Toltzis 2002.
Methods | STUDY DESIGN: NRT Risk of Bias: HIGH |
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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) |
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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 |
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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 |