The application of a Dutch consensus diagnostic strategy for pulmonary embolism in clinical practice.

In The Netherlands, the 'Dutch consensus strategy' was formulated in 1993 as a diagnostic strategy for patients with suspected pulmonary embolism. Four years after its introduction, the application of this strategy was investigated. A questionnaire was sent to the hospital management and the departments of internal medicine and pulmonology of all Dutch hospitals. In total, 384 questionnaires were sent out. The response rates of the internists and pulmonologists were 63 and 65%, respectively. The specialists reported to have followed the consensus strategy in 75% of the patients seen the month prior to the questionnaire. However, analysis of only the last patient with the suspicion of pulmonary embolism revealed that the consensus strategy was followed in 55 of the 162 patients. As well, an overuse and an underuse of the different diagnostic facilities was documented. Furthermore almost a quarter of the patients were treated without an ascertained diagnosis, whereas 11% were not treated despite an improper exclusion of venous thrombo-embolism. Compared to a survey in 1994, the use of the 'Dutch consensus strategy' has not improved dramatically. In 34% of the patients, the consensus strategy was strictly followed (i.e. without any additional investigation); however in 67% of the patients a proper diagnosis was achieved. In any diagnostic strategy, two aspects should be considered. First the availability of the different facilities. Second the acceptance of the strategy by the physicians, involved in the diagnosis of patients with clinically suspected pulmonary embolism.

Bleeding classification in clinical trials: observer variability and clinical relevance.

To evaluate the bleeding classification in a recent trial on venous thrombosis treatment, a selection of reported bleeding episodes was adjudicated twice by an independent committee and graded by the treating physician and independent clinical experts on the clinical severity and impact on the patient's life. The kappa values for the dichotomy major bleeding versus minor or no bleeding were 0.79 (95% CI, 0.57-1.0) for the agreement between the two members of the adjudication committee and 0.77 (95% CI, 0.52-1.0) for the agreement between both adjudication sessions. The kappa values for the dichotomy major or minor bleeding versus no bleeding were 0.42 and 0.44. The weighted kappa values for the agreement between the treating physician and the independent experts were 0.76 for the clinical severity and 0.79 for the impact on the patient's life (95% CI, 0.63-0.88 and 0.70-0.89). The association between the adjudication result expressed as major bleeding or minor or no bleeding and the clinical grading by the treating physician resulted in an ROC curve with an area under the curve of 0.98 for the clinical severity and 0.99 for the impact on the patient's life. The dichotomy major or minor bleeding versus no bleeding resulted in areas under the curve of 0.70 and 0.66. In conclusion, the applied criteria for major bleeding are reproducible and clinically relevant. The criteria for minor bleeding are not reproducible and are less associated with the observed clinical relevance.