Li 1999.
Methods | RCT Method of random allocation: not described; states randomisation was single‐blinded but remains unclear who was blinded. Masking: states single‐ blinded study but unclear who was blinded. Description of withdrawals and dropouts: numbers and reasons clearly stated ‐ treatment group ‐ 9 (opted not to use Y‐set ‐ 7; incomplete data ‐ 2). Analysis on intention to treat basis: no Duration of follow‐up: all patients followed for at least 12 months. Treatment group ‐ 937 patient‐months; control group ‐ 734 patient‐months. |
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Participants | 120 new ESRD patients admitted to CAPD programme. 60 in treatment group and 60 in control group (data on only 51 reported, see above). Male:female ratio: treatment group ‐ 28:32; control group ‐ 26:25. Age (mean,SD): treatment group ‐ 53.4(13.4) years; control group 49.3(14.2) years. Primary renal disease: treatment group ‐ glomerulonephritis (14); diabetes (11); adult polycystic kidney disease (2); hypertension (3); renal stone disease (5); others/unknown (25); control group ‐ glomerulonephritis (13); diabetes (11); adult polycystic kidney disease (4); hypertension (3); renal stone disease (0); others/unknown (20). Co‐morbidity: treatment group ‐ diabetes (15); HBsAg carriers (10); control group ‐ diabetes (14); HBsAg carriers (5). |
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Interventions | Double bag disconnect system (Ultrabag, Baxter) "pre‐assembled and sterilised as single unit". (treatment) vs Y‐set disconnect system (Ultraset, Baxter)(control). 3 exchanges per day. |
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Outcomes | Peritonitis Exit site infections Patient acceptance Hospitalisation Catheter removal Mortality | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |