Raviv 2012.
| Study characteristics | |||
| Patient sampling | Retrospective cross‐sectional study conducted between 01/01/2010 and 30/10/2010 | ||
| Patient characteristics and setting | 300 patients; males n = 112 (37.34%), females n = 188 (62.66%). Mean age of females was 54.38 ± 19.6 years and of males 53.7 ± 17.60 years Inclusion criteria: patients with suspected clinical presentation of PE and with low or intermediate pre‐test clinical probability of PE calculated with a modified Wells CPR Exclusion criteria: Patients with a high probability based on the Wells score were drawn out of the study, as they were not candidates for D‐dimer testing according to the guidelines. Patients for whom evaluation was incomplete or for whom any required data were insufficient were also excluded Patients with suspected clinical presentation of PE were recruited from the emergency room of BamBam Medical Centre, Northern Israel |
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| Index tests | LIA test D‐di (Stago Diagnostica, Asnieres‐sur‐Seine, France) thresholds between 800 ng/mL and 1000 ng/mL were used to determine the most appropriate D‐dimer value that study authors regarded as "standard" | ||
| Target condition and reference standard(s) | The reference standard was reported as "imaging studies ‐ default angiograms" | ||
| Flow and timing | Timing between index and reference standard tests was not reported | ||
| Comparative | |||
| Notes | Patients were stratified according to age as follows: 65 years and older, 40 to 65 years old, younger than 40 years. A linear relationship was noted between patient age and D‐dimer values, and a statistically significant difference in D‐dimer levels was observed between the older patient group and each of the other groups | ||
| 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 | ||
| Unclear | Unclear | ||
| 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 | |||