Division of Pulmonary and Critical Care, Department of Medicine, School of Medicine, Tulane University, New Orleans, Louisiana.
Pulmonary, Critical Care, and Sleep Medicine, Piedmont Healthcare, Atlanta, Georgia.
Ann Am Thorac Soc. 2022 Jun;19(6):916-924. doi: 10.1513/AnnalsATS.202107-897OC.
The diagnosis of idiopathic pulmonary fibrosis (IPF) remains challenging and can result in delayed or misdiagnosis. IPF diagnosis is based on 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. To determine the impact of the Envisia Genomic Classifier on physicians' clinical decision-making in the diagnosis and management of IPF. This prospective randomized decision impact survey was designed to test the hypothesis that including an Envisia UIP-positive result will increase IPF diagnoses, diagnostic confidence, and the recommendation for antifibrotic therapy. The survey included patients from the BRAVE (Bronchial Sample Collection for a Novel Genomic Test) study who had a high-resolution computed tomographic scan without a typical UIP pattern, an Envisia UIP-positive 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. U.S.-based pulmonologists from community and academic centers in geographically diverse practices were approached for inclusion in this study. 103 (65%) U.S.-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%) before Envisia to 107 (69%) after Envisia in the pre-post cohort and by 13% in the independent cohorts. High confidence (⩾90%) of interstitial lung disease 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%) before Envisia to 72 (46.4%) after Envisia in the pre-post cohort and by 11% in the independent cohorts. 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 in effectively managing patients to improve outcomes of patients with IPF.
特发性肺纤维化(IPF)的诊断仍然具有挑战性,可能导致诊断延迟或误诊。IPF 的诊断基于在没有可识别病因的情况下,存在放射性或组织学的普通间质性肺炎(UIP)模式。Envisia 基因组分类器是一种经过临床验证的分子诊断测试,可识别经支气管活检的 UIP。为了确定 Envisia 基因组分类器对医生在 IPF 的诊断和管理中临床决策的影响。这项前瞻性随机决策影响调查旨在检验以下假设:纳入 Envisia UIP 阳性结果将增加 IPF 的诊断、诊断信心和抗纤维化治疗的建议。该调查包括来自 BRAVE(支气管样本采集用于新型基因组测试)研究的患者,这些患者的高分辨率计算机断层扫描没有典型的 UIP 模式、Envisia UIP 阳性结果和多学科团队讨论的最终 IPF 诊断。每个病例以三种不同的格式呈现:一个前后队列,每个病例最初不呈现,然后呈现 Envisia,两个独立的队列,每个病例分别不呈现和呈现 Envisia。来自地理位置多样化的社区和学术中心的美国肺病学家被邀请参与这项研究。103 名(65%)美国肺病学家符合纳入标准,并对 11 个病例的 605 个病例进行了回顾。在前后队列中,Envisia 使 IPF 的诊断数量绝对增加了 39%,从 Envisia 之前的 47 例(30%)增加到 107 例(69%),在独立队列中增加了 13%。在前测队列和独立队列中,高置信度(≥90%)的间质性肺疾病诊断更为常见。在前后队列中,Envisia 使抗纤维化治疗的建议绝对增加了 36%,从 Envisia 之前的 15 例(10%)增加到 72 例(46.4%),在独立队列中增加了 11%。这项决策影响调查通过显示 IPF 诊断、诊断信心和抗纤维化治疗建议的显著增加,证明了 Envisia 分类器的临床效用,以帮助医生有效管理患者,改善 IPF 患者的预后。
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