Taylor Regina G, Hounchell Melanie, Ho Mona, Grupp-Phelan Jacqueline
From the Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.
Pediatr Emerg Care. 2015 May;31(5):348-52. doi: 10.1097/PEC.0000000000000368.
To examine the association of demographic and study characteristics in eligible subjects who agree to participate compared with those who did not participate in clinical research studies in a pediatric emergency department (PED).
Information for all families approached for participation in PED-based clinical research studies during a 6-year period was recorded in an electronic database. This included demographic factors, decision to participate, primary reason for not participating, and study characteristics. Forty studies were included in this analysis. Differences in participation rate among demographic and study characteristics were examined. Multivariable logistic regression was used to predict the likelihood of participation.
Participation rates were similar with respect to sex (50.1% in male vs 49.9% in female), whereas families with younger children were more likely to participate (mean age, 8.5 years vs 10.2 years among nonparticipants P < 0.001). White patients were more likely to participate than African American patients (54.7% vs 45.6% in African Americans, P < 0.001). The presence of compensation, brief time requirement, and older children was negatively associated with participation for moderate to very invasive studies. However, for noninvasive and mildly invasive studies, the presence of compensation and the time required were not associated with participation.
Study characteristics including invasiveness, time required of patients, and whether compensation is offered, along with demographic factors, influence participation in clinical studies conducted in the PED. When designing a research study in the PED, these, along with novel approaches to including all races and ethnicities in PED research, should be considered.
比较同意参与和未参与儿科急诊科（PED）临床研究的符合条件受试者的人口统计学和研究特征之间的关联。
在一个电子数据库中记录了6年期间所有被邀请参与基于PED的临床研究的家庭的信息。这包括人口统计学因素、参与决定、不参与的主要原因以及研究特征。本分析纳入了40项研究。研究了人口统计学和研究特征之间参与率的差异。使用多变量逻辑回归来预测参与的可能性。
性别方面的参与率相似（男性为50.1%，女性为49.9%），而有年幼儿童的家庭更有可能参与（平均年龄，参与者为8.5岁，非参与者为10.2岁，P<0.001）。白人患者比非裔美国患者更有可能参与（非裔美国人为45.6%，白人为54.7%，P<0.001）。对于中度至高度侵入性研究，提供补偿、时间要求短以及儿童年龄较大与参与呈负相关。然而，对于非侵入性和轻度侵入性研究，提供补偿和所需时间与参与无关。
包括侵入性、患者所需时间以及是否提供补偿在内的研究特征，连同人口统计学因素，会影响在PED中进行的临床研究的参与情况。在设计PED中的研究时，应考虑这些因素，以及在PED研究中纳入所有种族和族裔的新方法。
