Validation of a claims-based algorithm to identify cases of ulcerative colitis in Japan.


Journal

Journal of gastroenterology and hepatology
ISSN: 1440-1746
Titre abrégé: J Gastroenterol Hepatol
Pays: Australia
ID NLM: 8607909

Informations de publication

Date de publication:
Mar 2022
Historique:
revised: 06 10 2021
received: 28 05 2021
accepted: 31 10 2021
pubmed: 6 11 2021
medline: 29 3 2022
entrez: 5 11 2021
Statut: ppublish

Résumé

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. 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). 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. 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.

Sections du résumé

BACKGROUND AND AIM OBJECTIVE
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 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 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 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.

Identifiants

pubmed: 34738649
doi: 10.1111/jgh.15732
pmc: PMC9298722
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

499-506

Subventions

Organisme : Pfizer Japan Inc

Informations de copyright

© 2021 Pfizer Inc. Journal of Gastroenterology and Hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

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Auteurs

Haruei Ogino (H)

Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Hiromu Morikubo (H)

Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.

Keita Fukaura (K)

Department of gastroenterology, Saiseikai Futsukaichi Hospital, Fukuoka, Japan.

Tasuku Okui (T)

Medical information center, Kyushu University Hospital, Fukuoka, Japan.

Sean Gardiner (S)

Inflammation and Immunology, Pfizer Inc, New York, New York, USA.

Naonobu Sugiyama (N)

Inflammation & Immunology, Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.

Noritoshi Yoshii (N)

Inflammation & Immunology, Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.

Tsutomu Kawaguchi (T)

Inflammation & Immunology, Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.

Haoqian Chen (H)

Center for Pharmacoepidemiology and Treatment Science, Rutgers Institute for Health, Health Care Policy and Aging Research, New Brunswick, New Jersey, USA.

Edward Nonnenmacher (E)

Center for Pharmacoepidemiology and Treatment Science, Rutgers Institute for Health, Health Care Policy and Aging Research, New Brunswick, New Jersey, USA.

Soko Setoguchi (S)

Center for Pharmacoepidemiology and Treatment Science, Rutgers Institute for Health, Health Care Policy and Aging Research, New Brunswick, New Jersey, USA.
Department of Medicine, Rutgers Robert Wood Johnson Medical School and Institute for Health, New Brunswick, New Jersey, USA.

Naoki Nakashima (N)

Medical information center, Kyushu University Hospital, Fukuoka, Japan.

Taku Kobayashi (T)

Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.

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