Structured Data Capture
Summary
The Structured Data Capture (SDC) Profile provides an infrastructure for capturing, exchanging and using patient data within electronic health record (EHR) systems for clinical research, adverse event reporting and public health reporting. The utility of EHR data for supplemental purposes has been limited due to a lack of uniformity in the terminology and definitions of data elements across EHRs. This limitation is compounded by the fact that in a typical clinician workflow patient information is often recorded in an unstructured free-text format well after the episodes of care.
The SDC Profile provides specifications to enable an EHR system, or other application, to retrieve a structured data capture form and submit data from a completed form. The SDC Profile utilizes transactions from the IHE ITI Retrieve Form for Data Capture (RFD) Profile and an ISO/IEC 19763-13 based form definition, for requesting and receiving forms, and submitting data captured in forms in a standardized and structured format.
Benefits
Health care providers and others use various sources and methods to capture and synthesize patient-level data, EHRs have been recognized as the data source with the highest potential to provide timely and relevant data in a form that is quickly usable for quality and safety improvement, population health, and research (sometimes labeled "secondary" use or "reuse"). EHR data obtained during episodes of care will become increasingly valuable to healthcare organizations striving to leverage electronic information to drive efficiency and quality. Of particular interest are efforts to leverage clinical data captured during episodes of care and link the clinical data to supplemental data collected for other purposes including: 1) clinical research, 2) patient-safety event reporting, 3) public health reporting, and 4) determination of coverage. Once captured, aggregated and analyzed, these combined data can be used to identify trends, predict outcomes and influence patient care, drug development and therapy choices. Linking EHR data with other data in a uniform and structured way could accelerate quality and safety improvement, population health and research.
The SDC profile is a standard for exchanging structured data, whether it is used for a clinical trial, determination of coverage, or to report on a patient safety event, which can be collected in a timely manner, then readily compared and aggregated improving the overall quality, value and utility of these data. The identification and harmonization of standards for structured data capture within EHRs will not only help achieve this vision, but they will also help to:
- Reduce data collection burden on health care providers by enabling secure, single-point data entry that populates to multiple systems
- Decrease the need to make site-specific modifications to EHR system capabilities to enable participation in important reporting and research activities
- Lower the barriers to volunteer adverse event reporting on medical products to public health agencies leading to improvements in population health
Details
SDC profile defines the “question/answer set” (QAS) or Data Element (DE) content and structure of a Data-Entry Form (DEF) in a technology-agnostic XML format. SDC XML uses an XML Schema to define an XML-based information model that represents a generic DEF with generic DEs and related metadata. Rather than have an XML Schema for each form, SDC uses a single XML Schema that can be used to define an infinite number of different DEFs.
The SDC initiative has developed and validated a standards-based data architecture so that a structured set of data can be accessed from EHRs and be stored for merger with comparable data for other relevant purposes to include:
- The electronic Case Report Form (eCRF) used for clinical research including Patient Centered Outcomes Research (PCOR)
- The Incident Report used for patient safety reporting leveraging AHRQ ‘Common Formats’
- The Surveillance Case Report Form used for public health reporting of infectious diseases
- The collection of patient information used for determination of coverage, as resources permit.
- The electronic Cancer Checklists (eCC)
- The electronic Radiology Procedure Report Form used for patient procedure reports in cancer imaging.
The IHE SDC Use Case focuses on the functionality and interoperability required to allow a Provider to retrieve a form/template, auto-populate data within the form (when this functionality is implemented in the EHR system), enter additional data into the form/template, and transmit the form/template to an External Data Repository in a standard format. The standard format could be used as a means to provide data to end users. Optionally, data captured may be stored in the EHR associated with the individual patient and encounter as part of the permanent medical record.
Systems Affected
Systems involved in this profile are:
- EHR systems and Enterprise-wide information systems may find SDC an effective format to provide patient data.
- Departmental information systems may find SDC an effective format to provide data to end users and registries.
- Web application developers may find the standardized data capture within SDC to provide a clear direction for integration with a variety of data sources
Actors & Transactions:
Specification
Profile Status: Final Text <Replace "Final Text" with "Trial Implementation" or "Public Comment" as appropriate.>
Documents:
<Provide direct links to the specific volumes or supplements, and list the volume sections relevant to this profile. This is a simple inventory of official normative and informative text. If you would like to provide a reading guide or walkthrough of what is in each of the different sections for implementers or users, do that in the Profile FAQ or the Profile Implementation Page linked below. If the profile uses transactions from multiple Tech. Frameworks, repeat the structure below.>
IHE Radiology Technical Framework:
Underlying Standards:
<list all the standards on which the profile is based; if possible with links to sources>
See Also
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Related Profiles
<List profiles this one depends on, profiles that depend on this one, profiles that are synergistic with this one. Start with the name of the other profile as a link and then explain the relationship.>
- Reporting Workflow [RWF] may use Evidence Documents as inputs to the reporting process.
- Simple Image & Numeric Reports [SINR] may include data copied from Evidence Documents.
- Cross-enterprise Document Sharing for Imaging [XDS-I] can be used to share Evidence Documents between sites over a network.
- Portable Data for Imaging [PDI] can store Evidence Documents on media such as CDs.
- Import Reconciliation Workflow [IRWF] can fix patient ids, etc. of Evidence Documents when importing.
Consumer Information
The Profile FAQ Template answers typical questions about what the Profile does. <Replace the link with a link to the actual FAQ page for the Profile>
The Profile Purchasing Template describes considerations when purchasing equipment to deploy this Profile. <Replace the link with a link to the actual Purchasing page for the Profile>
Implementer Information
The Profile Implementation Template provides additional information about implementing this Profile in software. <Replace the link with a link to the actual Implementation page for the Profile>
Reference Articles
<List References (good and bad) (with link if possible) to Journal Articles that mention IHE's work (and hopefully include some analysis). Go ahead, Google: IHE <Profile Name> abstract or Google: IHE <Profile Name> and under the "more" select "Scholar". You might be surprised. >
Structured Data Capture Recording
This page is based on the Profile Overview Template