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

Por: Fukuma · S. · Ikenoue · T. · Bragg-Gresham · J. · Norton · E. · Yamada · Y. · Kohmoto · D. · Saran · R.
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 2 and end-stage renal disease.

Results

During 245 147 person-years’ follow-up among 50 604 participants (mean eGFR, 83.7 mL/min/1.73 m2; mean BMI, 24.1 kg/m2), 645 demonstrated eGFR decline (incidence rate 2.6/1000 person-years, 95% CI: 2.4 to 2.8). We observed continued initial changes in BMI for over 6 years and a U-shaped association between BMI change and eGFR decline. Compared with 0% change in BMI, adjusted HRs for changes of –10%, –4%, 4% and 10% were 1.53 (95% CI: 1.15 to 2.04), 1.14 (95% CI: 1.01 to 1.30), 1.16 (95% CI: 1.02 to 1.32) and 1.87 (95% CI: 1.25 to 2.80), respectively. The percentage of excess risk of BMI increase (>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.

Understanding the experiences of long-term maintenance of self-worth in persons with type 2 diabetes in Japan: a qualitative study

Por: Kato · A. · Yoshiuchi · K. · Fujimaki · Y. · Fujimori · S. · Kobayashi · Y. · Yamada · T. · Kobayashi · M. · Izumida · Y. · Suzuki · R. · Yamauchi · T. · Kadowaki · T.
Objective

Persons with type 2 diabetes are often stigmatised for having what is considered a lifestyle-related disease. Accordingly, some blame themselves for their condition, resulting in feelings of low self-worth that ultimately impact their self-management behaviours. However, there are no studies examining why some do not blame themselves for their condition and manage to maintain their self-worth in relation to their illness. This study aimed to explore an understanding of how such persons experience the maintenance of self-worth in relation to their illness over the lifelong course of treatment.

Design

A cross-sectional qualitative study. Face-to-face semistructured interviews were conducted with a purposive sampling strategy. The data was analysed using a qualitative descriptive method that involved concurrent data collection and constant comparative analysis.

Setting

Two tertiary-level hospitals in Japan.

Participants

Thirty-three outpatients with type 2 diabetes who currently had good glycaemic control but had previously had poor glycaemic control.

Results

Three themes explaining the maintenance of self-worth were identified: (1) Participants gained ‘control’ over their illness by living a ‘normal life.’ They found a way to eat preferred foods, dine out with family and friends, travel and work as usual; (2) Participants discovered the positive aspects of type 2 diabetes, as they felt ‘healthier’ from the treatment and felt a sense of security and gratitude for the care they received from healthcare professionals; (3) Participants discovered a new sense of self-worth by moving towards goals for type 2 diabetes treatment and experienced inner growth through positive lifestyle choices.

Conclusions

The process of restoring and maintaining self-worth should be brought to the attention of healthcare professionals in diabetes care. These professionals could help patients discover positive self-representations through diabetes treatment (eg, a realisation that one does not lack self-control) and could aid in increasing patient engagement in diabetes self-management.

Association of smoking habits with <i>TXNIP</i> DNA methylation levels in leukocytes among general Japanese population

by Keisuke Maeda, Hiroya Yamada, Eiji Munetsuna, Ryosuke Fujii, Mirai Yamazaki, Yoshitaka Ando, Genki Mizuno, Hiroaki Ishikawa, Koji Ohashi, Yoshiki Tsuboi, Shuji Hashimoto, Nobuyuki Hamajima, Koji Suzuki

Thioredoxin-interacting protein (TXNIP) inhibits the activity of thioredoxin (TXN), leading to increased oxidative stress. Expression of the TXNIP gene is regulated by DNA methylation. However, no study has reported the influence of lifestyle factors on TXNIP DNA methylation. Our goal was to determine the association between smoking habits and TXNIP DNA methylation levels in a Japanese population. We conducted a cross-sectional study of 417 subjects (180 males and 237 females) participating in a health examination. We used a pyrosequencing assay to determine TXNIP DNA methylation levels in leukocytes. The mean TXNIP DNA methylation level in current smokers (75.3%) was significantly lower than that in never and ex-smokers (never: 78.1%, p p = 0.013). Multivariable logistic regression analyses showed that the OR for TXNIP DNA hypomethylation was significantly higher in current smokers than that in never smokers, and significantly higher in current smokers with years of smoking ≥ 35 and Brinkman Index ≥ 600 compared to that in non-smokers. In conclusion, we found that current smokers had TXNIP DNA hypomethylation compared to never and ex-smokers. Moreover, long-term smoking and high smoking exposure also were associated with TXNIP DNA hypomethylation.

