Large Simple Trials and Knowledge Generation in a Learning Health System Workshop Summary (2013) / Chapter Skim
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5 Infrastructure Needs and Opportunities
5 Infrastructure Needs and Opportunities
Pages 35-42
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Kush • Technologies and resources that would allow the conduct of regulated clinical research from electronic sources, in particu lar, EHRs, without the use of paper exist.
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From page 36... ...
and other information systems and organizational arrangements to conduct LSTs. Richard Platt, professor and chair of the Harvard Medical School Department of Population Medicine at the Harvard Pilgrim Health Care Institute, addressed the issue of aligning care and research for greater integration.
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. Although the trial required only minor modifications to regular care, it required significant time and effort from a wide range of other HCA employees, including the vice president for clinical operations, the chief nursing officer, the quality improvement staff, the infection prevention team, the intensive care unit directors, pharmacy staff, supply chain management, and the information technology department.
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Administrative data provide information about the care delivered across the entire spectrum of health care locations, are available for large populations, and are more standardized than most EHR data. Organizational Consortia Are Often Required to Conduct LSTs Many of the important topics that LSTs could address will require consortia of organizations to make reasonable progress, but the formation of consortia raises issues concerning governance and data sharing.
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From page 39... ...
Looking ahead to the requirements and priorities for the generation of more evidence at the point of care, he noted that it will be important to rethink the relationship between research and clinical care, that buy-in from providers and the leaders of health care systems is key, and that a rational approach to regulatory oversight will be crucial. OBTAINING RESEARCH-QUALITY DATA FROM EHRs Rebecca Daniels Kush began her presentation by highlighting one of the major challenges to the efficiency of current clinical trials: the continued use of paper records and the multiple varied systems used across clinical sites.
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Kush explained that RFD, ODM, and CDASH do not depend on the particular EHR being used and that all of these pieces are available to support the establishment of a paperless eSource system for adverse event reporting and research. In 2012, FDA issued guidance to the industry on data from electronic sources for clinical research, or eSource, citing that such guidance would help ensure the reliability, quality, integrity, and traceability of data from electronic sources.
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BUILDING REUSABLE RESEARCH NETWORKS Carole M Lannon's presentation covered reusable research networks, which are collaborative research and quality improvement arrangements among health care organizations that can be used for multiple purposes by different stakeholders.
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From page 42... ...
She mentioned trends in health information technology that will enable large aggregate sets of data to be pulled from EHRs and even the use of patient sensors, as well as the exploitation of opportunities for distributed and collaborative production, in which patients and clinicians can work together to quickly tests what approaches work.
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