Stewardship Principles Research Articles

Human dignity and the pursuit of knowledge in Islamic thought: Insights from the Quran

This research examines the interplay between human dignity and the pursuit of knowledge within Islamic thought, using insights from the Quran. It explores how Islamic epistemology emphasizes the harmonious integration of divine revelation and human reason, underscoring the importance of knowledge as a key factor in both intellectual and spiritual development. By analyzing the contributions of classical Islamic scholars, such as Al-Farabi, Ibn Sina, and Al-Ghazali, alongside Western epistemological traditions, the study highlights complementary and contrasting approaches to understanding knowledge and its role in shaping ethics and governance. Furthermore, the research draws on contemporary case studies, such as the Marrakesh Declaration and Masdar City, to illustrate how Quranic principles of cooperation, justice, and environmental stewardship can inform modern societal frameworks. Ultimately, the study argues for the continued relevance of Islamic thought in addressing contemporary global challenges, emphasizing that the pursuit of knowledge not only advances scientific discovery but also promotes human dignity, justice, and societal well-being.

Therapeutic Indices of Topical Antiseptics in Wound Care: A Systematic Review.

Chronic wounds place a heavy burden on healthcare systems and markedly reduce the ability of patients to engage in activities of daily living. One major factor contributing to impaired wound healing is bacterial bioburden. With the rise in antibiotic resistance and the slowdown in antibiotic development pipelines, alternative antimicrobial strategies are important. The objective of this systematic review is to determine the topical antiseptic therapeutic index values for bacterial species commonly isolated from chronic wounds. The therapeutic index is a ratio of the lowest concentration that causes mammalian cell cytotoxicity over the minimum bactericidal concentration. Higher values indicate greater safety and potential clinical benefit. A systematic literature search was performed in Medline and Embase, resulting in the inclusion of 37 articles that reported on the minimum bactericidal concentration in bacterial species commonly isolated from chronic wounds and their cytotoxicity concentrations in mammalian cells. The therapeutic indices for the topical antiseptics included in this study were generally low, with most ranging between 0.5-3.0. The highest therapeutic index values for Escherichia coli (5.49), Staphylococcus aureus (6.31) and Pseudomonas aeruginosa (8.81) were achieved by hypochlorous acid, whereas the highest therapeutic index values for methicillin resistant S aureus (12.1) was achieved by polyhexamethylenebiguanide. Antibiotic stewardship principles may need to be applied to topical antiseptics due to some isolated evidence of topical antiseptic resistance and cross-resistance to antibiotics. The choice of antiseptic should not be made solely based on therapeutic index values, but individualized to the patient, with consideration for the wound healing condition that may include covert infection.

Building an Ethical and Trustworthy Biomedical AI Ecosystem for the Translational and Clinical Integration of Foundation Models.

Foundation Models (FMs) are gaining increasing attention in the biomedical artificial intelligence (AI) ecosystem due to their ability to represent and contextualize multimodal biomedical data. These capabilities make FMs a valuable tool for a variety of tasks, including biomedical reasoning, hypothesis generation, and interpreting complex imaging data. In this review paper, we address the unique challenges associated with establishing an ethical and trustworthy biomedical AI ecosystem, with a particular focus on the development of FMs and their downstream applications. We explore strategies that can be implemented throughout the biomedical AI pipeline to effectively tackle these challenges, ensuring that these FMs are translated responsibly into clinical and translational settings. Additionally, we emphasize the importance of key stewardship and co-design principles that not only ensure robust regulation but also guarantee that the interests of all stakeholders-especially those involved in or affected by these clinical and translational applications-are adequately represented. We aim to empower the biomedical AI community to harness these models responsibly and effectively. As we navigate this exciting frontier, our collective commitment to ethical stewardship, co-design, and responsible translation will be instrumental in ensuring that the evolution of FMs truly enhances patient care and medical decision-making, ultimately leading to a more equitable and trustworthy biomedical AI ecosystem.

