Development of a Culinary Intervention (Cooking Class) for Salt Reduction in Japanese Home Cooking: Strategies and Assessment.

Introduction: Culinary interventions (cooking classes) are a potential educational tool for salt reduction in the home diet, but their content has never been reported in detail. This study aimed to develop a cooking class for salt reduction, describe its rationale and structure so that other parties could replicate it, and preliminarily assess its impact on salt intake. Methods: A multidisciplinary research team developed a cooking class package to reduce salt content in the Japanese home diet. The package comprised its developmental policy, teaching methodology, a menu and recipes, and an implementation manual and aimed to allow third parties to replicate and modify the content. The team took the following step-by-step developmental approach. First, traditional home meals were modeled to create strategies contributing to a target of 2 g salt/meal. Then, educational topics were developed through these strategies, and finally, a dietitian produced menus and prepared documents for the class. The impact of the cooking class was assessed in a nonrandomized study of community residents. The outcome was differences in urinary salt excretion before and after the intervention. General linear models were used to account for the possible confounders. Results: The authors assumed 4-7 g salt/meal from analyzing typical Japanese home diets and developed 3 strategies: (1) restricting salt content in the main dish, (2) maintaining good tastes without salty dishes, and (3) balancing nutrition with low-salt dishes. On the basis of these strategies, the authors selected a total of 5 educational topics that participants could learn and apply at home: 1a, a simple and reliable technique to limit salt in a serving; 2a, excluding salty dishes; 2b, staple foods with notable flavor and aroma; 3a, flavoring without salt in side dishes; and 3b, ingredients that should be used intentionally. The team dietitian translated these educational topics into a menu and recipes for hands-on training and prepared a manual for conducting the class. The class developed using this approach was successfully overseen by a dietitian outside the research team. In the validation study, the intervention group (n=52) showed a greater decrease in urinary salt excretion than the control group (n=46), with an adjusted difference of -1.38 g (p=0.001). Conclusions: The authors developed a cooking class package for salt reduction so that third parties could replicate and modify the class. The significant salt reduction noted in this study warrants further studies to apply this cooking class to other populations.

Proton Pump Inhibitors and Hyporesponsiveness to Erythropoiesis-Stimulating Agents in Hemodialysis Patients: Results from the Japan Dialysis Outcomes and Practice Patterns Study.

INTRODUCTION: Hyporesponsiveness to erythropoiesis stimulating agents (ESAs) is important problem in dialysis patients. While proton pump inhibitors (PPIs) may inhibit iron absorption, few studies have examined associations between PPIs and ESA-resistant anemia in hemodialysis patients. This study examined the associations between PPIs and ESA-resistant anemia in hemodialysis patients. METHODS: The present study was a cross-sectional study using repeated 4-month observations, up to eight observations/patient, from the Japan Dialysis Outcomes and Practice Patterns Study (J-DOPPS). The primary outcome was erythropoietin resistance index (ERI). ESA dose, hemoglobin, proportion of erythropoietin-resistant anemia, transferrin saturation (TSAT), and ferritin were also examined. Linear or risk-difference regression models were used with generalized estimating equations to account for repeated measurements. RESULTS: Of 1,644 patients, 867 patients had PPI prescriptions (52.7%). Patients prescribed PPI had higher ERI, higher ESA dose, and lower TSAT levels. Multivariable analysis for 12,048 four-month observations showed significantly greater ERI in PPI users (adjusted difference 0.95 IU/week/kg/[g/dL] [95% CI: 0.40-1.50]). Significant differences were also found in ESA dose (336 IU/week [95% CI: 70-602]) and the prevalence of erythropoietin-resistant anemia (3.9% [2.0-5.8%]) even after adjusted for TSAT and ferritin. Among possible mediators between the association of PPIs and anemia, TSAT was significantly different between PPI users and non-users (adjusted difference, -0.82% [95% CI: -1.56 to -0.07]). CONCLUSIONS: This study showed the associations between PPI and ERI, ESA dose, and TSAT in hemodialysis patients; physicians should consider anemia's associations with PPIs in hemodialysis patients.

