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Integration of an Artificial Intelligence-Based Autism Diagnostic Device into the ECHO Autism Primary Care Workflow:
Kristin Sohl1, Erik Linstead2, Kelianne Heinz3
1ECHO Autism Communities, University of Missouri School of Medicine, Columbia, MO, United States.
Insights
Primary care clinicians can now diagnose autism faster using the ECHO Autism: Early Diagnosis (EDx) program integrated with Canvas Dx. This combined approach significantly reduces diagnostic wait times for children and improves caregiver satisfaction.
Area of Science:
- Pediatric healthcare innovation
- Autism spectrum disorder diagnostics
- Medical device integration in primary care
Background:
- Rising autism prevalence necessitates primary care involvement in diagnosis.
- ECHO Autism: Early Diagnosis (EDx) program trains clinicians for autism care in primary settings.
- Canvas Dx is an FDA-authorized Software as a Medical Device aiding autism diagnosis in children aged 18-72 months.
Purpose of the Study:
- To evaluate the feasibility and impact of integrating Canvas Dx into the ECHO Autism: EDx workflow.
- To measure the reduction in time from initial concern to autism diagnosis.
- To assess clinician and caregiver experiences with the integrated diagnostic process.
Main Methods:
- Prospective observational study involving children (18-72 months) with developmental delay concerns.
- Experienced ECHO Autism: EDx clinicians evaluated the device integration.
- Data collected via questionnaires, clinical record reviews, and device output analysis.
Main Results:
- Average time to autism diagnosis was 39.22 days, significantly shorter than specialist referrals (180-264 days).
- 93% of caregivers were satisfied and would recommend the evaluation.
- Canvas Dx provided determinate autism predictions for 52.5% of participants, consistent with clinical judgment.
Conclusions:
- The ECHO Autism: EDx plus Canvas Dx workflow offers substantial time savings and positive caregiver experiences.
- Integrating Canvas Dx into the EDx workflow is feasible and enhances diagnostic efficiency.
- Clinicians' expertise remains crucial for diagnosis, especially in indeterminate cases.
Background:
Pediatric specialist shortages and rapidly rising autism prevalence rates have compelled primary care clinicians to consider playing a greater role in the autism diagnostic process. The ECHO Autism: Early Diagnosis Program (EDx) prepares clinicians to screen, evaluate, differentiate, diagnose, and provide longitudinal care for children with autism in primary care settings. Canvas Dx is a prescription-only Software as a Medical Device designed to support clinical diagnosis or rule out of autism, including in primary care settings. It is authorized by the Food and Drug Administration for use, in conjunction with clinical judgment, in 18- to 72-month-olds with indicators of developmental delay.
Objective:
This study aims to assess the feasibility and impact of integrating the device into the ECHO Autism: EDx workflow. Time from the first clinical question of developmental delay to autism diagnosis is the primary endpoint. Secondary endpoints explore clinician and caregiver experience of device use.
Methods:
Children aged 18 to 72 months with concern for developmental delay indicated by either a caregiver or health professionals were eligible to participate in this prospective observational study. Experienced ECHO Autism: EDx clinicians were recruited to evaluate the inclusion of the device as part of their diagnostic evaluations. Outcome data were collected via a combination of electronic questionnaires, standard clinical care record reviews, and analysis of device outputs. Institutional review board approval was provided by the University of Missouri-Columbia (project number 2075722).
Results:
Eighty children and 7 clinicians completed the study. On average, time from clinical concern at study enrollment to final autism diagnosis was 39.22 days, compared to 180- to 264-day waits at adjacent specialist referral centers. The vast majority (93%, 50/54) of caregivers reported being satisfied with the ECHO Autism: EDx plus device evaluation their child received and endorsed that they would recommend it to others and that they felt comfortable using the device. The device produced determinate autism predictions or rule-outs for 52.5% of participants, and in all cases, these were consistent with the final clinical determination. Participating clinicians reported that device use was feasible and reduced several challenges associated with their previous diagnostic process; however, they noted it did not obviate the need for additional structured observation in every case.
Conclusions:
The ECHO Autism: EDx plus device workflow offers considerable time savings compared to specialty center referral and was strongly endorsed by caregiver participants. Embedding the device into the ECHO Autism: EDx workflow was feasible and helped streamline several workflow efficiencies. Clinicians still utilized their training and application and interpretation of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria when formulating the diagnosis for indeterminate cases.
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