The production of science is characterized by socio-political and technological forces that influence what knowledge is produced. In this context, empty reviews have received little attention, with debate ranging over the pros and cons of their publication. However, their dissemination may improve the ability to recognize and prioritize research gaps. The main aim of the study was to map empty reviews published in nursing science.
A scoping review in accordance with Arksey and O'Malley, Joanna Briggs Institute and Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews. The review protocol was registered in the Open Science Framework database in April 2025. Four databases and grey literature were searched; there were eligible scoping or systematic reviews defined as “empty” in the field of nursing. A modified framework of Patterns, Advances, Gaps, Evidence for practice, and Research recommendations was used to summarize the extracted data.
Fifteen empty reviews were identified. In terms of Patterns, the empty reviews were mainly published in high-income countries over the last 10 years and related to clinical practise and outcomes, education and training, organizational and human resources, and approaches to maternity care, mental health, and nursing education. In general, reporting guidelines were used, while funding was not documented. In terms of Recommendations, more primary studies, the development of tools and the strategic use of empty reviews to inform the funding and research agenda were suggested.
Empty reviews in nursing may indicate neglected or emerging areas that can help orient research agendas to ensure equity-oriented priorities and reduce the marginalization of under-investigated topics. Recognizing empty reviews as legitimate scholarly outputs supports transparent mapping of knowledge gaps, helping funders, institutions, and research programs direct resources to under-investigated areas. Dedicated registries that publicly report empty reviews, establish minimum reporting standards, and require explicit keywords in titles and abstracts would improve transparency and accessibility, and stimulate targeted primary research that can turn “empty” areas into active inquiry. From this perspective, empty reviews may attract research investment rather than be seen as methodological failures.
Examine the relationships between workplace trust, interpersonal trust, and nurses' physical and mental health, and specifically investigate the mediating role of resilience.
Nurses are central to healthcare delivery but frequently experience workplace violence, adversely affecting their well-being. Trust represents a higher-order mechanism that fosters positive attitudes and professional growth, potentially safeguarding nurses' resilience in coping with adversity. However, research elucidating how trust influences nurses' health via resilience remains limited.
A cross-sectional study was conducted using convenience sampling. A total of 2855 clinical nurses from general hospitals in Fujian Province, China, were surveyed between August and October 2022. Workplace trust and interpersonal trust were served as independent variables, Physical Component Summary and Mental Component Summary scores as dependent variables, and resilience as a mediator. Mediation analysis was performed using Mplus 8.3. The study was prepared and reported according to the STROBE checklist.
Mean scores were Physical Component Summary: 51.12 ± 8.90, and Mental Component Summary: 48.20 ± 10.18. Workplace trust had significant direct effects on both Physical Component Summary and Mental Component Summary. Interpersonal trust had no significant direct effects on Physical Component Summary or Mental Component Summary. Resilience demonstrated significant mediating effects: for workplace trust on Physical Component Summary and on Mental Component Summary; and for interpersonal trust on Physical Component Summary and on Mental Component Summary.
Workplace trust directly enhances nurses' physical and mental health. While interpersonal trust lacks a direct link to health outcomes, both workplace and interpersonal trust significantly improve nurses' health indirectly by bolstering resilience. Resilience serves as a critical pathway through which trust fosters well-being.
No patient or public contribution.
Nurse managers and healthcare administrators should prioritise interventions to cultivate workplace trust (e.g., fostering trust among colleagues, and between nurses and the organisation/management) and strengthen interpersonal trust and psychological resilience. Enhancing these protective factors will better equip nurses to manage occupational and personal stressors, ultimately safeguarding and improving their physical and mental health.
