Ostendorf 2005.
| Methods | Single‐centre RCT (Germany) | |
| Participants | Participants with haematological malignancy and needing a CVC for at least 7 days. No exclusion criteria were mentioned | |
| Interventions | C‐SS‐impregnated CVCs versus non‐impregnated CVCs | |
| Outcomes | Catheter colonization, CRBSI (referred to as 'catheter related bacteraemia') and attributed mortality and catheter‐related local infection | |
| Notes | Sources of funding: industry (catheter manufacturer or distributor) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants were allocated "through randomization ...." No further statements were made about how random sequence was generated and how allocation was implemented |
| Allocation concealment (selection bias) | Unclear risk | Participants were allocated "through randomization ...." No further statements were made about how random sequence was generated and how allocation was implemented |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The two catheter types were indistinguishable to users and patients (double‐blinded study design)." |
| Blinding of outcome assessment (detection bias) Microbiological outcomes like catheter colonization | Unclear risk | It was unclear whether the assessors of the microbiological outcomes were blinded to the status of the participants |
| Blinding of outcome assessment (detection bias) Clinical outcomes like CRBSI | Low risk | Quote: "The two catheter types were indistinguishable to users and patients (double‐blinded study design)." |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Sixty‐one catheters (24.9%) were excluded because of patient’s failure to notify the study team when the catheter was removed, or catheterization <24 h.” The authors did not state the number of catheters excluded from each group. They stated that the baseline characteristics of the 2 groups after excluding the 61 catheters were similar In view of the high exclusion rate and the relatively low event rates, particularly for CRBSI and attributed mortality, we judged the risk of attrition bias in this study as high |
| Selective reporting (reporting bias) | Unclear risk | All the outcomes specified in the Methods, including catheter colonization, CRBSI and attributed mortality and catheter‐related local infection, were reported in sufficient detail in the Results |
| Other bias | Low risk | None identified |