Rigorous Protocol Research Articles

Framing the Multi-Centre Qualitative Research Design as a Novel Methodology for Nursing and Healthcare Research: Reflections and A Methodological Discussion.

To discuss the multi-centre qualitative methodology as a unique design, articulate its guiding paradigm/theoretical perspectives, and highlight its methodological and methodical issues. A secondary objective is to generate further scholarly discourse regarding the multi-centre approach within the broader qualitative research tradition. Methodological discussion. Rather than an emphasis on only experiences, the multi-centre approach is presented as a unique design which also focuses on uncovering why a phenomenon or problem exists and perceptions regarding the phenomenon/problem. With its focus on capturing multiple subjective realities, the multi-centre qualitative design is arguably underpinned by pragmatist constructivism which offers a robust framework for researching phenomenon in a way that is both theoretically informed and practically relevant. Methodologically, the multi-centre qualitative research design emphasises a problem-centred enquiry, collaborative approach and rigorous study protocols, systematic site selection, contextual immersion and sensitivity and methodical flexibility. With the rapidly evolving nursing and global health landscape, the multi-centre design lends itself to exploring and capturing perceptions on a larger scale compared to single site studies. Careful planning, availability of adequate resources, rigorous protocols and quality assurance plans are critical to ensuring its success. The multi-centre approach offers the possibility of undertaking the same study across multiple settings/locations which has the potential to improve representation and strengthen transferability. This methodological discussion offers clarity regarding the use of the multi-centre approach and offering strategies for its subsequent uptake in nursing and healthcare research. Not applicable. No patient or public contribution.

Highly Effective Biocides against Pseudomonas aeruginosa Reveal New Mechanistic Insights Across Gram-Negative Bacteria.

Pseudomonas aeruginosa is a major nosocomial pathogen that persists in healthcare settings despite rigorous disinfection protocols due to intrinsic mechanisms conferring resistance. We sought to systematically assess cationic biocide efficacy against this pathogen using a panel of multidrug-resistant P. aeruginosa clinical isolates. Our studies revealed widespread resistance to commercial cationic disinfectants that are the current standard of care, raising concerns about their efficacy. To address this shortcoming, we highlight a new class of quaternary phosphonium compounds that are highly effective against all members of the panel. To understand the difference in efficacy, mechanism of action studies were carried out, which identified a discrete inner-membrane selective target. Resistance selection studies implicated the SmvRA efflux system (a transcriptionally regulated, inner membrane-associated efflux system) as a major determinant of resistance. This system is also implicated in resistance to two commercial bolaamphiphile antiseptics, octenidine and chlorhexidine, which was further validated herein. In sum, this work highlights, for the first time, a discrete inner-membrane specific mechanism for the bolaamphiphile class of disinfectants that contrasts with the prevailing model of indiscriminate membrane interactions of commercial amphiphiles paving the way for future innovations in disinfectant research.

How to catch prospective use? A comparative study of virtual environment movie and guided imaginary for projecting future users in a public space

Focusing on the design of a public space, we propose a methodological contribution to integrate possible future users to studies in prospective ergonomics. Our objective is to establish a rigorous protocol for comparing two methods of projecting potential usage. First, a projection interview based on a virtual environment movie and second, a Guided Imaginary Projection interview. We sought to determine to what extent these two methods provide participants with the ability to live a ‘quasi-experience’ of the space. This ‘quasi-experience’ is measured by a questionnaire inspired by the concepts of presence and absorption and by the analysis of the embodiment level of the discourse produced during the interviews, from embodied to general discourse. The results show that while the two methods produce similar results in terms of the level of projection experience, the virtual environment movie projection produces significantly more general discourse.