by Clarisse Kagoyire, Albert Ndagijimana, Gilbert Nduwayezu, Jean Nepo Utumatwishima, Jean Pierre Mpatswenumugabo, Marie Anne Mukasafari, Diane Rinda, Vedaste Ndahindwa, Kristina Elfving, Gunilla Krantz, Torbjörn Lind, Ali Mansourian, Renée Båge, Ewa Wredle, Elias Nyandwi, Aline Umubyeyi, Jean Baptiste Ndahetuye, Petter Pilesjö
Despite national progress, stunting remains prevalent in specific regions of Rwanda, highlighting the limitations of coarse-resolution data for effective mapping and intervention planning. This study explored optimal spatial resolution and analytical approach to capture localised dynamics and the multifactorial nature of stunting. A cross-sectional, population-based study was conducted in the Northern Province of Rwanda, focusing on children aged 1–36 months. Data were collected using structured questionnaires covering socio-demographic, economic, health, childcare, livestock factors and anthropometric measurements. Environmental characteristics were obtained from national datasets, while household geographic coordinates were captured using a customized mobile geodata platform (emGeo). After data cleaning, predictors were analysed using univariable and multivariable logistic regression as well as geographically weighted logistic regression (GWLR) to account for spatial heterogeneity. Among 601 children, stunting prevalence was 27% (boys 33.8%; girls 20.9%). GWLR improved model fit, increasing adjusted deviance explained from 34% to 39%. Significant predictors included child age (adjusted OR = 2.46; 95% CI: 1.78–3.39), male sex (OR = 2.83; 95% CI: 1.65–4.86), birthweight (OR = 0.71; 95% CI: 0.54–0.94), maternal autonomy (ability to refuse sexual intercourse; OR = 0.48; 95% CI: 0.27–0.86), inconsistent maternal social support (OR = 2.30; 95% CI: 1.20–4.42), household electricity access (OR = 0.48; 95% CI: 0.27–0.84) and handwashing facilities (OR = 0.21; 95% CI: 0.07–0.67). GWLR revealed substantial spatial heterogeneity in these factors, delineating areas where each factor matters most. This household-level, spatially explicit analysis reveals localised risk patterns often masked by aggregated national data. Prioritising context-specific interventions (such as electrification, hygiene promotion, and enhanced maternal social support), can enhance effectiveness. The proposed analytical workflow provides a model for addressing persistent stunting in other resource-limited settings.by Yaosen Du, Yiyong Yang, Xiaolong Wu, Pengju Gao, Hanchen Ma
To enhance the efficiency, safety, and data accuracy of drilling engineering, this study developed an integrated business management platform for drilling engineering grassroots units based on the Business Model Driven (BMD) approach. The platform is built on a “five horizontal, three vertical” cloud computing architecture, establishing a five-layer system from the infrastructure layer to the user layer horizontally, and supported by standard specifications, safety, and maintenance systems vertically, enabling collaboration across multiple business scenarios and data integration. Currently, four major modules with over 20 functionalities have been developed, supporting applications such as task coordination, engineering supervision, data analysis, and accident handling. Operational results demonstrate that the platform effectively promotes integrated management of drilling engineering through real-time data sharing, full-process quality control, and intelligent decision-making, thereby enhancing operational quality and safety, reducing accident risks, and providing critical technological support for the digital transformation and upgrading of the drilling industry.by Oksana Kovtun, Olga Cheshun, Oksana Pashchuk, Kostyantyn Dumchev
BackgroundUkraine’s HIV epidemic remains concentrated among key populations, with sex workers (SWs) facing overlapping vulnerabilities, including a history of injection drug use. Although overall HIV prevalence has declined, prevention coverage remains below national and global targets. Accurate mapping of sex work hotspots is essential for effective outreach, yet existing data are fragmented and incomplete, especially in privatized and digitally mediated environments. This study aimed to systematically identify and characterize sex work venues across eight Ukrainian cities and assess their coverage by HIV prevention services.
