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. 2015 Oct 2;112(40):672–679. doi: 10.3238/arztebl.2015.0672

eTable 2. Findings of per-protocol and intention-to-treat analyses for secondary outcomes at time t1.

Control group Intervention group Significance Effect size
Breast cancer Colon cancer Total Breast cancer Colon cancer Total Group Cancer type Interaction Group
M (SD); n M (SD); n M (SD); n M (SD); n M (SD); n M (SD); n p p p d*5 (95% CI)
SDM-Q-9*1
Per-protocol
Intention-to-treat*2
80.3 (19.6); 48
75.8 (20.3); 141
72.5 (23.7); 28
69.3 (21.8); 77
77.4 (21.4); 76
73.5 (21.2); 219
72.7 (20.6); 18
73.8 (20.8); 112
79.4 (23.9); 24
70.9 (22.2); 87
76.5 (22.5); 42
72.0 (21.4); 194
0.378
0.759
0.167
0.182
0.138
0.497
–0.07
(−0.45 to 0.31)
CARE*
3Per-protocol
Intention-to-treat*2
44.8 (5.7); 51
44.3 (5.5); 142
42.8 (7.9); 28
43.7 (6.5); 83
44.1 (6.6); 79
44.1 (5.9); 222
41.9 (7.8); 18
43.3 (6.2); 117
45.7 (3.9); 24
44.6 (4.8); 86
44.0 (6.1); 42
43.9 (5.7); 204
0.253
0.545
0.304
0.692
0.079*6
0.345
–0.03
(−0.41 to 0.34)
HADS-Anxiety*4
Per-protocol
Intention-to-treat*2
8.9 (4.5); 48
9.2 (4.2); 143
6.4 (3.9); 27
6.7 (4.2); 73
8.0 (4.4); 75
8.4 (4.4); 218
6.9 (3.0); 18
7.9 (4.2);116
7.7 (4.1); 23
7.8 (4.1); 82
7.3 (3.7); 41
7.9 (4.2); 201
0.090*6
0.054*6
0.020*7
0.001*8
0.055*6
0.036*7
−0.12
(−0.50 to 0.27)
HADS-Depression*4
Per-protocol
Intention-to-treat*2
6.3 (4.2); 49
6.5 (4.3); 138
6.5 (3.9); 28
6.2 (4.1); 78
6.3 (4.1); 77
6.4 (4.3); 216
4.1 (2.8); 18
4.8 (4.1); 121
7.3 (5.0); 23
7.2 (4.4); 82
5.9 (4.4); 41
5.8 (4.3); 202
0.063*6
0.094*6
0.839
0.940
0.076*6
0.038*7
−0.14
(−0.52 to 0.24)
EORTC-QLQ-30 Quality of Life*1
Per-protocol
Intention-to-treat*2
59.8 (20.4); 46
58.2 (21.1); 139
50.9 (27.3); 28
55.2 (24.8); 75
56.4 (23.5); 74
56.8 (22.6); 210
56.0 (21.5); 18
55.5 (22.9); 118
41.0 (26.0); 24
44.3 (21.5); 81
47.7 (25.1); 42
50.7 (23.1); 204
0.571
0.619
0.128
0.733
0.513
0.303
−0.27
(−0.65 to 0.11)
OPTION*1
Per-protocol
Intention-to-treat*2
24.2 (9.9); 70
23.1 (9.6); 145
17.1 (5.4); 28
16.8 (8.3); 79
22.1 (9.4); 98
21.1 (9.7); 222
33.6 (11.7); 20
30.5 (11.3); 116
25.5 (9.9); 27
21.7 (10.2); 83
29.0 (11.3); 47
26.9 (11.6); 199
0.012*7
0.016*7
0.072*6
0.084*6
0.921
0.681
0.56
(0.21 to 0.91)

Full findings reported in eMethods.

M, mean; SD, standard deviation; n, sample size; CI, confidence interval; SDM-Q-9, Shared Decision Making Questionnaire; CARE, Consultation and Relational Empathy Scale; HADS, Hospital Anxiety and Depression Scale; EORTC-QLQ-30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; OPTION, Observing Patient Involvement Scale

*1Scores range from 0 to 100. 0 is low, 100 high.

*2Intention-to-treat analysis assuming the most likely scenario: missing values for the control group were estimated on the basis of available data from the control group; missing values for physicians in the intervention group who had undergone training were estimated on the basis of available data from the intervention group; missing values for physicians in the intervention group who had not undergone training were estimated on the basis of data from the control group.

*3Scores range from 0 to 50. 0 is low, 50 high.

*4Scores range from 0 to 21. 0 is low, 21 high for anxiety/depression.

*5Cohen’s d was estimated using means and standard deviations of the intention-to-treat analysis and sample size of the per-protocol analysis.

*6 p <0.10; *7 p <0.05; *8 p <0.01