Raad 1997.
Methods | Multicentre RCT (USA) | |
Participants | Quote: "Hospitalized patients 18 years of age or older who required a triple‐lumen polyurethane central venous catheter at a new insertion site were asked to participate. We excluded pregnant women, patients who were allergic to rifampin or tetracycline, patients with dermatitis or a burn over the insertion site, and patients for whom the anticipated duration of catheterization was less than 3 days.” | |
Interventions | MR‐impregnated CVCs versus non‐impregnated CVCs | |
Outcomes | Catheter colonization and CRBSI | |
Notes | Sources of funding: partly from the industry (catheter manufacturer or distributor) and partly from institutional research fund | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random sequence generation and allocation were described in detail, as follows: Quote: ”All catheters were gas sterilized and placed in identical trays, and each tray was assigned an identification number. The trays were then randomly assigned into blocks of six: three with coated catheters and three with control catheters. Each block of trays was placed in boxes by Cook Critical Care, and the boxes were shipped to the five hospitals. When a patient was determined to be eligible, a tray was removed from the box (trays were removed one at a time, in sequential order from top to bottom), and that catheter was used for the patient. The catheter identification number was recorded on a data entry form and on the patient's medical chart.” |
Allocation concealment (selection bias) | Low risk | Random sequence generation and allocation were described in detail, as follows: Quote: ”All catheters were gas sterilized and placed in identical trays, and each tray was assigned an identification number. The trays were then randomly assigned into blocks of six: three with coated catheters and three with control catheters. Each block of trays was placed in boxes by Cook Critical Care, and the boxes were shipped to the five hospitals. When a patient was determined to be eligible, a tray was removed from the box (trays were removed one at a time, in sequential order from top to bottom), and that catheter was used for the patient. The catheter identification number was recorded on a data entry form and on the patient's medical chart.” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Neither the patient nor the clinician who inserted the device knew which catheter (coated or uncoated) had been used." |
Blinding of outcome assessment (detection bias) Microbiological outcomes like catheter colonization | Unclear risk | There was no specific statement on whether the assessors of the microbiological outcomes were blinded to the status of the catheter sample |
Blinding of outcome assessment (detection bias) Clinical outcomes like CRBSI | Low risk | Quote: "Neither the patient nor the clinician who inserted the device knew which catheter (coated or uncoated) had been used." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 32/298 catheters (10.4%) were excluded from the analysis due to a failure to obtain cultures (17 from the study group and 15 from the control group). Although the number excluded appeared balanced between the 2 groups, in view of the relatively low event rates for CRBSI and catheter colonization, it was unclear whether the results would be altered substantially should data from the excluded samples be available |
Selective reporting (reporting bias) | Unclear risk | The major clinical outcomes of CRBSI and catheter colonization were reported in sufficient detail in the Results. The authors provided a cost estimate of the 2 types of catheters, but the figures were presented narratively and were not suitable to be included in our meta‐analysis |
Other bias | Low risk | None identified |