BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSION This brief instrument that measures research attitudes may identify participants at risk for behaviors that cause missing data.

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研究态度问卷分数预测阿尔茨海默病临床试验退出

背景缺失数据是阿尔茨海默病临床试验中的一个显着问题。丢失数据的原因之一是参与者退出。研究态度问卷是一个包含 7 项的工具，用于衡量个人对生物医学研究的态度，分数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推移的表现，并检查研究态度问卷分数是否预测研究辍学和其他影响试验完整性的参与者行为。方法 研究态度问卷是在基线、第 26 周和第 52 周从 119 名参与者/研究伙伴二人组的每个成员中收集的，这些成员参加了一项 2 期、随机、双盲、安慰剂对照的轻度至中度阿尔茨海默病临床试验。受试者内纵向分析检查了每个人群中研究态度问卷分数随时间的变化。控制试验组和试验地点聚类的逻辑回归分析用于评估基线研究态度问卷分数是否预测试验完成、研究药物依从性和可选子研究的登记。结果 参与者和研究合作伙伴对研究态度问卷上的评分在统计上相似，而且随着时间的推移保持稳定。基线研究态度问卷得分高于 28.5 的参与者完成试验的可能性是得分较低者的 4.7 倍（95% 置信区间 = 1.01 至 21.95）。应用相同的截止值，基线研究合作伙伴研究态度问卷分数同样能够预测研究完成情况（优势比 = 4.2，95% 置信区间 = 1.71 至 10.32）。使用 27.5 的分数截止，较高的参与者研究态度问卷分数预测研究药物依从性（优势比 = 5.85，95% 置信区间 = 1.34 至 25.54）。研究态度问卷得分与参与可选子研究之间没有观察到任何关系。结论 这个衡量研究态度的简短工具可以识别有导致数据缺失行为风险的参与者。95% 置信区间 = 1.34 到 25.54）。研究态度问卷得分与参与可选子研究之间没有观察到任何关系。结论 这个衡量研究态度的简短工具可以识别有导致数据缺失行为风险的参与者。95% 置信区间 = 1.34 到 25.54）。研究态度问卷得分与参与可选子研究之间没有观察到任何关系。结论 这个衡量研究态度的简短工具可以识别有导致数据缺失行为风险的参与者。