Systematic Reviews

AbstractsO_ST_ABSBackgroundC_ST_ABSSelf-management is essential for stroke survivors to maintain a healthy lifestyle and reduce recurrence risk. Although theory-based self-management interventions are widely recommended, the theoretical frameworks underpinning them and their comparative effectiveness remain unclear. AimsTo systematically identify the theories, models, and frameworks (TMFs) used in self-management interventions for stroke survivors, to explore how they guide interventions, and evaluate their effectiveness on self-management behaviors and self-efficacy. MethodsPubMed, Embase, Web of Science, ProQuest Health & Medical Collection and the Cochrane Library were searched from inception to July 15, 2025. Randomized controlled trials or quasi-experimental studies evaluating theory-based self-management interventions for stroke survivors were included. Two reviewers independently screened studies, extracted data, and assessed risk of bias (Cochrane RoB 2.0). Meta-analyses were performed using random-effects models. ResultsFrom 11,495 records, 32 studies with 3,212 participants were included. Sixteen distinct TMFs were identified; self-efficacy theory was most frequent (13/32), followed by social cognitive theory (6/32). All TMFs were middle-range theories. Meta-analysis showed TMFs-based interventions significantly improved self-management behaviors (SMD = 4.26, 95%CI: 0.20-8.31, I{superscript 2} = 98.2%) and self-efficacy (SMD = 0.60, 95%CI: 0.32-0.88, I{superscript 2} = 72.8%). However, the effect for behaviors is likely inflated due to extreme heterogeneity and theoretical diversity. Theory-specific analysis of self-efficacy theory (k = 8) confirmed significant effects on self-efficacy (SMD = 0.64, 95%CI: 0.21-1.08). ConclusionsThis review identified 16 distinct theoretical models; self-efficacy theory was most frequently applied, followed by social cognitive theory. Theory-based interventions significantly improved self-management behaviours and self-efficacy.

BackgroundLung cancer compensation systems for occupational exposure to asbestos commonly apply Helsinki criteria, which assume 4% excess lung cancer risk per fibre-year of asbestos exposure. The Probability of Causation (PoC) is [≥]50% at 25 fibre-years (risk doubling threshold). Large case-control studies have suggested steeper exposure-response relations at lower exposures. We aimed to estimate PoC of asbestos-related lung cancer to evaluate exposure thresholds for compensation of lung cancer cases occupationally exposed to asbestos. MethodsRelative risk of asbestos-related lung cancer was estimated using two approaches: O_LIA meta-regression of 22 occupational studies forming the core evidence on cumulative asbestos exposure and lung cancer since the 1980s (130,341 participants). C_LIO_LIA meta-analysis of the recently conducted SYNERGY pooled case-control study (14 studies, 37,866 participants), adjusted for age, sex, smoking, and study. C_LI The likelihood that lung cancer was caused by asbestos was estimated as the PoC with 95% prediction intervals (95%PI). ResultsOccupational cohort studies produced a shallow exposure-response relation with substantial heterogeneity (I{superscript 2} = 92.7%). SYNERGY showed a steeper relation with 6.8% (95%PI: 0%-17.7%) lung cancer risk increase per fibre-year and lower heterogeneity (I{superscript 2} = 63.4%). PoC [≥]50% occurred at 62.93 (point estimate) and 18.2 fibre-years (upper 95%PI) for occupational asbestos studies, compared to 10.5 and 4.3, respectively, in SYNERGY. ConclusionsThe SYNERGY pooled case-control study provided exposure-response estimates that are more representative of current exposure to lower mixed asbestos fibres in the Netherlands, supporting lower exposure thresholds than the existing Helsinki criteria when estimating PoC in compensation contexts.

Background Trials in occupational populations, such as surgeons, face feasibility challenges due to high workload, restricted availability, and clinical heterogeneity, which may compromise recruitment, adherence, and retention. Objective To prespecify the feasibility framework and progression criteria for an internal pilot phase embedded within a pragmatic randomized controlled trial (RCT) comparing Mechanical Diagnosis and Therapy with generalized exercise in surgeons with chronic spinal pain. Design Protocol for a prespecified internal pilot phase embedded within a pragmatic, two-arm, parallel-group RCT. Methods The internal pilot will include the first four months of recruitment and aims to randomize at least 12 participants. Feasibility will be assessed across predefined domains, i.e., recruitment, eligibility, consent, intervention uptake, adherence, retention, data completeness, and treatment fidelity. Each domain is operationally defined and linked to prespecified progression criteria to ensure interpretability and decision-making utility. Criteria will be interpreted collectively to guide trial continuation. A minimal qualitative process evaluation will be embedded. Ethics and dissemination The host trial has received ethical approval (N-20240046) and is registered at ClinicalTrials.gov (NCT07293130). The findings from the internal pilot will be reported in a separate feasibility manuscript.

