Methods |
Single‐centre RCT (UK) |
Participants |
Quote: "Patients undergoing or having undergone transplant of the heart, heart‐lung, or lung(s) with concomitant immunosuppression, requiring central venous access, were recruited." There were no exclusion criteria provided |
Interventions |
C‐SS‐impregnated CVCs versus non‐impregnated CVCs |
Outcomes |
Catheter colonization, 'associated infections' which included CRBSI or positive cultures from other sites (like urine or other lines) and adverse effects |
Notes |
Sources of funding: industry (catheter manufacturer or distributor) |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Quote: "Patients were randomly allocated by computer‐generated random number" |
Allocation concealment (selection bias) |
Unclear risk |
The authors did not explain who performed the random sequence generation or provide information to enable an assessment of whether sequence generation was performed independently of recruitment and allocation |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
The authors stated specifically that blinding was not possible since the catheters in the 2 arms differed in colour |
Blinding of outcome assessment (detection bias)
Microbiological outcomes like catheter colonization |
Unclear risk |
The authors did not describe whether the assessors of microbiological outcomes were blinded |
Blinding of outcome assessment (detection bias)
Clinical outcomes like CRBSI |
High risk |
The authors stated specifically that blinding was not possible since the catheters in the 2 arms differed in colour |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
7/86 catheters (8.1%) were excluded from analysis. The authors did not state the assigned groups of these 7 catheters, but stated that they were excluded because they "were lost owing to deviation from the protocol, contamination of the catheter tips and death.”Due to the lack of information regarding the assigned groups of the excluded catheters, the risk of attrition bias in this study is unclear |
Selective reporting (reporting bias) |
Low risk |
The important outcomes specified in the Methods including catheter colonization and CRBSI were reported in the Results |
Other bias |
Low risk |
None identified |