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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