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Kimura M.,Hamamatsu University | Nakayasu K.,Ministry of Health Labour and Welfare | Ohshima Y.,Shizuoka Prefecture | Fujita N.,Chiba University | And 14 more authors.
Methods of Information in Medicine

Objectives: To promote healthcare information exchange between providers and to allow hospital information systems (HIS) export information in standardized format (HL7 and DICOM) in an environment of widespread legacy systems, which only can export data in proprietary format. Methods: Through the Shizuoka prefecture EMR project in 2004-2005, followed by the ministry's SS-MIX project, many software products have been provided, which consist of 1) a standardized storage to receive HL7 v2.5 mes sages of patient demographics, prescription orders, laboratory results, and diagnostic disease in ICD-10, 2) a referral letter creation system, 3) a formatted document creation system, 4) a progress note/nursing record system, and 5) an archive/viewer to incorporate incoming healthcare data CD and allow users to view on HIS terminal. Meanwhile, other useful applications have been produced, such as adverse event reporting and clinical information retrieval. To achieve the above-mentioned objectives, these software products were created and propagated, because users can use these software products, provided that their HIS can export the above information to the standardized storage in HL7 v2.5 format. Results: In 20 hospitals of Japan, the stand - ardized storage has been installed and some applications have been used. As major HIS vendors are shipping HIS with HL7 export function since 2007, HIS of 594 hospitals in Japan became capable of exporting data in HL7 v2.5 format (as of March 2010). Conclusions: In high CPOE installation rate (85% in 400+ bed hospitals), though most of them only capable of exporting data in proprietary format, prefecture and ministry projects were effective to promote healthcare information exchange between providers. The standardized storage became an infrastructure for many useful applications, and many hospitals started using them. Ministry designation of proposed healthcare standards was effective so as to allow vendors to conform their products, and users to install them. © Schattauer 2011. Source

Hori K.,Hamamatsu University School of Medicine | Kobayashi N.,Pro Bono Pharmacoepidemiologists Committee | Atsumi H.,Fukuroi Municipal Hospital | Atsumi H.,Chutoen General Medical Center | And 8 more authors.
Supportive Care in Cancer

Objective: Prophylaxis of chemotherapy (CT)-induced nausea and vomiting (CINV) is important for patient's quality of life and adherence to CT. Neurokinin receptor antagonist (NK1 antagonist) was marketed in Japan in December 2009 and the first guideline for antiemetics for CINV was released in May 2010 from Japan Society of Clinical Oncology (JSCO). We assessed changes in compliance with the JSCO guideline during the first 18 months from the launch of NK1 antagonist in Japan. Methods: Patient-level data was extracted locally using a nationwide distributed research network consisting of 39 hospitals. Monthly compliance rates for acute (day of CT) and delayed (days 2-5) phases were summarized according to the emetic risks. Results: In total, 81,739 CTs for 9,978 patients were analyzed. Prescription of oral NK1 antagonist was started in 31/39 hospitals during the study period. The compliance in acute phase for high emetic risk (HER) CTs gradually improved up to 39.3 % whereas it reached only to 10-15 % in delayed phase. The extra use of antiemetics decreased inversely to the increased compliance. Better compliance for HER CTs was associated with opioid use, younger age, second or later cycles, and CT regimens. Compliance in acute phase was better in inpatient whereas that in delayed phase was better in outpatients. Conclusions: A multi-hospital survey revealed that more than half of the HER CTs remained without accompanying the standard antiemetic therapies. Association with the compliance and CINV outcomes would be also interesting to explore. © 2013 Springer-Verlag. Source

Ichinohe K.,Fukuroi Municipal Hospital | Ijima M.,Kakegawa City Hospital | Usami T.,Fukujukai Hiryu Clinic | Baba S.,Hamamatsu University School of Medicine
Annals of the Royal College of Surgeons of England

