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AbstractObjectives:To assess the impact of nationwide outpatient antimicrobial stewardship interventions in the form of financial incentives for providers and provider education when antimicrobials are deemed unnecessary for uncomplicated respiratory infections and acute diarrhea.Methods:We collected data from a large claims database from April 2013 through March 2020 and performed a quasi-experimental, interrupted time-series analysis. The outcome of interest was oral antimicrobial prescription rate defined as the number of monthly antimicrobial prescriptions divided by the number of outpatient visits each month. We examined the effects of financial incentive to providers (ie, targeted prescriptions for those aged ≤2 years) and provider education (ie, targeted prescriptions for those aged ≥6 years) on the overall antimicrobial prescription rates and how these interventions affected different age groups before and after their implementation.Results:In total, 21,647,080 oral antimicrobials were prescribed to 2,920,381 unique outpatients during the study period. At baseline, prescription rates for all age groups followed a downward trend throughout the study period. Immediately after the financial incentive implementation, substantial reductions in prescription rates were observed among only those aged 0–2 years (−47.5 prescriptions per 1,000 clinic visits each month; 95% confidence interval, −77.3 to −17.6; P= .003), whereas provider education immediately reduced prescription rates in all age groups uniformly. These interventions did not affect the long-term trend for any age group.Conclusion:These results suggest that the nationwide implementation of financial incentives and provider education had an immediate effect on the antimicrobial prescription but no long-term effect.

Background: Chronic prostatitis (CP) can impair health-related quality of life (QOL), but the full impact of CP, including the impact of CP-like symptoms in men who have no CP diagnosis (CPS), is unknown. We estimated the impact of diagnosed CP (DCP) and CPS on Health-related QOL. Methods: From a representative nationwide survey of men aged 20–84 in Japan, we determined the prevalence of DCP and also of CPS. For CPS, we used Nickel’s criteria, which were used previously to estimate the prevalence of CP and are based on the NIH Chronic Prostatitis Symptom Index. To test the robustness of Nickel’s criteria, we used two other definitions of CPS (two sensitivity analyses). We measured QOL with the Short-Form 12-Item Health Survey. We compared the participants’ QOL scores with the national-norm scores, and with the scores of men who had benign prostatic hyperplasia (BPH). Results: Among the 5 010 participants, 1.4% had DCP and 3.7% had CPS. The sensitivity analyses resulted in CPS prevalence estimates of 3.1% and 4.5%. CPS was particularly common in younger participants (5.7% of those in their 30 s had CPS). QOL was very low among men with CP: In most areas (domains) of QOL, their scores were more than 0.5 standard deviation below the national-norm mean. Their mental-health scores were lower than those of men with BPH. The lowest scores among all 8 QOL domains were in role-functioning. Conclusions: CP is common, but it is underdiagnosed, particularly in younger men. Whether diagnosed or only suspected, CP’s impact on QOL is large. Because CP is common, and because it substantially impairs individuals’ QOL and can also reduce societal productivity, it requires more attention. Specifically, needed now is a simple tool for urologists and for primary care providers, to identify men, particularly young men, whose QOL is impaired by CP.

Background: Although respiratory rate has been a sensitive predictor for prognosis in acute settings, resting respiratory rate (RRR) is undervalued in chronic care. The clinical significance of RRR among older people is not well documented. Aim: We investigated the association between RRR and all-cause mortality among older outpatients. Methods: A retrospective cohort study exhaustively included patients who had undergone medical checkups in a facility between April 2017 and March 2018 and followed up for at least 2 years. We excluded patients who were less than 60 years of age or had not undergone regular outpatient appointments. Sex, age, smoking habits, history of hospitalization, polypharmacy, long-term care insurance certification status, Mazzaglia index, pulse rate, systolic blood pressure, and Charlson Comorbidity Index were measured at the baseline medical checkup. Survival was confirmed by chart review and by contacting physicians in charge. The risk ratios were estimated by converting the odds ratios derived from the multivariable logistic regression models. Results: Of the 853 patients who underwent baseline checkups, 749 were enrolled in the analyses; death occurred in 53 patients (7.1%), with no loss to follow-up. The RRR was independently associated with all-cause mortality after adjusting for covariates [adjusted risk ratio of RRR per 1 bpm = 1.14, 95% confidence interval (CI): 1.06 − 1.22]. Discussion: Given the independent association of RRR for existing predictors, this simple index seems worthy of consideration in further studies aimed at defining its predictive role in older people and in different settings. Conclusion: RRR was independently associated with all-cause mortality.

