Preliminary feasibility assessment of CDM-based active surveillance using current status of medical device data in medical records and OMOP-CDM.
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ABSTRACT:
SUBMITTER: Choi S
PROVIDER: S-EPMC8674329 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundDiabetes mellitus (DM) is an important public health concern in Singapore and places a massive burden on health care spending. Tackling chronic diseases such as DM requires innovative strategies to integrate patients' data from diverse sources and use scientific discovery to inform clinical practice that can help better manage the disease. The Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) was chosen as the framework for integrating data with disparate formats.ObjectiveThe study aimed to evaluate the feasibility of converting Singapore based data source, comprising of electronic health records (EHR), cognitive and depression assessment questionnaire data to OMOP CDM standard. Additionally, we also validate whether our OMOP CDM instance is fit for the purpose of research by executing a simple treatment pathways study using Atlas, a graphical user interface tool to conduct analysis on OMOP CDM data as a proof of concept.MethodsWe used de-identified EHR, cognitive, and depression assessment questionnaires data from a tertiary care hospital in Singapore to convert it to version 5.3.1 of OMOP CDM standard. We evaluate the OMOP CDM conversion by (1) assessing the mapping coverage (that is the percentage of source terms mapped to OMOP CDM standard); (2) local raw dataset versus CDM dataset analysis; and (3) Implementing Harmonized Intrinsic Data Quality Framework using an open-source R package called Data Quality Dashboard.ResultsThe content coverage of OMOP CDM vocabularies is more than 90% for clinical data, but only around 11% for questionnaire data. The comparison of characteristics between source and target data returned consistent results and our transformed data did not pass 38 (1.4%) out of 2,622 quality checks.ConclusionAdoption of OMOP CDM at our site demonstrated that EHR data are feasible for standardization with minimal information loss, whereas challenges remain for standardizing cognitive and depression assessment questionnaire data that requires further work.
| S-EPMC8357458 | biostudies-literature
Project description:Post-market medical device surveillance is a challenge facing manufacturers, regulatory agencies, and health care providers. Electronic health records are valuable sources of real-world evidence for assessing device safety and tracking device-related patient outcomes over time. However, distilling this evidence remains challenging, as information is fractured across clinical notes and structured records. Modern machine learning methods for machine reading promise to unlock increasingly complex information from text, but face barriers due to their reliance on large and expensive hand-labeled training sets. To address these challenges, we developed and validated state-of-the-art deep learning methods that identify patient outcomes from clinical notes without requiring hand-labeled training data. Using hip replacements-one of the most common implantable devices-as a test case, our methods accurately extracted implant details and reports of complications and pain from electronic health records with up to 96.3% precision, 98.5% recall, and 97.4% F1, improved classification performance by 12.8-53.9% over rule-based methods, and detected over six times as many complication events compared to using structured data alone. Using these additional events to assess complication-free survivorship of different implant systems, we found significant variation between implants, including for risk of revision surgery, which could not be detected using coded data alone. Patients with revision surgeries had more hip pain mentions in the post-hip replacement, pre-revision period compared to patients with no evidence of revision surgery (mean hip pain mentions 4.97 vs. 3.23; t?=?5.14; p?<?0.001). Some implant models were associated with higher or lower rates of hip pain mentions. Our methods complement existing surveillance mechanisms by requiring orders of magnitude less hand-labeled training data, offering a scalable solution for national medical device surveillance using electronic health records.
| S-EPMC6761113 | biostudies-literature
Project description:BackgroundAdverse drug reactions (ADRs) are regarded as a major cause of death and a major contributor to public health costs. For the active surveillance of drug safety, the use of real-world data and real-world evidence as part of the overall pharmacovigilance process is important. In this regard, many studies apply the data-driven approaches to support pharmacovigilance. We developed a pharmacovigilance data-processing pipeline (PDP) that utilized electronic health records (EHR) and spontaneous reporting system (SRS) data to explore pharmacovigilance signals.MethodsTo this end, we integrated two medical data sources: Konyang University Hospital (KYUH) EHR and the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). As part of the presented PDP, we converted EHR data on the Observation Medical Outcomes Partnership (OMOP) data model. To evaluate the ability of using the proposed PDP for pharmacovigilance purposes, we performed a statistical validation using drugs that induce ear disorders.ResultsTo validate the presented PDP, we extracted six drugs from the EHR that were significantly involved in ADRs causing ear disorders: nortriptyline, (hazard ratio [HR] 8.06, 95% CI 2.41-26.91); metoclopramide (HR 3.35, 95% CI 3.01-3.74); doxycycline (HR 1.73, 95% CI 1.14-2.62); digoxin (HR 1.60, 95% CI 1.08-2.38); acetaminophen (HR 1.59, 95% CI 1.47-1.72); and sucralfate (HR 1.21, 95% CI 1.06-1.38). In FAERS, the strongest associations were found for nortriptyline (reporting odds ratio [ROR] 1.94, 95% CI 1.73-2.16), sucralfate (ROR 1.22, 95% CI 1.01-1.45), doxycycline (ROR 1.30, 95% CI 1.20-1.40), and hydroxyzine (ROR 1.17, 95% CI 1.06-1.29). We confirmed the results in a meta-analysis using random and fixed models for doxycycline, hydroxyzine, metoclopramide, nortriptyline, and sucralfate.ConclusionsThe proposed PDP could support active surveillance and the strengthening of potential ADR signals via real-world data sources. In addition, the PDP was able to generate real-world evidence for drug safety.
