Changbin Lei, Yan Jiang, Ke Xu, Shanshan Liu, Hua Cao, Cong Wang
{"title":"Convolutional Neural Network Models for Visual Classification of Pressure Ulcer Stages: Cross-Sectional Study.","authors":"Changbin Lei, Yan Jiang, Ke Xu, Shanshan Liu, Hua Cao, Cong Wang","doi":"10.2196/62774","DOIUrl":"10.2196/62774","url":null,"abstract":"<p><strong>Background: </strong>Pressure injuries (PIs) pose a negative health impact and a substantial economic burden on patients and society. Accurate staging is crucial for treating PIs. Owing to the diversity in the clinical manifestations of PIs and the lack of objective biochemical and pathological examinations, accurate staging of PIs is a major challenge. The deep learning algorithm, which uses convolutional neural networks (CNNs), has demonstrated exceptional classification performance in the intricate domain of skin diseases and wounds and has the potential to improve the staging accuracy of PIs.</p><p><strong>Objective: </strong>We explored the potential of applying AlexNet, VGGNet16, ResNet18, and DenseNet121 to PI staging, aiming to provide an effective tool to assist in staging.</p><p><strong>Methods: </strong>PI images from patients-including those with stage I, stage II, stage III, stage IV, unstageable, and suspected deep tissue injury (SDTI)-were collected at a tertiary hospital in China. Additionally, we augmented the PI data by cropping and flipping the PI images 9 times. The collected images were then divided into training, validation, and test sets at a ratio of 8:1:1. We subsequently trained them via AlexNet, VGGNet16, ResNet18, and DenseNet121 to develop staging models.</p><p><strong>Results: </strong>We collected 853 raw PI images with the following distributions across stages: stage I (n=148), stage II (n=121), stage III (n=216), stage IV (n=110), unstageable (n=128), and SDTI (n=130). A total of 7677 images were obtained after data augmentation. Among all the CNN models, DenseNet121 demonstrated the highest overall accuracy of 93.71%. The classification performances of AlexNet, VGGNet16, and ResNet18 exhibited overall accuracies of 87.74%, 82.42%, and 92.42%, respectively.</p><p><strong>Conclusions: </strong>The CNN-based models demonstrated strong classification ability for PI images, which might promote highly efficient, intelligent PI staging methods. In the future, the models can be compared with nurses with different levels of experience to further verify the clinical application effect.</p>","PeriodicalId":56334,"journal":{"name":"JMIR Medical Informatics","volume":"13 ","pages":"e62774"},"PeriodicalIF":3.1,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11962570/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143712247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yuwen Zheng, Meirong Tian, Jingjing Chen, Lei Zhang, Jia Gao, Xiang Li, Jin Wen, Xing Qu
{"title":"Public Attitudes Toward Violence Against Doctors: Sentiment Analysis of Chinese Users.","authors":"Yuwen Zheng, Meirong Tian, Jingjing Chen, Lei Zhang, Jia Gao, Xiang Li, Jin Wen, Xing Qu","doi":"10.2196/63772","DOIUrl":"10.2196/63772","url":null,"abstract":"<p><strong>Background: </strong>Violence against doctors attracts the public's attention both online and in the real world. Understanding how public sentiment evolves during such crises is essential for developing strategies to manage emotions and rebuild trust.</p><p><strong>Objective: </strong>This study aims to quantify the difference in public sentiment based on the public opinion life cycle theory and describe how public sentiment evolved during a high-profile crisis involving violence against doctors in China.</p><p><strong>Methods: </strong>This study used the term frequency-inverse document frequency (TF-IDF) algorithm to extract key terms and create keyword clouds from textual comments. The latent Dirichlet allocation (LDA) topic model was used to analyze the thematic trends and shifts within public sentiment. The integrated Chinese Sentiment Lexicon was used to analyze sentiment trajectories in the collected data.</p><p><strong>Results: </strong>A total of 12,775 valid comments were collected on Sina Weibo about public opinion related to a doctor-patient conflict. Thematic and sentiment analyses showed that the public's sentiments were highly negative during the outbreak period (disgust: 10,201/30,433, 33.52%; anger: 6792/30,433, 22.32%) then smoothly changed to positive and negative during the spread period (sorrow: 2952/8569, 34.45%; joy: 2782/8569, 32.47%) and tended to be rational and peaceful during the decline period (joy: 4757/14,543, 32.71%; sorrow: 4070/14,543, 27.99%). However, no matter how emotions changed, each period's leading tone contained many negative sentiments.