Vanni 2011.

Study characteristics
Patient sampling	ERs of 3 hospitals located in 3 towns of the northern (Florence), middle (Rome), and southern (Pescara) regions of Italy; July 2006 to September 2006 Sampling: consecutive prospective sample
Patient characteristics and setting	Inclusion and exclusion criteria: Inclusion: presence at triage of acute focal neurologic deficit (including also signs of posterior circulation ischemia: vertigo, double vision, visual field defects or disorders of perception, balance, and co‐ordination) or a local EMS dispatch of suspected stroke. Exclusion: major trauma and coma (GCS ≤ 8); people with terminal illnesses (life expectancy < 3 months) Participant characteristics: age in all participants 72 (SD 14) years, in people with stroke 74 (SD 11) years, in people without stroke 69 (SD 16) years; P = 0.027; men in all participants 59%, in people with stroke 61%, in people without stroke 56%; P = 0.622
Index tests	Index test: CPSS (compared to The Triage® Stroke Panel including quantitative measurement of B‐type natriuretic peptide, fibrin degradation products containing D‐dimer, matrix metalloproteinase‐9 and S100β) Test administrator: trained nurses (at triage) Training: not reported
Target condition and reference standard(s)	Target condition: stroke, defined according to WHO criteria of "a focal or global neurologic deficit with symptoms lasting for 24 h or resulting in death before 24 hrs, which was considered to be due to a vascular cause after investigation" (reference standard positive). All other patients, including people with TIA (defined as clinical syndromes characterized by an acute loss of focal cerebral or monocular function with symptoms lasting < 24 hours and thought to be caused by inadequate blood supply as a result of thrombosis or embolism), were assigned to non‐stroke diagnosis and considered free of the target condition (reference standard negatives). Reference standard: stroke diagnosis established by a consensus of 3 experts (1 emergency physician, 1 specialist in internal medicine and 1 neurologist), blinded to the index test results, after reviewing all clinical data and brain imaging results. Stroke diagnosis established when at least 2 of the 3 experts matched. Non‐contrast‐enhanced CT scanning of the brain by a 12‐channel CT scanner was performed within 1 hour from emergency physician evaluation. MRI, MRA, CTA or conventional angiography was performed when appropriate.
Flow and timing	The mean time from symptom onset to presentation was 7 hours (range 1–24 hours), and only 32% of participants arrived at the hospital within 3 hours. Non‐contrast‐enhanced CT scanning of the brain by a 12‐channel CT scanner was performed within 1 hour from the emergency physician's evaluation.
Comparative
Diagnostic test accuracy data	Prevalence of stroke: 87/155 (56.1%)
Notes	Specific diagnosis in participants diagnosed with stroke/TIA: not reported Categorization of alternate diagnosis for participants who did not have stroke: 23/155 (15%) had TIA; other diagnoses not reported Comorbidities: Previous stroke or TIA: 21% Diabetes mellitus: 16% Atrial fibrillation: 12% SBP: 156 (SD 22) mmHg Funding: not declared
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	High
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