Association between early ondansetron use and the risk of sepsis in intensive care unit patients: a secondary data of the Medical Information Mart for Intensive Care IV database

Objective
This study planned to analyse the association between ondansetron use within 24 hours before intensive care unit (ICU) admission to within 48 hours after ICU admission and the risk of sepsis in ICU patients.

Design
A cohort study.

Setting and participants
Data of 65 366 participants in Medical Information Mart for Intensive Care IV from ICU in the Beth Israel Deaconess Medical Center.

Primary and secondary outcome measures
Sepsis was the primary outcome, which indicated patients with documented or suspected infection and acute change in total Sequential Organ Failure Assessment (SOFA) score ≥2 points. In-hospital mortality was the secondary outcome.

Results
There were 6737 patients with early ondansetron use. In total, 1646 patients suffered sepsis. According to the data from multivariate cox regression model, compared with participants without early ondansetron use, the risk of sepsis was reduced in participants with early ondansetron use relative to those without HR (HR=0.84, 95% CI: 0.76 to 0.93). The risk of in-hospital mortality was reduced in those with early ondansetron use (HR=0.63, 95% CI: 0.55 to 0.72). Subgroup analysis revealed that the association between early ondansetron use and decreased risk of sepsis was significant in participants aged

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Gennaio 2025

Sex hormone-dependent host-microbiome interactions and cardiovascular risk (XCVD): design of a longitudinal multi-omics cohort study

Introduction
Cardiovascular diseases (CVDs) present differently in women and men, influenced by host-microbiome interactions. The roles of sex hormones in CVD outcomes and gut microbiome in modifying these effects are poorly understood. The XCVD study examines gut microbiome mediation of sex hormone effects on CVD risk markers by observing transgender participants undergoing gender-affirming hormone therapy (GAHT), with findings expected to extrapolate to cisgender populations.

Methods and analyses
This observational, longitudinal cohort study includes baseline, 1- and 2-year follow-ups with transgender participants beginning GAHT. It involves comprehensive phenotyping and microbiome genotyping, integrating computational analyses of high-dimensional data. Microbial diversity will be assessed using gut, skin, and oral samples via 16S rRNA and shotgun metagenomic sequencing of gut samples. Blood measurements will include sex hormones, CVD risk markers, cardiometabolic parameters, cytokines, and immune cell counts. Hair samples will be analysed for cortisol. Participants will complete online questionnaires on physical activity, mental health, stress, quality of life, fatigue, sleep, pain, and gender dysphoria, tracking medication use and diet to control for confounders. Statistical analyses will integrate phenomic, lifestyle, and multi-omic data to model health effects, testing gut microbiome mediation of CVD risk as the endocrine environment shifts between that typical for cisgender men to women and vice versa.

Ethics and dissemination
The study adheres to Good Clinical Practice and the Declaration of Helsinki. The protocol was approved by the Charité Ethical Committee (EA1/339/21). Signed informed consent will be obtained. Results will be published in peer-reviewed journals and conferences and shared as accessible summaries for participants, community groups, and the public, with participants able to view their data securely after public and patient involvement review for accessibility.

Trial registration number
The XCVD study was registered on ClinicalTrials.gov (NCT05334888) as ‘Sex-differential host-microbiome CVD risk — a longitudinal cohort approach (XCVD)” on 4 April 2022. Data set link can be found at https://classic.clinicaltrials.gov/ct2/show/NCT05334888.

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Gennaio 2025

Enhancing physical activity during pregnancy using a multi-theory model: a study protocol for a randomised controlled trial in China

Background
Physical inactivity is a global concern and poses serious health risks. Physical inactivity is exacerbated and affects the health of both generations during the special period of pregnancy. Appropriate physical activity (PA) intervention programmes based on health behaviour change theory are lacking. This study aims to evaluate the effectiveness of a PA intervention based on the multi-theory model (MTM) by assessing changes in PA levels, MTM constructs, exercise self-efficacy, quality of life, prenatal depressive symptoms, gestational weight gain and pregnancy and delivery outcomes.

Methods and analysis
This single-centre, parallel, randomised, controlled trial will be conducted at a tertiary care institution in Hangzhou, China. A total of 72 pregnant women without contraindications to exercise at 14–27 weeks+6 days of gestation will be included. Participants will be randomly assigned to either the intervention or control group. The intervention group will engage in a 12 week PA intervention programme based on the MTM and delivered through WeChat, while the control group will receive standard antenatal care. Data will be collected at baseline, 6 weeks of the intervention, 12 weeks of the intervention and within 1 week of delivery. The primary outcomes will include PA levels measured by accelerometers and the PA in Pregnancy Questionnaire, along with the constructs of the MTM. Secondary outcomes will comprise exercise self-efficacy during pregnancy, quality of life, prenatal depressive symptoms, gestation weight gain and pregnancy and delivery outcomes. Data analysis will adhere to the Consolidated Standards of Reporting Trials 2010 statement and follow the intention-to-treat principle.

Ethics and dissemination
The study followed the ethical guidelines approved by the ethics committee of Women’s Hospital School of Medicine Zhejiang University (IRB-20230254-R, Approval Date: 27 July 2023). The results of the study will be submitted for publication and dissemination in a peer-reviewed journal. Participants will receive clarification regarding the study objectives, procedures and will be asked to sign informed consent in written form before the start of the study.

Trial registration number
ChiCTR2400080843. Prospectively registered on 8 February 2024.

