Correction: Electronic Health Record-Nested Reminders for Serum Lithium Level Monitoring in Patients With Mood Disorder: Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/40595.].

Assessment of myopic rebound effect after discontinuation of treatment with 0.01% atropine eye drops in Japanese school-age children.

PURPOSE: Having previously demonstrated the efficacy of 0.01% atropine eye drops for inhibiting progression of childhood myopia, we conducted additional analyses to assess post-treatment changes in myopia progression. STUDY DESIGN: Analysis of follow-up data from a previously reported randomized controlled trial METHODS: A mixed-effects model was used to compare intergroup changes in spherical equivalent (SE) and axial length (AL) at 1 month and 12 months after discontinuation of 2-year treatment with atropine or placebo in 167 school-age children. RESULTS: Follow-up measurements were available for 149 participants at 1 month after discontinuation of treatment and for 51 participants at 12 months after discontinuation. At 1 month post-treatment, differences between the atropine and placebo groups in least squares (LS) mean changes in SE and AL, respectively, from 24 months were -0.06 diopters (D) (95% CI: -0.21, 0.08; P = .39) and 0.02 mm (95% CI: -0.05, 0.08; P = .60). At 12 months post-treatment, intergroup differences (atropine vs placebo) in LS mean changes in SE and AL, respectively, were -0.13 D (95% CI: -0.35, 0.10; P = .26) and -0.02 mm (95% CI: -0.12, 0.09; P = .75). LS mean changes in SE and AL from treatment discontinuation did not differ between the groups at 1 or 12 months post-treatment. CONCLUSION: Axial elongation was significantly less in the atropine group than in the placebo group. The suppression effect obtained at 2 years was maintained after 12 months. The absence of intergroup differences in myopia progression since treatment cessation suggests that myopic rebound did not occur.

Electronic Health Record-Nested Reminders for Serum Lithium Level Monitoring in Patients With Mood Disorder: Randomized Controlled Trial.

BACKGROUND: Clinical guidelines recommend regular serum lithium monitoring every 3 to 6 months. However, in the real world, only a minority of patients receive adequate monitoring. OBJECTIVE: This study aims to examine whether the use of the electronic health record (EHR)-nested reminder system for serum lithium monitoring can help achieve serum lithium concentrations within the therapeutic range for patients on lithium maintenance therapy. METHODS: We conducted an unblinded, single-center, EHR-nested, parallel-group, superiority randomized controlled trial comparing EHR-nested reminders with usual care in adult patients receiving lithium maintenance therapy for mood disorders. The primary outcome was the achievement of therapeutically appropriate serum lithium levels between 0.4 and 1.0 mEq/L at 18 months after enrollment. The key secondary outcomes are included as follows: the number of serum lithium level monitoring except for the first and final monitoring; exacerbation of the mood disorder during the study period, defined by hospitalization, increase in lithium dose, addition of antipsychotic drugs or mood stabilizers, or addition or increase of antidepressants; adherence defined by the proportion of days covered by lithium carbonate prescription during the study period. RESULTS: A total of 111 patients were enrolled in this study. A total of 56 patients were assigned to the reminder group, and 55 patients were assigned to the usual care group. At the follow-up, 38 (69.1%) patients in the reminder group and 33 (60.0%) patients in the usual care group achieved the primary outcome (odds ratio 2.14, 95% CI 0.82-5.58, P=.12). The median number of serum lithium monitoring was 2 in the reminder group and 0 in the usual care group (rate ratio 3.62; 95% CI 2.47-5.29, P<.001). The exacerbation of mood disorders occurred in 17 (31.5%) patients in the reminder group and in 16 (34.8%) patients in the usual care group (odds ratio 0.97, 95% CI 0.42-2.28, P=.95). CONCLUSIONS: We found insufficient evidence for an EHR-nested reminder to increase the achievement of therapeutic serum lithium concentrations. However, the number of monitoring increased with relatively simple and inexpensive intervention. The EHR-based reminders may be useful to improve quality of care for patients on lithium maintenance therapy, and they have potentials to be applied to other problems. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry UMIN000033633; https://tinyurl.com/5n7wtyav.

Antiresorptive Drugs and the Risk of Femoral Shaft Fracture in Men and Women With Osteoporosis: A Cohort Study Using the National Database of Health Insurance Claims of Japan.