Blockchain in Education: Transforming Learning, Credentialing, and Academic Data Management

Background and Aims: Blockchain technology is critical in education for transforming learning, credentialing, and academic data management by ensuring secure, immutable, and transparent handling of academic records. This technology improves the integrity of credentials, streamlines administrative processes, and promotes personalized learning, resulting in a more dependable and efficient educational environment. This review is intended for educators, administrators, policymakers, and technologists who are interested in blockchain's potential to transform the education landscape. Methodology: The methodology for this review included a systematic approach to gathering and analyzing literature on blockchain in education. A rigorous protocol was used to screen, extract, and categorize relevant data from academic databases and supplementary sources. Thematic analysis, aided by tools such as NVivo, enabled a thorough understanding of blockchain's impact and prospects in educational settings. Results: Blockchain technology has the potential to transform the educational sector by addressing critical issues such as data security, credentialing, and administrative efficiency. Blockchain, which provides a decentralized, immutable system for managing educational records and credentials, can improve the integrity and accessibility of academic information, streamline processes, and support personalized learning experiences. Although challenges such as scalability, legal complexities, and institutional resistance persist, ongoing advancements and research are likely to pave the way for wider adoption. As educational institutions investigate and implement blockchain solutions, the technology's transformative impact on the global education system may result in a more transparent, equitable, and innovative learning environment for future generations. Conclusion: blockchain technology has the potential to revolutionize education by improving data security, credentialing, and administrative efficiency through its decentralized and immutable system. Despite current challenges, its continued development and implementation could result in a more transparent, equitable, and innovative educational environment.

Root causes analysis for improved containment integrity in LPG storage: A case study

AbstractA liquefied petroleum gas (LPG) storage system is a critical component designed for the storage of liquefied petroleum gas. LPG storage systems for hazardous materials require rigorous safety protocols to prevent catastrophic containment losses. However, complex interactions between equipment failure, human factors, and external events make prevention a persistent challenge. This study demonstrates the application of structured methods to systematically analyze, correct, and prevent loss of containment in LPG systems. In order to realize this, 8D methodology was used to analyze and solve the problem which included fault tree analysis (FTA) to identify the root causes. Additionally, the bow tie analysis (BTA) will be integrated into the analysis process to implement permanent mitigative actions and prevent the recurrence of similar issues in the future. As a result of this work, it was determined that by applying the proposed approach, the risk of undesired consequences was reduced compared to baseline levels. This study demonstrated the value of a structured suggested approach to improve containment integrity in high‐risk storage systems.

Pitfalls in Photochemical and Photoelectrochemical Reduction of CO2 to Energy Products.

The photochemical and photoelectrochemical reduction of CO2 is a promising approach for converting carbon dioxide into valuable chemicals (materials) and fuels. A key issue is ensuring the accuracy of experimental results in CO2 reduction reactions (CO2RRs) because of potential sources of false positives. This paper reports the results of investigations on various factors that may contribute to erroneous attribution of reduced-carbon species, including degradation of carbon species contained in photocatalysts, residual contaminants from synthetic procedures, laboratory glassware, environmental exposure, and the operator. The importance of rigorous experimental protocols, including the use of labeled 13CO2 and blank tests, to identify true CO2 reduction products (CO2RPs) accurately is highlighted. Our experimental data (eventually complemented with or compared to literature data) underline the possible sources of errors and, whenever possible, quantify the false positives with respect to the effective conversion of CO2 in clean conditions. This paper clarifies that the incidence of false positives is higher in the preliminary phase of photo-material development when CO2RPs are in the range of a few 10s of μg gcat-1 h-1, reducing its importance when significant conversions of CO2 are performed reaching 10s of mol gcat-1 h-1. This paper suggests procedures for improving the reliability and reproducibility of CO2RR experiments, thus validating such technologies.

