European Health Data and Evidence Network—learnings from building out a standardized international health data network

Objective: Health data standardized to a common data model (CDM) simplifies and facilitates research. This study examines the factors that make standardizing observational health data to the Observational Medical Outcomes Partnership (OMOP) CDM successful. Materials and methods: Twenty-five data partners (DPs) from 11 countries received funding from the European Health Data Evidence Network (EHDEN) to standardize their data. Three surveys, DataQualityDashboard results, and statistics from the conversion process were analyzed qualitatively and quantitatively. Our measures of success were the total number of days to transform source data into the OMOP CDM and participation in network research. Results: The health data converted to CDM represented more than 133 million patients. 100%, 88%, and 84% of DPs took Surveys 1, 2, and 3. The median duration of the 6 key extract, transform, and load (ETL) processes ranged from 4 to 115 days. Of the 25 DPs, 21 DPs were considered applicable for analysis of which 52% standardized their data on time, and 48% participated in an international collaborative study. Discussion: This study shows that the consistent workflow used by EHDEN proves appropriate to support the successful standardization of observational data across Europe. Over the 25 successful transformations, we confirmed that getting the right people for the ETL is critical and vocabulary mapping requires specific expertise and support of tools. Additionally, we learned that teams that proactively prepared for data governance issues were able to avoid considerable delays improving their ability to finish on time. Conclusion: This study provides guidance for future DPs to standardize to the OMOP CDM and participate in distributed networks. We demonstrate that the Observational Health Data Sciences and Informatics community must continue to evaluate and provide guidance and support for what ultimately develops the backbone of how community members generate evidence

Risks of complicated acute appendicitis in patients with psychiatric disorders

Background Acute appendicitis often presents with vague abdominal pain, which fosters diagnostic challenges to clinicians regarding early detection and proper intervention. This is even more problematic with individuals with severe psychiatric disorders who have reduced sensitivity to pain due to long-term or excessive medication use or disturbed bodily sensation perceptions. This study aimed to determine whether psychiatric disorder, psychotropic prescription, and treatment compliance increase the risks of complicated acute appendicitis. Methods The diagnosis records of acute appendicitis from four university hospitals in Korea were investigated from 2002 to 2020. A total of 47,500 acute appendicitis-affected participants were divided into groups with complicated and uncomplicated appendicitis to determine whether any of the groups had more cases of psychiatric disorder diagnoses. Further, the ratio of complicated compared to uncomplicated appendicitis in the mentally ill group was calculated regarding psychotropic dose, prescription duration, and treatment compliance. Results After adjusting for age and sex, presence of psychotic disorder (odds ratio [OR]: 1.951; 95% confidence interval [CI]: 1.218–3.125), and bipolar disorder (OR: 2.323; 95% CI: 1.194–4.520) was associated with a higher risk of having complicated appendicitis compared with absence of psychiatric disorders. Patients who are taking high-daily-dose antipsychotics, regardless of prescription duration, show high complicated appendicitis risks; High-dose antipsychotics for < 1 year (OR: 1.896, 95% CI: 1.077–3.338), high-dose antipsychotics for 1–5 years (OR: 1.930, 95% CI: 1.144–3.256). Poor psychiatric outpatient compliance was associated with a high risk of complicated appendicitis (OR: 1.664, 95% CI: 1.014–2.732). Conclusions This study revealed a close relationship in the possibility of complicated appendicitis in patients with severe psychiatric disorders, including psychotic and bipolar disorders. The effect on complicated appendicitis was more remarkable by the psychiatric disease entity itself than by psychotropic prescription patterns. Good treatment compliance and regular visit may reduce the morbidity of complicated appendicitis in patients with psychiatric disorders.This work was supported by the Technology Innovation Program (or Industrial Strategic Technology Development Program) (20004927, Upgrade of CDM based Distributed Biohealth Data Platform and Development of Verification Technology) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea), and the Bio Industrial Strategic Technology Development Program (20003883) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea), Bio & Medical Technology Development Program of the National Research Foundation of Korea funded by the Ministry of Health and Welfare, Ministry of Science and ICT, Ministry of Trade Industry and Energy (MOTIE, Korea) Disease Control and Prevention Agency (The National Project of Bio Big Data) (NRF‑2020M3E5D7085175), and Bio & Medical Technology Development Program of the National Research Foundation funded by the Ministry of Science & ICT (No. 2021M3A9E408078412)

Generating Reliable and Responsive Observational Evidence: Reducing Pre-analysis Bias

A growing body of evidence generated from observational data has demonstrated the potential to influence decision-making and improve patient outcomes. For observational evidence to be actionable, however, it must be generated reliably and in a timely manner. Large distributed observational data networks enable research on diverse patient populations at scale and develop new sound methods to improve reproducibility and robustness of real-world evidence. Nevertheless, the problems of generalizability, portability and scalability persist and compound. As analytical methods only partially address bias, reliable observational research (especially in networks) must address the bias at the design stage (i.e., pre-analysis bias) including the strategies for identifying patients of interest and defining comparators. This thesis synthesizes and enumerates a set of challenges to addressing pre-analysis bias in observational studies and presents mixed-methods approaches and informatics solutions for overcoming a number of those obstacles. We develop frameworks, methods and tools for scalable and reliable phenotyping including data source granularity estimation, comprehensive concept set selection, index date specification, and structured data-based patient review for phenotype evaluation. We cover the research on potential bias in the unexposed comparator definition including systematic background rates estimation and interpretation, and definition and evaluation of the unexposed comparator. We propose that the use of standardized approaches and methods as described in this thesis not only improves reliability but also increases responsiveness of observational evidence. To test this hypothesis, we designed and piloted a Data Consult Service - a service that generates new on-demand evidence at the bedside. We demonstrate that it is feasible to generate reliable evidence to address clinicians’ information needs in a robust and timely fashion and provide our analysis of the current limitations and future steps needed to scale such a service

