Patient, Family, and Center-Based Factors Associated with Attrition in Neonatal Clinical Research: A Prospective Study
Patient, Family, and Center-Based Factors Associated with Attrition in Neonatal Clinical Research: A Prospective Study
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DOI：
10.1159/000494105
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发表时间：
2019-01-01
期刊：
影响因子：
2.5
通讯作者：
Schmidt, Barbara
中科院分区：
文献类型：
--
作者：
DeMauro, Sara B.;Bellamy, Scarlett L.;Schmidt, Barbara
背景：失访或失访对纵向临床研究的完整性和有效性构成了重大威胁。在新生儿临床研究中，对自然减员的预测因子知之甚少，也没有先前的研究探讨过家庭参与婴儿研究的经历如何影响研究依从性。目的：在入组多中心早产和呼吸结局项目（PROP）观察性研究的早产儿中，确定与1年研究随访期间的损耗相关的新因素。方法：在出院时，研究协调员估计的可能性磨损。父母在出院时和1岁矫正年龄时完成了关于他们在研究中的经历的问卷调查。主要终点是在第一年完成4次PROP访谈。Logistic模型被用来评估婴儿，家庭和中心为基础的特征和损耗之间的关联。结果：在318名儿童中，283名（89%）符合主要终点。在双变量分析中，母亲受教育程度较低、家庭人口较多、公共保险和地点与自然减员相关（p < 0.05）。父母的调查反应，婴儿的特点，和网站的特点是无关的磨损。协调员对自然减员的预测与早期研究访谈的完成有关;这种影响随着时间的推移而减弱。在多变量分析中，母亲受教育程度较低和家庭人口较多是与自然减员最密切相关的因素。结论：未来的新生儿研究应评估新的策略，以减少与研究参与和强化研究目标的负担与家庭谁具有较低的教育水平，以促进参与和减少损耗偏见。(c)2019 S. Karger AG，巴塞尔
Background: Attrition, or loss to follow-up, presents a significant threat to the integrity and validity of longitudinal clinical research. Little is known about predictors of attrition in neonatal clinical research, and no prior studies have examined how families' experiences participating in research with their infants influences study compliance. Objective: To identify novel factors that were associated with attrition over 1 year of study follow-up among preterm infants enrolled in the multicenter Prematurity and Respiratory Outcomes Program (PROP) observational study. Methods: At discharge, research coordinators estimated the likelihood of attrition. The parents completed questionnaires about their experience with the study at discharge and at 1 year corrected age. The primary endpoint was completion of 4 PROP interviews during the first year. Logistic models were used to evaluate the associations between infant, family, and center-based characteristics and attrition. Results: Among 318 children, 283 (89%) met the primary endpoint. In bivariate analyses, lower maternal education, more people in the household, public insurance, and site were associated with attrition (p < 0.05). Parent survey responses, infant characteristics, and site characteristics were unrelated to attrition. Coordinators' prediction of attrition was associated with completion of early study interviews; this effect waned over time. In multivariable analyses, lower maternal education and more people in the household were the factors most strongly associated with attrition. Conclusion: Future neonatal research should evaluate novel strategies to decrease the burden associated with study participation and reinforcement of study goals with families who have lower educational levels to facilitate participation and decrease attrition bias. (c) 2019 S. Karger AG, Basel