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[Clinical pathways--practical aid for the physician? Example: clarification of the suspicion of tuberculosis].

Guidelines, clinical pathways and clinical algorithms are popular instruments nowadays to ensure quality as well as the economic efficiency of medical work. These terms themselves, however, are frequently defined only in a diffuse way. Thus, medical standard procedures often complicate clinical workflows more than to facilitate decision making in everyday life. In our department, feasible standardized approaches have been generated in the form of structured text documents, which on the one hand can aid clinical decision making at the bedside and on the other hand serve as medical sketches for the generation of operational treatment paths on an interdisciplinary level. Structure and content of such an instructional text are exemplified here using our standardized document for the diagnostic approach when tuberculosis is suspected.

Critical Pathways↗

Optimising workflow in andrology: a new electronic patient record and database.

AIM: To improve workflow and usability by introduction of a new electronic patient record (EPR) and database. METHODS: Establishment of an EPR based on open source technology (MySQL database and PHP scripting language) in a tertiary care andrology center at a university clinic. Workflow analysis, a benchmark comparing the two systems and a survey for usability and ergonomics were carried out. RESULTS: Workflow optimizations (electronic ordering of laboratory analysis, elimination of transcription steps and automated referral letters) and the decrease in time required for data entry per patient to 71%+/-27%, P<0.05, lead to a workload reduction. The benchmark showed a significant performance increase (highest with starting the respective system: 1.3+/-0.2 s vs. 11.1+/-0.2 s, mean+/-SD). In the survey, users rated the new system at least two ranks higher over its predecessor (P<0.01) in all sub-areas. CONCLUSION: With further improvements, today's EPR can evolve to substitute paper records, saving time (and possibly costs), supporting user satisfaction and expanding the basis for scientific evaluation when more data is electronically available. Newly introduced systems should be versatile, adaptable for users, and workflow-oriented to yield the highest benefit. If ready-made software is purchased, customization should be implemented during rollout.

Andrology↗

Design and implementation of a web-based patient portal linked to an ambulatory care electronic health record: patient gateway for diabetes collaborative care.

BACKGROUND: Despite the availability of expert guidelines and widespread diabetes quality improvement efforts, care of patients with diabetes remains suboptimal. Two key barriers to care that may be amenable to informatics-based interventions include (1) lack of patient engagement with therapeutic care plans and (2) lack of medication adjustment by physicians ("clinical inertia") during clinical encounters. METHODS: The authors describe the conceptual framework, design, implementation, and analysis plan for a diabetes patient web-portal linked directly to the electronic health record (EHR) of a large academic medical center via secure Internet access designed to overcome barriers to effective diabetes care. RESULTS: Partners HealthCare System (Boston, MA), a multi-hospital health care network comprising several thousand physicians caring for over 1 million individual patients, has developed a comprehensive patient web-portal called Patient Gateway that allows patients to interact directly with their EHR via secure Internet access. Using this portal, a specific diabetes interface was designed to maximize patient engagement by importing the patient's current clinical data in an educational format, providing patient-tailored decision support, and enabling the patient to author a "Diabetes Care Plan." The physician view of the patient's Diabetes Care Plan was designed to be concise and to fit into typical EHR clinical workflow. CONCLUSIONS: We successfully designed and implemented a Diabetes Patient portal that allows direct interaction with our system's EHR. We are assessing the impact of this advanced informatics tool for collaborative diabetes care in a clinic-randomized controlled trial among 14 primary care practices within our integrated health care system.

Ambulatory Care↗

Pre-operative dynamic interactive exploration of complex articular fractures using a novel 3D navigation tool.

