Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

ACTRN12623000598684p.

Length-for-age z-scores (LAZ) and stunting prevalence (%LAZ

We simulated a synthetic cohort with a harmonically downward-shifting LAZ trajectory from birth to 24 months of age, with mean LAZs similar to the HBGDki pooled South Asian cohorts, and without any input parameters intended to differentially affect individuals’ growth across the height distribution or at different ages. We compared HBGDki empirical estimates of age interval-specific frequencies of incident stunting onset and stunting reversal with those from the synthetic cohort. Using synthetic cohorts, we examined how estimates of incident onset and reversal were affected by missing data, magnitude of the whole-population shift in the LAZ distribution and strength of the between-time-point correlation. We also compared the 3–24 month pattern of linear growth faltering expressed as age-related trajectories of average growth delay (chronological age minus height–age), mean LAZ or stunting prevalence.

Empirical estimates of age interval-specific incident stunting onset and stunting reversal in the HBGDki cohorts were similar to those observed in a synthetic cohort. Variability in LAZ threshold-crossing event rates is explained by starting LAZ, between-time-point correlation and the magnitude of the whole-population shift in the LAZ distribution. Incident stunting onset is also affected by missing data in preceding intervals. Stunting reversal occurs due to within-child variability (ie, imperfect between-time-point correlation) in the absence of any other phenomena that cause stunted children to become non-stunted at a later age. The linear growth faltering pattern based on growth delay differed from corresponding age-related trajectories of mean LAZ or stunting prevalence.

In longitudinal studies of linear growth faltering in LMICs, LAZ threshold-crossing indicators are byproducts of whole-population shifts in LAZ and within-child variability and should be interpreted accordingly. Reporting incident stunting onset and reversal rates, or analyses in which children are grouped by the timing of LAZ threshold-crossing events, may detract from efforts to understand when and why nearly all children in LMICs grow more slowly than expected for their age. Since mean LAZ and stunting prevalence are unsuitable for quantifying the rate and timing of population-average postnatal linear growth faltering, growth delay is recommended for consideration as a preferred metric.

This study validates the previously tested Screening for Poverty And Related social determinants to improve Knowledge of and access to resources (‘SPARK Tool’) against comparison questions from well-established national surveys (Post Survey Questionnaire (PSQ)) to inform the development of a standardised tool to collect patients’ demographic and social needs data in healthcare.

Cross-sectional study.

Pan-Canadian study of participants from four Canadian provinces (SK, MB, ON and NL).

192 participants were interviewed concurrently, completing both the SPARK tool and PSQ survey.

Survey topics included demographics: language, immigration, race, disability, sex, gender identity, sexual orientation; and social needs: education, income, medication access, transportation, housing, social support and employment status. Concurrent validity was performed to assess agreement and correlation between SPARK and comparison questions at an individual level as well as within domain clusters. We report on Cohen’s kappa measure of inter-rater reliability, Pearson correlation coefficient and Cramer’s V to assess overall capture of needs in the SPARK and PSQ as well as within each domain. Agreement between the surveys was described using correct (true positive and true negative) and incorrect (false positive and false negative) classification.

There was a moderate correlation between SPARK and PSQ (0.44, p60), SPARK correctly classified 90.5% (n=176/191).

SPARK provides a brief 15 min screening tool for primary care clinics to capture social and access needs. SPARK was able to correctly classify most participants within each domain. Related ongoing research is needed to further validate SPARK in a large representative sample and explore primary care implementation strategies to support integration.

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.

Alzheimer’s disease (AD) impacts over 55 million individuals worldwide and remains the leading cause of dementia (60–70% of cases). By 2050, South and Southeast Asia are projected to have an older adult population more than double, bearing a major share of Alzheimer’s disease burden. This will exert a heavy strain on healthcare systems, particularly in resource-limited countries where support and infrastructure are already stretched. Despite this, no review has yet explored the regional epidemiology and associated risk factors in this context. Thus, this study protocol outlines to synthesise prevailing evidence from these densely populated regions, particularly low- and middle-income nations within South and Southeast Asia.

