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Background The quality of care received by a growing number of older patients with chronic kidney disease (CKD) has not been adequately examined. Objective The objective of this study was to assess the quality of CKD care among older patients and to clarify its association with the incidence of end-stage renal disease (ESRD). Research design This was a population-based cohort study. Subjects Older (65 y and above) CKD patients diagnosed between October 2010 and September 2014 from the National Database of Health Insurance Claims of Japan. Measures A composite quality score (QS) of 3 quality measures for CKD care during the 6 months after CKD diagnosis was computed. The validated quality measures included urine testing for proteinuria, nutritional guidance, and nonsteroidal anti-inflammatory drugs avoidance. To assess the association between the QS and ESRD incidence, we used instrumental variable analysis after stratification for the history of diabetes. Results Among the 890,773 older CKD patients, 2.9% progressed to ESRD (incidence rate of 12.5 per thousand person-years). In total, 59.9% underwent urine testing, 4.5% received nutritional guidance, and 91.2% avoided regular use of nonsteroidal anti-inflammatory drugs. An instrumental variable analysis revealed that a higher QS was associated with-lower ESRD incidence in patients diagnosed with diabetes (hazard ratio: 0.25, 95% confidence interval: 0.24-0.27 for each point higher score) but not in patients without a diagnosis of diabetes (hazard ratio: 0.99, 95% confidence interval: 0.92-1.05). Conclusion Among older CKD patients, quality of CKD care varied between patients, and better quality of CKD care was associated with a lower ESRD incidence in patients with diabetes but not in nondiabetic patients.

Background and Purpose— In Japan, nearly half of ischemic stroke patients receive edaravone for acute treatment. The purpose of this study was to assess the effect of edaravone on neurological symptoms in patients with ischemic stroke stratified by stroke subtype. Methods— Study subjects were 61 048 patients aged 18 years or older who were hospitalized ≤14 days after onset of an acute ischemic stroke and were registered in the Japan Stroke Data Bank, a hospital-based multicenter stroke registration database, between June 2001 and July 2013. Patients were stratified according to ischemic stroke subtype (large-artery atherosclerosis, cardioembolism, small-vessel occlusion, and cryptogenic/undetermined) and then divided into 2 groups (edaravone-treated and no edaravone). Neurological symptoms were evaluated using the National Institutes of Health Stroke Scale (NIHSS). The primary outcome was changed in neurological symptoms during the hospital stay (ΔNIHSS=NIHSS score at discharge−NIHSS score at admission). Data were analyzed using multivariate linear regression with inverse probability of treatment weighting after adjusting for the following confounding factors: age, gender, and systolic and diastolic blood pressure at the start of treatment, NIHSS score at admission, time from stroke onset to hospital admission, infarct size, comorbidities, concomitant medication, clinical department, history of smoking, alcohol consumption, and history of stroke. Results— After adjusting for potential confounders, the improvement in NIHSS score from admission to discharge was greater in the edaravone-treated group than in the no edaravone group for all ischemic stroke subtypes (mean [95% CI] difference in ΔNIHSS: −0.46 [−0.75 to −0.16] for large-artery atherosclerosis, −0.64 [−1.09 to −0.2] for cardioembolism, and −0.25 [−0.4 to −0.09] for small-vessel occlusion). Conclusions— For any ischemic stroke subtype, edaravone use (compared with no use) was associated with a greater improvement in neurological symptoms, although the difference was small (

