de Brito‐Ashurst 2013.
Study characteristics | ||
Methods |
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Participants |
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Interventions | Low salt group
High salt group
Co‐interventions
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Outcomes |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation to treatment was conducted by the study statistician using computer‐generated random blocks with block sizes between four and eight" |
Allocation concealment (selection bias) | Unclear risk | Quote: "Group assignment given to the researcher" Further information not provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unblinded; objective outcomes unlikely to be affected by performance bias; dietary behaviour may have differed due to lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes were objective and not immediately available, analysis was performed blinded. Quote: “Neither participants nor the dietitian administering the intervention could be blinded to treatment allocation. Data analysis was conducted by the study statistician who was blinded to treatment allocation.” Blinding of participants: no, blinding of investigators: no; blinding of outcomes assessors: no, blinding of data assessors: yes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for attrition unlikely to be related to allocation. 56 participants enrolled; 8 withdrew (14% attrition); unwilling to complete: 24‐hour urine collection (3), BP monitoring (2), attend dietary education (1) lost to follow‐up: death (1); emigration (1) Attrition by allocation: low salt group (3); high salt group (5) |
Selective reporting (reporting bias) | Low risk | No evidence of outcomes missing from report |
Bias from confounders | Unclear risk | Intervention is described as salt restriction Quote: "in addition to standard hypertension medication management" but unclear whether changes to medication occurred (or were measured) during follow up. Major confounders (potassium intake, body weight change, physical activity) measured and reported as 'unchanged'. Baseline imbalances: Change from baseline reported |
Other | Low risk | Funding: PhD scholarship from charitable trust Quote: "this study was funded by a PhD fellowship grant from the trustees of Barts and The London Charitable Foundation. The analysis, interpretation of data, generation of the manuscript and decision to submit for publication were carried out independently of the funding body" |