Background
Methods
Search strategy and selection criteria
Quality assessment, risk of bias and data analyses
Results
Description of studies
Study characteristics | Patient characteristics | Intervention characteristics | ||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Countrya
| Follow-up (months) | Study designb
| Sample size at baselinec
| No of patients who completed studyc
| Mean age | Sex (% male) | FEV1% predicted | % with a history of ≥ 1 exacerbation in year prior to study | Smoking status (% smokers) | Interventions categories according to CCM components* | Professions involved in delivering of the DM program** | |||||||||||||||||||
I | C | I | C | I | C | I | C | I | C | I | C | I | C | SMS | DEC | DSD | CIS | Total | RS | RN | GP | PHY | DIE | PHA | SW | Total | ||||
[36] | NL | 12 | Pre-post | 317 | NA | 222 | NA | 61 | NA | 56 | NA | 56 | NA | NS | NS | 40 | NA | ✓ | ✓ | ✓ | ✓ |
4
| ✓ | ✓ | ✓ |
3
| ||||
[31] | NL | 24 | RCT | 102 | 97 | 77 | 81 | 66 | 67 | 71 | 71 | 49 | 51 | 1.2 | 1.0 | 33 | 24 | ✓ | ✓ | ✓ |
3
| ✓ | ✓ | ✓ | ✓ |
4
| ||||
[37] | FR | 12 | RCT | 23 | 22 | 20 | 18 | 65 | 61 | 90 | 78 | 56 | 54 | NS | NS | 25 | 28 | ✓ |
1
| NS | NS | NS | NS | NS | NS | NS |
NS
| |||
[39] | USA | 12 | Case-control | 94 | 47 | NA | NA | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | ✓ | ✓ | ✓ |
3
| ✓ | ✓ | ✓ |
3
| |||||
[28] | NOR | 12 | RCT | 31 | 31 | 26 | 27 | 57 | 58 | 48 | 52 | 52 | 55 | NS | NS | 39 | 39 | ✓ | ✓ |
2
| ✓ | ✓ | ✓ | ✓ | ✓ |
5
| ||||
[38] | CAN | 12 | RCT | 96 | 95 | 86 | 79 | 70 | 69 | 52 | 59 | 45 | 46 | NS | NS | 25 | 26 | ✓ | ✓ | ✓ |
3
| ✓ | ✓ | ✓ |
3
| |||||
[29] | NL | 12 | RCT | 127 | 121 | 122 | 114 | 65 | 65 | 85 | 84 | 56 | 58 | 1.4 | 1.3 | 28 | 26 | ✓ |
1
| ✓ | ✓ |
2
| ||||||||
[30] | UK | 24 | RCT | 61 | 61 | 55 | 49 | 70 | 70 | 49 | 49 | 43 | 49 | 100e
| 100 | 30 | 20 | ✓ | ✓ |
2
| ✓ | ✓ |
2
| |||||||
[34] | USA | 12 | RCT | 372 | 371 | 336 | 323 | 69 | 71 | 98 | 98 | 36 | 38 | 100 | 100 | 22 | 23 | ✓ | ✓ | ✓ |
3
| ✓ | ✓ | ✓ |
3
| |||||
[32] | NZ | 12 | Case-control | 16 | 16 | NA | NA | 70 | 75 | 63 | 56 | 26 | NSd
| 100 | 100 | 13 | 19 | ✓ | ✓ |
2
| ✓ | ✓ | ✓ | ✓ |
4
| |||||
[33] | USA | 12 | Pre-post | 524 | NA | 349 | NA | 64 | NA | 51 | NA | NS | NA | NS | NA | NS | NA | ✓ | ✓ | ✓ |
3
| ✓ | ✓ | ✓ |
3
| |||||
Total (%) | 100 | 64 | 73 | 9 | 90 | 90 | 70 | 40 | 10 | 10 | 10 |
The quality of studies and risk of bias
Characteristic | Type | [36] | [31] | [37] | [39] | [28] | [38] | [29] | [30] | [34] | [32] | [33] | % |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Study population | 1. Clear description of in- and exclusion | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | - | 91 |
2. Clear description of drop-outs | - | ✓ | ✓ | - | ✓ | ✓ | ✓ | ✓ | ✓ | - | - | 64 | |
3. The study population consist of an intervention and control group | - | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | - | 82 | |
4. Relevant baseline characteristics are comparable | NA | ✓ | ✓ | - | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | NA | 89 | |
Intervention | 5. Random allocation | NA | ✓ | ✓ | - | ✓ | ✓ | ✓ | ✓ | ✓ | - | NA | 78 |
6. Clear description of type of intervention | ✓ | ✓ | - | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 91 | |
7. Clear description of the comparator | - | ✓ | ✓ | - | - | ✓ | - | - | - | - | - | 27 | |
8. Detailed characteristics of institution(s)/region in which the intervention is implemented are described | ✓ | - | ✓ | - | - | - | - | - | - | - | - | 18 | |
9. Co-interventions are avoided | ✓ | - | - | - | - | - | - | - | - | - | - | 9 | |
