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Table 4 Main swallow-related outcome measures and effect sizes (mean, standard deviation and 95% confidence intervals at baseline and final time-point included)

From: SIP SMART: a parallel group randomised feasibility trial of a tailored pre-treatment swallowing intervention package compared with usual care for patients with head and neck cancer

Outcome measure

Group

Baseline (T0) mean (±95% CI) SD

Between-group effect size (Cohen’s d)

6-months (T3) mean (±95% CI) SD

Between-group effect size (Cohen’s d)

FACT-H&N and MDADI: [n (baseline) intervention = 16 CAU = 15; n (T3) intervention = 12 CAU = 13]

 FACT-H&N total score

Intervention

104.38 (91.74–117.02) 23.71

0.14

89.98 (79.24–100.72) 16.9

0.83

Care as usual

101.28 (89.03–113.54) 22.13

76.9 (68.02–85.78) 14.69

 MDADI Composite

Intervention

83.49 (75.17–91.81) 15.62

0.36

69.74 (56.42–83.05) 20.95

0.61

Care as usual

77.82 (68.93–86.72) 16.06

59.35 (52.03–66.67) 12.11

Other measures: [n (baseline) intervention = 16 CAU = 16; n (T3) intervention = 13 CAU = 12]

 MIO - Jaw opening

Intervention

46.25 (39.44–53.06) 12.78

−0.15

43.00 (37.24–48.76) 9.53

0.68

Care as usual

47.81 (43.83–51.99) 9.84

34.33 (24.56–44.1) 15.38

 PSS HN Normalcy of diet

Intervention

70.00 (56.24–83.76) 25.82

−0.22

70.00 (52.21–87.79) 29.44

0.30

Care as usual

75.63 (62.43–88.82) 24.76

60.83 (41.21–80.46) 30.88

 FIGS Swallowing

Intervention

4.25 (3.84–4.66) .78

−0.35

4.15 (3.42–4.89) 1.21

0.53

Care as usual

4.50 (4.11–4.89) .73

3.50 (2.71–4.29) 1.24

MBS and PAS at T3: (intervention = 9 CAU = 10) – not performed for both groups at baseline

 PAS

Intervention

  

3.67 (1.24–6.1) 3.16

0.13

Care as usual

3.3 (1.36–5.24) 2.71

 MBS Imp (composite)

Intervention

  

6.44 (4.49–8.38) 2.53

0.24

Care as usual

5.96 (5.05–6.86) 1.27