Raad 1998.
Methods | Multicentre RCT (USA) | |
Participants | The only information provided by the authors of this paper on the participants was that they were ".... critically ill patients ..." | |
Interventions | MR‐impregnated CVCs versus non‐impregnated CVCs | |
Outcomes | Catheter colonization, premature catheter removal, duration of systemic antibiotics use and durability of the antimicrobial activity | |
Notes | Sources of funding: not stated | |
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: "Coated and uncoated catheters were packaged in identical trays, assigned a random number, and shipped to our study sites ... The randomization scheme consisted of blocks of six identical catheter trays: three for coated central venous catheters and three for control central venous catheters. Every block of six catheter trays was packed in a box. Central venous catheters were allotted to each eligible patient sequentially from the catheter trays which were removed from the box, one at a time, from top to bottom." |
Allocation concealment (selection bias) | Low risk | Random sequence generation and allocation were described in detail, as follows: Quote: "Coated and uncoated catheters were packaged in identical trays, assigned a random number, and shipped to our study sites … The randomization scheme consisted of blocks of six identical catheter trays: three for coated central venous catheters and three for control central venous catheters. Every block of six catheter trays was packed in a box. Central venous catheters were allotted to each eligible patient sequentially from the catheter trays which were removed from the box, one at a time, from top to bottom." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The catheters were prepared in‐house from identical materials but the authors did not mention whether the final appearance of the prepared and unprepared catheters remained identical in appearance, and whether those involved in the study knew the difference |
Blinding of outcome assessment (detection bias) Microbiological outcomes like catheter colonization | Unclear risk | The authors did not mention whether the assessors of the microbiological outcomes were blinded |
Blinding of outcome assessment (detection bias) Clinical outcomes like CRBSI | Unclear risk | The catheters were prepared in‐house from identical materials but the authors did not mention whether the final appearance of the prepared and unprepared catheters remained identical in appearance, and whether those involved in the study knew the difference |
Incomplete outcome data (attrition bias) All outcomes | Low risk | It appeared that all 40 participants initially randomized were analyzed |
Selective reporting (reporting bias) | High risk | The outcomes of catheter colonization and premature catheter removal were reported in sufficient detail in the Results. However the usage of systemic antibiotics was reported in the form of median and range and not mean and standard deviation, and so the data were unsuitable to be included in our meta‐analysis |
Other bias | Low risk | None identified |