Multimodal analgesic strategies designed to minimise perioperative opioid exposure are fundamental components of enhanced recovery after surgery (ERAS) pathways. Despite widespread implementation of ERAS protocols, the optimal analgesic regimen remains undefined, as the individual contributions of specific agents to overall analgesic efficacy and opioid-sparing effects are not fully elucidated. Intravenous lidocaine, a widely utilised local anaesthetic, possesses both analgesic and anti-inflammatory properties and has been associated with improved gastrointestinal recovery. This study seeks to pragmatically evaluate the impact of incorporating perioperative intravenous lidocaine infusion into established ERAS pathways on postoperative functional recovery.

The Impact of PerioperAtive LidocAine Infusions (IMPALA) on ERAS trial is a single-centre, pragmatic, cluster-randomised, double-blinded, placebo-controlled study. A total of 2290 patients undergoing elective colorectal surgery, emergency general surgery, urology, ventral hernia repair, surgical oncology or spine surgery will be randomly assigned to receive either intraoperative and postoperative intravenous lidocaine infusions (administered for up to 48 hours) or placebo as part of a standardised multimodal analgesic regimen integrated into established ERAS pathways. The primary outcome is case mix index–adjusted resource length of stay, defined as the time interval from surgical initiation to hospital discharge adjusted for case mix index. The primary outcome is total inpatient opioid consumption within the first 72 hours, reported in oral morphine milligram equivalents. Secondary outcomes include various in-hospital clinical endpoints derived from the electronic health record.

This protocol and accompanying statistical analysis plan outline the study design, primary and secondary endpoints and analytic methodology. The IMPALA-ERAS trial has received ethical approval from the Vanderbilt University Institutional Review Board (IRB: 250617). The findings will be disseminated via peer-reviewed publications and presentations at national conferences. Results from this trial are expected to inform evidence-based practices regarding perioperative lidocaine infusion and its potential contributions to enhanced postoperative recovery in surgical patients.

NCT07224711.

Psychosocial interventions are essential to support people living with dementia and their carers. A consensus on what is most important for research on psychosocial intervention in dementia and how intervention studies should best be conducted is currently lacking. This protocol describes the research plan aimed at achieving consensus on (i) the relevance of core elements (CEs) for the development, feasibility testing/piloting, evaluation and/or implementation phases of psychosocial interventions in dementia and (ii) methodologies (eg, design) and methods most suitable to address CEs per phase.

This study was co-designed with a multi-stakeholder advisory group and a multi-disciplinary INTERDEM (psychosocial INTERventions in DEMentia) Methodology Taskforce steering committee. It will involve a multi-phase modified Delphi design, including surveys and group discussions with stakeholders, namely people living with dementia, (informal/unpaid/family) carers, health and social care professionals, policy makers, representatives from insurance companies and psychosocial researchers. A series of iterative ‘rounds’ will be conducted. In round 1 (Phase 1: ‘identification’), stakeholders will be asked to complete an online survey rating the importance of CEs from the UK Medical Research Council (MRC) Framework, namely (i) consider context; (ii) develop, refine and (retest) programme theory; (iii) engage stakeholders; (iv) identify key uncertainties; (v) refine interventions and (vi) economic considerations per phase; propose relevant additional CEs and list methodologies/methods that most suitably address CEs. These ratings will be further explored through online discussion rounds (Phase 2: ‘elaboration’). In round 2 (Phase 3: ‘consensus’), participants will be asked to rate the importance of CEs again (ie, new CEs and where no consensus was reached in Phase 1) and the usefulness of methodologies/methods to address CEs. Outcomes will be discussed with the advisory group and steering committee (Phase 4: ‘validation’). This process (Phases 3 and 4) will be repeated until a consensus on CEs and methodologies/methods is achieved.

Ethical approval was received at Maastricht University (FHML-REC/2025/078) and the University of West London (UWL/REC/SBS-01195). Participants will sign informed consent prior to study participation. Results will be disseminated through a peer-reviewed publication, seminars, webinars, conferences, postgraduate dementia programmes, blogs, commissioner briefings and social media.

Open Science Framework (https://doi.org/10.17605/OSF.IO/DQRFA).

Walk-and-talk therapy integrates psychological support and physical activity conducted in outdoor environments, and has potential to better align with men’s preferences and masculine norms around emotional communication. Conventional indoor psychotherapy is effective for treating depression but can be less engaging for men, leading to less satisfaction and high rates of dropout. This trial aims to determine whether walk-and-talk therapy offers men with depressive symptoms clinically meaningful benefits over conventional indoor therapy.

