Conectar
Recent research indicates that around 8% of older people living in prison have signs or symptoms of dementia or mild cognitive impairment (MCI), yet the care they receive is not equivalent to care in the community and this means their needs may not be met. We co-developed an intervention specifically for older people living in prison with dementia/MCI (Dementia and Mild Cognitive Impairment in prison care pathway and training package–DECISION). To date, this has not been implemented or evaluated. This paper presents our protocol for a study to assess the feasibility and acceptability of DECISION.
This is a non-randomised, realist-informed mixed-methods feasibility study with integrated process evaluation, which will take place in two prisons in England. The intervention was codeveloped with experts with lived experience. Participants will include older people living in prison, staff working in prison and peer supporters. We will assess the feasibility and acceptability of the intervention (eg, numbers eligible; rates of recruitment and retention), and the evaluation design (eg, completion rates of standardised outcome measures). Methods will include semistructured, realist-informed interviews; an audit to assess implementation fidelity; focused ethnography; training questionnaires; and collection of resource use data. We will refine the DECISION programme theory using realist-informed methods to examine and refine how contexts and mechanisms interact to produce the intervention’s outcomes.
This study received a favourable ethical opinion from the Wales REC 3 Research Ethics Committee in January 2025 (reference number 24/WA/0323). HMPPS National Research Committee approval was also granted in January 2025 (reference number 2024-1451). Findings will be disseminated through a range of avenues, including stakeholder engagement events, open-access papers, conference presentations, evidence briefings for commissioners, providers and practitioners, and newsletters for service users.
The opioid crisis remains a significant public health emergency. Key contributors to this crisis include an increasingly toxic drug supply and inadequate health policies that rely on strategies to address opioid-related harms and underutilise primary prevention and early intervention approaches. To inform comprehensive prevention and early intervention strategies, research is needed to explore pathways involving hazardous opioid use (ie, daily opioid use that results in, and may arise from, disruptions to health, relationships, work or social functioning) and the individual, social and structural factors that shape such pathways. This qualitative study aims to address this research gap by exploring the substance use journeys of adults with lived or living experiences of hazardous opioid use who are receiving substance use treatment at a large Canadian mental health hospital.
A qualitative descriptive study informed by the life course perspective will be conducted. Data will be collected using participant-led timeline mapping in combination with semistructured interviews. Participants will include 20–30 adults who are receiving or have received substance use treatment from the hospital where the study is being conducted. Timelines and interviews will be analysed using thematic analysis. A brief demographic questionnaire will also be administered to describe characteristics of the sample.
Ethical approval was granted on 1 October 2025 by the Centre for Addiction and Mental Health Research Ethics Board (Protocol no. 2025/026). Findings will be reported through peer-reviewed publications, lay language reports and/or academic conferences on mental health and substance use health research.
Patient mental state deterioration presents significant challenges in acute hospital settings, affecting outcomes, increasing reliance on restrictive interventions, and placing additional strain on healthcare staff. Despite its prevalence, consensus on best practice remains limited. The De-escalation, Intervention, Early Response Team (DIvERT) is a pilot rapid response system introduced to improve early identification, enable timely interventions, reduce crisis incidents, and support ward staff in caring for patients with mental state deterioration.
A realist evaluation approach was used to test, validate, and refine program theories explaining DIvERT's mechanisms. Data collection included a cross-sectional survey, semi-structured interviews, field observations, a medical record audit, and incident report analysis. Analysis was guided by the Context-Mechanism-Outcome framework to explain DIvERT's effective functioning in responding to patient deterioration.
DIvERT facilitated early intervention through multidisciplinary collaboration, though organisational factors such as staffing constraints, workload pressures, and inconsistent assessment practices influenced effectiveness. Key mechanisms included structured escalation pathways, clinical skills, staff training, and interprofessional collaboration. Challenges included limited after-hours availability, reflecting the constraints of a pilot initiative, underreporting of incidents, and hierarchical decision-making. While causation cannot be directly established, trends indicate DIvERT was associated with fewer Code Grey responses, particularly during initial episodes of mental state deterioration.
