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Multicenter evaluation of an enzyme immunoassay (Platelia Aspergillus) for the detection of Aspergillus antigen in serum.

Invasive aspergillosis is a serious problem for immunocompromised patients, especially if neutropenic. The diagnosis of this infection is complicated, since clinical symptoms are often similar to those of other fungal diseases. The chance of detecting the presence of a specific antigen in the serum could confirm the suspected clinical diagnosis and. perhaps, be useful for the follow-up of the patient. The Medical Mycology Committee of the Associazione Microbiologi Clinici Italiani (AMCLI) decided to evaluate in a multicenter prospective study (from I November 1998 to 28 February 1999) the performance of the Platelia Aspergillus Kit (Bio-Rad) for the detection of Aspergillus galactomannan in human serum. The enrolled patients included various groups of immunosuppressed patients (mostly neutropenic). Blood samples were drawn at the time of enrollment. This decision was based upon a clinical diagnosis of probable aspergillosis (antibiotic non-responsive fever for at least 96 hours, cough, hemophthosis and positive chest X-ray). Additional blood samples were drawn on days 3, 6, 9, 12, 15 and 21. Culture and histopathologic examinations were performed according to the individual laboratory workflow. For each patient the laboratory filled a form with all the available clinical information, to create a database on which to evaluate the results of the test. During the study, 187 patients with various kinds of immunosuppression were enrolled. A total of 256 sera were tested: for 117 patients (62.6%) only the basal sample was tested, whereas for the 70 symptomatic patients (37.4%) multiple specimens (range: 1-6) were tested. The results allowed the laboratories to exclude (68.6%) or confirm (31.5%: confirmed and/or probable) the clinical diagnosis of invasive aspergillosis; 4 cases remained undetermined. Based on the results of this study, it seems that the use of this test should be limited to those patients with clinical symptoms of aspergillosis.

Antigens, Fungal↗

The clinical promise of mass spectrometry-based single-cell proteomics: from bedside to bench.

INTRODUCTION: Single-cell proteomics (SCP) is entering into a transformative phase, moving beyond technically demanding benchmarking studies toward robust and reproducible workflows capable of quantifying thousands of proteins per cell. These advances highlight SCP's potential to address clinically relevant questions by resolving cellular and pathological heterogeneity that remains obscured in bulk proteomics. AREAS COVERED: This review discusses current advances, challenges, and clinical applications of SCP based on literature identified through searches in major scientific databases. Many clinically relevant samples remain underexplored in SCP studies, in part because their application requires careful evaluation of pre-analytical variables that can strongly influence proteomic readouts. Current SCP methodologies vary according to sample type, experimental conditions, and available resources. Compared with single-cell RNA sequencing, SCP remains limited in cellular throughput, making it challenging to define optimal sample sizes and to reliably detect both abundant and rare cell populations. These limitations also make dataset integration difficult, as reduced cellular coverage and sampling depth increase data sparsity. Moreover, implementing quality control strategies across sequential SCP experiments is essential to ensure data robustness, comparability, and accurate biological interpretation. EXPERT OPINION: Applying SCP to clinical samples advances our understanding of biological complexity and holds potential to drive progress in translational and precision medicine.

Humans↗

Categorizing the unintended sociotechnical consequences of computerized provider order entry.

OBJECTIVE: To describe the kinds of unintended consequences related to the implementation of computerized provider order entry (CPOE) in the outpatient setting. DESIGN: Ethnographic and interview data were collected by an interdisciplinary team over a 7 month period at four clinics. MEASUREMENTS: Instances of unintended consequences were categorized using an expanded Diffusion of Innovations theory framework. RESULTS: The framework was clarified and expanded. There are both desirable and undesirable unintended consequences, and they can be either direct or indirect, but there are also many consequences that are not clearly either desirable or undesirable or may even be both, depending on one's perspective. The undesirable consequences include error and security concerns and issues related to alerts, workflow, ergonomics, interpersonal relations, and reimplementations. CONCLUSION: Consequences of implementing and reimplementing clinical systems are complex. The expanded Diffusion of Innovations theory framework is a useful tool for analyzing such consequences.