This review will include studies that reported epidemiological characteristics including prevalence, age of onset, mortality, and risk factors of AD and related dementias comprising in South and Southeast Asian regions. Studies published in any language from inception to date will be extracted from PubMed, Scopus, CINAHL, EMBASE and APA PsycNet, following Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) and Meta-Analysis of Observational Studies in Epidemiology (MOOSE) guidelines. We will also search grey literature sources and screen the reference lists of the articles selected for full-text review to identify additional relevant studies. Observational studies including case–control, cohort, and cross-sectional designs reporting desired outcomes will be included and appraised for quality assessment with the modified Newcastle-Ottawa Scale (mNOS). The included articles will be appraised by two independent reviewers, with a third resolving any conflicts. Pooled estimates of prevalence, age of onset and mortality will be analysed using random effect meta-analysis (REML) model. Associated risk factors, including modifiable and non-modifiable will be narratively synthesised. Forest plots will be used to visualise the findings, and heterogeneity across the included studies will be assessed using the I² and Cochrane’s Q statistics. Potential publication bias will be assessed using a funnel plot along with the Begg’s and Egger’s tests. Sensitivity and subgroup analyses will also be conducted to assess the robustness of pooled estimates and to explore potential sources of heterogeneity. Statistical analysis will be conducted using Rstudio (v.4.3.2) and GraphPad Prism V.9.0.2.

The systematic review is focused on the analysis of secondary data from published literature; thus, no ethical approval will be needed. The protocol will follow international standard guidelines, findings will be reported in a reputed journal and disseminated through (inter)national conferences, webinars and key stakeholders to inform policy, research and AD management strategies.

CRD 420251047105.

Hospitalisation is one of the most stressful life events for older adults, particularly for those who are pre-frail or frail. Multi-component community-based interventions have the potential to address the complex needs of older adults post-acute care admission. While some available interventions have been developed with end-user engagement, fully involving older people who are pre-frail or frail in the design of interventions has been less common. Multi-component community-based interventions that address the needs of older adults and their care partners with potential implementation barriers informed by healthcare providers, community partners and health system decision makers are needed. This protocol paper describes the planned process of co-designing for older patients discharged into the community, a Post-Acute Care Intervention for Frailty using Information and Communication technology.

The development of a complex multi-component frailty intervention which meets older people’s needs involves several concurrent tasks and methodologies, each informed by co-design and conducted with consideration to eventual implementation. These tasks include: (1) establishing a Research Advisory Board, (2) assessing the feasibility and validity of using hospital administrative data to identify frail or pre-frail older adults and their needs, (3) conducting a needs assessment of patients returning to the community, (4) mapping community assets to identify existing programmes and services to help tailor the intervention, (5) co-designing a multicomponent frailty intervention, (6) selecting study outcome measures and (7) selecting and tailoring a digital health patient portal to support intervention delivery, data capture and communication.

Each task requiring ethics approval will be submitted to the Hamilton Integrated Research Ethics Board at McMaster University. Results will be disseminated through peer-reviewed journal articles, conferences and networks of relevant knowledge users who have the capacity to promote dissemination of the results. A toolkit will be developed to help researchers and healthcare providers replicate the methodology for other populations.

Dyspnoea frequently leads to admissions in the Emergency Department (ED). Rapid and accurate diagnosis, specifically to distinguish acute heart failure from pneumonia and exacerbations of chronic obstructive pulmonary disease (COPD), is imperative to initiate appropriate therapy. This study aims to evaluate the feasibility and performance of the EMERgency ALgorithm efficiency for Dyspneic patient-UltraSound (EMERALD-US) algorithm using ultrasound (US) to diagnose the etiology of dyspnea in the ED-admitted patients.

