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BMC Primary Care
Published in: BMC Primary Care 1/2013

Open Access 01-12-2013 | Study protocol

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

Authors: Gea A Holtman, Leeuwen Yvonne Lisman-van, Boudewijn J Kollen, Johanna C Escher, Angelika Kindermann, Rheenen Patrick F van, Marjolein Y Berger

Published in: BMC Primary Care | Issue 1/2013

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Abstract

Background

Low 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).

Design

The 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.

Discussion

According 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.
Appendix
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Metadata
Title
Challenges in diagnostic accuracy studies in primary care: the fecal calprotectin example
Authors
Gea A Holtman
Leeuwen Yvonne Lisman-van
Boudewijn J Kollen
Johanna C Escher
Angelika Kindermann
Rheenen Patrick F van
Marjolein Y Berger
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Primary Care / Issue 1/2013
Electronic ISSN: 2731-4553
DOI
https://doi.org/10.1186/1471-2296-14-179

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