Institute for Health Outcomes and Process Evaluation Research IHope International

Kyoto, Japan

Institute for Health Outcomes and Process Evaluation Research IHope International

Kyoto, Japan

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PubMed | Sapporo Kita Clinic, Fukushima Medical University, Data and Society, University of Tokyo and 2 more.
Type: Journal Article | Journal: PloS one | Year: 2016

Although dialysis is typically started in an effort to prolong survival, mortality is reportedly high in the first few months. However, it remains unclear whether this is true in Japanese patients who tend to have a better prognosis than other ethnicities, and if health conditions such as functional status (FS) at initiation of dialysis influence prognosis.We investigated the epidemiology of early death and its association with FS using Japanese national registry data in 2007, which included 35,415 patients on incident dialysis and 7,664 with FS data. The main outcome was early death, defined as death within 3 months after initiation of hemodialysis (HD). The main predictor was FS at initiation of HD. Levels of functional disability were categorized as follows: severe (bedridden), moderate (overt difficulties in exerting basic activities of daily living), or mild/none (none or some functional disabilities).Early death remained relatively common, especially among elderly patients (overall: 7.1%; those aged 80 years: 15.8%). Severely and even only a moderately impaired FS were significantly associated with early death after starting dialysis (adjusted risk ratios: 3.93 and 2.38, respectively). The incidence of early death in those with impaired FS increased with age (36.5% in those with severely impaired FS and aged 80 years).Early death after starting dialysis was relatively common, especially among the elderly, even in Japanese patients. Further, early death was significantly associated with impaired FS at initiation of HD.


Nakaya I.,Iwate Prefectural Central Hospital | Namikoshi T.,Fukuyama City Hospital | Tsuruta Y.,Tokyo Women's Medical University | Nakata T.,Oita University | And 3 more authors.
Nephrology | Year: 2011

Aim: Hyperuricaemia is associated with chronic kidney disease (CKD) progression and cardiovascular events (CVE). In a US study, only 4% of rheumatologists initiated urate-lowering therapy in patients with asymptomatic hyperuricaemia (AHU). The present study aimed to clarify how Japanese board-certified nephrologists manage AHU in CKD patients. Methods: Questionnaires on management of AHU in CKD stage 3 or more were mailed to 1500 Japanese board-certified nephrologists, excluding paediatricians and urologists, randomly selected from the directory of the Japanese Society of Nephrology (n = 2976). Results: Five hundred and ninety-five nephrologists (40%) responded. Most nephrologists (84-89%) recommended that AHU in patients in CKD stages 3-5 should be treated, but fewer nephrologists (63%) recommended that AHU in patients of CKD stage 5D should be treated. The serum urate level to start urate-lowering therapy and the target serum urate level to be achieved (mg/dL) were 8.2 ± 0.9 and 6.9 ± 0.9, 8.4 ± 0.9 and 7.0 ± 1.0, 8.6 ± 1.0 and 7.3 ± 1.1, and 9.1 ± 1.2 and 7.8 ± 1.3 at stages 3, 4, 5 and 5D, respectively. The most frequently used maximal dosage of allopurinol was 100 mg/day at each stage. Benzbromarone was used in 52% of patients at stage 3, but only in 29%, 13% and 5% of patients at stages 4, 5 and 5D, respectively. The most important reasons to treat AHU at CKD stages 3-5 were prevention of CKD progression (45%), CVE (33%), gout (18%) and urolithiasis (3%). Conclusion: Most Japanese nephrologists treat AHU in pre-dialysis CKD with an aim to prevent CKD progression or CVE mainly by allopurinol. This large survey of Japanese nephrologists has identified the widespread practice of treating asymptomatic hyperuricaemia in stage 3-5 chronic kidney disease (CKD) patients, despite absence of controlled trial evidence of benefit for this practice. This study identifies a need for clinical trials to address the management of hyperuricaemia in patients with advanced CKD. © 2011 Asian Pacific Society of Nephrology.