Impact of treatment of hyperkalaemia on quality of life: design of a prospective observational cohort study of long-term management of hyperkalaemia in patients with chronic kidney disease or chronic heart failure in Japan.

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.

Infectious Risk and Variability of Hemoglobin Level in Patients Undergoing Hemodialysis.

Introduction: In the management of anemia in chronic kidney disease, hemoglobin levels often fall below or exceed target ranges. Past retrospective cohort studies of patients undergoing hemodialysis with conventional erythropoiesis stimulating agents (ESAs) found that hemoglobin level fluctuations predicted mortality and cardiovascular adverse events; long-acting agents were thereafter widely available. An updated validation by a prospective cohort study was needed. Methods: Using Cox regression models, we evaluated associations between hemoglobin variability and all-cause death, hospitalization, and cardiovascular, thrombotic, or infectious adverse event outcomes in 3063 hemodialysis patients' data from the Japanese Dialysis Outcomes and Practice Patterns Study (J-DOPPS) from 2012 to 2018. Results: During a median follow-up time of 2.5 years, all-cause mortality was lowest in the first quartile and tended to be higher in groups with greater hemoglobin variability (hazard ratio [HR]: 95% confidence interval for the fourth quartile of an absolute value of hemoglobin variability: 1.44 [0.99-2.08], P for trend = 0.056). Infectious event incidence in these patients was also lower in the first quartile than for the other quartiles (P for trend < 0.01). The association was more pronounced in patients with lower serum ferritin levels or iron supplementation. Cardiovascular and thrombotic event incidence was not associated with hemoglobin variability. Conclusions: Maintenance hemodialysis patients on ESA treatment with higher hemoglobin variability are at higher risk for all-cause mortality and particularly infectious events.

α-Blocker Use in Hemodialysis: The Japan Dialysis Outcomes and Practice Patterns Study.

Rationale & Objective: Despite α-blockers' use for hypertension as add-on therapy in patients treated with hemodialysis, scant information is available on their association, particularly with safety, in these patients. Study Design: Prospective cohort study. Setting & Participants: patients treated with hemodialysis and receiving antihypertensive agents in the Japan Dialysis Outcomes and Practice Patterns Study, phases 4-6, were analyzed. Exposure: Primary exposure was the prescription of α-blocking antihypertensive agents at baseline. Outcomes: Incident fractures, falls, and all-cause mortality. Analytical Approach: Multivariable Cox and modified Poisson regression analysis. Results: Of 5,149 patients treated with hemodialysis (mean age, 65 years; 68% men) receiving antihypertensive drugs, 717 (14%) received α-blocking agents. During a mean follow-up period of 2.0 years, 247 fractures, 525 falls, and 498 deaths occurred. Multivariable analysis showed no significant association of α-blocker use and increased risk of fractures (hazard ratio [HR], 0.92 [95% confidence interval {CI}, 0.61-1.38]), falls (HR, 0.94 [95% CI, 0.74-1.20]), or all-cause deaths (HR, 0.87 [95% CI, 0.64-1.20]) compared with α-blocker nonuse. α-Blocker use was, however, significantly associated with a decreased risk of all-cause mortality in the subgroup analysis, for example, patients who were older (HR, 0.71 [95% CI, 0.51-0.99]), were women (HR, 0.68 [95% CI, 0.48-0.95]), or reported a history of cardiovascular disease (HR, 0.67 [95% CI, 0.48-0.95]) or a predialysis blood pressure of ≥140 mm Hg (HR, 0.69 [95% CI, 0.49-0.98]). Limitations: Selection bias cannot be ruled out given the prevalent user analysis. Conclusions: No significant association between α-blocker use and the risk of worse safety-related outcomes was seen, indicating that clinicians may safely prescribe α-blockers to patients receiving hemodialysis who require blood pressure lowering. Plain-Language Summary: α-Blockers have been generally reserved for use as add-on therapy for resistant or refractory hypertension. However, little is known about the safety of α-blockers in patients treated by hemodialysis. We analyzed 5,149 patients receiving hemodialysis in Japan who were receiving antihypertensive drugs from the Japan Dialysis Outcomes and Practice Patterns Study. The results showed no significant increase in the risk of fractures, falls, or deaths for patients using α-blockers compared with those who did not, suggesting that α-blockers may be safely prescribed for patients receiving hemodialysis who need to lower their blood pressure.

