A Continuous Registry of Medical Record, Patient Input, and Epidemiological Data of Patients With Ulcerative Colitis: a Multicentre, Prospective, Observational Clinical Registry Study in Japan.

BACKGROUND: This registry aims to allow for a prospective non-interventional observational study of ulcerative colitis. This will facilitate monitoring of the current state of ulcerative colitis in Japan and improving the long-term disease course and adverse events associated with current treatment options. METHODS: Inclusion of patients from five centres in Japan is planned. The study is expected to take place from July 15, 2020, to November 30, 2024. Background, demographics, and medical history/information will be collected from electronic medical records at enrolment. Medical information including medications, laboratory data, and disease activity will be collected automatically from electronic medical records throughout the study. Patient-reported quality of life data will be collected directly from patients via smartphone. Efficacy endpoints (clinical remission rate, clinical improvement rate, and endoscopic healing rate) and safety endpoints (incidence of adverse events and specific ulcerative colitis-related events) will be collected according to treatment administered. Treatment categories include no treatment, 5-aminosalicylic acids, corticosteroids, immunomodulators, immunosuppressants, anti-tumour necrosis alpha agents, cytapheresis, Janus kinase inhibitors, anti-integrin antibodies, and anti-interleukin-12/23 antibodies. CONCLUSIONS: The dataset will include cross-sectional and longitudinal data and is expected to capture the state of ulcerative colitis in Japan. Patients will be included on a large scale, and the registry will be established automatically from electronic medical records and direct patient input, facilitating the accurate recording of medical information for patients with ulcerative colitis in Japan and minimizing limitations intrinsic to databases that require manual data entry, such as the burden on participating investigators and entry of data with errors/typos.

Effectiveness of Leakage Prevention System in Communicating Important Diagnostic Information.

In Japan, oversights of imaging or pathology examination results and diagnoses provided to patients have become a major problem because they affect patient prognosis. We have jointly developed and used the "Anti-Impact Information Leakage Prevention System (AiR)" since December 2019. This system works effectively because its introduction, which uses a data warehouse, has increased versatility and considerably improved the situation of confirmation and communication. We believe this system is working effectively.

Optimal Transport System for Acute Ischemic Stroke Patients: A Cost-Effectiveness Analysis.

This study conducted cost utility analysis comparing 4 systems of transporting acute ischemic stroke patients in Hokkaido, Japan. Hypothetical patients were generated on a geographic information system, and their outcomes were estimated according to their transport time to hospitals administering tissue plasminogen activator and/or endovascular thrombectomy. The transport systems where a neurointerventionist traveled for earlier endovascular thrombectomy were most cost-effective in some rural areas, while direct transportation to comprehensive stroke centers was more cost-effective in other areas.

Optimal allocation of physicians improves accessibility and workload disparities in stroke care.

BACKGROUND: Inequalities in access to stroke care and the workload of physicians have been a challenge in recent times. This may be resolved by allocating physicians suitable for the expected demand. Therefore, this study analyzes whether reallocation using an optimization model reduces disparities in spatial access to healthcare and excessive workload. METHODS: This study targeted neuroendovascular specialists and primary stroke centers in Japan and employed an optimization model for reallocating neuroendovascular specialists to reduce the disparity in spatial accessibility to stroke treatment and workload for neuroendovascular specialists in Japan. A two-step floating catchment area method and an inverted two-step floating catchment area method were used to estimate the spatial accessibility and workload of neuroendovascular specialists as a potential crowdedness index. Quadratic programming has been proposed for the reallocation of neuroendovascular specialists. RESULTS: The reallocation of neuroendovascular specialists reduced the disparity in spatial accessibility and the potential crowdedness index. The standard deviation (SD) of the demand-weighted spatial accessibility index improved from 125.625 to 97.625. Simultaneously, the weighted median spatial accessibility index increased from 2.811 to 3.929. Additionally, the SD of the potential crowdedness index for estimating workload disparity decreased from 10,040.36 to 5934.275 after optimization. The sensitivity analysis also showed a similar trend of reducing disparities. CONCLUSIONS: The reallocation of neuroendovascular specialists reduced regional disparities in spatial accessibility to healthcare, potential crowdedness index, and disparities between facilities. Our findings contribute to planning health policies to realize equity throughout the healthcare system.

