OBJECTIVE: We compared patient outcomes using two protocols: one routinely and the other selectively evaluating the calves completely during sonographic assessment of the lower extremities in patients with suspected deep venous thrombosis. SUBJECTS AND METHODS: In this randomized prospective study, patients were assigned to two groups. In one group, the deep calf veins were routinely evaluated in their entirety, and in the other group the calf was not evaluated unless the patient had symptoms or physical signs in the calf, in which case only the areas of symptoms or physical signs were evaluated. Patients were followed up for 3 months by medical record review, physician surveys, and telephone calls. An adverse outcome was a propagated deep venous thrombosis into the thigh or a pulmonary embolus. Examination times were recorded when possible. RESULTS: Of the 235 patients in the group in which the deep calf veins were routinely evaluated, we saw no adverse outcomes (0.0%; 97.5% one-sided confidence interval [CI], 0.6-1.6%). Of the 261 patients in the group in which the calf was only evaluated if there were signs or symptoms, we saw two adverse outcomes (0.8%; 95% CI, 0.1-2.7%). CONCLUSION: We found no significant difference in adverse outcomes in patients undergoing a protocol in which the deep calf veins were routinely evaluated or a protocol in which the calf was evaluated only if physical signs or symptoms were present.
RCT Entities:
OBJECTIVE: We compared patient outcomes using two protocols: one routinely and the other selectively evaluating the calves completely during sonographic assessment of the lower extremities in patients with suspected deep venous thrombosis. SUBJECTS AND METHODS: In this randomized prospective study, patients were assigned to two groups. In one group, the deep calf veins were routinely evaluated in their entirety, and in the other group the calf was not evaluated unless the patient had symptoms or physical signs in the calf, in which case only the areas of symptoms or physical signs were evaluated. Patients were followed up for 3 months by medical record review, physician surveys, and telephone calls. An adverse outcome was a propagated deep venous thrombosis into the thigh or a pulmonary embolus. Examination times were recorded when possible. RESULTS: Of the 235 patients in the group in which the deep calf veins were routinely evaluated, we saw no adverse outcomes (0.0%; 97.5% one-sided confidence interval [CI], 0.6-1.6%). Of the 261 patients in the group in which the calf was only evaluated if there were signs or symptoms, we saw two adverse outcomes (0.8%; 95% CI, 0.1-2.7%). CONCLUSION: We found no significant difference in adverse outcomes in patients undergoing a protocol in which the deep calf veins were routinely evaluated or a protocol in which the calf was evaluated only if physical signs or symptoms were present.