DUAAAL 2011.
| Study characteristics | ||
| Methods |
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| Participants |
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| Interventions | Low salt group
High salt group
Co‐interventions
Other information
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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: "An independent pharmacist randomised these sequences, using a computer program” |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Dietary interventions were open label but outcomes were objective and unlikely to be influenced by performance bias |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Additionally, we analysed the data for all 54 patients who were included (intention to treat). As the effect estimates and confidence intervals were very similar and the statistical and clinical conclusions did not change, we have not shown these data" 54 randomised, 2 withdrew after randomisation; 52 included in analysis |
| Selective reporting (reporting bias) | Low risk | Study was pre‐registered online and the pre‐specified outcomes were reported |
| Carry‐over effect | Low risk | Adequate intervention duration to reduce risk of carry‐over effect |
| Bias from confounders | High risk | Medication changes reported and did not occur during placebo phases. Comparison of usual intake versus low sodium intervention increases risk of dietary confounders ‐ reduction in body weight, potassium excretion and urinary urea in low salt phase suggests potential confounding |
| Other | Unclear risk | Funding: study supported by Novartis; declaration of non‐involvement by funder Quote: "Funding: Unrestricted grant from Novartis. No role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript" |