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CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials
No full textCritical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.</p
SPIRIT 2025 statement: updated guideline for protocols of randomized trials
No full textThe protocol of a randomized trial is the foundation for study planning, conduct, reporting and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Here, we aimed to systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. We completed a scoping review and developed a project-specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators and other reviewers.</p
Effect of a nurse-avatar guided discharge education smartphone application in people after acute coronary syndrome: a randomized controlled trial
No full textAims:Discharge education reduces recurrent cardiac events in people after acute coronary syndrome (ACS). This trial investigates the effectiveness of a self-administered avatar-based discharge education application (app) on knowledge and clinical outcomes among inpatients compared with usual care.Methods and results:Single-centre randomized controlled trial of adults hospitalized with ACS who were being discharged home. The app addressed heart disease diagnosis, treatment, risk factors, symptoms, and secondary prevention. Primary outcome was heart disease knowledge at three months. Secondary outcomes were quality of life, cardiac rehabilitation attendance, hospital re-presentations, symptom beliefs, physical activity, and smoking status. Satisfaction and app costs were also evaluated. Participants (n = 84) were 86% male and aged 60 ± 11 years. Both groups had improved knowledge and quality of life. There was no difference in knowledge between groups at three months after adjusting for baseline scores [0.88 points, 95% confidence interval (CI) −5.00, 6.76]. Cardiac rehabilitation attendance was 74% and 64% in the intervention and control groups, with no differences between groups (relative risk 1.15, 95% CI 0.87, 1.51). Ninety-two per cent found the app easy to use, but only 50% used the app as anticipated. Economic analysis showed that the intervention was dominant.Conclusion:In this sample of people with ACS with high cardiac rehabilitation attendance, the app was highly acceptable but did not improve knowledge compared with usual care. Knowledge improved in both groups and may have potential to reduce cost to the health service with the app. Further work should explore the most appropriate target audience for app-based education
FirstCPR: A pragmatic community organisation-based cluster randomised trial to increase community training and preparedness to respond to out-of-hospital cardiac arrest
No full textBackground: Bystander cardiopulmonary resuscitation (CPR) and defibrillation improve out-of-hospital cardiac arrest survival. However, basic life support (BLS) skills are low. Aim: The FirstCPR cluster randomised controlled trial aimed to test the effectiveness of a community organisation-targeted BLS education and training approach. Methods: Clusters (community organisations with 50+ members) were randomly allocated to intervention (12-month period of opportunities to access BLS education and training) or control (no intervention). Outcomes were assessed via surveys at 12 months and pre-specified analysis involved hierarchical mixed-models. Results: Of 165 randomised clusters (82 intervention), 58% were sports and 42% were social/faith-based. Most of the intervention clusters (74/82) participated in at least one intervention activity (15 in all activities). Factors such as the COVID-19 pandemic and organisation support impacted intervention uptake. Overall 924 members, across 93 clusters (407 from 57 intervention clusters; 517 from 36 control clusters), completed surveys. At 12-months, intervention organisation surveyed members reported higher rates of: being trained and willing to perform CPR on a stranger (primary outcome: 63.8% vs 46.9 %; Adjusted Odds Ratio (AOR) 2.22, 95% confidence interval (CI):1.50–3.30), confidence to use an automated external defibrillator (AED) (48.4% vs 26.4%; AOR:3.23, 95%CI:2.22–4.71) and willingness to use AEDs on a stranger (73.9% vs 62.9%; AOR:1.84, 95%CI:1.22–2.80). Conclusions: The results should be interpreted cautiously as the survey response rates were very low. However, survey respondents showed desired outcomes and key learnings for future research were gained
Association between dietary inflammatory or oxidative stress indices and biomarkers in cardiometabolic and related conditions: A systematic literature review