OBJECTIVE To develop and validate a scoring system for selection of patients who should proceed to endocrinologic examinations of primary aldosteronism in newly diagnosed hypertensive patients. METHODS A multivariate logistic regression analysis for primary aldosteronism was undertaken by use of seven possible primary aldosteronism markers, age less than 40 years, female sex, moderate-to-severe hypertension, hypokalemia, serum Na minus Cl at least 40 mmol/l, serum uric acid 237.92 μmol/l or less (4.0 mg/dl), and urine pH (U-pH) at least 7.0, in consecutive outpatients newly diagnosed with hypertension. The diagnostic criteria of primary aldosteronism were plasma aldosterone concentration-to-plasma renin activity ratio [ARR, (ng/dl)/(ng/ml per h)] at least 20 and at least one positive result in four types of challenge tests. RESULTS Of 130 patients, 24 were diagnosed with primary aldosteronism. The area under the receiver operating characteristic curve (AUC) for a logistic model incorporating all possible primary aldosteronism markers was 0.73 [95% confidence interval (CI): 0.61-0.85]. Removing high U-pH, female sex, and hypokalemia from the full model decreased the AUC by 0.059, 0.035, and 0.011, respectively. We devised pH of urine, female sex, low serum K (PFK) score, in which one point each was assigned to high U-pH, female sex, and hypokalemia. The prevalences of primary aldosteronism in patients with 0, 1, 2, and 3 points were 11, 14, 42, and 60%, respectively. In external validation datasets (n = 106), AUC of PFK score was significantly higher than that of hypokalemia alone (0.73, 95% CI: 0.63-0.83 vs. 0.53, 95% CI: 0.44-0.63, P

Pancreatectomy is an invasive surgery that is sometimes associated with complications. New-onset diabetes mellitus sometimes develops after partial pancreatectomy and severely affects the patient's quality of life. This study aimed to develop a preoperative prediction model of new-onset diabetes mellitus after partial pancreatectomy, which will help patients and surgeons to achieve more easily better common decisions on regarding whether to perform partial pancreatectomy. This retrospective cohort study analyzed medical records of patients who underwent partial pancreatectomy (total pancreatectomy excluded) from April 1, 2008, to February 28, 2016, which were available in the database provided by Medical Data Vision Co., Ltd. (Tokyo, Japan). The predictors were preoperative age, body mass index, hemoglobin A1c level, blood glucose level, and indication for partial pancreatectomy. The outcome was the development of new-onset diabetes mellitus at 1 to 12 months after partial pancreatectomy. We used a logistic regression model and calculated the scores of each predictor. To determine test performance, we assessed discrimination ability using the receiver operating characteristic curve and calibration with a calibration plot and the Hosmer-Lemeshow test. We also performed internal validation using the bootstrap method. Of 681 patients, 125 (18.4%) had new-onset diabetes mellitus after partial pancreatectomy. The developed prediction model had a possible range of 0 to 46 points. The median score was 13, and the interquartile range was 9 to 22. The C-statistics of the receiver operating characteristic curve on the score to predict the outcome was .70 (95% confidence interval [CI], .65-.75). Regarding the test performance, the Hosmer-Lemeshow test was not significant (P = .17), and calibration was good. In the bootstrapped cohorts, the C-statistics was .69 (95% CI, .62-.76). We developed a preoperative prediction model for new-onset diabetes mellitus after partial pancreatectomy. This would provide important information for surgeons and patients when deciding whether to perform partial pancreatectomy.

Background Postgastrectomy or esophagectomy symptoms can be a significant burden for patients. However, no standard scale for evaluating these symptoms has been established. We recently developed a postoperative symptom-specific scale. Study Design After a draft scale was prepared based on a pilot study, psychometric methods were used to assess its reliability and validity. This study involved specialized and multifaceted discussions by a team consisting of gastrointestinal surgeons, gastroenterologists, psychologists, and epidemiologic researchers. The draft questionnaire included 40 questions and 3 domains. A factor analysis was carried out to refine the items and subscale design. To assess the reliability, Cronbach's alpha and score distributions were estimated. To assess the criterion-related validity, the correlations with the Short Form (SF)-12, Gastrointestinal Symptom Rating Scale (GSRS), endoscopic findings, and nutritional indicators were analyzed. Results A total of 344 patients were enrolled in this study. In an exploratory factor analysis (principal factor method), the eigenvalue attenuation data showed 4 domains. The final scale, named the Esophagus and Stomach Surgery Symptom Scale (ES 4 ), included 23 items and 4 domains; 7 items for cervico-thoracic symptoms, 6 for abdominal hypersensitivity symptoms, 4 for abdominal distention symptoms, and 6 items for systemic symptoms. Cronbach's alphas for these domains were 0.82, 0.81, 0.79, and 0.74, respectively. The scale scores were normally distributed, and there were significant associations with the endoscopic findings, nutritional indicators, the summary score of the SF-12, and the GSRS. Conclusions The ES 4 scale has high psychometric validity and can evaluate the profiles and severity of postoperative symptoms. This scale is applicable as an outcomes measure for various interventional studies on esophagogastric surgery aimed at alleviating postoperative symptoms.