Collaborating with healthcare providers to understand their perspectives on a hospital-to-home warning signs intervention for rural transitional care: protocol of a multimethod descriptive study

Por: Fox · M. T. · Butler · J. I. · Sidani · S. · Durocher · E. · Nowrouzi-Kia · B. · Yamada · J. · Dahlke · S. · Skinner · M. W.
Introduction

This study builds on our prior research, which identified that older rural patients and families (1) view preparation for detecting and responding to worsening health conditions as their most pressing unmet transitional care (TC) need and (2) perceive an evidence-based intervention, preparing them to detect and respond to warning signs of worsening health conditions, as highly likely to meet this need. Yet, what healthcare providers need to implement a warning signs intervention in rural TC is unclear. The objectives of this study are (1) to examine healthcare providers’ perspectives on the acceptability of a warning signs intervention and (2) to identify barriers and facilitators to healthcare providers’ provision of the intervention in rural communities.

Methods and analysis

This multimethod descriptive study uses a community-based, participatory research approach. We will examine healthcare providers’ perspectives on a warning signs intervention. A purposive, criterion-based sample of healthcare providers stratified by professional designation (three strata: nurses, physicians and allied healthcare professionals) in two regions (Southwestern and Northeastern Ontario, Canada) will (1) rate the acceptability of the intervention and (2) participate in small (n=4–6 healthcare providers), semistructured telephone focus group discussions on barriers and facilitators to delivering the intervention in rural communities. Two to three focus groups per stratum will be held in each region for a total of 12–18 focus groups. Data will be analysed using conventional qualitative content analysis and descriptive statistics.

Ethics and dissemination

Ethics approval was obtained from the Office of Research Ethics at York University and the Health Sciences North Research Ethics Board. Findings will be communicated through plain language summary and policy briefs, press releases, manuscripts and conferences.

Pharmacologic and non-pharmacologic interventions to prevent hypersensitivity reactions of non-ionic iodinated contrast media: a systematic review protocol

Por: Umakoshi · H. · Nihashi · T. · Shimamoto · H. · Yamada · T. · Ishiguchi · H. · Takada · A. · Hirasawa · N. · Ishihara · S. · Takehara · Y. · Naganawa · S. · Davenport · M. · Terasawa · T.
Introduction

Iodinated contrast media are commonly used in medical imaging and can cause hypersensitivity reactions, including rare but severe life-threatening reactions. Although several prophylactic approaches have been proposed for severe reactions, their effects remain unclear. Therefore, we aim to review systematically the preventive effects of pharmacologic and non-pharmacologic interventions and predictors of acute, hypersensitivity reactions.

Methods and analysis

We will search the PubMed, EMBASE and Cochrane Central Register of Controlled Trials databases from 1 January 1990 through 31 December 2019 and will examine the bibliographies of eligible studies, pertinent review articles and clinical practice guidelines. We will include prospective and retrospective studies of any design that evaluated the effects of pharmacological and non-pharmacological preventive interventions for adverse reactions of non-ionic iodinated contrast media. Two assessors will independently extract the characteristics of the study and intervention and the quantitative results. Two independent reviewers will assess the risk of bias using standard design-specific validity assessment tools. The primary outcome will be reduction in acute contrast media-induced hypersensitivity reactions. The secondary outcomes will include characteristics associated with the development of contrast media-induced acute hypersensitivity reactions, and adverse events associated with specific preventive interventions. Unique premedication regimens (eg, dose, drug and duration) and non-pharmacological strategies will be analysed separately. Average-risk and high-risk patients will be considered separately. A meta-analysis will be performed if appropriate.

Ethics and dissemination

Ethics approval is not applicable, as this will be a secondary analysis of publicly available data. The results of the analysis will be submitted for publication in a peer reviewed journal.