MethodsIn 2021, we conducted a two-stage, multi-informant mapping study across eight Ukrainian cities, interviewing 1,212 secondary and 2,277 primary key informants, including SWs. Hotspots were characterized by type, perceived safety, access modality, operating schedule, and presence of SW subgroups. We used descriptive statistics, exploratory factor analysis, and multivariable mixed-effects regression to identify factors associated with HIV prevention service coverage.
ResultsOf 2,581 identified hotspots, 2,118 (82.1%) were validated as active. Apartments (43.2%), virtual platforms (11.7%), and street-based sites (11.1%) were the most common. Only 13.7% of hotspots were registered in the national HIV service registry, while 34.1% received prevention service delivery and 18.9% were reached by mobile vans. Coverage was highest at street-based and office-type venues and consistently lowest in private, virtual, and pimp-mediated settings. Service coverage was positively associated with 24/7 or daytime operation, higher perceived safety, open access, and the presence of SWs who inject drugs.
ConclusionsThis study provides comprehensive mapping of sex work hotspots in Ukraine, revealing persistent gaps in HIV prevention for less visible and harder-to-reach SWs. Community-led mapping achieved high validation rates (86.8%) and identified substantial unmet needs in digital and concealed hotspots. Routine hotspot mapping, combined with engagement with SW communities, is essential for data-driven, equitable, and adaptive HIV responses in rapidly changing contexts.
Stroke is one of the top causes of disability in Malaysia, yet caregivers have limited access to structured, culturally tailored education to support poststroke care.
To develop and validate the CaknaStrok Education Package (CEP), a blended learning intervention comprising a printed guidebook and a trilingual mobile health application for informal stroke caregivers in Malaysia.
Methodological study involving the development and validation of a caregiver education programme guided by the Analyse, Design, Develop, Implement, Evaluate (ADDIE) instructional design framework.
Development and validation were conducted in Malaysia between January 2022 and December 2023. Both experts and caregivers were recruited from two tertiary hospitals on the East Coast of Malaysia, with caregivers identified from inpatient wards and outpatient clinics at these hospitals.
Content validation involved 10 multidisciplinary experts. Face validation involved 14 informal stroke caregivers who met eligibility criteria, and all completed the study.
CEP was developed based on prior needs assessment and expert input. Content validation was undertaken using the Content Validity Index (CVI) and face validation using the Face Validity Index (FVI), both assessed on a four-point Likert scale. Qualitative feedback was also obtained from the participants.
CEP consists of six modules delivered via a printed guidebook and a trilingual app with videos, assessment tools and local resources. Experts rated the content highly valid (Scale-level (S)-CVI/the average method (Ave): 0.97–0.99 across domains). Caregivers reported strong acceptability (S-FVI/Ave: 0.95–0.99). Qualitative feedback from experts and caregivers informed refinements to content clarity, usability and presentation, including improved navigation, consistent language use and enhanced visual design. Suggestions requiring substantial structural changes were documented for future iterations.
The CEP shows strong content and face validity as a blended caregiver education tool. By combining printed and digital formats, CEP addresses cultural and access challenges and provides a scalable model for stroke caregiver education in Malaysia. Further pilot or feasibility studies are warranted to evaluate usability, engagement and implementation in real-world settings prior to effectiveness evaluation.
Endometriosis is a chronic, oestrogen-dependent condition with a wide range of symptoms and comorbidities that significantly affect physical, emotional and psychological well-being, as well as quality of life. Women with endometriosis often face complex treatment decisions with no universally accepted gold-standard therapy. Shared decision-making, supported by patient decision aids (PtDAs), can enhance patient knowledge and promote informed preferences and decisions. Digital PtDAs, in particular, offer potential for personalised, interactive and accessible decision support. Their characteristics, development process and evaluation in endometriosis care remain underexplored. The objective of this scoping review is to map the existing literature on digital PtDAs developed for women of reproductive age (18–49) with endometriosis, across a range of healthcare and digital health contexts.
