Farinas 2012.
Methods | STUDY DESIGN: RCT Risk of Bias: HIGH |
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Participants | PROVIDERS: all physicians in the hospital PARTICIPANTS: 1185 patients receiving at least 3 days of IV antibiotics (571 intervention, 614 control) CLINICAL PROBLEM: adherence to recommendations for change of therapy SETTING: 1 university hospital in Spain | |
Interventions | FORMAT: no valid prescribing outcome data. Educational outreach (review and recommend change)
DELIVERER: specialist (ID) physicians
COMPARISON: usual care
DESIRED CHANGE: increase appropriate antibiotic treatment SAMPLE SIZE: 571 intervention, 614 control POWER CALCULATION: no power calculation. No adjustment for intracluster correlation |
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Outcomes | PRESCRIBING: Choice but no valid outcome data (% adherence with recommendations, but no data about antibiotic use in terms of choice, route, or duration of treatment) CLINICAL: Balancing: length of stay and % treatment failure |
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Notes | FINANCIAL SUPPORT: Funding: Fondo de Investigaciones Sanitarias (FIS PI06/90094), and Instituto de Formación e Investigación Marqués de Valdecilla (IFIMAV) (API 06/03). Competing Interests: none declared 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 | Computer |
Allocation concealment (selection bias) | High risk | Randomisation stratified by clinical units, not blinded. Participants were randomised by groups (stratified randomisation by clinical units) to intervention or non‐intervention using the EPIDAT 3.1 programme (Dirección Xeral de Saúde Pública, Xunta de Galicia & Organización Panamericana de la Salud. Santiago de Compostela, Coruña, Spain, 2003). |
Blinding (performance bias and detection bias) All outcomes | High risk | Randomisation not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported on all participants. |
Selective reporting (reporting bias) | Unclear risk | The primary outcome (clinical failure) was complex and not entirely objective. |
Other bias | High risk | Unit of analysis error, no adjustment for intracluster correlation |
Baseline Outcomes similar? | Unclear risk | No data |
Free of contamination? | Low risk | 19 participants in the control group were excluded because they had ID consultation. |
Baseline characteristics similar? | Low risk | Table 1 |