Search

BackgroundAccurate and rapid clinical decisions based on real-world evidence are essential for patients with cancer. However, the complexity of chemotherapy regimens for cancer impedes retrospective research that uses observational health databases. ObjectiveThe aim of this study is to compare the anticancer treatment trajectories and patterns of clinical events according to regimen type using the chemotherapy episodes determined by an algorithm. MethodsWe developed an algorithm to extract the regimen-level abstracted chemotherapy episodes from medication records in a conventional Observational Medical Outcomes Partnership (OMOP) common data model (CDM) database. The algorithm was validated on the Ajou University School Of Medicine (AUSOM) database by manual review of clinical notes. Using the algorithm, we extracted episodes of chemotherapy from patients in the EHR database and the claims database. We also developed an application software for visualizing the chemotherapy treatment patterns based on the treatment episodes in the OMOP-CDM database. Using this software, we generated the trends in the types of regimen used in the institutions, the patterns of the iterative chemotherapy use, and the trajectories of cancer treatment in two EHR-based OMOP-CDM databases. As a pilot study, the time of onset of chemotherapy-induced neutropenia according to regimen was measured using the AUSOM database. The anticancer treatment trajectories for patients with COVID-19 were also visualized based on the nationwide claims database. ResultsWe generated 178,360 treatment episodes for patients with colorectal, breast, and lung cancer for 85 different regimens. The algorithm precisely identified the type of chemotherapy regimen in 400 patients (average positive predictive value >98%). The trends in the use of routine clinical chemotherapy regimens from 2008-2018 were identified for 8236 patients. For a total of 12 regimens (those administered to the largest proportion of patients), the number of repeated treatments was concordant with the protocols for standard chemotherapy regimens for certain cases. In addition, the anticancer treatment trajectories for 8315 patients were shown, including 62 patients with COVID-19. A comparative analysis of neutropenia showed that its onset in colorectal cancer regimens tended to cluster between days 9-15, whereas it tended to cluster between days 2-8 for certain regimens for breast cancer or lung cancer. ConclusionsWe propose a method for generating chemotherapy episodes for introduction into the oncology extension module of the OMOP-CDM databases. These proof-of-concept studies demonstrated the usability, scalability, and interoperability of the proposed framework through a distributed research network.

BackgroundSARS-CoV-2 is straining health care systems globally. The burden on hospitals during the pandemic could be reduced by implementing prediction models that can discriminate patients who require hospitalization from those who do not. The COVID-19 vulnerability (C-19) index, a model that predicts which patients will be admitted to hospital for treatment of pneumonia or pneumonia proxies, has been developed and proposed as a valuable tool for decision-making during the pandemic. However, the model is at high risk of bias according to the “prediction model risk of bias assessment” criteria, and it has not been externally validated. ObjectiveThe aim of this study was to externally validate the C-19 index across a range of health care settings to determine how well it broadly predicts hospitalization due to pneumonia in COVID-19 cases. MethodsWe followed the Observational Health Data Sciences and Informatics (OHDSI) framework for external validation to assess the reliability of the C-19 index. We evaluated the model on two different target populations, 41,381 patients who presented with SARS-CoV-2 at an outpatient or emergency department visit and 9,429,285 patients who presented with influenza or related symptoms during an outpatient or emergency department visit, to predict their risk of hospitalization with pneumonia during the following 0-30 days. In total, we validated the model across a network of 14 databases spanning the United States, Europe, Australia, and Asia. ResultsThe internal validation performance of the C-19 index had a C statistic of 0.73, and the calibration was not reported by the authors. When we externally validated it by transporting it to SARS-CoV-2 data, the model obtained C statistics of 0.36, 0.53 (0.473-0.584) and 0.56 (0.488-0.636) on Spanish, US, and South Korean data sets, respectively. The calibration was poor, with the model underestimating risk. When validated on 12 data sets containing influenza patients across the OHDSI network, the C statistics ranged between 0.40 and 0.68. ConclusionsOur results show that the discriminative performance of the C-19 index model is low for influenza cohorts and even worse among patients with COVID-19 in the United States, Spain, and South Korea. These results suggest that C-19 should not be used to aid decision-making during the COVID-19 pandemic. Our findings highlight the importance of performing external validation across a range of settings, especially when a prediction model is being extrapolated to a different population. In the field of prediction, extensive validation is required to create appropriate trust in a model.