Artificial Intelligence in Health Care: Current Applications and Issues

In recent years, artificial intelligence (AI) technologies have greatly advanced and become a reality in many areas of our daily lives. In the health care field, numerous efforts are being made to implement the AI technology for practical medical treatments. With the rapid developments in machine learning algorithms and improvements in hardware performances, the AI technology is expected to play an important role in effectively analyzing and utilizing extensive amounts of health and medical data. However, the AI technology has various unique characteristics that are different from the existing health care technologies. Subsequently, there are a number of areas that need to be supplemented within the current health care system for the AI to be utilized more effectively and frequently in health care. In addition, the number of medical practitioners and public that accept AI in the health care is still low; moreover, there are various concerns regarding the safety and reliability of AI technology implementations. Therefore, this paper aims to introduce the current research and application status of AI technology in health care and discuss the issues that need to be resolved.ope

A Data Analysis Methodology for Process Diagnosis and Redesign in Healthcare

Department of Management EngineeringDespite the disruptive and continuous development of healthcare environments, it still faces numerous challenges. Many of these are connected to clinical processes within the healthcare environment, which can be resolved through process analysis. At the same time, through the digitalization of healthcare, information from the various stakeholders in hospitals can be collected and stored in hospital information systems. On the basis of this stored data, evidence-based healthcare is possible, and this data-driven approach has become key to resolving medical issues. However, a more systematic data analysis methodology that covers the diagnosis and the redesign of clinical processes is required. Process mining, which aims to derive knowledgeable process-related insights from event logs, is a promising data-driven approach that is commonly used to address the challenges in healthcare. In other words, process mining has become a way to improve business process management in healthcare. For this reason, there have been numerous studies on clinical process analysis using process mining. However, these have mainly focused on investigating challenges facing clinical processes and have not reached a virtuous cycle until process improvement. Thus, a comprehensive data analysis framework for process diagnosis and redesign in healthcare is still required. \ud We identify three challenges in this research: 1) a lack of guidelines for data analysis to help understand clinical processes, 2) the research gap between clinical data analysis and process redesign in healthcare, and 3) a lack of accuracy and reliability in redesign assessment in healthcare. Based on these problem statements, this doctoral dissertation focuses on a comprehensive data analysis methodology for process diagnosis and redesign in healthcare. In particular, three frameworks are established to address important research issues in healthcare: 1) a framework for diagnosing clinical processes for outpatients, inpatients, and clinical pathways, 2) a framework for redesigning clinical processes with a simulation-based approach, and 3) a framework for evaluating the effects of process redesign. The proposed methodology has four steps: data preparation, data preprocessing, data analysis, and post-hoc analysis. The data preparation phase aims to extract data in a suitable format (i.e., event logs) for process mining data analysis. In this step, a method for obtaining clinical event logs from electronic health record data mapped using the common data model needs to be developed. To this end, we build an event log specification that can be used to derive event logs that consider the purpose, content, and scope of the data analysis desired by the user. After compiling the event logs, they are preprocessed to improve the accuracy and validity of the data analysis. The data analysis phase, which is the core component of the proposed methodology, consists of three components for process mining analysis: clinical process types, process mining types, and clinical perspectives. In the last phase, we interpret the results obtained from the data analysis with domain experts and perform a post-hoc analysis to improve clinical processes using simulations and to evaluate the previous data analysis results. For the first research issue, we propose a data analysis framework for three clinical process types: outpatients, inpatients, and clinical pathways. For each category, we provide a specific goal and include suitable fine-grained techniques in the framework which are either newly developed or based on existing approaches. We also provide four real-life case studies to validate the usefulness of this approach. For the second research issue, we develop a data-driven framework in order to build a discrete event simulation model. The proposed framework consists of four steps: data preparation and preprocessing, data analysis, post-hoc analysis, and further analysis. Here, we propose a mechanism for obtaining simulation parameters from process mining analysis from a control flow and performance perspective and automatically build a reliable and robust simulation model based on these parameters. This model includes realistic arrival rates and service times in a clinical setting. The proposed framework is constructed with a specific goal in mind (e.g., a decrease in waiting times), and the applicability of the framework is validated with a case study. For the final research issue, we develop a framework for evaluating the effects of process redesign. Two types of indicators are used for this: best practice implementation indicators to assess whether a specific best practice has been applied well or not and process performance indicators to understand the impact of the application of best practices. These indicators are explicitly connected to process mining functionalities. In other words, we provide a comprehensive method for assessing these indicators using clinical event logs. The usefulness of the methodology is demonstrated with real-life logs before and after a redesign. Compared to other existing frameworks in healthcare, this research is unique in constructing a healthcare-oriented data analysis methodology, rather than a generic model, that covers redesign in addition to diagnosis and in providing concrete analysis methods and data. As such, it is believed that this research will act as a motivation to extend the use of process mining in healthcare and will serve as a practical guideline for analyzing and improving clinical processes for non-experts.clos