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Hoy — Marzo 6th 2026Tus fuentes RSS

Disaggregating innovation for sustainable development in ASEAN: Panel evidence on the moderating role of government effectiveness

by Pureheart Ogheneogaga Irikefe, Mohammad Falahat, Ahmad Danial Zainudin, Ihtisham Ullah, Nohman Khan, Bernard Ojonugwa Anthony

With progress toward the 2030 Agenda faltering, many see innovation as a key to sustainable development. The Association of Southeast Asian Nations (ASEAN) bloc represents a unique opportunity to examine how innovation capabilities drive sustainability in diverse economic and developmental contexts. Using panel data for ASEAN countries from 2011 to 2022, this study breaks down innovation into the seven pillars of the Global Innovation Index (GII) and investigates their impact on the Sustainable Development Goal (SDG) Index; with the objective of identifying which GII pillars most strongly predict SDG, while examining the moderating role of government effectiveness and controlling the impacts of gross national income per capita and foreign direct investment. Fixed effects models were used to analyse the data and supplemented by Driscoll-Kraay standard errors, addressing unobserved heterogeneity and cross-sectional dependence. Results reveal that only Institutions and Infrastructure pillars exert a consistently positive impact on SDG performance. In contrast, Creative Outputs have a negative impact. Importantly, Government Effectiveness reverses the negative impact of Creative Outputs, so that this pillar becomes positive for SDG achievement, without significant moderation of the other six GII pillars when controlling for year effects. In conclusion, these findings contest the efficacy of universal innovation policies and underscore the imperative for nuanced, context‑specific ones. It is recommended that ASEAN governments prioritize institutional and infrastructural investments and develop tailored regulatory frameworks, such as green intellectual property regimes and digital economy standards, to harness the creative economy for inclusive, sustainable growth by explicitly integrating innovation strategies with governance reforms.

Multidrug resistance patterns and carbapenemase production among Gram-negative bacteria causing healthcare-associated infections in hospitalized patients at the University of Gondar Comprehensive Specialized Hospital, Northwest Ethiopia

by Kindu Alem, Mucheye Gizachew, Mulat Dagnew, Worku Ferede, Solomon Belay, Baye Gelaw, Feleke Moges

Background

Klebsiella pneumoniae, Acinetobacter species, and Pseudomonas aeruginosa are priority pathogens identified by the World Health Organization that have emerged as major causes of healthcare-associated infections. Their increasing resistance to multiple antimicrobial agents poses significant challenges to clinical management and infection control efforts.

Objective

This study aimed to determine the prevalence, associated risk factors, antimicrobial resistance patterns, and carbapenemase production of K. pneumoniae, Acinetobacter spp., and P. aeruginosa among hospitalized patients with suspected bloodstream, urinary tract, and surgical site healthcare-associated infections at the University of Gondar Comprehensive Specialized Hospital, Northwest Ethiopia.

Methods

A hospital-based cross-sectional study was conducted from August 2024 to June 2025 among 477 patients suspected of bloodstream, urinary tract, or surgical site healthcare-associated infections. Socio-demographic and clinical data were collected using a semi-structured questionnaire. Blood, urine, and wound/pus specimens were aseptically collected and inoculated on MacConkey, blood, and cysteine lactose electrolyte-deficient agar following standard microbiological techniques. Antimicrobial susceptibility testing was performed using the Kirby-Bauer disc diffusion method on Mueller-Hinton agar according to Clinical and Laboratory Standards Institute guidelines. Data were analyzed using SPSS version 27. Bivariate and multivariate logistic regression analyzes were used to identify factors associated with healthcare-associated infections. P value  Results

Among the 477 patients, 118 (24.7%) developed healthcare-associated infections caused by K. pneumoniae, Acinetobacter spp., and P. aeruginosa, with culture positivity rates of 14.9%, 4.8%, and 5%, respectively. Significant associated factors included age under five (AOR = 13.260, p K. pneumoniae, 69.6% of Acinetobacter spp., and 58.3% of P. aeruginosa isolates. Carbapenemase production occurred in 92%, 77.8%, and 57.1% of these carbapenem-resistant isolates, respectively. Amikacin, meropenem, and ciprofloxacin were the most effective antimicrobials, whereas chloramphenicol was effective only against K. pneumoniae.

Conclusion

This study showed high prevalence of multidrug resistance and carbapenemase production among K. pneumoniae, Acinetobacter spp., and P. aeruginosa in the study area, highlighting the urgent need to strengthen infection prevention and control measures and to promote antimicrobial stewardship programs.

Detection of spike protein in term placentas of COVID-19 vaccinated and/or SARS-CoV-2 infected women

by Catharina Bartmann, Vanessa Schmidt, Michael Mörz, Michael Schwab, Monika Rehn, Bettina Blau-Schneider, Achim Wöckel, Ulrike Kämmerer

Introduction

COVID-19 (Corona Virus Induced Disease-19) caused by the SARS-CoV-2 coronavirus can be a serious in pregnancy. Therefore, vaccination with modRNA vaccines was recommended depending on the immunity status for women of reproductive age and pregnant women since 2022. However, there are only preliminary data on transplacental transmission of the virus and modRNA from genetic vaccines so far.

