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Objectives In older patients, the diagnosis of acute pyelonephritis (APN) is challenging. The aim was to evaluate the added value of CT to history, physical examination and urinalysis for the diagnosis of APN in older patients with suspected infection with an unknown focus.Design Retrospective diagnostic study.Setting Department of General Medicine in an acute care hospital in Japan.Participants Patients aged ≥65 years who underwent blood cultures, a urine culture, and chest and abdominal CT to detect the focus of infection were included.Primary outcome measures Two radiologists independently reviewed four non-contrast CT signs: perirenal fat stranding, pelvicalyceal wall thickening, enlargement of the kidney and thickening of Gerota’s fascia. Findings on contrast-enhanced CT could not be evaluated due to an insufficient number of patients in whom contrast-enhanced CT was performed. An expert panel was used as the reference standard for APN. The added value of CT findings was quantified by comparing the diagnostic performance between a model based on 10 predictors available before CT and an extended model including the CT findings.Results Of 473 patients, 61 (14.8%) were diagnosed with APN. When the laterality of the CT findings was taken into account, the model fit was not improved by adding them. In the laterality-insensitive analysis, the model performance was significantly improved by adding the CT signs (likelihood-ratio test p=0.03; c-index 0.89 vs 0.91, p=0.03). However, their clinical utility was only to improve the classification of 11.5% of patients with APN.Conclusions The added value of non-contrast CT findings to history, physical examination and urinalysis was limited for the diagnosis of APN in older patients with a suspected infection with an unknown focus.

Introduction Hyperkalaemia (HK) is a frequent complication in patients with chronic kidney disease (CKD) and/or chronic heart failure (CHF). HK must be managed, both to protect patients from its direct clinical adverse outcomes and to enable treatment with disease-modifying therapies including renin–angiotensin–aldosterone system inhibitors. However, the experiences of patients undergoing treatment of HK are not clearly understood. Optimising treatment decisions and improving long-term patient management requires a better understanding of patients’ quality of life (QOL). Thus, the aims of this research are: (1) to describe treatment patterns and the impact of treatment on a patient’s QOL, (2) to study the relationships between treatment patterns and the impact of treatment on a patient’s QOL and (3) to study the relationships between the control of serum potassium (S-K) and the impact of treatment on a patient’s QOL, in patients with HK.Methods and analysis This is a prospective cohort study with 6 months of follow-up in 30–40 outpatient nephrology and cardiology clinics in Japan. The participants will be 350 patients with CKD or CHF who received their first potassium binders (PB) prescription to treat HK within the previous 6 months. Medical records will be used to obtain information on S-K, on treatment of HK with PBs and with diet, and on the patients’ characteristics. To assess the impact of treatment on a patient’s QOL, questionnaires will be used to obtain generic health-related QOL, CKD-specific and CHF-specific QOL, and PB-specific QOL. Multivariable regression models will be used to quantify how treatment patterns and S-K control are related to the impact of treatment on a patient’s QOL.Ethics and dissemination Institutional review boards at all participating facilities review the study protocol. Patient consent will be obtained. The results will be published in international journals.Trial registration number NCT05297409.

Abstract Advance care planning (ACP) is essential for end-of-life care, especially during the novel coronavirus disease 2019 (COVID-19) pandemic, and resilience is critical to deal with pandemic-related stressors. Therefore, we investigated the association between resilience ability and ACP discussions during the COVID-19 pandemic. A nationwide web-based survey was conducted in July 2021 in Japan. We analyzed the respondents’ ability to bounce back from stress (bouncing-back ability), positive stress coping (e.g., “seeking social support”, “planning”), and negative stress coping (e.g., “avoidance”, “alcohol and drug use”) in relation to ACP discussions using multivariable logistic regression models. In total, 2000 responses (86% participation rate) were received (mean age: 51.8 ± 16.7). Normal and high bouncing-back ability (adjusted odds ratio [AOR]: 1.69, 95% CI: 1.03–2.79; AOR: 2.07, 95% CI: 1.18–3.65, respectively) were significantly associated with the occurrence of ACP discussions. Seeking social support and planning were significantly associated with ACP discussions, whereas avoidance and alcohol and drug use were not. Both bouncing-back ability and positive stress coping were significantly associated with the occurrence of ACP discussions during the COVID-19 pandemic in Japan. These findings could be useful for aiding health-care providers involved in ACP discussions during the COVID-19 pandemic.

Abstract Metabolic syndrome and lumbar spinal stenosis (LSS) are common age-related diseases. However, the causal relationship between them remains unclear. This study aimed to identify the effects of LSS on metabolic syndrome incidence in community-dwelling adults. This prospective cohort study included participants of the Aizu cohort study (LOHAS) aged

Background: Breaches of ethics undermine the practice of medicine. In Japan, two major scandals involving clinical research and drug marketing occurred after the publication of clinical trials. To study the effects of those scandals, we evaluated changes in the use of first-generation angiotensin II receptor blockers (ARBs) after publication of relevant clinical trials and also after the subsequent scandals. Methods: We conducted a quasi-experimental design of an interrupted time series analysis (ITSA) on nationwide monthly drug-market data covering 12 years (2005 to 2017) in Japan. The main outcome was the use of first-generation ARBs (valsartan, candesartan, and losartan). The two exposures were the publication of ARB-related clinical-trial results (October 2006) and subsequent ARB-related scandals involving research and marketing (February 2013). A generalized estimating equation model was fitted for ITSA with a log link, Poisson distribution, robust variance estimators, and seasonality adjustment. Results: The publication of clinical trials was associated with 12% increase in the use of first-generation ARBs in Japan, and the subsequent ARB-related scandals was associated with 19% decrease. The decrease in the use of first-generation ARBs after the scandals was greater than the increase in their use after the publication of clinical-trial results. The net effect of the two exposures was a 9% decrease in the use of first-generation ARBs. Conclusions: The scandals were associated with decrease in the use of first-generation ARBs, and that decrease was greater than the increase associated with the publication of “successful” clinical trials, making the net effect not zero but negative.

Objective: 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. Methods: We conducted a cross-sectional study involving 269 Japanese community dwellers aged ≥75 years in 2015. AGE accumulation was non-invasively measured via skin autofluorescence (SAF) values using AGE Reader. The primary and secondary outcomes were the presence and severity of OAB evaluated using the Overactive Bladder Symptom Score (OABSS). Individuals with an urgency score of ≥2 and sum score of ≥3 were considered to have OAB. The associations of SAF with the prevalence and severity of OAB were assessed using logistic and linear regression models, respectively, adjusted for clinically important confounders. Results: The median age of participants was 78 years. Of 269 participants, 110 (40.9%) were men and 75 (27.9%) had OAB. The median SAF was 2.2 arbitrary units (AUs). Increasing median SAF was observed with increasing age. Multivariable analysis revealed that SAF was not associated with either the likelihood of having OAB (odds ratio per AU=0.77, 95% confidence interval: 0.37–1.62) or the natural log-transformed OABSS (β per AU=−0.07, 95% confidence interval: −0.26–0.12). Conclusions: In this study, AGE accumulation, as assessed by SAF, was not associated with the prevalence and severity of OAB in Japanese community-dwelling elderly people aged ≥75 years.

Abstract Background While survival of systemic lupus erythematosus (SLE) patients has improved substantially, problems remain in the management of their emotional health. Medium to high-dose glucocorticoid doses are known to worsen emotional health; the effect is unclear among patients receiving relatively low-dose glucocorticoids. This study aims to investigate the association between low glucocorticoid doses and emotional health in lupus low disease activity state (LLDAS). Methods This cross-sectional study drew on data from SLE patients in 10 Japanese institutions. The participants were adult patients with SLE duration of ≥ 1 year who met LLDAS criteria at the study visit from April 2018 through September 2019. The exposure was the daily glucocorticoid dose (mg oral prednisolone). The outcome was the emotional health score of the lupus patient-reported outcome scale (range: 0 to 100). Multiple linear regression analysis was performed with adjustment for confounders including disease-related damage, activity, and psychotropic drug use. Results Of 192 patients enrolled, 175 were included in the analysis. Their characteristics were as follows: female, 89.7%; median age, 47 years (interquartile range (IQR): 37.0, 61.0). Median glucocorticoid dose was 4.0 mg (IQR 2.0, 5.0), and median emotional health score 79.2 (IQR 58.3, 91.7). Multiple linear regression analysis showed daily glucocorticoid doses to be associated with worse emotional health (β coefficient = − 2.54 [95% confidence interval − 4.48 to − 0.60], P = 0.01). Conclusions Daily glucocorticoid doses were inversely associated with emotional health among SLE patients in LLDAS. Further studies are needed to determine whether glucocorticoid tapering leads to clinically significant improvements in emotional health.

