Search

Objective Tsushima mamushi (Gloydius tsushimaensis) is an endemic species of snake inhabiting only Tsushima Island, a remote Japanese island. We conducted a multicenter, retrospective study of G. tsushimaensis bites for the first time and developed a treatment algorithm that unified treatment on the island and is still in use today. Methods This is a multicenter, retrospective study comparing 72 cases from January 2005 to December 2018, before the introduction of the algorithm, and 12 cases from January 2019 to December 2020, after its introduction. Results There was no significant decrease in the maximum grade of symptoms after the introduction of the algorithm, but there was a decreasing trend (p=0.057). Conversely, the median of the maximum creatinine kinase levels was 343.5 IU/L (interquartile range: 115.5-4,745.5) before the algorithm's introduction and significantly lower (142.5; interquartile range: 111.3-163) after the algorithm's introduction (p=0.042). After the algorithm's introduction, the disseminated intravascular coagulation merger rate and the acute kidney injury incidence both dropped to 0%, from 9.7% and 6.9%, respectively, before the algorithm's introduction. There was no significant difference in the length of hospital stay before versus after the algorithm's introduction. Conclusion This study showed that the treatment algorithm can be safely and quickly applied. The algorithm's effectiveness is expected to be strengthened by the accumulation of more cases in the future.

Gloydius tsushimaensis is an endemic species inhabiting only Tsushima, a remote Japanese island, and is a distinct species from Gloydius blomhoffii widely distributed throughout mainland Japan and Gloydius brevicaudus and Gloydius ussuriensis which are geographically distributed in South Korea. This is the first multicenter retrospective study of G. tsushimaensis bites in Japan. A study of seventy-two patients who visited the former Izuhara Hospital, the former Naka Tsushima Hospital, Tsushima Hospital, and Kamitsushima Hospital during the fourteen years from January 1, 2005, to December 31, 2018, revealed the typical clinical characteristics of G. tsushimaensis bites. Five out of seventy-two cases (6.9%) showed severe hypofibrinogenemia, in which fibrinogen levels were below 100 mg/dl, which is an unreported clinical finding for G. blomhoffii bites. Generally, when fibrinogen levels are lower than 100 mg/dl, the bleeding risk increases, and it is perilous. Severe hypofibrinogenemia cases did not improve after G. blomhoffii antivenom administration. Additionally, all five cases had disseminated intravascular coagulation, and there were two cases of acute kidney injury and one death. five cases had a median maximum creatine kinase level of 5171 IU/l (Interquartile range: 4992–41,310). Although the mechanism is not precise, coagulation tests showed that the G. tsushimaensis venom contains a thrombin-like enzyme. Based on this research, we created an algorithm for the treatment of G. tsushimaensis bites and unified the treatment methods used on the island.

Purpose To establish a new medical information database network (designated MID-NET® ) to provide real-world data for drug safety assessments in Japan. Methods This network was designed and developed by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency in collaboration with 23 hospitals from 10 healthcare organizations across Japan. MID-NET® is a distributed and closed network system that connects all collaborative organizations through a central data center. A wide variety of data are available for analyses, including clinical and administrative information. Several coding standards are used to standardize the data stored in MID-NET® to allow the integration of information originating from different hospitals. A rigorous and consistent quality management system was implemented to ensure that MID-NET® data are of high quality and meet Japanese regulatory standards (good post-marketing study practice and related guidelines). Results MID-NET® was successfully established as a reliable and valuable medical information database and was officially launched in April 2018. High data quality with almost 100% consistency was confirmed between original data in hospitals and the data stored in MID-NET® . A major advantage is that approximately 260 clinical laboratory test results are available for analysis. Conclusions MID-NET® is expected to be a major data source for drug safety assessments in Japan. Experiences and best practices established in MID-NET® may provide a model for the future development of similar database networks.