Antimicrobial Drug Utilization and Resistance Trends in Septicemia Patients: A Comprehensive Study at a Tertiary Care Hospital

Background: Septicemia is still among the leading causes of morbidity and mortality worldwide, especially among patients in the intensive care unit. The right use of antimicrobial agents is central to the successful management of septicemia, but increasing incidences of antimicrobial resistance are a big challenge. Objective: This study aimed to quantify the antimicrobial usage, resistant organisms, and clinical performance in septicemia patients in a tertiary healthcare facility in Bangladesh. Methods: A prospective observational study was done in the Department of Medicine, Community Based Medical College Hospital, over a period of 16 months. One hundred and ten participants with septicemia and admitted to the ICU were recruited. Demographic data, antimicrobial consumption, microbiological results, and clinical outcomes were gathered and examined. Results: Most of the patients were male (54.5%) and within the age group of 31–40 years. Cephalosporins were the most common first-line antimicrobials (13.3%), while macrolides (12.3%) and carbapenems (11.7%) were at the second and third rank, respectively. There were frequent alterations in antimicrobial therapy; in 28 percent of cases, ceftriaxone was replaced by levofloxacin. Patients with resistant infections had the advantage of a longer hospital and ICU stay of at least 1 week (p<0.01). 16% in patients with resistant infections. Conclusion: The topics discussed in this study include the issues arising from septicemia management due to antimicrobial resistance, the requirement of broad-spectrum empiric therapy, often changing antimicrobial regimens, and overall poor outcomes for such resistant infections. Overall, the present results highlight the need for strict adherence to principles of antimicrobial stewardship, local resistance pattern monitoring, and the creation of novel therapeutic interventions. Additional multi-centered trials to determine strategies against septicemia and AMR in limited resource .........

AN UPDATE ON CURRENT STATUS OF ANTIBIOTIC RESISTANCE IN SALMONELLA TYPHI: A RETROSPECTIVE ANALYSIS OF BLOOD CULTURE REPORTS FROM A TERTIARY CARE HOSPITAL

Background: Pakistan bears most of the burden of drug-resistant typhoid, challenging its healthcare systems with substantial cost. This study’s purpose is to investigate resistance in community-acquired salmonella typhi to guide its evidence-based empiric treatment. Methods: This study used retrospective data from the microbiology laboratory, Khyber Teaching Hospital, Peshawar (September 2022-March 2023). Data of routine diagnostic samples for typhoid was retrieved from the database. Kirby–Bauer disk diffusion method was employed to determine the sensitivity of S. Typhi against a panel of 21 selected antibiotic discs (not exclusively for each isolate). Results: Among 1742 suspected patients, 239 (13.92%) were positive for S. Typhi with 212/238 (89.1%), 227/233 (97.4%), and 196/239 (82.0%) isolates resistant to chloramphenicol, ampicillin, and trimethoprim-sulfamethoxazole, respectively. High resistance (88.0% to ciprofloxacin) was detected against fluoroquinolones. Third-generation cephalosporins also showed poor activity with 144/158 (91.1%) and 120/136 (88.2%) resistance towards ceftriaxone and cefixime, respectively, except for cefoperazone/sulbactam (2/123, 1.6%). Among 157 tested isolates, 3 (1.9%), 9 (5.7%), and 123 (78.3%) were labeled as non-resistant, MDR, and XDR strains, respectively. XDRs were less resistant to azithromycin (1/114), piperacillin/tazobactam (1/123), carbapenems (0/123), and tigecycline (0/123). Conclusion: XDR S. Typhi was observed as the dominant strain in Peshawar regions for which azithromycin is still the drug of choice. With emerging resistance, azithromycin safety should be ensured through antibiotic stewardship principles. An interesting finding was the enhanced activity of cefoperazone/sulbactam, suggesting future studies. Alternative options are expensive antibiotics which can be used as a last resort. Keywords: Typhoid, Antibiotic resistance, Extensive drug-resistant (XDR) S. Typhi, Pakistan.