This study aimed to evaluate the influence of advanced glycation end-product (AGE) accumulation on the prevalence and severity of overactive bladder (OAB) in community-dwelling elderly adults.

The aim of this study is to characterize health related quality of life (HRQOL) in Japanese patients after bladder cancer surgery and to perform cross-cultural comparison between Japanese and American patients. Firstly, we cross-sectionally assessed HRQOL of 371 patients in Japan using the Bladder Cancer Index (BCI-Japanese). HRQOL of the four groups of patients (native bladder without intravesical therapy, native bladder with intravesical therapy, cystectomy with ileal conduit, and cystectomy with neobladder) were assessed. Secondly, we compared the Japanese with the American cohort (n = 315) from the original BCI paper. After adjusting for age and gender, the differences in each BCI subdomain score was analyzed. Among Japanese patients, the urinary domain function score was significantly lower among the cystectomy with neobladder group, compared to the cystectomy with ileal conduit group (p < 0. 01). Despite this, the urinary bother was comparable between the two groups. Although there were apparent differences between Japanese and American patients, there were few differences in Urinary and Bowel HRQOL. In three of the four treatment groups (other than native bladder with intravesical therapy), Japanese patients were more likely than Americans to report poor sexual function (p < 0.05). However, Japanese patients were less likely than Americans to be bothered by their lower sexual function, regardless of treatment (p < 0.05). HRQOL outcomes following treatment of bladder cancer in Japan are comparable to those in the USA, except for sexual functioning and sexual bother. The BCI can be used for cross-cultural assessments of HRQOL in bladder cancer patients.

Purpose: There is a paucity of data on the effect of intraoperative end-tidal carbon dioxide (EtCO2) levels on postoperative mortality. The purpose of this study was to investigate the relationship between intraoperative EtCO2and 90-day mortality in patients undergoing major abdominal surgery under general anesthesia. Methods: We conducted a historical cohort study of patients undergoing major abdominal surgery under general anesthesia at Kyoto University Hospital. We measured the intraoperative EtCO2, and patients with a mean EtCO2value &lt; 35 mm Hg were classified as low EtCO2. The time effect was determined based on minutes below an EtCO2of 35 mm Hg, and cumulative effects were evaluated by measuring the area under the threshold of 35 mm Hg for each patient. Results: Of 4,710 patients, 1,374 (29%) had low EtCO2and 55 (1.2%) died within 90 days of surgery. Multivariable Cox regression analysis—adjusted for age, American Society of Anesthesiologists Physical Status classification, sex, laparoscopic surgery, emergency surgery, blood loss, mean arterial pressure, duration of surgery, type of surgery, and chronic obstructive pulmonary disease—revealed an association between low EtCO2and 90-day mortality (adjusted hazard ratio, 2.2; 95% confidence interval [CI], 1.2 to 3.8; P= 0.006). In addition, severity of low EtCO2was associated with an increased 90-day mortality (area under the threshold; adjusted hazard ratio; 2.9, 95% CI, 1.2 to 7.4; P=0.02); for long-term exposure to an EtCO2&lt; 35 mm Hg (≥ 226 min), the adjusted hazard ratio for increased 90-day mortality was 2.3 (95% CI, 0.9 to 6.0; P= 0.08). Conclusion: A mean intraoperative EtCO2&lt; 35 mm Hg was associated with increased postoperative 90-day mortality.

Background: To evaluate the diagnostic accuracy and clinical utility of the acute aortic dissection detection risk score (ADD-RS) alone or with D-dimer as a screening test to exclude acute aortic syndrome.Methods: We conducted a systematic review and meta-analysis of studies examining the diagnostic accuracy of ADD-RS. We searched MEDLINE, Embase and Cochrane Controlled Register of Trials up to 12 December 2018.Results: We identified nine studies involving 26,598 patients for ADD-RS alone and 3421 patients with D-dimer. Overall, the methodological quality based on the Quality Assessment of Diagnostic Accuracy Studies 2 was moderate to high. Bivariate meta-analyses showed that the pooled sensitivities were 0.94 (95% confidence interval (CI) 0.90, 0.96) at the threshold of ADD-RS ≥1, 0.46 (95% CI, 0.34, 0.59) at ADD-RS ≥2, 1.00 (95% CI 0.99, 1.00) at ADD-RS ≥1 with D-dimer and 0.99 (95% CI 0.97, 1.00) at ADD-RS ≥2 with D-dimer. For the low prevalence population, failure rate and efficiency were 0.8% and 38.3% at ADD-RS ≥1, 0.03% and 14.5% at ADD-RS ≥1 with D-dimer, and 0.1% and 33.6% at ADD-RS ≥2 with D-dimer, respectively. For the high prevalence population, failure rate and efficiency were 3.8% and 33.3% at ADD-RS ≥1, 0.2% and 12.3% at ADD-RS ≥1 with D-dimer and 0.6% and 28.4% at ADD-RS ≥2 with D-dimer, respectively.Conclusions: ADD-RS alone or with D-dimer was a useful screening test with high sensitivity to exclude acute aortic syndrome. However, the optimal threshold of ADD-RS alone or with D-dimer may depend on the clinical setting.

