Patient Baseline Assessment Supported by NIAMS U01-AR45444-01A1 Copyright  1999, Trustees of Dartmouth College

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Copyright  1999, Trustees of Dartmouth College

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