Access to mechanical thrombectomy and ischemic stroke mortality in Japan: a spatial ecological study.

Background: Advances in stroke treatment have greatly improved outcomes; however, disparities in access to treatment might increase. Achieving equitable access to stroke treatment is a health policy challenge, as rapid treatment is essential for positive outcomes. This ecological cross-sectional study aimed to determine the relationship between the disparities in spatial accessibility to mechanical thrombectomy (SAMT) and stroke mortality rates in Japan, hypothesizing that disparities in SAMT may increase the differences in stroke mortality between regions. Methods: We used the average number of ischemic stroke (IS) deaths between 2020 and 2021 as the response variable; and SAMT, medical resources, and socioeconomic characteristics of each municipality as explanatory variables. A conditional autoregressive model was used to examine the association between the risk of stroke mortality and SAMT. The standardized mortality ratio (SMR) was mapped to understand the nationwide disparities in stroke mortality risk. Results: The median number of IS deaths was 17.5 persons per year in the municipalities (2020 to 2021). The study also found that municipalities with low SAMT were located in the northern part of Japan. The non-spatial regression model results indicated that poor accessibility, a small proportion of bachelor's degrees or higher, and a high proportion of workers in secondary industries were related to high IS mortality. Three models were evaluated using spatial analysis; Model 1 with accessibility indicators alone, Model 2 with medical resources added to Model 1, and Model 3 with socioeconomic characteristics added to Model 2. In Models 1 and 2, the population-weighted spatial accessibility index (PWSAI) showed a significant negative relationship with stroke mortality. However, this was not evident in Model 3. Mapping using Model 3 showed that the high-risk areas were predominantly located in northern Japan, excluding Hokkaido. Conclusion: Access to mechanical thrombectomy was estimated, and regional differences were observed. The relationship between accessibility and IS mortality is unknown; however, regardless of accessibility, municipalities with a high proportion of workers in secondary industries and a small proportion with bachelor's degrees or above are at risk of death from stroke.

Spatial-temporal analysis of cerebral infarction mortality in Hokkaido, Japan: an ecological study using a conditional autoregressive model.

BACKGROUND: Accessibility to stroke treatments is a challenge that depends on the place of residence. However, recent advances in medical technology have improved health outcomes. Nevertheless, the geographic heterogeneity of medical resources may increase regional disparities. Therefore, evaluating spatial and temporal influences of the medical system on regional outcomes and advanced treatment of cerebral infarction are important from a health policy perspective. This spatial and temporal study aims to identify factors associated with mortality and to clarify regional disparities in cerebral infarction mortality at municipality level. METHODS: This ecological study used public data between 2010 and 2020 from municipalities in Hokkaido, Japan. We applied spatial and temporal condition autoregression analysis in a Bayesian setting, with inference based on the Markov chain Monte Carlo simulation. The response variable was the number of deaths due to cerebral infarction (ICD-10 code: I63). The explanatory variables were healthcare accessibility and socioeconomic status. RESULTS: The large number of emergency hospitals per 10,000 people (relative risk (RR) = 0.906, credible interval (Cr) = 0.861 to 0.954) was associated with low mortality. On the other hand, the large number of general hospitals per 10,000 people (RR = 1.123, Cr = 1.068 to 1.178) and longer distance to primary stroke centers (RR = 1.064, Cr = 1.014 to 1.110) were associated with high mortality. The standardized mortality ratio decreased from 2010 to 2020 in Hokkaido by approximately 44%. Regional disparity in mortality remained at the same level from 2010 to 2015, after which it narrowed by approximately 5% to 2020. After mapping, we identified municipalities with high mortality rates that emerged in Hokkaido's central and northeastern parts. CONCLUSION: Cerebral infarction mortality rates and the disparity in Hokkaido improved during the study period (2010-2020). This study emphasized that healthcare accessibility through places such as emergency hospitals and primary stroke centers was important in determining cerebral infarction mortality at the municipality level. In addition, this study identified municipalities with high mortality rates that require healthcare policy changes. The impact of socioeconomic factors on stroke is a global challenge, and improving access to healthcare may reduce disparities in outcomes.

