The accuracy of the clinical diagnosis of new-onset idiopathic pulmonary fibrosis and other interstitial lung disease - A prospective study
The accuracy of the clinical diagnosis of new-onset idiopathic pulmonary fibrosis and other interstitial lung disease - A prospective study
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DOI：
10.1378/chest.116.5.1168
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发表时间：
1999-11-01
期刊：
影响因子：
9.6
通讯作者：
Godwin, JD
中科院分区：
文献类型：
--
作者：
Raghu, G;Mageto, YN;Godwin, JD
研究目的：目前，手术（开放或胸腔镜）肺活检（SLB）是诊断新发特发性肺纤维化（IPF）和其他间质性肺病（ILD）的金标准。在前瞻性研究中，尚未确定IPF和其他ILD子集临床诊断的准确性。我们研究了IPF和LLD临床诊断的准确性和有效性，而不是IF。设计：由ILD专家对患者和临床数据进行前瞻性独立评估，由胸部放射科医生对胸部放射学和高分辨率计算机断层扫描（HRCT）特征进行前瞻性独立评估，由肺部病理学家对连续患者的肺活检组织学特征进行前瞻性独立评估，以进行ILD诊断评估。设置：在ILD管理方面具有公认专业知识的第三大学医学中心。患者：社区患者转诊，对新发、未经治疗的非特异性ILD进行进一步明确的诊断评估。干预：通过将59例连续转诊以进一步诊断评估新发ILD的患者的SLB组织学特征与临床和放射学诊断进行比较，测定临床诊断和影像学诊断的敏感性和特异性。IPF和除IPF以外的ILD的诊断（仅基于胸片和HRCT特征）。ILD专家在进行全面的临床评估（包括HRCT扫描和支气管镜检查结果评价）后，独立做出具体的临床诊断。胸片和HRCT扫描分别由胸部放射科医生进行审查，他们独立做出放射学诊断。所有患者均在术前“临床”诊断后一个月内接受了SLB。临床医生和放射科医生的诊断进行了比较，然后与金标准的组织学diagnosis.Measurements和结果：在我们的中心的临床评价之前，85%的患者进行了SLB有非诊断性经支气管活检。在62%的病例中，仅通过临床特征即可准确诊断IPF和除IPF以外的ILD。在58%的病例中，对非IPF ILD进行了正确的影像学诊断。临床诊断非IPF ILD的敏感性和特异性分别为88.8%和40%。影像学诊断LLD而非IPF的敏感性和特异性分别为59%和40%。然而，临床诊断IPP的敏感性和特异性分别为62%和97%。放射学诊断IPF的敏感性和特异性分别为78.5%和90%。作为一家在ILD管理方面具有公认专业知识的中心，仅基于全面临床评估或HRCT特征诊断新发IPF的特异性非常高（分别为97%和90%），但灵敏度较低（分别为62%和78.5%）。因此，并非所有新发IPF患者都需要SLB进行诊断，但尽管经过专家评估，仍有近三分之一的新发IPF病例会漏诊IPF。除IPF外，LLD诊断的敏感性和特异性相对较低，这也强调了SLB适用于诊断不明确的ILD患者。
Study objectives: Presently, surgical (open or thoracoscopic) lung biopsy (SLB) is the gold standard for the diagnosis of new-onset idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILDs). The accuracy of a clinical diagnosis of IPF and other subsets of ILD has never been established in prospective studies. We investigated the accuracy and validity of a clinical diagnosis of IPF and LLD other than IF.Design: Prospective, independent evaluation of patients and clinical data by an ILD expert, of chest radiographic and high-resolution computed tomography (HRCT) features by a chest radiologist, and of histologic features of lung biopsy by a pulmonary pathologist in consecutive patients referred for a diagnostic evaluation of ILD.Setting: Tertiary university medical center with recognized expertise in management of ILD.Patients: Community patients referred for further definitive diagnostic evaluation of new-onset, untreated nonspecific ILD.Intervention: By comparing the histologic features of SLB in 59 patients consecutively referred for further diagnostic evaluation of new-onset ILD with the clinical and radiologic diagnoses, we determined the sensitivity and specificity of clinical diagnosis and radiologic. diagnosis (based on chest radiograph and HRCT features alone) of IPF and ILD other than IPF. A specific clinical diagnosis was independently made by the ILD expert after a thorough clinical assessment that included evaluation of an HRCT scan and bronchoscopic findings. The chest radiographs and HRCT scans were separately reviewed by the chest radiologist, who made a radiologic diagnosis independently. All patients underwent SLB within a month of preoperative "clinical" diagnosis. The clinician's and radiologist's diagnoses were then compared with the gold standard of histologic diagnosis.Measurements and results: Prior to the clinical evaluation at our center, 85% of patients who underwent SLB had nondiagnostic transbronchial biopsy. The diagnosis of IPF and ILD other than IPF was accurately made by clinical features alone in 62% of cases. The correct radiographic diagnosis of non-IPF ILD was made in 58% of the eases. The sensitivity and specificity of the clinical diagnosis of ILD other than IPF were 88.8% and 40%, respectively. The sensitivity and specificity of the radiographic diagnosis of LLD other than IPF were 59% and 40%, respectively. However, the sensitivity and specificity of the diagnosis of IPP on clinical grounds were 62% and 97%, respectively. The sensitivity and specificity of the radiologic diagnosis of IPF were 78.5% and 90%, respectively.Conclusions: Zn a center with recognized expertise in the management of ILD, die specificity of diagnosis of new-onset IPF based on a thorough clinical assessment or HRCT features alone is very high (97% and 90%, respectively), but the sensitivity is low (62% and 78.5%, respectively). Thus, not all patients with new-onset IPF require SLB for diagnosis, but a diagnosis of IPF will be missed in nearly one third of new-onset IPF cases despite evaluation by experts. The relatively low sensitivity specificity of the diagnosis of LLD other than IPF also emphasizes that an SLB is indicated in patients with ILD in whom the diagnosis is unclear.