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

Franz 2004.

Methods STUDY DESIGN: RCT
Risk of Bias: MEDIUM
Participants PROVIDERS: physicians in neonatal units
 PARTICIPANTS: 1291 neonates < 72 hours of age were randomised (656 intervention, 635 control)
CLINICAL PROBLEM: suspected bacterial infection
SETTING: 8 centres in 5 countries (Australia, Austria, Belgium, Germany, Sweden)
Interventions FORMAT, Interventions: dissemination of guideline; structural, introduction of testing for C‐reactive protein and interleukin‐8 with decision support algorithm
 Intervention Functions: education, enablement, environmental restructuring
DELIVERER: department physician
COMPARISON: usual care
DESIRED CHANGE: decrease excessive
POWER CALCULATION: yes, total of 1150 participants. Details in Appendix 3
Outcomes PRESCRIBING: Exposure: number of newborn infants who received antibiotic therapy
Notes FINANCIAL SUPPORT: Funding: grant P.575 from the Center for Applied Clinical Studies of the University of Ulm and Swedish Research Council. DPC (Los Angeles, CA) provided the Immulite automated analysers and the kits for determination of IL‐8 and sponsored the initial meeting of the investigators. 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 "Randomly assigned to 1 or 2 diagnostic algorithms using sealed opaque envelopes"
Allocation concealment (selection bias) Low risk  
Blinding (performance bias and detection bias) 
 All outcomes Low risk Done, IL‐8 results were only provided to physicians in the intervention group.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk  
Selective reporting (reporting bias) Low risk  
Other bias Low risk  
Baseline Outcomes similar? High risk No data
Free of contamination? Low risk  
Baseline characteristics similar? Low risk