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This systematic review aims to synthesise current evidence on gut microbiome profiles among children with sickle cell disease (SCD), assess the influence of analgesic and antibiotic use, and explore the contributions of environmental factors on their gut microbiota diversity. Through identification of consistent microbial patterns and gaps in the existing literature, this review will provide vital insight into potential microbiome-targeted strategies for improving health outcomes in paediatric SCD care.
Studies describing the gut microbiota among paediatric SCD human subjects (
Ethical approval will not be required as this is a systematic review of published data. The findings will be disseminated through publications in peer-reviewed journals and presentations at relevant scientific conferences.
CRD420251102736.
While needs assessment is the starting point of good quality care, there is anecdotal evidence of patients receiving different care in similar circumstances. This study aims to investigate whether practice variation exists in needs assessments conducted by home care nurses and to identify the factors influencing these assessments.
A cross-sectional, quantitative retrospective study.
Primary care; home care nursing in the Netherlands in 2023.
Sampling was based on criterion sampling. Home care organisations were approached based on the following inclusion criteria: organisations providing home care nursing in the Netherlands, organisations from various regions of the country and organisations offering different types of home care nursing (eg, paediatric or palliative care), funded under the Dutch Health Insurance Act (Zvw). Organisations were excluded if they provided home care nursing funded by sources other than the Dutch Health Insurance Act. Home care nurses were recruited from participating organisations, each of whom had recently assessed the care needs of at least five patients. In total, 28 organisations and 258 home care nurses participated in this study, thereby yielding data from 1615 patients.
Assessed and delivered minutes of home care per patient per week.
Variation was primarily associated with patient-related factors. After accounting for these factors, 83% (assessed minutes) and 88% (delivered minutes) of the total variation was attributed to the patient level, 8% (assessed minutes) and 10% (delivered minutes) to the home care nurses’ level and 9% (assessed minutes) and 2% (delivered minutes) to the organisational level. Due to inadequate documentation in electronic health records, many missing values were identified.
The lack of nursing documentation suggests that missing factors may have contributed to variations in needs assessments. Thus, further research should comprehensively explore the patient-related factors currently absent from nursing documentation.
The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability.
This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ
The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD.
This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners.
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.
Healthcare workers (HCWs) report overwhelming demands and experience crisis levels of burnout and unique challenges that further impair their mental health. Promotion of mental health among HCWs using information and communication technology (ICT) has received little empirical research attention and interventions for improving mental health resilience in HCWs are not well established.
Scoping review to map existing evidence and identify gaps for future research regarding the main barriers and facilitators of the acceptance of ICT-based interventions for improving resilience and mental health among HCWs working in all healthcare settings.
This protocol was developed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive bibliographic search will be conducted between October 2024 and October 2025 in Pubmed, Web of Science, PsycINFO, Scopus, Cochrane Library and CINAHL Ultimate (MedicLatina, Psychology and Behavioural Sciences Collection), with the assistance of a qualified research librarian, to retrieve studies describing data on the main barriers and facilitators to the acceptance of ICT-based interventions for improving resilience and mental health among HCWs working in healthcare settings. There will be no restrictions based on date of publication or language. Inclusion and exclusion criteria will be defined for each element of the PICO(D) framework, and both quantitative and qualitative data will be extracted. Quality will be assessed using the mixed methods assessment tool. Two independent investigators will perform the eligibility assessment and data extraction, and any disagreements will be resolved by a third reviewer. The main results will be narratively synthesised and analysed.
Since secondary data will be analysed, no ethical approval is required. The results will be disseminated through publications subject to peer review.
To identify sex-specific patterns based on determinants related to sleep quality, using a representative sample of the Spanish adult population.
Cross-sectional, age-stratified and sex-stratified study.
Community-based assessments in two Spanish provinces (Salamanca and Ávila).
Adults aged 25–65 years (n=500), equally distributed by sex and five age strata, selected from the regional health-card database.
Objective sleep metrics from wrist actigraphy (time in bed, total sleep time (TST), sleep efficiency, wake after sleep onset, number/duration of awakenings, fragmentation/movement indices) and self-reported sleep quality (Pittsburgh Sleep Quality Index).