This scoping review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews. A comprehensive three-step search, developed with an information specialist, will be conducted across MEDLINE (PubMed), CINAHL, Embase, Web of Science, Cochrane databases and grey literature sources. Citations will be imported into Rayyan for screening. Two independent reviewers will conduct study selection, data extraction and analysis. Data will be summarised using tables and descriptive content analysis to identify key features, development processes and evaluation methods of digital PtDAs. The review will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.
This review started off in July 2025, and the anticipated end date is November 2025. We plan to disseminate this research through publications, presentations at relevant national and international conferences and meetings with relevant stakeholders. This scoping review protocol has been registered at Open Science Framework (osf.io/fp86m). As this scoping review will use data from published and publicly available sources, research ethics approval is not required.
Hyperkalaemia (HK) is common in the emergency department (ED) and can cause life-threatening arrhythmias. Patiromer is a potassium binder whose role in acute HK management is uncertain; therefore, we investigated the efficacy and safety of patiromer as an adjunct to the standard of care treatment of HK in the ED.
A prospective, randomised, double-blind, placebo-controlled study.
16 ED sites across the USA.
Patients aged ≥18 years treated at a participating ED who were found to have serum potassium ≥5.8 mEq/L.
Participants were randomised 1:1 to standard combination therapy (25 g intravenous dextrose, 5 units intravenous insulin and 10 mg albuterol) with either patiromer or placebo. The initial dose was given within 1 hour of the potassium result, and the second dose 24 hours later.
The primary endpoint was net clinical benefit (NCB) at 6 hours, defined as the change in number of potassium-lowering interventions minus change in serum potassium. Adverse events (AEs) were also recorded.
The study was terminated early and did not reach the prespecified sample size. Overall, 111 patients (53 patiromer and 58 placebo) were analysed. Mean (SD) age was 61.34 (15.21) years, 34% were female, 48% white and 22.5% received chronic haemodialysis. Mean baseline potassium was 6.5 mmol/L. NCB at 6 hours was similar between patiromer and placebo (–0.6 vs –0.4; p=0.44). Potassium levels at 2, 4 and 6 hours were similar between the groups (5.50 vs 5.70, 5.45 vs 5.65, 5.50 vs 5.60; patiromer and placebo (all p>0.05)). The number of interventions per patient was similar (p>0.05) between groups at each time point. The proportion of patients experiencing AEs was not significant between the patiromer and placebo groups (16.98% vs 32.76%; p=0.08).
No differences in efficacy were reported in this study, which was underpowered to detect statistical efficacy of patiromer over placebo.
To assess the levels of knowledge, attitudes and practices (KAP) toward skin cancer prevention among Malaysian adults and to examine differences in KAP across socio-demographic groups.
Cross-sectional online survey.
Community-based study conducted in Malaysia using social media recruitment.
A total of 386 adults aged ≥18 years residing in Malaysia. Most participants were young adults (86.3%), female (55.4%) and of Chinese ethnicity (65.5%). Healthcare professionals were excluded.
Primary outcomes were levels of knowledge, attitude and preventive practices toward skin cancer, measured using the validated KAP-SC-Q (Knowledge, Attitude and Practice of Skin Cancer Questionnaire) and categorised as poor, moderate or good. Secondary outcomes included differences in KAP across socio-demographic and clinical characteristics, analysed using independent t-tests and 2 tests.
Over half of participants demonstrated poor knowledge of skin cancer (56.0%) and the vast majority showed inadequate preventive practices (84.2%), while attitudes toward skin cancer were predominantly positive (62.4%). Significant differences in mean KAP scores and categorical levels were observed across several socio-demographic variables. Participants with tertiary education had higher knowledge (14.32 vs 12.61) and attitude scores (20.01 vs 15.95; p
Malaysian adults exhibited limited knowledge and very poor preventive practices toward skin cancer despite generally positive attitudes. These findings highlight substantial gaps between awareness and behaviour and support the need for targeted public health interventions to correct misconceptions, improve risk perception especially in high-risk groups and promote effective ultraviolet protection behaviours.