Methods

The study population included 106 women who have given birth at the Department of Obstetrics and Gynecology, University Hospital of Würzburg during November 2020 to October 2022. In addition to medical data and vaccination history, immunohistochemical examination of the placenta was performed with antibodies against SARS-CoV-2 spike and nucleocapsid proteins. RNAscope in situ Hybridization was used to show RNA detection in positive placental tissues as a proof of concept.

Results

Altogether, 87% of participants received at least one vaccine dose against SARS-CoV-2 and 56 women (42 vaccinated, 14 not vaccinated) contracted COVID-19. In total, 31 placentas were found positive for the spike protein. Spike positive cells were predominantly Hofbauer cells and trophoblasts. In three cases of vaccinated and then infected woman, an additional nucleocapsid staining was detected, but there was no significant difference in staining pattern in correlation to the vaccine/COVID-19 status. Interestingly, we did not find viral RNA in the investigated samples, but we could show a positive in situ Hybridization of BNT162b2 and S-encoding mRNA-1273 in two individual samples.

Discussion

The spike protein of SARS-CoV-2 has been be detected in placental Hofbauer and Trophoblast cells as well as villous endothelia after infection and vaccination indicating a possible transplacental transfer or uptake. These findings may suggest a potential for transplacental transfer or cellular uptake; however, the extent, mechanisms, and clinical significance of this phenomenon remain to be fully understood.Clinical trial registration: DRKS00022506.

Enhanced lung volumes and pressures in traditional wind instrument musicians: The case of the Mejwez

by Mohammad Z. Darabseh, Aseel Aburub, Ragad Alkaraki, Abdullah Saber Alshammari, Yazan Almansi, Ghaith Dalalah, Csaba Melczer, Pongrác Ács

To evaluate pulmonary function and respiratory muscle strength in Mejwez players compared to predicted norms, and to assess the influence of smoking behaviours on these outcomes. A cross-sectional study was conducted involving adult Mejwez players. Spirometric parameters (forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), and FEV₁/FVC) and respiratory pressures (maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)) were measured and compared to predicted values. Multiple linear regression was used to assess the impact of smoking behaviours on respiratory outcomes. Mejwez players demonstrated significantly higher FEV₁ (+0.38 L, p 

Meningococcal carriage and transmission dynamics in college students in Louisville, Kentucky

by Forest W. Arnold, Leslie Wolf Parrish, Subathra Marimuthu, Jamie Findlow, Angela Quinn, Vidyulata Salunkhe, Daniya Sheikh, Phillip Bressoud, T’shura Ali, Dawn Balcom, Mohammad Ali, Ryan S. Doster, Deepti Deepti, Mohammad Tahboub, Fama Ndiaye, Jay Lucidarme, Stephen A. Clark, Ray Borrow, Paul Balmer, Steven Gootee, for the CERID study group

Background

Neisseria meningitidis is a cause of meningitis and outbreaks of it among young adults, especially college students. Rates of nasopharyngeal colonization and prevalence of specific capsular groups vary with age, geography as well as time, and may be influenced by meningococcal vaccination. The objective of this study was to measure the change in colonization rate, and define which meningococcal genogroups were present, in college students over a 3-month semester.

Methods

This was a prospective, longitudinal cohort study with sequential oropharyngeal swabbing among college students at the University of Louisville (UofL) in Louisville, Kentucky from August to November 2022. Participants were ≥18 years of age and were enrolled within 48 hours of moving to campus-affiliated housing. Oropharyngeal swabs were collected at enrollment, one month and at three months. Samples were screened for N. meningitidis, and isolates were characterized using phenotypic and genotypic methods. Behavior questionnaires were obtained at each visit to identify risk factors for N. meningitidis colonization.

Results

A total of 1047 participants were seen initially, of whom 821 attended all three visits. The baseline colonization rate was 3.5% followed by 3.9% after one month and 5.7% after three months. The genogroups of recovered isolates were capsule null (48%), B (38%; of which 11% were expressing capsule) and E (12%). No genogroup ACWY isolates were recovered. A total of 36% of participants had a history of receiving at least one MenB vaccine dose and 74% had a history of receiving at least one MenACWY vaccine. Risk factors for N. meningitidis nasopharyngeal carriage included being a second-year student, living on campus for the second year, smoking/vaping, kissing and sexual contact.