Standardised baseline assessments collected sociodemographic, clinical, mental-health and lifestyle variables using validated instruments. Actigraphy (ActiGraph GT3X+) recorded triaxial acceleration at 30 Hz over 5 days; data were aggregated in 60 s epochs (ActiLife). Sleep/wake was classified with Cole-Kripke and nocturnal episodes identified with Tudor-Locke before deriving sleep indices. Two-step cluster analysis was applied separately by sex.
Three clusters were identified for each sex, with age and educational level being the most influential factors. In men, the 65-year-old cluster with university education and lower anxious–depressive load showed the highest sleep efficiency (91.8±3.8%) and the lowest TST (351.7±74.8 min). In contrast, the 35-year-old cluster with middle or high school presented the lowest efficiency (88.3±10.0%) and higher TST (368.1±83.8 min). In women, the 55-year-old cluster with middle or high school and low emotional load showed the highest efficiency (93.6±2.8%), despite a reduced TST (352.0±79.7 min), while the 35-year-old cluster, with middle or high school and high levels of anxiety and depression, showed the worst efficiency metrics (89.5±3.9%) and a higher TST (394.8±67.3 min).
Sleep quality in Spanish adults is heterogeneous across sex-specific clusters shaped by age, education and mental-health burden. Cluster-based characterisation may support tailored public-health interventions.
Eating disorders are complex mental health conditions characterised by pathological behaviours related to food intake, often accompanied by a chronic obsession with weight control. Their prevalence is increasing, with an earlier onset and greater severity among young people. Universal prevention, through multicomponent strategies that tackle modifiable risk factors, has emerged as a promising tool. This paper reports the study protocol designed to assess the effectiveness and cost-effectiveness of the PRETA (Prevención de los Trastornos de la Alimentación) programme in reducing the risk of eating disorders and related modifiable risk factors among preadolescents in the school setting.
The PRETA programme will be assessed by means of an open, community-based, multicentre, controlled trial using 1:1 matched-pairs cluster randomisation at the school level. Schools in Tenerife (Spain) will be assigned to the PRETA programme or a waitlist control group. Participants include 5th- or 6th-grade students (10–13 years old), their parents and teachers. The PRETA programme is a universal, school-based, multicomponent programme designed to reduce eating-disorder risk and modifiable risk factors. Its main component is an interactive online platform called e-PRETA, complemented by training sessions for families and teachers. e-PRETA includes nine 45-minute sessions addressing risk factors, such as dietary habits, beauty standards, media literacy, self-esteem, emotional regulation and social skills. A total of 1068 children from 12 schools will participate. The primary outcome will be the risk of developing eating disorders (Children’s Eating Attitudes Test-26 item version). Secondary outcome measures are body dissatisfaction (Adapted Contour Drawing Rating Scale), eating disorder traits (Eating Disorder Inventory-2), internalisation of appearance ideals (Sociocultural Attitudes Towards Appearance Questionnaire-4) and self-esteem (Rosenberg Self-Esteem Scale). Outcomes will be assessed at baseline and postintervention (3 months). Additional baseline covariates such as electronic device use, parental feeding attitudes, physical activity, sleep duration and screen time will also be collected. Programme effectiveness will be analysed using generalised mixed models. Cost-effectiveness will be assessed by comparing the incremental costs associated with the implementation of the PRETA programme with its estimated effectiveness.
Ethics approval has been obtained from the Ethics Committee for Research with Medicines at the University Hospital of the Canary Islands (CHUC_2021_78). Written informed consent will be obtained from the parents or legal guardians of all participants. Results will be disseminated through scientific publications and conferences.
Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%–1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.
The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard ‘one-size-fits-all’ approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).
The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.
Our aim is to develop a Framework of Measurement for people living with Long COVID and their caregivers for use in Long COVID research and clinical practice. Specifically, we will characterise evidence pertaining to outcome measurement and identify implementation considerations for use of outcome measures among adults and children living with Long COVID and their caregivers.