Protocols for bulk off-line fluid inclusion extraction for the analysis of δ13C-CH4 and δ13C-CO2 using a cavity ring-down spectroscopy (CRDS) analyser

Fluid inclusions are a window into deep geological fluids, providing unique access to their nature and composition. The isotopic composition of CO2 and CH4 hosted in fluid inclusions is a powerful proxy to assess the origin and transformation of deep geological fluids, giving insights into carbon sources, fluxes, and degassing in a wide variety of geodynamic settings. Over the last 5 decades, techniques have been developed to extract fluid inclusions from their host minerals and measure their bulk composition. These techniques are often challenged by analytical artifacts including high blank levels of CO2 and CH4, fluid re-speciation, gas adsorption, and diffusion. Since these processes may alter the pristine composition of gases liberated from fluid inclusions, rigorous protocols are needed in order to evaluate the isotopic integrity of the extracted volatile species. In this study, we introduce new protocols for bulk off-line fluid inclusion extraction for the analysis of δ13C-CH4 and δ13C-CO2 using a Cavity Ring-Down Spectroscopy (CRDS) analyser (Picarro G2201-i). Two mechanical fluid extraction techniques are compared: ball milling in ZrO2 jars and sample crushing in a stainless steel sealed tube under a hydraulic press. Blanks and isotopically labelled tests with the ball milling technique suggest that rotation speed, grinding stock filling degree and filling type alter the CH4 and CO2 concentrations and isotopic compositions measured by the CRDS analyser. In contrast, the crushing technique does not generate measurable quantities of blank CH4 and CO2. The protocols presented in this study allow to extract, detect, and analyse δ13C of CH4 and CO2 for concentrations above 10 and 1,000 ppm respectively. Interlaboratory experiments allowed to replicate previously measured δ13C-CH4 values in natural fluid inclusions within 1‰ with both extraction techniques. This study highlights the potential of combining simple bulk off-line fluid inclusion extraction techniques with a CRDS analyser for δ13C analysis of CO2 and CH4 without gas separation being required.

Continent urinary diversion and management of pouch calculi as a late complication: A case series

Objective: Following cystectomy, there are several reconstructive options. A continent cutaneous urinary diversion (CUD) avoids an ileal conduit if patients are unsuitable for an orthotopic neobladder. Reservoir stone formation is common, and management is challenging. Our data present incidence and management of calculi following Indiana pouch reconstruction after radical cystectomy. Patients and Methods: Prospective database review identified 30 patients with Indiana pouch CUD in our series of 450 open cystectomies. Paper, electronic medical records, and radiological imaging were reviewed. Results: Six (20%) patients with up to 15 years follow-up were identified with stones. At cystectomy, all patients were stone free with normal renal function and electrolytes. Time to first stone formation was 29–60 months. Eighty percent became recurrent stone formers. Management involved a combination of endoscopic LASER litholapaxy, percutaneous and open access. All patients had a functioning CUD following stone treatment. Time to stone recurrence improved with assessment for metabolic abnormalities, timed pouch emptying, pouch irrigation and treatment of urine infections. Conclusion: The risk of stone formation and requirement for rigorous post-operative prevention protocols should be discussed with patients. Follow-up for this group should be lifelong to include imaging and metabolic monitoring. Management requires a multimodal, multi-disciplinary approach. Level of evidence: Not applicable

B-245 Novel monoclonal antibodies validated specifically for immunohistochemistry by performance assessment on tissue microarrays