The health economic effects of an imaging technology-based telemedicine system for rural neuro-emergency patient care.

OBJECTIVE: "Join," an imaging technology-based telemedicine system, allows simultaneous radiological information sharing between physically remote institutions, virtually connecting advanced medical institutions and rural hospitals. This study aimed to elucidate the health economics effect of Join for neurological telemedicine in rural areas in Hokkaido, Japan. METHODS: Information concerning 189 requests for patient transfer from Furano Kyokai Hospital, a regional rural hospital, to Asahikawa Medical University Hospital (AMUH), an advanced academic medical institution, was retrospectively collected. The Join system was established between Furano Kyokai Hospital and AMUH in February 2019. Data collected from patients between April 2017 and December 2018 were included in the non-Join group, and those collected between February 2019 and October 2020 were included in the Join group. Clinical variables, reasons for patient transfer requests, duration of hospital stay, and medical costs per patient were analyzed between these two groups. Furthermore, clinical characteristics were compared between patients who were transferred and not transferred based on Join. RESULTS: More patients were discharged < 7 days after transfer to AMUH in the non-Join group compared with the Join group (p = 0.02). When focusing on the Join group, more patients who were not transferred were discharged < 1 week (p < 0.01). On the other hand, more patients required surgery (p = 0.01) when transferred. The ratio of patients whose medical cost was < USD5000 substantially decreased, from 33% for the non-Join group to 13% for the Join group. CONCLUSIONS: An imaging technology-based telemedicine system, Join, contributed to reducing unnecessary neuro-emergency patient transfer in a remote rural area, and telemedicine with an integrated smartphone system allowed medical personnel to effectively triage at a distance neuro-emergency patients requiring advanced tertiary care.

Consideration of Usefulness of Leakage Prevention System for Critical Diagnostic Information Transmission.

In our country, overlooking and failing to communicate the results of imaging examinations and pathological examinations to patients is a problem. This is because it affects the prognosis of the patients. With the introduction of this system, the situation improved within six months, so this system was useful. However, there are some things that remain unaddressed even after notification by the system, so human intervention as well as the system is considered necessary.

Kidney Outcomes Associated With SGLT2 Inhibitors Versus Other Glucose-Lowering Drugs in Real-world Clinical Practice: The Japan Chronic Kidney Disease Database.

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 (P heterogeneity ≥ 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.

Analysis of Factors Inhibiting the Dissemination of Telemedicine in Japan: Using the Interpretive Structural Modeling.

Background: Telemedicine is not significantly spreading globally and large variations in its availability and use exist internationally. Although many factors already inhibit the dissemination of telemedicine, its complexly intertwined factors make it more difficult to solve this problem. This study aimed to analyze and visualize relationships among factors inhibiting the dissemination of telemedicine. We applied the interpretive structural modeling method and cross-impact matrix multiplication applied to classification analysis. Materials and Methods: Factors inhibiting the dissemination of telemedicine in Japan were extracted by literature review and hearing from four medical informatics experts belonging to a university or hospital using the Kawakita Jiro method. Results: Eighteen factors were extracted as those inhibiting the dissemination of telemedicine service in Japan: initial and operation cost, research data, legal development, profitability, usability, human resources, image quality, network speed, information security, technical limitation, restriction for clinical practice, practice continuity, target use case, burden for physicians, respondence, risks for clinical safety, understanding of medical staff, and understanding of patients. The hierarchical structure chart showed a nine-level structure and the cross-impact matrix showed the relationship among factors and the classification of them inhibiting the dissemination of telemedicine. Discussion: We found that the underlying factors were high implementation and operation costs, low research data, and risks for clinical safety. Implementation and operation costs, research data, legal development, and profitability have high driving power; thus, it is expected that the elimination of these inhibiting factors would lead to the dissemination of telemedicine. Conclusions: There are many kinds of factors inhibiting the dissemination of telemedicine in Japan. The result of this showed the structure of these factors visually and could be useful to solve the problem inhibiting the dissemination of telemedicine effectively and efficiently.

Characteristics of Type-2 Diabetics Who are Prone to High-Cost Medical Care Expenses by Bayesian Network.

