Everyday Clinical Practice Research Articles

AI may help to predict thyroid nodule malignancy based on radiomics features from [18F]FDG PET/CT

BackgroundThe number of thyroid cancer diagnoses has been increasing for several decades, with a significant part of cases being detected incidentally (thyroid incidentaloma, TI) by imaging studies performed for reasons other than thyroid disease, including PET/CT with [18F]FDG. The chacteristics of the detected TI cannot be determined solely on the basis of conventional parameters used in everyday clinical practice, such as SUVmax. In recent years, there has been a growing interest in radiomics, which is a quantitative method of analyzing radiological images based on the analysis of image texture. Textural analysis may be helpful, as it allows to characterize features invisible to the physician with the naked eye.ResultsOf the 54 patients who presented focal [18F]FDG-avid TI and had subsequent fine needle aspiration biopsy, 4 patients were excluded from the analysis due to the unavailability of the final diagnostic information. Hence, in the final analysis, data from 50 patients were used (39 females and 11 males) with a mean age of 58.5 ± 11.26. Of these 50 patients, 11 (22.0%) [18F]FDG-avid nodules were diagnosed as malignant. The performance of the XGBoost model in assessing [18F]FDG-avid TI was similar (0.846 [confidence interval, CI, 95% 0.737–0.956]) to SUVmax (0.797 [CI 95%: 0.622–0.973]; p = 0.60).ConclusionsWith an AI-based algorithm using radiomics features it is possible to detect the malignancy of thyroid nodule. However, no statistically significant differences were observed between the AI and radiomics approach, and when using a conventional measure, i.e., SUVmax.

Next-Generation Long-Acting Anti-VEGF Therapies for the Treatment of Diabetic Macular Edema

The outcomes of diabetic macular edema (DMO) treatment have improved following the introduction of intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors. However, real-world data indicate that the treatment burden associated with intravitreal injections in DMO patients leads to significant differences in outcomes between randomized clinical trials and everyday clinical practice. Long-acting intravitreal drugs and devices used in DMO may help bridge this gap by achieving optimal treatment with more feasible injection regimens. Purpose: The purpose of this chapter is to analyze new drugs and devices for the treatment of DMO, explain their mechanisms of action, summarize key research findings, and discuss potential limitations and safety profiles. The analysis covers: brolucizumab, faricimab, conbercept, KSI-301, and the port delivery system (PDS). Treatment strategies using these drugs and technologies may serve as the first step in controlling the global epidemic of diabetic eye disease. Material and Methods: A review and analysis of randomized clinical trials and clinical studies from 2014 to 2025 available in PubMed and Google Scholar. Findings: Longer-acting anti-VEGF therapies can reduce treatment burden by extending intervals between injections (up to 12–16 weeks or more). Brolucizumab and faricimab showed non-inferior visual acuity gains compared to aflibercept, with fewer injections. KSI-301 and PDS platforms also demonstrated promising safety and extended dosing intervals, although further data are needed. Research and practical limitations: Some trials remain ongoing, and long-term safety profiles require further confirmation. High treatment costs, varied patient adherence, and the logistics of regular monitoring still pose significant challenges.

Interobserver Agreement of the Eczema Area and Severity Index for Atopic Dermatitis Severity Assessment: A Real-World Evidence Study.

Background: The Eczema Area and Severity Index (EASI) has been suggested to show a good to excellent level of concordance. However, in everyday clinical practice, there is a perceived low level of concordance. Objective: To assess the degree of concordance in the EASI scores in a real-world clinical setting. Methods: This transversal study assesses interobserver concordance of EASI among 5 evaluators between January and October 2024. Results: For the head and neck area, unacceptable concordance was found for all the items in EASI. In the trunk area, there was acceptable concordance for the affected surface area (0.686 [95% confidence interval {CI}: 0.539-0.799]) but unacceptable concordance for the other items. For the upper and lower extremities, unacceptable concordance was observed for all items. The total EASI interclass correlation coefficient showed moderate concordance (0.754 [95% CI: 0.659-0.838]). Despite moderate concordance for the total EASI score, the median EASI range for the same patient was 13, indicating significant heterogeneity between evaluators. Discussion and Conclusion: This study highlights the variability of the EASI in the evaluation of atopic dermatitis (AD) in a real-world clinical practice setting, suggesting that patient-reported outcome measures and experiences should be given more importance as additional AD severity measures.

Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme

IntroductionInvestigator-initiated trials (IITs) bridge the gap between applied clinical research and everyday clinical practice. However, they require the skilled multidisciplinary teams from different backgrounds but all with clinical trial training to ensure trials are designed, conducted and reported according to best practice and regulatory standards. The availability of trainings to fulfil these needs is limited. The CONSCIOUS II project facilitated to expand the supply of such programmes. The objective is to describe the curriculum designed for PhD students and early-career researchers, and evaluate participants’ perceptions and feedback after completion of the training.MethodsThe curriculum was developed according to key principles that underpin building of competencies relevant to quality IITs and transdisciplinary skills. A multidisciplinary team created the curriculum, elaborated a comprehensive set of study materials, including the training platform. This team also conducted an international, collaborative pilot course. The effectiveness of the educational materials for the target audience was assessed through questionnaires administered after the pilot course. Additionally, all learning materials, including the video recordings of the pilot course, were externally evaluated.ResultsA 12-chapter thoroughly revised curriculum was developed for asynchronous preparation and served as a pre-class reading for a 3-month pilot course. The chapters, along with supplementary materials, and recordings of the pilot course are freely accessible on the CONSCIOUS II training platform. This platform facilitates the dissemination and implementation in the existing curricula. The feedback from both the pilot course participants and the stakeholders was uniformly positive across all survey aspects.ConclusionThis remote programme which combines asynchronous and synchronous components with international and interprofessional collaboration effectively addresses the gap in developing core competencies for the 21st -century clinical researchers. The implementation of this curriculum has the potential to improve the quality of IITs.

Automated method for measuring L-asparaginase activity

The main goal of L-asparaginase therapy in acute lymphoblastic leukemia (ALL) is complete depletion of asparagine in the blood and cerebrospinal fluid, accompanied by the death of tumor blasts. Asparagine is difficult to measure reliably due to its rapid degradation ex vivo. Serum asparaginase activity correlates well with asparagine depletion. International guidelines clearly state the need for therapeutic drug monitoring (TDM) of asparaginase activity in the blood to improve clinical outcomes in the treatment of patients with ALL. The aim of the article is to describe the adaptation of the method for measuring asparaginase activity in blood serum on a modern biochemical analyzer for use in everyday clinical practice of TDM. Materials and methods. Asparaginase activity was determined using the method of coupled enzymatic reactions accompanied by oxidation of reduced β-nicotinamide adenine dinucleotide (NADH) and a decrease in absorption at a wavelength of 340 nm. The rate of absorption decrease is proportional to the asparaginase activity in the test sample. All measurements were performed on an automatic biochemical analyzer AU 480 (Beckman Coulter). Results of the method adaptation for measurements on an automatic biochemical analyzer: limit of detection (LoD)=7.3 IU/L, lower limit of quantification (LoQ)=13.0 IU/L. Intra-assay precision was 2.1 and 0.97%, respectively, for control samples with an activity of 81.6 and 571.4 IU/L. Inter-assay precision for these control sera was 6.4 and 5.5%, respectively. Conclusion. The analytical characteristics of the method meet the requirements for bioanalytical methods and are close to those established in the work that we took as a basis for adaptation. The automated method allows for the full implementation of real-time TDM of asparaginase in patients with ALL.

Anatomical Variations of the Auditory Cortex and their Clinical Significance, Prevalence and a Review of the Literature.

