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Alarm fatigue, a multifactorial desensitization of staff to alarms, can harm both patients and health care staff in intensive care units (ICUs), especially due to false and nonactionable alarms. Increasing amounts of routinely collected alarm and ICU patient data are paving the way for training machine learning (ML) models that may help reduce the number of nonactionable alarms, potentially increasing alarm informativeness and reducing alarm fatigue. At present, however, there is no publicly available dataset or process that routinely collects information on alarm actionability (ie, whether an alarm triggers a medical intervention or not), which is a key feature for developing meaningful ML models for alarm management. Furthermore, case-based manual annotation is too slow and resource intensive for large amounts of data. We propose a scalable method to annotate patient monitoring alarms associated with patient-related variables regarding their actionability. While the method is aimed to be used primarily in our institution, other clinicians, scientists, and industry stakeholders could reuse it to build their own datasets. The interdisciplinary research team followed a mixed methods approach to develop the annotation method, using data-driven, qualitative, and empirical strategies. The iterative process consisted of six steps: (1) defining alarm terms; (2) reaching a consensus on an annotation concept and documentation structure; (3) defining physiological alarm conditions, related medical interventions, and time windows to assess; (4) developing mapping tables; (5) creating the annotation rule set; and (6) evaluating the generated content. All decisions were made based on feasibility criteria, clinical relevance, occurrence frequency, data availability and quantity, structure, and storage mode. The annotation guideline development process was preceded by the analysis of the institution's data and systems, the evaluation of device manuals, and a systematic literature review. In a multidisciplinary consensus-based approach, we defined preprocessing steps and a rule-based annotation method to classify alarms as either actionable or nonactionable based on data from the patient data management system. We have presented our experience in developing the annotation method and provided the generated resources. The method focuses on respiratory and medication management interventions and includes 8 general rules in a tabular format that are accompanied by graphical examples. Mapping tables enable handling unstructured information and are referenced in the annotation rule set. Our annotation method will enable a large number of alarms to be labeled semiautomatically, retrospectively, and quickly, and will provide information on their actionability based on further patient data. This will make it possible to generate annotated datasets for ML models in alarm management and alarm fatigue research. We believe that our annotation method and the resources provided are universal enough and could be used by others to prepare data for future ML projects, even beyond the topic of alarms.

The German initiative “National Research Data Infrastructure for Personal Health Data” (NFDI4Health) focuses on research data management in health research. It aims to foster and develop harmonized informatics standards for public health, epidemiological studies, and clinical trials, facilitating access to relevant data and metadata standards. This publication lists syntactic and semantic data standards of potential use for NFDI4Health and beyond, based on interdisciplinary meetings and workshops, mappings of study questionnaires and the NFDI4Health metadata schema, and literature search. Included are 7 syntactic, 32 semantic and 9 combined syntactic and semantic standards. In addition, 101 ISO Standards from ISO/TC 215 Health Informatics and ISO/TC 276 Biotechnology could be identified as being potentially relevant. The work emphasizes the utilization of standards for epidemiological and health research data ensuring interoperability as well as the compatibility to NFDI4Health, its use cases, and to (inter-)national efforts within these sectors. The goal is to foster collaborative and inter-sectoral work in health research and initiate a debate around the potential of using common standards.

Background: The standard Fast Healthcare Interoperability Resources (FHIR) is widely used in health information technology. However, its use as a standard for health research is still less prevalent. To use existing data sources more efficiently for health research, data interoperability becomes increasingly important. FHIR provides solutions by offering resource domains such as “Public Health & Research” and “Evidence-Based Medicine” while using already established web technologies. Therefore, FHIR could help standardize data across different data sources and improve interoperability in health research. Objective: The aim of our study was to provide a systematic review of existing literature and determine the current state of FHIR implementations in health research and possible future directions. Methods: We searched the PubMed/MEDLINE, Embase, Web of Science, IEEE Xplore, and Cochrane Library databases for studies published from 2011 to 2022. Studies investigating the use of FHIR in health research were included. Articles published before 2011, abstracts, reviews, editorials, and expert opinions were excluded. We followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and registered this study with PROSPERO (CRD42021235393). Data synthesis was done in tables and figures. Results: We identified a total of 998 studies, of which 49 studies were eligible for inclusion. Of the 49 studies, most (73%, n=36) covered the domain of clinical research, whereas the remaining studies focused on public health or epidemiology (6%, n=3) or did not specify their research domain (20%, n=10). Studies used FHIR for data capture (29%, n=14), standardization of data (41%, n=20), analysis (12%, n=6), recruitment (14%, n=7), and consent management (4%, n=2). Most (55%, 27/49) of the studies had a generic approach, and 55% (12/22) of the studies focusing on specific medical specialties (infectious disease, genomics, oncology, environmental health, imaging, and pulmonary hypertension) reported their solutions to be conferrable to other use cases. Most (63%, 31/49) of the studies reported using additional data models or terminologies: Systematized Nomenclature of Medicine Clinical Terms (29%, n=14), Logical Observation Identifiers Names and Codes (37%, n=18), International Classification of Diseases 10th Revision (18%, n=9), Observational Medical Outcomes Partnership common data model (12%, n=6), and others (43%, n=21). Only 4 (8%) studies used a FHIR resource from the domain “Public Health & Research.” Limitations using FHIR included the possible change in the content of FHIR resources, safety, legal matters, and the need for a FHIR server. Conclusions: Our review found that FHIR can be implemented in health research, and the areas of application are broad and generalizable in most use cases. The implementation of international terminologies was common, and other standards such as the Observational Medical Outcomes Partnership common data model could be used as a complement to FHIR. Limitations such as the change of FHIR content, lack of FHIR implementation, safety, and legal matters need to be addressed in future releases to expand the use of FHIR and, therefore, interoperability in health research.

