Overview of Analyses, Statistical Methods, and Scale and Timing of Measuresa
Analysis | ||||||
---|---|---|---|---|---|---|
Propensity Score Matching | Primary Outcomes Assessment | Secondary Outcomes Assessment | Sensitivity Analyses | |||
Logistic Regression | Generalized Estimating Equations | Cox Proportional Hazards Regression | Generalized Estimating Equations | |||
Measure | Scale | Timing (months) | Variable type | Variable type | Variable type | Variable type |
Age | Categorical | 0 | Independent | NIA | NIA | NIA |
Gender | Dichotomous | 0 | Independent | NIA | NIA | NIA |
Race | Categorical | 0 | Independent | NIA | NIA | NIA |
Duration of LBP | Categorical | 0 | Independent | NIA | NIA | NIA |
Pain catastrophizing | Categorical | 0 | Independent | NIA | NIA | NIA |
Pain self-efficacy | Categorical | 0 | Independent | NIA | NIA | NIA |
Chronic widespread pain | Dichotomous | 0 | Independent | NIA | NIA | NIA |
Ever had work loss ≥1 month due to LBP | Dichotomous | 0 | Independent | NIA | NIA | NIA |
Ever received disability or workers' compensation benefits due to LBP | Dichotomous | 0 | Independent | NIA | NIA | NIA |
Ever filed a law suit or legal claim due to LBP | Dichotomous | 0 | Independent | NIA | NIA | NIA |
Prior low back surgery | Dichotomous | 0 | Independent | NIA | NIA | NIA |
Health-related quality of life | Continuous | 0 | Independent | NIA | NIA | NIA |
LBP intensity (NRS) | Continuous | 0, 3, 6, 9, 12 | Independent | Dependent | NIA | Dependent |
Back-related disability (RMDQ) | Continuous | 0, 3, 6, 9, 12 | Independent | Dependent | NIA | Dependent |
Pain impact (PI) | Continuous | 0, 3, 6, 9, 12 | Independent | Dependent | NIA | Dependent |
MIC - NRS | Dichotomous | 0, 3, 6, 9, 12 | NIA | NIA | Dependent | NIA |
MIC - RMDQ | Dichotomous | 0, 3, 6, 9, 12 | NIA | NIA | Dependent | NIA |
MIC - PI | Dichotomous | 0, 3, 6, 9, 12 | NIA | NIA | Dependent | NIA |
LTOT (initial assignment to LTOT or control group) | Dichotomous | 0, 3 | Dependent | Independent | Independent | Independent |
LTOT (continuous opioid use, defined as 0, 3, 6, 9, or 12 months) | Categorical | 0, 3, 6, 9, 12 | NIA | Independent | Independent | Independent |
LTOT (dose response, defined as 0, 1, 2, 3, or 4 quarters of opioid use) | Categorical | 0, 3, 6, 9, 12 | NIA | Independent | Independent | Independent |
LTOT (dose response, defined as number of MMEs used at baseline) | Continuous | 0 | NIA | Independent | Independent | Independent |
LTOT (continuous opioid use or abstention for 12 months) | Dichotomous | 0, 3, 6, 9, 12 | NIA | Independent | Independent | Independent |
↵Abbreviations: LBP, low back pain; LTOT, long-term opioid therapy; MIC, minimally important change; MME, morphine milligram equivalent; NIA, not included in analysis; NRS, numerical rating scale; PI, pain impact; RMDQ, Roland-Morris Disability Questionnaire.
Note: aParticipants in the control group were classified as having no opioid exposure or dose in all analyses.