The aims of this study were to investigate the long-term effects of living donor liver transplantation (LDLT) on the health-related quality of life (HRQOL) of donors with the Short Form 36 health survey and to determine the risk factors for poor outcomes. Between June 1990 and June 2004, LDLT was performed 1000 times at Kyoto University Hospital. In July 2005, 997 of the 1000 donors were contacted by mail so that data on their HRQOL could be collected. In all, 578 donors responded (ie, there was a 58.0% response rate). The norm-based HRQOL scores for donors were better than the scores for Japanese norms across all time periods. All scores were similar for left lobe donors (n = 367) and right lobe donors (n = 211). For all donors, a multivariate logistic regression analysis revealed that age, the number of months until recovery to the preoperative health status, hospital visits due to donation-related symptoms, rest from work related to donation in the past month, and the existence of 2 or more comorbidities were significantly associated with decreased HRQOL scores. Postoperative complications and recipient mortality were not predictors of poor HRQOL. In conclusion, HRQOL was better for both right lobe donors and left lobe donors versus the Japanese norm population in the long term (mean postdonation period = 6.8 years). However, the prolongation of symptoms or sequelae related to donation lowered mental health or social functioning. The emergence of comorbidities after donation also significantly affected HRQOL in the long term. Careful follow-up and sustained counseling are required for donors with risk factors for lower HRQOL.

Prescription patterns for hemodialysis patients with secondary hyperparathyroidism have varied widely since market introduction of cinacalcet. This study examined associations between prescription patterns and subsequent laboratory values.Using a Mineral and Bone Disorder Outcomes Study for Japanese CKD Stage 5D Patients subcohort, 1716 prevalent hemodialysis patients (4048 sets for repeated measures between January 2008 and July 2009) with an intact parathyroid hormone (iPTH) level180 pg/ml who used intravenous vitamin D receptor activator (VDRA) without cinacalcet were selected. Prescription patterns were defined based on cinacalcet administration (starting or not) and VDRA dosage change (decreased [-25%], stable [-25% to 25%], or increased [25%]). Proportion differences (PDs) were determined for decreasing iPTH levels by at least one category (180, 180-299, 300-499, and ≥500 pg/ml) and for achieving target phosphorus (3.5-6.0 mg/dl) and calcium (8.4-10.0 mg/dl) levels, adjusting for potential confounders.The starting cinacalcet and increased VDRA patterns were associated with decreasing iPTH levels (PD, 0.25 and 0.13; 95% confidence intervals [95% CIs], 0.19-0.31 and 0.09-0.17, respectively); combination use had an additive association (PD, 0.34; 95% CI, 0.20-0.42). The starting cinacalcet and decreased VDRA combination was associated with simultaneously achieving target phosphorus (PD, 0.12; 95% CI: 0.04-0.20) and calcium (PD, 0.09; 95% CI, 0.01-0.17) levels.Certain combinations of cinacalcet and VDRA were associated with decreasing iPTH and achieving targets for phosphorus and calcium. Combinations may prove advantageous versus VDRA alone in managing secondary hyperparathyroidism.