OBJECTIVES: Trauma surgeons possess specific anticipative pathoanatomical and procedural domain knowledge that can be used for information extraction from original CT image data. This knowledge so far remains unused in clinical workflow and surgeons do not take an active part in the process of image generation and processing. The objectives of our work are to propose and employ a strategy to directly involve surgeons in a dynamic image exploration process and to exemplarily assess the clinical use of this approach for pre-operative diagnosis of complex articular fractures. METHODS: We used an interactive 3D navigation tool with a novel human-computer interface for the exploration of articular fractures of two selected anatomical structures. The system offers dynamic interaction with a virtual 3D reconstruction model and the possibility to create on-the-fly oblique multiplanar reformations by tracking hand movements. Three expert surgeons performed exemplary explorations and rated the use of the method for preoperative diagnosis in informal interviews. RESULTS: The approach and the system were well received by the three surgeons. The dynamic interaction was rated to be helpful in understanding fracture morphology. Two examples--a radius and a calcaneal fracture--are presented. CONCLUSIONS: Surgeons with their specific domain knowledge should be involved in the process of image processing. The benefit of using oblique multiplanar reformations for pre-operative planning in articular fractures appears to be substantial and they should therefore be included in radiological and surgical textbooks. Further evaluation is necessary to assess the use of interactive exploration systems in routine diagnosis.

Feasibility Studies↗

Pentax confocal endomicroscope: a novel imaging device for in vivo histology of the upper and lower gastrointestinal tract.

With advances in endoscopic imaging tools, it is becoming increasingly possible to find, assess and treat numerous gastrointestinal (GI) pathologies at the time of endoscopy. This article focuses on the newly developed Pentax confocal endomicroscope that enables in vivo microscopic imaging of the upper and lower GI tract in histological detail at the time of patient examination without the collection of biopsies. The optical imaging technique has the potential to revolutionize clinical workflows in endoscopy through high-resolution fluorescence imaging of cellular and subcellular detail from the surface and subepithelial layers of the GI mucosa. The device incorporates a full screen, high-resolution charge coupled device as well as a confocal microscope. Preliminary data from blinded clinical studies suggests that the use of this device can increase the diagnostic yield for disease detection in conditions such as ulcerative colitis and Barrett's esophagus, where diagnosis using white light endoscopy is problematic. The early detection and diagnosis of GI abnormalities through the collection of 'optical' biopsies or targeted mucosal excisional biopsies has the potential to improve patient outcomes and enable early therapeutic intervention.

Barrett Esophagus↗

Trends in PACS image storage and archive.

PACS is widely used in hospitals and is considered a mission critical system for around-the-clock daily clinical operation. Scheduled or unscheduled downtime of the main PACS archive storage or server could potentially cripple the entire PACS operation. This is especially the case in a filmless hospital environment. Therefore, in a downtime event, it is most desirable for users to have only a minimal performance impact without interruption of clinical data flow or loss of data and to have available historical PACS studies. This paper summarizes some of the developments in the design and implementation of a reliable PACS that insures maximum uptime for end users while preserving the integrity of the PACS data and making it available during downtime events. It also details strategy for developing proper clinical workflow contingency procedures when a scheduled downtime event to the main archive storage and server occurs. Specifically, the design and implementation of a fault-tolerant (FT) main archive server, the development of a FT back-up archive using an application service provider (ASP) model, and the clinical experiences while upgrading a main archive server and migrating the stored PACS data to new storage media will be discussed.

California↗

Analyzing computer based patient records: a review of literature.

A wide-ranging literature review of computer-based patient record (CPR) implementation over the past decade reveals that clinical, workflow, administrative, and revenue enhancement benefits of the CPR outweigh barriers and challenges--but only if healthcare organizations redesign certain work processes. Among other key efforts, organizations must train and motivate users to navigate CPR systems, as well as develop a common structured language. Clinicians who used CPRs found that electronic access to clinical information saves time and provides a thorough and efficient way to manage patient information.

Decision Support Systems, Clinical↗

Implementing outpatient order entry to support medical necessity using the patient's electronic past medical history.

Physician order entry is difficult to implement, both in inpatient and outpatient settings. Such systems must integrate conveniently into clinical workflows, and provide sufficient benefit to offset the burden of system use. For outpatient order entry, significant advantages can accrue when systems incorporate medical necessity guidelines - improved billing and adherence to governmental policies. The authors developed and implemented an outpatient order entry system that utilizes an electronically accessible history of patient, provider, and clinic-related diagnoses in assisting providers (when possible and appropriate) to select compliant justifications for tests and procedures. The pilot implementation site, active for more than six months, has been the Vanderbilt University Page Campbell Cardiology Clinic, with 34 providers.

Ambulatory Care↗

New x-ray tube performance in computed tomography by introducing the rotating envelope tube technology.

