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Recent Change in Treatment of Disseminated Intravascular Coagulation in Japan: An Epidemiological Study Based on a National Administrative Database

Clinical and Applied Thrombosis/Hemostasis 1-7 ª The Author(s) 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/1076029615575072 cat.sagepub.com

Atsuhiko Murata, MD, PhD1, Kohji Okamoto, MD, PhD2, Toshihiko Mayumi, MD, PhD3, Keiji Muramatsu, MD1, and Shinya Matsuda MD, PhD1

Abstract This study investigated the time trends and hospital factors affecting the use of drugs for infectious disease-associated disseminated intravascular coagulation (DIC) based on a national administrative database. A total of 14 324 patients with infectious disease-associated DIC were referred to 1041 hospitals from 2010 to 2012 in Japan. Patients’ data were collected from the administrative database to determine time trends and hospital factors affecting the use of drugs for DIC. Three study periods were established, namely, the fiscal years 2010 (n ¼ 3308), 2011 (n ¼ 5403), and 2012 (n ¼ 5613). The use of antithrombin, heparin, protease inhibitors, and recombinant human soluble thrombomodulin (rhs-TM) for DIC was evaluated. The frequency of use of antithrombin, heparin, and protease inhibitors decreased while that of rhs-TM significantly increased from 2010 to 2012 in Japan (25.1% in 2010, 43.1% in 2011, and 56.8% in 2012; P < .001, respectively). Logistic regression showed that the study period was associated with the use of rhs-TM in patients with DIC. The odds ratio (OR) for 2011 was 2.34 (95% confidence interval [CI], 2.12-2.58; P < .001) whereas that for 2012 was 4.34 (95% CI, 3.94-4.79; P < .001). A large hospital size was the most significant factor associated with the use of rhs-TM in patients with DIC (OR, 3.14; 95% CI, 2.68-3.66; P < .001). The use of rhs-TM has dramatically increased. A large hospital size was significantly associated with the increased use of rhs-TM in patients with DIC from 2010 to 2012 in Japan. Keywords disseminated intravascular coagulation, time trend, hospital factors, recombinant human soluble thrombomodulin, administrative database

Introduction Disseminated intravascular coagulation (DIC) is a serious clinical condition characterized by excess production of fibrin and consumption bleeding in small vessels with resultant activation of the coagulation system.1,2 This critical condition usually requires accurate diagnosis and prompt treatment of both the DIC and its underlying cause. Such treatment is important to improve affected patients’ survival rates and prognoses.1-3 Some previous studies have found that patients with DIC have high mortality rates; thus, DIC has been recognized as a life-threatening condition worldwide.4-6 Although the current management of DIC is primarily focused on treating any associated underlying medical conditions, clinical practice guidelines have pointed out that anticoagulant therapy should also be required.7 Historically, drugs such as antithrombin, heparin, and protease inhibitors have been frequently used as anticoagulant therapies for patients with DIC, particularly for DIC associated with infectious

disease.8,9 Recombinant human soluble thrombomodulin (rhsTM), a new biological agent and promising treatment option for DIC, was approved in 2008 in Japan.10 The use of rhsTM is expected to replace traditional management for patients with DIC in Japan.10

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Department of Preventive Medicine and Community Health, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan 2 Department of Surgery, Yahata Municipal Hospital, Kitakyushu, Fukuoka, Japan 3 Department of Emergency Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan Corresponding Author: Atsuhiko Murata, Department of Preventive Medicine and Community Health, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan. Email: [email protected]

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Clinical and Applied Thrombosis/Hemostasis

However, no epidemiological studies have evaluated changes in the use of old and new drugs for patients with DIC over time based on a national administrative database. In addition, no data are available on hospital factors that influence the choice of new drugs for patients with DIC with adjustment for time trend effects. Clarification of time trends or institutional attributes regarding the use of drugs for anticoagulant therapy could contribute to studies of quality management of patient medical care for DIC. In this study, we investigated the recent time trends of the use of specific drugs as anticoagulant therapy for patients with infectious disease-associated DIC and hospital factors affecting the use of drugs for DIC among Japanese hospitals. This was achieved with the use of the national administrative database of the Diagnosis Procedure Combination (DPC), which is the Japanese case-mix system currently in use.

Material and Method The health care system of Japan has severe financial problems because of the expenses of new medical technology, a rapidly aging society, and extended patient hospitalization periods.11-13 To address these issues, the Ministry of Health, Labour, and Welfare and its affiliated research institute have begun investigating whether the Japanese case-mix classification system, namely, the DPC, can be used to standardize medical profiling and payment.11-13 Japanese case-mix projects based on the DPC system were introduced to 82 academic hospitals (the National Cancer Center, the National Cardiovascular Center, and 80 university hospitals) in 2003.11-15 Reimbursement from health insurance using the DPC system is common practice in Japan. According to the administrative database of the DPC system, the number of acute-care hospitals has increased. Enormous amounts of inpatient data are collected annually, covering approximately 90% of the total acute-care inpatient hospitalizations.11-15 This system also collects important data during hospitalization in addition to the characteristics of the unique reimbursement system. Each patient’s financial data, claim information, and discharge summary (including the principal diagnosis, complications, and comorbidities during hospitalization) are thoroughly recorded in the administrative database of the DPC system. These data are coded using the International Classification of Diseases and Injuries, Tenth Revision (ICD-10) code. Additionally, this administrative database contains comprehensive medical information, including all interventional or surgical procedures, medications, and devices that have been indexed in the original Japanese code. The Ministry of Health, Labour, and Welfare of Japan assigns these codes.11-15 The date and amount of daily care delivered are also recorded in the DPC administrative database.11-15

Study Setting From the DPC administrative database, we selected 14 324 Japanese patients with infectious disease-associated DIC in

1041 hospitals participating in the DPC (83 academic and 958 community hospitals) between 2010 and 2012. These hospitals are dispersed throughout Japan and play leading roles in providing acute-care medicine, advancing medical research, and educating students and medical residents.11-15 For the present analysis, 3 study periods were established according to the following fiscal years: 2010 (n ¼ 3308), 2011 (n ¼ 5403), and 2012 (n ¼ 5613). The survey of DPC-participating hospitals has been conducted by the DPC research group. The DPC-participating hospitals send all the anonymized data to the DPC research group, which in turn sends it to the server in our department.11-15 The use of DPC data was permitted by all institutions and hospitals that provided detailed data. The research protocol of the study was approved by the ethics committee of medical care and research of the University of Occupational and Environmental Health, Kitakyushu, Japan.

Study Variables Study variables included age; sex; chronic comorbid conditions; use of ambulance transportation and the intensive care unit (ICU); hospital type, size, region, and volume; proportion of hospitals with emergency centers; in-hospital mortality; length of stay (LOS); medical cost incurred during hospitalization; and drugs used as anticoagulant therapies for patients with DIC. Age was stratified as follows:

Recent Change in Treatment of Disseminated Intravascular Coagulation in Japan: An Epidemiological Study Based on a National Administrative Database.

This study investigated the time trends and hospital factors affecting the use of drugs for infectious disease-associated disseminated intravascular c...
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