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Design of the PROUD study: PCR faeces testing in outpatients with diarrhoea
Alwin Schierenberg1, Martine D Nipshagen2, Berna D L Broekhuizen3
1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, P.O. Box 85500, 3584 CG, Utrecht, The Netherlands. a.schierenberg@umcutrecht.nl.
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.
Insights
The PROUD study evaluated polymerase chain reaction (PCR) for infectious intestinal disease (IID) diagnostics in primary care. It assessed PCR
Area of Science:
- Clinical diagnostics
- Infectious diseases
- Public health microbiology
Background:
- Infectious intestinal disease (IID) is a significant cause of morbidity and general practitioner (GP) visits in developed nations.
- Polymerase chain reaction (PCR) offers improved sensitivity and speed for enteropathogen detection compared to traditional methods.
- The cost-effectiveness and real-world impact of introducing PCR in primary care for IID remain unquantified.
Purpose of the Study:
- To determine the health effects and cost-effectiveness of implementing PCR diagnostics for IID in primary care.
- To estimate the current occurrence of major enteropathogens in primary care patients presenting with IID.
- To provide updated prevalence data for enteropathogens using sensitive PCR techniques.
Main Methods:
- A before-and-after cohort study design was employed, comparing conventional testing (2010-2011) with PCR testing (2013-2014).
- Data on patient characteristics, healthcare utilization, and disease outcomes were collected from electronic records.
- Routine faecal samples from 2014 were screened using PCR to determine enteropathogen prevalence.
Main Results:
- The study quantifies the costs and health effects associated with the introduction of PCR techniques.
- It provides updated and sensitive estimates of enteropathogen occurrence in primary care settings.
- Comparison between conventional and PCR periods will elucidate the impact of diagnostic shifts.
Conclusions:
- The PROUD study provides crucial data on the value of PCR diagnostics in primary care for IID.
- Findings will inform healthcare policy regarding the adoption of advanced diagnostic technologies.
- Updated enteropathogen prevalence data will aid in understanding the epidemiology of IID.