This realist evaluation highlights the value of structured escalation pathways, multidisciplinary collaboration, organisational support, and tailored training in managing mental state deterioration. Preliminary trends suggest DIvERT may enable more proactive and timely early intervention, whereas traditional reactive hospital emergency response for aggression (Code Grey) was more often linked to repeat incidents. Workforce constraints and inconsistent assessment limited effective functioning, underscoring the need for strengthened training, integration into workflows, and improved after-hours coverage to support scalability and long-term success.
This study demonstrates that a proactive rapid response model (DIvERT) can strengthen the recognition and management of mental state deterioration in acute hospital settings. By formalising escalation pathways, improving interdisciplinary collaboration, and tailoring training to staff needs, the model supports safer and more timely responses to patient deterioration. Embedding such approaches into organisational workflows has implications for patient safety, staff confidence, and system efficiency.
The study addressed the challenge of inconsistent and reactive responses to patient mental state deterioration, which are often reliant on crisis interventions such as Code Grey. DIvERT facilitated early intervention through structured escalation processes, improved interdisciplinary collaboration, and enhanced staff skills. However, organisational barriers such as workforce constraints, after-hours gaps, and inconsistent use of mental state deterioration assessment tools limited its effective functioning. Findings are directly relevant to clinicians in acute hospital settings (particularly nursing and allied health staff), hospital administrators responsible for patient safety and workforce planning, and policymakers overseeing standards for recognising and responding to acute deterioration. The results highlight where investment in training, structured escalation systems, and organisational support can reduce reliance on restrictive interventions and improve both patient and staff safety.
This evaluation adhered to the Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) II reporting standards for realist evaluations, as outlined in the EQUATOR Network guidelines.
This study did not include patient or public involvement in its design, conduct, or reporting.
Managing patients' mental state deterioration in acute hospital settings is a critical challenge, requiring prompt specialised intervention to mitigate adverse outcomes. Current responses vary widely across health systems. Integrating rapid response systems that incorporate mental health expertise offers a promising approach to reduce risks and adverse outcomes.
To evaluate how a response system manages patient mental state deterioration in acute hospital settings, focusing on the mechanisms driving system effectiveness, for whom it works and under what circumstances, using a realist-informed theory-testing approach with field observation.
We conducted non-participant field observations in one trauma and one surgical unit over 4 months to examine the contexts, mechanisms and outcomes shaping a mental state deterioration response system. Observations captured multidisciplinary interactions, escalation processes and decision-making. Structured field notes were thematically coded using a realist framework to refine program theories and identify key factors influencing timely intervention.
Twenty responses were observed, most in the trauma unit. The system worked best when bedside nurses escalated early signs of deterioration, prompting timely intervention. Multidisciplinary collaboration involving nurse unit managers, liaison psychiatry, doctors and allied health professionals activated mechanisms of integrated assessment and coordinated care, enabling both medical and mental health needs to be addressed. Competing medical acuity demands at times reduced system availability. Teleconferencing supported specialist input when in-person attendance was not possible, ensuring person-centred care.
System functioning depended on early risk communication by bedside nurses and proactive multidisciplinary collaboration. Organisational support and staff training are essential to address operational challenges. Findings provide evidence for strengthening response systems to deliver timely, comprehensive interventions that improve physical and mental health outcomes.
DIvERT (De-escalation, Intervention, Early, Response, Team) is a proactive rapid response model of care piloted to improve the management and outcomes of patients experiencing mental state deterioration in acute hospital settings. The model achieves this through structured escalation pathways, proactive interventions and coordinated multidisciplinary collaboration to integrate medical and mental health care. Strengthening organisational support and staff training further reduces reliance on restrictive practices and promotes safer, person-centred care.