Abstract Background Insomnia is a major public health problem affecting an estimated 852 million adults worldwide. Current pharmacological treatments, including benzodiazepines and Z-drugs, carry serious risks of dependency, cognitive impairment, and adverse events. These limitations have driven growing interest in complementary and alternative therapies, particularly herbal sedatives, which are perceived as natural and safer. However, evidence on their safety and efficacy remains insufficient and patchy. Objective: This review evaluated the effectiveness of lesser known herbal sedatives for insomnia. Methods The protocol was registered with PROSPERO (CRD420251101795). Eligibility was defined using the PICO framework: Population: adults aged [≥]18 years with insomnia; Interventions: Passiflora incarnata, Hawthorn, Melissa officinalis, Chamomile, Viola odorata, Nelumbo nucifera, Rhodiola rosea, and Eschscholtzia californica. Comparators: placebo or usual care; Primary and Secondary Outcomes: sleep quality (Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale), sleep duration, and sleep latency. Databases and registers were searched from January 2005 to July 2025. Randomized controlled trials, nonrandomized controlled trials, clinical trials, and observational studies were included. Five reviewers independently screened studies. Data extraction used a structured Excel spreadsheet. Risk of bias was assessed using RoB 2.0 for randomized trials and ROBINS-I V2 for nonrandomized studies. Random-effects meta-analyses (DerSimonian and Laird) were conducted in RevMan. Narrative synthesis followed SWiM guidelines. Results From 1,294 records, 32 studies met eligibility criteria. Meta-analysis of 23 RCTs demonstrated a statistically significant pooled effect favouring herbal sedatives (SMD -0.77, 95% CI -1.14 to -0.40, p=0.0001), with substantial heterogeneity (I square=92%). Subgroup analysis showed larger effects for chamomile (SMD -1.06) and Melissa officinalis (SMD -0.66). Most RCTs had high overall risk of bias; nonrandomized studies predominantly had critical risk of bias. Conclusions This systematic review provides preliminary evidence that several herbal sedatives, particularly chamomile and Melissa officinalis, may improve insomnia-related outcomes. However, methodological weaknesses, high risk of bias, and substantial heterogeneity limit evidence strength. Future research requires standardized extracts, large multicentre RCTs, and extended follow-up.

BackgroundCranioplasty following decompressive craniectomy can be performed using various implant materials, with titanium and polyetheretherketone (PEEK) being the most commonly used synthetic options. However, their comparative safety and clinical performance remain debated. This systematic review and meta-analysis aimed to compare titanium-based cranioplasty with PEEK and other synthetic or autologous materials regarding implant survival, complications, functional outcomes, cosmetic results, and operative metrics. MethodsThis systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines and registered in PROSPERO (CRD). A comprehensive search was performed in PubMed, Embase, Scopus, Web of Science, and the Cochrane Database of Systematic Reviews (CDSR) without language or date restrictions. A total of 1,026 records were identified (Embase n = 263, Web of Science n = 272, Scopus n = 293, PubMed n = 193). After removal of 550 duplicates, 78 articles underwent full-text review, and 38 comparative studies met the eligibility criteria for qualitative synthesis. Three studies directly comparing titanium and PEEK with extractable infection data were included in the meta-analysis. Risk of bias was assessed using Joanna Briggs Institute (JBI) tools. ResultsForty-one studies encompassing heterogeneous patient populations and study designs were included, predominantly retrospective cohort studies. Titanium demonstrated shorter operative times and lower intraoperative blood loss compared with autologous bone and, in most studies, compared with PEEK and PMMA. Implant survival outcomes were heterogeneous: PEEK frequently showed lower exposure rates but higher rates of subgaleal fluid collection. Compared with autologous bone, titanium had higher exposure rates but avoided resorption-related failures. Infection outcomes varied across materials; however, pooled meta-analysis demonstrated a significantly lower odds of postoperative infection with titanium compared with PEEK (random-effects model), with moderate heterogeneity. Functional and neurological outcomes were largely comparable across materials, and cosmetic satisfaction was generally high regardless of implant type. ConclusionsTitanium cranioplasty provides favorable operative efficiency and competitive complication rates compared with alternative materials. While exposure risk may be higher than PEEK, pooled evidence suggests a lower infection risk with titanium. Overall, implant material selection should consider patient-specific risk factors, defect characteristics, and surgeon expertise. Further high-quality prospective studies are warranted to strengthen comparative evidence.

