Gorbea 1984.
Methods | Alternately allocated controlled clinical trial | |
Participants | 123 adult patients in a surgical ICU who required IV therapy for the required period of time. Hospital, USA | |
Interventions | Administration set changes at 24 or 48 hours | |
Outcomes |
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Notes | Exclusions: patients receiving PN through a central line. Confounders: The 24 hour group had a greater no. of catheters/participant and a greater proportion receiving antibiotics Central catheters: 38% PN: 0% (central), not stated for peripheral Loss to follow‐up: 22% | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Poor random sequence generation; easily predictable Quote: "alternatively assigned" |
Allocation concealment (selection bias) | High risk | Not feasible because of poor sequence generation |
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 | Low risk | Attrition adequately described 157 enrolled, 34 dropouts (15 in 24 hours, 19 in 48 hours) because of early discharge or death |
Selective reporting (reporting bias) | Low risk | No pre‐protocol |
Other bias | High risk | Difference in baseline characteristics of concern
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