Association of the National Health Guidance Intervention for Obesity and Cardiovascular Risks With Health Outcomes Among Japanese Men

メタボ健診・特定保健指導制度の課題を提言 --エビデンスに基づく制度改善に期待--. 京都大学プレスリリース. 2020-10-09.Importance: Obesity and cardiovascular risks have become major public health problems. However, evidence is limited as to whether population-level lifestyle interventions for obesity and cardiovascular risk factors are associated with improved population health outcomes. Objective: To investigate the association of the national health guidance intervention in Japan with population health outcomes. Design, Setting, and Participants: This cohort study used a regression discontinuity design that included men aged 40 to 74 years who participated in the national health screening program in Japan from April 2013 to March 2018. Exposures: Assignment to the national health guidance intervention (counseling on healthy lifestyle and appropriate clinical follow-up for individuals found to have waist circumference of 85 cm or greater with 1 or more cardiovascular risk factors during annual national health screening program). Main Outcomes and Measures: Changes in obesity status (body weight, body mass index, waist circumference), and cardiovascular risk factors (blood pressure, hemoglobin A1c level, and low-density lipoprotein cholesterol level) 1 to 4 years after screening. Results: Of 74 693 men (mean [SD] age, 52.1 [7.8] years; mean [SD] baseline waist circumference, 86.3 [9.0] cm), the assignment to the health guidance intervention was associated with lower weight (adjusted difference, −0.29 kg; 95% CI, −0.50 to −0.08; P = .005), body mass index (−0.10; 95% CI, −0.17 to −0.03; P = .008), and waist circumference (−0.34 cm; 95% CI, −0.59 to −0.04; P = .02) 1 year after screening. The observed association of the guidance assignment attenuated over time and was no longer significant by years 3 to 4. No evidence was found that the health guidance intervention was associated with changes in participants’ systolic blood pressure, diastolic blood pressure, hemoglobin A1c level, or low-density lipoprotein cholesterol level in years 1 to 4. Conclusions and Relevance: Among working-age men in Japan, the national health guidance intervention was not associated with clinically meaningful weight loss or other cardiovascular risk factor reduction. Further research is warranted to understand the specific design of lifestyle interventions that are effective in improving obesity and cardiovascular risk factors

Premorbid Clinical Frailty Score and 30‐day mortality among older adults in the emergency department

Objectives: The association between frailty and short-term prognosis has not been established in critically ill older adults presenting to the emergency department. We sought to examine the association between premorbid frailty and 30-day mortality in this patient population. Methods: This is a retrospective observational study on older adults aged over 75 who were triaged as Level 1 resuscitation with subsequent admissions to intermediate units or intensive care units (ICUs) in a single critical care center, from January to December 2019. We excluded patients with out-of-hospital cardiac arrest or those transferred from other hospitals. Frailty was evaluated by the Clinical Frailty Scale (CFS) from the patients' chart reviews. The primary outcome was 30-day mortality, and we examined the association between frailty scored on the CFS and 30-day mortality using a multivariable logistic regression model with CFS 1-4 as a reference. Results: A total of 544 patients, median age: 82 years (interquartile rang 78 to 87), were included in the study. Of these, 29% were in shock and 33% were in respiratory failure. The overall 30-day mortality was 15.1%. The adjusted risk difference (95% confidence interval [CI]) in mortality for CFS 5, CFS 6, and CFS 7-9 was 6.3% (-3.4 to 15.9), 11.2% (0.4 to 22.0), and 17.7% (5.3 to 30.1), respectively; and the adjusted risk ratio (95% CI) was 1.45 (0.87 to 2.41), 1.85 (1.13 to 3.03), and 2.44 (1.50 to 3.96), respectively. Conclusion: The risk of 30-day mortality increased as frailty advanced in critically ill older adults. Given this high risk of short-term outcomes, ED clinicians should consider goals of care conversations carefully to avoid unwanted medical care for these patients

Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005–2017

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

Body mass index change and estimated glomerular filtration rate decline in a middle-aged population: health check-based cohort in Japan

Background: Obesity is a growing public health problem worldwide. We evaluated the mediators and association between changes in obesity metrics and renal outcomes in the general population. Methods: Using the Japanese nationwide health check-based cohort from April 2011 to March 2019, we selected individuals aged 40–74 years, with a baseline estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2, whose body mass index (BMI) change was assessed. The primary outcome was combined 30% decline in eGFR, eGFR 4%) mediated by three risk factors (blood pressure, haemoglobin A1c and total cholesterol), was 13.3%. Conclusion: In the middle-aged Japanese population, both, increase and decrease in BMI were associated with subsequent eGFR decline. Changes in risk factors mediated a small proportion of the association between BMI increase and eGFR decline. Our findings support the clinical significance of monitoring BMI as a renal risk factor

Learning Health System In A Senior Retirement Community: A Platform To Promote Implementation Research

