Encephalitis is brain parenchyma inflammation, frequently resulting in seizures which worsens outcomes. Early anti-seizure medication could improve outcomes but requires identifying patients at greatest risk of acute seizures. The SEIZURE (SEIZUre Risk in Encephalitis) score was developed in UK cohorts to stratify patients by acute seizure risk. A ‘basic score’ used Glasgow Coma Scale (GCS), fever and age; the ‘advanced score’ added aetiology. This study aimed to evaluate the score internationally to determine its global applicability.

Patients were retrospectively analysed regionally, and by country, in this international evaluation study. Univariate analysis was conducted between patients who did and did not have inpatient seizures, followed by multivariable logistic regression, hierarchical clustering and analysis of the area under the receiver operating curves (AUROC) with 95% CIs.

2032 patients across 13 countries were identified, among whom 1324 were included in SEIZURE score calculations and 970 were included in regression modelling. The involved countries comprised 19 organisations spanning all WHO regions.

The primary outcome was measuring inpatient seizure rates.

Autoantibody-associated encephalitis, low GCS and presenting with a seizure were frequently associated with inpatient seizures; fever showed no association. Globally, the score had limited discriminatory ability (basic AUROC 0.58 (95% CI 0.55 to 0.62), advanced AUROC 0.63 (95% CI 0.60 to 0.66)). The scoring system performed acceptably in western Europe, excluding Spain, with the best performance in Portugal (basic AUROC 0.82 (95% CI 0.69 to 0.94), advanced AUROC 0.83 (95% CI 0.72 to 0.95)).

The SEIZURE score performed best in several countries in Western Europe but performed poorly elsewhere, partly due to differing and unknown aetiologies. In most regions, the score did not reach a threshold to be clinically useful. The Western European results could aid in designing clinical trials assessing primary anti-seizure prophylaxis in encephalitis following further prospective trials. Beyond Western Europe, there is a need for tailored, localised scoring systems and future large-scale prospective studies with optimised aetiological testing to accurately identify high-risk patients.

The Core Outcome Measures for Improving Dementia Care (COM-IC) project aims to develop a core outcome set for measuring the quality of care provided to people living with dementia in routine care settings. In a previous stage of the project, 17 core outcomes were identified. This study is the next step, aiming to review the literature to identify existing or recommended, validated scales for measuring the identified core outcomes.

A rapid review

Six electronic databases (PubMed, Embase (Elsevier), CINAHL Complete (EBSCOhost), APA PsycINFO (EBSCOhost), Web of Science (Clarivate) and Scopus (Elsevier) were searched. Searches were completed on 12 July 2024.

Peer-reviewed systematic reviews or original validation studies of scales measuring dignity; engagement in advance care planning; pain; quality of life; feeling safe and secure; emotional well-being; diagnosis of dementia; behavioural and psychological symptoms of dementia; the importance of relationships; meaningful activities; hygiene and comfort; resource utilisation and safety incidents for people living with dementia were included. Peer-reviewed systematic reviews or original validation studies of the scales to measure informal carers’ quality of life, their educational opportunities, formal carers’ morale and dementia-specific qualifications were also included. All studies were required to have been conducted among people living with dementia or carers, as appropriate, and to have full texts available in English.

Data on the scale’s name, the number of subscales, subscales’ names, the number of items, response options, scoring, estimated time to complete the scale, recommended frequency of data collection and the setting where the scale was first validated were extracted. Findings are presented in figures, tables and narrative texts.

A total of 88 validated scales were identified. No scales measuring dignity, engagement in advance care planning, feeling safe and secure, hygiene or safety incidents were validated for people living with dementia. No scale was identified to measure the importance of relationships for people living with dementia, the formal carers’ dementia-specific qualifications or the educational opportunities for informal carers. The review also describes the 50 recommended or validated scales.

Several validated or recommended scales exist to measure core outcomes identified as important for assessing the quality of care provided to people living with dementia in routine care settings. This review offers COM-IC stakeholders and other potential users with information on the validated/recommended scales to measure these core outcomes.

