Institute of Primary Care, University and University Hospital of Zurich, Switzerland.
Department of Gastroenterology and Hepatology, University Hospital Zurich, Switzerland.
PLoS One. 2019 Nov 21;14(11):e0224961. doi: 10.1371/journal.pone.0224961. eCollection 2019.
Diagnosis of inflammatory bowel disease (IBD) in primary care (PC) is challenging and associated with a considerable diagnostic delay. Using a calprotectin test for any PC patient with abdominal complaints would cause significant costs. The 8-item-questionnaire CalproQuest was developed to increase the pre-test probability for a positive Calprotectin. It is a feasible instrument to assess IBD in PC, but has not yet been evaluated in clinical routine. This study, therefore, aimed to validate whether the CalproQuest increases pretest-probability for a positive fecal Calprotectin.
Prospective diagnostic trial. The CalproQuest consists of 4 major and 4 minor questions suggestive for IBD. It is considered positive if ≥ 2 major or 1 major and 2 minor criteria are positive. Primary outcome: Sensitivity and specificity of the CalproQuest for Calprotectin levels ≥ 50 μg/g and for positive IBD diagnosis among patients referred to endoscopic evaluation at secondary care level. Secondary finding: Patient-reported diagnostic delay.
156 patients from 7 study centers had a complete CalproQuest and fecal Calprotectin test. The sensitivity and specificity of CalproQuest for Calprotectin ≥ 50 μg/g was 36% and 57%. The sensitivity and specificity of the CalproQuest for positive IBD diagnosis was 37% and 67%. The diagnostic delay was 61 months (SD 125.2).
In this prospective diagnostic study, the sensitivity and specificity of CalproQuest for Calprotectin levels ≥ 50 μg/g and positive IBD diagnosis were poor. Additional prospective studies concerning the ideal cut-off values, validity and cost-effectiveness of a combined use with the Calprotectin test in the PC setting are necessary.
在初级保健（PC）中诊断炎症性肠病（IBD）具有挑战性，并且与相当大的诊断延迟相关。对任何有腹部不适的 PC 患者使用钙卫蛋白检测都会导致显著的成本增加。为了提高钙卫蛋白检测阳性的预测概率，开发了 8 项问题问卷 CalproQuest。它是一种在 PC 中评估 IBD 的可行工具，但尚未在临床常规中进行评估。因此，本研究旨在验证 CalproQuest 是否可以提高粪便钙卫蛋白检测阳性的预测概率。
前瞻性诊断试验。CalproQuest 由 4 个主要问题和 4 个提示 IBD 的次要问题组成。如果≥2 个主要问题或 1 个主要问题和 2 个次要问题阳性，则认为是阳性。主要结局：CalproQuest 对粪便钙卫蛋白水平≥50μg/g 和二级保健评估时需要进行内镜检查的患者中阳性 IBD 诊断的敏感性和特异性。次要发现：患者报告的诊断延迟。
来自 7 个研究中心的 156 名患者完成了 CalproQuest 和粪便钙卫蛋白检测。CalproQuest 对粪便钙卫蛋白≥50μg/g 的敏感性和特异性分别为 36%和 57%。CalproQuest 对阳性 IBD 诊断的敏感性和特异性分别为 37%和 67%。诊断延迟为 61 个月（SD 125.2）。
在这项前瞻性诊断研究中，CalproQuest 对粪便钙卫蛋白水平≥50μg/g 和阳性 IBD 诊断的敏感性和特异性较差。需要进一步进行前瞻性研究，以确定最佳截断值、CalproQuest 在 PC 环境中的有效性和成本效益，并与钙卫蛋白检测联合使用。
