EndoTrac is a line-attached sheath-type traction device that enables us to control the direction and the force of traction during endoscopic submucosal dissection (ESD). The efficacy of EndoTrac for gastric ESD has not been fully verified.

The G-Trac study is a multicentre (nine general hospitals and two university hospitals in Japan) collaborative trial assessing the efficacy of EndoTrac for gastric ESDs. Patients with superficial gastric neoplasms will be enrolled and randomly assigned to undergo either conventional ESD or EndoTrac ESD. Allocation will be stratified according to tumour location, operator experience and tumour diameter at an allocation rate of 1:1. The type of endoknife used will be confirmed before randomisation. The primary outcome, procedure time, will be compared between the groups in both intention-to-treat and per-protocol analyses using the Wilcoxon rank sum test. The efficacy-related, safety-related and device-related outcomes will be assessed in the secondary analysis. The planned sample size of the 142 patients in the two groups will enable us to detect a difference with a power of 80% by using the Wilcoxon rank sum test, assuming an effect size of 0.54, asymptotic relative efficiency of 0.864 and a two-sided type 1 error rate of 5%.

This trial was approved by the certified review board of Kobe University (22 December 2022). The results from this trial will be disseminated through peer-review journals, presentations at national and international conferences, and data sharing with other researchers.

jRCT1052220166.

This study aimed to evaluate the predictive value of admission D-dimer levels for in-hospital mortality in patients with COVID-19 and acute ischaemic stroke.

Cohort (prospective).

Tertiary referral hospital in the capital city of Indonesia conducted from June to December 2021.

60 patients with acute ischaemic stroke and COVID-19 were included. Patients were classified into D-dimer groups (low and high) according to a 2 110 ng/mL cut-off value, determined via receiver operating characteristic analysis.

The primary outcome was in-hospital mortality, with admission D-dimer levels as the major predictor. Secondary outcomes included associations between other demographic and clinical variables and the admission D-dimer value. Kaplan-Meier method was used to carry out survival analysis, with univariable and multivariable Cox regression performed to assess the association of D-dimer levels and other confounding variables (including demographic, clinical and laboratory parameters) with in-hospital mortality.

The findings demonstrated an association between elevated admission D-dimer levels (≥2 110 ng/mL) and an increased likelihood of death during hospitalisation. The adjusted HR was 14.054 (95% CI 1.710 to 115.519; p=0.014), demonstrating an increase in mortality risk after accounting for confounders such as age and diabetes history. Other significant predictors of mortality included a history of diabetes and increased white blood cell count.

Admission D-dimer levels may be a useful predictive indicator for the likelihood of death during hospitalisation in individuals with COVID-19 and acute ischaemic stroke.

This study aimed to examine the association between home meal preparer and salt intake among haemodialysis patients, including daily dietary status. We hypothesised that salt intake is higher among individuals who rely on meal preparation from others than those who prepare meals by themselves.

Cross-sectional study.

Two medical facilities in Fukushima Prefecture, Japan.

237 haemodialysis outpatients who visited one of the medical facilities between February 2020 and August 2021 and were diagnosed with anuria, defined as urination of

Salt intake amount was calculated from the results of predialysis and postdialysis blood draws, using Watson’s formula based on predialysis weight, predialysis serum sodium level, postdialysis weight and serum sodium level at the end of dialysis.

Salt intake was significantly higher in participants who relied on meal preparation from others (‘relying on others’) than those who prepared meals by themselves (‘self-prepared’) (B=1.359; 95% CI: 0.495 to 2.222). No statistical difference was found between individuals who ate out or ate takeout (‘outsourcing’) and those who prepared their own meals (‘self-prepared’). These results were robust after adjustment for confounding factors.

The present study revealed an association between self-preparation of meals at home and reduced salt intake among dialysis patients. Our findings suggest that whoever is the home meal preparer is possibly a social determinant of salt intake. To improve the prognosis of haemodialysis patients, actively reaching out to the family and assessing their social environment, such as identifying the home meal preparer and, if the patient relies on others for meal preparation, conducting nutritional/dietary guidance for that person, are effective in enhancing salt reduction.

SARS-CoV-2 has impacted globally the care of chronic diseases. However, direct evidence from certain vulnerable communities, such as Indigenous communities in Latin America, is missing. We use observational data from a health district that primarily serves people of Maya K’iche’ ethnicity to examine the care of type 2 diabetes in Guatemala during the pandemic.

We used a parallel convergent mixed methods design. Quantitative data (n=142 individuals with diabetes) included glycated haemoglobin (HbA1c), blood pressure, body mass index and questionnaires on diabetes knowledge, self-care and diabetes distress. Quantitative data was collected at two points, at baseline and after COVID restrictions were lifted. For quantitative outcomes, we constructed multilevel mixed effects models with multiple imputation for missing data. Qualitative data included interviews with providers, supervisors and individuals living with diabetes (n=20). We conducted thematic framework analysis using an inductive approach.

