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OBJECTIVE Randomized controlled trials have shown kidney-protective effects of sodium–glucose cotransporter 2 (SGLT2) inhibitors, and clinical practice databases have suggested that these effects translate to clinical practice. However, long-term efficacy, as well as whether the presence or absence of proteinuria and the rate of estimated glomerular filtration rates (eGFR) decline prior to SGLT2 inhibitor initiation modify treatment efficacy among type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) patients, is unknown. RESEARCH DESIGN AND METHODS Using the Japan Chronic Kidney Disease Database (J-CKD-DB), a nationwide multicenter CKD registry, we developed propensity scores for SGLT2 inhibitor initiation, with 1:1 matching with patients who were initiated on other glucose-lowering drugs. The primary outcome included rate of eGFR decline, and the secondary outcomes included a composite outcome of 50% eGFR decline or end-stage kidney disease. RESULTS At baseline, mean age at initiation of the SGLT2 inhibitor (n = 1,033) or other glucose-lowering drug (n = 1,033) was 64.4 years, mean eGFR was 68.1 mL/min per 1.73 m2, and proteinuria was apparent in 578 (28.0%) of included patients. During follow-up, SGLT2 inhibitor initiation was associated with reduced eGFR decline (difference in slope for SGLT2 inhibitors vs. other drugs 0.75 mL/min/1.73 m2 per year [0.51 to 1.00]). During a mean follow-up of 24 months, 103 composite kidney outcomes occurred: 30 (14 events per 1,000 patient-years) among the SGLT2 inhibitors group and 73 (36 events per 1,000 patient-years) among the other drugs group (hazard ratio 0.40, 95% CI 0.26–0.61). The benefit provided by SGLT2 inhibitors was consistent irrespective of proteinuria and rate of eGFR decline before initiation of SGLT2 inhibitors (Pheterogeneity ≥ 0.35). CONCLUSIONS The benefits of SGLT2 inhibitors on kidney function as observed in clinical trials translate to patients treated in clinical practice with no evidence that the effects are modified by the underlying rate of kidney function decline or the presence of proteinuria.

Big data has been a hot topic in medical and healthcare research. Big data in healthcare is considered to comprise massive amounts of information from various sources, including electronic health records (EHRs), administrative or claims data, and data from self-monitoring devices. Biomedical research has also generated a significant portion of big data relevant to healthcare. Other large datasets arise from cohorts that are recruited and followed on the basis of specific questions, although such research questions may later be expanded to enable other investigations. While the availability of big data offers many possibilities for an improved understanding of disease and treatment, the need for careful and productive use of statistical concepts should be kept in mind. Patient data routinely collected via electronic means are called real-world data (RWD) and are becoming common in healthcare research. RWD and big data are not synonymous with each other, but the two terms seem to be used without distinction with respect to observational studies. In this article, we review hypertension-related papers that use big data or RWD. There are many other sources of big data or RWD that are not covered here, each of which may pose special challenges and opportunities. While randomized clinical trials (RCTs) are considered to be the criterion standard for generating clinical evidence, the use of real-world evidence (RWE) to evaluate the efficacy and safety of medical interventions is gaining interest. On-going efforts to make use of RWD to generate RWE for regulatory decisions, as well as the challenges confronted, including reliability (quality) and relevance (fitness for purpose) of data, will also be addressed.

The Japan Chronic Kidney Disease (CKD) Database (J-CKD-DB) is a large-scale, nation-wide registry based on electronic health record (EHR) data from participating university hospitals. Using a standardized exchangeable information storage, the J-CKD-DB succeeded to efficiently collect clinical data of CKD patients across hospitals despite their different EHR systems. CKD was defined as dipstick proteinuria ≥1+ and/or estimated glomerular filtration rate 2 base on both out- and inpatient laboratory data. As an initial analysis, we analyzed 39,121 CKD outpatients (median age was 71 years, 54.7% were men, median eGFR was 51.3 mL/min/1.73 m2) and observed that the number of patients with a CKD stage G1, G2, G3a, G3b, G4 and G5 were 1,001 (2.6%), 2,612 (6.7%), 23,333 (59.6%), 8,357 (21.4%), 2,710 (6.9%) and 1,108 (2.8%), respectively. According to the KDIGO risk classification, there were 30.1% and 25.5% of male and female patients with CKD at very high-risk, respectively. As the information from every clinical encounter from those participating hospitals will be continuously updated with an anonymized patient ID, the J-CKD-DB will be a dynamic registry of Japanese CKD patients by expanding and linking with other existing databases and a platform for a number of cross-sectional and prospective analyses to answer important clinical questions in CKD care.