This assessor-blinded, parallel group randomised controlled trial is comparing the efficacy of walk-and-talk therapy to conventional indoor therapy for men with depressive symptoms. After randomisation, all participants receive 10 fortnightly 1-hour individual psychotherapy sessions over 20 weeks as either: (1) conventional indoor therapy (sitting down indoors) or (2) walk-and-talk therapy (walking outdoors). Participants are assessed at ‘pre-intervention’ (baseline), ‘post-intervention’ (5 months post baseline) and ‘follow-up’ (12 months post baseline) time points. The primary outcome is change in overall psychological distress (21-item version of the Depression, Anxiety and Stress Scale (DASS-21)) at post-intervention. Secondary outcomes include male-type depression symptoms, mental well-being, suicidal ideation and quality of life. Costing data is being collected for cost-effectiveness analysis. Linear mixed models will be used to examine the impact of group (conventional indoor vs walk-and-talk), time (baseline, 5-month and 12-month) and the group-by-time interaction for primary and secondary outcomes.

This study is approved by the University of Newcastle Human Research Ethics Committee (H-2024-0090). Results will be published in an open access peer-reviewed journal and disseminated through conference presentations.

ACTRN12624000794505.

Steatotic liver disease (SLD), particularly its metabolic forms (metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis), is highly prevalent worldwide yet remains substantially underdiagnosed. Neck circumference (NC) is a simple anthropometric measure reflecting upper-body adiposity and cardiometabolic risk and has been increasingly investigated as a potential screening or risk-stratification tool for SLD. However, existing evidence is heterogeneous, and no comprehensive meta-analysis has synthesised the diagnostic performance of NC for detecting SLD. This systematic review and meta-analysis aim to evaluate the diagnostic accuracy and predictive value of NC in adults and to explore sources of heterogeneity across populations and study characteristics.

A systematic search of PubMed, Scopus, Web of Science and the Cochrane Library will be conducted for English-language studies published between January 2010 and September 2025. Observational studies in adults reporting NC measurements and confirmed steatotic liver disease diagnosed by imaging or biopsy will be included. Two reviewers will independently perform study selection and data extraction. Risk of bias and methodological quality will be assessed using a dual-framework approach: the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool for diagnostic accuracy domains and the Joanna Briggs Institute (JBI) critical appraisal checklists for broader observational study design considerations. The primary outcomes are pooled sensitivity and specificity of neck circumference for detecting steatotic liver disease. Secondary outcomes include ORs, relative risks, correlation coefficients and diagnostic accuracy measures, as well as comparisons with other anthropometric indicators. Random-effects meta-analyses will be conducted where appropriate, with subgroup, sensitivity and publication bias analyses planned. Certainty of evidence for primary diagnostic accuracy outcomes (pooled sensitivity and specificity) and key secondary association outcomes will be assessed using the Grading of Recommendations Assessment, Development and Evaluation framework.

Ethical approval is not required, as this study synthesises published data. Results will be disseminated through peer-reviewed publication and scientific conferences to inform clinicians, researchers and policymakers on the potential role of neck circumference in screening and risk stratification for steatotic liver disease.

Genitourinary syndrome of menopause (GSM) is a chronic, oestrogen-deficient condition that is frequently underdiagnosed and undertreated. Although low-dose vaginal estriol improves epithelial trophism and microbial balance, a substantial proportion of women report persistent symptoms. High-quality randomised evidence evaluating combined therapeutic strategies remains scarce. Energy-based modalities, including the erbium:YAG (Er:YAG) laser (=2940 nm), have been proposed as adjunctive treatments. This trial aims to assess the efficacy of Er:YAG laser therapy combined with vaginal estriol compared with estriol alone in postmenopausal women with GSM.

This is a single-centre, randomised, double-blind, controlled clinical trial. Postmenopausal women aged 45–70 years with vaginal pH ≥5.0 and at least one moderate GSM symptom (Visual Analogue Scale ≥4) will be eligible. Exclusion criteria include current systemic or local hormone therapy, previous vaginal energy-based treatment, abnormal cervical cytology and body mass index ≥35 kg/m². All participants will receive vaginal estriol cream (0.5 mg per dose) daily for 14 days, followed by twice-weekly administration for 16 weeks. Participants will be randomised (1:1) to receive either estriol plus sham Er:YAG laser or estriol plus active Er:YAG laser. Three laser sessions will be delivered at approximately 4-week intervals. Assessments will occur at baseline, monthly during treatment and 4 months after the final session. The primary outcome is the Vulvovaginal Health Index, with the primary endpoint defined as the change from baseline to 4 months post-treatment, reflecting sustained effect. Secondary outcomes include GSM symptom severity, vaginal microbiome composition (16S rRNA sequencing), quality of life (Menopause Rating Scale) and sexual function (Female Sexual Function Index). Data will be analysed using repeated-measures analysis of variance or appropriate non-parametric tests, with significance set at p