Ambulatory Care↗

Real-world deployment of a fine-tuned pathology foundation model for lung cancer biomarker detection.

Artificial intelligence models using digital histopathology slides stained with hematoxylin and eosin offer promising, tissue-preserving diagnostic tools for patients with cancer. Despite their advantages, their clinical utility in real-world settings remains unproven. Assessing EGFR mutations in lung adenocarcinoma demands rapid, accurate and cost-effective tests that preserve tissue for genomic sequencing. PCR-based assays provide rapid results but with reduced accuracy compared with next-generation sequencing and require additional tissue. Computational biomarkers leveraging modern foundation models can address these limitations. Here we assembled a large international clinical dataset of digital lung adenocarcinoma slides (N = 8,461) to develop a computational EGFR biomarker. Our model fine-tunes an open-source foundation model, improving task-specific performance with out-of-center generalization and clinical-grade accuracy on primary and metastatic specimens (mean area under the curve: internal 0.847, external 0.870). To evaluate real-world clinical translation, we conducted a prospective silent trial of the biomarker on primary samples, achieving an area under the curve of 0.890. The artificial-intelligence-assisted workflow reduced the number of rapid molecular tests needed by up to 43% while maintaining the current clinical standard performance. Our retrospective and prospective analyses demonstrate the real-world clinical utility of a computational pathology biomarker.

Humans↗

PACS-based functional magnetic resonance imaging.

The picture archiving and communication system (PACS) technology reaches its 10th anniversary. Retrospectively no one could foresee the impact the PACS would have to the health care enterprise, but it is common consent today, that PACS is the key technology crucial to daily clinical image operations and especially to image related basic and clinical research. During the past 10 years the PACS has been matured from a research and developmental stage into commercial products which are provided by all major modality and health care equipment vendors. The PACS, originally implemented in the Radiology Department, needs to grow and has already carried well beyond departmental limits conquering all image relevant areas inside the hospital. During the past 10 years a dramatic development in imaging techniques especially within MRI emerged. Advanced 3D- and 4D-MR imaging techniques result in much more images and more complex data objects than ever before which need to be implemented into the existing PACS. These new imaging techniques require intensive post-processing apart from the imaging modality which need to be integrated into the image workflow and the PACS implementation. Along with these new imaging techniques new clinical applications, e.g. stroke detection, and research applications, e.g. study of heart and brain function, in Neurology and Cardiology require changes to the traditional PACS concept. Therefore inter-disciplinary image distribution will become the high-water mark for the next 10 years in the PACS endeavor. This paper focuses on one new advanced imaging technique, functional magnetic resonance imaging (fMRI), and discusses how fMRI data is defined, what fMRI requires in terms of clinical and research applications and how to implement fMRI in the existing PACS.

Brain↗

Comparison of two automated systems for the isolation of mycobacteria from clinical specimens.

The Bactec MGIT 960 (Becton-Dickinson, UK) automated mycobacterial liquid culture system was compared with the Bactec 9000 MB (Becton-Dickinson) in order to assess ease of use, diagnostic reliability and safety features. One thousand twenty-nine clinical specimens were cultured in parallel, yielding a total of 125 (12.1%) mycobacterial isolates, including 71 Mycobacterium tuberculosis and 18 Mycobacterium avium. The Bactec MGIT 960 demonstrated a mycobacterial recovery rate and speed of detection equivalent to that of the Bactec 9000 MB for clinically important isolates. The Bactec MGIT 960 integrates smoothly into laboratory workflow, does not require needle inoculation and has a much larger capacity than the Bactec 9000 MB.

Bacteriological Techniques↗

Reduction of broad-spectrum antibiotic use with computerized decision support in an intensive care unit.

