Stoiser 2002.
| Methods | Multicentre RCT (Austria) | |
| Participants | Patients who were immunocompromised from various causes including cancer, haematological disorders, bone marrow and other organ transplant requiring implantation of a CVC were included in this study. No exclusion criteria were stated | |
| Interventions | Silver‐impregnated CVCs versus non‐impregnated CVCs | |
| Outcomes | Catheter colonization (referred to as 'catheter contamination'), clinically diagnosed sepsis (referred to as 'clinical infection') and the use of antibiotics (referred to as the 'antibiotic index') | |
| Notes | Sources of funding: not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “After giving informed consent, the patients were randomized to receive either a conventional polyurethane catheter (Arrow1, Reading, PA, USA), or a silver‐impregnated catheter (ArgenTec1, Fa, City, Country).” It was not stated how the random sequence was generated |
| Allocation concealment (selection bias) | Unclear risk | There was no information about the method of allocation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | There were no statements about blinding in the paper. Blinding appeared unlikely as the 2 types of catheters were from 2 different manufacturers (Arrow and Argen Tec) and they differed in appearance |
| 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 |
| Blinding of outcome assessment (detection bias) Clinical outcomes like CRBSI | High risk | There were no statements about blinding in the paper. Blinding appeared unlikely as the 2 types of catheters were from 2 different manufacturers (Arrow and Argen Tec) and they differed in appearance |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 97/154 (63%) of the catheters were analyzed. The reasons for excluding 54 participants were given as follows: "Fifty‐seven patients had to be excluded from evaluation due to removal of the catheter prior to day 3, accidental removal of the catheter, transfer of the patient to another hospital, or death prior to the end of the study." We felt that the rate of exclusion was high, and the reasons given for exclusion could be related to the true outcomes, for example, catheter removal prior to day 3 or death might be related to infection; accidental removal of the catheter would not preclude a catheter culture unless it occurred without knowledge of the personnel involved in the study |
| Selective reporting (reporting bias) | Low risk | The outcomes specified in the Methods including clinically diagnosed sepsis, catheter colonization and the use of antibiotics were reported in sufficient detail in the Results |
| Other bias | Low risk | None identified |