BACKGROUND: This cohort study aimed to estimate incidence rates of femoral shaft fracture in patients who were treated with antiresorptive drugs. METHODS: We used data from the National Database of Health Insurance Claims of Japan from April 2009 and October 2016. All patients with new use of an antiresorptive drug, prescription-free period of ≥3 months, and no prior femoral fractures were included. Femoral shaft fractures were identified using a validated definition based on International Classification of Diseases, 10th revision (ICD-10) codes. Incidence rate ratios were estimated using Poisson regression, with adjustment for sex, age, and the Charlson Comorbidity Index. RESULTS: We identified 7,958,655 patients (women: 88.4%; age ≥75 years: 51.2%). Femoral shaft fractures were identified in 22,604 patients. Incidence rates per 100,000 person-years were 74.8 for women, 30.1 for men, 30.1 for patients aged ≤64 years, 47.7 for patients aged 65-74 years, and 99.0 for patients aged ≥75 years. Adjusted incidence rate ratios in patients taking versus not taking each type of antiresorptive drug were 1.00 (95% confidence interval [CI], 0.98-1.03) for bisphosphonates, 0.46 (95% CI, 0.44-0.48) for selective estrogen receptor modulators, 0.24 (95% CI, 0.18-0.32) for estrogens, 0.75 (95% CI, 0.71-0.79) for calcitonins, and 0.93 (95% CI, 0.84-1.03) for denosumab. The adjusted incidence rate ratio for alendronate was 1.18 (95% CI, 1.14-1.22). CONCLUSION: The incidence rates of femoral shaft fracture varied across patients treated with different antiresorptive drugs. Further research on a specific antiresorptive drug can increase understanding of the risk of femoral shaft fracture.

Safety assessment of robotic gastrectomy and analysis of surgical learning process: a multicenter cohort study.

BACKGROUND: The safety of robotic gastrectomy (RG) for gastric cancer in daily clinical settings and the process by which surgeons are introduced and taught RG remain unclear. This study aimed to evaluate the safety of RG in daily clinical practice and assess the learning process in surgeons introduced to RG. METHODS: Patients who underwent RG for gastric cancer at Kyoto University and 12 affiliated hospitals across Japan from January 2017 to October 2019 were included. Any morbidity with a Clavien-Dindo classification grade of II or higher was evaluated. Moreover, the influence of the surgeon's accumulated RG experience on surgical outcomes and surgeon-reported postoperative fatigue were assessed. RESULTS: A total of 336 patients were included in this study. No conversion to open or laparoscopic surgery and no in-hospital mortality were observed. Overall, 50 (14.9%) patients developed morbidity. During the study period, 14 surgeons were introduced to robotic procedures. The initial five cases had surprisingly lower incidence of morbidity compared to the following cases (odds ratio 0.29), although their operative time was longer (+ 74.2 min) and surgeon's fatigue scores were higher (+ 18.4 out of 100 in visual analog scale). CONCLUSIONS: RG was safely performed in actual clinical settings. Although the initial case series had longer operative time and promoted greater levels of surgeon fatigue compared to subsequent cases, our results suggested that RG had been introduced safely.

Developing a health economic model for Asians with type 2 diabetes based on the Japan Diabetes Complications Study and the Japanese Elderly Diabetes Intervention Trial.

INTRODUCTION: Cost-effectiveness analyses are becoming increasingly important in Japan following the introduction of a health technology assessment scheme. The study objective was to develop an economic model to evaluate the cost-effectiveness of two interventions for type 2 diabetes in a Japanese population. RESEARCH DESIGN AND METHODS: The Japan Diabetes Complications Study/Japanese Elderly Diabetes Intervention Trial risk engine (JJRE) Cost-Effectiveness Model (JJCEM) was developed, incorporating validated risk equations in Japanese patients with type 2 diabetes from the JJRE. Weibull regression models were developed for progression of the model outcomes, and a targeted literature review was performed to inform default values for utilities and costs. To illustrate outcomes, two simulated analyses were performed in younger (aged 40 years) and older (aged 80 years) Japanese populations, comparing a hypothetical treatment with placebo. RESULTS: The model considers a population based on user-defined values for 11 baseline characteristic parameters and simulates rates of diabetic complications over a defined time horizon. Costs, quality-adjusted life years, and an incremental cost-effectiveness ratio are estimated. The model provides disaggregated results for two competing interventions, allowing visualization of the key drivers of cost and utility. A scatterplot of simulations and cost-effectiveness acceptability curve are generated for each analysis. CONCLUSIONS: This is the first cost-effectiveness model for East Asian patients with type 2 diabetes, developed using Japan-specific risk equations. This population constitutes the largest share of the global population with diabetes, making this model highly relevant. The model can be used to evaluate the cost-effectiveness of anti-diabetic interventions in patients with type 2 diabetes in Japan and other East Asian populations.

