To compare HIV testing coverage, prevalence and care cascade engagement between fisherfolk and the general population, and to assess the relevance of individual and community-level definitions of fisherfolk in understanding variation in HIV status and testing.

Primary data collection and cross-sectional analysis in 1 year of the SchistoTrack community-based cohort.

52 shoreline villages in Pakwach, Buliisa and Mayuge districts in rural Uganda.

A total of 3197 individuals aged 5–92 years were tested for HIV in 2024. A subset of 124 HIV-positive participants had viral load measured in 2025. Statistical analyses focused on 1931 adults aged 15 years and older.

The primary outcomes were lifetime HIV testing, testing in the past 12 months and current HIV status. Secondary measures included self-reported care cascade outcomes and viral load suppression.

Overall, 6.94% (134/1931) of adult participants aged 15 years and older were with HIV (people with HIV (PWH)), of whom 22.39% (30/134) were newly diagnosed. 6% (25/415) of adults reporting fishing activities were HIV-positive. Of those, 80% (20/25) were status-aware, 76% (19/25) were on antiretroviral therapy, and 100% (8/8) of those who knew their viral load reported viral suppression. No significant differences in care cascade engagement were found between PWH reporting fishing activities and the general population. Measured viral suppression was 70.59% (72/102) among PWH with no significant differences by fishing activities. Fishing activities were significantly associated with higher odds of ever testing for HIV (OR 1.76 (95% CI 1.22 to 2.54)), but not with testing in the past 12 months or HIV status. No consistent district-level differences were observed.

Individuals reporting fishing activities had higher lifetime testing and comparable HIV prevalence and care cascade engagement to the general population. Gaps remain in recent testing, status awareness and viral suppression for fisherfolk.

Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.

The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.

The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.

NCT06714630.

Glaucoma is the leading cause of irreversible blindness worldwide and the number of people with glaucoma is expected to increase to more than 112 million by the year 2040, making it a disease of public health interest. However, there is no consensus on public health indicators to monitor glaucoma care coverage. This scoping review aims to summarise published indicators for monitoring effective glaucoma care coverage globally, focusing on care needs, use of care services and outcomes achieved.

We will include studies that report the development and use of public health indicators for effective glaucoma care coverage in patients aged 18 years and older. Studies published from 1 January 2000, in all languages, will be included, provided they can be accurately and easily translated into English using Google Translate. Searches will be conducted by an information specialist on MEDLINE, Embase, Global Health and CENTRAL in the Cochrane Library. Two reviewers working independently will screen the search results, select studies for inclusion and extract data; any disagreements will be discussed with or resolved by a third reviewer. Data will be presented in tabular form, followed by a narrative synthesis based on the review objectives.

Ethical approval is not required as the review will use published data. Results will be published in a peer-reviewed journal, and summarised results will be available and contribute to the development of standardised glaucoma care indicators.

OSF registration on 19 May 2025: https://osf.io/zsyw9/

The COVID-19 pandemic accelerated telehealth adoption, offering remote consultations via phone and video. Allied health services are one part of the healthcare system where telehealth, in specific teleconsultations, has been applied and has shown promising results in improving healthcare access by breaking down financial, logistical and geographic barriers. However, more insight is needed into the consumer’s perspective. A consumer is anyone who has used, currently uses or will use telehealth for allied health services. Therefore, this study explores consumer experiences and preferences, identifying barriers and facilitators to telehealth for allied health services.

This qualitative study used focus group discussions to evaluate consumers’ experiences with telehealth for allied health services. Allied health was defined as healthcare professionals distinct from medical, dental and nursing fields. Eight focus groups with 57 participants were conducted. The participants were recruited from the general public as well as seldom represented communities such as a support service focused on improving and maintaining members’ mental health, the deaf and hard-of-hearing community, young disabled people and the Pacific Islander community. An inductive thematic analysis was used to analyse the data.

Five main themes were identified. First, the consumer with their individual characteristics and context played a major role in the suitability of telehealth. Second, the allied health practitioner and their skills influenced the quality and therefore the success of remote consultations. Further, the relationship between consumer and practitioner contributed to the success of telehealth. The appointment itself was equally often discussed. While telehealth improved access to care, remote appointments were seen as more suitable for questions and verbal exchanges. Lastly, the technology was an important factor with the availability of necessary technology and the accessibility of it playing a central role.