Study design Cross-sectional survey. OBJECTIVE.: To investigate the relationship between low back pain (LBP) and metabolic syndrome (Mets) in community-based Japanese subjects. SUMMARY OF BACKGROUND DATA.: Relatively few reports have demonstrated a relationship between general pain and Mets, and none have addressed the relationship between LBP and Mets. Methods This study enrolled 2650 people from among residents aged 40 to 74 years in Tadami and Minamiaizu, Fukushima, Japan, who participated in health checkups conducted in 2008. LBP was defined as lower back pain continuing for more than 24 hours and severe enough to merit treatment, or it was based on clinical prediction rules from the clinical diagnosis support tool to identify patients with lumbar spinal stenosis. Mets was defined according to the Japanese criteria recommended by the Japanese Society of Internal Medicine. Prevalence of Mets was recorded for subjects with and without LBP. The relationship between LBP and Mets was investigated, using a generalized linear model. With LBP as the main explanatory variable and Mets as the outcome variable, risk ratios of Mets were calculated for men and women. Results In this study, we analyzed a total of 1395 subjects. In men, the prevalence of Mets was 21.2% in those without LBP and 24.7% in those with LBP. In women, the prevalence of Mets was 12.4% in those without LBP and 23.7% in those with LBP. After adjusting for factors such as age, body mass index, occupational status, SF-36 mental health, and physical activity level, no relationship was noted between LBP and Mets in men. However, in women, the risk ratio for Mets in subjects with LBP compared with those without LBP was 1.5 (95% confidence interval, 1.0-2.1). Conclusion We observed a tendency toward higher prevalence of Mets among those with LBP than among those without it in women, but not in men.

Control of serum concentrations of calcium (Ca), phosphorus (P), and parathyroid hormone (PTH) is essential for management of secondary hyperparathyroidism (SHPT).This is a planned interim analysis of a longitudinal cohort study. The settings are dialysis facilities in Japan. Eligible patients comprise all those who were receiving hemodialysis at one of 86 participating facilities and who have SHPT. Using data from a random sample (n = 3276) of the participants from January 2008 through June 2009, we measured changes in the percentages of patients who were within the national guideline-specified target ranges of Ca (8.4 to 10 mg/dl), P (3.5 to 6.0 mg/dl), and intact PTH (iPTH) (60 to 180 pg/ml), and changes in prescriptions of drugs targeting SHPT. We used regression models to identify factors affecting the achievement of the guideline-specified targets.There were no notable changes in the percentage of patients who were within the guideline for Ca, P, or both. The percentage who were within the iPTH guideline increased from 14.5% to 43.3% (P0.001). There were no remarkable changes in the percentage of patients receiving vitamin D or phosphate binders. The percentage who received cinacalcet increased from 0% to 29%. Prescription of cinacalcet was associated with improvement or target-achievement for iPTH and for Ca by 16.8 percentage points (95% CI: 8.1 to 17.0) and by 12.6 percentage points (13.7 to 19.9), respectively.In the routine care of hemodialysis patients, increasing use of cinacalcet was associated with better control of SHPT.

The aim of this study was to evaluate the relation between pre-nephrology visit (PNV) and 1-yr patient survival after hemodialysis (HD) induction.Data were analyzed from 8500 incident HD patients (on HDor=30 d) in the Dialysis Outcomes and Practice Patterns Study (DOPPS) phases I and II. A visit to a nephrologist at least 1 mo before starting HD was regarded as PNV. Cox regression was used to estimate the adjusted hazard ratio (AHR) for mortality in the first year of HD in both patient- and facility-level analyses. All models were adjusted for age, sex, race, socioeconomic factors, cause of ESRD, 14 comorbid conditions, hemoglobin, serum albumin, and serum creatinine; accounted for facility clustering effects; and were stratified by country.In patient-level analysis, PNV was associated with significantly lower risk for death (AHR 0.57; P0.0001). Facility-level analysis also showed a significant lower risk for death in facilities with greater prevalence of PNV in both continuous models (AHR 0.92 per 10% greater facility mean %PNV; P0.0004) and in categorical models (AHR 0.71 for facilities with90% of patients receiving PNV [first quartile] compared with facilities with71% of patients receiving PNV [fourth quartile]; P = 0.001).These results provide not only patient-level but also facility practice evidence that PNV is related to improved patient survival during the first year after initiation of HD, indicating the possible mortality benefits with more increased attention to PNV.

