This study aimed to analyse temporal trends in fertility and birth rates, examine maternal characteristics and forecast future demographic changes in Georgia.

This was a retrospective observational study using population-level data from the National Statistics Office of Georgia (Geostat) and the Georgian Birth Registry (GBR). Temporal trends were analysed using Prais-Winsten regression models and annual percentage changes (APCs) and future projections were generated using autoregressive integrated moving average (ARIMA) models.

The study included data on 543 662 live births retrieved from the Geostat for the period 2014–2024. Additionally, maternal characteristics were analysed for 366 684 births recorded in the GBR for the period 2017–2024. Selection criteria included all live births during the study period, with no specific exclusion criteria applied.

Primary outcome measures were trends in the total fertility rate (TFR) and crude birth rate (CBR) over the study period (2014–2024) and their projections for 2025–2034. Secondary outcome measures were concurrent changes in maternal characteristics, including maternal age, nationality, place of residence, region of residence and parity.

Between 2014 and 2024, Georgia’s TFR declined from 2.30 to 1.68 children per woman (APC=3.12%, 95% CI –3.65 to –2.59), and the CBR dropped from 16.3 to 10.7 births per 1000 population per year (APC=4.39%, 95% CI –4.63 to –4.15). Fertility rates decreased most significantly among women aged

Georgia is undergoing a demographic transition characterised by declining fertility rates and delayed childbearing. Assuming the mechanisms underlying 2014–2024 data remain unchanged, projections indicate a continued decline in fertility and birth rates by 2034, which may pose significant social and economic challenges for the country. Further research is needed to explore the underlying factors driving these trends and to develop strategies to address the potential implications of this demographic shift.

The increasing global burden of long-term illnesses necessitates high-quality data to inform effective interventions, particularly in low-resource settings. Despite the critical role of data collectors in health research, their lived experiences and challenges remain understudied, especially in low- and middle-income countries (LMICs) like Nigeria. This study explored the experiences, barriers and facilitators encountered by field researchers working with individuals living with long-term illnesses.

A qualitative, descriptive phenomenological design was employed, involving in-depth interviews with 12 research coordinators across 12 healthcare facilities in Nigeria. Participants were purposively selected from the Nigeria Implementation Science Alliance–Model Innovation and Research Centres. Data were analysed using Colaizzi’s phenomenological method, with thematic analysis to identify key patterns.

Field researchers described both rewarding experiences and significant obstacles. While they found value in contributing to impactful research, they faced emotional strain from engaging with sensitive narratives. Key barriers included low health literacy, cultural and religious constraints, hesitation to engage in the study and logistical constraints such as unreliable infrastructure. Facilitators included prefield training, trust-building and support systems. Recommendations emphasised ethical adherence, continuous skill development, context-appropriate incentives and streamlined data collection tools.

The study underscores the need for systemic support for data collectors, including mental health resources, adaptive methodologies and institutional policies that address logistical and emotional issues. These findings advocate for participant-centred, ethically sound research practices to enhance data quality and collector well-being in long-term illness studies.

Future research needs to evaluate interventions to optimise data collection processes in LMICs.

Acute pain is an expected symptom for adolescents after outpatient surgery. In the USA, postoperative analgesic regimens frequently include prescription opioids. Increasing attention from clinicians, patients and other healthcare leaders has been directed toward non-opioid strategies, such as combining non-steroidal anti-inflammatory drugs (NSAIDs) plus acetaminophen, as potential first-line options for managing postoperative pain. However, the effectiveness and safety of home regimens that include versus exclude opioids for adolescents are unclear. The Comparing Analgesic Regimen Effectiveness and Safety after surgery for Kids study evaluates the effectiveness and safety of NSAIDs plus acetaminophen alone (NSAID regimen) versus NSAIDs and acetaminophen plus a low-dose opioid regimen (opioid regimen).

This study is a pragmatic, multicentre randomised controlled clinical trial recruiting 900 patients aged 12–20 years undergoing three common outpatient surgeries (tonsillectomy, laparoscopic cholecystectomy, knee arthroscopy) across four health systems. We will recruit patients prior to surgery and individuals will be randomised 1:1 with stratification to receive prescriptions for either the NSAID regimen or the opioid regimen. The primary effectiveness outcome is patient-reported pain intensity, while the primary safety outcome is adverse medication-related symptoms both assessed over the first 2 weeks after surgery. Secondary outcomes include quality of recovery, healthcare-related quality of life and rates of problematic substance use and chronic prescription opioid use, assessed up to 1 year after surgery.

