Robotic rehabilitation on locomotion is a new approach in amyotrophic lateral sclerosis (ALS) and previous studies showed its feasibility. In this study, we aim to evaluate safety, patient’s experience and efficacy of a gait training programme with the Atalante exoskeleton, compared with usual care, on walking ability, functional capacity and other symptoms associated with ALS.
EXALS is a monocentric, prospective, interventional, open trial. 20 slowly progressing patients with gait deficits will be recruited. The study is conducted in three phases, each lasting 6 weeks, following the ABA procedure. Phase B represents the intervention phase, during which patients practise their gait training at a rhythm of three sessions/week, as an add-on to usual care. In the two phases A, patients receive usual care with no additional treatment. An evaluation is planned before, in the middle and at the end of each phase. The primary outcome of the study is safety and tolerability of the Atalante exoskeleton. Secondary outcomes include: participants’ subjective impact and experience, attitude and motivation, efficacy and interactivity of the exoskeleton, walking ability, functional capacity, spasticity, balance, postural stability, lower limb muscle strength, quality of life, pain, fatigue, anxiety and depression. Statistical analyses will include descriptive methods for all variables and adverse events. Quantitative outcomes are analysed using repeated-measures ANOVA (analysis of variance) across the seven visits, with post hoc tests applied when appropriate. Nominal outcomes are evaluated using Cochran’s Q test with McNemar pairwise comparisons when significant. Associations between variables are examined using Spearman correlation coefficients. Missing data will be replaced using linear interpolation, and sensitivity analyses will be planned. Qualitative interview data are analysed using thematic analysis.
This study was approved by the French ethics committee CPP Nord-Ouest I (no. 23.02378.000201). Participant data are anonymised and securely stored in the laboratory’s database, accessible only to the research team. Results will be disseminated through peer-reviewed journals and conferences.
Glaucoma is an optic neuropathy caused by the gradual degeneration of retinal ganglion cells. This study aimed to investigate the knowledge, attitude and practice (KAP) towards glaucoma among ophthalmic inpatients.
A web-based questionnaire.
Local hospital.
Ophthalmic inpatients (n=1238).
The primary outcome was the patients’ KAP.
Multivariable logistic regression analysis showed that rural residence (OR=0.488, 95% CI 0.313 to 0.762, p=0.002), college education or above (OR=4.996, 95% CI 2.942 to 8.483, p
Ophthalmic inpatients might have moderate knowledge and attitude, but a proactive practice towards glaucoma. A history of glaucoma, previous glaucoma surgery, education level, residency and alcohol consumption were potentially associated with knowledge and attitudes towards glaucoma among ophthalmic inpatients.
Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.
To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.
The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.
MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.
MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.
MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.
This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.
Outcome reporting in studies on sacrococcygeal teratoma (SCT) is highly heterogeneous, which limits comparability across studies and thus hampers the development of international treatment guidelines.
Variation in treatment and access to facilities contributes to differences in outcome reporting between centres and countries. Establishing a Core Outcome Set (COS) can improve consistency in outcome reporting and facilitate global collaboration and data comparison. We therefore aim to develop a Core Outcome Set for SCT (COS-SCT) using the Delphi method to achieve consensus on key outcomes. This will enhance the standardisation of outcome reporting and improve the quality of research and clinical care for SCT patients globally.
The development of the COS-SCT will consist of three phases. First, a systematic review will be performed to identify outcomes reported in studies on the surgical treatment of SCT in children. Second, an international Delphi survey will be conducted among key stakeholders, including clinicians, researchers and patient representatives, to establish consensus on outcome prioritisation. Finally, a consensus meeting with representatives from all stakeholder groups will be held to ratify the final Core Outcome Set. The study will follow methodological guidance from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and will be developed and reported in accordance with the Core Outcome Set Standards for Development (COS-STAD) and Core Outcome Set Standards for Reporting (COS-STAR).
The medical research ethics committee of the Amsterdam University Medical Centre (Amsterdam UMC) confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and therefore a full review by the ethics committee is not required. This study is registered in the COMET initiative database. Results will be disseminated in peer-reviewed academic journals and conference presentations.