OBJECTIVE: To implement and evaluate the effect of a computerized decision support tool on antibiotic use in an intensive care unit (ICU). DESIGN: Prospective before-and-after cohort study. SETTING: Twenty-four bed tertiary hospital adult medical/surgical ICU. PARTICIPANTS: All consecutive patients from May 2001 to November 2001 (N = 524) and March 2002 to September 2002 (N = 536). INTERVENTION: A real-time microbiology browser and computerized decision support system for isolate directed antibiotic prescription. MAIN OUTCOME MEASURES: Number of courses of antibiotic prescribed, antibiotic utilization (defined daily doses (DDDs)/100 ICU bed-days), antibiotic susceptibility mismatches, and system uptake. RESULTS: There was a significant reduction in the proportion of patients prescribed carbapenems [odds ratio (OR) = 0.61, 95% confidence interval (CI) = 0.39-0.97, P = 0.04], third-generation cephalosporins (OR = 0.58, 95% CI = 0.42-0.79, P = 0.001), and vancomycin (OR = 0.67, 95% CI = 0.45-1.00, P = 0.05) after adjustment for risk factors including Apache II score, suspected infection, positive microbiology, intubation, and length of stay. The decision support tool was associated with a 10.5% reduction in both total antibiotic utilization (166-149 DDDs/100 ICU bed days) and the highest volume broad-spectrum antibiotics. There were fewer susceptibility mismatches for initial antibiotic therapy (OR = 0.63, 95% CI = 0.39-0.98, P = 0.02) and increased de-escalation to narrower spectrum antibiotics. Uptake of the program was high with 6028 access episodes during the 6-month evaluation period. CONCLUSIONS: This tool streamlined collation and clinical use of microbiology results and integrated into the daily ICU workflow. Its introduction was accompanied by a reduction in both total and broad-spectrum antibiotic use and an increase in the number of switches to narrower spectrum antibiotics.

Adult↗

Next-generation informatics. A new picture of quality medicine.

It's up to the physician executive to make an informed choice when selecting a "next-generation" information system. Look for systems that truly integrate (not merely interface) managed care components, clinical capabilities, and other features in a model that mimics the workflow of an actual practice. Take the time to learn about the technology. Consider how a vendor's product will work at every point within your organization. Seven critical features that physician executives should consider in their decision-making are described.

Decision Making↗

Electronic signature for medical documents--integration and evaluation of a public key infrastructure in hospitals.

OBJECTIVES: Our objectives were to determine the user-oriented and legal requirements for a Public Key Infrastructure (PKI) for electronic signatures for medical documents, and to translate these requirements into a general model for a signature system. A prototype of this model was then implemented and evaluated in clinical routine use. METHODS: Analyses of documents, processes, interviews, observations, and of the available literature supplied the foundations for the development of the signature system model. Eight participants of the Department of Dermatology of the Heidelberg University Medical Center evaluated the implemented prototype from December 2000 to January 2001, during the course of an intervention study. By means of questionnaires, interviews, observations and database analyses, the usefulness and user acceptance of the electronic signature and its integration into electronic discharge letters were established. RESULTS: Since the major part of medical documents generated in a hospital are signature-relevant, they will require electronic signatures in the future. A PKI must meet the multitude of responsibilities and security needs required in a hospital. Also, the signature functionality must be integrated directly into the workflow surrounding document creation. A developed signature model, fulfilling user-oriented and legal requirements, was implemented using hard and software components that conform to the German Signature Law. It was integrated into the existing hospital information system of the Heidelberg University Medical Center. At the end of the intervention study, the average acceptance scores achieved were mean = 3.90; SD = 0.42 on a scale of 1 (very negative attitude) to 5 (very positive attitude) for the electronic signature procedure. Acceptance of the integration into computer-supported discharge letter writing reached mean = 3.91; SD = 0.47. On average, the discharge letters were completed 7.18 days earlier. CONCLUSION: The electronic signature is indispensable for the further development of electronic patient records. Application-independent hard and software components, in accordance with the signature law, must be integrated into electronic patient records, and provided to certification services using standardized interfaces. Signature-oriented workflow and document management components are essential for user acceptance in routine clinical use.

Authorship↗

Prenatal care: a strategic first step toward EMR acceptance.

