Background The conventional approach for clinical studies is to identify a cohort of potentially eligible patients and then screen for enrollment. In an effort to reduce the cost and manual effort involved in the screening process, several studies have leveraged electronic health records (EHR) to refine cohorts to better match the eligibility criteria, which is referred to as phenotyping. We extend this approach to dynamically identify a cohort by repeating phenotyping in alternation with manual screening. Methods Our approach consists of multiple screen cycles. At the start of each cycle, the phenotyping algorithm is used to identify eligible patients from the EHR, creating an ordered list such that patients that are most likely eligible are listed first. This list is then manually screened, and the results are analyzed to improve the phenotyping for the next cycle. We describe the preliminary results and challenges in the implementation of this approach for an intervention study on heart failure. Results A total of 1,022 patients were screened, with 223 (23%) of patients being found eligible for enrollment into the intervention study. The iterative approach improved the phenotyping in each screening cycle. Without an iterative approach, the positive screening rate (PSR) was expected to dip below the 20% measured in the first cycle; however, the cyclical approach increased the PSR to 23%. Conclusions Our study demonstrates that dynamic phenotyping can facilitate recruitment for prospective clinical study. Future directions include improved informatics infrastructure and governance policies to enable real-time updates to research repositories, tooling for EHR annotation, and methodologies to reduce human annotation.
Background: Calculated panel reactive antibody (cPRA) scoring is used to assess whether platelet refractoriness is mediated by human leukocyte antigen (HLA) antibodies in the recipient. cPRA testing uses a national sample of US kidney donors to estimate the population frequency of HLA antigens, which may be different than HLA frequencies within local platelet inventories. We aimed to determine the impact on patient cPRA scores of using HLA frequencies derived from typing local platelet donations rather than national HLA frequencies. Methods: We built an open-source web service to calculate cPRA scores based on national frequencies or custom-derived frequencies. We calculated cPRA scores for every hematopoietic stem cell transplantation (HSCT) patient at our institution based on the United Network for Organ Sharing (UNOS) frequencies and local frequencies. We compared frequencies and correlations between the calculators, segmented by gender. Finally, we put all scores into three buckets (mild, moderate, and high sensitizations) and looked at intergroup movement. Results: 2531 patients that underwent HSCT at our institution had at least 1 antibody and were included in the analysis. Overall, the difference in medians between each group's UNOS cPRA and local cPRA was statistically significant, but highly correlated (UNOS vs. local total: 0.249 and 0.243, ρ = 0.994; UNOS vs. local female: 0.474 and 0.463, ρ = 0.987, UNOS vs. local male: 0.165 and 0.141, ρ = 0.996; P < 0.001 for all comparisons). The median difference between UNOS and cPRA scores for all patients was low (male: 0.014, interquartile range [IQR]: 0.004–0.029; female: 0.0013, IQR: 0.003–0.028). Placement of patients into three groups revealed little intergroup movement, with 2.96% (75/2531) of patients differentially classified. Conclusions: cPRA scores using local frequencies were modestly but significantly different than those obtained using national HLA frequencies. We released our software as open source, so other groups can calculate cPRA scores from national or custom-derived frequencies. Further investigation is needed to determine whether a local-HLA frequency approach can improve outcomes in patients who are immune-refractory to platelets.
BACKGROUND While usage of EHRs has substantially increased over the past decade, building clinical applications remains challenging for multiple reasons, including security and privacy considerations, data integration, application distribution, and application deployment. OBJECTIVE We discuss the importance of platforms for health IT development, and specifically describe “igia,” an open-source collection of software packages that enable developers to build and deploy applications more efficiently. METHODS igia is an open-source collection of software packages and repositories that allow a healthcare application developer to develop and deploy EHR-linked applications more efficiently. RESULTS igia was built with several principles: first, it is open-source. Second, igia leverages best-practice solutions wherever possible. Third, it is designed to be used in operational, “clinically-ready” settings. Fourth, igia focuses on reusability and platform-level functionality, so that developers can focus on application development. Finally, igia leverages existing standards, to emphasize interoperability and health IT ecosystem integration. Features include a microservices architecture, SMART on FHIR, data integration, and care management modules. CONCLUSIONS Platforms could improve the efficiency of health IT software development. We describe “igia,” an open-source platform for building clinical applications. We hope that such a platform will reduce barriers to developing clinical applications by providing “out of the box” functionality for many common healthcare IT tasks. igia is released under an MPL v2.0 with code and documentation freely available on GitHub.
Motivation The i2b2 platform is used at major academic health institutions and research consortia for querying for electronic health data. However, a major obstacle for wider utilization of the platform is the complexity of data-loading that entails a steep curve of learning the platform’s complex data-schemas. To address this problem, we have developed the i2b2-etl package that simplifies the data loading process, which will facilitate wider deployment and utilization of the platform. Results We have implemented i2b2-etl as a Python application that imports ontology and patient data using simplified input file schemas and provides inbuilt record-number de-identification and data-validation. We describe a real-world deployment of i2b2-etl for a population-management initiative at MassGeneral Brigham. Availability i2b2-etl is a free, open-source application implemented in Python available under the Mozilla 2 license. The application can be downloaded as compiled docker images. A live demo is available at https://i2b2clinical.org/demo-i2b2etl/ (username: demo, password: Etl@2021). Supplementary information Supplementary data are available at Bioinformatics online.
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