A successful extubation process is critical for the future health outcomes of paediatric patients, as it tests the functioning of the respiratory system without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety or discomfort in patients, which may sometimes lead to an increased likelihood of reintubation. Music-based interventions and therapies have been shown to be effective in reducing anxiety and stress levels in ventilated patients in the paediatric intensive care unit (PICU), but studies evaluating the effect of music therapy during the extubation process in the PICU are scarce.

This is a pragmatic multicentre randomised clinical trial with two parallel arms. The intervention group will receive standard care + music therapy during the extubation process, and the control group will receive standard care alone. The main outcome measure is heart rate, which will be measured every minute for 5 min pre-extubation, during the extubation process and up to 10 min postextubation. Secondary outcome measures are: oxygen saturation, respiratory rate, blood pressure and heart rate variability. A total of 82 patients will be randomised.

This study was approved by the Research Ethics Committee of the Fundación Universitaria Sanitas (CEIFUS 1356-24, date of approval: 3 May 2024). All parents or legal guardians of patients will sign a written informed consent, and if applicable, assent from participants will be sought. The results will be disseminated through publications in peer-reviewed journals, conferences and presentations at the hospitals’ clinical committees.

Version 1.0, 18 December 2024.

NCT06591533, trial registration date: 10 September 2024.

Our objective was to examine the barriers and facilitators encountered by primary and secondary healthcare professionals when collaborating at the care continuum between primary and secondary care. We aimed to identify specific challenges, observed benefits and proposed changes. By analysing these experiences and identifying opportunities for redesign, we aimed to define specific domains that could improve collaboration, thereby supporting sustainable access to and quality of care in the face of rising demand and constrained resources.

A qualitative exploratory study using semi-structured interview data guided by two domains of the Consolidated Framework for Implementation Research (CFIR), including Inner Setting—Tension for Change and Individual Characteristics, as well as selected implementation outcomes defined by Proctor et al, all viewed through a service (re)design lens.

Consultation and communication between primary and secondary healthcare professionals in a Dutch urbanised area.

37 users of collaboration services (eg, telephone, correspondence) were interviewed between August 2021 and October 2022, including 14 general practitioners (GPs) (10 females, 4 males) and 23 specialists (10 females, 13 males).

Four key domains with subthemes, subdivided per operation and CFIR domain, were identified as central to optimising the collaboration of professionals within the primary-secondary care continuum: (1) software and record integration; (2) seamless personal interaction; (3) eliminating a sense of ‘us vs them’ and (4) gaps in continuity of care.

This study reveals that healthcare professionals in both primary and secondary care face similar collaboration challenges due to system-level issues and inadequate collaboration tools, leading to increased workload, miscommunication and reduced quality of care. Improving collaboration between GPs and specialists requires not only adjustments to individual services, but a comprehensive overhaul of the referral and back-referral process. A more integrated approach, addressing key domains, is crucial for enhancing care quality, streamlining workflows and improving health outcomes.

To estimate condition-specific patient travel distances and associated carbon emissions across common chronic diseases in routine National Health Service (NHS) care, and to assess the potential carbon savings of modal shifts in transportation.

Retrospective population-based cohort study.

NHS Greater Glasgow and Clyde, Scotland.

6599 patients aged 50–55 years at diagnosis, including cardiovascular disease (n=1711), epilepsy (n=1044), cancer (n=716), rheumatoid arthritis (RA; n=172) and a matched control group based on age, sex and area-level deprivation (n=2956).

Annual home-to-clinic distances and associated carbon emissions modelled under four transport modes (petrol car, electric car, bus, train) across five time points: 2-year prediagnosis, diagnosis year and 2-year postdiagnosis.

Mean annual travel distances to hospital varied by condition and peaked at diagnosis. Patients with cancer had the highest travel distances (161 km/patient/year for men; 139 km/patient/year for women), followed by RA (approximately 78 km/patient/year). The matched control group travelled 2/patient/year to 8.0 kg CO₂/patient/year. Bus travel resulted in intermediate emissions, estimated between 10.5 and 8.0 kg CO₂/patient. When travel was modelled using electric vehicles, emissions dropped between 3.5 and 2.7 kg for all conditions. Train travel produced similarly low emissions. Reducing petrol car travel from 100% to 60% lowered emissions up to 6.6 kg CO₂/patient.