Introduction: Although predialysis hemoglobin concentration is affected by interdialytic weight gain (IDWG), the interaction between these parameters is not well understood. Methods: Using data from the Japanese Dialysis Outcomes and Practice Pattern Study phases 1–5, we analyzed patients who underwent maintenance hemodialysis. The exposure variable was hemoglobin concentration, and the effect modifier was IDWG at baseline. These 2 categorical variables were then combined and analyzed. The primary outcome was major adverse cardiovascular events (MACEs). Hazard ratios were estimated using a Cox model for the association between exposure and MACEs after adjusting for potential confounders. We examined additive interactions between hemoglobin concentration and IDWG by calculating the relative excess risk due to interaction, which is defined as a departure from the additivity of effects. Results: A total of 8234 patients were enrolled. During a median follow-up of 2.1 years, 1062 (12.9%) patients developed MACEs. In IDWG categories of

Abstract Background In chronic kidney disease (CKD), patients’ adherence to prescriptions for diet and for medications might depend on the degree to which they have hope that they will enjoy life, and that hope could vary with the stage of CKD. The aims of this study were to quantify both the association of CKD stage with health-related hope (HR-Hope), and the association of that hope with psychological and physiological manifestations of adherence. Methods This was a cross-sectional study involving 461 adult CKD patients, some of whom were receiving dialysis. The main exposure was HR-Hope, measured using a recently-developed 18-item scale. The outcomes were perceived burden of fluid restriction and of diet restriction, measured using the KDQOL, and physiological manifestations of adherence (systolic and diastolic blood pressure [BP], and serum phosphorus and potassium levels). General linear models and generalized ordered logit models were fit. Results Participants at non-dialysis stage 4 and those at stage 5 had lower HR-Hope scores than did those at stage 2 or 3 (combined). Those at non-dialysis stage 5 had the lowest scores. HR-Hope scores of participants at stage 5D were similar to those of participants at stage 4, but they were lower than the scores of participants at stage 2 or 3 (combined). Higher HR-Hope scores were associated with lower perceived burdens of fluid restriction and of diet restriction (adjusted ORs per ten-point difference were 0.82 and 0.84, respectively). Higher HR-Hope scores were associated with lower systolic BP (adjusted mean difference in systolic BP per ten-point difference in HR-Hope scores was − 1.87 mmHg). In contrast, HR-Hope scores were not associated with diastolic BP, serum phosphorus levels, or serum potassium levels. Conclusions Among CKD patients, HR-Hope is associated with disease stage, with psychological burden, and with some physiological manifestations of adherence.

Abstract Background There is limited evidence on the association between short-term changes in mineral and bone disorder parameters and survival in maintenance hemodialysis patients. Methods We investigated the association between changing patterns of phosphorus, calcium and intact parathyroid hormone levels and all-cause mortality in hemodialysis patients with secondary hyperparathyroidism. Each parameter was divided into three categories (low [L], middle [M] and high [H]), and the changing patterns between two consecutive visits at 3-month intervals were categorized into nine groups (e.g., L-L and M-H). The middle category was defined as 4.0–7.0 mg/dL for phosphorous, 8.5–9.5 mg/dL for calcium and 200–500 pg/mL for intact parathyroid hormone. Adjusted incidence rates and rate ratios were analyzed by weighted Poisson regression models accounting for time-dependent exposures. Results For phosphorus, shifts from low/high to middle category (L-M/H-M) were associated with a lower mortality compared with the L-L and H–H groups, whereas shifts from middle to low/high category (M-L/M-H) were associated with a higher mortality compared with the M-M group. For calcium, shifts from low/middle to high category (L–H/M-H) were associated with a higher mortality compared with the L-L and M-M groups, whereas shifts from high to middle category (H-M) were associated with a lower mortality compared with the H–H group. For intact parathyroid hormone, shifts from low to middle category (L-M) were associated with a lower mortality compared with the L-L group. Conclusions Changes in the 3-month patterns of phosphorus and calcium toward the middle category were associated with lower mortality. Our study also suggests the importance of avoiding hypercalcemia.

Abstract Background The impact of length of hospital stay on activities of daily living (ADLs) has not specifically been investigated among dialysis patients. Therefore, we attempt to verify the association between the length of hospital stay and the decline in ADLs among hemodialysis patients. Methods This prospective cohort study used data from the Japanese Dialysis Outcomes and Practice Patterns Study (J-DOPPS). We included 2442 hemodialysis patients aged ≥40 years from the J-DOPPS phase V (2012–2015) and subsequently excluded those who had already lost basic activities of daily living (BADLs) as demonstrated by dependency in at least three of the five BADLs at baseline and for whom changes in ADLs had been evaluated for less than 90 days. The main exposure was the cumulative length of hospital stay during the follow-up period. The primary outcomes were a decline in at least one of the five BADLs and eight instrumental activities of daily living (IADLs). We compared risk ratios (RRs) for 30-day increments for hospital stays with 10-year increments for age and having diabetes. Results A total of 849 patients were included in the statistical analysis. The cumulative length of hospital stay was significantly associated with a risk of decline in ADLs (adjusted RRs [95% confidence intervals] per 30-day increments: 1.42 [1.15 to 1.75] for BADLs, 1.38 [1.13 to 1.68] for IADLs). The adjusted RRs [95% CI] for 10-year increments in age were 1.20 [0.96 to 1.50] and 1.21 [1.00 to 1.47]. The adjusted RRs [95% CI] for having diabetes were 1.36 [0.97 to 1.91] for BADLs and 1.38 [1.04 to 1.84] for IADLs. Conclusion The impact of a 30-day increment in the cumulative length of hospital stay on the decline in ADLs was comparable to that of a 10-year increase in age and having diabetes.

Objectives This study aimed to investigate the association between kyphotic posture and future loss of independence (LOI) and mortality in community-dwelling older adults.Design Prospective cohort study.Setting Two Japanese municipalities.Participants We enrolled 2193 independent community-dwelling older adults aged≥65 years at the time of their baseline health check-up in 2008. Kyphotic posture was evaluated using the wall-occiput test (WOT) and classified into three categories: non-kyphotic, mild (>0 and ≤4 cm) and severe (>4 cm).Primary and secondary outcome measures The primary outcome was mortality and the secondary outcomes were LOI (new long-term care insurance certification levels 1–5) and a composite of LOI and mortality. A Cox proportional hazards model was used to estimate the adjusted HRs (aHRs).Results Of the 2193 subjects enrolled, 1621 were included in the primary analysis. Among these, 272 (17%) and 202 (12%) were diagnosed with mild and severe kyphotic postures, respectively. The median follow-up time was 5.8 years. Compared with the non-kyphotic group, the aHRs for mortality were 1.17 (95% CI 0.70 to 1.96) and 1.99 (95% CI 1.20 to 3.30) in the mild and severe kyphotic posture groups, respectively. In the secondary analysis, a consistent association was observed for LOI (mild: aHR 1.70, 95% CI 1.13 to 2.55; severe: aHR 2.08, 95% CI 1.39 to 3.10) and the LOI-mortality composite (mild: aHR 1.27, 95% CI 0.90 to 1.79; severe: aHR 1.83, 95% CI 1.31 to 2.56).Conclusion Kyphotic posture was associated with LOI and mortality in community-dwelling older adults. Identifying the population with kyphotic posture using the WOT might help improve community health.

Objectives To examine the association between facility-level adherence to phosphorus management guidelines and mortality among patients with haemodialysis, and to explore the facility-related factors associated with facility-level guideline adherence.Design Prospective cohort study.Setting The Dialysis Outcomes and Practice Pattern Study, which included 57 representative dialysis facilities in Japan between 2012 and 2015.Participants A total of 2054 adult patients who received maintenance haemodialysis were included. We defined exposure according to the following four categories, depending on whether facility-level target ranges of serum phosphorus concentration adhered to the Japanese clinical practice guidelines: adherence group (lower limit ≥3.5 mg/dL and upper limit ≤6.0 mg/dL), low-target group (lower limit 6.0) and high-target group (lower limit ≥3.5 and upper limit >6.0).Primary outcome measure The primary outcome was the patient all-cause mortality rate.Results The mortality rate among the patients was 7.3 per 100 person-years; 27 facilities (47%) set targets according to the guidelines. HRs for mortality with reference to the adherence group were 1.04 (95% CI 0.76 to 1.43) in the low-target group, 1.11 (95% CI 0.68 to 1.81) in the wide-target group and 1.95 (95% CI 1.12 to 3.38) in the high-target group. Involvement of dieticians in dialysis treatment was associated with facility-level guideline adherence (OR 4.51; 95% CI 1.15 to 17.7).Conclusions A higher facility-level target range for phosphorus was associated with increased patient mortality. Among facilities that set the target according to the guidelines, dieticians tended to be involved in dialysis care. These findings suggest the importance of reviewing facilities’ treatment policies in relation to updated guidelines and the need to work with relevant professionals.

