| Creators: | Claerhout, Brecht and Kalra, Dipak and Mueller, Christina and Singh, Gurparkash and Ammour, Nadir and Meloni, Laura and Blomster, Juuso and Hopley, Mark and Kafatos, George and Garvey, Almenia and Kuhn, Peter and Lewi, Martine and Vannieuwenhuyse, Bart and Marchal, Benoit and Patel, Ketan and Schindler, Christoph and Sundgren, Mats |
|---|---|
| Title: | Federated electronic health records research technology to support clinical trial protocol optimization: Evidence from EHR4CR and the InSite platform |
| Item Type: | Article or issue of a publication series |
| Projects: | DigiHealth |
| Journal or Series Title: | Journal of biomedical informatics : JBI |
| Page Range: | Digital Paper 103090 |
| Date: | 2019 |
| Divisions: | Gesundheitsmanagement |
| Abstract (ENG): | Objective To determine if inclusion/exclusion (I/E) criteria of clinical trial protocols can be represented as structured queries and executed using a secure federated research platform (InSite) on hospital electronic health records (EHR) systems, to estimate the number of potentially eligible patients. Methods Twenty-three clinical trial protocols completed during 2011–2017 across diverse disease areas were analyzed to construct queries that were executed with InSite using EHR records from 24 European hospitals containing records of >14 million patients. The number of patients matching I/E criteria of each protocol was estimated. Results All protocols could be formalized to some extent into a medical coding system (e.g. ICD-10CM, ATC, LOINC, SNOMED) and mapped to local hospital coding systems. The median number of I/E criteria of protocols tested was 29 (range: 14–47). A median of 55% (range 38–89%) of I/E criteria in each protocol could be transformed into a computable format. The median number of eligible patients identified was 26 per hospital site (range: 1–134). Conclusion Clinical trial I/E eligibility criteria can be structured computationally and executed as queries on EHR systems to estimate the patient recruitment pool at each site. The results further suggest that an increase in structured coded information in EHRs would increase the number of I/E criteria that could be evaluated. Additional work is needed on broader deployment of federated platforms such as InSite. |
| Forthcoming: | No |
| Language: | English |
| Link eMedia: | Download |
| Citation: | Claerhout, Brecht and Kalra, Dipak and Mueller, Christina and Singh, Gurparkash and Ammour, Nadir and Meloni, Laura and Blomster, Juuso and Hopley, Mark and Kafatos, George and Garvey, Almenia and Kuhn, Peter and Lewi, Martine and Vannieuwenhuyse, Bart and Marchal, Benoit and Patel, Ketan and Schindler, Christoph and Sundgren, Mats (2019) Federated electronic health records research technology to support clinical trial protocol optimization: Evidence from EHR4CR and the InSite platform. Journal of biomedical informatics : JBI, 90. Digital Paper 103090. ISSN 1532-0480 |
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