Cohort profile: the WHO Child Mortality Risk Stratification Multi-Country Pooled Cohort (WHO-CMRS) to identify predictors of mortality through early childhood

Purpose
To provide details of a pooled data set that will be used to estimate absolute and relative mortality risks and other outcomes among children less than 59 months of age and the predictive performance of common risk exposures, both individually and in combination.

Participants
Children from birth to 5 years of age recruited at health facilities or community settings into 33 longitudinal observational or intervention studies in 17 low- and middle-income countries.

Findings to date
The data set includes 75 287 children with a median age of 3 months (IQR 1–12) at first measurement. In the pooled sample, 2805 (3.7%) of the study children died. Data on birth weight was recorded in 19 studies, and gestational age in 13 studies. Among these, 14% of the included children were reported as having low birth weight, and 14% had preterm birth. At first measurement, 33% of the children were stunted, 24% were wasted and 35% underweight. 13% and 7% of caregivers reported that their child had acute diarrhoea or acute lower respiratory tract infection before the study visit, respectively. The proportion of children reported as breastfed at any study visit decreased from 99% at age

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Novembre 2024

Monitoring drug Efficacy through Multi-Omics Research initiative in Alzheimers Disease (MEMORI-AD): A protocol for a multisite exploratory prospective cohort study on the drug response-related clinical, genetic, microbial and metabolomic signatures in Filipino patients with Alzheimers disease

Introduction
Dementia is one of the leading causes of disability among older people aged 60 years and above, with majority eventually being diagnosed with Alzheimer’s disease (AD). Pharmacological agents approved for dementia include acetylcholinesterase enzyme (AChE) inhibitors like rivastigmine, donepezil and galantamine and the N-methyl-D-aspartate (NMDA) receptor antagonist memantine, prescribed as monotherapy or in combination with each other, depending on the severity of disease. There is currently no available study demonstrating the clinical response to these drugs for AD in the Filipino population. Hence, this protocol aims to characterise the clinical, genetic, microbial and metabolic factors associated with drug responses to donepezil, rivastigmine and/or memantine for AD in a cohort of Filipinos with late-onset AD.

Methods and analysis
This protocol involves a multisite descriptive study that will use two study designs: (1) a descriptive, cross-sectional study to characterise the clinical profile of Filipino dementia patients with AD and (2) an exploratory prospective cohort study to investigate drug response-related genetic, gut microbiome and metabolome signatures of a subset of the recruited AD patients. At least 153 patients with mild or moderate AD aged 65 years old and above will be recruited regardless of their treatment status. A subset of these patients (n=60) who meet inclusion and exclusion criteria will be included further in the exploratory cohort study. These patients will be grouped according to their baseline medications and will be observed for treatment response in 6 months. The cognitive, functional and behavioural domains of patients and levels of functioning will be measured using different assessment tools. Drug responses of Filipino patients will then be investigated employing multi-omics technology to characterise genetic variations via whole exome sequencing, gut microbiome profile via shotgun metagenomic sequencing and metabolome profile via liquid chromatography with mass spectrometry.

Ethics and dissemination
The study has received ethical clearance from the Department of Health Single Joint Research Ethics Board (SJREB-2022–15). Results of psychometric scales will be made available to enrolled patients. The study results will be presented at national/international conferences and published in international peer-reviewed scientific journals, and summaries of the results will be provided to the study funders and institutional review boards of the three tertiary referral hospitals.

Trial registration number
Philippine Health Research Registry ID PHRR230220-0054116; ClinicalTrials.gov ID NCT05801380

Leggi
Novembre 2024

Constipation among workers with depression/anxiety: a retrospective study using a claims database and survey data in Japan

Objectives
To investigate the prevalence, associated factors, treatment status and burden of constipation in workers with depression or anxiety.

Study design
This was a retrospective observational study using a pre-existing database.

Setting
Claims data from October to November 2022 and data from the survey conducted in November 2022 were extracted from the database.

Participants
This study included self-reported workers who completed the survey, after excluding those with major mental disorders diagnosed as distinct from depression or anxiety and constipation due to organic diseases identified by International Classification of Diseases (ICD-10) codes.