Principles and Significance of Nitrogen Management for Blackberry Production

Blackberry cultivation presents significant opportunities for fruit growers in subtropical regions, where nitrogen (N) is identified as a crucial macronutrient for optimal production. Given the variability in climate and soil conditions, determining the ideal N fertilizer amount can be complex. Effective blackberry cultivation requires careful attention to the principles of nutrient stewardship, including the selection of appropriate N sources, application rates, timing, and placement. Recommended N rates generally range from 25–45 kg/ha in the first year and 45–70 kg/ha in subsequent years, with adjustments based on plant type and regional conditions. The choice of fertilizer, particularly NH4+, is beneficial for blackberry plants, which thrive in acidic soils and show improved biomass and chlorophyll levels with this form of N. Research on N-cycling reveals its importance in supporting new plant growth, such as primocane development. However, improper N management, either excessive or insufficient, can negatively impact flower bud production and, consequently, fruit setting and yield. By using databases such as Google Scholar, Scopus, and Web of Science, this review synthesizes existing research on the role of N in blackberry cultivation, emphasizing the importance of precise fertilization practices tailored to regional climate and soil conditions. By highlighting variations in recommended N amounts and underscoring the principles of nutrient stewardship, this review aims to guide growers in achieving sustainable and high-quality blackberry production.

Oral versus intravenous empirical antibiotics in children and adolescents with uncomplicated bone and joint infections: a nationwide, randomised, controlled, non-inferiority trial in Denmark

Bone and joint infections (BJIs) are treated with intravenous antibiotics, which are burdensome and costly. No randomised controlled studies have compared if initial oral antibiotics are as effective as intravenous therapy. We aimed to investigate the efficacy and safety of initial oral antibiotics compared with initial intravenous antibiotics followed by oral antibiotics in children and adolescents with uncomplicated BJIs. From Sept 15, 2020, to June 30, 2023, this nationwide, randomised, non-inferiority trial included patients aged 3 months to 17 years with BJIs who presented to one of the 18 paediatric hospital departments in Denmark. Exclusion criteria were severe infection (ie, septic shock, the need for acute surgery, or substantial soft tissue involvement), prosthetic material, comorbidity, previous BJIs, or antibiotic therapy for longer than 24 h before inclusion. Patients were randomly assigned (1:1), stratified by C-reactive protein concentration (<35 mg/L vs ≥35 mg/L), to initially receive either high-dose oral antibiotics or intravenous ceftriaxone (100 mg/kg per day in one dose). High-dose oral antibiotics were coformulated amoxicillin (100 mg/kg per day) and clavulanic acid (12·5 mg/kg per day) in three doses for patients younger than 5 years or dicloxacillin (200 mg/kg per day) in four doses for patients aged 5 years or older. After a minimum of 3 days, and upon clinical improvement and decrease in C-reactive protein, patients in both groups received oral antibiotics in standard doses. The primary outcome was sequelae after 6 months in patients with BJIs, defined as any atypical mobility or function of the affected bone or joint, assessed blindly, in all randomised patients who were not terminated early due to an alternative diagnosis (ie, not BJI) and who attended the primary outcome assessment. A risk difference in sequelae after 6 months of less than 5% implied non-inferiority of the oral treatment. Safety outcomes were serious complications, the need for surgery after initiation of antibiotics, and treatment-related adverse events in the as-randomised population. This trial was registered with ClinicalTrials.gov, NCT04563325. 248 children and adolescents with suspected BJIs were randomly assigned to initial oral antibiotics (n=123) or initial intravenous antibiotics (n=125). After exclusion of patients without BJIs (n=54) or consent withdrawal (n=2), 101 patients randomised to oral treatment and 91 patients randomised to intravenous treatment were included. Ten patients did not attend the primary outcome evaluation. Sequelae after 6 months occurred in none of 98 patients with BJIs in the oral group and none of 84 patients with BJIs in the intravenous group (risk difference 0, one-sided 97·5% CI 0·0 to 3·8, pnon-inferiority=0·012). Surgery after randomisation was done in 12 (9·8%) of 123 patients in the oral group compared with seven (5·6%) of 125 patients in the intravenous group (risk difference 4·2%, 95% CI -2·7 to 11·5). We observed no serious complications. Rates of adverse events were similar across both treatment groups. In children and adolescents with uncomplicated BJIs, initial oral antibiotic treatment was non-inferior to initial intravenous antibiotics followed by oral therapy. The results are promising for oral treatment of uncomplicated BJIs, precluding the need for intravenous catheters and aligning with the principles of antimicrobial stewardship. Innovation Fund Denmark and Rigshospitalets Forskningsfond.