Ethical approval has been obtained from the Human Research Ethics Committee of UNINOVE. Written informed consent will be obtained. Findings will be disseminated via peer-reviewed journals and scientific meetings.

NCT06873971.

Asthma is one of the most prevalent long-term health conditions affecting pregnant women. Poorly controlled asthma during pregnancy is associated with adverse maternal and fetal outcomes and may predispose offspring to long-term respiratory morbidity. The current ‘one size fits all’ approach to asthma management during pregnancy is not optimally effective for approximately half of the pregnant women with asthma. A personalised medicine approach to managing airways disease is required. The treatable traits approach focuses on the identification and treatment of traits in the pulmonary, extra-pulmonary and behavioural domains, which are identifiable, measurable, clinically relevant (linked to exacerbation risk or poor asthma control) and treatable. This manuscript outlines the protocol for the Treatable Traits for Asthma Management in Pregnancy (TTAP) study. The purpose of the TTAP study is to prospectively determine the prevalence of a range of treatable traits from these three domains in pregnant women with asthma and determine which traits are associated with exacerbation risk, poor asthma control and poor asthma-related quality of life. Additionally, this study will assess differences in trait prevalence and clinical relevance in pregnant women from regional versus metropolitan hospitals in Australia and in different antenatal models of care.

The TTAP study is a multicentre, prospective observational cohort study. Study participants are pregnant women with asthma attending antenatal clinics at 10 metropolitan and regional hospitals (public and private) in NSW and Victoria, Australia. Assessment of traits from the pulmonary, extrapulmonary and behavioural domains as well as asthma outcomes is conducted at three gestational timepoints: 12–16 weeks, 22–26 weeks and 32–36 weeks of pregnancy. A follow-up assessment of asthma outcomes is conducted at 2–4 weeks postpartum. The outcomes assessed are asthma exacerbations requiring medical intervention (primary outcome), asthma symptom control and asthma-related quality of life. Traits and outcomes will be assessed using questionnaires, direct questioning, measurement of biomarkers, physical measurements and assessment of routinely collected data from medical records.

The Hunter New England Human Ethics Committee (2024/ETH01289) has approved the TTAP study protocol. Outcomes will be published in peer-reviewed journals, presented at scientific conferences and disseminated online to participants, clinicians and other pregnant women with asthma and their families via the Asthma in Pregnancy Toolkit website https://asthmapregnancytoolkit.org.au/.

Intracerebral haemorrhage (ICH) accounts for approximately 15% of all strokes in Denmark and remains associated with high mortality and morbidity. It is challenging to distinguish neoplastic from non-neoplastic causes of ICH in the acute setting, and CT findings that may aid early differentiation have not been fully characterised. Existing ICH-classification systems (SMASH-U, H-ATOMIC and CLAS-ICH) have not been directly compared for diagnostic accuracy in this setting. Identifying radiological and clinical factors associated with underlying aetiology may support faster diagnosis, reduce time to workup related to potential underlying cancer and facilitate early targeted treatment of the underlying cause of ICH.

This study is a retrospective observational cohort including all patients admitted with acute ICH to the Department of Neurology, University Hospital of Southern Denmark, Aabenraa between January 2014 and December 2024 (estimated approximately n=610). Medical records and initial non-enhanced CT scans will be reviewed. Two neurologists and two radiologists, blinded to final diagnosis, will independently extract clinical presentation, topographical and volumetric haemorrhage characteristics, and classify each case using the abovementioned ICH-classification systems. Primary analyses will assess associations between clinical and radiological features and underlying neoplastic vs non-neoplastic aetiology. Secondary analyses will compare diagnostic performance of classification systems using sensitivity, specificity and receiver operating characteristic curves. Multivariate logistic regression models will be applied with Holm correction for multiple comparisons.

The study has been submitted to the National Danish Research Ethics Committee and the Danish Data Protection Agency. As data derive from completed disease courses, no patient contact is expected. Results will be disseminated through peer-reviewed journals, conferences and scientific presentations.

