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. 2016 Jul 13;2016(7):CD010140. doi: 10.1002/14651858.CD010140.pub2

Prager 1984.

Methods Single‐centre RCT (USA)
Study period: not reported
Setting: hospital departments of General Surgery (123), Medicine (20), Thoracic Surgery (19), Neurosurgery (8), Obstretrics and Gynaecology (3), Paediatrics (3) and others (3)
Participants All hospital inpatients who required a CVC
Number of participants: 159 adults, 3 children
Number of catheters; 179
Age: not reported
Sex: not reported
Interventions Skin antisepsis applied daily after CVC insertion.
  1. Intervention A: povidone‐iodine for skin antisepsis

  2. Control: no skin antisepsis

Outcomes
  • Catheter colonisation

  • "Catheter‐related septicaemia" (catheter‐related BSI)


Outcomes assessed at various points during in‐patient stay.
Notes Funding source: supported in part by the Purdue Frederick Company, Wilmington, Delaware.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk The exact method of sequence generated was not described. However, in the 'Methods', the authors stated that patients were randomised according to hospital registration number, suggesting that they used alternation, instead of true randomisation.
Allocation concealment (selection bias) High risk As above
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Although the authors did not explicitly say, it was unlikely that the participants and the care providers were blinded, as the study assessed skin antisepsis versus no skin antisepsis.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding of microbiological outcome assessor not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Although the authors did not describe any withdrawals, it appeared that all catheters that were initially enrolled were analysed in the originally assigned groups.
Selective reporting (reporting bias) Low risk Authors reported the major outcomes of catheter colonisation and catheter‐related BSI as stated in the 'Methods' in sufficient detail in the 'Results'.
The authors also reported an additional outcome of skin erythema. However, this was reported as an overall percentage of patients with colonised catheters, not according to the allocated groups, and so it did not allow data extraction for meta‐analysis. Nevertheless, this did not affect our judgment on the overall risk of reporting bias in any major way.
Other bias High risk There was a unit of analysis issue in which the number of catheters analysed exceeded the number of participants by nearly 10%, and the outcomes were reported using catheters as the units.