Antimicrobial Audit and Stewardship Practices among Hospitalised Patients: A Retrospective Study

Background: Empirical broad-spectrum antibiotic use leads to misuse, side effects, antimicrobial resistance, and higher costs. This necessitates antimicrobial stewardship programs (AMSP) to promote judicious antibiotic use. This study aimed to analyze antibiotic prescription patterns and culture request frequencies in surgical wards and intensive care units (ICU). Methodology: This retrospective study by the department of Microbiology in a tertiary care hospital was undertaken in surgical wards and ICUs. Data on baseline characteristics, antibiotic usage, and culture requests were collected. The microbiology laboratory used Kirby-Bauer disk diffusion for antimicrobial testing. An infection control nurse audited antibiotic administration. Results: This retrospective study spanned eight months (June 2023 to January 2024) and included 1018 patients from surgical wards and ICUs. Of the 1018 patients, 83.8% were male, with 52% aged 21-40 years. Confirmed infections were found in 25% of patients, predominantly Gram-negative bacteria (94.2%). The most common organisms were Escherichia coli (72.2%), Klebsiella pneumoniae (10.19%), and Pseudomonas aeruginosa (5.8%). Cephalosporins were the most prescribed antibiotics (89.7%). Only 41.5% of antibiotic prescriptions matched culture sensitivity reports, with 58.5% inappropriately prescribed. Hospital stays were under 15 days mostly (86%). Conclusion: Empirical antibiotic use is prevalent, with infrequent culture-based adjustments. Only 41.5% of antibiotics matched culture reports. AMSPs and education on stewardship principles are essential to address inappropriate antimicrobial use.

Making a case for outpatient parenteral antimicrobial therapy (OPAT).

In the wake of the COVID-19 pandemic, and its negative impact on both acute and elective care and decline in available inpatient resources, there is an imperative to maximize safe and effective alternatives to inpatient hospital care. Properly governed outpatient parenteral antimicrobial therapy (OPAT) services embed the principles of antimicrobial stewardship (AMS) (including use of early oral therapy) and support admission avoidance and early discharge for a growing range of patient groups with complex infections through well-organized multidisciplinary team working. Expansion of OPAT aligns with the UK's national strategy to deliver care closer to home and cost-effectively maximize use of inpatient resources. OPAT serves as an exemplar to other ambulatory services and presents opportunities for developing and assuring AMS strategies within the rapidly developing hospital-at-home and virtual ward environments.

GREEN SCHOOLS: A BRIEF REVIEW

Green schools represent an innovative educational model that seamlessly integrates environmental stewardship principles with teaching methods to create enriching learning environments. In addition to focusing on conserving resources, they prioritize student well-being and instill a deep environmental consciousness, shaping a generation dedicated to sustainability. This article explores the significance, objectives and advantages of green schools, emphasizing their critical role in fostering a sustainable future through comprehensive education and increased environmental awareness. The research specifically underscores the economic and environmental significance of green schools, highlighting their capacity to lower operational costs while simultaneously reducing environmental impact and promoting a more sustainable planet for future generations.

Antibiotic Stewardship in the Neonatal Intensive Care Unit.

Antibiotic stewardship is a multidisciplinary, evidence-based approach to optimize antibiotic use and mitigate development of antibiotic resistance. Neonates have high rates of antibiotic exposure, particularly those born preterm and admitted to the NICU, and mounting evidence describes the adverse consequences of such exposures in the absence of infection. Here, we review the general principles of antibiotic stewardship and how they can be applied in NICUs. The unique characteristics of NICUs and patients cared for in this setting, which warrant unique implementation strategies and special considerations are discussed. We summarize current antibiotic use metrics for assessment of responses to stewardship interventions and changes over time, and review evidence-based infection prevention practices in the NICU. Current recommendations for empiric antibiotic use in the NICU and the utility of infection biomarkers are summarized. Lastly, given the growing global threat of increasing antibiotic resistance, specific threats in the NICU are highlighted.