PURPOSE To examine the potential role of Medical Information Database Network (MID-NET® ), a newly established Japanese medical information database network, in postmarketing drug safety assessments through the characterization of its advantages and limitations in five pilot studies. METHODS The pilot studies were designed to address three major objectives in postmarketing drug safety assessments, ie, the examination of actual drug utilization, the impact of safety-related regulatory actions, and drug-associated risks. The five studies were conducted on the following topics: (a) utilization of codeine-containing products and its relationship with respiratory depression, (b) impact of a Dear Healthcare Professional letter on hypocalcemia incidence associated with denosumab (Ranmark® ) use, (c) risk of acute myocardial infarction associated with antidiabetic drug use, (d) risk of glucose metabolism disorders associated with atypical antipsychotic drug use, and (e) prospective monitoring of abnormal laboratory test results during new drug prescriptions. RESULTS The pilot studies were successfully conducted and demonstrated the value of MID-NET® in postmarketing drug safety assessments. In particular, the ability to utilize laboratory test results as objective clinical indicators is a major advantage of this database. Potential limitations include a relatively small sample size and a lack of patient-level data linkages among hospitals. CONCLUSIONS MID-NET® was confirmed to be a valuable database for postmarketing drug safety assessments. The use of laboratory test results to define clinical outcomes may allow more objective and accurate analyses to be conducted. These studies furthered our understanding of the characteristics of MID-NET® , including its advantages and limitations.

What is known and objective Since its introduction in April 2012, denosumab has been administered to approximately 7,300 patients as of August 2012, and 32 cases of serious hypocalcaemia after denosumab administration, including two deaths, have been reported in Japan. A Dear Healthcare Professional Letter of Rapid Safety Communication ('Blue letter') was released to warn about the risks of hypocalcaemia associated with denosumab. The goal of this study therefore was to measure the impact of regulatory action on denosumab-induced hypocalcaemia in Japan by using an electronic medical information database (MID). Methods We used two different aggregated data sets based on MIDs (data sets one and two). The patients studied were those who were newly prescribed denosumab or zoledronic acid between April 2012 and September 2014. We assessed four indicators: (a) the proportion of patients with calcium supplementation at the initial denosumab treatment, (b) the proportion of patients who underwent a serum calcium test, (c) the average number of serum calcium tests performed and (d) the prevalence of hypocalcaemia. All indices were aggregated by every 3 months. To evaluate the impact of regulatory action, we used difference in difference (DID) analysis. Results and discussion The proportion of patients with calcium supplementation at the initial denosumab treatment increased year by year in both data sets. The average number of serum calcium tests increased year by year in data set two. There was a significant difference in the prevalence of hypocalcaemia in data set two. This suggests that the estimate of impact of the regulatory action may vary according to the database. In DID analysis, however, significant influences of the regulatory action on combination use with a calcium supplement were detected in both data sets. What is new and conclusion There was a significant influence on combination use of denosumab with vitamin D and/or calcium supplement in both data sets. That there was no apparent increase in the prevalence of denosumab-induced hypocalcaemia, suggests that the regulatory action had an impact in the clinical setting studied. Such regulatory actions may play an important role in the promotion of drug safety.

Purpose The purpose of this study is to evaluate the accuracy of gastrointestinal (GI) perforation ICD-10 coding in the Diagnosis Procedure Combination (DPC) database and to examine drug exposure risk factors for GI perforation. Methods A total of 100 patients with GI perforation ICD-10 codes were selected randomly from Kagawa University Hospital's DPC database between April 2011 and December 2016. Two experienced specialist physicians independently reviewed the medical records and classified cases as "definite A," "definite B," "probable," or "no GI perforation." The positive predictive values (PPVs) of "definite A/B" cases were calculated after stratification by sex, age, ICD-10 code, and diagnostic information in the DPC data. The number of prescribed drugs with side effects of GI perforation according to historical data was compared between "definite A/B" and "no GI perforation" cases. Results The overall PPV was 47.0% (95% confidence interval [CI], 36.9-57.2). However, the PPVs for the three categories of diagnostic information in the DPC data ("main diagnosis," "diagnosis causing admission," and "most resource-intensive diagnosis") were each more than 70% after excluding inappropriate patients. Additionally, the PPV focused on these three categories was 76.3% (95% CI, 59.8-88.6). Prescribed drugs with side effects of GI perforation were more frequently detected in "definite A/B" cases (P = .028). Conclusions Although the overall PPV for GI perforation based on ICD-10 code was low, our results suggest that the PPV could be improved by appropriate selection of DPC diagnosis category and that use of multiple medications enhances the risk of GI perforation.

