Continuous monitoring of physiological data using the patient vital status fusion score in septic critical care patients.

Accurate and standardized methods for assessing the vital status of patients are crucial for patient care and scientific research. This study introduces the Patient Vital Status (PVS), which quantifies and contextualizes a patient's physical status based on continuous variables such as vital signs and deviations from age-dependent normative values. The vital signs, heart rate, oxygen saturation, respiratory rate, mean arterial blood pressure, and temperature were selected as input to the PVS pipeline. The method was applied to 70 pediatric patients in the intensive care unit (ICU), and its efficacy was evaluated by matching high values with septic events at different time points in patient care. Septic events included systemic inflammatory response syndrome (SIRS) and suspected or proven sepsis. The comparison of maximum PVS values between the presence and absence of a septic event showed significant differences (SIRS/No SIRS: p < 0.0001, η2 = 0.54; Suspected Sepsis/No Suspected Sepsis: p = 0.00047, η2 = 0.43; Proven Sepsis/No Proven Sepsis: p = 0.0055, η2 = 0.34). A further comparison between the most severe PVS in septic patients with the PVS at ICU discharge showed even higher effect sizes (SIRS: p < 0.0001, η2 = 0.8; Suspected Sepsis: p < 0.0001, η2 = 0.8; Proven Sepsis: p = 0.002, η2 = 0.84). The PVS is emerging as a data-driven tool with the potential to assess a patient's vital status in the ICU objectively. Despite real-world data challenges and potential annotation biases, it shows promise for monitoring disease progression and treatment responses. Its adaptability to different disease markers and reliance on age-dependent reference values further broaden its application possibilities. Real-time implementation of PVS in personalized patient monitoring may be a promising way to improve critical care. However, PVS requires further research and external validation to realize its true potential.

Targeted Data Quality Analysis for a Clinical Decision Support System for SIRS Detection in Critically Ill Pediatric Patients.

BACKGROUND: Data quality issues can cause false decisions of clinical decision support systems (CDSSs). Analyzing local data quality has the potential to prevent data quality-related failure of CDSS adoption. OBJECTIVES: To define a shareable set of applicable measurement methods (MMs) for a targeted data quality assessment determining the suitability of local data for our CDSS. METHODS: We derived task-specific MMs using four approaches: (1) a GUI-based data quality analysis using the open source tool openCQA. (2) Analyzing cases of known false CDSS decisions. (3) Data-driven learning on MM-results. (4) A systematic check to find blind spots in our set of MMs based on the HIDQF data quality framework. We expressed the derived data quality-related knowledge about the CDSS using the 5-tuple-formalization for MMs. RESULTS: We identified some task-specific dataset characteristics that a targeted data quality assessment for our use case should inspect. Altogether, we defined 394 MMs organized in 13 data quality knowledge bases. CONCLUSIONS: We have created a set of shareable, applicable MMs that can support targeted data quality assessment for CDSS-based systemic inflammatory response syndrome (SIRS) detection in critically ill, pediatric patients. With the demonstrated approaches for deriving and expressing task-specific MMs, we intend to help promoting targeted data quality assessment as a commonly recognized usual part of research on data-consuming application systems in health care.

Achieving Interoperable Datasets in Pediatrics: A Data Integration Approach.

Despite their increased secondary value for developing applications and knowledge gain, routine, harmonized and standardized datasets are often not available in Pediatrics. We propose a data integration pipeline towards an interoperable routine dataset in pediatric intensive care medicine. Our three-level approach involves identifying relevant data from primary source systems, developing local data integration processes, and converting data into a standardized, interoperable format using openEHR. We modeled 15 openEHR templates and established 31 interoperable ETL processes, resulting in anonymized, standardized data of about 4,200 pediatric patients that were loaded into a harmonized database. Based on our pipeline and templates, we successfully integrated the first part of this data in our openEHR data repository. We seek to inspire other pediatric intensive care units to adopt similar approaches, with the aim of breaking down heterogenous data silos and promoting secondary use of routine data.

Developing a Data Driven Approach for Early Detection of SIRS in Pediatric Intensive Care Using Automatically Labeled Training Data.

Critical care can benefit from analyzing data by machine learning approaches for supporting clinical routine and guiding clinical decision-making. Developing data-driven approaches for an early detection of systemic inflammatory response syndrome (SIRS) in patients of pediatric intensive care and exploring the possibility of an approach using training data sets labeled automatically beforehand by knowledge-based approaches rather than clinical experts. Using naïve Bayes classifier and an artificial neuronal network (ANN), trained with real data labeled by (1) domain experts ad (2) a knowledge-based decision support system (CDSS). Accuracies were evaluated by the data set labeled by domain experts using a 10-fold cross validation. The ANN approach trained with data labeled by domain experts yielded a specificity of 0.9139 and sensitivity of 0.8979, whereas the approach trained with a data set labeled by a knowledge-based CDSS achieves a specificity of 0.9220 and a sensitivity of 0.8887. ANN yielded promising results for data-driven detection of pediatric SIRS with real data. Our comparison shows the feasibility of using training data labeled automatically by knowledge-based approaches rather than manually allocated by experts.

Towards an Evolutionary Open Pediatric Intensive Care Dataset in the ELISE Project.

