| Methods |
Study design: Controlled Before‐After Study with Cross‐Over |
| Participants |
USA. Health care workers in sixteen nursing units excluding pediatrics, obstetrics‐gynaecology and intensive care, performing procedures which required the use of IV systems. We estimated that the number of workers in each groups was around 220. All IV insertions in the selected units during a period of six months. Eight units belonged to the intervention group and eight units to the control group, and the roles were switched in the middle of the study period. |
| Interventions |
Use of a needleless intermittent intravenous access system with a reflux valve. Control group used a conventional heparin lock. |
| Outcomes |
Number of reported percutaneous injuries per study week. Secondary outcomes: Local complications at insertion site, bacteraemia of patients, device‐related complications, staff satisfaction and cost analysis. |
| Notes |
Study includes information about costs; We calculated the RR (SE) for needlestick injuries of the intervention and the control group based on our estimates of the number of persons and the number of needlestick injuries reported by the authors. We added 0.5 to fill empty cells. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
No randomisation. |
| Allocation concealment (selection bias) |
High risk |
No randomisation. |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
No information about blinding. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Authors indicated that study was completed in 16 medical and surgical units. The outcome data appears to be reported for the 16 units. No outcome data at the unit level. |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes are reported and correspond to the ones mentioned in the method section. |
| Similar recruitment of groups |
Low risk |
The intervention and control groups were from the same hospital. There is no information about the FTE change during study period. The study was completed within a short period of time (25 weeks), staff difference between before and after intervention is unlikely to be different. |
| Adjustment for baseline differences |
Unclear risk |
Authors specified that the wards for the control and intervention were similar in terms of staff‐to‐patient ratio and the type of illness of the patients. The units were different in terms of speciality for the control and intervention group. No information is available to compare the control and intervention groups for the number of staff, working experience, age and sex. Adjustment for baseline differences is not reported in the analysis. |
| Other bias |
High risk |
The outcome, NSI, is reported by study weeks. There is no information about number of FTE or number of devices used. Although the staff‐to‐patient ratios were similar, we do not know if the number or type of procedures were similar in both groups. |