Objective: This study aims to determine the characteristics of Type 2 diabetic patients who are more likely to cause high-cost medical expenses using the Bayesian network model. Methods: The 2011-2015 receipt data of Iwamizawa city, Japan were collected from the National Health Insurance Database. From the record, we identified patients with Type 2 diabetes with the following items: age, gender, area, number of days provided medical services, number of diseases, number of medical examinations, annual healthcare expenditures, and the presence or absence of hospitalization. The Bayesian network model was applied to identify the characteristics of the patients, and four observed values were changed using a model for patients who paid at least 3607 USD a year for medical expenses. The changes in the conditional probability of the annual healthcare expenditures and changes in the percentage of patients with high-cost medical expenses were analyzed. Results: After changing the observed value, the percentage of patients with high-cost medical expense reimbursement increased when the following four conditions were applied: the patient "has ever been hospitalized", "had been provided medical services at least 18 days a year", "had at least 14 diseases listed on medical insurance receipts", and "has not had specific health checkups in five years". Conclusions: To prevent an excessive rise in healthcare expenditures in Type 2 diabetic patients, measures against complications and promoting encouragement for them to undergo specific health checkups are considered as effective.

[Willingness to Acceptance for the Information Leakage of Medical Information Data Using the Contingent Valuation Method].

Appropriate information security measures are very important for today's highly computerized hospitals to maintain the trust from patients. If once the personal information leakage of medical information was occurred, the hospital could lose their trust that has built for long time so far. It is important for hospitals to know the impact of the leakage accident previously advance to decide the investment for information security. The purpose of this study is to evaluate the impact of medical information leakage. The comforting fee for the patient's mental damage as the willingness to accept (WTA) was estimated, when the information leak occurred from a hospital using the contingent valuation method (CVM). Questionnaire survey was conducted using an internet survey service in Japan. We asked for 300 citizens about the use of personal information communication equipment and information security measures and their awareness for the information leakage. In addition, we presented a hypothetical scenario regarding information leakage of own medical information, asked the WTA as the comforting fee by the one choice of acceptance or rejection for the presented fee. In 300 responses, 190 were could be used for WTA estimation. WTA as the comforting fee when the information leakage of medical care information occurred, was estimated 570,541 yen in total. The result was similar with the value estimated by the damage compensation payment estimation model.

[Examination of the Important Factor during Implementation of the Medical Equipment and Hospital Information System Using the Correlation Analysis].

During medical equipment and hospital information system implementation in small- and medium-sized hospitals, the system introduction often advances after system selection by the management. However, in reality, the requirements of the systems between the management and staff layers were different. Therefore, the system did not often satisfy staff demands, resulting in increased dissatisfaction of the staff for the system. It was important to consider the staff's opinion at the selection of the system manufacturer, vendor, and system to resolve their dissatisfaction for a system. In this study, we let the staff decrease these dissatisfactions in selecting a system manufacturer, vendor, and a system at the system implementation. Therefore, we consider a more useful system implementation method through the staff's motivation building by the questionnaire result analysis. The questionnaire was carried out after each event in relation to system implementation. The enforcement of event for system implementation was useful for the staff's motivation building, because we can consider the staff's opinion with staff understanding. During system implementation, it was important and/or necessary for building the staff's motivation for the success of the system implementation and to utilize it after the implementation.

Are the recorded data of flash glucose monitoring systems influenced by radiological examinations?

The FreeStyle Libre Pro® flash glucose monitoring system is easy to use in diabetes care. However, the influence of radiological examination on recorded data has not been reported. The sensor should be removed prior to examinations involving strong magnetic or electromagnetic radiation. In the present study, it was assumed that radiological examination was performed without removing the FreeStyle Libre Pro® sensor in certain unanticipated situations. We researched the integrity of data recorded by the FreeStyle Libre Pro® system following exposure to chest X-rays, computed tomography (CT), radiotherapy (RT), and magnetic resonance imaging (MRI). Fifty sensors were exposed to chest X-ray, CT, RT, and MRI (1.5-T and 3.0-T), and the recorded data were compared with those obtained before the tests. Ten sensors were included in each group. There were no unread data or errors when the sensors were read. No change was observed before and after the examination for all tests.