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 |
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| 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 |
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| 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 | ||