| S-EPMC8130307 | biostudies-literature
Project description:BackgroundThe process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI).MethodsWe used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion.ResultsWe analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access-site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to September 30, 2015.ConclusionsA strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.).
| S-EPMC6145132 | biostudies-literature
Project description:Background A computerized 12-lead electrocardiogram (ECG) can automatically generate diagnostic statements, which are helpful for clinical purposes. Standardization is required for big data analysis when using ECG data generated by different interpretation algorithms. The common data model (CDM) is a standard schema designed to overcome heterogeneity between medical data. Diagnostic statements usually contain multiple CDM concepts and also include non-essential noise information, which should be removed during CDM conversion. Existing CDM conversion tools have several limitations, such as the requirement for manual validation, inability to extract multiple CDM concepts, and inadequate noise removal.Objectives We aim to develop a fully automated text data conversion algorithm that overcomes limitations of existing tools and manual conversion.Methods We used interpretations printed by 12-lead resting ECG tests from three different vendors: GE Medical Systems, Philips Medical Systems, and Nihon Kohden. For automatic mapping, we first constructed an ontology-lexicon of ECG interpretations. After clinical coding, an optimized tool for converting ECG interpretation to CDM terminology is developed using term-based text processing.Results Using the ontology-lexicon, the cosine similarity-based algorithm and rule-based hierarchical algorithm showed comparable conversion accuracy (97.8 and 99.6%, respectively), while an integrated algorithm based on a heuristic approach, ECG2CDM, demonstrated superior performance (99.9%) for datasets from three major vendors.Conclusion We developed a user-friendly software that runs the ECG2CDM algorithm that is easy to use even if the user is not familiar with CDM or medical terminology. We propose that automated algorithms can be helpful for further big data analysis with an integrated and standardized ECG dataset.
| S-EPMC9492322 | biostudies-literature
Project description:Eligibility criteria are important for clinical research protocols or clinical practice guidelines for determining who qualify for studies and to whom clinical evidence is applicable, but the free-text format is not amenable for computational processing. In this paper, we described a practical method for transforming free-text clinical research eligibility criteria of Alzheimer's clinical trials into a structured relational database compliant with standards for medical terminologies and clinical data models. We utilized a hybrid natural language processing system and a concept normalization tool to extract medical terms in clinical research eligibility criteria and represent them using the OMOP Common Data Model (CDM) v5. We created a database schema design to store syntactic relations to facilitate efficient cohort queries. We further discussed the potential of applying this method to trials on other diseases and the promise of using it to accelerate clinical research with electronic health records.
| S-EPMC5893219 | biostudies-literature
Project description:ObjectiveThe large-scale collection of observational data and digital technologies could help curb the COVID-19 pandemic. However, the coexistence of multiple Common Data Models (CDMs) and the lack of data extract, transform, and load (ETL) tool between different CDMs causes potential interoperability issue between different data systems. The objective of this study is to design, develop, and evaluate an ETL tool that transforms the PCORnet CDM format data into the OMOP CDM.MethodsWe developed an open-source ETL tool to facilitate the data conversion from the PCORnet CDM and the OMOP CDM. The ETL tool was evaluated using a dataset with 1000 patients randomly selected from the PCORnet CDM at Mayo Clinic. Information loss, data mapping accuracy, and gap analysis approaches were conducted to assess the performance of the ETL tool. We designed an experiment to conduct a real-world COVID-19 surveillance task to assess the feasibility of the ETL tool. We also assessed the capacity of the ETL tool for the COVID-19 data surveillance using data collection criteria of the MN EHR Consortium COVID-19 project.ResultsAfter the ETL process, all the records of 1000 patients from 18 PCORnet CDM tables were successfully transformed into 12 OMOP CDM tables. The information loss for all the concept mapping was less than 0.61%. The string mapping process for the unit concepts lost 2.84% records. Almost all the fields in the manual mapping process achieved 0% information loss, except the specialty concept mapping. Moreover, the mapping accuracy for all the fields were 100%. The COVID-19 surveillance task collected almost the same set of cases (99.3% overlaps) from the original PCORnet CDM and target OMOP CDM separately. Finally, all the data elements for MN EHR Consortium COVID-19 project could be captured from both the PCORnet CDM and the OMOP CDM.ConclusionWe demonstrated that our ETL tool could satisfy the data conversion requirements between the PCORnet CDM and the OMOP CDM. The outcome of the work would facilitate the data retrieval, communication, sharing, and analysis between different institutions for not only COVID-19 related project, but also other real-world evidence-based observational studies.