Get PDFInflammation and oxidative stress contribute to the progression of chronic diseases, and the volume of research in this area is rapidly expanding. Various dietary indices have been developed to determine the overall inflammatory or oxidative stress potential of a diet; however, few have been validated in cardiometabolic disease populations. This review aimed to explore the association between dietary indices and biomarkers of inflammation and oxidative stress in adults with cardiometabolic conditions. Four databases were systematically searched for literature in any language (Embase, CINAHL, CENTRAL, and MEDLINE) with 12,177 deduplicated records identified. Seventeen studies of adults with metabolic syndrome, cardiovascular disease, type 2 diabetes, non-alcoholic fatty liver disease or chronic kidney disease were included. Fourteen studies were observational studies, one study was a clinical trial, and one was a randomised controlled trial. Four dietary indices were reported on with most studies (n=11) reporting on the dietary inflammatory index. The most reported biomarker was C-reactive protein. The findings were narratively synthesised. Results were inconclusive due to the heterogeneity of dietary indices and their use, disease states, and biomarkers reported. Only one study reporting on the dietary inflammatory index assessed all 45 parameters. Observational studies, particularly retrospective designs (n=7) are subject to recall and selection biases, potentially presenting overestimated results. Further research is required to determine the relationship between dietary indices and biomarkers of inflammation and oxidative stress in cardiometabolic disease populations. Future research should be rigorous, prospective, assess the full range of index parameters, and examine biomarkers the tool was developed for.</p
A Mixed Methods Exploration of Patient and Clinician Perspectives of Pelvic Examinations in Emergency Departments
No full textObjectives:To explore and describe patients' expectations, perceptions and experiences of having a pelvic examination (PV) in the emergency department (ED) and to describe ED clinicians' attitudes and perceptions regarding PVs.Methods:A mixed methods study using questionnaires and semi-structured interviews with patients and clinicians at two EDs in the same health service (tertiary ED and urban district ED) between May 2023 and February 2024. Quantitative data are reported descriptively using means and proportions. A qualitative descriptive approach and thematic analysis were used to develop themes from interviews and gather granular insights from participants' first-hand experiences.Results:Clinicians completed 84 questionnaires and nine interviews. Patients completed 63 questionnaires and eight interviews. Quantitative and qualitative data were merged to form four themes: (1) the variable clinical utility of the PV in ED, (2) lack of ED clinician confidence and training, (3) bedside manner as primary influence on patient experience, and (4) the inadequate ED setting for performing intimate exams.Conclusions:The utility of PVs in ED remains ambiguous and it is vital to avoid unnecessary invasive exams. However, urgent PVs will sometimes be needed and participants have made actionable suggestions to improve the clinical care delivered when performing PVs in ED. The four themes can inform future strategies to advance clinicians' training, confidence and skill level when performing PVs. This will lead to overall enhanced patient experience and satisfaction and reduce downstream negative consequences of having an inadequate PV experience in ED
Body Composition Characteristics of Elite Senior and Under 23 Australian Sprint Kayakers
Get PDFThe aim of this study was to compare body composition characteristics of elite senior and U23 sprint kayak athletes and report body composition changes during the COVID-19-interrupted preparation for the Tokyo 2020 Summer Olympics. A total of 32 Australian kayakers (Men: 20 (Senior = 13, U23 = 7); Women: 12, (Senior = 5, U23 = 7)) undertook body composition assessment using dual-energy X-ray absorptiometry (DXA) from 2017 to 2021. The first DXA assessment for each athlete was used for a cross-sectional analysis to compare senior and U23 sprint kayak athletes. Of the thirty-two kayakers, five senior men kayakers had repeat DXA scans over the data collection period which were used to monitor longitudinal changes in body composition. Senior men kayak athletes were heavier than U23 athletes (p = 0.017; 10.4 ± 1.9 kg; d = 1.23) but had similar body composition. In contrast, body mass was not different between senior and U23 women kayak athletes (p = 0.187), however senior women athletes had a significantly higher lean body mass (LBM; p = 0.048; 5.1 ± 1.3 kg, d = 1.32) and lower body fat percentage (p = 0.011; −4.3 ± 0.8%, d = 1.82). The five senior men kayakers exhibited a non-significant decrease in fat mass (p = 0.774; 2.9 ± 3.0 kg, d = 0.97) and increase in LBM (p = 0.234; 2.2 ± 5.9 kg, d = 0.38) across the Olympic quadrennial with little change in body mass. Senior men kayak athletes while heavier, have similar body composition compared to their U23 counterparts, whereas senior women kayakers are similar in body mass but differ in body composition compared to their younger counterparts. The relative influence of maturation, specificity of training, or dietary strategies on the observed differences in body composition between senior and U23 men and women kayak athletes are currently unknown and warrant further investigation