Trial registration number: COMET registration number 3485
To evaluate the performance of Ghana’s environmental surveillance (ES) system for poliovirus (PV) detection from 2018 to 2022 using standardised indicators developed by the WHO and the US Centers for Disease Control and Prevention.
A retrospective performance evaluation using 10 key indicators benchmarked against global targets for PV surveillance.
Seven regions across Ghana, participating in the national ES programme implemented under the Global Polio Eradication Initiative.
Wastewater sampling was conducted at designated ES sites, supported by field collection teams and laboratory personnel responsible for sample acquisition, processing and reporting of PV detection results.
Detection rates of PV and non-polio enteroviruses (NPEVs), timeliness of sample collection and reporting, data quality and system stability.
A total of 738 wastewater samples were collected. The system demonstrated high sensitivity, detecting circulating vaccine-derived PV type 2 in 51 (6.9%) of samples, Sabin PV types 1 and 3 in 61 (9.5%) and 114 (17.8%), respectively, and NPEVs in 491 (66.5%) of samples. Over 80% of samples met the recommended 21-day collection-to-reporting time frame. Data quality exceeded the ≥80% threshold, and workflows remained stable throughout the evaluation period.
Ghana’s ES system for PV was found to be flexible, stable and effective in generating high-quality data for early detection and public health response. These findings underscore the system’s critical role in supporting polio eradication efforts and highlight its potential as a model for surveillance in similar settings.
Postoperative pain is common, with approximately one-third of surgical patients experiencing severe acute pain and 10–20% developing chronic post-surgical pain (CPSP). Evidence shows that female patients are at higher risk of pain after sex non-specific surgery, thus sex- or gender-specific differences in pain treatment efficacy with potential consequences for perioperative pain management are to be expected. Considering the clinical and societal burden of poorly managed postoperative pain, the GEPard project comprises two systematic reviews, GEPard 1: sex- and/or gender-specific differences in efficacy of perioperative pain management for certain (major) surgical procedures in adult patients; and GEPard 2: sex- and/or gender-specific differences in the dosing, efficacy and adverse effects of the most common systemic perioperative non-opioid- and co-analgesics across all sex non-specific surgical procedures in adult patients.
The reviews will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Handbook. MEDLINE, Embase, Cochrane Library, Web of Science, Scopus, ClinicalTrials.gov and PsycINFO will be searched. We will include randomised controlled trials (RCTs) and systematic reviews/meta-analyses reporting outcomes disaggregated by sex and/or gender in adult surgical patients. For GEPard 1, this applies to selected major surgical procedures; for GEPard 2, to all non-sex-specific surgical procedures. Interventions include regional anaesthesia, systemic analgesics and psychological strategies for GEPard 1 and non-opioid- as well as co-analgesics for GEPard 2. Two reviewers will independently screen and extract the data. Cochrane Risk of Bias Tool 2.0 (RoB 2) and AMSTAR 2 tools will assess study quality. Random-effects or Bayesian meta-analyses will be performed where possible; otherwise, narrative synthesis will be applied. GRADE methodology will assess evidence certainty.
No ethical approval is required for these reviews. Findings will be disseminated via peer-reviewed publications, patient organisations and professional societies. Data will be shared via Zenodo or Open Science Framework (OSF), following FAIR principles.
The systematic review protocols for both reviews have been registered in PROSPERO on 29 August 2025 (Registration-ID: CRD420251121393 (GEPard1), CRD420251121536 (GEPard2).
Patient-reported experience measures (PREMs) are measures of patients’ perceptions of care they receive. PREMs are critical in developing and evaluating programmes that aim to improve patient healthcare experiences and quality of care (QoC) according to patient-defined needs. This review aims to map key domains of PREMs across distinct healthcare technical areas and life stages from globally available literature.
A scoping review adapting Arksey and O’Malley’s framework and Joanna Briggs Institute’s guidelines for the conduct of scoping reviews.
Google Scholar, PubMed, WHO, US Academy of Medicine and USAID Momentum.
PREMs literature from electronic repositories of grey and peer-reviewed publications, published in English historically up to September 2023.