Measurement of all relevant cost categories | 10. Inclusion of development /implementation /operating costs | - | - | - | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | - | 64 |
11. Inclusion of healthcare utilization costs | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | |
12. Inclusion of direct non-medical and non-direct costs | - | ✓ | - | - | ✓ | - | ✓ | - | - | - | - | 27 | |
13. Justification for omitting costs categories | - | - | - | - | NA | ✓ | NA | - | - | - | - | 11 | |
Measurement of all relevant outcome categories | 14. Healthcare delivery process | ✓ | - | - | - | ✓ | - | - | - | - | - | - | 18 |
15. Patient behaviour | ✓ | ✓ | ✓ | - | - | - | ✓ | - | - | - | - | 36 | |
16. Biomedical and physiological health outcomes | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | |
17. Health related quality of life and/or mortality and/or (quality) adjusted life years | ✓ | ✓ | ✓ | - | - | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 82 | |
18. Justification of omitting outcome categories | NA | - | ✓ | - | - | - | - | - | - | - | - | 10 | |
Measurement and valuation of data | 19. Perspective explicitly mentioned | ✓ | ✓ | - | - | ✓ | ✓ | ✓ | - | ✓ | - | - | 55 |
20. The sources of resource utilization are described and justified | ✓ | ✓ | ✓ | - | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 91 | |
21. The resource use and costs are reported separately | - | ✓ | - | ✓ | ✓ | ✓ | - | ✓ | ✓ | ✓ | ✓ | 73 | |
22.The effects are measured in appropriate units | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | |
23. Data analysis is performed according intention-to-treat principle | ✓ | ✓ | - | - | - | ✓ | ✓ | - | ✓ | - | - | 45 | |
Presentation of data | 24. Allowance made for uncertainty in the estimates of the costs | ✓ | ✓ | ✓ | - | ✓ | - | ✓ | - | ✓ | - | - | 55 |
25. Allowance made for uncertainty in the estimates of the effects | ✓ | ✓ | ✓ | ✓ | ✓ | - | ✓ | - | ✓ | - | - | 64 | |
26. Incremental analysis of costs and effects are performed | - | ✓ | - | - | - | - | ✓ | - | - | - | - | 36 | |
Discussion of the study results | 27. The results are interpreted adequate | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 |
28. The results are compared with other studies and allowances are made for potential differences in study methodology | ✓ | ✓ | ✓ | - | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | - | 82 | |
29. The study discusses the generalizability of the results to other settings and patient groups | ✓ | ✓ | - | ✓ | - | ✓ | ✓ | - | ✓ | - | - | 55 | |
30. The study discusses issues of implementation of the intervention | ✓ | ✓ | - | ✓ | - | ✓ | - | - | - | - | - | 36 | |
Total quality of study (%)
| 70 | 80 | 60 | 40 | 66 | 70 | 76 | 50 | 67 | 43 | 29 |
Results on costs
Development, implementation, operating | Healthcare utilization | Informal care | Direct-non medical costs | Productivity loss | Total | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Medication | Physician visits | Specialist visits | Other outpatient | ED visits | Hospitalization | Total healthcare utilization | ||||||
[36] | -47 |
-47
| ||||||||||
[31] | 6681
| -12 | -42 | 20381
| -424 | 22291
| -65 | 693 |
2856
| |||
[37] | -507* | 1150 | 652 |
652
| ||||||||
[39] | 2007 | 79 | -20982
| -2019* |
-13
| |||||||
[28] | 200 | -182 | -145* | -13 | -708 | -999 | 47* | -944 |
-1689
| |||
[38]# | 2976 | -22 | -2 | -158 | -2448 | -2630 |
347
| |||||
[29]# | 728 | 42 | -6 | -92 | -56 | 280 |
950
| |||||
[30]# | 94 | -79 | -79 |
15
| ||||||||
[34]# | 545 | 13 | -118 | -936* | -1042 |
-497
| ||||||
[32]# | 1850 | -2004 | -2004 |
-154
| ||||||||
[33]# | 712 | -357 | -1804 | -2160 |
-1448
|
Characteristics | Subgroup* | Healthcare utilization costs | Hospitalization costs | |||
