Buxton 1979.
Methods | Randomized controlled trial | |
Participants | 600 patients who had new infusions begun within the previous 24 hours. Four general medical wards (each with an ICU) and 4 general surgical wards at a general hospital, USA | |
Interventions | Administration set changes at 24 or 48 hours | |
Outcomes |
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Notes | Exclusions: IV sets in for < 48 hours; heparin locks, PN, participants previously in study, cannulation < 2 weeks, protocol failure Central catheters: 0% PN: 0% Loss to follow‐up: 39% | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Adequate random sequence generation used Quote: "used a random number table to assign each new patient" |
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 | Blinded outcome assessment (phlebitis) Quote: "a nurse or physician observer who had no knowledge of when each patient's AS was changed evaluated each patient daily for the presence of phlebitis" (p. 765) Not discussed whether IV fluid colonization outcome was assessed by blinded scientists No explanation about how BSIs were detected |
Incomplete outcome data (attrition bias) All outcomes | High risk | Minimal attrition information provided Quote: "A total of 987 patients were initially entered into the study, but 387 patient infusions were stopped in < 48 h" (p. 765) Possible participants treated at 24 hours had bacteraemia less than 48 hours, so intention to treat principle not upheld |
Selective reporting (reporting bias) | Low risk | No pre‐protocol All outcomes provided |