Methods |
Study design: parallel RCT
Study time frame/recruitment period: 1 March 2008 to 31 May 2013
Follow‐up period: day 180 post catheter insertion
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Participants |
Country: Australia
Setting: multicentre (2 sites)
ESKD patients over 18 years of age, who will be receiving CAPD or APD within 4 weeks of insertion of a PD catheter
Number: treatment group 1 (39); treatment group (42); control group (41)
Mean age ± SD (years): treatment group 1 (60.92 ± 15.2); treatment group 2 (57.55 ± 17.9); control group (54.41 ± 15.5)
Sex (M/F): treatment group 1 (22/17); treatment group 2 (20/22); control group (26/15)
Diabetes: treatment group 1 (15/39); treatment group 2 (14/42); control group (14/41)
Exclusion criteria: a history of psychological illness or condition which resulted in inability to understand or comply with the requirements of the study or if there is an acute infectious episode in the last month before enrolment
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Interventions |
Treatment group 1
Treatment group 2
Control group
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Outcomes |
|
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomisation sequence was generated using STATA software (permuted block) |
Allocation concealment (selection bias) |
Low risk |
Sealed envelopes |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not blinded |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not blinded |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No dropout |
Selective reporting (reporting bias) |
Low risk |
Published protocol before study |
Other bias |
High risk |
Protocol violation present |