Effects of iron-based phosphate binders on mortality and cardiovascular events in patients receiving maintenance dialysis.

Phosphate binders are the main treatment for hyperphosphatemia in patients with chronic kidney disease, and iron-based phosphate binders have been used with increasing frequency in recent years. This study examined the association of the use of iron-based, rather than non-iron-based, phosphate binders with the incidence of cardiovascular events, in a real-world setting. We used data from a cohort comprising representative adult patients on maintenance hemodialysis in Japan. The exposure of interest was the time-varying use of phosphate binders, classified into "iron-based", "only non-iron-based", and "no use". The primary outcome was a composite of cardiovascular events and all-cause deaths. A marginal structural Cox regression model was used to deal with possible time-dependent confounding. Of the 2247 patients from 58 hemodialysis facilities, iron-based and only non-iron-based phosphate binders were used in 328 (15%) and 1360 (61%), respectively, at baseline. Hazard ratios (95% confidence intervals) for iron-based and non-iron-based phosphate binders versus no use of phosphate binders were 0.35 (0.24, 0.52) and 0.44 (0.33, 0.58), respectively. The hazard ratio for iron-based relative to non-iron-based phosphate binders was 0.81 (0.58, 1.13), which was not statistically significant. Further studies are warranted to elucidate whether the use of iron-based phosphate binders reduces the event rate.

Validation of a new instrument for measuring disease-specific quality of life: A pilot study among patients with chronic kidney disease and hyperkalemia.

BACKGROUND: To prepare for a longitudinal study of the effects of potassium-lowering treatment on quality of life (QOL), we quantified the validity of a new disease-specific instrument for measuring QOL, using data from patients who had hyperkalemia (HK) due to chronic kidney disease (CKD) or chronic heart failure, and were also being treated with potassium binders (PBs). METHODS: In this cross-sectional study, the participants were 98 patients at five outpatient clinics in Japan. The outcome measures were the Medical Outcomes Study 36-item short-form (SF-36), a widely used generic measure of QOL, and the Quality of Life Disease-specific Impact Scale (QDIS-7), a recently-developed disease-specific measure of QOL. Internal-consistency reliability was quantified, and factor analysis was done to confirm hypothesized QOL dimensions. Validation tests used two external criteria: CKD stage, and PB formulation. PB formulation was used because different formulations are associated with different degrees of patients' burden. Using a previously-described method, we computed the relative validity (RV) of the two measures. RESULTS: Two factor scoring of the SF-36 and one factor scoring of the QDIS-7, as standardized from previous studies, were confirmed. The RVs showed that the QDIS-7 was much more valid than the SF-36, for discriminating between groups defined clinically (by CKD stage), and also between groups defined by PB formulation. Reliability was satisfactory: 0.73-0.95 for the SF-36 and 0.86 for the QDIS-7. CONCLUSIONS: The QDIS-7 with CKD or PB attributions was more valid than the SF-36 for measuring the effects of CKD and of PB formulation on QOL.

Cohort profile: Alliance for Quality Assessment in Healthcare-Dialysis (AQuAH-D) prospective cohort study of patients on haemodialysis in Japan.