This literature review aims to present anatomical variations in the primary and secondary auditory cortex, and an analysis of the categories (or classifications) of variation. Many types of variation of the auditory cortex have been described, but there is a need to classify these variations and reveal their clinical implications. A detailed search in PubMed medical database was conducted, from October 2023 to November 2024 using the terms ("anatomical") AND ("variations" OR "categories" OR "types" OR "differences") AND ("human" OR "man") AND ("auditory cortex" OR "auditory cortex" [MeSH]) and 44 articles were found. Applying the inclusion and exclusion criteria, 29 articles were finally selected. A number of asymmetries have been recorded related to the size of the cortex between the two hemispheres, the number of Heschl's gyri and Heschl's gyrus surface variations, the distribution of gray and white matter, and the surface and size of the secondary auditory cortex. Reviews, and all prospective and retrospective studies, as well as case reports, were eligible for this review. Variations were found amongst patients of reduced auditory ability and the non-hearing impaired, musicians, amateur musicians, and non-musicians, right and left-handed people, men and women, and people with high and low pitch perception ability. Furthermore, variations were detected in people with dyslexia and learning disabilities. A significant number of anatomical variations of the auditory cortex have been recorded, and closer research will contribute to our comprehension of the origin of some discrepancies in everyday clinical practice.

Quality of life (QoL) of cancer patients in routine clinical care using the example of checkpoint inhibition therapy - A Delphi Consensus

Introduction: The introduction of immune checkpoint inhibitors (CPIs) in oncology has improved the long-term perspectives of many patients and is bringing the quality of life (QoL) into focus as a treatment-relevant variable. In clinical routine, standardized and reliable tools for collecting, understanding, and utilizing QoL information are needed. In the current work, an interdisciplinary consensus on aspects of QoL in standard clinical practice has been put forth. Methods: After independent, structured individual interviews with members of an interdisciplinary expert panel (n=12), ten theses on QoL with particular consideration regarding CPI therapy were drafted. These formed the basis of a multi-stage, independent, anonymous, externally commented, qualitative Delphi process. During the period 05-12/2022, the panel developed interdisciplinary consensus recommendations for recording QoL and its role in decision-making in everyday care. Results: Out of ten theses, five recommendations arranged into three subject areas were agreed upon. QoL is considered a multifactorial and dynamic parameter that goes far beyond treatment-associated side effects. Mindful communication with the patient is considered the basis for QoL assessment and QoL modification. In everyday clinical practice, QoL should be documented and assessed in a structured, regular, and individualized way, thereby providing a basis for decisions on treatment options. Conclusion: The individual QoL of cancer patients should be assessed before and throughout therapy. Especially for long-term responders of CPI therapy and in the adjuvant setting, QoL appears to be treatment relevant. The recommendations based on the Delphi method provide practical assistance.

Initial etiotropic therapy of acute bacterial respiratory tract infections in children in the context of current clinical guidelines

The implementation of clinical guidelines in daily practice has not made the desired progress as yet and is restrained by various factors, a significant part of which are subjective. The leading factor among them is that the doctors underestimated the practical benefits of their use in clinical settings. Antibiotic indications for the most common acute bacterial infectious and inflammatory respiratory diseases, such as acute streptococcal tonsillitis/pharyngitis, acute purulent otitis media, community-acquired pneumonia, acute bacterial sinusitis, are presented in the context of current clinical guidelines. The article discusses the principles of choice of first-line antibiotics, the mode of administration and recommended dosage regimens, taking into account the class of recommendations and the level of evidence. Amoxicillin and amoxicillin/clavulanate are the main antibacterial drugs for the treatment of these diseases, which in these cases should be used orally in accordance with clinical guidelines. However, taking into account the availability of these antibiotics in many dosage forms (dispersible tablets; film-coated tablets; powder for suspension), it is advisable to pay attention to a variety of advantages of drugs that are available as dispersible tablets. Again, we emphasise that due to the implementation of clinical guidelines into everyday clinical practice, the rational initial antibiotic therapy will not only significantly increase the effectiveness of treatment of acute bacterial respiratory infections, but will also contribute to solving one of the global challenges facing healthcare right now i.e. reduction of the rate of development of antibiotic-resistant strains. All these considerations require paediatricians to pay close attention to the mandatory implementation of clinical guidelines in addressing the issues of prescribing antibiotics when treating acute respiratory infections in pediatric patients, which has become the essence of this publication.

Caregivers’ burden and psychological distress in bipolar disorder in everyday clinical practice

Caregivers’ burden and psychological distress in bipolar disorder in everyday clinical practice

Understanding the Meaning Attributed to Patients' Lived Experience Beyond a Diagnostic Label: Applications of Interpretive Phenomenology to Nursing Practice.