Condition-specific estimates of healthcare-related travel emissions provide baseline understanding of the opportunities and challenges for decarbonising healthcare. Emission reduction is most achievable through modal shift, yet such shifts depend on factors beyond NHS control—such as transport infrastructure, digital access and social equity. Multisectoral strategies, including targeted telemedicine and integrated transport and urban planning, are critical to achieving net-zero healthcare while maintaining equitable access to care.

Several antibiotic stewardship interventions have been proven effective and safe for reducing the high number of antibiotic prescriptions in late preterm and term neonates at risk of early-onset sepsis (EOS). For successful translation of EOS interventions to clinical practice, implementation strategies should be employed targeting stakeholders. The primary aim of this study is to assess the impact of implementing an antibiotic stewardship bundle, including the EOS calculator, procalcitonin-guided therapy and intravenous-to-oral switch therapy on antibiotic exposure for EOS in Dutch secondary hospitals. Secondary aims are to examine additional clinical outcomes and implementation outcomes.

We will conduct a multicentre, prospective implementation study with interrupted time series and before-after analyses at the paediatric or specialised neonatal departments of 11 Dutch secondary hospitals and their surrounding neonatal care networks. A multimodal implementation strategy, designed using Implementation Mapping, is employed to facilitate implementation. The study population is twofold: (1) neonates born at 34 weeks of gestation or later with suspected EOS that will receive intervention-related care and (2) paediatricians, paediatric residents, neonatal nurses, maternity nurses and parents who are the focus of the implementation strategies. The primary outcome is days of antibiotic therapy per 1000 live-born neonates, which will be evaluated using interrupted time series analysis as well as before-after comparison. Secondary clinical outcomes will be assessed by comparing clinical data from the 12 months pre-implementation and post implementation. Implementation outcomes are adoption, fidelity, feasibility and acceptability of the interventions and fidelity and appropriateness of the implementation strategies. Implementation outcomes will be assessed using both qualitative and quantitative methods, including surveys, individual interviews and focus group interviews. A mixed-methods approach will be used to integrate clinical and implementation outcomes.

The Medical Ethics Committee United (MEC-U) declared (reference: W24.132) that this study does not fall under the Dutch Medical Research Involving Human Subjects Act (WMO). Subsequently, ethical approval was granted by the Scientific Committee of the Franciscus Hospital (T110). The scientific committees of all participating sites adopted this decision and granted permission for local conduct of the study. As electronic health record data are sampled retrospectively and anonymously, a waiver of consent was given to collect these data. Informed consent will be obtained from participants completing surveys or taking part in interviews and focus group discussions. The findings will be disseminated through journal publications and conference presentations. Furthermore, practice and policy recommendations will be collaboratively developed with partner organisations.

NCT06845332.

International pilot projects focusing on next-generation sequencing in newborn screening (NBS), that is, genomic NBS (gNBS), have been established thanks to continuous therapeutic progress and the massive development of new genetic technologies with rapidly decreasing costs. Given the highly encouraging results of the French SeDeN project regarding anticipated acceptability among professionals and parents, it is now appropriate to launch a similar pilot project in France, in collaboration with other international initiatives under the International Consortium on Newborn Sequencing framework.

PERIGENOMED is a large-scale project designed to provide the first concrete evidence on the relevance of gNBS in France. It includes two clinical trials. We present here the design chosen for the first clinical trial (PERIGENOMED-CLINICS 1). PERIGENOMED-CLINICS 1 aims to assess the feasibility, real-world acceptability, psychosocial impact and organisational pathways of panel-based genomic newborn screening in France, involving 2500 participants. Solo-GS targeting two lists of gene–disease dyads responsible for treatable (list 1; 400 genes, 171 diseases/group of diseases) or actionable (list 2 optional; 407 genes, 218 diseases/group of diseases) rare and severe early-onset diseases will be proposed in five health institutions. Ancillary social and impact studies will also be included.

