Ishani 2016.
Methods |
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Participants |
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Interventions |
Intervention group
Control group
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Outcomes | Primary outcome (measured at 12 months)
Secondary outcomes (measured at 12 months)
Intermediate study outcomes (measured at 12 months)
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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: "Randomly assigned to receive the intervention or usual care using a centralized computer‐generated randomization scheme using permuted block sizes of 2, 4, or 6. Randomization was stratified by eGFR (<30 vs >30 mL/min/1.73 m2), presence of diabetes, and occurrence of a hospitalization in the past year" |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization occurred over the telephone by an individual blinded to patient identity" |
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 | High risk | Likely blinding would have been broken |
Blinding of outcome assessment (detection bias) Objective outcome | Low risk | Outcome assessors were blinded. all outcomes were objective |
Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | No subjective outcomes were measured |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 participant (of 601) withdrew consent; used intention‐to‐treat analyses |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | Unclear risk | baseline characteristics between groups similar, limited generalisability possible due to high proportion of men, met sample size calculation for power |