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Introduction:Patients undergoing hemodialysis (HD) have higher predialysis plasma osmolality. Several studies have suggested lower osmolality to be associated with worse outcomes in patients not undergoing HD. However, no studies have examined the association between osmolality and mortality among patients undergoing HD. Objective:We aimed to examine the association between predialysis plasma calculated osmolality and all-cause mortality. Methods:This was a prospective cohort study of 1,240 patients undergoing HD participating in the Japanese Dialysis Outcomes and Practice Patterns Study phase 5 (2012–2015). The exposure was predialysis plasma osmolality, calculated as 2 × (serum sodium concentration [mmol/L]) + (serum urea nitrogen [mg/dL])/2.8 + (serum glucose [mg/dL])/18. The primary outcome was all-cause mortality. The secondary outcome was the change in systolic blood pressure (SBP) during HD. We used a marginal structural model with stabilized weights to estimate the association between calculated osmolality and all-cause mortality in the presence of time-varying confounders affected by prior exposure. Results:Mean baseline plasma calculated osmolality was 306.8 ± 8.6 mOsm/kg. Low predialysis calculated osmolality was associated with higher mortality (adjusted hazard ratio 1.52, 95% confidence interval [CI]: 1.30–1.78 by each 10 mOsm/L lower osmolality). The association was consistent across clinically relevant subgroups. Predialysis osmolality was significantly associated with intradialytic SBP change (mean difference 0.96 [95% CI: 0.05–1.88] mm Hg per each 10 mOsm/L lower osmolality). Conclusions:Low predialysis calculated osmolality was an independent risk factor of all-cause mortality.

Prior observational studies suggest an association between intra-pancreatic fat deposition (IPFD) and pancreatic ductal adenocarcinoma (PDAC); however, the causal relationship is unclear. To elucidate causality, we conduct a prospective observational study using magnetic resonance imaging (MRI)-measured IPFD data and also perform a Mendelian randomization study using genetic instruments for IPFD. In the observational study, we use UK Biobank data (N = 29,463, median follow-up: 4.5 years) and find that high IPFD (>10%) is associated with PDAC risk (adjusted hazard ratio [HR]: 3.35, 95% confidence interval [95% CI]: 1.60–7.00). In the Mendelian randomization study, we leverage eight out of nine IPFD-associated genetic variants (p < 5 × 10−8) from a genome-wide association study in the UK Biobank (N = 25,617) and find that genetically determined IPFD is associated with PDAC (odds ratio [OR] per 1-standard deviation [SD] increase in IPFD: 2.46, 95% CI: 1.38–4.40) in the Pancreatic Cancer Cohort Consortium I, II, III (PanScan I-III)/Pancreatic Cancer Case-Control Consortium (PanC4) dataset (8,275 PDAC cases and 6,723 non-cases). This study provides evidence for a potential causal role of IPFD in the pathogenesis of PDAC. Thus, reducing IPFD may lower PDAC risk.

Background:Hemodialysis (HD) patients occasionally experience minor asymptomatic elevation in C-reactive protein (CRP) levels, which may be associated with difficulty in managing renal anemia using erythropoiesis-stimulating agents (ESAs). Here, we assessed whether elevation of CRP predicts future incidences of ESA hyporesponsiveness. Methods:A total of 2,956 HD patients lacking ESA hyporesponsiveness and infectious diseases were enrolled, and the association between CRP levels and incidence of ESA hyporesponsiveness was assessed. CRP levels were divided into 4 categories (normal [<1.0 mg/l], mild [1.0= CRP <3.0 mg/l], moderate [3.0= CRP <10.0 mg/l] and high [=10.0 mg/l]). The primary outcome was the cumulative incidence of ESA hyporesponsiveness, defined as a failure to achieve hemoglobin level =10 g/dl despite receiving high doses of ESAs (=9,000 U/week recombinant human epoetin [rHuEPO]-a or rHuEPO-ß and =60 µg/week darbepoetin-a) during 12 months of follow-up. Results:The cumulative incidence of ESA hyporesponsiveness was 134 (4.8%) occurrences over 4 months and 300 (12.4%) over 12 months. The elevated CRP groups had significantly higher incidence of ESA hyporesponsiveness over 4 months of follow-up than the normal reference group (adjusted relative risk [RR] 1.6, 95% CI 1.0-2.6 for moderate; adjusted RR 2.5, 95% CI 1.5-4.1 for high). Furthermore, the association remained consistent even over 12 months (adjusted RR 1.4, 95% CI 1.0-1.8 for moderate; adjusted RR 1.6, 95% CI 1.1-2.4 for high). Conclusions:Elevated CRP levels were associated with future incidence of ESA hyporesponsiveness from low-grade inflammation (3.0= CRP <10.0 mg/l).