Two lead reviewers with support from the technical working group co-created a review framework of healthcare technical areas, life stages and PREMs domains. We screened eligible articles, prioritising reviews except for technical areas with no reviews, where we then selected individual studies. We charted, analysed and synthesised data from 52 eligible articles.
PREMs literature has recently increased, especially in low-income and middle-income countries (LMICs), although studies in high-income countries (HICs) dominate in proportion (n=38; 73.1%). Out of 52 eligible articles, technical areas with most publications were sexual and reproductive health (n=21; 40.4%) and general outpatient care (n=11; 21.2%). Studies in adulthood (n=24; 46.2%) and from pregnancy and birth to postnatal (n=16; 30.8%) were most represented. PREMs studies reported mostly on communication and rapport (n=33; 63.5%) and respect and dignity (n=42; 80.8%) domains. Nearly a quarter (n=12; 23.1%) of the articles included only validated tools; the rest included a combination of validated and unvalidated measures. Of the tools relating to life stages of babies, younger children and older adults, the majority (n=17; 94.4%) included patient proxies.
PREMs, as an important component of QoC measurement, are increasing across several healthcare technical areas and life stages with commonalities and notable distinctions in measurement domains and tools. Evidence on PREMs largely comes from HICs. Evidence on critical, yet sometimes overlooked domains, highlights key QoC implementation gaps. The adaptation and utilisation of PREMs in programmes, especially in LMICs and under-represented technical areas, present opportunities to close the QoC disparities in those settings. Strategic, concerted efforts towards the harmonisation of PREMs tools across multiple life course stages and technical areas are critically needed in high-level quality improvement efforts.
To test the feasibility and acceptability of a newly developed model of neonatal nurse-controlled analgesia to manage pain in the post-operative infant.
The study utilised a single-centre two-arm parallel, unblinded randomised controlled external pilot trial design.
The pilot trial was conducted in a surgical neonatal tertiary intensive care unit in Brisbane, Australia. Eligible infants were randomised to receive either post-operative pain management care via a model of neonatal nurse-controlled analgesia or standard care. Feasibility and acceptability were the primary outcomes. Seven feasibility outcomes were assessed by a traffic light system to delineate progression to a larger trial. Acceptability and clinical utility of the model of care by staff were assessed by feedback from an anonymous questionnaire that was administered at the completion of the trial period. Secondary outcomes included parental attitudes and perceptions of post-operative pain management to help establish primary outcomes for a larger randomised controlled trial.
Overall staff found the formalised model beneficial for managing post-operative pain but found the complexity of the model and ability to titrate analgesia based only on documented pain scores barriers requiring further consideration. Three of the seven feasibility outcomes failed to reach ‘greenlight’ targets to progress to a larger trial with adherence to the model, and the proportion of eligible infants not recruited was allocated a ‘redlight’. Secondary outcomes were comparable and support future study.
This pilot feasibility study has shown that a model of neonatal nurse-controlled analgesia can be safely implemented and utilised in the post-operative care of the surgical neonate. Further exploration of the barriers to model adherence and recruitment is warranted before a future larger trial is undertaken.
Though not all primary outcomes reached an acceptable range for further progression, this pilot feasibility study provided invaluable learning and has provided direction for future research into the provision of a family integrated and responsive model of analgesia.
This study is reported in line with the Consolidated Standards of Reporting Trials (CONSORT): Extension to randomised pilot and feasibility trial and the TIDieR Checklist (Template for Intervention, Description and Replication).
No patient or public contribution was utilised for this study.
Trial Registration: ACTRN12623000643673—the trial was prospectively registered
NHS Health Checks (NHSHCs) provide individuals with cardiovascular disease (CVD) risk scores alongside advice and signposting to behaviour change support. A particular problem is that the support people receive is often poorly delivered, absent or not tailored to the needs of people in deprived communities, which risks exacerbating health inequalities. Improving this support is critical if NHSHCs are to achieve their goals of prevention and equity.
To explore needs and preferences for behaviour change support among adults in deprived areas, using a digital prototype presenting CVD risk information and signposting to services.
