| Ginsberg JS et al, 1998, Canada | 1250 consecutive referred patients to teaching hospital thromboembolic clinic with putative diagnosis of PE (73 lost to follow up) | Cohort | Diagnostic utility of a combination of low clinical probability of PE on clinical assessment with −ve SimpliRED d-dimer | Negative predictive value of 99% | Exclusion criteria “lost” 484 of original 1881 patients screened then further 147 excluded because of non-consent |
| Wells PS et al, 2000, Canada | 1211 patients with presumptive diagnosis of PE broken into derivation and validation set | Diagnostic test | Sensitivity of clinical decision rule with addition of SimpliRED latex agglutination test E | 87.8%–88.3% (validation-derivation) | Actual methodology not fully demonstrated, for example, gold standard definition predictive values and likelihood ratios not given |
| Farrell S, 2000, USA | 198 patients presenting to US ED with suspected thromboembolic disease | Diagnostic test | Diagnostic utility of a combination of low clinical probability of PE on clinical assessment with −ve SimpliRED d-dimer | Negative predictive value 97% | Estimation of clinical probability was with implicit not explicit methods |
| | | | Sensitivity 84% | |
| | | | | 12% patients “lost” in study |
| MacGillavry MR, 2001, Netherlands | 404 adults, both in and outpatients in teaching hospitals with putative diagnosis of thromboembolic disease | Diagnostic test | Sensitivity and specificity of using a clinical probability and SimpliRED d-dimer test | Sensitivity 98% | Over 50% exclusion rate for entry into study. Implicit methods only for determining clinical probability |
| | | | Specificity 11% | |
| Wells P, 2001, Canada | 946 adult patients referred for assessment of ? PE | Cohort | Diagnostic utility of a combination of low clinical probability of PE on clinical assessment with −ve SimpliRED d-dimer | Negative predictive value 99.5%. | Investigation protocol violations occurred in nearly 10% of the patients |