Primary retroperitoneal transitional cell carcinomas (TCCs) are extremely rare neoplasms for which prognosis is very poor. We present a case that underwent complete remission after radiotherapy and concurrent oral chemotherapy. A 68-year-old woman presented with acute onset of bloody stool. Urgent colonoscopy only detected haemorrhoids. Subsequent abdominal ultrasonography revealed a mass of 7cm in maximal diameter in the left iliac fossa. Laparotomy disclosed a retroperitoneal mass that could not be dissected and therefore only incision biopsy was performed. After a final diagnosis of primary retroperitoneal TCC, chemotherapy with tegafur-uracil (UFT) was initiated but was not effective. Subsequently, radiotherapy was initiated concurrently with UFT at a total dose of 50Gy in 25 fractions. At 20 months after radiotherapy, the tumour seemed to have completely remitted. At the last follow-up, ten years from radiotherapy, computed tomography revealed no recurrence. We identified only three single case reports regarding primary retroperitoneal TCC over the last five decades. All patients died from the tumour 8-24 months after diagnosis or treatment. Based on the success of our case, radiotherapy with concurrent oral chemotherapy should be considered as an option for unresected cases. Source

Yoshimura K.,Kyoto University | Uehara K.,Nagoya University | Tojima Y.,Chukyo Hospital | Kawai S.,Tsushima City Hospital | And 6 more authors.

Background: Although, in Western countries, oxaliplatin-based regimens have been established as a gold standard treatment for patients with stage III or high risk stage II colon cancer after curative resection, in Japan fluorouracil-based regimens have been widely accepted and recommended in the guidelines for adjuvant settings in patients with stage III colon cancer. S-1, an oral preparation evolved from uracil and tegafur, has equivalent efficacy to uracil and tegafur/leucovorin for treating patients with advanced colorectal cancer and might be a suitable regimen in an adjuvant setting. However, the completion rate of the standard six-week cycle of the S-1 regimen is poor and the establishment of an optimal treatment schedule is critical. Therefore, we will conduct a multicenter randomized phase II trial to compare six-week and three-week cycles to establish the optimal schedule of S-1 adjuvant therapy for patients with stage III colon cancer after curative resection.Methods/Design: The study is an open-label, multicenter randomized phase II trial. The primary endpoint of this study is three-year disease-free survival rate. Secondary endpoints are the completion rate of the treatment, relative dose intensity, overall survival, disease-free survival, and incidence of adverse events. The sample size was 200, determined with a significance level of 0.20, power of 0.80, and non-inferiority margin of a 10% absolute difference in the primary endpoint.Discussion: Although S-1 has not been approved yet as a standard treatment of colon cancer in an adjuvant setting, it is a promising option. Moreover, in Japan S-1 is a standard treatment for patients with stage II/III gastric cancer after curative resection and a promising option for patients with colorectal liver metastases in an adjuvant setting. However, a six-week cycle of treatment is not considered to be the best schedule, and some clinicians use a modified schedule, such as a three-week cycle to keep a sufficient dose intensity with few adverse events. Therefore, it will be useful to determine whether a three-week cycle has an equal or greater efficacy and tolerance to side-effects compared with the standard six-week cycle schedule, and thus may be the most suitable treatment schedule for S-1 treatment.Trial registration: The University Hospital Medical Information Network (UMIN) Clinical Trials Registry UMIN000006750. © 2013 Yoshimura et al.; licensee BioMed Central Ltd. Source

Kojima T.,Nagoya University | Kaneko A.,Nagoya Medical Center | Hirano Y.,Toyohashi Municipal Hospital | Ishikawa H.,Red Cross | And 16 more authors.
Modern Rheumatology

Biologic agents have proven to be effective against rheumatoid arthritis (RA) in clinical trials and postmarketing surveillance (PMS) studies. However, limited follow-up periods and strict criteria for recruitment might lead to an underestimation of adverse events. To document the long-term course of patients with RA treated with biologics in clinical settings, we established the Tsurumai Biologics Communication Registry (TBCR). First, we retrospectively collected data of patients registered for any biologic PMS study or clinical trial at participatinginstitutes. Thus far, thirteen institutes have joined the registry and 860 patients have been identified. Comparing baseline characteristics by age and initiation year of biologics, young patients had significantly less joint damage and dysfunction and a higher dose of concomitant methotrexate (MTX) compared to older patients. Older age and functional class were significantly related to the incidence of adverse events that resulted in discontinuation of the 1st biologic treatment. The TBCR is in its initial stages, and information on all patients newly starting biologic therapy at participating institutes is being collected prospectively. Differences in baseline characteristics by age and initiation year of biologics need to be carefully evaluated in order to report on drug-related survival and long-term prognosis, using follow-up data in the near future. © Japan College of Rheumatology 2011. Source

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