Behavioural outcomes following in utero exposure to anti-seizure medication: protocol for a systematic review
Bibliographic record
Abstract
Abstract Introduction Prenatal exposure to certain antiseizure medications (ASMs) has been associated with increased risk of adverse neurodevelopmental outcomes in offspring. While the cognitive and intellectual outcomes of ASM-exposed offspring have been well-described, the long-term behavioural and functional sequalae in these children have received less attention. This systematic review aims to synthesise evidence on the relationship between prenatal ASM exposure and postnatal adverse neurodevelopmental outcomes, focusing on non-cognitive and intellectual domains of neurodevelopment including reduced social, emotional, behavioural, and adaptive functioning, as well as the frequency of neurodevelopmental and psychiatric disorders. This will have meaningful clinical implications for how we counsel women taking ASMs in pregnancy. Methods and analysis Studies reporting predefined neurodevelopmental outcomes will be identified by electronic searches of MEDLINE, PsychINFO, EMBASE, as well as additional manual and grey literature searches. Eligible studies will report outcomes of offspring exposed to ASMs in utero either prospectively or retrospectively from 1990 to present, with screening performed in duplicate. We will use the Newcastle-Ottawa Scale to conduct methodological quality assessments of included observational studies. A narrative synthesis will be used to report on the review findings. Meta-analysis is not anticipated. Ethics and dissemination Ethics clearance is not required for the current study. The systematic review will be prepared as a journal article and published in a peer-reviewed journal upon completion. PROSPERO registration number PROSPERO CRD42021281919 Article Summary Strengths and limitations of this study This protocol was developed and written according to the PRISMA-P guidelines Publication of this protocol ensures transparency and reproducibility of the methods of the systematic review, as well as reduces the likelihood of review duplication Restricting publications to English only may introduce bias whereby some relevant data is not included Meta-analysis is not likely to be possible due to heterogeneity in study methodology, reducing the strength of the conclusions that can be drawn Targeting psychosocial and behavioural outcomes allows for a more nuanced understanding of the long-term clinical consequences of prenatal ASM-exposure
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.073 | 0.077 |
| Meta-epidemiology (narrow) | 0.006 | 0.005 |
| Meta-epidemiology (broad) | 0.019 | 0.017 |
| Bibliometrics | 0.012 | 0.012 |
| Science and technology studies | 0.004 | 0.005 |
| Scholarly communication | 0.008 | 0.008 |
| Open science | 0.005 | 0.005 |
| Research integrity | 0.006 | 0.006 |
| Insufficient payload (model declined to judge) | 0.075 | 0.009 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".