SUBLIME 2016.
Methods |
|
|
Participants |
|
|
Interventions |
Intervention group
Control group
|
|
Outcomes | Outcomes measured at baseline, 3, 6, 9 months
|
|
Notes |
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study described as randomised, method of random sequence generation not reported |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) Blinding of participants | High risk | Could not have been blinded |
Blinding of participants and personnel (performance bias) Blinding of personnel | Unclear risk | Insufficient information to permit judgement |
Blinding of outcome assessment (detection bias) Objective outcome | Low risk | Objective data such as BP, 24‐hour urine sodium, cost‐analysis |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | No reporting of how well being and quality of life is measured |
Incomplete outcome data (attrition bias) All outcomes | High risk | 28% drop out in intervention, 3.3% drop out in control ‐ no mention if these participants differed; no mention of whether used ITT analyses |
Selective reporting (reporting bias) | High risk | Insufficient information to permit judgement |
Other bias | Unclear risk | Insufficient information to permit judgement |