Background and aimsWe evaluated the efficacy of the Stroke Riskometer mobile phone App to change the Lifes Simple 7(R) (LS7(R)) risk factor score at 6 months post-randomisation. Methods and designThis Phase III, prospective, outcome assessor-blinded, 2-arm randomised controlled trial (RCT) in Australia and New Zealand recruited participants from August 2021 to January 2024. Inclusion criteria: age [≥]35 and [≤]75 years; [≥]2 risk factors; smartphone ownership; no cardiovascular disease history. The intervention group was given access to the App; the usual care group received one e-mail with generic risk factor information. The primary outcome was the mean between group difference in LS7(R) (score 0 [poor] to 14 [ideal] comprising blood pressure, cholesterol, glucose, body mass index, smoking, physical activity and diet) from baseline to 6 months post-randomisation. Secondary outcomes were between group changes in individual LS7 items. Analyses were performed using intention to treat (ITT) principles with ANCOVA and linear mixed models to examine differences between groups, with pre-specified per protocol and subgroup analyses. ResultsWe randomised 862 participants (mean {+/-} SD age 58{+/-}11 years; 63% women; 74% Caucasian). At 6 months post-randomisation in ITT analyses, the mean difference between usual care (n=433) and intervention (n=429) groups in the change in LS7(R) score from baseline was 0.03 (95% CI -0.19, 0.25, p=0.79). Per protocol analyses (n=320 usual care; n=276 intervention) were similar (mean difference in change 0.11 95% CI -0.12, 0.34, p=0.34). Compared to usual care in ITT analyses, the intervention group had a borderline increase in metabolic equivalent of task (MET) minutes/week of physical activity (313.42 95% CI -2.80, 629.65, p=0.05), with no differences in other LS7(R) items. DiscussionAmong a general population aged 35 to 75 years with [≥]2 stroke risk factors, there was no evidence that having access to the App changed overall LS7(R) scores at 6-month follow-up. Participants in the intervention group did have a small increase in physical activity, compared to the usual care group after 6 months, but not other individual risk factors.

BackgroundSystematic reviews are important for informing public health policies and program selection; however, they are time- and resource-intensive. Artificial intelligence (AI) offers a solution to reduce these labour-intensive requirements for various aspects of systematic review production, including data extraction. To date, there is limited robust evidence evaluating the accuracy and efficiency of AI for data extraction. This study within a review (SWAR) aimed to determine whether human data extraction assisted by an AI research assistant (Elicit(R)) is noninferior to human-only data extraction in terms of accuracy (i.e. agreement) and time-to-completion. Secondary aims included comparing error types and costs. MethodsA two-arm noninferiority SWAR was conducted to compare AI-assisted and human-only data extraction from 50 RCTs chronic disease interventions. Participants were randomised to extract all data required for conducting a review, using either the AI-assisted or human-only method. Accuracy was assessed using a three-point rubric by an independent assessor blinded to group allocation, based on agreement between extracted data and the assessor. Accuracy scores were standardized to a 0-100 scale. Analysis included overall and subgroup accuracy (data group and data type) using paired t-tests. Time-to-completion was self-reported by data extractors. Type of errors were coded by type and severity, and costs were calculated for data extraction, preparation of files, training and the Elicit(R) Pro subscription. ResultsThere was no difference in overall accuracy between the AI-assisted and human-only arms (mean difference (MD) 0.57 (on a 0-100 scale), 95% confidence interval (CI) -1.29, 2.43). Subgroup analysis by data group found AI-assisted to be more accurate than human-only data extraction for data variables describing intervention and control group (MD 4.75, 95% CI 2.13, 7.38), but otherwise no subgroup differences were observed. AI-assisted data extraction was significantly faster (MD 24.82 mins, 95% CI 18.80, 30.84). The AI-assisted arm made similar error types (missed or omitted data: AI-assisted 3.6%, human-only 3.4%) and severity (minor errors: AI-assisted 6.7%, human-only 6.5%) and cost $181.98 less than the human-only data extraction across the 50 studies. ConclusionAI-assisted data extraction using Elicit(R) showed noninferior accuracy, faster completion times, similar error types and severity, and lower costs compared to human-only extraction. These efficiency gains, without loss in accuracy suggest AI-assisted data extraction can replace one human-only data extractor in future systematic reviews of RCTs. Future research should explore different models of AI data extraction such as two AI-assisted extractors or AI-only extractor with human-only extractor, and comparison of AI-assisted to AI-only.

Purpose: To understand how the Philips PAP device recall affected patient experiences, clinical practice, and health system responses. Methods: From November 2022 to August 2023, we interviewed individuals with OSA, physicians, respiratory therapists and health system leaders. We also received emailed responses from Health Canada. Interviews explored participants' experiences with the recall announcement and communication, their own responses and perceptions of actions taken by others, the overall impact of the recall and suggestions for improving future recall processes. Interviews were analyzed using an inductive thematic approach. Results: We interviewed 47 participants (16 individuals with OSA, 10 physicians, 17 public or private respiratory therapists, five health system leaders). Themes were organized into four domains: recall communication, execution, participant experiences, and the policy and regulatory context. Participants were confused due to inadequate information from Philips throughout the process. The burden of notifying patients and tracing devices mostly fell to healthcare providers and vendors, while replacement efforts were disorganized and frustrating. Individuals with OSA experienced emotional distress over therapy decisions and difficulties navigating the recall. Healthcare providers described moral distress from being unable to support patients adequately, and vendors faced additional logistical and financial strain. While regulatory authorities reported that Philips followed standard procedures, participants expressed a loss of trust in both the manufacturer and oversight systems. Conclusions: Interviews revealed that poor communication and execution of the Philips recall caused confusion, frustration and significant emotional and financial burden. Collaborative, context-specific strategies are required to improve future recalls.

