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Results of 2 Randomized Controlled Trials of Test Performance Characteristics

Colin M. Sox, MD, MS; Thomas D. Koepsell, MD, MPH; Jason N. Doctor, PhD; Dimitri A. Christakis, MD, MPH

Arch Pediatr Adolesc Med. 2006;160:487-492.

Objective  To determine whether presenting test performance characteristics influences clinical management.

Design  Two questionnaire-based, randomized controlled trials.

Setting  Mailed surveys with 2 clinical vignettes.

Participants  Randomly selected US pediatricians (N=1502).

Intervention  Vignette-specific, randomly assigned test information: no additional information (control), test characteristics (TC), or TC defined. In the pertussis vignette, the TC group received the direct fluorescent antibody test's sensitivity and specificity, and the TC defined group received the same information with definitions. In the urinalysis vignette, the TC group received the false-positive rate of persistent microhematuria in predicting renal disease, and the TC defined group received a definition of this information.

Main Outcome Measures  In the pertussis vignette, diagnostic test choice and management of erythromycin therapy and hospital discharge plans. In the urinalysis vignette, serum laboratory testing and nephrology referral plans.

Results  Six hundred fifty-three participants (49.5% of those eligible) returned completed surveys. In the pertussis vignette, significantly more of the TC (73%) and TC defined (71%) groups ordered the best-performing test than did controls (21%) (P<.001 for both comparisons). Receiving test characteristics did not significantly affect erythromycin therapy or hospital discharge plans (P.40). In the urinalysis vignette, the TC defined group referred to nephrology (30%) and checked laboratory tests (88%) significantly more often than did controls (19%, P=.01; 78%, P=.01, respectively), but the TC and control groups' testing and referral plans did not differ significantly (22% vs 19%, P=.36; 75% vs 78%, P=.48, respectively).

Conclusion  Providing test performance characteristics influenced certain clinical decisions, sometimes in unexpected ways.

Author Affiliations: Center for Child Health Care Studies, Department of Ambulatory Care and Prevention, Harvard Medical School, and Harvard Pilgrim Healthcare, Boston, Mass (Dr Sox); Departments of Epidemiology (Dr Koepsell), Medical Education (Dr Doctor), and Health Services (Dr Koepsell), and Pediatrics (Dr Christakis), University of Washington, and Child Health Institute and Children's Hospital and Regional Medical Center (Dr Christakis), Seattle.

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