PURPOSE: The global burden of kidney failure is increasing, but the treatment of kidney failure varies widely between patients, between dialysis facilities and over time. The Alliance for Quality Assessment in Healthcare-Dialysis (AQuAH-D) aims to conduct efficient and timely cohort studies on associations between those variations and clinical and patient-reported outcomes. PARTICIPANTS: Included are outpatients aged 20 years old or older who are undergoing haemodialysis and have consented to participate. A total of 2895 patients were enrolled from 25 facilities in Japan between August 2018 and July 2020 and are to be followed until 31 December 2026. Chart review and annual questionnaires are used to collect data on patient characteristics and on outcomes including quality of life. Data on medications, haemodialysis prescriptions and blood tests are obtained from existing electronic records. Data are collected retrospectively from 1 January 2017 to patient enrolment, and prospectively from patient enrolment until the end of December 2026. FINDINGS TO DATE: To date, the mean age is 68.3 (SD 12.2) years and 35.2% are female. The most common cause of kidney failure is diabetic nephropathy (37.4%). In January 2020, the facilities' median weekly doses of erythropoietin stimulating agent (ESA) and of intravenous vitamin D ranged from 1846 to 9692 IU (epoetin alfa equivalent) and 0.78 to 2.25 µg (calcitriol equivalent), respectively. The facilities' percentages of patients to whom calcimimetics are prescribed varied from 19% to 79%. During the retrospective period (averaging 1.85 years per participant), the incidence rates of any hospitalisation and of hospitalisation due to cardiovascular disease were 67.2 and 12.0 per 100 person-years, respectively. FUTURE PLANS: AQuAH-D data will be updated every 6 months and will be available for studies addressing a wide range of research questions, using the advantages of granular data and quality-of-life measurement of ageing patients on haemodialysis.

Patient Journey and Disease-Related Burden in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension: A Mixed Methods Study.

BACKGROUND: Understanding patient journey and burden of disease in patients with chronic thromboembolic pulmonary hypertension (CTEPH) helps improve diagnostic and treatment processes. OBJECTIVES: This study aimed to explore patient journey from time of disease onset to a definitive diagnosis and disease burden in Japanese patients with CTEPH. METHODS: A mixed-methods study exploring patient journey and disease burden of 33 Japanese patients with a definitive diagnosis of CTEPH. The patients from 2 university hospitals underwent semistructured interviews. Data were transcribed into verbatim records, and 2 independent researchers conducted thematic analyses. Data concerning patient journey were also analyzed quantitatively with supplementary use of medical records. RESULTS: Median times from initial onset of symptoms to a confirmed diagnosis and first visitation to a medical institution to a definitive diagnosis of CTEPH were 32 and 20 months, respectively. Thematic analyses found that, for patients, reasons for delay in seeking initial consultations included misattribution of symptoms to aging or lack of physical strength. For healthcare providers, reasons for delays in diagnosis included poor recognition of CTEPH and difficulty in recalling the disease as a differential diagnosis. Burdens of CTEPH were caused by physical symptoms, and mental and social issues, including restriction of daily activities owing to oxygen therapy, disappointment with the intractable nature of the disease, poor understanding of the disease by other people, and lack of social networks. CONCLUSIONS: This study highlighted physical, mental, and social burdens in patients with CTEPH and possible missed opportunities in making the diagnosis of CTEPH during the patient journey. Increasing disease awareness in healthcare providers and networking among patients may contribute to better patient care.

Type I Angiotensin II Receptor Blockade Reduces Uremia-Induced Deterioration of Bone Material Properties.

Chronic kidney disease (CKD) is associated with a high incidence of fractures. However, the pathophysiology of this disease is not fully understood, and limited therapeutic interventions are available. This study aimed to determine the impact of type 1 angiotensin II receptor blockade (AT-1RB) on preventing CKD-related fragility fractures and elucidate its pharmacological mechanisms. AT-1RB use was associated with a lower risk of hospitalization due to fractures in 3276 patients undergoing maintenance hemodialysis. In nephrectomized rats, administration of olmesartan suppressed osteocyte apoptosis, skeletal pentosidine accumulation, and apatite disorientation, and partially inhibited the progression of the bone elastic mechanical properties, while the bone mass was unchanged. Olmesartan suppressed angiotensin II-dependent oxidation stress and apoptosis in primary cultured osteocytes in vitro. In conclusion, angiotensin II-dependent intraskeletal oxidation stress deteriorated the bone elastic mechanical properties by promoting osteocyte apoptosis and pentosidine accumulation. Thus, AT-1RB contributes to the underlying pathogenesis of abnormal bone quality in the setting of CKD, possibly by oxidative stress. © 2020 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Changes in 3-month mineral and bone disorder patterns were associated with all-cause mortality in prevalent hemodialysis patients with secondary hyperparathyroidism.