Conclusions

An increase in N. meningitidis colonization over the 3-month semester was observed from 3.5% to 5.7%. The overall proportion of student carriers was significantly lower, and there were no genogroup A, C, W or Y strains isolated compared to studies conducted prior to the availability of meningococcal vaccines and the COVID-19 pandemic. However, genogroup B carriage, transmission and acquisition were almost identical to pre-COVID pandemic studies. This study reinforces the importance of periodic epidemiological monitoring of carriage as well as disease.

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Integrating sequence-based GWAS and comparative genomic analysis reveals conservation and species-specificity of putative functional variants influencing tail length and tail abnormalities in pigs and sheep

by Xuying Zhang, Johanna Mainzer, Isabella Giambra, Tong Yin, Petra Engel, Hannah Hümmelchen, Henrik Wagner, Axel Wehrend, Christiane Egerer, Katharina Gerhards, Gerald Reiner, Sven König

Long tails trigger tail biting in pigs and increase the risk of flystrike infections in sheep. Tail docking has been a common management practice in both species for decades, but increasingly conflicts with legal animal welfare guidelines. Sustainable solutions require breeding strategies targeting shorter tails. In consequence, the aims were to conduct whole-genome sequencing (WGS)-based genome-wide association studies (GWAS) and comparative genomic analyses (CGA) to explore functional elements influencing tail traits. Phenotypically divergent experimental populations of pigs and sheep were established through unified selection and mating experiments. Tail traits included tail length (TL) measured at birth, and tail abnormalities (TA) assessed radiographically at 14 weeks of age. WGS-based GWAS identified a significant locus on SSC18 in pigs and suggestive loci for TL in both species, which, together with previously reported loci for TA, were further analyzed by CGA. The genomic windows of the significant locus on SSC18 in pigs and the TL GWAS locus on OAR4 in sheep were found to be conserved, harboring six common genes with predicted functional variants. These variants were jointly associated with TL (Plm) in both species in linear regression models adjusted for sex, age of the dam, body length, and body weight. In other GWAS locus windows (±1 Mb), species-specific TL candidate genes were identified in sheep (HOXB13, MUC5B, EPB41L3, MTCL1, PIEZO2, MPPE1, and LOXHD1) and in pigs (KNL1, DISP2, SPRED1, TGFB2, and HAND1), each harboring associated putative functional variants. For TA, sheep-specific candidates (PGM2, LRRC66, CRACD, LOC105601916, and SH2D4B) and pig-specific candidates (MYOT, TMCO6, and PCDHAC2) were revealed using logistic regression models (Pglm). GO analyses of candidate genes predicted shared biological processes between sheep and pigs, whereas pathway analyses indicated that common carbohydrate metabolism pathways, along with species-specific immune and inflammatory signaling, and pig-specific TGF-β signaling and endochondral ossification, may contribute to tail length variation and abnormalities. These findings provided deeper insights into the genetic basis of differential embryonic tail morphogenesis and perinatal tail development across species.

COVID-19 knowledge, attitudes, and practices among people vulnerable to HIV in Uganda: A cross-sectional cohort analysis

by Job Kasule, Julius L. Tonzel, Natalie Burns, Tyler Hamby, Roger Ying, Grace Mirembe, Immaculate Nakabuye, Hannah Kibuuka, Margaret Yacovone, Betty Mwesigwa, Trevor A. Crowell, for the Multinational Observational Cohort of HIV and other Infections (MOCHI) Study Group

Background

People with behavioral vulnerability to HIV face barriers to healthcare engagement that may impede uptake of non-pharmaceutical and other interventions to prevent COVID-19. Understanding COVID-19 knowledge, attitudes, and practices in this population can inform disease prevention efforts during future pandemics.

Materials and methods

From October 2022 to September 2024, we enrolled participants aged 14–55 years without HIV who endorsed recent sexually transmitted infection, injection drug use, transactional sex, condomless sex, and/or anal sex with male partners. At enrollment, we collected socio-behavioral data, including assessments of COVID-19 knowledge, attitudes, and practices. Robust Poisson regression with purposeful variable selection was used to estimate prevalence ratios with 95% confidence intervals for factors associated with COVID-19 preventive practices.

Results

Among 418 participants, 228 (56.9%) were female, the median age was 21 years (interquartile range 19−24), and 362 (84.9%) reported sex work. Knowledge about SARS-CoV-2 transmission routes was high (95.4%) but lower for the consequences of genetic variants (48.5%−69.7%) and possibility for asymptomatic infection or transmission (66.7%−80.8%). Handwashing was practiced by 90.8% of participants in the preceding month, whereas mask-wearing (76.5%), avoiding symptomatic people (73.7%), and any history of COVID-19 vaccination (46.9%) were less prevalent. Males were more likely to report avoiding symptomatic people (adjusted prevalence ratio 1.16 [95% confidence interval 1.03–1.31]) and COVID-19 vaccination (1.30 [1.05–1.60]). Enrollment during the BQ.1/BQ.1.1 Omicron wave was associated with less mask-wearing (0.81 [0.67–0.99]) but more vaccination (1.59 [1.29–1.95]).