Quantitative data was collected between June 2019 and February 2021, with a median of 487 days between data collection points. HbA1c worsened +0.54% (95% CI, 0.14 to 0.94) and knowledge about diabetes decreased –3.54 points (95% CI, –4.56 to –2.51). Qualitatively, the most important impact of the pandemic was interruption of the regular timing of home visits and peer group meetings which were the standard of care.

The deterioration of diabetes care was primarily attributed to the loss of regular contact with healthcare workers. The results emphasize the vulnerability of rural and Indigenous populations in Latin America to the suspension of chronic disease care.

We examined literacy related to healthy gestational weight gain (GWG) in immigrant and native Japanese mothers and determined whether it is associated with children’s birth weight.

Longitudinal cohort study.

As the baseline survey in the Japan Environment and Children’s Study (JECS), mothers completed self-administered questionnaires distributed by hand during pregnancy. The self-administered questionnaires used in this study were distributed by mail 6 months after delivery. Children’s birth weight, actual GWG and any complications during delivery were recorded by obstetricians collaborating with JECS.

Of 97 452 mothers who consented to participate in the JECS during pregnancy between January 2011 and March 2014, 67 953 were included in this study after exclusions for multiple births, multiple instances of consent by the same pregnant woman, miscarriages/stillbirths or withdrawal from the study within 3 years after participating. In total, 324 immigrant mothers and 963 native Japanese mothers were selected by propensity score matching for analysis.

Data were collected on maternal literacy related to healthy GWG at the baseline survey, and data on actual GWG and children’s birth weight were collected by obstetricians. The associations of knowledge about healthy GWG and mothers’ actual GWG with maternal nativity status were examined using a ² or Student’s t-test.

More native Japanese mothers than immigrant mothers knew the appropriate GWG and reason the for needing to know this. Actual GWG was significantly higher among the immigrant mothers, but was within the recommended range. The low birthweight (LBW) incidence was significantly higher among the native mothers.

Immigrant mothers to Japan had less knowledge about appropriate GWG, but their actual GWG was appropriate and they delivered fewer LBW infants than native Japanese mothers. These findings may indicate the presence of other protective factors for pregnancy or delivery among immigrant mothers.

To assess whether acoustic stimulations relieve venipuncture pain and determine which stimulation is the most effective type.

Systematic review and network meta-analysis.

PubMed, Cochrane Central Register of Controlled Trials, Excerpta Medica dataBASE, Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov and the International Clinical Trials Registry Platform databases were systematically searched in September 2023.

Randomised controlled trials evaluating the efficacy of acoustic stimulations on patients undergoing venipuncture were eligible. Acoustic stimulations were classified into seven categories: five types of acoustic stimulations (music medicine (researcher selected), music medicine (patient selected), music therapy, sounds with linguistic meaning and sounds without linguistic meaning) and two controls (only wearing headphones and no treatment).

Primary outcomes included self-reported pain intensity assessed during venipuncture and treatment cost, and secondary outcomes were self-reported mental distress and adverse events.

Of 6406 citations, this network meta-analysis included 27 studies including 3416 participants; the mean age was 31.5 years, and 57% were men. Among the five types of acoustic stimulations, only musical interventions, such as music medicine (patient selected) (standardised mean difference (SMD) –0.44 (95% CI: –0.84 to –0.03); low confidence), music medicine (researcher selected) (SMD –0.76 (95% CI: –1.10 to –0.42); low confidence) and music therapy (SMD –0.79 (95% CI: –1.44 to –0.14); low confidence), were associated with improved pain relief during venipuncture compared with no treatment. No significant differences existed between the types of acoustic stimulations. Free-of-charge acoustic stimulations were provided to patients, and no specific adverse events were reported. In many studies, the risk of bias was rated high because of the difficulty of blinding the intervention to the participants and the self-reported pain outcome.

Music interventions were associated with reduced venipuncture pain. Comparisons between types of acoustic stimulations revealed no significant differences. Therefore, music intervention could be a safe and inexpensive pain relief method for venipuncture.

CRD42022303852.

The ageing populations in developed countries are a global concern, with increasing numbers of older adults facing physical, cognitive and psychological challenges, resulting in reduced quality of life and higher healthcare costs. Healthcare expenditure worldwide has been on the rise, especially among older adults, emphasising the importance of enabling independent living while reducing healthcare costs. Occupational therapy holds promising outcomes in promoting functional independence and enhancing the quality of life for older adults, but research on its cost-effectiveness remains limited. This systematic review aims to evaluate the recent evidence on the cost-effectiveness of occupational therapy interventions for older adults from a pragmatic perspective.

This systematic review will cover full economic evaluations, including cost-effectiveness, cost-utility and cost–benefit analyses, by reviewing randomised and cluster randomised controlled trials. The participants will be aged over 65 years without disease or disability restrictions. Primary outcomes will be assessed using functional status and quality-of-life assessments. Studies published before July 2023 will be searched in PubMed, Web of Science and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases, with no language restrictions.

Ethical approval is not required for this literature-based systematic review. The study’s findings will update the evaluation of occupational therapy’s cost-effectiveness in older adults and will be made public by publishing them in scholarly journals.

CRD42023453558.

Physical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.

In this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.

Ethical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.

NCT03841669.