Palmay 2014.
Methods | STUDY DESIGN: cluster RCT, stepped wedge, service level Risk of Bias: MEDIUM |
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Participants | PROVIDERS: all physicians in 6 hospital services PARTICIPANTS: all patients in 6 hospital services, 6 clusters (services) CLINICAL PROBLEM: use of targeted antibiotics (carbapenems (ertapenem, meropenem), piperacillin‐tazobactam, 3rd‐generation cephalosporins (ceftazidime, ceftriaxone), fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin), and intravenous vancomycin) SETTING: 1 university hospital in Canada, 6 services: Neurosurgery, Orthopaedics, Nephrology, General Internal Medicine, Cardiology, General Surgery/Trauma | |
Interventions | FORMAT: Interventions: educational outreach by review and recommend change; reminders (circumstantial, physical, written recommendation on each patient reviewed) NB the authors describe their intervention as "audit and feedback", but there was no feedback of data over time about progress to goal, just review with feedback about individual patients. Intervention Functions: enablement, environmental restructuring, persuasion DELIVERER: AMT COMPARISON: usual care DESIRED CHANGE: decrease excessive POWER CALCULATION: no information |
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Outcomes | PRESCRIBING: Choice: use of target antibiotics in days of therapy/1000 OBD MICROBIAL: Clostridium difficile infection and infection with antibiotic‐resistant organisms FINANCIAL: time required to implement the intervention in critical‐care wards is described in Elligson 2012a. |
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Notes | FINANCIAL SUPPORT: Funding: Ontario Ministry of Health and Canadian Institutes of Health Research. Competing Interests: none declared ADDITIONAL DATA: email response with additional details about the intervention from authors including Elligson 2012a describing the design and cost of implementing the intervention in critical‐care wards Microbial Risk of Bias: MEDIUM: case definition low, unplanned intervention low, other infection control UNCLEAR |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The order of implementation of the intervention on the 6 clinical services was determined by random number generation performed by a statistician uninvolved in daily stewardship activities. |
Allocation concealment (selection bias) | Low risk | Following a 6‐month control period during which none of the services received antimicrobial stewardship (1 May 2010 to 31 October 2011), the intervention was introduced to each additional service at 1‐month intervals, beginning on 1 November 2010. By 1 April 2011, clinical rollout was complete. |
Blinding (performance bias and detection bias) All outcomes | High risk | Blinding was not possible. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Prescribing outcome data were from pharmacy computer. |
Selective reporting (reporting bias) | Low risk | Prescribing outcome data were from pharmacy computer. |
Other bias | Low risk | Unit of analysis was service, and clustering was included in the model. "Negative binomial regression, accounting for clustering at the level of service using random effects as well as for secular and seasonal trends, was used to compare overall targeted antimicrobial utilization in the control and intervention periods for the analysis involving patients qualifying for the stewardship intervention as well as the analysis of all admitted patients. The unit of analysis was each service’s mean monthly targeted days of therapy count. The covariates included in these multivariable models were study period, study month (as a continuous variable), and season" |
Baseline Outcomes similar? | Low risk | Table 4 |
Free of contamination? | High risk | Contamination could have occurred during the rollout of intervention over 6 months. |
Baseline characteristics similar? | Low risk |