The future demands of computed tomography imaging regarding the x-ray source can be summarized with higher scan power, shorter rotation times, shorter cool down times and smaller focal spots. We report on a new tube technology satisfying all these demands by making use of a novel cooling principle on one hand and of a novel beam control system on the other hand. Nowadays tubes use a rotating anode disk mainly cooled via radiation. The Straton x-ray tube is the first tube available for clinical routine utilizing convective cooling exclusively. It is demonstrated that this cooling principle makes large heat storage capacities of the anode disk obsolete. The unprecedented cooling rate of 4.8 MHU/min eliminates the need for waiting times due to anode cooling in clinical workflow. Moreover, an electronic beam deflection system for focal spot position and size control opens the door to advanced applications. The physical backgrounds are discussed and the technical realization is presented. From this discussion the superior suitability of this tube to withstand g-forces well above 20 g created by fast rotating gantries will become evident. Experience from a large clinical trial is reported and possible ways for future developments are discussed.

Equipment Design↗

The Swiss Orthopaedic Registry.

Following the tradition of the IDES European Hip Registry inaugurated by M. E. Müller in the 1960s, the Institute for Evaluative Research in Orthopaedic Surgery at the University of Bern started a new era of data collection using internet technology (www.memdoc.org). With support of the Swiss Orthopaedic Society, the pilot of the Swiss Orthopaedic Registry was conducted, and in cooperation with different academic and non-academic centers the practicability of integrating the various data collection instruments into the daily clinical workflow was evaluated. Three different sizes of hip and knee questionnaires were compiled, covering the individual demands of the participating hospitals whereby the smaller questionnaires always represent a subset of the next larger one. Different types of data collection instruments are available: the online interface, optical mark reader paper questionnaires, and barcode sheets. Precise implant tracking is implemented by scanning the implant barcodes directly in the operating theaters and linking them to the clinical data set via a central server. In addition, radiographic information can be linked with the clinical data set. The pilot clinics suggested enhancements to the user interface and additional features for data management. Also, recommendations were made to simplify content in some instances and diversify in others. With a new software release and adapted questionnaires the Swiss Orthopaedic Registry was officially launched in Summer 2005.

Arthroplasty, Replacement, Hip↗

Understanding recurrence in Mycobacterium avium complex pulmonary disease: genotypic strategies to support clinical decision-making.

Pulmonary disease caused by Mycobacterium avium complex (MAC-PD) is a chronic, recurrent disease, and its high recurrence rate after treatment makes clinical management difficult. Distinguishing whether recurrence is due to persistence of existing strains or reinfection with new strains is essential for establishing treatment strategies, preventing overuse of antimicrobials, and establishing infection control measures. According to reports, 54%-74% of MAC-PD recurrence is due to reinfection, which may be mainly related to environmental reservoirs such as household water supply. In this review, we present various clinical scenarios in which MAC-PD recurrence may occur and examine genotyping techniques as a strategy to distinguish and respond to them. From traditional methods such as IS1245-based restriction fragment length polymorphism, pulsed-field gel electrophoresis, and hsp65 and rpoB gene sequencing to high-resolution analysis techniques such as multilocus sequence testing and whole-genome sequencing, the latest molecular typing methods are comprehensively summarized. Integrating these genotype data into clinical settings, standardizing single-nucleotide polymorphism-based interpretation thresholds, and promoting the establishment of a global MAC strain database will make a substantial contribution to more accurately distinguishing the recurrence mechanisms of MAC-PD and establishing personalized treatment strategies.IMPORTANCEThe global burden of nontuberculous mycobacterial pulmonary disease (PD) is increasing, with Mycobacterium avium (MAC)-PD being the most prevalent and clinically challenging form. Its low treatment success rates, high frequency of recurrence, and persistent environmental exposure complicate both diagnosis and management. A critical clinical issue is determining whether recurrence represents true relapse, due to persistence of the original strain, or reinfection with a new strain, as this guides treatment and prevents overtreatment. Genotypic strategies capable of resolving strain-level differences can improve diagnostic accuracy, prevent misclassification, and ultimately support more informed treatment decisions. Therefore, integrating genotyping data into clinical workflows, standardizing single-nucleotide polymorphism thresholds, and establishing a global MAC strain database will not only support personalized treatment but also enhance the broader public health response to this disease.

