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. 2017 Feb 9;2017(2):CD003543. doi: 10.1002/14651858.CD003543.pub4

Senn 2004.

Methods STUDY DESIGN: RCT
Risk of bias: MEDIUM
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
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)
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
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