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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| Format: | Article |
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MDPI AG
2021-09-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/13/10/1531 |
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| author | Yoshihiro Noguchi Shunsuke Yoshizawa Keisuke Aoyama Satoaki Kubo Tomoya Tachi Hitomi Teramachi |
| author_facet | Yoshihiro Noguchi Shunsuke Yoshizawa Keisuke Aoyama Satoaki Kubo Tomoya Tachi Hitomi Teramachi |
| author_sort | Yoshihiro Noguchi |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-10T06:17:15Z |
| format | Article |
| id | doaj.art-72c7a61606364668a4b4a4e39ecfacc9 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-10T06:17:15Z |
| publishDate | 2021-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-72c7a61606364668a4b4a4e39ecfacc92023-11-22T19:37:01ZengMDPI AGPharmaceutics1999-49232021-09-011310153110.3390/pharmaceutics13101531Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug InteractionsYoshihiro Noguchi0Shunsuke Yoshizawa1Keisuke Aoyama2Satoaki Kubo3Tomoya Tachi4Hitomi Teramachi5Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4, Daigakunishi, Gifu-shi 501-1196, Gifu, JapanLaboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4, Daigakunishi, Gifu-shi 501-1196, Gifu, JapanLaboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4, Daigakunishi, Gifu-shi 501-1196, Gifu, JapanLaboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4, Daigakunishi, Gifu-shi 501-1196, Gifu, JapanLaboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4, Daigakunishi, Gifu-shi 501-1196, Gifu, JapanLaboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4, Daigakunishi, Gifu-shi 501-1196, Gifu, JapanThe 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.https://www.mdpi.com/1999-4923/13/10/1531spontaneous reporting systemsdrug–drug interactionreporting odds ratio (ROR)Ω shrinkage measure |
| spellingShingle | Yoshihiro Noguchi Shunsuke Yoshizawa Keisuke Aoyama Satoaki Kubo Tomoya Tachi Hitomi Teramachi Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions Pharmaceutics spontaneous reporting systems drug–drug interaction reporting odds ratio (ROR) Ω shrinkage measure |
| 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 | spontaneous reporting systems drug–drug interaction reporting odds ratio (ROR) Ω shrinkage measure |
| url | https://www.mdpi.com/1999-4923/13/10/1531 |
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