</p><p><strong>Conclusions: </strong>This study simultaneously examined the dynamics of theme change and sentiment evolution in crises involving violence against doctors. It discovered that public sentiment evolved alongside thematic changes, with the dominant negative tone from the initial stage persisting throughout. This finding, distinguished from prior research, underscores the lasting influence of early public sentiment. The results offer valuable insights for medical institutions and authorities, suggesting the need for tailored risk communication strategies responsive to the evolving themes and sentiments at different stages of a crisis.</p>","PeriodicalId":56334,"journal":{"name":"JMIR Medical Informatics","volume":"13 ","pages":"e63772"},"PeriodicalIF":3.1,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969123/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143665520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Molly Ehrig, Garrett S Bullock, Xiaoyan Iris Leng, Nicholas M Pajewski, Jaime Lynn Speiser
{"title":"Imputation and Missing Indicators for Handling Missing Longitudinal Data: Data Simulation Analysis Based on Electronic Health Record Data.","authors":"Molly Ehrig, Garrett S Bullock, Xiaoyan Iris Leng, Nicholas M Pajewski, Jaime Lynn Speiser","doi":"10.2196/64354","DOIUrl":"10.2196/64354","url":null,"abstract":"<p><strong>Background: </strong>Missing data in electronic health records are highly prevalent and result in analytical concerns such as heterogeneous sources of bias and loss of statistical power. One simple analytic method for addressing missing or unknown covariate values is to treat missingness for a particular variable as a category onto itself, which we refer to as the missing indicator method. For cross-sectional analyses, recent work suggested that there was minimal benefit to the missing indicator method; however, it is unclear how this approach performs in the setting of longitudinal data, in which correlation among clustered repeated measures may be leveraged for potentially improved model performance.</p><p><strong>Objectives: </strong>This study aims to conduct a simulation study to evaluate whether the missing indicator method improved model performance and imputation accuracy for longitudinal data mimicking an application of developing a clinical prediction model for falls in older adults based on electronic health record data.</p><p><strong>Methods: </strong>We simulated a longitudinal binary outcome using mixed effects logistic regression that emulated a falls assessment at annual follow-up visits. Using multivariate imputation by chained equations, we simulated time-invariant predictors such as sex and medical history, as well as dynamic predictors such as physical function, BMI, and medication use. We induced missing data in predictors under scenarios that had both random (missing at random) and dependent missingness (missing not at random). We evaluated aggregate performance using the area under the receiver operating characteristic curve (AUROC) for models with and with no missing indicators as predictors, as well as complete case analysis, across simulation replicates. We evaluated imputation quality using normalized root-mean-square error for continuous variables and percent falsely classified for categorical variables.</p><p><strong>Results: </strong>Independent of the mechanism used to simulate missing data (missing at random or missing not at random), overall model performance via AUROC was similar regardless of whether missing indicators were included in the model. The root-mean-square error and percent falsely classified measures were similar for models including missing indicators versus those with no missing indicators. Model performance and imputation quality were similar regardless of whether the outcome was related to missingness. Imputation with or with no missing indicators had similar mean values of AUROC compared with complete case analysis, although complete case analysis had the largest range of values.</p><p><strong>Conclusions: </strong>The results of this study suggest that the inclusion of missing indicators in longitudinal data modeling neither improves nor worsens overall performance or imputation accuracy. Future research is needed to address whether the inclusion of missing indicators is useful in pr","PeriodicalId":56334,"journal":{"name":"JMIR Medical Informatics","volume":"13 ","pages":"e64354"},"PeriodicalIF":3.1,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11924964/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Assessing Total Hip Arthroplasty Outcomes and Generating an Orthopedic Research Outcome Database via a Natural Language Processing Pipeline: Development and Validation Study.","authors":"Nicholas H Mast, Clara L Oeste, Dries Hens","doi":"10.2196/64705","DOIUrl":"10.2196/64705","url":null,"abstract":"<p><strong>Background: </strong>Processing data from electronic health records (EHRs) to build research-grade databases is a lengthy and expensive process. Modern arthroplasty practice commonly uses multiple sites of care, including clinics and ambulatory care centers. However, most private data systems prevent obtaining usable insights for clinical practice.