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Table 3 Changes in patient distress due to breathlessness (primary outcome), mastery, anxiety and depression, by trial arm, for patients with non-malignant conditions

From: The clinical and cost effectiveness of a Breathlessness Intervention Service for patients with advanced non-malignant disease and their informal carers: mixed findings of a mixed method randomised controlled trial

 

t1a

t2

t3

t4

t5

Difference in mean t3 adjusted for baseline (I minus C)

With 95 % confidence interval

p-value

 

Mean (SD)

Mean (SD)

Mean (SD)

Mean (SD)

Mean (SD)

Control arm (waiting list)

Baseline

Control

Completed control

Midway intervention

Completed intervention

   

Intervention arm (fast-track)

Baseline

Midway intervention

Completed intervention

Post-intervention

Post-intervention

   

Primary outcome: NRS distress due to breathlessness (0-10)b

Control arm (waiting list)

5.61 (3.23)

5.03 (2.84)

4.05 (2.57)

3.73 (2.85)

3.36 (2.63)

-0.24

(-1.30,0.82)

p = 0.65

Intervention arm (fast-track)

6.24 (2.53)

4.66 (2.85)

4.02 (2.49)

n/a

4.25 (2.92)

Key secondary outcomes:

CRQc mastery (1-7)

Control arm (waiting list)

4.13 (1.25)

4.03 (1.25)

4.24 (1.17)

4.42 (1.30)

4.74 (1.09)

0.43

(-0.02,0.89)

p = 0.06

Intervention arm (fast-track)

3.85 (1.33)

4.44 (1.29)

4.49 (1.35)

n/a

4.72 (1.11)

HADSb anxiety (0-21)

Control arm (waiting list)

8.32 (4.30)

9.05 (4.47)

8.61 (4.25)

8.00 (4.83)

7.56 (4.16)

-0.76

(-1.95,0.44)

p = 0.21

Intervention arm (fast-track)

7.80 (3.87)

7.77 (3.49)

7.45 (3.97)

n/a

7.57 (3.82)

HADSb depression (0-21)

Control arm (waiting list)

7.71 (3.81)

7.97 (4.11)

7.71 (3.83)

7.86 (4.67)

7.47 (4.16)

-0.61

(-1.76,0.54)

p = 0.29

Intervention arm (fast-track)

6.73 (3.32)

6.62 (3.65)

6.28 (3.97)

n/a

6.80 (4.21)

Number of respondents

77-79

75-80

77-79

35-37

69-72

   
  1. aFor those with a t3 score
  2. bHigh score is worse
  3. cHigh score is better