Key features for bias assessment of randomised trials Citation Method of Allocation Blinding Loss to Use of Ceasing study Reporting all Funding source randomisation concealment early for benefit outcome where results required Cappuccio Low risk Low risk (handled Participants: 2% (one No (unclear risk) No (low risk) Yes (low risk) International et al. generated by author not low risk participant) Foundation for – (1997) numbers handled involved in clinical low risk the Promotion Providers: low by author not assessment) of Nutrition risk involved in the Research and clinical Nutrition Outcome assessment) Education (low assessors: risk) unclear risk 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 Carney et II Adults (30 All participants Blood pressure 11 6 weeks Sodium tablets: Mean changes – (supine for 10 al. 65 years), were randomly 272 + 24 between low min, erect for (1991), with allocated to a mmol/24hr sodium diet to 5 min) Australia over cross-over arm: normal sodium Placebo tablets: study diet: Note change 170 + 24 treated in standing BP
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 Cappuccio et al. (1997) Low risk numbers handled by author not involved in the clinical assessment) Low risk (handled by author not involved in clinical assessment) Participants: low risk Providers: low risk Outcome assessors: unclear risk 2% (one participant) – low risk No (unclear risk) No (low risk) Yes (low risk) International Foundation for the Promotion of Nutrition Research and Nutrition Education (low risk) 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 Carney et al. (1991), Australia study II Adults (30 – 65 years), with treated All participants were randomly allocated to a cross-over arm: Blood pressure (supine for 10 min, erect for 5 min) Note change in standing BP 11 6 weeks Sodium tablets: 272 + 24 mmol/24hr Placebo tablets: 170 + 24 Mean changes between low sodium diet to normal sodium diet: generated over
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