Abstract Background The low data publication rate for Food and Drug Administration (FDA)-approved drugs, and discrepancies between FDA-submitted versus published data, remain a concern. We investigated the publication statuses of sponsor-submitted clinical trials supporting recent anticancer drugs approved by the FDA, with a focus on immune checkpoint inhibitors (ICPis). Methods We identified all ICPis approved between 2011 and 2014, thereby obtaining 3 years of follow-up data. We assessed the clinical trials performed for each drug indication and matched each trial with publications in the literature. The primary benchmark was the publication status 2 years post-approval. We examined the association between time to publication and drug type using a multilevel Cox regression model that was adjusted for clustering within drug indications and individual covariates. Results Between 2011 and 2014, 36 anticancer drugs including 3 ICPis were newly approved by the FDA. Of 19 trials investigating the 3 ICPis, 11 (58%) were published within 2 years post-approval. We randomly selected 10 of the 33 remaining anticancer drugs; 68 of 101 trials investigating these drugs (67%) were published. Overall, the publication rate was 66% at 2 years post-approval with a median time to publication of 2.3 years. There was no significant difference in the time to trial publication between ICPis and other anticancer drugs (adjusted hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.8–1.7; P = 0.55). However, findings related to non-ICPis investigated specifically in randomized phase 2 or phase 3 trials were significantly more likely to be published earlier than those related to ICPis (adjusted HR, 7.4; 95% CI, 1.8–29.5; P = 0.005). Conclusion One in 3 sponsor-submitted trials of the most recently approved anticancer drugs remained unpublished 2 years post-FDA approval. We found no evidence that the drug type was associated with the time to overall trial publication.

Abstract Achieving calcium, phosphorus, and intact parathyroid hormone (PTH) targets helps improve dialysis population outcomes. We aimed to assess the population-level associations of achievement of those targets with survival using population-attributable-fractions (PAFs). We conducted a case-cohort study using data from 8229 haemodialysis patients with mildly elevated intact PTH, treated at 86 dialysis facilities in Japan. We examined associations among calcium, phosphorus, intact PTH, and mortality over 3 years. We estimated PAFs for achieving the targets of calcium, phosphorus, and intact PTH from the adjusted hazard ratios by Cox regression models. Proportions within the recommended range were 55.8%, 63.3%, and 39.1% for calcium (8.4–10.0 mg/dL), phosphorus (3.5–6.0 mg/dL) and intact PTH (60–240 pg/mL), respectively. The mortality rate was 5.7 per 100 person-years. Mortality was independently associated with non-achievement of targets. Regarding the population-level impact, statistically significant PAFs were found for achieving the combination of calcium and phosphorus (8.8%; 95% CI, 1.1–16.0). Further, PAF for combined calcium, phosphorus, and intact PTH was the largest (16.8%; 95% CI, 5.6–30.4). In conclusion, there might be additive and substantial population-level associations between survival and the achievement of calcium, phosphorus, and intact-PTH targets in the haemodialysis population with mildly elevated intact PTH.

Objectives Longitudinal studies, which consider multimorbidity patterns, are useful for better clarifying the effect of multimorbidity on health-related quality of life (HRQoL) and for identifying the target population with poorer clinical outcomes among patients with multimorbidity. This study aimed to examine the effects of different multimorbidity patterns on the decline in HRQoL.Design Nationwide prospective cohort study.Setting Japanese adult residents.Participants Residents aged ≥50 years selected by the quota sampling method.Primary outcome measure Clinically relevant decline in HRQoL was defined as a 0.50 SD (5-point) decrease in the 36-Item Short Form Health Survey (SF-36) component summary scores for 1 year.Results In total, 1211 participants completed the follow-up survey. Among the multimorbidity patterns identified using confirmatory factor analysis, multivariable logistic regression analyses revealed that high cardiovascular/renal/metabolic and malignant/digestive/urologic pattern scores were significantly associated with the clinically relevant decline in SF-36 physical component summary score (adjusted OR (aOR)=1.25, 95% CI: 1.08 to 1.44 and aOR=1.28, 95% CI: 1.04 to 1.58, respectively). High cardiovascular/renal/metabolic pattern score was also significantly associated with the clinically relevant decline in SF-36 role/social component summary score (aOR=1.23, 95% CI: 1.06 to 1.42).Conclusions Our study revealed that multimorbidity patterns have different effects on the clinically relevant decline in HRQoL for 1 year. These findings can be useful in identifying populations at high risk and with poor clinical outcomes among patients with chronic diseases and multimorbidity for efficient resource allocation.

Objectives A previous study reported that food consumption is useful to rule out bacteraemia in hospitalised patients. We aimed to validate the diagnostic performance of (1) food consumption and (2) a previously reported algorithm using food consumption and shaking chills for bacteraemia in patients admitted to hospital with suspected infection.Design Prospective cohort study.Setting Department of General Medicine in two acute care hospitals in Japan.Participants A total of 2009 adult patients who underwent at least two blood cultures on admission.Primary outcome measures The reference standard for bacteraemia was judgement by two independent specialists of infectious diseases. Food consumption was evaluated by the physician in charge asking the patient or their caregivers the following question on admission: ‘What percentage of usual food intake were you able to eat during the past 24 hours?’Results Among 2009 patients, 326 patients were diagnosed with bacteraemia (16.2%). Diagnostic performance of food consumption was sensitivity of 84.4% (95% CI 80.1 to 88), specificity of 19.8% (95% CI 18 to 21.8), positive predictive value (PPV) of 16.9% (95% CI 15.2 to 18.9) and negative predictive value (NPV) of 86.8% (95% CI 83.1 to 89.8). The discriminative performance was an area under the curve of 0.53 (95% CI 0.50 to 0.56). The performance of the algorithm using food consumption and shaking chills was sensitivity of 89% (95% CI 85.1 to 91.9), specificity of 18.8% (95% CI 17 to 20.7), PPV of 17.5% (95% CI 15.7 to 19.4) and NPV of 89.8% (95% CI 86.2 to 92.5).Conclusion Our results did not show the usefulness of food consumption and the algorithm using food consumption and shaking chills for the diagnosis of bacteraemia in patients admitted to hospital with suspected infection.

ObjectivesTo investigate the longitudinal association of urgency urinary incontinence (UUI) with loss of independence (LOI) or death among independent community-dwelling older adults.DesignPopulation-based cohort study.SettingThe Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS), Minami-Aizu Town and Tadami Town, Fukushima, Japan.ParticipantsA total of 1,580 participants aged ≥65 years who underwent a health check-up conducted by LOHAS in 2010.MeasurementsExposure was defined as the presence of UUI, which was measured by a questionnaire based on the definition of UUI from the International Continence Society. The primary outcome was defined as incidence of LOI or death. After the check-up in 2010, the outcome was monitored until March 2014. A multivariable Cox proportional hazard analysis was performed to estimate the hazard ratio for the outcome. Ten potential confounders were adjusted in the analysis. Furthermore, we defined the secondary outcomes as two separate outcomes, LOI and death, and performed the same analysis.ResultsAmong all participants, 328 reported UUI. The incidence rates of the outcome were 20.4 and 11.4 (per 1,000 person-years) among participants with and without UUI, respectively. After multivariable adjustment, those who experienced UUI showed a substantial association with LOI or death (HR, 1.65; 95% CI, 1.01-2.68). However, they did not show such an association with LOI alone (HR, 1.07; 95% CI, 0.49-2.33). On the other hand, those with UUI exhibited a substantial association with death (HR, 2.23; 95% CI, 1.22-4.31).ConclusionsIn this study, UUI was associated with the occurrence of LOI or death; however, UUI is not associated with the occurrence of LOI alone among independent community-dwelling older adults. Our results suggest that there may be a difference between UUI-associated diseases that cause LOI and those that cause death.