The infrequent assessment of vitality in clinical practice may be partially due to an inadequate understanding of vitality and the lack of a concise method of assessing it. This study aimed to examine the association of a simple 1-item “vitality” question measuring self-reported energy level with clinical outcomes.

Background/Aims:Hemodialysis patients are at high risk of hospitalization and their condition may worsen with repeated hospitalization. The aim of this study was to evaluate the impact of the cumulative number of hospitalizations on post-discharge mortality. Methods:This study was a prospective cohort study. We examined 3,359 adult patients on hemodialysis for at least 90 days who participated in the Japanese Dialysis Outcomes and Practice Patterns Study phases 3 and 4 (2005–2012). The patients hospitalized within 3 months before enrollment were excluded. The main exposure was the time-varying cumulative number of hospitalizations during the follow-up period. Hazard ratios (HRs) for all-cause mortality rate after discharge were estimated by time-dependent Cox regressions after adjusting for potential confounders. Results:The median follow-up time was 2.7 years, and 873 (26%) patients experienced at least 1 hospitalization during follow-up. The hospitalization rate was 0.23 per person-year and the mortality rate was 0.036 per person-year. The HR and 95% CI for post-discharge mortality increased as the cumulative number of hospitalizations increased: once, 1.41 (0.99–2.00); and twice or more, 2.27 (1.59–3.23). The cause-specific hospitalization categories, “infectious disease” and “cancer,” affected post-discharge mortality HRs in a similar manner: 2.41(1.32–4.41) and 2.70 (1.23–5.93), respectively. Conclusion:A higher cumulative number of hospitalizations is associated with increased post-discharge mortality in chronic hemodialysis patients. The cause-specific hospitalizations category of “infectious disease” showed an impact on mortality similar to that of hospitalization for “cancer.” Therefore, physicians should pay more attention to reducing preventable hospitalizations.

AbstractBackground:Maternal employment may affect child care styles and contribute to the increasing prevalence of overweight children. We explored the potential risk factors for becoming overweight during early childhood, especially in the child care environment.Methods:We conducted a retrospective cohort study using data from health check-up services from 2007 to 2015 in Kobe, Japan. The main outcome was being overweight at age 3 years, which was defined by the International Obesity Task Force cutoffs. Environmental, maternal, and infantile factors were examined as possible risk factors for childhood overweight.Results:Of 31,463 infants, 1315 (4.2%) were classified as overweight at age 3 years. Compared with children who were cared for by their mothers during the day at 4 and 18 months, the adjusted odds ratio (aOR) for becoming overweight for those who were not cared for by their mothers was 1.52: 95% confidence interval (CI), 1.16–1.99. Long sleep duration was associated with lower risk of childhood overweight: aOR, 0.79; 95% CI, 0.66–0.96.Conclusion:Less daytime care by mothers and shorter sleep duration were associated with increased risk of becoming overweight during childhood. Further studies are needed to determine on how the effect of those factors may be diminished with respect to childhood overweight.

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Introduction: Although a few dialysis facilities conduct a complete blood cell count for some patients at post-dialysis, including hemoglobin, clinical findings supporting the interpretation of results are scarce. The aim of this study was to investigate the association between post-dialysis hemoglobin level and vascular access failure with clinical data.Methods: Study design: Case crossover design. Setting: Japanese dialysis facilities, which routinely take post-dialysis blood samples, including complete blood cell counts at least once a month. Participants: Hemodialysis patients who experienced vascular access failure in January 2010 until December 2014. Exposure: Post-dialysis hemoglobin level. Main outcome: Vascular access failure treated with endovascular treatment or operation. Statistical analysis: Self-matched odds ratios and 95% confidence intervals were estimated by comparing post-dialysis hemoglobin just before events (“case”) with levels at 6 and 12 months before events (“control”) using conditional logistic regression, and presented with restricted cubic spline.Results: Two hundred and thirty hemodialysis patients with vascular access failure were identified. Mean post-dialysis hemoglobin level before the failure was 11.8 g/dL (standard deviation 1.7). The spline curve showed that higher post-dialysis hemoglobin levels above 11.8 g/dL had a greater odds ratio for vascular access failure. Post-dialysis hemoglobin levels and odds ratios (95% confidence interval) for vascular access failure relative to the reference value (Hb 11.8 g/dL) were Hb 12.0 g/dL, 1.1 (1.0-1.1); Hb 14.0 g/dL, 1.4 (1.0-2.0); and Hb 16.0 g/dL, 2.1 (1.1-4.3).Conclusions: A higher post-dialysis hemoglobin level was associated with vascular access failure. Higher post-dialysis Hb could be a factor that triggers vascular access failure.