Discussion

We observed variable COVID-19 knowledge and attitudes among Ugandan adolescents and adults with little impact on COVID-19 preventive practices. Efforts to address suboptimal uptake of disease preventive practices during this and future disease outbreaks will require more than just improving knowledge.

Adoption and implementation of teleaudiology as a telehealth model in Jordan and Arab countries: A cross-sectional survey

by Hala M. AlOmari, Hanady Bani Hani, Telda Alkhateeb, Dua’ Qutaishat

Background and objectives

Telehealth is the provision of healthcare services remotely via telecommunications technology. The implementation, clinical applications, and perceived effectiveness of telehealth among audiologists across the Arab region, particularly following its accelerated adoption due to the COVID-19 pandemic was investigated.

Materials and methods

A cross-sectional survey was conducted between April and June 2024 among 194 audiologists from multiple countries. A non-probability purposive sampling approach was implemented. The respondents were grouped into providers and non-providers of telehealth services. The questionnaire collected data on demographics, service delivery models, telehealth applications, training background, and perceived challenges. Descriptive and inferential analyses were performed to identify predictors of teleaudiology adoption.

Results

46.9% of the sample reported providing telehealth services. Many of them (69.2%) indicated that they began offering telehealth services following the COVID-19 pandemic. Synchronous delivery was commonly utilised. Younger professionals and those employed in public institutions were more likely to engage in remote service delivery (p Conclusions

The audiologists’ reported perceptions and experiences indicate that teleaudiology remains limited in clinical diagnostic service delivery. Broader integration of teleaudiology practices may benefit from enhanced professional training, the development of standardised guidelines, and investment in technological infrastructure to support access to remote hearing healthcare.

Protocol for a systematic review and meta-analysis of pharmacological and non-pharmacological interventions for chronic pain management in chronic kidney disease

by Chi Peng Chan, Babaniji Omosule, Courtney Lightfoot, Ellesha A. Smith, Ffion Curtis, James O. Burton, Paul Gardner, Sarah Jasat, Sherna F. Adenwalla, Jyoti Baharani, Daniel S. March

Background

Chronic pain affects up to 60% of people with chronic kidney disease (CKD), yet remains under-recognised and under-treated. Pain management in this population is complicated by altered drug pharmacokinetics, polypharmacy, and the potential nephrotoxicity of conventional analgesics. Despite the high prevalence and significant impact on quality of life, evidence-based guidance specific to pain management in CKD remains limited.

Objectives

This systematic review aims to evaluate the effectiveness and safety of both pharmacological and non-pharmacological interventions in reducing chronic pain intensity among people with CKD on dialysis, not on dialysis, and kidney transplant recipients, across all stages of CKD.

Methods

The primary outcome is the effectiveness of interventions in reducing chronic pain intensity as assessed by pain assessment tools. We will conduct a comprehensive search of MEDLINE, Embase, CINAHL, Web of Science, and ClinicalTrials.gov from their inception to the present date to identify studies for chronic pain management in people living with CKD. Study screening will be conducted independently by two reviewers. One reviewer will extract data from each study, with a second reviewer cross-checking for accuracy and completeness. Data will be extracted on study characteristics, participant demographics, intervention components, pain outcomes, and adverse events. The certainty of evidence will be evaluated independently by two reviewers using the GRADE approach. Where applicable, data will be combined in meta-analyses using random-effects models. Additionally, a network meta-analysis will be performed if enough studies are available.

Expected results

This review will synthesise the current evidence for pain management strategies in CKD, by evaluating effectiveness of interventions among people receiving different renal replacement therapy modalities with varying pain and disease phenotypes. Findings will highlight the comparative effectiveness of various interventions while considering their safety profiles specific to the CKD context. The review will identify gaps in the literature and provide recommendations for clinical practice and future research.

Significance

This review seeks to deliver a thorough evaluation of pain management strategies for people living with CKD. This systematic review is supported by the UK Kidney Association (UKKA), and findings will inform the upcoming UKKA guideline on symptoms management in people with CKD, alongside the other symptoms including itch, fatigue, and gastrointestinal symptoms. This review will aid clinicians in making well-informed decisions regarding pain management strategies, ensuring a balance between effectiveness and the specific risks associated with CKD.

