gov/pubmed/34766419
http://dx.doi.org/10.1002/mpr.1900
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