Introduction: In an effort to develop a Learning Health System (LHS) for a healthy ageing society, this study launched an Internet of Things (IoT) platform in a senior residential community to continuously generate behavior logs. Methods: Considering that older adults experience difficulties in technology adaptation and declined information processing abilities, senior residents only needed to carry around a card sized beacon which was the tracking device. Participant recruitment took place in a continuing care retirement community. Individual feedback was obtained quarterly. Results: During the first 16 months, 111 residents, aged 67 to 97 years, joined the program, and nearly 90% of them were consistently monitored in their everyday lives. Participants’ average daily walking distance was slightly less than 1 km. The average time spent socializing was between 1 to 1.5 hours per day. Conclusion: The IoT platform offers the possibility of extending the target population and scope of data, as well as incorporating experimental study designs. It is expected that factors affecting older people’s everyday lives and their consequences on health outcomes are continuously studied, learned from and improved

Effectiveness of music therapy for alleviating pain during haemodialysis access cannulation for patients undergoing haemodialysis: a multi-facility, single-blind, randomised controlled trial

Background: Repeated pain during haemodialysis access cannulations is a serious problem for haemodialysis patients even when prescribed oral or topical analgesics. Although some studies have observed the efficacy of music therapy for improving pain and anxiety, its effectiveness during haemodialysis access cannulations during dialysis is uncertain. The purpose of this study is to investigate the effects of music therapy for pain when cannulating haemodialysis access for haemodialysis patients. Methods: A prospective, multi-facility, single-blind, crossover, randomised controlled trial will be implemented. The intervention includes listening to Mozart, along with a white noise control condition. One hundred twenty haemodialysis patients will be enrolled across five facilities. Patients will be randomly allocated to either an Early-sequence group or a Later-sequence group. The Early-sequence group will receive cannulation while listening to Mozart\u27s Sonata for two pianos in D major (K.448) during the second week (Music period) and white noise during the fourth week (White noise period). The Later-sequence group will receive cannulation along with white noise first, followed by Mozart. All patients will also undergo cannulation during a no-sound period (wearing only headphones) during the first and third week (No-sound period). The music or no-music protocol will begin 8 min prior to the cannulating procedure, and participants will finish listening after starting haemodialysis during each period. The primary outcomes that will be assessed include the Visual Analogue Scale (VAS) score for pain during cannulation, and secondary outcomes are blood pressure, heart rate, VAS anxiety score, State-Trait Anxiety Inventory score, and salivary amylase activity. The operators who are in charge of haemodialysis access cannulation will be blind to the listening condition and VAS report. Discussion: The proposed study has several methodological benefits. First, using white noise is a suitable control condition for addressing the role of sound in pain management. Additionally, using a crossover design with repeated measurements can help control individual differences between participants, which should better distinguish between- and within-participant variability. Overall, music therapy is a safe and inexpensive intervention that does not have the problematic side effects typically associated with pharmacological treatment. If effective, music therapy can be easily implemented for reducing pain and anxiety during cannulation. Trial registration: This trial was prospectively registered to UMIN Clinical Trials Registry on 1 July 2018 (UMIN 000032850)

血液透析患者における食塩摂取と全死亡

京都大学0048新制・論文博士博士(医学)乙第13289号論医博第2187号新制||医||1039(附属図書館)(主査)教授 中山 健夫, 教授 柳田 素子, 教授 佐藤 俊哉学位規則第4条第2項該当Doctor of Medical ScienceKyoto UniversityDFA

Undiagnosed and untreated chronic kidney disease and its impact on renal outcomes in the Japanese middle-aged general population

[Background] The effectiveness of identifying and monitoring early-stage chronic kidney disease (CKD) is not fully recognised. This study quantified people with undiagnosed CKD among the middle-aged Japanese population and clarified potential risks of untreated CKD. [Methods] We included 71 233 individuals who underwent annual health check-ups (AHC) in 2014 for both baseline and follow-up proteinuria and serum creatine measurements. CKD was identified by AHC data as proteinuria or estimated glomerular filtration rate (eGFR) 3 mL/min/1.73 m2/year or proteinuria incidence over 3 years, between those who visited a physician for CKD treatment within 6 months after AHC and those who did not. [Results] CKD prevalence was 5.7% (5.2% undiagnosed and 0.5% diagnosed). Only 2.1% of the patients with undiagnosed CKD visited a physician for CKD treatment within 6 months after AHC. Between-group risk differences in instrumental variable adjustment models showed that those left untreated progressed to kidney diseases 16.3% more often than those who visited physicians for CKD treatment. [Conclusion] CKD was undiagnosed in 5.2% of the middle-aged general population. Only a few people visited physicians for CKD treatment. Visiting physicians for CKD treatment during the first 6 months after screening may be associated with a lower risk of kidney disease progression

Letter to the Editor: Lack of requirements for conducting meta-analysis to evaluate the association between the TLR2 Arg753Gln polymorphism and the risk of sepsis

The original article was published in Critical Care 2015 19:416 (https://doi.org/10.1186/s13054-015-1130-3