The burden of diabetes-related chronic kidney disease (CKD) on individuals and society is increasing, shifting attention toward improving the quality of care for patients with CKD and diabetes. We assessed the quality of CKD care and its association with long-term dialysis, acute kidney injury (AKI), and death.

The dialysis practice guideline in Japan sets a limit on the allowed interdialytic weight gain (IDWG) <6%. However, the effects of relative gain of fluid volume to body weight may differ in presence of morbid conditions. Here, we examined whether or not the associations between IDWG and mortality differ by serum albumin (sAlb), a nutritional and illness marker.

Diabetic hemodialysis patients with hemoglobin A1c (HbA1c) levels below 6.5% and over 8.0% face a higher mortality risk. To determine the optimal glycemic control in Japanese patients, we examined the association between HbA1c and mortality in 2,300 Japanese diabetic patients on maintenance hemodialysis with HbA1c levels determined at enrollment in the Japanese Dialysis Outcomes and Practice Patterns Study (JDOPPS) phases 2-5, using Cox regression analysis with adjustment for baseline age, sex, dialysis vintage, 12 general comorbidities, hemoglobin, albumin and creatinine levels, and insulin use; stratification by JDOPPS phase; and facility clustering taken into account. Overall, 54% of patients had HbA1c levels under 6.0, including 14% with HbA1c levels under 5.0. Insulin or oral diabetes medications were used less frequently in patients with higher HbA1c levels. The dependence of mortality on HbA1c level was U shaped. When the group with the lowest mortality (HbA1c 6.0-7.0) was used as a reference, the hazard ratios for HbA1c categories under 5.0, 5.0-6.0, 7.0 to under 8.0, and 8.0 and greater were, respectively, 1.56 (95% confidence interval, 1.05-2.33), 1.26 (0.92-1.71), 1.23 (0.79-1.89), and 2.10 (1.32-3.33) in the adjusted model. The HbA1c level was not associated with self-reported hypoglycemic episodes in JDOPPS phase 5. The HbA1c levels in diabetic hemodialysis patients differ considerably between Japan and those reported from Western countries. Thus, our findings highlight the importance of domestic guidelines for glycemic control by race and country.

Introduction The relationship between intradialytic ultrafiltration volume and vascular access (VA) patency remains unclear. Using data from the Japan Dialysis Outcomes and Practice Patterns Study, we analyzed whether large-volume ultrafiltration was associated with VA failure in hemodialysis patients.Methods We included 2736 patients for whom it was possible to evaluate VA patency and bodyweight change during dialysis. Patients were divided into three groups according to the tertile of intradialytic ultrafiltration by bodyweight: low, -9.5%-3.8%; middle, 3.8%-5.1%; and high, 5.1%-13.7%. Primary VA patency was defined as the time to first VA intervention, and secondary patency as the time to creation of a new VA. Hazard ratios for VA failure were compared across groups by using Cox regression models adjusted for age, sex, body mass index, diabetes, hemoglobin and phosphorus levels, Kt/V, and erythropoiesis-stimulating agent and antiplatelet use.Results For the low, middle, and high groups, the incidences of primary and secondary VA patency were 4.7, 5.6, and 6.7 events/100 person-years and 1.3, 1.6, and 1.7 events/100 person-years, respectively. Adjusted hazard ratios for primary VA patency in the middle and high groups versus the low group were 1.16 (95% confidence interval [CI], 0.88-1.52) and 1.41 (95% CI, 1.07-1.87), respectively; those for secondary VA patency were 1.29 (95% CI, 0.78-2.13) and 1.45 (95% CI, 0.86-2.45), respectively.Discussion Large-volume ultrafiltration during dialysis tended to increase VA failure in hemodialysis patients. We thus recommend smaller ultrafiltration volumes during hemodialysis to secure VA safely.

