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Brief Profile Proposal for 2010 - 2011 QRPH Planning Committee Landen Bain, Davera Gabriel

Redaction Services. Brief Profile Proposal for 2010 - 2011 QRPH Planning Committee Landen Bain, Davera Gabriel September 24, 2009. The Problem.

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Brief Profile Proposal for 2010 - 2011 QRPH Planning Committee Landen Bain, Davera Gabriel

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  1. Redaction Services Brief Profile Proposal for 2010 - 2011 QRPH Planning Committee Landen Bain, Davera Gabriel September 24, 2009

  2. The Problem • The profile addresses a gap identified by HITSP I.S.158, the need to strip, i.e. redact, non-protocol requested data from a CCD or other document in the process of pre-populating a clinical research case report form. • Redaction Services addresses a gap in the use of RFD along with CRD. RFD + CRD create a solution space which Redaction Services completes. • With the progress of RFD and CRD, both tested, demo’d and implemented, and with the additional impetus of both HITSP and CCHIT reference, the market should be well primed to adopt this profile.

  3. Use Case Dr. Jones is conducting research into the efficacy of pain control methods for patients with chronic pain. Participating institutions with valid data sharing agreements populate CRD templates with data from their EHR with only those data elements that are a part of the approved protocol. Jack Robertson is a Registered Nurse and research assistant working with Dr. Jones on this study. It is Jack’s role to obtain and / or conduct pain assessments per the protocol specified assessment instrument throughout the course of the study. Jack is able to view the available pain assessments populated by as a function of the redacted requests to the available EHRs, but not the remainder of the information requested for the study. Jack conducts the pain assessments per protocol specifications, and these are provided electronically for inclusion in EHRs only for those institutions that have valid data sharing agreements with Dr. Jones or her institution.

  4. Proposed Standards & Systems • Redaction services uses RFD and CRD as well as the HL7 structured document Continuity of Care. It works with EHR and electronic data capture systems, which enact the core RFD actors: forms filler, forms manager, data receiver, data archiver. • The alternative to the redaction approach is to create a template CDA for each research protocol, a daunting if not impossible task.

  5. Discussion • Redaction services requires about the same level of effort as CRD. • Landen Bain, CDISC, and Davera Gabriel of UC California Davis are willing to act as editors. • Redaction services opens the way to use standard, pre-existing templates for secondary purposes. This capability will likely have value to other domains than clinical research.

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