Antimicrobial resistance (AMR) is one of the most urgent global health threats, responsible for an estimated 4.95 million deaths annually, including 1.27 million directly linked to drug-resistant infections. Nigeria is particularly affected, ranking 19th globally in AMR-related mortality, with an estimated 64 500 attributable and 263 400 associated deaths in 2019. These estimates are likely conservative due to limited surveillance. Economically, AMR could cost Nigeria 5%–7% of its GDP by 2050.
Despite this burden, antibiotic misuse remains widespread, with 42% of adults and over 46% of children under 5 receiving antibiotics without prescriptions. At the primary healthcare (PHC) level, where most antibiotics are prescribed, challenges such as limited diagnostics, inconsistent prescription and poor access to digital tools hinder effective antimicrobial stewardship (AMS).
The primary objective of this study is to assess the knowledge, attitudes and practices regarding antimicrobial resistance (AMR) among PHC prescribers in Imo State, Nigeria. A secondary objective is to explore preliminary indicators of their digital readiness to inform future technological interventions for AMS.
A cross-sectional study using an online questionnaire.
PHC facilities across all 27 local government areas of Imo State, Nigeria.
A purposive sample of 547 facility-based public PHC prescribers included 84% of all facility Officers-in-Charge of health facilities in the state and 16% of other PHC workers who were involved in prescription.
The primary outcome measures were composite scores for knowledge (adequate/inadequate), attitude (positive/negative) and prescribing practice (good/poor), derived from a validated questionnaire. Secondary measures included sources of AMR information and indicators of digital readiness.
While 77.1% demonstrated adequate knowledge, only 32.7% exhibited positive attitudes and 88.5% reported poor prescribing practices. Attitude was the strongest predictor of good practice (OR=17.585, p
These findings underscore a critical gap between knowledge and practice, driven in part by limited access to digital decision-support tools. To address the documented gaps in tool access and training, strengthening digital inclusion through context-adapted e-learning, offline-compatible AMS tools and simplified digital antibiograms is a necessary implication for improving antibiotic stewardship and clinical outcomes at the PHC level.
Fibrosing interstitial lung disease (F-ILD) are a heterogeneous group of diseases with multiple subtypes. Both idiopathic pulmonary fibrosis and other ILDs associated with a risk of developing progressive pulmonary fibrosis (PPF) are subtypes of this category. A multidisciplinary team discussion, including a chest high-resolution CT (HRCT), is usually considered the gold standard for diagnosis of F-ILD. Repeated HRCT is one of several established methods to assess progression and thus development of PPF, but it is associated with substantial costs and radiation exposure. Thoracic ultrasound (TUS) and other ultrasound (US) methods have emerged as radiation-free methods for both diagnosing and monitoring disease severity in F-ILD. Yet, consistent knowledge on the use of different TUS- and US methods in patients with F-ILD is limited.
The LORD study is a prospective cohort study conducted in participants with F-ILD at a tertiary ILD centre in Denmark. Physiological testing and patient-related outcome measures, together with TUS- and US examinations, will be performed at inclusion, after 6 and 12 months. The correlations between these assessments will be evaluated. HRCT will be conducted between 3 months prior to and 1 month after baseline, and after 1 year. At least 34 participants will be included.
The protocol was approved by the Danish Data Protection Agency (journal number: 22/45135) and the Science Ethics Committee for the Region of Southern Denmark (journal number: S-20220036). Results will be published in peer-reviewed international journals and will be presented at an international congress.
Systemic sclerosis (SSc) is a rare autoimmune disease characterised by skin and organ fibrosis, vasculopathy and immune dysregulation. Given the disease heterogeneity and severity, accurate prognostic and predictive markers are needed. Blood immunophenotyping by flow or mass cytometry offers a promising non-invasive approach to identify immune signatures associated with disease subtypes, complications (eg, interstitial lung disease, scleroderma renal crisis, digital ulcers) and treatment responses. However, findings remain inconsistent and lack clinical standardisation. This systematic review aims to identify cytometry-based blood immune markers associated with clinical outcomes in SSc.