Exploring the relationship between mental health and urban green space soundscapes: A scoping review

by Elham Ahmadi, Sophia Baierl, Stephan Voss, Ida Asenkerschbaumer, Ursula Berndt, Leonie Bernhard, Anita Hennig, Anna-Lena Würfele, Michaela Coenen

Urban soundscapes, particularly those experienced in green spaces, have been increasingly recognized as factors that influence human mental health. This scoping review explores the existing literature on soundscapes within urban green spaces and their associated mental health outcomes. It aims to classify the methodologies used in this domain, identify mental health outcomes related to urban green space soundscapes, and examine specific soundscape elements and their correlations with mental health. A systematic search of peer-reviewed studies was conducted. After screening titles, abstracts, and full texts, 22 studies met the inclusion criteria. Diverse methodological approaches were identified, with an emphasis on quantitative multi-method designs. Commonly studied mental health outcomes include stress reduction, mood enhancement, perceived restorativeness, and cognitive restoration. Standardized psychometric tools, such as the Perceived Stress Scale (PSS-14), Positive and Negative Affect Schedule (PANAS) and Perceived Restorativeness Soundscape Scale (PRSS) are frequently used as outcome measures. Natural soundscape elements such as birdsong, water sounds, and rustling leaves had a positive association with relaxation and perceived mental restoration throughout all studies, while mechanical sounds, such as traffic noise were linked to adverse mental health outcomes. These findings highlight that natural soundscapes in urban green spaces have a potential positive relationship with mental health by reducing stress and enhancing mood. However, the cross-sectional design and methodological heterogeneity of the included studies limit causal interpretation. Future research should explore multi-sensory experiences and examine soundscapes in diverse urban contexts to provide more robust insights into their relationship with mental health. The practical implications suggest that urban planners should prioritize integrating natural sound elements into urban areas to improve mental health. The study protocol of this scoping review had been registered at OSF (osf.io/4r7gd).

Mental health help-seeking intentions among health workers in the east coast of peninsular Malaysia: Perceived barriers and predictive factors

by Muhammad Syafiq Kunyahamu, Aziah Daud, Ijlal Syamim Mohd Basri, Tengku Alina Tengku Ismail, Mohd Faiz Md Tahir

Introduction

Mental health problems among health workers are a growing concern globally, including in Malaysia. Despite the availability of mental health services, some health workers do not seek professional help. This study aims to determine the level of health workers’ intention to seek professional help, examine the barriers they perceive, and identify predictors of mental health help-seeking intention.

Methods

This cross-sectional study involved 470 health workers in the East Coast region of Peninsular Malaysia. Data was collected using a self-administered questionnaire. Linear regression analysis was employed to identify the predictors of professional help-seeking intention.

Results

The mean score for mental health help-seeking intention was 4.90 (SD = 1.03). Perceived need for help positively predicted help-seeking intention (B = 0.532, p  Conclusions

This study highlights the roles of the perceived need for help and perceived stigma barriers in predicting health workers’ help-seeking intentions, offering a basis for targeted interventions and policies to enhance mental health support within Malaysian healthcare settings.

Exploratory study on the impact of <i>Ganoderma australe</i> extract on gut microbiota and immune gene expression in honey bees exposed to <i>Vairimorpha ceranae</i>

by Sarah Zuern, Bella Romero, Carlos Spichiger, Leandro Ortiz, Alejandro Jerez, Esteban Basoalto, Max Emil Schön, Sigisfredo Garnica

The microsporidium Vairimorpha (Nosema) ceranae is an emerging threat to honey bees (Apis mellifera), known to disrupt gut microbiota and suppress immune responses, potentially contributing to colony losses. Fungal extracts have recently gained interest as sources of bioactive compounds with antimicrobial and immunomodulatory potential. In this study, we explored the effects of different dietary supplements—sugar syrup, HiveAlive™, and a novel Ganoderma australe extract (GanoBee)—on gut bacterial composition and immune-related gene expression in honey bees subjected to experimental exposure to V. ceranae 1 x 104 spores per bee. The GanoBee diet altered the gut microbiota, notably reducing the relative abundance of Rhizobiaceae (Bartonella apis) and increasing Frischella compared to other treatments. While alpha diversity was not significantly affected by diet or exposure to V. ceranae, beta diversity differed significantly in bees fed with GanoBee. Additionally, the expression of the antimicrobial peptide genes abaecin and hymenoptaecin was elevated in both exposed and unexposed bees fed with GanoBee, depending on the sampling day. However, the establishment of V. ceranae infection appeared limited, likely due to low spore viability, and mortality in control bees was higher than expected. The low Vairimorpha ceranae infection levels observed in this study are likely attributable to reduced spore viability caused by storage conditions and/or suboptimal environmental conditions within the laboratory cages. Post hoc analyses indicated that the high viscosity of GanoBee-supplemented diets likely contributed to the elevated bee mortality observed, underscoring a critical limitation of the experimental design related to diet formulation and delivery method. These physical factors complicate the interpretation of treatment efficacy and highlight the importance of optimizing feeding protocols to avoid confounding effects. Despite these constraints, GanoBee demonstrated promising potential as a modulator of gut microbiota composition and immune-related gene expression, supporting the need for further research under improved and carefully controlled experimental conditions.

Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design: A protocol

by Claire L. Chan, Saskia Eddy, Jennie Hejdenberg, Ben Morgan, Heather M. Morgan, Gillian Lancaster, Clare Robinson, Sandra M. Eldridge

Background

The National Institute for Health and Care Research accepts applications for pilot and feasibility studies to their Research for Patient Benefit (RfPB) programme. There has been limited work describing the design practices of these applications and funding status. Knowing some of the qualities which may contribute towards a pilot or feasibility study application successfully gaining funding could help researchers improve the quality of their applications. Therefore, this study describes the protocol for a review looking at the characteristics of funded and non-funded external pilot trial applications. In particular, the primary objective is to describe the planned sample size and sample size justifications.

Methods

The study will be conducted on 100 applications from Competition 31–37 with a randomised feasibility design, identified and given access to us by RfPB where the lead applicant has consented. We will screen these applications to identify the external pilot trials, first looking through the titles and then the full text. Following this, we will extract data on information such as medical area, study design, objective(s), sample size, sample size justification, and funding outcome stage one and two. Validation will be performed on 20% of the data extracted; discrepancies will be resolved by discussion or a third reviewer will decide if there is no consensus. We will use descriptive statistics to summarise quantitative data, and will analyse qualitative data using thematic analysis. Findings will be summarised through discussion with the project contributors to produce a reader-friendly guidance document.

Discussion

This work will provide a more complete picture of RfPB external randomised pilot and feasibility trials. The findings will assist researchers when planning their pilot trials, and could help improve the quality of submitted applications.

Protocol Registration

Open Science Framework protocol registration DOI: https://doi.org/10.17605/OSF.IO/PYKVG.

Utility of Xpert MTB/RIF using bronchoalveolar lavage samples for the diagnosis of pulmonary tuberculosis in negative or sputum-scarce adults: a systematic review and meta-analysis protocol

Introduction

Tuberculosis is the leading cause of death globally from a single infectious agent. Early diagnosis is critical to reducing morbimortality. In cases of negative smear microscopy or limited sputum production, bronchoalveolar lavage (BAL) samples offer an alternative for diagnosis. Culture, the gold standard, requires a high bacterial load, extensive infrastructure and is time-consuming. Xpert MTB/RIF provides faster results with a higher cost. Previous systematic reviews present substantial limitations, including significant heterogeneity. Therefore, the diagnostic utility of Xpert MTB/RIF using BAL samples in adults with negative or scant sputum for pulmonary tuberculosis (PTB) needs to be reassessed.

Methods and analysis

A systematic search of MEDLINE, Embase, LILACS and Web of Science will be conducted without language or publication date restriction. Cross-sectional diagnostic studies of negative or sputum-scarce adults with presumptive PTB who underwent bronchoscopy to obtain samples for Xpert MTB/RIF and culture will be included. Screening and data extraction will be performed independently. Methodological quality will be assessed using the QUADAS-2 tool. A bivariate hierarchical random-effects model will synthesise sensitivity and specificity. Meta-analysis will be performed using Meta-DiSc 2.0. Heterogeneity will be assessed using I2 and Cochrane thresholds. Subgroup analyses will be performed based on study design, population differences, country, culture method and risk of bias. Publication bias will be investigated using a funnel plot. The certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. There was no patient or public involvement in the development of the systematic review protocol.

Ethics and dissemination

Ethical approval is not required as this study will use publicly available data. Findings will be disseminated through peer-reviewed publication.

PROSPERO registration number

CRD42025639440.

Pragmatic, open-label, multicentre, randomised controlled trial to guide initial therapy for immune checkpoint inhibitor-induced inflammatory arthritis comparing standard of care (prednisolone) to adalimumab without glucocorticoids: REACT trial protocol

Por: Fisher · B. A. · Rowe · A. · Hodson · C. · Wilkhu · M. · Williams · E. · Turner · E. · Allard · A. · Blake · T. · Bombardieri · M. · Cope · A. P. · Dubey · S. · Mankia · K. · Malley · T. · Moore · O. · Payne · M. · Plummer · R. · Tilby · M. · Tillett · T. · Wong · E. · Wu · Y. · Filer · A. · Pra
Introduction

Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment through targeted disruption of the physiological pathways that maintain tissue tolerance, but which are co-opted by cancers to evade immunosurveillance. Thus, the resultant T-cell activity often causes immune-related adverse events including immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA). ICI-IA results in functional impairment that frequently persists, even after ICI discontinuation, with substantial quality-of-life impacts for cancer survivors.

A high-quality body of evidence to guide ICI-IA management remains an unmet need. Pharmacological treatment may be prolonged, typically begins with non-specific immunosuppression, including systemic steroids, and is usually only rationalised to more targeted therapy in resistant cases. Moreover, retrospective data suggest the high dose glucocorticoids sometimes used in new-onset ICI-IA may be associated with worse cancer outcomes.