The study incorporates stakeholder collaboration, including patient partners, surgeons, professional organisations., and health insurance payors, to ensure ethical conduct and relevance. This study is overseen by a single institutional review board with certificate of confidentiality. Findings will be disseminated through academic publications, conferences and community outreach to inform patients, parents, surgical teams and policymakers about optimal pain management strategies for adolescents after surgery.

NCT06671002.

Doxycycline as post-exposure prophylaxis (doxy-PEP) has emerged as an efficacious strategy to reduce Chlamydia trachomatis (C. trachomatis), Neisseria gonorrhoeae (N. gonorrhoeae) and syphilis (sexually transmitted infections (STIs)) among gay, bisexual and other men who have sex with men (GBM). There is a need to identify prescribing criteria that maximise the number of STIs averted while minimising excessive use.

In this prospective longitudinal cohort study with repeated measures and biobehavioural data collection, participants completed a questionnaire and tested for STIs at each visit.

Community-based, population-level study conducted in three large Canadian cities between February 2017 and July 2023.

2449 GBM were recruited through respondent-driven sampling (RDS); 1998 had ≥1 follow-up visit, contributing 7551 person-years of observation. Eligible participants were aged ≥16 years, cis- or transgender men, reported sex with another man in the past 6 months and resided in Montreal, Toronto or Vancouver.

Adjusted rate ratios (aRR) of STIs, accounting for RDS recruitment, loss to follow-up and confounding were estimated using generalised estimating equations (GEE) Poisson regression. For identified STI risk factors, the proportions of STIs averted through doxy-PEP prescription (based on the efficacy of doxy-PEP for each bacterial STI) and the number needed to treat (NNT) for 1 year to avert one STI, assuming 100% adherence, were calculated.

Among 1998 participants, the combined incidence rate of any C. trachomatis, N. gonorrhoeae and syphilis infection was 29.5 (95%CI 27.3 to 31.9) per 100 person-years. STI risk factors that had the most impact as doxy-PEP criteria were history of any of the three STIs in the past 12 months (P12M) (aRR=2.0, 95% CI 1.8 to 2.2, 36% STI averted, NNT=2.1); ≥10 male sexual partners in the past 6 months (P6M) (aRR=3.8, 95% CI 3.0 to 4.9, 41% STI averted, NNT=2.4); HIV-pre-exposure prophylaxis (PrEP) use P6M (aRR=1.7, 95% CI 1.5 to 2.0, 29% STI averted, NNT=2.5); use of any chemsex-related substance P6M (aRR=1.2, 95% CI 1.1 to 1.4, 28% STI averted, NNT=2.6); and group sex event attendance P6M (aRR=1.2, 95% CI 1.1 to 1.3, 27% STI averted, NNT=2.3). Reporting≥10 male sex partners P6M represented the most useful criterion for syphilis prevention (52% syphilis infections averted, NNT=20). Prescribing doxy-PEP to GBM having any of the following STI risk factors, namely, ≥1 bacterial STI P12M, ≥10 male sex partners P6M, or HIV-PrEP use P6M, would substantially increase the proportion of all STI diagnoses potentially averted (60%) with minimal increase of the NNT (2.7).

This work informs on the impact of various doxy-PEP clinical prescribing criteria and demonstrates the benefit of focusing on any of the following three criteria: ≥1 bacterial STI P12M, ≥10 male sex partners P6M or HIV-PrEP use P6M.

For adolescents living with higher body weight, changing lifestyle behaviours can be met with challenges due to psychosocial factors, such as mental health and emotional challenges. Few behavioural interventions have included skill development to manage these mental health and emotional challenges.

The feasibility of a dialectical behavioural therapy (DBT)–enhanced lifestyle intervention will be evaluated through a pilot randomised controlled trial. We will recruit 90 adolescents aged 14–17 years with a body mass index Z-score >1.4 and mild-to-moderate depressive symptoms to participate with a caregiver in the trial. Adolescents will be randomised 2:2:1 to one of the three study arms: (A) behavioural lifestyle intervention with DBT skills training, (B) behavioural lifestyle intervention alone (ie, without DBT skills training) or (C) control. The interventions will include two sessions weekly for 16 weeks that include (1) one modified DBT skills training with two facilitators, supervised by a clinical psychologist, combined with one behavioural lifestyle session delivered by a dietitian and/or a kinesiologist and (2) two behavioural lifestyle sessions alone. DBT skills training will consist of teaching mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and walking the middle path modules. Behavioural sessions will be guided by evidence-based practices for goal setting, dietary counselling, improving sleep, reducing screen time and structured physical activity. The main outcomes are enrolment rates, adherence to the intervention and retention rates for follow-up measurements. The secondary outcome will be changes in the quality of life (Pediatric Quality of Life Inventory) and daily physical activity levels between baseline and immediately post-intervention. Adolescents will participate in a focus group incorporating photo elicitation to explore satisfaction, acceptability and perceived benefits of the study arms.