近年，電子カルテが普及し，診療結果を電子的に記録することが一般的になってきた．電子データの共有・二次利用のためには，記録項目・用語の標準化が必要である．我々は腹部超音波検査に関する所見項目・用語について国内の種々の教科書から取材した結果と，診療施設で入力されたデータの検討を元に，コンピュータ用にオントロジーの性質を持った用語集案を作成した．この用語集は階層構造で用語同士の関係を表しており，多くの同義語を用語集の中で利用出来るように設計した．用語集の編集には専用のツールを作成し，このツールからはClaMLと呼ばれるXMLを用いた用語集の国際的表現方法で用語集を出力出来る．この機能により，用語集を多くのシステムで半自動的に取り込むことを目指している．

This article summarizes the consensus reached at the Summit on Color in Medical Imaging held at the Food and Drug Administration (FDA) on May 8–9, 2013, co-sponsored by the FDA and ICC (International Color Consortium). The purpose of the meeting was to gather information on how color is currently handled by medical imaging systems to identify areas where there is a need for improvement, to define objective requirements, and to facilitate consensus development of best practices. Participants were asked to identify areas of concern and unmet needs. This summary documents the topics that were discussed at the meeting and recommendations that were made by the participants. Key areas identified where improvements in color would provide immediate tangible benefits were those of digital microscopy, telemedicine, medical photography (particularly ophthalmic and dental photography), and display calibration. Work in these and other related areas has been started within several professional groups, including the creation of the ICC Medical Imaging Working Group.

Summary What is known and objective The implementation of appropriate epidemiological methodology using medical information databases (MIDs) to evaluate the effects of regulatory actions has been highly anticipated. To assess scientific methods for active pharmacovigilance using MIDs, we conducted a quantitative assessment of the impact of two regulatory actions by the Japanese government: (i) restriction of use of oseltamivir in teenagers in March 2007 and (ii) caution against the co-administration of omeprazole (OPZ) with clopidogrel (CPG) in April 2010. Methods Data were obtained from four hub hospitals in Japan. We measured the seasonal proportion of patients prescribed oseltamivir to those prescribed neuraminidase inhibitors for the 2002/2003 to 2010/2011 seasons. The monthly proportion of patients co-administered OPZ and CPG (OPZ+CPG) to those prescribed CPG was measured from May 2009 to April 2011. We evaluated the changes observed with implementation of the regulatory actions. To estimate the impact of the actions, we conducted segmented regression analysis using interrupted time series data. The impact was assessed by two parameter estimates of the regression model: the change in level for short-term effects and change in trend for long-term effects. Results and discussion The use of oseltamivir in the target 10–19 years age group showed a significant and large decline (63·16%) immediately after the intervention (P = 0·0008). No change was observed in OPZ+CPG, although there was a relative inhibitory trend for OPZ+CPG compared with co-administration of lansoprazole or rabeprazole with CPG as the control group. When restricted to new users of CPG, the stratified results were consistent with the overall results. What is new and conclusion The current analysis demonstrates the effectiveness of two regulatory actions. The results of the current study indicate that MID research can contribute to assessing and improving pharmacovigilance activities.

Context Predicting prognosis using noninvasive and objective tools may facilitate end-of-life decisions for terminal cancer patients, their families, and other health care professionals. Objectives To investigate if the shock index (SI), along with decreased level of consciousness (DLOC), is a reliable tool for predicting short-term survival time in terminal cancer patients. Methods A two-part retrospective cohort study was performed on 670 consecutive adult hospice patients. Part 1 of the study was performed to investigate the reliability of SI and DLOC on admission and to make a simple tool for predicting survival time. Part 2 of the study was to validate the tool's reproducibility and analyze the correlation between SI, DLOC, and survival time. Results In Part 1, multivariate Cox proportional hazards analyses for all study patients revealed that SI ≥ 1.0 in patients with DLOC was a significant risk factor of death (hazard ratio 3.08; 95% CI 1.72–5.53; P = 0.000). Generalized additive models confirmed that DLOC patients with SI = 1.0 had 9.58 days of mean survival time (MST). Receiver operating characteristic curve analyses of SI in patients with DLOC revealed that a survival time of less than three days was most reliably predicted. In Part 2, an increase in SI statistically decreased survival time. The upper 95% CIs of the calculated mean survival time for DLOC patients with SI ≥ 1.0 were less than one week. Bootstrap analyses revealed that the 95% CIs of the predicted survival time were 4.54–6.18 days in DLOC patients with SI = 1.0. Conclusion An SI ≥ 1.0 along with DLOC is a highly reliable tool for predicting short-term survival time in terminal cancer patients.