Do prestige sensitivity and altruism moderate the effects of customers’ emotions on WOM? An investigation of luxury retailers
No full textPurposeThis study adopts the stimulus–organism–response model to examine relationships between the retail environment and customers’ emotions (i.e. pleasure and arousal), prestige sensitivity and word-of-mouth (WOM) intentions towards two luxury retailers: Luxury Brand A and Luxury Brand B.Design/methodology/approachData were obtained from a sample of 135 Chinese customers who had purchased Luxury Brand A and 130 Chinese customers who had purchased Luxury Brand B directly from each retailer. The relationships between these two retailers were compared via partial least squares–Henseler’s multi-group analysis (MGA).FindingsFindings indicated that pleasure and arousal did not play mediating roles between the retail environment and WOM intention for either customer group. Prestige sensitivity did not moderate customers’ emotions about Luxury Brand A or Luxury Brand B. Altruism served as a moderator between emotions (i.e. pleasure/arousal) and WOM intention regarding Luxury Brand B but was not a significant moderator for Luxury Brand A. Additionally, MGA suggested non-significant differences between Luxury Brands A and B. Implications for the luxury retail literature and luxury marketers are provided accordingly.Originality/valueThis study is one of the earliest to examine the moderating roles of price sensitivity and altruism on associations between the retail environment and customers’ emotions, prestige sensitivity, and WOM intentions in a luxury retail context. An MGA of customers for Luxury Brand A and Luxury Brand B was innovatively performed to evaluate the proposed framework
Profiling “Noncombat” Musculoskeletal Injuries in Special Operations Forces A Systematic Review
No full textBackground: Special Operations Forces (SOF) personnel are at a high risk of musculoskeletal (MSK) injury. The aims of this systematic review were to a) profile MSK injuries sustained by SOF personnel and b) identify evidence-based injury prevention strategies. Methods: Registered with the Open Science Framework, the protocol followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Of the 3,773 studies identified, 14 met the eligibility criteria, with 6 additional studies identified following screening of the reference lists of the included studies. Extracted data were summated in five naturally occurring MSK injury themes: 1) incidence in SOF populations; 2) anatomical location; 3) nature; 4) mechanism; and 5) risk factors. Results: Injury incidence ranged from 8 to 846 injuries per 1,000 personnel per year with the lower extremities as the most reported site of injury. The leading nature of MSK injuries were strains and sprains, while the most common mechanism of injury was physical training. Smoking, physical performance, movement limitations, muscular asymmetries, and imbalances were reported as factors that can increase MSK injury risk.Conclusion: This review informs injury prevention strategies within SOF populations, notably, reducing run mileage and alternating running with weight load walking, educating Operators on proper lifting technique, and analyzing force plate testing data to guide program design and implementation
Opportunities, challenges, and future prospects of establishing a hospitality institution in the UAE: a case study of the Abu Dhabi Hospitality Academy, Les Roches
No full textThe establishment of a world-class hospitality academy in the UAE represents a strategic milestone in the nation’s ambition to position itself as a global leader in tourism and hospitality while preserving Emirati cultural identity and nurturing local talent. This study examines the opportunities, challenges, and future prospects of establishing a new hospitality institution, with a focus on Les Roches’ expansion into Abu Dhabi in partnership with the Department of Culture and Tourism (DCT). This paper highlights the importance of aligning educational offerings with industry needs to equip Emirati students with the skills necessary to become future hospitality leaders. Additionally, it explores how embedding Emirati cultural identity within the curriculum can enhance the sector’s global competitiveness while maintaining local authenticity. The findings highlight the role of international collaboration, curriculum design, and infrastructure investment in shaping a successful institution that contributes to the UAE’s vision for hospitality excellence. Implications for policymakers, educators, and industry leaders are discussed to provide insights into the future of hospitality education in the region