Abstract:
Background: Historically, to capture infant formula growth monitoring study (GMS) endpoints (weight, length, head circumference (HC)), caregivers have been required to visit study sites with their infant. To address the burden of site visits, a decentralized clinical trial (DCT) approach for GMS would enable caregivers to capture endpoints in real time via teleconference with study staff. Given the inherent concern with non-clinical personnel conducting measurements, this study aims to demonstrate reliability between measurements taken among clinically trained personnel and telehealth guided infant caregivers as a direct indicator of data quality.
Methods: Four silicone, non-vinyl dolls with anthropometrics representative of infants were measured. In a crossover design, each doll was issued to three arms of study participants to complete anthropometric measurements (weight (kg), length (cm) and HC (cm)): 1) individuals with no healthcare training (Caregivers; n=7) who were guided via telehealth call with study staff; 2) board certified pediatric health care professionals (HCPs; n=7); and 3) study staff board certified pediatric registered nurses to provide measurement gold scores (n=3). Inter- and intra-observer technical error of measurement (TEM), average bias relative to the gold standard, and coefficient of reliability were calculated.
Results: Inter and intra-observed TEM estimates for caregivers were below the maximum allowed error based on the gold standard (2xTEM Gold Standard) with 95% precision margin, for all measurements. For HCPs, only the intra-observer TEM for length measurement and inter-observer TEM for HC and length measurements were within twice the gold standard TEM. There was no evidence of bias for either the caregivers’ or HCPs’ measurements compared with the gold standard. Coefficients of reliability were greater than 0.96 for all three measurements.
Conclusion: This study demonstrates telehealth led caregivers can capture accurate and reliable anthropometric measurements, supporting the confidence in and utilization of a DCT approach for infant formula GMS.
Audience Take Away
- Will help individuals understand the shifting state of the infant formula growth and monitoring study space and how it is shifting, in tandem with the FDA, toward higher quality, more efficient, and lower cost clinical trial, through DCT designs enabling increased number of players in the space, thus pushing the standard infant formula quality
