1. Patient Baseline Assessment
Supported by NIAMS U01-AR A1
Copyright  1999, Trustees of Dartmouth College

2. Baseline Assessment Occurs immediately after Enrollment Form completed
Patient must have reviewed and signed the Informed Consent
Patient completes directly on the Touchpad
Up to 140 questions
Copyright  1999, Trustees of Dartmouth College

3. Baseline Assessment Contents Demographics Oswestry SF-36 EQ-5D
Visual Analog Scale
HUI
Insurance Status
Occupation
Employment and Income
Compensation
Copyright  1999, Trustees of Dartmouth College

4. Main Health Outcome Measures
Functional Health Status
Disease Specific Health Status
Generic Health Status
Quality-Adjusted Life Years (QALYs)
Preference Classification Systems
Societal perspective
Direct Utility Assessment
Individual perspective
Copyright  1999, Trustees of Dartmouth College

5. Functional Health Status
Disease Specific Health Status
Impact of their spine problem on function
Designed to separate out the effect of other problems or co-morbidities
Theoretically more sensitive to change with treatment.
Copyright  1999, Trustees of Dartmouth College

6. Functional Health Status
Generic Health Status
Measure overall health
Allows comparisons among different diseases
Captures negative side effects of treatment
May be less responsive to specific interventions
Copyright  1999, Trustees of Dartmouth College

7. Disease Specific Health Status
Oswestry Disability Index
Patient self-reported functional limitation due to back or leg pain
Several prior studies of validity and reliability
Several different versions available
SPORT using the version from MODEMS
Copyright  1999, Trustees of Dartmouth College

8. Oswestry Disability Index
9 Dimensions assessed “in the past week”
Dressing
Lifting
Walking and running
Sitting
Standing
Sleeping
Social and Recreational Life
Traveling
Sex life
Copyright  1999, Trustees of Dartmouth College

9. General Health Status SF-36 36 item questionnaire
some “now”
some “during the past 4 weeks”
extensively tested for reliability and validity
well established age specific norms
Copyright  1999, Trustees of Dartmouth College

10. SF - 36 8 subscales Bodily Pain Vitality Mental Health
General Health Perception
Physical Function
Role Limitations - Physical
Role Limitations - Emotional
Social Functioning
Copyright  1999, Trustees of Dartmouth College

11. SF - 36 Main Outcome Measures Bodily Pain Physical Functioning
Copyright  1999, Trustees of Dartmouth College

12. To estimate QALYs
Need quantitative estimates of patient preferences for health outcomes (i.e., utility for current health)
Range from 0 to 1
0 - worst health state imaginable (death)
1 - perfect health
Copyright  1999, Trustees of Dartmouth College

13. Preference Classification Systems
Define a level of function and then use a societal valuation of that health state from population studies to assign a utility
Copyright  1999, Trustees of Dartmouth College

14. Preference Classification Systems
Health Utilities Index (HUI)
15 items
Implemented at baseline and annually
EQ - 5D (from the EuroQol instrument)
5 Items
Implemented at each study visit
Copyright  1999, Trustees of Dartmouth College

15. Direct Utility Assessment
Ask the patient for their personal valuation of their health state, as opposed to a societal valuation
Visual Analog Scale
Implemented at each study visit
Copyright  1999, Trustees of Dartmouth College

16. Insurance, Employment, Income
Ask the patient about their insurance status, occupation, work status, missed work, income, disability status
Baseline data necessary in order to assess changes in employment and earning potential over time (economic impact)
Copyright  1999, Trustees of Dartmouth College

17. Copyright  1999, Trustees of Dartmouth College

18. Treatment Assignment Immediately after Baseline Assessment
Record Observational Cohorts treatment preference
Randomization module run for randomized patients
Non-surgical portion of treatment plan recorded for all patients
Copyright  1999, Trustees of Dartmouth College