Abstract Background Immunohistochemistry (IHC) is a laboratory immunoassay that is a pillar of diagnostic pathology, particularly in the identification and characterization of neoplasms and other diseases/disorders. Though performed routinely, rigorous SOP protocols must be determined empirically for each molecular target, beginning with antibody selection. Both traditional polyclonal and hybridoma-based monoclonal antibodies have been employed in the past, though monoclonal, and particularly recombinant monoclonal, antibodies are preferred. However, any reagent used for diagnostic purposes must be meticulously validated to minimize, if not eliminate, erroneous interpretations of IHC assays. Thus, the extent of validation is the pivotal aspect for establishing an antibody as a reliable diagnostic tool for IHC applications. Methods GeneTex has assembled an extensive catalog of rabbit and mouse monoclonal antibodies validated specifically for IHC. These antibodies are tested on both human normal tissue and cancer tissue microarrays, with upwards of 76 normal and numerous tumor tissues included. Images of the staining are available for all the tested tissues. This broad spectrum of tissues allows a researcher to assess the performance of the antibody on known positive and negative samples, thereby minimizing the risk of false positive or false negative readouts (Gown, 2016). In addition, the data images are of sufficient resolution to determine proper cellular localization of the signal. This special catalog of IHC-optimized reagents are listed under the “HistoMAX” designation. New antibodies will be added continuously, many of them being fully recombinant rabbit monoclonals manufactured using a multi-parameter FACS-based methodology to select antigen-specific IgG+ memory B cells from an immunized rabbit with subsequent cloning of the matched IgG heavy and light chains (Starkie et al., 2016). These recombinant antibodies will be validated following the same approach described above. Results Presently more than 130 mouse or rabbit monoclonal antibodies are available in the HistoMAX line of IHC-validated products and are directed against a spectrum of important targets. This includes antibodies for the commonly analyzed cytokeratins 5, 6, 7, 18, 19, and 20, among many others. Antibodies for CTLA4 and PD-L1 headline products for immunology and immunotherapy research, while other reagents are directed against various cadherins. Hormone receptor antibodies are also represented, with antibodies against estrogen receptor alpha, progesterone receptor, Her2/ErbB2, and the androgen receptor. There are also antibodies against various key “Cluster of Differentiation” (CD) proteins as well as other membrane proteins such as ACE2. Many antibodies are relevant to the study of human malignancies, such as CD66e/CEACAM5/CEA, MSH6, p63, MUC1, Collagen IV, EpCAM, PAX6, PAX8, GP2, TRIM29, S100, and GAD65. All antibodies were evaluated as described above. Conclusions Antibodies are application-specific reagents, and the best antibodies for IHC are validated through systematic staining of a multitude of normal and abnormal tissues. This is the only way that an antibody’s performance for IHC can be critically assessed. The HistoMAX reagents consist only of those monoclonal antibodies that have generated expected signals, or the lack of a signal, in a wide range of tissues in a manner consistent with the literature.

5-year Oncologic Outcomes Following Primary Partial Gland Cryo-Ablation (PPGCA) Prospective Cohort Study of Men with Intermediate-Risk Prostate Cancer

To assess 5-year oncologic outcomes following primary partial gland cryo-ablation (PPGCA) in intermediate risk prostate cancer. Of 476 men undergoing PPGCA enrolled in our prospective oncologic and functional outcomes study, 313 had MRI concordant intermediate risk prostate cancer with no out-of-field Gleason Grade Group (GGG) ≥2, gross extracapsular extension or extreme apical disease on pre-treatment mpMRI. PSA was monitored every 6 months, and mpMRI at 6-12, 24, 42 and 60 months. Protocol biopsy at 6-12 months and 24 months were discontinued after interim analysis showing low rates of clinically-significant prostate cancer (csPCa) defined as any GGG≥2 disease. Freedom-from-failure (FFF) was defined as no prostate cancer specific mortality, metastatic disease, or whole-gland salvage treatment (WGST) RESULTS: csPCa was detected in 33 (10.5%) subjects. 91 had ≥4.5 years of follow-up data with a mean of 8.9, 3.4, and 2.0 surveillance PSA tests, MRIs, and prostate biopsies; none were lost to follow-up. At 5-years, rates of freedom-from-recurrence of in-field, out-of-field and overall csPCa were 86% (95% CI: 78-96), 85% (95% CI: 63-94), and 70% (95% CI: 57-84). The proportion with freedom-from-failure (FFF) at 5 years was 89% (95% CI: 83-95). None died from prostate cancer, 1 (1%) developed metastasis, 15 (16.5%) underwent WGST, and 15 (16.5%) underwent salvage focal therapy (FT). Only 3 of 91 (3.3%) eligible men were noncompliant with 5-year surveillance protocol. Very encouraging intermediate-term oncological outcomes following PPGCA were observed with very high compliance to a rigorous prospective protocol for identifying recurrent csPCa.

