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The bedside investigation of pulmonary embolism diagnosis study: a double-blind randomized controlled trial comparing combinations of 3 bedside tests vs ventilation-perfusion scan for the initial investigation of suspected pulmonary embolism.
Arch Intern Med. 2006 Jan 23; 166(2):181-7.AI

Abstract

BACKGROUND

We sought to determine whether using combinations of 3 bedside tests (7-variable clinical model, non-enzyme-linked immunosorbent assay D-dimer test, and alveolar dead-space fraction) to exclude pulmonary embolism (PE) before diagnostic imaging was as safe as a standard strategy of starting with ventilation-perfusion (V/Q) scan.

METHODS

In this double-blind, randomized, controlled equivalency trial, patients were randomized to initial bedside tests or to initial V/Q scan without bedside tests. Patients assigned to the bedside test group had a sham V/Q scan performed if at least 2 of 3 bedside test results were negative; otherwise, they underwent an actual V/Q scan. Further diagnostic management was determined by a blinded physician after V/Q scan. The primary outcome measure was recurrent venous thromboembolic events during 3 months among patients who were not taking anticoagulant agents after the initial investigations were completed.

RESULTS

Four hundred fifty-eight consecutive adults with suspected PE were eligible for the study; 398 of 399 consenting and randomized patients completed the study. The follow-up venous thromboembolic event rate was 2.4% in the bedside test group vs 3.0% in the V/Q scan group (P = .76). Pulmonary embolism was excluded in 34% (67/199) of the bedside test group patients with at least 2 negative results on 3 bedside tests vs 18% (35/199) excluded using only the 7-variable clinical model and the D-dimer test.

CONCLUSION

Excluding PE with at least 2 negative results on 3 bedside tests safely eliminates the need for diagnostic imaging in 34% of patients with suspected PE.

Authors+Show Affiliations

University of Ottawa, Ottawa Health Research Institute, and Department of Medicine, Ottawa Hospital, Ottawa, Ontario, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16432086

Citation

Rodger, Marc A., et al. "The Bedside Investigation of Pulmonary Embolism Diagnosis Study: a Double-blind Randomized Controlled Trial Comparing Combinations of 3 Bedside Tests Vs Ventilation-perfusion Scan for the Initial Investigation of Suspected Pulmonary Embolism." Archives of Internal Medicine, vol. 166, no. 2, 2006, pp. 181-7.
Rodger MA, Bredeson CN, Jones G, et al. The bedside investigation of pulmonary embolism diagnosis study: a double-blind randomized controlled trial comparing combinations of 3 bedside tests vs ventilation-perfusion scan for the initial investigation of suspected pulmonary embolism. Arch Intern Med. 2006;166(2):181-7.
Rodger, M. A., Bredeson, C. N., Jones, G., Rasuli, P., Raymond, F., Clement, A. M., Karovitch, A., Brunette, H., Makropoulos, D., Reardon, M., Stiell, I., Nair, R., & Wells, P. S. (2006). The bedside investigation of pulmonary embolism diagnosis study: a double-blind randomized controlled trial comparing combinations of 3 bedside tests vs ventilation-perfusion scan for the initial investigation of suspected pulmonary embolism. Archives of Internal Medicine, 166(2), 181-7.
Rodger MA, et al. The Bedside Investigation of Pulmonary Embolism Diagnosis Study: a Double-blind Randomized Controlled Trial Comparing Combinations of 3 Bedside Tests Vs Ventilation-perfusion Scan for the Initial Investigation of Suspected Pulmonary Embolism. Arch Intern Med. 2006 Jan 23;166(2):181-7. PubMed PMID: 16432086.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The bedside investigation of pulmonary embolism diagnosis study: a double-blind randomized controlled trial comparing combinations of 3 bedside tests vs ventilation-perfusion scan for the initial investigation of suspected pulmonary embolism. AU - Rodger,Marc A, AU - Bredeson,Christopher N, AU - Jones,Gwynne, AU - Rasuli,Pasteur, AU - Raymond,François, AU - Clement,Anne Marie, AU - Karovitch,Alan, AU - Brunette,Helene, AU - Makropoulos,Dimitri, AU - Reardon,Mark, AU - Stiell,Ian, AU - Nair,Rama, AU - Wells,Philip S, PY - 2006/1/25/pubmed PY - 2006/2/24/medline PY - 2006/1/25/entrez SP - 181 EP - 7 JF - Archives of internal medicine JO - Arch Intern Med VL - 166 IS - 2 N2 - BACKGROUND: We sought to determine whether using combinations of 3 bedside tests (7-variable clinical model, non-enzyme-linked immunosorbent assay D-dimer test, and alveolar dead-space fraction) to exclude pulmonary embolism (PE) before diagnostic imaging was as safe as a standard strategy of starting with ventilation-perfusion (V/Q) scan. METHODS: In this double-blind, randomized, controlled equivalency trial, patients were randomized to initial bedside tests or to initial V/Q scan without bedside tests. Patients assigned to the bedside test group had a sham V/Q scan performed if at least 2 of 3 bedside test results were negative; otherwise, they underwent an actual V/Q scan. Further diagnostic management was determined by a blinded physician after V/Q scan. The primary outcome measure was recurrent venous thromboembolic events during 3 months among patients who were not taking anticoagulant agents after the initial investigations were completed. RESULTS: Four hundred fifty-eight consecutive adults with suspected PE were eligible for the study; 398 of 399 consenting and randomized patients completed the study. The follow-up venous thromboembolic event rate was 2.4% in the bedside test group vs 3.0% in the V/Q scan group (P = .76). Pulmonary embolism was excluded in 34% (67/199) of the bedside test group patients with at least 2 negative results on 3 bedside tests vs 18% (35/199) excluded using only the 7-variable clinical model and the D-dimer test. CONCLUSION: Excluding PE with at least 2 negative results on 3 bedside tests safely eliminates the need for diagnostic imaging in 34% of patients with suspected PE. SN - 0003-9926 UR - https://www.unboundmedicine.com/medline/citation/16432086/The_bedside_investigation_of_pulmonary_embolism_diagnosis_study:_a_double_blind_randomized_controlled_trial_comparing_combinations_of_3_bedside_tests_vs_ventilation_perfusion_scan_for_the_initial_investigation_of_suspected_pulmonary_embolism_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/archinte.166.2.181 DB - PRIME DP - Unbound Medicine ER -