Exploratory assessment of treatment-dependent random-effects distribution using gradient functions.

In analyzing repeated measurements from randomized controlled trials with mixed-effects models, it is important to carefully examine the conventional normality assumption regarding the random-effects distribution and its dependence on treatment allocation in order to avoid biased estimation and correctly interpret the estimated random-effects distribution. In this article, we propose the use of a gradient function method in modeling with the different random-effects distributions depending on the treatment allocation. This method can be effective for considering in advance whether a proper fit requires a model that allows dependence of the random-effects distribution on covariates, or for finding the subpopulations in the random effects.

Assessment of asthma severity according to treatment steps in Japanese pediatric patients: a descriptive cross-sectional study using an administrative claims database.

OBJECTIVES: Japan has one of the highest asthma prevalence rates in Asia; however, there is a lack of epidemiological studies on asthma among children in Japan. This study aimed to describe the severity of asthma and the prescription patterns for its treatment among pediatric patients, by using a large-scale claims database. METHODS: The analysis datasets were extracted from the JMDC database for the period of April 1, 2009 to March 30, 2015; included records were restricted to patients between 2 and 15 years of age. The Japanese Pediatric Guidelines for the treatment and management of asthma (JPGL) steps were used as a proxy for asthma treatment and severity. We also described the characteristics of asthma in children by stratifying the prevalence and incidence cohorts by index years. RESULTS: In the prevalence cohort (56% male), from 2010 to 2014, approximately 80-90% of the children received step 1 or 2 treatment, with the remainder receiving step 3 or 4 treatment, as defined by the JPGL. The majority (approximately 90%) of patients visited clinics for asthma treatment, while a minority visited hospitals. CONCLUSIONS: Our study showed the severity of asthma among Japanese pediatric patients, as well as their demographic characteristics, using a large-scale claims database. The majority of pediatric asthma patients received treatment for mild-to-moderate asthma, while less than 10% received treatment for severe asthma.

Electronic health record nested pragmatic randomized controlled trial of a reminder system for serum lithium level monitoring in patients with mood disorder: KONOTORI study protocol.

BACKGROUND: The weaknesses of classical explanatory randomized controlled trials (RCTs) include limited generalizability, high cost, and time burden. Pragmatic RCTs nested within electronic health records (EHRs) can be useful to overcome such limitations. Serum lithium monitoring has often been underutilized in real-world practice in Japan. This trial aims to evaluate the effectiveness of the EHR-nested reminder system for serum lithium level monitoring in the maintenance of therapeutic lithium concentration and in the improvement of the quality of care for patients on lithium maintenance therapy. METHODS: The Kyoto Toyooka nested controlled trial of reminders (KONOTORI trial) is an EHR-nested, parallel-group, superiority, stratified, permuted block-randomized controlled trial. Screening, random allocation, reminder output, and outcome collection will be conducted automatically by the EHR-nested trial program. Patients with a mood disorder taking lithium carbonate for maintenance therapy will be randomly allocated to the two-step reminder system for serum lithium monitoring or to usual care. The primary outcome is the achievement of therapeutic serum lithium concentration between 0.4 and 1.0 mEq/L at 18 months after informed consent. DISCUSSION: The KONOTORI trial uses EHRs to enable the efficient conduct of a pragmatic trial of the reminder system for lithium monitoring. This may contribute to improved quality of care for patients on lithium maintenance therapy. TRIAL REGISTRATION: University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000033633. Registered on 3 July 2018.

Real-world pharmacological treatment patterns of patients with young-onset Parkinson's disease in Japan: a medical claims database analysis.