IntroductionHaving developed a clinical prediction rule (CPR) for bacteremia among hemodialysis (HD) outpatients (BAC-HD score), we performed external validation.Materials & methodsData were collected on maintenance HD patients at two Japanese tertiary-care hospitals from January 2013 to December 2015. We enrolled 429 consecutive patients (aged ≥ 18 y) on maintenance HD who had had two sets of blood cultures drawn on admission to assess for bacteremia. We validated the predictive ability of the CPR using two validation cohorts. Index tests were the BAC-HD score and a CPR developed by Shapiro et al. The outcome was bacteremia, based on the results of the admission blood cultures. For added value, we also measured changes in the area under the receiver operating characteristic curve (AUC) using logistic regression and Net Reclassification Improvement (NRI), in which each CPR was added to the basic model.ResultsIn Validation cohort 1 (360 subjects), compared to a Model 1 (Basic Model) AUC of 0.69 (95% confidence interval [95% CI]: 0.59-0.80), the AUC of Model 2 (Basic model + BAC-HD score) and Model 3 (Basic model + Shapiro's score) increased to 0.8 (95% CI: 0.71-0.88) and 0.73 (95% CI: 0.63-0.83), respectively. In validation cohort 2 (96 subjects), compared to a Model 1 AUC of 0.81 (95% CI: 0.68-0.94), the AUCs of Model 2 and Model 3 increased to 0.83 (95% CI: 0.72-0.95) and 0.85 (95% CI: 0.76-0.94), respectively. NRIs on addition of the BAC-HD score and Shapiro's score were 0.3 and 0.06 in Validation cohort 1, and 0.27 and 0.13, respectively, in Validation cohort 2.ConclusionEither the BAC-HD score or Shapiro's score may improve the ability to diagnose bacteremia in HD patients. Reclassification was better with the BAC-HD score.

AimTo clarify the association of poor oral function with loss of independence (LOI) or death in functionally independent older adults in the community.MethodsWe conducted a secondary analysis of data from a prospective cohort study in two municipalities in Japan. We included participants who were older than 65 years of age and had no certification in long-term care at baseline. Poor oral function was evaluated by the Kihon Checklist. Among participants with poor oral function, they were further classified by the degree of quality of life (QOL) impairment due to dysphagia. Main outcome is LOI or death from all cause. The hazard ratio (HR) and 95% confidence of intervals (CIs) were estimated by Cox proportional hazard models adjusted for potential confounders.ResultsOf 1,272 participants, 150 participants (11.8%) had poor oral function. The overall incidence of LOI or death was 10.0% in the participants with poor oral function, while 3.3% in the participants without. Participants with poor oral function were more likely to develop LOI or death than those without (crude HR = 3.17 [95% CIs 1.74-5.78], adjusted HR = 2.30 [95% CIs 1.22-4.36]). 10 participants (0.79%) were classified as poor oral function with QOL impairment, and were more likely to develop LOI or death than those without poor oral function (crude HR = 7.45 [95% CIs 1.80-30.91], adjusted HR = 8.49 [95% CIs 1.88-38.34]).ConclusionsPoor oral function was associated with higher risk of LOI or death in functionally independent older adults in the community.

Objective To investigate the association between work schedules and motivation for behavioural change of lifestyle, based on the transtheoretical model (TTM) in workers with overweight or obesity.Design A cross-sectional observational study.Setting A healthcare examination centre in Japan.Participants Between April 2014 and March 2016, we recruited 9243 participants who underwent healthcare examination and met the inclusion criteria, namely, age 20–65 years, body mass index (BMI) ≥25 kg/m2 and full-time workers.Exposure Night and shift (night/shift) workers were compared with daytime workers in terms of motivation for behavioural change.Primary and secondary outcome measures The primary outcome was action and maintenance stages of change (SOC) for lifestyle in TTM. In a subgroup analysis, we investigated interactions between characteristics, including age, sex, BMI, current smoking, alcohol habits, hours of sleep and working hours.Results Overall, 1390 participants (15.0%) were night/shift workers; night/shift workers were younger (median age (IQR): 46 (40–54) vs 43 (37–52) years) and the proportion of men was lesser (75.4 vs 60.9%) compared with daytime workers. The numbers of daytime and night/shift workers in the action and maintenance SOC were 2113 (26.9%) and 309 (22.2%), respectively. Compared with daytime workers, night/shift workers were less likely to demonstrate action and maintenance SOC (adjusted OR (AOR): 0.85, 95% CI: 0.74 to 0.98). In a subgroup analysis that included only those with long working hours (≥10 hours/day), results revealed a strong inverse association between night/shift work and action and maintenance SOC (AOR: 0.65, 95% CI: 0.48 to 0.86). A significant interaction was observed between long working hours and night/shift work (P for interaction=0.04).Conclusions In workers with overweight or obesity, a night/shift work schedule was associated with a lower motivation for behavioural change in lifestyle, and the association was strengthened in those with long working hours.

ObjectivesTo investigate the association of mental health and subjective physical functioning with future antibiotic prescriptions.DesignProspective cohort study.SettingA rural town in Japan.ParticipantsParticipants who completed the baseline survey (2008-2010) of the Locomotive Syndrome and Health Outcomes in the Aizu Cohort Study (LOHAS) were recruited. Participants were limited to those without comorbidities according to the Charlson comorbidity index. Participants using antibiotics at baseline were excluded. Mental health and physical functioning were assessed using the Mental Health and Physical Functioning domains of the Short-Form 12 Health Survey, and depressive symptoms were assessed using the Mental Health Inventories at baseline.Main outcome measuresThe main outcome was antibiotic prescriptions found in claims data during 1 year after the baseline survey.ResultsA total of 967 participants were included in the analysis, and 151 (15.6%) participants with at least one missing variable for the confounding factors were excluded, leaving 816 participants for the primary analysis. Among the 816 participants, 65 (8.0%) were newly prescribed at least one antibiotic during the 1-year follow-up period. The most frequently prescribed antibiotics were third-generation cephalosporins (44 prescriptions; 35.5%), macrolides (28 prescriptions; 22.6%), and quinolones (23 prescriptions; 18.6%). A multivariable logistic regression analysis showed an association between higher mental health scores and future antibiotic prescriptions (adjusted odds ratio [AOR], 1.40 per 1 standard deviation [SD] increase; 95% confidence interval [CI], 1.03-1.90), whereas no significant relationship was observed between Physical Functioning scores and future antibiotic prescriptions (AOR, 0.95 per 1 SD increase; 95% CI, 0.75-1.22). During the secondary analysis, adults with depressive symptoms were less likely to be prescribed antibiotics (AOR, 0.27; 95% CI, 0.11-0.70).ConclusionsBetter mental health was associated with increased future antibiotic prescriptions for healthy community-dwelling Japanese adults, suggesting that mentally healthier adults could be a target population for reducing antimicrobial use.

Objective The associations of physical multimorbidity with depressive symptoms have been investigated in a number of studies. However, whether patterns of chronic physical conditions have comparatively different associations with depressive symptoms remains unclear. This study aimed to investigate the associations of physical multimorbidity patterns with depressive symptoms.Design This study was designed as a nationwide cross-sectional survey in Japan.Setting General sample of the Japanese population.Participants Adult Japanese residents were selected by a quota sampling method. Data were analysed from 1788 residents who reported one or more chronic health conditions.Results Among four physical multimorbidity patterns: cardiovascular-renal-metabolic (CRM), skeletal-articular-digestive (SAD), respiratory-dermal (RDE) and malignant-digestive-urologic (MDU), multivariable logistic regression analyses revealed that the RDE pattern showed the strongest association with depressive symptoms (aOR=1.68, 95% CI: 1.21 to 2.31 for the pattern score highest quartile, compared with the lowest quartile), followed by SAD and MDU patterns (aOR=1.41, 95% CI: 1.01 to 1.98 for the SAD pattern score highest quartile; 1.41, 95% CI: 1.01 to 1.96 for the MDU pattern score highest quartile, compared with the lowest quartile). In contrast, the CRM pattern score was not significantly associated with depressive symptoms (aOR=1.31, 95% CI: 0.90 to 1.89 for the pattern score highest quartile, compared with the lowest quartile).Conclusions Physical multimorbidity patterns have different associations with depressive symptoms. Among these patterns, patients with the RDE pattern may be at a higher risk for developing depressive symptoms. This study reinforces the evidence that cluster pattern of chronic health conditions is a useful measure for clinical management of multimorbidity as it is differently associated with mental health status, which is one of the crucial outcomes for multimorbid patients.

