Wei Shu-Chen, Tung Chien-Chih, Weng Meng-Tzu, Wong Jau-Min
Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Department of Integrated Diagnostics & Therapeutics, National Taiwan University Hospital, Taipei, Taiwan.
Intest Res. 2018 Oct;16(4):546-553. doi: 10.5217/ir.2018.00052. Epub 2018 Oct 10.
BACKGROUND/AIMS: Fecal calprotectin (fC) level is a predictive marker of mucosal healing for patients with inflammatory bowel disease (IBD). Home fC tests are now available. We evaluated the performance of the smartphone-based IBDoc home testing system in patients with IBD and obtained their feedback as an objective patient-reported outcome.
This prospective study enrolled consecutive patients with IBD in clinical remission. fC in the same stool sample was assessed by using both the laboratory test (Quantum Blue calprotectin test) and home test (IBDoc). The correlation between the 2 tests was analyzed using the Pearson method. In addition, the patients were asked to fill a questionnaire based on their experience.
Fifty-one patients with IBD (68 tests and 49 questionnaires) were included. The correlation between Quantum Blue test and IBDoc was good (r=0.776, P<0.0001). After the test, 56% patients found IBDoc easy to perform, and 96% were satisfied with it. Thirty-nine patients (80%) had a strong (>70%) probability to use it for future monitoring if the price was acceptable. By using 250 μg/g as the cutoff, the agreement between home test and laboratory results was 80%, and by using 600 μg/g as the cutoff, the agreement increased to 92%.
The correlation between the laboratory and home tests was good. Most patients found the home test to be feasible and easy to use and preferred it over laboratory test and endoscopy for monitoring. Therefore, the home test could be used as an objective patient-reported outcome.
背景/目的：粪便钙卫蛋白（fC）水平是炎症性肠病（IBD）患者黏膜愈合的预测标志物。现在已有家用fC检测方法。我们评估了基于智能手机的IBDoc家用检测系统在IBD患者中的性能，并将患者反馈作为客观的患者报告结局。
这项前瞻性研究纳入了连续的临床缓解期IBD患者。使用实验室检测（量子蓝钙卫蛋白检测）和家用检测（IBDoc）对同一粪便样本中的fC进行评估。采用Pearson方法分析两种检测方法之间的相关性。此外，要求患者根据自身经验填写问卷。
纳入51例IBD患者（68次检测和49份问卷）。量子蓝检测与IBDoc之间的相关性良好（r = 0.776，P < 0.0001）。检测后，56%的患者认为IBDoc易于操作，96%的患者对其满意。如果价格可接受，39例患者（80%）有很大可能性（>70%）在未来监测中使用它。以250μg/g作为临界值，家用检测与实验室结果的一致性为80%，以600μg/g作为临界值，一致性提高到92%。
实验室检测与家用检测之间的相关性良好。大多数患者认为家用检测可行且易于使用，并且在监测方面比实验室检测和内镜检查更受青睐。因此，家用检测可作为客观的患者报告结局。
