Hasler Susann, Zahnd Nadine, Müller Salomé, Vavricka Stephan, Rogler Gerhard, Tandjung Ryan, Rosemann Thomas
Institute of Primary Care, University Hospital of Zürich, Zürich, Switzerland.
IBDnet (http://www.ibdnet.ch), Stadtspital Triemli, Zürich, Switzerland.
BMJ Open. 2015 Mar 10;5(3):e007306. doi: 10.1136/bmjopen-2014-007306.
Diagnosis of inflammatory bowel disease (IBD) in primary healthcare is challenging and often associated with a considerable diagnostic delay. This delay is associated with worse disease progression and outcomes. Although testing for faecal calprotectin is a useful screening tool to identify patients who need endoscopy for IBD, the widespread use may not be appropriate due to the low prevalence of patients with IBD among all patients attending a general practitioner (GP) with gastrointestinal symptoms. To increase the appropriate application of the faecal calprotectin test, an 8-item questionnaire, the CalproQuest, has been developed to increase pretest probability for a positive test result.
This is a prospective diagnostic trial. The study consists of two independent and consecutive parts A and B, conducted by gastroenterologists (A) and GPs (B), respectively. Patients included in part A are referred to the gastroenterologist for any endoscopic evaluation. Patients included in part B present at their GP because of ongoing unspecific gastrointestinal symptoms (abdominal pain, bloating, stool irregularities, diarrhoea) for at least 2 weeks. CalproQuest consists of four main and four secondary questions specific for IBD; it is considered positive if ≥2 main criteria are answered positively or one main criterion and two secondary criteria are answered positively. In part A, the sensitivity and specificity of CalproQuest for stool calprotectin levels ≥50 μg/g faeces and for positive IBD diagnosis will be investigated. In part B, the feasibility of CalproQuest in daily primary healthcare practice will be assessed.
The study protocol was approved by the Ethics Committee of the Kanton Zurich (reference KEK-ZH-number 2013-0516). The results will be published in a peer-reviewed journal and shared with the worldwide medical community.
ISRCTN66310845.
在基层医疗保健中诊断炎症性肠病（IBD）具有挑战性，且常常伴有显著的诊断延迟。这种延迟与更差的疾病进展和结局相关。尽管粪便钙卫蛋白检测是一种有用的筛查工具，可用于识别需要接受IBD内镜检查的患者，但由于在所有因胃肠道症状就诊于全科医生（GP）的患者中IBD患者的患病率较低，广泛使用该检测可能并不合适。为了增加粪便钙卫蛋白检测的合理应用，已开发出一份包含8个条目的问卷CalproQuest，以提高检测结果为阳性的预检概率。
这是一项前瞻性诊断试验。该研究由两个独立且连续的部分A和B组成，分别由胃肠病学家（A）和全科医生（B）进行。纳入部分A的患者因任何内镜检查评估被转诊至胃肠病学家处。纳入部分B的患者因持续至少2周的非特异性胃肠道症状（腹痛、腹胀、大便异常、腹泻）就诊于其全科医生处。CalproQuest由四个主要问题和四个针对IBD的次要问题组成；如果≥2个主要标准回答为阳性或1个主要标准和2个次要标准回答为阳性，则被视为阳性。在部分A中，将研究CalproQuest对于粪便钙卫蛋白水平≥50μg/g粪便以及IBD阳性诊断的敏感性和特异性。在部分B中，将评估CalproQuest在日常基层医疗实践中的可行性。
研究方案已获得苏黎世州伦理委员会批准（参考编号KEK-ZH-2013-0516）。研究结果将发表在同行评审期刊上，并与全球医学界共享。
ISRCTN66310845。