The role of education in sustainable development: training for effective public administration and development of environmental and food security

This article delves into the profound role of education in shaping sustainable values and fostering a conscientious attitude toward the environment. It examines how education serves as a transformative tool, instilling principles of environmental stewardship and ethical responsibility within individuals. Additionally, the article explores contemporary approaches to seamlessly integrating sustainable development and education. It elucidates how innovative strategies intertwine these two domains, propelling a paradigm shift in learning methodologies and curriculum design. By bridging the gap between theoretical knowledge and actionable insights, the article underscores the dynamic potential of education to cultivate a generation of informed global citizens committed to sustainable practices. Through a comprehensive analysis of these themes, the article underscores the pivotal role of education in nurturing a conscious and responsible approach to the environment while embracing progressive methodologies for achieving the synergy between sustainable development and education.

Perioperative Opioid Stewardship Program: Barriers and Promotors of Implementation and Sustainability

Perioperative opioid stewardship programs aim to harness the benefits of opioid analgesia for managing acute post-surgical pain whilst mitigating potential harm. Healthcare worker stakeholders are vital for the effective program introduction and continuation. However, their perceptions of program barriers and promotors are underexplored. We conducted twenty semi-structured interviews with healthcare workers across three health services that introduced a perioperative opioid stewardship program. The participants included specialist pain medicine physicians, anaesthetist managers, pain nurses, pharmacists and Junior Medical Officers. Interviews were transcribed and coded both inductively and deductively against the Consolidated Framework of Implementation Research. Key themes from the data were reviewed, refined and reported. Participants were generally aware of perioperative opioid stewardship principles but senior clinicians reported greater specific program knowledge. Adherence to the discharge opioid prescription guideline was promoted by hospital leadership endorsement and workflow integration. A universal barrier to program adherence was inadequate resourcing. Lack of role clarity was a barrier to patient discharge opioid education. Hospital-community prescriber communication was variable but generally limited to written discharge summaries rather than a comprehensive, personalised approach. Introducing an Electronic Medical Record was universally seen as an opportunity to promote better program integration and sustainment. This study deepens our current understanding of the drivers of observed perioperative opioid stewardship program outcomes from the perspective of healthcare worker stakeholders. The findings could be used to optimise existing programs or to guide the implementation of new programs to achieve effective clinical change.

InChI isotopologue and isotopomer specifications

This work presents a proposed extension to the International Union of Pure and Applied Chemistry (IUPAC) International Chemical Identifier (InChI) standard that allows the representation of isotopically-resolved chemical entities at varying levels of ambiguity in isotope location. This extension includes an improved interpretation of the current isotopic layer within the InChI standard and a new isotopologue layer specification for representing chemical intensities with ambiguous isotope localization. Both improvements support the unique isotopically-resolved chemical identification of features detected and measured in analytical instrumentation, specifically nuclear magnetic resonance and mass spectrometry.Scientific contributionThis new extension to the InChI standard would enable improved annotation of analytical datasets characterizing chemical entities, supporting the FAIR (Findable, Accessible, Interoperable, and Reusable) guiding principles of data stewardship for chemical datasets, ultimately promoting Open Science in chemistry.

General practitioners’ management of mastitis in breastfeeding women: a mixed method study in Australia

BackgroundMastitis is a common reason new mothers visit their general practitioner (GP). In Australia, the Therapeutic Guidelines: Antibiotic provides practical advice to GPs managing a range of infections, including mastitis. It is not known if Australian GPs prescribe antibiotics and order investigations as recommended for the management of mastitis.MethodsA convergent mixed methods design integrated quantitative analysis of a general practice dataset with analysis of interviews with GPs. Using the large-scale primary care dataset, MedicineInsight, (2021–2022), antibiotics prescribed and investigations ordered for mastitis encounters were extracted. Mastitis encounters were identified by searching ‘Encounter reason’, ‘Test reason’ and ‘Prescription reason’ free text field for the term ‘mastitis’; ‘granulomatous mastitis’ was excluded. Clinical encounters for mastitis occurring within 14 days of a previous mastitis encounter were defined as belonging to the same treatment episode. Semi-structured interviews were conducted with 14 Australian GPs using Zoom or telephone in 2021–2022, and analysed thematically. The Pillar Integration Process was used to develop a joint display table; qualitative codes and themes were matched with the quantitative items to illustrate similarities/contrasts in findings.ResultsDuring an encounter for mastitis, 3122 (91.7%) women received a prescription for an oral antibiotic; most commonly di/flucloxacillin ([59.4%]) or cefalexin (937 [27.5%]). Investigations recorded ultrasound in 303 (8.9%), blood tests (full blood examination [FBE]: 170 [5.0%]; C-reactive protein [CRP]: 71 [2.1%]; erythrocyte sedimentation rate [ESR]: 34 [1.0%]) and breast milk or nipple swab cultures in approximately 1% of encounters. Analysis using pillar integration showed consistency between quantitative and qualitative data regarding mastitis management. The following themes were identified:- GPs support continued breastfeeding.- Antibiotics are central to GPs' management.- Antibiotics are mostly prescribed according to Therapeutic Guidelines.- Analgesia is a gap in the Therapeutic Guidelines.- Low use of breast milk culture.ConclusionsPrescribing antibiotics for mastitis remains central to Australian GPs’ management of mastitis. Interview data clarified that GPs were aware that antibiotics might not be needed in all cases of mastitis and that delayed prescribing was not uncommon. Overall, GPs followed principles of antibiotic stewardship, however there is a need to train GPs about when to consider ordering investigations.

Integrating reinforcement learning and metaheuristics for safe and sustainable health tourist trip design problem

This study aims to address the critical challenge of enhancing safety within the domain of health and wellness tourism through the framework of sustainable travel design. Given the rising demand for secure and sustainable tourism experiences, this investigation explores the integration of safety considerations into the strategic planning and execution of tourist journeys. The central focus of this research revolves around the development and application of the Modified Reinforcement Learning-Artificial Multiple Intelligence System (MRL-AMIS). Operating within a multi-objective framework, the objective of this study is to optimize essential parameters encompassing environmental sustainability, economic viability, tourist preferences, and societal acceptability, with a specific emphasis on safety. The efficacy of the proposed methodology is rigorously evaluated across various tourist group scenarios, providing a comprehensive assessment of its applicability. Our computational analyses unequivocally demonstrate the superiority of the proposed approach in enhancing safety, surpassing existing methods such as genetic algorithms, differential evolution algorithms, particle swarm optimization, etc., by 15%-25%. These findings underscore the effectiveness of the proposed method in seamlessly integrating safety considerations into the realm of sustainable tourism planning. This study highlights the potential of the proposed method as an advanced tool in the strategic planning of sustainable tourism, particularly within the context of health and wellness tourism. It constitutes a significant contribution to the field of sustainable tourism by offering an innovative approach that prioritizes safety while upholding the principles of environmental stewardship, economic viability, and societal sustainability.

Cakewalk or catastrophe? Exploring the realities of climate diet

ABSTRACT This article critically examines the concept of ‘climate diet’ as a potential solution to mitigate the environmental impact of food production and consumption. It explores the complex relationship between diet and climate change, highlighting the significant contribution of food production to greenhouse gas emissions. The notion of climate diet − adopting plant-based diets to reduce carbon footprints − is discussed alongside its practical challenges and criticisms. While plant-based diets offer promising environmental benefits, including reduced emissions and resource usage, the feasibility of widespread adoption is hindered by cultural, economic and social factors. Additionally, critiques regarding individual versus systemic responsibility, accessibility and broader structural reforms are addressed. The article emphasises the need for holistic and inclusive approaches to sustainable eating, recognising the interconnectedness of food, health and the environment. Achieving meaningful change requires collaborative efforts across sectors and stakeholders, guided by principles of equity, accessibility and environmental stewardship.