225 patients of 50 years and above, presenting with acute non-traumatic dyspnoea, across six participating EDs will be enrolled. Patients will undergo a lung, a simplified four-chamber cardiac and a venous US. A physician, blinded to any clinical data or previous results, will execute the algorithm. The algorithm’s performance will be assessed using a receiver operating characteristic (ROC) curve. Secondary objectives include an evaluation of the protocol’s feasibility in the ED, an assessment of the concordance between the EMERALD-US algorithm diagnoses and results from other diagnostic tests (including laboratory work and imaging), as well as an evaluation of the algorithm’s performance in diagnosing other causes of dyspnoea, such as pulmonary embolism or pleural effusion, and the 30-day mortality rate.

The study protocol was approved by the French Committee for the Protection of Persons (CPP) (RCB n°2018-A02136-49). Misdiagnosis of dyspneic patients on ED admission has been associated with inappropriate treatment, prolonged hospital stays and increased mortality, particularly among elderly patients. The implementation of protocols like the EMERALD-US algorithm can help physicians in expedited decision-making and diagnosis without increasing ED visit durations.

NCT03691857.

To estimate the prevalence of established atherosclerotic cardiovascular disease (eASCVD) and the prevalence of ASCVD high-risk patients as defined by the European Society of Cardiology (ESC) among the Egyptian population of the Prevalence and Clinical Management of Atherosclerotic Cardiovascular Diseases in Patients With Type 2 Diabetes (PACT)-Middle East and Africa study.

An observational, multicentre, cross-sectional study.

Eight secondary care centres in Egypt.

550 adult males and females who provided informed consent and had been diagnosed with type 2 diabetes mellitus (T2DM) for at least 180 days. Participants were excluded if they had participated previously in the study, had been diagnosed with T1DM, experienced mental incapacity, were unwilling to participate, had a known language barrier precluding adequate understanding or cooperation or had a known congenital heart disease or malformation.

The primary outcome was the proportion of patients with eASCVD, while the secondary outcome was the proportion of patients with T2D with high risk of ASCVD and without eASCVD.

Prevalence of eASCVD was 108/550 (19.6%, 95% CI 16.5% to 23.2%), and the prevalence of high risk for ASCVD in the population without eASCVD was 378/442 (85.5%, 95% CI 81.9% to 88.5%). Approximately 99% of the study population was categorised as ESC very high risk or high risk for CVD. On assessing utilisation of antidiabetic medications with cardiovascular benefit, only 20% were receiving sodium-glucose cotransporter-2 inhibitors, and 3% were receiving glucagon-like peptide-1 analogues.

The prevalence of eASCVD and high risk for ASCVD in Egypt is alarming, and the inadequate pharmacological control increases the ASCVD burden in the T2DM population. This calls for immediate, comprehensive action to reassess T2DM care.

NCT05317845.

SARS-CoV-2 is now endemic and expected to remain a health threat, with new variants continuing to emerge and the potential for vaccines to become less effective. While effective vaccines and natural immunity have significantly reduced hospitalisations and the need for critical care, outpatient treatment options remain limited, and real-world evidence on their clinical and cost-effectiveness is lacking. In this paper, we present the design of the Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID). By evaluating multiple treatment options in a pragmatic adaptive platform trial, this study will generate high-quality, generalisable evidence to inform clinical guidelines and healthcare decision-making.