PubMed | Anjo Kosei Hospital, Fukushima Medical University, Niigata University, Hiroshima University and 2 more.
Type: Journal Article | Journal: PloS one | Year: 2015

Few risk scores are available for predicting mortality in chronic kidney disease (CKD) patients undergoing predialysis nephrology care. Here, we developed a risk score using predialysis nephrology practice data to predict 1-year mortality following the initiation of haemodialysis (HD) for CKD patients.This was a multicenter cohort study involving CKD patients who started HD between April 2006 and March 2011 at 21 institutions with nephrology care services. Patients who had not received predialysis nephrology care at an estimated glomerular filtration rate (eGFR) of approximately 10 mL/min per 1.73 m2 were excluded. Twenty-nine candidate predictors were selected, and the final model for 1-year mortality was developed via multivariate logistic regression and was internally validated by a bootstrapping technique.A total of 688 patients were enrolled, and 62 (9.0%) patients died within one year of HD initiation. The following variables were retained in the final model: eGFR, serum albumin, calcium, Charlson Comorbidity Index excluding diabetes and renal disease (modified CCI), performance status (PS), and usage of erythropoiesis-stimulating agent (ESA). Their -coefficients were transformed into integer scores: three points were assigned to modified CCI3 and PS 3-4; two to calcium>8.5 mg/dL, modified CCI 1-2, and no use of ESA; and one to albumin<3.5 g/dL, eGFR>7 mL/min per 1.73 m2, and PS 1-2. Predicted 1-year mortality risk was 2.5% (score 0-4), 5.5% (score 5-6), 15.2% (score 7-8), and 28.9% (score 9-12). The area under the receiver operating characteristic curve was 0.83 (95% confidence interval, 0.79-0.89).We developed a simple 6-item risk score predicting 1-year mortality after the initiation of HD that might help nephrologists make a shared decision with patients and families regarding the initiation of HD.


Akizawa T.,Showa University | Kido R.,Institute for Health Outcomes and Process Evaluation Research iHope International | Kido R.,Kyoto University | Fukagawa M.,Tokai University | And 7 more authors.
Clinical Journal of the American Society of Nephrology | Year: 2011

Background and objectives: Control of serum concentrations of calcium (Ca), phosphorus (P), and parathyroid hormone (PTH) is essential for management of secondary hyperparathyroidism (SHPT). Design, setting, participants, & measurements: This is a planned interim analysis of a longitudinal cohort study. The settings are dialysis facilities in Japan. Eligible patients comprise all those who were receiving hemodialysis at one of 86 participating facilities and who have SHPT. Using data from a random sample (n = 3276) of the participants from January 2008 through June 2009, we measured changes in the percentages of patients who were within the national guideline-specified target ranges of Ca (8.4 to 10 mg/dl), P (3.5 to 6.0 mg/dl), and intact PTH (iPTH) (60 to 180 pg/ml), and changes in prescriptions of drugs targeting SHPT. We used regression models to identify factors affecting the achievement of the guideline-specified targets. Results: There were no notable changes in the percentage of patients who were within the guideline for Ca, P, or both. The percentage who were within the iPTH guideline increased from 14.5% to 43.3% (P < 0.001). There were no remarkable changes in the percentage of patients receiving vitamin D or phosphate binders. The percentage who received cinacalcet increased from 0% to 29%. Prescription of cinacalcet was associated with improvement or target-achievement for iPTH and for Ca by 16.8 percentage points (95% CI: 8.1 to 17.0) and by 12.6 percentage points (13.7 to 19.9), respectively. Conclusions: In the routine care of hemodialysis patients, increasing use of cinacalcet was associated with better control of SHPT. © 2011 by the American Society of Nephrology.


Fukuma S.,Kyoto University | Fukuma S.,Institute for Health Outcomes and Process Evaluation Research IHope International | Kurita N.,Kyoto University | Kurita N.,Institute for Health Outcomes and Process Evaluation Research IHope International | And 4 more authors.
Kidney International Supplements | Year: 2013

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. © 2013 International Society of Nephrology.


PubMed | Fukushima Medical University, National Cerebral and Cardiovascular Center, Saga University, Kyoto University and Institute for Health Outcomes and Process Evaluation Research IHope International
Type: Journal Article | Journal: Age and ageing | Year: 2015