INTRODUCTION: Young-onset Parkinson's disease is reported to comprise 5-10% of all Parkinson's disease cases; however, as physicians encounter a limited number of these patients, their treatment patterns are still unclear. METHODS: We performed a descriptive study using the large Japanese medical claims database to describe the epidemiology and real-world pharmacological treatment patterns of newly diagnosed patients with young-onset Parkinson's disease. Patients aged 21-50 years in whom Parkinson's disease was newly diagnosed between January 1, 2005 and March 31, 2016 were included. We excluded individuals with Parkinson's-related diseases and those using antipsychotics to eliminate the possibility of drug-induced parkinsonism. The patients' demographics, comorbidities, prescribing patterns, and changes in levodopa equivalent daily dose were analyzed. RESULTS: We identified 131 newly diagnosed young-onset Parkinson's disease patients (median age, 44.2 years). The most common comorbidities were depression (23.7%), hypertension (23.7%), and insomnia (22.9%). Of these patients, 122 were prescribed antiparkinson drugs. During the study period, the proportion of patients who were prescribed dopamine agonists, levodopa, and anticholinergics were 77.1%, 44.3%, and 27.5%, respectively. Dopamine agonists (49.2%) were most commonly prescribed initially, followed by anticholinergics (23.8%), levodopa (19.7%), and others (4.1%). The levodopa equivalent daily dose increased steadily with longer disease duration. CONCLUSIONS: Dopamine agonists were most frequently prescribed during the study period and were the initial treatment of choice. We also observed a change in levodopa equivalent daily dose over the disease course. This study provides a descriptive overview of real-world prescribing patterns in young-onset Parkinson's disease patients.

Prescription pattern and trend of oral contraceptives in Japan: A descriptive study based on pharmacy claims data (2006 - 2014).

OBJECTIVE: The use of combined oral contraceptives (COC) as a contraceptive method is still limited in Japan, used only by 1.1% of women of reproductive age. The usage pattern of COC, such as continuation and preparation switch, between COC generations was investigated using large datasets. METHODS: This descriptive study spanning from 2006 to 2014 used nationwide prescriptions based on administrative databases, including both reimbursed and non-reimbursed drugs. All the first-time COC users were included as a cohort. Usage patterns considering trends, continuation, and switch of COC generations were also investigated. RESULTS: Of the 38,123 patients, the overall mean age at initial use of COC was 32.9 years. Of the first-time users, 51.2%, 23.7%, 5.6%, and 19.5% received first-, second-, third-, and fourth-generation COCs, respectively. The overall rate of continuation was 59.1%, and the rate of first-time use with switching to other generations within 180 days was 3.1%. CONCLUSION: We revealed the actual usage of COC in Japan with frequent prescriptions of first- or fourth-generation COCs and relatively high age at initial use. Moreover, the COC continuation rate was low, and switch was limited. Further studies into its proper usage are recommended.

Costs associated with febrile neutropenia in Japanese patients with primary breast cancer: post-hoc analysis of a randomized clinical trial.

BACKGROUND: Febrile neutropenia (FN), a decrease in blood neutrophils accompanied by fever, is a major adverse event (AE) associated with cancer chemotherapy. We aimed to estimate the direct medical costs associated with FN management in breast cancer patients within a clinical trial with pegfilgrastim, a pegylated form of recombinant granulocyte colony-stimulating factor (G-CSF). METHODS: We obtained data from 346 Japanese breast cancer patients in a randomized, placebo-controlled clinical trial comparing FN incidence due to TC adjuvant chemotherapy (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2) between pegfilgrastim-treated and placebo groups. We estimated mean costs for chemotherapy drugs, drugs for all AEs and FN, and hospitalization for all AEs and FN. We also calculated mean costs associated with drugs and hospitalization for FN specifically for patients who developed FN in the placebo group. RESULTS: For the pegfilgrastim and placebo groups, the total cost during the first cycle of chemotherapy was ¥189 135 and ¥98 106. This difference is associated with prophylactic use of pegfilgrastim. Our analysis clarified in the placebo group that FN incidents of 119/173 (68.6%), the mean drug cost related to all AEs and hospitalization caused by the first cycle of chemotherapy were ¥14 411and ¥11 180, respectively. The cost of each for FN treatment was ¥16 429 for the placebo group. The mean treatment cost for patients who developed FN in placebo group, was ¥11 145 for drugs and ¥28 420 for drugs and hospitalization. CONCLUSIONS: Pegfilgrastim reduced the costs incurred for both drugs and hospitalization for AEs as well as FN, although the total medical cost during the chemotherapy increased. Our study constitutes baseline data for further health economic evaluations of pegfilgrastim.

Preoperative Blood Tests Conducted Before Low-Risk Surgery in Japan: A Retrospective Observational Study Using a Nationwide Insurance Claims Database.