</p><p><strong>Objective: </strong>This study aims to create an automated natural language processing (NLP) pipeline for extracting clinical concepts from EHRs related to orthopedic outpatient visits, hospitalizations, and surgeries in a multicenter, single-surgeon practice. The pipeline was also used to assess therapies and complications after total hip arthroplasty (THA).</p><p><strong>Methods: </strong>EHRs of 1290 patients undergoing primary THA from January 1, 2012 to December 31, 2019 (operated and followed by the same surgeon) were processed using artificial intelligence (AI)-based models (NLP and machine learning). In addition, 3 independent medical reviewers generated a gold standard using 100 randomly selected EHRs. The algorithm processed the entire database from different EHR systems, generating an aggregated clinical data warehouse. An additional manual control arm was used for data quality control.</p><p><strong>Results: </strong>The algorithm was as accurate as human reviewers (0.95 vs 0.94; P=.01), achieving a database-wide average F1-score of 0.92 (SD 0.09; range 0.67-0.99), validating its use as an automated data extraction tool. During the first year after direct anterior THA, 92.1% (1188/1290) of our population had a complication-free recovery. In 7.9% (102/1290) of cases where surgery or recovery was not uneventful, lateral femoral cutaneous nerve sensitivity (47/1290, 3.6%), intraoperative fractures (13/1290, 1%), and hematoma (9/1290, 0.7%) were the most common complications.</p><p><strong>Conclusions: </strong>Algorithm evaluation of this dataset accurately represented key clinical information swiftly, compared with human reviewers. This technology may provide substantial value for future surgeon practice and patient counseling. Furthermore, the low early complication rate of direct anterior THA in this surgeon's hands was supported by the dataset, which included data from all treated patients in a multicenter practice.</p>","PeriodicalId":56334,"journal":{"name":"JMIR Medical Informatics","volume":"13 ","pages":"e64705"},"PeriodicalIF":3.1,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11922490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Large Language Model-Based Critical Care Big Data Deployment and Extraction: Descriptive Analysis.","authors":"Zhongbao Yang, Shan-Shan Xu, Xiaozhu Liu, Ningyuan Xu, Yuqing Chen, Shuya Wang, Ming-Yue Miao, Mengxue Hou, Shuai Liu, Yi-Min Zhou, Jian-Xin Zhou, Linlin Zhang","doi":"10.2196/63216","DOIUrl":"10.2196/63216","url":null,"abstract":"<p><strong>Background: </strong>Publicly accessible critical care-related databases contain enormous clinical data, but their utilization often requires advanced programming skills. The growing complexity of large databases and unstructured data presents challenges for clinicians who need programming or data analysis expertise to utilize these systems directly.</p><p><strong>Objective: </strong>This study aims to simplify critical care-related database deployment and extraction via large language models.</p><p><strong>Methods: </strong>The development of this platform was a 2-step process. First, we enabled automated database deployment using Docker container technology, with incorporated web-based analytics interfaces Metabase and Superset. Second, we developed the intensive care unit-generative pretrained transformer (ICU-GPT), a large language model fine-tuned on intensive care unit (ICU) data that integrated LangChain and Microsoft AutoGen.</p><p><strong>Results: </strong>The automated deployment platform was designed with user-friendliness in mind, enabling clinicians to deploy 1 or multiple databases in local, cloud, or remote environments without the need for manual setup. After successfully overcoming GPT's token limit and supporting multischema data, ICU-GPT could generate Structured Query Language (SQL) queries and extract insights from ICU datasets based on request input. A front-end user interface was developed for clinicians to achieve code-free SQL generation on the web-based client.</p><p><strong>Conclusions: </strong>By harnessing the power of our automated deployment platform and ICU-GPT model, clinicians are empowered to easily visualize, extract, and arrange critical care-related databases more efficiently and flexibly than manual methods. Our research could decrease the time and effort spent on complex bioinformatics methods and advance clinical research.