Childrenʼs decisional capacity in the assent process for a complex inflammatory bowel disease research protocol
Bibliographic record
Abstract
To assess children's ability to provide meaningful assent for a research protocol investigating the epidemiology, serologic characteristics and possible genetic markers in patients with IBD and their biologic parents. This study involved obtaining assent and consent form the children and their parents, respectively. IRB approval for all forms used in this study was obtained and the same forms are currently in use in a multi-center study involving 8 large pediatric centers in the USA and Canada. During the assent procedure for an IBD study, children's understanding of ten key study elements was assessed using a standard 0-2 scale (2, complete understanding; 1, partial understanding; 0, no understanding or incorrect understanding). Total understanding score was calculated as the average score of the ten questions. Parental understanding was also assessed. Children were subdivided into three categories based on age, and scores were compared to parental scores using Fisher exact test. A minimum capacity score was set at the mean parental score minus two standard deviations. Internal validity was assessed using Chronbach's alpha coefficient calculation. 25 parents, 7 children aged 15-18 years, 13 children aged 11-14 years, and 5 children aged 7-10 years were enrolled. Parental mean (SD) was 1.83 0.16); therefore a minimum capacity score was calculated at 1.51. Children aged 15-18 scored 1.73 (0.31); compared to parental cohort p=0.43; 5 (71%) scored above 1.51. Children aged 11-14 scored 1.41 (0.34); compared to parental cohort p<0.001; 9 (69%) scored above 1.51. Children aged 7-10 scored 0.98 (0.57); compared to parental cohort p=0.03; 1 (20%) scored above 1.51. Chronbach's alpha calculated on responses of all children was 0.90. Age was associated with ability to understand research protocols, however there was considerable variability. While some older children scored well below adults, some younger children scored at a level that would qualify their decisionmaking as competent. As such, investigators need to develop a more sophisticated theory of assent that recognizes the wide variability in cognitive abilities of children at different ages.
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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 | 0.157 | 0.168 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.004 | 0.002 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.005 |
| Research integrity | 0.003 | 0.007 |
| Insufficient payload (model declined to judge) | 0.027 | 0.008 |
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".