All study procedures have been reviewed and approved by relevant French ethics committees and regulatory authorities (CPP Est II-2024-A02224-43, 1 January 2025). Results of the project will be disseminated through peer-reviewed publications, national and international conferences, and public engagement initiatives, in coordination with stakeholders.

NCT06875089.

Sexual and reproductive health (SRH) for adolescents is a global public health concern. Access to SRH information and services regarding contraception is necessary, particularly in underserved regions, such as the French overseas territories of Reunion Island and Guadeloupe, where indicators for teenage pregnancy and abortion are significantly high. This study protocol describes the methodology to be used to assess the feasibility of a peer-led contraception education programme for high school students using social media.

A multicentre, exploratory sequential mixed-methods with a pre-post design, prospective study is being conducted in Guadeloupe and on Reunion Island. The qualitative component started on 31 May 2025, and the study will continue until 30 June 2026. Participants will be aged 15 to 19 years and will attend high school. In Phase 1, focus groups will explore the adolescents’ perceptions of peer influencers in contraceptive education and their suggestions for organising a prevention programme on social media. These findings will directly inform the intervention in Phase 3. At this stage of this phase, peer influencers will also be identified. Phase 2 will train selected peer educators in SHR, digital content creation to prepare them for intervention design and delivery. Phase 3 consists of the co-construction, implementation and evaluation of the intervention. Outcomes will include feasibility, acceptability, adoption, fidelity and exploratory effectiveness. The primary outcome will be peer engagement defined as the completion of at least 70% of the planned educational tasks.

This study has received ethical approval from the Comité de Protection des Personnes under RIPH3 (ID-RCB: 2025-A00358-41) and will follow the French ethical standards for low-intervention research. Results will be shared in scientific publications and with participating schools.

NCT06943209.

Intrapartum-related complications are a leading cause of adverse perinatal outcomes, including stillbirths, neonatal deaths and intrapartum-related neonatal encephalopathy (IP-NE). We assessed the prevalence of adverse intrapartum-related outcomes, evaluated the association between IP-NE and obstetric and fetal risk factors, and examined whether emergency referral and emergency caesarean section (CS) modified this association through interaction effects.

Cross-sectional with a nested case–control study.

Two hospitals in rural Eastern Uganda.

Women giving birth to a live or stillborn baby weighing >2000 g between June and December 2022.

We used prospectively collected perinatal e-registry data to assess the prevalence of adverse perinatal outcomes. Logistic regression with interaction with postregression margins analysis was used to determine the association between IP-NE and emergency referral and emergency CS across risk groups of hypertensive disorders, antepartum haemorrhage, prolonged/obstructed labour and birth weight.

Adverse perinatal outcomes were stillbirths, 24-hour neonatal deaths and IP-NE (defined as Apgar score

Of 6550 births, 10.2% had an adverse perinatal outcome: 3.8% stillbirths, 0.6% neonatal deaths and 5.7% IP-NE. Adverse outcomes were higher among neonates whose mothers had antepartum haemorrhage (31.3%) or prolonged/obstructed labour (27.2%) compared with those whose mothers had no complications. Emergency referral and CS did not change the association between IP-NE and obstetric risk, except in prolonged/obstructed labour. Without emergency CS, the predicted probability of IP-NE was 0.73 (95% CI 0.51 to 0.95); with CS, it decreased to 0.45 (95% CI 0.39 to 0.50).

Neonates born to mothers with obstetric complications had low healthy survival rates. Emergency referral and CS did not alter the risks of IP-NE in women with obstetric complications except for obstructed or prolonged labour, highlighting that these interventions may not be implemented with sufficient timeliness or quality, and/or that additional, more targeted strategies beyond referral and CS are needed to address IP-NE.