Abstract Background Although many hemodynamically unstable trauma patients undergo computed tomography (CT) to identify a source of bleeding, this practice is currently only recommended by a few guidelines. To clarify whether CT has harmful effects among these patients, we examined the association between CT during initial management and mortality among unstable blunt trauma patients. Methods This was a retrospective cohort study based on Japan Trauma Data Bank 2004–2014 registry data. Study population was adult blunt trauma patients with hypotension on arrival. The primary outcome was the in-hospital mortality. Two types of analyses were performed to adjust for confounding factors including propensity score inverse probability of treatment weighted (IPTW) and instrumental variable (IV) analysis. Results Among 5,809 patients who met inclusion criteria, 5,352 (92.1%) underwent CT. The No CT group was more likely to have severe physiological conditions and lower probability of survival than those of the CT group. In IPTW analysis adjusting for measured confounders, we found a significant protective effect of undergoing CT on in-hospital mortality (excess deaths: −20.6 per 100 patients, 95% CI −26.2 to −14.9). In IV analysis adjusting both for measured and unmeasured confounders, the association between CT and mortality was not statistically significant (excess deaths: −4.1 per 100 patients, 95% CI −23.1 to 14.8). Discussion We did not find clinically meaningful harmful effect of CT on survival for unstable blunt trauma patients even after adjusting both for measured and unmeasured confounders. Conclusions Our results did not support the recommendation of current guideline. We suggest physicians should consider CT as one of the diagnostic options even when patients are unstable.

Abstract 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.

Objectives Our study aimed to examine the longitudinal association between social participation and both mortality and the need for long-term care (LTC) simultaneously.Design A prospective cohort study with 9.4 years of follow-up.Setting Six Japanese municipalities.Participants The participants were 15 313 people who did not qualify to receive LTC insurance at a baseline based on the data from the Aichi Gerontological Evaluation Study (AGES, 2003–2013). They received a questionnaire to measure social participation and other potential confounders. Social participation was defined as participating in at least one organisation from eight categories.Primary and secondary outcome measures The primary outcomes were classified into three categories at the end of the 9.4 years observational period: living without the need for LTC, living with the need for LTC and death. We estimated the adjusted OR (AOR) using multinomial logistic regression analyses with adjustment for possible confounders.Results The primary analysis included 9741 participants. Multinomial logistic regression analysis revealed that social participation was associated with a significantly lower risk of the need for LTC (AOR 0.82, 95% CI 0.69 to 0.97) or death (AOR 0.78, 95% CI 0.70 to 0.88).Conclusions Social participation may be associated with a decreased risk of the need for LTC and mortality among elderly patients.

Objectives Differences in the association of haemoglobin concentration with mortality or adverse cardiovascular events in haemodialysis patients before and after experiencing cardiovascular disease are unclear. We aimed to assess the influence of cardiovascular-comorbid condition on the association between haemoglobin concentration and mortality.Design A prospective cohort study.Setting The Dialysis Outcomes and Practice Patterns Study Dialysis in phases 2 to 4 (2002 to 2011), including 80 randomly selected dialysis facilities in Japan (J-DOPPS).Participants 5515 adult haemodialysis patients.Primary and secondary outcome measures Primary outcome was all-cause mortality. Cardiovascular mortality and adverse cardiovascular events were also evaluated. The association of these outcomes with haemoglobin concentration, categorised into six classes by 1.0 g/dL units, and cardiovascular-comorbid condition, treated as a time-dependent variable updated every 4 months, was evaluated. Adjusted hazard ratios (aHRs) were computed using a time-dependent Cox model with interaction test for cardiovascular comorbidity.Results Over a median 2.0 years, 847 all-cause and 326 cardiovascular deaths, and 1000 adverse cardiovascular events occurred. Compared with haemoglobin 11.0 to 11.9 g/dL, the aHRs of mortality at the lowest range (

Introduction Ulcerative colitis (UC) is a chronic inflammatory disease that mainly affects the colon in young patients. Typical symptoms of UC are bloody diarrhoea and faecal urgency, which disturb the quality of life (QOL) of patients, and intractable UC leads to hospitalisation and colectomy. To improve relevant outcomes such as symptoms, QOL and colectomy, many clinical questions need to be resolved regarding what the ideal lifestyle, psychosocial burden and optimal practice patterns are. In this YOu and Ulcerative colitis: Registry and Social network (YOURS) study, we will investigate the effect of lifestyle, psychosocial factors and practice patterns on patient-reported outcomes (PRO), hospitalisation rate and colectomy rate in Japanese patients with UC.Methods and analysis For this prospective cohort study, we recruited 2006 patients from five hospitals (Tokyo and Chiba; May 2018–January 2019). Patients will be able to access their own data and compare them with summarised data from all patients on the website beyond the YOURS study. At baseline, patients will answer a questionnaire regarding lifestyle (diet, exercise, sleep and work), psychosocial factors (stress, depression and social support) and PRO (symptoms and QOL). Information on practice patterns (eg, medications, endoscopy frequency) will be collected from electronic medical records. Gaps between patients’ needs and healthcare professionals’ practice will be identified. Follow-up surveys will be conducted periodically for approximately 3 years. Research questions suggested by patients and healthcare professionals may be used in subsequent surveys. Results from the YOURS study will demonstrate optimal UC management strategies to improve relevant outcomes.The study was approved by the ethics committees of five investigational sites before starting the study. The results will be submitted to journals.UMIN000031995.

BACKGROUND:Older adults' discussions with family, or with physicians, or with both, about advance care planning (ACP) are increasingly regarded as important for the management of end-of-life care, and yet the factors that induce older adults to engage in ACP discussions are poorly understood. For example, in older adults, is stronger connectedness with family and friends (stronger "networks") associated with ACP discussions? By facilitating, or by impeding ACP discussions? We sought to evaluate the associations between ACP discussions and social networks in Japanese older adults. METHODS:In July 2016 we conducted a cross-sectional survey on 355 community-dwelling patients aged ≥65 years visiting community hospital clinics in Fukushima, Japan. We used the Lubben Social Network Scale (LSNS-6, the shortest available LSNS scale) to assess social networks and recorded two components of social network structure, marital status (dichotomized as "married" vs. "single / other") and living status ("living with others" vs. "living alone"). One item asked if patients had had ACP discussions. We analyzed the LSNS-6 social network and marital and living status data in relation to the occurrence of ACP discussions using multiple logistic regression models with adjustments for possible confounding factors. RESULTS:Respondents' social network was "limited" in 16% of cases; 61% had had ACP discussions. Respondents with a limited social network had a significantly lower tendency to have had ACP discussions than respondents with an "adequate" social network (adjusted odds ratio [AOR]: 0.35; 95% confidence interval [CI]: 0.18-0.66; P < 0.001). Marital status and living status were not significantly associated with ACP discussion. CONCLUSIONS:Among Japanese older adults, weaker social networks may be associated with a lower tendency to discuss ACP. Our findings may help practitioners to quickly screen populations at risk for inadequate ACP discussion by using the LSNS-6.

Vehicles can be classified by configuration as either bonnet-type or cab-over type according to engine location. Compared to bonnet-type, the front compartment of cab-over type vehicles is considerably shorter; thus, it may be less likely to absorb the energy generated in a collision, and in turn be unable to prevent deformation of the occupant space and protect occupants from injury. This study was a cohort study involving 943 occupants of mini-vehicles who were injured in frontal collision accidents between 2001 and 2015 and transferred to Ohta Nishinouchi Hospital. The vehicle configuration was divided into bonnet-type and cab-over type (i.e., truck-type and wagon-type). The tested outcomes were anatomical-specific severe injury of the pelvis and extremities, the head and neck, the abdomen, and the chest. To estimate adjusted odds ratios (AOR) for associations between vehicle configuration and anatomical-specific severe injury, we fitted generalized estimating equations for each outcome. Compared with bonnet-type vehicles, a greater risk of serious pelvis and extremities injury was found for both truck (AOR: 2.21; 95% Confidence Interval [95% CI]: 1.22-4.00) and wagon-type vehicles (AOR: 3.43; 95%CI 1.60-7.39). For serious head and neck injury, truck-type vehicles were associated with greater risk (AOR: 2.04; 95% CI: 1.10-3.79) than bonnet-type vehicles, whereas wagon-type vehicles were not. Compared with the occupants of bonnet-type vehicles, cab-over type vehicle occupants were more likely to have serious pelvis and extremities injury during frontal collisions. Additionally, truck-type vehicle occupants were more likely to have serious head and neck injury than bonnet-type vehicle occupants. These findings are expected to promote safer behaviors for vehicle occupants and the automobile industry.

