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

Annane 2013.

Methods STUDY DESIGN: RCT
Risk of Bias: HIGH
Participants PROVIDERS: all physicians in participating ICUs
 PARTICIPANTS: all patients in the ICUs with sepsis. Over a 3‐year period, 62/1250 screened patients were eligible for the study, of whom 31 were randomised to each arm
 CLINICAL PROBLEM: sepsis
 SETTING: 8 hospitals in France
Interventions FORMAT, Interventions: structural ‐ rapid testing of PCT with decision support algorithm
Intervention Functions: enablement, environmental restructuring
DELIVERER: departmental physician
 COMPARISON: usual care
 DESIRED CHANGE: decrease excessive
POWER CALCULATION: yes, 140 participants in total (70 in each arm) would be needed (details in Appendix 3)
Outcomes PRESCRIBING: exposure, % receiving antibiotics at day 5
CLINICAL: mortality, length of ICU stay, length of hospital stay
MICROBIAL: colonisation with MRSA (nasal swab) and GNRB (rectal swabs)
Notes FINANCIAL SUPPORT: Funding: commercial, Thermo Fisher B.R.A.H.M.S. France, a subsidiary of the maker of the PCT assay used in this study. Competing interests: none declared
ADDITIONAL INFORMATION: supplementary online file has PCT algorithm, authors provided full study protocol (in French)
Microbial Risk of Bias: MEDIUM (no data about infection control)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated
Allocation concealment (selection bias) Low risk Central allocation
Blinding (performance bias and detection bias) 
 All outcomes High risk PCT levels not reported on control participants.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No participants lost to follow‐up.
Selective reporting (reporting bias) Low risk No participants lost to follow‐up.
Other bias High risk Study stopped prematurely because of low recruitment.
Baseline Outcomes similar? Unclear risk No data
Free of contamination? Low risk PCT levels not reported on control participants.
Baseline characteristics similar? Low risk Table 1