Rickard 2004.
Methods | Randomized controlled trial | |
Participants | 251 ICU patients with a CVC receiving any combination of crystalloids, lipids and non‐lipid PN | |
Interventions | Administration set changes at 72 hours or no change up to 144 hours | |
Outcomes |
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Notes | Fluid container bags were changed every 24 hours Central catheters: 100% PN: separate data available for participants receiving PN Loss to follow‐up: 5% | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Adequate random sequence generation Quote: "A computerised random‐number generator randomized each CVC to either receive a routine set change or have the original administration set left intact for the duration of catheterization" (p. 651) |
Allocation concealment (selection bias) | High risk | Not originally reported, after checking with author: not adequately concealed |
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 | Low risk | Main outcome: CR‐BSI concealed: laboratory staff were blinded to the study group Quote: "a blinded intensivist reviewed microbiological results .... and cases of systemic inflammatory response syndrome using strict definitions to diagnose" (p. 651) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "29 (7.1%) of the CVCs were not cultured due to autopsy or lost or contaminated specimens ... these were equally distributed between the groups" (p. 652) No information in manuscript re CR‐BSI missing outcomes; clarified with author, daily check of microbiological reporting system was undertaken |
Selective reporting (reporting bias) | Low risk | No pre‐protocol Primary outcome variables were specified and reported on |