Table 3.
Comparison of outcomes at 2 weeks and discharge from hospital in 73 patients across three trials by treatment assignment (pharyngeal electrical stimulation versus sham/placebo). Data are number (%), median [interquartile range], or mean (standard deviation). Comparison by binary logistic regression (BLR), ordinal logistic regression (OLR), or multiple regression (MR), with 95% confidence intervals. Adjustment: full model is adjusted for trial, relevant baseline score, age, and impairment (NIHSS); partial model is adjusted for trial only.
| Trials/patients | PES | Sham | Difference/odds ratio (95% CI) | 2p | Difference/odds ratio (95% CI) | 2p | |
|---|---|---|---|---|---|---|---|
| Statistical model | 37 | 36 | Adjusted, full | Adjustment, trial | |||
| 2 weeks | |||||||
| PAS (/8) | 3/55 | 3.4 (1.7) | 4.1 (1.7) | −0.9 (−1.7, −0.1) | 0.020 | −0.7 (−1.6, 0.2) | 0.13 |
| Mean of first three | 3/55 | 3.2 (1.7) | 3.9 (1.9) | −0.9 (−1.7, 0.0) | 0.044 | −0.6 (−1.5, 0.3) | 0.19 |
| Cumulative (/48) | 3/54 | 19.3 (9.6) | 24.4 (10.4) | −6.0 (−10.7, −1.4) | 0.011 | −4.7 (−9.8, 0.5) | 0.078 |
| Number of boli >3 | 3/55 | 2.2 (2.1) | 3.3 (2.0) | −1.4 (−2.2, −0.6) | <0.001 | −1.0 (−2.1, 0.0) | 0.055 |
| Any bolus >3 (%) | 3/55 | 22 (75.9) | 24 (92.3) | 0.05 (0, 0.96) | 0.047 | 0.26 (0.05, 1.49) | 0.13 |
| Worst [/8] | 3/55 | 5 [2] | 6 [3] | 0.37 (0.11, 1.18) | 0.092 | 0.7 (0.27, 1.81) | 0.46 |
| DSRS (/12) | 2/63 | 3.5 (3.8) | 4.9 (4.4) | −1.7 (−3.2, −0.1) | 0.040 | −1.3 (−3.3, 0.7) | 0.19 |
| Score >3 (%) | 2/63 | 10 (30.3) | 16 (53.33) | 0.25 (0.07, 0.89) | 0.032 | 0.39 (0.14, 1.10) | 0.075 |
| Score >7 (%) | 2/63 | 6 (18.2) | 7 (23.3) | 0.54 (0.12, 2.36) | 0.41 | 0.79 (0.23, 2.78) | 0.71 |
| NIHSS (/42) | 2/44 | 7.9 (5.6) | 9.1 (8.5) | 0.4 (−2.5, 3.4) | 0.77 | −1.1 (−5.2, 3.1) | 0.62 |
| Died (%) | 1/35 | 0 (0) | 1 (5.6) | — | — | — | — |
| RTI (%) | 2/63 | 4 (12.1) | 4 (13.3) | — | — | 0.83 (0.18, 3.74) | 0.81 |
| Discharge | |||||||
| Hospital stay (days) | 3/73 | 50.2 (25.3) | 71.2 (60.4) | −16.2 (−36.2, 3.7) | 0.11 | −18.5 (−39.0, 1.9) | 0.075 |
| Died, in hospital (%) | 1/35 | 0 (0) | 1 (5.6) | — | — | — | — |
| Died, end of trial (%) | 1/35 | 1 (5.9) | 1 (5.6) | 1.2 (0.1, 25.8) | 0.91 | 1.1 (0.1, 18.5) | 0.97 |
Scores for death: DSRS = 13, NIHSS = 43, and PAS = 9.
DSRS: dysphagia severity rating scale; NIHSS: National Institutes of Health Stroke Scale; PAS: penetration aspiration score; RTI: respiratory tract infection (chest infection or pneumonia).