A comparative analysis of remote auditing in Albania: How it affects the quality of enterprise auditing

This paper conducts an extensive examination to explore the impact of remote auditing on audit quality. It aims to ascertain whether remote audit processes can match or exceed the standards set by traditional on-site audits. The study encompasses various remote audit methods, advantages, and challenges. The study employs a mixed methods approach, gathering and analyzing data through both quantitative measures and qualitative techniques. This includes surveys directed at audit professionals to glean insights into remote auditing and its effects on audit quality. Survey findings are analyzed according to a balance scorecard. The findings indicate that remote auditing has the potential to deliver high-quality audits but requires robust technological infrastructure, effective communication channels, and rigorous data protection protocols.

Engaging sexual minority adolescents in nationwide at-home HIV prevention research in the U.S

ObjectivesThis study examined research-related privacy and confidentiality concerns among adolescent sexual minority males (ASMM) and provides lessons learned to inform recruitment and enrollment strategies for this population. MethodsParticipants were a 2017–2018 internet-based U.S. national sample of sexual minority adolescents who responded to self-report measures of privacy and confidentiality concerns. Results: Bivariate chi-square tests were used to identify participants’ mean differences in worry and likelihood of privacy breach occurrences. Many participants reported privacy-related concerns within remote HIV prevention research. ConclusionsStudy protocols were designed to ensure participants felt safe participating in online HIV prevention research. However, there are challenges to enroll participants with rigorous protocols for ensuring safety and privacy.

Causal Relationship between Ischemic Stroke and Malignant Brain Tumors: A Two-Sample Mendelian Randomization Analysis

Object: Contemporary observational research has identified associations between cerebrovascular accidents, commonly referred to as strokes, and malignant cerebral neoplasms. However, these studies fall short of elucidating the presence of a direct causal relationship between the two conditions. In our investigation, we employ aggregated data derived from large-scale population-based genome-wide association studies (GWASs), to interrogate the potential causal linkages between these two pathologies. Method: This investigation leverages the two-sample Mendelian randomization (MR) methodology to elucidate the genetic underpinnings of the causal nexus between malignant cerebral neoplasms and ischemic cerebrovascular accidents. Rigorous quality control protocols were enacted to identify SNPs that exhibit a robust association with the exposure variable, namely malignant brain tumors. Analytical strategies, including MR-Egger regression, weighted median, inverse-variance weighted (IVW), simple mode, and weight mode methods, constituted the core of our MR analytical framework. Predominantly, the findings hinge upon the IVW method. To fortify the veracity of our conclusions, an array of sensitivity analyses such as MR-Egger regression, weighted median, MR pleiotropy, MR-PRESSO and radial MR, were deployed to meticulously evaluate heterogeneity and pleiotropy. Result: The findings derived from the IVW model reveal an absence of a significant causal nexus between malignant cerebral neoplasms and any categorization of cerebrovascular accidents, encompassing any strokes (AS) (OR 0.998, 95% CI 0.99-1.01, P=0.741), any ischemic strokes (AIS) (OR 0.999, 95% CI 0.99-1.01, P=0.999), large artery strokes (LAS) (OR 0.993, 95% CI 0.97-1.02, P=0.603), cardioembolic strokes (CES) (OR 1.012, 95% CI 0.99-1.03, P=0.275), and small vessel strokes (SVS) (OR 0.998, 95% CI 0.98-1.02, P=0.880) with respect to either an escalation or reduction in risk. Additionally, the analyses did not unveil any indications of heterogeneity or horizontal pleiotropy within the dataset. On a genome-wide scale, none of the variants associated with malignant brain tumors demonstrated relevance to the investigated outcomes. Conclusion: The outcomes of this MR investigation reveal the absence of a causal linkage between malignant cerebral neoplasms and ischemic cerebrovascular accidents. Nonetheless, the observed correlation between these two pathologies warrants attention, underscoring the necessity for heightened surveillance and care for individuals concurrently afflicted with both conditions.

Chronic Low Back Pain Causal Risk Factors Identified by Mendelian Randomization: a Cross-Sectional Cohort Analysis.