---|---|---|---|---|---|---|
Study (N) | Mean difference (min-max) | Study (N) | Mean difference (min-max) | |||
Intervention
| CCM | 1-2 | 3 | -428 (-1875 to 1018) | 3 | -311 (-1667 to 1045) |
3+ | 5 | -1047 (-2230 to 137) | 3 |
-1378 (-2609 to -164)
| ||
Number of involved healthcare provider disciplines | 2-3 | 4 |
-1328 (-2554 to -101) | 2 |
-1674 (-3155 to -192)
| |
4+ | 3 | -282 (-2510 to 1945) | 3 | -610 (-1770 to 550) | ||
Intervention duration (months) | 0-12 | 2 | -345 (-1986 to 1296) | 2 | -156 (-1820 to 1508) | |
12+ | 6 | -1066 (-2232 to 99) | 4 |
-1406 (-2566 to -246)
| ||
Study
| Design | RCT | 5 |
-866 (-1550 to -183)
| ||
Non-RCT | 3 | -1074 (-2945 to 797) | ||||
Region | EU | 4 | -168 (-1043 to 706) | 3 | -323 (-1405 to 758) | |
Non-EU | 4 |
-1731 (-2507 to -955)
| 3 |
-1681 (-3070 to -293)
| ||
Quality of study | 0-60 | 3 | -872 (-3253 to 1509) | 2 | 806 (-1843 to 3456) | |
60+ | 5 |
-816 (-1543 to -89)
| 4 |
-1266 (-2283 to -250)
| ||
Patient
| Age | 0-65 | 3 | -307 (-1195 to 581) | 2 | -156 (-1820 to 1508) |
65+ | 4 | -1128 (-2694 to 437) | 4 |
-1406 (-2566 to -246)
| ||
% male | 0-60 | 4 |
-929 (-1829 to -29)
| 3 |
-1790 (-3180 to -401)
| |
60+ | 3 | 98 (-1568 to 1764) | 3 |
-738 (-1437 to -39)
| ||
GOLD | 2 | 4 | -168 (-1043 to 706) | 3 | -323 (-1405 to 758) | |
3+ | 3 |
-1558 (-2740 to -375)
| 3 |
-1681 (-3070 to -293)
| ||
Exacerbation | Yes | 2 |
-1047 (-1633 to -462)
| 2 |
-941 (-1474 to -407)
| |
No** | 6 |
-850 (-1626 to -74)
| 4 | -920 (-2441 to 601)
|
Results on effects
Biomedical, physiological health outcomes and exacerbations | Health related quality of life | Relative Risk of mortality | |
---|---|---|---|
[36] | RD | RD | |
• Fev1% predicted= -0.02 | • SGRQ= -0.03 | ||
• Fev1 reversibility= -0.27 | • VAS= 0.03* | ||
• Tiffeneau index= 0.02 | |||
[31] | RR | SMD | • 1.01(0.30-3.37) |
• Hospitalization= 0.78 (0.69-0.89) | • SGRQ=-0.15* | ||
• VAS= 1.01 | |||
• Exacerbations= 1.39 (1.10-1.74) | • EQ-5D= 0.17 | ||
SMD | |||
• MRC= 0.58* | |||
• 6MWD= 0.30 | |||
• Endurance time=0.37* | |||
• Handgrip force= 0.24 | |||
• PI max= 0.29 | |||
• BMI= -1.22 | |||
• Fev1% predicted= -0.13 | |||
[37] | SMD | SMD | |
• 6MWD= 0.99* | • SGRQ= 0.01 | ||
• Peak work rate=-0.88 | • VAS=-0.07 | ||
• Peak Vo2= -0.06 | |||
• Energy= -0.30* | |||
• Pain= 0.20 | |||
• Emotional reaction= -0.90* | |||
• Sleep= 3.62 | |||
• Isolation= -0.40 | |||
• Physical mobility=0.18 | |||
• Voorrips total= 1.27* | |||
[39] | RR | ||
• Hospitalization= 0.35 (0.29-0.43) | |||
• ED visits= 0.39 (0.33-0.45) | |||
[28] | RR | ||
• Days in hosp= 0.28 (0.24-0.32) | |||
• Absenteeism from work= 0.05 (0.03-0.09) | |||
[38]# | RR | SMD | • 0.55 (0.19-1.58) |
• Hospitalization= 0.54(0.48- | • SGRQ= -0.29* | ||
• 0.61)* | |||
• Hospitalization 1 or more= 0.64(0.45-.91)* | |||
• ED visits=0.64 (0.53-0.78)* | |||
• ED visit 1 or more= 0.64(0.48-0.86)* | |||
SMD | |||
• Fev1=0.00 | |||
• FVC=0.00 | |||
[29]# | SMD | SMD | • 0.95 (0.20-4.63) |
• 6MWD= -0.09 | • SGRQ= -0.03 | ||
[30]# | RR | • 0.50 (0.20-1.25) | |
• Hospitalization= 1.20 (1.04-1.38) | due to COPD=0.13 (0.02-0.97)* | ||
• Hospitalization 1 or more= 1.08 (0.74-1.57) | |||
• Exacerbation 1 or more= 1.00 (0.87-1.15) | |||
[34]# | RR | • 0.75 (0.50-1.13) | |
• Hospitalization= 0.72 (0.65-0.79)* | |||
• ED visits=0.73 (0.68-0.79)* | |||
[32]# | RR | • 0.33 (0.04-2.87) | |
• Hospitalization= 1.72 (1.02-2.90) | |||
• Hospitalization 1 or more = 1.08 (0.75-1.57) | |||
[33]# | RD | RD | |
• Hospitalization=-0.53 | • SGRQ=-0.04 | ||
• ED visits=-0.66 | |||
• ICU admission=-0.57 | |||
• Absenteeism from work= -0.77 |