Challenges in diagnostic accuracy studies in primary care: the fecal calprotectin example

BMC Family Practice

Study Protocol

Gea A Holtman¹  Marjolein Y Berger¹  Boudewijn J Kollen¹  Leeuwen Yvonne Lisman-van¹  Rheenen Patrick F van²  Angelika Kindermann³  Johanna C Escher⁴ 

[1] Department of General Practice, FA21, University of Groningen, University Medical Center Groningen, PO Box 196, 9700, Groningen, AD, The Netherlands;Department of Pediatric Gastroenterology, Beatrix Children’s Hospital/University of Groningen, University Medical Center Groningen, PO Box 30001, 9700, Groningen, RB, The Netherlands;Department of Pediatric Gastroenterology, Emma Children’s Hospital/Academic Medical Center, PO Box 22700, 1100, Amsterdam, DE, The Netherlands;Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children’s Hospital, PO Box 2060, 3000, Rotterdam, CB, The Netherlands;

关键词: Primary care;    Risk of bias;    diagnostic research;    Calprotectin;    Inflammatory bowel disease;   

DOI  :  10.1186/1471-2296-14-179

 received in 2013-08-28, accepted in 2013-11-21,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundLow disease prevalence and lack of uniform reference standards in primary care induce methodological challenges for investigating the diagnostic accuracy of a test. We present a study design that copes with these methodological challenges and discuss the methodological implications of our choices, using a quality assessment tool for diagnostic accuracy studies (QUADAS-2).DesignThe study investigates the diagnostic value of fecal calprotectin for detecting inflammatory bowel disease in children presenting with chronic gastrointestinal symptoms in primary care. It is a prospective cohort study including two cohorts of children: one cohort will be recruited in primary care and the other in secondary/tertiary care. Test results of fecal calprotectin will be compared to one of the two reference standards for inflammatory bowel disease: endoscopy with histopathological examination of mucosal biopsies or assessment of clinical symptoms at 1-year follow-up.DiscussionAccording to QUADAS-2 the use of two reference standards and the recruitment of patients in two populations may cause differential verification bias and spectrum bias, respectively. The clinical relevance of this potential bias and methods to adjust for this are presented. This study illustrates the importance of awareness of the different kinds of bias that result from choices in the design phase of a diagnostic study in a low prevalence setting. This approach is exemplary for other diagnostic research in primary care.

【 授权许可】

Unknown   
© Holtman et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.