What problem did the study address? Acute hospitals face persistent challenges in responding to patient mental state deterioration alongside medical acuity, with existing rapid response systems often insufficiently integrated with mental health expertise. What were the main findings? Field observations of the DIvERT model demonstrated that proactive integration of mental health expertise, supported by organisational investment in training, clear escalation protocols and multidisciplinary collaboration, enabled earlier intervention and more coordinated responses. Where and on whom will the research have an impact? These findings have implications for acute hospital services, informing system-level improvements to rapid response models that support patient safety, reduce adverse events and improve staff wellbeing.
This study adhered to the relevant EQUATOR guidelines. Specifically, reporting followed the RAMESES II (Realist And Meta-narrative Evidence Syntheses: Evolving Standards II) reporting standards, which provide criteria for transparent and rigorous reporting of realist evaluation methodology.
No patient or public contribution.
Pain in patients with rheumatoid arthritis (RA) is an unmet clinical need. Targeting joint inflammation with disease-modifying antirheumatic drugs has not resulted in the anticipated reduction in pain for many patients. This can partly be explained by the concept of central sensitisation whereby spinal and supraspinal pathways have a lower threshold of activation, leading to increased perception of pain. Synovial stromal cells, such as fibroblasts, are also thought to play a role through peripheral sensitisation of nerves in the joint. Synovial fibroblasts are known to produce pro-algesic mediators such as interleukin 6 and nerve growth factor at the messenger RNA level. These pro-algesic mediators could activate sensory nerve fibres that send signals from the joint to the spinal cord, thereby driving persistent pain in RA. The purpose of this study is to evaluate which pro-algesic mediators are produced by lining versus sub-lining fibroblasts and whether the level of these mediators correlates with clinical measures of pain in patients with RA.
FiND-Pain RA is a multicentre observational study which will recruit 50 patients with seropositive RA who attend the rheumatology department of Guy’s and St Thomas’ Hospital, London, and the Nuffield Orthopaedic Centre, Oxford. Clinical examination, pain-focused patient-reported outcome measures, ultrasound examination and ultrasound-guided synovial biopsy of the knee will be performed. The levels of known and putative pro-algesic mediators will be measured in fibroblasts from the lining and sub-lining layer of the synovium. The location and spatial morphology of sensory nerve fibres and their proximity to lining and sub-lining fibroblasts will be characterised. The primary outcome will be to determine whether the knee pain scores of participants correlate with the level of leukaemia inhibitory factor, a novel putative pain-mediator expressed in sub-lining fibroblasts. The secondary outcomes will be to determine whether other pro-algesic mediators produced by lining or sub-lining fibroblasts correlate with clinical measures of pain and to assess the location and proximity of sensory nerve fibres to lining versus sub-lining fibroblasts.
The study is a sub-study of the PUMIA (Pain Phenotypes and their Underlying Mechanisms in Inflammatory Arthritis) study, which has been approved by the Bromley Research Ethics Committee (REC: 21/LO/0712). The findings of this study will be disseminated through open-access publications, as well as scientific and clinical conferences.
To explore how Early Career Nurses perceive their preparedness for nursing practice, the teaching and learning experiences, and the role of professional experience placements on their professional development.
A qualitative study using a hermeneutic phenomenological approach.
The study involved 25 Early Career Nurses who participated in follow-up interviews 4 years post-graduation in Australia between 2022 and 2024. Data were collected through semi-structured interviews and analysed using Thematic Analysis.
Three key themes emerged: gaps in preparedness, the power of being embedded and too many balls to juggle. Participants indicated a mixed sense of preparedness with significant gaps in clinical skills. They emphasised the critical role of professional experience placements and mentorship to bridge the gap between theoretical knowledge and practical application. Placements and mentorship opportunities were considered essential to develop confidence and competence for effective nursing practice.
The study highlights the necessity for nursing curricula to address significant gaps in clinical skills, particularly in surgical and emergency nursing. By incorporating more simulation-based learning, interprofessional education and robust mentorship programmes, nursing education can better prepare graduates for the realities of clinical practice. These enhancements will help ease the transition from academic training to clinical practice, reducing reality shock and fostering a more confident, competent and resilient nursing workforce.
