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

Toltzis 2002.

Methods STUDY DESIGN: NRT
Risk of Bias: HIGH
Participants PROVIDERS: all physicians (paediatricians) on the ICU
 PARTICIPANTS: all neonates in the ICU
 CLINICAL PROBLEM: neonates with proven or suspected infections caused by gram‐negative bacteria
 SETTING: 1 neonatal ICU in 1 hospital in the USA
Interventions FORMAT: no valid prescribing data. Restrictive by removal, monthly rotation of the antibiotic regimen used for empirical prescribing of patients with proven or suspected gram‐negative infections
DELIVERER: specialist physician (ICU)
 COMPARISON: standard practice
 DESIRED CHANGE: reduce excessive (colonisation with multiresistant bacteria)
Outcomes MICROBIAL: incidence of colonisation with multiantibiotic‐resistant aerobic gram‐negative bacilli
Notes FINANCIAL SUPPORT: Funding: grant HD 31323‐05 from the National Institutes of Health Competing Interests: no information
ADDITIONAL DATA: no response from authors to request for additional data
Microbial Risk of Bias: MEDIUM Case definition Low, Planned intervention Low, Other infection control Unclear
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk NRT with monthly rotation of regimens
Allocation concealment (selection bias) High risk Not possible with this study design
Blinding (performance bias and detection bias) 
 All outcomes High risk Not possible with this study design
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Not stated whether screening samples obtained from all patients
Selective reporting (reporting bias) Unclear risk Not stated whether screening samples obtained from all patients
Other bias Unclear risk NOT CLEAR Microbial Outcome Risk of Bias Criteria Case definition: DONE Colonisation by screening. "For the purpose of this study, an 'antibiotic‐resistant Gram‐negative organism' was defined as any Gram‐negative bacillus resistant to gentamicin, piperacillin‐tazobactam, or ceftazidime. Pharyngeal and rectal swab specimens were obtained on all infants every Monday, Wednesday, and Friday". Planned intervention: DONE; Other infection control, Isolation: IC practices: NOT CLEAR Not described, but it is reasonable to assume that they were the same for the intervention and control groups due to the controlled clinical trial design.
Baseline Outcomes similar? Unclear risk Not stated
Free of contamination? Unclear risk Not stated, but doctors likely to have been managing patients in more than 1 study phase.
Baseline characteristics similar? Low risk Results, paragraph 1