Key features for bias assessment of randomised trials Citation Method of Allocation Blinding Loss to Use of Ceasing study Reporting all Funding randomisation concealment early for benefit outcome source where results required Watt et al. Unclear (methods Unclear Participants: Low risk (two Unclear No (Low risk) Yes (Low risk) British Heart (1983) of randomisation Low risk participants Foundation not described) lost one from Providers: Low each group) risk Outcome assessors: unclear Summary table Citation Study Population Intervention Outcomes Sample size Intervention Compliance to Results & design level measured duration sodium target location of relevant to (urinary data) research question Watt et Double II Adults aged All participants SBP, DBP 66 (statistical 4 weeks each Data presented Mean changes (measured al. blind, 22-23 years, were randomly analyses intervention based on the two between seated), MAP (1985), allocated to a were arm groups: placebo and and cross-over arm for conducted higher sodium Group 1 (low risk cross determined group (for low for HT): 128.4mmol from a
Key features for bias assessment of randomised trials Citation Method of randomisation Allocation concealment Blinding Loss to Use of where required Ceasing study early for benefit Reporting all outcome results Funding source Watt et al. (1983) Unclear (methods of randomisation not described) Unclear Participants: Low risk Providers: Low risk Outcome assessors: unclear Low risk (two participants lost one from each group) Unclear No (Low risk) Yes (Low risk) British Heart Foundation Summary table Citation & location Study design level of Population Intervention Outcomes measured relevant to research question Sample size Intervention duration Compliance to sodium target (urinary data) Results Watt et al. (1985), Double blind, cross II Adults aged 22-23 years, and determined from a All participants were randomly allocated to a cross-over arm for SBP, DBP (measured seated), MAP 66 (statistical analyses were conducted 4 weeks each intervention arm Data presented based on the two groups: Group 1 (low risk for HT): 128.4mmol Mean changes between placebo and higher sodium group (for low
Sodium%20Supporting%20Document%201%20%20Systematic%20Literature%20Review.docx