This study has received ethical approval from the University of Manitoba’s Biomedical Research Ethics Committee (HS24295-H2020:427), Hamilton Health Sciences & McMaster University (HiREB 18159) and The Conjoint Health Research Ethics Board (CHREB), University of Calgary (REB24-1084). Results will be disseminated through publication in peer-reviewed journals and be relevant to researchers and clinicians involved in paediatrics and paediatric weight management.

NCT05338944.

Polysubstance use (PSU), particularly opioid-involved and stimulant-involved PSU, is a growing issue in the USA. PSU increases the risk of negative health consequences, including infectious diseases, worsening physical and mental health conditions, and overdose-related deaths. These consequences occur in the context of varying health risk behaviours, substance-related preferences, and treatment engagements among people with PSU. To inform improvements in prevention, harm reduction, and substance use disorder (SUD) treatment, additional research is needed to comprehensively understand the current context and drivers of PSU preferences, motivations, and behaviours.

Herein, we describe the protocol for a prospective cohort study designed to capture detailed patterns, profiles, and trajectories of PSU, with the aim of comprehensively examining the drivers of PSU behaviours and SUD treatment utilisation. Adults (ages 18–75; n=400) who engage in PSU will be recruited from healthcare institutions, an established participant database maintained by an adjacent SUD research team, and online advertisements. Study assessments will capture dynamic patterns, choice preferences, and motivators of PSU via behavioural economic (BE) measures, detailed Timeline Follow-Back (TLFB) interviews, and self-administered surveys. The assessment timeline will include a baseline survey and TLFB interview, weekly TLFB interviews for 4 weeks post-baseline, and follow-up surveys and TLFB interviews at 4-, 8-, and 12-months post-baseline.

The study is funded through the National Institutes of Health Helping to End Addiction Long-term (HEAL) initiative and was approved by the University of Michigan Medical Institutional Review Board. Findings will be disseminated to academic, clinical, and community partners through the Michigan Innovations in Addiction Care through Research and Education programme. Results from this study will inform actionable and practical insights relevant to the delivery of personalised care in the context of PSU.

Glucosamine is a commonly used ‘over the counter’ dietary supplement. Previous research has identified an association between glucosamine use and several positive health outcomes. However, a plausible biological mechanism for these associations has not yet been identified, meaning the causality of these relationships remains unclear. A protective effect of glucosamine on the vascular endothelium has been suggested as one such possible mechanism. Albuminuria is an early marker of endothelial dysfunction within the kidney and is associated with progression of kidney disease and adverse cardiovascular outcomes. In order to provide insights into the potential biological mechanisms underlying a protective association of glucosamine use with health outcomes, we evaluated evidence for an association between glucosamine use and albuminuria in UK Biobank (N=436 200).

Univariable and multivariable ordinal logistic regression were performed to evaluate evidence for an association between self-reported glucosamine use and albuminuria (measured as urine albumin creatinine ratio (uACR) categories). As a secondary analysis, we performed Mendelian randomisation (MR) to demonstrate the difficulties in inferring causality in this relationship using currently available data, using summary genetic data from UK Biobank and CDKGen (N=67 452).

We found that people who used glucosamine were more likely to be in a lower uACR group (OR 0.81, 95% CI 0.80 to 0.83, px10^–16). This association was robust to sensitivity analyses and was maintained after adjustment for age, sex and measures of obesity. In our MR analysis, we found little evidence for an association of genetically proxied glucosamine use on albuminuria (change in log uACR (mg/g) per SD change in genetic liability=1.11, 95% CI –3.01 to 5.23, p=0.60).

We found that detectable albuminuria was common in UK Biobank participants and we are the first to show that use of glucosamine supplements was associated with lower levels. Though this fits with a plausible biological role of the vascular endothelium in a potential protective effect of glucosamine use on many health outcomes, whether this relationship is causal or confounded remains unclear. We further discuss the inherent difficulties in using genetic instruments to proxy supplement use in MR analyses and highlight the need for a genome-wide association study of measured circulating glucosamine levels.

Patients who survive admission to intensive care unit (ICU) for critical illness are at high risk of developing muscle atrophy and weakness, commonly diagnosed as ICU-acquired weakness (ICUAW). The development of ICUAW is closely linked to long-term symptoms and impairments known as post-intensive care syndrome (PICS). Despite heightened recognition of impairments, there is limited research supporting effective interventions to improve muscle and physical outcomes after hospital discharge. Prior to developing and testing interventions for ICU survivors, it is imperative to understand the trajectory of muscle and physical function recovery following an ICU stay. The purpose of this study is to longitudinally investigate skeletal muscle health and physical function outcomes after ICU admission.

