Methods |
Single‐centre RCT (UK) |
Participants |
Quote: "All ICU patients requiring elective central venous access were considered eligible for inclusion in this study." The author did not provide any exclusion criteria |
Interventions |
C‐SS‐impregnated CVCs versus non‐impregnated CVCs |
Outcomes |
Clincially diagnosed sepsis (referred to as 'SIRS'), CRBSI, all‐cause mortality, catheter colonization, catheter‐related local infections, premature catheter removal |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: “… the patient was randomly allocated to receive either a standard triple lumen CVC (Arrow International) or a C‐SS bonded triple‐lumen type (Arrowguard TM).” No further details were given about how the random sequence was generated |
Allocation concealment (selection bias) |
Unclear risk |
The authors did not provide enough information to enable an assessment of whether the random sequence was generated independently of recruitment and allocation |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
There was no clear statement about blinding, although it was unlikely as the study catheter (Arrowgard) and control catheter (Arrow International) differed in appearance, and the authors did not report any measures taken to blind those involved in the study |
Blinding of outcome assessment (detection bias)
Microbiological outcomes like catheter colonization |
Unclear risk |
It was unclear whether the microbiological outcome assessors were blinded |
Blinding of outcome assessment (detection bias)
Clinical outcomes like CRBSI |
High risk |
There was no clear statement about blinding, although it was unlikely as the study catheter (Arrowgard) and control catheter (Arrow International) differed in appearance, and the authors did not report any measures taken to blind those involved in the study |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
The number analyzed in each arm was the same as the number of participants initially randomized. It was unclear whether this represented 100% follow‐up or whether the authors had included the drop‐outs. The authors did not provide any explanation of the number of withdrawals |
Selective reporting (reporting bias) |
Unclear risk |
All the important outcomes as specified in the Methods, including sepsis, proven CRBSI, catheter colonization and all‐cause mortality were reported in the Results |
Other bias |
Low risk |
None identified |