Lii 2007.
Methods |
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Participants |
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Interventions | Treatment group
Control 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: "An independent research assistant (unaware of the baseline data) carried out the concealed randomisation procedure using a random computer‐generated list." Comment: Random computer‐generated list is considered as low risk of bias |
Allocation concealment (selection bias) | Unclear risk | Quote: "An independent research assistant (unaware of the baseline data) carried out the concealed randomisation procedure using a random computer‐generated list." Comment: Method of allocation concealment was not reported in sufficient detail to perform an adjudication |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and/or the investigators was not reported. The methods of intervention and control treatment were physically different. Participants and investigators could be aware on the treatment allocation group |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The outcomes were considered subjective. The Strategies Used by People to Promote Health (SUPPH), the BDI‐II and the Short Form‐36 (SF‐36) were self‐reported measurements. As such, the outcome assessment was conducted by participants who could be aware of the treatment received. We judged the outcome assessment to be at high risk of bias for these outcome measures |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Out of 60 original patients randomly assigned into experimental or control groups, 48 completed the study. [...] After intervention for eight weeks, there were 12 patients who dropped out, including 10 in the treatment group and two in the control group. Reasons for dropout included obligations at home, transfers to another haemodialysis unit or time conflicts." Comment: 10/30 in the intervention group and 2/30 in the control group were lost to the follow‐up (> 10% loss to follow‐up; there was a differential loss between groups) |
Selective reporting (reporting bias) | High risk | There was no published protocol for this study. This study did not report many patient‐centred outcomes that might be expected for a study of this type (i.e. fatigue, death, dialysis withdrawal, adverse events) |
Other bias | Low risk | No evidence of other sources of bias |