Structured AbstractO_ST_ABSObjectiveC_ST_ABSThis mixed-methods study investigated the lived-experience perspectives of receiving a novel, brief digital mental health intervention after psychological trauma. The online gamified imagery-competing task intervention (ICTI) involves one researcher-guided session followed by self-use. Tested in two randomised controlled trials (GAINS-01; GAINS-02), ICTI led to fewer intrusive memories at week-4, with the reduction sustained over 24 weeks, alongside reductions in post-traumatic stress. Here, we contrasted user experiences of ICTI with an Active Control (AC; music-listening task), and explored longer-term impact in qualitative interviews to contextualise GAINS-02 findings. Methods and AnalysisThe GAINS-02 trial randomised healthcare staff experiencing intrusive memories after work-related trauma to ICTI (N=40), AC (N=39), or treatment-as-usual (TAU; N=20). Expectancy was assessed before the researcher-guided session (Day 0), acceptability at week-4, and usage tracked for 24-weeks. Semi-structured interviews (N=27) were conducted in ICTI and AC arms only (15 at week-4; 12 during 12-24-weeks). Interviews were analysed using reflexive thematic analysis. ResultsPrior to use, many trial participants did not think the intervention would work, favouring AC over ICTI. However, after completing the tasks, participants found ICTI more acceptable and relevant to intrusive memories than AC. After the one guided session, median ICTI usage the next four weeks was 4.00 times with little additional use (once more) over the next 20 weeks because of lack of need. Potential implementation facilitators included ease of use, and advantages over existing interventions due to not needing to talk about the trauma, brevity, and lesser resource commitment. Perceived barriers included a lack of staff and manager education about the nature and consequences of intrusive memories, with a need for workplace buy-in and demonstration of organisational benefits. ConclusionHealthcare staff experiencing workplace-related trauma found ICTI to be acceptable and effective for reducing intrusive memories with low effort and emotional burden, even among participants who initially expressed scepticism. Participants highlighted implementation considerations including offering ICTI both within and outside the workplace, and providing a self-guided version of ICTI with optional support. Future work should assess cost-effectiveness, impacts on presenteeism and retention, and real-world implementation including the feasibility and effectiveness of a self-guided ICTI. Summary BoxO_ST_ABSWhat is already known on this topicC_ST_ABSIn a previous randomised controlled trial (GAINS-01) with Intensive Care Unit (ICU) staff exposed to work-related trauma, a brief online gamified imagery-competing task intervention (ICTI) reduced intrusive memories compared to usual care at four-weeks. What this study addsThe GAINS-02 randomised controlled trial replicated GAINS-01 and extended results by comparing ICTI to an active control (AC; music listening) task, enrolling hospital staff from outside ICU, and a follow-up period of 24-weeks. Qualitative interviews found that, despite initial scepticism from healthcare staff prior to using the intervention, ICTI was more acceptable than an AC due to specific effects on swiftly reducing intrusive memories and requiring minimal support or usage after an initial researcher-guided session. After one guided session, ICTI was used 4 more times in the first four weeks, with little additional usage (once) thereafter because of lack of need (i.e., no longer experiencing intrusive memories). How this study might affect research, practice or policyICTI is an efficacious scalable intervention to relieve staff of intrusive memories with effects sustained for at least 6-months. It was found to be more acceptable to participants than alternatives, requiring less time commitment than standard psychological treatments.

IntroductionFamily Constellation Therapy (FCT) has been widely disseminated in clinical, public health, and judicial settings despite persistent concerns regarding its theoretical basis, safety, and the limited availability of rigorous randomised evidence supporting its clinical use. ObjectiveThe aim of this systematic review is to assess the effects of FCT across all clinical conditions, explicitly considering both benefits and harms; and summarise the characteristics of studies and intervention settings used in randomised controlled trials of FCT. MethodsFollowing a prospectively registered protocol (CRD420251136190), we conducted a systematic search of seven databases (PubMed, EMBASE, APA PsycInfo, CENTRAL, BVS, Web of Science, and CINAHL) and grey literature (ICTRP and ProQuest database) without language or date restrictions to identify published and unpublished randomised controlled trials of FCT. Study selection, data extraction, risk of bias (RoB 2), and certainty of evidence (GRADE) were performed in duplicate. Statistical analyses followed a prospectively registered analysis plan with prespecified criteria for data pooling and for handling analytical limitations. ResultsNo reliable evidence was found to support the use of FCT for any condition across both clinical and non-clinical samples. All trials included were judged to be at high risk of bias and all comparisons were rated as very low-certainty evidence. Concerns regarding potential adverse effects were identified, and the available data was insufficient to establish the effectiveness of the intervention, precluding any clinical recommendation. ConclusionClinicians, policymakers, and consumers should reconsider adopting FCT while reliable evidence is not available.

BackgroundPlatform trials are an efficient trial design which enable testing of multiple interventions simultaneously. They could advance knowledge of treatments for intracerebral haemorrhage (ICH). We aimed to investigate the views of clinicians involved in stroke research on recruitment to a future platform trial for ICH. MethodsBetween April and July 2025, we conducted a UK-wide online survey of clinicians actively involved in stroke research using convenience sampling through professional organisations. Participants considered factors related to the consent process and research environment and could provide optional free text responses about additional barriers or facilitators to recruitment. We used descriptive statistics for quantitative data and content analysis for qualitative data. ResultsAmong 73 respondents, 46 (63%) were female, 36 (50%) were stroke physicians, 24 (34%) nurses, 6 (8%) allied health professionals, and 7 (10%) were in other roles. 36 (49%) had >20 years clinical experience, 45 (61%) reported spending <10% of their role in research. 66 (91%) thought that a platform trial would be a good option for testing interventions for patients with stroke due to ICH. Across 11 modifiable factors, clinicians most frequently rated perceived importance of the research question as a facilitator of recruitment (94%), while clinician preference for specific treatments was most frequently rated as a barrier (48%). Two themes emerged from free text responses: study design and infrastructure. Regarding study design respondents perceived consent procedures (n=9), study materials (n=8), study procedures (n=8), eligibility assessment (n=6), the research question (n=3) and randomization (n=3) as important for a future platform trial. Regarding infrastructure, emergent factors were staffing (n=17), local research culture and capacity (n=9), research governance and delivery (n=6), and training (n=6). ConclusionThe overwhelming majority of respondents from the UK clinical stroke community supported a platform trial for ICH, although the influence of survey responder bias is unknown.

PurposeTo quantify and compare the peak force applied on the glottis during endotracheal intubation across five laryngoscopy techniques, two intubation conditions (standard and simulated laryngospasm), and two operator experience levels, and to assess the effects of stylet use and operator anthropometric characteristics on applied force. MethodsThis prospective, manikin-based experimental study enrolled 50 operators (30 experienced, 20 less experienced). Each performed endotracheal intubation using five techniques: direct laryngoscopy and videolaryngoscopy with a Macintosh blade, each with and without stylet, and videolaryngoscopy with a hyperangulated blade with stylet. A calibrated force sensor positioned at the glottis measured peak forces during standard and simulated laryngospasm conditions. Non-parametric statistical methods were used (Mann-Whitney U, Wilcoxon signed-rank, Friedman tests); effect sizes are reported as rank-biserial correlations. ResultsAcross all techniques, median glottic forces ranged from 4.8 N (IQR: 3.3-6.5) for videolaryngoscopy without stylet to 11.1 N (IQR: 7.5-14.5) for direct laryngoscopy with stylet under standard conditions. No significant differences in applied force were observed between experienced and less experienced operators for any technique-condition combination (all adjusted p = 1.0; |r| [&le;] 0.27). Stylet use significantly increased glottic force across all conditions and groups (median increases 3.4-7.3 N; all p < 0.001; rank-biserial r [&ge;] 0.75). Videolaryngoscopy with a Macintosh blade produced significantly lower forces than hyperangulated videolaryngoscopy under standard conditions (adjusted p = 0.049). Neither grip strength nor hand size correlated with applied force. ConclusionGlottic force during endotracheal intubation is determined primarily by technique and stylet use, not operator experience or anthropometrics. Stylet use is the single largest modifiable contributor to glottic force. These findings have implications for device selection, clinical training, and strategies to minimize airway trauma during intubation. IMPLICATION STATEMENTThis manikin-based study quantifies glottic forces during endotracheal intubation across laryngoscopy techniques, stylet use, and operator experience levels, providing the first comprehensive characterization of right-hand forces transmitted through the tube. Stylet use consistently and substantially increases glottic force regardless of technique or operator experience, informing device selection and training strategies to minimize airway trauma.

BackgroundHelmet use is a proven safety measure that reduces the risk of head injury among cyclists and e-scooter riders. Despite legal requirements for pedal bikes and e-bikes in Australia, compliance varies, particularly among users of electric vehicles. The growing popularity of e-bikes and e-scooters in urban areas presents new public health challenges, yet observational data on helmet use, behavioural determinants, and the effectiveness of safety interventions remain limited. AimPhase 4 of the Helmet Use in Canberra study aims to identify demographic and behavioural predictors of unsafe riding and to explore perceived barriers and facilitators to helmet use, including compliance with existing regulations. MethodsA cross-sectional survey will be administered to Canberra residents aged 18 years or older, both online and in-person. The survey will assess attitudes toward helmet use, perceptions of head injury risk, and the deterrent effect of fines. Data will capture demographic characteristics, vehicle type, riding behaviours under varying conditions, and opinions regarding mandatory helmet laws and signage interventions. Survey responses will be de-identified, securely stored, and analysed using descriptive statistics and ordinal logistic regression to evaluate factors influencing compliance. Survey findings will be triangulated with observational and hospital data from earlier study phases. Expected ResultsThe survey is anticipated to provide insights into public attitudes toward helmet use, the perceived effectiveness of fines as behavioural deterrents, and the acceptability of policy interventions. These findings will inform evidence-based strategies to improve helmet compliance and reduce head injuries among urban riders. Trial RegistrationAustralian and New Zealand Clinical Trials Registry (ANZCTR) [ACTRN12626000245392].

