Table 3 Comparison of outcomes over multiple time points (T2 and T3)
From: Decision aids for second-line palliative chemotherapy: a randomised phase II multicentre trial
| Â | Â | Â | Â | Linear mixed models | ||
|---|---|---|---|---|---|---|
Measure (answer scale)1 | Â | Intervention group2 Mean (SD) | Control group2 Mean (SD) | Covariates in model | Difference between intervention and control group averaged over T2 and T3, adjusted for T13 (95% CI) | Two- sided p value |
Main outcome measures | ||||||
 Well-being | ||||||
  Anxiety4 (0-21 ) | T1 | 5.7 (4.0) | 5.6 (4.0) | Group | -0.1 (-1.1;0.9) | 0.808 |
T2 | 6.6 (4.5) | 6.1 (4.5) | Baseline | Â | Â | |
T3 | 5.5 (4.1) | 5.9 (4.6) | Time | Â | Â | |
  Depression (0-21) | T1 | 5.1 (3.6) | 4.1 (3.0) | Group | -0.7 (-1.7;0.3) | 0.142 |
T2 | 5.6 (4.2) | 5.6 (4.2) | Baseline | Â | Â | |
T3 | 5.3 (3.6) | 5.2 (3.5) | Â | Â | Â | |
  General health (0-10) | T1 | 6.5 (1.6) | 7.1 (1.7) | Group | -0.2 (-0.8;0.5) | 0.615 |
T2 | 5.7 (1.8) | 6.1 (1.9) | Baseline | Â | Â | |
T3 | 5.8 (2.0) | 5.9 (1.7) | Â | Â | Â | |
  Cancer worries (1-4) | T1 | 2.1 (0.6) | 2.0 (0.6) | Group | -0.1 (-0.3;0.1) | 0.192 |
T2 | 2.1 (0.5) | 2.1 (0.6) | Baseline | Â | Â | |
T3 | 2.1 (0.6) | 2.2 (0.7) | Â | Â | Â | |
  HRQoL: physical functioning (0-100) | T1 | 75.2 (22.3) | 79.2 (18.1) | Group | -2.2 (-9.2;4.8) | 0.536 |
T2 | 68.2 (22.5) | 72.3 (21.0) | Baseline | Â | Â | |
T3 | 67.9 (25.0) | 71.1 (22.1) | Â | Â | Â | |
  HRQoL: emotional functioning (0-100) | T1 | 81.0 (22.0) | 80.5 (20.2) | Group | 3.5 (-3.4;10.5) | 0.318 |
T2 | 74.3 (22.0) | 73.6 (27.1) | Baseline | Â | Â | |
T3 | 79.7 (20.2) | 75.5 (25.2) | Â | Â | Â | |
Additional outcome measures | ||||||
 Coping | ||||||
  Helplessness/Hopelessness (1-4) | T1 | 1.8 (0.6) | 1.7 (0.5) | Group | 0.0 (-0.1;0.2) | 0.759 |
T2 | 1.8 (0.6) | 1.8 (0.5) | Baseline | Â | Â | |
T3 | 1.9 (0.6) | 1.8 (0.5) | Â | Â | Â | |
  Fighting Spirit (1-4) | T1 | 2.9 (0.6) | 3.2 (0.6) | Group | -0.0 (-0.2;0.1) | 0.568 |
T2 | 2.7 (0.6) | 3.0 (0.6) | Baseline | Â | Â | |
T3 | 2.8 (0.7) | 2.8 (0.7) | Â | Â | Â | |
  Avoidance (1-4) | T1 | 2.5 (0.7) | 2.6 (0.8) | Group | 0.1 (-0.0;0.3) | 0.094 |
T2 | 2.5 (0.7) | 2.6 (0.7) | Baseline | Â | Â | |
T3 | 2.5 (0.7) | 2.3 (0.7) | Â | Â | Â | |
  Perceived participation (1-5) | T2 | 3.1 (1.0) | 2.8 (0.9) | Group | 0.2 (-0.2;0.5) | 0.395 |
T3 | 2.9 (1.0) | 2.9 (0.8) | Â | Â | Â | |
 Information-related measures | ||||||
  Amount of information received (1-7) | T1 | 3.8 (0.6) | 3.9 (0.3) | Group | -0.1 (-0.3;0.0) | 0.157 |
T2 | 3.8 (0.7) | 4.0 (0.4) | Baseline | Â | Â | |
T3 | 3.8 (0.5) | 3.9 (0.3) | Â | Â | Â | |
 Satisfaction with quality of information (1-6) | ||||||
  Severe adverse events | T2 | 4.8 (0.9) | 4.8 (1.0) | Group | 0.0 (-0.3;0.4) | 0.802 |
T3 | 4.5 (1.2) | 4.4 (1.1) | Time | Â | Â | |
  Tumour response | T2 | 4.5 (1.0) | 4.4 (1.2) | Group | 0.1 (-0.2;0.5) | 0.536 |
T3 | 4.3 (1.1) | 4.2 (1.1) | Â | Â | Â | |
  Survival | T2 | 4.0 (1.3) | 4.0 (1.3) | Group | 0.1 (-0.3;0.6) | 0.540 |
T3 | 4.0 (1.2) | 3.6 (1.4) | Â | Â | Â | |
 Knowledge | ||||||
  Subjective knowledge5 | T1 | 6.5 (1.2) | 6.6 (1.0) | Group | 0.5 (0.1; 0.9) | 0.022 |
T2 | 6.7 (1.2) | 6.3 (1.3) | Baseline | Â | Â | |
 Decision-related measures | ||||||
  Decision satisfaction-uncertainty (1-5 ) | T2 | 4.1 (0.6) | 4.0 (0.7) | Group | 0.1 (-0.1;0.3) | 0.155 |
T3 | 4.1 (0.6) | 3.9 (0.4) | Â | Â | Â | |
  Decision control (1-5) | T2 | 4.2 (0.7) | 4.3 (0.6) | Group | -0.1 (-0.3;0.2) | 0.617 |
T3 | 4.3 (0.6) | 4.3 (0.6) | Â | Â | Â | |
  Weighing pros and cons (1-5) | T2 | 4.2 (0.8) | 3.9 (1.0) | Group | 0.2 (-0.1;0.5) | 0.118 |
T3 | 4.0 (1.1) | 3.8 (0.8) | Â | Â | Â | |
 Treatment attitudes toward both options | ||||||
  Valuations: chemotherapy + BSC (1-10) | T2 | 7.5 (1.7) | 7.2 (1.6) | Group | 0.1 (-0.5;0.7) | 0.677 |
T3 | 7.1 (1.8) | 7.3 (1.7) | Â | Â | Â | |
  Valuations: BSC alone (1-10) | T2 | 3.7 (2.1) | 4.3 (2.1) | Group | -0.4 (-1.2;0.3) | 0.246 |
T3 | 4.1 (2.3) | 4.6 (2.4) | Â | Â | Â | |