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. 2019 Apr 9;2019(4):CD011427. doi: 10.1002/14651858.CD011427.pub2

Berglund 2014.

Study characteristics
Patient sampling Sweden, Stockholm county, for 6 months in 2008
Sampling: people calling the Swedish equivalent of 911 in Sweden, Stockholm county were sampled.
(EMCC procedure prior to ambulance assessment: when the nurse at the EMCC suspected stroke with onset within 6 hours the inclusion criteria were checked. If the criteria were met, the nurse opened a sealed envelope of the priority level. The FAST test was then an optional tool for the nurse at the EMCC to use for identifying symptoms of stroke. The nurse was free to include the participant on her/his own suspicion of stroke. As the study aimed to analyze priority code and delay, the FAST test was not mandatory for the EMCC as it might have caused a delay).
Almost one‐third of the participants in the study were identified and included from the ambulance, when missed from the EMCC. The ambulance contacted the EMCC to have a code for randomization and the priority level. All participants included in the study were tested for FAST by the ambulance personnel (hence, the sampling considered consecutive; this was confirmed by authors).
Patient characteristics and setting Inclusion and exclusion criteria: suspected stroke with symptom onset within 6 hours; ages 18–85 years; previous independence in activities of daily living; and no other acute condition requiring a priority level 1 (see HASTA study).
Participant characteristics: ages 22–93 years; 55.5% men
Index tests Index test: FAST (prespecified threshold, positive if ≥ 1)
Test administrator: registered specialist nurse and a registered general nurse or an ambulance educated staff, a paramedic.
Training: all personnel at the ambulance companies supplying the Stockholm area with ambulance transport participated in 1 lecture about stroke and the FAST test, prior to start of the study. The personnel at the EMCC were also given education of stroke and FAST, adjusted for testing FAST by telephone, prior to study start. All emergency calls concerning medical issues were connected to and evaluated by a registered nurse.
Target condition and reference standard(s) Target condition: stroke or TIA
Reference standard: CT brain scan and in some cases CTA or MRI, neurologic exam, if necessary, EEG (differential diagnosis), laboratory tests. People with obvious signs of other conditions than stroke, such as diabetes or alcohol intoxication might not have been evaluated by a CT scan. All participants received a final diagnosis by a neurologist or stroke specialist.
Flow and timing Withdrawals: 39 (4.3%) left at home or deviated from the ER before seeing a doctor, considered as non‐stroke diagnoses.
Comparative  
Diagnostic test accuracy data Prevalence of stroke/TIA: 472/900 (52%)
FAST: TP = 387; FP = 255; FN = 85; TN = 173
Combined data from EMCC (nurse) and ambulance (paramedic)
Notes Categorization of alternate diagnoses: 472 (52%) stroke/TIA, 166 (18%) neurology, 223 (25%) non‐neurology; 39 (4%) unknown
Funding: declared, provided by the authors as supplementary data.
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Prospective design Yes    
    Low Low
DOMAIN 2: Index Test Index 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    
    Low Low
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    
    Low Low
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? Yes    
Did all patients receive a reference standard? Yes    
    Low