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. 2020 Mar 9;2020(3):CD013546. doi: 10.1002/14651858.CD013546
Domain Signalling question Criterion
1. Participant selection
1.1. Risk of bias Was a consecutive or random sample of patients enrolled? Yes if consecutive or random sampling is stated in the paper
No if convenient sampling is used instead
Unclear if the sampling procedure is not clearly described
Did the study avoid inappropriate exclusions? Yes if all infants that meet our definition of target population have been included
No if the following groups have been excluded: exclusion of the infants based on cEEG or aEEG findings
Unclear if the inclusion and exclusion criteria and methods of selection are not sufficiently clearly described to make a judgement
1.2. Concerns regarding applicability Is there concern that the included participants do not match the review question? Target population: infants with clinically suspected seizures or infants at risk of seizures
High concern if sample is different from target population
Low concern if sample meets the target population criteria
Unclear if not sufficient detail reported to make a decision
2. Index test
2.1. Risk of bias Were the index test results interpreted without knowledge of the results of the reference standard? Yes if clear from the paper
No if clear that there was no blinding
Unclear if information is not sufficient to make a decision
If threshold was used, was it prespecified? Not relevant, as diagnosis of seizure is not a continuous outcome
2.2. Concerns regarding applicability Is there concern that the index test, its conduct or interpretation differ from the review question? Index test: aEEG with or without raw trace/automated seizure detection algorithm, interpreted by neonatal clinicians in real‐time, used for detection of electrical seizures in neonatal infants
High concern if index test and/or its performance different from review question e.g. aEEG derived from cEEG; retrospective interpretation of aEEG
Low concern if index test and/or its performance relevant to review question
Unclear if not sufficient detail reported to make a decision
3. Reference standard
3.1. Risk of bias Is the reference standard likely to correctly classify the target condition? Optimal reference standard: cEEG recorded using at least following 9 electrodes (Fp1, Fp2, C3, C4, Cz, T3 (or T7), T4 (or T8), O1, and O2) and interpreted by a specialist (e.g. neurologist, clinical neurophysiologist) trained or experienced in neonatal cEEG interpretation
Yes if the reference standard meet the above criteria
No if it does not
Unclear if information insufficient to make a decision
Were the reference standard results interpreted without knowledge of the results of the index test? Yes if clear from the paper
No if clear that there was no blinding
Unclear if information is not sufficient to make a decision
3.2. Concerns regarding applicability Is there concern that the target condition as defined by the reference standard does not match the review question? Target condition: electrographic seizures of at least 10 seconds' duration
High concern if target condition different from review question
Low concern if target condition relevant to review question
Unclear if not sufficient detail reported to make a decision
4. Flow and timing
4.1. Risk of bias Was there an appropriate interval between index test(s) and reference standard?
Did all participants receive a reference standard?
 
 Did participants receive the same reference standard?
 
 Were all participants included in the analysis?
Appropriate time interval between index test and reference standard: cEEG and aEEG must be simultaneously recorded
Yes if all participants who were enrolled in the study were also included in the analysis