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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