1.This paper reports the statistical analysis plan for the AVERT-DOS trial: A Phase 3, Multi Arm, Multi Stage, Covariate Adjusted, Response Adaptive, Randomised Trial to Determine Optimal Early Mobility Training after Stroke. It contains a trial overview, regulatory information and details of the planned main analyses for the study protocol version Version 5; 15 June 2025.

BackgroundHelmet use is a proven safety measure that reduces the risk of head injury among cyclists and e-scooter riders. Despite legal requirements for pedal bikes and e-bikes in Australia, compliance varies, particularly among users of electric vehicles. The growing popularity of e-bikes and e-scooters in urban areas presents new public health challenges, yet observational data on helmet use, behavioural determinants, and the effectiveness of safety interventions remain limited. AimPhase 3 of the Helmet Use in Canberra study aims to characterise head injury presentations associated with cycling and e-scooter use and examine their association with helmet use and injury severity. MethodsDe-identified emergency department records from The Canberra Hospital will be retro-spectively analysed for presentations involving cycling or e-scooter-related head injuries during the study period. Extracted variables will include age, sex, vehicle type, documented helmet use, injury diagnosis, severity indicators, and date/time of presentation. Descriptive statistics will summarise injury patterns, while regression analyses will evaluate associations between helmet use and injury severity, controlling for demographic and contextual factors. Sensitivity analyses will address missing helmet data and subgroup differences by vehicle type, age, and gender. Expected ResultsIt is hypothesised that lower helmet use will correlate with higher rates and greater severity of head injury presentations. Findings will provide a population-level perspective on helmet effectiveness, inform local injury prevention strategies, and guide public safety interventions. Trial RegistrationAustralian and New Zealand Clinical Trials Registry (ANZCTR) [ACTRN12626000245392]

BackgroundHelmet use is a proven safety measure that reduces the risk of head injury among cyclists and e-scooter riders. Despite legal requirements for pedal bikes and e-bikes in Australia, compliance varies, particularly among users of electric vehicles. The growing popularity of e-bikes and e-scooters in urban areas presents new public health challenges, yet observational data on helmet use, behavioural determinants, and the effectiveness of safety interventions remain limited. AimPhases 1 and 2 aim to assess helmet use among e-bike, pedal bike, and e-scooter riders in Canberra, and evaluate the impact of health-benefit and legal-penalty signage on compliance. MethodsThis study employs a multi-phase, quasi-experimental observational design across three urban bike paths in Canberra. Phase 1 (Baseline): Helmet use will be recorded via discreet video surveillance, capturing vehicle type, estimated age group, gender presentation, and weather conditions. Phase 2 (Intervention): Two sites will receive signage emphasising either safety benefits or legal penalties, while a third site serves as a control; post-intervention observations will assess changes in helmet compliance. Expected ResultsBaseline helmet use is expected to be higher among pedal bike riders than e-bike and e-scooter riders. Signage interventions are anticipated to increase compliance, with potential variation by message type, vehicle type, and rider demographics. Trial RegistrationAustralian and New Zealand Clinical Trials Registry (ANZCTR) [ACTRN12626000245392]