The findings reinforce existing research while highlighting new insights from often under-represented groups, emphasising the importance of telehealth choice, accessible technology and quality standards.

Nasogastric tubes (NGTs) are standard practice in the management of adhesive small bowel obstruction (ASBO). Their insertion can be associated with significant patient discomfort and complications. Current research suggests that patients with ASBO managed with NGTs may experience poorer outcomes and higher rates of operative intervention compared with those managed without. However, to date, there are no prospective clinical trials evaluating this.

This study will be designed as a single centre, prospective, non-inferiority randomised controlled trial to determine if the avoidance of an NGT is non-inferior to its use in ASBO. Patients meeting inclusion criteria will be randomised to either receive an NGT or no NGT for ASBO management. The primary outcome will be the rate of operative intervention as determined by review of medical records at day 30 post discharge. Secondary outcomes will include rate of bowel resection or bowel ischaemia, length of hospital and intensive care unit (ICU) stay, time to operative intervention, rate of ICU admission, incidence of postoperative complications (Clavien-Dindo classification), quality of life scores (European Quality of Life 5 Dimension 5 Level: EQ-5D-5L) at admission, day 30 and day 90, 90-day mortality, incidence of pulmonary complications (Melbourne Group Scale), rate of NGT specific complications and rate of Gastrografin use. The study will be powered at 80% to detect a clinically relevant difference of 10% between groups receiving an NGT compared with no NGT, requiring a total of 490 study participants. Statistical analysis will follow intention to treat principles. Differences between treatment arms will be summarised using mean differences, 95% CIs and p values.

This study has been approved by the Hunter New England Human Research Ethics Committee (2023/ETH00296). Results will be disseminated through peer-reviewed publication and conference presentations.

This study has been registered prospectively in the Australia and New Zealand Clinical Trials Registry (ACTRN12623000341628).

Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.

Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.

Ten hospitals across four Canadian provinces.

Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.

The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.

Domain-specific recruitment rates and protocol adherence.

During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).

The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.

NCT05893147.

This study aimed to evaluate the feasibility of delivering a vocational rehabilitation intervention (Return to Work After Trauma—ROWTATE), remotely to individuals recovering from traumatic injuries. The primary objectives were to assess therapists’ training and competence, adapt the intervention and training for remote delivery and assess the feasibility and fidelity of remote delivery to inform a definitive randomised controlled trial.

A mixed-methods feasibility study incorporating (1) telerehabilitation qualitative literature review, (2) qualitative interviews preintervention and postintervention with therapists and patients, (3) a team objective structured clinical examination to assess competency, (4) usefulness of training, attitudes towards (15-item Evidence-Based Practice Attitude Scale) and confidence in (4-item Evidence Based Practice Confidence Scale) evidence-based practice, intervention delivery confidence (8-bespoke questions) and intervention behaviour determinants (51-items Theoretical Domains Framework) and (5) single-arm intervention delivery feasibility study.

The study was conducted in two UK Major Trauma Centres. The intervention and training were adapted for remote delivery due to the COVID-19 pandemic.

Therapists: Seven occupational therapists (OTs) and clinical psychologists (CPs) were trained, and six participated in competency assessment. Seven OTs and CPs participated in preintervention interviews and surveys; six completed post-intervention interviews and four completed post-training surveys. Patients: 10 patients were enrolled in the single-arm feasibility study and 4 of these participated in postintervention qualitative interviews. Inclusion criteria included therapists involved in vocational rehabilitation delivery and patients admitted to major trauma centres. Exclusion criteria included participation in other vocational rehabilitation trials or those who had returned to work or education for at least 80% of preinjury hours. Intervention: The ROWTATE vocational rehabilitation intervention was delivered remotely by trained OTs and CPs. Training included competency assessments, mentoring and adaptation for telerehabilitation. The intervention was delivered over multiple sessions, with content tailored to individual patient needs.