PROSPERO registration number

CRD42019134003

A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics: study protocol for the J-SUPPORT 1901 (ACCESS) study

Por: Fujiwara · M. · Inagaki · M. · Shimazu · T. · Kodama · M. · So · R. · Matsushita · T. · Yoshimura · Y. · Horii · S. · Fujimori · M. · Takahashi · H. · Nakaya · N. · Kakeda · K. · Miyaji · T. · Hinotsu · S. · Harada · K. · Okada · H. · Uchitomi · Y. · Yamada · N.
Introduction

One of the reasons for the high mortality rate from cancer in people with schizophrenia is delay in diagnosis. Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening. Therefore, we developed a case management (CM) intervention to encourage participation in cancer screening. The purpose of this study was to examine the efficacy of CM to encourage participation in cancer screening for people with schizophrenia, with particular focus on colorectal cancer screening by faecal occult blood testing, compared with usual intervention (UI), namely, municipal public education.

Methods and analysis

This is an individually randomised, parallel group trial with blinded outcome assessments. The participants will be randomly allocated to either the CM plus UI group or UI alone group in a 1:1 ratio using a web-based program at a data management centre. The primary end point of the study is participation in colorectal cancer screening in the year of intervention, which will be assessed based on municipal records.

Ethics and dissemination

This study is performed in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan’s Ministry of Education, Science, and Technology and the Ministry of Health, Labour, and Welfare and the modified Act on the Protection of Personal Information as well as the Declaration of Helsinki. This study was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital on 23 April 2019 (approval number: RIN1904-003). The findings of this trial will be submitted to an international peer-reviewed journal.

Trial registration number

UMIN000036017.

Effect of an educational leaflet on the frequency of seat belt use and the rate of motor vehicle accidents during pregnancy in Japan in 2018: a prospective, non-randomised control trial with a questionnaire survey

Por: Morikawa · M. · Yamada · T. · Kogo · H. · Sugawara · M. · Nishikawa · A. · Fukushi · Y. · Hirayama · E. K. · Ishioka · S.-i. · Watari · H.
Objective

To determine whether an educational leaflet had any effect on seat belt use, seat preference and motor vehicle accidents rate during pregnancy in Japan.

Design

Prospective, non-randomised control trial with a questionnaire survey.

Setting

Eight obstetric hospitals in Sapporo, Japan.

Participants

2216 pregnant women, of whom 1105 received the leaflet (intervention group) and 1111 did not (control group).

Interventions

Distribution of an educational leaflet on seat belt use to women in the intervention group.

Primary outcome measures

The effect of an educational leaflet on seat belt use, each pregnant woman’s seat preference and the women’s rates of motor vehicle accidents rate during their pregnancies. To evaluate the effects, the intervention group’s responses to the questionnaires were compared with those of the control group.

Results

The proportion of subjects who always used seat belts during pregnancy was significantly higher in the intervention group (91.3%) than in the control group (86.7%; p=0.0005). Among all subjects, the percentage of women who preferred the driver’s seat was lower during pregnancy (27.0%) than before pregnancy (38.7%), and the percentage of women who preferred the rear seat was higher during pregnancy (28.8%) than before pregnancy (21.0%). These two rates did not differ between two groups. Seventy-one women (3.2%) reported experiencing a motor vehicle accident during pregnancy. The motor vehicle accident rate for the intervention group (3.3%) was similar to that for the control group (3.2%).

Conclusions

An educational seat belt leaflet was effective in raising the rate of consistent seat belt use during pregnancy, but it did not decrease the rate of motor vehicle accidents. The wearing of seat belts should be promoted more extensively among pregnant women to decrease rates of pregnancy-related morbidity and mortality from motor vehicle accidents.

A comprehensive validation of very early rule-out strategies for non-ST-segment elevation myocardial infarction in emergency departments: protocol for a multicentre prospective cohort study

Por: Tada · M. · Azuma · H. · Yamada · N. · Kano · K.-i. · Nagai · H. · Maeda · S. · Ishida · H. · Aoyama · T. · Okada · R. · Kawano · T. · Kobuchi · T. · Uzui · H. · Matano · H. · Iwasaki · H. · Maeno · K. · Shimada · Y. · Yoshida · H. · Ando · M. · Murakami · Y. · Iwakami · N. · Kishimoto · S. · Iw
Introduction

Recent advances in troponin sensitivity enabled early and accurate judgement of ruling-out myocardial infarction, especially non-ST elevation myocardial infarction (NSTEMI) in emergency departments (EDs) with development of various prediction-rules and high-sensitive-troponin-based strategies (hs-troponin). Reliance on clinical impression, however, is still common, and it remains unknown which of these strategies is superior. Therefore, our objective in this prospective cohort study is to comprehensively validate the diagnostic accuracy of clinical impression-based strategies, prediction-rules and hs-troponin-based strategies for ruling-out NSTEMIs.