| S-EPMC8791245 | biostudies-literature
Project description:The current generation of sequencing technologies has led to significant advances in identifying novel disease-associated mutations and generated large amounts of data in a high-throughput manner. Such data in conjunction with clinical routine data are proven to be highly useful in deriving population-level and patient-level predictions, especially in the field of cancer precision medicine. However, data harmonization across multiple national and international clinical sites is an essential step for the assessment of events and outcomes associated with patients, which is currently not adequately addressed. The Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) is an internationally established research data repository introduced by the Observational Health Data Science and Informatics (OHDSI) community to overcome this issue. To address the needs of cancer research, the genomic vocabulary extension was introduced in 2020 to support the standardization of subsequent data analysis. In this review, we evaluate the current potential of the OMOP CDM to be applicable in cancer prediction and how comprehensively the genomic vocabulary extension of the OMOP can serve current needs of AI-based predictions. For this, we systematically screened the literature for articles that use the OMOP CDM in predictive analyses in cancer and investigated the underlying predictive models/tools. Interestingly, we found 248 articles, of which most use the OMOP for harmonizing their data, but only 5 make use of predictive algorithms on OMOP-based data and fulfill our criteria. The studies present multicentric investigations, in which the OMOP played an essential role in discovering and optimizing machine learning (ML)-based models. Ultimately, the use of the OMOP CDM leads to standardized data-driven studies for multiple clinical sites and enables a more solid basis utilizing, e.g., ML models that can be reused and combined in early prediction, diagnosis, and improvement of personalized cancer care and biomarker discovery.
| S-EPMC9569469 | biostudies-literature
Project description:BackgroundThe advancement of information technology has immensely increased the quality and volume of health data. This has led to an increase in observational study, as well as to the threat of privacy invasion. Recently, a distributed research network based on the common data model (CDM) has emerged, enabling collaborative international medical research without sharing patient-level data. Although the CDM database for each institution is built inside a firewall, the risk of re-identification requires management. Hence, this study aims to elucidate the perceptions CDM users have towards CDM and risk management for re-identification.MethodsThe survey, targeted to answer specific in-depth questions on CDM, was conducted from October to November 2020. We targeted well-experienced researchers who actively use CDM. Basic statistics (total number and percent) were computed for all covariates.ResultsThere were 33 valid respondents. Of these, 43.8% suggested additional anonymization was unnecessary beyond, "minimum cell count" policy, which obscures a cell with a value lower than certain number (usually 5) in shared results to minimize the liability of re-identification due to rare conditions. During extract-transform-load processes, 81.8% of respondents assumed structured data is under control from the risk of re-identification. However, respondents noted that date of birth and death were highly re-identifiable information. The majority of respondents (n = 22, 66.7%) conceded the possibility of identifier-contained unstructured data in the NOTE table.ConclusionOverall, CDM users generally attributed high reliability for privacy protection to the intrinsic nature of CDM. There was little demand for additional de-identification methods. However, unstructured data in the CDM were suspected to have risks. The necessity for a coordinating consortium to define and manage the re-identification risk of CDM was urged.
| S-EPMC9259248 | biostudies-literature
Project description:Patients with irritable bowel syndrome (IBS) are at increased risk of osteoporosis and osteoporotic fracture. This study investigated whether IBS medication attenuated the rate of osteoporosis and osteoporotic fracture risk. We conducted a retrospective large-scale multicenter study across eight hospital databases encoded in the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The primary outcome was the incidence of osteoporosis, whereas secondary outcomes were osteoporotic fractures. After 1:4 matching, 24,723 IBS patients, 78,318 non-IBS patients, 427,640 non-IBS patients with IBS medication, and 827,954 non-IBS patients without IBS medication were selected. The risk of osteoporosis was significantly increased in the IBS group compared to the non-IBS group (hazard ratio (HR) 1.33; confidence interval (CI) 1.17~1.51). Even in patients who were not diagnosed with IBS, the risk of osteoporosis was significantly increased in those with IBS medication compared to those without (HR 1.77, CI 1.62~1.93). The risk of osteoporotic fracture was significantly increased in the IBS medication group (HR 1.69, CI 1.55~1.84). Patients exposed to IBS treatment even without IBS diagnosis were at increased risk of osteoporosis and osteoporotic fracture. Early diagnosis and treatment of osteoporosis should be considered in patients who have received medication for IBS symptoms.
| S-EPMC8126251 | biostudies-literature