The objective was to determine whether central-venous oxygen saturation (ScvO2<70%) can be detected from the difference between invasively and noninvasively measured systolic blood pressure (BP) (ie, ΔBP defined as arterial BP minus noninvasive BP).

Patients receiving long-term dialysis have among the highest mortality and hospitalization rates. In the nonrenal literature, functional dependence is recognized as a contributor to subsequent disability, recurrent hospitalization, and increased mortality. A higher burden of functional dependence with progressive worsening of kidney function has been observed in several studies, suggesting that functional dependence may contribute to both morbidity and mortality in dialysis patients.

AbstractBackground/Aims:Bone fracture is often complicated in hemodialysis (HD) patients. Metabolic acidosis is related to bone disease and muscle wasting, but it is not known whether acid-base disturbance is associated with the risk of bone fractures. The aim of this study was to clarify the association of serum bicarbonate level with bone fracture in HD patients. Methods:Using a subcohort of the Mineral and Bone Disorder Outcomes Study for Japanese CKD Stage 5D Patients (MBD-5D), 890 prevalent HD patients (age: 62 years old, male: 62.8, duration of dialysis: 8.3 years) with secondary hyperparathyroidism were studied. After measuring predialysis serum bicarbonate at a 2-day interdialytic interval, we prospectively followed them every 3 months, and examined the occurrence of any type of bone fracture or hospitalization due to fracture over a 3-year observation period. Results:Seventy-four bone fractures and 47 hospitalizations due to fracture were observed during the follow-up period. HD patients with serum bicarbonate <20 mmol/l had a 1.93 (95 CI 1.01-3.71)-fold higher risk for all-cause fractures than those with serum bicarbonate of 20.0-21.9 mmol/l. A higher bicarbonate level (≥22 mmol/l) was also related to an increased risk of bone fracture. A restricted cubic regression spline disclosed that the higher or the lower than 21.0 mmol/l of serum bicarbonate, the greater the risk for bone fracture. Conclusion:Both a lower level and a higher level of predialysis bicarbonate concentration were associated with risk of bone fracture in HD patients with secondary hyperparathyroidism.© 2014 S. Karger AG, Basel

Hemodialysis patients with mineral and bone disorders (MBDs) have an abnormally high relative risk of death, but their absolute risk of death is unknown. Further, previous studies have not accounted for possible time-dependent confounding of the association between MBD markers and death due to the effect of markers of MBD on treatments, which subsequently may affect MBD markers.

Work Performance Assessed by a Newly Developed Japanese Version of the Work Limitation Questionnaire in a General Japanese Adult Population: Misa TAKEGAMI, et al. Department of Preventive Medicine and Epidemiologic Informatics, National Cerebral and Cardiovascular Center— The Work Limitations Questionnaire (WLQ) was recently developed to measure health‐related decrements in ability to perform job roles among employed individuals. The purpose of this study was to develop and test a Japanese version of the WLQ. Developing the Japanese version of the WLQ involved translations, back‐translations, and a pilot study. Using data obtained from a nationwide survey, 4,600 people aged ≥20 years were selected from the entire population of Japan by stratified random sampling. We ultimately used data from a total of 1,358 workers out of 2,266 subjects who filled out the self‐administered questionnaire. We computed the proportion of missing data, measured internal consistency reliability, and tested for convergent and discriminant validity, concurrent validity, known groups validity, and the factor structure of this instrument. For the Japanese version of the WLQ, the percentages of missing values for each scale ranged from 3.6% to 7.8%. Internal consistency reliability was high, and Cronbach's α was ≥0.7 for all subscales. Subjects with headache and orthopedic pain had significantly higher WLQ subscale scores than subjects without. Higher WLQ subscale scores were associated with depressive symptoms as measured with the Hospital Anxiety and Depression Scale (p<0.001). The Japanese WLQ provides reliable and valid information on at‐work disability for group‐level comparisons and tracking therapeutic outcomes.

Studies investigating the association between glycated hemoglobin (HbA1c) level and mortality risk in diabetic patients receiving hemodialysis have shown conflicting results.

