Raad 2001.
Methods | Randomized controlled trial | |
Participants | 428 cancer patients requiring IV therapy. Tertiary university cancer centre, USA | |
Interventions | Administration set changes at 72 or 96 to 168 hours | |
Outcomes |
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Notes | Exclusions: not stated Central catheters: 100% PN: Data from PN participants couldn't be used, as they included participants receiving blood Loss to follow‐up: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Adequate random sequence generation Quote: "prospective randomized study" (abstract) Quote: "computer‐generated randomization list" (p. 136‐7) |
Allocation concealment (selection bias) | Unclear risk | Not discussed |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not discussed, not feasible because of study design |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not discussed, not feasible because of study design |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome blinding possible but not discussed |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No mention of any missing data or attrition |
Selective reporting (reporting bias) | Unclear risk | No pre‐protocol Stopped early (n = 512) after interim analysis showed 3 IR‐BSI in 96 to 167 hour group (P = 0.09) |
Other bias | Unclear risk | Outcome definition of contaminated tip was ≥ 10 cfu |