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Table 4 Summary of humanistic burden evidence

From: Clinical, humanistic, and economic burden of chronic obstructive pulmonary disease (COPD) in Canada: a systematic review

References/study period

Patient group

N

Scale

Baseline score, mean (SD)

Endpoint score, mean (SD)

Change from baseline, mean (SD)

SF-36 score

 Appleton et al. [54]/November 1999–September 2001

Salmeterol

172

PH

36.5 (10.0) [N = 146]

37.1 (10.5) [N = 131]

0.3 (7.7) [N = 146]; mean difference vs placebo: 0.30; 95 % CI (−1.3, 1.9)

ME

49.3 (10.8) [N = 146]

50.0 (10.5) [N = 131]

1.1 (10.0) [N = 146]; mean difference vs placebo 0.03; 95 % CI (−1.9, 1.9)

Placebo

176

PH

36.1 (9.5) [N = 156]

36.8 (10.3) [N = 144]

0.1 (6.4) [N = 156]

ME

48.8 (11.0) [N = 156]

50.3 (10.6) [N = 144]

1.1 (9.1) [N = 156]

 HajGhanbari et al. [25]/study period not reported

COPD patients

47

PH

 

35.2 (1.7) p = 0.000; AMD vs control: 16.9

 

ME

 

42.0 (1.8) p = 0.000; AMD vs control: 12.8

 

Healthy controls

47

PH

 

52.0 (1.3)

 

ME

 

54.7 (1.30)

 

 Moullec et al. [22]/Apr 2004–May 2006

Usual care

50

PH

37 (10)

  

ME

47 (12)

  

Intervention

60

PH

35 (8) p = 0.33

  

ME

45 (12) p = 0.26

  

 Lacasse et al. [55]/12 weeks

Paroxetine

12

PH

18.6 (10.0)

  

MH

53.1(23.2)

  

Placebo

11

PH

19.0 (9.9); p = 0.9

  

MH

58.0 (16.8); p = 0.4

  

SGRQ scores

 Appleton et al. [54]/November 1999–September 2001

Salmeterol

172

T

46.2 (18.0) [N = 150]

41.6 (19.0) [N = 124]

−2.9 (11.1) [N = 150]

S

59.6 (18.4) [N = 150

55.4 (19.7) [N = 124]

−3.0 (15.8) [N = 150]

A

61.6 (21.9) [N = 150

53.3 (23.8) [N = 124]

−5.9 (15.4) [N = 150]

I

33.5 (20.7) [N = 150]

30.6 (20.0) [N = 124]

−1.2 (13.6) [N = 150]

Placebo

176

T

46.8 (16.6) [N = 157]

44.7 (18.6) [N = 139]

−1.3 (10.3) [N = 157]

S

56.7 (19.6) [N = 157]

57.3 (21.6) [N = 139]

1.4 (15.5) [N = 157]

A

62.7 (18.9) [N = 157]

59.7 (22.4) [N = 139]

−3.0 (15.0) [N = 157]

I

34.8 (18.9) [N = 157]

32.4 (20.3) [N = 139]

−1.2 (11.5) [N = 157]

 Aaron et al. [56]/October 2003–January 2006

Tiotropium + placebo

156

T

  

−4.5

S

   

A

   

I

   

Tiotropium + salmeterol

148

T

  

−6.3, p = 0.02

S

   

A

   

I

   

Tiotropium + fluticasone/salmeterol

145

T

  

−8.6, p = 0.01

S

   

A

   

I

   

 Chan et al. [20]/1 year

Tiotropium

608

T

 

40.9

 

S

 

44.4

 

A

   

I

 

28.5

 

Placebo

305

T

 

43.7, p < 0.01

 

S

 

49.3, p < 0.01

 

A

   

I

 

31.3, p < 0.01

 

 Low et al. [27]/study period not reported

Patient

67

T

 

 

S

 

57.68 (24.71) [N = 66]; mean difference vs spouse: 1.73; p = 0.497

 

A

 

70.42 (17.44) [N = 67]; mean difference vs spouse: −0.21; p = 0.771

 

I

 

41.05 (22.83) [N = 66]; mean difference vs spouse: 5.6; p = 0.002

 

Spouse

67

T

 

 

S

 

59.41 (23.05) [N = 65]

 

A

 

70.21 (18.72) [N = 66]

 

I

 

47.29 (23.12) [N = 65]

 

 Moullec et al. [22]/Apr 2004–May 2006

Usual care

50

T

49 (18)

  

S

55 (16)

  

A

66 (23)

  

I

38 (20)

  

Intervention

60

T

48 (16), p = 0.72

  

S

54 (18), p = 0.74

  

A

65 (20), p = 0.85

  

I

37 (19), p = 0.72

  

Chronic Respiratory Questionnaire Scores (CRQ)

 Lacasse et al. [55]/12 weeks

Paroxetine

12

TG

   

D

3.4 (0.9), p = 1.0

  

E

3.5 (0.9), p = 0.8

  

M

4.3 (1.0), p = 0.2

  

F

3.6 (0.8), p = 0.3

  

Placebo

11

TG

  

D

3.4 (0.6)

  

E

3.7 (1.0)

  

M

4.9 (0.9)

  

F

3.2 (1.1)

  

 Bourbeau et al. [57] 6 months

Budesonide

39

TG

  

D

19.9 (6.2)

 

−1.8 (−3.9 to 0.2)

E

37.9 (6.9)

 

−1.9 (−5.3 to 1.4)

M

21.4 (4.2)

 

−0.5 (−2.4 to 1.4)

F

20.7 (3.6)

 

−3.0 (−4.9 to −1.2)

Placebo

40

TG

 

D

19.5 (5.8)

 

−0.5 (−2.3 to −1.3)

E

36.2 (9.6)

 

−0.6 (−3.4 to 2.2)

M

21.7 (5.8)

 

−1.3 (−3.0 to 0.5)

F

19.3 (5.6)

 

−1.4 (−3.1 to 0.3)

 Leigh et al. [24]/4-week treatment period

Overall population

40

TG

17.5 (3.6)

Post-PB: 18.1 (3.5)

Post-BDN: 19.4 (3.4)

Post-PDN: 21.0 (3.4)

 

D

3.7 (1.0)

Post-PB: 3.9 (0.9)

Post-BDN: 4.4 (1.1)

Post-PDN: 4.6 (1.3)

 

E

   

M

   

F

   

Physical activity

 Vozoris et al. [23]/1994–2007

Obese COPD patients

858

Inactivitya; restricted activitya

Inactive: 68 % patients

Activity restriction: 72 % patients

  

Non-obese COPD patients

2611

Inactivitya; restricted activitya

Inactive: 60 % patients

Activity restriction: 60 % patients

  

 Rocker et al. [26]. Study period not reported

Severe, stable COPD patients

8

Palliative performance scale

Scores ranged from 50 to 70 %

  
  1. A activity score, AMD absolute mean difference, BDN budesonide, D dyspnea, E emotional function, F fatigue, M mastery, ME Mental Health summary score, PB placebo, PDN prednisone, PH Physical Health summary score, S symptoms score, T total score, TG total (Global) score, I impact score
  2. aCanadian Fitness and Lifestyle Research Institute defined Inactivity as total daily energy expenditure value of < 1.5 kcal/kg/day; restricted activity: sometimes or often had difficulty with simple activities such as walking, climbing stairs, and bending