Ambulatory care is defined as the provision of medical treatment by healthcare professionals outside an inpatient hospital setting. While well-established in acute medicine, uptake of ambulatory pathways in emergency general surgery (EGS) is variable and optimal design and delivery is unclear in this context. This systematic review sought to (1) appraise current EGS ambulatory pathway literature and (2) ascertain the constituent components across the identified pathways, guiding the development of comprehensive templates for future EGS ambulatory pathways.

Systematic review.

PubMed, Embase, Medline and Cochrane Library, from 5 December 2018 to 5 December 2023 inclusive.

All primary observational studies (ie, case–control, cohort studies and randomised controlled trials (RCTs)) were included. Case series and conference abstracts were excluded due to the high likelihood of incomplete data. Studies reporting paediatric or non-surgical populations, or ambulatory surgical care within a primary care setting, were also excluded.

General study characteristics (year and journal of publication, country of origin, study design, disease area, number of patients receiving ambulatory management and use of control groups) were recorded. To identify the constituent components of EGS ambulatory pathways, an initial subset of five papers was reviewed, from which four categories were identified (decision-making processes, scoring/classification systems, investigations and care escalation and discharge criteria). An additional fifth component (‘follow-up’) was identified during data extraction. Reporting of the constituent components of ambulatory pathways was also extracted, as well as outcomes including readmission, complications and mortality.

Of 43 included studies, there were 8 RCTs, 31 cohort studies and 4 studies using other methods. Reporting of all aspects of EGS ambulatory pathways was heterogeneous. 24 (56%) papers reported the specialty and grade of clinician acting as senior decision-maker. 17 different scoring/classification systems were used. 32 (74%) papers described using investigations to select ambulatory patients, including blood tests (n=12) and imaging (n=16). Eight studies (19%) specified both care escalation and discharge criteria. Information about follow-up was described in 29 papers, with location (n=29), time points (n=26), personnel (n=16) and the form of the follow-up (n=23) all reported variably. Readmission rates were recorded in 34 studies and ranged from 0% to 13%. Most studies (n=32) reported 30-day readmission, although 48 hours (n=1) and 90 days (n=1) were also used. Mortality was recorded in 24 papers, with 21 reporting a mortality rate of 0 and the remaining 3 reporting rates of

Key components of published EGS ambulatory pathways include decision-making processes, scoring/classification systems, investigations, care escalation and discharge criteria, and follow-up. However, this information is currently inconsistently reported. Future work to identify and agree on guidelines for the ‘core’ components of ambulatory EGS pathways is needed, to facilitate cross-study comparisons, and crucially, provide a ‘gold-standard’ framework for developing future ambulatory pathways.

To understand general practitioners’ (GPs’) experience of existing care pathways for people with moderate-severe Alzheimer’s Disease (AD) and explore their attitudes towards potential modifications to these pathways.

Secondary thematic analysis of qualitative interviews, originally conducted with GPs to explore prescribing of memantine in general practice. The theoretical domains framework was used to structure the data.

The study participants were recruited via an online survey completed by GPs across England.

Semi-structured, qualitative interviews were conducted with thirteen male and ten female GPs from a range of general practices in England.

Insights into GPs’ views and experiences regarding existing and possible care pathways for individuals with moderate to severe AD.

Gaps in GPs’ current levels of knowledge and skill in respect of caring for patients with moderate-to-severe AD affect their confidence and ability to identify opportunities for additional treatments. While GPs emphasise their role as providers of holistic care, features of the current healthcare context, including a lack of additional funding, inhibit their willingness to assume additional responsibilities as part of a revised pathway.

A considerable knowledge, skills and confidence gap must be addressed to support the implementation of new care pathways that include revised responsibilities for GPs. GPs need appropriate support and resources to manage their patients’ changing needs and to provide the best possible pharmacological management as the disease develops.

To increase the sustainability of healthcare, clinical trials must assess the environmental impact of interventions alongside clinical outcomes. This should be guided by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) extensions, which will be developed by The Implementing Climate and Environmental Outcomes in Trials Group. The objective of the scoping review is to describe the existing methods for reporting and measuring environmental outcomes in randomised trials. The results will be used to inform the future development of the SPIRIT and CONSORT extensions on environmental outcomes (SPIRIT-ICE and CONSORT-ICE).