A longitudinal qualitative study involving focus groups and semi-structured follow-up interviews.
Adults from minoritised ethnic groups eligible for NHSHCs, recruited online and through a community centre, with both methods targeting high-deprivation areas.
Participants were first shown the digital prototype in focus groups to generate discussion. Follow-up interviews captured more in-depth reflections on needs for behaviour change support. Data were analysed using reflexive thematic analysis.
We conducted four focus groups and 20 follow-up interviews with 23 adults, predominantly of South Asian ethnicity living in areas of high deprivation. We developed three themes: (1) Trusted information to counter confusion and misinformation; (2) Support that makes change feel possible and meaningful, through culturally and personally relevant advice that addresses unhelpful beliefs about risk reduction and behaviour change and (3) Ensuring access to inclusive, socially connected environments that feel supportive and conducive to action.
For minoritised ethnic adults in deprived areas, NHSHC support should build on everyday practices and foster positive perceptions of services. Alongside service-level changes, policy action is needed to remove structural barriers (eg, cost, safety) that limit people’s ability to act on advice. Such changes could enhance the programme’s contribution to reducing inequalities in CVD prevention.
This study aimed to determine the prevalence and factors associated with pre-diabetes and undiagnosed type 2 diabetes (UDD) in Cambodia.
This analysis used data from the WHO World Health Survey Plus, which was collected using a cross-sectional design with a GIS-based, three-stage sampling approach. Multiple logistic regression was used to identify key associated factors, based on a significance level of p
Data were collected from all 25 provinces in Cambodia between 12 March 2023 and 31 May 2023.
4427 individuals aged 18 years or older, residing in the selected household for at least 6 months in the past year.
Pre-diabetes (Haemoglobin A1c (HbA1c) 5.7%–6.4%) and UDD (HbA1c≥6.5%), without prior knowledge of having type 2 diabetes (T2D).
The weighted prevalences of pre-diabetes and UDD were 26.4% (95% CI 24.0% to 29.0%) and 9.3% (95% CI 7.9% to 11.0%). Pre-diabetes prevalence was higher in urban areas compared with rural areas (adjusted OR, aOR=1.2, 95% CI 1.0 to 1.4), males (aOR=1.7, 95% CI 1.3 to 2.3), individuals aged 40–49 (aOR=1.8, 95% CI 1.4 to 2.4), individuals aged 50+ years group (aOR=2.9, 95% CI 2.3 to 3.6) compared with the 18–39 years group, overweight individuals (aOR=1.7, 95% CI 1.4 to 2.0), obese (aOR=2.1, 95% CI 1.5 to 3.0) and those with elevated total triglycerides (aOR=1.3, 95% CI 1.1 to 1.5). Similar risk factors were identified for UDD, with the addition of hypertension (aOR=1.6, 95% CI 1.3 to 2.0) and high waist circumference (aOR=2.0, 95% CI 1.5 to 2.7).
The high prevalence of pre-diabetes and UDD in Cambodia is a pressing public health concern. Urgent and intensive interventions are needed to effectively prevent and manage T2D, particularly among urban residents, older persons and individuals with metabolic risk factors.
To characterise long-term trajectory of recovery in individuals with long covid.
Prospective cohort.
Single-centre, specialist post-COVID service (London, UK).
Individuals aged ≥18 years with long covid (hospitalised and non-hospitalised) from April 2020 to March 2024.
Routine, prospectively collected data on symptoms, quality of life (including Fatigue Assessment Scale (FAS) and EuroQol 5 Dimensions (EQ-5D), return to work status and healthcare utilisation (investigations, outpatient and emergency attendances). The primary outcome was recovery by self-reported >75% of ‘best health’ (EQ-5D Visual Analogue Scale) and was assessed using Cox proportional hazards regression models over 4 years. Linked National Health Service England registry data provided secondary care healthcare utilisation and expenditure.
