The UAMS CTMS and the National Children’s Study

1. The UAMS CTMS and the National Children’s Study William R. Hogan, MD, MS Division of Biomedical Informatics University of Arkansas for Medical Sciences May 10, 2011

2. The National Children’s Study (NCS) • Goals: • Improve the health and well-being of children • Discover the environmental factors that significantly affect the outcomes of child health • Long-term, prospective cohort study • Targeted enrollment of 100,000 children • Follow children from before birth to age 21

3. The “Environment” Includes • Natural and man-made environmental factors • Biological and chemical factors • Physical surroundings • Social factors • Behavioral influences and outcomes • Genetics • Cultural and family influences and differences • Geographic [sic] locations

4. Two Phases • Vanguard Study ― evaluate the feasibility, acceptability, and cost of: • Three different recruitment strategies • Study procedures and outcome assessments that are to be used in the Main Study • Main Study ― discover exposure–outcome relationships with a data driven, evidence-based approach. We are here!

5. NCS Challenges • Numerous and diverse: • Types of data • Study centers • Not just study data collection (studying the study) • Data uniformity, quality, and transparency • Long time horizon (at least 25 years) • INTEROPERABILITY

6. Interviews/Assessments/Questionnaires In-Person/Phone Self-Administered Questionnaire Diaries/Medical Visit Logs Medical Care Log Environmental Indoor Air House Dust Drinking Water Visual Assessment (indoor) Visual Assessment (outdoor) Soil GPS reading at entry to structure Indoor Air (self-collected) House Dust (self-collected) Other Medical Record - Ultrasound Chart Abstraction – Inpatient/Outpatient Community Based Food, Air Collection Child Care Locations Neighborhood Assessment Physical Exam Anthropometric Blood Pressure Ultrasound Neonatal Exam Infant Physical Exam Lung Function Physical Activity Hearing Assessment Vision Assessment BIA Biospecimen Collection Pregnancy Tests Vaginal Swabs Blood / Saliva Blood Spot (heel) Urine (self-collected) Hair Nails Cord Blood Umbilical Cord, Placenta Meconium Breast Milk/Formula Saliva

7. Consider a 25-Year Time Horizon… In 1985: • First Internet domain name registered • Market share of PC/clones exceeds that of Commodore for the first time • Oracle releases first ever client-server database • Apple Macintosh and CD-ROM are one year old • Hard drives are 10-20MB In 1990: • Microsoft Windows 3.0 released • MS Word is one year old • Proposal for World Wide Web hand converted from MS Word to HTML

8. Twenty-five Years from Now… …we will almost certainly have: • New programming languages • New methods for data management • New architectures • Completely different applications • Unforeseen revolutions in how we create, store, manage, and process information

9. Interoperability • Across • Sites • Time • Standards • Minimal standards adoption • Current standards often confused, confusing • Proprietary vendor incentives for non-compliance

10. Initial Impressions • No single software application is sufficient • Standards will be essential • Open-source is ideal • Data collection methods open to inspection and criticism • No vendor sun-setting/lock in • Adaptable to new technology and platforms in the next 25 years • No disincentives to standards compliance

11. UAMS CTMS • University of Arkansas for Medical Sciences Clinical Trials Management Suite • A suite of open-source applications founded on caBIG components for supporting all elements of a clinical trial • Pioneered by our Winthrop P. Rockefeller Cancer Institute

12. UAMS CTMS Components • C3PR • LimeSurvey • OpenClinica • PSC • caTissue Suite • WebSSO/CAS • Address lookup tool Tools relevant to NCS short and medium term…

13. C3PR • Participant registration • Demographics • Study epoch • Eligibility criteria • Consents/versions • Notes: • Need to capture data on screened participants so that we do not continually approach women who refused • Women may get pregnant again or may not carry to birth, so we need to be able to move participants back and forth through epochs

14. Identifiers Consents Epochs Eligibility Criteria

16. LimeSurvey • Fully open-source • It provides: • Templates and conditional logic • Reusable label sets for responses to multiple items • Tokens with data allow pre-population of name, dob… • Sophisticated, multiple language support • Grid controls for data entry • Easy sharing of surveys, items • Access controls • Many data export options (e.g. SPSS) • Very broad community

20. In Production • C3PR: • 133 registrations • 58 participants (57 mothers, 1 child) • 9 child participant registrations pending resolution of new issue • LimeSurvey: • 5 instruments • 1 each • Self-administered questionnaire • Participant’s evaluation of NCS visit • NCS staff survey

21. Instruments Completed to Date

22. C3PR Changes for NCS • Integration with other tools • Study subject communication management • Capturing familial relationships between study subjects • Capture household relationships – cohabitation • Unrestricted epoch transfer • Capture date ranges for a subject’s residence • Change which data elements are captured for a study based on its type • Change registration wizard layout based on study design Contractor has already begun work!

23. From the NCS Program Office, 03/18/11 • All Study Centers must be utilizing an open architecture non proprietary informatics system for case management and data acquisition… • All NCS locations must be transitioned away from subcontractor proprietary systems by May 15, 2011. Of the three main subcontractors working with NCS study centers, two are starting to make their source code open, to NCS Study Centers at least

24. OPPORTUNITY • The NCS Program Office envisions two or more communities built around common software solutions • We have submitted a proposal to facilitate one of them • We have shared our instrument implementations in LimeSurvey freely • We are studying what it would take to share C3PR and PSC templates, configurations, etc.

25. Summary • We successfully adapted our caBIG-based CTMS to the NCS! • We are live with C3PR, LimeSurvey, and our custom address-lookup tool • We are planning for: • PSC • caTissue • Improvements to/integration of all • Our tools are approved by NCS Program Office • There is an opportunity to include NCS as key stakeholder in open-source community

26. Acknowledgements • Winthrop P. Rockefeller Cancer Institute • CTSA grant: award 1UL1RR029884 from the NCRR. The content is solely the responsibility of the author and does not necessarily represent the views of the National Center for Research Resources or the National Institutes of Health. • NCS Team: Dr. Charlotte Hobbs, Dr. Jim Robbins, Pearl McElfish, Linda Smith, Rosie Harris, Steve Cochran, Debra Napoli, Topeka Stacey, Anthony McGuire, Akheel Ahmed, Shariq Tariq, Melissa Casteel • CTMS Team: Dr. UmitTopaloglu, Cheryl Lane, Dr. Laura Hutchins, Dr. Tom Kieber-Emmons, Dr. Peter Emanuel, Jiang Bian, ZhidanFeng, Samuel Jackson