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Browsing by Author "Atreja, Ashish"
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Item Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry(Elsevier, 2021-01) Kelly, Colleen R.; Yen, Eugene F.; Grinspan, Ari M.; Kahn, Stacy A.; Atreja, Ashish; Lewis, James D.; Moore, Thomas A.; Rubin, David T.; Kim, Alison M.; Serra, Sonya; Nersesova, Yanina; Fredell, Lydia; Hunsicker, Dea; McDonald, Daniel; Knight, Rob; Allegretti, Jessica R.; Pekow, Joel; Absah, Imad; Hsu, Ronald; Vincent, Jennifer; Khanna, Sahil; Tangen, Lyn; Crawford, Carl V.; Mattar, Mark C.; Chen, Lea Ann; Fischer, Monika; Arsenescu, Razvan I.; Feuerstadt, Paul; Goldstein, Jonathan; Kerman, David; Ehrlich, Adam C.; Wu, Gary D.; Laine, Loren; Medicine, School of MedicineBackground & Aims Fecal microbiota transplantation (FMT) is used commonly for treatment of Clostridioides difficile infections (CDIs), although prospective safety data are limited and real-world FMT practice and outcomes are not well described. The FMT National Registry was designed to assess FMT methods and both safety and effectiveness outcomes from North American FMT providers. Methods Patients undergoing FMT in clinical practices across North America were eligible. Participating investigators enter de-identified data into an online platform, including FMT protocol, baseline patient characteristics, CDI cure and recurrence, and short and long-term safety outcomes. Results Of the first 259 participants enrolled at 20 sites, 222 had completed short-term follow-up at 1 month and 123 had follow-up to 6 months; 171 (66%) were female. All FMTs were done for CDI and 249 (96%) used an unknown donor (eg, stool bank). One-month cure occurred in 200 patients (90%); of these, 197 (98%) received only 1 FMT. Among 112 patients with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (n = 5 [2%]) and abdominal pain (n = 4 [2%]); 3 patients (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 patients (1%) and inflammatory bowel disease in 2 patients (1%). Conclusions This prospective real-world study demonstrated high effectiveness of FMT for CDI with a good safety profile. Assessment of new conditions at long-term follow-up is planned as this registry grows and will be important for determining the full safety profile of FMT.Item Real world performance of the 21st Century Cures Act population-level application programming interface(Oxford University Press, 2024) Jones, James R.; Gottlieb, Daniel; McMurry, Andrew J.; Atreja, Ashish; Desai, Pankaja M.; Dixon, Brian E.; Payne, Philip R. O.; Saldanha, Anil J.; Shankar, Prabhu; Solad, Yauheni; Wilcox, Adam B.; Ali, Momeena S.; Kang, Eugene; Martin, Andrew M.; Sprouse, Elizabeth; Taylor, David E.; Terry, Michael; Ignatov, Vladimir; Mandl, Kenneth D.; Health Policy and Management, Richard M. Fairbanks School of Public HealthObjective: To evaluate the real-world performance of the SMART/HL7 Bulk Fast Health Interoperability Resources (FHIR) Access Application Programming Interface (API), developed to enable push button access to electronic health record data on large populations, and required under the 21st Century Cures Act Rule. Materials and methods: We used an open-source Bulk FHIR Testing Suite at 5 healthcare sites from April to September 2023, including 4 hospitals using electronic health records (EHRs) certified for interoperability, and 1 Health Information Exchange (HIE) using a custom, standards-compliant API build. We measured export speeds, data sizes, and completeness across 6 types of FHIR. Results: Among the certified platforms, Oracle Cerner led in speed, managing 5-16 million resources at over 8000 resources/min. Three Epic sites exported a FHIR data subset, achieving 1-12 million resources at 1555-2500 resources/min. Notably, the HIE's custom API outperformed, generating over 141 million resources at 12 000 resources/min. Discussion: The HIE's custom API showcased superior performance, endorsing the effectiveness of SMART/HL7 Bulk FHIR in enabling large-scale data exchange while underlining the need for optimization in existing EHR platforms. Agility and scalability are essential for diverse health, research, and public health use cases. Conclusion: To fully realize the interoperability goals of the 21st Century Cures Act, addressing the performance limitations of Bulk FHIR API is critical. It would be beneficial to include performance metrics in both certification and reporting processes.