A comprehensive search will be conducted on three databases: PubMed, Web of Science and Cochrane Library, from their inception to the date of the final search (21 December 2025). Data will be extracted and analysed using a predefined charting form. Studies published in English or French reporting the use of flow or mass cytometry for peripheral blood cells phenotyping in adults with SSc will be included. Comparators will include healthy controls, other autoimmune diseases, disease severity groups and treatment response subgroups. The primary outcome will be the association with the diffuse cutaneous subtype, while secondary outcomes will include overall survival and disease-specific mortality, organ involvement, progression of the disease and treatment response.
Ethical approval is not required as this review is an analysis of published scientific literature and does not involve patients. The results of this systematic literature review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences.
CRD420250644594.
Active self-management by patients following acute coronary syndrome (ACS) can reduce recurrent events. Patient education for transitioning from hospital to home promotes effective self-management but can be limited in the acute setting due to time and resource pressures. Patients from ethnic minority and immigrant backgrounds face additional language, cultural and health literacy barriers to receiving patient education. Self-administered virtual patient education presents an innovative solution to these challenges. This study aims to evaluate a co-adapted, virtual avatar nurse-guided, discharge education application (app) for Chinese-speaking patients following ACS.
This multicentre, assessor-blinded, randomised controlled trial will recruit 98 Chinese-speaking inpatients following ACS with evaluation at 1 and 3 months postdischarge. Control participants in the control group will receive the usual ward-based patient discharge education. Intervention participants will additionally receive the education app installed on their devices before hospital discharge with unlimited access during the study period. Cultural relevance and linguistic accuracy for this Chinese version of an existing app were ensured through co-adaptation with Chinese-speaking consumers; the primary outcome will be coronary heart disease (CHD) knowledge, and secondary outcomes will include knowledge, attitudes and beliefs regarding heart attack symptoms and responses, CHD self-management behaviours, utilisation of healthcare services and quality of life. A process evaluation will be conducted alongside the trial to assess the acceptability and feasibility of the app. Between-group comparisons will be made using 95% CIs, accounting for baseline differences using linear mixed effects or mixed effects logistic regression models.
The Western Sydney Local Health District Human Research Ethics Committee has approved this study protocol (26 February 2024, amendment number 2) (2024/STE00147), with site-specific authorisations obtained from each participating hospital. The results will be disseminated through peer-reviewed journal articles and presentations at scientific conferences.
ACTRN12624000408583.
To assess anaesthesia capacity and practice in Sierra Leone by enumerating the anaesthesia workforce by volume, training level and distribution across urban and rural areas and facility ownership; estimating the prevalence of anaesthesia methods used for common surgical procedures by provider category; and evaluating hospital infrastructure and the availability of essential anaesthesia-related medications and equipment.
A nationwide, cross-sectional, facility-based study combining structured questionnaires administered through face-to-face interviews with facility leads and retrospective review of surgical and anaesthesia logbooks.
Public and private hospitals and clinics in Sierra Leone providing surgical care with general, regional or local anaesthesia within an operating theatre.
69 of 78 eligible surgical facilities nationwide were included. Facilities providing surgical services between September 2022 and August 2023 were eligible; facilities without registries or declining participation were excluded.
Across participating facilities, the anaesthesia workforce comprised 198 full-time positions, predominantly non-physician providers, with only 40.4% (80/198) trained to administer anaesthesia independently. Ketamine-based and spinal anaesthesia were most common, while general anaesthesia with a protected airway accounted for just 5.0% (415/8339) of procedures. Anaesthesia practices varied by provider training level. Essential infrastructure, equipment and medications fell below international minimum standards, with shortages most pronounced in rural facilities.
