儿童炎症性肠病个体化抗性淀粉试点试验中影响保真度的因素：一项保真度研究方案
Factors contributing to fidelity in a pilot trial of individualized resistant starches for pediatric inflammatory bowel disease: a fidelity study protocol.
作者信息
Castillo Gisell, Mack David R, Lalu Manoj M, Singleton Ruth, Fergusson Dean A, Stintzi Alain, Harrison Megan, Presseau Justin
机构信息
Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, Ontario, K1H 8L6, Canada.
Children's Hospital of Eastern Ontario Inflammatory Bowel Disease Centre, Ottawa, Ontario, Canada.
出版信息
Pilot Feasibility Stud. 2021 Mar 19;7(1):75. doi: 10.1186/s40814-021-00815-1.
BACKGROUND
The consumption of resistant starches is a promising adjuvant therapy for patients with inflammatory bowel disease. Rigorous evaluation of resistant starches in this setting depends on the intervention being delivered, received, and enacted as intended, that is, with fidelity. As part of a planned pilot trial, participants will be randomized to ingest resistant starches or a placebo. They will also be asked to collect stool samples and keep symptom and dose diaries to inform trial outcomes. We aim to identify potential factors impacting fidelity to the receipt and enactment of trial intervention and data collection activities from the perspective of patients and caregivers in the trial. Identifying fidelity barriers and enablers at the pilot trial phase of a clinical intervention may help to determine optimization processes when expanding to multiple sites in future trials.
METHODS
We will conduct 15-30 semi-structured interviews with pilot trial participants (aged 8-17) and their caregivers. Trial participants will be approached for interviews approximately 6 months after the start of their trial participation. Personal projects analysis, a tool for understanding how individuals manage competing demands in their daily lives, will guide an in-depth exploration of how trial participants engage in activities related to intervention and data collection fidelity (ingesting resistant starches or placebo, collecting stool samples, keeping a symptom and dose diary) amidst the complexities of daily living.
DISCUSSION
The present study will seek to explore and demonstrate how theory-informed fidelity assessments can be conducted alongside pilot trials to inform future multisite trials. Study results will clarify what factors may affect fidelity to trial intervention and data collection activities. Results may suggest what to modify to optimize the design and conduct, and ensure the integrity, of future multisite trials. Conducting process evaluations alongside clinical trials has the potential to improve our understanding of trial participant experiences. Results will provide a better understanding of how trial participants manage to engage in necessary trial activities along with other priorities.
背景
食用抗性淀粉对炎症性肠病患者来说是一种很有前景的辅助治疗方法。在这种情况下，对抗性淀粉进行严格评估取决于干预措施是否按预期实施、接受和执行，即是否具备保真度。作为一项计划中的试点试验的一部分，参与者将被随机分配摄入抗性淀粉或安慰剂。他们还将被要求收集粪便样本，并记录症状和剂量日记，以便为试验结果提供信息。我们旨在从试验中患者和护理人员的角度，识别影响试验干预措施的接受和执行以及数据收集活动保真度的潜在因素。在临床干预的试点试验阶段识别保真度障碍和促进因素，可能有助于确定在未来试验扩展到多个地点时的优化过程。
方法
我们将对试点试验参与者（8至17岁）及其护理人员进行15至30次半结构化访谈。在试验参与者开始参与试验约6个月后，将邀请他们参加访谈。个人项目分析是一种用于理解个人如何在日常生活中应对相互竞争需求的工具，将指导深入探索试验参与者如何在日常生活的复杂性中参与与干预和数据收集保真度相关的活动（摄入抗性淀粉或安慰剂、收集粪便样本、记录症状和剂量日记）。
讨论
本研究将寻求探索和证明如何在试点试验的同时进行基于理论的保真度评估，以为未来的多地点试验提供信息。研究结果将阐明哪些因素可能影响试验干预和数据收集活动的保真度。结果可能会建议进行哪些修改以优化未来多地点试验的设计和实施，并确保其完整性。在临床试验的同时进行过程评估有可能增进我们对试验参与者体验的理解。结果将更好地理解试验参与者如何在兼顾其他优先事项的同时参与必要的试验活动。
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