Snydman 1987.
Methods | Alternately allocated controlled clinical trial | |
Participants | 170 adult patients admitted to the medical and surgical ICUs receiving IV therapy for the required period Medical and surgical ICUs, USA | |
Interventions | Administration set changes at 48 or 72 hours | |
Outcomes |
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Notes | Exclusions: previously enrolled in study or receiving blood products, PN or lipids. Confounders: The no. of burettes per line was statistically lower in the 72 hour group Central catheters: 27% PN: 0% Loss to follow‐up: 52% | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Poor random sequence generation Quote: "alternatively assigned" (abstract) |
Allocation concealment (selection bias) | High risk | Easily predictable, inadequate concealment |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not discussed, but not feasible in the study design |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not discussed, but not feasible in the study design |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Phlebitis measures were undertaken by staff blinded to culture results, but not known if they were blinded to the group Not discussed whether outcome assessors were blinded during cultures |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No discussion of attrition and missed cultures Originally 356 enrolled (176/180) but (71/115) dropped as discharged/died < 48/72 hours Imbalanced groups n = 105 (48 hours), n = 62 (72 hours) |
Selective reporting (reporting bias) | Low risk | No pre‐protocol |
Other bias | High risk | Results given per AS, not per participant 1.5 days longer ICU stay for 72 hour group Higher antibiotic courses in the 48 hour group Imbalanced AS cultured (745/449) between groups |
AS: administration set, BSI: bloodstream infection, cfu: colony forming units, CR‐BSI: catheter‐related bloodstream infection, CVC: central venous catheter, h: hours, ICU: Intensive Care Unit, IR‐BSI: infusate‐related bloodstream infection, IV: intravenous, NICU: Neonatal Intensive Care Unit, no.: number, PN: parenteral nutrition.