This protocol is reported in accordance with the SPIRIT 2025 guidelines for clinical trial protocols. IntroductionYoung children, from birth to age 5 y are particularly vulnerable to indoor air pollutants and respiratory pathogens. Portable air purifiers (or filtration) and upper-room ultraviolet germicidal irradiation (UVGI) are two widely used interventions with the potential to improve indoor air quality (IAQ) and reduce sick-related absences. However, a review of the literature revealed no real-world randomised studies evaluating their effectiveness in reducing young childrens sick-related absences in early care and education (ECE) classrooms. Methods and AnalysisThe OK-AIR study is a longitudinal, cluster-randomised 2x2 factorial trial conducted in Head Start centers using two implementation cohorts: Cohort 1 (five Head Start centers and 20 classrooms from 2023 to 2024) and Cohort 2 (11 centers and 59 classrooms from 2025 to 2026), with expanded inclusion of rural areas. Cohort 1 enrolled 204 children, 48 teachers and 5 site directors, and Cohort 2 enrolled 462 children, 97 teachers and 11 site directors. Within each center, four classrooms are randomised to: (1) control; (2) portable filtration; (3) upper-room ultraviolet germicidal irradiation (UVGI); or (4) both interventions. Cohort 2 was initially planned as a second factorial trial but was amended to a purifier-only design due to funding changes; details are provided in the protocol amendments section. We collect continuous IAQ data, including particulate matter (PM) with aerodynamic diameters [&le;]1 {micro}m (PM1), [&le;]2.5 {micro}m (PM2.5), [&le;]4 {micro}m (PM4), and [&le;]10 {micro}m (PM10); total volatile organic compounds (TVOCs) index; nitrogen oxides (NOx) index; carbon monoxide (CO), noise; temperature; and relative humidity, alongside daily child absences. Seasonal environmental surface swabs (dining tables and toilet flooring) are tested by Reverse-Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) for Influenza A/B, Respiratory Syncytial Virus (RSV), Human Parainfluenza Virus Type 3 (HPIV3), Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), and Norovirus. IAQ monitoring is structured across Winter, Spring, Summer, and Fall, including designated baseline/off-period weeks to characterize temporal and seasonal variability in environmental measures across classrooms and centers. Multi-informant surveys (Director, Teacher, Parent) capture contextual factors, and childrens social-emotional development is assessed using teacher ratings on the Devereux Early Childhood Assessment (DECA). The primary outcome is the sick-related absence rate, analyzed as cumulative absences over the attendance year while accounting for clustering by school and classroom using generalized mixed-effects models. Secondary outcomes include childrens social-emotional ratings, IAQ metrics and pathogen detection rates; analyses of IAQ incorporate time/seasonal structure, and season-stratified absenteeism analyses will be treated as secondary/exploratory refinements. An economic evaluation will estimate incremental intervention costs and cost-effectiveness/cost-benefit (such as cost per sick-related absence day averted). Ethics and DisseminationThis study was approved by the Institutional Review Board (IRB) at the University of Oklahoma. Findings will be shared through peer-reviewed publications; presentations at local, state, and national conferences; research briefs developed for lay and policy audiences; and community briefings prioritizing the participating early childhood programs and communities. DisclaimerThe views expressed are those of the authors and do not reflect the official views of the Uniformed Services University or the United States Department of War. Strengths and Limitations of This StudyO_LIReal-world longitudinal cluster RCT: The study uses a rigorous longitudinal cluster-randomised 2x2 factorial design in real-world ECE settings. C_LIO_LICombined interventions: Interventions target both air filtration and disinfection, allowing for combined and comparative evaluation. C_LIO_LIObjective air-quality monitoring: Continuous monitoring of IAQ metrics provides objective and reliable data on environmental change. C_LIO_LIEnvironmental pathogen surveillance: qPCR on surface swabs yields an objective biological outcome to triangulate with IAQ and absences. C_LIO_LIComprehensive context and child measures: Multi-method and multi-reporter data collection includes Head Start attendance records, continuous air monitoring, pathogen detection, contextual surveys completed by center directors, teachers, and parents, and standardized social-emotional assessments (DECA) completed by classroom teachers. Head Start program records providing childrens longer-term health data available through Health Insurance Portability and Accountability Act (HIPAA) authorization. C_LIO_LIClustered/temporal complexity: Seasonal design accounts for variation over time but may introduce complexity in modeling temporal effects. C_LIO_LIPractical Implications: Study findings will have practical implications for Head Start and other ECE programs striving to maximize child attendance with cost effective strategies. C_LI

Abstract Background: The association between chronic lung disease (CLD) and osteoporosis (OP) is well-recognized, but the direction and magnitude of this relationship remain debated, particularly in aging populations. We aimed to quantify the bidirectional association between CLD (including COPD and asthma) and incident OP using a two-stage individual participant data (IPD) meta-analysis of three large longitudinal cohorts. Methods: We harmonized and analyzed individual-level data from the Health and Retirement Study (HRS, USA), the Survey of Health, Ageing and Retirement in Europe (SHARE, Europe), and the English Longitudinal Study of Ageing (ELSA, UK), all comprising adults aged greater than or equal to[&ge;]50 years. In the first stage, Cox proportional hazards models were fitted separately in each cohort to estimate hazard ratios (HRs) for the forward (CLD[-&gt;]OP) and reverse (OP[-&gt;]CLD) associations, adjusting for a comprehensive set of confounders (demographics, lifestyle, comorbidities, functional status). In the second stage, cohort-specific log HRs were pooled using fixed-effect meta-analysis. Heterogeneity was assessed with the I-squared statistic. Results: A total of 40,050 participants were included across the three cohorts. The pooled HR for incident OP among individuals with baseline CLD was 1.37 (95% confidence interval [CI] 1.24-1.51), with similar estimates for COPD (HR 1.47, 95% CI 1.27-1.69) and asthma (HR 1.35, 95% CI 1.22-1.50). For the reverse association, baseline OP was associated with increased risk of incident CLD (pooled HR 1.16, 95% CI 1.05-1.29), COPD (HR 1.28, 95% CI 1.11-1.47), and asthma (HR 1.17, 95% CI 1.05-1.30). Heterogeneity was low across all analyses (I2[&le;]7.5%). Conclusion: This two-stage IPD meta-analysis provides robust evidence of a bidirectional relationship between CLD and OP in older adults. These findings underscore the need for integrated screening and management of both conditions in aging populations.

ImportanceChronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity and mortality in the United States (US), largely driven by cigarette smoking and characterized by progressive lung injury. While e-cigarettes are promoted as a less harmful alternative to cigarette smoking, their long-term health effects, including the impact of prolonged use on COPD incidence among adults who have smoked, are not well understood. ObjectiveTo evaluate the prospective association between duration of e-cigarette use and incident COPD among US adults aged 40 years or older with a history of cigarette smoking, and to determine whether baseline respiratory symptoms modify this association. Design, Settings, and ParticipantsWe used data from Waves 4 to 7 (2017-2022) of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative US longitudinal cohort study. Our analysis included adults aged 40 years or older who currently or formerly smoked cigarettes. Main Outcomes and MeasuresThe outcome was incident, self-reported COPD diagnosis. The main exposure was the time-varying duration of e-cigarette use. Baseline functionally important respiratory symptoms were defined by a validated index. Multivariable models adjusted for demographics, COPD risk factors, and detailed tobacco use history, including cigarette smoking status, time since quitting, and pack-years. ResultsAmong 4,895 adults aged 40 year or older who currently or formerly smoked cigarettes, 408 reported an incident COPD diagnosis. Among individuals with baseline respiratory symptoms, longer e-cigarette use duration was associated with increased COPD risk (adjusted hazard ratio [AHR]: 1.28, 95% CI: 1.16, 1.40), whereas no significant association was observed among those without baseline respiratory symptoms (AHR: 1.01, 95% CI: 0.92, 1.12). Results were consistent after adjusting for cumulative cigarette exposure and other risk factors and remained robust across multiple sensitivity analyses. Conclusion and RelevanceProlonged e-cigarette use may increase COPD risk among individuals with pre-existing respiratory vulnerabilities. Although switching from combustible cigarettes remains an important harm reduction strategy, behavioral counseling and pharmacotherapy should be prioritized for those at high risk for COPD, with e-cigarette cessation support available to high-risk former smokers. Continued surveillance and research are warranted as e-cigarette products and use patterns evolve. Key PointsO_ST_ABSQuestionC_ST_ABSDoes longer e-cigarette use increase COPD risk in adults with a smoking history? FindingsIn this national cohort study of U.S. adults aged 40+ who currently or formerly smoked, e-cigarette duration was associated with higher self-reported COPD incidence among individuals with respiratory symptoms at baseline (adjusted hazard ratio [AHR] 1.28, 95% CI 1.16, 1.40) but not among those without symptoms (AHR 1.01, 95% CI 0.92, 1.12). MeaningProlonged e-cigarette use may increase COPD risk among individuals with respiratory vulnerabilities. While cigarette cessation should remain the priority, evidence-based e-cigarette cessation strategies are needed to prevent long-term use in this population.

BackgroundMindfulness-based interventions (MBIs) have been increasingly adopted in educational settings to support cognitive development in youth. Executive function (EF)--encompassing inhibitory control, working memory, and cognitive flexibility--is a plausible target of MBI given its reliance on attention regulation. However, prior reviews have yielded mixed conclusions, partly due to inconsistent construct definitions and the pooling of heterogeneous outcome measures. ObjectivesTo (1) estimate the pooled effect of MBI on EF in youth aged 3-18 years using only construct-validated, direct EF measures, (2) examine potential moderators including age group, EF domain, and risk of bias, and (3) test dose-response relationships via meta-regression on intervention duration. MethodsWe searched PubMed, PsycINFO, CINAHL, Scopus, and Web of Science from inception to March 2026, supplemented by reference-list searches from two existing systematic reviews and a scoping review. Only English-language publications were eligible. Eligible studies were randomised controlled trials (RCTs) or quasi-RCTs of MBI (excluding yoga-only interventions) in typically developing youth, with at least one direct behavioural or computerised EF outcome. Risk of bias was assessed using Cochrane RoB 2. Hedges g was computed for each study, and pooled using a DerSimonian-Laird random-effects model. Subgroup analyses by age group, EF domain, and risk of bias were conducted, alongside leave-one-out sensitivity analyses, Eggers regression test, trim-and-fill, and Knapp-Hartung-adjusted meta-regression on intervention duration. Evidence certainty was rated using GRADE. ResultsThirteen RCTs (nine school-age, four preschool; total N = 1,560) met inclusion criteria. The pooled effect was g = 0.365 (95% CI 0.264 to 0.465; p < .00001), with negligible heterogeneity (I2 = 0.0%; Q = 6.76, p = .87). Effects were consistent across age groups (school-age g = 0.389; preschool g = 0.318) and EF domains (inhibitory control, working memory, cognitive flexibility; pbetween = .60). Meta-regression on intervention duration (4-20 weeks) was non-significant (p = .79). The effect was robust in leave-one-out analyses, in the low risk-of-bias subgroup (g = 0.361; k = 8), and after trim-and-fill adjustment (g = 0.354). The 95% prediction interval (0.252 to 0.477) was entirely positive. GRADE certainty was rated MODERATE, downgraded once for risk of bias. ConclusionsMBIs appear to produce a small, statistically significant improvement in EF in youth aged 3-18 years, with moderate certainty of evidence per the GRADE framework. The effect is consistent across preschool and school-age samples and across EF domains, with no significant dose-response relationship within the 4-20 week range studied. Emerging mediation evidence suggests that EF improvement may serve as an important pathway through which MBI supports emotion regulation, though this requires replication. Further large-scale, pre-registered RCTs with active control conditions and longitudinal follow-up are warranted.