STEPS 2016.
Methods | Computerised randomisation Single‐blind; outcome assessor blinded Analysis by ITT Baseline characteristics balanced |
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Participants | International, multi‐centre trial 162 participants; 94 men Mean age 74.4 years Dysphagia identified clinically and by videofluoroscopy |
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Interventions | Rx: active pharyngeal electrical stimulation C: sham pharyngeal electrical stimulation Follow‐up: up to 12 weeks |
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Outcomes | Primary: change in PAS at 2 weeks from baseline Secondary: safety outcomes, clinical dysphagia (Dysphagia Severity Rating Scale, PAS at 12 weeks), dependency (mRS), activities of daily living/disability (BI), impairment (NIHSS), health‐related quality of life (European Quality of Life‐5 Dimensions (EQ‐5D), nutritional measures (weight, mid‐arm circumference, and blood albumin)) |
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Notes | Exclusions: history of dysphagia, dysphagia from a condition other than stroke, advanced dementia, implanted pacemaker or cardiac defibrillator in situ, unstable cardiopulmonary status or a condition that compromised cardiac or respiratory status, distorted oropharyngeal anatomy, additional diagnosis of progressive neurological disorder, receiving continuous oxygen treatment, pregnant or nursing mother | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by computer‐generated permuted blocks |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Researcher delivering the intervention not blinded |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Assessor and participant blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | 181 participants randomised; only 123 participants completed all 3 treatments |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | None identified |