Akyildiz 2018.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, single‐site, non‐inferiority, 'per‐protocol' approach Setting: PICU, tertiary (university‐affiliated hospital), Kayseri, Turkey Recruitment: January 2014 to December 2015 Maximum follow‐up: in‐hospital stay |
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Participants | 180 children in paediatric ICU randomised; 160 completed follow‐up
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Interventions |
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Outcomes |
Primary outcomes: cardiac output and other haemodynamic measures Secondary outcome: in‐hospital mortality |
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Notes |
Trial registration: not confirmed. Internal (university) documentation: registration TSA‐2014‐5299 Trial funding/Sponsor: Erciyes University Scientific Research Unit Conflict of interest: study authors declare they have none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "Randomization was provided by a coin toss" (Akyildiz 2018 p 2) |
Allocation concealment (selection bias) | High risk | No information was provided beyond the statement above |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Blinding of personnel for this intervention is not feasible, but in our view, for objective outcomes such as mortality (the primary outcome used within this review), we graded risk of bias as 'low' |
Blinding of outcome assessment (detection bias) Objective measures | Low risk | Blinding of mortality (the primary outcome used within this review) is not relevant, and we will grade risk of bias as 'low' |
Blinding of outcome assessment (detection bias) Subjective measures | Low risk | "Cardiologists who assessed the cardiac output measurements were blinded to treatment allocations" (Akyildiz 2018 p 2) No other subjective outcomes were used in this review |
Incomplete outcome data (attrition bias) All outcomes | High risk | There was a differential loss to follow‐up, with more losses in the restrictive arm (1 loss in the liberal arm and 19 in the other) |
Selective reporting (reporting bias) | Unclear risk | No evidence of prospective registration; trial protocol unavailable; information insufficient to make a judgement |
Other bias | Low risk | None apparent |