The Effect of Definitions and Cancer Prevalence on Diagnostic Yield Estimates of Bronchoscopy: A Simulation-based Analysis.

Abstract

Rationale: Studies of bronchoscopy have reported diagnostic yield (DY) using different calculation methods, which has hindered comparisons across studies. Objectives: To quantify the effect of the variability of four methods on DY estimates of bronchoscopy. Methods: We performed a simulation-based analysis of patients undergoing bronchoscopy using variations around base case assumptions for cancer prevalence (60%), distribution of nonmalignant findings, and degree of follow-up information at a fixed sensitivity of bronchoscopy for malignancy (80%). We calculated DY, the rate of true positives and true negatives (TNs), using four methods. Method 1 considered malignant and specific benign findings at index bronchoscopy as true positives and TNs, respectively. Method 2 included nonspecific benign findings as TNs. Method 3 considered nonspecific benign findings cases as TNs only if follow-up confirmed benign disease. Method 4 counted all cases with a nonmalignant diagnosis as TNs if follow-up confirmed benign disease. A scenario analysis and probabilistic sensitivity analysis were conducted to demonstrate the effect of parameter estimates on DY. A change in DY of >10% was considered clinically meaningful. Results: Across all pairwise comparisons of the four methods, a DY difference of >10% was observed in 76.7% of cases (45,992 of 60,000 comparisons). Method 4 resulted in DY estimates that were >10% higher than estimates made with other methods in >90% of scenarios. Variation in cancer prevalence had a large effect on DY. Conclusions: Across a wide range of clinical scenarios, the categorization of nonmalignant findings at index bronchoscopy and cancer prevalence had the largest impact on DY. The large variability in DY estimates across the four methods limits the interpretation of bronchoscopy studies and warrants standardization.