Table 2.
Number of participants | TEA total score | TEA domains | ||||
---|---|---|---|---|---|---|
Substance use | Health | Lifestyle | Community | |||
Reliability | ||||||
Internal consistency, Cronbach’s alpha | 410 | 0.90 | 0.93b | 0.84b | 0.84b | 0.86b |
Test-retest reliability, ICC (95% CI)a | 177 | 0.69 (0.60–0.76) | 0.65 (0.55–0.72) | 0.71(0.63–0.77) | 0.65 (0.56–0.73) | 0.61(0.51–0.69) |
Known groups validity, mean (SD) TEA score | ||||||
Current health status (SF-36 Item 1) | ||||||
Excellent | 56 | 29.4 (9.8) | 7.3 (2.9) | 7.1 (2.9) | 7.7 (2.6) | 7.4 (2.8) |
Very good | 167 | 26.5 (9.7) | 6.5 (3.1) | 6.5 (2.7) | 6.7 (2.6) | 6.8 (2.7) |
Good | 140 | 24.0 (9.1) | 6.3 (3.0) | 5.6 (2.5) | 6.1 (2.4) | 6.1 (2.5) |
Fair/Poor | 47 | 21.1 (9.0) | 5.9 (2.9) | 4.5 (2.5) | 5.3 (2.6) | 5.3 (3.1) |
P-valuec | <0.001 | 0.097 | <0.001 | <0.001 | <0.001 | |
Convergent/divergent validity, Pearson correlations | ||||||
OC VAS | 410 | −0.13** | −0.07 | −0.15** | −0.14** | −0.11* |
ASI-Lite | ||||||
Medical status | 329 | −0.04 | 0.00 | −0.09 | −0.07 | 0.00 |
Employment status | 298 | −0.05 | −0.10 | −0.03 | −0.01 | −0.04 |
Alcohol use | 296 | 0.00 | 0.03 | −0.07 | 0.00 | 0.04 |
Drug use | 281 | −0.12 | −0.12* | −0.11 | −0.08 | −0.08 |
Legal status | 288 | −0.08 | −0.10 | −0.06 | −0.08 | −0.06 |
Social/family status | 313 | −0.05 | 0.00 | −0.09 | −0.06 | −0.04 |
Psychiatric status | 309 | 0.06 | 0.06 | −0.01 | 0.07 | 0.08 |
SF-36 | ||||||
PCS | 410 | 0.11* | 0.04 | 0.16** | 0.11* | 0.07 |
MCS | 410 | 0.25*** | 0.06 | 0.30*** | 0.26*** | 0.26*** |
EQ-5D-5L | ||||||
Utility index | 410 | 0.30*** | 0.18*** | 0.34*** | 0.28*** | 0.26*** |
VAS | 410 | 0.17*** | 0.05 | 0.20*** | 0.16** | 0.17*** |
Ability to detect change in current health statusd, mean (SD) TEA score | ||||||
Improvement | 189 | 13.5 (10.9) | 3.4 (3.9) | 3.5 (2.9) | 3.4 (3.0) | 3.3 (3.1) |
No change | 177 | 11.5 (10.6) | 3.2 (3.8) | 2.6 (3.0) | 2.9 (3.0) | 2.8 (3.1) |
Decline | 44 | 8.7 (9.7) | 2.3 (3.2) | 2.0 (3.0) | 2.4 (2.5) | 2.0 (3.0) |
Notes: aStable participants were defined based on last two visits in the open-label safety study and limited to those with stable urine drug screen results between these last visits. bAlpha if item deleted. cP-value is based on the overall ANOVA. d“Improved” defined as a ≥1-point increase between screening and baseline, “no change” defined as the same score at screening and baseline, and “declined” defined as a ≥1-point decline between screening and baseline. *P<0.05; **P<0.01; ***P<0.001.
Abbreviations: ASI-Lite, Addiction Severity Index-Lite; EQ-5D-5L, 5 level EuroQol 5 dimensions instrument; ICC, intraclass correlation coefficient; MCS, mental component summary, OC, opioid craving; PCS, physical component summary; SF-36, 36-Item Short Form Health Survey; VAS, visual analog scale.