Severe shortages of certified anaesthesia providers, limited anaesthesia techniques and inadequate material resources remain major barriers to safe anaesthesia and surgical care in Sierra Leone. Targeted investments in workforce development, infrastructure and resource allocation—particularly in rural areas—are required to improve the safety, quality and equity of anaesthesia care nationwide.
Non-communicable diseases (NCDs) are rapidly escalating in developing countries and social factors such as the dynamics of the family play an important part in the lifestyle choices that lead to the onset and maintenance of chronic illness. There remains a gap in Malaysia as the majority of the studies were focused on the normal population rather than directly towards persons having NCDs. This study aimed to examine emerging risk factors such as family functionality and its association with NCD.
A cross-sectional survey was conducted using a multistage random sampling method.
Urban residential areas in Selangor, Malaysia.
A total of 2542 adults residing in urban areas of Selangor were recruited.
Family functionality was measured using the APGAR (Adaptation, Participation, Gain or Growth, Affection and Resources) scale and multiple logistic regression was performed to measure the association between emerging risk factors and NCD.
The prevalence of diabetes mellitus and hypertension was 10.8% and 6.1%, respectively. Widowed/separated status (adjusted OR (AOR) 41.53, 95% CI 19.06 to 90.48, p value=0.001) was reported to be a predictor of diabetes. As for hypertension, familial functionality (AOR 4.2, 95% CI 1.11 to 14.50, p value
There is a growing concern that family functionality is an emerging risk factor for NCDs. Future family-centred health promotion programmes should be incorporated to improve self-management behaviours and health outcomes.
Integrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool.
This international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomised clinical trial.
The protocol was approved by the participant ethics committees. Results will be disseminated in scientific conferences and peer-reviewed journals.
Patients in intensive care units (ICUs) and their families face existential physical, psychosocial and spiritual distress. Integrating palliative care (PC) into ICU care may benefit patients, relatives and ICU clinicians. Prior PC studies have shown a reduction in ICU length of stay (LOS) and distressing symptoms without altering overall mortality. A shorter ICU LOS may alleviate the burden for patients and relatives and help optimise the use of limited intensive care resources. PC in the ICU, however, remains underused, partly due to limited access and knowledge of ICU clinicians. Also, robust data regarding the effectiveness and cost-effectiveness of PC treatment in the ICU are scarce. We established the ‘enhancing palliative care in ICUs’ (EPIC) study to implement a system-based harmonised practice model across European ICUs. The aim is to investigate if early integration of PC via telemedicine, clinician education and bedside tools is effective and cost-effective, ultimately benefiting patients, relatives and ICU clinicians.
This multicentre, controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase aims to recruit around 2,000 patients from five European countries. All adult patients admitted to participating ICUs—with an ICU LOS exceeding 72 hours, where cancer is not the primary cause of critical illness, and who are not expected to die within the next 24 hours—are screened for the need for specialised PC based on the attending physician’s judgement. This judgement is triggered by the presence of one or more of the following: (1) significant disagreement among ICU team members and/or relatives about the appropriateness of current ICU treatment, (2) considerations of limiting life-sustaining therapy or (3) the anticipation that a specialised PC consultation may benefit the patient, their relatives or the ICU team. Patients identified as needing specialised PC and their relatives are then enrolled after obtaining written informed consent.
The complex intervention consists of (a) a blended-learning programme to foster knowledge and attitude about PC among ICU clinicians, (b) bedside tools, including a checklist to identify patients in need of PC and a factsheet and (c) standardised telemedical consultations from trained EPIC interventionists. Patient and relative follow-up is conducted 3 months post-ICU discharge. Outcomes include clinical measures (including ICU LOS (primary outcome), severity of critical illness, invasive treatments and health-related quality of life), economic endpoints (resource use, costs, cost–consequence situation, cost-effectiveness), ICU clinician burnout and distress, and patient and family perception about the quality of symptom management, care and communication. Endpoint analyses will employ generalised linear mixed models, accounting for the clustered data structure and stepped wedge design.
