Children’s HospitalUCSFDivision of Adolescent Medicine

Web-Enabled Research Platform:The SIMS Study

Carolyn Bradner Jasik, MDMichele Mietus-Snyder, MD

Michael Jarrett

Department of Pediatrics

University of California San Francisco

Children’s HospitalUCSFDivision of Adolescent Medicine

Source: Ogden CL (2006).

Children’s HospitalUCSFDivision of Adolescent Medicine

Children’s HospitalUCSFDivision of Adolescent Medicine

Children’s HospitalUCSFDivision of Adolescent Medicine

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

Children’s HospitalUCSFDivision of Adolescent Medicine

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.

Children’s HospitalUCSFDivision of Adolescent Medicine

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!

Children’s HospitalUCSFDivision of Adolescent Medicine

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.

Children’s HospitalUCSFDivision of Adolescent Medicine

Survey (base only)Administrative DataDemographicsMedical History: HPI, social, family, etc.Parent Intake History

The Reality

• Relational approach made sense, but data extract is LARGE and hard to manage!

Visit (base, 2, 6, 12mo)Provider AssessmentNursing AssessmentChild questionnairesParent questionnairesLabsExtra pilot measures (not used ultimately)

Block (base, 2, 6, 12mo)Nutrition AssessmentPhysical Activity Assessment

Employment (mult members per fam)Family member demographic information

MacArthur SES (parent and child)Answers to ladder questionnaire

Sibling DataObesity history, etc.

Children’s HospitalUCSFDivision of Adolescent Medicine

The Ideal

Admin (base)DemographicsRecruitmentPhone communication

Survey (base)HPIPMHSHFH

Provider Visit (base, 2, 6, 12)HistoryPhysical ExamPlan

Block (base, 2, 6, 12mo)Nutrition AssessmentPhysical Activity Assessment

Nursing Visit (base, 2, 6, 12)Height, weight, vitalsBMI calculator

FitnessGram (base, 2, 6, 12)

Child Psych ?s (base, 2, 6, 12)RCMASCEBQPerceived StressPQL

Disordered eating screen (base, 2, 6, 12)

Sub-study urine creatinine(base, 6)

Labs (base, 2, 6, 12)

Pilot Data(base)

Employment (mult members per fam)Family member demographic information

MacArthur SES (parent and child)Answers to ladder questionnaire

Sibling DataObesity history, etc.

Parent Psych ?s (base, 2, 6, 12)CEBQPerceived StressPQL

Children’s HospitalUCSFDivision of Adolescent Medicine

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 ($)

Children’s HospitalUCSFDivision of Adolescent Medicine

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

Children’s HospitalUCSFDivision of Adolescent Medicine

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

Children’s HospitalUCSFDivision of Adolescent Medicine

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

Children’s HospitalUCSFDivision of Adolescent Medicine

Demonstration

Children’s HospitalUCSFDivision of Adolescent Medicine

Children’s HospitalUCSFDivision of Adolescent Medicine

Future Directions

Make the technology part of the study itself!

Children’s HospitalUCSFDivision of Adolescent Medicine

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

Children’s HospitalUCSFDivision of Adolescent Medicine

Jane Doe, MD FAAPObesity Specialist

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Children’s HospitalUCSFDivision of Adolescent Medicine

Children’s HospitalUCSFDivision of Adolescent Medicine

If you build it, he will come.

Children’s HospitalUCSFDivision of Adolescent Medicine

Acknowledgments

• 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