|MURDOCK Informatics (reported by Jessie Tenenbaum, Doug Wixted, and Anita Walden)
MIDR i2b2 deployment
A proof-of-concept i2b2 instance is being developed for the MIDR to evaluate i2b2 as a technology solution moving forward. Loading metadata into the i2b2 instance has been completed. Additional progress has been largely on hold while the developer’s effort was needed on other tasks, but as of 5 September, work has re-commenced. The first task will be loading a 1,000-row selected subset of registry data. Next steps after that will include review of the metadata structure by the MIDR team, design and implementation of a streamlined process for future data transfer, and performance testing with a more realistic number of records.
A confluence of separate but related initiatives are coming together at an opportune time for next steps with respect to incorporation of omic data in the MIDR:
- The Biobank Standard Terminology Project is underway, including a group focused on omic data.
- Some Horizon 2 projects are beginning to think about genomic data.
- The CTSA Omics Data Standards Working Group has completed preliminary work and is ready to do some in-depth work to evaluate existing data standards in a specific omic area, likely to be transcriptomics, but will depend in part on the needs of H2 investigators.
- Two potential projects under consideration involve secondary analysis of an existing genomic dataset, providing a real-world use case to guide requirements.
A revised version of the MURDOCK Study Governance document has been completed based on input from a number of stakeholders. It was distributed to MURDOCK Leadership and will be discussed in an upcoming Leadership meeting. This document describes in detail the orchestration of people, processes, technology, and policy to leverage, optimize, and maximize the value of both MURDOCK data and other aspects of the Study, including biospecimens, infrastructure, and human expertise. In particular, two key areas the document addresses are data governance- how data is generated/acquired, stored, and accessed using role-based permissions, and MURDOCK Study research proposals- how sub-studies are to be proposed, reviewed, approved, and executed.
In parallel, a distinct IRB Protocol for the MIDR itself (as opposed to references to it in the Horizon 1 and Horizon 1.5 protocols) has been developed and is being submitted for IRB approval. Having this separate protocol is necessary to enable use of the MIDR (which holds a limited data set) for review preparatory to research.
MURDOCK Registry Web Enrollment
The MURDOCK Registry development team is working to provide Registry participants with the option of completing their enrollment forms online and submitting them to the Kannapolis office prior to their enrollment visit. Completing enrollment forms and any follow-up forms via the web is expected to increase enrollment and improve follow-up compliance.
Progress on the web enrollment functionality completed since the last iteration includes:
- Email Template Prototypes – The team demonstrated several prototypes for the email notifications to the web users. These templates can be modified by the Kannapolis study office.
- Completed Nightly Processor Web Enrollment Form Version Change Notification – When a new version of the form is ready to be released, a notification email to inform participants they have so many days to complete and submit their current version of the form before it is deleted and replaced with the new version of the form.
- Web Participant Management Tool Implementation – A tool for administrative users to manage web participant accounts and forms.
- New Form Data Elements – Alternate contact data elements have been added to the Registry system.
- Reason for Change for the Web Enrollment form review – This functionality was completed for forms submitted by the participant and reviewed by the study staff during a visit with the participant.
- Import physical addresses and produce GIS data extract – (partially complete).
It is anticipated that testing the developed items and evaluation of the tools needed to code the medications will take three weeks. Results will be reviewed by the team at their meeting on 18 September.
The project team is reviewing the heuristics test results and the user acceptance test results. The findings will be ranked in order of severity and then discussed with the developers for implementation. The public will also participate in the testing to ensure the tool is user friendly, intuitive, and provides the information needed. The Internal Review Board documents are being reviewed by the Kannapolis office prior to being submitted for approval.
Horizon 2 Data Transfers
Access and procedures have been established to enable investigators/staff for the Severe Acne and Physical Performance Studies to access pdf copies of CRFs that Kannapolis study staff have scanned and reside on a secure FTP site. In addition to CRFs, files from Actigraph accelerometers (used in the Physical Performance Study) are being transferred in this manner.
Systems have been identified and will be evaluated for coding the medications collected in the registry, a step needed for analysis and reporting. Initial investigation has been done on the National Center for Biomedical Ontology (NCBO) tools using the RxNorm terminology for coding both legacy free text data and data entry moving forward. A research side project will evaluate the accuracy rate for coding existing data and characterize the types of entries that cannot be mapped through the tool.
RXNORM, which is produced by the National Library of Medicine, has an annotator specifically used for coding medications and is also being evaluated to determine accuracy and ease of use and implementation.
Electronic Health Record (EHR) Data
MURDOCK Study informaticians are working with the two major healthcare providers in Kannapolis/Cabarrus County, Carolinas Healthcare System (CHS; source of primary care for 55% of current participants) and Novant Health (source of primary care for 10% of participants) to share electronic health record (EHR) data for MURDOCK participants.
The CHS data warehouse and analytics team (DA2, formerly the Dickson Institute) and Duke Data Warehouse group, with support from the MURDOCK Study, are planning a visit to Duke so CHS can learn more about building the Duke enterprise data warehouse [i.e. Decision Support Repository (DSR)].
Novant leadership is interested in using Epic as a common EHR platform between Novant and Duke, leveraging the interoperability between systems to share data securely for common patients. This would facilitate integration of clinical data from Novant for the MURDOCK Study, and may provide a secure method to do so. Doug Wixted, Informatics Project Leader for the MURDOCK Study, is working with Keith Griffin, Novant CMIO (MURDOCK champion and lead contact) and Novant compliance personnel regarding a Data Use Agreement (DUA) and related privacy and security considerations. Evaluation of the Epic Care Everywhere application for the MURDOCK Study is in nascent stages; however, efforts to determine feasibility have been initiated from both sides.