Informed Consent for Pediatric Lyme Meningitis Study: In-Person vs Remote Approach

Remote consent approaches may facilitate enrollment in emergency medicine-based research when eligibility confirmation is delayed. We examined how the location of approach for consent (in-person vs. remote) impacted enrollment rates in our recently completed multicenter study comparing intravenous ceftriaxone vs. oral doxycycline for children with Lyme meningitis (NIAID R01A151180-02A1).

We performed a 21-center prospective observational study of patients aged 1 to 21 years with Lyme meningitis. Eligible children had meningitis, a positive two-tier Lyme disease serology (which took several days to return results), and a plan to treat with either intravenous ceftriaxone or oral doxycycline. Potentially eligible patients with pending Lyme disease tests were provided a study information sheet and asked permission for later contact. Study teams approached eligible caregivers (age < 18 years) or patients (18-21 years) during clinical encounters (in-person) or by telephone (remote) with assent obtained as indicated. We compared the proportion of eligible patients enrolled by location of approach.

Of the 363 eligible patients with Lyme meningitis over the study period, study teams approached 302 patients (83.2% of eligible) and enrolled 253 (83.8% of approached). Documented reasons for non-approach were inability to contact families (n=38), unavailable research staff (n=2) and clinician request (n=1). Four children whose caregiver provided consent did not provide assent. Enrollment rates were similar for remote (196/229, 85.6%) and in-person approach [57/69, 82.6%; difference 3.0%, 95% confidence interval -5.9, 14.3%]. Three enrolled children were later found ineligible and were withdrawn.

Given delays in confirming study eligibility, the majority of children with Lyme meningitis were approached remotely with similar enrollment success as an in-person approach. Remote consent may provide an important tool for emergency medicine research when eligibility criteria are confirmed after the initial encounter. Future studies should evaluate optimal methods for post-encounter subject and family contact.