Chronic kidney disease-mineral and bone disorder (CKD-MBD) has recently attracted attention in light of its association with clinical outcomes, such as fracture, cardiovascular disease, and mortality. Management of CKD-MBD has therefore come to have a central role in dialysis practice. Cinacalcet, a newly developed drug, has changed prescription patterns in many centers based on different changes in MBD markers than those observed with active vitamin D derivatives. As physicians require real-world evidence to guide their treatment decisions with respect to MBD management, we conducted the Mineral and Bone Disorder Outcomes Study for Japanese CKD Stage 5D Patients (MBD-5D), a 3-year observational study involving prevalent hemodialysis patients with secondary hyperparathyroidism (SHPT). Here, we review the results from the MBD-5D and discuss issues of MBD management in the cinacalcet era. Three years since the introduction of cinacalcet, 40% of hemodialysis patients with SHPT have come to use cinacalcet, enjoying marked improvement in management of circulating MBD markers, such as intact parathyroid hormone (PTH), phosphorus, and calcium. Combination therapy with cinacalcet and a vitamin D receptor activator (VDRA) may allow physicians to choose more suitable prescription patterns based on patient characteristics and therapeutic purposes. We observed an additive association between ‘starting cinacalcet’ and ‘increased VDRA dose,’ with marked improvement in the control of intact PTH levels. Further, the combination pattern of ‘starting cinacalcet’ and ‘decreased VDRA dose’ was associated with better achievement of target serum phosphorus and calcium levels. Future studies should examine the effect of different prescription patterns for SHPT treatment on clinical outcomes.

AbstractBackground:Vascular access (VA) guidelines recommend the native arteriovenous fistula (AVF) as VA of first choice for chronic hemodialysis patients. AVF management is important in hemodialysis patient care. AVF survival is associated with various physical factors, but the effects of dialysis treatment factors upon AVF survival are still not clear. Methods:Study patients were treated at 498 dialysis facilities participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS) 2 or 3 (2002-2007). Analyses included 1,183 incident hemodialysis patients (on dialysis ≤7 days and using an AVF at study entry) and 949 prevalent patients (on dialysis >7 days at DOPPS entry and using a new AVF created during study observation). AVF survival was modeled from the study entry date for incident patients and date of first AVF use for prevalent patients. Predictors of primary and final AVF survival were compared across Japan, North America and Europe/Australia/New Zealand (EUR/ANZ) with adjustments for patient characteristics. Results:No meaningful relationship was seen between AVF survival and various physician and staff practices. However, patients with prior catheter use displayed higher rates of primary and final AVF failure. Final AVF failure rates were higher in facilities with higher median blood flow rates (BFR). They were also greater in North America and EUR/ANZ than in Japan, but this difference was substantially attenuated after accounting for regional differences in facility median BFR. Conclusion:AVF longevity differed according to the DOPPS region, and was related to prior patient catheter use and facility BFR practice. Further longitudinal studies may help demonstrate meaningful associations between VA-handling skill and patency.Copyright © 2013 S. Karger AG, Basel

AbstractBackground/Aims:Resistance to erythropoiesis-stimulating agent (ESA) is associated with mortality in hemodialysis (HD) patients. Time-dependent variability of ESA resistance has been not investigated adequately, although consistently high ESA resistance is expected to be a high risk for mortality. Our aim, therefore, was to investigate consistently high ESA resistance as an independent predictor of mortality in HD patients. Methods:This study evaluated 2,104 Japanese HD patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) III. ESA resistance index (ERI) was defined as the weekly weight-adjusted dose of ESA divided by hemoglobin concentration. The average ERI was calculated from ERI levels every 4 months throughout the observation period for each patient. To assess the size of the fluctuation in average ERI during the observation periods according to ERI quartiles at the enrollment periods, six patient groups were defined on the basis of patterns of ERI level fluctuation: low-low (Low), intermediate-intermediate (Intermediate), high-high (High), low-intermediate, intermediate-high, and low-high. Results:The number of deaths among the patients was 227 (10.8), which included 113 (5.4) cases of cardiovascular disease (CVD). In multivariate analysis after adjustment for age, albumin, C-reactive protein, comorbidities, etc., the High group was independently and significantly related to all-cause and CVD-related mortality (OR = 2.33, 95 CI: 1.33-4.07, p = 0.002, and OR = 2.09, 95 CI: 1.05-4.14, p = 0.035, respectively). Conclusion:Factoring out fluctuating ERI increases the ability of consistently high ERI levels as an independent risk factor for all-cause and CVD mortality in HD patients.Copyright © 2013 S. Karger AG, Basel

To examine the association between degree of underreporting energy intake and psychosocial (including interpersonal and personal) factors among hemodialysis patients in Japan.