Rather than turn a practice upside-down with a "big bang" implementation or replace old workflows with entirely new ones, executives must survey and understand those clinical areas where the needs are real and the value of an electronic medical record to clinicians is immediate and obvious. For these and other reasons, obstetrics may be the best place to test an electronic medical record.

Access to Information↗

The rubber meets the road: integrating the Unified Medical Language System Knowledge Source Server into the computer-based patient record.

Ongoing improvements in the content of the Unified Medical Language System, coupled with the recent release of the Internet-based Knowledge Source Server (KSS), have prompted us to develop an interface between the KSS and our computer-based patient record. We confronted many challenges while developing a robust interface to an Internet-based server, and in integrating the process of codification into the workflow of clinicians. An initial evaluation of the interface in the clinical environment suggests that acceptable performance is attainable. The benefits of using an Internet-accessible tool in a clinical information system appear to justify the effort required.

Humans↗

Library strategies differentially shape microbial, functional, and host signals in clinical metagenomic sequencing.

Metagenomic next-generation sequencing (mNGS) is increasingly used in infectious disease diagnostics, yet how library preparation shapes the microbial, functional, and host signals recovered from clinical samples remains poorly defined. Here, we performed a within-sample parallel comparison of three mNGS library preparation strategies-DNA-based libraries (DNAlib), RNA-based libraries (RNAlib), and total nucleic acid-based libraries (TNAlib)-across a diverse range of clinical specimens spanning five sample types. Using a curated clinical infectome as a benchmark, we show that library strategies are not interchangeable but capture distinct biological dimensions of the same specimen. RNAlib provided the most comprehensive standalone recovery of the clinical infectome, with improved detection of RNA viruses and cellular pathogens, enhanced resolution of resistance and virulence signals, and preservation of infection-associated host immune signatures. DNAlib showed stronger baseline recovery of DNA viruses and broader host genome coverage, whereas the TNAlib workflow evaluated here largely behaved as an intermediate strategy rather than a consistent improvement over dedicated DNA- or RNA-based workflows. Together, these results establish that the library preparation protocol is a major determinant of how clinical mNGS data should be interpreted and provide a framework for selecting sequencing strategies according to specific diagnostic and biological questions.IMPORTANCEMetagenomic sequencing is increasingly used in infectious disease research and clinical diagnostics, but different library preparation strategies may recover fundamentally different biological signals from the same sample. These signals include not only pathogens but also background microbes, microbial functional activity, and host immune-response patterns. Here, we systematically compared DNA-, RNA-, and total nucleic acid-based metagenomic sequencing libraries using the same clinical samples processed in parallel. We found that the three strategies did not provide equivalent information. RNA-based sequencing generated the most informative single-library view of infection, particularly for RNA viruses, cellular pathogens, functional microbial signals, and host immune-response patterns. DNA-based sequencing was more effective for DNA virus and host genome recovery, whereas the total nucleic acid sequencing workflow evaluated here generally behaved as an intermediate strategy. These findings show that library preparation can substantially influence the interpretation of metagenomic data.

functional characterization↗

Artificial intelligence (AI) uses in stereotactic radiosurgery (SRS): diagnosis with brain metastasis (BM) - A systematic review.