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.

Relationship between serum calcium or phosphate levels and mortality stratified by parathyroid hormone level: an analysis from the MBD-5D study.

INTRODUCTION: There is limited evidence about the association between calcium and phosphate levels and mortality stratified by intact parathyroid hormone (iPTH) level. METHODS: We investigated whether differences in iPTH level affect the relationship between calcium and phosphate levels and all-cause mortality in hemodialysis patients with secondary hyperparathyroidism (SHPT). Calcium and phosphate levels were categorized as low (< 8.5 mg/dL, < 4.0 mg/dL), medium (≥ 8.5-< 9.5 mg/dL, ≥ 4.0-< 7.0 mg/dL), and high (≥ 9.5 mg/dL, ≥ 7.0 mg/dL), respectively. iPTH levels were grouped into < 300 or ≥ 300 pg/mL. Adjusted incidence rate ratios (aIRRs) were analyzed by weighted Poisson regression. RESULTS: For calcium, patients with higher iPTH (≥ 300 pg/mL) had significantly higher all-cause mortality rates in the high than in the medium category (aIRR 1.99, 95% confidence interval [CI] 1.16-3.42), and tended to have a higher mortality rate in the low category (aIRR 2.04, 95% CI 0.94-4.42). Patients with lower iPTH (< 300 pg/mL) had higher mortality rates in the high than in the medium category (aIRR 1.65, 95% CI 1.39-1.96). For phosphate, the mortality rate was significantly higher in the high than in the medium category in patients with higher and lower iPTH (aIRR 3.23, 95% CI 1.63-6.39 for iPTH ≥ 300 pg/mL; aIRR 1.58, 95% CI 1.06-2.36 for iPTH < 300 pg/mL). CONCLUSION: High calcium and phosphate levels were associated with increased risk of mortality irrespective of iPTH level.

Effectiveness of cinacalcet treatment for secondary hyperparathyroidism on hospitalization: Results from the MBD-5D study.

OBJECTIVES: To elucidate the effect of cinacalcet use on all-cause and cause-specific hospitalization outcomes using a prospective cohort of maintenance hemodialysis patients. METHODS: We 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. RESULTS: Among 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). CONCLUSIONS: Cinacalcet 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.

Level of Low Back Pain-Related Disability Is Associated with Risk of Subsequent Falls in an Older Population: Locomotive Syndrome and Health Outcomes in Aizu Cohort Study (LOHAS).

OBJECTIVES: To examine the longitudinal association between baseline disability due to low back pain (LBP) and future risk of falls, particularly significant falls requiring treatment, in a community-dwelling older population. METHODS: This was a prospective population-based cohort study using data from the Locomotive Syndrome and Health Outcomes in Aizu Cohort Study (LOHAS; 2008-2010). A total of 2,738 residents aged ≥60 years were enrolled. LBP was assessed using the Roland-Morris Disability Questionnaire (RMDQ), and the level of LBP-related disability was divided into three categories (none, low, and medium to high). Incidence of falls over the following year was determined using a self-reported questionnaire after the one-year follow-up period. The risk ratio (RR) for LBP-related disability associated with any fall and any fall requiring treatment was estimated using log binomial regression models. RESULTS: Data were analyzed for 1,358 subjects. The prevalence of LBP at baseline was 16.4%, whereas 122 (8.9%) participants reported a low level of LBP-related disability and 101 (7.4%) reported medium to high levels of LBP-related disability. Incidence of any fall and falls requiring treatment was reported by 22.1% and 4.6% of participants, respectively. Subjects with medium to high levels of disability were more likely to experience subsequent falls (adjusted RR = 1.53, 95% confidence interval [CI] = 1.21-1.95) and falls requiring treatment (adjusted RR = 2.55, 95% CI = 1.41-4.60) than those with no LBP-related disability. CONCLUSIONS: Level of LBP-related disability was associated with an increased risk of serious falls in a general population of community-living older adults. These findings can alert health care providers involved in fall prevention efforts to the important issue of activity-related disability due to LBP.

