Tsai 2015.
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: "The random allocation sequence was generated using free online software providing randomly permuted blocks and random block sizes". Comment: Investigators describes a random component in the sequence generation that could be considered as low risk of bias |
Allocation concealment (selection bias) | Low risk | Quote: "Another independent research assistant who did not participate in participant enrolment, data collection, or data analyses generated the allocation sequence. The allocation sequence was concealed in sequentially numbered, opaque, sealed envelopes that were safeguarded by the primary investigator (one of us, P‐ST) until it was time to assign the participants to groups. The dialysis nurse who delivered the intervention ensured that each envelope was still sealed, wrote a participant’s name." Comment: investigators could not foresee assignment and it could be considered as low risk of bias |
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: "This was an outcome assessor–blind, randomisation controlled trial. [...] An independent research assistant (one of us, S‐HT) who was not involved in implementing the intervention and who was blinded to participants’ group allocation performed the outcome assessment." Comment: The outcome assessment was conducted by the assessor who was unaware of the treatment received. We judged the outcome assessment to be at low risk of bias for these outcome measures |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Sixty‐four participants were randomised equally to either the intervention or the control group. Three participants in the control group subsequently withdrew because of hospitalisation; and four participants in the control group refused to complete post‐test questionnaires at Week 6. Only the 57 participants who completed the posttest questionnaires were included in the data analysis." Comment: As reported in the flow chart, 0/32 in nurse‐led breathing training group and 7/32 in control group were lost to 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 |