On 23 January, the U.S. Department of Health and Human Services Office of the National Coordinator (ONC) of Health IT launched a new initiative: Structured Data Capture (SDC). The specific challenge that the SDC initiative is addressing is that electronic health record (EHR) data has been of limited use for purposes outside of the direct care of a particular patient due to “a lack of uniformity in the terminology and definition of data elements across EHRs.” Thus, the SDC Scope Statement is: “To define the necessary requirements that will drive the identification and harmonization of standards to facilitate the collection of supplemental EHR-derived data.” The initial use cases are electronic case report forms (eCRFs) for research and safety reports. The value of this initiative was cited in the slides and the draft SDC charter:

 

“The identification and harmonization of standards for the structured data capture within EHRs will […] help reduce a) the data collection burden on health care providers by enabling secure, single-point data entry that populates to multiple systems and b) the need to make site-specific modifications to EHR system capabilities in order to enable participation in important reporting and research activities.”

 

This is a first step towards “Meaningful Use 3” to achieve a Learning Health System. The HHS/ONC team specifically stated that CDISC Retrieve Form for Data Capture (RFD), which CDISC developed with Integrating the Healthcare Enterprise (IHE), and CDISC CDASH are to be leveraged so as not to reinvent the wheel.

 

Do the value statements sound at all familiar? Through its Healthcare Link Initiative, CDISC has been paving the way to realize similar value. The goals of the CDISC eSource (e.g. EHR, eDiary, EDC) Data Interchange (eSDI) Initiative were: a) to make it easier for physicians to conduct clinical research, b) collect data only once in an industry standard format for multiple downstream uses, and thereby; c) improve data quality and patient safety. See this link.

 

CDISC is very proud to be a part of the Structured Data Capture (SDC) Community and encourages all CDISC members and supporters to join and become engaged. Follow this link.

 

According to the EHR Association: “Many healthcare sites would like to participate in clinical research for the betterment of health science. If this participation is to be feasible to the sites, the burden of participation must be eased. RFD, collaboration between healthcare IT and clinical research sponsors, will open the door to widespread, cost-effective clinical research participation.” See the EHRA Endorsement Letter for RFD. Click here. 

 

The adoption of EHRs is rapidly increasing throughout the United States; CDISC is involved with the IMI EHR4CR project in Europe; and, Japan is using EHRs for Research (see the session to be led by Ken Toyoda in the CDISC Asia-Pacific Interchange program on 21 February). This broad adoption is providing us with an unprecedented opportunity to increase the capacity for research by making it easier for clinicians to participate. Workflow enablers like RFD have been shown to decrease serious adverse event (SAE) reporting from 34 minutes to less than a minute in the ASTER Project led by Pfizer; just think of the opportunity in store for research! Click here.

 

CDISC CDASH and RFD are ready. The challenge could be the “CDEs,” which we will discuss further in another blog. In the meantime, inform yourself about this SDC initiative. It could potentially make your life easier, and should have a significant impact on healthcare. For more information about the SDC Initiative, please visit the HHS ONC Wiki.

 

 

 

By Andrea Vadakin

CDISC, Manager of Public Releations