Vasant 2016.
Methods | Computerised randomisation Single‐blind trial; outcomes assessed by blinded therapist Analysis by ITT |
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Participants | 3 centres in UK 36 participants; 22 men All dysphagia identified by bedside screening swallow test and videofluoroscopy Baseline characteristics reported as similar 1 participant withdrawn and lost to follow‐up Baseline prognostic factors similar between groups |
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Interventions | Rx: pharyngeal electrical stimulation n = 18 C: sham n = 18 Duration: 3 days Follow‐up: 3 months |
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Outcomes | Death, swallow function, dysphagia | |
Notes | Exclusions: advanced dementia, other neurological conditions that may explain dysphagia, previous history of dysphagia, presence of cardiac pacemaker or implanted cardiac defibrillator, diagnosis other than stroke (e.g. brain tumour), significant structural abnormalities of the mouth or throat and requiring continuous oxygen treatment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation through a concealed computer programme |
Allocation concealment (selection bias) | Low risk | Concealed via a computerised programme |
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 | Participants and assessors blinded to group allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 participant lost to follow‐up (withdrawn), 2 participants (1 from each group) died before follow‐up at 3 months |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | None identified |