Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Department of Neurology, Georgetown University, Washington, DC, USA.
Clin Trials. 2021 Apr;18(2):237-244. doi: 10.1177/1740774520982315. Epub 2021 Jan 10.
Missing data are a notable problem in Alzheimer's disease clinical trials. One cause of missing data is participant dropout. The Research Attitudes Questionnaire is a 7-item instrument that measures an individual's attitudes toward biomedical research, with higher scores indicating more favorable attitudes. The objective of this study was to describe the performance of the Research Attitudes Questionnaire over time and to examine whether Research Attitudes Questionnaire scores predict study dropout and other participant behaviors that affect trial integrity.
The Research Attitudes Questionnaire was collected at baseline and weeks 26 and 52 from each member of 119 participant/study partner dyads enrolled in a Phase 2, randomized, double-blind, placebo-controlled mild-to-moderate Alzheimer's disease clinical trial. Within-subject longitudinal analyses examined change in Research Attitudes Questionnaire scores over time in each population. Logistic regression analyses that controlled for trial arm and clustering in trial sites were used to assess whether baseline Research Attitudes Questionnaire scores predicted trial completion, study medication compliance, and enrollment in optional substudies.
Participants and study partners endorsed statistically similar ratings on the Research Attitudes Questionnaire that were stable over time. Participants with baseline Research Attitudes Questionnaire scores above 28.5 were 4.7 (95% confidence interval = 1.01 to 21.95) times as likely to complete the trial compared to those with lower scores. Applying the same cutoff, baseline study partner Research Attitudes Questionnaire scores were similarly able to predict study completion (odds ratio = 4.2, 95% confidence interval = 1.71 to 10.32). Using a score cutoff of 27.5, higher participant Research Attitudes Questionnaire scores predicted study medication compliance (odds ratio = 5.85, 95% confidence interval = 1.34 to 25.54). No relationship was observed between Research Attitudes Questionnaire score and participation in optional substudies.
This brief instrument that measures research attitudes may identify participants at risk for behaviors that cause missing data.
在阿尔茨海默病临床试验中，数据缺失是一个显著的问题。数据缺失的一个原因是参与者脱落。研究态度问卷是一种由 7 个项目组成的工具，用于衡量个体对生物医学研究的态度，得分越高表示态度越积极。本研究的目的是描述研究态度问卷随时间的变化，并探讨研究态度问卷得分是否能预测研究脱落以及其他影响试验完整性的参与者行为。
从参加 2 期、随机、双盲、安慰剂对照轻度至中度阿尔茨海默病临床试验的 119 名参与者/研究伙伴对中，每个成员在基线和第 26 周和第 52 周收集研究态度问卷。对每个群体的研究态度问卷评分随时间的纵向变化进行了个体内分析。采用控制试验臂和试验点聚类的逻辑回归分析，评估基线研究态度问卷评分是否预测试验完成、研究药物依从性以及参加可选子研究。
参与者和研究伙伴对研究态度问卷的评价在统计学上相似，且随时间稳定。基线研究态度问卷评分高于 28.5 的参与者完成试验的可能性是评分较低者的 4.7 倍（95%置信区间=1.01 至 21.95）。使用相同的截止值，基线研究伙伴研究态度问卷评分也能很好地预测试验完成（比值比=4.2，95%置信区间=1.71 至 10.32）。使用 27.5 的评分截止值，较高的参与者研究态度问卷评分预测研究药物依从性（比值比=5.85，95%置信区间=1.34 至 25.54）。研究态度问卷评分与参加可选子研究之间没有关系。
这个简短的测量研究态度的工具可能可以识别出有行为导致数据缺失风险的参与者。