Unearthing the meaning patients' attribute to their lived experience beyond a diagnostic label has profound implications to reconceptualize the caring art of nursing practice. Featured throughout this article are lessons learnt from caring for a patient who had received a stigmatizing diagnosis of liver cirrhosis. Contained within such heavily stigmatized diagnoses are various preunderstandings (e.g., negative views about substance misuse) that are often informed by dominant societal beliefs, which can impede nurses' ability to authentically care for patients across the lifespan. Interpretive phenomenology is a philosophical tradition dedicated to the description of lived experience; this philosophy can facilitate an understanding of how things appear in the world in which they exist. By applying interpretive phenomenology to nursing practice, nurses can understand the essence that patients' attribute to their diagnostic label by authentically exploring their lifeworld. Utilizing the philosophical underpinnings of interpretive phenomenology, this article proposes opportunities to inform the way nurses care for patients by exploring how a Gadamerian fusion of horizons and holistic approach to care can reconceptualize nursing practice. Understanding the meaning patients' attribute to their lived experiences is a critical step to optimizing care by granting nurses the opportunity to ascribe meaning in their everyday clinical practice, which can motivate positive patient outcomes and a continuous evolution of their authentic being.

Real-world Effectiveness of Ustekinumab Versus Anti-TNF or Vedolizumab in Ulcerative Colitis: Induction and 12-Month Maintenance Results from the Prospective, Observational RUN-UC Study.

Real-world evidence (RWE) studies of ustekinumab (UST) in ulcerative colitis (UC) are needed because randomized controlled trials do not represent unselected patient populations in everyday clinical practice. Patients with UC were recruited when starting biologic therapy for the first time or switching to a new biologic therapy. This study assessed the effectiveness of maintenance therapy with UST in comparison to anti-TNF or vedolizumab (VDZ) at 12 months. Between 2020-2022, 507 UC patients starting biologic therapy for the first time or switching to a new biologic therapy were enrolled at 34 IBD-specialized centres in Germany. After excluding patients receiving other biologics or small molecules, as well as those with stomas or missing outcomes, the final sample consisted of 476 patients. The outcomes were clinical response, clinical remission (CR), and steroid-free remission. Propensity score (PS) adjustment with inverse probability of treatment weighting (IPTW) was used to reduce the effect of confounding due to physician selection of therapy. A total of 476 patients with UC were included in the analysis (UST: 147, anti-TNF: 168, VDZ: 161). Treatment persistence over 12 months differed significantly (p < 0.001) between UST (93.9%), VDZ (87.0%), and anti-TNF (75.0%). The PS-weighted effectiveness of UST in the mITT analysis at month 12 was not significantly different to anti-TNF or VDZ (CR: UST 26.9%, anti-TNF 34.7%, VDZ 40.9%; p=0.063). In the prospective RUN-UC study with PS-weighted groups, UST showed higher treatment persistence but no significant difference in maintenance effectiveness compared to anti-TNF or VDZ in UC.

Updated position paper on "Ecological sustainability in anesthesiology and intensive care medicine" with specific recommendations for action of the German Society for Anesthesiology and Intensive Care Medicine and the Professional Association of German Anesthesiologists-Update 2024 : Compiled by the Forum Sustainability in Anesthesiology from the Professional Association of German Anesthesiologists (BDA) and the German Society for Anesthesiology and Intensive Care

Anthropogenic climate change is progressing, with global warming now reaching 1.1 °C. At the same time, further environmental crises that jeopardize the conservation of our natural resources can be observed. The effects on health are obvious and we are already witnessing them in Germany.The healthcare sector itself contributes to arelevant extent to national greenhouse gas emissions and the field of anesthesiology and intensive care medicine is aparticularly resource-intensive area. For this reason, the Professional Association of German Anesthesiologists (BDA) and the German Society of Anesthesiology and Intensive Care Medicine (DGAI) were among the first professional associations and medical societies to publish aposition paper entitled "Ecological sustainability in anesthesiology and intensive care medicine" in 2020. This is now available in an updated version from November 2024.It contains 33specific recommendations in the following 7 areas: 1)the use of volatile anesthetics and other medications, 2)the use of consumables, 3)waste management, 4)sustainable mobility concepts, 5)energy-saving measures in the operating theater and intensive care unit, 6)research and teaching and 7)strategies to mitigate the impact of environmental changes on healthcare services in our discipline. This paper summarizes the recommendations. It explains the main changes compared to the 2020 version, with aparticular focus on the new evidence behind the recommendations. The specific recommendations are intended to help anesthetists to initiate changes in everyday clinical practice, interprofessionally and in cooperation with other disciplines, which affect their own area of work and the entire hospital.

