Am J Respir Crit Care Med. 2018 Dec 15;198(12):e116-e136. doi: 10.1164/rccm.201810-1895ST.
Thousands of biomarker tests are either available or under development for lung diseases. In many cases, adoption of these tests into clinical practice is outpacing the generation and evaluation of sufficient data to determine clinical utility and ability to improve health outcomes. There is a need for a systematically organized report that provides guidance on how to understand and evaluate use of biomarker tests for lung diseases.
We assembled a diverse group of clinicians and researchers from the American Thoracic Society and leaders from the National Heart, Lung, and Blood Institute with expertise in various aspects of precision medicine to review the current status of biomarker tests in lung diseases. Experts summarized existing biomarker tests that are available for lung cancer, pulmonary arterial hypertension, idiopathic pulmonary fibrosis, asthma, chronic obstructive pulmonary disease, sepsis, acute respiratory distress syndrome, cystic fibrosis, and other rare lung diseases. The group identified knowledge gaps that future research studies can address to efficiently translate biomarker tests into clinical practice, assess their cost-effectiveness, and ensure they apply to diverse, real-life populations.
We found that the status of biomarker tests in lung diseases is highly variable depending on the disease. Nevertheless, biomarker tests in lung diseases show great promise in improving clinical care. To efficiently translate biomarkers into tests used widely in clinical practice, researchers need to address specific clinical unmet needs, secure support for biomarker discovery efforts, conduct analytical and clinical validation studies, ensure tests have clinical utility, and facilitate appropriate adoption into routine clinical practice.
Although progress has been made toward implementation of precision medicine for lung diseases in clinical practice in certain settings, additional studies focused on addressing specific unmet clinical needs are required to evaluate the clinical utility of biomarkers; ensure their generalizability to diverse, real-life populations; and determine their cost-effectiveness.
目前已有数千种生物标志物检测方法可用于或正在开发用于肺部疾病。在许多情况下，这些检测方法在临床实践中的应用速度超过了生成和评估充分数据以确定临床效用和改善健康结果的能力。因此，需要有一份系统组织的报告，为如何理解和评估用于肺部疾病的生物标志物检测方法提供指导。
我们召集了来自美国胸科学会的来自不同背景的临床医生和研究人员，以及国家心肺血液研究所的在精准医学各个方面具有专业知识的领导者，共同审查目前肺部疾病的生物标志物检测方法的现状。专家们总结了目前可用于肺癌、肺动脉高压、特发性肺纤维化、哮喘、慢性阻塞性肺疾病、脓毒症、急性呼吸窘迫综合征、囊性纤维化和其他罕见肺部疾病的生物标志物检测方法。该小组确定了未来研究可以解决的知识空白，以便将生物标志物检测方法有效地转化为临床实践，评估其成本效益，并确保它们适用于不同的真实人群。
我们发现，肺部疾病的生物标志物检测方法的现状因疾病而异。尽管如此，肺部疾病的生物标志物检测方法在改善临床护理方面具有很大的潜力。为了有效地将生物标志物转化为广泛应用于临床实践的检测方法，研究人员需要解决具体的临床未满足的需求，为生物标志物的发现工作提供支持，进行分析和临床验证研究，确保检测具有临床实用性，并促进其在常规临床实践中的适当采用。
尽管在某些情况下已经在临床实践中实施精准医学用于肺部疾病方面取得了进展，但需要进一步开展研究，以解决特定的未满足的临床需求，评估生物标志物的临床实用性；确保其对不同的真实人群的普遍性；并确定其成本效益。
