RATIONALE: The diagnosis of idiopathic pulmonary fibrosis (IPF) remains challenging and can result in delayed or misdiagnosis. IPF diagnosis is based upon the presence of either a radiographic or histologic usual interstitial pneumonia (UIP) pattern in the absence of an identifiable etiology. The Envisia Genomic Classifier is a clinically validated molecular diagnostic test that identifies UIP in transbronchial biopsies. OBJECTIVE: To determine the impact of the Envisia Genomic Classifier on physician's clinical decision making in the diagnosis and management of IPF. METHODS: This prospective randomized decision impact survey was designed to test the hypothesis that including an Envisia UIP positive (UIP+) result will increase IPF diagnoses, diagnostic confidence levels, and the recommendation for antifibrotic therapy. The survey included patients from the BRAVE study who had an HRCT scan without a typical UIP pattern, an Envisia UIP+ result, and a final diagnosis of IPF by multidisciplinary team discussion. Each case was presented in three different formats: a pre-post cohort where each case is presented initially without and then with Envisia, and two independent cohorts where each case is presented without and with Envisia, respectively. RESULTS: U.S. based pulmonologists from community and academic centers in geographically diverse practices were approached for inclusion in this study. 103 (65%) US-based pulmonologists met the inclusion criteria and provided 605 case reviews of 11 patient cases. The number of IPF diagnoses increased with Envisia by an absolute difference of 39% from 47 (30%) pre-Envisia to 107 (69%) post-Envisia in the pre-post cohort and by 13% in the independent cohorts. High confidence (> 90%) of ILD diagnoses was more commonly seen with Envisia in both the pre-post cohort and in the independent cohorts. Recommendation for antifibrotic treatment increased with Envisia by an absolute difference of 36% from 15 (10%) pre-Envisia to 72 (46.4%) post-Envisia in the pre-post cohort and by 11% in the independent cohorts. CONCLUSIONS: This decision impact survey suggests the clinical utility of the Envisia Classifier by demonstrating a significant increase in IPF diagnoses, diagnostic confidence, and recommendation for antifibrotic therapies to assist physicians to effectively manage patients to improve outcomes of patients with IPF.
- Lasky, J. A.
- Case, A.
- Unterman, A.
- Kreuter, M.
- Scholand, M. B.
- Chaudhary, S.
- Lofaro, L. R.
- Johnson, M.
- Huang, J.
- Bhorade, S. M.
- Kennedy, G. C.