This protocol outlines the methodology for a scoping review, which will be conducted in two distinct sections: (1) identifying any existing guidelines, reviews or methodological studies describing environmental impacts of interventions and (2) identifying how environmental outcomes are reported in randomised trial protocols and trial results. A search specialist will search major medical databases, reference lists of trial publications and clinical trial registries to identify relevant publications. Data from the included studies will be extracted independently by two review authors. Based on the results, a preliminary list of items for the SPIRIT and CONSORT extensions will be developed.

This study does not include any human participants, and ethics approval is not required according to the Declaration of Helsinki. The findings from the scoping review will be published in international peer-reviewed journals, and the findings will be used to inform the design of a Delphi survey of relevant stakeholders.

Registered with Open Science 28 of February 2025.

The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments’ sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes.

This is a protocol for SPIRIT and CONSORT extensions on reporting climate and environmental outcomes in randomised trials termed SPIRIT-Implementing Climate and Environmental (ICE) and CONSORT-ICE. The development of the extensions will consist of five phases: phase 1—project launch, phase 2—review of the literature, phase 3—Delphi survey, phase 4—consensus meeting and phase 5—dissemination and implementation. The phases are expected to overlap. The SPIRIT-ICE and CONSORT-ICE extensions will be developed in parallel. The extensions will guide researchers on how and what to report when assessing climate and environmental outcomes.

The protocol was submitted to the Danish Research Ethics Committees, Denmark in June 2025. Ethics approval is expected in September 2025. The SPIRIT and CONSORT extensions will be published in international peer-reviewed journals.

Exposure to prescription opioids following traumatic injury can increase the risk of developing tolerance, persistent opioid use and opioid use disorder. The mechanisms underlying opioid tolerance or dependence are not well understood, and no biomarkers predict risk. Opioid exposure causes epigenetic modifications, including alterations in microRNA (miRNA) expression. Several miRNAs, which regulate synaptic plasticity, are hypothesised to underlie substance use disorders and influence µ-opioid receptor levels, modulating opioid tolerance. This project aims to develop a bio-behavioural signature to predict persistent opioid use and chronic pain up to 6 months post-discharge.

The study will use a prospective cohort design, enrolling 180 adult patients at a Level I Trauma Center who are prescribed opioids at discharge. Prospective data will be collected in the hospital and at 7 days and 1, 3 and 6 months post-discharge. Biological data (genotyping and miRNA levels) and clinical measures of opioid use, pain, pain sensitivity (EEG) and psychosocial functioning will be collected at each time point. Bayesian regression methods will be used to identify baseline clinical, genetic, epigenetic and psychosocial predictors of opioid use and pain outcomes at 6 months post-discharge. Growth mixture modelling will identify distinct subgroups with varying trajectories, followed by Bayesian hierarchical modelling to predict trajectory classification based on predictor variables.

Ethics approval for this study was obtained from the University of Texas Health Science Center at Houston Committee for the Protection of Human Subjects (HSC-MS-24–0314). Findings will be disseminated in peer-reviewed scientific journals and at national and international conferences.

Various instruments exist for assessing agitation and broader non-cognitive symptoms in dementia (NCSD). However, the feasibility and practicality of using these instruments in residential settings with people with advanced dementia have not been evaluated. The aim of our review is to identify the available evidence regarding tools for measuring (1) Agitation and (2) NCSD in people with advanced dementia in residential settings, in terms of use (feasibility and psychometric properties) in this population.

Literature searches will be carried out in Medline, Embase, CINAHL, PsycInfo, Scopus, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials. Grey literature databases and relevant websites will also be explored for guidance documents, task reports, etc. A three-stage screening process will be adopted and will include pilot testing of source selectors. Two reviewers will independently perform title and abstract screening, then full text screening, against the defined eligibility criteria. This scoping review protocol was registered with Open Science Framework (https://osf.io/p7g86).

Due to the nature of the scoping review, ethical approval is not required. Results will be disseminated in a peer-reviewed journal and at international conferences.

To quantify the carbon footprint of a sample of clinical trials for neurological disorders.

Cross-sectional study.

Two clinical trial registries were searched on 29 December 2022 for phase 2–4 randomised controlled trials led from and recruiting in the UK, enrolling people with any of the 15 neurological disorders with the highest global burden, that had started recruitment or been registered in the preceding 5 years. Eligible trials were invited to share data to estimate emissions in each of the 10 modules of the Low Carbon Clinical Trials footprinting guidance. The primary outcome measure was kg of carbon dioxide equivalent (CO₂e).