Nursing education must integrate more simulation-based learning and interprofessional education opportunities, which are crucial for bridging the gap between theoretical knowledge and practical application, ensuring that graduates are adequately prepared for the demands of clinical practice. Additionally, professional experience placements and mentorship should be prioritised to develop the confidence and competence for effective nursing practice.
This study adheres to the Consolidated criteria for reporting qualitative research guidelines.
No Patient or Public Contribution.
The USA has the highest incarceration rate in the world, with 1 in 48 adults under correctional supervision. Approximately half of state and federal prisoners are parents, nearly 80% of women in jails are mothers, and an estimated 1 in 14 children have had an incarcerated parent. Incarceration increases the risk of physical and mental health issues, family strain and disconnection and housing and employment instability. Children of incarcerated parents are particularly vulnerable to health problems, behavioural issues and academic struggles. Given these impacts, there is growing interest in using strategies besides incarceration that address both community safety concerns and promote parental and family well-being. Efforts to keep people out of jail and prison most commonly include deflection (before arrest) and diversion or alternatives to incarceration (after arrest but before conviction, or after conviction but as an alternative to prison or jail). However, there is limited understanding of what is known about these approaches when used with parents and a lack of empirical evidence about their effectiveness. This scoping review aims to map concepts, document evidence and identify knowledge gaps about parent and caregiver-focused alternatives to incarceration in the USA.
This scoping review will characterise alternatives to incarceration across the criminal legal system for parents and caregivers and map existing concepts and research in the field. The review will be conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols Extension for Scoping Reviews (PRISMA-ScR) guidelines. Five interfaces with one or more databases will be searched including EBSCOhost, ProQuest, Web of Science, PubMed, HeinOnline and SCOPUS, in addition to Google Scholar and Google. All available published articles and grey literature on US-based alternatives to incarceration for parents and caregivers (18+) will be considered. Two research team members will independently screen sources based on inclusion criteria and resolve any disagreements through discussion or a third reviewer if necessary. The findings will be charted, synthesised and reported. The study will be conducted from approximately November 2025 to August 2026.
Ethics approval is not required for this scoping review. The findings will be disseminated through academic publications, conference presentations and to policy and practice audiences. The results will help inform a research agenda aimed at improving the development, implementation and evaluation of parent-focused alternatives to incarceration in the USA.
This protocol is registered with Open Science Framework registries (https://osf.io/39zn8).
While loneliness has been recognised as a global public health concern, there are still knowledge gaps about how to prevent or reduce loneliness. The Social Relationship Expectations (SRE) Framework (Akhter-Khan et al, 2023) has been developed to enhance mechanism-based interventions targeting individuals’ expectations for social relationships. However, no scale has yet been developed to measure these expectations. We aim to measure SRE across the six interdependent dimensions identified in the theoretical framework, across diverse settings. This protocol outlines the methodology for developing the SRE scale.
The scale will be developed using both inductive and deductive techniques in a multicountry observational study. First, items will be extracted from published qualitative studies on loneliness and SRE across 15 lower-middle-income countries and from a qualitative focus group study with older Myanmar and Thai adults. Second, using a Delphi process for item development, experts across five world regions (Africa, the Americas, Asia, Europe and Oceania) will be involved in the item selection and scale creation process. A preliminary item pool will be administered in English, German and Chinese. Classical test theory as well as network analysis will be used to assess the dimensionality of the scale, understand item relationships and clusters, and select the final items for the SRE scale.
Ethics approval for the scale development has been obtained from King’s College London (reference number: MRSP-24/25-46512). Informed consent will be obtained from all participants prior to completing the cognitive interviews and online surveys. Results will be disseminated in peer-reviewed journals in collaboration with coauthors across different countries and disciplines.