Globally, more than 700 000 people commit suicide annually. In Sweden, the yearly incidence ranges between 1000 and 1500 people, which is higher than the global average. The aim of this study is to estimate the economic burden related to indirect costs that suicide has imposed on Swedish society between 2010 and 2019.

National population-based cross-sectional study.

All suicides in Sweden between 2010 and 2019, using data from the Swedish National Cause of Death Registry.

Indirect costs associated with suicides, estimated using the human capital approach, including productivity loss over 1-year and lifetime horizons.

Between 2010 and 2019, 1406 to 1591 suicides occurred annually in Sweden, resulting in approximately 26 500 productive life years lost each year. In 2019, the productivity loss due to suicides was estimated at 44 million over a 1-year horizon and 935 million over a lifetime horizon. The corresponding per-person costs were 37 000 and 778 000, respectively.

This study provides valuable insights into the economic burden of suicide on Swedish society. It underlines the potential economic benefits of effective suicide prevention, aligning with previous research highlighting the substantial returns—both monetary and in terms of human well-being—that successful prevention strategies can yield.

Although poor mental health among young people has been increasing in the past decades, many young people are reluctant to use traditional mental healthcare. To cater to the needs of young people, various youth-friendly treatment options have been developed. These include the youth-friendly health service (YFHS) standards put forth by the WHO in 2012 and the integrated youth services (IYS) for mental health developed in certain countries globally. However, no synthesis of the effect of these services on youth mental health has been conducted. The aim of the proposed study is to conduct a systematic review of the effect of mental health treatments conducted within YFHS and IYS clinics. The primary research question is what effect mental health interventions given at ‘youth-friendly’ clinics for treating mental health, such as IYS and YFHS, have on the mental health and quality of life (QoL) of young people?

A preliminary search for other reviews on the topic was conducted during the first half of 2024, after which a protocol of the present study was registered in PROSPERO. In May 2024, a search was carried out in the PubMed, PsycINFO, CINAHL and Web of Science databases, which gave references for 12 738 papers to be screened for inclusion in the review, and a follow-up search was carried out in April 2025, yielding a further 2182 references. For inclusion, studies must have participants between 12 and 25 years of age; interventions be given at clinics designed to be ‘youth-friendly’ or given at an IYS; control condition, if any, consisting of standard care or waiting list; outcomes must be mental health symptomology or QoL. To be included, studies must be published from 2012 and onwards. Screening of titles and abstracts in the initial search was carried out independently by two reviewers. Screening of studies found in the follow-up search and in the reference lists of included articles will be carried out in the same way. Data analysis of the initial search was conducted in the latter half of 2024, while final data analysis including the results from the follow-up search is ongoing. The Cochrane risk of bias assessment tools will be used to assess bias of included articles, and certainty of the evidence will be evaluated according to the GRADE methodology. A meta-analysis of the results will be performed if a sufficient amount of homogenous data is found; otherwise, a synthesis without meta-analysis will be conducted.

The proposed review may form a valuable synthesis of the state of the art of treatment options catering to young people. Investigating the effectiveness of YFHS or IYS in treating young people’s mental health may inform future directions for development and research. The present study does not need ethical approval, since only previously published, ethically approved data are used in the current study. The findings of the study will be disseminated through submissions to peer-reviewed journals and international conferences, as well as disseminated within the Swedish YFHS community.

ID nr CRD42024528687.

Canadian guidelines recommend HIV testing for individuals being evaluated for syphilis. Our objective was to examine three aspects of HIV testing (ie, if an HIV test occurred, the timing of the HIV test in relation to the syphilis test and the proportion with a positive HIV test result) among syphilis tests between 2017 and 2022 from individuals with no evidence of a previous HIV diagnosis.

This study is a retrospective analysis of comprehensive laboratory testing data from Ontario’s provincial public health laboratory.

Direct fluorescent antibody (DFA) and serological non-prenatal syphilis tests were conducted from 1 January 2017 to 31 December 2022, from individuals aged ≥15 years with no evidence of a previous HIV diagnosis (n=3 001 058 total tests). Positive syphilis tests were categorised using the rapid plasma reagin (RPR) titre as ‘current’ (DFA+/RPR≥1:8) or ‘historical’ (RPR

The number and proportion of syphilis tests with a corresponding HIV test on the same day or within 7, 28, 90 or 180 days, and, among those with an HIV test within 28 days, the number and proportion with an HIV-positive test result.