Salinger Scale for Classification of Perifollicular Inflammation

Perifollicular inflammation is a key factor in several hair loss conditions, yet its objective assessment remains a challenge due to the lack of standardized measurement tools. The Salinger Scale, developed by trichologists in collaboration with the International Association of Trichologists (IAT), aims to provide a non-invasive, clinically reliable method for evaluating perifollicular inflammation severity. The scale consists of a five-point classification system ranging from 0 (no inflammation) to 4 (extreme inflammation), using high-resolution trichoscopic images. Over 2,000 de-identified images from clinical settings in Sydney and Nairobi were analyzed, classified, and reviewed to ensure accuracy and usability. Unlike traditional invasive methods such as biopsies, the Salinger Scale allows for objective, reproducible, and patient-friendly assessment. This standardized tool has the potential to enhance clinical decision-making, improve treatment evaluation, and facilitate global research collaboration in trichology and dermatology. Future studies will further validate and refine the scale based on expert feedback, ensuring its integration into everyday clinical practice.

Imaging of Adrenal Incidentalomas: What Actually Happens in Everyday Clinical Practice?

There are numerous guidelines offering varying advice on the management of adrenal incidentalomas. The American College of Radiology (ACR) white paper recommends no follow-up for lesions with benign appearances. Our aim was to audit the indications for adrenal CT in the context of the ACR recommendations and to assess the long-term follow-up and outcome of these incidental lesions. A retrospective cohort study was performed identifying patients who had undergone adrenal CT from 1 January 2016 to 31 December 2018. Patients with symptoms of adrenal hypersecretion and malignancy were excluded. Radiology reports were analysed, with collected data also including patient demographics, referring team, lesion characteristics, radiologist recommendations, biochemical tests and histology. A total of 168 adrenal CTs were performed in 130 patients during the study period. 88 CTs (52%) were not in accordance with the ACR recommendations, as they were for the evaluation of adrenal incidentalomas previously characterised as benign. 93% of lesions had benign imaging appearances, none of which demonstrated evidence of malignant transformation. 70% of patients with benign-appearing lesions had excess imaging deemed not required as per the ACR recommendations. A large proportion of adrenal CTs are performed to evaluate incidental lesions previously characterised as benign. The ACR white paper recommends that these do not require further imaging; however, in most cases, this is not being followed. Radiologists should be encouraged to recommend no follow-up for benign-appearing adrenal lesions in accordance with the ACR recommendations and have confidence that it is reasonable and safe to do so.

Morning Salivary Cortisone Versus Serum Cortisol in the Overnight Dexamethasone Suppression Test (ODNST): Evaluation in a Clinical Setting.