We will conduct a scoping study involving: (1) an evidence review and (2) a two-phased consultation, using methodological steps outlined by the Arksey and O’Malley Framework and Joanna Briggs Institute. We will answer the following question: What is known about outcome measures used to describe, evaluate or predict health outcomes among adults and children living with Long COVID and their caregivers? Evidence review: we will review peer review published and grey literature to identify existing outcome measures and their reported measurement properties with people living with Long COVID and their caregivers. We will search databases including MEDLINE, Embase, CINAHL, PsycINFO and Scopus for articles published since 2020. Two authors will independently review titles and abstracts, followed by full text to select articles that discuss or use outcome measures for Long COVID health outcomes, pertain to adults or children living with Long COVID and/or their caregivers and are based in research or clinical settings. We will extract data including article characteristics, terminology and definition of Long COVID, health outcomes assessed, characteristics of outcome measures, measurement properties and implementation considerations. We will collate and summarise data to establish a preliminary Framework of Measurement. Consultation phase 1: we will conduct an environmental scan involving a cross-sectional web-based questionnaire among individuals with experience using or completing outcome measures for Long COVID, to identify outcome measures not found in the evidence review and explore implementation considerations for outcome measurement in the context of Long COVID. Consultation phase 2: we will conduct focus groups to review the preliminary Framework of Measurement and to highlight implementation considerations for outcome measurement in Long COVID. We will analyse questionnaire and focus group data using descriptive and content analytical approaches. We will refine the Framework of Measurement based on the focus group consultation using community-engaged approaches with the research team.
Protocol approved by the University of Toronto Health Sciences Research Ethics Board (protocol #46503) for the consultation phases of the study. Outcomes will include a Framework of Measurement, to enhance measurement of health outcomes in Long COVID research and clinical practice. Knowledge translation will also occur in the form of publications and presentations.
While group, task-oriented, community-based exercise programs (CBEPs) delivered in-person can increase exercise and social participation in people with mobility limitations, challenges with transportation, cost and human resources, threaten sustainability. A virtual delivery model may help overcome challenges with accessing and delivering in-person CBEPs. The study objective is to estimate the short-term effect of an 8-week, virtual, group, task-oriented CBEP called TIME™ (Together in Movement and Exercise) at Home compared with a waitlist control on improving everyday function in community-dwelling adults with mobility limitations.
A randomised controlled trial incorporating a type 1 effectiveness-implementation hybrid design is being conducted in four Canadian metropolitan centres. We aim to stratify 200 adults with self-reported mobility limitations by site, participation alone or with a partner, and functional mobility level, and randomise them using REDCap software to either TIME™ at Home or a waitlist control group. During TIME™ at Home classes (2 classes/week, 1.5 hours/class), two trained facilitators stream a 1-hour exercise video and facilitate social interaction prevideo and postvideo using Zoom. A registered healthcare professional at each site completes three e-visits to monitor and support implementation. Masked evaluators with physical therapy training evaluate participants and their caregivers at 0, 2 and 5 months using Zoom. The primary outcome is the change in everyday function from 0 to 2 months, measured using the physical scale of the Subjective Index of Physical and Social Outcome. The study is powered to detect an effect size of 0.4, given α=0.05, power=80% and a 15% attrition rate. Secondary outcomes are mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, caregiver confidence in care-recipient balance and cost-effectiveness. A multimethod process evaluation is proposed to increase understanding of implementation fidelity, mechanisms of effect and contextual factors influencing the complex intervention. Qualitative data collection immediately postintervention involves interviewing approximately 16 participants and 4 caregivers from the experimental group, and 8 participants and 4 caregivers from the waitlist control group, and all healthcare professionals, and conducting focus groups with all facilitators to explore experiences during the intervention period. A directed content analysis will be undertaken to help explain the quantitative results.
TIME™ at Home has received ethics approval at all sites. Participants provide verbal informed consent. A data safety monitoring board is monitoring adverse events. We will disseminate findings through lay summaries, conference presentations, reports and journal articles.
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