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

Sitges‐Serra 1985.

Methods Randomized controlled trial
Participants 52 adult surgical patients undergoing PN through a subclavian catheter
 Appears to have been a hospital in Spain
Interventions Administration set changes at 48 or 96 hours
Outcomes
  • IR‐BSI

  • Catheter colonization

  • CR‐BSI

Notes Exclusions: not stated
 Central catheters: 100%
 PN: 100%
 Loss to follow‐up: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Inadequate random sequence generation; easily predictable
Quote: "patients randomly assigned to one of two groups according to their hospital number" (p. 322)
Allocation concealment (selection bias) High risk Inadequate concealment; use of hospital number easily predictable
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 Outcome blinding possible but not discussed
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Minimal information provided regarding attrition; no mention of missing samples
Selective reporting (reporting bias) Low risk No pre‐protocol
Other bias Unclear risk PN mean four days longer in group A (not statistically significant)
No other demographic data presented