We included 3590 individuals (63.3% female, 73.5% non-hospitalised, median age 50.0 years, 71.9% with ≥2 doses of COVID-19 vaccination), who were followed up for a median of 136 (0–346) days since first assessment and 502 (251–825) days since symptom onset. At first assessment, 33.2% of employed individuals were unable to work. Dominant symptoms were fatigue (78.7%), breathlessness (68.1%) and brain fog (53.5%). 33.4% of individuals recovered to >75% of best health prior to clinic discharge (recovery occurred median 202 (94–468) days from symptom onset). Vaccinated individuals were more likely to recover faster (pre: HR 2.93 (2.00–4.28) and post: HR 1.34 (1.05–1.71) COVID-19 infection), whereas recovery hazard was inversely associated with FAS (HR 0.37 (0.33–0.42)), myalgia (HR 0.59 (0.45–0.76)) and dysautonomic symptoms (HR 0.46 (0.34–0.62)). There was high secondary care healthcare utilisation (both emergency and outpatient care). Annual inpatient and outpatient expenditure was significantly lower in hospitalised individuals while under the service. When compared with the prereferral period, emergency department attendances were reduced in non-hospitalised patients with long covid, but outpatient costs increased.
In the largest long covid cohort from a single specialist post-COVID service to date, only one-third of individuals under follow-up achieved satisfactory recovery. Fatigue severity and COVID-19 vaccination at presentation, even after initial COVID-19 infection, was associated with long covid recovery. Ongoing service provision for this and other post-viral conditions is necessary to support care, progress treatment options and provide capacity for future pandemic preparedness. Research and clinical services should emphasise these factors as the strongest predictors of non-recovery.
To evaluate the incremental diagnostic value and sub-phenotyping capability of Cardiovascular Magnetic Resonance (CMR) compared with Transthoracic Echocardiography (TTE) in patients with elevated left ventricular filling pressure (LVFP).
Prospective registry study. [Results from ClinicalTrials.gov ID NCT05114785]
A single NHS hospital in the UK.
The primary outcome was the rate of diagnostic discordance between TTE and CMR. Secondary outcomes included the characterisation of specific pathologies identified by CMR where TTE was normal, non-diagnostic or provided a non-specific diagnosis.
CMR demonstrated diagnostic discordance with TTE in 74% (n=194) of cases. In patients with a normal TTE (n=54), CMR identified heart failure with preserved ejection fraction (HFpEF) in 46% (n=25) and ischaemic heart disease (IHD) in 19% (n=10). For non-diagnostic TTE cases (n=15), CMR detected HFpEF in 53.3% (n=8) and IHD in 26.7% (n=4). Among those with non-specific left ventricular hypertrophy on TTE (n=47), CMR revealed HFpEF in 45% (n=21) and hypertrophic cardiomyopathy in 34% (n=16).
CMR markedly improves diagnostic precision and sub-phenotyping in patients with elevated LVFP, identifying key conditions like HFpEF, IHD and specific cardiomyopathies that TTE frequently misses. These findings highlight CMR’s critical role as a complementary imaging tool for refining diagnoses and informing management strategies in cardiovascular conditions.
To identify the factors influencing the choice of private healthcare facilities among individuals experiencing tuberculosis (TB) symptoms.
Cross-sectional study.
The data for this study were obtained from a cross-sectional population-based TB prevalence survey conducted in 33 districts of Tamil Nadu, a state in southern India, between February 2021 to July 2022.
130 932 individuals, 15 years and above, residents of the selected cluster for the past 1 month, were included. Hospitalised patients, sick/morbid individuals and the institutional population were excluded.
Of 143 005 eligible individuals, 130 932 (91.6%) participated. Among them, 9540 individuals were found to have at least one TB symptom. Of these symptomatic individuals, 2678 sought healthcare, with 62.7% in the public facilities and 37.3% in private facilities. Factors associated with seeking care in the private healthcare facilities included working in organised sector (aOR: 1.3; 95% CI 1.0 to 1.7; p
Conversely, individual with symptom of weight loss (aOR: 0.4; 95% CI 00.3 to 00.6; p25 years (aOR: 0.6; 95% CI 0.4 to 0.9; p
The study highlights the distinct factors that could affect healthcare seeking for TB symptoms in the public and private healthcare settings for TB and the need for tailored interventions and customised healthcare policies to address such gaps and distinctions in care seeking.
