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. 2018 Oct 30;2018(10):CD000323. doi: 10.1002/14651858.CD000323.pub3

Carnaby 2006i.

Methods Computerised randomisation
Blinded outcome assessments by SLT
ITT
 (Control vs low‐intensity data set)
Baseline prognostic factors balanced between treatment groups
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
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