Healthcare System Research Collaboratory-Coordinating Center – Rethinking Clinical Trials


by Asba Tasneem

The Collaboratory Coordinating Center (CC), intended to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research, is working towards its ultimate goal of ensuring physicians and patients are able to make decisions based on the best available clinical evidence. Collaboratory CC has been working with demonstration projects to create a durable infrastructure that facilitates multicenter studies and reuse of data, creating best practices, tools, and knowledge that will ultimately impact policy and practice.

The Collaboratory website features a Knowledge Repository (KR), an expertly curated body of resources and publications selected and/or produced by Collaboratory stakeholders. The KR will be complemented by Re-thinking Clinical Trials, a “living” textbook of pragmatic clinical trials that combines the authoritative qualities of a trusted publication with the flexibility of a controlled “Wiki” environment that allows content to be constantly refined by authorized individuals. To accelerate the conduct of EHR-based PCTs, the KR will promote harmonization and standardization of data elements that are used to describe a particular study population.

This effort is led by Robert Califf, MD. Collaborating members of this project team include principal investigators from several therapeutic areas and staff members from DCRI-CRI, DCTI-IT, DCRI-Communications, and CTTI.



by Swati Chakraborty

Duke is participating in a study planning phase funded by an NIH Phased Innovation Award for the NIH Common Fund Effort for the Health Care System Research Collaboratory. The study, Night-time Dosing of Anti-hypertensive Medications: A Pragmatic Clinical Trial, will compare the likelihood of major cardiovascular (CV) events between the intervention group taking night-time doses of one or more anti-hypertensive medications and control group taking morning doses of all ant-ihypertensive medications The study’s planning phase to design the randomized open-label pragmatic trial is a UH2 demonstration project.

The primary holder of the UH2 is the University of Iowa, under the direction of the Principal Investigator, Dr. Gary Rosenthal. The Duke team includes Eric Eisenstein, DBD, Bimal Shah, PhD, Swati Chakraborty, and Linda Shaw. The team is assisting in study design, workflow planning, protocol development, and cohort identification. The Duke Databank for Cardiovascular Disease (DDCD) is being used to estimate outcome event rates; the Decision Support Repository (DSR) is the primary source of

Grand Rounds on the study were presented on August 2, 2013. To view the Grand Rounds, go to:

Horvath Invited to Speak at NC HIMSS

May 1-2, 2014 | Raleigh, NC

Monica Horvath, PhD along with Greg Nelson, MMCi, ThotWave Technologies, LLC, will present a session titled “Change Brings Challenges: Defining Analytics at a Health System with Priorities in Research, Education, and Clinical Care” at the NC HIMSS Conference in Raleigh, May 1-2, 2014. The presentation addresses challenges faced during the deployment of a new EHR.

Johnson Named AMIA Policy Committee Co-Chair



Constance M. Johnson, PhD, MS, RN was named Policy Committee Co-Chair for the American Medical Informatics Association (AMIA)’s Nursing Informatics Working Group (NIWG). As indicated on AMIA’s website, the NIWG “serves as the United States’ representative to the International Medical Informatics Association (IMIA) Nursing Informatics Special Interest Group.”

Johnson Speaks for the Duke-Johnson & Johnson Nurse Leadership Program



Constance M. Johnson, PhD, MS, RN did a presentation on using data to drive decision making December 10, 2013. The presentation was organized by the Duke University Department of Community and Family Medicine as part of the Duke-Johnson & Johnson Nurse Leadership Program, a year-long, part-time program focused on developing advanced practice nurses as leaders in the clinical setting.

DUSON Informatics Program Revamped, New Courses Added



The informatics program in the School of Nursing has made major revisions to its curriculum as a result of published core competencies. New courses added are:

  • Cognitive Informatics in Healthcare
  • Data Analytics I & II
  • Database Systems in Healthcare: Design, Management, and Connectivity
  • Health Information Technology Leadership

These new offerings join these existing courses:

  • Introduction to Health Informatics
  • Health Informatics Research Seminar
  • Scholarly Dimensions I: Science Development, Study Design & Statistics
  • Scholarly Dimensions II: Evidence-Based Practice
  • Professional Transitions: Advanced Practice Nurse Research Seminar
  • Facilitating Student Learning
  • Population Health in a Global Society
  • Health Information Exchange Standards, Methods, & Models
  • Synthesis of Specialty Practice
  • System Design, Implementation, Evaluation, & Maintenance

Encryption Requirement for Sensitive Electronic Information (SEI)



The Duke Medicine Mobile Computing and Storage Device Standard outlines the requirements for encryption of Sensitive Electronic Information (SEI). Any mobile computing and storage device containing Duke Medicine SEI, regardless of ownership, must employ encryption as outlined in the standard. Duke Medicine laptops must employ Whole Disc Encryption (WDE) and have the IBM Endpoint Manager (IEM) client installed. Other mobile storage devices (e.g., flash drives, discs, tablets, etc.) may use WDE or file encryption. An Encryption FAQ and instructions on how to encrypt are available online to assist Duke Medicine employees in meeting these requirements.

Device How to Encrypt
Windows laptop Symantec WDE
Mac OS X laptop Symantec or FileVault2* WDE
Tablets, smart phones WDE native to device
Flash drives, discs, CDs, DVDs, other Symantec file encryption or other AES 256 apps

*allowed via current policy exception

Hammond Delivers Presentation to Students at Aalborg University in Denmark



W. Ed Hammond, PhD traveled to Aalborg University in Denmark to deliver a segment of the university’s PhD course in health informatics. His presentations were titled “Key Driving Forces in Health Informatics” and “A Personal History of Medical Informatics.” Dr. Hammond was one of seven faculty leading this course. The others included:

Professor Christian Nøhr, Aalborg University
A/Professor Pernille Bertelsen, Aalborg University
A/Professor Stig Kjær Andersen, Aalborg University
Professor Finn Kensing, Copenhagen University
Deputy Manager Ib Johansen, MedCom, Denmark
Electronic Health Record Specialist, Jens Warfvinge, Aarhus University Hospital

Hammond Reappointed to NCHICA Board of Directors



W. Ed Hammond, PhD

W. Ed Hammond, PhD has been re-elected to the Board of Directors of the North Carolina Healthcare Information & Communications Alliance, Inc. (NCHICA). His appointment was approved in September at the organization’s 19th Annual Conference & Exhibition, held September 9-11, 2013 in Asheville, NC. Dr. Hammond’s term will expire in 2016.

Call For Papers: Computational Sustainability and Meaningful Use (CSMU)



The editorial board of CSMU 2014 has released a call for papers for the 1st International Workshop on Emerging Technologies for Computational Sustainability and Meaningful Use, scheduled for August 7-8, 2014 in Ottawa, Canada. Their announcement states:

“CSMU 2014 is a great place for sustainability leaders and healthcare/education/management/computer science/engineering innovators to find new ways to inspire their organizations, learn practical ways to make changes and contribute to international understanding of sustainable institutions. CSMU 2014 enables to network with management and technical professionals across the health/education/science spectrum. It also enables you to take away ideas (e.g. whether the meaningful use movement in USA is good for other places?), tools and methods as well as to explore sustainable models and how to measure their affectivity. Finally it will enables you to include your solutions at the prestigious Springer proceeding. However, you can still present an extended abstract or a poster to share your research or case study.”

Ed Hammond, PhD, Director of the Duke Center for Health Informatics, is a member of the Program Committee. Additional details can be found on their website.