Abstract：
Radiotherapy of lung cancer may cause pneumonitis that generally occurs weeks or months following therapy and can be missed. This prospective trial aimed to pave the way for a mobile application (app) allowing early diagnosis of pneumonitis. The primary goal was the identification of the optimal cut-off of a score to detect pneumonitis of grade ≥2 after radiotherapy for lung cancer. Based on the severity of symptoms (cough, dyspnea, fever), scoring points were 0−9. Receiver operating characteristic (ROC)-curves were used to describe the sensitivity and specificity. The area under the ROC-curve (AUC) was calculated to judge the accuracy of the score, Youden-index was employed to define the optimal cut-off. Until trial termination, 57 of 98 patients were included. Eight of 42 patients evaluable for the primary endpoint (presence or absence of radiation pneumonitis) experienced pneumonitis. AUC was 0.987 (0.961−1.000). The highest sensitivity was achieved with 0−4 points (100%), followed by 5 points (87.5%), highest specificity with 5−6 points (100%). The highest Youden-index was found for 5 points (87.5%). The rate of patient satisfaction with the symptom-based scoring system was 93.5%. A cut-off of 5 points was identified as optimal to differentiate between pneumonitis and no pneumonitis. Moreover, pneumonitis was significantly associated with an increase of ≥3 points from baseline (p < 0.0001). The scoring system provided excellent accuracy and high patient satisfaction. Important foundations for the development of a mobile application were laid.
摘要：
肺癌的放射治疗可能会导致肺炎，通常在治疗后数周或数月发生，可能会错过。这项前瞻性试验旨在为允许早期诊断肺炎的移动应用程序（应用程序）铺平道路。主要目标是确定肺癌放疗后检测≥2级肺炎的最佳评分截止值。根据症状的严重程度（咳嗽，呼吸困难,发烧)，得分0-9分。使用受试者工作特征（ROC）曲线来描述灵敏度和特异性。计算ROC曲线下面积(AUC)以判断评分的准确性,采用Youden指数来定义最佳截止值。直到审判终止，98例患者中的57例被包括在内。可评估主要终点（是否存在放射性肺炎）的42例患者中有8例经历了肺炎。AUC为0.987(0.961-1.000)。最高的灵敏度达到0-4点（100％），其次是5分(87.5%)，最高特异性为5-6分（100%）。Youden指数最高，为5分（87.5％）。患者对基于症状的评分系统的满意度为93.5%。5点的截断值被认为是区分肺炎和无肺炎的最佳选择。此外，肺炎与基线的≥3点增加显著相关(p<0.0001)。评分系统提供了出色的准确性和较高的患者满意度。为开发移动应用程序奠定了重要基础。