ObjectivesTo elucidate the effect of cinacalcet use on all-cause and cause-specific hospitalization outcomes using a prospective cohort of maintenance hemodialysis patients.MethodsWe used data from a prospective cohort of Japanese hemodialysis patients with secondary hyperparathyroidism and examined baseline characteristics as well as longitudinal changes. All patients were cinacalcet-naïve at study enrollment. Further, we used a marginal structural model to account for time-varying confounders on cinacalcet initiation and hospitalization outcomes, and an Andersen-Gill-type recurrent event model to account for any recurring events of hospitalization in the outcome analysis using the weighted dataset.ResultsAmong the 3,276 patients, cinacalcet treatment was initiated in 1,384 patients during the entire follow-up. Cinacalcet users were slightly younger, included more patients with chronic glomerulonephritis and fewer patients with diabetes, were more likely to have a history of parathyroidectomy, and were more often used receiving vitamin D receptor activator, phosphate binders, and iron supplements. The overall hospitalization analysis yielded a hazard ratio (HR) of 0.97 (95% confidence interval [CI]: 0.80, 1.18). A trend toward a mild protective association was observed for cardiovascular-related hospitalizations (HR: 0.85; 95% CI: 0.64, 1.14). In the subgroup analysis, a protective association was seen due to cinacalcet use for infection-related hospitalizations in the lowest intact parathyroid hormone group (HR: 0.36; 95% CI: 0.14, 0.95).ConclusionsCinacalcet initiation in patients on maintenance hemodialysis had no effect on all-cause and cause-specific hospitalizations. Although the overall association was statistically not significant, cinacalcet may have a protective association on cardiovascular-related hospitalization in all patients and infection-related hospitalization in patient with low intact parathyroid hormone.

BACKGROUND:Although cancer management in dialysis patients has become a commonly encountered issue, known as "onco-nephrology", few evidence-based clinical recommendations have been proposed. Here, we examined the variation in referral behaviors adopted by dialysis physicians on encountering dialysis patients with signs/symptoms suggestive of cancer. METHODS:We conducted a vignette-based study in August 2015. We sent a 14-page questionnaire to 191 dialysis physicians, including the representative dialysis facilities participating in a Japanese dialysis cohort (the Japan Dialysis Outcomes and Practice Patterns Study). Using vignette scenarios for respiratory, digestive, and urological areas, we assessed the referral behaviors (expert referral or not) adopted by dialysis physicians on encountering dialysis patients with symptoms suggestive of cancer. Each scenario contained three patient functional factors: age (60 or 75 years), performance status (PS 0 or 1), and cognitive dysfunction (absence or presence). We examined the association between physician factors, patient factors, and referral behaviors. RESULTS:We obtained 94 replies (response rate: 49.2%). For the respiratory scenarios, 38.3% and 51.9% of physicians reported watchful waiting when encountering bilateral and unilateral pleural effusion, respectively. In digestive and urologic scenarios, most physicians (>85%) selected expert referral. We detected differences in referral behaviors between scenarios with different cancer biological factors. However, we found consistency in referral behaviors within the same scenario, even with different patient functional factors (intra-class correlation coefficients within each scenario all >0.7). CONCLUSIONS:Physicians' referral behaviors for dialysis patients suspected of having cancer vary for different cancer biological factors (probability of having cancer). However, the referral behaviors are similar for different patient functional factors (age, PS, and cognitive dysfunction).

Falls and fall-related fractures are a major public health problem among the older adults. Although objective measures of poor vision have been reported to be associated with falls, the association of self-reported visual function and vision-specific quality of life (QOL) with falls has been inconsistent across several studies. We investigated the association of self-reported visual function and vision specific QOL with falls in community-dwelling older adults.We conducted a cross-sectional analysis using the baseline data from participants of the Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS), which is an ongoing population-based cohort study to evaluate the association of physical dysfunction with the clinical outcomes in community-dwelling people. In the present study, the participants aged over 65 years in 2010 were eligible. The exposure variable was the composite score of the VFQ-J11, which was newly developed using item response theory to evaluate vision specific QOL, and the self-reported outcomes were any fall and frequent falls (≥2) over a 1-month period. We estimated odds ratios using separate logistic regression models adjusted for relevant confounding factors.Among 1624 participants, the median (interquartile range) composite score of VFQ-J11 was 86.8 (76.0-95.9). Any fall and frequent falls were reported by 13.9% and 5.4% of participants, respectively. The composite score of the VFQ-J11 was significantly associated with both frequent falls (adjusted ORs per 10 points, 0.80; 95% CI, 0.68-0.93) and any fall (adjusted ORs per 10 points, 0.84; 95% CI, 0.76-0.94).We found that the composite score of the VFQ-J11 was associated with falls in community-dwelling older adults. Detecting individuals with visual impairments associated with falls using the VFQ-J11 and improvement in the score by interventions could prevent falls. We may consider adding self-reported visual function and vision-specific QOL to conventional risk factors for fall among older adults.

Hemodialysis patients are exposed to disease- and treatment-related stresses, and use various coping strategies to deal with these stresses. Although some studies have reported the association of coping strategies with mortality or health-related quality of life (QOL) in some populations, the effect of coping strategies on clinical outcomes in hemodialysis patients remains unclear. We investigated the association in a longitudinal design among Japanese hemodialysis patients.We examined Japanese hemodialysis patients who participated in the Dialysis Outcomes and Practice Patterns Study (DOPPS) IV, which was conducted between 2009 and 2012. The exposure variable was stress coping strategy, as assessed using subscales in Coping Strategies Inventory Short Form: problem-focused engagement, problem-focused disengagement, emotion-focused engagement, and emotion-focused disengagement. Hazard ratios were estimated using Cox proportional hazard model for all-cause mortality and mean differences for change in health-related QOL in 1 year were estimated using a regression model.Among 1,354 patients, only problem-focused engagement was significantly associated with longer survival; other subscales were not associated with all-cause mortality after adjustment for potential confounding factors. In terms of health-related QOL, the subscale of problem-focused engagement was also associated with improvement in physical functioning and mental health among 1,045 patients. Emotion-focused disengagement was associated with deterioration in mental health, but not with change in physical functioning. The other subscales were not associated with change in physical functioning or mental health.Among hemodialysis patients, "problem-focused engagement" coping strategies were associated with longer survival and also with improvement in physical functioning and mental health. To achieve greater longevity and improve QOL in hemodialysis patients under ongoing stresses, problem-focused engagement should be encouraged.

To our knowledge, no reliable clinical prediction rule (CPR) for identifying bacteremia in hemodialysis (HD) patients has been established. The aim of this study was to develop a CPR for bacteremia in maintenance HD patients visiting the outpatient department.This multicenter cohort study involved consecutive maintenance HD patients who visited the outpatient clinic or emergency room of seven Japanese institutions between August 2011 and July 2013. The outcome measure was bacteremia diagnosed based on the results of blood cultures. The candidate predictors for bacteremia were extracted through a literature review. A CPR for bacteremia was developed using a coefficient-based multivariable logistic regression scoring method, and calibration was performed. The test performance was then assessed for the CPR.Of 507 patients eligible for the study, we analyzed the 293 with a complete dataset for candidate predictors. Of these 293 patients, 48 (16.4%) were diagnosed with bacteremia. At the conclusion of the deviation process, body temperature ≥ 38.3°C, heart rate ≥ 125 /min, C-reactive protein ≥ 10 mg/dL, alkaline phosphatase >360 IU/L, and no prior antibiotics use within the past week were retained and scored. The CPR had a good fit for the model on calibration. The AUC of the CPR was 0.76, and for score CPR ≥ 2, the sensitivity and specificity were 89.6% and 51.4%, respectively.We established a simple CPR for bacteremia in maintenance HD patients using routinely obtained clinical information in an outpatient setting. This model may facilitate more appropriate clinical decision making.

[This corrects the article DOI: 10.1371/journal.pone.0169975.].