</p>","PeriodicalId":56334,"journal":{"name":"JMIR Medical Informatics","volume":"13 ","pages":"e63216"},"PeriodicalIF":3.1,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11922493/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"GPT-3.5 Turbo and GPT-4 Turbo in Title and Abstract Screening for Systematic Reviews.","authors":"Takehiko Oami, Yohei Okada, Taka-Aki Nakada","doi":"10.2196/64682","DOIUrl":"10.2196/64682","url":null,"abstract":"<p><strong>Unlabelled: </strong>This study demonstrated that while GPT-4 Turbo had superior specificity when compared to GPT-3.5 Turbo (0.98 vs 0.51), as well as comparable sensitivity (0.85 vs 0.83), GPT-3.5 Turbo processed 100 studies faster (0.9 min vs 1.6 min) in citation screening for systematic reviews, suggesting that GPT-4 Turbo may be more suitable due to its higher specificity and highlighting the potential of large language models in optimizing literature selection.</p>","PeriodicalId":56334,"journal":{"name":"JMIR Medical Informatics","volume":"13 ","pages":"e64682"},"PeriodicalIF":3.1,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11922487/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Natasha Lee Jørgensen, Camilla Hoffmann Merrild, Martin Bach Jensen, Thomas B Moeslund, Kristian Kidholm, Janus Laust Thomsen
{"title":"The Perceptions of Potential Prerequisites for Artificial Intelligence in Danish General Practice: Vignette-Based Interview Study Among General Practitioners.","authors":"Natasha Lee Jørgensen, Camilla Hoffmann Merrild, Martin Bach Jensen, Thomas B Moeslund, Kristian Kidholm, Janus Laust Thomsen","doi":"10.2196/63895","DOIUrl":"10.2196/63895","url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence (AI) has been deemed revolutionary in medicine; however, no AI tools have been implemented or validated in Danish general practice. General practice in Denmark has an excellent digitization system for developing and using AI. Nevertheless, there is a lack of involvement of general practitioners (GPs) in developing AI. The perspectives of GPs as end users are essential for facilitating the next stage of AI development in general practice.</p><p><strong>Objective: </strong>This study aimed to identify the essential prerequisites that GPs perceive as necessary to realize the potential of AI in Danish general practice.</p><p><strong>Methods: </strong>This study used semistructured interviews and vignettes among GPs to gain perspectives on the potential of AI in general practice. A total of 12 GPs interested in the potential of AI in general practice were interviewed in 2019 and 2021. The interviews were transcribed verbatim and thematic analysis was conducted to identify the dominant themes throughout the data.</p><p><strong>Results: </strong>In the data analysis, four main themes were identified as essential prerequisites for GPs when considering the potential of AI in general practice: (1) AI must begin with the low-hanging fruit, (2) AI must be meaningful in the GP's work, (3) the GP-patient relationship must be maintained despite AI, and (4) AI must be a free, active, and integrated option in the electronic health record (EHR). These 4 themes suggest that the development of AI should initially focus on low-complexity tasks that do not influence patient interactions but facilitate GPs' work in a meaningful manner as an integrated part of the EHR. Examples of this include routine and administrative tasks.</p><p><strong>Conclusions: </strong>The research findings outline the participating GPs' perceptions of the essential prerequisites to consider when exploring the potential applications of AI in primary care settings. We believe that these perceptions of potential prerequisites can support the initial stages of future development and assess the suitability of existing AI tools for general practice.</p>","PeriodicalId":56334,"journal":{"name":"JMIR Medical Informatics","volume":"13 ","pages":"e63895"},"PeriodicalIF":3.1,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11921986/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143618008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abrar Alturkistani, Thomas Beaney, Geva Greenfield, Ceire E Costelloe