AbstractWe previously demonstrated that anemia was not associated with mortality in hemodialysis patients with cardiovascular disease (CVD). Since diabetes mellitus (DM) accelerates CVD, the influence of DM on the relationship between anemia and mortality was examined using the data obtained from 1,385 DM patients and 2,583 non-DM hemodialysis patients recruited into the Dialysis Outcomes Practice Pattern Study in Japan (J-DOPPS). When all patients were stratified into four groups on their hematocrit levels, mortality rate was significantly and steadily lower in the subgroups with the higher levels of hematocrit by the Kaplan-Meier method (p = 0.0003 by log-rank test). When DM and non-DM patients were analyzed separately, a significant association of lower hematocrit levels with higher mortality disappeared in DM patients (p = 0.6280), in contrast with its retention in non-DM counterparts (p < 0.0001). Multivariable-adjusted Cox proportional hazards models demonstrated a significant association between hematocrit with all-cause mortality in non-DM patients after adjustment for age, gender, BMI, hemodialysis duration, SBP, DBP, albumin, total cholesterol, calcium, phosphorus, and intact PTH (p = 0.046), whereas this association disappeared in DM patients in the same model (p = 0.583). In conclusion, these results suggested that the association between anemia and higher mortality disappeared in DM hemodialysis patients, in contrast with non-DM counterparts.Copyright © 2012 S. Karger AG, Basel

Abstract: Background: During esophagectomy, laparoscopy can be used together with thoracoscopy, but it is not known whether a combined thoracoscopic–laparoscopic procedure is associated with fewer postoperative complications than open esophagectomy, and without compromising oncological outcome. Methods: This was a longitudinal cohort study that included 185 esophageal cancer patients, including 72 who underwent combined thoracoscopic–laparoscopic esophagectomy (TLE), 34 who underwent thoracoscopic esophagectomy (TE), and 79 who underwent open esophagectomy (OE) between January 2002 and May 2010. The main outcome measures were postoperative respiratory and overall complications. The secondary outcome was 2-year relapse-free survival (RFS). Results: Respiratory complications occurred in 9 patients who underwent TLE, 13 who underwent TE, and 31 who underwent OE. TLE was associated with fewer respiratory complications (TLE vs. OE: odds ratio [OR], 0.22; 95% confidence interval [CI], 0.09–0.53 and TE vs. OE: OR, 0.71; 95% CI 0.29–1.76). Overall complications occurred in 34 patients who underwent TLE, 20 who underwent TE, and 54 who underwent OE. TLE was associated with fewer overall complications (TLE vs. OE: OR, 0.47; 95% CI 0.23–0.94 and TE vs. OE: OR, 0.51; 95% CI 0.21–1.25). The 2-year RFS rates were similar among the three groups: 71.6% for TLE, 57.7% for TE, and 58.3% for OE (TLE vs. OE: hazard ratio, 0.65; 95% CI 0.35–1.20 and TE vs. OE: hazard ratio, 0.91; 95% CI 0.45–1.82). Conclusion: Unlike TE, TLE was associated with fewer postoperative complications than was OE, with no compromise of 2-year RFS. A randomized controlled trial with longer follow-up is needed.

Patient responsiveness to erythropoiesis-stimulating agents (ESAs), notoriously difficult to measure, has attracted attention for its association with mortality. We defined categories of ESA responsiveness and attempted to clarify their association with mortality.

Associations between Hours Worked, Symptoms and Health Resource Utilization among Full‐time Male Japanese Workers: Keiko Sato, et al. Department of Epidemiology and Health Care Research, Graduate School of Medicine and Public Health, Kyoto University— To investigate the association between hours worked, symptoms experienced, and health resource utilization. Data were collected from a nationally representative sample of households in Japan. We studied full‐time male workers aged 18–65 yr who worked 100 h or more per month. First, we examined the association between hours worked and symptoms experienced. Second, we examined the association between hours worked and the type of health resource utilized, such as physician visits, over‐the‐counter (OTC) medication use, dietary supplement use, and complementary and alternative medicine (CAM) provider visits. We used a multivariable negative binominal model in each analysis. Of the 762 male workers, 598 reported experiencing symptoms at least once a month. We categorized participants based on the number of hours worked per month (h/mo): 100–200 h/mo, 201–250 h/mo, and over 250 h/mo. Compared with those working 201–250 h/ mo, those working 100–200 h/mo had more frequent physician visits (rate ratio:1.67, 95% CI: 1.17 to 2.38) and those working over 250 h/mo had significantly lower rates of CAM provider visits and tended to use dietary supplements for symptoms. Participants who worked 201–250 h/mo used OTC medication most frequently. No significant association was observed between the number of hours worked and number of symptoms experienced. The more hours worked by full‐time male workers, the more likely they were to use health resources that had a lower time requirement. Greater attention should be paid to patterns of health resource utilization among workers and their consequent Influence on long‐term health status.