Table 3.
Change to PROMIS domains over the observational period with medicinal cannabis treatment [23, 24, 25, 26]
| Measure (range) | First (n = 71) mean (SD) | Last (n = 71) mean (SD) | p value | Improved n (%) | Not changed n (%) | Worsened n (%) | MCID |
|---|---|---|---|---|---|---|---|
| PROMIS-29 domains | |||||||
| Pain intensity (0–10) | 6.3 (2.1) | 5.7 (2.3) | 0.053 | 24 (32.9) | 33 (45.2) | 16 (21.9) | 2.0 [23] |
| Domains as T-scores (population mean | 50, SD 10) | ||||||
| Pain interference | 64.7 (7.9) | 63.5 (8.4) | 0.16 | 27 (37) (34.1) | 26 (35.6) | 20 (27.4) | 2.0 [23] |
| Fatigue | 54.9 (10.6) | 55.5 (10.3) | 0.62 | 26 (35.6) | 25 (34.2) | 22 (30.1) | 2.5 [24] |
| Sleep disturbance | 53.6 (10.0) | 51.4 (9.5) | 0.13 | 36 (49.3) | 11 (15.1) 13 | 26 (35.6) | 2.0^ |
| Anxiety | 52.7 (8.6) | 53.2 (10.2) | 0.61 | 17 (23.3) | 37 (50.7) | 19 (26.0) | 2.3 [25] |
| Depression | 53.2 (8.8) | 52.8 (9.1) | 0.67 | 17 (23.3) | 37 (50.7) | 19 (26.0) | 3.0 [25] |
| Satisfaction with social role | 40.5 (9.5) | 40.4 (8.3) | 0.93 | 23 (31.5) | 34 (46.6) | 16 (21.9) | 2.0^ |
| Physical function | 35.8 (8.3) | 36.2 (7.7) | 0.58 | 26 (35.6) | 30 (41.1) | 17 (23.3) | 1.9 [23, 26] |
| Impact score (raw score, 8–50) | 33.5 (10.2) | 31.1 (10.0) | 0.034* | 35 (47.9) | 21 (28.8) | 17 (23.3) | 3.0 [23] |
| Impact shift | − | − | − | 17 (23.6) | 43 (58.3) | 13 (18.1) | − |
Bold values indicate the placement of the cohort majority. Impact shift is defined as change from mild impact (8–27) to moderate impact (28–34) to severe impact (>35) based on impact score cutoffs. A positive impact shift shows patients changed in a positive direction from a detrimental impact level to a lesser one (i.e., severe → moderate/moderate → mild). MCID, minimal clinically important difference.
^
MCID = 2.0 as default given there is no published MCID value in the literature to reference.
*
p < 0.05 compared to first (paired Student's t test).