Franz 2004.
Methods | STUDY DESIGN: RCT Risk of Bias: MEDIUM |
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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) |
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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 |
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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 |
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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 |