{"title":"Prescription Refill Adherence Before and After Patient Portal Registration in Among General Practice Patients in England Using the Clinical Practice Research Datalink: Longitudinal Observational Study.","authors":"Abrar Alturkistani, Thomas Beaney, Geva Greenfield, Ceire E Costelloe","doi":"10.2196/50294","DOIUrl":"10.2196/50294","url":null,"abstract":"<p><strong>Background: </strong>Patient portal use has been associated with improved patient health and improved adherence to medications, including statins. However, there is limited research on the association between patient portal registration and outcomes such as statin prescription refill adherence in the context of the National Health Service of England, where patient portals have been widely available since 2015.</p><p><strong>Objective: </strong>We aimed to explore statin prescription refill adherence among general practice patients in England.</p><p><strong>Methods: </strong>This study was approved by the Clinical Practice Research Datalink Independent Scientific Advisory Committee (ID: 21_000411). We used patient-level general practice data from the Clinical Practice Research Datalink in England. The data included patients with cardiovascular disease, diabetes, and chronic kidney disease, who were registered on the patient portal. The primary aim was to investigate whether statin prescription refill adherence, defined as ≥80% adherence based on the medication possession ratio, improved after patient portal registration. We used a multilevel logistic regression model to compare aggregate adherence 12 months before and 12 months after patient portal registration.</p><p><strong>Results: </strong>We included 44,141 patients in the study. The analysis revealed a 16% reduction in the odds of prescription refill adherence 12 months after patient portal registration (odds ratio [OR]: 0.84, 95% CI 0.81-0.86) compared to 12 months before registration in the fully adjusted model for patient- and practice-level variables.</p><p><strong>Conclusions: </strong>This study evaluated prescription refill adherence after patient portal registration. Registering to the portal does not fully explain the mechanisms underlying the relationship between patient portal use and health-related outcomes such as medication adherence. Although a small reduction in prescription refill adherence was observed, this reduction disappeared when the follow up time was reduced to 6 months. Given the limitations of the study, reduction in prescription refill adherence cannot be entirely attributable to patient portal registration. However, there may be potential confounding factors influencing this association which should be explored through future research.</p>","PeriodicalId":56334,"journal":{"name":"JMIR Medical Informatics","volume":"13 ","pages":"e50294"},"PeriodicalIF":3.1,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11918981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143607238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Salma Malik, Zoi Pana Dorothea, Christos D Argyropoulos, Sophia Themistocleous, Alan J Macken, Olena Valdenmaiier, Frank Scheckenbach, Elena Bardach, Andrea Pfeiffer, Katherine Loens, Jordi Cano Ochando, Oliver A Cornely, Jacques Demotes-Mainard, Sergio Contrino, Gerd Felder
{"title":"Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE Project.","authors":"Salma Malik, Zoi Pana Dorothea, Christos D Argyropoulos, Sophia Themistocleous, Alan J Macken, Olena Valdenmaiier, Frank Scheckenbach, Elena Bardach, Andrea Pfeiffer, Katherine Loens, Jordi Cano Ochando, Oliver A Cornely, Jacques Demotes-Mainard, Sergio Contrino, Gerd Felder","doi":"10.2196/65590","DOIUrl":"10.2196/65590","url":null,"abstract":"<p><strong>Background: </strong>Data standards are not only key to making data processing efficient but also fundamental to ensuring data interoperability. When clinical trial data are structured according to international standards, they become significantly easier to analyze, reducing the efforts required for data cleaning, preprocessing, and secondary use. A common language and a shared set of expectations facilitate interoperability between systems and devices.</p><p><strong>Objective: </strong>The main objectives of this study were to identify commonalities and differences in clinical trial metadata, protocols, and data collection systems/items within the VACCELERATE project.</p><p><strong>Methods: </strong>To assess the degree of interoperability achieved in the project and suggest methodological improvements, interoperable points were identified based on the core outcome areas-immunogenicity, safety, and efficacy (clinical/physiological). These points were emphasized in the development of the master protocol template and were manually compared in the following ways: (1) summaries, objectives, and end points in the protocols of 3 VACCELERATE clinical trials (EU-COVAT-1_AGED, EU-COVAT-2_BOOSTAVAC, and EU-COVPT-1_CoVacc) against the master protocol template; (2) metadata of all 3 clinical trials; and (3) evaluations from a questionnaire survey regarding differences in data management systems and structures that enabled data exchange within the VACCELERATE network.