Methods and analysis

In total, 1500 consecutive adult patients with symptoms suggestive of acute coronary syndrome will be prospectively recruited from five EDs in two tertiary-level, two secondary-level community hospitals and one university hospital in Japan. The study has begun in July 2018, and recruitment period will be about 1 year. A board-certified emergency physician will complete standardised case report forms, and independently perform a clinical impression-based risk estimation of NSTEMI. Index strategies to be compared will include the clinical impression-based strategy; prediction rules and hs-troponin-based strategies for the following types of troponin (Roche Elecsys hs-troponin T; Abbott ARCHITECT hs-troponin I; Siemens ADVIA Centaur hs-troponin I; Siemens ADVIA Centaur sensitive-troponin I). The reference standard will be the composite of type 1 MI and cardiac death within 30 days after admission to the ED. Outcome measures will be negative predictive value, sensitivity and effectiveness, defined as the proportion of patients categorised as low risk for NSTEMI. We will also evaluate inter-rater reliability of the clinical impression-based risk estimation.

Ethics and dissemination

The study is approved by the Ethics Committees of the Kyoto University Graduate School and Faculty of Medicine and of the five hospitals where we will recruit patients. We will disseminate the study results through conference presentations and peer-reviewed journals.

Molidustat for the treatment of renal anaemia in patients with non-dialysis-dependent chronic kidney disease: design and rationale of two phase III studies

Por: Yamamoto · H. · Taguchi · M. · Matsuda · Y. · Iekushi · K. · Yamada · T. · Akizawa · T.
Introduction

Anaemia is a common complication of chronic kidney disease (CKD). Owing to the limitations of erythropoiesis-stimulating agents (ESAs), the current standard of care, there is a need to develop new therapies. Hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitors might be a promising new treatment option. Molidustat is an oral HIF-PH inhibitor that stimulates the endogenous, predominantly renal, production of erythropoietin and was generally well tolerated in phase IIb clinical trials. Here, we report the design and rationale of two studies from the molidustat phase III programme: MolIdustat once dailY improves renal Anaemia By Inducing erythropoietin (MIYABI).

Methods and analysis

MIYABI Non-Dialysis-Correction (ND-C) and MIYABI Non-Dialysis-Maintenance (ND-M) are randomised, open-label, parallel-group, multicentre studies that aim to demonstrate the efficacy of molidustat treatment compared with darbepoetin alfa in patients with anaemia and non-dialysis-dependent CKD. The secondary objectives are to assess the safety, pharmacokinetics and pharmacodynamics of molidustat treatment. MIYABI ND-C will recruit patients currently untreated with ESAs, whereas patients treated with an ESA will enter MIYABI ND-M. Each study will recruit 150 patients who will be randomised in a 1:1 ratio to receive either molidustat or darbepoetin alfa for 52 weeks, with efficacy evaluated during weeks 30–36. Study drug doses will be titrated regularly using an interactive voice/web response system with the aim of maintaining the patients’ haemoglobin (Hb) levels between ≥110 and

Ethics and dissemination

The protocols were approved by ethics committees at all participating sites. These studies will be conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. Results arising from these studies will be published in peer-reviewed journal(s).

Trial registration numbers

NCT03350321; Pre-results, NCT03350347; Pre-results.

Molidustat for the treatment of renal anaemia in patients with dialysis-dependent chronic kidney disease: design and rationale of three phase III studies

Por: Akizawa · T. · Taguchi · M. · Matsuda · Y. · Iekushi · K. · Yamada · T. · Yamamoto · H.
Introduction

New medications for anaemia associated with chronic kidney disease (CKD) are desirable, owing to the limitations of erythropoiesis-stimulating agents (ESAs), the current standard of care. Molidustat is a novel hypoxia-inducible factor prolyl-hydroxylase inhibitor that stimulates erythropoietin production, predominately in the kidney. We report methodological details of three phase III trials, named MolIdustat once dailY improves renal Anaemia By Inducing erythropoietin (MIYABI), designed primarily to investigate the efficacy of molidustat therapy in adults with renal anaemia and dialysis-dependent CKD.