BACKGROUND: To embrace the need for freely accessible training data sets originating from the real world, in the ELISE project, we integrate source data from a pediatric intensive care unit and provide it to researchers. OBJECTIVE: We present our vision, initial results and steps on a trail towards an evolutionary open pediatric intensive care data set. METHODS: Our evolution plan for the data set comprises three steps. The final data set will include raw clinical data and labels on critical outcomes such as organ dysfunction and sepsis, generated automatically by computerized and well-evaluated methods. RESULTS: First step resulted in an initial version data set available in a central repository. CONCLUSIONS: Our approach has great potential to provide a comprehensive open intensive care data set labeled for critical pediatric outcomes and, thus, contributing to overcome the current lack of real-world pediatric intensive care data usable for training data-driven algorithms.

Prediction models for SIRS, sepsis and associated organ dysfunctions in paediatric intensive care: study protocol for a diagnostic test accuracy study.

INTRODUCTION: Systemic inflammatory response syndrome (SIRS), sepsis and associated organ dysfunctions are life-threating conditions occurring at paediatric intensive care units (PICUs). Early recognition and treatment within the first hours of onset are critical. However, time pressure, lack of personnel resources, and the need for complex age-dependent diagnoses impede an accurate and timely diagnosis by PICU physicians. Data-driven prediction models integrated in clinical decision support systems (CDSS) could facilitate early recognition of disease onset. OBJECTIVES: To estimate the sensitivity and specificity of previously developed prediction models (index tests) for the detection of SIRS, sepsis and associated organ dysfunctions in critically ill children up to 12 hours before reference standard diagnosis is possible. METHODS AND ANALYSIS: We conduct a monocentre, prospective diagnostic test accuracy study. Clinicians in the PICU of the tertiary care centre Hannover Medical School, Germany, continuously screen and recruit patients until the adaptive sample size (originally intended sample size of 500 patients) is enrolled. Eligible are children (0-17 years, all sexes) who stay in the PICU for ≥12 hours and for whom an informed consent is given. All eligible patients are independently assessed for SIRS, sepsis and organ dysfunctions using corresponding predictive and knowledge-based CDSS models. The knowledge-based CDSS models serve as imperfect reference standards. The assessments are used to estimate the sensitivities and specificities of each predictive model using a clustered nonparametric approach (main analysis). Subgroup analyses ('age groups', 'sex' and 'age groups by sex') are predefined. ETHICS AND DISSEMINATION: This study obtained ethics approval from the Hannover Medical School Ethics Committee (No. 10188_BO_SK_2022). Results will be disseminated as peer-reviewed publications, at scientific conferences, and to patients in an appropriate dissemination approach. TRIAL REGISTRATION NUMBER: This study was registered with the German Clinical Trial Register (DRKS00029071) on 2022-05-23. PROTOCOL VERSION: 10188_BO_SK_2022_V.2.0-20220330_4_Studienprotokoll.

Designing an openEHR-Based Pipeline for Extracting and Standardizing Unstructured Clinical Data Using Natural Language Processing.

BACKGROUND: Merging disparate and heterogeneous datasets from clinical routine in a standardized and semantically enriched format to enable a multiple use of data also means incorporating unstructured data such as medical free texts. Although the extraction of structured data from texts, known as natural language processing (NLP), has been researched at least for the English language extensively, it is not enough to get a structured output in any format. NLP techniques need to be used together with clinical information standards such as openEHR to be able to reuse and exchange still unstructured data sensibly. OBJECTIVES: The aim of the study is to automatically extract crucial information from medical free texts and to transform this unstructured clinical data into a standardized and structured representation by designing and implementing an exemplary pipeline for the processing of pediatric medical histories. METHODS: We constructed a pipeline that allows reusing medical free texts such as pediatric medical histories in a structured and standardized way by (1) selecting and modeling appropriate openEHR archetypes as standard clinical information models, (2) defining a German dictionary with crucial text markers serving as expert knowledge base for a NLP pipeline, and (3) creating mapping rules between the NLP output and the archetypes. The approach was evaluated in a first pilot study by using 50 manually annotated medical histories from the pediatric intensive care unit of the Hannover Medical School. RESULTS: We successfully reused 24 existing international archetypes to represent the most crucial elements of unstructured pediatric medical histories in a standardized form. The self-developed NLP pipeline was constructed by defining 3.055 text marker entries, 132 text events, 66 regular expressions, and a text corpus consisting of 776 entries for automatic correction of spelling mistakes. A total of 123 mapping rules were implemented to transform the extracted snippets to an openEHR-based representation to be able to store them together with other structured data in an existing openEHR-based data repository. In the first evaluation, the NLP pipeline yielded 97% precision and 94% recall. CONCLUSION: The use of NLP and openEHR archetypes was demonstrated as a viable approach for extracting and representing important information from pediatric medical histories in a structured and semantically enriched format. We designed a promising approach with potential to be generalized, and implemented a prototype that is extensible and reusable for other use cases concerning German medical free texts. In a long term, this will harness unstructured clinical data for further research purposes such as the design of clinical decision support systems. Together with structured data already integrated in openEHR-based representations, we aim at developing an interoperable openEHR-based application that is capable of automatically assessing a patient's risk status based on the patient's medical history at time of admission.