Objectives Given that persons with a stronger belief in internal health locus of control (HLC) have been shown to comply well with medical advice, HLC internality may play an important role in low-back pain (LBP) prevention and management because it requires the patient's own commitment. Previous studies in conditions other than LBP have shown that the use of complementary and alternative medicine (CAM) is associated with high HLC internality. Here, we examined the relationship between CAM facility visits and internality of HLC in persons with LBP. Methods We analyzed the data from the Health Diary Study, which surveyed the health-related behavior of 3477 persons sampled from the general population of Japan. Among 2377 participants aged 18 to 75 years, 673 reported LBP during the study period. We examined CAM facility visits and HLC among 81 previously untreated LBP patients who sought care from western medical doctors or CAM providers during the 1-month study period. Results Of the 81 patients, 40 reported at least 1 CAM visit, whereas 41 visited western medical doctors only. Participants who visited CAM facilities had a higher internality score than those who visited western medical doctors after controlling for age, sex, size of residential city, and bodily pain score of the Short Form-8 Health Survey scale. Discussion Visitors to CAM facilities had a stronger belief in internal HLC. This finding suggests that visitors to CAM facilities are more sensitive to educational intervention for the self-management of LBP than those who visit western medicine. In order not to miss the opportunity of reaching these patients, the education should be more emphasized on CAM facilities.

We evaluated the correspondence between UCLA PCI and the Extended Prostate Cancer Index Composite for Japanese patients with localized prostate cancer.A total of 385 patients treated with retropubic radical prostatectomy, external beam radiation, hormonal therapy or select watchful waiting from 2002 to 2006 were enrolled. For this study we used equipercentile linking, a technique that identifies scores on the 2 measures that have the same percentile rank.Urinary and sexual functions showed a strong correlation (r = 0.85 and 0.93, respectively, p0.0001). In contrast, the correlation for bowel function was relatively weak (r = 0.47, p0.0001). The correlations of each Extended Prostate Cancer Index Composite bother domain with UCLA PCI were 0.6 (p0.0001). The linking between each scale of the Extended Prostate Cancer Index Composite and UCLA PCI domains showed that an Extended Prostate Cancer Index Composite urinary function score of 73 was equivalent to a UCLA PCI score of 60. With regard to urinary bother an Extended Prostate Cancer Index Composite score of 69 to 84 was equivalent to a UCLA PCI score of 75. A sexual function score of 18 on UCLA PCI corresponded to an Extended Prostate Cancer Index Composite score of 12 and a sexual bother score of 50 on UCLA PCI corresponded to an Extended Prostate Cancer Index Composite score of 56 to 88.The urinary and sexual domains of UCLA PCI and the Extended Prostate Cancer Index Composite showed strong correlations. In contrast, the correlation for the bowel domain was relatively weak. The results of the linking analysis between UCLA PCI and the Extended Prostate Cancer Index Composite may have implications useful for their interpretation.

Objectives Effective treatment of obstructive sleep apnoea (OSA) with nasal continuous positive airway pressure (nCPAP) lowers blood pressure (BP). The long-term effects of nCPAP treatment on BP in OSA patients are not well known. The time period of such treatment sufficient to lower BP in OSA patients is also not known. We investigated compliance with long-term nCPAP therapy and its effects on BP. Methods This observational study involved 66 OSA patients [59 men, seven women; mean age, 51 (48-54) years; body mass index (BMI), 28.7 (27.7-29.7) kg/m 2 ; apnoea and hypopnoea, 50.3 (45.6-55.0)/h; 95% confidence intervals]. BP and BMI were measured before the study and at two checkpoints after usage of nCPAP [620 (552-688) and 1071 (1000-1143) days]. Results The different times between the first and second checkpoints for detecting objective compliance were 17 (4-30) min (P = 0.003). Diastolic BP decreased by 5.9 (3.1 -8.7) mmHg after 600 days nCPAP treatment and by 4.6 (2.0-7.2) mmHg after 1000 days (P = 0.0006). Systolic BP and BMI did not change significantly. Usage of nCPAP treatment for a daily average of 3 h was needed to achieve a significant decrease in diastolic BP [7.4 (4.3-10.6) mmHg, P< 0.0001]. Diastolic BP of normotensive OSA patients did not change significantly by nCPAP treatment, but that of hypertensive OSA patients decreased significantly within 1 month-3 years of nCPAP treatment whether or not medication was used. Conclusions In patients with severe OSA, the use of nCPAP for a daily average of 3 h would be sufficient to decrease the diastolic BP of hypertensive OSA patients.

