Design of the PROUD study: PCR faeces testing in outpatients with diarrhoea

Abstract

Background: Infectious intestinal disease (IID) is an important cause of morbidity in developed countries and a frequent reason for general practitioner (GP) consultation. In recent years polymerase chain reaction (PCR) based techniques have gradually replaced conventional enteropathogen detection techniques like microscopy and culture in primary care patients suspected of IID. PCR features testing of multiple enteropathogens in a single faecal sample with shorter turnaround times and greater sensitivity compared to conventional techniques. However, the associated costs and benefits have not been quantified. Furthermore, primary care incidence and prevalence estimates of enteropathogens associated with IID are sparsely available and predominantly based on conventional techniques. The PROUD-study (PCR diagnostics in Outpatients with Diarrhoea) determines: 1) health (care) effects and 2) cost-effectiveness of PCR introduction in primary care patients suspected of IID; 3) occurrence of major enteropathogens in primary care patients suspected of IID. Methods: A before-after cohort study will be performed of patients with suspected IID consulting a GP in the Utrecht General Practitioner Network (UGPN), covering the before period (2010-2011) with conventional testing and the after period (2013-2014) with PCR testing. Prospective study data on patient characteristics and primary outcome measures (i.e. healthcare use and disease outcome) will be collected from electronic patient and laboratory records in 2015 and 2016. The effect of PCR introduction is investigated by comparing the primary outcome measures and their associated healthcare costs between the conventional period and the PCR period, and is followed by a cost-effectiveness analysis. To determine the occurrence of enteropathogens associated with IID in primary care, routine care faeces samples from the year 2014 will be screened using PCR. Discussion: The PROUD-study will quantify the costs and effects of the introduction of PCR techniques for enteropathogens in primary care patients suspected of IID and generate up-to-date and sensitive estimates of enteropathogen occurrence among primary care patients.