| Methods |
Multicentre RCT (USA) |
| Participants |
Quote: "Adults expected to require a CVC for more than 60 hours were eligible. There were no eligibility constraints related to diagnoses, hospital unit, or anticipated treatments or procedures. Patients were excluded if: they had a history of allergic reactions to silver, platinum or carbon black; were expected to live for seven days or less; had evidence of a burn or dermatitis at the catheter insertion site; were pregnant or lactating; or had a catheter placed in the same proposed site previously." |
| Interventions |
SPC‐impregnated CVCs versus non‐impregnated CVCs |
| Outcomes |
Bacteraemia, CRBSI and catheter colonization |
| 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: "A computer‐generated randomization schedule was used to avoid potential bias in catheter selection." |
| Allocation concealment (selection bias) |
Unclear risk |
There was no information about how allocation was implemented to enable an assessment of whether random sequence was generated independently of allocation |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "... due to the difference in appearance of the CVCs, blinding could not be achieved.” |
| Blinding of outcome assessment (detection bias)
Microbiological outcomes like catheter colonization |
Unclear risk |
There was no specific statement about whether the microbiological outcome assessors were blinded. |
| Blinding of outcome assessment (detection bias)
Clinical outcomes like CRBSI |
Unclear risk |
Quote: "... due to the difference in appearance of the CVCs, blinding could not be achieved.” |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
160 catheters (23%) were excluded from the analysis. The reasons for exclusion were inadvertent contamination or disposal of the catheters, or a transit time of more than 24 hours before culture. The authors stated that "There were no significant differences in patient characteristics between the evaluable (266 control, 273 test) and non‐evaluable (83 control, 77 test) groups." However, the high exclusion rate in this study posed a high risk of attrition bias |
| Selective reporting (reporting bias) |
Unclear risk |
All the outcomes specified in the Methods, including bacteraemia, CRBSI and catheter colonization, were reported in sufficient detail in the Results |
| Other bias |
Low risk |
None identified |
