Jakobsen 1986.
| Methods | Randomized controlled trial | |
| Participants | 325 patients likely to receive IV therapy for at least 3 days. Three surgical and five medical centres, Denmark | |
| Interventions | Administration set changes at 24, 48, 72, 96 or 120 hours | |
| Outcomes | Catheter colonization | |
| Notes | Exclusions: cannula change due to extravasation; PN in main line Central catheters: 0% PN: mixed (not in main line) Loss to follow‐up: 27% | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Unclear randomization method Quote: "a prospective randomized trial" (p. 218) |
| Allocation concealment (selection bias) | Unclear risk | Not discussed |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not discussed, not feasible because of research design |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not discussed, not feasible because of research design |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome blinding possible but not discussed Quote: "All sampling was carried out by the physicians conducting the study" (p. 219) |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Inadequate information provided regarding attrition Quote: "If cannulae [were] removed because of extravasation, the patient was excluded from the study" (p. 218) Quote: "527 patient[s] admitted to the study; 140 were excluded for various reasons and as expected form the study design, the number excluded increased from group 1 to group 5" (p. 219) |
| Selective reporting (reporting bias) | Unclear risk | No pre‐protocol BSI not reported by group |
| Other bias | High risk | Quote: "The results were evaluated once a week and the study was designed to stop if a statistically significant difference in contamination rates of the cannulae and/or administration sets was found between any of the groups" (p. 219) No baseline statistics by group provided, just "no epidemiological difference was found" No correction for time at risk or multiple sampling |