Carnaby 2006i.
Methods | Computerised randomisation Blinded outcome assessments by SLT ITT (Control vs low‐intensity data set) Baseline prognostic factors balanced between treatment groups |
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Participants | 1 centre in Australia 306 participants; baseline characteristics similar Enrolment within 2 weeks of stroke onset: mean/median 2 days, range 0 to 12 days Clinical and videofluoroscopic evidence of dysphagia |
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Interventions | Rx 1: standardised high‐intensity swallowing therapy (n = 102) Rx 2: standardised low‐intensity swallowing therapy (n = 102); split into (n = 51) for each data set C: usual care (n = 102) Treatment for up to 1 month | |
Outcomes | Outcomes: time to return to normal diet; aspiration pneumonia; dysphagia (PHAD score < 85) | |
Notes | Trial completed and published 2006 Exclusions: previous swallowing therapy, head and neck surgery, inability to consent Follow‐up: 6 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Treatment allocation based on a computer‐generated random numbers list generated via the SPSS statistical package |
Allocation concealment (selection bias) | Low risk | Randomisation schedule held at the trial office, remote from the study environment; assignment to 1 of 3 treatment options by a telephone call to the trial office made by the study speech pathologist |
Blinding (performance bias and detection bias) All outcomes | High risk | All people involved in the study unaware of treatment allocation, apart from participants and the study speech pathologist who treated participants Assigned to high‐intensity and low‐intensity groups |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and speech pathologist aware of treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessed by an independent speech pathologist, who was unaware of treatment allocation, every month for 6 months after randomisation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 participants lost to follow‐up before 6‐month analysis |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | None identified |