This study aims to assess travel time, associated costs, challenges and factors influencing healthcare facility choices among persons with cancer in Southern India.
An explanatory sequential mixed methods study.
The study was conducted in the cancer care outpatient department at a tertiary care centre in Puducherry, Southern India.
A total of 192 persons with cancer aged 18 to 65 years, diagnosed with breast, lip and oral cavity, cervical, lung or upper gastrointestinal cancers, and attending the cancer care centre between 2023 and 2024, were enrolled in the study through systematic random sampling. Additionally, 10 in-depth interviews were conducted using purposive sampling.
Of the 192 participants, 89 (46.4%) belonged to a lower socioeconomic group, and 178 (92.7%) reported experiencing financial hardship while undergoing cancer treatment. The median travel time to a tertiary care centre was 4.3 hours (IQR: 2.07–7.3), with a median direct non-medical cost of Indian Rupees (INR) 453 (IQR: 200–987). Median expenditures for travel, food and accommodation were INR 200 (IQR: 123–400), INR 360 (IQR: 150–613) and INR 30 (IQR: 20–60), respectively, per single visit. A significant proportion of participants (n=146, 76%) were unaware of nearby cancer treatment centres and relied on peer recommendations when choosing their place of treatment. Key challenges identified included long-distance travel, financial burden due to high food and transportation costs and limited affordability for accommodation.
The study highlights that prolonged travel time and associated costs pose substantial financial strain on cancer-affected families. Enhancing awareness of available healthcare facilities, implementing patient-friendly travel and accommodation support systems and decentralising cancer care services can improve accessibility and mitigate both travel and financial burdens.
Published clinical trials offer valuable insights into the clinical research landscape in Portuguese-speaking African countries (PSAC)—Angola, Cabo Verde, Guinea-Bissau, São Tomé and Príncipe and Mozambique. The objective of this comprehensive scoping review is to systematically map and analyse randomised clinical trials (RCTs) evaluating pharmacological interventions conducted in PSAC from 1995 to 2024, in order to identify research trends, targeted diseases, geographic distribution and evidence gaps to better understand the development and evolution of clinical trials in the region. This is the first comprehensive scoping review to examine the clinical trials landscape in PSAC.
This scoping review adheres to the Joanna Briggs Institute methodology for scoping reviews, which builds on the Arksey and O’Malley methodological framework (refined by Levac et al) and will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. A dual-search strategy will be used, consulting 4 electronic databases (MEDLINE, EMBASE, African Index Medicus, Cochrane Central Register of Clinical Trials) and 3 clinical trials registries platforms (Clinicaltrials.gov, International Clinical Trials Registry Platform, Pan African Clinical Trials Registry). Eligible studies will include RCTs conducted in at least one of the PSAC. Extracted data will include trial characteristics, targeted diseases, phases and designs, funding and ethical compliance. Risk of bias (RoB) will be assessed using the Cochrane RoB tool V.2.0 to evaluate the quality of the evidence included in the scoping review. Conclusions will be drawn upon the comparison between countries and their scope of clinical research, together with comparison with countries from other geographies, considering disease profiles.
Ethical approval is not required. Results will be disseminated through a peer-reviewed publication, conference presentation and in plain language in social media, both in Portuguese and in English.
This protocol is registered in the Open Science Framework https://osf.io/5nhc9.
Outcome from large vessel occlusion stroke can be significantly improved by time-critical thrombectomy but treatment is only available in regional comprehensive stroke centres (CSCs). Many patients are first admitted to a local primary stroke centre (PSC) and require transfer to a CSC, which delays treatment and decreases the chance of a good outcome. Access to thrombectomy might be improved if eligible patients could be identified in the prehospital setting and selectively redirected to a CSC. This study is evaluating a new specialist prehospital redirection pathway intended to facilitate access to thrombectomy.