BACKGROUND: Brain metastases (BM) are the most common intracranial tumors in adults, and stereotactic radiosurgery (SRS) has become a mainstay of management. However, several diagnostic challenges persist in the SRS pathway, particularly the differentiation of radiation necrosis (RN) from true tumor progression, which conventional MRI and even advanced imaging techniques often cannot reliably resolve. Recent advances in artificial intelligence (AI) offer the potential to address these diagnostic limitations. This systematic review synthesizes current literature on AI applications for MRI-based diagnostic decision support in BM patients undergoing SRS, with a focus on radiomics and deep learning tools for distinguishing RN from progression, classifying molecular and histologic subtypes, and predicting treatment response. METHODS: A systematic review was performed in accordance with PRISMA guidelines. PubMed, Web of Science, and Scopus were searched using a targeted query combining terms related to AI, brain metastasis, diagnosis or imaging, and SRS. After screening 483 records and applying strict inclusion and exclusion criteria, 18 studies published between 2015 and 2025 were included. Data were extracted on study design, cohort characteristics, imaging modality, AI methodology, validation strategy, and reported diagnostic performance. RESULTS: Among the 18 included studies, AI models demonstrated strong performance across diagnostic tasks in the BM-SRS pathway. The differentiation of RN from true tumor progression was the most extensively studied application, addressed by 14 of 18 studies, with reported AUCs ranging from 0.71 to 0.94. Support vector machines, random-forest ensembles, convolutional neural networks, and transformer-based multimodal architectures were widely used. The literature evolved from single-sequence radiomic classifiers in 2018 to multimodal deep learning frameworks fusing imaging with clinical and genomic data in 2025. Contrast-enhanced T1-weighted MRI was the dominant imaging input, and texture-based radiomic features (GLCM, GLSZM, GLDM, and wavelet-derived features) were the most consistently predictive. The highest-performing models reached AUCs of 0.85-0.91 through multimodal integration of imaging with clinical and genomic features, and consistently outperformed expert neuroradiologist read on matched cases. Remaining studies addressed longitudinal segmentation-based detection of local failure and adverse radiation effects, BRAF mutation status in melanoma BM, early Gamma Knife treatment response, and primary tumor histology classification, with more variable performance. CONCLUSION: AI models, particularly those integrating MRI-derived radiomic features with clinical and genomic data, show high accuracy in supporting diagnostic decisions for BM patients treated with SRS. The post-SRS differentiation of radiation necrosis from true tumor progression has reached the greatest level of maturity and is closest to clinical translation, with potential to reduce unnecessary biopsies, personalize surveillance intervals, and rationalize treatment-pathway decisions. Other diagnostic applications, including molecular subtyping and primary tumor histology classification, remain exploratory and require further multicenter validation. Integration of AI tools into multidisciplinary tumor-board workflows, combined with prospective validation and standardized reporting, will be essential to realize the full clinical benefits of AI in SRS for brain metastases.

Humans↗

Evaluation of a filmless radiology pilot--a preliminary report.

The development of the Multimedia Electronic Medical Record System (MEMRS) promises new opportunities to significantly reduce the routine use of film as the medium for viewing radiological medical images. The effect of this change to digital media on physician workflow and the perceived value and utility of medical images is an area of ongoing investigation. In this study we examined oncology clinicians use of medical images in a MEMRS. We conducted observational studies of clinicians during a filmless radiology pilot study in which a filmless environment was simulated but the actual film was available on request. This observational study was the first step in a comprehensive evaluation designed to elucidate the issues surrounding the implementation of a filmless radiology environment. We identified and examined several of these issues, including physician concern regarding the utility of digital images for clinical use and comparison with film, the need to address the effects of image compression with clinicians, and the workflow changes necessary to incorporate digital image use into a clinical practice.

Attitude of Health Personnel↗

Applications of artificial intelligence in robot-assisted surgery: a systematic review.

To characterize applications of artificial intelligence (AI) in robot-assisted surgery, summarize technical and clinical performance, and assess the quality of the available evidence. PubMed, Web of Science Core Collection, and Scopus were searched for English-language journal articles published from 1 January 2020 through 31 October 2025. Randomized, observational, model-development, validation, and feasibility studies evaluating AI in robot-assisted surgery or closely related image-guided minimally invasive workflows were eligible. Two reviewers independently performed study selection, data extraction, and risk-of-bias assessment. Owing to heterogeneity in surgical procedures, AI tasks, analytical units, validation strategies, and outcomes, findings were synthesized descriptively without statistical pooling. The review was registered in the International Prospective Register of Systematic Reviews (CRD420251175699). Seventeen studies were included: seven clinical prediction or decision-support studies, eight intraoperative recognition, segmentation, or image-guided studies, and two training or workflow studies. Five prediction studies reported area-under-the-curve values of 0.74-0.95. Technical studies reported F1 or Dice scores of 0.525-0.995 and task-specific accuracies of 0.840-0.998. Two randomized studies suggested benefits for personalized suturing feedback and automated camera control, but neither established improved patient outcomes. Only one study had low overall risk of bias; the remaining studies were at high or unclear risk or raised some concerns. AI applications in robot-assisted surgery show promise for prediction, intraoperative perception, training, and workflow support. Evidence primarily demonstrates technical feasibility rather than established clinical effectiveness. Independent multicenter validation and prospective evaluation of patient, educational, and workflow outcomes are required before widespread implementation.