BACKGROUND: Routine preoperative testing is discouraged before low-risk surgery because testing does not provide any beneficial effect in terms of patient outcome. However, few studies have assessed the utilization of hospital health care resources in terms of preoperative tests in a real-world setting. Here, we aimed to assess the prevalence and factors associated with preoperative blood tests before low-risk surgery in Japan. METHODS: In this retrospective observational study, we used the nationwide insurance claims data of Japan. Patients who underwent low-risk surgeries between April 1, 2012 and March 31, 2016, were included. Our primary outcome was the receipt of any preoperative tests within 60 days before an index procedure: complete blood count, basic metabolic panel, coagulation tests, and liver function tests. We performed a descriptive analysis to estimate the proportions of preoperative blood tests, and examined the associations between patient-level and institutional-level factors and preoperative blood tests, using multilevel logistic regression analysis. Interinstitutional variation in the utilization of preoperative tests was summarized using the median odds ratio (OR). RESULTS: The study sample included 59,818 patients (mean [standard deviation] age, 44.0 [11.3] years; 33,574 [56.1%] women) from 9746 institutions. The overall proportion of each test was: complete blood count, 58.7%; metabolic panel, 47.8%; coagulation tests, 36.6%; and liver function tests, 48.5%. The proportion receiving any preoperative tests in the overall sample was 59.5%. Multilevel logistic regression analysis indicated that preoperative blood tests were associated with the Charlson comorbidity index score (score ≥3: adjusted OR, 4.21; 95% confidence interval [CI], 3.69-4.80), anticoagulant use (adjusted OR, 4.12; 95% CI, 2.35-7.22), type of anesthesia (general anesthesia: adjusted OR, 5.69; 95% CI, 4.85-6.68; regional anesthesia: adjusted OR, 3.76; 95% CI, 3.28-4.30), surgical setting (inpatient procedure: adjusted OR, 3.64; 95% CI, 3.30-4.00), and number of beds (≥100 beds: adjusted OR, 3.61; 95% CI, 3.19-4.08). The median institutional-specific proportion of preoperative tests was 40.0% (interquartile range, 0%-100%). The median OR for interinstitutional variation in ordering preoperative tests was 4.34. These findings were consistent across a sensitivity analysis. CONCLUSIONS: Preoperative blood tests were performed before 59.5% of low-risk surgeries. Preoperative tests were associated with the type of anesthesia, patient characteristics, and medical facility status. There was a substantial interinstitutional variation in the utilization of preoperative tests.

Analysis of the evidence-practice gap to facilitate proper medical care for the elderly: investigation, using databases, of utilization measures for National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB).

As Japan becomes a super-aging society, presentation of the best ways to provide medical care for the elderly, and the direction of that care, are important national issues. Elderly people have multi-morbidity with numerous medical conditions and use many medical resources for complex treatment patterns. This increases the likelihood of inappropriate medical practices and an evidence-practice gap. The present study aimed to: derive findings that are applicable to policy from an elucidation of the actual state of medical care for the elderly; establish a foundation for the utilization of National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), and present measures for the utilization of existing databases in parallel with NDB validation.Cross-sectional and retrospective cohort studies were conducted using the NDB built by the Ministry of Health, Labor and Welfare of Japan, private health insurance claims databases, and the Kyoto University Hospital database (including related hospitals). Medical practices (drug prescription, interventional procedures, testing) related to four issues-potential inappropriate medication, cancer therapy, chronic kidney disease treatment, and end-of-life care-will be described. The relationships between these issues and clinical outcomes (death, initiation of dialysis and other adverse events) will be evaluated, if possible.

Impact of health insurance coverage for Helicobacter pylori gastritis on the trends in eradication therapy in Japan: retrospective observational study and simulation study based on real-world data.