BACKGROUND:Cardiovascular (CV) events are the primary cause of death and becoming bedridden among hemodialysis (HD) patients. The Framingham risk score (FRS) is useful for predicting incidence of CV events in the general population, but is considerd to be unsuitable for the prediction of the incidence of CV events in HD patients, given their characteristics due to atypical relationships between conventional risk factors and outcomes. We therefore aimed to develop a new prognostic prediction model for prevention and early detection of CV events among hemodialysis patients. METHODS:We enrolled 3,601 maintenance HD patients based on their data from the Japan Dialysis Outcomes and Practice Patterns Study (J-DOPPS), phases 3 and 4. We longitudinaly assessed the association between several potential candidate predictors and composite CV events in the year after study initiation. Potential candidate predictors included the component factors of FRS and other HD-specific risk factors. We used multivariable logistic regression with backward stepwise selection to develop our new prediction model and generated a calibration plot. Additinially, we performed bootstrapping to assess the internal validity. RESULTS:We observed 328 composite CV events during 1-year follow-up. The final prediction model contained six variables: age, diabetes status, history of CV events, dialysis time per session, and serum phosphorus and albumin levels. The new model showed significantly better discrimination than the FRS, in both men (c-statistics: 0.76 for new model, 0.64 for FRS) and women (c-statistics: 0.77 for new model, 0.60 for FRS). Additionally, we confirmed the consistency between the observed results and predicted results using the calibration plot. Further, we found similar discrimination and calibration to the derivation model in the bootstrapping cohort. CONCLUSIONS:We developed a new risk model consisting of only six predictors. Our new model predicted CV events more accurately than the FRS.

Socioeconomic status (SES) factors such as employment, educational attainment, income, and marital status can affect the health and well-being of the general population and have been associated with the prevalence of chronic kidney disease (CKD). However, no studies to date in Japan have reported on the prognosis of patients with CKD with respect to SES. This study aimed to investigate the influences of employment and education level on mortality and hospitalization among maintenance hemodialysis (HD) patients in Japan.Data on 7974 HD patients enrolled in Dialysis Outcomes and Practice Patterns Study phases 1-4 (1999-2011) in Japan were analysed. Employment status, education level, demographic data, and comorbidities were abstracted at entry into DOPPS from patient records. Mortality and hospitalization events were collected during follow-up. Patients on dialysis < 120 days at study entry were excluded from the analyses. Cox regression modelled the association between employment and both mortality and hospitalization among patients < 60 years old. The association between education and outcomes was also assessed. The association between patient characteristics and employment among patients < 60 years old was assessed using logistic regression.During a median follow-up of 24.9 months (interquartile range, 18.4-32.0), 10% of patients died and 43% of patients had an inpatient hospitalization. Unemployment was associated with mortality (hazard ratio [HR] = 1.57; 95% confidence interval [CI]: 1.05-2.36) and hospitalization (HR = 1.25; 95% CI: 1.08-1.44). Compared to patients who graduated from university, patients with less than a high school (HS) education and patients who graduated HS with some college tended to have elevated mortality (HR = 1.41; 95% CI, 1.04-1.92 and HR = 1.36; 95% CI: 1.02-1.82, respectively) but were not at risk for increased hospitalizations. Factors associated with unemployment included lower level of education, older age, female gender, longer vintage, and several comorbidities.Employment and education status were inversely associated with mortality in patients on maintenance HD in Japan. Employment but not education was also inversely associated with hospitalizations. After adjustment for comorbidities, the associations with clinical outcomes tended to be stronger for employment than education status.

Health-related quality of life (HRQOL) is often prioritized over long-term survival in elderly patients. Although a longer dialysis session length (DSL) has been shown to reduce mortality, its effects on improving the HRQOL are unknown.Using data from the Japan Dialysis Outcomes and Practice Patterns Study (J-DOPPS), patients aged ≥ 65 years on maintenance hemodialysis were enrolled. DSL was categorized as short (240 minutes). The primary outcomes were changes in mental health (ΔMH) and physical functioning (ΔPF) scores assessed using the Japanese version of SF-12, in one year. The differences in the ΔMH and ΔPF among the three groups were assessed via regression (beta) coefficients derived using a linear regression model.Of 1,187 patients at baseline, 319 (26.9%) had a short length, 686 (57.8%) a medium length, and 182 (15.3%) a long length. We assessed the ΔMH data from 793 patients and the ΔPF data from 738. No significant differences in the ΔMH were noted for the short or long groups compared with the medium group (score difference: 0.26, 95% confidence interval [CI]: -4.17 to 4.69 for short; score difference: -1.15, 95% CI: -6.17 to 3.86 for long). Similarly, no significant differences were noted for these groups versus the medium group in ΔPF either (score difference: -1.43, 95% CI: -6.73 to 3.87 for short; score difference: -1.71, 95% CI: -7.63 to 4.22 for long).A shorter DSL might have no adverse effects on MH or PF for elderly patients.

Anemia is an important prognostic factor in hemodialysis patients. It has been reported that parathyroidectomy ameliorates anemia and reduces the requirement of postoperative erythropoiesis-stimulating agents. The objective of this study was to assess the effect of cinacalcet, which is considered as a pharmacological parathyroidectomy, on anemia in hemodialysis patients.We used data from a prospective cohort of Japanese hemodialysis patients with secondary hyperparathyroidism; the criteria were: intact parathyroid hormone concentrations ≥ 180 pg/mL or use of an intravenous or oral vitamin D receptor activator. All patients were cinacalcet-naïve at study enrollment. The main outcome measure was achievement of the target hemoglobin level (≥10.0 g/dL), which was measured repeatedly every 6 months. Cinacalcet exposure was defined as cumulative time since initiation. Both conventional longitudinal models and marginal structural models were adjusted for confounding factors.Among 3,201 cinacalcet-naïve individuals at baseline, cinacalcet was initiated in 1,337 individuals during the follow up. Cinacalcet users were slightly younger; included more patients with chronic glomerulonephritis and fewer with diabetes; were more likely to have a history of parathyroidectomy; and were more often on activated vitamin D agents, phosphate binders, and iron supplements. After adjusting for both time-invariant and time-varying potential confounders, including demographics, comorbidities, comedications, and laboratory values, each additional 6-month duration on cinacalcet was associated with a 1.1-fold increase in the odds of achieving the target hemoglobin level.Cinacalcet may improve anemia in chronic hemodialysis patients with secondary hyperparathyroidism, possibly through pathways both within and outside the parathyroid hormone pathways. Further investigations are warranted to delineate the roles of cinacalcet not only in the management of chronic kidney disease-mineral and bone disorder but also in anemia control.

OBJECTIVES:(1) To develop a clinical prediction rule to identify patients with bacteremia, using only information that is readily available in the emergency room (ER) of community hospitals, and (2) to test the validity of that rule with a separate, independent set of data. DESIGN:Multicenter retrospective cohort study. SETTING:To derive the clinical prediction rule we used data from 3 community hospitals in Japan (derivation). We tested the rule using data from one other community hospital (validation), which was not among the three "derivation" hospitals. PARTICIPANTS:Adults (age ≥ 16 years old) who had undergone blood-culture testing while in the ER between April 2011 and March 2012. For the derivation data, n = 1515 (randomly sampled from 7026 patients), and for the validation data n = 467 (from 823 patients). ANALYSIS:We analyzed 28 candidate predictors of bacteremia, including demographic data, signs and symptoms, comorbid conditions, and basic laboratory data. Chi-square tests and multiple logistic regression were used to derive an integer risk score (the "ID-BactER" score). Sensitivity, specificity, likelihood ratios, and the area under the receiver operating characteristic curve (i.e., the AUC) were computed. RESULTS:There were 241 cases of bacteremia in the derivation data. Eleven candidate predictors were used in the ID-BactER score: age, chills, vomiting, mental status, temperature, systolic blood pressure, abdominal sign, white blood-cell count, platelets, blood urea nitrogen, and C-reactive protein. The AUCs was 0.80 (derivation) and 0.74 (validation). For ID-BactER scores ≥ 2, the sensitivities for derivation and validation data were 98% and 97%, and specificities were 20% and 14%, respectively. CONCLUSIONS:The ID-BactER score can be computed from information that is readily available in the ERs of community hospitals. Future studies should focus on developing a score with a higher specificity while maintaining the desired sensitivity.

Dental practice income and expenses according to treatment types were compared in order to obtain information for cost accounting of dental treatments and to establish successful management methods for dental treatments in order to improve the balance of dental clinics. The results of our study are as follows: (1) For class I restoration for molars, the balance of inlay restoration was higher than that of CR filling, while the balance per minute for CR filling was higher than that for inlay restoration. Inlay restoration would be more profitable for dental clinics with a relatively small number of patients, whereas for clinics with many patients, composite resin filling would be more profitable to increase income. (2) There is a need for a system to increase the number of patients receiving regular dental check-ups. (3) It is important to train dental hygienists to perform regular dental check-ups. (4) There is a need to reconsider the present medical fee points for oral hygiene instruction and root canal treatment because their balance per minute is quite low. (5) It is important to establish a system to increase the number of patients who choose non-insured treatment for crown restorations in order to increase the management balance of dental clinics in Japan.