Therapists found the training useful, reported positive attitudes (Evidence-Based Practice Attitude Scale mean=2.9 (SD 0.9)) and high levels of confidence in delivering evidence-based practice (range 75%–100%) and the ROWTATE intervention (range 80%–100%). Intervention barriers identified pretraining became facilitators post-training. Half the therapists needed additional support post-training through mentoring or additional training. The intervention and training were successfully adapted for remote delivery. High levels of fidelity (intervention components delivered: OTs=84.5%, CPs=92.9%) and session attendance rates were found (median: OT=97%, CP=100%). Virtually all sessions were delivered remotely (OT=98%, CP=100%). The intervention was acceptable to patients and therapists; both considered face-to-face delivery where necessary was important.

The ROWTATE intervention was delivered remotely with high fidelity and attendance and was acceptable to patients and therapists. Definitive trial key changes include modifying therapist training, competency assessment, face-to-face intervention delivery where necessary and addressing lower fidelity intervention components.

ISRCTN74668529.

People experiencing severe and multiple disadvantage (SMD: homelessness, substance use and criminal offending) have multiple intersecting unmet health and social care needs and high mortality rates, often due to street-drug overdose. Pilot randomised controlled trials (RCTs) suggest an integrated, holistic, collaborative outreach intervention (Pharmacy Homeless Outreach Engagement Non-medical Independent Prescribing Rx (PHOENIx)) involving generalist-trained pharmacists, nurses or General Practitioners accompanied by staff from third sector homeless organisations may improve outcomes, including reducing overdose.

Multicentre, parallel group, prospective RCT with parallel economic and process evaluation. Set in six areas of Scotland, UK, 378 adults with SMD will be recruited and randomised (stratified by setting and previous non-fatal overdoses) to PHOENIx intervention in addition to usual care (UC) or UC. Aiming to meet participants weekly for 9–15 months, PHOENIx teams assess and address health and social care needs while referring onwards as necessary, co-ordinating care with wider health and third sector teams. During a person-centred consultation, in the participants’ choice of venue, and taking account of the participant’s priorities, the NHS clinician may prescribe, de-prescribe and treat, for example, wound care, and refer to other health services as necessary. The third sector worker may help with welfare benefit applications, social prescribing or advocacy, for example, securing stable housing. Pairings of clinicians and third sector workers support the same participants. The primary outcome is time to first fatal/non-fatal street-drug overdose at nine months. Secondary endpoints include health-related quality of life, healthcare use and criminal justice encounters. A health economic evaluation will assess cost per quality adjusted life year of PHOENIx relative to standard care. A parallel qualitative process evaluation will explore the perceptions and experiences of PHOENIx, by participants, stakeholders and PHOENIx staff.

The primary and other time-to-event secondary outcomes will be analysed by Cox proportional hazards regression.

IRAS number 345246, approved 23/10/2024 by North of Scotland Research Ethics Service. Results will be shared with participants, third sector homelessness organisations, health and social care partnerships, then peer-reviewed journals and conferences worldwide, from the first quarter of 2027.

ISRCTN12234059 registered on 20/2/2025 (ISRCTN).

Growing evidence points towards the integral role of both central and peripheral inflammation across all neurodegenerative diseases, including dementia with Lewy bodies (DLB) and Alzheimer’s disease (AD). The immune alterations observed in these diseases may occur long before the onset of clinical and cognitive symptoms; however, the exact timing and role of inflammation in the pathogenesis of neurodegenerative disease remains unclear. Findings to date are conflicting, with most work focused on AD rather than other dementias and most studies from single sites and cross-sectional. Through longitudinally examining detailed phenotypes of the peripheral immune system using mass cytometry, the Immune Profiling in Early Cognitive Disorders study aims to uncover specific immune signatures in early AD and DLB, how these signatures change over time and how they relate to disease progression and cognitive changes.

Blood, cerebrospinal fluid, saliva and urine samples will be collected from a cohort of participants with either prodromal (mild cognitive impairment) or early dementia due to Lewy bodies or AD (MCI-LB and DLB; and MCI-AD and AD), alongside healthy controls. Through immunophenotyping with mass cytometry, detailed immune fingerprints will be identified for these groups. We will assess which key combinations of immune cell clusters are predictive of disease phenotype, cognitive decline and progression to dementia. Samples will also be evaluated with novel techniques to measure markers of degenerative pathology and inflammation.