Outcome measures
The subjects were divided into three groups: treated depression/anxiety, untreated depression/anxiety and no depression/anxiety. The prevalence of constipation, factors associated with constipation and medications prescribed for constipation were analysed. Work productivity and quality of life (QOL) were compared between three subgroups based on constipation status: treated constipation, untreated constipation and no constipation subgroup.

Results
Of the 18 585 respondents in the analysis population, 950 respondents (5.1%) were classified into the treated depression/anxiety group, 6035 respondents (32.5%) into the untreated depression/anxiety group and the remaining respondents into the no depression/anxiety group (11 600 (62.4%)). The prevalence of constipation was 22.5% in the treated group, 22.3% in the untreated group and 10.4% in the no depression/anxiety group, respectively. Depression and anxiety severity were independently associated with an increased risk of constipation. In all groups, the most commonly prescribed drug class was osmotic laxatives. Work productivity and QOL tended to indicate a greater burden in the untreated constipation subgroup than in the treated or no constipation subgroups.

Conclusions
The prevalence of constipation was twice as high if workers had depression/anxiety. Considering that the comorbidity of constipation with mental disorders may increase multiple burdens, appropriate medical interventions are required to treat both mental (depression/anxiety) and physical (constipation) conditions. This should be widely recognised by physicians and employers.

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Novembre 2024

Health-related quality of life in adults with metabolic syndrome: a multi-level analysis of family and individual level variation

Purpose
The current study aimed to investigate the associations between metabolic syndrome (MetS) with health-related quality of life (HRQoL) using multilevel analysis among the Iranian adult population.

Methods
This cross-sectional study was conducted in the framework of the Tehran Lipid and Glucose Study (TLGS). Participants were 6113 participants (3318 women and 2795 men) aged≥20 years of the TLGS seventh phase who had completed data on HRQoL and MetS. HRQoL was assessed using the short-form 12-item health survey V.2 and MetS defined based on the guidelines outlined in the Joint Interim Statement. The two-level model was fitted to assess the association between MetS and HRQoL.

Results
The prevalence of MetS and its components was higher in men, and regardless of metabolic status, men exhibited higher HRQoL values. The deleterious impact of MetS on HRQoL was more pronounced in women, while the detrimental effects of MetS on men’s HRQoL were confined to specific subscales. These results were obtained through multilevel analysis, considering both familial and individual variation levels. Moreover, our investigation highlighted the positive influence of leisure-time physical activity on both the physical and mental component summaries (PCS and MCS, respectively), regardless of gender. Education had a greater positive impact on PCS in both sexes. Additionally, a history of cardiovascular diseases was associated with a decline in mental and physical HRQoL, while age was linked to a decline in PCS and MCS, and smoking was associated with a decline in MCS.

Conclusion
This study revealed the significant influence of gender, as well as the unique characteristics and circumstances of individuals, on the relationship between MetS and HRQoL in a general population with low/middle income.

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Novembre 2024

Nomogram model for predicting medication adherence in patients with various mental disorders based on the Dryad database

Objective
Treatment compliance among psychiatric patients is related to disease outcomes. How to assess patient compliance remains a concern. Here, we established a predictive model for medication compliance in patients with psychotic disorders to provide a reference for early intervention in treatment non-compliance behaviour.

Design
Clinical information for 451 patients with psychotic disorders was downloaded from the Dryad database. The Least Absolute Shrinkage and Selection Operator regression and logistic regression were used to establish the model. Bootstrap resampling (1000 iterations) was used for internal validation and a nomogram was drawn to predict medication compliance. The consistency index, Brier score, receiver operating characteristic curve and decision curve were used for model evaluation.

Setting
35 Italian Community Psychiatric Services.

Participants
451 patients prescribed with any long-acting intramuscular (LAI) antipsychotic were consecutively recruited, and assessed after 6 months and 12 months, from December 2015 to May 2017.