318 randomised controlled trials were found, nine were eligible and six shared data (three completed and three ongoing). The module with the highest estimated CO₂e for each trial was the Clinical Trial Unit staff emissions (median 24 126 kg CO2e, IQR 10 395–78,867; range 45–79% of overall emissions of each trial); commuting accounted for >50% of CO₂e in this module. The second and third highest modules were trial-specific participant assessments (median 11 497 kg CO2e, IQR 825–15,682) and trial supplies and equipment (median 1161 kg CO₂e, IQR 226–6632). The total carbon footprint of these six trials involving 2248 participants at 239 sites was 2 63 215 kg CO₂e.

Emissions by Clinical Trials Unit staff were the top modifiable carbon hotspot in six randomised controlled trials for people with neurological disorders, which had a total carbon footprint equivalent to 1364 passengers’ return aeroplane journeys between London and Edinburgh.

An important goal of advance care planning (ACP) is ensuring that patients receive care concordant with their preferences. High-quality evidence is needed about the effect of ACP on this and other outcomes.

Planning Ahead is a randomised controlled trial to test the effectiveness of facilitated ACP in community-dwelling older adults including those with normal cognition and those with Alzheimer’s Disease and Related Dementias (ADRD) who are at high risk of death. The primary aim is to determine the effect of the intervention on discordance between preferences for medical treatments and the treatments received in the year after the intervention. Secondary outcomes include decision-making quality, care at the end of life and cost. Eligible patients have a primary care provider at one of two Midwest health systems, have an approximate 33% mortality risk and do not have a POLST form at baseline. Patients with capacity can invite the person they would choose to be their healthcare decision maker to participate as a study partner. A surrogate decision maker enrols and receives the intervention for patients who lack capacity due to ADRD. The intervention uses the Respecting Choices Advanced Steps (RCAS) model of ACP delivered by a registered nurse and includes identification of the patient’s values and goals, education about ACP and the POLST form and the opportunity to complete a POLST form.

The study is approved by the Indiana University Institutional Review Board. Primary and secondary analyses will be published in peer-reviewed journals. We also plan dissemination through the media. We will construct a deidentified data set that could be available to other researchers. Survey data will be preserved and shared via the NIH-supported National Archive of Computerised Data on Ageing’s (NACDA) Open Ageing Repository (OAR).

NCT04070183.

Youth electronic cigarette (e-cigarette) use is a global health challenge, with multiple jurisdictions wrestling with appropriate responses, in the face of limited evidence available on effective interventions. Identifying and synthesising evidence on the effects of interventions to prevent youth e-cigarette use is required to inform prevention-focussed health policy and practice.

We plan to undertake an individual participant data (IPD) prospective meta-analysis (PMA). We will conduct systematic searches to identify eligible planned or ongoing randomised controlled trials (RCTs) using trial registries via WHO ICTRP and ClinicalTrials.gov and databases Medline, Embase, CENTRAL, PsycINFO, Web of Science, CINAHL and Europe PMC. We will also search grant websites for additional studies. We will include any RCT of e-cigarette and cigarette prevention interventions for youth including non-smoking and non-vaping youth aged 10 to 19 years, with no intervention, waitlist, usual care or active control. Primary outcomes will be measures of current or ever e-cigarette use. Secondary outcomes include measures of current and ever cigarette (conventional cigarette) use.

Investigators from relevant trials will be invited to join the Synthesis using Prospective meta-Analysis to Reduce youths’ E-cigarette use (SPARKE) consortium prior to trial outcomes being known using harmonised methods. They are then asked to share their data within 12 months of trial completion.

The primary outcomes will be analysed in a two-stage IPD meta-analysis model under an intention-to-treat framework. First, effect estimates and variances will be calculated for each trial with log-binomial regression models adjusting for key prognostic factors. For cluster RCTs, a nested random effect will be specified within trials to account for correlations within clusters. Second, effect estimates will be combined across trials in a random treatment effect, inverse variance meta-analysis model. Effect estimates will be reported as relative risk ratios with 95% CIs.

This study aims to generate and expedite the synthesis of data regarding prevention interventions for adolescent e-cigarette use to inform real-world decision making. Findings will be of interest to key stakeholders, including policy makers and research funders.

Each trial will be responsible for obtaining their own ethics approval. While secondary analysis of data does not usually require ethics approval, we have received cross-institutional ethics approval from the University of Sydney (2023/714) and the University of Newcastle (H-2023–0389).