Outcomes of informed consent among parents of children in cancer clinical trials
Bibliographic record
Abstract
BACKGROUND: Clinical trials are central to pediatric oncology, yet the process and outcomes of informed consent are poorly understood. We evaluated correlates of understanding among parents of pediatric trial participants, and explored differences in the process and outcome of informed consent between parents and a comparison group of adult participants. PROCEDURE: We administered the Quality of Informed Consent (QuIC) to parents of children who were newly enrolled onto a cancer trial. We identified independent correlates of knowledge among parents, and compared parents' knowledge to that of a contemporaneous group of adult participants, using multiple linear regression models. RESULTS: Parents (n = 47) were less likely than adult participants (n = 204) to report having enough time to learn about the trial (64% vs. 87%, P = 0.001) or sufficient opportunity for questions (79% vs. 93%, P = 0.01), and reported lower overall satisfaction with the consent process (71% vs. 90%, P = 0.002). The mean parental knowledge score was 73.6 (95% confidence interval [CI] 69.5-77.8, theoretical maximum 100). Knowledge did not differ between parents and adult trial participants. In multivariate analysis, two predictors were significantly associated with higher parent knowledge scores: consent sought by the study's principal investigator (increment 13.6, CI 2.7-24.6) and physician-reported poor prognosis (increment 13.8, 95% CI 5.4-22.1). CONCLUSIONS: Although we observed no differences in knowledge between parents of pediatric cancer trial participants and their adult counterparts, parents report more problems with the informed consent process for their trials. The increased prevalence of problems is likely due to clinical and contextual differences between pediatric and adult trials.
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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 | 0.009 | 0.053 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".