Study design: Survey of a random sample of all registered residents of Japan between the ages of 20 and 79 years (n = 2966), focusing on those who had had low back pain (LBP) within the past month (n = 906). Objective: To learn more about the characteristics of people in whom the severity of LBP and the disability attributed to that pain are discrepant. Summary of background data: LBP can cause disability, but levels of pain and of disability can be discrepant. Some people with severe pain are only slightly disabled, some with mild pain are very disabled, and others have no such discrepancy. METHODS.: Severity of LBP was measured with a visual analog scale. Disability was measured with the Roland-Morris Disability Questionnaire, which quantifies disability in many daily activities, not necessarily disability related to employment. The respondents also provided demographic information, and completed the SF-36 and questionnaires about perceived stress, employment, and satisfaction with employment. Results: In about 45% of those patients with LBP, the severity of the pain and level of disability attributed to that pain were discrepant. People with a high level of disability despite only mild pain were older, felt more stress, were more depressed, worked more overtime, and were less satisfied with their job content, income, working conditions, and relationships with coworkers. People with little disability despite severe pain were the opposite in all those respects. Conclusions: A group of patients with LBP can be identified for whom the most appropriate interventions should consider psychosocial factors.

Background This study had four goals: (1) to evaluate an index of health-related quality of life (HQOL) among renal-transplant recipients in Japan, (2) to compare HQOL of renal-transplant recipients with that of the Japanese population as a whole, and (3,4) to study associations of HQOL with renal function and with the time since transplantation. Methods Questionnaires were distributed to 570 subjects. All were outpatients, were 16 years old or older, and were studied at least 1 year after they had received their latest renal transplant. HQOL was assessed with the Short Form 36-item health survey. Subjects' physicians provided data on renal function. Associations of HQOL with serum creatinine concentration and with the time since transplantation were evaluated by logistic regression. Results The response rate was 83%. Data from patients with diabetes and from those who had had at least two renal transplants were excluded; data from 395 recipients were analyzed. On the physical functioning, general health perception, vitality, and social functioning scales, the patients' scores were significantly lower than the Japanese national-norm scores. General health perception was particularly low. Serum creatinine concentrations were associated with general health perception, vitality, and social functioning. Longer times since transplantation were associated with better social functioning. Conclusions Although social and physical functioning may improve after transplant surgery, a low self-rating of general health seemed to remain. The rarity of renal transplantation in Japan and other psychosocial factors may explain the low self-rating of general health in Japanese renal-transplant recipients.

Objective : To evaluate the effectiveness of CPR prior to electrical shock stratified by the duration from ambulance call to CPR in witnessed out-of-hospital cardiac arrest patients with VF. Study Design : Population-based observational study (May 1, 1998–December 31, 2006). Settings : Osaka, Japan with a population of 8.8 million. Subjects : We analyzed the Utstein Style data on patients who met the following inclusion criteria: witnessed by citizens, 18 years or older, initial recorded cardiac rhythm was VF or pulseless VT, bystander CPR was not performed. Methods : Subjects were divided into three groups according to the duration from the initiation of CPR by ambulance personnel to first electrical shock; immediate shock group: first electrical shock were given in 0–1 minute after CPR was initiated; 2–3 min delayed group: first electrical shock were given in 2–3 minutes after CPR initiated; and ≥4 min delayed group: first electrical shock were given in more than 4 minutes. Main outcome measure : Survival at one month. Results : 909 patients were included in the current analysis. In immediate shock group, survival at one month decreased with an increase in interval between ambulance call and the initiation of CPR. In contrast, 2–3 min delayed group had better prognosis than immediate shock group if CPR was initiated between 8–9 minutes after ambulance call (13% vs. 27% of one month survival; OR 2.50; 95% CI. 1.02–6.00; P=0.045). Conclusion : Our findings suggested that 2–3 minute-delayed electrical shock was associated with better prognosis compared with immediate electrical shock if CPR by ambulance personnel was initiated in 8–9 minutes from ambulance call.