Humans↗

Models for guideline representation.

Despite the great emphasis that the medical community has dedicated to clinical practice guidelines in the last few decades, it has become clear that it is difficult to adequately distribute texts (paper-based guidelines) and for them to be used by final users. The reasons for this are manifold: the large number of guidelines delivered each year, their necessary updates on the face of new scientific evidence, the text is not always free from ambiguities, etc. When these problems became evident, the medical informatics community hypothesised that more formal electronic versions would increase the probability of the effective diffusion of guidelines and also physicians' compliance to them. This claim was based on a few hypotheses: one is that formal models, such as flowcharts or other graphical metaphors, provide a more friendly and immediate way of reading a guideline, thus improving learning and absorbing of the guideline content (e. g. using formal models as educational/simulation tools); another hypothesis is that formal models allow easier guideline integration with the daily clinical workflow, raising the possibility of building real-time decision support systems, which again should improve physicians' compliance. This paper focuses on the issues that must be taken into account when modelling guidelines to ensure their effective implementation in real-world computerised environments.

Computer Simulation↗

Imaging technologies and techniques.

Equipment manufacturers provide contrast-specific detection techniques that have excellent sensitivity and excellent agent-to-tissue specificity along with helpful tools that improve workflow efficiency dramatically. Excellent contrast agents have been approved for LV opacification and are available worldwide. Techniques designed for low-MI imaging offer real-time acquisition capabilities and lead to faster examinations. Techniques designed for medium-MI imaging offer better sensitivity than low-MI techniques while maintaining the benefit of rapid image acquisition. Techniques designed for high-MI imaging offer the best sensitivity with longer acquisition times. These techniques are viable means for imaging contrast agents tailored to clinical needs. Progress by contrast agent manufacturers, equipment manufacturers, and physicians will continue to drive improvements in the areas of detection and clinical workflow for improved patient care.

Coronary Circulation↗

Accurate identification of abnormal ploidy using an artificial intelligence model in preimplantation genetic testing.

