Integration of an FDA-Authorized Digital Autism Diagnostic Tool Into an Outpatient Developmental Pediatrics Workflow: Preliminary Quality Improvement Study

BACKGROUND Long wait times and specialist shortages delay autism spectrum disorder (ASD) diagnosis, often beyond the period when early intervention is most effective. Digital diagnostic tools may help increase diagnostic capacity by supporting clinicians in delivering timely autism evaluations within routine outpatient care. OBJECTIVE This study aimed to conduct a preliminary assessment of the integration of a digital autism diagnostic device (Canvas Dx) into an outpatient developmental pediatrics workflow, including a descriptive evaluation of agreement between device outputs and specialist clinical diagnoses and an exploration of clinician and caregiver experience. METHODS A single-center, prospective quality improvement study evaluated the implementation and performance of Canvas Dx in a specialty developmental pediatrics clinic. Canvas Dx is a Food and Drug Administration (FDA)–authorized digital ASD diagnostic device approved for use in children aged 18 to 72 months with caregiver or health care provider concern for developmental delay. Eligible children were consecutively prescribed Canvas Dx during the study period and completed the assessment as part of routine clinical care. Device diagnostic outputs were compared with the final specialist clinical diagnoses. Clinician and caregiver feedback was collected to explore their experience with the assessment process and perceived workflow impact via poststudy surveys that captured both structured quantitative questions and open-ended qualitative questions. RESULTS A total of 28 children were included (mean age 52.2, SD 13.8 months; 7/28, 25% female), with an autism prevalence of 67.9% (19/28) based on specialist diagnosis. The device generated a determinate result for 22 (78.6%) participants. Among participants with determinate device results, sensitivity was 94.1% (95% CI 73%-99%) and specificity was 80% (95% CI 37.6%-96.4%). Positive predictive value was 94.1% (95% CI 73%-99%), and negative predictive value was 80% (95% CI 37.6-96.4%) when compared with specialist diagnosis. These estimates were imprecise, particularly for specificity and negative predictive value, because of the small number of participants without an ASD diagnosis. Clinicians reported improved insights and ease of use during evaluation visits, and caregivers reported high satisfaction with the assessment process. CONCLUSIONS This preliminary quality improvement assessment demonstrates the feasibility of integrating Canvas Dx into a routine outpatient developmental pediatrics workflow and provides initial descriptive data on agreement with specialist diagnostic determinations and clinician and caregiver experience. Given the small sample size and resulting imprecision of diagnostic performance estimates, these findings should be interpreted as preliminary and used to inform larger prospective evaluations of diagnostic performance and workflow impact.