Section of Pediatric Gastroenterology, Department of Pediatrics and Child Health, University of Manitoba, Winnipeg, Manitoba, Canada.
PLoS One. 2018 Nov 8;13(11):e0206965. doi: 10.1371/journal.pone.0206965. eCollection 2018.
The aim of this study was to determine the proportion of patients' caregivers willing to participate in clinical research and examine the possible barriers against recruitment to clinical research in children with inflammatory bowel disease.
In a cross-sectional study, caregivers and children with inflammatory bowel disease were surveyed via a questionnaire that addressed parents' willingness to participate in clinical studies and factors influencing their willingness to participate.
A total of 118 caregivers to children with inflammatory bowel disease [median age 14.5, IQR: 12.0-15.8 years, 60 boys, 61 (52%) with Crohn's disease] who were followed for a median duration of 1.73 years (IQR 0.4-3.6 years) completed the survey. One hundred and four (88.2%) caregivers answered "Definitely" or "Probably" to participate in clinical research while 14 (11.8%) were "Neutral" or "Probably" unwilling to participate (P<0.001). Patients were less likely to participate in clinical research if they had longer disease duration (P = 0.019), or were in clinical relapse (P = 0.03). Parents' education, income, age of children at diagnosis, money incentive, disease relapse and medications at the time of the survey did not have any significant effect on willingness to participate.
The majority of children with inflammatory bowel disease and their caregivers are willing to participate in clinical research.
本研究旨在确定患者照顾者参与临床研究的比例，并探讨招募儿童炎症性肠病患者参与临床研究的可能障碍。
采用横断面研究，通过问卷调查了炎症性肠病患儿的照顾者和儿童，该问卷涉及父母参与临床研究的意愿以及影响其参与意愿的因素。
共有 118 名炎症性肠病患儿的照顾者（中位年龄 14.5 岁，IQR：12.0-15.8 岁，60 名男孩，61 名（52%）患有克罗恩病）完成了调查。他们的中位随访时间为 1.73 年（IQR 0.4-3.6 年）。104 名（88.2%）照顾者回答“肯定”或“可能”参与临床研究，而 14 名（11.8%）则表示“中立”或“可能”不愿意参与（P<0.001）。如果患儿疾病持续时间较长（P = 0.019）或处于临床复发期（P = 0.03），则患儿参与临床研究的可能性较低。父母的教育程度、收入、孩子诊断时的年龄、金钱激励、疾病复发和调查时的药物使用对参与意愿没有任何显著影响。
大多数炎症性肠病患儿及其照顾者愿意参与临床研究。
