Abstract
BackgroundDiagnosis 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.MethodsProspective 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.Results156 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).ConclusionIn 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.
Highlights
The estimated prevalence of inflammatory bowel disease (IBD), consisting of Crohn’s Disease (CD), ulcerative colitis (UC) and indeterminate colitis (IC) [1], is 0.2% in the western world [2]
It is not surprising that physicians are often faced with the diagnostic challenge to differentiate patients with IBD from functional gastrointestinal disorders, namely irritable bowel syndrome (IBS), based on its much higher prevalence estimated at 10–15% [3]
A further problem is the low specificity of the test and relatively high costs
Summary
The estimated prevalence of inflammatory bowel disease (IBD), consisting of Crohn’s Disease (CD), ulcerative colitis (UC) and indeterminate colitis (IC) [1], is 0.2% in the western world [2]. It is not surprising that physicians are often faced with the diagnostic challenge to differentiate patients with IBD from functional gastrointestinal disorders, namely irritable bowel syndrome (IBS), based on its much higher prevalence estimated at 10–15% [3] These challenges are reflected in the considerable diagnostic delay of IBD [1], associated with a significantly increased risk of morbidity and mortality [4]. Primary outcome: Sensitivity and specificity of the CalproQuest for Calprotectin levels 50 g/g and for positive IBD diagnosis among patients referred to endoscopic evaluation at secondary care level. CONCLUSION: In this prospective diagnostic study, the sensitivity and specificity of CalproQuest for Calprotectin levels 50 g/g and positive IBD diagnosis were poor. This study, aimed to validate whether the CalproQuest increases pretest-probability for a positive fecal Calprotectin
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