Methods and analysis

MIYABI Haemodialysis-Correction (HD-C) is a single-arm trial (24-week treatment duration) in approximately 25 patients on haemodialysis, currently untreated with ESAs. MIYABI Peritoneal Dialysis (PD) is a single-arm trial (36 week treatment duration) in approximately 50 patients on peritoneal dialysis, treated or untreated with ESAs. MIYABI Haemodialysis-Maintenance (HD-M) is a randomised, active-controlled, double-blinded, double-dummy trial (52-week treatment duration) comparing molidustat with darbepoetin alfa in approximately 225 patients on haemodialysis, treated with ESAs. Molidustat (starting dose 75 mg/day) will be titrated 4-weekly to maintain haemoglobin in predetermined target ranges. The primary objective is to evaluate the efficacy of molidustat, using the following measures: the rate of rise in haemoglobin (g/L/week) at the first dose change up to week 8 (MIYABI HD-C); responder rate (MIYABI HD-C and MIYABI PD); mean haemoglobin level during weeks 33–36 and non-inferiority to darbepoetin alfa shown by change in mean haemoglobin level from baseline (MIYABI HD-M). The secondary objectives are to assess safety, pharmacokinetics and pharmacodynamics. These trials will provide the first evaluations of molidustat therapy in patients receiving either peritoneal dialysis or currently untreated with ESAs on haemodialysis, and provide further evidence in patients treated with ESAs on haemodialysis.

Ethics and dissemination

The protocols were approved by ethics committees at all participating sites. The trials will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results arising from these studies will be published in peer-reviewed journal(s).

Trial registration numbers

NCT03351166; Pre-results, NCT03418168; Pre-results, NCT03543657; Pre-results

Effect of real-time visual feedback device 'Quality Cardiopulmonary Resuscitation (QCPR) Classroom with a metronome sound on layperson CPR training in Japan: a cluster randomized control trial

Por: Tanaka · S. · Tsukigase · K. · Hara · T. · Sagisaka · R. · Myklebust · H. · Birkenes · T. S. · Takahashi · H. · Iwata · A. · Kidokoro · Y. · Yamada · M. · Ueta · H. · Takyu · H. · Tanaka · H.
Objectives

‘Quality Cardiopulmonary Resuscitation (QCPR) Classroom’ was recently introduced to provide higher-quality Cardiopulmonary Resuscitation (CPR) training. This study aimed to examine whether novel QCPR Classroom training can lead to higher chest-compression quality than standard CPR training.

Design

A cluster randomised controlled trial was conducted to compare standard CPR training (control) and QCPR Classroom (intervention).

Setting

Layperson CPR training in Japan.

Participants

Six hundred forty-two people aged over 15 years were recruited from among CPR trainees.

Interventions

CPR performance data were registered without feedback on instrumented Little Anne prototypes for 1 min pretraining and post-training. A large classroom was used in which QCPR Classroom participants could see their CPR performance on a big screen at the front; the control group only received instructor’s subjective feedback.

Primary and secondary outcome measures

The primary outcomes were compression depth (mm), rate (compressions per minute (cpm)), percentage of adequate depth (%) and recoil (%). Survey scores were a secondary outcome. The survey included participants’ confidence regarding CPR parameters and ease of understanding instructor feedback.

Results

In total, 259 and 238 people in the control and QCPR Classroom groups, respectively, were eligible for analysis. After training, the mean compression depth and rate were 56.1±9.8 mm and 119.2±7.3 cpm in the control group and 59.5±7.9 mm and 116.8±5.5 cpm in the QCPR Classroom group. The QCPR Classroom group showed significantly more adequate depth than the control group (p=0.001). There were 39.0% (95% CI 33.8 to 44.2; p

Conclusions

QCPR Classroom helped students achieve high-quality CPR training, especially for proper compression depth and full recoil. For good educational achievement, a novel QCPR Classroom with a metronome sound is recommended.

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