Table 3 Evaluation of agreement between case report forms and patient reported data
Assessment | Follow-up (months) | No. (%) | Concordant pairs (%) | Agreement (95% CI) | Kappa (95% CI) | Gwet’s AC1 (95% CI) | Odds of agreement (95% CI) | ||
|---|---|---|---|---|---|---|---|---|---|
CRFa | Questionnaire | Positive | Negative | ||||||
Swelling groin or lower extremities | 3 | 46 (1) | 805 (24) | 2620/3385 (77) | 0.10 (0.07; 0.13) | 0.87 (0.86; 0.88) | 0.08 (0.06;0.10) | 0.71 (0.69; 0.73) | 48 (17.6;200.4) |
Complications and readmissionsb | 3 | 373 (10) | 1041 (29) | 2624/3556 (74) | 0.34 (0.31; 0.37) | 0.84 (0.83; 0.85) | 0.22 (0.19;0.25) | 0.62 (0.59; 0.64) | 5.4 (4.3;6.8) |
12 | 187 (6) | 479 (14) | 2884/3334 (87) | 0.32 (0.28; 0.37) | 0.93 (0.92; 0.93) | 0.27 (0.22;0.31) | 0.84 (0.82; 0.85) | 10.2 (7.5;14) | |
24 | 195 (10) | 245 (13) | 1554/1884 (82) | 0.25 (0.20; 0.30) | 0.90 (0.89; 0.91) | 0.15 (0.09;0.21) | 0.78 (0.75; 0.81) | 3.1 (2.2;4.4) | |
Reoperations | 12 | 115 (4) | 348 (11) | 2877/3150 (91) | 0.41 (0.35; 0.47) | 0.95 (0.95; 0.96) | 0.38 (0.32;0.43) | 0.90 (0.89; 0.91) | 52 (32;88) |
24 | 171 (8) | 264 (13) | 1877/2078 (90) | 0.54 (0.48; 0.60) | 0.95 (0.94; 0.95) | 0.49 (0.43;0.55) | 0.88 (0.86; 0.90) | 26 (18;38) | |
Additional (chemo) radiotherapy after surgery or due to local recurrence or metastases | 12 | 212 (7) | 260 (8) | 3084/3182 (97) | 0.79 (0.75; 0.83) | 0.98 (0.98; 0.99) | 0.78 (0.73;0.82) | 0.96 (0.96; 0.97) | 297 (187;489) |
24 | 207 (7) | 233 (8) | 2721/2863 (95) | 0.68 (0.63; 0.73) | 0.97 (0.97; 0.98) | 0.65 (0.60;0.70) | 0.94 (0.93; 0.95) | 79 (55;115) | |
Local recurrence and metastases | 12 | 159 (5) | 49 (2) | 2739/2897 (95) | 0.24 (0.16; 0.32) | 0.97 (0.97; 0.98) | 0.22 (0.14;0.30) | 0.94 (0.93; 0.95) | 21 (12;38) |
24 | 197 (7) | 44 (2) | 2643/2836 (93) | 0.20 (0.13; 0.27) | 0.96 (0.96; 0.97) | 0.18 (0.11;0.25) | 0.93 (0.92; 0.94) | 18 (10;34) | |