QI Recommendations.

BackgroundControlled 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.MethodsWe 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.ResultsThe 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.ConclusionsResearcher-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.背景 受控人体感染模型（CHIM）试验是通过在受控环境中故意感染健康志愿者，以研究人类疾病进程，从而加速疫苗开发的有效工具。CHIM试验可能会对参与者造成生理、心理及社会层面的伤害。参与者需经历长期住院与每日样本采集，这可能带来不适体验。目前学界对CHIM试验参与者的体验与决策过程的了解仍十分有限。 方法 本研究依托加拿大疫苗学中心（CCfV）的百日咳博德特菌CHIM试验，开展了一项改良型扎根理论研究。26名参与者在其参与该为期一年的CHIM试验的全程中，于四个时间节点接受半结构化访谈；研究采用持续比较法同步开展数据收集与分析，直至达到理论饱和，并构建出一个新兴理论模型，用以刻画参与者在CHIM试验全程中的动态体验。 结果 该新兴概念模型以核心范畴"信任伙伴关系"为核心，描绘了试验全程中参与者与研究者之间关系的演变历程。在决策阶段，建立信任至关重要，这一过程通过研究者与参与者间的透明沟通，以及对过往经历与个人价值观的考量得以实现。在住院隔离阶段，研究者与参与者的持续互动及情感支持，为维系信任伙伴关系提供了助力。在门诊参与阶段，则通过高效沟通、持续的后续护理，以及对参与者贡献的认可，维持了信任伙伴关系。研究团队在CHIM试验参与的全阶段均提出了质量改进（QI）建议。 结论 参与者与研究者之间的信任是CHIM试验参与者体验中不可或缺的组成部分。在规划与协调未来的CHIM试验时，应充分考量这些质量改进建议。