BackgroundAlthough electronic health records (EHRs) have been widely used in secondary assessments, clinical documents are relatively less utilized owing to the lack of standardized clinical text frameworks across different institutions. ObjectiveThis study aimed to develop a framework for processing unstructured clinical documents of EHRs and integration with standardized structured data. MethodsWe developed a framework known as Staged Optimization of Curation, Regularization, and Annotation of clinical text (SOCRATex). SOCRATex has the following four aspects: (1) extracting clinical notes for the target population and preprocessing the data, (2) defining the annotation schema with a hierarchical structure, (3) performing document-level hierarchical annotation using the annotation schema, and (4) indexing annotations for a search engine system. To test the usability of the proposed framework, proof-of-concept studies were performed on EHRs. We defined three distinctive patient groups and extracted their clinical documents (ie, pathology reports, radiology reports, and admission notes). The documents were annotated and integrated into the Observational Medical Outcomes Partnership (OMOP)-common data model (CDM) database. The annotations were used for creating Cox proportional hazard models with different settings of clinical analyses to measure (1) all-cause mortality, (2) thyroid cancer recurrence, and (3) 30-day hospital readmission. ResultsOverall, 1055 clinical documents of 953 patients were extracted and annotated using the defined annotation schemas. The generated annotations were indexed into an unstructured textual data repository. Using the annotations of pathology reports, we identified that node metastasis and lymphovascular tumor invasion were associated with all-cause mortality among colon and rectum cancer patients (both P=.02). The other analyses involving measuring thyroid cancer recurrence using radiology reports and 30-day hospital readmission using admission notes in depressive disorder patients also showed results consistent with previous findings. ConclusionsWe propose a framework for hierarchical annotation of textual data and integration into a standardized OMOP-CDM medical database. The proof-of-concept studies demonstrated that our framework can effectively process and integrate diverse clinical documents with standardized structured data for clinical research.

BackgroundAlthough telehealth is considered a key component in combating the worldwide crisis caused by COVID-19, the factors that influence its acceptance by the general population after the flattening of the COVID-19 curve remain unclear. ObjectiveWe aimed to identify factors affecting telehealth acceptance, including anxiety related to COVID-19, after the initial rapid spread of the disease in South Korea. MethodsWe proposed an extended technology acceptance model (TAM) and performed a cross-sectional survey of individuals aged ≥30 years. In total, 471 usable responses were collected. Confirmatory factor analysis was used to examine the validity of measurements, and the partial least squares (PLS) method was used to investigate factors influencing telehealth acceptance and the impacts of COVID-19. ResultsPLS analysis showed that increased accessibility, enhanced care, and ease of telehealth use had positive effects on its perceived usefulness (P=.002, P

Background: The Observational Medical Outcome Partners-Common Data Model (OMOP-CDM) is an international standard for harmonizing electronic medical record (EMR) data. However, since it does not standardize unstructured data, such as medical imaging, using this data in multi-institutional collaborative research becomes challenging. To overcome this limitation, extensions such as the Radiology Common Data Model (R-CDM) have emerged to include and standardize these data types., Objective: This work aims to demonstrate that by standardizing optical coherence tomography (OCT) data into an R-CDM format, multi-institutional collaborative studies analyzing changes in retinal thickness in patients with long-standing chronic diseases can be performed efficiently., Methods: We standardized OCT images collected from two tertiary hospitals for research purposes using the R-CDM. As a proof of concept, we conducted a comparative analysis of retinal thickness between patients who have chronic diseases and those who have not. Patients diagnosed or treated for retinal and choroidal diseases, which could affect retinal thickness, were excluded from the analysis. Using the existing OMOP-CDM at each institution, we extracted cohorts of patients with chronic diseases and control groups, performing large-scale 1:2 propensity score matching (PSM). Subsequently, we linked the OMOP-CDM and R-CDM to extract the OCT image data of these cohorts and analyzed central macular thickness (CMT) and retinal nerve fiber layer (RNFL) thickness using a linear mixed model., Results: OCT data of 261,874 images from Ajou University Medical Center (AUMC) and 475,626 images from Seoul National University Bundang Hospital (SNUBH) were standardized in the R-CDM format. The R-CDM databases established at each institution were linked with the OMOP-CDM database. Following 1:2 PSM, the type 2 diabetes mellitus (T2DM) cohort included 957 patients, and the control cohort had 1603 patients. During the follow-up period, significant reductions in CMT were observed in the T2DM cohorts at AUMC (P=.04) and SNUBH (P=.007), without significant changes in RNFL thickness (AUMC: P=.56; SNUBH: P=.39). Notably, a significant reduction in CMT during the follow-up was observed only at AUMC in the hypertension cohort, compared to the control group (P=.04); no other significant differences in retinal thickness were found in the remaining analyses., Conclusions: The significance of our study lies in demonstrating the efficiency of multi-institutional collaborative research that simultaneously uses clinical data and medical imaging data by leveraging the OMOP-CDM for standardizing EMR data and the R-CDM for standardizing medical imaging data., (© ChulHyoung Park, So Hee Lee, Da Yun Lee, Seoyoon Choi, Seng Chan You, Ja Young Jeon, Sang Jun Park, Rae Woong Park. Originally published in JMIR Medical Informatics (https://medinform.jmir.org).)