Glioblastoma multiforme (GBM) is an aggressive primary brain tumour associated with a poor prognosis despite standard-of-care treatment, including surgical resection, radiotherapy and temozolomide (TMZ) chemotherapy. Certepetide (also known as LSTA1, CEND-1) is an investigational tumour-penetrating peptide that facilitates the extravascular delivery and intratumoural penetration of co-administered immune/chemotherapeutics; however, it has not yet been evaluated in clinical trials for the treatment of intracranial malignancies.
LSTA1-GBM-2A is an exploratory phase 2a, double-blind, placebo-controlled, randomised, proof-of-concept investigator-initiated trial assessing the safety, tolerability and preliminary efficacy of certepetide in combination with standard-of-care TMZ, compared with TMZ with a matching placebo, in subjects with newly diagnosed GBM.
The trial is funded by Lisata Therapeutics, sponsored by Tartu University Hospital and conducted at hospitals in Estonia and Latvia. Subjects are randomised in a 2:1 ratio. Following initial surgery and radiotherapy with concurrent TMZ, the subjects receive intravenous certepetide or placebo alongside six cycles of adjuvant TMZ treatment. The primary endpoint is overall survival. The target number of subjects is 30. The first subject was recruited in January 2024, and accrual is ongoing.
This study was approved by the Republic of Estonia State Agency of Medicines (17 October 2023) and the State Agency of Medicines of the Republic of Latvia (1 February 2024). The results of this study will be published in peer-reviewed journals and reported at academic conferences.
2023-506813-23-00.
Diets high in ultraprocessed food (UPF) are associated with poor health outcomes and weight gain. Healthcare workers are particularly at risk of consuming diets high in UPF due to erratic work patterns, high stress and limited access to fresh food at work. Despite this, no interventions to date have specifically targeted a reduction in UPF intake in healthcare workers.
This article describes the development and content of a 6-month behavioural support intervention targeting a reduction in UPF intake in UK healthcare workers. The intervention was offered to all participants who took part in the UltraProcessed versus minimally processed Diets following UK dietAry guidance on healTh outcomEs trial—a two-stage study in which Stage 1 was a controlled-feeding crossover randomised controlled trial of provided UPF versus minimally processed food (MPF) diets (published previously) and was completed before the start of Stage 2. Stage 2, reported here, aimed to support participants to reduce their UPF consumption, increase MPF and increase physical activity in real-world settings. The intervention was developed using the behaviour change wheel framework, which systematically links behavioural diagnoses to intervention functions, incorporating the capability, opportunity and motivation model for behaviour change. It included tailored one-to-one and group support sessions, bespoke digital and print resources and a mobile-optimised website. The detailed description is intended to support future replication and adaptation. The acceptability and feasibility of the intervention will be assessed using quantitative and qualitative data in a future paper.
Sheffield Research Ethics Committee approved the trial (22/YH/0281). Findings will be disseminated through peer-reviewed publications, conference presentations and summaries shared with participants and stakeholders.
To identify gait biomechanical characteristics associated with pain and cartilage damage in individuals with patellofemoral joint osteoarthritis (PFJ OA) during a stair descent activity.
Cross-sectional observational study.
University-based motion analysis laboratory and musculoskeletal imaging centre.
83 participants entered the study; 66 participants (41 female, 25 male) completed all components required for this analysis. Participants were recruited via electronic health records following clinical knee MRI. Inclusion criteria included MRI-confirmed patellofemoral cartilage lesions using Whole Organ MRI Score (WORMS) gradings (WORMS >1), pain during stair ambulation, body mass index (BMI) ≤35 and informed consent. Exclusion criteria were tibiofemoral abnormalities (WORMS >1), prior knee trauma, gait-altering conditions, MRI contraindications or pregnancy.
Primary outcomes included knee joint kinematics and during stair descent, assessed during three-dimensional motion capture, patient-reported outcomes from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire and WORMS gradings to assess severity of cartilage abnormalities. Regression analyses were performed to examine correlations of biomechanics, age and BMI with pain and cartilage damage. Analyses were also performed on male and female participants separately.
