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Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions

The reporting odds ratio (ROR) is easy to calculate, and there have been several examples of its use because of its potential to speed up the detection of drug–drug interaction signals by using the “upward variation of ROR score”. However, since the validity of the detection method is unknown, this...

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Autores principales: Noguchi, Yoshihiro, Yoshizawa, Shunsuke, Aoyama, Keisuke, Kubo, Satoaki, Tachi, Tomoya, Teramachi, Hitomi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8537362/
https://www.ncbi.nlm.nih.gov/pubmed/34683823
http://dx.doi.org/10.3390/pharmaceutics13101531
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author Noguchi, Yoshihiro
Yoshizawa, Shunsuke
Aoyama, Keisuke
Kubo, Satoaki
Tachi, Tomoya
Teramachi, Hitomi
author_facet Noguchi, Yoshihiro
Yoshizawa, Shunsuke
Aoyama, Keisuke
Kubo, Satoaki
Tachi, Tomoya
Teramachi, Hitomi
author_sort Noguchi, Yoshihiro
collection PubMed
description The reporting odds ratio (ROR) is easy to calculate, and there have been several examples of its use because of its potential to speed up the detection of drug–drug interaction signals by using the “upward variation of ROR score”. However, since the validity of the detection method is unknown, this study followed previous studies to investigate the detection trend. The statistics models (the Ω shrinkage measure and the “upward variation of ROR score”) were compared using the verification dataset created from the Japanese Adverse Drug Event Report database (JADER). The drugs registered as “suspect drugs” in the verification dataset were considered as the drugs to be investigated, and the target adverse event in this study was Stevens–Johnson syndrome (SJS), as in previous studies. Of 3924 pairs that reported SJS, the number of positive signals detected by the Ω shrinkage measure and the “upward variation of ROR score” (Model 1, the Susuta Model, and Model 2) was 712, 2112, 1758, and 637, respectively. Furthermore, 1239 positive signals were detected when the Haldane–Anscombe 1/2 correction was applied to Model 2, the statistical model that showed the most conservative detection trend. This result indicated the instability of the positive signal detected in Model 2. The ROR scores based on the frequency-based statistics are easily inflated; thus, the use of the “upward variation of ROR scores” to search for drug–drug interaction signals increases the likelihood of false-positive signal detection. Consequently, the active use of the “upward variation of ROR scores” is not recommended, despite the existence of the Ω shrinkage measure, which shows a conservative detection trend.
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spelling pubmed-85373622021-10-24 Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions Noguchi, Yoshihiro Yoshizawa, Shunsuke Aoyama, Keisuke Kubo, Satoaki Tachi, Tomoya Teramachi, Hitomi Pharmaceutics Article The reporting odds ratio (ROR) is easy to calculate, and there have been several examples of its use because of its potential to speed up the detection of drug–drug interaction signals by using the “upward variation of ROR score”. However, since the validity of the detection method is unknown, this study followed previous studies to investigate the detection trend. The statistics models (the Ω shrinkage measure and the “upward variation of ROR score”) were compared using the verification dataset created from the Japanese Adverse Drug Event Report database (JADER). The drugs registered as “suspect drugs” in the verification dataset were considered as the drugs to be investigated, and the target adverse event in this study was Stevens–Johnson syndrome (SJS), as in previous studies. Of 3924 pairs that reported SJS, the number of positive signals detected by the Ω shrinkage measure and the “upward variation of ROR score” (Model 1, the Susuta Model, and Model 2) was 712, 2112, 1758, and 637, respectively. Furthermore, 1239 positive signals were detected when the Haldane–Anscombe 1/2 correction was applied to Model 2, the statistical model that showed the most conservative detection trend. This result indicated the instability of the positive signal detected in Model 2. The ROR scores based on the frequency-based statistics are easily inflated; thus, the use of the “upward variation of ROR scores” to search for drug–drug interaction signals increases the likelihood of false-positive signal detection. Consequently, the active use of the “upward variation of ROR scores” is not recommended, despite the existence of the Ω shrinkage measure, which shows a conservative detection trend. MDPI 2021-09-22 /pmc/articles/PMC8537362/ /pubmed/34683823 http://dx.doi.org/10.3390/pharmaceutics13101531 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Noguchi, Yoshihiro
Yoshizawa, Shunsuke
Aoyama, Keisuke
Kubo, Satoaki
Tachi, Tomoya
Teramachi, Hitomi
Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions
title Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions
title_full Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions
title_fullStr Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions
title_full_unstemmed Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions
title_short Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions
title_sort verification of the “upward variation in the reporting odds ratio scores” to detect the signals of drug–drug interactions
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8537362/
https://www.ncbi.nlm.nih.gov/pubmed/34683823
http://dx.doi.org/10.3390/pharmaceutics13101531
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