Tumour necrosis factor (TNF) inhibition strategies are well established with excellent efficacy and safety profiles in ‘spontaneous’ inflammatory arthritides including rheumatoid and psoriatic arthritis. Mechanistic evidence from ex vivo and murine studies also supports the utility of anti-TNF therapy for steroid-refractory cases of ICI-IA. Although good clinical responses have been reported in this setting, the REACT trial (REmission induction of Arthritis caused by Cancer ImmunoTherapy) aims to provide randomised and robust clinical evidence for deploying targeted therapy earlier in ICI-IA management. It will test whether up-front anti-TNF therapy can more effectively and quickly control symptoms, reduce glucocorticoid exposure, prevent early ICI discontinuation and increase the frequency of drug-free ICI-IA remission.

Methods and analysis

REACT is a prospective, multicentre, open-label, superiority, two-arm, randomised controlled clinical trial to guide initial therapy for patients with ICI-IA. The trial will compare the current standard of care (initial prednisolone; Arm A) with the anti-TNF drug, adalimumab without glucocorticoids (Arm B).

The primary outcome is glucocorticoid-free arthritis remission rate at 24 weeks where remission is defined as: (i) No use of systemic or intra-articular glucocorticoids (except when used for adrenal insufficiency) within 4 weeks prior to assessment at 24 weeks; and (ii) absence of synovitis on clinical examination.

Ethics and dissemination

The protocol was approved by East Midlands—Leicester South Research Ethics Committee on 31-Oct-2024 (Ref: 24/EM/0202). Participants are required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number

ISRCTN18217497.

Hepatitis B virus infection and its determinants among pregnant women in Ethiopia: protocol for umbrella review of systematic review and meta-analysis 2025

Por: Bekele · M. · Oche · W. O. · Geltore · T. E. · Sileshi · E. · Hadaro · T. S. · Alano · B. A. · Abera · W.
Introduction

Among the five hepatitis viruses, the hepatitis B virus (HBV) is a major cause of serious acute and chronic liver infections worldwide. The major public health impact of HBV infection arises from chronic liver disease, including cirrhosis and hepatocellular carcinoma, which predominantly affects young and middle-aged adults of both sexes. Therefore, preventive interventions focusing on mothers and infants are critical due to vertical and early childhood transmission dynamics.

HBV prevalence largely varies among pregnant women in Ethiopia because of multiple interrelated factors. This umbrella review will consolidate all existing systematic reviews and create a more reliable picture of HBV infection and its determinants among pregnant women in Ethiopia.

Methods and analysis

This umbrella review will be conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses reporting standards. The review will focus on identifying and integrating evidence from eligible systematic reviews and meta-analyses, with methodological quality appraised using the MeaSurement Tool to Assess systematic Reviews instrument. A comprehensive literature search strategy will be developed using relevant Medical Subject Headings alongside free-text keywords. Electronic searches will be conducted in PubMed/MEDLINE, African Journals Online, Web of Science, Scopus and Google Scholar. Statistical heterogeneity among the included reviews will be quantified using the I² statistic. Data management and meta-analytic procedures will be performed using STATA version 17, and effect estimates will be presented with corresponding 95% CIs to determine statistical precision.

Ethics and dissemination

This review uses only published or publicly available data, so ethics approval is not required. Findings will be disseminated via peer-reviewed publications, conference presentations and shared with policymakers, healthcare partners, clinicians and patients to inform policy, enhance education and guide future research.

PROSPERO registration number

PROSPERO (CRD420251118982).

Fighting for care: how can we better support people with multiple long-term conditions who are accessing community mental health groups? A qualitative interview study within a UK arts therapies trial

Por: Hounsell · L. · Millard · E. · Medlicott · E. · Fry · E. · Fernandes · J. · Carr · C.
Objective

To explore the impact of multiple long-term conditions (MTLCs) and a comorbid mental health condition on decision-making processes, attendance and engagement in NHS community-based therapy groups.

Design

Qualitative in-depth interviews analysed using reflexive codebook analysis as part of a study within a trial.

Setting

Secondary community mental health teams from two UK sites.

Participants

Purposive sample of 20 participants recruited to a randomised controlled trial of group therapies (arts therapies and counselling) holding a mental health diagnosis and self-reported as having at least one additional physical health condition.

Results

Six themes were constructed: (1) MLTCs influenced arts modality choices and goals; (2) importance of planning ahead to be organised; (3) the journey loomed over participants; (4) the impact of MLTCs on group attendance and participation; (5) the group was valued and important; (6) determination and fighting to get what I need.

Decisions about arts modalities and group attendance were based on a self-perceived level of felt capability. It was important for participants to plan in advance and feel informed ahead of making commitments, enabling them to prepare and manage symptoms. Travelling to the groups was dreaded, and many participants required support with travel in order to attend. Managing symptoms during the journey and groups was challenging; however, participants had a strong determination to uphold the commitment to attend despite their difficulties, as the group was highly valued.

