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. 2021 Oct 18;2021(10):CD012679. doi: 10.1002/14651858.CD012679.pub2

Daniels 2016.

Study characteristics
Patient Sampling Consecutive
Patient characteristics and setting Inclusion criteria: suspected stroke
Exclusion criteria: non‐stroke neurological disease; head/neck structural changes; dysphagia unrelated to stroke; TIA/stroke ruled out; not competent/no legally authorised representative; medically unstable; repeat stroke; previously participated in the study; > 3 weeks from symptom onset; > 5 days from admission; childbearing potential female; deceased
Setting: 1 × Michael E DeBakey Veterans Affairs Medical Center – comprehensive stroke centre
Index tests RAS3 and WST from RAS3
Target condition and reference standard(s) Aspiration in patients with suspected stroke
VFSS
Flow and timing 8 patients who received the index test were not reported on. Reasons for no VFSS included C‐spine surgery evident on X‐ray (n = 1) and no oral intake before surgery (n = 1)
Reasons for exclusion from VFSS analyses included dysphagia history prior to stroke (n = 2), equipment failure (n = 1), and C‐spine damage (n = 3)
Interventions between index/reference tests: not reported
Index to reference test time interval within 2 hours of screening; mean (SD) 0.49 (0.24) hours
Comparative  
Notes  
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Did the study avoid inappropriate exclusions? Yes    
Was a two‐gate design avoided? Yes    
Could the selection of patients have introduced bias?   Low risk  
Are there concerns that the included patients and setting do not match the review question?     Low concern
DOMAIN 2: Index Test (All tests)
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
If a threshold was used, was it pre‐specified? Yes    
Could the conduct or interpretation of the index test have introduced bias?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Yes    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Low risk  
Are there concerns that the target condition as defined by the reference standard does not match the question?     Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? No    
Could the patient flow have introduced bias?   Low risk