There are a number of risk factors- from biological, psychological, and social domains- for non-specific chronic low back pain (cLBP). Many cLBP treatments target risk factors on the assumption that the targeted factor is not just associated with cLBP but is also a cause (i.e, a causal risk factor). In most cases this is a strong assumption, primarily due to the possibility of confounding variables. False assumptions about the causal relationships between risk factors and cLBP likely contribute to the generally marginal results from cLBP treatments. The objectives of this study were to a) using rigorous confounding control compare associations between modifiable causal risk factors identified by Mendelian randomization (MR) studies with associations in a cLBP population and b) estimate the association of these risk factors with cLBP outcomes. Cross sectional analysis of a longitudinal, online, observational study. 1,376 participants in BACKHOME, a longitudinal observational e-Cohort of U.S. adults with cLBP that is part of the NIH Back Pain Consortium (BACPAC) Research Program. Pain, Enjoyment of Life, and General Activity (PEG) Scale. Five risk factors were selected based on evidence from MR randomization studies: sleep disturbance, depression, BMI, alcohol use, and smoking status. Confounders were identified using the ESC-DAG approach, a rigorous method for building directed acyclic graphs based on causal criteria. Strong evidence for confounding was found for age, female sex, education, relationship status, financial strain, anxiety, fear avoidance and catastrophizing. These variables were used to determine the adjustment sets for the primary analysis. Potential confounders with weaker evidence were used for a sensitivity analysis. Participants had the following characteristics: age 54.9 ± 14.4 years, 67.4% female, 60% never smokers, 29.9% overweight, 39.5% obese, PROMIS sleep disturbance T-score 54.8 ± 8.0, PROMIS depression T-score 52.6 ± 10.1, Fear-avoidance Beliefs Questionnaire 11.6 ± 5.9, Patient Catastrophizing Scale 4.5 ± 2.6, PEG 4.4 ± 2.2. In the adjusted models alcohol use, sleep disturbance, depression, and obesity were associated with PEG, after adjusting for confounding variables identified via a DAG constructed using a rigorous protocol. The adjusted effect estimates- the expected change in the PEG outcome for every standard deviation increase or decrease in the exposure (or category shift for categorical exposures) were the largest for sleep disturbance and obesity. Each SD increase in the PROMIS sleep disturbance T-score resulted in a mean 0.77 (95% CI: 0.66, 0.88) point increase in baseline PEG score. Compared to participants with normal BMI, adjusted mean PEG score was slightly higher by 0.37 points (95% CI: 0.09, 0.65) for overweight participants, about 0.8 to 0.9 points higher for those in obesity classes I and II, and 1.39 (95% CI: 0.98, 1.80) points higher for the most obese participants. Each SD increase in the PROMIS depression T-score was associated with a mean 0.28 (95% CI: 0.17, 0.40) point increase in baseline PEG score, while each SD decrease in number of alcoholic drinks per week resulted in a mean 0.12 (95%CI: 0.01, 0.23) increase in baseline PEG score in the adjusted model. Several modifiable causal risk factors for cLBP - alcohol use, sleep disturbance, depression, and obesity- are associated with PEG, after adjusting for confounding variables identified via a DAG constructed using a rigorous protocol. Convergence of our findings for sleep disturbance, depression, and obesity with the results from MR studies, which have different designs and biases, strengthens the evidence for causal relationships between these risk factors and cLBP (1). The estimated effect of change in a risk factors on change in PEG were the largest for sleep disturbance and obesity. Future analyses will evaluate these relationships with longitudinal data.

Implementing a Phase II Quality Control Protocol for a High Precision 137Cs Dosimetry Calibration Irradiator.

