| Methods |
Multicentre RCT (Spain) |
| Participants |
Methods, study population: " All consecutive patients aged 18 years or older admitted to the ICUs of seven teaching hospitals in Spain from November, 1999, to April, 2002, who were likely to require a CVC at a new insertion site for 3 days or more were eligible. Only one catheter per patient was studied. Allergy to minocycline or rifampin was an exclusion criterion." |
| Interventions |
MR‐impregnated CVCs versus non‐impregnated CVCs |
| Outcomes |
Catheter colonization, CRBSI, 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) |
Low risk |
Quote: "Catheter trays wrapped in identical folders were randomly assigned in blinded fashion according to computer‐generated identification numbers, in blocks of six (three from each group), so that the catheter trays would be removed from the box one at a time in the prescribed, random order from the top to the bottom." |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Catheter trays wrapped in identical folders were randomly assigned in blinded fashion according to computer‐generated identification numbers, in blocks of six (three from each group), so that the catheter trays would be removed from the box one at a time in the prescribed, random order from the top to the bottom." |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
The author stated that this was a 'double‐blind' trial, but did not specify how blinding was achieved for the participants and carer, as MR catheters and control catheters differed in appearance: although produced by the same manufacturer, MR catheters and non‐impregnated catheters were likely to have different external labelling |
| Blinding of outcome assessment (detection bias)
Microbiological outcomes like catheter colonization |
Unclear risk |
It was not stated whether the assessors of microbiological outcomes were blinded |
| Blinding of outcome assessment (detection bias)
Clinical outcomes like CRBSI |
Unclear risk |
The author stated that this was a 'double‐blind' trial, but did not specify how blinding was achieved for the participants and carer, as MR catheters and control catheters differed in appearance: although produced by the same manufacturer, MR catheters and non‐impregnated catheters were likely to have different external labelling |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
41/228 MR study catheters (18%) and 57/237 control catheters (24%) were excluded from analysis for microbiological outcomes. The reasons for exclusion were as follows: removal without notification (26 in the MR group and 37 in the control group), death (14 in the MR group and 17 in the control group), administrative reasons (1 in the MR group and 3 in the control group). The authors reported that the baseline characteristics of the analyzed participants (187 in the MR group and 180 in the control group) were well‐balanced between the 2 groups, and all the major outcomes that could be assessed, including 'septic episodes' and CRBSI were also measured in the 98 participants excluded from microbiological analysis |
| Selective reporting (reporting bias) |
Unclear risk |
All the major outcomes specified in the Methods, including clinical septic episodes, CRBSI and catheter colonization were reported in sufficient detail in the Results |
| Other bias |
Low risk |
None identified |