This study was approved by the Preston North West Research Ethics committee (21/NW/0314) and is registered with the ISRCTN registry (ISRCTN62392656). The study is ongoing (since June 2022). Baseline visits are being undertaken, and follow-up visits have started for some participants. Full data analyses will be completed and submitted for publication upon conclusion of the study.

Early childhood—specifically, the period from 0 to 6 years of age—is a critical time in children’s lives with rapid growth in their cognitive, social and emotional development. This period has also been shown to be the most effective time for early interventions. The use of artificial Intelligence (AI) for supporting early child development is increasing alongside the rapid advancement of technology. AI can be used directly by children (eg, for implementing adaptive technologies), by individuals who interact with children (eg, educators, parents, nurses), and by individuals indirectly supporting early child development (eg, early childhood researchers or policy analysts). This scoping review will provide a roadmap for relevant stakeholders on how AI has been applied within and across different contexts to support infants and young children’s development, as well as the most predominant AI technologies used across various contexts.

The current study follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review The search syntax will be applied in PsycINFO, ERIC, Education Source, CINHAL, MEDLINE, Embase and IEEE Xplore. The purpose of this study is to curate and synthesise academic papers to examine the application of AI for supporting the development of children between birth and age 6 years of age. Studies with children or individuals who work directly or indirectly with children will be included. Part of the abstract and full-text screening will be conducted by two researchers, with discrepancies being resolved by the lead authors. In addition, AI will be used to help with study screening and data extraction once confirmed to be reliable (Cohen’s kappa >0.80). Thematic and content analyses will be conducted to identify the types of AI products used and their applications in different contexts, the most predominant AI products used within and across each context, as well as how children’s developmental outcomes are impacted by the use of these AI products. Where applicable, visualisations such as tables, graphs and figures will be used to synthesise the data across contexts and AI products used to support early development of young children.

Forcibly displaced children and adolescents in the WHO European Region have high mental health needs, yet few manage to access mental health services and even fewer receive high-quality care. Addressing this gap is crucial, as inadequate mental health support has profound and lasting negative effects on individuals, families and communities. This scoping review aims to identify and synthesise the available evidence on the barriers and facilitators to quality mental healthcare for forcibly displaced children and adolescents in the WHO European Region.

Quantitative, qualitative and mixed-method studies that examine barriers and facilitators of quality mental healthcare for forcibly displaced children and adolescents in the WHO European Region will be included. Eligible participants include forcibly displaced children and adolescents, mental healthcare providers, policymakers and humanitarian actors in the mental health and psychosocial support field. We will adhere to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews) guidelines. A comprehensive search of databases, including Embase, Medline, PsycINFO, Scopus and Web of Science, will be conducted. We will systematically search for relevant studies published between January 2004 and December 2024. At least two reviewers will independently screen titles, abstracts and full texts. Data extraction will involve systematically charting relevant information from included studies. We will use the WHO Quality Standards for Child and Adolescent Mental Health Services as an analytical lens to map the evidence. Our study will provide a comprehensive overview of the barriers and facilitators to quality mental healthcare for forcibly displaced children and adolescents, and identify knowledge gaps and areas for potential quality improvement.

Ethical approval will not be required since this study will retrieve data from already published research and no new data will be collected. The results of this study will be published in a peer-reviewed journal and presented at international conferences in order to disseminate to academic and non-academic stakeholders such as non-governmental organisations, government bodies and community organisations involved in mental healthcare for forcibly displaced persons.

https://doi.org/10.17605/OSF.IO/AK74F.

Adolescents and young adults (AYAs) in low- and middle-income countries (LMICs) are at high risk of harmful sexual and reproductive health (SRH) practices due to limited knowledge, low availability or acceptability of modern contraceptives, gender inequality and cultural practices like child marriage. Preventive and educational interventions by lay health workers or through technological means are a cost-effective and scalable solution. Unfortunately, too little is currently known about the scope, content and conditions of the effectiveness and sustainability of these approaches and synthetic evidence on this topic is scarce. To help fill this knowledge gap and to identify where further research is needed, we will conduct a scoping review of technology-based or lay health-worker delivered preventive and educational SRH interventions targeting AYAs in LMICs. This information is valuable to both policymakers and researchers as it provides a synthesis of existing interventions, highlights best practices for their implementation and identifies potential avenues for future research.