</p><p><strong>Results: </strong>The noncommonalities identified in the protocols and metadata were attributed to differences in populations, variations in protocol design, and vaccination patterns. The detailed metadata released for all 3 vaccine trials were clearly structured using internal standards, terminology, and the general approach of Clinical Data Acquisition Standards Harmonisation (CDASH) for data collection (eg, on electronic case report forms). VACCELERATE benefited significantly from the selection of the Clinical Trials Centre Cologne as the sole data management provider. With system database development coordinated by a single individual and no need for coordination among different trial units, a high degree of uniformity was achieved automatically. The harmonized transfer of data to all sites, using well-established methods, enabled quick exchanges and provided a relatively secure means of data transfer.</p><p><strong>Conclusions: </strong>This study demonstrated that using master protocols can significantly enhance trial operational efficiency and data interoperability, provided that similar infrastructure and data management procedures are adopted across multiple trials. To further improve data interoperability and facilitate interpretation and analysis, shared data should be structured, described, formatted, and stored using widely recognized data and metadata standards.</p><p><strong>Trial registration: </strong>EudraCT 2021-004526-29; https://www.clinicaltrialsr","PeriodicalId":56334,"journal":{"name":"JMIR Medical Informatics","volume":"13 ","pages":"e65590"},"PeriodicalIF":3.1,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11928774/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143582409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Applying Robotic Process Automation to Monitor Business Processes in Hospital Information Systems: Mixed Method Approach.","authors":"Adam Park, Se Young Jung, Ilha Yune, Ho-Young Lee","doi":"10.2196/59801","DOIUrl":"10.2196/59801","url":null,"abstract":"<p><strong>Background: </strong>Electronic medical records (EMRs) have undergone significant changes due to advancements in technology, including artificial intelligence, the Internet of Things, and cloud services. The increasing complexity within health care systems necessitates enhanced process reengineering and system monitoring approaches. Robotic process automation (RPA) provides a user-centric approach to monitoring system complexity by mimicking end user interactions, thus presenting potential improvements in system performance and monitoring.</p><p><strong>Objective: </strong>This study aimed to explore the application of RPA in monitoring the complexities of EMR systems within a hospital environment, focusing on RPA's ability to perform end-to-end performance monitoring that closely reflects real-time user experiences.</p><p><strong>Methods: </strong>The research was conducted at Seoul National University Bundang Hospital using a mixed methods approach. It included the iterative development and integration of RPA bots programmed to simulate and monitor typical user interactions with the hospital's EMR system. Quantitative data from RPA process outputs and qualitative insights from interviews with system engineers and managers were used to evaluate the effectiveness of RPA in system monitoring.</p><p><strong>Results: </strong>RPA bots effectively identified and reported system inefficiencies and failures, providing a bridge between end user experiences and engineering assessments. The bots were particularly useful in detecting delays and errors immediately following system updates or interactions with external services. Over 3 years, RPA monitoring highlighted discrepancies between user-reported experiences and traditional engineering metrics, with the bots frequently identifying critical system issues that were not evident from standard component-level monitoring.</p><p><strong>Conclusions: </strong>RPA enhances system monitoring by providing insights that reflect true end user experiences, which are often overlooked by traditional monitoring methods. The study confirms the potential of RPA to act as a comprehensive monitoring tool within complex health care systems, suggesting that RPA can significantly contribute to the maintenance and improvement of EMR systems by providing a more accurate and timely reflection of system performance and user satisfaction.</p>","PeriodicalId":56334,"journal":{"name":"JMIR Medical Informatics","volume":"13 ","pages":"e59801"},"PeriodicalIF":3.1,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11928770/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143576067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}