There are two activities for Japanese endoscopy information system. One is for a standard terminology (Minimal Standard Terminology: MST) for endoscopy reporting. Other is Integrating Healthcare Enterprise Japan (IHE-J) for an integration of hospital information system. In IHE-J activity, the members revealed specificities of an endoscopy workflow by making a comparison with a radiology workflow. The authors will propose a scheme for systematic standardization based on our experiences in the standardization activities.

Since 1994, following the leading efforts by the European Society for Gastrointestinal Endoscopy, Organisation Mondiale d'Endoscopie Digestive (OMED) has succeeded in compiling minimal number of terms required for computer generation of digestive endoscopy reports nicknamed MST (Minimal Standard Terminology). Though with some insufficiencies, and though developed only for digestive endoscopy, MST has been the only available terminology that is globally standardized in medicine. By utilizing the merits of a unified, structured terminology that can be used in multiple languages we can utilize the data stored in different languages as a common database. For this purpose, a standing, terminology-managing organization that manages and maintains and, when required, expands the terminology on a global level, is absolutely necessary. Unfortunately, however, the organization that performs version control of MST (OMED terminology, standardization and data processing committee) is currently suspending its activity. Medical practice of the world demands more and more specialization, with resultant needs for information exchange among specialized territories. As the cooperation between endoscopy and pathology has become currently the most important problem in the Endoscopy Working Group of Integrating Healthcare Enterprise-Japan (IHE-J,) the cooperation among different specialties is essential. There are DICOM or HL7 standards as the protocols for storage, and exchange (communication) of the data, but there is yet no organization that manages the terminology itself astride different specialties. We hereby propose to establish, within IEEE, for example, a system that promotes standardization of the terminology that can transversely describe a patient, and that can control different societies and groups, as far as the terminology is concerned.

When therapy using IFN (interferon) medication for chronic hepatitis patients, various conceptual knowledge/rules will benefit for giving a treatment. The paper describes our work on cooperatively using various data mining agents including the GDT-RS inductive learning system for discovering decision rules, the LOI (learning with ordered information) for discovering ordering rules and important features, as well as the POM (peculiarity oriented mining) for finding peculiarity data/rules, in a spiral discovery process with multi-phase such as pre-processing, rule mining, and post-processing, for multi-aspect analysis of the hepatitis data and meta learning. Our methodology and experimental results show that the perspective of medical doctors will be changed from a single type of experimental data analysis towards a holistic view, by using our multi-aspect mining approach.

We have proposed a method called Decision Tree Graph-Based Induction (DT-GBI), which constructs a classifier (decision tree) for graph-structured data while simultaneously constructing attributes for classification. Graph-Based Induction (GBI) is utilized in DT-GBI for efficiently extracting typical patterns from graph-structured data by stepwise pair expansion (pairwise chunking). Attributes, i.e., substructures useful for classification task, are constructed by GBI on the fly while constructing a decision tree in DT-GBI. We applied DT-GBI to four classification tasks of hepatitis data using only the time-series data of blood inspection and urinalysis, which was provided by Chiba University Hospital. In the first and second experiments, the stages of fibrosis were used as classes and a decision tree was constructed for discriminating patients with F4 (cirrhosis) from patients with the other stages. In the third experiment, the types of hepatitis (B and C) were used as classes, and in the fourth experiment the effectiveness of interferon therapy was used as class label. The preliminary results of experiments, both constructed decision trees and their predictive accuracies, are reported in this paper. The validity of extracted patterns is now being evaluated by the domain experts (medical doctors). Some of the patterns match experts' experience and the overall results are encouraging.

The hepatitis temporal database collected at Chiba university hospital between 1982--2001 was recently given to challenge the KDD research. The database is large where each patient corresponds to 983 tests represented as sequences of irregular timestamp points with different lengths. This paper presents a temporal abstraction approach to mining knowledge from this hepatitis database. Exploiting hepatitis background knowledge and data analysis, we introduce new notions and methods for abstracting short-term changed and long-term changed tests. The abstracted data allow us to apply different machine learning methods for finding knowledge part of which is considered as new and interesting by medical doctors.