Annane 2013.
Methods | STUDY DESIGN: RCT Risk of Bias: HIGH |
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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) |
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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) |
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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) |
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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 |