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Table 6 Equivalence analysis between PROM and ePROM (N = 24)

From: Reliability of the electronic patient reported outcome measures for assessing xerostomia, dysphagia and quality of life in Spanish patients with head and neck cancer: a randomised crossover design

Outcome measures

PROM

ePROM

Equivalence test*

Mean (SD)

Mean (SD)

95% CI of mean difference

Left tail ap value

Right tail b

p value

Xerostomia

The XI

36.21 (9.05)

33.00 (8.20)

1.27; 5.15

0.0034

< 0.001

VAS

6.71 (2.66)

6.75 (2.45)

-0.53; 0.45

< 0.001

< 0.001

Upper lip (RODI)

2.21 (1.25)

2.21 (1.18)

-0.31; 0.31

< 0.001

< 0.001

Anterior palate (RODI)

2.33 (1.24)

2.29 (1.08)

-0.34; 0.43

< 0.001

< 0.001

Inside cheeks (RODI)

2.33 (1.20)

2.00 (0.98)

-0.01; 0.65

< 0.001

< 0.001

Posterior palate (RODI)

3.21 (1.28)

2.88 (1.26)

-0.05; 0.72

< 0.001

< 0.001

Lower lip (RODI)

2.75 (1.26)

2.42 (1.18)

-0.03; 0.70

< 0.001

< 0.001

Floor of the mouth (RODI)

2.42 (1.14)

2.38 (1.06)

-0.32; 0.40

< 0.001

< 0.001

Posterior tongue (RODI)

2.79 (1.41)

2.75 (1.26)

-0.36; 0.44

< 0.001

< 0.001

Anterior tongue (RODI)

2.92 (1.35)

2.54 (1.10)

-0.10; 0.85

0.0064

< 0.001

Pharynx (RODI)

3.08 (1.38)

2.83 (1.43)

-0.13; 0.63

< 0.001

< 0.001

Dry mouth (35)

61.11 (33.57)

29.72 (29.46)

-9.96; 12.74

0.007

0.002

Sticky saliva (35)

50.00 (35.44)

48.61 (35.41)

-8.33; 11.11

0.004

< 0.001

Dry mouth and sticky saliva (43)

59.72 (30.26)

56.95 (26.43)

-5.17; 10.73

0.036

0.002

Dysphagia

EAT-10

13.25 (9.50)

11.25 (7.93)

0.28; 3.72

0.120

< 0.001

Swallowing problems (35)

21.87 (17.69)

22.22 (16.97)

-5.04; 4.35

< 0.001

< 0.001

Swallowing (43)

20.83 (17.72)

19.79 (14.71)

-1.76; 3.85

< 0.001

< 0.001

Quality of life

Global health (30)

68.75 (18.07)

65.97 (20.98)

-1.70; 7.26

0.118

< 0.001

  1. Abbreviations: CI confidence interval, EAT-10 Eating Assessment Tool-10, ePROM electronic Patient Reported Outcome Measures, MCID Minimal Clinically Important Differences, MID Minimal Important Difference, SD standard deviation, PROM Patient Reported Outcome Measures, RODI Regional Oral Dryness Inventory, VAS Visual Analogue Scale for xerostomia, XI Xerostomia Inventory, 30 EORTC QLQ-C30, 35 EORTC QLQ-H&N35, 43 EORTC QLQ-H&N43
  2. aLeft tail significance indicates μPROM – μePROM > MCID or MID
  3. bRight tail significance indicated μPROM – μePROM < MCID or MID
  4. *Based on the equivalence test using the score MCID or MID as the tolerably difference