BackgroundThe Japan Chronic Kidney Disease Database (J-CKD-DB) is a nationwide clinical database of patients with chronic kidney disease (CKD) based on electronic health records. The objective of this study was to assess the prevalences of hyperuricemia and electrolyte abnormalities in Japanese patients with CKD.MethodsIn total, 35,508 adult outpatients with estimated glomerular filtration rates of 5-60 ml/min/1.73 m2 in seven university hospitals were included this analysis. The proportions of patients with CKD stages G3b, G4, and G5 were 23.5%, 7.6%, and 3.1%, respectively.ResultsLogistic regression analysis showed that prevalence of hyperuricemia was associated with CKD stages G3b (adjusted odds ratio [95% confidence interval]: 2.12 [1.90-2.37]), G4 (4.57 [3.92-5.32]), and G5 (2.25 [1.80-2.80]). The respective prevalences of hyponatremia, hypercalcemia, hyperphosphatemia, and narrower difference between serum sodium and chloride concentrations were elevated in patients with CKD stages G3b, G4, and G5, compared with those prevalences in patients with CKD stage G3a. The prevalences of hyperkalemia were 8.3% and 11.6% in patients with CKD stages G4 and G5, respectively. In patients with CKD stage G5, the proportions of patients with optimal ranges of serum uric acid, potassium, corrected calcium, and phosphate were 49.6%, 73.5%, 81.9%, and 56.1%, respectively.ConclusionsWe determined the prevalences of hyperuricemia and electrolyte abnormalities in Japanese patients with CKD using data from a nationwide cohort study.

BackgroundThe Japan Chronic Kidney Disease Database (J-CKD-DB) is a nationwide clinical database of patients with chronic kidney disease (CKD) based on electronic health records. The objective of this study was to assess the prevalence of anemia and the utilization rate of erythropoiesis-stimulating agents (ESAs) in Japanese patients with CKD.MethodsIn total, 31,082 adult outpatients with estimated glomerular filtration rates of 5-60 ml/min/1.73 m2 in seven university hospitals were included this analysis. The proportions of patients with CKD stages G3b, G4, and G5 were 23.5%, 7.6%, and 3.1%, respectively.ResultsThe mean (standard deviation) hemoglobin level of male patients was 13.6 (1.9) g/dl, which was significantly higher than the mean hemoglobin level of female patients (12.4 (1.6) g/dl). The mean (standard deviation) hemoglobin levels were 11.4 (2.1) g/dl in patients with CKD stage G4 and 11.2 (1.8) g/dl in patients with CKD stage G5. The prevalences of anemia were 40.1% in patients with CKD stage G4 and 60.3% in patients with CKD stage G5. Logistic regression analysis showed that diagnoses of CKD stage G3b (adjusted odds ratio [95% confidence interval]: 2.32 [2.09-2.58]), G4 (5.50 [4.80-6.31]), and G5 (9.75 [8.13-11.7]) were associated with increased prevalence of anemia. The utilization rates of ESAs were 7.9% in patients with CKD stage G4 and 22.4% in patients with CKD stage G5.ConclusionsWe determined the prevalence of anemia and utilization rate of ESAs in Japanese patients with CKD using data from a nationwide cohort study.

To help clinicians find better evidence, a metadata schema for Evidence Based Medicine (EBM) is developed. Dublin Core metadata standard (DC) was adopted to help build a metadata schema. An experimental system was developed to test the validity of the metadata and full text papers of clinical therapy on stomach ulcer extracted using PubMed. An EBM metadata schema was developed. Citations were created from original papers using the metadata schema. Three clinicians evaluated papers by utilizing metadata and full texts respectively. Agreement of evaluation was analyzed, and the result on weighted kappa was 0.55 (95%CI, 0.42---0.67). It reveals that there is moderate agreement between evaluation of metadata citations and full texts. It is possible to use the metadata to select papers before reading the full texts. A further study should be made to prove the applicability of the metadata in the real world setting.

当院において、業務の効率化を図る目的でコンピュータオーダリングシステムが導入された。しかし、ORTの業務はますます複雑多様化している。そこで、さらに適切でかつ安全な視能矯正管理を行い、これを患者に還元するため、視能矯正のワークフロー分析により電子的業務マニュアルを作成した。分析はKJ法により行い、臨床に関する業務項目を関連図にまとめた。これをもとに電子的業務マニュアルを作成、視能矯正全体の流れ、外来システム、入院システム、各業務の詳細を示した。本マニュアルにより視能矯正システムが視覚化および標準化され、臨床全体の流れと部分的な詳細な内容との相互関係が明確になった。これは、臨床面、教育面、研究面で有用であり、各要素が相互に結びつき機能することで患者中心のより良い医療を提供できるものと考えた。

pulse wave velocity (PWV), PWV vadprssure, and Serum lipid levels are tested whether or not they are there 1s no dgnificmt difference PWV measurements in healthy sulsiects -9 - '. E is arid the in patients with cardiovd disease. to exclude subjects who ' in the future Since it is very dSficuk will epective analysis of the data archives Seems to be essentiaL

In order to investigate the problem of comedical staff shortage in hospital, a survey has been conducted on radiological technologists. The questionnaire included questions about the size of hospital, amount of work, and respondents themselves. We present the main results of the survey, and discuss that the standpoint of comedical staff is a valid ground for evaluating shortage of comedical staff and for determining staffing which is appropriate in a real sense.