Multimorbidity, characterised by the coexistence of two or more chronic conditions, represents a growing challenge for health systems, adversely affecting quality of life, self-care, treatment adherence and service utilisation. Within the context of self-regulation in health, the Common-Sense Model of Self-Regulation of Health and Illness (CSM) proposes that illness perceptions—such as beliefs about causes, control, consequences, timeline and illness identity—influence health behaviours. Despite consolidated evidence in single-disease contexts, little is known about how these perceptions operate when multiple conditions coexist, particularly due to the need to integrate potentially conflicting representations. To date, no systematic reviews have synthesised these relationships specifically in populations with multimorbidity. This protocol describes the methods for a systematic review aimed at examining how illness perceptions are associated with treatment adherence, self-care and indicators of chronic condition management in adults with multimorbidity.

This systematic review will be reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Observational studies involving adults (≥18 years) with multimorbidity, which assess illness perceptions using validated instruments and report outcomes related to treatment adherence, self-care or self-management behaviours, will be included. The search will be conducted in the PubMed, Scopus, Web of Science, Embase, CINAHL, PsycINFO and LILACS databases, using combinations of descriptors related to illness perception, multimorbidity and health behaviours. Two independent reviewers will conduct study selection, data extraction and methodological quality assessment. The risk of bias will be assessed using the Newcastle-Ottawa Scale, and the overall quality of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Where appropriate, meta-analysis will be conducted using measures of association (eg, ORs, relative risk or HRs); otherwise, a structured narrative synthesis will be performed. Subgroup analyses will be conducted when data are available.

As it uses exclusively secondary and published data, this review does not require approval by a research ethics committee. The results will be submitted for publication in a peer-reviewed journal and disseminated at relevant scientific conferences.

CRD420251266292.

E-cigarette use (often referred to as ‘vaping’) has increased rapidly over the past decade. Tobacco smoking is a well-established risk factor for adverse perioperative outcomes. While UK guidance supports e-cigarette use as a harm reduction and smoking cessation strategy, the perioperative implications of e-cigarette use are unclear. This scoping review aims to map the breadth and nature of the available evidence on e-cigarette use in the perioperative setting. It will describe how perioperative e-cigarette use is defined and measured, identify the perioperative populations and settings which have been studied, summarise reported perioperative outcomes and identify key knowledge gaps that should be addressed in future research.

This review will be conducted in accordance with Joanna Briggs Institute methodology and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines. MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane Central, Web of Science and grey literature sources will be systematically searched from 2003, when the first commercially available e-cigarette was introduced, to February 2026. Studies will be screened, and data extracted by two independent reviewers. Studies of any design examining perioperative e-cigarette use in the perioperative period, across all surgical specialities, will be included. Data will be synthesised narratively and presented using tabular and visual summaries. The study will be undertaken between 9 February and 1 August 2026.

Ethical approval is not required for scoping reviews. Findings will be disseminated by conference presentation and publication in a peer-reviewed open-access journal and communication with stakeholders.

Older patients admitted under surgical care have longer length of stay (LOS) and are at risk of functional decline, hospital-acquired complications and geriatric syndromes. Embedded specialist geriatrician models within surgical care teams can reduce length of stay and perioperative complications. Evidence gaps remain regarding the implementation of these models of care and their impact on patient outcomes. This study aims to measure hospital, patient and implementation outcomes of an embedded perioperative geriatric service in a large Australian tertiary referral hospital.

This hybrid type 1 effectiveness-implementation trial involves four services (emergency general, elective general, urology and vascular surgery), with a predicted reach of >2000 patients over 24 months. The intervention consists of a proactive geriatrician-led service providing a comprehensive geriatric assessment and ongoing review during the acute admission. Service evaluation will be via (1) traditional hospital outcomes (primary outcome LOS); (2) implementation outcomes; and (3) patient reported outcomes across three 6 month phases: (1) prior to service implementation; (2) during service implementation and (3) continued service but without active implementation. Data analysis will include descriptive statistics of patient demographics, clinical characteristics and implementation outcomes; cost-effectiveness; univariate and multivariate analysis of outcomes against demographic and clinical characteristics and thematic analysis of qualitative data.

This trial has been approved by the Hunter New England Research Ethics Committee (2024_ETH023259). The findings will be disseminated via peer-reviewed publications and conference presentations. The research team will facilitate adoption more broadly within the health service.

Australian New Zealand Clinical Trials Registry (ACTRN12625000404426)