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Published on: November 7, 2018
Clinical Impact of Multiplex Molecular Diagnostic Testing in Children With Acute Gastroenteritis Presenting to an
Andrew T Pavia1, Daniel M Cohen2, Amy L Leber2
1Departments of Pediatrics and Internal Medicine, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, Utah, USA.
Insights
Multiplex molecular testing for children with gastroenteritis significantly increased pathogen detection and reduced healthcare return visits by 21%. Further research is needed to identify specific patient groups who benefit most.
Area of Science:
- Pediatric Emergency Medicine
- Clinical Diagnostics
- Infectious Diseases
Background:
- Multiplex molecular diagnostic panels improve gastrointestinal pathogen detection.
- Limited data exist on the clinical and patient-centered outcomes of these advanced diagnostic tests.
Purpose of the Study:
- To evaluate the impact of multiplex molecular testing on children with acute gastroenteritis in emergency departments.
- To assess the effect on clinical outcomes, including return healthcare visits.
Main Methods:
- A prospective, multicenter, stepped-wedge trial was conducted across 5 children's hospitals.
- Caregivers were interviewed to collect data on symptoms, risk factors, and subsequent medical visits.
- The study compared a pre-intervention period (clinician-discretion testing) with an intervention period (universal multiplex molecular testing).
Main Results:
- Pathogen detection increased from 3.3% to 74% (clinically relevant: 2.1% to 15%) with multiplex testing.
- The intervention was associated with a 21% reduction in return visits to healthcare providers (OR, 0.79; 95% CI, .70-.90).
- No significant difference was observed in appropriate treatment rates (11.3% vs 19.6%, P = .22).
Conclusions:
- Routine multiplex molecular testing in pediatric emergency departments detects more pathogens in acute gastroenteritis.
- This testing strategy led to a significant decrease in patient return visits.
- Further research is recommended to identify patient subgroups who would most benefit from this diagnostic approach.
Background:
Multiplex molecular diagnostic panels have greatly enhanced detection of gastrointestinal pathogens. However, data on the impact of these tests on clinical and patient-centered outcomes are limited.
Methods:
We conducted a prospective, multicenter, stepped-wedge trial to determine the impact of multiplex molecular testing at 5 academic children's hospitals on children presenting to the emergency department with acute gastroenteritis. Caregivers were interviewed on enrollment and 7-10 days after enrollment to determine symptoms, risk factors, subsequent medical visits, and impact on family members. During the pre-intervention period, diagnostic testing was performed at the clinician's discretion . During the intervention period, multiplex molecular testing was performed on all children, with results available to clinicians. The primary outcome was return visits to a healthcare provider within 10 days of enrollment.
Results:
Potential pathogens were identified by clinician-ordered tests in 19 of 571 (3.3%) in the pre-intervention period compared with 434 of 586 (74%) in the intervention period; clinically relevant pathogens were detected in 2.1% and 15%, respectively. In the multivariate model, the intervention was associated with a 21% reduction in the odds of any return visit (odds ratio, 0.79; 95% confidence interval, .70-.90) after adjusting for potential confounders. Appropriate treatment was prescribed in 11.3% compared with 19.6% during the intervention period (P = .22).
Conclusions:
Routine molecular multiplex testing for all children who presented to the ED with acute gastroenteritis detected more clinically relevant pathogens and led to a 21% decrease in return visits. Additional research is needed to define patients most likely to benefit from testing. Clinical Trials Registration. NCT02248285.