OBJECTIVES: To explore the prevalence of Helicobacter pylori infection in Japan and the trends of its eradication therapy before and after the changes of the insurance coverage policy, first started in 2000, and expanded to cover H. pylori-positive gastritis in 2013. The impacts that the changes brought were estimated. METHODS: In this retrospective observational study and simulation study based on health insurance claims data, product sales data and relevant studies, individuals who received triple therapy (amoxicillin, clarithromycin, proton-pump inhibitors or potassium-competitive acid blockers) were defined as the first-time patients for H. pylori eradication in two Japanese health insurance claims databases (from approximately 1.6 million and 10.5 million individuals). Each sales data of eradication packages and examination kits were used to estimate the number of H. pylori-eradicated individuals nationwide. The prevalence of H. pylori infection, including the future rate, was predicted using previous studies and the estimated population trend by a national institute. Cases completed prior to the policy change on insurance coverage were simulated to estimate what would have happened had there been no change in the policy. RESULTS: The numbers of patients first received eradication therapy were 81 119 and 170 993 from two databases. The nationwide estimated number of patients successfully eradicated was approximately 650 000 per year between 2001 and 2012, whereas it rapidly rose to 1 380-000 per year in 2013. The estimated prevalence of infection in 2050 is 5%, this rate was estimated to be 28% and 22% if the policy changes had not occurred in 2000 and 2013, respectively. CONCLUSIONS: The impact of policy changes for H. pylori eradication therapy on the prevalence of infection was shown. The results suggest that insurance coverage expansion may also reduce the prevalence in other countries with a high prevalence of H. pylori infection if the reinfection is low.

Evaluation of a maternal health care project in South West Shoa Zone, Ethiopia: before-and-after comparison.

BACKGROUND: Despite recent achievements in health targets, Ethiopia still faces challenges in health service delivery. Between 2012 and 2015, a non-governmental organisation (NGO), Doctors with Africa CUAMM, implemented a multifaceted project aimed at improving access to maternal and child health services in three districts in Ethiopia. This paper evaluates the performance of this project, based on four maternal health indicators. METHODS: A before-and-after study utilising data collected through cross-sectional surveys involving 999 women was conducted. The date of delivery was used to stratify the intervention period as follows: pre-intervention, early intervention, and late intervention. Changes during the intervention in the coverage of four antenatal care (ANC) visits, receipt of three basic components of ANC, skilled birth attendant (SBA) at delivery, and postnatal care (PNC) in seven days were assessed using logistic regression, adjusting for socio-demographic factors. RESULTS: There was an increase in the coverage of receipt of all three ANC components and SBA at delivery between the pre-intervention period and the late intervention period. The percent of health centre deliveries increased from 7.3 % in the pre-intervention period to 35.6 % in the late intervention period. The odds of receiving all three components of ANC were twice higher in the late intervention period than in the pre-intervention period (OR 2.09; 95 % CI 1.12-3.89). The odds of SBA at delivery were five times higher in the late intervention period than in the pre-intervention period (OR 5.04; 95 % CI 2.53-10.06). There was no significant change in the coverage of four ANC visits and PNC after accounting for sociodemographic factors. CONCLUSIONS: This NGO implemented maternal health project in three districts in Ethiopia was associated with increased likelihood that a pregnant woman would receive three basic components of ANC and be assisted by a SBA at delivery. Increase in skilled birth attendance was driven by increased utilisation of health centres. More efforts are needed to bolster the coverage of ANC and PNC.

Assessment of kidney dysfunction with cystatin C- and creatinine-based estimated glomerular filtration rate and predicting type 2 diabetes: Toranomon Hospital Health Management Center Study 21.

OBJECTIVE: Whether early stages of kidney dysfunction assessed by the estimated glomerular filtration rate from cystatin C measurements (eGFRCysC) rather than from creatinine measurements (eGFRCr) would more precisely reflect the risk of developing type 2 diabetes (T2D) has not been clarified. We compared the risk of developing T2D associated with renal dysfunction indicated by eGFRCysC or eGFRCr measurements. METHODS: Studied were 2131 Japanese individuals without diabetes. Hazard ratios (HRs) for the development of T2D over 3-5 y were calculated across categories of eGFRCysC and eGFRCr, respectively. RESULTS: Reduced levels of eGFRCysC were associated with a step-wise increase in the cumulative incidence rate of T2D (p=0.007). In comparison with the eGFRCysC >85th percentile group (≥ 117.4 ml/min/1.73 m(2)), the lowest group, which was the eGFRCysC <15th percentile group (<86.2 ml/min/1.73 m(2)), had an adjusted HR of 2.30 (95% CI 1.13, 4.68) for T2D. Compared with the eGFRCr >85th percentile group, the lowest eGFRCr group (<15th percentile) had an HR of 1.19 (0.63, 2.24) for T2D. However, individuals with eGFRCr <60 ml/min/1.73 m(2) had a significantly increased risk of T2D. Clustering of both low eGFRCysC and low eGFRCr further elevated the HR for T2D compared with the presence of either. CONCLUSIONS: Although eGFRCr in ranges indicating chronic kidney disease reflected an elevated risk of developing diabetes, earlier stages of kidney dysfunction indicated by reduced eGFRCysC, which could not be captured by reduced eGFRCr, would be a marker for an elevated risk of developing T2D.