STUDY QUESTION: Can ultra-low-coverage whole-genome sequencing (ulc-WGS) accurately identify abnormal ploidy during preimplantation genetic testing (PGT)? SUMMARY ANSWER: The artificial intelligence (AI)-based PGT-Plus model demonstrates high accuracy in ploidy detection, offering a cost-effective solution that enhances clinical utility of PGT. WHAT IS KNOWN ALREADY: The predominant PGT for aneuploidy can identify chromosomal aneuploidies but cannot determine ploidy status. Transferring embryos with ploidy abnormalities can result in miscarriage and molar pregnancy. On the other hand, in ART, fertilization is assessed by morphological pronuclear assessment at the zygote stage. However, it has a low specificity in the prediction of abnormal ploidy status and embryos deemed abnormally fertilized can yield healthy pregnancies. Accurately identified abnormal ploidy in PGT-A can resolve current limitations and expand the utility range of PGT-A. Several studies have identified ploidy abnormalities; however, they were mainly based on single-nucleotide polymorphism (SNP) arrays or needed to combine additional targeted-next-generation sequencing (NGS) information. Studies based on ulc-WGS remain scarce. STUDY DESIGN SIZE DURATION: The study consisted of two stages: methodology establishment and validation. An AI model, named PGT-Plus, was developed using 653 samples with known ploidy status, which was further validated using 792 different ploidy status samples. In the clinical application stage, the approach was used to analyse the ploidy status of 19&#x2009;103 normally fertilized PGT blastocysts and 140 single pronucleus (1PN)-derived blastocysts collected between May 2022 and December 2023. All blastocysts were tested using trophectoderm biopsy and NGS. PARTICIPANTS/MATERIALS SETTING METHODS: The methodology is based on the ulc-WGS data. First, based on samples with known ploidy status: the heterozygosity rate of high-frequency biallelic SNPs, the likelihood ratio (LLR) of alleles was calculated under different assumptions ('both parental homologs' [BPH] from a single parent, 'single parental homolog' [SPH] from each parent, disomy, and monosomy) by leveraging allele frequencies and linkage disequilibrium (LD) measured in the 1000 genomes project database. Twenty-three continuous candidate features derived from heterozygosity rates and LLRs of chromosomes or selected windows were included to establish the ploidy prediction AI model. Gini importance analysis and multicollinearity mitigation was performed for feature selection, then the performance of Random Forest (RF), Support Vector Machine (SVM), and Logistic Regression for modelling was compared. Subsequently, the parameter optimization was performed based on the RF model. Ploidy constitution concordance was evaluated in known ploidy status samples. The frequency of abnormal ploidy in normal fertilized PGT blastocysts and 1PN-derived blastocysts (including conventional IVF and ICSI) was evaluated. MAIN RESULTS AND THE ROLE OF CHANCE: Eleven features were collected for model architecture compared to SVM and Logistic Regression; RF achieved superior performance for ploidy detection. The AI model achieved an AUC of 1 for genome-wide-uniparental diploidy (GW-UPD), 1 for triploidy, and 0.99 for diploidy. For the 792 validation samples, 99.5% of samples were successfully detected using the AI model, and the model showed 100% accuracy for ploidy classification. In the clinical application stage, out of 19&#x2009;103 PGT samples, 19&#x2009;069 were successfully analysed using the model, with 110 (0.57%) identified as having abnormal ploidy embryos. Among these, 12.7% (14/110) were identified as GW-UPD, and 87.3% (96/110) were triploid. Among 5563 diploid blastocysts transferred, 3478 clinical pregnancies were achieved. Subsequent ploidy analysis was performed for 217 spontaneous abortion and 935 prenatal diagnostic samples, and no abnormal ploidy was identified. Furthermore, of the 140 1PN embryos tested, 40 (28.6%) exhibited GW-UPD, 3 (2.1%) exhibited triploidy, and 97 (69.3%) were determined to be biparental and normally fertilized. Among the 97 biparental embryos, 46 were diploid, 11 were mosaic, and 40 were aneuploid. In terms of the insemination pattern, the percentage of abnormal ploidy in ICSI was significantly higher than in conventional IVF (P&#x2009;<&#x2009;0.01, 37.1% vs. 2.9%, respectively). With full informed consent, 20 patients without euploidy from normal fertilization chose 1PN-derived biparental and diploid blastocysts to transfer, resulting in 10 clinical pregnancies and 9 ongoing pregnancies. LARGE-SCALE DATA: N/A. LIMITATIONS REASONS FOR CAUTION: Some rare ploidy abnormalities, such as polyploidy with an equal number of identical sets of chromosomes and ploidy mosaicism cannot be accurately identified. Moreover, the origin of abnormal ploidy was not identified due to the unavailability of DNA from both parents. WIDER IMPLICATIONS OF THE FINDINGS: The PGT-Plus AI model provides a ploidy evaluation method based on the conventional PGT-A data and integrates directly into standard PGT-A workflows. Clinical utility results suggest that the model is a valuable tool for identifying embryos with abnormal ploidy in PGT-A and rescuing normal diploid embryos from abnormally fertilized embryos. These findings demonstrate that PGT-Plus significantly enhances the diagnostic accuracy of PGT. STUDY FUNDING/COMPETING INTERESTS: This study was supported by grants from Major Scientific Program of CITIC Group (No. 2023ZXKYB34100, to Ge.L.), Hunan Provincial Grant for Innovative Province Construction (2019SK4012), Hunan Xiangjiang New District (Changsha High-tech Zone) key core technology research project in 2023, and Science Foundation of Hunan Province (Grant 2023JJ30422). All authors declared no conflicts of interest..

artificial intelligence↗

DNA sequencing for microbial surveillance in cystic fibrosis airways: advances, challenges, and clinical translation.

SUMMARYDNA sequencing has revolutionized microbial surveillance in cystic fibrosis (CF), transforming pathogen identification from culture-dependent to total microbial community identification using molecular-based approaches. Techniques such as 16S rRNA gene sequencing have uncovered the complexity of the CF airway microbiome, while shotgun metagenomics, metatranscriptomics, and viromics now provide strain-level, functional, and viral insights beyond bacterial identification. Despite these advances, key technical and logistical challenges remain, including the processing of high-viscosity sputum samples, overwhelming host DNA contamination, managing large data sets, and the integration of complex bioinformatic outputs into clinical workflows. Emerging innovations such as host DNA depletion protocols, targeted enrichment panels, and adaptive sampling on Oxford Nanopore platforms are helping to overcome these barriers, improving microbial recovery and sequencing efficiency. As cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies are changing the lives of people with cystic fibrosis (pwCF), sequencing offers an unprecedented opportunity to track potential microbial adaptation in response. This review investigates current advances, limitations, and translational opportunities in DNA sequencing for CF airway microbiome surveillance, highlighting how these technologies can help reshape research and clinical microbiology in the post-modulator era.