Treatment of infections caused by multidrug-resistant Gram-negative bacilli: A practical approach by the Italian (SIMIT) and French (SPILF) Societies of Infectious Diseases

The emergence of multidrug-resistant Gram-negative bacilli and the development of new antibiotics have complicated the selection of optimal regimens. International guidelines are valuable tools, but are limited by the scarcity of high-quality randomized trials in many situations. A panel of experts from the French and Italian Societies of Infectious Diseases aimed to address unresolved issues in clinical practice based on their experience, an updated literature review and open discussions. The panel reached consensus for the following 'first choices': (i) cefepime for ventilator-acquired pneumonia due to AmpC β-lactamase-producing Enterobacterales; (ii) the β-lactam/β-lactamase inhibitor combination most active in vitro, or cefiderocol combined with fosfomycin, and aerosolized colistin or aminoglycosides, for severe pneumonia due to Pseudomonas aeruginosa resistant to ceftolozane-tazobactam; (iii) high-dose piperacillin-tazobactam (including loading dose and continuous infusion) for complicated urinary tract infections (cUTIs) caused by extended-spectrum β-lactamase-producing Enterobacterales with piperacillin-tazobactam minimum inhibitory concentration (MIC) ≤8 mg/L; (iv) high-dose cefepime for cUTIs due to AmpC β-lactamase-producing Enterobacterales other than Enterobacter spp. if cefepime MIC ≤2 mg/L; (v) ceftolozane-tazobactam or ceftazidime-avibactam plus metronidazole for intra-abdominal infections (IAIs) due to third-generation cephalosporin-resistant Enterobacterales; (vi) ceftazidime-avibactam plus aztreonam plus metronidazole for IAIs due to metallo-β-lactamase-producing Enterobacterales; (vii) ampicillin-sulbactam plus colistin for bloodstream infections (BSIs) caused by carbapenem-resistant Acinetobacter baumannii; (viii) meropenem-vaborbactam for BSIs caused by Klebsiella pneumoniae carbapenemase-producing Enterobacterales; and (ix) ceftazidime-avibactam plus fosfomycin for neurological infections caused by carbapenem-resistant P. aeruginosa. These expert choices were based on the necessary balance between antimicrobial stewardship principles and the need to provide optimal treatment for individual patients in each situation.

Critical importance of correctly defining and reporting secondary endpoints when assessing the ethics of research biopsies.

This article reviews the implementation challenges to the American Society of Clinical Oncology's ethical framework for including research biopsies in oncology clinical trials. The primary challenges to implementation relate to the definitions of secondary endpoints, the scientific and regulatory framework, and the incentive structure that encourages inclusion of biopsies. Principles of research stewardship require that the clinical trials community correctly articulate the scientific goals of any research biopsies, especially those that are required for the patient to enroll on a trial and receive an investigational agent. Furthermore, it is important to sufficiently justify the characterization of secondary (as distinguished from exploratory) endpoints, protect the interest of research participants, and report accurate and complete information to ClinicalTrials.gov and the published literature.

Ureterorenoscopic Stone Removal without Antibiotic Prophylaxis

Introduction: The aim of this study was to assess the feasibility of sparing routine antibiotic prophylaxis in patients without preoperative urinary tract infection undergoing ureterorenoscopy (URS) for stone removal. Methods: A retrospective, monocentric study was conducted to evaluate the outcome of a modified perioperative antibiotic management strategy according to the principles of antibiotic stewardship. Patients with preoperative unremarkable urine culture received no antibiotic prophylaxis for URS stone removal (NoPAP). The NoPAP group was compared to a historic URS cohort, when antibiotic prophylaxis (PAP) was standard of care. Analysis focused on postoperative complications. Results: Postoperative fever occurred in 1% of the NoPAP and 2% of the PAP patients (p = 0.589). Clavien 1–3 complications did not differ between groups with 9% in the NoPAP and 6.2% in the PAP (p = 0.159). No Clavien 4–5 complications were seen. We identified a residual stone (p = 0.033) and an ASA score 3–4 (p = 0.004) as significant risk factors for postoperative fever. By sparing routine antibiotic prophylaxis, the overall antibiotic usage was reduced from 100% (PAP) to 8.3% (NoPAP). Conclusion: Sparing a routine antibiotic prophylaxis during URS for stone removal seems feasible in patients with unremarkable preoperative urine culture for most of the patients. A prospective validation is warranted.