Identifying Treatment Effect Modifiers in the STarT Back Trial: A Secondary Analysis

Abstract

Identification of patient characteristics influencing treatment outcomes is a top low back pain (LBP) research priority. Results from the STarT Back Trial support the effectiveness of prognostic stratified care for LBP compared to current best care, however patient characteristics associated with treatment response have not yet been explored. The purpose of this secondary analysis was to identify treatment-effect modifiers within the STarT Back Trial at 4 months follow-up (n=688). Treatment response was dichotomized using back-specific physical disability measured by the Roland-Morris Disability Questionnaire (=7). Candidate modifiers were identified using previous literature and evaluated using logistic regression with statistical interaction terms to provide preliminary evidence of treatment-effect modification. Socioeconomic status (SES) was identified as an effect modifier for disability outcomes (OR = 1.71, P=.028). High SES patients receiving prognostic stratified care were 2.5 times less likely to have a poor outcome compared to low SES patients receiving best current care (OR = 0.40, P=.006). Education level (OR = 1.33, P=.109) and number of pain medications (OR = 0.64, P=.140) met our criteria for effect modification with weaker evidence (0.20>P=0.05). These findings provide preliminary evidence for SES, education, and number of pain medications as treatment-effect modifiers of prognostic stratified care delivered in the STarT Back Trial.