In medical physics, rigorous quality assurance and quality control protocols are vital for precise dose delivery applications. In many health physics applications, the allowable uncertainty for various processes is often greater than that of medical physics due to looser safety ties. This results in less demand for quality control and uncertainty analyses, since these may not be needed. However, certain applications can benefit from a comprehensive quality control program, as it may yield important insights, such as air kerma monitoring in dosimetry calibrations for environmental and low-dose applications. By implementing a thorough quality control program tailored to specific contexts and needs, uncertainties associated with dose measurements can be quantified with greater accuracy and reliability. This proactive approach not only ensures the integrity of data collected but also enhances understanding of the measured doses. For these reasons, a comprehensive quality control initiative was implemented following documented failures in a 137Cs dosimetry calibration irradiator. This involved systematic charge collection using NIST-traceable ion chambers to observe long-term changes. A Phase I quality control protocol was previously implemented, which employed Shewhart control charts and Nelson's rules to analyze various datasets subgrouped under different conditions. This study addresses the development of a Phase II protocol, which focuses more on uncertainty quantification of systematic errors and irradiator changes, and air kerma precision for dosimetry calibrations. A designed experiment was performed to identify how much systematic errors influence the air kerma. Emphasis was placed on stricter quality assurance protocols, continuous data collection, and additional control charts to monitor short-term changes, such as exponentially weighted moving average control charts. A pre-irradiation control process was implemented to verify that the total air kerma met the measurement quality objective and to show how various uncertainties were applied before calibration. This study indicates how uncertainty is applied given observed air kerma measurements from the irradiator. Ongoing efforts aim to streamline the quality control procedure, ensure consistent data collection, and assess its impact on dosimetry applications.

Software as a Medical Device (SaMD) in Digestive Healthcare: Regulatory Challenges and Ethical Implications.

The growing integration of software in healthcare, particularly the rise of standalone software as a medical device (SaMD), is transforming digestive medicine, a field heavily reliant on medical imaging for both diagnosis and therapeutic interventions. This narrative review aims to explore the impact of SaMD on digestive healthcare, focusing on the evolution of these tools and their regulatory and ethical challenges. Our analysis highlights the exponential growth of SaMD in digestive healthcare, driven by the need for precise diagnostic tools and personalized treatment strategies. This rapid advancement, however, necessitates the parallel development of a robust regulatory framework to ensure SaMDs are transparent and deliver universal clinical benefits without the introduction of bias or harm. In addition, the discussion highlights the importance of adherence to the FAIR principles for data management-findability, accessibility, interoperability, and reusability. However, enhanced accessibility and interoperability require rigorous protocols to ensure compliance with data protection guidelines and adequate data security, both of which are crucial for effective integration of SaMDs into clinical workflows. In conclusion, while SaMDs hold significant promise for improving patients' outcomes in digestive medicine, their successful integration into clinical workflow depends on rigorous data protection protocols and clinical validation. Future directions include the need for adequate clinical and real-world studies to demonstrate that these devices are safe and well-suited to healthcare settings.

Study of Bacterial Contamination in the Operating Room and Newborn Intensive Care Unit: Effects of the Predominantly Used Antibiotics at Sabratha Teaching Hospital

Contamination by bacteria in the operating room (OR) and newborn intensive care units (NICU) has continued to increase the incidence of nosocomial infections and a center point of multidrug-resistant (MDR) pathogens. This study was to examine the spread of bacteria isolated from inanimate surfaces in the operating room and neonatal intensive care units at Sabratha Teaching Hospital and find out the effectiveness of the most antimicrobial used. Methods: At the Sabratha Teaching Hospital in Sabratha, Libya, a cross-sectional, descriptive study was conducted in the OR and NICU from February to May 2024. A total of 22 swab samples were collected from high-contact environmental surfaces. Isolation, identification, and antibiotic sensitivity patterns were performed via standard techniques. Results: After 48 hours of incubation, (54.5 %) of the swabbed surfaces showed positive bacterial growth and 45.5% showed no bacterial growth, of which 25% had gram-positive bacteria and 75% had gram-negative bacteria. Staphylococcus saprophyticus 3 (25%) was the identified gram-positive bacterial isolate, and Klebsiella spp. 5 (55.5%) and Pseudomonas aeruginosa 4 (44.4%) were the probable gram-negative bacterial isolates. The antimicrobial susceptibility pattern of clinical pathogens tested Staphylococcus epidermides and Klebsiella spp showed similar patterns which were sensitive to most antimicrobials used, while Pseudomonas aeruginosa was highly resistant to Cotrimoxazole, Cefatoxime, Cefixitin, Ceftazidime, Ceftricillin, and Calvu amoxicillin. Conclusion: This study confirms the need for rigorous disinfection protocols and hand hygiene to reduce the spread of these pathogens in the OR and NICU.