Cystic Fibrosis↗

Decision support for health care: the PROforma evidence base.

Cancer Research UK has developed PROforma, a formal language for modelling clinical processes, along with associated tools for creating decision support, care planning, clinical workflow management and other applications. The PROforma method has been evaluated in a variety of settings: in primary health care (prescribing, referral of suspected cancer patients, genetic risk assessment) and in specialist care of patients with breast cancer, leukaemia, HIV infection and other conditions. About nine years of experience have been gained with PROforma technologies. Seven trials of decision support applications have been published or are in preparation. Each of these has shown significant positive effects on a variety of measures of quality and/or outcomes of care. This paper reviews the evidence base for the clinical effectiveness of these PROforma applications, and previews the CREDO project -- a multi-centre trial of a complex PROforma application for supporting integrated breast cancer care across primary and secondary care settings.

Breast Neoplasms↗

A Clinically Integrated Pediatric Patient-Derived Xenograft Program Enables Evaluation of Cohort and Patient-Specific Biology and Therapeutic Strategies.

UNLABELLED: Preclinical translational research has increasingly utilized patient-derived xenograft (PDX) models for mechanistic and experimental therapeutic studies, yet most existing models have been developed from adult cancer types. We describe the establishment of a PDX program to expand the availability of pediatric-specific PDXs for preclinical research and enable studies of pediatric cancer histologies, including ultrarare diseases. Processes for PDX generation were integrated into established clinical workflows to facilitate universal model generation. Methodologies for tissue procurement, processing, and cryopreservation were optimized to enable intra- and interinstitutional PDX model generation. Over a 6-year span, 388 PDX tumor models representing more than 40 diagnoses were generated, including ultrarare tumors and longitudinal models established from pretherapy, posttherapy, and relapse tumors from the same patient. Genomic characterization of these PDXs demonstrates excellent concordance and recapitulation of molecular alterations of the source tumor. Successful PDX generation was enhanced from relapsed samples, was higher in sarcomas compared with other solid tumor types, and was a negative prognosticator for clinical outcome. With a broad portfolio of molecularly annotated models, we demonstrate utility for validating cross-histology biomarker-driven therapeutic strategies by demonstrating antitumor activity of an MAT2A inhibitor in MTAP-deficient PDXs. Universal model creation also allows for experimental validation of therapeutic hypotheses on a patient-specific basis, as we describe the characterization of a novel RAF1 fusion (EPB41L2::RAF1) in an osteosarcoma PDX. Development of a diverse collection of pediatric PDX models enables hypothesis-driven and cross-histology studies that expand our understanding of cancer biology and aid ongoing drug prioritization efforts in rare tumors. SIGNIFICANCE: A clinically integrated, genomically annotated pediatric PDX portfolio supported by systematic benchmarking of model generation facilitates exploratory biomarker-driven and patient-specific translational studies.

Humans↗

Analog to digital workflow improvement: a quantitative study.

This study tracked a radiology department's conversion from utilization of a Kodak Amber analog system to a Kodak DirectView DR 5100 digital system. Through the use of ProModel Optimization Suite, a workflow simulation software package, significant quantitative information was derived from workflow process data measured before and after the change to a digital system. Once the digital room was fully operational and the radiology staff comfortable with the new system, average patient examination time was reduced from 9.24 to 5.28 min, indicating that a higher patient throughput could be achieved. Compared to the analog system, chest examination time for modality specific activities was reduced by 43%. The percentage of repeat examinations experienced with the digital system also decreased to 8% vs. the level of 9.5% experienced with the analog system. The study indicated that it is possible to quantitatively study clinical workflow and productivity by using commercially available software.

Efficiency, Organizational↗