This review will include studies on SRH preventive and educational interventions targeting AYAs aged 10–24 years in LMICs. It encompasses interventions delivered by lay health workers or via technological means, assessing various outcomes including but not limited to SRH literacy, sexual risk behaviours, pregnancies, sexually transmitted infections and gender-based violence. Key databases, including PubMed via MEDLINE and Embase, will be searched from 1 January 2000 up to 23 January 2024, using a comprehensive search strategy. Screening will be conducted using Covidence software. Data extraction will cover study details, methods, intervention strategies, outcomes and findings. A narrative synthesis will be conducted following synthesis without meta-analysis guidelines.

The scope of this scoping review is limited to publicly accessible databases that do not require prior ethical approval for access. The findings will be disseminated through peer-reviewed journal publications, as well as presentations at national and international conferences and stakeholder meetings in LMICs.

The final protocol is prospectively registered with the Open Science Framework on 7 May 2024 (osf.io/vna2z).

People living with multiple long-term conditions (MLTC) admitted to hospital have worse outcomes and report lower satisfaction with care. Understanding how people living with MLTC admitted to the hospital are cared for is a key step in redesigning systems to better meet their needs. This scoping review aimed to identify existing evidence regarding clinical decision-making and care pathways for people with MLTC admitted to the hospital. In addition, we described research methods used to investigate hospital care for people living with MLTC.

A scoping review methodological framework formed the basis of this review. We took a narrative approach to describe our study findings.

A search of Medline, Embase and PsycInfo electronic databases in July 2024 captured relevant literature published from 1996 to 2024.

Studies that explored care pathways and clinical decision-making for people living with MLTC or co-morbidities, studies conducted fully or primarily in secondary or tertiary care published in English Language and with full text available.

Titles and abstracts were independently screened by two authors. Extracted data included country of origin, aims, study design, any use of an analytical framework or design, type of analyses performed, setting, participant group, number of participants included, health condition(s) studied and main findings. Included studies were categorised as either: studies reviewing existing literature, studies reviewing guidance, studies utilising qualitative methods or ‘other’.

A total of 521 articles were screened, 17 of which met the inclusion criteria. We identified a range of investigative methods. Eight studies used qualitative methods (interviews or focus groups), four were guideline reviews, four were literature reviews and one was classified as ‘other’. Often, researchers choose to combine methods, gathering evidence both empirically and from reviews of existing evidence or guidelines. However, none of the empirical qualitative studies directly or solely investigated clinical decision-making when treating people living with MLTC in acute care and the emergency department. Studies identified complexities in care for people living with MLTC, and some authors attempted to make their own recommendations or draft their own guidance to counter these.

This scoping review highlights the limitations of the current evidence base, which, while diverse in methods, provides sparse insights into clinical decision-making and care pathways for people living with MLTC admitted to hospital. Further research is recommended, including reviews of guidelines and gathering insights from both healthcare professionals and people living with MLTC.

Elder neglect by both informal and formal caregivers is common, particularly among persons with dementia, and has serious health consequences but is under-recognised and under-reported. Persons with dementia are often unable to report neglect due to memory and language impairments, increasing their vulnerability. Screening for elder mistreatment and initiation of intervention in primary care clinics may be helpful, but few evidence-based tools or strategies exist. We plan to: (1) develop a novel primary care screening tool to identify elder neglect in persons with dementia, (2) develop an innovative technology-driven intervention for caregivers and (3) pilot both for feasibility and acceptability in primary care.

We will use a multistep process to develop a screening tool, including a modified Delphi approach with experts, and multivariable analysis comparing confirmed cases of neglect in patients with dementia from the existing data registry to non-neglected controls. We will develop an evidence-based, technology-driven caregiving intervention for neglect with an expert panel and iterative beta testing. Following the development of the protocol for implementation of the tool and intervention with associated training, we will pilot test both the tool and intervention in older adult patients and caregivers. We will conduct provider focus groups and interviews with patients and caregivers to assess usability and will modify the tool and intervention. These studies are in preparation for a future randomised trial.

Initial phases of this project have been reviewed and approved by the Weill Cornell Medicine Institutional Review Board, protocol #22-06024967, with initial approval on 1 July 2022. We aim to disseminate our results in peer-reviewed journals, at national and international conferences and among interested patient groups and the public.

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.