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Web-Enabled Research Platform: The SIMS Study

Web-Enabled Research Platform: The SIMS Study. Carolyn Bradner Jasik, MD Michele Mietus-Snyder, MD Michael Jarrett Department of Pediatrics University of California San Francisco. Source: Ogden CL (2006). The SIMS Study. RCT of mindfulness-based program for obese children ages 9-12

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Web-Enabled Research Platform: The SIMS Study

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  1. Web-Enabled Research Platform:The SIMS Study Carolyn Bradner Jasik, MDMichele Mietus-Snyder, MDMichael Jarrett Department of Pediatrics University of California San Francisco

  2. Source: Ogden CL (2006).

  3. The SIMS Study • RCT of mindfulness-based program for obese children ages 9-12 • Goal recruitment = 160 • Intervention = 6 weekly sessions reviewing mindfulness techniques vs. standard of care • Sites = Children’s Hospital Oakland and San Francisco General Hospital • Status = completed pilot phase and 1st intervention group

  4. Our Research Group • 1 junior faculty mentor (PI), 1 RA, 2 collaborators (clinical fellows), and our contractor. • Study funded by an American Heart Association grant.

  5. Why we picked QuesGen • Multiple sites made web-based attractive • Data available real-time • The contractor did most of the work • Required less staff on study days to administer survey, etc. • Less staff needs for data entry/cleaning • Short time-line for collection to analysis • It’s very cool!

  6. The SIMS Study: Data Management • Data Collection • Intake and Follow-up visits (2, 6, 12 mo) • At each visit… • Parent questionnaire • Child questionnaire • Labs • Nutrition/Physical activity assessment (on-line) • Provider assessment (history and physical exam) • Administrative Data • Demographics/contact information • Appointment tracking, etc.

  7. The Reality Sibling Data Obesity history, etc. • Relational approach made sense, but data extract is LARGE and hard to manage! Employment (mult members per fam) Family member demographic information Visit (base, 2, 6, 12mo) Provider Assessment Nursing Assessment Child questionnaires Parent questionnaires Labs Extra pilot measures (not used ultimately) Survey (base only) Administrative Data Demographics Medical History: HPI, social, family, etc. Parent Intake History MacArthur SES (parent and child) Answers to ladder questionnaire Block (base, 2, 6, 12mo) Nutrition Assessment Physical Activity Assessment

  8. The Ideal Provider Visit (base, 2, 6, 12) History Physical Exam Plan Sibling Data Obesity history, etc. Employment (mult members per fam) Family member demographic information Nursing Visit (base, 2, 6, 12) Height, weight, vitals BMI calculator Survey (base) HPI PMH SH FH MacArthur SES (parent and child) Answers to ladder questionnaire FitnessGram (base, 2, 6, 12) Child Psych ?s (base, 2, 6, 12) RCMAS CEBQ Perceived Stress PQL Disordered eating screen (base, 2, 6, 12) Sub-study urine creatinine (base, 6) Parent Psych ?s (base, 2, 6, 12) CEBQ Perceived Stress PQL Pilot Data (base) Block (base, 2, 6, 12mo) Nutrition Assessment Physical Activity Assessment Labs (base, 2, 6, 12) Admin (base) Demographics Recruitment Phone communication

  9. What We Did Right • Did not use EXCEL/ACCESS • No paper forms • Web-based vs. desktop/network • Resisted the urge to get “fancy” • Anticipated analysis needs while developing database • Partnered with other researchers ($)

  10. Our Pitfalls • Allow more time for development • Allocate more funds • Be more prepared for contractor meetings • Take full advantage of the technology • Trust the technology • Trust our participants less (more data input “checks”) • Anticipate report/extract needs earlier • Collect less data • First extract 6 months after data collection started • Mentor actually used it for the first time this month

  11. The Cost (financial and personal) • $10,000 for contractor fees • Real cost likely much higher • I spent ~100 hours on development • I needed to be available via page during all data collection days to triage issues/questions

  12. Words of Wisdom • For your first time, try and work within a larger team to learn from experience • Over-estimate how much time it will take and the cost • Use, don’t abuse, your contractor • Identify a primary database “guru” in the team • Understand the technology before you start to create your database and data collection • Encourage input from your data programmer, RAs, and study coordinator • Always have back-ups and paper just in case

  13. Demonstration

  14. Future Directions Make the technology part of the study itself!

  15. Future Directions • Adapt tool for research and clinical use • Integrate clinical assessment and research data collection • Pilot study in UCSF obesity clinic • Pie in the sky…create shared research database for regional obesity clinics

  16. I have 30 min to spend… SPORTS Acute Otitis Media NAEPP Vanderbilt Bright Futures BMI+ BMI AMA Jane Doe, MD FAAP Obesity Specialist GAPS NDEP2004 NCEP NHBPEP GLAD-PC

  17. If you build it, he will come.

  18. Michele Mietus-Snyder, MD Robert H. Lustig, MD Zoe Foster Andrea Garber, PhD Kris Madsen, MD Charles Irwin, MD Mary-Ann Shafer, MD Michael Kohn, MD Michael JarrettFounder and CEO Acknowledgments

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