Resources are increasingly spent on artificial intelligence (AI) solutions for medical applications aiming to improve diagnosis, treatment, and prevention of diseases. While the need for transparency and reduction of bias in data and algorithm development has been addressed in past studies, little is known about the knowledge and perception of bias among AI developers. This study's objective was to survey AI specialists in health care to investigate developers' perceptions of bias in AI algorithms for health care applications and their awareness and use of preventative measures. A web-based survey was provided in both German and English language, comprising a maximum of 41 questions using branching logic within the REDCap web application. Only the results of participants with experience in the field of medical AI applications and complete questionnaires were included for analysis. Demographic data, technical expertise, and perceptions of fairness, as well as knowledge of biases in AI, were analyzed, and variations among gender, age, and work environment were assessed. A total of 151 AI specialists completed the web-based survey. The median age was 30 (IQR 26-39) years, and 67% (101/151) of respondents were male. One-third rated their AI development projects as fair (47/151, 31%) or moderately fair (51/151, 34%), 12% (18/151) reported their AI to be barely fair, and 1% (2/151) not fair at all. One participant identifying as diverse rated AI developments as barely fair, and among the 2 undefined gender participants, AI developments were rated as barely fair or moderately fair, respectively. Reasons for biases selected by respondents were lack of fair data (90/132, 68%), guidelines or recommendations (65/132, 49%), or knowledge (60/132, 45%). Half of the respondents worked with image data (83/151, 55%) from 1 center only (76/151, 50%), and 35% (53/151) worked with national data exclusively. This study shows that the perception of biases in AI overall is moderately fair. Gender minorities did not once rate their AI development as fair or very fair. Therefore, further studies need to focus on minorities and women and their perceptions of AI. The results highlight the need to strengthen knowledge about bias in AI and provide guidelines on preventing biases in AI health care applications.

Patient monitoring technology has been used to guide therapy and alert staff when a vital sign leaves a predefined range in the intensive care unit (ICU) for decades. However, large amounts of technically false or clinically irrelevant alarms provoke alarm fatigue in staff leading to desensitisation towards critical alarms. With this systematic review, we are following the Preferred Reporting Items for Systematic Reviews (PRISMA) checklist in order to summarise scientific efforts that aimed to develop IT systems to reduce alarm fatigue in ICUs. 69 peer-reviewed publications were included. The majority of publications targeted the avoidance of technically false alarms, while the remainder focused on prediction of patient deterioration or alarm presentation. The investigated alarm types were mostly associated with heart rate or arrhythmia, followed by arterial blood pressure, oxygen saturation, and respiratory rate. Most publications focused on the development of software solutions, some on wearables, smartphones, or headmounted displays for delivering alarms to staff. The most commonly used statistical models were tree-based. In conclusion, we found strong evidence that alarm fatigue can be alleviated by IT-based solutions. However, future efforts should focus more on the avoidance of clinically non-actionable alarms which could be accelerated by improving the data availability. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021233461 , identifier: CRD42021233461.

Increasing digitalization in the medical domain gives rise to large amounts of health care data, which has the potential to expand clinical knowledge and transform patient care if leveraged through artificial intelligence (AI). Yet, big data and AI oftentimes cannot unlock their full potential at scale, owing to nonstandardized data formats, lack of technical and semantic data interoperability, and limited cooperation between stakeholders in the health care system. Despite the existence of standardized data formats for the medical domain, such as Fast Healthcare Interoperability Resources (FHIR), their prevalence and usability for AI remain limited. In this paper, we developed a data harmonization pipeline (DHP) for clinical data sets relying on the common FHIR data standard. We validated the performance and usability of our FHIR-DHP with data from the Medical Information Mart for Intensive Care IV database. We present the FHIR-DHP workflow in respect of the transformation of \"raw\" hospital records into a harmonized, AI-friendly data representation. The pipeline consists of the following 5 key preprocessing steps: querying of data from hospital database, FHIR mapping, syntactic validation, transfer of harmonized data into the patient-model database, and export of data in an AI-friendly format for further medical applications. A detailed example of FHIR-DHP execution was presented for clinical diagnoses records. Our approach enables the scalable and needs-driven data modeling of large and heterogenous clinical data sets. The FHIR-DHP is a pivotal step toward increasing cooperation, interoperability, and quality of patient care in the clinical routine and for medical research.