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

STEPS 2016.

Methods Computerised randomisation
Single‐blind; outcome assessor blinded
Analysis by ITT
Baseline characteristics balanced
Participants International, multi‐centre trial
162 participants; 94 men
Mean age 74.4 years
Dysphagia identified clinically and by videofluoroscopy
Interventions Rx: active pharyngeal electrical stimulation
C: sham pharyngeal electrical stimulation
Follow‐up: up to 12 weeks
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))
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