Conclusions

MLTCs have a large impact on people’s capacity to engage in community groups, requiring additional planning and effort. The scale of this impact is often not recognised. Despite this, the benefits of groups for people with MLTCs are especially important, including motivation to leave the house, opportunities for socialisation and a means of reaching one’s own goals. Clinicians are recommended to accommodate the needs of MLTCs when designing community group interventions and consider multiple attendees with MLTCs in the group composition to improve attendance and group engagement.

Trial registration number

ISRCTN88805048.

Effectiveness and cost-effectiveness of a 9 week multi-component cycling programme versus an existing single cycling training session: protocol for the Cycle Nation Communities randomised controlled trial

Por: Lawlor · E. R. · Gabler Trisotti · M. F. · McIntosh · E. · McConnachie · A. · Gill · J. M. R. · Gray · C. M.
Introduction

Cycling can be beneficial for health, well-being and the environment; however, cycling participation in the UK remains low. Effective and cost-effective strategies are needed to support people in the community to increase cycling. The Cycle Nation Communities randomised controlled trial (RCT) will evaluate whether a 9 week multi-component cycling programme (Cycle Nation) is more effective and cost-effective than an existing national cycle training session on cycling participation, transport use and health and well-being.

Methods and analysis

This pragmatic, single-blinded, two-arm RCT will recruit ≥268 adults who cycle infrequently. Participants will be randomised to the 9 week multi-component individual/social-level group-based Cycle Nation programme or an existing national standard single group-based cycle training session. Both arms will be delivered by community-based cycling organisations in Glasgow. Participants will complete self-reported measurements at baseline, 12 weeks and 12 months. The primary outcome is the proportion of participants cycling at least weekly at 12 months. Secondary outcomes include proportion of participants cycling at least weekly at 12 weeks; change in weekly number of rides and minutes of cycling and use of private car, taxi, public transport and walking at 12 weeks and 12 months; change in motivation, perceptions of cycling safety, confidence to cycle, self-esteem, vitality, health-related quality of life and perceived general physical health at 12 weeks and 12 months. A within-trial economic evaluation from a National Health Service/personal social service and a broader societal perspective will be undertaken. Pending within-trial results, a long-term model may be developed. An embedded process evaluation will use participant and facilitator interviews, participant acceptability questionnaires, facilitator delivery proforma and session observations.

Ethics and dissemination

Ethical approval has been obtained from the University of Glasgow Medical, Veterinary and Life Sciences Ethics Committee (11 April 25). Findings will be published in peer-reviewed journals and communicated to stakeholders and the public.

Trial registration number

NCT07005674.

Feasibility of the ICF CoreSets for Autism Strengths and Needs Assessment in NHS diagnostic services in England: protocol for a randomised pilot trial

Por: Day · M. · Scargill · K. · Poole · D. · Kellar · I. · Young · T. A. · Bölte · S. · Clarke · S. · Lodge · K.-M. · Woods · A. · Freeth · M.
Introduction

There are approximately 700 000 autistic people in the UK, and autism is increasingly being diagnosed in adulthood. Diagnosis on its own does not provide adequate information to plan post-diagnostic support for autistic people, and clinicians often plan support without the use of validated standardised tools which may exacerbate inequities in care. This study will evaluate a novel strengths and needs assessment, based on the WHO’s International Classification of Functioning, Disability and Health CoreSet for Autism, for use in adult diagnostic services immediately on receipt of an autism diagnosis. Potential issues, including the length of the assessment, timing of delivery and selection bias, will be explored as part of the trial process evaluation.

Methods and analysis

A two-arm, multisite, randomised pilot trial design will be used to evaluate the ICF CoreSets for Autism Strengths and Needs Assessment in three diagnostic services in England. A total of 72 newly diagnosed autistic adults will be recruited across the three sites over a 6-month period and randomised into an assessment group (strengths and needs assessment plus standard care) and a treatment as usual group (standard care only). The assessment group will receive a summary report of their strengths and needs on completion of the assessment. Both groups will complete measures of mental health and quality of life at baseline and 3 months follow-up (Patient Health Questionnaire-9, Generalised Anxiety Disorder questionnaire-7, Recovering Quality of Life questionnaire-10, EuroQoL-5D). Acceptability and feasibility will be measured for the strengths and needs assessment and for trial procedures using standardised measures, progression criteria and qualitative data from clinician focus groups and interviews with a subsample of autistic participants. The study design and procedures are being co-produced with an autistic advisor/patient and public involvement lead and with a steering group of autistic adults.

Ethics and dissemination

This study was reviewed by the East Midlands—Nottingham 2 Research Ethics Committee and was given Health Research Authority approval on 18 March 2025 (REC reference:25/EM/0041). The results will be disseminated via reports to the funder (NIHR), a peer-reviewed journal paper and academic conferences. We will email a summary report of findings to study participants and will invite participants to an information dissemination event at the end of the study. Links to reports and a lay summary will be provided on the research group’s website: https://sharl.sites.sheffield.ac.uk/home

Trial registration number

ISRCTN10283350.

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