Table 3. Clinical meaningfulness of change by effect size in patient-reported outcomes from baseline to each timepoint (2 weeks titration, then 1-, 2-, and 3-months post-titration) and mean post-treatment follow-up in patients with any health condition prescribed medical cannabis.
| PROM | Mean scores at baseline and each follow-up timepoint | Mean post-treatment overall | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Titration | ES (95% CI) |
Baseline | 1- Month |
ES (95% CI) |
Baseline | 2- Month |
ES (95% CI) |
Baseline | 3- Month |
ES (95% CI) |
Baseline | Mean Follow-up |
ES (95% CI) |
P c | ||
|
HRQLa EQ-5D-5L Utility Score |
|||||||||||||||||
| N | 1608 | 1608 |
0.46 (0.39, 0.53) |
1925 | 1925 | 1672 | 1672 | 1653 | 1653 | 2325 | 2325 | ||||||
| Mean (SD) |
0.42 (0.29) |
0.55 (0.27) |
0.42 (0.29) |
0.55 (0.28) |
0.46 (0.39, 0.52) |
0.41 (0.30) |
0.58 (0.28) |
0.59 (0.52, 0.65) |
0.41 (0.29) |
0.58 (0.28) |
0.60 (0.53, 0.67) |
0.41 (0.29) |
0.57 (0.28) |
0.54 (0.47, 0.59) |
<0.001 | ||
| QLQ-C30 Summary Score | |||||||||||||||||
| N | 1574 | 1574 | 1900 | 1900 | 1648 | 1648 | 1629 | 1629 | 2297 | 2297 | |||||||
| Mean (SD) |
60.20 (16.41) | 69.74 (16.30) |
0.62 (0.55, 0.69) |
59.81 (16.46) |
70.26 (16.49) |
0.63 (0.57, 0.70) |
59.75 (16.88) | 71.02 (17.02) |
0.66 (0.59, 0.73) |
59.56 (16.75) |
71.16 (17.22) |
0.68 (0.61, 0.75) |
59.85 (16.63) |
70.54 (16.75) |
0.64 (0.58, 0.70) |
<0.001 | |
|
Pain
b QLQ-C30 (or QLQ-C15Pal) Pain subscale |
|||||||||||||||||
| N | 1598 | 1598 | 1921 | 1921 | 1667 | 1667 | 1645 | 1645 | 2326 | 2326 | |||||||
| Mean (SD) |
58.80 (31.71) |
47.26 (29.95) | 0.37 (0.30, 0.44) |
59.42 (31.11) |
45.75 (29.29) |
0.45 (0.39, 0.52) |
59.62 (31.20) | 44.70 (29.92) | 0.49 (0.42, 0.56) |
59.64 (31.10) |
43.99 (29.61) |
0.52 (0.45, 0.58) |
58.86 (31.34) |
45.42 (29.69) |
0.45 (0.38, 0.50) |
<0.001 | |
|
Sleep
b PROMIS Sleep Disturbance 8b T-scores |
|||||||||||||||||
| N | 1568 | 1568 | 1894 | 1894 | 1635 | 1635 | 1619 | 1619 | 2299 | 2299 | |||||||
| Mean (SD) |
51.27 (3.41) |
51.49 (3.39) |
-0.06 (-0.13, 0.01) |
51.30 (3.42) |
51.33 (3.53) |
-0.01 (-0.07, 0.06) |
51.29 (3.51) |
51.24 (3.56) |
0.01 (-0.05, 0.08) |
51.28 (3.48) |
51.32 (3.57) |
-0.01 (-0.08, 0.06) |
51.26 (3.49) |
51.37 (3.5) |
0.03 (-0.03, 0.09) |
0.29 | |
|
Fatigue
b PROMIS Fatigue 13a T-scores |
|||||||||||||||||
| N | 1568 | 1568 | 1895 | 1895 | 1635 | 1635 | 1619 | 1619 | 2299 | 2299 | |||||||
| Mean (SD) |
58.30 (8.17) |
54.50 (8.14) | 0.47 (0.39, 0.54) |
58.32 (8.07) |
54.25 (8.30) |
0.50 (0.43, 0.56) |
58.51 (8.09) |
53.97 (8.36) |
0.55 (0.48, 0.62) |
58.34 (8.09) |
53.92 (8.55) |
0.53 (0.46, 0.60) |
58.37 (8.11) |
54.16 (7.60) |
0.54 (0.48, 0.59) |
<0.001 | |
|
Depression
b DASS-21 Depression subscale |
|||||||||||||||||
| N | 1570 | 1570 | 1895 | 1895 | 1639 | 1639 | 1624 | 1624 | 2299 | 2299 | |||||||
| Mean (SD) |
15.10 (10.95) |
11.15 (10.06) |
0.38 (0.31, 0.45) |
15.09 (10.86) |
10.90 (9.79) |
0.41 (0.34, 0.47) |
14.96 (10.83) |
10.55 (9.83) |
0.43 (0.36, 0.50) |
14.97 (10.71) |
10.34 (9.81) |
0.45 (0.38, 0.52) |
15.20 (10.90) |
10.73 (9.87) |
0.44 (0.37, 0.49) |
<0.001 | |
|
Anxiety
b DASS-21 Anxiety subscale |
|||||||||||||||||
| N | 1570 | 1570 | 1895 | 1895 | 1639 | 1639 | 1624 | 1624 | 2299 | 2299 | |||||||
| Mean (SD) |
10.26 (8.67) |
7.33 (6.86) |
0.37 (0.30, 0.44) |
10.42 (8.69) |
7.28 (6.97) |
0.40 (0.33, 0.46) |
10.36 (8.76) |
6.94 (7.03) |
0.43 (0.36, 0.50) |
10.57 (8.74) |
7.10 (7.18) |
0.43 (0.36, 0.50) |
10.57 (8.75) |
7.17 (7.01) |
0.45 (0.37, 0.49) |
<0.001 | |
ES: Standardized mean-difference effect size (Cohen’s d), bold indicates clinically meaningful change determined by effect size (d≥0.5).
a Higher scores indicate better HRQL.
b Higher scores indicate worse symptoms.
c p-value for mean difference of baseline to mean post-treatment follow-up across all participants (2-tailed T-test).