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. 2013 Nov 25:14:179.
doi: 10.1186/1471-2296-14-179.

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

Gea A Holtman  1 , Yvonne Lisman-van Leeuwen, Boudewijn J Kollen, Johanna C Escher, Angelika Kindermann, Patrick F van Rheenen, Marjolein Y Berger
Affiliations

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

Gea A Holtman et al. BMC Fam Pract. .

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.

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Figures

Figure 1
Figure 1
Flow chart of the DOK study. The PCP or pediatric gastroenterologist selects eligible children. At baseline inclusion, exclusion criteria and red flag symptoms are determined. The parents and child ≥10 years complete two questionnaires, i.e. a Questionnaire on Pediatric Gastrointestinal Symptoms (QPGS) and a symptoms questionnaire, in addition feces (parasites and colon pathogens) are obtained. Children meeting 1 ≥ red flag symptoms are evaluated for eligibility for endoscopy by a pediatric gastroenterologist. Children without red flag symptoms receive a 1-year follow-up. The arrows indicate that the PCP can refer a child during follow-up for endoscopic evaluation and the children who are not eligible for endoscopy receive a follow-up. After 1 year, information about diagnosis and clinical symptoms is collected based on the two above-mentioned questionnaires.
See this image and copyright information in PMC

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