This study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. Clusters are ambulance stations (or teams) which are work bases for ambulance practitioners. Intervention allocated ambulance practitioners use the Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (‘SPEEDY’) pathway which comprises initiation according to specific criteria followed by contact with CSC staff who undertake a remote assessment to select patients for direct CSC admission. Control allocated ambulance practitioners continue to provide standard care which comprises admission to a local PSC and transfer to a CSC for thrombectomy if required. A co-primary outcome of thrombectomy treatment rate and time from stroke symptom onset to thrombectomy treatment will evaluate the impact of the pathway. Secondary outcomes include key aspects of emergency care including prehospital/hospital time intervals, receipt of other treatments including thrombolysis, and performance characteristics of the pathway. A broad population of all ambulance practitioner suspected and confirmed stroke patients across participating regions is being enrolled with a consent waiver. Data about SPEEDY pathway delivery are captured onto a study case record form, but all other data are obtained from routine healthcare records. Powered on a ‘primary analysis population’ (ischaemic stroke patients with pathway initiation criteria), 894 participants will detect an 8.4% difference in rate and data from 564 thrombectomy procedures will detect a 30 minute difference in time to treatment. The full study population is estimated to be approximately 80 000. Regression modelling will be used to examine primary and secondary outcomes in several analysis populations. The economic analyses will include cost-effectiveness and cost–utility analyses, and calculation of willingness to pay at a range of accepted threshold values. The process evaluation involves semi-structured interviews with professionals and patient/family members to explore views and experiences about the SPEEDY pathway.
This study has ethical, Health Research Authority and participating NHS Trust approvals.
Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.
Healthcare professionals are increasingly burdened by clerical tasks, contributing to reduced job satisfaction, heightened burnout and potential risk for patient safety. Despite ongoing efforts to promote patient-centred care, direct interaction time with patients remains limited, affecting both professional fulfillment and the quality of patient experience. In response, hospitals have begun implementing structured programmes to enhance protected patient time, though their effectiveness remains uncertain. The Geneva University Hospitals (HUG) developed the ‘More Time at Patients’ Side’ (MTP) programme, integrating Lean management and Design Thinking principles to optimise clinical interactions. This study aims to evaluate an MTP booster intervention, designed to reinforce selected programme elements, using a cluster-randomised controlled trial focusing on patient pain management and healthcare professional job satisfaction.
The MTP Booster will be implemented in selected units at HUG across internal medicine, surgery, rehabilitation, palliative care and paediatrics units. Originally launched in 2017, the MTP programme introduced structured medical rounds, delegated clerical tasks and communication tools such as patient whiteboards. The booster intervention follows a stepped-wedge cluster-randomised design, with immediate reactivation in intervention units and delayed implementation in control units. The intervention consists of two key components: (A) a collaborative selection of MTP elements to reinforce, based on their feasibility and perceived usefulness and (B) structured integration of audit and feedback into daily routines, including on-site observations and staff training. The primary outcome is the quality of pain management, measured by the timely administration of analgesia. Secondary outcomes include pain documentation, patient satisfaction, healthcare professional work satisfaction, burnout levels, turnover risk and absenteeism. Other MTP-related audits are suspended during the study to preserve methodological integrity, and concurrent institutional initiatives will be documented as potential confounders.
The trial has a declaration of no objection by Swissethics (2024-00169). All final results will be reported in accordance with the Consolidated Standards of Reporting Trials extended for cluster-randomised trials. We intend to publish the results of this trial in an international peer-reviewed journal, irrespective of the results.
The trial is currently in the pre-results stage and is registered at ClinicalTrials.gov, ID: NCT06491797, 9 July 2024.
This paper aims to describe the development of an inventory of chronic ambulatory care sensitive conditions (ACSCs) relevant to the Malaysian context and identify potentially preventable hospitalisations in the Malaysian Ministry of Health (MOH) facilities based on the developed list.
Consultative panel discussion, multi-panel modified Delphi and secondary health data analysis.
Setting: Malaysian MOH healthcare facilities.
42 experts from the family medicine and internal medicine specialties (modified Delphi), and 2022 inpatient data from MOH hospitals (secondary health data analysis).
A list of chronic ACSCs tailored to the Malaysian context and the proportion of potentially preventable hospitalisation in MOH hospitals.
