Lee 2015.
| Study characteristics | |||
| Patient sampling | Dongguk University Ilsan Hospital, Korea, from August 2013 to February 2014 Sampling: prospective, consecutive sample (people who had come to the emergency care center directly). |
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| Patient characteristics and setting |
Inclusion criteria: age ≥ 18 years; presentation symptoms: weakness of extremities, dysarthria, sensory changes, alternation of consciousness, speech disturbance, visual disturbance, gait disturbance, dizziness, severe headache, syncope; hospital arrival within 12 hours from symptom onset. Exclusion criteria: age < 18 years; symptoms caused by trauma; transfer from other hospitals Participant characteristics: mean age 59.7 (SD 16.1) years in all included participants; 68.6 (SD 13.1) years in people with stroke/TIA; 54.6 (SD 15.5) years in people without stroke/TIA 45.2% men; 61.0% men in stroke or TIA group; 36.2% men in without stroke/TIA group |
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| Index tests |
Index test: ROSIER, FAST (applied consecutively, information supplied by the authors), usual cutoff ≥ 1 used for both scales Test administrator: emergency physicians (including residents and ER consultants) Training: 3 hours of training on theory of stroke and the acute stroke registration system from an emergency medicine specialist |
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| Target condition and reference standard(s) |
Target condition: stroke/TIA Reference standard: final diagnosis of stroke/TIA signed off by a neurologist after reviewing clinical information and results MRI (confirmed by the authors). Classification of stroke was according to Oxford Community Stroke Project. |
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| Flow and timing | Interval between index test and reference standard < 14 days. 23 (7%) participants excluded from analysis due to incomplete data (information supplied by the authors upon request) | ||
| Comparative | |||
| Diagnostic test accuracy data |
Prevalence of stroke/TIA: 113/312 (36.2%) ROSIER: TP = 98; FP = 14; FN = 15; TN = 185 FAST: TP = 97; FP = 15; FN = 16; TN = 184 |
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| Notes |
Proportion of ischemic, hemorrhagic and TIA Ischemic 77/312 (24.7%) Hemorrhage 21/312 (6.7%) TIA 14/312 (4.5%) Specific diagnosis in participants diagnosed with stroke or TIA: 32 (28.3%) lacunar stroke, 28 (24.8%) partial anterior circulation stroke, 14 (12.4%) primary ICH, 14 (12.4%) TIA, 13 (11.5%) total anterior circulation stroke, 7 (6.2%) SAH, 4 (4.4%) posterior circulation stroke Categorization of alternate diagnosis for participants who did not have an ischemic stroke: 59/312 (18.9%) non‐specific dizziness, 39/312 (12.5%) primary headache, 30/312 (9.6%) BPPV, 15/312 (4.8%) vestibular neuritis, 12/312 (3.8%) syncope, 8/312 (2.6%) migraine, 7/312 (2.2%) drug intoxication, 6/312 (1.9%) facial palsy, 23/312 (7.4%) other Comorbidities (% in patients with ischemic vs hemorrhagic vs TIA) Hypertension 140 (44.9%) vs 74 (65.5%) vs 66 (33.2%); P < 0.001* Diabetes mellitus 51 (16.3%) vs 26 (23.0%) vs 25 (12.6%); P < 0.025* Previous stroke 33 (10.6%) vs 19 (16.8%) vs 14 (7.0%); P < 0.012* Hyperlipidemia 33 (10.6%) vs 16 (14.2%) vs 17 (8.5%); P < 0.129* Heart disease 21 (6.7%) vs 12 (10.6%) vs 9 (4.5%); P < 0.058* Smoking 53 (17.0%) vs 30 (26.5%) vs 23 (11.6%); P < 0.001* Current medication (% in patients with ischemic vs hemorrhagic vs TIA) Aspirin 35 (11.2%) vs 20 (17.7%) vs 15 (7.5%); P < 0.009* Plavix 15 (4.8%) vs 9 (8.0%) vs 6 (3.0%); P < 0.058* Warfarin 2 (0.6%) vs 0 (0%) vs 2 (1.0%); P < 0.537 *Statistically significant. Funding: not reported |
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| 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? | Unclear | ||
| Unclear | 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? | No | ||
| Did all patients receive a reference standard? | Yes | ||
| High | |||