Longitudinal Association Between Subjective Fatigue and Future Falls in Community-Dwelling Older Adults: The Locomotive Syndrome and Health Outcomes in the Aizu Cohort Study (LOHAS).

OBJECTIVE: We examined the longitudinal association between the severity of fatigue and falls in community-dwelling older adults. METHOD: Subjective fatigue was assessed using the Short Form 36 Health Survey (SF-36) Vitality subscale and classified into four categories by quartile (mildest, mild, moderate, severe). The main outcome was the incidence of any falls during the 2-year follow-up period. RESULTS: Of the 751 participants, 236 (31.4%) experienced falls during the 2-year period. In multivariable logistic regression analysis with adjustment for possible confounding factors, the adjusted odds ratios (and 95% confidence intervals) for mild, moderate, and severe categories (vs. mildest category) of 1.60 (0.94-2.75), 1.87 (1.12-3.11), and 2.15 (1.23-3.76), respectively ( p for trend = .007). DISCUSSION: Our results suggest that the severity of fatigue is associated with the risk of subsequent falls for community-dwelling older adults even after adjustment for possible confounding factors.

Quality of life after single-incision laparoscopic cholecystectomy: A randomized, clinical trial.

BACKGROUND: Controversy continues as to whether single-incision laparoscopic cholecystectomy, with the somewhat larger incision at the umbilicus, may lead to a worse postoperative quality of life and more pain compared with the more classic 4-port laparoscopic cholecystectomy. The aim of this study was to compare single-incision and 4-port laparoscopic cholecystectomy from the perspective of quality of life. METHODS: This study was a multicenter, parallel-group, open-label, randomized clinical trial. A total of 120 patients who were scheduled to undergo elective cholecystectomy were randomly assigned 1:1 into the single-incision laparoscopic cholecystectomy or the 4-port laparoscopic cholecystectomy group and then assessed continuously for 2 weeks during the postoperative period. The primary outcome was quality of life, defined as the time to resume normal daily activities. Postoperative pain was also assessed. To explore the heterogeneity of treatment effects, we assessed the interactions of sex, age, and working status on recovery time. RESULTS: A total of 58 patients in the single-incision group and 53 in the 4-port group (n = 111, 47 male, mean age 57 years) were analyzed. The mean time to resume daily activities was 10.2 days and 8.8 days, respectively, for single-incision and 4-port laparoscopic cholecystectomy (95% confidence interval -0.4 to 3.2, P = .12). Similarly, the time to relief from postoperative pain did not differ significantly between the groups. Statistically insignificant but qualitative interactions were noted; in the subgroups of women, full-time workers, and patients younger than 60 years, recovery tended to be slower after single-incision laparoscopic cholecystectomy. CONCLUSION: Postoperative quality of life did not differ substantially between single-incision laparoscopic cholecystectomy and 4-port laparoscopic cholecystectomy. Patients younger than 60 years, women, and full-time workers tended to have a somewhat slower recovery after single-incision laparoscopic cholecystectomy.

Association Between the Discrepancy in Self-Reported and Performance-Based Physical Functioning Levels and Risk of Future Falls Among Community-Dwelling Older Adults: The Locomotive Syndrome and Health Outcomes in Aizu Cohort Study (LOHAS).

