Primary and Secondary Outcome Measures at 3 and 6 Months
| Outcome | 3 Months | 6 Months | ||||||
|---|---|---|---|---|---|---|---|---|
| Intervention, Median (IQR) | Usual Care, Median (IQR) | Univariate Difference, Median (95% CI)a | Multivariate Difference, Median (95% CI)b | Intervention, Median (IQR) | Usual Care, Median (IQR) | Univariate Difference, Median (95% CI)a | Multivariate Difference, Median (95% CI)b | |
| Primary outcome | ||||||||
| VSS-SF total score | 6 (3–12) | 9 (5–15) | 2.52 (1.17 to 3.87; P <.001) | 2.75 (1.39 to 4.12; P <.001) | 6 (3–14) | 7 (4–17) | 2.38 (0.31 to 4.46; P = .03) | 2.26 (0.39 to 4.12; P = .02) |
| Secondary outcomes | ||||||||
| VSS-SF vertigo subscale score | 3 (1–7) | 4 (2–9) | 1.42 (0.50 to 2.33; P = .003) | 1.49 (0.54 to 2.43; P = .002) | 4 (1–6) | 4 (2–11) | 1.00 (−0.25 to 2.25; P = .12) | 0.93 (−0.24 to 2.10; P =.12) |
| VSS-SF autonomic symptoms subscale score | 3 (0–6) | 4 (2–6) | 1.19 (0.37 to 2.01; P = .005) | 1.03 (0.12 to 1.94; P = .03) | 3 (1–6) | 4 (1–7) | 1.38 (0.62 to 2.14; P <.001) | 1.33 (0.63 to 2.03; P <.001) |
| DHI score | 24 (12.5–38) | 28 (16–52) | 5.33 (1.41 to 9.26; P = .008) | 6.15 (2.81 to 9.49; P <.001) | 22 (8–40) | 26 (12–46) | 5.58 (1.19 to 10.0; P =.01) | 5.58 (1.19 to 10.0; P =.01) |
| HADS anxiety score | 6 (3–9) | 6 (3–9) | 0.88 (0.02 to 1.75; P = .046) | 0.82 (0.03 to 1.61; P = .04) | 6 (3–9) | 6 (3–9) | 0.17 (−0.83 to 1.16; P = .74) | 0.10 (−0.97 to 1.16; P =. 86) |
| HADS depression score | 3 (1–5) | 4 (1–7) | 0.55 (−0.06 to 1.15; P = .08) | 0.55 (−0.18 to 1.28; P = .18) | 2 (1–6) | 4 (1–6) | 0.29 (−0.23 to 0.80; P = .27) | 0.24 (−0.25 to 0.73; P =.33) |
| Patient-reported improvement, No. (%) | 76/122 (62.3) | 42/128 (32.8) | 0.28 (0.18 to 0.45; P <.001) | 0.27 (0.17 to 0.44; P <.001) | 70/109 (64.2) | 50/122 (41.0) | 0.38 (0.25 to 0.59; P <.001) | 0.41 (0.26 to 0.65; P <.001) |
DHI = Dizziness Handicap Inventory; IQR = interquartile range; VSS-SF = Vertigo Symptoms Scale–Short Form; HADS = Hospital Anxiety and Depression Scale.
↵a Difference between groups controlling for baseline value and clustering.
↵b Difference between groups controlling for baseline value, clustering, and other significant covariates.