Significant associations were found between biomechanical characteristics and KOOS scores (pain, symptoms and patellofemoral) as well as cartilage damage. For the whole cohort, greater knee flexion at late stance was linked to worse KOOS scores (β=0.53 to 0.71, p
Altered knee biomechanics during stair descent are linked to worse knee pain, function and cartilage damage in PFJ OA, with sex-specific differences emphasising the need for individualised interventions to address movement abnormalities.
To evaluate clinical nurses' perceptions and acceptability of procedure videos developed to support them during rare clinical procedures. In addition, a secondary aim was to investigate whether these videos reduce anxiety and enhance clinical reasoning.
A descriptive multi-methods study within a pre-post-implementation evaluation design.
Seven locally developed procedure videos (non-invasive ventilation (n = 2), temporary cardiac pacing (n = 3) and pericardiocentesis (n = 2)) were evaluated using questionnaires before and after a 6-month implementation period at a local health district in Australia. Participants self-rated their clinical reasoning skills in response to video procedures, mapped against the Clinical Reasoning cycle stages. The Spielberger State–Trait Anxiety Inventory (STAI) assessed anxiety towards rare procedures. Data from open-ended questions were analysed using inductive content analysis.
A total of 247 participants completed the pre-implementation questionnaire, and 133 completed the post-implementation questionnaire. Before implementation, many reported feeling heightened anxiety when faced with rare or infrequent procedures, reporting levels that exceeded commonly accepted clinical thresholds for concern. Content analysis revealed persistent concerns among participants, including the need for support during new procedures and a fear of making errors. Before implementation, participants reported searching online for videos to support undertaking new procedures. Following implementation, most participants reported that viewing the videos enhanced their learning experience and improved their clinical reasoning. Perceived anxiety towards undertaking rare procedures was not significantly different from post-implementation.
This study highlights the need for timely support during infrequent clinical procedures, as participants reported anxiety about them. It also demonstrates that procedure videos are valued tools for nurses before rare clinical procedures.
Rare procedures are linked to nurse anxiety and mixed emotions, some of which may be eustress. Organisations can enhance clinical resources for nursing staff by providing online videos tailored to local practices and context, which many nurses find helpful for improving clinical reasoning when undertaking rare procedures.
This study highlights the anxiety nurses experience before rare procedures and the significance of incorporating multimedia resources, especially online videos, in nursing professional development for rarely performed procedures. Additionally, it informs employers about nursing staff preferences.
SQUIRE 2.0 reporting was adhered to.
None.
The aim of this research was to describe factors that influence Intensive Care Unit liaison nurses' decision to stand down a medical emergency team call response. The decision to end a medical emergency team response for a deteriorating patient is referred to as the medical emergency team call stand-down decision. Intensive Care Unit liaison nurses, also known internationally as critical care outreach nurses, make medical emergency team call stand-down decisions in complex and challenging clinical environments. However, the factors influencing these decisions are not well described in the literature.
Exploratory descriptive qualitative study.
Seven Intensive Care Unit liaison nurses who attended medical emergency team calls in a large acute metropolitan tertiary referral public hospital, with a mature three-tiered rapid response system, were observed and interviewed. Observations of 50 medical emergency team call responses and 50 post medical emergency team call interviews were conducted between March 2022 and August 2022. Findings were analysed using inductive content analysis.
Intensive Care Unit liaison nurse decisions to stand down MET call responses were influenced by three intrinsic factors: (1) propositional knowledge, (2) experiential knowledge, (3) situational knowledge and information processing styles. Intensive Care Unit liaison nurses utilised these intrinsic factors to support their decision to terminate medical emergency team call response.
This study explored the intrinsic influences on individual Intensive Care Unit liaison nurses in deciding to end a medical emergency team call. By highlighting these individual influences on decision-making, the findings may be used to support medical emergency team responders educational needs and identification of potential heuristics and biases inherent in clinical decision-making which contribute to adverse events.