Saliva hormone measurement is increasingly being applied in everyday clinical practice. In relation to salivary cortisone measurement, there is a particular advantage, with minimal chance of cross-reaction with prescribed glucocorticoids and greater convenience. We evaluated the utility of salivary cortisone measurement in patients undergoing an overnight dexamethasone suppression test (ONDST). Individuals undergoing an ONDST had parallel measurement of serum cortisol and salivary cortisone at 0900 following midnight dexamethasone (1 mg). Salivary cortisone was measured by electrospray positive liquid chromatography tandem mass spectrometry. The threshold for adequate suppression of salivary cortisone was< 2.7nmol/L; serum cortisol was< 50nmol/L. Results for 34 individuals which included 21% men (mean age 49.4 years) and 79% women (mean age 56.7 years) were analysed. Serum cortisol did not suppress in 22/34 cases. Salivary cortisone did not suppress in two of the cases where cortisol did suppress. We found a strong correlation between 0900 salivary cortisone and serum cortisol after 1 mg ONDST (r2 = 0.65, p = 0.009). When performance of post-dexamethasone salivary cortisone (< 2.7nmol/L) alone in relation to suppression of serum cortisol (< 50nmol/L) was analysed all but 2 individuals were correctly classified. They had values for post dexamethasone salivary cortisone/serum cortisol of respectively 5.9/23 nmol/L (presented with unexplained fatigue, case 25) and 7/32 nmol/L (investigated for cyclical Cushing's Syndrome that was excluded, case 29). Agreement was 94.1%, kappa 0.87, p < 0.0001. The sensitivity of salivary cortisone for potential Cushing's syndrome as indicated by the post-dexamethasone 0900 serum cortisol was 100% (all cases of potential cortisol excess (0900 cortisol > 50nmol/L) were picked up) and specificity of 84.6% with a positive predictive value of 90.5% of salivary cortisone (using serum cortisol as the standard) and negative predictive value of 100% in relation to ruling out cortisol excess. We have provided further evidence that ONDST salivary cortisone has potential to be the first-line test for suspected Cushing's syndrome, not requiring venepuncture or attendance at hospital, with 100% sensitivity and reasonable specificity. Application of the salivary cortisone test has the potential for significant savings of money and time in this and other contexts.

Class-I and Class-II Restorations with the Application of a Flowable Composite as an Intermediate Layer-A Narrative Review of Clinical Trials.

The objective of this review is to investigate the effect of an additional layer of flowable composite for cavity lining on the clinical outcome of direct posterior composite restorations. The PICO question (patient, intervention, comparison, and outcome) was stated as follows: Does the additional application of a flowable composite as a cavity liner improve the clinical outcome of Class-I and Class-II restorations? The electronic databases MEDLINE, Web of Science, LILAS, and BBO were assessed for identifying relevant clinical studies. After removal of duplicate records, 309 records could be identified and, after a screening of the title and abstract, 20 articles were selected for full-text analysis. Finally, six studies met the eligibility criteria and were included in this review for further investigation. Four of the included studies have a follow-up period of two years, while the other two studies had an observation period of three and seven years, respectively. No significant differences in annual failure rates were observed between restorations with and without a flowable composite liner. Consequently, the additional usage of flowable composites as a cavity liner seems to have no effect on the clinical longevity of direct composite restorations in Class-I and Class-II cavities. Therefore, the application of a flowable composite is a possible option in everyday dental clinical practice.

Phenotyping the Use of Cangrelor in Percutaneous Coronary Interventions.

The use of antiplatelet agents is essential in percutaneous coronary interventions, both periprocedurally and in the post-interventional period. Procedural antiplatelet therapy, aiming to limit ischemic complications, is mostly administered with oral agents, including aspirin and P2Y12 inhibitors. However, there are several limitations in the use of oral P2Y12 inhibitors, including their difficult administration in patients presenting with cardiogenic shock and their relatively slower onset of action, leaving a significant period of the procedure with a suboptimal antiplatelet effect. These pitfalls could be avoided with the use of cangrelor, the only available intravenous P2Y12 inhibitor, which has a rapid onset and offset antiplatelet effect, as well as a favorable pharmacological profile. The use of cangrelor has been increasing in recent years, with several studies aiming to determine what the optimal patient phenotype to receive such treatment ultimately is and how its use could be adjunctive to oral P2Y12 inhibitors. Therefore, the aim of this review is to provide an overview of the pharmacological profile of cangrelor and an update regarding the clinical evidence supporting its use, as well as to discuss the optimal patient phenotype, related clinical algorithms, and future implications for larger implementation of this agent into everyday clinical practice.

Off-label drug use in palliative medicine: Delphi study for the consensus of evidence-based treatment recommendations.