OBJECTIVES: A discrepancy in self-reported and performance-based physical functioning levels is often observed among older adults. We investigated the association of discrepancy in self-reported and performance-based physical functioning levels with risk of future falls among community-dwelling older adults. DESIGN: Prospective cohort study. SETTING: Two communities in Fukushima Prefecture, Japan. PARTICIPANTS: 1379 older adults who took part in the yearly health checkup in both 2009 and 2010. MEASURES: The performance-based and self-reported physical functioning levels were evaluated by the Timed Up and Go test and the Short-Form 12 Health Survey (Japanese version) physical functioning subscale, respectively. We divided the participants into 4 groups based on the combinations of low or high performance-based and self-reported physical functioning groups, which were classified by age- and sex-specific reference values. The main outcome was the occurrence of any falls within the 1-year follow-up period, assessed using a self-reported questionnaire. RESULTS: A total of 22% of the participants reported the occurrence of a fall during the follow-up period. In multivariable logistic regression analysis, the adjusted odds ratios of the high self-reported and low performance-based, low self-reported and high performance-based, and low self-reported and low performance-based physical functioning groups were 1.10 (95% confidence interval [CI], 0.67-1.82), 1.76 (95% CI, 1.17-2.66), and 1.80 (95% CI, 1.11-2.90), respectively, compared with the high self-reported and high performance-based physical functioning group. CONCLUSIONS: Our findings suggest that the discrepancy as high performance-based but low self-reported physical functioning level is associated with an increased risk of future falls in older adults aged 65-89 years. Clinicians should carefully assess older adults whose subjective perception of their physical functioning capacity is lower than those in similar age and sex groups, even if their actual physical functioning appears to be objectively high.

Multimorbidity patterns in relation to polypharmacy and dosage frequency: a nationwide, cross-sectional study in a Japanese population.

In the present study, we aimed to identify multimorbidity patterns in a Japanese population and investigate whether these patterns have differing effects on polypharmacy and dosage frequency. Data was collected on 17 chronic health conditions via nationwide cross-sectional survey of 3,256 adult Japanese residents. Factor analysis was performed to identify multimorbidity patterns, and associations were determined with excessive polypharmacy [concurrent use of ≥ 10 prescription or over-the-counter (OTC) medications] and higher dosage frequency ( ≥ 3 doses per day). Secondary outcomes were the number of concurrent prescription medications and the number of concurrent OTC medications. We used a generalized linear model to adjust for individual sociodemographic characteristics. Five multimorbidity patterns were identified: cardiovascular/renal/metabolic, neuropsychiatric, skeletal/articular/digestive, respiratory/dermal, and malignant/digestive/urologic. Among these patterns, malignant/digestive/urologic and cardiovascular/renal/metabolic patterns showed the strongest associations with excessive polypharmacy and the number of concurrent OTC medications. Malignant/digestive/urologic, respiratory/dermal, and skeletal/articular/digestive patterns were also associated with higher dosage frequency. Multimorbidity patterns have differing effects on excessive polypharmacy and dosage frequency. Malignant/digestive/urologic pattern may be at higher risk of impaired medication safety and increased treatment burden, than other patterns. Continued study is warranted to determine how to incorporate multimorbidity patterns into risk assessments of polypharmacy and overall treatment burden.

Association Between Subjective Sleep Quality and Future Risk of Falls in Older People: Results From LOHAS.

Background: Inadequate sleep is correlated with morbidity and mortality among older adults. However, the longitudinal relationship between subjective sleep quality and risk of falls in the elderly population remains to be clarified. Methods: Study participants were from Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS) sites (1,071 community-dwelling people ≧65 years of age, mean: 71 years). Subjective sleep quality was measured by the Pittsburgh Sleep Quality Index (PSQI). Occurrence of falls (defined as experiencing at least one fall) during the subsequent year was ascertained by a self-reported questionnaire. Results: Mean global PSQI score was 4.3 (SD 3.2), with 28.9% of participants rating their sleep quality as poor (PSQI > 5). A total of 210 participants (19.6%) fell at least once in the year following sleep examination. Multivariable analysis revealed that participants reporting worse subjective sleep quality had significantly higher odds of experiencing falls during the 1-year follow-up period (adjusted odds ratio [AOR] = 1.50 for each three-point increase in global PSQI score; 95% confidence interval [CI] = 1.20, 1.89). Participants in the highest global PSQI score (PSQI > 5) quartile had significantly increased odds of experiencing falls compared to those in the lowest global score quartile (PSQI < 2; AOR = 2.14; 95% CI = 1.09, 4.22). This association was similarly significant in subgroup analyses for older men and women, nonusers of sleep medication, and those without a history of falls at baseline. Conclusion: Subjective poor sleep quality, as measured by the PSQI, is longitudinally associated with greater risk of experiencing falls in community-dwelling older adults.