Josephson 1985.
Methods | Randomized controlled trial | |
Participants | 173 medical patients who had an IV started in the previous 24 hours. 350 bed university hospital, USA | |
Interventions | Administration set changes at 48 hours or no change for the remainder of the cannula placement (i.e. at least 72 hours) | |
Outcomes |
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Notes | Exclusions: casein, fat emulsions or blood in lines or vascular line monitoring systems Central catheters: 0% PN: 0% 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: "were randomly assigned according to a table of random numbers" (abstract and p. 368) |
Allocation concealment (selection bias) | Unclear risk | Not discussed |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not discussed, not feasible because of research design |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not discussed, not feasible because of research design |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome blinding possible but not discussed |
Incomplete outcome data (attrition bias) All outcomes | High risk | Imbalanced attrition Quote: "Patients whose IVs were in place for fewer than three days or whose tubing change protocol was broken prior to three days of therapy were dropped from the study". This occurred 166 times in the 48 hour group and 106 times in the no‐change group" (p. 368) |
Selective reporting (reporting bias) | Unclear risk | No pre‐protocol Only 26% of tips were cultured (all were required, as it was a secondary endpoint) |
Other bias | High risk | Multiple infusions per participant randomly assigned |