Lost in subtitling: do Arabic satellite TV channels and DVDs speak the same language?

Subtitling taboo comedy has recently emerged as one of the most complex issues in audiovisual translation in the Arab world. Translating this genre across language and cultural barriers demands meticulous attention to the norms and expectations of the target viewers’ culture. However, despite the growing interest in this area, further research is necessary to understand this phenomenon and its mechanisms. Therefore, this paper delves into this thorny issue and investigates the various levels of censorship and their frequency in the Arabic subtitles displayed on satellite TV channels and DVDs. The corpus analysed consists of 16 episodes from seasons 9, 10, and 11 of the American sitcom Two and a Half Men aired on MBC4, one of the most prominent Arabic TV channels, and the DVD version of these episodes. A comparative linguistic analysis was conducted on the original dialogues of the selected episodes and their Arabic subtitles, highlighting instances of censorship and identifying the strategies employed. The results of the analysis indicate that Arab subtitlers have implemented a more rigorous censorship approach in rendering taboo language, such as sexual references and swear words on TV channels compared to DVDs. Based on descriptive translation studies, the analysis reveals that Arab subtitlers working for MBC4 relied on three main strategies of censorship: euphemisation, semantic mistranslation, and omission. Furthermore, it is observed that the satellite channel has implemented rigorous censorship protocols pertaining to homosexuality, leading to the omission of certain scenes altogether. This action was taken to avoid any potential discomfort or offence to Arab viewers. It is evident that dominant ideologies and relevant censorship practices play a significant role in modifying the linguistic and visual content of the original sitcom, hindering the target viewers from following the storyline of the episodes and grasping the intended humour.

Fostering academic excellence: The synergy of self-leadership, knowledge exchange, and innovative practices in higher education

This concept paper presents a comprehensive systematic literature review examining the interconnected roles of self-leadership, knowledge exchange, and innovative practices in enhancing academic performance within higher education institutions. The review synthesizes existing research to identify key themes and relationships, proposing a conceptual framework that integrates these elements. Following a rigorous protocol, including a thorough search strategy and clear inclusion criteria, the review analyzes selected studies to reveal the pivotal role of self-leadership in boosting academic staff performance through enhanced self-motivation and self-regulation. Furthermore, knowledge exchange and innovative practices emerge as crucial mediators in the relationship between self-leadership and academic excellence. The resulting conceptual framework highlights the interplay between these variables, suggesting potential pathways for higher education institutions to cultivate a culture of continuous improvement and innovation. This paper concludes by discussing theoretical and practical implications, emphasizing the need for institutions to prioritize the development of self-leadership skills, create supportive environments for knowledge exchange, and encourage innovative practices to elevate academic performance. The systematic literature review and proposed framework provide a foundation for future empirical research and offer valuable insights for academic leaders and policymakers seeking to enhance institutional effectiveness in higher education

How structural biology has changed our understanding of icosahedral viruses.

Cryo-electron microscopy and tomography have allowed us to unveil the remarkable structure of icosahedral viruses. However, in the past few years, the idea that these viruses must have perfectly symmetric virions, but in some cases, it might not be true. This has opened the door to challenging paradigms in structural virology and raised new questions about the biological implications of "unusual" or "defective" symmetries and structures. Also, the continual improvement of these technologies, coupled with more rigorous sample purification protocols, improvements in data processing, and the use of artificial intelligence, has allowed solving the structure of sub-viral particles in highly heterogeneous samples and finding novel symmetries or structural defects. In this review, I initially analyzed the case of the symmetry and composition of hepatitis B virus-produced spherical sub-viral particles. Then, I focused on Alphaviruses as an example of "imperfect" icosahedrons and analyzed how structural biology has changed our understanding of the Alphavirus assembly and some biological implications arising from these discoveries.