Development and Validation of Interstitial Lung Disease Identification Algorithms in Japan’s Post-Marketing Drug Safety Surveillance Platform, MID-NET®

Development and Validation of Interstitial Lung Disease Identification Algorithms in Japan’s Post-Marketing Drug Safety Surveillance Platform, MID-NET® | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 4 December 2025 V1 Latest version Share on Development and Validation of Interstitial Lung Disease Identification Algorithms in Japan’s Post-Marketing Drug Safety Surveillance Platform, MID-NET® Authors : Masatoshi Tanigawa 0000-0003-2676-356X [email protected] , Wakako Horiki , Takahiro Nonaka , Hotaka Maruyama , Koichiro Takahashi , Hironori Sadamatsu , Yuki Kurihara , … Show All … , Ryusuke Inoue , Yoko Kataoka , Hiroaki Dobashi , Keizo Anzai , Masaharu Nakayama , Yoshiaki Uyama 0000-0002-0430-9887 , and Hideto Yokoi Show Fewer Authors Info & Affiliations https://doi.org/10.22541/au.176485157.75372935/v1 233 views 138 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Purpose : To develop and validate algorithms for the identification of interstitial lung disease (ILD) in Japan’s medical information database network, MID-NET ® . Methods : A total of 375 possible ILD cases at three hospitals were initially identified from MID-NET ® . Two independent physicians conducted a medical review to confirm or rule out the diagnosis at each hospital. The positive predictive value (PPV) and relative sensitivity (rSe) of seven ILD identification algorithms, incorporating diagnostic codes, prescribed medications (steroids, immunosuppressive agents, and anti-fibrotic agents), laboratory test values (KL-6 and SP-D), and CT imaging records, were then evaluated against the medical review. Results : The PPV for the seven algorithms ranged from 54.3% to 100.0%, while rSe ranged from 6.8% to 76.5%. A trade-off was observed between PPV and rSe. Algorithm-3 , which limited cases to confirmed diagnosis or mandatory diagnosis fields, demonstrated a good balance between PPV (61.8%) and rSe (57.6%). Adding laboratory values to Algorithm-3 yielded higher PPVs of approximately 72% in Algorithms-4 and 5, but with some reduction in rSe. The source of diagnosis code and use of anti-fibrotic agents had the greatest impact on PPV and rSe. Medical review showed high inter-rater agreement, with Cohen’s kappa statistic of 0.90 (95% confidence interval: 0.87–0.95). Conclusion : This study analyzed seven ILD identification algorithms, with the most optimal being those that included the required diagnostic fields. These findings support the use of validated algorithms for outcome identification in pharmacovigilance and clinical research. Supplementary Material File (pds-25-1028-file001.docx) Download 343.64 KB Information & Authors Information Version history V1 Version 1 04 December 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords identification algorithms interstitial lung disease mid-net® pharmacovigilance positive predictive value validation studies Authors Affiliations Masatoshi Tanigawa 0000-0003-2676-356X [email protected] Kagawa Daigaku Igakubu Fuzoku Byoin View all articles by this author Wakako Horiki Dokuritsu Gyosei Hojin Iyakuhin Iryo Kiki Sogo Kiko View all articles by this author Takahiro Nonaka Dokuritsu Gyosei Hojin Iyakuhin Iryo Kiki Sogo Kiko View all articles by this author Hotaka Maruyama Dokuritsu Gyosei Hojin Iyakuhin Iryo Kiki Sogo Kiko View all articles by this author Koichiro Takahashi Saga Daigaku Igakubu Fuzoku Byoin View all articles by this author Hironori Sadamatsu Saga Daigaku Igakubu Fuzoku Byoin View all articles by this author Yuki Kurihara Saga Daigaku Igakubu Fuzoku Byoin View all articles by this author Ryusuke Inoue Tohoku Daigaku Byoin View all articles by this author Yoko Kataoka Kagawa Daigaku Igakubu Fuzoku Byoin View all articles by this author Hiroaki Dobashi Kagawa Daigaku Igakubu Fuzoku Byoin View all articles by this author Keizo Anzai Saga Daigaku Igakubu Fuzoku Byoin View all articles by this author Masaharu Nakayama Tohoku Daigaku Daigakuin Igakukei Kenkyuka Igakubu Igaku Johogaku Bunya View all articles by this author Yoshiaki Uyama 0000-0002-0430-9887 Dokuritsu Gyosei Hojin Iyakuhin Iryo Kiki Sogo Kiko View all articles by this author Hideto Yokoi Kagawa Daigaku Igakubu Fuzoku Byoin View all articles by this author Metrics & Citations Metrics Article Usage 233 views 138 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Masatoshi Tanigawa, Wakako Horiki, Takahiro Nonaka, et al. Development and Validation of Interstitial Lung Disease Identification Algorithms in Japan’s Post-Marketing Drug Safety Surveillance Platform, MID-NET®. Authorea . 04 December 2025. DOI: https://doi.org/10.22541/au.176485157.75372935/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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