Table 2.
Primary and secondary outcomes at 12 months (continuous outcomes)
|
Usual care group |
Intervention group |
Mean difference (95% CI)* | p value | |||
|---|---|---|---|---|---|---|
| Number of patients | Mean (SD) | Number of patients | Mean (SD) | |||
| Co-primary outcomes | ||||||
| BPI severity (0 to 10, best to worst) | 100 | 3·67 (2·52) | 212 | 3·14 (2·43) | −0·65 (−1·17 to −0·13) | 0·014 |
| BPI interference (0 to 10, best to worst) | 100 | 4·08 (2·90) | 213 | 3·52 (2·79) | −0·68 (−1·29 to −0·08) | 0·026 |
| Secondary outcomes | ||||||
| OKS (0 to 48, worst to best) | 93 | 27·16 (9·72) | 201 | 28·44 (10·23) | 2·68 (0·58 to 4·78) | 0·013 |
| DN-4 (0 to 7, best to worst) | 94 | 2·94 (2·12) | 195 | 3·07 (2·07) | −0·10 (−0·55 to 0·35) | 0·653 |
| PainDETECT (−1 to 38, best to worst) | 94 | 12·69 (7·53) | 198 | 12·87 (7·70) | −0·93 (−2·51 to 0·65) | 0·249 |
| Pain Catastrophizing Scale† (0 to 52, best to worse) | 91 | 13·75 (13·07) | 195 | 11·82 (12·60) | 0·90 (0·70 to 1·16) | 0·428 |
| PaSol: solving pain (0 to 24, worst to best) | 89 | 13·21 (7·93) | 193 | 12·69 (8·11) | −1·18 (−3·09 to 0·74) | 0·226 |
| PaSol: meaningful life (0 to 30, worst to best) | 90 | 19·81 (8·28) | 193 | 19·20 (8·92) | −0·64 (−2·83 to 1·55) | 0·565 |
| PaSol: acceptance of pain (0 to 18, worst to best) | 87 | 8·55 (5·32) | 191 | 8·54 (5·85) | −0·22 (−1·65 to 1·20) | 0·757 |
| PaSol: belief in solution (0 to 12, worst to best) | 90 | 5·91 (4·34) | 193 | 5·74 (4·34) | −0·38 (−1·47 to 0·70) | 0·490 |
| Patient Satisfaction Scale (25 to 100, worst to best) | 89 | 68·73 (21·71) | 197 | 71·10 (23·46) | 3·79 (−1·47 to 9·06) | 0·157 |
| ICECAP-A (−0·001 to 1, worst to best) | 91 | 0·78 (0·21) | 197 | 0·78 (0·19) | 0·03 (−0·004 to 0·06) | 0·085 |
| SF-12 (physical; 0 to 100, worst to best) | 93 | 36·96 (9·95) | 195 | 37·70 (9·71) | 2·07 (−0·10 to 4·23) | 0·061 |
| SF-12 (mental; 0 to 100, worst to best) | 93 | 48·58 (11·25) | 195 | 48·07 (11·04) | −0·08 (−2·29 to 2·12) | 0·940 |
| HADS: anxiety (0 to 21, best to worst) | 92 | 5·96 (4·67) | 198 | 6·05 (4·37) | −0·70 (−1·47 to 0·08) | 0·079 |
| HADS: depression (0 to 21, best to worst) | 90 | 6·07 (4·27) | 197 | 5·98 (3·84) | −0·69 (−1·47 to 0·10) | 0·086 |
BPI=Brief Pain Inventory. OKS=Oxford Knee Score. DN-4=Douleur Neuropathique 4. PaSol=Pain Solutions Questionnaire. ICECAP-A=ICEpop CAPability measure for Adults. SF-12=12-item Short Form Survey. HADS=Hospital Anxiety and Depression Scale.
*
All analyses are adjusted for hospital site, baseline BPI subscores and baseline score for each outcome measure.
†
Analysed on a log scale because this improved the normality of the residuals. Estimates are back-transformed to the original scale.