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. 2013 Sep 15;2013(9):CD003588. doi: 10.1002/14651858.CD003588.pub3

Maki 1987.

Methods Randomized controlled trial
Participants 487 patients in the general surgical, medical oncology, surgical ICU and Centre for Trauma and Life Support. Acute care hospital, USA
Interventions Administration set changes at 48 or 72 hours
Outcomes
  • IR‐BSI

  • All‐cause BSI

Notes Exclusions: patients with granulocytopenia
 Central catheters: 56%
 PN: 12%
 Loss to follow‐up: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "was randomized" (p. 1778)
Allocation concealment (selection bias) Unclear risk Not discussed
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 Unclear risk Outcome blinding possible but not discussed
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Minimal attrition information provided; no mention of numbers randomly assigned or any missing data
Inaccurate reporting in results section between Table 1 (participant number = 487; AS number = 1374) and text quote: "1479 patient IV infusions were studied" (p. 1778)
Selective reporting (reporting bias) Unclear risk No IR‐BSI reported
 No pre‐protocol
Other bias Unclear risk Not independent units of measure (i.e. per AS, not per participant)