Xiao Lan, Lv Nan, Rosas Lisa G, Karve Shweta, Luna Veronica, Jameiro Elizabeth, Wittels Nancy, Ma Jun
Palo Alto Medical Foundation Research Institute, Palo Alto, CA 94301, USA.
Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, USA and.
Health Educ Res. 2016 Dec;31(6):729-737. doi: 10.1093/her/cyw048. Epub 2016 Oct 10.
High retention and treatment adherence are essential to ensure the quality of evidence from clinical trials. Strategies for improving these have been explored but actual rates in lifestyle intervention trials indicate challenges. This study examined the use of a motivational interviewing-informed strategy during interactive group orientations prior to obtaining informed consent, collecting baseline data and randomization in a healthy dietary pattern intervention trial for asthma control in adults. The themes generated from small group discussions and echoed in large group discussions during the orientation sessions helped potential participants better understand the scientific rationale of the research design and procedures and the practical implications for them to participate in the study. Potential participants reported significantly lower confidence of completing the study after the group orientation. This suggests that the group orientations helped potential participants identify challenges to completing the study, have more realistic expectations about participation and be prepared if enrolled. Both retention (92% of 90 participants at 6 months) and intervention attendance (99% of 46 intervention participants attended 80% of 11 weekly group/individual sessions) were high, suggesting the motivation interviewing-informed group orientation strategy may help improve retention and adherence in clinical trials.
高保留率和治疗依从性对于确保临床试验证据的质量至关重要。人们已经探索了改善这些情况的策略，但生活方式干预试验的实际比率表明存在挑战。本研究在一项针对成人哮喘控制的健康饮食模式干预试验中，在获得知情同意、收集基线数据和随机分组之前的互动小组介绍期间，考察了采用基于动机性访谈的策略。在介绍环节中，小组讨论产生并在大组讨论中得到呼应的主题，帮助潜在参与者更好地理解了研究设计和程序的科学原理以及他们参与研究的实际影响。潜在参与者在小组介绍后报告完成研究的信心显著降低。这表明小组介绍帮助潜在参与者识别了完成研究的挑战，对参与有更现实的期望，并在入选后做好准备。保留率（90名参与者中的92%在6个月时）和干预出勤率（46名干预参与者中的99%参加了11次每周小组/个人会议中的80%）都很高，这表明基于动机性访谈的小组介绍策略可能有助于提高临床试验中的保留率和依从性。