Patients with chronic kidney disease, especially those undergoing dialysis treatment and having secondary hyperparathyroidism, have a high risk of bone fracture. The renin-angiotensin system (RAS) is associated with osteoclastic bone resorption. We aimed to examine whether the use of RAS inhibitors reduces the incidence of fracture in hemodialysis patients.This was a multicenter, 3-year, prospective, observational study. From 2008 to 2011, maintenance hemodialysis patients with secondary hyperparathyroidism (N = 3,276) treated with angiotensin converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB) at baseline were followed for a mean of 2.7 years. The association between the use of ACEI/ARB and hospitalization rate owing to fracture was examined by using Cox regression models. Effect modifications by the severity of secondary hyperparathyroidism (intact parathyroid hormone [iPTH] level), sex, and systolic blood pressure were also examined. The incidence proportion of fracture-related hospitalization was 5.42% throughout the observation period. ACEI/ARB use was associated with a lower rate of fracture-related hospitalization (adjusted hazard ratio, 0.65; 95% confidence interval [CI], 0.45-0.92). This association was not significantly affected by sex (P = 0.56) or systolic blood pressure levels (P = 0.87). The hazard ratios adjusted by iPTH levels were qualitatively different, but not statistically significant (P = 0.11): 0.77 (95% CI, 0.42-1.39), 0.38 (95% CI, 0.20-0.73), 0.59 (95% CI, 0.29-1.21), and 1.29 (95% CI, 0.58-2.42) for the first, second, third and fourth quartiles of iPTH, respectively.Use of RAS inhibitors is associated with a lower rate of fracture-related hospitalization in hemodialysis patients with secondary hyperparathyroidism.ClinicalTrials.gov NCT00995163.

Digital rectal examination (DRE) has been traditionally recommended to evaluate acute appendicitis, although several reports indicate its lack of utility for this diagnosis. No meta-analysis has examined DRE for diagnosis of acute appendicitis.To assess the role of DRE for diagnosis of acute appendicitis.Cochrane Library, PubMed, and SCOPUS from the earliest available date of indexing through November 23, 2014, with no language restrictions.Clinical studies assessing DRE as an index test for diagnosis of acute appendicitis.Two independent reviewers extracted study data and assessed the quality, using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Bivariate random-effects models were used for the pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio (DOR) as point estimates with 95% confidence intervals (CI).The main outcome measure was the diagnostic performance of DRE for diagnosis of acute appendicitis.We identified 19 studies with a total of 7511 patients. The pooled sensitivity and specificity were 0.49 (95% CI 0.42-0.56) and 0.61 (95% CI 0.53-0.67), respectively. The positive and negative likelihood ratios were 1.24 (95% CI 0.97-1.58) and 0.85 (95% CI 0.70-1.02), respectively. The DOR was 1.46 (0.95-2.26).Acute appendicitis cannot be ruled in or out through the result of DRE. Reconsideration is needed for the traditional teaching that rectal examination should be performed routinely in all patients with suspected appendicitis.

Little is known about actual dietary patterns and their associations with clinical outcomes in hemodialysis patients. We identified dietary patterns in hemodialysis patients in Japan and examined associations between dietary patterns and clinical outcomes.We used data from 3,080 general-population participants in the Hisayama study (year 2007), and data from 1,355 hemodialysis patients in the Japan Dialysis Outcomes and Practice Patterns Study (JDOPPS: years 2005-2007). Food intake was measured using a brief self-administered diet-history questionnaire (BDHQ). To identify food groups with the Hisayama population data, we used principal components analysis with Promax rotation. We adjusted the resulting food groups for total daily energy intake, and then we used those adjusted food-group scores to identify dietary patterns in the JDOPPS patients by cluster analysis (Ward's method). We then used Cox regression to examine the association between dietary patterns and a composite of adverse clinical outcomes: hospitalization due to cardiovascular disease or death due to any cause.We identified three food groups: meat, fish, and vegetables. Using those groups we then identified three dietary patterns: well-balanced, unbalanced, and other. After adjusting for potential confounders, we found an association between an unbalanced diet and important clinical events (hazard ratio 1.90, 95% C.I. 1.19-3.04).Hemodialysis patients whose diet was unbalanced were more likely to have adverse clinical outcomes. Thus hemodialysis patients might benefit not only from portion control, but also from a diet that is well-balanced diet with regard to the food groups identified here as meat, fish, and vegetables.

PURPOSE: In clinical ophthalmology as in other fields, measuring patient-reported outcomes imposes a burden on patients. To decrease that burden, we used item-response theory (IRT) to develop and test a short version of the National Eye Institute's Visual Function Questionnaire (VFQ). METHODS: We analyzed VFQ data from 276 adults in Japan. Most of them had glaucoma, cataract, or macular degeneration. Their visual acuity (Snellen fraction) averaged 20/120 (range: 20/13 to 20/2000) for the better eye, and 20/200 (range: 20/13 to 20/2000) for the worse eye. We used a polytomous IRT model, the Generalized Partial Credit Model as implemented in software for parameter scaling of rating data (PARSCALE). To select items for inclusion in the short version we examined each item's location on the latent-trait continuum, its slope, and its frequency of missing data. We also ensured representation of all 7 domains that are important in Japan. To examine the characteristics of the resulting scale, we computed its test information (an index of precision that can vary with the value of the latent trait), and carried out validation testing. RESULTS: From 32 of the original VFQ items, we selected 11. The scale comprising those 11 items (the VFQ-J11) had test information greater than 9 for values of the latent trait between -2.0 and +0.8. The item thresholds were well-targeted for patients with vision problems. Scores on the VFQ-J11 correlated strongly and in the expected direction with measures of visual field and corrected visual acuity. As expected for a valid measure, those scores also improved by a large amount (almost one standard deviation) after cataract surgery. CONCLUSION: This 11-item instrument can provide reliable and the valid data on visual functioning in patients with ophthalmic problems. It is expected to be less of a burden on respondents, while it maintains good psychometric properties.

The presence of hope has been found to influence an individual's ability to cope with stressful situations. The objective of this study is to evaluate the relationship between medical errors, hope and burnout among practicing physicians using validated metrics. Prospective cohort study was conducted among hospital based physicians practicing in Japan (N = 836). Measures included the validated Burnout Scale, self-assessment of medical errors and Herth Hope Index (HHI). The main outcome measure was the frequency of self-perceived medical errors, and Poisson regression analysis was used to evaluate the association between hope and medical error. A total of 361 errors were reported in 836 physician-years. We observed a significant association between hope and self-report of medical errors. Compared with the lowest tertile category of HHI, incidence rate ratios (IRRs) of self-perceived medical errors of physicians in the highest category were 0.44 (95%CI, 0.34 to 0.58) and 0.54 (95%CI, 0.42 to 0.70) respectively, for the 2(nd) and 3(rd) tertile. In stratified analysis by hope score, among physicians with a low hope score, those who experienced higher burnout reported higher incidence of errors; physicians with high hope scores did not report high incidences of errors, even if they experienced high burnout. Self-perceived medical errors showed a strong association with physicians' hope, and hope modified the association between physicians' burnout and self-perceived medical errors.

BACKGROUND: Many patients with chronic kidney disease (CKD) suffer from fatigue caused by anemia, but that anemia can be reversed. Successful treatment can be measured as a decrease in fatigue and an increase in energy or vitality, particularly on the vitality (VT) subscale of the SF-36. Changes in VT scores are most commonly interpreted in terms of minimally important differences or standardized effect sizes, but neither a minimally important difference nor a standardized effect size provides information about how patients' activities are affected. Therefore, we analyzed the association between differences in VT scores and a variable that is meaningful to patients and to society the frequency of going out. STUDY DESIGN: Questionnaire survey. Analyses of differences among participants at baseline, and analyses of differences within participants over time. SETTING AND PARTICIPANTS: CKD patients who were not on dialysis and were involved in a study of anti-anemia therapy. PREDICTOR: VT scores. OUTCOME: Frequency of going out. MEASUREMENTS: VT scores and the frequency of going out. RESULTS: At baseline, higher VT scores and younger age were associated with going out more often, while sex and the presence of diabetic nephropathy were not associated with the frequency of going out. Greater changes in VT scores over time were associated with greater changes in the frequency of going out, in univariate and multivariate analyses. CONCLUSIONS: At baseline, VT was associated with the frequency of going out. Increases in VT were also associated with increases in the frequency of going out. These results show how VT scores can be linked to daily activities that are important to individual patients and to society.