Exploring the participant experience in controlled human infection model (CHIM) trials: A modified grounded theory study
Bibliographic record
Abstract
BACKGROUND: Controlled human infection model (CHIM) trials are useful tools for accelerating vaccine development through the deliberate infection of healthy volunteers in a controlled environment to study the course of disease in humans. CHIM trials may pose physical, psychological, and social harms to participants. Participants are subjected to long inpatient stays and daily sample collection, which may be uncomfortable. Very little is known about the CHIM trial participant experience and decision-making process. METHODS: We conducted a modified grounded theory study, embedded within the Canadian Center for Vaccinology (CCfV)'s Bordetella pertussis CHIM trial. Twenty six participants engaged in semi-structured interviews at four time periods throughout their year-long involvement in the CHIM trial, using a constant comparative approach of simultaneous data collection and analysis. This process continued until saturation was reached and an emerging theoretical model was constructed depicting the CHIM trial participant experience over time. RESULTS: The emergent conceptual model centered around the core category "A Trusting Partnership", depicting the evolution of the participant-researcher relationship throughout the experience. Establishing trust was critical during the decision-making phase, facilitated through transparent researcher-participant communication and consideration of past experiences and values. Supporting the trusting partnership during the inpatient isolation phase was facilitated through ongoing researcher-participant engagement and emotional support. During outpatient participation, maintaining the trusting partnership was achieved through effective communication, consistent follow-up care, and recognition of participants' contributions. Quality improvement (QI) recommendations were identified across all phases of CHIM trial participation. CONCLUSIONS: Researcher-participant trust is an integral component of the CHIM trial participant experience. QI recommendations should be taken into consideration when planning and coordinating future CHIM trials.
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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 | 0.112 | 0.094 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.010 | 0.017 |
| Scholarly communication | 0.008 | 0.008 |
| Open science | 0.004 | 0.010 |
| Research integrity | 0.003 | 0.006 |
| Insufficient payload (model declined to judge) | 0.002 | 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 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".