Sohne 2004.
| Study characteristics | |||
| Patient sampling | Prospective cross‐sectional study | ||
| Patient characteristics and setting | 538 patients (72% of 747); 72% of study participants (people at low risk of PE) were outpatients. Mean age of people with PE was 62 years (range 14 to 95), those without PE had a mean age of 52 years (17 to 92) Inclusion criteria: a consecutive sample of patients recruited from the Amsterdam Medical Centre (AMC) with clinical suspicion of PE, but non‐high clinical probability Exclusion criteria: younger than 18 years of age, pregnant, had received vitamin K antagonists or heparin at a therapeutic dose for longer than 24 hours, had already undergone objective testing for venous thromboembolism, had an indication for thromboembolism, written informed consent could not be obtained CPR used to calculate a pre‐test probability was Wells, and a score ≤ 4 was regarded as a non‐high probability of PE |
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| Index tests | Plasma D‐dimer concentration was measured by a quantitative rapid immunoturbidimetric D‐dimer assay (Tinaquant D‐dimer®, Roche Diagnositica, Mannheim, Germany). The cutoff value for a positive test result was 0.5 mg/L, which was stated but was not justified | ||
| Target condition and reference standard(s) | The reference standard was V/Q scanning in combination with compression ultrasound or pulmonary angiography | ||
| Flow and timing | Timing between index and reference standard tests was not reported | ||
| Comparative | |||
| Notes | Study authors reported 3‐month follow‐up of all patients to document the accuracy and safety of the use of D‐dimer in a low probability group | ||
| 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 | ||
| Low | Low | ||
| DOMAIN 2: Index Test All tests | |||
| 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 | ||
| Unclear | Unclear | ||
| DOMAIN 4: Flow and Timing | |||
| Was there an appropriate interval between index test and reference standard? | Unclear | ||
| Were all patients included in the analysis? | Yes | ||
| Unclear | |||
CTPA: computerised tomography pulmonary angiography CPR: clinical prediction rule CT: computerised tomography CTA: computerised tomography angiography DVT: deep vein thrombosis HIV: human immunodeficiency virus IV: intravenous MDCT: Multiple detector computerised tomography NVP: negative predictive values PA: pulmonary angiography PE: pulmonary embolism V/Q: ventilation/perfusion VTE: venous thromboembolism