Methods |
Study design: parallel RCT
Study time frame/recruitment period: February 2003 to February 2006
Follow‐up period: All patients were followed up until death, kidney transplantation, completion of PD therapy, or the end of the study on 24 March 2006, whichever came first
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Participants |
Country: Australia
Setting: multicentre (2 sites)
Adults patients with ESKD (stage 5 CKD) who required insertion of a Tenckhoff catheter for PD
Number: treatment group (70); control group (62)
Mean age ± SD (years): treatment group (56.3 ± 15.7); control group (57.6 ± 15.7)
Sex (M/F): treatment group (40/30); control group (42/30)
Diabetes: treatment group (29/70); control group (19/62)
Exclusion criteria: history of psychological illness or condition that interfered with the ability to understand or comply with requirements of the study
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Interventions |
Treatment group
Control group
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Outcomes |
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Notes |
Stop of end points: all patients were followed up until death, kidney transplantation, completion of PD therapy, or the end of the study on March 24, 2006, whichever came first
Funding source: none
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐generated random number list with randomisation blocks of 20 |
Allocation concealment (selection bias) |
Low risk |
Random number with randomisation blocks of 20 |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Insufficient information to permit judgement |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Insufficient information to permit judgement |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No dropouts |
Selective reporting (reporting bias) |
Low risk |
Low risk, most outcomes were reported |
Other bias |
High risk |
Unequal baseline characteristics |