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Table 3 Evaluation of agreement between case report forms and patient reported data

From: Agreement between patient reported outcomes and clinical reports after radical prostatectomy - a prospective longitudinal study

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)
  1. a Case Report Form
  2. b Reasons: Pain in surgical wound, lower or upper part of abdomen, bleeding from surgical would, urinary tract or catheter