This protocol describes a single site, prospective, observational study in adult patients who have survived a critical illness (ie, sepsis or acute respiratory failure). Patients will participate in a battery of testing including primary outcomes: muscle power and physical function; and secondary outcomes: muscle strength, muscle size, endurance and physical activity (by accelerometry) at hospital discharge and 3, 6, and 12 months post-discharge. A subset of patients will participate in muscle biopsy and venipuncture. To examine if the trajectory of recovery predicts primary outcomes, we will perform multivariate linear regression models in 150 evaluable patients. To examine differences in molecular and cellular outcomes in plasma and muscle tissue, a control group of community-dwelling adults without history of an ICU stay will be enrolled as a comparator group. Enrolment started on 18 October 2022 with an estimated completion date of 1 August 2027.

This protocol was approved by the University of Kentucky Office of Research Integrity Medical Internal Review Board (# 77407), with patients providing informed written consent. We anticipate our findings to establish recovery trajectories, improving the classification of patients who experience sustained physical disability. Improved identification of recovery trajectories of muscle and physical function enables future studies to employ an individually targeted rehabilitation approach, that is, precision medicine, with the goal of improving patient outcomes. The cellular findings will support the development of novel interventions specifically designed for detecting underlying mechanisms. We intend to disseminate findings to patients, healthcare professionals, the public and other relevant groups via conference presentations and manuscripts without publication restrictions.

NCT05537298.

Patient safety culture plays a crucial role in reducing clinical errors. By improving healthcare professionals’ and patients’ understanding of human fallibility and error attribution, patient care can be enhanced, fostering greater engagement from both groups. A Just Culture approach, which balances accountability and learning from errors, is a key factor in fostering this safety culture. The DECIDE Project aims to: (1) examine the conceptualisation of human fallibility within and beyond healthcare, (2) identify barriers and facilitators to Just Culture adoption, (3) assess the impact of psychoeducational interventions on professionals’ and social leaders’ attitudes toward clinical errors and (4) develop a roadmap for Just Culture implementation in healthcare.

A 36-month mixed-methods study including qualitative research, a survey of 1255 healthcare professionals, an experimental study with 180 participants (60 per arm) testing interventions based on cognitive dissonance and reasoned action theories and a consensus conference to develop a Just Culture roadmap. Participants include professionals from hospitals, primary care, long-term care, nursing homes and social leaders in Spain. The qualitative data collected during stages 1 and 4 will be analysed using MAXQDA software. In identifying factors related to the implementation of Just Culture during stage 2, ANOVA, t-tests and multiple linear regression will be conducted. To examine the effects of the interventions in phase 3, a linear mixed-effects model for repeated measures will be employed.

This study has received ethical approval from three institutional review boards. Findings will be disseminated through peer-reviewed publications, conference presentations and policy recommendations aimed at integrating Just Culture into national and international patient safety strategies. By promoting a constructive approach to errors, the project could enhance incident reporting, strengthen professional engagement in safety policies and foster a culture of learning and accountability. Its findings will guide policy recommendations for integrating Just Culture into national and international patient safety strategies, with potential applications beyond Spain.

NCT06835517.

Exposure to prescription opioids following traumatic injury can increase the risk of developing tolerance, persistent opioid use and opioid use disorder. The mechanisms underlying opioid tolerance or dependence are not well understood, and no biomarkers predict risk. Opioid exposure causes epigenetic modifications, including alterations in microRNA (miRNA) expression. Several miRNAs, which regulate synaptic plasticity, are hypothesised to underlie substance use disorders and influence µ-opioid receptor levels, modulating opioid tolerance. This project aims to develop a bio-behavioural signature to predict persistent opioid use and chronic pain up to 6 months post-discharge.

The study will use a prospective cohort design, enrolling 180 adult patients at a Level I Trauma Center who are prescribed opioids at discharge. Prospective data will be collected in the hospital and at 7 days and 1, 3 and 6 months post-discharge. Biological data (genotyping and miRNA levels) and clinical measures of opioid use, pain, pain sensitivity (EEG) and psychosocial functioning will be collected at each time point. Bayesian regression methods will be used to identify baseline clinical, genetic, epigenetic and psychosocial predictors of opioid use and pain outcomes at 6 months post-discharge. Growth mixture modelling will identify distinct subgroups with varying trajectories, followed by Bayesian hierarchical modelling to predict trajectory classification based on predictor variables.

Ethics approval for this study was obtained from the University of Texas Health Science Center at Houston Committee for the Protection of Human Subjects (HSC-MS-24–0314). Findings will be disseminated in peer-reviewed scientific journals and at national and international conferences.