Results
432 patients with psychotic disorders were included for model construction; among these, the compliance rate was 61.3%. The Drug Attitude Inventory-10 (DAI-10) and Brief Psychiatric Rating Scale (BPRS) scores, multiple hospitalisations in 1 year and a history of long-acting injectables were found to be independent risk factors for treatment noncompliance (all p

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Novembre 2024

Abstract 4144560: Phase 2 Open-label, Single-arm, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Camostat Mesylate in Patients with Protein-losing Enteropathy after Fontan Operation-Preliminary Outcome

Circulation, Volume 150, Issue Suppl_1, Page A4144560-A4144560, November 12, 2024. Introduction:Protein-losing enteropathy (PLE) is a multifaceted condition that profoundly affects the systemic health and quality of life of Fontan patients. Despite medical progress, the treatment of PLE remains a significant challenge. This study investigates the efficacy and safety of Camostat Mesylate for managing PLE patients who have undergone the Fontan operation.Hypothesis:We hypothesize that Camostat Mesylate will enhance the gut environment, resulting in increase of serum albumin levels and decrease of stool alpha-1 antitrypsin levels in PLE patients following Fontan operation.Methods:This phase 2, multicenter, open-label, single-arm trial included patients over 4 years old diagnosed with PLE following Fontan operation. Camostat Mesylate was added to conventional treatments, with follow-up assessments at 1, 3, and 6 months, and a final evaluation one month after discontinuation. Efficacy was measured by changes in serum albumin, stool alpha-1 antitrypsin levels, and PLE symptoms such as diarrhea, edema, weight changes, and ascites.Results:Nineteen patients were enrolled in the study, of whom fifteen patients completed follow-up as per protocol. The median age was 15 years (interquartile range, 12.0-21.3). The median time between the Fontan operation and PLE diagnosis was 2.4 years. Serum albumin levels increased from 2.5 to 2.6 g/dL (p=0.504), and stool alpha-1 antitrypsin levels decreased significantly from 280.0 to 172.1 mg/dL (p=0.033). Notably, patients with diarrhea at baseline showed substantial improvement in both parameters, with increased serum albumin levels from 1.8 to 2.2 g/dL and decreased stool alpha-1 antitrypsin levels from 220.3 to 80.2 mg/dL. No serious adverse events were reported during study period.Conclusions:Camostat Mesylate demonstrated safety and efficacy, reducing stool alpha-1 antitrypsin in PLE patients after Fontan operation, especially those with diarrhea at baseline. Therefore, Camostat Mesylate could be considered as an additional treatment option for patients with PLE following Fontan operation.Key words:Camostat mesylate; protein-losing enteropathy; Fontan operationSource of Funding:This research was funded by SNUH Lee Kun-hee Child Cancer&Rare Disease Project, Republic of Korea.

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Novembre 2024

Abstract 4143265: Unveiling Gender Disparities in Chagas Disease patients with cardiac involvement: Insights from the NIS Database

Circulation, Volume 150, Issue Suppl_1, Page A4143265-A4143265, November 12, 2024. Background:Chagas disease (CD) is caused by a protozoan named Trypanosoma cruzi, in its chronic stage it may present with organ involvement, including the heart. Previous studies suggest that being a male is associated with increased mortality in CD. Understanding gender disparities associated with this condition is imperative for better patient management.Hypothesis:Gender has an impact on the outcome of CD with cardiac involvement.Aim:To investigate if gender has an impact on the clinical outcomes of CD with cardiac involvement.Methods:We examined the National Inpatient Sample data from 2016-2020, and conducted a retrospective descriptive study. We included all patients 18 years and older, male and female, diagnosed with CD with cardiac involvement. We excluded patients who were younger than 18 years of age. Baseline socio-demographic characteristics, comorbidities, and outcomes of the two groups were described. Hypothesis testing for categorical variables was performed using Chi-Square. Continuous variables were tested with a Student t-test. Statistical significance was defined as a two-tailed p-value of

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Novembre 2024

Abstract 4144512: Impact of Nutritional Status on Transcatheter Edge-to-Edge Repair Outcomes in Mitral Regurgitation: Insights from a National Database Analysis

Circulation, Volume 150, Issue Suppl_1, Page A4144512-A4144512, November 12, 2024. Introduction:Transcatheter edge-to-edge repair of the mitral valve with the MitraClip has offered a less invasive percutaneous alternative to surgical repair in select candidates with mitral regurgitation. Various factors impact the outcomes of MitraClip. We investigated the impact of nutritional status on the outcomes of MitraClip.Methods:Utilizing the nationwide inpatient sample data for years from January 1, 2016, and December 31, 2021, patients who underwent MitraClip were identified. They were categorized based on obesity and protein energy malnutrition (PEM). Statistical significance was assigned at p

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Novembre 2024