No patient or public contribution.
By understanding the influences on an individual's clinical decision-making, strategies can be put in place for educational development and support for experiential learning. The study highlights areas of potential bias and heuristic use that may lead to sub-optimal clinical decisions and increased risk for deteriorating patients. Research findings can be applied internationally to a range of rapid response systems and critical care outreach teams that respond to deteriorating patients.
The consolidated criteria for reporting qualitative research (COREQ) guidelines were used for reporting this study.
Acute intracerebral haemorrhage (ICH) is devastating with a 1 month mortality rate of ~40%. Cerebral oedema can complicate acute ICH and is associated with poor outcome. In patients with large ICH, the accompanying swelling increases mass effect and causes brain herniation. Mannitol, an osmotic diuretic, is used to treat cerebral oedema after traumatic brain injury, but its safety and efficacy in ICH is unclear. We aim to assess the feasibility of a phase II randomised, controlled trial of mannitol in patients with ICH with, or at risk of, cerebral oedema to inform a definitive trial.
The mannitol for cerebral oedema after acute intracerebral haemorrhage trial (MACE-ICH) aims to include 45 ICH participants from 10 UK sites with estimated largest diameter of haematoma volume >2 cm, presenting within 72 hours of onset with, or at risk of, cerebral oedema (limited Glasgow Coma Scale (GCS)8) with or without mass effect. Participants will be randomised (1:1:1) to 1 g/kg 10% single-dose intravenous mannitol, 1 g/kg 10% mannitol followed by a second dose at 24 hours, or standard care alone. Outcome assessors will be masked to treatment allocation. Feasibility outcomes include proportion of patients approached being randomised, participants receiving allocated treatment, recruitment rate, treatment adherence and follow-up. Secondary outcomes include serum electrolytes and osmolality at days 1–2; change in ICH and oedema volume at day 5; number of participants who developed urinary tract infection, GCS and National Institutes of Health Stroke Scale at day 5±2; length of hospital stay, discharge destination and death up to day 28; death and death or dependency by day 180 and disability (Barthel Index), quality of life (EuroQol, 5-D) and cognition (telephone mini-mental state examination) at day 180.
MACE-ICH received ethics approval from the East Midlands-Leicester Central research ethics committee (22/EM/0242). The trial is funded by a National Institute for Health and Care Research RfPB grant (203080). The results will be published in an academic journal and disseminated through academic conferences and patient support groups. Reporting will be in line with Consolidated Standards of Reporting Trials recommendations.
ISRCTN15383301; EUDRACT 2022-000283-22.
Acknowledging equality, diversity and inclusion (EDI) in research is not only a moral imperative but also an important step in avoiding bias and ensuring generalisability of results. This protocol describes the development of STAndards for ReporTing EDI (START-EDI) in research, which will provide a set of minimum standards to help researchers improve their consistency, completeness and transparency in EDI reporting. We anticipate that these guidelines will benefit authors, reviewers, editors, funding organisations, healthcare providers, patients and the public.
To create START-EDI reporting guidelines, the following five stages are proposed: (i) establish a diverse, multidisciplinary Steering Committee that will lead and coordinate guideline development; (ii) a systematic review to identify the essential principles and methodological approaches for EDI to generate preliminary checklist items; (iii) conduct an international Delphi process to reach a consensus on the checklist items; (iv) finalise the reporting guidelines and create a separate explanation and elaboration document; and (v) broad dissemination and implementation of START-EDI guidelines. We will work with patient and public involvement representatives and under-served groups in research throughout the project stages.
The study has received ethical approval from the Imperial College London Research Ethics Committee (study ID: 7592283). The reporting guidelines will be published in open access peer-reviewed publications and presented in international conferences, and disseminated through community networks and forums.
The project is pre-registered within the Open Science Framework (https://osf.io/8udbq/) and the Enhancing the Quality and Transparency of Health Research Network.
FreshRSS 