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Table 3 Baseline characteristics for different PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) patient populations

From: The impact of surgeon and patient treatment preferences in an orthopaedic trauma surgery trial

  Excluded patients Eligible patients   
A
Excluded based on exclusion criteria or other valid reason
B
Other sole reason for exclusion assessed to be lack of equipoise
C
Total
D
Non-consent
E
Consented and randomised
F
Total
p value for
B vs F1
p value for
D vs E2
Characteristic (N = 570) (N = 117) (N = 687) (N = 313) (N = 250) (N = 563)   
Gender
 Male, n (%) 160 (28%) 25 (21%) 185 (27%) 75 (24%) 58 (23%) 133 (24%) 0.5863 0.8003
 Female, n (%) 404 (72%) 92 (79%) 496 (73%) 236 (76%) 192 (77%) 428 (76%)   
 Missing, n 6 0 6 2 0 2   
Age (years)
N 531 113 644 298 250 548   
 Mean (SD) 70.6 (16.77) 69.9 (14.63) 70.5 (16.41) 68.5 (13.04) 66.0 (11.94) 67.4 (12.60) 0.0624 0.0224
 Median 74.1 72.0 73.6 70.6 66.9 69.1   
  < 65 years, n (%) 180 (34%) 32 (28%) 212 (33%) 109 (37%) 108 (43%) 217 (40%) 0.0243 0.1143
  ≥ 65 years, n (%) 351 (66%) 81 (72%) 432 (67%) 189 (63%) 142 (57%) 331 (60%)   
 Missing, n 39 4 43 15 0 15   
Fracture type
 One or both tuberosities involved, n (%) 342 (60%) 69 (59%) 411 (60%) 229 (73%) 193 (77%) 422 (75%) < 0.0013 0.2723
 Neither tuberosity involved, n (%) 228 (40%) 48 (41%) 276 (40%) 84 (27%) 57 (23%) 141 (25%)   
Affected shoulder
 Left, n (%) 273 (51%) 62 (54%) 335 (51%) 160 (53%) 125 (50%) 285 (52%) 0.6563 0.4863
 Right, n (%) 266 (49%) 53 (46%) 319 (49%) 142 (47%) 125 (50%) 267 (48%)   
 Missing, n 31 2 33 11 0 11   
Days since injury
N 570 117 687 313 250 563 0.8535 0.1115
 Mean (SD) 4.9 (4.93) 5.6 (5.41) 5.0 (5.01) 5.2 (4.72) 5.7 (4.89) 5.4 (4.80)   
 Median 3 3 3 4 4 4   
  1. 1Potential bias relating to surgeon preferences, 2Potential bias relating to patient preferences, 3Chi-squared test (df = 1), 4Independent t test, 5Wilcoxon rank-sum test. SD standard deviation