no study has examined the longitudinal association between hand-grip strength and mental health, such as depressive symptoms.we investigated the relationship between baseline hand-grip strength and the risk of depressive symptoms.a prospective cohort study.a prospective cohort study with a 1-year follow-up was conducted using 4,314 subjects from community-dwelling individuals aged 40-79 years in two Japanese municipalities, based on the Locomotive Syndrome and Health Outcomes in Aizu Cohort Study (LOHAS, 2008-10).we assessed baseline hand-grip strength standardised using national representative data classified by age and gender, and depressive symptoms at baseline and after the follow-up using the five-item version of the Mental Health Inventory (MHI-5).the 4,314 subjects had a mean age of 66.3 years, 58.5% were women, and mean unadjusted hand-grip strength was 29.8 kg. Multivariable random-effect logistic regression analysis revealed that subjects with lower hand-grip strength (per 1SD decrease) had higher odds of having depressive symptoms at baseline [adjusted odds ratio (AOR) 1.15, 95% confidence interval (CI) 1.06-1.24; P = 0.001]. Further, lower hand-grip strength (per 1SD decrease) was associated with the longitudinal development of depressive symptoms after 1 year (AOR 1.13, 95% CI 1.01-1.27; P = 0.036).using a large population-based sample, our results suggest that lower hand-grip strength, standardised using age and gender, is both cross-sectionally and longitudinally associated with depressive symptoms.


PubMed | Fukushima Medical University, Showa University, National Graduate Institute for Policy Studies, Institute for Health Outcomes and Process Evaluation Research iHope International and 2 more.
Type: | Journal: Scientific reports | Year: 2016

Cinacalcet lowers parathyroid hormone levels. Whether it can prolong survival of people with chronic kidney disease (CKD) complicated by secondary hyperparathyroidism (SHPT) remains controversial, in part because a recent randomized trial excluded patients with iPTH <300 pg/ml. We examined cinacalcets effects at different iPTH levels. This was a prospective case-cohort and cohort study involving 8229 patients with CKD stage 5D requiring maintenance hemodialysis who had SHPT. We studied relationships between cinacalcet initiation and important clinical outcomes. To avoid confounding by treatment selection, we used marginal structural models, adjusting for time-dependent confounders. Over a mean of 33 months, cinacalcet was more effective in patients with more severe SHPT. In patients with iPTH 500 pg/ml, the reduction in the risk of death from any cause was about 50% (Incidence Rate Ratio [IRR]= 0.49; 95% Confidence Interval [95% CI]: 0.29-0.82). For a composite of cardiovascular hospitalization and mortality, the association was not statistically significant, but the IRR was 0.67 (95% CI: 0.43-1.06). These findings indicate that decisions about using cinacalcet should take into account the severity of SHPT.


PubMed | Showa University, Institute for Health Outcomes and Process Evaluation research iHope International, Fukushima Medical University and Osaka City University
Type: | Journal: Clinical and experimental nephrology | Year: 2016

Serum ferritin concentration >100ng/mL was associated with a higher risk of death in hemodialysis patients in Japan, whereas such an association was less clear in hemodialysis patients in Western countries. Since Japanese dialysis patients are generally less inflamed than those in Western countries, inflammation may modify the association between serum ferritin and the adverse outcomes.We performed an observational cohort study using data from 2606 Japanese hemodialysis patients who participated in the Dialysis Outcomes and Practice Patterns Study (DOPPS) III (2005-2008) or DOPPS IV (2009-2012). The predictor was serum ferritin category (<50, 50-99.9, 100-199.9, and 200ng/mL), and the primary and secondary outcomes were all-cause mortality and cardiovascular hospitalization, respectively. C-reactive protein (CRP, cut-off by 0.3mg/dL) and serum albumin (cut-off by 3.8g/dL) were stratification factors related to systemic inflammation.After adjustment for relevant confounding factors, a U-shaped association was observed between serum ferritin and all-cause mortality in the group with low CRP levels, whereas such relationship was not significant in the high CRP counterparts. In contrast, we found a linear association between serum ferritin and cardiovascular hospitalization in the low CRP and high CRP groups commonly. Similar results were obtained when the total cohort was stratified by serum albumin.Serum ferritin showed different patterns of association with all-cause mortality in hemodialysis patients with versus without inflammation, whereas its association with cardiovascular hospitalization was similar regardless of inflammatory conditions.


PubMed | Bosei Hospital, Kyoto University, Institute for Health Outcomes and Process Evaluation Research iHope International and J DOPPS Research Group Japan
Type: Journal Article | Journal: The journal of vascular access | Year: 2016

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.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.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.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.


PubMed | Showa University, Tokai University, Harvard University, Institute for Health Outcomes and Process Evaluation Research iHope International and 2 more.
Type: Journal Article | Journal: PloS one | Year: 2016

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-nave 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-nave 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.

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