CanTreatCOVID is an open-label, individually randomised, multicentre, national adaptive platform trial designed to evaluate the clinical and cost-effectiveness of therapeutics for non-hospitalised SARS-CoV-2 patients across Canada. Eligible participants must present with symptomatic SARS-CoV-2 infection, confirmed by PCR or rapid antigen testing (RAT), within 5 days of symptom onset. The trial targets two groups that are expected to be at higher risk of more severe disease: (1) individuals aged 50 years and older and (2) those aged 18–49 years with one or more comorbidities. CanTreatCOVID uses numerous approaches to recruit participants to the study, including a multifaceted public communication strategy and outreach through primary care, outpatient clinics and emergency departments. Participants are randomised to receive either usual care, including supportive and symptom-based management, or an investigational therapeutic selected by the Canadian COVID-19 Outpatient Therapeutics Committee. The first therapeutic arm evaluates nirmatrelvir/ritonavir (Paxlovid), administered two times per day for 5 days. The second therapeutic arm investigates a combination antioxidant therapy (selenium 300 µg, zinc 40 mg, lycopene 45 mg and vitamin C 1.5 g), administered for 10 days. The primary outcome is all-cause hospitalisation or death within 28 days of randomisation.

The CanTreatCOVID master protocol and subprotocols have been approved by Health Canada and local research ethics boards in the participating provinces across Canada. The results of the study will be disseminated to policy-makers, presented at conferences and published in peer-reviewed journals to ensure that findings are accessible to the broader scientific and medical communities. This study was approved by the Unity Health Toronto Research Ethics Board (#22-179) and Clinical Trials Ontario (Project ID 4133).

NCT05614349

This study aimed to determine the prevalence and antimicrobial susceptibility profile of non-fermenting Gram-negative bacilli (NFGNB) isolated from clinical samples in a tertiary care hospital in Niger.

Prospective, cross-sectional study.

The study was carried out in a tertiary care hospital in Niger.

All clinical samples received at the bacteriology laboratory during the study period for diagnostic purposes were included.

Out of 548 clinical Gram-negative isolates, 60 strains of NFGNB (10.94%) were isolated. These NFGNB strains were mainly isolated from male patients (62%, n=37) with a mean age of 41.2±27.3 years. NFGNB was more frequent in urine samples (91.7%), followed by pus (6.6%). Among the NFGNB strains isolated, Acinetobacter baumannii was predominant (60%), followed by Pseudomonas aeruginosa (18.3%) and Stenotrophomonas maltophilia (13.33%). 20% (n=12) of NFGNB isolated were multidrug-resistant (MDR), including 13.33% (n=8) carbapenem-resistant A. baumannii and 6.67% (n=4) carbapenem-resistant P. aeruginosa. There is no statistically significant association between MDR-NFGNB and age, sex and origin of patients (p>0.05).

Our study revealed a relatively high MDR-NFGNB prevalence rate in a Nigerien tertiary care hospital. These findings emphasise the need for vigilant antibiotic stewardship, with appropriate infection prevention and control practices to curb the emergence and spread of MDR-NFGNB infections in hospital settings.

Statins are among the most widely used drugs. While they are effective for primary and secondary prevention of cardiovascular (CV) disease in middle-aged subjects, their benefits for prevention in older adults (aged ≥70 years) without CV disease are uncertain, particularly for those with multimorbidity. Statin side effects and drug interactions are common in older patients and may negatively impact quality of life. To date, the only randomised controlled trial (RCT) investigating statin discontinuation in older adults has demonstrated no difference in survival but did note a small improvement in quality of life for those who discontinued statins. However, this trial exclusively enrolled patients with a life expectancy

This study is a multicentre, randomised, non-inferiority trial conducted in both inpatient and outpatient settings in Switzerland, France and the Netherlands, targeting patients using statins for primary prevention. 1800 participants are randomly assigned 1:1 to either discontinue (intervention arm) or continue (control arm) statin therapy. The primary objective is to compare the primary composite endpoint of major CV events (non-fatal myocardial infarction or non-fatal ischaemic stroke) and all-cause death between the control and intervention groups over a follow-up duration of up to 48 months. We hypothesise that discontinuing statins does not result in shorter event-free survival, with a non-inferiority margin set at 5.2 weeks over a 2-year observation period. Secondary objectives are to compare patient-centred outcomes (health-related quality of life, muscle pain symptoms, falls and sarcopenia) and all-cause death, non-CV death, major CV events and coronary and peripheral artery revascularisation. The study is open-labelled, with blinded outcome adjudication of the primary endpoints.

