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Table 4 Pressures at ROIs

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

42

307.92 (84.87)

263.56 (98.19)

↓

13.85 (20.24)

(7.55–20.16)

−3.395

0.001

6 M

25

276.53 (53.78)

240.96 (69.94)

↓

11.94 (24.11)

(1.98–21.89)

−2.704

0.007

Digital Supply Chain

0 M

42

308.88 (88.93)

244.08 (87.83)

↓

20.52 (15.79)

(15.54–25.50)¥

−5.208

0.000

6 M

32

298.95 (84.57)

271.75 (80.49)

↓

8.01 (18.69)

(1.27–14.75)

−2.431

0.015

Difference

 

T-D

M-W U

p

T-D

M-W U

p

 

T-D

t

p

95% CI

  

0 M

 

−0.96

880

0.986

19.48

1001

0.287

 

−6.67

1.675*

0.098

(−1.26 to 14.59)

  

6 M

 

−22.42

343

0.359

−30.79

297

0.098

 

3.93

0.693**

0.491

(−15.28 to 7.43)

  
  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
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Journal of Foot and Ankle Research

ISSN: 1757-1146