Robotic Surgical Procedures↗

Comfort and Usability of Digital Versus Conventional Custom-Fit Mouthguards: A Randomized Clinical Trial.

BACKGROUND/OBJECTIVES: The use of mouthguards protects teeth and the supporting tissues against impacts. Digital impressions and 3D-printed models can reduce manufacturing steps and minimize discomfort. This study evaluated the fit, comfort, and usability of custom-made mouthguards, obtained by conventional and digital workflow, in amateur athletes. MATERIALS AND METHODS: Amateur athletes were recruited for this randomized, double-blind, crossover clinical study. Each participant received two 4-mm-thick custom-fit mouthguards made of ethylene vinyl acetate (EVA) sheets using two protocols: conventional impression using alginate to produce dental stone cast (CMP) and intraoral digital scanning to produce 3D-printed resin models (DMP). Each mouthguard was worn during all training and matches over 3&#x2009;months. The order of mouthguard use was randomly assigned. Patient satisfaction with the impression protocol and mouthguard use, model accuracy, and mouthguard fit were assessed. RESULTS: Overall, 46 participants completed the study. The DMP protocol required less execution time (p&#x2009;=&#x2009;0.023), caused less discomfort (p&#x2009;=&#x2009;0.018), anxiety (p&#x2009;=&#x2009;0.008), nausea (p&#x2009;=&#x2009;0.027), difficulty breathing (p&#x2009;<&#x2009;0.001), and unpleasant taste (p&#x2009;=&#x2009;0.006) compared to the CMP protocol. The pain (p&#x2009;=&#x2009;0.971) perceived by the participants was similar in both impression protocols. The CMP-mouthguards were considered to be better fitting by the majority of participants (p&#x2009;=&#x2009;0.027). Between-group comparisons revealed that DMP-mouthguard caused less discomfort immediately postadaptation (p&#x2009;=&#x2009;0.034), with no significant differences observed at 30 or 90&#x2009;days. CONCLUSIONS: The digital workflow demonstrated to be efficient in the fabrication of mouthguards. Digital impression was more comfortable, requiring less execution time, with more accurate printed models and produced mouthguards with reported comfort and fit levels similar to those manufactured conventionally.

Humans↗

IMRT: high-definition radiation therapy in a community hospital.

A multileaf collimator (MLC)-based intensity-modulated radiation therapy (IMRT) program was implemented successfully at Monmouth Medical Center, a community hospital at Long Branch, New Jersey. Our clinical experience gained in the treatment of over 80 patients using IMRT for prostate, head and neck, and brain is reviewed, and some of the clinical issues are also, discussed. Implementation of the IMRT requires a treatment planning system, computer-controlled beam-shaping aperture, electronic record and verify system, and a good physics quality assurance program. These components, by grouping them efficiently, have created a seamless workflow for our complete radiotherapy process of IMRT. Each of these radiotherapy processes are discussed for clarity and the clinical importance is also evaluated. Of particular interest is inverse treatment planning that will impact treatment delivery such as beam orientation, treatment ports, and organ motion of IMRT. A checklist for physics and departmental quality assurance is suggested, with the intention of providing systematic workflow, making IMRT feasible at a community medical center setting. This is especially important because most of our cancer patients received radiation therapy locally. Lastly, the reimbursement issue affecting the implementation of IMRT at our medical center is also discussed to justify this new treatment protocol for future clinical outcomes.

Head and Neck Neoplasms↗