A study of consent for participation in a non-therapeutic study in the pediatric intensive care population
Bibliographic record
Abstract
OBJECTIVE: To document the legal guardian-related barriers to consent procurement, and their stated reasons for non-participation in a paediatric critical care research study. STUDY DESIGN: A multicentre, prospective, cohort study. PARTICIPANTS: Legal guardians of children who participated in a multicentre study on adrenal insufficiency in paediatric critical illness. Data were collected on all consent encounters in the main study. METHODS: Screening data, reasons for consent not being obtained, paediatric risk of mortality (illness severity) scores and age were collected on all 1707 patients eligible for participation in the Adrenal Insufficiency Study. RESULTS: The main barriers to approaching legal guardians for consent were lack of availability of the legal guardians (321/1707) and language barriers (84/1707). Legal guardians of 917 patients were approached with an overall consent rate of 42% (range 14-56% across the seven sites). 81% of the 528 legal guardians who declined consent provided an unsolicited reason for refusal. The three most commonly stated reasons were: being overwhelmed (117/429), not wanting anything else done to their child (63/429) and not wanting an additional medication (53/429). In addition, 14.2% cited research-related concerns as the reason for their non-participation. CONCLUSIONS: Barriers to consent procurement in a non-therapeutic paediatric critical care study appear to occur at many levels with lack of availability of legal guardians, and legal guardians feeling overwhelmed, being the most commonly recorded reasons. Further research into the impact of these findings on the validity and generalisability of the results of such studies is necessary prior to the development and study of future consent models.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.026 | 0.201 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.007 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".