Off-label use of drugs is an integral part of everyday clinical practice in palliative medicine. However, it is associated with many uncertainties, that is, drug therapy safety or legal issues including cost coverage. Healthcare professionals often lack time and resources for comprehensive literature search and patient-specific risk-benefit analyses. The aim of this project is to develop, evaluate and rate agreement/disagreement on treatment recommendations for off-label use in adult palliative medicine. Online Delphi study with two rounds each to rate agreement/disagreement with treatment recommendations for off-label use in adult palliative medicine. An international expert panel consisting of physicians, pharmacists and nurses working in palliative care evaluated previously developed recommendations based on the best available evidence. /participants:Professionals (physicians, pharmacists, nursing staff) working in inpatient and home palliative care involved in the medication process were recruited as experts to participate. Between 64 and 75 experts participated in the first two Delphi studies. A total of 64/68 recommendations on 21 drugs and 14 applications were agreed upon. Topics related to routes of administration as well as indications for sialorrhea, bronchorrhea, xerostomia, pruritus, singultus, fistula, gastroparesis and hot flashes. Recommendations that reached consensus are available to health care professionals via a free of charge database. For many off-label use applications, it is likely that there will be no registration studies and therefore no drug approvals in the future. The consensus-based recommendations are intended to facilitate individual treatment planning for prescribers and to enable a more reflected handling of off-label use.

Cutting-edge European guidelines for managing lower extremity peripheral arterial disease - Featuring selected insights on PAD management.

The new guidelines for the management of peripheral arterial and aortic diseases (PAAD) from the European Society of Cardiology and endorsed by the European Society of Vascular Medicine (ESVM), emphasize on a comprehensive and multidisciplinary approach focusing on prevention, diagnosis, treatment, and follow-up of patients with a wide range of PAAD, including lower extremity peripheral arterial disease (PAD). The aim of this summary, focusing on PAD and coordinated by the Young Academy of ESVM, is to provide young angiologists with the fundamental principles of these guidelines and to assist them in navigating their everyday clinical practice. PAD diagnosis relies on objective evaluation of flow/oxygen reduction at rest, with arterial ultrasound as the first imaging modality to confirm the presence of arterial lesions. The main goals of PAD management are not only to improve functioning and prevent the occurrence of adverse events at the lower limb level, but also to reduce the overall atherosclerotic burden and achieve the general well-being of patients. To this end, traditional and nontraditional cardiovascular risk factors need to be properly addressed through lifestyle changes and tailored drug therapies. For patients with exertional limb symptoms, supervised exercise training is recommended. Interventional treatment is indicated for limb salvage in patients with chronic limb threatening ischemia and may also be discussed in a multidisciplinary setting in less severe patients with persisting symptoms and reduced quality of life after a minimum period of optimal medical treatment including exercise therapy. For trainees or young specialists in Angiology/Vascular Medicine, these guidelines provide essential elements to improve patient management, encourage interdisciplinary collaboration, and ensure an integrated approach to vascular diseases.

Focus: artificial intelligence in medicine-Legal aspects of using large language models in clinical practice

The use of artificial intelligence (AI) and natural language processing (NLP) methods in medicine, particularly large language models (LLMs), offers opportunities to advance the healthcare system and patient care in Germany. LLMs have recently gained importance, but their practical application in hospitals and practices has so far been limited. Research and implementation are hampered by acomplex legal situation. It is essential to research LLMs in clinical studies in Germany and to develop guidelines for users. How can foundations for the data protection-compliant use of LLMs, particularly cloud-based LLMs, be established in the German healthcare system? The aim of this work is to present the data protection aspects of using cloud-based LLMs in clinical research and patient care in Germany and the European Union (EU); to this end, key statements of alegal opinion on this matter are considered. Insofar as the requirements for use are regulated by state laws (vs. federal laws), the legal situation in Berlin is used as abasis. As part of aresearch project, alegal opinion was commissioned to clarify the data protection aspects of the use of LLMs with cloud-based solutions at the Charité- University Hospital Berlin, Germany. Specific questions regarding the processing of personal data were examined. The legal framework varies depending on the type of data processing and the relevant federal state (Bundesland). For anonymous data, data protection requirements need not apply. Where personal data is processed, it should be pseudonymized if possible. In the research context, patient consent is usually required to process their personal data, and data processing agreements must be concluded with the providers. Recommendations originating from LLMs must always be reviewed by medical doctors. The use of cloud-based LLMs is possible as long as data protection requirements are observed. The legal framework is complex and requires transparency from providers. Future developments could increase the potential of AI and particularly LLMs in everyday clinical practice; however, clear legal and ethical guidelines are necessary.