Leake 1999.
Methods |
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Participants |
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Interventions | Treatment group
Control group 1
Control group 2
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) | Unclear risk | Quote: "Blocks of patients were first categorised by sex, months on dialysis and whether they had a comorbid diagnosis of diabetes; there were then randomly assigned to a condition." Comment: Sequence generation methods were not reported in sufficient detail to perform an adjudication |
Allocation concealment (selection bias) | Unclear risk | 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 | Low risk | Quote: "Patients completed a questionnaire that served as a baseline measure of adjustment. [...] Four female research assistants, who were unaware of the conditions and hypotheses of the study, conducted the interviews. [...] The first author, who was unaware of the condition to which each patient was assigned, administered the questionnaires at the three time points." Comment: The first author administered the questionnaires and he was unaware on the treatment assigned group |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Data for the 1‐month post‐treatment assessment were not available for 1 male patient who ceased treatment before the 1‐month assessment." Comment: Overall, 1/42 participants was lost to the follow‐up (< 10% loss to follow‐up, it was not clear if there was a substantial 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. life participation, fatigue, death, dialysis withdrawal, adverse events) |
Other bias | Unclear risk | It was not clear if there was evidence of imbalance at baseline. Not reported in sufficient detail to perform an adjudication |