An intelligent terminal has been developed to provide the clinical staffs with a means of utmost simplicity to communicate with the computer. Only 16 keys and a single switch are all which are involved in any terminal operation. The members of the operating system are the interpreter of TEXTOR (a language developed in this study), editor, monitor, and data-communication handler. This system configuration greatly reduces the cost for data communication compared with the conventional communication systems.

We have developed a computer method to make a diagnosis for an emergency patient using the data reported by a person who has no technical knowledge of medicine such as a member of the public or an ambulance attendant. The speedy instruction will be made possible by a computer diagnosis, by which an ambulance attendant could deliver the patient expeditiously to the most appropriate medical facility. We first conducted a survey by means of questionnaire and investigated the relationship between the patients' data and diagnosis of medical doctors. It was shown that fairly accurate diagnosis could be made on treatment, hospitalization, an appropriate medical department and need of urgent care, using simple information like age, sex, cause of illness or injury, and 15 symptoms which trained laymen could judge. Accuracy of the diagnosis was 79.3% on the average.

Hierarchical organization of information on drug-drug interactions is presented. The drug categories and drugs known to be involved in interactions are represented as nodes, and they are partly ordered according to inclusive relationships. Interactions among them are represented by a relation called the interacting relation. A partial ordering is defined on the solution set of the interacting relation based on the inclusive relationships among the nodes, and the set of the maximal elements is defined as the maximal interacting relation. These maximal elements are stored in a computer as explicit links joining the nodes, and during the process of interaction checking, they are superimposed on all the subordinate nodes. Thus possible interactions between given drugs can be found by applying the general rules of interactions. An experimental system is implemented based on this representational scheme, and the efficiency of the scheme as a basis of an advanced information management system for drug-drug interactions is discussed.

We have established a discrimination value that classifies serum lipid levels, that is, total cholesterol, phospholipid, triglyceride, and beta-lipoprotein, into normal or abnormal state. The analysis was made using the linear discriminant function based on 720 normal subjects and 294 patients with coronary heart disease and/or diabetes mellitus. Basically, the function denoted as f is a linear combination of the predictor variables x(1),x(2),...,x(n) weighted by w(0),w(1),w(2),...,w(n). First, we obtained a function from the training set that consists of age-matched 204 normals and 204 patients. The predictor variables used are four serum constituents and age. Next, we tested the cross-validation of this function by the remainder of the samples (test set). Finally, we obtained a discrimination value, by which 96.1% of the training set and 96.3% of the test set was correctly classified.

We have been developing a database for gastric cancer screening test since 1979. People who live in the city area voluntarily undergo the test once a year, and the data of each examinee are stored into the file constituting a record for each visit. Up to the present time, 91 400 records have been entered into the database. The file is supported by FLXFL, an interactive system for programming-free data management and analysis, which runs on a PDP 11/44. A record consists of 56 items, that is: examinee's name, address, telephone number, past history, family history, present complaints, radiographic findings of the gastrointestinal tract and so forth. Data other than X-ray and gastro-camera findings are taken by questionnaire. Using the data in the file, we have statistically analysed whether each data item is useful or not for detecting a patient with gastric cancer. The results of the analyses are presented in this paper.

It has been generally considered that FORTRAN is inferior to MUMPS and other computer languages in its facility to manipulate files and that it is not satisfactorily competent to handle databases. However, it is our finding that FORTRAN is the most widely used language in patient data management systems discussed in recently published papers. Therefore, it now seems appropriate to review and evaluate the validity of this general belief. The objective of this study is to establish a file management system in FORTRAN 77 for use in the construction of a clinical database. Comparative study is conducted on several problems associated with file manipulation, that is, time requirement for file access and access methods for data retrieval.

An approach to the problem of nursing staff scheduling in a hospital is presented. For scheduling nurses, a variety of requirements with varied levels of significance has to be taken into account simultaneously. Because of the nature of the problem, where it is difficult to define what is the optimal solution in a strict sense, we aimed at automating scheduling by following the manual method in a faithful manner. A system for nurse scheduling has been implemented on a personal computer using Prolog. It determines favorable shift assignments on a day-to-day basis, referring to the information accumulated in the data base. In Prolog, various requirements can be expressed with relative ease, and the process of the manual method can be incorporated into the system in a natural way. The computer simulation has been conducted to test the system performance, and the obtained results demonstrated the validity of the approach.

Pulse wave patterns at a finger and a toe are obtained using photoplethysmography. The data recorded at two recording sites are transformed by digital filters into six waveforms and the transmission time of each wave is estimated by the crosscorrelation function. Relationships between the transmission times, age, and parameters obtained from several laboratory tests are examined using multiple regression analysis. The results may be summarised as follows: the power of photoplethysmograms of a finger and a toe is concentrated in the range below 6 or 8 Hz; age correlates highly with the transmission time of a pulse wave rather than with velocity; the multiple correlation coefficients between age and the transmission times is 0·853 in male and 0·866 in female; there are no differences of transmission time among disease types; the correlations between age and other parameters measured by laboratory tests, that is, total cholesterol, phospholipid, triglyceride, β-lipoprotein, are very small.