The trial protocol has received approval from the local ethics committees in Switzerland, France and the Netherlands. Results will be published in a peer-reviewed journal.

Clinicaltrials.gov: NCT05178420; BASEC (Swiss Ethics Commission): 2021-01513; FOPH (Swiss national portal): SNCTP000005172; Netherlands Trial Register: NL83907.058.23; France Trial Register: 22.04747.000158– IDRCB 2022-A02481-42.

To provide evidence of the cost savings of a quality improvement (QI) initiative preventing healthcare-associated infections (HAIs) in critical care settings.

A micro-costing study focused on financial data related to a nationwide multicentric project preventing central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).

Brazilian public healthcare system.

Adult, paediatric and neonatal intensive care units (ICUs) participating in the QI initiative.

This collaborative QI project implemented a multifaceted strategy to enhance infection-control measures. Participating ICUs reported the number of patients with and without HAIs and information on each HAI’s aggregate average cost (AC), which was analysed following the Brazilian Ministry of Health’s micro-costing guidelines. The 1-year preintervention period evidenced an aggregated AC in adult, paediatric and neonatal ICUs, respectively, of Intl$21 763.5 (95% CI 20 683.6 to 22 843.0), Intl$34 062.4 (95% CI 25 819.6 to 42 304.9) and Intl$32 903.2 (95% CI 29 203.6 to 36 602.4) for CLABSI; Intl$25 202.5 (95% CI 24 276.6 to 26 127.8), Intl$44 753.6 and Intl$17 238.4 for VAP and Intl$19 166.3 (95% CI 17 676.2 to 20 656.1) and Intl$55 873.3 (95% CI 43 563.1 to 68 183.1) for CAUTI (not included neonatal ICUs).

The cost savings were estimated using the HAIs prevented—expenses avoided—during the QI intervention period from September 2021 to December 2023. The HAIs prevented were estimated using the difference between observed and predicted infections based on the aggregated preintervention baseline.

Of the 188 participating ICUs, 31 voluntarily completed and provided the requested financial data with 100% accuracy. Considering the prevented 7342 HAIs for adult, paediatric and neonatal ICUs, respectively: 1647, 86 and 205 CLABSI; 3775, 114 and 118 VAP; and 1377 and 20 CAUTI, we estimated a saving of Intl$175.3 million (95% CI 153.2 to 180.9 million) to the Brazilian unified health system and a resultant estimated return on investment (ROI) of 890%.

This QI collaborative is a value-based initiative preventing HAIs in adult, paediatric and neonatal ICUs in South American settings. The substantial cost savings and a remarkable ROI underscore the economic viability of investing in comprehensive QI infection prevention strategies.

Weight loss is often recommended as the primary intervention for infertility in individuals with high body mass index. However, focusing on body mass index might overlook other important factors like cardiometabolic health. This study aims to examine cardiometabolic health in patients seeking fertility treatment and its impact on reproductive outcomes.

A cross-sectional analysis of 800 systematically selected participants (400 couples) will be completed on a single visit to the study site. This session will involve taking blood samples to examine metabolic biomarkers, the completion of questionnaires assessing preconception health factors and an exercise ‘step test’ to assess cardiorespiratory fitness. Metabolic panels will be compared with target values and, where available, normative population data. Fitness data will be transformed into normative percentile values based on the participant’s age and sex. Patients will be followed for 2 years to allow yearly data collection related to conception, gestation and parturition. Associations between cardiometabolic health during the preconception phase and reproductive outcomes will be examined.

The Newfoundland and Labrador Health Research Ethics Board has provided ethical approval for this study (HREB #20230825). Each patient will be required to give written consent prior to any data collection. We will share study findings at conferences and submit manuscripts to peer-reviewed journals. Additionally, we will create knowledge translation presentations for Newfoundland and Labrador Fertility Services and Family Practice Clinics.