DEFINITION AND ASSESSMENT OF INFANT NEURODEVELOPMENTAL DELAYS IN PREGNANCY STUDIES: AN AI-ASSISTED TARGETED LITERATURE
Author(s)
Shahrzad Salmasi, MSc, PhD1, James M. Gwinnutt, PhD2, Julien Heidt, BS, MS3, Niamh McGuinness, PhD4, Lenon Mendes Pereira5, Emily Bratton, PhD, MSPH6, Christina Mack, MSPH, PhD7.
1IQVIA, Vancouver, BC, Canada, 2IQVIA, Reading, United Kingdom, 3IQVIA, Durham, NC, USA, 4IQVIA, Ottawa, ON, Canada, 5IQVIA, USA, 6IQVIA, Hillsborough, NC, USA, 7IQVIA, Chapel Hill, NC, USA.
1IQVIA, Vancouver, BC, Canada, 2IQVIA, Reading, United Kingdom, 3IQVIA, Durham, NC, USA, 4IQVIA, Ottawa, ON, Canada, 5IQVIA, USA, 6IQVIA, Hillsborough, NC, USA, 7IQVIA, Chapel Hill, NC, USA.
OBJECTIVES: Developmental delay (DD) is a key outcome in pregnancy studies. We aimed to summarize how DD is defined and assessed in pregnancy studies.
METHODS: We searched PubMed for prospective cohort studies published since 2020 assessing DD in liveborn infants with prenatal exposure to drugs, vaccines, or alcohol. Study screening (title/abstract and full text) and data extraction were performed using a validated agentic literature artificial intelligence platform, with human-in-the-loop to ensure accuracy.
RESULTS: Across the 30 eligible studies (median n=431), 45 unique DD assessment tools were used (infancy: 10 unique tools; toddler period: 9; preschool years: 18; school age: 11). The most frequently used tools were the Bayley Scales of Infant Development and the Ages and Stages Questionnaire (ASQ), (n=8 studies each). The number of unique DD assessment tools used per study ranged from 1 to 6 (median: 2) and was higher for studies with DD assessment >5 years of age, reflecting the increasing complexity and domain specificity of development with age. Assessment timing ranged from 3 days post-birth to 21 years. Only 6 studies assessed outcomes beyond age 5. There was considerable variability in the time points of DD assessment even among the studies with the same assessment tool and exposure. The mean number of studies using the same tool for the same age group, with overlapping assessment time was 1.2. Despite broad age applicability of many tools, longitudinal DD assessment was rare. The frequency of DD assessments using the same tool per study ranged from 1 to 8 (median: 1). Differences were observed in DD definition (e.g. cut-off point for ASQ).
CONCLUSIONS: Heterogeneity was observed in choice of assessment tool (even within the same age group), assessment timing/frequency and DD definition among studies with the same tool or exposure of interest. Greater standardization is needed to facilitate evidence synthesis.
METHODS: We searched PubMed for prospective cohort studies published since 2020 assessing DD in liveborn infants with prenatal exposure to drugs, vaccines, or alcohol. Study screening (title/abstract and full text) and data extraction were performed using a validated agentic literature artificial intelligence platform, with human-in-the-loop to ensure accuracy.
RESULTS: Across the 30 eligible studies (median n=431), 45 unique DD assessment tools were used (infancy: 10 unique tools; toddler period: 9; preschool years: 18; school age: 11). The most frequently used tools were the Bayley Scales of Infant Development and the Ages and Stages Questionnaire (ASQ), (n=8 studies each). The number of unique DD assessment tools used per study ranged from 1 to 6 (median: 2) and was higher for studies with DD assessment >5 years of age, reflecting the increasing complexity and domain specificity of development with age. Assessment timing ranged from 3 days post-birth to 21 years. Only 6 studies assessed outcomes beyond age 5. There was considerable variability in the time points of DD assessment even among the studies with the same assessment tool and exposure. The mean number of studies using the same tool for the same age group, with overlapping assessment time was 1.2. Despite broad age applicability of many tools, longitudinal DD assessment was rare. The frequency of DD assessments using the same tool per study ranged from 1 to 8 (median: 1). Differences were observed in DD definition (e.g. cut-off point for ASQ).
CONCLUSIONS: Heterogeneity was observed in choice of assessment tool (even within the same age group), assessment timing/frequency and DD definition among studies with the same tool or exposure of interest. Greater standardization is needed to facilitate evidence synthesis.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO199
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Relating Intermediate to Long-term Outcomes
Disease
Neurological Disorders