From 2017 to 2022, 1 516 726 and 1 484 332 syphilis tests among males and females, respectively, were included in the analysis. Individuals with a positive syphilis result were less likely to be tested for HIV within 28 days of their syphilis test compared with those with a negative syphilis test result (74.7% vs 91.1% in males, 97.5% CI (–0.17 to –0.16); 65.2% vs 92.4% in females, 97.5% CI (–0.28 to –0.26)). Males with ‘current’ positive syphilis test results were less likely than males with ‘historical’ positive syphilis results to be tested for HIV within 28 days (69.1% vs 76.6%, 97.5% CI (–0.084 to –0.066)); this was not true in females (67.1% vs 64.4%, 97.5% CI (0.0062 to 0.049)). Males overall and males with ‘current’ syphilis were more likely to be diagnosed as HIV-positive (p

Most individuals who tested for syphilis at Public Health Ontario were also tested for HIV; however, those who tested positive for syphilis were less likely to be tested, representing an opportunity for enhanced HIV testing. Ensuring that individuals with syphilis are tested for HIV may help identify previously undiagnosed individuals living with HIV.

Despite an increasing use of screens among preschool children and evidence suggesting potential adverse effects, there is a paucity of longitudinal research that aims to disentangle the multifaceted components of screen use and their unique associations with development. We present a protocol for a large-scale national longitudinal study with repeated measurements in Danish preschool children, with the aim of investigating the cross-sectional and cross-lagged longitudinal associations between screen use and psychological outcomes.

The Digital Child Study is a national prospective observational cohort of Danish preschool children. Baseline parent-report data collection commenced in 2024 via online questionnaires, and in total will include three time points over 1 year: baseline (age 4 years), and follow-ups at 6 and 12 months (ages 4.5 and 5 years). Participants were divided into two waves based on birth dates, starting in March and September 2024. Recruitment targeted parents and primary caregivers of all Danish children born between specific dates in 2020. Of 30 235 children whose parents were sent invitations, baseline questionnaire data were available for 11 690 (39%).

Children’s screen use was measured by detailed information of amount, content and timing of children’s screen use, and the broader context, incorporating parental mediation strategies, attitudes, motivations and practices. Cognitive and socioemotional developmental outcomes were measured using validated tools such as the Strengths and Difficulties Questionnaire, the Nordic Five-to-Fifteen parent questionnaire and the Behaviour Rating Inventory of Executive Function—Preschool Version. Questionnaire data will be linked to national social and health registries to enable long-term follow-up. Statistical analyses will include longitudinal modelling to explore associations between screen use and developmental outcomes, with sensitivity analyses for robustness. The study’s large sample size provides high statistical power to detect meaningful effects.

The study adheres to ethical research guidelines, ensuring voluntary participation, confidentiality and compliance with data protection laws, with approvals from relevant authorities. Findings will be disseminated through peer-reviewed publications, conferences and plain-language summaries to engage stakeholders and the broader community.

Neonatal death and later disability remain common sequelae of hypoxic-ischaemic encephalopathy (HIE) despite the now standard use of therapeutic hypothermia (HT). New therapeutic approaches to brain protection are required. Melatonin is an indolamine hormone with free-radical scavenging, antiapoptotic, anti-inflammatory and gene regulatory neuroprotective properties, which has extensive preclinical evidence of safety and efficacy. Pharmacokinetic (PK) data suggest it is necessary to reach melatonin levels of 15–30 mg/L within 6–8 hours of hypoxia-ischaemia for brain protection. We developed a novel Good Manufacturing Practice (GMP) grade melatonin in ethanol 50 mg/mL solution for intravenous use. In preclinical studies, ethanol is an adjuvant excipient with additional neuroprotective benefit; optimised dosing protocols can achieve therapeutic melatonin levels while limiting blood alcohol concentrations (BACs).

The Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study is a first-in-human, international, multicentre, phase 1 safety study of intravenous melatonin in babies with moderate/severe HIE receiving HT. Sixty babies will be studied over two phases: a dose escalation study including four dose levels to establish the recommended phase 2 dose (RP2D), followed by a 6-month cohort expansion study of RP2D to further characterise PKs and affirm safety. Participants will receive a 2-hour intravenous infusion of melatonin within 6 hours of birth, followed by five maintenance doses every 12 hours to cover the period of HT. Plasma melatonin and BACs will be monitored. The RP2D will be based on the attainment of therapeutic melatonin levels while limiting BACs and the frequency of dose-limiting events (DLEs). A Bayesian Escalation with Overdose Control approach will be used to estimate the risk of DLE per dose level, with a target level of

Approval has been given by the London Central National Health Service Health Research Authority Ethics Committee (25/LO/0170) and UK Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency. Separate approvals have been sought in Ireland and Australia. Dissemination will be via peer-reviewed journals, conference presentations, public registries and plain language summaries for parent/legal guardian(s), in accordance with national requirements.

ISRCTN61218504. EU CT: 2025-520538-49-00.

Publication based on the UK protocol V.3.0, 08 May 2025

Cluster analysis, a machine learning-based and data-driven technique for identifying groups in data, has demonstrated its potential in a wide range of contexts. However, critical appraisal and reproducibility are often limited by insufficient reporting, ultimately hampering the interpretation and trust of key stakeholders. The present paper describes the protocol that will guide the development of a reporting guideline and checklist for studies incorporating cluster analyses—Transparent Reporting of Cluster Analyses.

Following the recommended steps for developing reporting guidelines outlined by the Enhancing the QUAlity and Transparency Of health Research Network, the work will be divided into six stages. Stage 1: literature review to guide development of initial checklist. Stage 2: drafting of the initial checklist. Stage 3: internal revision of checklist. Stage 4: Delphi study in a global sample of researchers from varying fields (n=) to derive consensus regarding items in the checklist and piloting of the checklist. Stage 5: consensus meeting to consolidate checklist. Stage 6: production of statement paper and explanation and elaboration paper. Stage 7: dissemination via journals, conferences, social media and a dedicated web platform.

Due to local regulations, the planned study is exempt from the requirement of ethical review. The findings will be disseminated through peer-reviewed publications. The checklist with explanations will also be made available freely on a dedicated web platform (troca-statement.org) and in a repository.

The majority of people globally who have undergone limb amputations are living in low- and middle-income countries. For those with lower-limb amputations, ambulatory mobility with a prosthesis is considered a key factor for achieving independent living; however, little is known of determinants of mobility for prosthesis users in low- to middle-income countries. In this study, we sought to assess levels of self-reported mobility in Cambodian prosthesis users and to identify determinants associated with their ambulant mobility.

Cross-sectional survey.

Three secondary care centres located in urban and rural Cambodia.

Adults receiving prosthetic services for a major lower-limb amputation.

The Khmer version of the LCI-5 and the mobility dimension of the EuroQol five-dimensional five levels (EQ-5D-5L) were used as dependent variables, while personal, physical, psychological and social determinants served as independent variables. Associations were assessed using hierarchical and ordinal regression analyses.

347 participants completed the survey. Determinants that were negatively associated with mobility outcomes were as follows: being female, having an amputation due to dysvascular complications, using an above-knee prosthesis and reporting higher levels of psychological distress. Social determinants did not appear to have any major association with mobility outcomes.

Findings highlight the multidimensional nature of mobility and suggest that future interventions may benefit from targeting female prosthesis users and those with diabetes or vascular disease. Mental health interventions addressing symptoms of anxiety and depression may also contribute to improved mobility outcomes. Social determinants explored in the study were not associated with significant changes in mobility scores. This may be due to high overall levels of mobility, a relatively homogenous group or failure to identify context-specific variables that impact on mobility outcomes.