EPIC complies with the Declaration of Helsinki and has been approved by all local ethics committees. A decision-making structure is established to ensure trial procedures are carried out according to Good Clinical Practice. Study findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public. Sets of anonymised study data will be made available following Findable, Accessible, Interoperable, and Reusable principles.
Tibial plateau fractures present a complex orthopaedic challenge and usually require surgical intervention to restore joint alignment and stability as well as to prevent complications. In practice, determining the most appropriate surgical approach, implant selection and positioning remains a challenge and depends on the surgeon’s experience and patient-specific factors. Therefore, this scoping review aims to map the current evidence on surgical fixation methods for proximal tibia fractures in adults. In particular, we seek to first assess study types and their distribution across levels of evidence and second to identify knowledge gaps to support evidence-based surgical planning.
The proposed scoping review will be conducted in accordance with the JBI methodology for scoping reviews and will be reported as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Information for this study will be gathered from Medline, Cochrane and Embase. Data analysis will involve categorising the studies by their level of evidence and extracting predefined parameters, including fracture characteristics, surgical approach, implant type and key findings relevant to the review question. The study focuses on surgically stabilised intra-articular proximal tibia fractures in adults. Only English- and German-language studies that are available in full text and published after 1995 will be included.
No ethical approval is required. The findings of the proposed review will be disseminated through publications in peer-reviewed journals.
Open Science Framework, osf.io/g9zfu.
Atrial fibrillation (AF), with a prevalence of 1–2%, is the most common cardiac arrhythmia. AF is associated with a fivefold increased risk of cardioembolic events; approximately 20% of all strokes are caused by AF. Pulmonary vein isolation (PVI) has become the first-line treatment for AF. However, PVI cannot eliminate the residual stroke risk. Current guidelines recommend that anticoagulation be continued in this specific group of patients, regardless of the presence or absence of AF. In this large AF population post-PVI, who are considered to be in an earlier stage of AF, it is unknown whether left atrial appendage closure (LAAC) offers an alternative to direct oral anticoagulant (DOAC) therapy.
The trial will be a prospective, randomised, multicentre non-inferiority study comparing two treatment strategies in AF patients after atrial ablation. Patients will be randomly assigned to either percutaneous LAAC (group A) or DOAC treatment (group B) in a 1:1 ratio; both sequential and concomitant planned ablation with or without LAAC are accepted. Randomisation will be conducted using web-based randomisation software. A total of 1012 participants (506 patients per group) will be enrolled. The primary effectiveness measure will be the occurrence of any of the specified events within 24 months after randomisation: stroke/transient ischaemic attack/systemic thromboembolism, cerebral haemorrhage, other major haemorrhages (Bleeding Academic Research Consortium ≥2), cardiovascular mortality and all-cause mortality.
The study was approved by the Ethical Review Board of Shanghai Chest Hospital, China (KS(Y)20287). Written informed consent will be obtained from all participants. The trial will follow the Declaration of Helsinki and Good Clinical Practice. Confidentiality will be maintained with anonymised, securely stored data. Findings will be disseminated through peer-reviewed publications and conferences.
ChiCTR2000036538.
This systematic review aims to synthesise current evidence on gut microbiome profiles among children with sickle cell disease (SCD), assess the influence of analgesic and antibiotic use, and explore the contributions of environmental factors on their gut microbiota diversity. Through identification of consistent microbial patterns and gaps in the existing literature, this review will provide vital insight into potential microbiome-targeted strategies for improving health outcomes in paediatric SCD care.
Studies describing the gut microbiota among paediatric SCD human subjects (
Ethical approval will not be required as this is a systematic review of published data. The findings will be disseminated through publications in peer-reviewed journals and presentations at relevant scientific conferences.
CRD420251102736.