Validation of a claims‐based algorithm to identify cases of ulcerative colitis in Japan
Background and Aim The prevalence of ulcerative colitis (UC) is increasing in Japan. Validated claims‐based definitions are required to investigate the epidemiology of UC and its treatment and disease course in clinical practice. This study aimed to develop a claims‐based algorithm for UC in Japan....
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| Veröffentlicht in: | Journal of gastroenterology and hepatology Jg. 37; H. 3; S. 499 - 506 |
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| Hauptverfasser: | , , , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
| Veröffentlicht: |
Australia
Wiley Subscription Services, Inc
01.03.2022
John Wiley and Sons Inc |
| Schlagworte: | |
| ISSN: | 0815-9319, 1440-1746, 1440-1746 |
| Online-Zugang: | Volltext |
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| Zusammenfassung: | Background and Aim
The prevalence of ulcerative colitis (UC) is increasing in Japan. Validated claims‐based definitions are required to investigate the epidemiology of UC and its treatment and disease course in clinical practice. This study aimed to develop a claims‐based algorithm for UC in Japan.
Methods
A committee of epidemiologists, gastroenterologists, and internal medicine physicians developed a claims‐based definition for UC, based on diagnostic codes and claims for UC treatments, procedures (cytapheresis), or surgery (postoperative claims). Claims data and medical records for a random sample of 200 cases per site at two large tertiary care academic centers in Japan were used to calculate the positive predictive value (PPV) of the algorithm for three gold standards of diagnosis, defined as physician diagnosis in the medical records, adjudicated cases, or registration in the Japanese Intractable Disease Registry (IDR).
Results
Overall, 1139 claims‐defined UC cases were identified. Among 393 randomly sampled cases (mean age 44; 48% female), 94% had received ≥ 1 systemic treatment (immunosuppressants, tumor necrosis factor inhibitors, corticosteroids, or antidiarrheals), 7% had cytapheresis, and 7% had postoperative claims. When physician diagnosis was used as a gold standard, PPV was 90.6% (95% confidence interval [CI]: 87.7–93.5). PPV with expert adjudication was also 90.6% (95% CI: 87.7–93.5). PPVs with enrollment in the IDR as gold standard were lower at 41.5% (95% CI: 36.6–46.3) due to incomplete case registration.
Conclusions
The claims‐based algorithm developed for use in Japan is likely to identify UC cases with high PPV for clinical studies using administrative claims databases. |
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| Bibliographie: | This work was sponsored by Pfizer Japan Inc. All authors participated in the conception and development of this article. HO, HM, KF, TO, HC, EN, SS, NN, and TKo were involved in study design, data collection, and analysis. All authors critically reviewed the manuscript and approved the final draft prior to submission. Conflict of interest Financial support HO, KF, TO, and NN have received funding from Pfizer Inc to attend study‐related meetings. HM has received funding from Pfizer Inc to attend study‐related meetings and has received research funding from the Japan Foundation of Applied Enzymology. SG, NS, and NY are employees and stockholders of Pfizer Inc. TKa was formerly employed by Pfizer Inc. HC and EN have no potential conflict of interest to declare. SS has served as a member of a US FDA advisory committee; has served as a consultant for Medtronic, Merck, and Pfizer Inc; and has received research funding from Bristol‐Myers Squibb, the Cystic Fibrosis Foundation, Daiichi Sankyo, the National Institutes of Health, the Patient‐Centered Outcomes Research Institute, Pfizer Inc, and Pfizer Japan. TKo has received personal fees from AbbVie GK, Ajinomoto Pharma, Alfresa Pharma, Asahi Kase Medical, Astellas, Celltrion, Covidien, EA Pharma Co Ltd, Eisai Co Ltd, Eli Lilly, Ferring Pharmaceuticals, Gilead Sciences, Janssen, JIMRO Co Ltd, Kyorin Pharmaceutical Co Ltd, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kyaku, Pfizer Inc, Takeda Pharmaceutical, Thermo Scientific, and ZERIA; grants from AbbVie GK, Alfresa Pharma, Asahi Kasei Medical, EA Pharma Co Ltd, Kyorin Pharmaceutical Co Ltd, Mochida Pharmaceutical, Nippon Kyaku, Otsuka Holdings Co Ltd, Thermo Fisher Scientific, and ZERIA; and funding from Pfizer Inc to attend study‐related meetings. Author contributions ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Author contributions: All authors participated in the conception and development of this article. HO, HM, KF, TO, HC, EN, SS, NN, and TKo were involved in study design, data collection, and analysis. All authors critically reviewed the manuscript and approved the final draft prior to submission. Conflict of interest: HO, KF, TO, and NN have received funding from Pfizer Inc to attend study‐related meetings. HM has received funding from Pfizer Inc to attend study‐related meetings and has received research funding from the Japan Foundation of Applied Enzymology. SG, NS, and NY are employees and stockholders of Pfizer Inc. TKa was formerly employed by Pfizer Inc. HC and EN have no potential conflict of interest to declare. SS has served as a member of a US FDA advisory committee; has served as a consultant for Medtronic, Merck, and Pfizer Inc; and has received research funding from Bristol‐Myers Squibb, the Cystic Fibrosis Foundation, Daiichi Sankyo, the National Institutes of Health, the Patient‐Centered Outcomes Research Institute, Pfizer Inc, and Pfizer Japan. TKo has received personal fees from AbbVie GK, Ajinomoto Pharma, Alfresa Pharma, Asahi Kase Medical, Astellas, Celltrion, Covidien, EA Pharma Co Ltd, Eisai Co Ltd, Eli Lilly, Ferring Pharmaceuticals, Gilead Sciences, Janssen, JIMRO Co Ltd, Kyorin Pharmaceutical Co Ltd, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kyaku, Pfizer Inc, Takeda Pharmaceutical, Thermo Scientific, and ZERIA; grants from AbbVie GK, Alfresa Pharma, Asahi Kasei Medical, EA Pharma Co Ltd, Kyorin Pharmaceutical Co Ltd, Mochida Pharmaceutical, Nippon Kyaku, Otsuka Holdings Co Ltd, Thermo Fisher Scientific, and ZERIA; and funding from Pfizer Inc to attend study‐related meetings. Financial support: This work was sponsored by Pfizer Japan Inc. |
| ISSN: | 0815-9319 1440-1746 1440-1746 |
| DOI: | 10.1111/jgh.15732 |