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Table 5 Site of Highest Pressure

From: A randomised controlled trial and cost-consequence analysis of traditional and digital foot orthoses supply chains in a National Health Service setting: application to feet at risk of diabetic plantar ulceration

 

n

Control

Orthotic

 

Orthotic Effect

Mean (SD)

Mean (SD)

Mean (SD)

95% CI

Wilcoxon Rank

(kPa)

(kPa)

(%)

(LB - UB)

Z

p

Traditional Supply Chain

0 M

26

309.67 (101.33)

261.52 (110.67)

↓

14.91 (20.56)

(5.89–22.87)

−2.679

0.007

6 M

22

251.12 (64.98)

209.84 (63.83)

↓

16.71 (17.25)

(9.06–24.35)

−3.652

0.000

Digital Supply Chain

0 M

26

318.95 (109.78)

240.03 (113.36)

↓

24.43 (20.18)

(16.27–32.58)¥

−4.026

0.000

6 M

19

321.32 (90.33)

279.74 (90.05)

↓

12.41 (20.23)

(2.65–22.16)

−2.334

0.020

Difference

T-D

M-W U

p

T-D

M-W U

p

 

T-D

t

p

95% CI

  

0 M

 

−9.28

355

0.756

21.49

279

0.280

 

−9.520

−1.695**

0.096

(−20.80 to 1.76)

 

6 M

 

−70.20

316

0.005

−69.90

312

0.007

 

4.300

0.726**

0.473

(−7.72 to 16.31)

 
  1. LB Lower Bound, ↑: Increase in pressure for custom orthotics compared to flat control, ↓: Decrease in pressure for custom orthotics compared to flat control. Statistical significant difference between control and orthotic was assessed via related samples Wilcoxon Rank test ǂ: p < 0.05, ф: p < 0.01. T-D: Mean for Traditional group minus Mean for Digital Group. Non-Inferiority was assessed against a predefined margin of 11.29%. ¥:Lower bound of the 95% Confidence interval for the intervention effect was greater than the NI margin