Prospective validation of wells criteria in the evaluation of patients with suspected pulmonary embolism

Study objective: The literature suggests that the D-dimer is useful in patients suspected of having pulmonary embolism and who have a low pretest probability of disease. A previously defined clinical decision rule, the Wells Criteria, may provide a reliable and reproducible means of determining this pretest probability. We evaluate the interrater agreement and external validity of Wells Criteria in determining pretest probability in patients suspected of having pulmonary embolism. Methods: This was a prospective observational study. Trained research assistants enrolled patients during 120 random 8-hour shifts. Patients who underwent imaging for pulmonary embolism after a medical history, physical examination, and chest radiograph were enrolled. Treating providers and research assistants determined pretest probability according to Wells Criteria in a blinded fashion. Two D-dimer assays were run. Three-month follow-up for the diagnosis of pulmonary embolism was performed. Interrater agreement tables were created. K Values, sensitivities, and specificities were determined. Results: Of the 153 eligible patients, 3 patients were missed, 16 patients declined, and 134 (88%) patients were enrolled. Sixteen (12%) patients were diagnosed with pulmonary embolism. The K values for Wells Criteria were 0.54 and 0.72 for the trichotomized and dichotomized scorings, respectively. When Wells Criteria were trichotomized into low pretest probability (n=59, 44%), moderate pretest probability (n=61, 46%), or high pretest probability (n=14, 10%),the pulmonary embolism prevalence was 2%, 15%, and 43%, respectively. When Wells Criteria were dichotomized into pulmonary embolism-unlikely (n=88, 66%) or pulmonary embolism-likely (n=46, 34%), the prevalence was 3% and 28%, respectively. The immunoturbidimetric and rapid enzyme-linked immunosorbent assay D-dimer assays had similar sensitivities (94%) and specificities (45% versus 46%). Conclusion: Wells Criteria have a moderate to substantial interrater agreement and reliably risk stratify pretest probability in patients with suspected pulmonary embolism.