[Awareness survey of Healthcare Number System pros and cons according to medical doctors in Japan].

OBJECTIVES: After bills to launch the Social Security and Tax Number System were enacted in 2013, health and political officials have considered the Healthcare Number System (the System). However, little is known about doctors' awareness and concerns about the System. This study aimed to measure how many doctors disagree with the System, examine the doctors' characteristics, and analyze the benefits and harms of the System that they identified. METHODS: A cross-sectional survey was conducted of doctors via the Internet. The participants were selected from a convenience sample of a panel of doctors based on stratified sampling including four groups: working at a hospital and <45 years; working at a hospital and ≥45 years; working at a clinic and <45 years; and working at a clinic and ≥45 years. The main outcome was how many doctors agreed or disagreed with the System. The prevalence was calculated for each group, and their characteristics were examined using multivariable logistic regression analysis. The responses to open-ended questions concerning the Systems' benefits and harms were analyzed using qualitative content analysis. RESULTS: There were 562 respondents (68%). By group, 16/143 (11%), 25/138 (18%), 31/132 (23%), and 43/149 (29%) doctors, respectively, thought that the System was unnecessary. The variables that correlated with the main outcome were age (per 5 years; odds ratio [95% confidence interval], 1.14 [1.01-1.29]) and type of medical facility (working at a clinic; 1.99 [1.30-3.08]). The doctors identified that unifying information could decrease administrative duties, facilitate inter-facility collaboration, and prevent inappropriate medical consultations. This could result in decreased healthcare costs and personalized healthcare. However, the doctors also identified that integrating information and dealing with big data could increase information leakage and information management, cause over-monitoring of doctors, and enable the inappropriate use of integrated information. This could result in deteriorating healthcare. Since some information should not be integrated, the System raises ethical considerations about privacy. CONCLUSION: Among the doctors surveyed here, 10-30% thought the System was unnecessary. These respondents tended to be older and work at a clinic. The System could decrease the cost of healthcare and enable personalized healthcare but could also increase information leakage and information management, cause over-monitoring of doctors, and enable the inappropriate use of integrated information. Prior to System introduction, we should facilitate consensus-building about protecting and utilizing personal information as well as consider the related ethical issues, and doctors' characteristics and concerns.

Cost-Effectiveness of Proton Pump Inhibitor Co-Therapy in Patients Taking Aspirin for Secondary Prevention of Ischemic Stroke.

BACKGROUND: Low-dose aspirin (ASA) is effective for secondary prevention of ischemic stroke but can increase the risks of hemorrhagic stroke, upper gastrointestinal bleeding (UGIB), and dyspepsia. Prophylactic administration of proton pump inhibitors (PPIs) reduces the risks of these digestive symptoms. We investigated the cost effectiveness of adding a PPI to ASA therapy for ischemic stroke patients in Japan. METHODS: A Markov state-transition model was developed to compare the cost effectiveness of ASA monotherapy with ASA plus PPI co-therapy in patients with histories of upper gastrointestinal ulcers and ischemic stroke. The model takes into account ASA adherence rate and adverse effects due to ASA, including hemorrhagic stroke and UGIB. The analysis was performed from the perspective of healthcare payers in 2013. RESULTS: In the base case, total life-years by PPI co-therapy and monotherapy were 16.005 and 15.932, respectively. The difference in duration of no therapy (no ASA or PPI) between the therapies was 558.5 days, which would prevent 30.3 recurrences of ischemic stroke per 1000 person-years. The incremental cost-effectiveness ratio of PPI co-therapy relative to monotherapy was ¥1,191,665 (US$11,458) per life-year gained. In a one-way sensitivity analysis, PPI co-therapy was consistently cost effective at a willingness to pay of ¥5,000,000 (US$48,077) per life-year gained. In a probabilistic sensitivity analysis, the probability that PPI co-therapy was cost effective was 89.74% at the willingness to pay. CONCLUSIONS: Co-therapy with ASA plus PPI appears to be cost-effective compared with ASA monotherapy. The addition of PPI also appeared to prolong the duration of ASA therapy, thereby reducing the risk of ischemic stroke.