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Gennaio 2025

Developing standards for the implementation of stepped care in child and youth mental health service settings: protocol for a multi-method, delphi-based study

Introduction
Canadian youth mental health (YMH) systems have the potential to urgently tackle the mental health treatment gap currently impacting young people, and stepped care (SC) is one model that can address this need. The adoption of SC models can guide the development of better-connected YMH systems by simplifying transitions and care pathways. To do so requires robust standards that are co-created across stakeholder groups, including with lived experience experts, to ensure the effective implementation of SC models.

Methods and analysis
This study aims to establish standards for implementing SC in Canadian child and YMH service settings by convening and developing a learning alliance (LA) of 65 individuals, translating guiding principles to standards via consensus methods (Delphi study), and operationalising and applying draft standards to three test ecosystems. Members of the LA will be recruited via snowball and purposive recruitment techniques to complete an e-Delphi study over three to four rounds until consensus is achieved. Participants will rank their agreement with including specific clause items in the final standard, and will be given opportunities to provide feedback and suggest revisions during each round. Comments will be analysed, scored and coded accordingly. Once consensus has been achieved, members of the LA will consider the application of these implementation standards in three settings that could benefit from SC. The protocol for this study was registered at Open Science Framework (https://doi.org/10.17605/OSF.IO/J5UNW).

Ethics and dissemination
The protocol has been approved by the Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l’Ouest-de-l’Île-de-Montréal—Mental Health and Neuroscience subcommittee. As part of the ethics approval, informed consent forms for all Delphi participants were created and distributed to participants ahead of the Delphi. This includes parental consent forms for all LA members participating in the study who are under the age of 18. On completion, the project will ultimately support the implementation of SC in diverse service systems and guide the development of a robust and connected mental health delivery system in Canada. The final standard will be shared with relevant government bodies and health planners and disseminated via academic and other platforms.

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Dicembre 2024

Efficacy in predicting mortality of patients with heart failure using heart rate before intensive care unit discharge: a retrospective cohort study from MIMIC-IV Database

Objective
Heart rate serves as a critical prognostic factor in heart failure (HF) patients. We hypothesise that elevated heart rate in critically ill HF patients on discharge from the intensive care unit (ICU) could be linked to adverse outcomes.

Design
A single-centre retrospective cohort study.

Setting
This study used data collected between 2008 and 2019 from the Medical Information Mart for Intensive Care IV (V.2.0) Database.

Participants
From the 76 943 ICU stays, we enrolled 2365 patients in this study.

Primary and secondary outcome measures
We observed correlations between in-hospital mortality and ICU discharge heart rate of 83.56±15.81 beats per minute (bpm) (survivors) vs 93.84±17.28 bpm (non-survivors, p

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Dicembre 2024

Protocol for a multi-domain scoping review to identify measures of decision-making ability in an ageing population

Introduction
Deficits in decision-making (DM) can lead to adverse outcomes across multiple domains such as financial management and medical care. By hindering such DM abilities, cognitive impairment (CI) often affects quality of life. Routine screening for CI, however, does not include systematic and comprehensive assessment of DM ability. While there are many DM measures, there is considerable heterogeneity in what constructs are measured and the populations in which they have been validated. This scoping review protocol details the proposed comprehensive examination of published literature on DM measures used in adults aged 45 years and older.

Methods and analysis
Arksey and O’Malley’s (2005) scoping review methodology framework will guide the current scoping review. We will systematically search Embase (Elsevier), MEDLINE (Ovid), PsycINFO (Ebsco), Cochrane Library (Wiley), Web of Science (Clarivate) and Scopus (Elsevier) to identify the studies meeting our eligibility criteria. We will review literature published between January 2018 and November 2023. Following best practice recommendations, a two-stage study selection process will be applied. First, titles and abstracts will be independently reviewed by two reviewers based on our eligibility criteria. Second, full texts will be screened and data will be extracted only from the articles included after the full review. The results of the current scoping review will be reported in adherence to PRISMA-Scr guidelines.

Ethics and dissemination
This study does not require ethics approval as the scoping review methodology involves reviewing results from publicly available published materials. Results of the scoping review will be submitted for publication in a peer-reviewed journal.

Trial registration number
NIA grant number 1U24AG082022-01.

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Dicembre 2024

Nomogram based on the log odds of negative lymph node/T stage can predict the prognosis of patients with colorectal cancer: a retrospective study based on SEER database and external validation in China

Objectives
This study investigated the prognostic role of log odds of negative lymph node/T stage (LONT) and established a nomogram based on LONT to predict the prognosis in colorectal cancer (CRC) patients.

Design
A retrospective cohort study.

Setting and participants
We enrolled 80 518 CRC patients from the Surveillance, Epidemiology and End Results database between 2010 and 2015. The dataset was split into a training cohort (56 364 patients) and a validation cohort (24 154 patients) at a ratio of 7:3. Furthermore, 500 CRC patients who underwent surgery in the Tenth Affiliated Hospital of Southern Medical University between 1 January 2017 and 20 December 2018, were recruited as the external validation set.

Outcome measures
1-, 3- and 5-year cancer-specific survival (CSS).

Methods
The univariate and multivariate Cox regression analyses were carried out to identify the significant independent prognostic factors of CSS. A nomogram was established based on LONT to predict the prognosis. The performance of the nomogram was comprehensively assessed via the time-dependent receiver operating characteristic curve, concordance index (C-index), calibration curve and decision curve analysis (DCA) comprehensively. Moreover, Kaplan-Meier curves were performed to assess the CSS of the three risk subgroups.

Result
LONT was a significant independent prognostic factor for CSS (LONT1 vs LONT2, HR=0.670, 95% CI 0.642 to 0.698, p

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Dicembre 2024