113 Simplifying consent - Use of the novel integrated consent model in paediatric clinical research
Bibliographic record
Abstract
Abstract Primary Subject area Hospital Paediatrics Background Obtaining informed consent from patients to participate in clinical research has traditionally been a cumbersome process, often requiring lengthy documentation and the involvement of trained research staff. Moreover, this process can be a burden to the patient/family. As a result, progress in paediatric research and enabling continual improvement in care has been slow. In the last decade, research ethicists have proposed a new “integrated consent model” (ICM) for obtaining informed consent for pragmatic clinical trials that compare standard-of-care interventions, where there is clinical equipoise. In most cases of ICM, only a brief discussion with verbal consent is required, along with a handout on study purpose, risks, benefits, and procedures. This allows for a more condensed consent process, which maximizes clarity and minimizes information overload. ICM also allows the patient/family to maintain prospective autonomy and decision-making, as compared with deferred or waived consent. The ICM model allows staff in the circle of care to obtain consent, which minimizes the stress of meeting an additional person. To our knowledge, ICM has not yet been used in the paediatric population. Objectives The objective of this abstract is to report on the utility of ICM in a non-randomized clinical trial carried out in the inpatient setting of a tertiary children’s hospital. Design/Methods We compared two widely accepted standards of care for maintaining peripheral intravenous catheter patency in a cohort of children, namely continuous infusion (“to keep the vein open” or TKVO) versus saline lock (SL). The ICM process was reviewed and approved by REB. Nurses in the circle of care received a study package that included an REB approved “consent script” to be read to the patient/family, a single page information sheet, and instructions on documenting the obtained verbal consent in the patient’s chart (Graphic 1). Results With ICM, 79% of participants were recruited into the trial by a nurse. Patient recruitment was completed 4 months ahead of the predicted schedule (Figure 1). Nursing, research, and medical staff were satisfied with ICM and found it easy to administer. ICM occurred smoothly and quickly for patients/families, with no interference with their medical care and practically no disruption to their daily schedule. Conclusion ICM is a practical alternative to laborious traditional consent models, is associated with higher patient recruitment rates, and is less burdensome for the patient/family. Paediatricians should be aware of the utility of this novel consent model.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.353 | 0.431 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.001 | 0.006 |
| Scholarly communication | 0.006 | 0.007 |
| Open science | 0.003 | 0.007 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.011 | 0.002 |
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".