10 conditions were identified as chronic ACSCs for Malaysia, namely angina, asthma, chronic kidney disease, convulsions and epilepsy, chronic obstructive pulmonary disease, diabetes mellitus, heart failure, hypertension, iron deficiency anaemia and ischaemic heart disease. In 2022, these conditions accounted for 8.6% of potentially preventable hospitalisations among the total hospitalisations in MOH hospitals.
This study provides a base list of chronic ACSCs tailored to the Malaysian context, which enables monitoring of potentially preventable hospitalisations due to chronic conditions. The findings underscore a proportion of hospital admissions that could potentially be avoided through interventions that enhance outpatient care. The conditions identified as ambulatory care sensitive provide specific targets for policy action and resource allocation to optimise outpatient health services and thus reduce the burden of hospitalisations in the country.
Malaysian National Medical Research Register, NMRR ID-23–02149-TBZ (https://nmrr.gov.my/research-directory/45c901d6-f121-4e79-9f38-dd7d283ec9a6).
The objective of this scoping review is to map out what has been published in the scientific literature on the relationship between climate change-related events and how these overlap with associated changes in resource availability, transactional sex and HIV incidence and prevalence, within fishing communities in the Lake Victoria basin. This objective is informed by the fact that climate change and the associated natural resource strains in the Lake Victoria region have exacerbated existing inequities within fishing communities. Vulnerable populations, especially women, engage in strategies such as transactional sex to cope with the uncertainty of natural resource-dependent livelihoods. This practice greatly increases women’s risk of contracting HIV in this region, with prevalence rates four to five times the national averages. This scoping review will thus show how the existing empirical literature reports on climate change, transformation in natural resources and livelihoods, and transactional sex and HIV in the Lake Victoria region.
Studies that meet the following inclusion criteria will be included: align with at least two of the major concepts of interest, including climate change, transactional sex, HIV/AIDS, Lake Victoria Basin and/or empirical studies; are published in English and after 2012; and focus on the Lake Victoria basin. The scoping review will be guided by the JBI Manual for Evidence Synthesis: Scoping Reviews, supported by the standard principles of Arksey and O’Malley. The specific search strategies to be implemented were developed with guidance from an experienced research librarian to align with the inclusion criteria. The search will be conducted in relevant global databases, with two reviewers screening the results and extracting relevant data points. Finally, results will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews flow diagram, and summarised in figures, tables and text.
The scoping review is designed to comprehensively scope the existing literature and document the coverage of linkages between transactional sex, HIV/AIDS and sustainable livelihoods in the context of climate change with a view to informing health systems responses to human health specific to the HIV epidemic.
The proposed scoping review is registered with the Open Science Foundation (OSF), registration number:https://doi.org/10.17605/OSF.IO/9DTW4.
Shared decision-making is widely advocated in policy and practice, but how it is to be applied in a high-stakes clinical decision such as major lower limb amputation due to chronic limb-threatening ischaemia or diabetic foot is unclear. The aim of this study was to explore the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation.
A qualitative study (done as part of a broader mixed-methods study) using semi-structured interviews. Interview transcriptions were analysed using thematic analysis.
Vascular centres in three large National Health Service hospitals in Wales and England, UK, between 1 October 2020 and 30 September 2022.
A purposive sample of 18 patients for whom major lower limb amputation was considered as a treatment option/carried out, with interviews conducted before or within 4 months of amputation and 4–6 months after amputation. A further purposive sample of 20 healthcare professionals (including eight surgeons) involved in supporting or conducting major lower limb amputation decision-making.
Five major categories were identified that highlighted the challenges of ensuring shared decision-making associated with major lower limb amputation: (i) patients’ limited understanding, (ii) variable patient attitudes to decision-making, (iii) healthcare professionals’ perceived challenges to sharing decision-making, (iv) surgeons’ paternalism and (v) patients’ and healthcare professionals’ decisional regret/possible consequences of challenges.
Amputation is a life-changing decision for both patients and healthcare professionals, with huge consequences. Despite being considered the gold standard, our findings highlight several challenges to effective shared decision-making for major lower limb amputation. Shared decision-making training for healthcare professionals is paramount if these limitations are to be addressed and patients are to feel confident in being adequately informed about the treatment decisions that they make.