The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.
Department of Pediatrics, College of Medicine, The Ohio State University, Columbus, OH, USA.
Clin Trials. 2020 Apr;17(2):223-230. doi: 10.1177/1740774519893307. Epub 2020 Jan 27.
BACKGROUND/AIMS: The is a brief questionnaire recommended by the National Research Council to address dropout concerns and improve prediction of missing data in clinical trials, although implementation has been very limited. As a formative study in pediatric research, the relationship between caregiver intentions and study compliance was investigated in a 180-day trial of dietary supplementation of preterm toddlers. Treatment effect estimation in the context of missing data was also explored.
Study compliance (i.e. study completion, supplement adherence, and diary completion) was tracked over three study visits. Baseline questionnaires asked caregivers about intentions concerning study completion via the , screened for mental health symptoms (depression, trait anxiety), and captured family demographics. Simple and multiple logistic regression models were built to examine associations between caregiver intent and compliance outcomes. The was also employed as an auxiliary variable to account for missing data within mixed models estimating the treatment effect on the primary outcomes.
Of the 316 caregiver-child dyads included, 95% of caregivers with low intentions had a child complete the study, but only 87% of caregivers with high intentions had a child complete the study. Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20). No effect measure modification by caregiver mental health, child sex, or annual income was detected. Income was the only significant predictor of study non-completion; the lowest income group was almost four times more likely to be study non-completers compared with the highest income group, even after adjustment for child sex and caregiver mental health (adjusted odds ratio = 3.59, 95% confidence interval: 1.38, 9.31). When using as an auxiliary variable, similar results were obtained when compared with the original treatment effect estimates on the primary outcomes.
Contrary to prior adult studies, there is no clear relationship between caregiver intentions and study compliance. Findings elucidate the complexities of caregiver-child interactions during pediatric trial participation.
背景/目的：《研究人员意向量表》是由美国国家研究委员会推荐的一份简短问卷，用于解决脱落问题并提高临床试验中缺失数据的预测能力，尽管实施范围非常有限。作为儿科研究中的一项形成性研究，我们调查了在一项针对早产儿的饮食补充 180 天试验中，照顾者的意图与研究依从性之间的关系。我们还探讨了在缺失数据情况下的处理效果估计。
在三次研究访视中跟踪研究依从性（即研究完成、补充剂依从性和日记完成）。基线问卷通过《研究人员意向量表》询问照顾者对完成研究的意图，筛查心理健康症状（抑郁、特质焦虑），并记录家庭人口统计学资料。采用简单和多元逻辑回归模型来检验照顾者意图与依从性结果之间的关联。在估计主要结局处理效果的混合模型中，我们还将《研究人员意向量表》用作辅助变量来处理缺失数据。
在纳入的 316 对照顾者-儿童中，95%低意向完成研究的照顾者的孩子完成了研究，但只有 87%高意向完成研究的照顾者的孩子完成了研究。低意向完成研究与研究不完成的可能性降低 60%以上有关，但置信区间包含零值（优势比：0.36；95%置信区间：0.11，1.20）。未检测到照顾者心理健康、儿童性别或年收入对研究不完成的效应修正。收入是研究不完成的唯一显著预测因素；与收入最高的组相比，收入最低的组几乎是研究不完成者的四倍，即使在调整了儿童性别和照顾者心理健康后也是如此（调整后的优势比=3.59；95%置信区间：1.38，9.31）。当使用《研究人员意向量表》作为辅助变量时，与主要结局的原始处理效果估计相比，得到了类似的结果。
与先前的成人研究结果相反，照顾者的意图与研究依从性之间没有明确的关系。研究结果阐明了儿科试验参与过程中照顾者-儿童互动的复杂性。
