Electronic data capture

Abstract: Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.

Abstract: Research Electronic Data Capture (REDCap) is a web-based application developed by Vanderbilt University to capture data for clinical research and create databases and projects.

Abstract: Objectives: Even though today most university hospitals have already implemented commercial hospital information systems and started to build up comprehensive electronic medical records, reuse of such data for data warehousing and research purposes is still very rare. Given this situation, the focus of this paper is to present an overview on exemplary projects, which have already tackled this challenge, reflect on current initiatives within the United States of America and the European Union to establish IT infrastructures for clinical and translational research, and draw attention to new challenges in this area. Methods: This paper does not intend to provide a fully comprehensive review on all the issues of clinical routine data reuse. It is based, however, on a presentation of a large variety of historical, but also most recent activities in data warehousing, data retrieval and linking medical informatics with translational research. Results: The article presents an overview of the various international approaches to this issue and illustrates concepts and solutions which have been published, thus giving an impression of activities pursued in this field of medical informatics. Further, problems and open questions, which have also been named in the literature, are presented and three challenges (to establish comprehensive clinical data warehouses, to establish professional IT infrastructure applications supporting clinical trial data capture and to integrate medical record systems and clinical trial databases) related to this area of medical informatics are identified and presented. Conclusions: Translational biomedical research with the aim “to integrate bedside and biology” and to bridge the gap between clinical care and medical research today and in the years to come, provides a large and interesting field for medical informatics researchers. Especially the need for integrating clinical research projects with data repositories built up during documentation of routine clinical care, today still leaves many open questions and research challenges. Consideration of regulatory requirements, data privacy issues, data standards as well as people/organizational issues are prerequisites in order to vanquish existing obstacles.