Senn 2004.
Methods | STUDY DESIGN: RCT Risk of bias: MEDIUM |
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Participants | PROVIDERS: residents on medical and surgical wards
PATIENTS: 251 patients were recruited, 126 intervention and 125 control CLINICAL PROBLEM: adult patients receiving IV antibiotics for 3 to 4 days with no modification since starting treatment SETTING: single 800‐bed university hospital in Switzerland. Data collected over 5 months. POWER CALCULATION: yes, 135 patients in each group, but the trial was underpowered because the observed effect was lower than predicted. Details in Appendix 3 |
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Interventions | FORMAT: Interventions: dissemination of questionnaire about guidelines; reminders (circumstantial and physical, questionnaire mailed to the resident in charge of patients who were receiving IV antibiotic treatment. The questionnaire asked 3 questions regarding possible adaptation of antibiotic therapy on day 3 or 4, and was collected 24 hours later. If the resident had not yet completed it at that time, he/she was reminded once to do so.)
Intervention Functions: education, enablement, environmental restructuring DELIVERER: AMT COMPARISON: control patients with no intervention DESIRED CHANGE: reduction in established management (reduction in duration of IV therapy) TIMING: intervention at the point of decision making (potential modification 3 to 4 days after start of antibiotics) |
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Outcomes | PRESCRIBING: Choice: % of patients discontinuing IV antibiotics and hazard ratio adjusted for patients' Karnofsky functional index | |
Notes | FINANCIAL SUPPORT: Funding: Quality Improvement Committee of the Lausanne University Hospital and grant 32–63128.00 of the Swiss National Science Foundation. Competing Interests: no information ADDITIONAL DATA: no response from authors to request for additional data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients allocated ... by using a computer generated randomizations list" |
Allocation concealment (selection bias) | Low risk | "Concealment of allocation was achieved as the physician in charge of the patient was involved after randomizations" |
Blinding (performance bias and detection bias) All outcomes | High risk | "This was a randomised, controlled, open trial" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Primary outcome measure (duration of IV antibiotics) collected on all patients. Only 70% of questionnaires returned for the intervention group, which could account for the intervention effect being lower than expected. However, this did not affect outcome assessment. |
Selective reporting (reporting bias) | Low risk | Complete primary outcome data |
Other bias | High risk | The study was underpowered. |
Baseline Outcomes similar? | Low risk | Pre‐study group, data collected for 2 months before intervention to estimate the magnitude of possible observation bias (Figure 2). |
Free of contamination? | Low risk | The pre‐intervention group data were comparable to the control group, suggesting minimal observation bias. |
Baseline characteristics similar? | Low risk | Presented in Table 1 |